Environmental Strategies to Prevent the Non-Medical Use of Prescription Drugs

Environmental Strategies to Prevent the Non-Medical Use of Prescription Drugs
Pills on presription pad
Nancy Admin Thu, 10/04/2018 - 01:54 PM EDT

Environmental Prevention Strategies (EPS) are population-based interventions that change the context in which individuals make decisions.1 EPS are important because they have the potential to alter the environment in such a way as to compel large numbers of individuals to make healthy choices. This potential for widespread change is especially appealing to substance abuse prevention leaders and practitioners working at the state and local levels whose constituents are especially concerned about increasing rates of non-medical use of prescription drugs (NMUPD) and NMUPD overdose.

There are numerous EPS designed to reduce prescription drug misuse. However, many involve prevention approaches unfamiliar to substance abuse prevention practitioners; and few have been evaluated using rigorous research methods. Still, federal agencies have recommended several environmental strategies to prevent NMUPD based on sound logic or theory as well as preliminary evidence of effectiveness.

This guide includes information gathered from existing research and practice literature on environmental strategies that aim to reduce NMUPD. For each strategy, the guide includes information on: the populations for which the original strategy was designed, evaluation outcomes that provide evidence of effectiveness, and additional resources (e.g., links to additional guidelines) for readers.

Environmental strategies designed to reduce NMUPD and/or its consequences are organized into seven main categories:

  1. Raising awareness through education (Education)
  2. Tracking and monitoring the prescribing and dispensing of prescription drugs (Tracking and Monitoring)
  3. Enacting laws, regulations and policies that reduce access to commonly abused pharmaceuticals (Retail Access)
  4. Providing ways for consumers to safely and legally return unused drugs (Proper Medication Disposal)
  5. Enforcing new and existing policies, laws, and regulations (Enforcement)
  6. Reducing overdose through harm reduction approaches (Harm Reduction)
  7. Modifying multiple aspects of the social and physical environment (Multi-component)

The overall purpose of this guide is to help substance abuse prevention leaders and practitioners working at the state and local levels understand the breadth of environmental strategies that have the potential to prevent NMUPD. In addition, practitioners can use the guide to assist in selecting strategies that fit their strategic plan as well as are feasible to implement given resources, readiness, and funding restrictions. The detail provided on each strategy also can help states track activities associated with implementation for evaluation purposes.

1 See, for example, Freiden, T. R. (2010). A framework for public health action: The health impact pyramid. American Journal of Public Health, 100(4), 590-595; McLeroy, K. R., Bibeau, D., Steckler, A. and Glanz, K. (1988). An ecological perspective for health promotion programs. Health Education Quarterly, 15(4), 351-378; and Treno, A., & Lee, J. (2002). Approaching alcohol problems through an environmental lens. Alcohol Research & Health, 26(1), 35-40.

Organization

Organization Nancy Admin Thu, 10/04/2018 - 02:59 PM EDT

This guide is organized according to seven types of environmental change strategies identified in our review of the literature: education, tracking and monitoring, retail access, proper medication disposal, enforcement, harm reduction, and multicomponent strategies. For each strategy, we provide a record that contains the following information:

  • The strategy name. This is a general strategy name (e.g., social-marketing-campaigns) rather than the name of a specific program (e.g., Use Only As Directed). For multi-component strategies, however, we do include specific program names.
  • A brief one- or two-sentence description of the strategy to provide an overview.
  • The strategy objective describes the mechanism by which the strategy is thought to reduce or prevent substance abuse outcomes and their related consequences (e.g., to reduce the supply of prescription drugs available for diversion, misuse, or abuse).
  • Detailed information on the typical elements needed for implementation (in chronological order).
  • Population groups for which the strategy was designed and, if applicable, with which the strategy has been implemented and evaluated.
  • Evaluation outcomes related to reduction or prevention of the strategy.
  • Detailed guidelines for implementation that are available from external sources (e.g., print- and web-based implementation tutorials, guidebooks or manuals).
  • Whether the program has been acknowledged by national agencies or organizations and the names of those entities.
  • References are the sources of information from which the record was derived.

How Did We Get Here?

How Did We Get Here? Nancy Admin Thu, 10/04/2018 - 03:05 PM EDT

To identify the strategies included in this tool, we reviewed reports available online that outline specific nonmedical use of prescription drug prevention strategies including:

Second, we conducted a thorough search of the academic literature published between 2005 and 2015. We did this to identify additional systems change strategies not featured in the reports listed above.

Searches were conducted in health and psychological databases such as the Child Development & Adolescent Studies, ERIC, PYSCHARTICLES, Psychology and Behavioral Sciences Collection, PSYCHINFO, SOCINDEX, Academic Search Complete, Education Research Complete, MEDLINE, Health Policy Reference Center, and Google Scholar databases.

Search terms included "prescription drug," "opioid," "opiates," "sedatives," "tranquilizers," and "simulants," in any combination with: "intervention," "program," "regulation," "law," "policy," "enforcement," "campaign," or "strategy." If any search yielded over 100 studies, additional terms were added to narrow down the results, including "effective" and "evaluation."

Overview: Using This Tool

Overview: Using This Tool Nancy Admin Thu, 10/04/2018 - 03:14 PM EDT

There are a number of ways prevention practitioners can use this tool. Practitioners can:

  • Browse the individual strategy records by domain of interest (e.g., tracking and monitoring or harm reduction) to see which have produced outcomes and target population groups that parallel prevention priorities in their states or communities. For example, which strategies are associated with changes in prescriber behavior, prescription drug misuse, or opioid overdose rates?
  • Check out the objectives (mechanisms of change) for different strategy records to see which strategies address prioritized risk (or protective) factors. For example, if a state is addressing opioid consumption and has prioritized the risk factor “availability” or “access”, which strategies focus on limiting availability of or access to prescription drugs that can be misused or diverted for nonmedical purposes?
  • Review records to identify the critical elements required to understand a given environmental change strategy and its consequences. Click on the links provided in the guidelines for more detailed information.
  • Determine, when reviewing critical elements, whether their states or communities have the resources and abilities necessary for the select strategy, based on their capacity assessment. Practitioners should also identify those areas where they need to build capacity or, if necessary, adapt selected strategies to better fit local circumstances.
  • Find those strategies or programs their states and communities are already using and identify the core elements they hope to track when conducting their process evaluation. This guide can also help practitioners design process evaluation tools.
  • Review references for strategies of interest to determine how others have conducted process and outcome evaluations of specific environmental strategies.

Please note: This tool does not identify or categorize programs as effective or ineffective, nor does it rate strategies based on their strength of evidence. For this reason, we recommend that practitioners use this tool in conjunction with other documents, registries, systems, or research studies that provide information on the evidence of strategy effectiveness, such as those listed in the How Did We Get Here? section. These registries can help practitioners identify strategies that best address substance abuse prevention needs to be identified through careful epidemiological assessment.

  • Persuade members of the public to contact their elected representatives to urge support of, or opposition to, proposed or pending legislation or appropriations or any regulation, administrative action, or order issued by the executive branch of any Federal, state or local government.
  • Attempt to influence Federal, state, or local legislative or executive branches negotiations or actions, including communications to a legislator or executive official that refer to and reflect a view on a specific measure (legislative or executive).

The Department of Health and Human Services (HHS) fully supports federal restrictions on lobbying using federal funds by HHS grant recipients. In general, recipients of federal funds are not allowed to use said federal funding to lobby federal, state, or local officials or their staff to receive additional funding or influence legislation. As a general matter, these lobbying restrictions preclude recipients from: Spending federal funds to influence an officer or employee of any agency or Congressional member/staff regarding federal awards; using grants funds provided to non-profit organizations or institutions of higher education to influence an election, contribute to a partisan organization, or influence enactment or modification of any pending federal or state legislation; or expending federal funds to influence federal, state, or local officials or legislation.

Appropriations Acts for Fiscal Years 2012, 2013, 2014, and 2015, expand anti-lobbying restrictions and provide:

No part of any appropriation contained in this Act or transferred pursuant to section 4002 of Public Law 111-148 shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any State or local legislature itself, or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any State or local government, except in presentation to the executive branch of any State or local government itself.

No part of any appropriation contained I this Act or transferred pursuant to section 4002 of Public Law 111-148 shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or executive order proposed or pending before the Congress or any State government, State legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a State, local or tribal government in policymaking and administrative processes within the executive branch of that government.

The prohibitions in subsections [above] shall include any activity to advocate or promote any proposed, pending or future Federal, State, or local tax increase, or any proposed, pending, or future requirement or restriction on any legal consumer product, including its sale or marketing, including but not limited to the advocacy or promotion of gun control.

Additional information on Federal Restrictions on Lobbying for HHS Financial Assistance Recipients can be found here: https://www.hhs.gov/grants/grants/grants-policies-regulations/lobbying-restrictions.html#xi.

Educational Strategies

Educational Strategies Nancy Admin Thu, 10/04/2018 - 03:20 PM EDT

Educational strategies are often implemented to prime a community for action. How can one address and reduce NMUPD, if there is limited understanding of the nature and scope of the problem? How can prescribers implement appropriate practices without information on what’s required to do so? One way to do this is by making key information known to the general public, and to those who distribute prescription drugs (e.g., prescribers and manufacturers) through different channels. However, while information dissemination can be associated with contributing factors such as perceptions of harm, such strategies appear insufficient to produce behavior change related to NMUPD. On the other hand, educational strategies that do more than merely disseminate information are associated with reductions in NMUPD consumption and consequences. These types of educational strategies include those that are:

  • Implemented system-wide. Prescribers educated on state-level dosing guidelines and proper use of the prescription drug monitoring program (PDMP) reduced their inappropriate prescribing habits and their patients had fewer overdose deaths.1
  • Based on a formative research. Exposure to social marketing campaigns that are grounded in local data and designed using feedback from the target audience was associated with declines in unintentional overdose deaths from prescription opioids.2

Educational strategies summarized in this section include the following:

1 Cochella, S., & Bateman, K. (2012). Provider detailing: an intervention to decrease prescription opioid deaths in Utah. Pain Medicine, 12(Suppl 2) S73–S76

2 Johnson, E. M., Porucznik, C. A., Anderson, J. W., & Rolfs, R. T. (2011). State-level strategies for reducing prescription drug overdose deaths: Utah’s prescription safety program. Pain Medicine, 12(Suppl 2), S66–S72.

Direct-to-Consumer Prescription Drug Advertising Restrictions

Direct-to-Consumer Prescription Drug Advertising Restrictions Nancy Admin Thu, 10/04/2018 - 03:25 PM EDT

Description

Direct-to-consumer prescription drug advertising restrictions are the regulations placed on pharmaceutical companies that use direct-to-consumer pharmaceutical advertising (DTCPA) to market their products and to educate the general public about the benefits and risks of prescription drugs (Ventola, 2011). The U.S. Food and Drug Administration (FDA) regulates DTCPA for all prescription drugs, including scheduled drugs.

Objective(s)

To reduce patient misinformation about prescription drugs and to prevent over-prescription

Typical Elements

While the FDA regulates DTCPA, drug manufacturers are not required to obtain clearance from the FDA prior to disseminating an ad. As a result, drug companies are held liable to FDA regulations only after a violation has been identified (Ventola, 2011). FDA DTCPA regulations apply to four categories of promotional materials (FDA, 2013):

  • Product claim advertisements—DTCPA that names a drug and discusses its benefits and risks (FDA, 2013):
    • Ads must not be false or misleading in any way.
    • Companies are encouraged to use clear language that consumers will understand.
    • All product claim ads, regardless of the media in which they appear, must include key components—such as the name of the drug, its FDA-approved uses, and its most significant risks—within the main part of the ad.
    • Print product claim ads must include a brief summary of all risks listed in the product's approved prescribing information.
    • Under the FDA Amendments Act of 2007, print advertisements must include the following statement: "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088" (FDA, 2013, ¶ 6).
    • Broadcast product claim ads (TV, radio, telephone) must include the drug's most important risks in audio form. In addition, they must either list all the risks or provide sources where viewers can find the FDA-approved prescribing information that presents all the risks.
    • When the FDA finds a violation, a warning letter is sent to drug manufacturers requesting corrective action: a plan to withdraw the DTCPA and provide accurate information to the DTCPA's audience.
      • Note: In 2003, the FDA sent such a letter to Purdue Pharma regarding the print marketing for OxyContin (FDA, 2015).
  • Reminder advertisements—DTCPA that gives the name of a drug but not the drug's uses. These ads assume that the audience is already aware of the drug and its uses (FDA, 2013).
    • The ads do not have to contain risk information, because they do not say what the drug does or how well it works.
    • They cannot suggest, in either words or pictures, anything about the drug's benefits or risks (for example, a reminder ad for a drug that helps treat asthma should not include a drawing of a pair of lungs, as this implies the drug's usage).
    • They are not allowed for drugs that the FDA considers to have serious risks.
      • Note: Drugs with serious risks are required to have a special warning, often called a "boxed warning," in all of their advertising and in each drug's FDA-approved prescribing information. Boxed warnings are required for drugs that can cause serious adverse reactions, which either (a) are not proportional to their benefits, or (b) can be prevented through appropriate and monitored use. Boxed warnings are also required for drugs given FDA "approval with restrictions to safe use" (such as extended-release and long-acting opioids) (FDA, 2011, p. 11).
  • ​Help-seeking advertisements—DTCPA that describes a disease or condition but does not recommend or suggest a specific drug treatment (FDA, 2013):
    • Ads can include a drug company's name and can also provide a telephone number to call for more information.
    • The FDA does not consider these "drug ads" and does not regulate true help-seeking DTCPA. If an ad recommends or suggests the use of a specific drug, it is considered a product claim ad and must comply with FDA rules.
    • Help-seeking ads are regulated by the Federal Trade Commission.
  • Other product claim promotional materials, such as "promotional labeling" and brochures, materials mailed to consumers, and other types of materials given out by drug companies. If these materials mention the drug's benefit(s), they must also include the drug's prescribing information.
    • Note: The United States and New Zealand are the only industrialized countries that allow DTCPA of prescription drugs (World Health Organization, 2009).
  • Additional restrictions on prescription drug DTCPA have been proposed (Ventola, 2011; Vogt, 2005), for example:
    • Delaying advertising for new prescription products
      • Note: The Pharmaceutical Research and Manufacturers of America trade association issued guidelines after the 2004 Vioxx recall, recommending that DTCPA for new prescription drugs be delayed until "the drug's safety profile is fully established and health care professionals are educated as to the drug's proper use" (Ventola, 2011, "Delay Advertising for New Products," ¶ 2). Although these guidelines are voluntary, in 2007, many drug manufacturers waited an average of 15 months after FDA approval before beginning DTCPA.
    • Requiring FDA pre-clearance of DTCPA to ensure that it meets current regulations before being seen by the public
      • Note: In 2008, the FDA planned to implement a pre-clearance program primarily funded by user fees from drug manufacturers; however, the program was cancelled due to inadequate funding.
    • Establishing regulations for online DTCPA that require online content to include a notification if sponsored by a drug manufacturer
    • Requiring DTCPA to replace qualifying statements with quantitative data from clinical trials
    • Improving patient comprehension and ensuring that more consumers understand the information and product risks by requiring all language in DTCPA to adhere to a lower literacy standard
    • Banning ads for specific products and replacing current DTCPA with non-branded information campaigns that promote the benefits of drug classes and encourage consumers to discuss treatment options with their healthcare providers
    • Banning all prescription drug DTCPA
      • Note: The United States did not allow DTCPA for prescription drugs until 1985, and maintained strict requirements over the content of ads until 1997 (World Health Organization, 2009).

Populations

General public, prescription drug manufacturers

Outcomes

  • Economic simulations have linked the expansion of prescription drug DTCPA from 1995 to 2005 with a 19% increase in prescription drug expenditures during that time (Dave & Saffer, 2010).
  • A systematic review of the empirical literature on DTCPA found insufficient evidence to support claims that DTCPA is an effective educational vehicle or is effective at promoting adherence to prescribed regimens (Frosh, Grande, Tarn, & Kravitz, 2010).
  • In a 2002 survey of 500 office-based primary care and specialist physicians, respondents reported that although DTCPA increases patient awareness of prescription drugs and potential treatments for health conditions, it does not increase awareness of potential risks. Physicians also reported increased pressure from patients to issue prescriptions (Aiken, Swasy, & Braman, 2004).
  • DTCPA that presents numeric information (such as "25% of patients") has been linked to improved understanding of the risks and benefits of prescription drugs relative to non-numeric presentations (West et al., 2013).

Guidelines

Articles 86 to 88 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

Prescription Drug Advertising.

Guiding Principles on Direct to Consumer Advertising About Prescription Medicines.

Acknowledged by

U.S. Food and Drug Administration. The Impact of Direct-to-Consumer Advertising.

References

Aiken, K. J., Swasy, J. L., & Braman, A. C. (2004). Patient and physician attitudes and behaviors associated with DTC promotion of prescription drugs: Summary of FDA survey research results. Retrieved from https://www.sciencedirect.com/science/article/abs/pii/S0362331913000311

Dave, D., & Saffer, H. (2010). The impact of direct-to-consumer advertising on pharmaceutical prices and demand. National Bureau of Economic Research Working Paper 15969. Retrieved from http://www.nber.org/papers/w15969.pdf

Frosch, D. L., Grande, D., Tarn, D. M., & Kravitz, R. L. (2010). A decade of controversy: Balancing policy with evidence in the regulation of prescription drug advertising. American Journal of Public Health, 100(1), 24–32. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2791253/

U.S. Food and Drug Administration. (2011). Guidance for industry: Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—Content and format. Retrieved from http://www.fda.gov/downloads/Drugs/Guidances/ucm075096.pdf

U.S. Food and Drug Administration. (2013). Prescription drug advertising. Retrieved from https://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/default.htm

U.S. Food and Drug Administration. (2015). Timeline of selected FDA activities and significant events addressing opioid misuse and abuse. Retrieved from https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm338566.htm

Ventola, C. L. (2011). Direct-to-consumer pharmaceutical advertising: Therapeutic or toxic? Pharmacy and Therapeutics, 36(10), 669–674, 681–684. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/

Vogt, D. U. (2005). Direct-to-consumer advertising of prescription drugs. Washington, DC: Congressional Research Service. Retrieved from http://congressionalresearch.com/RL32853/document.php

West, S. L., Squiers, L. B., McCormack, L., Southwell, B. G., Brouwer, E. S., Ashok, M., . . . Sullivan, H. W. (2013). Communicating quantitative risks and benefits in promotional prescription drug labeling or print advertising. Pharmacoepidemiology and Drug Safety, 22(5), 447–458.

World Health Organization. (2009). Direct-to-consumer advertising under fire. Bulletin of the World Health Organization, 87(8). Retrieved from http://www.who.int/bulletin/volumes/87/8/09-040809/en/

Requirements for Drug Manufacturers Regarding Prescriber Education

Requirements for Drug Manufacturers Regarding Prescriber Education Nancy Admin Thu, 10/04/2018 - 03:32 PM EDT

Description

The requirements for drug manufacturers regarding prescriber education, decreed by the U.S. Food and Drug Administration (FDA), were established to fund the development and dissemination of specific educational materials on extended-release and long-acting (ER/LA) opioids, including materials for prescribers and patients, and to conduct ongoing assessment of the reach and effectiveness of these efforts.

Objective(s)

To enhance patients'; and providers'; understanding of the risks associated with misuse of opioids and to increase providers'; knowledge of appropriate prescribing practices for such drugs

Typical Elements

  • The FDA-implemented Risk Evaluation and Mitigation Strategy for ER/LA opioids requires drug manufacturers to support prescriber education programs (FDA, 2014; Gudin, 2012). Prescriber opioid education seeks to reduce opioid abuse or overdose while maintaining legitimate and appropriate access to pain management drugs (FDA, 2013).
  • Two manufacturer-produced documents are required for each approved opioid (FDA, 2013, 2014):
    • A one-page Medication Guide that identifies important information about the drug';s known and potential risks (U.S. Department of Health and Human Services, 2013). A paper version of the guide must be given to each patient who receives the drug. An Internet version of the guide must be made available to patients and healthcare providers.
    • A Communication Plan, which the manufacturer sends to healthcare providers (including prescribers, dispensers, state licensing authorities, professional associations, and all other U.S. Drug Enforcement Administration registrants) within 60 days of drug approval. The plan includes a "Dear Healthcare Provider Letter" that explains the drug';s risks (FDA, 2014, p. 4).
  • The FDA requires prescription drug manufacturers to create and offer independent, voluntary ER/LA opioid training programs for healthcare providers through educational grants to accredited continuing medical education (CME) providers (FDA, 2014).
    • Manufacturers must work with CME accrediting bodies to ensure that the trainings are appropriate to prescribers'; medical specialties (FDA, 2014) and that they fulfill any state CME requirements for pain management licensure (American College of Emergency Physicians, 2013).
    • A "post-course knowledge assessment" is required (FDA, 2013, p. 26).
    • Training can be independently audited to confirm that the required conditions have been met (FDA, 2013).
      • Note: The FDA does not have authority to regulate physicians or other healthcare providers and cannot require them to participate in a training program.
  • The FDA recommends that education programs, sponsored by manufacturers, address the following issues (FDA, 2014; Gregory, 2013):
    • Assessing patients'; opioid abuse potential by completing a physical examination and all other appropriate documentation, and using opioid risk assessment tools (e.g., the Opioid Risk Tool; Diagnosis, Intractability, Risk, Efficacy; and Screener and Opioid Assessment for Patients with Pain-Revised)
    • How to initiate and discontinue opioid use and modify ongoing prescriptions
    • How to appropriately oversee opioid use, including setting, discussing, and evaluating treatment goals with patients, and when and how to use drug testing
    • How to counsel patients and caregivers about safe opioid use
    • General and specific information about drug characteristics, toxicities, and interactions
      • Note: The FDA has the authority to reject a manufacturer';s training program if the training is biased toward the manufacturer';s drug.

Populations

Prescribers of opioids, individuals with opioid prescriptions

Outcomes

Though not specific to opioids, a meta-analysis of CMEs found the following (Cervero & Gaines, 2014):

  • 79% of studied CMEs were effective at improving clinical knowledge, while 42% were effective at improving patient outcomes
  • Interactive CMEs can be more effective than didactic CMEs, although the sample size was too small to draw any definitive conclusions

Guidelines

Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS). 

Introduction for the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics.

Acknowledged by

Food and Drug Administration. Extended Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS).

Office of National Drug Control Policy, Executive Office of the President. Epidemic: Responding to America's Prescription Drug Abuse Crisis.

References

American College of Emergency Physicians. (2013). Continuing medical education for licensure reregistration. Retrieved from https://www.americanseminar.com/ckfinder/userfiles/files/continuing-medical-education-licensure(1).pdf

Cervero, R., & Gaines, J. (2014). Effectiveness of continuing medical education: Updated synthesis of systematic reviews. Retrieved from http://www.accme.org/sites/default/files/2014_Effectiveness_of_Continuing_Medical_Education_Cervero_and_Gaines_0.pdf

Gregory, T. B. (2013). How to safely prescribe long-acting opioids. Journal of Family Practice, 62(Supp12), S12–S18.

Gudin, J. A. (2012). The changing landscape of opioid prescribing: Long-acting and extended-release opioid class-wide Risk Evaluation and Mitigation Strategy. Therapeutics and Clinical Risk Management, 8, 209–217. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3346202/

U.S. Department of Health and Human Services. (2013). Addressing prescription drug abuse in the United States: Current activities and future opportunities. Behavioral Health Coordinating Committee, Prescription Drug Abuse Subcommittee. Retrieved from https://www.cdc.gov/drugoverdose/pdf/HHS_Prescription_Drug_Abuse_Report_09.2013.pdf

U.S. Food and Drug Administration. (2013). Extended-release (ER) and long-acting (LA) opioid analgesics Risk Evaluation and Mitigation Strategy (REMS). Retrieved from https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf

U.S. Food and Drug Administration. (2014). Introduction for the FDA blueprint for prescriber education for extended-release and long-acting opioid analgesics. Retrieved from http://media01.commpartners.com/ASAM/jul29/ERLAREMSBlueprint.pdf

Information Dissemination Campaigns

Information Dissemination Campaigns Nancy Admin Thu, 10/04/2018 - 03:36 PM EDT

Description

Information dissemination campaigns use mass media (TV, Internet, radio, newspaper, and billboard) to distribute information to the general population.

Objective(s)

To raise public awareness of appropriate prescription drug use and to promote safe use of prescription drugs

Typical Elements

  • Campaigns to disseminate information on drug misuse prevention are funded and organized by state or national agencies. The goal of the campaign is to encourage behavioral change.
  • Campaigns are guided by three objectives (Ferri, Allara, Bo, Gasparrini, & Faggiano, 2013):
    • Give warning: Explain the dangers and risks of a range of substances
    • Empower: Illustrate how to contribute to drug misuse prevention through individual behavior (especially for parents), and provide information about where and how to seek support, counseling, and treatment for drug use
    • Support: Provide information about existing prevention interventions or programs, including programs in communities and schools, and programs targeted to families
  • They are based on one of two theoretical models (Ferri et al., 2013):
    • The Health Belief Model posits that individuals' lack of knowledge about the associated health risks and harms of misusing drugs can lead to drug use, and that the provision of factual information on the dangers of drug use should create negative attitudes that will deter use.
    • The Theory of Reasoned Action/Theory of Planned Behavior considers that drug use is a rational decision for many individuals, based on their attitudes toward drugs, their perception of social norms toward drug use, and their perceived ability to control their use. The provision of factual information countering these attitudes should lead individuals to determine that use is not a rational decision.
  • These campaigns vary in terms of target audience, method of delivery, scope, and/or objectives (Ferri et al., 2013):
    • The target audience is usually the general public or, more specifically, the youth population.
    • Delivery methods vary by platform (TV, Internet, radio, print, billboard, classroom, etc.) and content type (advertisement, short film, lecture, interactive course, etc.).
    • The scope can range from individual community efforts to nationwide campaigns.
    • Campaign objectives are driven by the campaign's message (the behavioral change that the campaign is seeking to influence).

Populations

General public, youth

Outcomes

  • Although information dissemination campaigns are common, few have been formally evaluated for effectiveness. Campaigns regularly target illegal drugs, but those targeting the abuse of diverted legal drugs are less common (Ferri et al., 2013).
  • A meta-analysis of 15 studies determined that the evidence is inconclusive regarding the effect of information dissemination campaigns on drug use or attitudes toward drug use. The meta-analysis primarily studied campaigns focusing on marijuana use, methamphetamine use, or general illicit drug use; only one campaign was specific to prescription drug abuse prevention (Ferri et al., 2013).
  • The campaign that included prescription drug use as a targeted goal was an Internet-based campaign designed to cover multiple sessions. The campaign targeted Asian American female youth ages 10–14 and their mothers, seeking to reduce the youths' drug use and abuse, including prescription drug abuse. The study found that the campaign was successful in reducing rates of alcohol, marijuana, and illicit prescription drug use (Fang, Schinke, & Cole, 2010).

Guidelines

No guidelines have been found regarding information dissemination campaigns for the general public.

Acknowledged by

Office of National Drug Control Policy. Epidemic: Responding to America's Prescription Drug Abuse Crisis

References

Fang, L., Schinke, S. P., & Cole, K. C. (2010). Preventing substance use among early Asian-American adolescent girls: Initial evaluation of a web-based, mother-daughter program. Journal of Adolescent Health, 47(5), 529–532. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964276/pdf/nihms191591.pdf

Ferri, M., Allara, E., Bo, A., Gasparrini, A., & Faggiano, F. (2013). Media campaigns for the prevention of illicit drug use in young people. The Cochrane Database of Systematic Reviews, 6, Article No. CD009287. Retrieved from http://researchonline.lshtm.ac.uk/967502/1/ferri_Cochrane2013.pdf

Social Marketing Campaigns

Social Marketing Campaigns Nancy Admin Thu, 10/04/2018 - 03:40 PM EDT

Description

Social marketing campaigns use techniques adapted from commercial marketing to encourage favorable and voluntary behavior change.

Objective(s)

To influence community attitudes, norms, and behaviors regarding the nonmedical use of prescription drugs (NMUPD).

Typical Elements

  • The first step of a social marketing campaign is to conduct a comprehensive assessment of local prevention needs and capacity, in order to identify the following (Gabriel et al., 2008; Grier & Bryant, 2005; National Highway Traffic Safety Administration [NHTSA], 2001; Work Group for Community Health and Development, 2014):
    • The specific problem you intend to address in your community
      • Note: For example: What NMUPD problems and behaviors are occurring? How often? Where? How do youth obtain prescription drugs for nonmedical use? What risk and protective factors contribute to this problem?
    • The segment of the population you intend to reach and influence through social marketing (the focus population)
      • Note: Who is most affected by the problem? Most likely to change their behavior? Most feasible to reach? The goal is to reach the subsets of individuals who engage in high levels of risky behavior and/or who share lifestyles, behaviors, and values that make them likely to respond similarly to an intervention (Forthofer & Bryant, 2000). Be specific when defining these demographics. This segmentation will help campaigns determine effective communication and distribution strategies for key social marketing messages.
  • The next step is to conduct audience research on the following (Grier & Bryant, 2005; Lefebvre & Flora, 1988; NHTSA, 2001; Work Group for Community Health and Development, 2014):
    • Perceived benefits of NMUPD and related behaviors
    • Perceived benefits of refraining from NMUPD and related behaviors
    • Perceived barriers to and benefits of the desired behavior change
    • Ideas about how to make abstaining more appealing (more comfortable, fun, or popular)
    • Readiness for change
    • Preferred channels of communication (such as text messages, posters, TV, radio, websites, Twitter)
  • Based on this audience research, the campaign designs its key message (Grier & Bryant, 2005; Substance Abuse and Mental Health Services Administration [SAMHSA], n.d.; Work Group for Community Health and Development, 2014):
    • Identifying the desired behavior you hope to bring about through social marketing (for example, abstaining from NMUPD)
    • Identifying the perceived benefits of and barriers to engaging in the desired behavior
    • Choosing a single perceived benefit to focus on emphasizing how that benefit outweighs the perceived barriers
      • Note: Avoid fear or scare tactics. Fear can have weaker effects and unintended damaging effects in real-world social marketing campaigns. Maladaptive responses (such as chronic heightened anxiety or complacency) can result, especially with at-risk populations (Hastings, Stead, & Webb, 2004).
    • Demonstrating that the perceived barriers to change can be overcome using language that is easy to understand and culturally appropriate
  • The campaign selects a communication channel, based on the preferences of the target audience. The message should be tailored to work well for each selected communication channel (NHTSA, 2001; Work Group for Community Health and Development, 2014). For example:
    • A text message or tweet will need to grab the focus population's attention using just a few words.
    • A poster should be eye-catching.
    • A radio or TV spot will require the right spokesperson.
  • Campaigns conduct research (for example, by using focus groups) to test the focus population's response to the message, the selected communication channels, and the messenger/spokesperson (if applicable). This feedback gives campaigns an opportunity to fine-tune the message and delivery methods, as needed, (Gabriel et al., 2008; Grier & Bryant, 2005; Lefebvre & Flora, 1988; SAMHSA, n.d.; Work Group for Community Health and Development, 2014).
  • To give the focus population maximum exposure to the message, it should be delivered frequently, using multiple communication channels, and zeroing in on places that are frequently accessed by the focus population (Gabriel et al., 2008; Work Group for Community Health and Development, 2014).
  • The campaign should monitor and document message delivery, actual message reach, and reception (Lefebvre & Flora, 1988; SAMHSA, n.d.; Work Group for Community Health and Development, 2014). For example, campaigns might track spokespeople used, communication channels used, dates, and which focus audience the message targeted.

Populations

General public

Outcomes

Exposure to social marketing campaigns has been associated with the following outcomes:

  • Increased perceptions of harm among parents regarding teen prescription drug abuse (Media Campaign, 2009)
  • A greater likelihood of parents reporting intentions to control the supply of prescription drugs in their home (Media Campaign, 2009)
  • Decreased unintentional overdose deaths from prescription opioids (Johnson, Porucznik, Anderson, & Rolfs, 2011)

Compared to those who were not exposed to the American Medicine Chest Challenge media campaign, exposed individuals were significantly statistically more likely to (Yanovitzky, 2011):

  • Take inventory of their prescription drugs
  • Lock their medicine cabinets
  • Dispose of leftover prescription drugs at a collection site
  • Talk to their children about the dangers of NMUPD

Guidelines

Community Tool Box. Section 2: Conducting a Social Marketing Campaign.

Social Marketing and Public Health Intervention.

Social Marketing in Public Health.

Ten Steps for Developing a Social Marketing Campaign.

Acknowledged by

No acknowledgements have been found regarding the role of social marketing campaigns in preventing NMUPD and/or its consequences.

References

Forthofer, M. S., & Bryant, C. A. (2000). Using audience-segmentation techniques to tailor health behavior change strategies. American Journal of Health Behavior, 24(1), 36–43.

Gabriel, R., Becker, L., Leahy, S. K., Landy, A. L., Metzger, J., Orwin, R., . . . Stein-Seroussi, A. (2008). Assessing the fidelity of implementation of the Strategic Prevention Framework in SPF SIG-funded communities: User's guide and fidelity assessment rubrics (version 2).

Grier, S., & Bryant, C. A. (2005). Social marketing in public health. Annual Review of Public Health, 26, 319–339.

Hastings, G., Stead, M., & Webb, J. (2004). Fear appeals in social marketing: Strategic and ethical reasons for concern. Psychology & Marketing, 21(11), 961–986.

Johnson, E. M., Porucznik, C. A., Anderson, J. W., & Rolfs, R. T. (2011). State-level strategies for reducing prescription drug overdose deaths: Utah's prescription safety program. Pain Medicine, 12(Suppl 2), S66–S72.

Lefebvre, R. C., & Flora, J. A. (1988). Social marketing and public health intervention. Health Education Quarterly, 15(3), 299–315.

Media Campaign. (2009). Effectiveness of a mass media campaign for parents on teen prescription drug use. Drug Prevention and Social Marketing Brief, 4, 1–3. Retrieved from www keeprxsafe com/documents/Rx%20campaign.pdf

National Highway Traffic Safety Administration. (2001). Community how to guide on . . . media relations. Retrieved from https://www.nhtsa.gov/people/injury/alcohol/Community%20Guides%20HTML/Book7_MediaRelations.html

Substance Abuse and Mental Health Services Administration (SAMHSA). (n.d.). Understanding social marketing. Rockville, MD: Center for the Application of Prevention Technologies, SAMHSA. Retrieved from https://www.samhsa.gov/capt/tools-learning-resources/understanding-social-marketing

Work Group for Community Health and Development. (2014). Chapter 45, Section 2: Conducting a Social Marketing Campaign. Lawrence, KS: University of Kansas. Retrieved from https://ctb.ku.edu/en/table-of-contents/sustain/social-marketing/conduct-campaign/main

Yanovitzky, I. (2011). The American Medicine Chest Challenge (AMCC): 2010 media campaign evaluation: Eagleton survey data. New Brunswick, NJ: Rutgers, The State University of New Jersey. Retrieved from http://www.drugfreenj.org/assets/_control/content/files/rutgersnjreport.pdf

Systemwide Patient Education

Systemwide Patient Education Nancy Admin Thu, 10/04/2018 - 03:44 PM EDT

Description

Systemwide patient education efforts provide information regarding the dangers of prescription drug misuse and abuse. They can target broad populations (patient groups, youth) or populations with or who are at risk for substance use disorders (Haegerich, Paulozzi, Manns, & Jones, 2013).

Objective(s)

To provide knowledge about and change attitudes toward prescription drugs, ultimately resulting in their safe use and proper disposal

Typical Elements

  • Systemwide patient education includes assessment, feedback, motivational interviewing, and brief interventions.
  • Information is provided on the effects of a particular drug, adherence (how to take the drug properly), the dangers of misuse and abuse (American College of Preventive Medicine, 2015), and the risks and benefits of a particular drug, so patients can make informed decisions (Pennsylvania Medical Society, 2014).
  • Patients are told how to securely and responsibly dispose of unused medication (see Prescription Drug Takeback Programs).
  • Several key points are emphasized (Health Team Works, 2011):
    • Sharing prescription drugs is illegal
    • Avoid openly discussing your medications with others
    • Keep prescribed medication in a safe, locked place (not a medicine cabinet)
    • Treat prescription drugs like cash or credit cards—many medications have a high street value and are stolen from homes or vehicles
    • Even some over-the-counter drugs (such as pseudoephedrine) have abuse potential and should be safeguarded
  • Education is tailored to individual patient's needs and considers the patient's influences and experiences as defined by his or her language, culture, gender, race and ethnicity, age, cognitive function, educational level (including literacy and health literacy), and local community resources (Substance Abuse and Mental Health Services Administration [SAMHSA], 2011).
  • Prevention efforts are focused on patients who have or are at risk for a substance use disorder.
    • Note: Primary care centers, hospital emergency rooms, trauma centers, and other community settings provide opportunities for early intervention with at-risk substance users before more severe consequences occur (SAMHSA, 2013).
  • For patient education to become institutionalized, a "normative shift" in healthcare practice is needed. Each department within an agency must see the benefit of integrating prevention into primary care practice (The National Center on Addiction and Substance Abuse at Columbia University [CASA], 2012, p. 6).
  • Before implementing systemwide patient education, the organization's readiness to implement effective strategies or programs in clinical practices must be determined. Sites considering this strategy should do the following (Health Team Works, 2008):
    • Study the model and its associated guidelines
    • Determine if and how it can be best applied within their practice, given the patient population
    • Determine whether it can generate revenue or remain cost-neutral for their site (CASA, 2012)
    • Identify behavioral health resources in their community for brief therapy referrals
    • Determine the best way to implement screening in their practice
      • Note: Most sites incorporate screening into an overall health history questionnaire.
    • Consider how to administer the brief assessment instrument for patients who need additional assessment
    • Develop a staffing plan for screening and assessment
    • Select a leader for the implementation, who will also coordinate training and monitoring
    • Train clinicians (and non-clinical staff) and assign responsibilities
      • Note: For example, determine which staff members will administer the screenings, complete the flow sheets, arrange referrals, and handle billing.
    • Establish a record-keeping system that protects client confidentiality
    • Reinforce the strategy with staff through (1) reminders, (2) collecting success stories, and (3) accepting feedback to modify the implementation, as needed

Populations

Patients and individuals who have or are at risk for a substance use disorder

Outcomes

  • Findings from a systematic literature review note that the quality of evidence for the effect of patient education programs is moderate to low (Haegerich et al., 2014).
  • Based on the scant availability of published research on screenings and brief interventions for drug use, in 2008 the U.S. Preventive Services Task Force concluded that the evidence regarding screening for illicit drug use was inadequate to evaluate the balance of benefits and harms of screening adolescents, adults, and pregnant women (SAMHSA, 2013).

Guidelines

Use, Abuse, Misuse and Disposal of Prescription Pain Medicine Clinical Reference.

Practice Guidelines for the Treatment of Patients with Substance Use Disorders (2nd ed.).

An SBIRT Implementation and Process Change Manual for Practitioners.

Best Practices to Address Opioid Abuse, Misuse and Diversion.

Pennsylvania Guidelines on the Use of Opioids to Treat Chronic Non-Cancer Pain.

Medication Guidelines.

Systems-Level Implementation of Screening, Brief Intervention, and Referral to Treatment. Technical Assistance Publication (TAP) Series 33.

Acknowledged by

U.S. Department of Health and Human Services, Behavioral Health Coordinating Committee. Addressing Prescription Drug Abuse in the United States.

References

American College of Preventive Medicine. (2011). Use, abuse, misuse and disposal of prescription pain medicine clinical reference. Retrieved from https://c.ymcdn.com/sites/www.acpm.org/resource/resmgr/timetools-files/painmedsclinicalreference.pdf

Haegerich, T. M., Paulozzi, L. J., Manns, B. J., & Jones, C. M. (2014). What we know, and don't know, about the impact of state policy and systems-level interventions on prescription drug overdose. Drug and Alcohol Dependence, 145, 34–47.

Health Team Works. (2008). Screening, brief intervention, and referral to treatment: Strategies for implementing SBIRT in clinical practices. Retrieved from https://www.integration.samhsa.gov/clinical-practice/HealthTeamWorks_Strategies_for_Implementing_SBIRT_in_Clinical.pdf

Health Team Works. (2011). SBIRT guideline supplement: Prescription drug abuse prevention. Denver, CO: SBIRT Colorado.

The National Center on Addiction and Substance Abuse at Columbia University. (2012). An SBIRT implementation and process change manual for practitioners. Retrieved from http://www.casacolumbia.org/sites/default/files/files/An-SBIRT-implementation-and-process-change-manual-for-practitioners.pdf

Pennsylvania Medical Society. (2014). Pennsylvania guidelines on the use of opioids to treat chronic noncancer pain. Retrieved from https://www.pamedsoc.org/detail/article/PA-Opioid-Guidelines

Substance Abuse and Mental Health Services Administration. (2011). Managing chronic pain in adults with or in recovery from substance use disorders. Treatment Improvement Protocol (TIP) Series 54. HHS Publication No. (SMA) 12-4671. Rockville, MD: Author. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK92048/pdf/Bookshelf_NBK92048.pdf

Substance Abuse and Mental Health Services Administration. (2013). Systems-level implementation of screening, brief intervention, and referral to treatment. Technical Assistance Publication (TAP) Series 33. HHS Publication No. (SMA) 13-4741. Rockville, MD: Author. Retrieved from https://www.integration.samhsa.gov/sbirt/TAP33.pdf

Systemwide Prescriber Education

Systemwide Prescriber Education Nancy Admin Thu, 10/04/2018 - 03:47 PM EDT

Description

Systemwide prescriber education programs educate prescribers about the benefits and risks of prescribing opioids, including strategies to prevent abuse, while maintaining legitimate and appropriate access to opioids.

Objective(s)

To reduce unnecessary prescriptions for opioids through prescriber education

Typical Elements

  • Information is provided to prescribers on how to best use opioids to treat chronic non-cancer pain (see Systemwide Patient Education), how to identify patients who may be at risk for abuse, and how to deal with substance abuse screening, treatment, and referrals (U.S. Department of Health and Human Services [HHS], 2013).
  • Prescriber education may be available from many sources, including events sponsored by drug manufacturers, continuing medical education (CME) programs, educational materials developed by interested organizations, and state-mandated training events.
    • Note: See the FDA Blueprint for Prescriber Education for Extended Release and Long-Acting Opioid Analgesics.
  • The Centers for Disease Control and Prevention (CDC) highlight 12 recommendations for primary care clinicians who are treating patients (18 years and older) with chronic pain via outpatient settings. The voluntary recommendations based on emerging research evidence. provide guidance on (Dowell, Haegerich, & Chou, 2016):
    • Determining initiation or continuation of opioid therapy
    • Selecting type of opioid, proper dosage, duration, follow-up, and discontinuation
    • Assessing the risk and addressing harms of opioid use
  • Through its Risk Evaluation and Mitigation Strategy (REMS) for opioids, the U.S. Food and Drug Administration (FDA) requires prescription drug manufacturers to sponsor the following types of prescriber education (FDA, 2013, 2014a, 2014b):
    • A Communication Plan that informs healthcare providers (including prescribers, dispensers, state licensing authorities, professional associations, and all other U.S. Drug Enforcement Administration registrants) about new prescription drugs. The plan must be published within 60 days of drug approval and must include a "Dear Healthcare Provider Letter" that explains the drug's potential and known risks (FDA, 2014a).
    • A Medication Guide for each drug intended for patients that provides more detailed information about the drug's use and risks (FDA, 2014b).
    • Voluntary opioid training programs for healthcare providers, delivered by an accredited CME provider (FDA, 2013). These programs are financially supported by independent educational grants from extended-release and long-acting opioid analgesic companies.
  • Forty-five states and the District of Columbia require physicians to obtain a certain number of CME credits per year to maintain their licensure (American College of Emergency Physicians [ACEP], 2013):
    • CMEs cover a wide range of topics, although some states require credits in specific topics (such as pain management, geriatric care, cultural competence, domestic violence, and patient safety).
    • Accredited CME programs may offer credits related to appropriate prescribing practices, often adhering to the FDA guidelines for manufacturer-sponsored education requirements (Safe and Competent Opioid Prescribing Education, n.d.).
  • Interested community-based organizations and states can develop educational materials and programs for prescribers focusing on, for example, safe and effective pain management and prescribing practices, risk assessment, and potential patient education tools (Physicians for Responsible Opioid Prescribing, n.d.). Project Lazarus is an example of a community-based prevention model.
  • States can require prescribers to receive training related to effective pain management, patient risk assessment, etc. as a condition of their licensure renewal (Massachusetts Legislature, n.d.).
  • HHS and the federal agencies within this department have developed a number of initiatives to support prescriber education efforts (HHS, 2013):
    • The Substance Abuse and Mental Health Services Administration (SAMHSA) offers an in-person CME course on safe opioid prescribing practices, a clinical support system for opioid prescribers, and free online training courses and resources (SAMHSA, 2012). SAMHSA's courses focus on managing chronic non-cancer pain through collaborative care models.
    • The National Institutes of Health (NIH) developed curriculum resources on prescription opioid abuse and designated 12 professional schools as Centers of Excellence in Pain Education to serve as development hubs for additional resources.
    • NIH also developed two video-based CME modules on prescription drug abuse and pain management.
    • The Centers for Medicare and Medicaid Services created a Medicaid Education Toolkit for pharmacy staff, which discusses drug diversion and prevention.
    • The FDA created its REMS for opioids, which requires manufacturer-sponsored training.
    • The Centers for Disease Control and Prevention and the FDA each support ongoing evaluations of the impact of prescriber education.

Populations

Opioid prescribers

Outcomes

  • In Washington State, optional opioid prescriber educational guidelines were associated with a 27% decrease in the number of workers on disability compensation who received an opioid prescription, and a 50% decrease in overdose deaths among those individuals (Franklin et al., 2012).
  • In Utah, expanded prescriber education programs focusing on recommended practices and using the state's PDMP were associated with a 14% decrease in medication-related overdose deaths and a 60–80% reduction in inappropriate prescribing habits among prescribers (Cochella & Bateman, 2011).
  • CMEs focusing on buprenorphine use and best prescribing practices in two U.S. regions were associated with greater prescriber knowledge and improved clinical behavior (Lofwal, Wunsch, Nuzzo, & Walsh, 2011).
  • Though not specific to opioids, a meta-analysis of CMEs found that 79% of studied CMEs were effective at improving clinical knowledge, while 42% were effective at improving patient outcomes (Cervero & Gaines, 2014). In addition, interactive CMEs can be more effective than didactic CMEs, but the sample size was too small to draw any definitive conclusions.

Guidelines

Cautious, Evidence-Based Opioid Prescribing.

CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016

Introduction for the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics.

Interagency Guideline on Opioid Dosing for Chronic Non-Cancer Pain: An Educational Aid to Improve Care and Safety with Opioid Therapy—2010 Update.

Pennsylvania Guidelines on the Use of Opioids to Treat Chronic Noncancer Pain.

Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids.

SAMHSA Opioid Overdose Toolkit: Information for Prescribers.

Safe and Effective Opioid Prescribing for Chronic Pain.

SAFE Opioid Prescribing: Strategies, Assessment, Fundamentals, Education.

Acknowledged by

National Alliance for Model State Drug Laws. Model Health Professionals Training Act.

National Conference of Insurance Legislators. Best Practices to Address Opioid Abuse, Misuse and Diversion.

Office of National Drug Control Policy. Epidemic: Responding to America's Prescription Drug Abuse Crisis.

U.S. Department of Health and Human Services, Behavioral Health Coordinating Committee. Addressing Prescription Drug Abuse in the United States: Current Activities and Future Opportunities.

U.S. Food and Drug Administration. Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS).

References

Cervero, R., & Gaines, J. (2014). Effectiveness of continuing medical education: Updated synthesis of systematic reviews. Retrieved from http://www.accme.org/sites/default/files/2014_Effectiveness_of_Continuing_Medical_Education_Cervero_and_Gaines_0.pdf

Cochella, S., & Bateman, K. (2012). Provider detailing: an intervention to decrease prescription opioid deaths in Utah. Pain Medicine, 12(Suppl 2) S73–S76.

Dowell, D., Haegerich, T. M., & Chou, R. (2016). CDC guideline for prescribing opioids for chronic pain—United States, 2016. JAMA. Retrieved from https://jamanetwork.com/journals/jama/fullarticle/2503508.

Franklin, G. M., Mai, J., Turner, J., Sullivan, M., Wickizer, T., & Fulton-Kehoe, D. (2012). Bending the prescription opioid dosing and mortality curves: Impact of the Washington State opioid dosing guideline. American Journal of Industrial Medicine, 55(4), 325–331.

Lofwal, M. R., Wunsch, M. J., Nuzzo, P. A., & Walsh, S. L. (2011). Efficacy of continuing medical education to reduce the risk of buprenorphine diversion. Journal of Substance Abuse Treatment, 41(3), 321–329.

Massachusetts Legislature. (n.d.). General Laws, Part 1, Title XV, Chapter 94C, Section 18. Retrieved from https://malegislature.gov/Laws/GeneralLaws/PartI/TitleXV/Chapter94C/Section18

Physicians for Responsible Opioid Prescribing. (n.d.). Cautious, evidence-based opioid prescribing. Retrieved from http://www.supportprop.org/wp-content/uploads/2014/01/PROP_OpioidPrescribing.pdf

Safe and Competent Opioid Prescribing Education. (n.d.). What is the SCOPE of pain? Retrieved from https://www.scopeofpain.com/about-us/

Substance Abuse and Mental Health Services Administration (SAMHSA). (2012). COPE: Collaborative opioid prescribing education. Rockville, MD: National Registry of Evidence-based Programs and Practices, SAMHSA.

U.S. Department of Health and Human Services. (2013). Addressing prescription drug abuse in the United States: Current activities and future opportunities. Retrieved from https://www.cdc.gov/drugoverdose/pdf/HHS_Prescription_Drug_Abuse_Report_09.2013.pdf

U.S. Food and Drug Administration. (2013). Extended-release (ER) and long-acting (LA) opioid analgesics Risk Evaluation and Mitigation Strategy (REMS). Retrieved from https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf

U.S. Food and Drug Administration. (2014a). Guidance for industry and FDA Staff—Dear health care provider letters: Improving communication of important safety information. Retrieved from https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm233769.pdf

U.S. Food and Drug Administration. (2014b). Introduction for the FDA blueprint for prescriber education for extended-release and long-acting opioid analgesics. Retrieved from http://www.fmda.org/2017/Blueprint%20Opioid%20LA.ER%20REMS%20as%20of%201.20.2017.pdf

Tracking and Monitoring Strategies

Tracking and Monitoring Strategies Nancy Admin Thu, 10/04/2018 - 03:54 PM EDT

Tracking and monitoring strategies help law enforcement and regulatory agencies detect "doctor shoppers" and identify prescribers who have unusual prescribing practices. The best known example of tracking and monitoring interventions are prescription drug monitoring programs (PDMPs), which are electronic databases that track prescribing and dispensing of opioid analgesics and other controlled substances have been implemented in many states. In those states with a functioning PDMP, there were significantly lower increases in the number of Oxycodone shipments, intentional exposures to NMUPDs, and treatment admissions associated with NMUPD. Other types of tracking and monitoring strategies include those focused specifically on prescriber behavior, such as regulations requiring physical exams, and regularly scheduling in-person visits with patients at risk for NMUPD. Another strategy requires that patients show identification to pharmacists before dispensation. To date, there has been limited studies examining the effectiveness of tracking and monitoring regulations in reducing NMUPD; however tracking and monitoring strategies are more likely to be effective if they are:

  • Implemented in conjunction with other state initiatives and enforcement strategies. For example, model pain clinic regulations (i.e., required state registration, mandatory use of the prescription drug monitoring program, prohibition of physicians dispensing drugs from their offices) when implemented with increased enforcement have been associated with reductions in drug diversion rates and overdose deaths.1
  • Mandated and proactive. States that require prescribers and pharmacists to participate in their prescription drug monitoring programs (PDMPs) have lower incidence of doctor shopping behavior, and reduction in the overall dispensing of controlled substances.2 In addition, the greatest reductions in per capita supply of prescription pain relievers and stimulants occurred in states with a proactive PDMP rather than one that is reactive.3

Another tracking and monitoring strategy is Triplicate prescription programs (TPPs) which require physicians to issue prescriptions for certain controlled substances using multiple copy forms, with the extra copies either retained for record-keeping purposes or submitted to monitoring agencies. Some states implemented TPPs as precursors to PDMPs. The New York TPP demonstrated significant reductions in problematic benzodiazepine use, pharmacy hopping, and non-problematic benzodiazepine use with decreases mostly among African American individuals.4

Tracking and monitoring strategies, summarized here, include the following:

1 Johnson, H., Paulozzi, L., Porucznik, C., Mack, K., & Herter, B. (2014). Decline in drug overdose deaths after state policy changes—Florida, 2010–2012. Morbidity and Mortality Weekly Report, 63(26), 569–574. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a3.htm

2 PDMP Center of Excellence. (2014). Mandating PDMP participation by medical providers: Current status and experience in selected states. Waltham, MA: Brandeis University.

3 A proactive PDMP identifies and investigates potential cases of misuse, generating unsolicited reports whenever suspicious behavior is detected. A reactive PDMP generates reports only in response to a specific inquiry made by a prescriber, dispenser, or other party with appropriate authority. Simeone, R., & Holland, L. (2006). An evaluation of prescription drug monitoring programs. Washington, DC: U.S. Department of Justice, Office of Justice Programs. Retrieved from http://www.simeoneassociates.com/simeone3.pdf

4 Pearson, S.-A., Soumerai, S., Mah, C., Zhang, F., Simoni-Wastila, L., Salzman, C., . . . Ross-Degnan, D. (2006). Racial disparities in access after regulatory surveillance of benzodiazepines. Archives of Internal Medicine, 166(5), 572–579. Retrieved from https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/409923

DEA "Closed System" Requirements

DEA "Closed System" Requirements Peggy Kelley Thu, 10/25/2018 - 10:43 AM EDT

Description

U.S. Drug Enforcement Administration (DEA) “closed system” requirements call for all legitimate handlers of controlled substances to register and account for all distributions under the Controlled Substances Act of 1973 (CSA) and the Secure and Responsible Drug Disposal Act of 2010 (SRDDA) (DEA, 2006). In a closed system, record-keeping is required for controlled substances from the creation to disposal, thus keeping controlled substances within the system. Pharmaceutical controlled substances found outside this closed system are said to have been diverted (Brushwood, 2006).

Objective(s)

To regulate and track the distribution of prescription drugs containing controlled substances with the goal of limiting availability for diversion

Typical Elements

Under the CSA, registration and accounting of controlled substances is required for all manufacturers, distributers, hospitals, physicians, pharmacists, researchers, and others that handle controlled drugs (DEA, 2006). Under a closed system:

  • Authorized personnel must account for controlled substances at every phase of the process, from production through prescription, distribution, and return (as needed).
  • All individuals and organizations that manufacture, distribute, or handle controlled substances must register with the DEA (Yeh, 2012). The DEA must determine that the registration is “consistent with the public interest” (Yeh, 2012, p. 6), using such criteria as the expected effects on public health and safety, and registrant compliance with state and federal laws. The DEA can deny, suspend, or revoke registrations.
  • Individuals and organizations whose state licenses or registrations are revoked must surrender their DEA registration or face civil or criminal penalties. The “majority of investigations into possible violations of controlled substance laws are carried out by state authorities,” (DEA, 2006, p. 4); the DEA relies on state actions to determine whether to revoke registration.
  • End users (patients) are not required to register, as they are not part of the closed system (Yeh, 2012).
  • Registrants are required, for at least two years, to maintain accurate records and detailed inventories of all controlled substances manufactured, received, delivered, sold, stored, dispensed, or otherwise disposed of (Yeh, 2012).
  • Manufacturers must maintain records of all controlled substance shipments and must receive a special order form from registered purchasers before shipping Schedule I or II substances (Yeh, 2012).
  • Manufacturers must forward to the DEA filled paper orders for Schedule I or II substances within 30 days and filled electronic orders within 2 days (Yeh, 2012).
  • Manufacturers must complete Automated Reports and Consolidated Orders System reports for all shipments of Schedule I or II substances and certain Schedule III or IV substances (Yeh, 2012).
  • Registered Internet pharmacies must submit monthly reports to the DEA on the total amounts of dispensed controlled substances (Yeh, 2012).
  • Schedule I substances cannot be prescribed or dispensed to patients (Yeh, 2012).
  • Schedule II–V substances can be prescribed and dispensed to patients following DEA regulations for communicating prescriptions to pharmacies (Yeh, 2012).
  • The CSA authorizes the DEA to limit the annual production of Schedule I or II controlled substances (Yeh, 2012).
  • The CSA requires DEA registrants to “provide effective controls and procedures to guard against theft and diversion of controlled substances” and to be prepared to alter their security measures should a controlled substance change schedule classification (Yeh, 2012, p. 15).
  • DEA registrants can dispose of unwanted controlled substances in one of three ways (Yeh, 2012, p. 16):
    • “The distributor or dispenser may return the controlled substance to the pharmaceutical manufacturer who accepts returns of outdated or damaged controlled substances.
    • “The distributor, dispenser, or manufacturer may itself dispose of the controlled substances under procedures specified by federal regulation.
    • “The distributor, dispenser, or manufacturer may transfer the controlled substances to a ‘reverse distributor’ to take custody of the controlled substances for the purpose of returning them to the manufacturer or arranging for their disposal.”

The SRDDA expands the disposal options for DEA registrants and gives end users a legal mechanism to safely and securely dispose of controlled substances. Disposal options include takeback events, mail-back events, and authorized collection receptacles (DEA, 2012). Under the SRDDA:

  • Manufacturers, distributors, and pharmacies are authorized to voluntarily conduct mail-back events and maintain collection receptacles for use by the general public (the end users).
  • Law enforcement agencies have the authority to dispose of controlled substances, hold events, and maintain collection receptacles.
  • Registrants are “prohibited from manufacturing, distributing, or dispensing controlled substances not authorized under their specific registration,” under penalty of fines, imprisonment, or both (Yeh, 2012, p. 14).
  • Registrants who improperly dispense or request authorized controlled substances can be subject to U.S. Attorney General-ordered injunctions to cease improper operations or to declaratory judgments terminating their registration (Yeh, 2012).

Populations

Pharmaceutical companies, shipping companies, pharmacies, physicians, hospitals, consumers

Outcomes

No outcome data have been found regarding the role of DEA “closed system” requirements in preventing the nonmedical use of prescription drugs and/or its consequences.

Guidelines

A Security Outline of the Controlled Substances Act of 1970. 

Chemical Handler’s Manual: A Guide to Chemical Control Regulations. 

Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act. 

Practitioner’s Manual: An Informational Outline of the Controlled Substances Act. 

Acknowledged by

No acknowledgements have been found regarding the role of DEA “closed system” requirements in preventing the nonmedical use of prescription drugs and/or its consequences.

References

Brushwood, D.  B. (2006, May 31). A Balanced Approach to Chronic Pain Management: The Closed System of Controlled Substance Distribution. Retrieved from https://www.medscape.org/viewarticle/532074_2

U.S. Drug Enforcement Administration. (2006). Practitioner’s manual: An informational outline of the Controlled Substances Act. Washington, DC: U.S. Department of Justice. Retrieved from http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf

U.S. Drug Enforcement Administration. (2012). Disposal of controlled substances: Notice of proposed rule making. Federal Register, 77(246). Retrieved from http://www.deadiversion.usdoj.gov/fed_regs/rules/2012/fr1221_8.htm

Yeh, B. T. (2012). The Controlled Substances Act: Regulatory requirements. Washington, DC: Congressional Research Service. Retrieved from https://fas.org/sgp/crs/misc/RL34635.pdf

 

DEA Regulations for Communicating Controlled Substance Prescriptions to Pharmacies

DEA Regulations for Communicating Controlled Substance Prescriptions to Pharmacies Dot Wheeler Wed, 10/24/2018 - 01:54 PM EDT

Description

The U.S. Drug Enforcement Administration (DEA) regulations for communicating controlled substance prescriptions to pharmacies (including electronic prescriptions) outline the rules for submission of these prescriptions from licensed prescribing providers to pharmacies; in addition, the regulations clearly define the roles of practitioners’ secretaries, assistants, and other authorized agents.

Objective(s)

To ensure that prescriptions for controlled substances are medically valid and intentional, thereby reducing access to prescription drugs for diversion purposes

Typical Elements

The Comprehensive Drug Abuse Prevention and Control Act of 1970 “mandates that [the] DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances” (DEA, 2010b, p. 61613). To support this system and to ensure that it remains closed at the point of sale, the DEA created regulations for the communication of controlled substance prescriptions from licensed prescribing providers to pharmacies. Under these regulations:

  • Prescribers are prohibited from delegating the medical determination of need for a controlled substance (DEA, 2010b). Prescriptions must be issued by prescribers “acting in the usual course of their professional practice” (DEA, 2010b, p. 16237).
  • Providers are prohibited from delegating their signatory approval, their approval of the elements of a prescription, or their responsibility for ensuring that all required elements of a prescription are included: patient name and address; drug name and strength; quantity prescribed; directions for use; and the name, address, and DEA number of the issuing practitioner (DEA, 2010b).
    • Note: Agents who can be delegated prescription-related tasks are individuals who consent to act on behalf of the prescriber, who have the prescriber assent to act on their behalf, and who have a fiduciary relationship with the prescriber. In addition, a prescriber’s secretary, assistant, or other delegated agent can prepare the prescription.
  • Delegated agents are permitted to transmit prescriptions for Schedule III, IV, and V controlled substances (DEA, 2010b).
    • Pharmacies can only dispense Schedule III, IV, and V controlled substances with a written, oral, or faxed prescription.
    • Patients can only transmit written prescriptions
    • Prescribers or their delegated agents can transmit oral or faxed prescriptions in addition to written prescriptions.
    • Oral and faxed prescriptions must contain all the required elements except the signatory approval.
  • Prescriptions are required for Schedule II controlled substances to be dispensed with a written prescription, with the following exceptions (DEA, 2010b):
    • Emergency oral prescriptions can be transmitted only by a prescriber and must be followed up by a written prescription within seven days.
    • Schedule II prescriptions for individuals in a hospice or a long-term care facility can be transmitted by fax by a delegated agent.
  • For controlled drugs, electronic communications are permitted as a substitute for written prescriptions. However, any electronic transmittal system between prescribers and pharmacies must meet four primary DEA requirements to the greatest extent possible (DEA, 2010a):
    • Only licensed prescribers can sign electronic prescriptions, and prescriber offices must take steps to protect against theft of prescriber electronic IDs.
    • The system must be designed to prevent prescribers from denying that they authorized prescriptions.
    • The records of prescriptions must meet judicial system standards for use in legal actions without requiring large numbers of witnesses to verify records.
    • The system must be designed to prevent prescriptions from being altered after their creation and to prevent pharmacists from creating prescriptions.
  • The regulations acknowledge that the Medicare Modernization Act of 2003 requires Medicare Part D plans to support electronic prescription systems if any covered providers or pharmacies choose to implement them (AHRQ, 2015).
  • Pharmacists are encouraged to inquire about a prescription’s legitimacy (DEA, 2010b).

The regulations recognize six levels of sophistication in “e-prescribing” systems, with levels 5 and 6 including the electronic transmittal of prescriptions (Agency for Healthcare Research and Quality [AHRQ], 2015, p. 1):

  • Level 1: Electronic reference handbook
  • Level 2: Stand-alone prescription writer
  • Level 3: Patient-specific prescription creation or refilling
  • Level 4: Medication management (access to medication history, warnings, and alerts)
  • Level 5: Connectivity to dispensing site
  • Level 6: Integration with an electronic medical record
    • Note: All six levels have been found to decrease medication errors and improve patient safety to different degrees (AHRQ, 2015). AHRQ-funded evaluation of different e-prescribing systems is ongoing.

Populations

Prescribers, prescribers’ staff, pharmacists 

Outcomes

No outcome data have been found regarding the role of DEA regulations for communicating controlled substance prescriptions to pharmacies in preventing prescription drug misuse and/or its consequences.

Guidelines

Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies. 

Electronic Prescriptions for Controlled Substances. 

Acknowledged by

Agency for Healthcare Research and Quality. Electronic Prescribing. 

References

Agency for Healthcare Research and Quality. (2015). Electronic Prescribing. Retrieved from http://healthit.ahrq.gov/key-topics/electronic-prescribing

U.S. Drug Enforcement Administration. (2010a, March 31). Electronic prescriptions for controlled substances. Federal Register, 75 FR 16235 (pp. 16235–16319). Retrieved from https://www.federalregister.gov/articles/2010/03/31/2010-6687/electronic-prescriptions-for-controlled-substances

U.S. Drug Enforcement Administration. (2010b, October 6). Role of authorized agents in communicating controlled substance prescriptions to pharmacies. Federal Register, 75 FR 61613 (pp. 61613–61617). Retrieved from https://www.federalregister.gov/articles/2010/10/06/2010-25136/role-of-authorized-agents-in-communicating-controlled-substance-prescriptions-to-pharmacies

 

Mandatory Use of Prescription Drug Monitoring Programs

Mandatory Use of Prescription Drug Monitoring Programs Peggy Kelley Wed, 10/24/2018 - 03:26 PM EDT

Description

Mandatory use of prescription drug monitoring programs (PDMPs) is a legal mandate by the state for prescribers (and, in some states, dispensers) to register with and/or use the state PDMP when prescribing (or dispensing) a Schedule II drug or other controlled drug. A PDMP is a statewide electronic database that collects designated data on substances dispensed in the state. The PDMP is housed by a specified statewide regulatory, administrative, or law enforcement agency, which distributes data to professionals who are authorized under state law to receive this information (National Alliance for Model State Drug Laws [NAMSDL], 2009).

Objective(s)

To limit the over-prescription of opioids and other controlled substances by increasing prescribers’ and dispensers’ use of PDMPs

Typical Elements

State requirements regarding who must register with the PDMP and whether registrants are then required to use it vary (PDMP Center of Excellence [COE], 2014). States can require:

  • Only prescribers to register with a PDMP
  • Both prescribers and dispensers to register with the PDMP
  • Only certain prescribers to register with the PDMP, for example, those at pain management practices (National Alliance for Model State Drug Laws [NAMSDL], 2013)
  • Potential prescribers to register with the PDMP before they can prescribe controlled substances (NAMSDL, 2013)
  • Both prescribers and dispensers to actively use the PDMP
  • Prescribers to use the PDMP only under certain circumstances
    • Note: For example, in Nevada, prescribers must use the PDMP only when they suspect that a patient may seek the medicine for a reason other than treatment of a medical condition. In Oklahoma, use of the PDMP is required only when prescribing methadone (PDMP COE, 2014).
    • The status of PDMPs changes rapidly, and these examples may no longer be current. NAMSDL catalogs PDMP laws by state and is the best source for up-to-the-minute information.

When instituting mandatory use of PDMPs, states can require the following of prescribers:

  • Acquisition of licensed prescriber and pharmacist files from appropriate licensure boards (PDMP COE, 2014)
  • An online registration process for licensed prescribers and pharmacists that, based on licensee files, allows for automated verification of the applicant’s driver’s license number, prescriber or pharmacist license number, and DEA license number (PDMP COE, 2014)
  • A social marketing campaign to persuade medical professionals that the required use of the PDMP is in the best interests of patients and providers; the campaign should include evidence that PDMPs can help improve clinical decision-making without burdening medical workflow (PDMP COE, 2014)
  • Development and delivery of a Web-based training module on the use and benefits of PDMP data for prescribers and dispensers (PDMP COE, 2013)
  • Dedicated staff and resources to handle the increase in demand on the PDMP system (PDMP COE, 2014)
  • Stipulations on whether to make prescribers immune from liability for checking or failing to check the PDMP, to encourage use (Haffajee, Jena, & Weiner, 2015)
  • Guidance-based available evidence, and regular and rigorous evaluation of the requirements (Haffajee, Jena, & Weiner, 2015)
    • Note: Haffajee et al. (2015) recommend that policymakers “seriously explore and evaluate more positive approaches [to improving PDMP use], including pay-for-performance, malpractice discounts, or immunity from liability for prescribers who diligently use the systems” (p. 892). The authors note that while PDMP mandates can be effective, they should apply only to clinically appropriate circumstances.

Populations

Prescribers, dispensers, and users of controlled substances

Outcomes

Mandatory use of PDMPs has been linked to the following:

  • Lower incidence of doctor shopping in Tennessee and New York (PDMP COE, 2014)
  • A 35% growth in prescribers active on Utah’s PDMP (NAMSDL, 2013)
  • Increased use of the PDMP in Kentucky, New York, Tennessee, and Ohio (PDMP COE, 2014)
  • Fewer individuals with an opioid prescription and fewer prescriptions for all opioids in Tennessee and New York (PDMP COE, 2014)
  • A reduction in the overall dispensing of controlled substances in Kentucky (PDMP COE, 2014)

Guidelines

Mandating PDMP Participation by Medical Providers: Current Status and Experience in Selected States. 

Mandating PDMP Participation by Medical Providers: Current Status and Experience in Kentucky. 

State Advocacy Guide to Prescription Drug Monitoring Program Legislation and Regulations. 

Kentucky Meets Gold Standard for Prescription Drug Monitoring Programs. 

Acknowledged by

National Conference of Insurance Legislators. Best Practices to Address Opioid Abuse, Misuse and Diversion. 

References

Haffajee, R. L., Jena, A. B., & Weiner, S. G. (2015, March 3). Mandatory use of prescription drug monitoring programs. Journal of the American Medical Association, 313(9), 891–892. Retrieved from https://jamanetwork.com/journals/jama/fullarticle/2107540

National Alliance for Model State Drug Laws. (2013, September 25). Emerging PMP issues: Legal analysis. Presentation at the Harold Rogers PDMP National Meeting, Washington, D.C. Retrieved from http://www.pdmpassist.org/pdf/PPTs/National2013/26-9-A%20Green.pdf

National Alliance for Model State Drug Laws. (2009, August). Prescription Drug Monitoring Programs: A Brief Overview. Retrieved from  https://namsdl.org/wp-content/uploads/Prescription-Drug-Monitoring-Programs-PMPs-and-Health-Insurance-Portability-and-Accountability-Act-HIPAA-Brief-Overview.pdf

PDMP Center of Excellence. (2013). Mandating PDMP participation by medical providers: Current status and experience in Kentucky. Waltham, MA: Brandeis University. Retrieved from https://olis.leg.state.or.us/liz/2015R1/Downloads/CommitteeMeetingDocument/51774

PDMP Center of Excellence. (2014). Mandating PDMP participation by medical providers: Current status and experience in selected states. Waltham, MA: Brandeis University. Retrieved from https://docplayer.net/20900402-Mandating-pdmp-participation-by-medical-providers-current-status-and-experience-in-selected-states.html

Model Pain Clinic Regulations

Model Pain Clinic Regulations Peggy Kelley Thu, 10/25/2018 - 10:14 AM EDT

Description

Model pain clinic regulations are designed to prevent facilities from prescribing controlled substances indiscriminately or inappropriately.

Objective(s)

To reduce the over-prescription and/or inappropriate prescription of controlled substances

Typical Elements

The National Alliance for Model State Drug Laws (NAMSDL) and the National Safety Council (NSC) jointly developed model pain clinic regulations for states (NAMSDL & NSC, 2014).

  • Note: State definitions of “pain clinics” vary; however, they are generally defined as facilities that focus on treating and managing pain through the prescription and dispensation of controlled substances. While some pain clinics can become illicit “pill mills,” legitimate pain clinics are valid medical facilities (U.S. Department of Health and Human Services, 2013).

The model regulations recommend that states develop certification requirements, which allow pain clinics to demonstrate adherence to state regulations. NAMSDL and NSC recommend that the certification process include the following (NAMSDL & NSC, 2014):

  • A description and definition of key terms (such as “pain clinic”)
  • A description of the required certification processes and procedures for clinics, for example:
    • Posting the certificate in a clearly visible location
    • Submitting a new certification application when there are changes in clinic ownership
    • Making certifications valid for only one or two years, at which point they must be renewed
    • Making certifications valid for only a single physical location, and requiring each location to obtain a separate certification
    • Reporting modifications to a clinic’s name, address, and ownership to the relevant regulatory agency within a specified time frame
  • The criteria for denying or revoking certification, for example:
    • Lack of adherence to certification requirements
    • Lack of qualified staff
    • Lack of proper care
    • Felony conviction of a clinic’s owner or core staff member
    • Drug Enforcement Administration revocation of the clinic’s license number
    • Provision of false or misleading statements or materials to state authorities
    • Misdemeanors or felonies involving controlled substances
    • Failure to file required reports
    • Failure to maintain proper patient and prescription records
  • An explanation of which facilities are exempt from pain clinic regulations, for example (NAMSDL & NSC, 2014, pp. 14­–15):
    • Ambulatory surgical centers
    • Clinics that do not prescribe controlled substances for pain treatment
    • Surgical clinics that prescribe narcotics for post-operative pain
    • Hospices
    • Federally operated hospitals
    • Hospitals and associated outpatient facilities 
    • Medical or dental schools and associated outpatient clinics
    • Nursing homes  
    • Nursing schools and associated outpatient clinics
    • Osteopathic schools and associated outpatient clinics
    • Long-term care facilities
    • State-operated facilities
  • The penalties for operating, owning, or managing a non-exempt pain clinic without certification, which can include civil or criminal fines and prosecution
  • What is required of clinic owners (for example, holding certain licenses and/or board certifications, not having criminal convictions)

The model regulations recommend that states require pain clinics to do the following (NAMSDL & NSC, 2014):

  • Designate one person (such as a clinical director) who is responsible for day-to-day clinic operations and compliance
  • Ensure that certain individuals (including owners, medical directors, and clinic managers) are onsite for at least a certain percentage of the operating hours
  • Follow state restrictions regarding the prescription and dispensation of controlled substances (for example, requiring a physical exam prior to prescribing)
  • Interact with the state’s Prescription Drug Monitoring Program
  • Ensure that clinic professionals meet all state medical board requirements
  • Meet physical environment standards, for example (Office of National Drug Control Policy, 2011):
    • Sanitary facilities
    • Clearly posted signs and notifications
    • Adequate reception and waiting areas
    • Private examination rooms
    • Appropriate file storage
    • Locked storage for controlled substances
    • Restrooms for staff and patients
    • Counterfeit-resistant prescription pads
  • Follow state inspection requirements, such as procedures for allowing state inspectors to review patient records
  • Maintain and securely store records and/or collect certain data, for example (NAMSDL & NSC, 2014):
    • Patient identifiers
    • Medical history
    • Prescription monitoring reports
    • The chief complaint and diagnosis
    • Lab orders and results
    • Pathology and radiology reports
    • Substances prescribed or dispensed
    • A patient-signed agreement regarding treatment

Populations

Pain clinic directors, providers, patients

Outcomes

In Florida, when combined with other state initiatives and enforcement actions, model pain clinic regulations were associated with reductions in the following (Johnson, Paulozzi, Porucznik, Mack, & Herter, 2014):

  • Number of drug prescriptions
  • Number of prescribers dispensing a high volume of oxycodone prescriptions
  • Overdose deaths
  • Drug diversion rates

Guidelines

Menu of Pain Management Clinic Regulation.

State Statutes and Regulations Relative to Chronic Pain and Pain Management. Emphasis on Pain Management Clinics: Brief Summary of Federal Provisions. 

Acknowledged by

National Conference of Insurance Legislators.Best Practices to Address Opioid Abuse, Misuse and Diversion. 

Office of National Drug Control Policy. Epidemic: Responding to America’s Prescription Drug Abuse Crisis.

References

Johnson, H., Paulozzi, L., Porucznik, C., Mack, K., & Herter, B. (2014). Decline in drug overdose deaths after state policy changes—Florida, 2010–2012. Morbidity and Mortality Weekly Report, 63(26), 569–574. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a3.htm

National Alliance for Model State Drug Laws & National Safety Council. (2014). Prescription drug abuse, addiction and diversion: Overview of state legislative and policy initiatives. Part 2: State regulation of pain clinics and legislative trends relative to regulating pain clinics.

Office of National Drug Control Policy. (2011). Epidemic: Responding to America’s prescription drug abuse crisis. Retrieved from https://www.ncjrs.gov/pdffiles1/ondcp/rx_abuse_plan.pdf 

U.S. Department of Health and Human Services. (2013). Addressing prescription drug abuse in the United States: Current activities and future opportunities. Behavioral Health Coordinating Committee, Prescription Drug Abuse Subcommittee. Retrieved from https://www.cdc.gov/drugoverdose/pdf/HHS_Prescription_Drug_Abuse_Report_09.2013.pdf

 

Physical Exam Prior to Prescribing

Physical Exam Prior to Prescribing Peggy Kelley Thu, 10/25/2018 - 10:34 AM EDT

Description

A physical exam prior to prescribing requires healthcare providers, under state law, to obtain a patient history, perform a patient evaluation, and/or document the existence of a bona fide physician-patient relationship prior to prescribing controlled substances.

Objective(s)

To limit unnecessary access to controlled substances

Typical Elements

The exact requirements vary by and within states, depending on the type of prescription (Centers for Disease Control and Prevention [CDC], 2015):

  • States can include a patient examination as part of their prescribing regulations, forbid pharmacists from filling prescriptions if they suspect that an examination did not occur, or both. 
    • Note: Forty-one states and the District of Columbia require prescribers or dispensers to ensure that prescriptions are the result of a patient examination.
  • State provisions regarding the type of exams required vary (CDC, 2015):
    • Physical exams are required in Alabama, Alaska, Arizona, Arkansas, Connecticut, Delaware, Florida, Georgia, Hawaii, Indiana, Iowa, Kentucky, Louisiana, Maine, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and the District of Columbia.
    • An “appropriate” or “sufficient” examination, instead of or in addition to a physical exam, is required in California, Connecticut, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, Texas, Vermont, and the District of Columbia.
    • An unspecified examination (meaning there are no specific standards for that examination) is required in California, Idaho, Iowa, Kentucky, Montana, Nebraska, Nevada, New Jersey, Oregon, and South Carolina.
  • State provisions regarding the types of prescriptions that require exams likewise vary (CDC, 2015):
    • Exams are for required for all drug types, including controlled substances, in Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, and the District of Columbia.
    • Pain management prescriptions require an exam in Alabama, Florida, Iowa, Kentucky, Louisiana, Maine, New Jersey, New Mexico, Ohio, Oklahoma, Tennessee, Texas, Washington, and the District of Columbia.
    • Specific controlled substances, specific schedules of controlled substances, and/or drugs for the treatment of specific disorders require exams in Arkansas, Iowa, Kentucky, Louisiana, Minnesota, Mississippi, Nevada, New Jersey, Ohio, Oklahoma, Rhode Island, South Carolina, Utah, and Washington State.
  • States vary in the penalties imposed for prescribing without an exam (CDC, 2015):
    • Failure to conduct a required exam is considered unprofessional conduct and punishable by the licensing board in Alabama, Arizona, California, Delaware, Michigan, Nevada, New Hampshire, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, and Wisconsin.
    • Failure to conduct a required exam can lead to license or application revocation or rejection in Florida and Tennessee.
    • Failure to conduct a required exam leads to criminal liability in Kentucky, Louisiana, and Virginia.
    • Licensing boards will report failure to conduct an exam to the attorney general in Arkansas.

Populations

Prescribers, pharmacists

Outcomes

No outcome data have been found regarding the role of physical exams prior to prescribing in preventing the nonmedical use of prescription drugs and/or its consequences.

Guidelines

Prescription Drug Physical Examination Requirements. 

Acknowledged by

No acknowledgements have been found regarding physical exams prior to prescribing in preventing the nonmedical use of prescription drugs and/or its consequences

References

Centers for Disease Control and Prevention. (2015). Prescription drug physical examination requirements. Retrieved from https://www.cdc.gov/phlp/docs/pdpe-requirements.pdf

 

Prescriber Requirements to Regularly See Pain Management Patients

Prescriber Requirements to Regularly See Pain Management Patients Peggy Kelley Thu, 10/25/2018 - 10:38 AM EDT

Description

Prescriber requirements to regularly see pain management patients are instituted by states or state medical boards, who can require regular visits to patients who have been prescribed opioids—monitoring their dosages, re-evaluating their continued need and their treatment plans, and monitoring them for warning signs of addiction or abuse (National Alliance for Model State Drug Laws, 2010).

Objective(s)

To monitor and control the use of opioids by pain management patients

Typical Elements

  • Note: The Federation of State Medical Boards (FSMB) released model policies for the prescription of opioids in 1998, with updates released in 2004 and 2013. Most state medical boards have implemented regulations based on these model policies (FSMB, n.d., 2013).

The state- or state medical board-imposed requirements can include the following elements:

  • Prescriber understanding of best practices in pain management (FSMB, 2013)
  • A comprehensive initial exam provided to patients prior to prescribing opioids (FSMB, 2013)
  • Individual treatment plans and goals developed in collaboration with the patient (FSMB, 2013)
  • Individual treatment contracts developed in collaboration with the patient, outlining the rights and responsibilities of the patient and the prescriber regarding the use of opioids (Bendix, Verdon, & Zimlich, 2013)
  • Implementation of opioid trial periods—which include set evaluation points and feature regular adjustments in prescription dosage until the appropriate amount is set—prior to issuing long-term prescriptions (FSMB, 2013)
  • Ongoing monitoring of long-term opioid use, adjusting the treatment plan and goals based on the results of regular, in-person patient visits (FSMB, 2013)
    • Note: Patients who regularly delay or miss scheduled monitoring sessions are often at risk for developing substance use disorders (Oliver & Taylor, 2003). As part of the monitoring process, prescribers are often required to see opioid patients at least once per month and whenever a prescription needs renewal.
  • Documentation of patient medication status, functional impairment, and awareness during the re-evaluation process (Oliver & Taylor, 2003)
  • Periodic urine testing to assess treatment plan adherence and to determine the presence of non-prescribed opioids, as appropriate (FSMB, 2013)
  • Referral of patients to substance abuse or mental health professionals, as necessary (FSMB, 2013)
  • Discontinuation of opioid use after additional consultation with a patient if the treatment plan goals are being met (FSMB, 2013)
  • Maintenance of comprehensive medical records (FSMB, 2013)
  • Compliance with DEA “closed system” requirements and regulations regarding transmitting prescriptions to pharmacies (FSMB, 2013)
    • Note: Requirements to regularly see pain management patients are based on the premise that unintentional and inappropriate prescriptions are primarily the result of prescribers’ insufficient understanding of a patient’s initial assessment, overuse of opioid prescriptions to treat pain, inadequate monitoring of opioid use, failure to adhere to patient education and informed consent practices, improper dosing, and/or failure to use opioid risk mitigation strategies (FSMB, 2013).

Populations

Prescribers, patients using controlled substances

Outcomes

No outcome data have been found regarding the role of prescriber requirements to regularly see patients in preventing the nonmedical use of prescription drugs or its consequences.

Guidelines

Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain. 

Pain Management Polices: Board-by-Board Overview. 

Acknowledged by

No acknowledgements have been found regarding the role of prescriber requirements to regularly see patients in preventing the nonmedical use of prescription drugs or its consequences.

References

Bendix, J., Verdon, D. R., & Zimlich, R. (2013). The true cost of pain management in your practice: Physicians cite need for better communication to successfully treat pain and monitor for possible abuse. Medical Economics, 90(5), 30–33. 

Federation of State Medical Boards. (n.d.). Pain management policies: Board-by-board overview. Retrieved from http://www.fsmb.org/siteassets/advocacy/key-issues/pain-management-by-state.pdf

Federation of State Medical Boards. (2013). Model policy on the use of opioid analgesics in the treatment of chronic pain. Retrieved from http://www.azdo.gov/Files/FSMBPainMgmt.pdf

National Alliance for Model State Drug Laws. (2010). Pain management and pain clinics: State statutes and regulations. Retrieved from https://namsdl.org/wp-content/uploads/State-Statutes-and-Regulations-Relative-to-Chronic-Pain-and-Pain-Management.pdf

Oliver, R. L., & Taylor, A. (2003). Chronic opioid rules: Prescribing opioids for chronic pain requires set rules, a written plan, periodic re-evaluation, and vigilance to prevent illegal diversion of controlled substances. Practical Pain Management, 3(2), 1–8. Retrieved from https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/chronic-opioid-rules

 

Prescription Drug Monitoring Programs

Prescription Drug Monitoring Programs Peggy Kelley Thu, 10/25/2018 - 10:35 AM EDT

Description

A prescription drug monitoring program (PDMP) is a statewide electronic database that tracks the prescribing and dispensing of opioid analgesics and other controlled substances in the state. The PDMP is housed by a specified statewide regulatory, administrative, or law enforcement agency, which distributes data to individuals who are authorized under state law to receive it, such as prescribers, pharmacists, law enforcement officers, and licensing officials (National Alliance for Model State Drug Laws [NAMSDL], 2009).

Objective(s)

To decrease access to and the availability of opioids and other controlled substances by limiting their over-prescription

Typical Elements

Across states, PDMPs can vary in a number of ways, for example: 

  • Which controlled substances (Schedules II–V) are tracked
  • The agency that houses the database (health/regulatory, law enforcement, or administrative)
  • Authorized users (prescribers, pharmacists, state licensing officials, and/or law enforcement)
  • Registration and usage requirements
  • Reporting style (proactive vs. reactive)
    • Note: A reactive PDMP generates reports only in response to a specific inquiry made by a prescriber, dispenser, or other party with appropriate authority. A proactive PDMP identifies and investigates potential cases of misuse, generating unsolicited reports whenever suspicious behavior is detected.

Prescribers

  • Prescribers use a secure website to access the PDMP in order to do the following:
    • Check prescription histories prior to issuing new prescriptions
    • Collect and enter prescription information for all applicable classes of controlled substances (Schedules II–V) (Clark, Eadie, Kreiner, & Strickler, 2012; Perrone & Nelson, 2012)
  • Prescribers can also participate in training programs on the purpose of the PDMP and the importance of routinely consulting the database when prescribing opioids or other controlled substances (Clark et al., 2012).
    • Note: As of August 2014, 48 states and Guam had operational PDMPs, while New Hampshire and the District of Columbia had statutory authority for PDMPs but had not yet operationalized their programs (Haegerich, Paulozzi, Manns, & Jones, 2014; NAMSDL, 2015).
  • When electronic prescribing is not possible, prescribers use a serialized, tamperproof prescription form to help prevent forgeries and counterfeits (Clark et al., 2012).
    • Note: Online accessibility (instead of access by mail or fax) results in higher rates of PDMP use by prescribers and pharmacists (Fleming, Chandwani, Barner, Weber, & Okoro, 2013).

Pharmacy Workers

Pharmacy workers use PDMPs in a number of ways:

  • Submitting information on prescriptions dispensed, either in real time or no more than seven days from the date the prescription was dispensed (Clark et al., 2012; Perrone & Nelson, 2012)
  • Recording that patients showed positive identification when picking up prescriptions and how patients paid for their prescriptions (including cash transactions)
  • Checking for data on prescriber disciplinary action and patient lock-in status to ensure that the presented prescription is advisable to dispense
    • Note: In law enforcement-governed PMDPs, healthcare provider use was lower than with PDMPs governed by health or pharmacy boards (Fleming et al., 2013).

PDMP Regulators/Administrators

Those responsible for regulation or administration of the PDMP must do the following:

  • Consider whether to require registration and/or use of the PDMP, for which users, and under what circumstances (Haffajee, Jena, & Weiner, 2015)

    • Note: Haffajee et al. (2015) suggest that to encourage PDMP use, “policymakers should seriously explore and evaluate more positive approaches [instead of PDMP mandates], including pay-for-performance, malpractice discounts, or immunity from liability for prescribers who diligently use the systems” (p. 892).
  • Integrate electronic medical records and Electronic Prescribing of Controlled Substances systems with PDMP data (Clark et al., 2012):
    • As prescribers enter the name of a drug for e-prescription, the patient’s history from the PDMP automatically appears on the prescriber’s device
    • As each e-prescription is sent to a pharmacy, a copy is routed to the PDMP
    • When the e-prescription is dispensed, the PDMP matches the pharmacy’s dispensing record to the corresponding e-prescription from the prescriber to detect any unauthorized modifications; if using a proactive PDMP, the regulator or administrator reports the unauthorized modifications to the appropriate agency
  • Limit access to information by pharmacists, law enforcement, prescribers, and other authorized users
  • When conducting analyses, de-identify PDMP records to hide patient-level information while retaining linked individual records in a dataset (Clark et al., 2012)
    • Note: The database contains patient-level data, transmitted in real time, through encryption, during the patient’s visit. A patient report includes prior controlled substance prescriptions, the substance prescribed (including generic name), the dose prescribed, the dispense date, the prescriber’s name, the pharmacy used, and the address(es) used by the patient (Baehren et al., 2010; Perrone & Nelson, 2012).
  • Establish cross-state data-sharing agreements to limit “doctor shoppers”  from crossing state lines to obtain more prescriptions
    • Note: States need Memoranda of Understanding (MOUs) to make sure that data are shared fairly, securely, and in compliance with regulations. Questions to consider when creating an MOU (Finklea, Sacco, & Bagalman, 2014):
    • How is the information to be reported?
    • How will the relevant states use the information?
    • What are the guidelines for data retention?
    • If a data breach occurs, what are the state’s responsibilities?
    • Are there conflict-resolution procedures?
    • What are the consequences of data misuse?
  • Establish a proactive PDMP, where possible, and follow proactive PDMPs’ best practices—for example, provide unsolicited reports to prescribers, dispensers, licensing boards, and law enforcement (PDMP Center of Excellence [COE], 2014)
  • Determine criteria that the PDMP will use to identify risky behavior by a patient, a prescriber, or a dispenser that would cause the system to issue an unsolicited report, for example (PDMP COE, 2014):
    • If a patient is prescribed opioids by four different prescribers and gets medications filled from four different pharmacies within a three-month time frame
    • If a patient visits more than one pharmacy on the same day
    • If a patient uses more than one payment method within a short time period
    • If a prescriber prescribes dosages outside accepted norms
    • If a dispenser has high rates of cash payments (especially for prescriptions duplicating those covered by Medicaid)
    • If a dispenser fills duplicate or excessive prescriptions without seeking prescriber confirmation
  • Minimize over-reporting by using specific data parameters
    • Note: Too many false positives might produce “alert fatigue” among users and undermine credibility. The optimal criteria for unsolicited reporting can vary by state.
  • Educate and train report recipients to understand the meaning, uses, and data limitations of unsolicited reports
  • Communicate with report recipients to determine whether the reports are helpful to them or whether the criteria should be adjusted
  • Consult with practitioner groups and law enforcement agencies to determine activities that will warrant criminal investigation
  • Facilitate cross-agency communication on unsolicited reports concerning practitioners to make sure that aberrant prescribers or dispensers are referred to the appropriate agency (licensing boards vs. drug control) and that investigations will not be compromised
  • Track the outcomes and effects of unsolicited reporting (for example, on PDMP use, aberrant prescribing, and doctor shopping), using PDMP data and data from other relevant sources

Populations

Prescribers, dispensers, and users of controlled substances

Outcomes

PDMPs are associated with the following outcomes:

  • In Ohio, altering opioid prescription behavior among emergency department prescribers for patients with non-traumatic pain management (Baehren et al., 2010)
  • In North Carolina, increasing prescriber confidence in prescribing (and denying) prescriptions for controlled substances (Garrettson & Ringwalt, 2013)
  • In both Connecticut and Rhode Island, increasing the number of doctors who take a clinical response (such as screening for drug abuse, revisiting the pain/treatment agreement, or referring the patient to substance abuse treatment) when confronted with possible doctor shopping or suspicious behavior, rather than a legal intervention or inaction (Green et al., 2012)
  • In Nevada (PDMP COE, 2011) and France (Pradel et al., 2009), a reduction in indicators of doctor shopping
  • In British Columbia, a reduction in inappropriately filled prescriptions for opioids and benzodiazepines (Dormuth et al., 2012)
  • In Virginia, a reduction in the time spent by law enforcement and regulatory investigators on suspected drug diversion cases (U.S. General Accounting Office, 2002; Virginia Department of Health Professions & Virginia State Police, 2004)

Compared to states without PDMPs, states with PDMPs have significant reductions in the following:

  • Oxycodone shipments (Reisman, Shenoy, Atherly, & Flowers, 2009)
  • Prescription opioid treatment admissions per year (Reisman et al., 2009)
    • Note: The greatest reductions in per capita supply of prescription pain relievers and stimulants occurred in states with a proactive PDMP (Simeone & Holland, 2006).
  • The supply and abuse of Schedule II opioids, with proactive programs having a larger impact than reactive programs (Simeone & Holland, 2006)
  • Benzodiazepine use, especially among young women; persons living in zip codes that are urban, comprise predominantly black populations, or have a high density of poor households (Ross-Degnan et al., 2004); and those with a seizure disorder (Simoni-Wastila et al., 2004)
  • Drug abuse or misuse over time, both in the general population and within the population seeking treatment at opioid treatment programs (Reifler et al., 2012)
    • Note: One study found decreased retail distribution of Schedule II opioid analgesics but increased retail distribution of Schedule III opioid analgesics in states with PDMPs compared to those without PDMPs (Twillman, 2006).

Guidelines

Components of a Strong Prescription Monitoring Program. 

Guidance on PDMP Best Practices: Options for Unsolicited Reporting. 

Memorandum of Understanding: Writing Guide for States with Prescription Monitoring Programs. 

Model Prescription Monitoring Program (PMP) Act. 

Prescription Drug Monitoring Programs

Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices. 

State Prescription Monitoring Statues and Regulations List.   

Acknowledged by

U.S. Department of Health and Human Services, Behavioral Health Coordinating Committee. Addressing Prescription Drug Abuse in the United States: Current Activities and Future Opportunities.

U.S. Department of Justice, Bureau of Justice Assistance. Prescription Drug Monitoring Program (PDMP).

National Conference of Insurance Legislators. Best Practices to Address Opioid Abuse, Misuse and Diversion. 

Office of National Drug Control Policy. Epidemic: Responding to America’s Prescription Drug Abuse Crisis.

References

Baehren, D. F., Marco, C. A., Droz, D. E., Sinha, S., Callan, M., & Akpunonu, P. (2010). A statewide prescription monitoring program affects emergency department prescribing behaviors. Annals of Emergency Medicine, 56(1), 19–23. Retrieved from  https://cdn.ymaws.com/californiaacep.org/resource/resmgr/files/Safe_Prescribing_Resources/A_Statewide_Prescription_Mon.pdf

Clark, T., Eadie, J., Kreiner, P., & Strickler, G. (2012). Prescription drug monitoring programs: An assessment of the evidence for best practices. Philadelphia, PA: The Pew Charitable Trusts. Retrieved from http://www.pdmpassist.org/pdf/Resources/Evidence_PDMP_Best_Practices_Report.pdf

Dormuth, C. R., Miller, T. A., Huang, A., Mamdani, M. M., Juurlink, D. N., & Canadian Drug Safety and Effectiveness Research Network. (2012). Effect of a centralized prescription network on inappropriate prescriptions for opioid analgesics and benzodiazepines. Canadian Medical Association Journal, 184(16), E852–E856.

Finklea, K., Sacco, L. N., & Bagalman, E. (2013). Prescription drug monitoring programs. Washington, DC: Congressional Research Service. Retrieved from https://www.researchgate.net/publication/290978748_Prescription_drug_monitoring_programs

Fleming, M. L., Chandwani, H., Barner, J. C., Weber, S. N., & Okoro, T. T. (2013). Prescribers and pharmacists requests for Prescription Monitoring Program (PMP) data: Does PMP structure matter? Journal of Pain and Palliative Care Pharmacotherapy, 27(2), 136–142.

Garrettson, M., & Ringwalt, C. (2013). An evaluation of the North Carolina controlled substances reporting system: Part I user surveys. Washington, DC: U.S. Department of Justice, Bureau of Justice Assistance. Retrieved from https://c.ymcdn.com/sites/safestates.site-ym.com/resource/resmgr/imported/Garrettson.pdf

Green, T. C., Mann, M. R., Bowman, S. E., Zaller, N., Soto, X., Gadea, J., . . . Friedmann, P. D. (2012). How does use of a prescription monitoring program change medical practice? Pain Medicine, 13(10), 1314–1323.

Haegerich, T. M., Paulozzi, L. J., Manns, B. J., & Jones, C. M. (2014). What we know, and don’t know, about the impact of state policy and systems-level interventions on prescription drug overdose. Drug Alcohol Dependence, 145, 34–47.

Haffajee, R. L., Jena, A. B., & Weiner, S. G. (2015). Mandatory use of prescription drug monitoring programs. Journal of the American Medical Association, 313(9), 891–892.

National Alliance for Model State Drug Laws.(2009, August). Prescription Drug Monitoring Programs: A Brief Overview. Retrieved from  https://namsdl.org/wp-content/uploads/Prescription-Drug-Monitoring-Programs-PMPs-and-Health-Insurance-Portability-and-Accountability-Act-HIPAA-Brief-Overview.pdf

National Alliance for Model State Drug Laws. (2015). Annual review of prescription monitoring programs. Retrieved from http://www.namsdl.org/library/3449DDCF-BB94-288B-049EB9A92BAD73DF/

Paulozzi, L. J., Kilbourne, E. M., & Desai, H. A. (2011). Prescription drug monitoring programs and death rates from drug overdose. Pain Medicine, 12(5), 747–754. 

Paulozzi, L. J., & Stier, D. D. (2010). Prescription drug laws, drug overdoses, and drug sales in New York and Pennsylvania. Journal of Public Health Policy, 31(4), 422–432.

PDMP Center of Excellence. (2011). Nevada’s proactive PMP: The impact of unsolicited reports. Notes from the Field 2.5. Waltham, MA: Brandeis University. Retrieved from http://www.pdmpassist.org/pdf/Resources/nevada_nff_10_26_11.pdf

PDMP Center of Excellence. (2014). Guidance on PDMP best practices: Options for unsolicited reporting. Waltham, MA: Brandeis University. Retrieved from http://www.pdmpassist.org/pdf/COE_documents/Add_to_TTAC/Update%20to%20Brandeis%20COE%20Guidance%20on%20Unsolicited%20Reporting%20final.pdf

Perrone, J., & Nelson, L. S. (2012). Medication reconciliation for controlled substances—An “ideal” prescription-drug monitoring program. New England Journal of Medicine, 366(25), 2341–2343.

Pradel, V., Frauger, E., Thirion, X., Ronfle, E., Lapierre, V., Masut, A., . . . Micallef, J. (2009). Impact of a prescription monitoring program on doctor-shopping for high dosage buprenorphine. Pharmacoepidemiology and Drug Safety, 18(1), 36–43.

Reifler, L. M., Droz, D., Bailey, J. E., Schnoll, S. H., Fant, R., Dart, R. C., & Bartelson, B. B. (2012). Do prescription monitoring programs impact state trends in opioid abuse/misuse? Pain Medicine, 13(3), 434–442.

Reisman, R. M., Shenoy, P. J., Atherly, A. J., & Flowers, C. R. (2009). Prescription opioid usage and abuse relationships: An evaluation of State Prescription Drug Monitoring Program efficacy. Substance Abuse: Research and Treatment, 3, 41–51.

Ross-Degnan, D., Simoni-Wastila, L., Brown, J. S., Gao, X., Mah, C., Cosler, L. E., . . . Soumerai, S. B. (2004). A controlled study of the effects of state surveillance on indicators of problematic and non-problematic benzodiazepine use in a Medicaid population. International Journal of Psychiatry in Medicine, 34(2), 103–123.

Simeone, R., & Holland, L. (2006). An evaluation of prescription drug monitoring programs. Washington, DC: U.S. Department of Justice, Office of Justice Programs. Retrieved from http://www.simeoneassociates.com/simeone3.pdf

Simoni-Wastila, L., Ross-Degnan, D., Mah, C., Gao, X., Brown, J., Cosler, L. E., . . . Soumerai, S. B. (2004). A retrospective data analysis of the impact of the New York triplicate prescription program on benzodiazepine use in Medicaid patients with chronic psychiatric and neurologic disorders. Clinical Therapeutics, 26(2), 322–336.

Twillman, R. (2006). Impact of prescription monitoring programs on prescription patterns and indicators of opioid abuse. Journal of Pain, 7(4S), S6.

U.S. General Accounting Office. (2002). Prescription drugs: State monitoring programs provide useful tool to reduce diversion (Report No. GAO-02-634). Retrieved from http://www.gao.gov/new.items/d02634.pdf

Virginia Department of Health Professions & Virginia State Police. (2004). Prescription monitoring program: Report of the Virginia Department of Health Professions and Virginia State Police. Richmond, VA: Authors.

Requiring Patient Identification Prior to Prescription Drug Dispensation

Requiring Patient Identification Prior to Prescription Drug Dispensation Peggy Kelley Thu, 10/25/2018 - 10:46 AM EDT

Description

Requiring patient identification prior to prescription drug dispensation is one of many methods by which states limit the sale of prescription drugs. States can require pharmacists to request identification (ID) prior to dispensing a controlled substance, and require patients to show ID prior to picking up a controlled substance prescription.

Objective(s)

To better control access to prescription drugs

Typical Elements

  • As of 2013, 33 states require pharmacists to request patient IDs before dispensing a controlled substance (National Alliance for Model State Drug Laws [NAMSDL], 2013).
  • Twenty-four states require patients to show ID before picking up a controlled substance prescription, either in all cases or under specific circumstances (Centers for Disease Control and Prevention [CDC], n.d.).
  • States vary in their regulations governing whether or when a patient ID is required prior to dispensing a controlled substance (CDC, n.d.; NAMSDL, 2013). For example:
    • Delaware requires ID for any controlled substances.
    • Connecticut, Hawaii, Idaho, Indiana, Louisiana, Maine, Michigan, Minnesota, New Mexico, New York, North Dakota, Oklahoma, South Carolina, Texas, and Virginia require ID if the patient is unknown to the pharmacist.
    • Florida, Idaho, Massachusetts, Nevada, New Mexico, Virginia, and West Virginia require ID when certain potentially suspicious criteria are present (for example, the patient pays in cash, or the patient has prescriptions for the same or similar controlled substances from more than one practitioner).
    • Florida, Georgia, Illinois, Maine, Minnesota, New Mexico, North Carolina, Vermont, Virginia, and West Virginia require ID for specific schedules of prescription drugs.
    • Florida, Maine, North Carolina, Oregon, and Virginia allow pharmacists to use their own discretion when dispensing controlled substances.
    • Maine requires ID for out-of-state prescriptions.
    • Idaho, Minnesota, and Nevada require ID if the prescription is not covered at least in part by a health plan.
  • States also vary in the types of ID required (CDC, n.d.; NAMSDL, 2013):
    • Connecticut, Florida, Louisiana, and Minnesota accept any photo ID.
    • Massachusetts and Oklahoma accept any government ID.
    • Delaware, Hawaii, Idaho, Nevada, New Mexico, South Carolina, and West Virginia accept photographic government ID.
    • Illinois, Indiana, New York, Oregon, and Texas accept “positive” or “appropriate” (or similar language) documents or ID, such as a government or photo ID.
      • Note: State statutes vary to the extent that they specify the requirements of these IDs, with some states requiring a combination of photo and government ID and others only requiring “appropriate identification.” Common requirement-fulfilling IDs are driver’s licenses, military IDs, employer IDs, and college IDs.
  • State provisions vary in defining the circumstances when a pharmacist can dispense to a patient without ID in spite of a state ID law (CDC, n.d.; NAMSDL, 2013):
    • Florida, Hawaii, Massachusetts, and Vermont allow this if the pharmacist can confirm a patient’s identity and/or the validity of the prescription by other means.
    • Massachusetts, Michigan, and Texas allow this if the pharmacist determines that not dispensing the medication will be detrimental to the patient’s health.
  • States vary in their requirements for pharmacist documentation (CDC, n.d.; NAMSDL, 2013):
    • In Connecticut, Delaware, Florida, Hawaii, Idaho, Indiana, Maine, Massachusetts, Nevada, Oklahoma, South Carolina, and Virginia, pharmacists must record the “unique number” and/or ID source.
    • In Florida, Hawaii, Idaho, Nevada, and Virginia, pharmacists must obtain a photocopy of the ID.
    • In Hawaii and Idaho, pharmacists must capture the patient’s signature.

Populations

Pharmacists

Outcomes

No outcome data have been found regarding the role of requiring patient identification prior to prescription drug dispensation in preventing the nonmedical use of prescription drugs and/or its consequences.

Guidelines

Pharmacist’s Manual—Sections IX–XIV. 

States that Require an ID From a Recipient Prior to Dispensing Prescriptions for Controlled Substances. 

Acknowledged by

National Alliance for Model State Drug Laws. Model Prescription Accountability Act. 

References

Centers for Disease Control and Prevention. (n.d.). Menu of state prescription drug identification laws. Retrieved from https://www.cdc.gov/phlp/docs/menu-pdil.pdf

National Alliance for Model State Drug Laws. (2013). States that require an ID from a recipient prior to dispensing prescriptions for controlled substances. Retrieved from https://namsdl.org/wp-content/uploads/States-that-Require-ID-Prior-to-Dispensin.pdf

Triplicate Prescription Programs (TPP)

Triplicate Prescription Programs (TPP) Peggy Kelley Thu, 10/25/2018 - 10:48 AM EDT

Description

Triplicate prescription programs (TPPs), also known as “Multiple Copy Prescriptions or “Trip (Triplicate) Scrips,” require physicians to issue prescriptions for certain controlled substances using multiple copy forms, with the extra copies either retained for record-keeping purposes or submitted to pharmacies and/or monitoring agencies. Some states used TPPs as precursors to modern PDMPs.

Objective(s)

To monitor the prescribing of controlled substances

Typical Elements

  • States can elect to use TPP to supplement their electronic monitoring programs (Simoni-Wastila & Toler, n.d.).
  • Prescription forms are pre-numbered sequentially and tinted to make reproduction and fraud more difficult (Department of Health and Human Services [DHHS], 1992).
  • Prescribers obtain their prescription forms from state-approved security printers (Simoni-Wastila & Toler, n.d.).
    • Note: Hawaii does not require use of a state-issued form, but only requires a form that is in triplicate (DHHS, 1992).
  • In triplicate programs, the prescriber keeps one copy of the prescription, another is kept by the pharmacist and the third is sent to a State agency by the pharmacist. The state agency keeps the form as data and retrospectively analyzes to identify aberrant prescribing, dispensing, or using (DHHS, 1992).

Populations

Prescribers, pharmacists

Outcomes

After the first year of the program (DHHS, 1992):

  • Texas experienced a 52% reduction in Schedule II prescriptions (and an additional 16% reduction after the second year.
  • Rhode Island experienced a 36.3% reduction.

Illinois experienced a 109% increase in Schedule II prescriptions (e.g., morphine sulfate) between 1985 and 1989 after implementation (DHHS, 1992).

In Chicago, IL, emergency room data mentioning pentazocine (narcotic analgesic) decreased by 92% after the introduction of the multiple copy prescription program (DHHS, 1992)

NY Triplicate Program for Benzodiazepines was associated with significant reductions in (Pearson et al., 2006):

  • Problematic benzodiazepine use
  • Pharmacy hopping
  • Non-problematic benzodiazepine use

Non-problematic and potentially problematic use decreased the most among African Americans, despite already having a lower baseline use rate than the white or Hispanic use (Pearson et al., 2006).

Guidelines

Multiple copy prescription programs: State experiences. 

State-issued prescription forms.

Triplicate Prescription Program.

Acknowledged by

No acknowledgements have been found regarding the role of triplicate prescription programs in preventing prescription drug misuse and/or its consequences.

References

Department of Health and Human Services. (1992). Multiple copy prescription programs: State experiences (DHHS Publication No. OEI-12-91-00490). Washington, DC: U.S. Government Printing Office.

New York Department of Health. (2016). Electronic prescribing. Retrieved from http://www.health.ny.gov/professionals/narcotic/electronic_prescribing/.

Pearson, S., Soumerai, S., Mah, C., Zhang, F., Simoni-Wastila, L., Salzman, C., . . . Ross-Degnan, D. (2006). Racial disparities in access after regulatory surveillance of benzodiazepines. Archives of Internal Medicine, 166(5), 572–579. doi: 10.1001/archinte.166.5.572

Simoni-Wastila, L., & Toler, W. (n.d.). State-issued prescription forms. Retrieved from https://c.ymcdn.com/sites/www.safestates.org/resource/resmgr/imported/Simoni%20Wastila.pdf

 

Retail Access Restrictions

Retail Access Restrictions Peggy Kelley Thu, 10/25/2018 - 02:06 PM EDT

Retail access restrictions involve policies and regulations that limit access to commonly abused prescription drugs. When a person goes to a pharmacy to fill a prescription, there may be rules and guidelines on how many pills can be dispensed at a time, or how many prescriptions can be dispensed at once. These restrictions can be instituted by government entities, but also by health insurance companies. The main idea is to limit the amount or type of prescription drugs one person can obtain individually in order to reduce doctor shopping behavior and to reduce the amount of controlled drugs in circulation throughout the community. The evidence of the effectiveness of these strategies are limited but promising. For example, doctor shopping laws when implemented in conjunction with Prescription Drug Monitoring Programs have been associated with a reduction in doctor shopping behavior and obtainment of nonmedically-necessary prescriptions.1 In addition, Patient Review and Restriction Programs have been associated with a reduction in expenditures and use of controlled substances.2

Retail access restrictions, summarized here, include the following:

1 Pearson, S.-A., Soumerai, S., Mah, C., Zhang, F., Simoni-Wastila, L., Salzman, C.,  . . .  Ross-Degnan, D. (2006). Racial disparities in access after regulatory surveillance of benzodiazepines. Archives of Internal Medicine, 166(5), 572–579. Retrieved from https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/409923

Pradel, V., Frauger, E., Thirion, X., Ronfle, E., Lapierre, V., Masut, A.,  . . .  Micallef, J. (2009). Impact of a prescription monitoring program on doctor-shopping for high dosage buprenorphine. Pharmacoepidemiology and Drug Safety, 18(1), 36–43.

2 Blake, S. G. (1999, March). Drug expenditures: The effect of the Louisiana Medicaid lock-in on prescription drug utilization and expenditures. Drug Benefit Trends, 11(3), 45–55; Chinn, F. J. (1985). Medicaid recipient lock-in program—Hawaii’s experience in six years. Hawaii Medical Journal, 44(1), 9–18; and Mitchell, L. (2009). Pharmacy lock-in program promotes appropriate use of resources. Oklahoma State Medical Association Journal, 102(8), 276. 

Delisting OxyContin (Canada)

Delisting OxyContin (Canada) Peggy Kelley Thu, 10/25/2018 - 02:25 PM EDT

Description

Delisting OxyContin (or any prescription drug) is the process of removing it from a public or private insurance plan’s drug formulary, rendering it no longer covered for enrollees.

Objective(s)

To reduce the clinical use and availability of OxyContin in Canada

Typical Elements

In March 2012, Ontario, Canada, delisted OxyContin from its public drug plan (which provides coverage to about 20% of the Ontario population by serving individuals who receive public welfare, disability, or seniors’ benefits). A majority of the other Canadian provinces followed suit, and the Canadian federal government delisted OxyContin from the federal drug plan (Ontario Ministry of Health and Long-Term Care, 2012).

Delisting a drug:

  • Declares that drug ineligible for reimbursement by a particular insurer
  • Requires insurance plans to remove that drug (in this case, OxyContin) from their formulary 
    • Note: All insurance plans—including public plans—maintain a list of covered prescription drugs and requirements that enrollees must meet for a claim to be accepted. This list is known as the “prescription drug formulary” or the “pharmacy benefit drug list” (United Healthcare, 2015). Many plans can change their formulary at any time—adding, removing, or altering coverage—with only limited notice (United Healthcare, 2015).
  • In Canada, necessitates that provincial governments:
    • Identify a replacement drug for the formulary
    • Develop a transition process for individuals who are currently prescribed the drug
    • Review existing strategies for combating prescription drug misuse and abuse (Ontario Ministry of Health and Long-Term Care, 2012)
      • Note: The provincial public drug plans identified OxyContin’s tamper-resistant replacement, OxyNeo, as the replacement drug; however, they made OxyNeo available to patients only for a transition period of up to one year. Doctors who believe that it is still medically necessary to prescribe OxyNeo must submit requests on a case-by-case basis, providing all relevant medical information as well as the “clinical rationale” for using the unlisted drug.
  • Does not prevent physicians from prescribing that drug
    • Note: Delisted drugs can be paid for out of pocket or by another insurance plan that did not delist the drug (Fischer & Keates, 2012). In Canada, individuals covered under private drug plans can still receive reimbursement for OxyContin and OxyNeo, if the drugs are still included in their plan’s formulary (Ontario Ministry of Health and Long-Term Care, 2012).

Populations

Prescribers, patients, pharmacies

Outcomes

  • Delisting OxyContin was associated with a reduction in oxycodone dispensing in Ontario, although several jurisdictions in Ontario saw no effect. Reductions also occurred in Alberta, which did not delist OxyContin (Fischer, Jones, & Rehm, 2014).
  • Delisting was linked to an ongoing reduction in oxycodone use in Ontario (which began in 2011), although causal influence has not been empirically established (Fischer, Ialomiteanu, Kurdyak, Mann, & Rehm, 2013).

Guidelines

No guidelines have been found for delisting OxyContin.

Acknowledged by

No acknowledgements have been found regarding the role of delisting OxyContin in preventing prescription drug misuse and/or its consequences.

References

Fischer, B., Ialomiteanu, A., Kurdyak, P., Mann, R. E., & Rehm, J. (2013). Reductions in nonmedical prescription opioid use among adults in Ontario, Canada: Are recent policy interventions working? Substance Abuse Treatment, Prevention and Policy, 8, 7. Retrieved from https://substanceabusepolicy.biomedcentral.com/track/pdf/10.1186/1747-597X-8-7

Fischer, B., Jones, W., & Rehm, J. (2014). Trends and changes in prescription opioid analgesic dispensing in Canada 2005–2012: An update with a focus on recent interventions. BMC Health Services Research, 14, 90. Retrieved from https://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-14-90

Fischer, B., & Keates, A. (2012). “Opioid drought,” Canadian-style? Potential implications of the “natural experiment” of delisting OxyContin in Canada. International Journal of Drug Policy, 23(6), 495–497.

Ontario Ministry of Health and Long-Term Care. (2012). The way forward: Stewardship for prescription narcotics in Ontario. Report to the Minister of Health and Long-Term Care from the Expert Working Group on Narcotic Addiction. Catalogue No. 015919 75. Queen’s Printer for Ontario. Retrieved from http://www.health.gov.on.ca/en/public/publications/mental/docs/way_forward_2012.pdf

United Healthcare. (2015). Prescription Drug Plans. Retrieved from https://www.uhc.com/employer/pharmacy/total-cost-management/prescription-drug-list

Doctor Shopping Laws

Doctor Shopping Laws Peggy Kelley Thu, 10/25/2018 - 02:26 PM EDT

Description

Doctor-shopping laws target patients who obtain multiple prescriptions for controlled substances from multiple prescribers or pharmacies without disclosing their other prescriptions.

Objective(s)

To deter patients from obtaining multiple prescriptions for controlled substances for abusive or diversionary purposes

Typical Elements

Every state and the District of Columbia has a fraud law to prevent doctor-shopping, and most of them contain some version of the language from the Narcotic Drug Act of 1932 (NDA) or the Uniform Controlled Substances Act of 1970 (CSA). Additionally, 20 states have implemented more specialized doctor-shopping laws (Centers for Disease Control and Prevention [CDC], n.d.).

  • California, Colorado, Connecticut, Hawaii, Indiana, Maryland, Minnesota, Missouri, Montana, New York, Oklahoma, Vermont, Virginia, and Washington State use NDA language in their general fraud law (CDC, n.d.).
    • Note: The “Fraud or Deceit” section of the NDA states, “No person shall obtain or attempt to obtain a narcotic drug, or procure or attempt to procure the administration of a narcotic drug, (a) by fraud, deceit, misrepresentation, or subterfuge; . . . or (c) by the concealment of a material fact . . . ” (CDC, n.d., p. 2).
  • Alaska, Delaware, Illinois, Louisiana, Massachusetts, Michigan, Mississippi, Nebraska, Nevada, North Dakota, Oregon, South Dakota, Texas, Utah, West Virginia, Wyoming, and Washington, D.C., use CSA language in their general fraud law (CDC, n.d.).
    • Note: Relative to the NDA, the CSA “include[s] similar language; however, it [does] not include the phrase ‘concealment of material fact’” (CDC, n.d., p. 2).
  • Alabama, Arkansas, Arizona, Florida, Georgia, Idaho, Iowa, New Hampshire, New Mexico, North Carolina, Pennsylvania, Rhode Island, South Carolina, Tennessee, and Wisconsin use both NDA and CSA language in their general fraud law (CDC, n.d.).
    • Note: Although there are few substantive differences in the language used in the NDA and CSA, the Acts are not identical. States using both Acts’ language can have two separate statutes or a single statute pulling language from each Act.
  • Kansas, Kentucky, Maine, New Jersey, and Ohio use neither NDA nor CSA language in their general fraud law (CDC, n.d.).
  • Connecticut, Florida, Georgia, Hawaii, Illinois, Louisiana, Maine, Montana, North Carolina, New Hampshire, Nevada, New York, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, West Virginia, and Wyoming have specialized doctor-shopping laws with levels of detail not found in NDA or CSA—for example, laws regarding the timeframe during which patients must disclose previous and existing prescriptions to prescribers or pharmacists, and the types of prescriptions that patients must disclose (CDC, n.d.).
  • Penalties for violating doctor-shopping laws specify a range of consequences based on an individual’s history of past offenses and the scope of the violation (National Alliance for Model State Drug Laws [NAMSDL], 2010).
    • The charge for individuals who violate a doctor-shopping law can range from a Class A misdemeanor to a Class C felony, depending on the state and other factors (NAMSDL, 2010).
    • Penalties can include fines up to $5,000 or anywhere from 1 to 25 years in prison.

Populations

Prescribers, pharmacies, patients

Outcomes

When implemented in conjunction with PDMPs, doctor-shopping laws have been associated with reductions in the following:

  • Pharmacy hopping and nonmedically-necessary prescriptions of benzodiazepines in New York (Pearson et al., 2006)
  • Prescription drug diversion indicators in France, such as the number of identified instances of doctor-shopping and the percentage of certain types of prescriptions obtained through doctor-shopping (Pradel et al., 2009)
  • “Inappropriate prescriptions” for opioids and benzodiazepines in British Columbia
    • Note: This study identified “inappropriate prescriptions” as those for 30 or more doses issued and filled by a different prescriber and pharmacy within seven days of an earlier prescription for the same medication (Dormuth, Miller, Huang, Mamdani, & Juurlink, 2012).

Guidelines

Doctor Shopping Laws.

State Doctor Shopping and Prescription Fraud Statutes. 

Acknowledged by

Office of National Drug Control Policy. Epidemic: Responding to America’s Prescription Drug Crisis

References

Centers for Disease Control and Prevention. (n.d.). Doctor shopping laws. Retrieved from http://www.cdc.gov/phlp/docs/menu-shoppinglaws.pdf

Dormuth, C. R., Miller, T. A., Huang, A., Mamdani, M. M., & Juurlink, D. N. (2012). Effect of a centralized prescription network on inappropriate prescriptions for opioid analgesics and benzodiazepines. Canadian Medical Association Journal, 184(16), E852–E856. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3494359/

National Alliance for Model State Drug Laws. (2010). State doctor shopping & prescription fraud statutes. Retrieved from https://namsdl.org/wp-content/uploads/State-Doctor-Shopping-and-Prescription-Fraud-Stautes.pdf

Office of National Drug Control Policy. (2011). Epidemic: Responding to America’s prescription drug abuse crisis. Retrieved from https://www.ncjrs.gov/pdffiles1/ondcp/rx_abuse_plan.pdf

Pearson, S.-A., Soumerai, S., Mah, C., Zhang, F., Simoni-Wastila, L., Salzman, C.,  . . .  Ross-Degnan, D. (2006). Racial disparities in access after regulatory surveillance of benzodiazepines. Archives of Internal Medicine, 166(5), 572–579. Retrieved from https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/409923

Pradel, V., Frauger, E., Thirion, X., Ronfle, E., Lapierre, V., Masut, A.,  . . .  Micallef, J. (2009). Impact of a prescription monitoring program on doctor-shopping for high dosage buprenorphine. Pharmacoepidemiology and Drug Safety, 18(1), 36–43.

Limits on Prescription Drug Dispensation and Sales

Limits on Prescription Drug Dispensation and Sales Peggy Kelley Thu, 10/25/2018 - 02:27 PM EDT

Description

Limits on prescription drug dispensation and sales were suggested by the federal Controlled Substances Act (CSA), which outlines specific guidelines. However, some states (and health insurance companies) have further regulations regarding the dispensation of controlled substances.

Objective(s)

To limit access to controlled substances that have the potential for misuse and abuse

Typical Elements

  • Sub-federal restrictions on prescription drug dispensation and sales fall into several broad categories:
    • The time after a prescription is issued during which a pharmacist can fill a prescription
    • The quantity of a drug that may be prescribed and/or dispensed
    • The ability to prescribe refills and/or the quantity of those refills
    • Prescriptions issued orally (“called in”)
    • The quantity of a drug that may be prescribed by health practitioners other than doctors (physician assistants, nurse practitioners, etc.)
    • The identification required to collect a prescription
  • Health insurers (including Medicaid) can impose limitations on the time between prescriptions based on the days’ supply (for example, Medicaid will not pay for a new prescription until 85% of the days’ supply has elapsed; Centers for Disease Control and Prevention [CDC], 2015).
  • While federal law does not set a time limit within which controlled substance prescriptions must be filled after being signed by the practitioner, some states and insurance companies have instituted such limits (Rannazzisi & Caverly, 2006; CDC, 2015). 
  • There are no specific federal limits on the quantity of drugs dispensed via a prescription, but states and some insurance carriers have created specific quantity limitations based on a host of factors, including drug schedule, drug type, and patient diagnosis (Rannazzisi & Caverly, 2006). These laws limit the drug by days’ supply, by dosage units, or both. Five states have set limits for all prescription drugs or all controlled drugs, while 23 states and the District of Columbia have restrictions for specific schedules of drugs (CDC, 2015). For example (CDC, 2015):
    • Missouri limits Schedule II prescriptions to a 30-day supply, while limiting Schedules III, IV, and V prescriptions to a 90-day supply
    • South Carolina limits Schedules III-V to a 30-day supply
    • Seven states and the District place special restrictions on oral prescriptions
  • Under federal law, prescriptions for Schedule II substances cannot be refilled. Prescriptions for Schedule III and IV controlled substances can be refilled up to five times in six months, and prescriptions for Schedule V controlled substances can be refilled as authorized by the practitioner. However, a practitioner can issue multiple prescriptions for a Schedule II drug, allowing a patient up to a 90-day supply, if the following conditions are met (Leonhart, Rannazzisi, & Caverly, 2010):
    • Each separate prescription is issued for a legitimate medical purpose by a practitioner acting in the “usual course of professional practice” (Leonhart, Rannazzisi, & Caverly, 2010, p. 3)
    • The practitioner provides written instructions on each prescription indicating the earliest date that a pharmacy can fill it
    • The practitioner concludes that there is not excessive risk of diversion or abuse
    • Multiple prescriptions are allowable under applicable state laws
    • The practitioner complies fully with all other applicable requirements under the CSA and Code of Federal Regulations, as well as any additional state laws
  • Additional regulations regarding prescription refills can be based on a variety of factors, for example (FSMB, n.d.):
    • In Oklahoma, a new prescription for a specific controlled substance voids any existing refills or other prescriptions for the same drug, and refills cannot be granted at the same time as the initial filling of the prescription for Schedule III or IV controlled substances
    • In South Carolina, no prescription can be refilled sooner than 48 hours prior to the time that the prescription should be consumed, if the prescribed daily dosage is divided into the total prescribed amount
    • In Utah, the dispensing date of a second or third prescription can be no less than 30 days from the dispensing date of the previous prescription (though some exceptions apply)
  • Under federal law, oral (“call in”) prescriptions for Schedule II controlled substances are allowable only in emergency situations, and significant restrictions apply to faxed prescriptions. However, oral prescriptions are allowed for Schedule III and IV controlled substances (Rannazzisi & Caverly, 2006).  
  • Limitations can be imposed on prescribers who are not doctors. While prescriptions for controlled substances can be issued by a Drug Enforcement Administration-registered practitioner (including physicians, dentists, and mid-level practitioners) under specific conditions, some states limit the prescribing abilities of non-doctors. Kentucky, North Carolina, and Pennsylvania, for example, limit the prescription of controlled substances by nurse practitioners (CDC, 2012).
  • Health plans (both private and public) can impose quantity or days’ supply limitations and refill limitations on their enrollees. For example, Arizona, Delaware, and New Jersey’s Medicaid programs impose limitations on prescription quantity and days’ supply and refills, which apply to all prescription medications, including controlled substances (Arizona Health Care Cost Containment System Administration, 2014; General Assembly of the State of Delaware, 2006; New Jersey Division of Medical Assistance and Health Services, 2004).

Populations

Pharmacists, prescribers, patients

Outcomes

No outcome data have been found regarding limits on prescription drug dispensation and sales in preventing the nonmedical use of prescription drugs and/or its consequences.

Guidelines

Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act. 

Acknowledged by

Centers for Disease Control and Prevention. State Laws on Prescription Drug Misuse and Abuse. 

References

Arizona Health Care Cost Containment System Administration. (2014). Arizona Administrative Code § R9-22-209. Retrieved from http://apps.azsos.gov/public_services/Title_09/9-22.pdf

Centers for Disease Control and Prevention. (2012, August 27–28). Patient review and restriction programs: Lessons learned from state Medicaid programs. CDC Expert Panel Meeting Report, Atlanta, GA. Retrieved from http://www.cdc.gov/drugoverdose/pdf/pdo_patient_review_meeting-a.pdf

Centers for Disease Control and Prevention. (2015). Prescription Drug Time and Dosage Limit Laws. Retrieved from http://www.cdc.gov/phlp/docs/menu_prescriptionlimits.pdf

Federation of State Medical Boards. (n.d.). Pain management policies: Board-by-board overview. Retrieved from  http://www.fsmb.org/siteassets/advocacy/key-issues/pain-management-by-state.pdf

General Assembly of the State of Delaware. (2006). 16 Delaware Code § 3005B. Retrieved from http://delcode.delaware.gov/sessionlaws/ga143/chp017.shtml

Leonhart, M. M., Rannazzisi, J. T., & Caverly, M. W. (2010). Pharmacist’s manual: An informational outline of the Controlled Substances Act. Springfield, VA: Drug Enforcement Administration. Retrieved from www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf

New Jersey Division of Medical Assistance and Health Services. (2004). New Jersey Administrative Code § 10:51-1.15. Retrieved from https://www.state.nj.us/humanservices/providers/rulefees/regs/NJAC%2010_51%20Pharmaceutical%20Servies%20Manual.pdf

Rannazzisi, J. T., & Caverly, M. W. (2006). Practitioners manual: An informational outline of the Controlled Substances Act. Springfield, VA: Drug Enforcement Administration. Retrieved from http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf

 

Patient Review and Restriction Programs

Patient Review and Restriction Programs Peggy Kelley Thu, 10/25/2018 - 02:28 PM EDT

Description

Patient review and restriction programs (PRRs), also called “lock-in” programs, enable public and private insurers to restrict patients who are suspected of prescription drug abuse or misuse to a single designated provider and/or pharmacy. They are implemented to: improve care coordination, reduce diversion of controlled drugs, and reduce expenditures for medically unnecessary care (Roberts & Skinner, 2014).

Objective(s)

To limit access to commonly abused prescription drugs

Typical Elements

  • States can implement PRRs within any insurance program to restrict patients who are suspected of prescription drug misuse or abuse, but PRRs are most common in state Medicaid programs because of the relatively high rate of opioid prescriptions (Raofi & Schappert, 2006), hospitalizations due to narcotics, and emergency room (ER) visits due to drug poisoning among Medicaid recipients (Centers for Disease Control and Prevention [CDC], 2012).
  • States determine whether and how to implement PRRs. The federal government gives states wide latitude to implement Medicaid PRRs (42 CFR 431.54[e]). However, state Medicaid programs can only impose restrictions if the PRRs meet all three of the following conditions (42 CFR 431.54 [e][1]–[3]):
    • The PRR gives patients notice and an opportunity for a hearing
    • The PRR ensures that restricted patients still have reasonable access to services
    • The PRR exempts emergency services from the restriction
      • Note: Currently, 46 states operate Medicaid PRRs. Evidence of PRRs could not be identified for Arizona, California, New Mexico, and South Dakota (Roberts & Skinner, 2014).
  • States determine who to enroll in Medicaid PRR based on patient over-use of controlled drugs. Most states base their definition of “over-utilization of controlled drugs” on the number of prescriptions filled, the number of pharmacies visited, and/or the number of prescribers seen over a certain period.
    • Note: One study found that explicit enrollment criteria were publicly available for only 16 of 46 identified PRR programs (Roberts & Skinner, 2014).
  • PRRs establish patient selection criteria that considers the following (adapted from CDC, 2012, p. 4):
    • Using claims data and current fraud prevention activities to detect areas of aberrant behavior for future monitoring
    • Targeting patients who use the drugs that are most likely to be abused
    • Combining objective patient selection criteria with subjective review, based on clinical judgment
    • Choosing criteria that complement other state programs, for example, using data from state prescription drug monitoring programs (PDMPs)
    • Including specific behaviors that have been linked to risk of abuse and/or overdose (for example, high daily opioid dosage in morphine milligram equivalents; a large number of prescriptions obtained by a patient during a given time period, especially overlapping prescriptions; a large number of prescribers for a patient in a given time period; and a large number of pharmacies dispensing to a patient during a given time period)
    • Excluding patients who receive treatment for certain conditions, such as cancer
      • Note: Examples of state-specific criteria are available in Appendix A of the CDC report Patient Review & Restriction Programs.
      • In Kentucky, for example, Medicaid recipients are selected for a PRR if they meet the following conditions within two consecutive 180-calendar-day periods: receive services from more than five different providers, receive more than 10 different opioid prescription drugs, and receive opioid prescriptions from more than three different pharmacies (Kentucky Legislature, 2010).
      • In Idaho, Medicaid recipients are selected for a PRR after the following conditions are analyzed upon referral: a medication profile for the potential overuse of target medications; six or more benzodiazepine claims in the last 60 days; eight or more opiate claims within the last 60 days; three or more Tramadol claims or 480 tablets within the last 60 days; continuous use of skeletal muscle relaxants for more than six months; multiple providers; multiple pharmacies; excessive ER use; and screening of health conditions for a history of drug dependence or abuse (Magellan Medicaid Administration, 2011).
  • States make provisions regarding the scope of PRR restrictions. Most Medicaid PRRs restrict enrollees to a single prescribing physician and a single pharmacy for the duration of their PRR enrollment; however, some states are more or less restrictive (Roberts & Skinner, 2014).
    • Note: Examples of less restrictive PRRs are Florida, whose PRR only limits enrollees to a single pharmacy, placing no restrictions on prescribing physicians; Wyoming, whose PRR limits enrollees to two prescribers and two pharmacies (Roberts & Skinner, 2014); and Missouri’s program allows restricting access to a single pharmacy, a single physician, or both (Missouri Department of Social Services, 2012).
    • An example of a more restrictive PRR is Nebraska, whose PRR uses a five-tier system based on enrollees’ drug-seeking behavior (Roberts & Skinner, 2014).
  • States can impose restrictions regarding the duration of PRR enrollment (Roberts & Skinner, 2014). Most PRR enrollment periods last 12–24 months. Many PRRs also require re-enrollment periods for subsequent violations, which often last longer than the initial enrollment period.
    • Note: Thirteen states employ 12-month enrollment periods, and 15 states enroll patients for 24 months. However, Texas and Virginia employ 36-month enrollment periods, while New Jersey and Pennsylvania require four years and five years of enrollment, respectively (Roberts & Skinner, 2014; State of Texas Administrative Code, 2013; State of Virginia, 1998).
  • States can use the following strategies to implement a Medicaid PRR (adapted from CDC, 2012):
    • Pursuing interstate data-sharing (for example, between PDMPs and Medicaid programs), if legally authorized
    • Ensuring that the prescriber and pharmacy to which a patient is restricted have not been reported for aberrant prescribing or dispensing patterns
    • Collaborating with law enforcement and/or drug diversion specialists to ensure consistent program management
    • Leveraging resources across departments (such as state health departments, Medicare programs, Boards of Pharmacy, PDMPs, and professional associations) to minimize duplicity and cost and to ensure that resources are appropriately leveraged
    • Ensuring that staffing levels are adequate for a growing patient volume
    • Ensuring that appropriate competencies are represented, including those with knowledge of pharmacy, clinical issues (such as drug interactions), case management and care coordination, administration (customer service), and analysis/evaluation
    • Seeking a balanced investment in staffing and automation systems
    • Seeking ongoing program recognition and support
    • Building multi-sector partnerships that emphasize common goals (for example, encouraging people to be healthier, reducing fraud and related costs, increasing patient safety)
    • Evaluating PRRs and effectively communicating the successes of PRR efforts
      • Note: One 2014 study concluded that “the high degree of variability seen in [Medicaid “lock-in” programs] across states and the limited availability of actionable program evaluation data for public consumption suggest [that] much work is needed to establish [PRR] standards. Development of [PRR] best practices will require a more concerted effort on the part of researchers and policymakers to work together to rigorously evaluate [PRRs] for purposes beyond proprietary, internal use” (Roberts & Skinner, 2014, p. 444).

Populations

Public and private insurers, patients

Outcomes

State-level studies found that PRR programs were associated with numerous positive outcomes, including reductions in expenditures and use of controlled substances:

  • In Missouri, PRR implementation was associated with $1.8 to $10.9 million in savings per year (approximately $6.8 to $41.3 million per year in 2012 dollars) (Singleton, 1997).
  • Hawaii’s PRR restricted 270 patients between 1977 and 1983, with an estimated cost savings of $900,000 ($2 million in 2012 dollars). Implementation of the Hawaii PRR was also associated with general decreases in the degree of abuse for all enrollees (Chinn, 1985).
  • In Louisiana, the PRR was associated with reduced polypharmacy among restricted patients, decreased use of Schedule II narcotics, and lower pharmaceutical expenditures (Blake, 1999).
  • Oklahoma PRR enrollees saw reductions in the use of narcotic medications, the use of multiple pharmacies and physicians, and ER visits. The PRR was associated with an average savings of $600 per enrollee (Mitchell, 2009).
  • Ohio’s PRR was associated with reductions in monthly dosage for narcotic analgesics, sedatives, and non-narcotic analgesics (Tanenbaum & Dyer, 1990).
  • Washington State’s PRR showed reductions in controlled substance use and unnecessary healthcare use while achieving substantial cost savings (Coolen, 2009).

Exploratory analyses using a micro-simulation model and Medicaid claims data found that the type of criteria that states apply to PRRs can influence outcomes (Melnikow, Yang, Soulsby, Ritley, & Kizer, 2012):

  • PRRs with less selective criteria (those that define risk more broadly) can produce a larger population from which greater reductions in total opioid overdose prevention can be realized and over which the fixed program cost can be spread.
  • PRRs with more selective criteria (those that define risk more narrowly) can capture a smaller but higher-risk population, which results in higher per enrollee fixed program costs. However, the averted (and presumably higher) health care costs demonstrate a cost-effective alternative.

Guidelines

Patient Review and Restriction programs: Lessons Learned from State Medicaid Programs. 

Acknowledged by

Centers for Medicare and Medicaid Services. Drug Diversion in the Medicaid Program: State Strategies for Reducing Prescription Drug Diversion in Medicaid. 

Pew Charitable Trust. Pew Supports Patient Review and Restriction Programs in Medicare, Part D. 

U.S. Department of Health and Human Services, Behavioral Health Coordinating Committee. Addressing Prescription Drug Abuse in the United States. 

References

Blake, S. G. (1999, March). Drug expenditures: The effect of the Louisiana Medicaid lock-in on prescription drug utilization and expenditures. Drug Benefit Trends, 11(3), 45–55.

Centers for Disease Control and Prevention. (2012, August 27–28). Patient review and restriction programs: Lessons learned from state Medicaid programs. CDC Expert Panel Meeting Report, Atlanta, GA.

Chinn, F. J. (1985). Medicaid recipient lock-in program—Hawaii’s experience in six years. Hawaii Medical Journal, 44(1), 9–18.

Coolen P. (2009). Patient review and coordination program for medical assistance clients who need assistance in appropriate use of services. Olympia, WA: Washington State Department of Health and Social Services. Retrieved from: https://cdn.ymaws.com/www.safestates.org/resource/resmgr/imported/Patient%20Review%20Coordination%20program6.pdf

Exceptions to certain State plan requirements, 42 CFR § 431.54. (2007). Retrieved from:
https://www.law.cornell.edu/cfr/text/42/431.54

Kentucky Legislature. (2010). 907 KAR 1:677. Medicaid recipient lock-in program. Kentucky Administrative Regulations. Retrieved from  https://apps.legislature.ky.gov/Law/KAR/907/001/677.pdf

Melnikow, J., Yang, Z., Soulsby, M., Ritley, D., & Kizer, K. (2012, December). Approaches to Drug Overdose Prevention Analytical Tool (ADOPT): Evaluating Cost and Health Impacts of a Medicaid Patient Review and Restriction Program. Retrieved from https://health.ucdavis.edu/iphi/Programs/OOD/resources/CDC%20Opioid%20Project_Final%20Report.pdf

Missouri Department of Social Services. (2012). Rules of Department of Social Services. 13 CSR 70-4.070: Title XIX recipient lock-in program. Retrieved from https://www.sos.mo.gov/cmsimages/adrules/csr/current/13csr/13c70-4.pdf

Mitchell, L. (2009). Pharmacy lock-in program promotes appropriate use of resources. Oklahoma State Medical Association Journal, 102(8), 276. 

Raofi, S., & Schappert, S. M. (2006). Medication therapy in ambulatory medical care; United States, 2003–2004. Vital and Health Statistics, Series 13(163), 1–40.

Roberts, A. W., & Skinner, A. C. (2014). Assessing the present state and potential of Medicaid controlled substance lock-in programs. Journal of Managed Care and Specialty Pharmacy, 20(5), 439–446c.

Singleton, T. E. (1997). Missouri’s lock-in: Control of recipient misutilization. Journal of Medical Management, 1, 10–17. 

State of Texas Administrative Code. (2013, April). Rule 354.2405—Medicaid recipient utilization review and control. Retrieved from http://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=1&pt=15&ch=354&rl=2405

State of Virginia. (1998). 12VAC30-130-810. Client medical management program for recipients. Retrieved from http://leg1.state.va.us/cgi-bin/legp504.exe?000+reg+12VAC30-130-810 

Tanenbaum, S. J., & Dyer J. L. (1990). The dynamics of prescription drug abuse and its correctives in one state Medicaid program. In B. B. Wilford (Ed.), Balancing the response to prescription drug abuse (pp. 229–238). Chicago, IL: American Medical Association.

 

Prescribed Product Gift Ban and Disclosure Law (Vermont)

Prescribed Product Gift Ban and Disclosure Law (Vermont) Peggy Kelley Thu, 10/25/2018 - 02:30 PM EDT

Description

Vermont’s prescribed product gift ban and disclosure law places numerous restrictions on most gifts from manufacturers of prescription drugs, biological products, or medical devices to healthcare providers, including healthcare professionals, facilities, pharmacists, plan administrators, and their office staff. The law was instituted in 2009; minor amendments were made in 2011, 2012 and 2017.

Objective(s)

To eliminate incentives for prescribing or dispensing medically unnecessary prescription drugs, biological products, and medical devices

Typical Elements

  • Vermont’s law requires that manufacturers of prescribed products, and companies and persons “engaged in the production, preparation, propagation, compounding, processing, packaging, repacking, distributing, or labeling” (Vermont Office of the Attorney General [OAG], 2009, p. 2) of prescribed products, disclose all allowable gifts to the following persons or entities:
    • Healthcare professionals
    • Hospitals
    • Nursing homes
    • Pharmacists
    • Health benefit plan administrators
    • Any other person authorized to dispense prescribed products or purchase them for distribution
  • The law places a ban on all gifts except those explicitly exempted in the law’s text (Vermont OAG, 2009):
    • Free samples
    • Rebates and discounts
    • Articles and journals
    • Loans of medical devices
    • Medical device demonstrations or evaluation units
    • Honoraria for faculty at a bona fide conference or seminar
    • Scholarships to attend professional conferences or seminars
    • Conference sponsorships
    • Royalties and licensing fees
    • Technical training on medical devices
    • Bona fide clinical trial expenses
    • Research project expenses
    • Other reasonable economic benefits provided at fair market value
  • The law requires that manufacturers disclose all gifts, except for samples, rebates and discounts, royalties, and licensing fees (Vermont OAG, 2009). Manufacturers who submit at least one disclosure must pay an annual fee of $500. Disclosures must:
    • Be made to the Vermont OAG
    • Include the “value, nature, purpose, and recipient information” for all gifts (Vermont OAG, 2009, p. 7)
    • Be provided on a reporting-period basis, covering April 1 of each year to the following year
  • The Vermont OAG submits an annual disclosure report to the state legislature and governor before releasing all disclosed data in a searchable format on its website (Vermont OAG, 2009).
  • As needed, the OAG can bring civil suits against any noncompliant company for “injunctive relief, costs, and attorney fees” (Vermont OAG, 2009, p. 9). The Office can also issue a civil fine of $10,000 for each violation of the law (Vermont OAG, 2009).
    • Note: In 2012, awareness of each of Vermont’s requirements among healthcare providers ranged from 28.4% to 93.8% (Kennedy, Possidente, & Pinckney, 2013).
    • Currently, Vermont is the only state with a specific prescribed products gift ban and disclosure law. Massachusetts implemented a similar ban in 2009 but repealed it in 2012. Other restrictions and reporting requirements vary by state (National Conference of State Legislatures, 2013; O’Reilly, 2012; Vermont OAG, 2014).

Populations

Manufacturers, dispensers of prescribed products, healthcare providers

Outcomes

The law has been linked to a decline in the number of pharmaceutical gift expenditures to healthcare providers, from 15,880 in FY2008 to 3,122 in FY2010 (Vermont OAG, 2011).

Guidelines

Guide to Vermont’s Prescribed Products Gift Ban and Disclosure Law for 2017 Disclosures. 

No. 51. An Act Relating to Modifications to the Ban on Gifts by Manufacturers of Prescribed Products. 

2014 Expenditure Disclosure Form for Manufacturers of Prescribed Products. 

Acknowledged by

Vermont Office of the Attorney General. Disclosures by Manufacturers of Prescription Drugs, Biological Products and Medical Devices. 

References

Kennedy, A. G., Possidente, C. J., & Pinckney, R. G. (2013). Awareness and perceptions of Vermont’s prescribed product gift ban and disclosure law by prescribers and pharmacists. Journal of Pharmacy Practice, 26(1), 36–42. Retrieved from http://journals.sagepub.com/doi/abs/10.1177/0897190012451932

National Conference of State Legislatures. (2013). Marketing and direct-to-consumer advertising (DTCA) of pharmaceuticals. Retrieved from http://www.ncsl.org/research/health/marketing-and-advertising-of-pharmaceuticals.aspx

O’Reilly, K. B. (2012, July 23). Ban on pharma meals for physicians overturned. American Medical News. Retrieved from  https://hollowhorn.files.wordpress.com/2018/02/20120723giftban.pdf

Vermont Office of the Attorney General. (2017). Guide to Vermont’s prescribed products gift ban and disclosure law for FY17. Retrieved from https://ago.vermont.gov/wp-content/uploads/2018/01/2017-Vermont-Prescribed-Products-Gift-Ban-Guide.pdf

Vermont Office of the Attorney General. (2011). Prescribed product disclosures: Report of Vermont Attorney General William H. Sorrell for fiscal year 2010. Retrieved from https://ago.vermont.gov/wp-content/uploads/2018/02/FY10-Prescribed-Product-Disclosures-Report.pdf

Vermont Office of the Attorney General. (2014). Prescribed product disclosures: January 1, 2013 to December 31, 2013. Retrieved from https://ago.vermont.gov/wp-content/uploads/2018/02/2013-Prescribed-Products-Disclosure-Report.pdf

 

Restricting Internet Access to Prescription Drugs

Restricting Internet Access to Prescription Drugs Peggy Kelley Thu, 10/25/2018 - 02:31 PM EDT

Description

Restricting Internet access to prescription drugs involves instituting laws and policies that place numerous limits on online pharmacies, including restrictions on the sale and purchase of controlled drugs.

Objective(s)

To prevent the misuse and abuse of prescription drugs by limiting access

Typical Elements

  • The sale and dispensation of pharmaceuticals involves a complex regulatory structure at both the federal and state levels (Fung, Woo, & Asch, 2004)
  • Numerous federal agencies govern the marketing and sales of prescription drugs (U.S. Food and Drug Administration [FDA], 2011):
    • The FDA regulates drugs and medical devices for safety and effectiveness and determines what drugs are legal for sale.
    • The Federal Trade Commission and the FDA oversee drug sellers’ legal claims regarding their products, and govern marketing practices at the national level.
    • U.S. Customs and Border Protection (CBP) and the U.S. Postal Service (USPS) enforce laws related to the shipment of prescription drugs.
    • The U.S. Drug Enforcement Administration (DEA) governs the prescription and dispensation of controlled drugs. All prescribers and dispensers of controlled drugs must register with the DEA, and the DEA is authorized to enforce the lawful administration of controlled drugs.
      • Note: Some states allow pharmacies to dispense naloxone without a prescription.
  • By federal law, online pharmacies are required to do the following (National Alliance for Model State Drug Laws [NAMSDL], 2009):
    • Post information related to their physical location (the name of the pharmacy and its address and telephone number)
    • Post the qualifications (license number) of the pharmacist in charge
    • Post the certification of registration for its brick‐and‐mortar operation
    • Post an endorsement from the DEA
      • Note: While online prescription drugs sales can be performed lawfully, only 3% of online pharmacies reviewed by the National Association of Boards of Pharmacy (NABP) were in compliance with U.S. laws and practice standards (FDA, 2013).
  • Federal law prohibits the sale of prescription drugs (controlled or otherwise) to an individual without a valid prescription (FDA, 2011).
  • Internet sales are permissible with a valid prescription (which usually requires a physical examination by a licensed professional) and when the seller is approved by the appropriate authorities (including state authorities) to sell and ship pharmaceuticals in and to the jurisdiction in question (NAMSDL, 2009).
  • A number of federal regulations curtail “no prescription” sales (Foreman & Block, 2006):
    • “No prescription” websites are online venders that sell prescription drugs (particularly opioids and other controlled drugs) without a valid prescription. Despite their illegality, these websites remain common—in part because enforcement poses a significant challenge.
    • Enforcement requires cooperation between the DEA, CBP, USPS, and FDA.
    • Enforcement practices can exist at four points in the illegal sales process: (1) search engines that list “no prescription” websites, (2) credit card companies that process “no prescription” transactions, (3) delivery companies that deliver “no prescription” products, (4) and Internet Service Providers that host “no prescription” websites.
  • State regulations govern the ability to prescribe and/or dispense pharmaceuticals by the following entities (FDA, 2011):
    • State medical boards that oversee medical practices in each state, including issuing licenses and governing practitioners’ ability to issue prescriptions
    • State Boards of Pharmacy that oversee pharmacists and pharmacies within their jurisdiction, handling pharmacy regulation, licensing, inspection, investigation, and enforcement
  • States enact legislation specifically to regulate Internet pharmacies. However, much of this legislation is focused on ensuring that online pharmacies are subject to existing laws, and establishing penalties for illegal sales (NAMSDL, 2009). Some states have taken more specific action:
    • In 2008, Kentucky passed a law requiring all pharmacies that dispense more than 25% of their total prescription volume as a result of Internet prescriptions to obtain Verified Internet Pharmacy Practice Sites (VIPPS) certification (NASMDL, 2009).
      • Note: In 1999, NABP created the VIPPS program to provide accreditation to Internet pharmacies that comply with the licensing and inspection requirements of their state and each state in which they dispense drugs. VIPPS also verifies that accredited pharmacies comply with criteria regarding patient privacy, the authentication and security of prescription orders, quality assurance, and meaningful consultation between patients and pharmacists (NABP, 2014).
    • Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Mississippi, Nevada, North Carolina, Texas, Virginia, and the District of Columbia have enacted legislation that specifically defines and/or governs Internet pharmacies (NAMSDL, 2009).
  • A number of other practices to further limit access to controlled drugs from online sales are in place, for example:

Populations

Pharmacies conducting business on the Internet, individuals who purchase prescription drugs online

Outcomes

No outcome data have been found regarding the role of restricting Internet access to prescription drugs in preventing the nonmedical use of prescription drugs and/or its consequences.

Guidelines

Buying Medicines Over the Internet: Quick Tips for Buying Online. 

Educational Resources: Buying Medicine and Medical Products Over the Internet. 

State and federal regulation of Internet pharmacies

Acknowledged by

U.S. Food and Drug Administration. Buying Medicines Over the Internet: Quick Tips for Buying Online

U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control. Consumer Alert: DEA warning—Buying Drugs Online May Be Illegal and Dangerous! 

References

Foreman, R. F., & Block, L. G. (2006). The marketing of opioid medications without prescription over the Internet. Journal of Public Policy and Marketing, 25(2), 133–146.

Fung, C. H., Woo, H. E., & Asch, S. M. (2004). Controversies and legal issues of prescribing and dispensing medications using the Internet. Mayo Clinic Proceedings, 79(2), 188–194.

National Alliance for Model State Drug Laws. (2009). State and federal regulation of Internet pharmacies. Retrieved from https://namsdl.org/wp-content/uploads/State-and-Federal-Regulation-of-Internet-Pharmacies.pdf

National Association of Boards of Pharmacy. (2014). Verified Internet Pharmacy Practice Sites Program. Retrieved from https://nabp.pharmacy/programs/vipps/

U.S. Food and Drug Administration. (2011). Buying drugs online: It’s convenient and private, but beware of “rogue sites.” Retrieved from https://www.webmd.com/a-to-z-guides/buying-drugs-online-convenient-private-beware-rogue-sites#1

U.S. Food and Drug Administration. (2013). BeSafeRX: For the Media. Retrieved from https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/BuyingMedicinesOvertheInternet/BeSafeRxKnowYourOnlinePharmacy/ucm294170.htm#FAQs

 

Proper Medication Disposal

Proper Medication Disposal Peggy Kelley Thu, 10/25/2018 - 02:33 PM EDT

Proper medication disposal provides safe and responsible ways for people to get rid of prescription drugs kept in their homes. Take-back programs, a popular proper medication disposal strategy, provide avenues to reduce the supply available for diversion. The logic behind take-back programs goes something like this: If people dispose of their drugs, then they may be less likely to offer them to friends or family, have drugs ingested by and poison young children or unknowing guests, or have drugs taken from their homes for illicit purposes. Prescription Drug Take-Back Programs collect individuals’ unwanted or expired prescription drugs voluntarily through the use of drop boxes or take-back events. Evidence does not support the logic provided above in terms of how Take-Back programs influence individuals’ misuse; however, we do know that these programs collect thousands of pounds of drugs with only 10% of the drugs being commonly abused prescription drugs.1 Practice-based evidence indicates that Take-Back programs also can be implemented to increase awareness of NMUPD and enhance community readiness to implement a more comprehensive prevention strategy.2

Given the insufficient evidence supporting proper medication disposal, SAMHSA/CSAP grantees should consider rigorously evaluating such endeavors to determine their effectiveness in reducing NMUPD and its associated consequences.

Proper medication disposal strategies, summarized here, include the following:

1 Ma, C. S., Batz, F., Juarez, D. T., & Ladao, L. C. (2014). Drug take back in Hawai'i: Partnership between the University of Hawai’i Hilo College Of Pharmacy and the Narcotics Enforcement Division. Hawaii Journal of Medicine & Public Health73(1), 26-31.

2 G. Rots, personal communication, July 30, 2015

Prescription Drug Takeback Programs

Prescription Drug Takeback Programs Peggy Kelley Thu, 10/25/2018 - 02:34 PM EDT

Description

Prescription drug takeback programs offer a mechanism for consumers to safely and legally return unused drugs to the proper authorities.

Objective(s)

To reduce the supply of prescription drugs available for diversion, misuse, or abuse

Typical Elements

  • While takeback programs can be structured in several different ways, the four most common types are pharmacy-based permanent collections, law-enforcement-based permanent collections, event-style programs in the community, and mail-back programs.
  • Takeback programs generally accept all forms of drugs, including over-the-counter and prescription drugs, both uncontrolled and controlled (U.S. Drug Enforcement Administration [DEA], 2014b, 2014c, 2014d).
  • Takeback programs that accept controlled drugs must be operated in conjunction with a collector who is authorized by the DEA or with local law enforcement. The following DEA registrants can receive authorization to take back controlled drugs: retail pharmacies, manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals, and clinics (DEA, 2014b, 2014c, 2014d). 
  • Authorized collectors can maintain collection receptacles at a registered location and/or operate mail-back programs (if the collector has an onsite means of destruction) (DEA, 2014b, 2014c, 2014d). Retail pharmacies, hospitals, and clinics with onsite pharmacies can manage collection receptacles at long-term care facilities (DEA, 2014b, 2014c, 2014d).
  • Authorized collectors must comply with certain collection, handling, storage, transportation, and disposal regulations (Product Stewardship Institute [PSI], n.d.) that are set by federal, state, and local entities and vary by state and locality. Takebacks also are subject to DEA regulations that place restrictions on the nature of the secured drop-off bins (DEA, 2014b, 2014c, 2014d).
  • Costs can vary, depending on the structure of the program (mailback vs. drop-off bins) (Avalere Health, n.d.); some programs can expend more than $300,000 for secured drop-off bins (Simons, 2010).
  • Law enforcement entities (such as the local police) can collect controlled substances according to their own established protocols (DEA, 2014c, 2014d).
  • Individuals are required to dispose of only the drugs that they are lawfully permitted to possess (drugs that were prescribed to them, to their dependents, or to a deceased person whose property they are in charge of) (DEA, 2014c, 2014d).
    • Note: The National Alliance of Model State Drug Laws (NAMSDL) compiles the status of state-specific takeback legislation, including funding and collection information where available (NAMSDL, 2015). The PSI Go-to-Guide for Safe Drug Take-Back offers state-specific information on takeback initiatives in select states.
  • Pharmacies who wish to become a takeback location should do the following:
    • Apply for collector status
    • Check with state regulatory agencies, local government agencies, and state boards of pharmacy to evaluate local policy regarding local collection, handling, storage, transportation, and disposal regulations (PSI, n.d.)
    • Determine what collection tools (for example, secured drop-off bins) they will use, and develop policies and procedures to ensure compliance with all applicable laws and regulations
    • Work with their reverse distributor to ensure proper destruction (as per local laws)
    • Consider the costs associated with collection tools and destruction, and identify potential revenue streams
    • Consider whether they wish to offer an incentive for participation in the takeback program (Fass, 2011)
  • Communities who want to support local takeback programs should do the following:
    • Identify existing collection locations through the DEA Office of Diversion Control’s search utility
    • Consider working with the retail pharmacies in the community
    • If no local pharmacies wish to operate a takeback program, contact local law enforcement or a local Drug Free Community coalition for additional guidance
      • Note: The nearest coalition can be found on the website of the Community Anti-Drug Coalitions of America. Communities might also consider a mailback program or a DEA-style takeback event and the costs associated with each design (such as envelopes and collection personnel), or destruction options (through law enforcement or a reverse distributor) and the associated costs.
  • ​​Factors that contribute to the success of a prescription drug takeback program include legal and regulatory compliance (federal, state, and local), consumer convenience, sustainability (including but not limited to funding), outreach and education, and partnerships with law enforcement (Avalere, n.d.; PSI, n.d.).

Populations

General population, DEA-registered collectors (including pharmacy staff)

Outcomes

While no evaluations have found a relationship between takeback programs and rates of prescription drug misuse or abuse (or related measures), some information is known about takeback programs (Haegerich, Paulozzi, Manns, & Jones, 2014):

  • Between 2009 and 2011, takeback events in Tennessee and Virginia collected 16,956 containers of prescription drugs, of which 9.3% were controlled drugs (Gray & Hagemeier, 2012).
  • From 2011 to 2012, in 11 drug takeback events in Hawaii, more than 8,000 pounds of prescription drugs were collected, of which 10% were controlled substances (Ma, Bartz, Juarez, & Ladao, 2014).
  • Between 2011 and 2013, 11 sites in Maine collected 553,019 units of prescription drugs at DEA takeback events, of which controlled substances accounted for 9.1% (Stewart et al., 2014).
  • Controlled drugs accounted for 17% of those returned to Maine’s mailback program as of 2010 (University of Maine, 2010). 
  • Between 2012 and 2014, the DEA’s National Take Back Day collected 4,823,251 pounds of prescription drugs (DEA, 2014a).
    • Note: All of these data reference takebacks that were conducted prior to the implementation of the Secure and Responsible Disposal Act of 2010 even though publication dates are post 2010.

Guidelines

Disposal Regulations: Registrant Fact Sheet

Disposal Act: Long-Term Care Facility Fact Sheet

Lessons Learned: Voluntary Pharmaceutical Take-Back Programs in the Great Lakes States. 

Starting a Drug Take-Back Program. 

Safe Medicine Disposal for Maine: A Handbook and Summary Report.

Acknowledged by

U.S. Environmental Protection Agency. How to Dispose of Medicines Properly. 

U.S. Food and Drug Administration. Disposal of Unknown Medicines: What You Should Know.

National Conference of Insurance Legislators. Best Practices to Address Opioid Abuse, Misuse and Diversion.

Office of National Drug Control Policy. Epidemic: Responding to America’s Prescription Drug Abuse Crisis.

U.S. Senator Ed Markey (D-MA). Overdosed: A Comprehensive Federal Strategy for Addressing America’s Prescription Drug and Heroin Epidemic.

References

Avalere Health. (n.d.). Safe disposal of unused controlled substances: Current challenges and opportunities for reform. Retrieved from http://www.ncdoi.com/osfm/safekids/Documents/OMD/SafeDisposalOfUnusedControlledSubstancesReport.pdf

Fass, J. A. (2011). Prescription drug take-back programs. American Journal of Health-System Pharmacy, 68(7), 567–570.

Gray, J. A., & Hagemeier, N. E. (2012). Prescription drug abuse and DEA-sanctioned drug take-back events: Characteristics and outcomes in Rural Appalachia. Archives of Internal Medicine, 172(15), 1186–1187. Retrieved from https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1203518

Haegerich, T. M., Paulozzi, L. J., Manns, B. J., & Jones, C. M. (2014). What we know, and don’t know, about the impact of state policy and systems-level interventions on prescription drug overdose. Drug Alcohol Dependence, 145, 34–47.

Ma, C. S., Bartz, F., Juarez, D. T., & Ladao, L. C. (2014). Drug take back in Hawai’i: Partnership between the University of Hawai’i Hilo College of Pharmacy and the Narcotics Enforcement Division. Hawaii Journal of Medicine and Public Health, 73(1), 26–31. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3901169/

National Alliance for Model State Drug Laws. (2015). Controlled substances: Return and disposal bill status update. Retrieved from https://namsdl.org/wp-content/uploads/Controlled-Substances-Return-and-Disposal-2016-Legislative-Session-Bill-Status-Update.pdf

Product Stewardship Institute. (n.d.). Starting a drug take-back program. Retrieved from http://www.productstewardship.us/?page=Start_Drug_Takeback

Simons, T. E. (2010). Drug take-back programs: Safe disposal of unused, expired, or unwanted medications in North Carolina. Retrieved from http://www.ncdoi.com/osfm/safekids/documents/omcwhitepaper.pdf

Stewart, H., Malinowski, A., Ochs, L., Jaramillo, J., McCall, K., & Sullivan, M. (2014). Inside Maine’s medicine cabinet: Findings from the Drug Enforcement Administration’s medication take-back events. American Journal of Public Health, 105(1), e65–e71.

University of Maine. (2010). Safe medicine disposal for Maine: A handbook and summary report. Retrieved from https://digitalcommons.library.umaine.edu/moca_service/1/ 

U.S. Drug Enforcement Administration. (2014a). DEA and partners collect 309 tons of pills on ninth prescription drug take-back day. Retrieved from https://www.dea.gov/press-releases/2014/11/05/dea-and-partners-collect-309-tons-pills-ninth-prescription-drug-take-back

U.S. Drug Enforcement Administration. (2014b). Disposal of Controlled Substances: Final Rule: 21 CFR Parts 1300, 1301, 1304, et al. Retrieved from http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf

U.S. Drug Enforcement Administration. (2014c). Disposal regulations: Registrant fact sheet. Retrieved from www.deadiversion.usdoj.gov/drug_disposal/fact_sheets/disposal_registrant.pdf

U.S. Drug Enforcement Administration. (2014d). Disposal act: Long-term care facility fact sheet. Retrieved from http://www.deadiversion.usdoj.gov/drug_disposal/fact_sheets/disposal_ltcf.pdf

 

Enforcement Strategies

Enforcement Strategies Peggy Kelley Thu, 10/25/2018 - 02:36 PM EDT

In order for laws and regulations to be effective, they must be enforced. Police officers and law enforcement personnel therefore are key stakeholders and should be partners in prevention efforts. This means involving law enforcement on community advisory boards, health task forces, or coalitions to actively engage them in the work. While police are vital, they are not the only ones who can work on enforcement in the community. Local practitioners, school personnel, youth, and parents can work with law enforcement to:

  • Shut down “pill mills.” These initiatives can deter aberrant prescribing practices and increase the likelihood that pain clinics will appropriately prescribe prescription drugs to patients. Burgeoning research suggests they can reduce overdose rates.
  • Educate and train law enforcement personnel on supply and harm reduction strategies. Law enforcement may need current information and up-to-date training on the nascent policies and procedures surrounding recognizing clandestine pill mills and responding properly to drug overdoses. They can use this information to focus their work; thus, potentially reducing the supply of controlled substances in the community, and saving lives by providing appropriate antidotes when encountering overdoses on the job.
  • Implement and sustain a tip and reward program. These programs encourage individuals to anonymously report to law enforcement information about prescription drug diversion happening in the community. Law enforcement can then act on this information; thereby potentially lessening the amount of controlled substances available in the community. 

Enforcement strategies, summarized here, include the following:

Initiatives to Shut Down "Pill Mills" (Florida)

Initiatives to Shut Down "Pill Mills" (Florida) Peggy Kelley Thu, 10/25/2018 - 02:38 PM EDT

Description

The initiatives to shut down “pill mills” in Florida began in 2010. “Pill mills” are pain clinics that inappropriately prescribe large quantities of prescription drugs to patients. They can comprise a single physician or a group of physicians, often operating over a large geographic area, who cater to individuals seeking prescription drugs for nonmedical reasons. They accept only anonymous payment methods—primarily cash (Betses & Brennan, 2013).

Objective(s)

To prevent physician-driven diversion of prescription drugs and to limit the supply of prescription drugs available for diversion

Typical Elements

Florida’s widespread effort employed a variety of strategies to achieve its objectives:

  • Maintaining a medical examiner report system that required medical examiners to provide detailed information on every death in which a drug (prescription or illicit) was identified as a cause of death. Florida’s system enables the state to report more detailed overdose information than other states (Johnson et al., 2014).
    • Note: From 2003 to 2009, Florida experienced a large increase in the number of pill mills operating in the state and saw a 61% increase in the number of annual fatal prescription drug overdoses (1,804 to 2,904) (Johnson, Paulozzi, Porucznik, Mack, & Herter, 2014).
  • Implementing pain clinic regulations and certification requirements, which are designed to prevent facilities from prescribing controlled substances indiscriminately or inappropriately, and which grant authority to state agencies to shut down violating pain clinics (Johnson et al., 2014).
    • Note: Prior to Florida, in 2010, only three states had specific pain clinic regulations. By 2013, 13 states had implemented such regulations.
  • Having state law enforcement agencies conduct raids on pill mills—seizing assets and arresting owners and prescribers. Florida established regional task forces to focus on pill mills in specific areas and cooperated extensively with the Drug Enforcement Administration.
  • Enacting prescription drug limits of sale, which forbid physicians from dispensing Schedule II or III prescription drugs from their offices.
  • Putting into practice the mandatory use of Prescription Drug Monitoring Programs (PDMPs) by pharmacies, requiring all pharmacies to register with the state PDMP and to report patient and prescriber data.

Populations

Physicians, pharmacists, patients, law enforcement 

Outcomes

Florida’s initiatives were associated with a 23.2% reduction in the state’s prescription drug overdose rate, from 14.5 to 11.1 overdoses per 100,000 individuals, a statistically significant decrease (Johnson et al., 2014).

Guidelines

See guidelines for related records, such as Model Pain Clinic Regulations, Law Enforcement Training on Supply Reduction, Limits on Prescription Drug Dispensation and Sales, and Mandatory Use of Prescription Drug Monitoring Programs.

Acknowledged by

National Conference of Insurance Legislators. Best Practices to Address Opioid Abuse, Misuse and Diversion. 

References

Betses, M., & Brennan, T. (2013). Abusive prescribing of controlled substances: A pharmacy view. New England Journal of Medicine, 369(11), 989–991. Retrieved from https://www.nejm.org/doi/full/10.1056/NEJMp1308222

Johnson, H., Paulozzi, L., Porucznik, C., Mack, K., & Herter, B. (2014). Decline in drug overdose deaths after state policy changes—Florida, 2010–2012. Morbidity and Mortality Weekly Report, 63(26), 569–574. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a3.htm

Law Enforcement Training on Harm Reduction

Law Enforcement Training on Harm Reduction Peggy Kelley Thu, 10/25/2018 - 02:40 PM EDT

Description

Law enforcement training on harm reduction involves preparing law enforcement to better respond to and prevent drug overdoses, including those caused by prescription drugs. Most such training focuses on opioid overdoses. The Bureau of Justice Affairs (BJA) and several states’ law enforcement agencies have recently begun offering harm-reduction training to state and local law enforcement officers, in addition to supply-reduction training. Some states have also authorized community-based organizations to train lay responders and law enforcement in naloxone administration (New York State Division of Criminal Justice Services, 2014).

Objective(s)

To reduce the harm caused by prescription drug misuse and abuse

Typical Elements

Before the training, it’s important to do the following:

  • Determine the state’s system for providing supplemental training courses to law enforcement officers
    • Note: Some states require training to be provided through state-administered classes, while others allow law enforcement agencies to implement their own onsite training. Training on naloxone administration is usually provided by local hospital staff, other health professionals, or community-based organizations that provide naloxone access (BJA, 2014).
  • Identify a funding source to equip law enforcement officers with naloxone kits and then train officers to use them
  • Acquire the naloxone kits, to be dispensed after the training
  • Acquire BJA training manuals and other resources from states that have already initiated harm-reduction training, to be shared with participants (BJA, 2014)
  • Secure trainers who possess the required state training certifications
    • Note: For example, New York requires police trainers to receive certification from an Instructor Development Course approved by the state Office of Public Safety.
  • Seek cooperation with law enforcement commanders, both to ensure that training is required for officers and to assure them that such training will be available
  • If needed, request technical assistance from BJA, state agencies, or nonprofits

Harm-reduction training generally takes place over multiple days, or during a single day with breaks to prevent fatigue. Sessions can include some or all of the following (New York State Division of Criminal Justice Services, 2014):

  • Lectures on a variety of topics, for example:
    • The purpose of harm-reduction training for law enforcement
    • Background on prescription drugs and other opioids
    • The signs and symptoms of an overdose
    • The purpose of naloxone, how it works, and how to administer it
    • State laws protecting lay administrators of naloxone
    • The role of community organizations that provide naloxone
    • How to handle individuals post-administration of naloxone
    • How to complete a naloxone incident report
  • Opportunities to practice administering naloxone in cases of opioid overdose (U.S. Department of Justice, 2014)
  • An assessment of the state’s naloxone access law (New York State Division of Criminal Justice Services, 2014):
    • As of December 2014, 27 states and the District of Columbia allow nonmedical personnel, including law enforcement, to use naloxone without civil or criminal liability (The Network for Public Health Law, 2014)
    • As of March 2015, state and local law enforcement agencies in 19 states have received training to administer naloxone (North Carolina Harm Reduction Coalition, 2015)
    • As of December 2014, 23 states restrict naloxone administration exclusively to medical professionals, and do not allow law enforcement officers or other laypersons to administer it (The Network for Public Health Law, 2014)
  • Development of a naloxone incident report for law enforcement use

After completing the training, participants are assessed on their ability to do the following (New York State Division of Criminal Justice Services, 2014):

  • Identify the existence and location of community naloxone programs
  • Explain the purpose of syringe-access programs and Good Samaritan laws
  • Identify the characteristics of opioid overdose
  • Identify the steps to care for a person suffering from an opioid overdose
  • Demonstrate how to use naloxone to treat an opioid overdose

Populations

Law enforcement personnel

Outcomes

No outcome data have been found regarding the role of law enforcement training on harm reduction in preventing the non-medical use of prescription drugs and/or its consequences.

Guidelines

Naloxone and Overdose Prevention for Law Enforcement Toolkit. 

Law Enforcement Naloxone Toolkit. 

Opioid Overdose and Intranasal Naloxone Training for Law Enforcement: Trainer’s Guide

Opioid Overdose Education and Naloxone Distribution: MDPH Naloxone Pilot Project Core Competencies

Acknowledged by

Office of National Drug Control Policy, Executive Office of the President. Epidemic: Responding to America’s Prescription Drug Abuse Crisis. 

U.S. Department of Health and Human Services. Behavioral Health Coordinating Committee. Addressing Prescription Drug Abuse in the United States: Current Activities and Future Opportunities

U.S. Department of Justice, Bureau of Justice Assistance. Law Enforcement Nalaxone Toolkit

References

Bureau of Justice Assistance. (2014). Law enforcement naloxone toolkit. Washington, DC: U.S. Department of Justice. Retrieved from https://www.bjatraining.org/tools/naloxone/all

The Network for Public Health Law. (2014). Legal interventions to reduce overdose mortality: Naloxone access and overdose Good Samaritan laws. Retrieved from https://www.networkforphl.org/_asset/qz5pvn/network-naloxone-10-4.pdf

New York State Division of Criminal Justice Services. (2014). Opioid overdose and intranasal naloxone training for law enforcement: Trainer’s guide. Retrieved from https://www.bjatraining.org/sites/default/files/naloxone/Opioid%20Overdose%20Intranasal%20Naloxone%20Training%20-%20Trainer%20Guide.pdf

North Carolina Harm Reduction Coalition. (2015). Law enforcement departments carrying naloxone. Retrieved from http://www.nchrc.org/law-enforcement/us-law-enforcement-who-carry-naloxone/

U.S. Department of Justice. (2014). Attorney General Holder announces plans for federal law enforcement personnel to begin carrying naloxone. Retrieved from http://www.justice.gov/opa/pr/attorney-general-holder-announces-plans-federal-law-enforcement-personnel-begin-carrying

Law Enforcement Training on Supply Reduction

Law Enforcement Training on Supply Reduction Peggy Kelley Thu, 10/25/2018 - 02:39 PM EDT

Description

Law enforcement training on supply reduction prepares law enforcement officers to recognize and reduce the availability of illicit drugs and diverted legal substances, including prescription drugs.

Objective(s)

To reduce the availability of prescription drugs for nonmedical use

Typical Elements

  • Supply-reduction training:
    • Can be spread over 2–14 days and is usually conducted in person
    • Covers all drug enforcement laws, including prescription drug diversion
    • Includes some or all of the following topics: tactical aspects of drug enforcement; operational planning; management of confidential sources; recognizing clandestine laboratory operations; legal issues; executive decision-making; professionalism within the ranks; supervising, motivating, and evaluating officers; detecting drug-related crimes; recognizing drug types; and roadside interviewing (Federal Law Enforcement Training Centers [FLETC], n.d.; U.S. Drug Enforcement Administration [DEA], n.d.)
  • Federal and state agencies offer supply-reduction training to state and local law enforcement supervisors and officers on reducing the availability of illicit drugs and diverted legal substances, for example, by preventing prescription drug diversion.
    • Note: The U.S. Department of Justice (DOJ) and the U.S. Department of Homeland Security primarily support diversion prevention training for state and local law enforcement through the Drug Unit Commanders Academy, Narcotics Supervisor Leadership Program, and FLETC (DEA, n.d.).
  • Federal law enforcement agents receive specialized supply-reduction training through internal programs accredited by the Federal Law Enforcement Training Accreditation (FLETA) board (FLETA, n.d.).
  • Federal agencies fund training and technical assistance centers (TTACs) that support federal, state, and local agencies through training and technical assistance programs, events, and courses on specific topics, including supply reduction (National Training and Technical Assistance Center [NTTAC], n.d.). Supply-reduction training is generally offered through resource guides and in-person courses and is tailored to the agency’s specific circumstances (NTTAC, n.d.).
    • Note: For example, DOJ funded Brandeis University’s Prescription Drug Monitoring Program (PDMP) TTAC to develop a PDMP training course for law enforcement. The course covered how PDMPs operate; how law enforcement can access and interact with PDMPs; and how to interpret, disseminate, and validate PDMP reports for stakeholders (Brandeis University, 2013).Law enforcement can use PDMP data to help identify potential areas of the community that have high supply.
  • State and local police academies provide specialized diversion courses for state law enforcement officers (Brandeis University, 2013; Morris County Public Safety Training Academy, n.d.).
  • Nonprofit and law enforcement organizations (such as Crime Stoppers USA, the Federal Bureau of Investigation—Law Enforcement Executive Development Association [FBI-LEEDA], the National Association of Drug Diversion Investigators [NADDI], the National Association of State Controlled Substance Authorities, and the Pharmaceutical Security Institute) often partner to offer supply-reduction training and technical assistance which is funded by pharmaceutical industry grants, fundraising, membership fees, and training fees (FBI-LEEDA, n.d.; NADDI, 2015; RxSafetyMatters, n.d., 2013). Typically, these trainings are founded and/or managed by former or current law enforcement personnel and address the following topics: leadership and management, current diversion trends, recognizing diversion activities, and current laws related to supply reduction.

Populations

Law enforcement officers and supervisors

Outcomes

Though not entirely attributable to training efforts, in 2013 law enforcement seized 1,194,748 diverted dosage units of oxycodone, 83,449 diverted dosage units of hydrocodone, and 1,363 diverted dosage units of hydromorphone (DEA, 2014).

Guidelines

Prescription drug monitoring program administrators guide for training law enforcement. 

Acknowledged by

Office of National Drug Control Policy. Epidemic: Responding to America’s Prescription Drug Abuse Crisis. 

Federal Law Enforcement Training Accreditation. Accredited Programs. 

Office of National Drug Control Policy. National Drug Control Strategy 2014. 

U.S. Department of Homeland Security, Federal Law Enforcement Training Centers. Drug Law Enforcement Training Program (XP). 

U.S. Department of Justice. Narcotic and Dangerous Drug Section (NDDS). 

U.S. Department of Justice, Bureau of Justice Assistance, National Training and Technical Assistance Center. About Us.

References

Brandeis University. (2013). Prescription drug monitoring program administrators guide for training law enforcement. Waltham, MA: Prescription Drug Monitoring Program Training and Technical Assistance Center, The Heller School for Social Policy and Management at Brandeis University. Retrieved from http://www.pdmpassist.org/pdf/PDMP_admin/LE_USE_OF_PDMP_CURRICULUM_Final.pdf

Federal Bureau of Investigation—Law Enforcement Executive Development Association. (n.d.). Who we are. Retrieved from https://fbileeda.org/page/Who_we_are

Federal Law Enforcement Training Accreditation. (n.d.). Accredited programs. Retrieved from https://www.fleta.gov/accredited-programs

Federal Law Enforcement Training Centers. (n.d.). Drug law enforcement training program (XP). Washington, DC: U.S. Department of Homeland Security. Retrieved from https://www.fletc.gov/drug-law-enforcement-training-program-xp/drug-law-enforcement-training-program-xp

Morris County Public Safety Training Academy. (n.d.). Alphabetical course listing. Retrieved from https://academy.morriscountynj.gov/police/course-descriptions/

National Association of Drug Diversion Investigators. (2015). Welcome. Retrieved from https://www.naddi.org/

National Training and Technical Assistance Center. (n.d.). About us. Washington, DC: Bureau of Justice Assistance, U.S. Department of Justice. Retrieved from https://www.bjatraining.org/about

Office of National Drug Control Policy. (n.d.). HIDTA initiatives. Retrieved from https://obamawhitehouse.archives.gov/ondcp/hidta-initiatives

RxSafetyMatters. (n.d.). Law enforcement and government: A resource guide to help stem the illegal trafficking of prescription drug abuse. Retrieved from www. rxsafetymatters.org/wp-content/uploads/2013/10/RXSM_LawEnforceGov-V2.pdf 

U.S. Drug Enforcement Administration. (n.d.). Domestic training—State and local training. Washington, DC: U.S. Department of Justice. Retrieved from www. dea.gov/ops/Training/StateLocal.shtml

U.S. Drug Enforcement Administration. (2014). National drug threat assessment summary 2014. Washington, DC: U.S. Department of Justice. Retrieved from  https://publicintelligence.net/dea-drug-threats-2014/

 

Tip and Reward Programs

Tip and Reward Programs Peggy Kelley Thu, 10/25/2018 - 02:41 PM EDT

Description

Tip and reward programs enable individuals to submit tips, sometimes anonymously, to law enforcement or private organizations working with law enforcement about crimes involving prescription drugs (theft, fraud, etc.). Some programs offer monetary rewards for tips that lead to arrests.

Objective(s)

To encourage individuals with information about prescription drug diversion to come forward and report it to law enforcement

Typical Elements

  • Tip and reward programs were established by the U.S. Drug Enforcement Administration (DEA), which accepts tips from individuals about potential crimes in its jurisdiction, including prescription drug diversion (DEA, 2015).
  • The programs can be implemented by private and non-governmental organizations working with law enforcement, such as prescription drug manufacturers, to offer rewards for tips on prescription drug diversion (RxPatrol, 2012; RxTip, 2015).
  • Tip and reward programs can be instituted as clearinghouses of “data related to pharmacy robberies, burglaries and theft that involve the loss of controlled substances” for law enforcement (RxPatrol, 2012, ¶ 1).
  • Such programs can promote formal or informal relationships between pharmacies, federal and state agencies, and other security professionals as they work to better address crimes involving prescription drugs (RxPatrol, 2012).
  • Monetary reward sizes will likely vary, depending on the nature of the tip (RxPatrol, 2012).
    • Note: RxPatrol offers rewards of up to $2,500 for tips that lead to arrests. The DEA offers rewards of up to $5 million, but only for arrests of major drug traffickers (RxPatrol, 2012; U.S. Department of State, n.d.).
  • Programs can choose to use different reporting tools (hotlines, online forms, etc.).
  • Some programs accept anonymous tips.

Populations

Law enforcement, the general public

Outcomes

No outcome data have been found regarding the role of tip and reward programs in preventing the nonmedical use of prescription drugs and/or its consequences.

Guidelines

Report Submission Form for Suspected Unlawful Sales of Pharmaceutical Drugs on the Internet. 

Acknowledged by

No acknowledgements have been found regarding the role of tip and reward programs in preventing the nonmedical use of prescription drugs and/or its consequences.

References

RxPatrol. (2012). What’s RxPatrol? Retrieved from http://www.rxpatrol.com/aboutrxpatrol/

RxTip. (2015). About the program. Retrieved from rxtip. org/about-the-program/

U.S. Department of State. (n.d.). Narcotics Reward Program: Target information. Retrieved from https://www.state.gov/j/inl/narc/rewards/

U.S. Drug Enforcement Administration. (2015). Submit a tip. Retrieved from https://www.dea.gov/submit-tip

Harm Reduction Strategies

Harm Reduction Strategies Peggy Kelley Thu, 10/25/2018 - 02:45 PM EDT

The number of fatalities from prescription drug overdose has risen over the past years.1 Harm reduction strategies focus on reducing fatality rates, by targeting individuals who are at high risk for overdose, current users of opioids or heroin. These types of strategies entail enactment of policies that provide users access to antidotes and protection from legal repercussion of use. For example, state naloxone access laws allow the prescribing and dispensing of naloxone2 to substance users or to lay administrators.3 Implementation of these laws have been associated with greater use of 911 in the event of an overdose4, and increased ability to recognize an overdose when it is happening.5 Incidentally, individuals sometime wonder whether these laws actually increase use, research suggests that they have not led to an increase in drug use or high-risk behavior.6 In addition, a second harm reduction strategy listed in this document, Abuse Deterrent Drug Formulations, involves reformulating the prescription drugs chemically, so that the properties of the drug change and users are less likely to experience a “high” when taken not as prescribed. This strategy has been associated with a decrease in OxyContin abuse and misuse; however the positive effects are short lived because research found that participants moved on to misusing other opioids.7

Harm reduction strategies, summarized here, include the following:

1 United States General Accounting Office. (2003). OxyContin abuse and diversion and efforts to address the problem: Highlights of a government report. Journal of Pain & Palliative Care Pharmacotherapy18(3), 109. Retrieved from https://www.gao.gov/new.items/d04110.pdf

2 an opioid receptor antagonist that reverses opiate overdose

3 non-medical first responders, potential overdose bystanders, and family and friends of opioid users

4 Banta-Green, C. J., Kuszler, P. C., Coffin, P. O., & Schoeppe, J. A. (2011). Washington’s 911 Good Samaritan drug overdose law—Initial evaluation results. Seattle, WA: Alcohol and Drug Abuse Institute, University of Washington. Retrieved from http://stopoverdose.org/evaluation-of-washington-good-samaritan-law/

5 Haegerich, T. M., Paulozzi, L. J., Manns, B. J., & Jones, C. M. (2014). What we know, and don’t know, about the impact of state policy and systems-level interventions on prescription drug overdose. Drug and Alcohol Dependence, 145, 34–47.

6 Haegerich, T. M., Paulozzi, L. J., Manns, B. J., & Jones, C. M. (2014). What we know, and don’t know, about the impact of state policy and systems-level interventions on prescription drug overdose. Drug and Alcohol Dependence, 145, 34–47.

7 Cicero, T. J., Ellis, M. S., & Surratt, H. L. (2012). Effect of abuse-deterrent formulation of OxyContin. New England Journal of Medicine, 367(2), 187–189. doi: doi:10.1056/NEJMc1204141

Abuse Deterrent Drug Formulations

Abuse Deterrent Drug Formulations Peggy Kelley Thu, 10/25/2018 - 02:46 PM EDT

Description

Abuse-deterrent prescription drug formulations are designed to inhibit prescription drugs’ abusive properties. These alterations can take many forms, including physical alterations (alterations to a drug’s manufactured form that are designed to deter individuals from extracting its active ingredient) and pharmacological alterations (adding an active ingredient that reduces or prevents the “high” associated with abuse).

Objective(s)

To deter prescription drug diversion and abuse

Typical Elements

  • As of February 2015, the U.S. Food and Drug Administration (FDA) does not require any specific abuse-deterrent formulations. However, the FDA does require that prescription drug manufacturers warn of the risks of abuse in drug labels and marketing, and it regulates the use of abuse-deterrent marketing claims (FDA, 2013; Woodcock, 2014).
  • The FDA also has the authority to withdraw or block approval for a prescription drug if there is an otherwise identical prescription drug that contains abuse deterrents (FDA, 2013; Woodcock, 2014).
  • As of February 2015, the FDA has approved at least 11 abuse-deterrent formulations (Webster et al., 2011); however, only 3 meet FDA standards for abuse-deterrent marketing claims (Woodcock, 2014).
    • Note: The FDA has also begun approving non-opioid prescription drugs for pain management, approving five such drugs over the past 10 years.
  • Categories of abuse-deterrent formulations include the following (FDA, 2013):
    • Physical barriers: Changing the drug composition to prevent chewing, crushing, cutting, grating, or grinding
    • Chemical barriers: Changing the drug composition to prevent opioid extraction, using solvents
    • Agonist/antagonist combinations: Adding an active ingredient that reduces or prevents the “high” associated with abuse
    • Aversion formulations: Adding an active ingredient that causes an unpleasant sensation if the drug is altered or taken at a high dosage
    • Delivery system alterations: Changing the method of drug delivery to one more resistant to abuse (e.g., from oral tablets to patches or implants)
    • Prodrug alterations: Changing the drug composition so the drug is inert until reaching the gastrointestinal tract
  • The FDA recommends that the development of a new abuse-deterrent formula should include data from three types of studies (although there can be exceptions) in order to obtain a “full and scientifically rigorous understanding” of the formula’s effect on the drug’s potential for abuse (FDA, 2013, p. 5):
    • Laboratory manipulation and extraction studies, which evaluate individuals’ ability to overcome or compromise the proposed formulation
    • Pharmacokinetic studies, which examine the biological properties of the proposed formulation, including the effects of continued abuse attempts
    • Clinical abuse potential studies, which assess the impact of the proposed formulation on its effectiveness at making abuse of the drug “less attractive or less rewarding” (FDA, 2013, p. 2)
  • The FDA has created four tiers of marketing claims (FDA, 2013):
    • The drug is formulated with physicochemical barriers to abuse
    • When the drug is manipulated, it is expected to reduce or block the effect of the opioid
    • The drug is expected to result in a meaningful reduction in abuse
    • The drug has demonstrated reduced abuse in a community
  • Drug manufacturers are now required to submit evaluation data supporting their claims.

Populations

Drug manufacturers

Outcomes

Among anonymous survey respondents with an opioid dependence, the abuse-deterrent formulation of OxyContin has been linked to the following (Cicero, Ellis, & Surrat, 2012):

  • A decrease in the selection of OxyContin as the primary drug of abuse from 35.6% to 12.8% of respondents over 21 months
  • A decrease in past-30-day abuse of OxyContin from 47.4% to 30.0%
  • No evidence that individuals ceased their drug abuse:
    • 24% of respondents overcame the abuse-deterrent formulation
    • 66% of respondents switched to another opioid (heroin, most often)

Guidelines

Abuse-Deterrent Opioids—Evaluation and Labeling: Guidance for Industry. 

Acknowledged by

U.S. Department of Health and Human Services. Addressing Prescription Drug Abuse in the United States: Current Activities and Future Opportunities.

References

Cicero, T., Ellis, M., & Surrat, H. (2012). Effect of abuse-deterrent formulation of OxyContin. New England Journal of Medicine, 367, 187–189. Retrieved from http://www.nejm.org/doi/full/10.1056/NEJMc1204141

U.S. Food and Drug Administration. (2013). Abuse-deterrent opioids—evaluation and labeling: Guidance for industry. Retrieved from https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm334743.pdf

Webster, L., St. Marie, B., McCarberg, B., Passik, S. D., Panchal, S. J., & Voth, E. (2011). Current status and evolving role of abuse-deterrent opioids in managing patients with chronic pain. Journal of Opioid Management, 7(3), 235–245. Retrieved from http://kolonline.com/

Woodcock, J. (2016). Public meeting on abuse deterrent formulations: Framing the issues. Silver Spring, MD: FDA Center for Drug Evaluation and Research. Retrieved from https://www.fda.gov/Drugs/NewsEvents/ucm509853.htm

 

State Naloxone Access Laws

State Naloxone Access Laws Peggy Kelley Thu, 10/25/2018 - 02:48 PM EDT

Description

State naloxone laws allow the prescribing and dispensing of naloxone (an opioid receptor antagonist that reverses opiate overdose) to substance users with documented risk factors for overdose, or to lay administrators (including nonmedical first responders, potential overdose bystanders, and family and friends of opioid users). 

Objective(s)

To increase access to opioid overdose antidotes among high-risk populations

Typical Elements

Naloxone access laws vary by state and can include some or all of the following provisions (Davis, 2015; National Alliance for Model State Drug Laws [NAMSDL], 2015):

  • Permission for naloxone “standing order” prescriptions for individuals who are at risk for overdose and who have not been physically examined by a prescriber (Davis, 2015, p. 1)
  • Permission for “third-party prescriptions” that allow doctors and pharmacists to prescribe and dispense naloxone to someone who is not directly at risk for an overdose
    • Currently, 24 states—California, Colorado, Connecticut, Delaware, Georgia, Indiana, Kentucky, Maine, Maryland, Massachusetts, New Jersey, New Mexico, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Utah, Vermont, Virginia, Washington, Wisconsin—and the District of Columbia allow this (Davis, 2015, p. 1).
    • Generally third-party prescriptions are written to friends or family of at-risk users, or to other laypersons who may have contact with at-risk users.
  • Permission for pharmacists to dispense naloxone to individuals without a prescription
    • Eight states—California, Kentucky, New Hampshire, New Mexico, New York, Rhode Island, Vermont, and Washington state allow this.
    • States can also remove criminal or civil penalties for individuals who possess naloxone without a prescription (California State Board of Pharmacy, 2015).
  • Removal of prescribers’ civil, criminal, or professional liability in instances when naloxone is administered to an individual other than the patient to whom they prescribed the drug (Heller & Stancliff, 2007)
  • Removal of healthcare providers’ civil, criminal, or professional liability for the provision of naloxone
    • Ten states—California, Colorado, Delaware, Maine, New Jersey, Ohio, Pennsylvania, Rhode Island, Tennessee, and Wisconsin—have removed all liability.
    • Five states—Connecticut, Minnesota, New Mexico, North Carolina, and Utah—have removed criminal and civil liability.
    • Three states—Illinois, Massachusetts, and New York—have removed criminal and professional liability.
    • Three states—Kentucky, Maryland, and Washington—have removed only professional liability.
    • One state—Georgia—removed civil liability only.
  • Removal of first responders’ civil, criminal, or professional liability for administering naloxone according to specific guidelines
    • Six states—Delaware, Louisiana, Michigan, Ohio, Pennsylvania, and Wisconsin—have removed all liability.
    • Three states—Georgia, Indiana, and Oklahoma—have removed civil liability only.
  • Removal of lay administrators’ civil, criminal, or professional (such as Unauthorized Practice of Medicine penalties) liability for administering naloxone
    • Five states—California, Delaware, Maryland, Oregon, and Virginia—and the District of Columbia require lay administrators to receive training prior to administrating naloxone.
      • Note: As of 2010, 188 community programs nationwide provided access to naloxone (U.S. Department of Health and Human Services, 2013). 
  • “Good Samaritan” provisions, which encourage bystanders to administer naloxone and to summon emergency responders in a timely manner, without fear of arrest or other negative legal consequences (Burris et al., 2009)
    • These provisions can include immunity from charges related to causing the victim’s death, and the possession or distribution of drugs or drug paraphernalia.
    • The provisions can apply even if the individual sold the drug to the victim.
  • Implementation of state- or local-level naloxone access programs (such as the Lazarus Project), which educate providers about naloxone access law, provide overdose response education, and train personnel to administer naloxone (Enteen et al., 2010)

Naloxone access programs are required to register with the state. Common characteristics of naloxone access programs include the following (Burris et al., 2009):

  • Providing education and training to injection drug users and other individuals who are likely to witness an opioid overdose
  • Forming an advisory group to provide guidance during program implementation (McAuley, Best, Taylor, Hunter, & Robertson, 2012)
  • Cultivating a practitioner network to increase opportunities for networking, peer support, and best practices dissemination (McAuley et al., 2012)
  • Requiring participant responders to call 911 when witnessing an overdose
  • Requiring responders to report the name, address, and phone number of the overdose victim and the status of the naloxone injection

Populations

Opioid users, physicians, emergency responders, police, policymakers, the general public

Outcomes

  • Among opioid users, awareness of naloxone access laws was associated with greater use of 911 in the event of an overdose (Banta-Green, Kuszler, Coffin, & Schoeppe, 2011).
  • A meta-analysis of 12 evaluations of naloxone access programs found that the programs were associated with (1) successful training of both individuals at high risk of an overdose and their friends and family to recognize an opioid overdose and appropriately administer naloxone, and (2) no increase in drug use or high-risk behavior (Haegerich, Paulozzi, Manns, & Jones, 2014).

Guidelines

Implementing an Overdose Good Samaritan Law: The Example of Seattle, Washington.

Legal Interventions to Reduce Overdose Mortality: Naloxone Access and Overdose Good Samaritan Laws.

State Naloxone and Good Samaritan Legislation as of July 15, 2014.

Acknowledged by

National Conference of Insurance Legislators. Best Practices to Address Opioid Abuse, Misuse and Diversion

U.S. Department of Health and Human Services. Addressing Prescription Drug Abuse in the United States: Current Activities and Future Opportunities

Office of National Drug Control Policy. Good Samaritan Overdose Response Laws: Lessons Learned from Washington State

Substance Abuse and Mental Health Services Administration. Opioid Overdose Toolkit: Facts for Community Members. 

References

Banta-Green, C. J., Kuszler, P. C., Coffin, P. O., & Schoeppe, J. A. (2011). Washington’s 911 Good Samaritan drug overdose law—Initial evaluation results. Seattle, WA: Alcohol and Drug Abuse Institute, University of Washington. Retrieved from http://stopoverdose.org/evaluation-of-washington-good-samaritan-law/

Burris, S., Beletsky, L., Castagna, C., Coyle, C., Crowe, C., & McLaughlin, J. M. (2009). Stopping an invisible epidemic: Legal issues in the provision of naloxone to prevent opioid overdose. Drexel Law Review, 1(2), 273–339.

California State Board of Pharmacy. (2015). Overdose rescue drug now available without prescription: Pharmacists can furnish naloxone for opioid overdose. Retrieved from http://www.pharmacy.ca.gov/publications/naloxone_media_release.pdf

Davis, C. S. (2015). Legal interventions to reduce overdose mortality: Naloxone access and overdose Good Samaritan laws. Princeton, NJ: Robert Wood Johnson Foundation. Retrieved from https://www.networkforphl.org/_asset/qz5pvn/naloxone-_FINAL.pdf

Enteen, L., Bauer, J., McLean, R., Wheeler, E., Huriaux, E., Kral, A. H., & Bamberger, J. D. (2010). Overdose prevention and naloxone prescription for opioid users in San Francisco. Journal of Urban Health, 87(6), 931–941.

Haegerich, T. M., Paulozzi, L. J., Manns, B. J., & Jones, C. M. (2014). What we know, and don’t know, about the impact of state policy and systems-level interventions on prescription drug overdose. Drug and Alcohol Dependence, 145, 34–47.

Heller, D. I., & Stancliff, S. (2007). Providing naloxone to substance users for secondary administration to reduce overdose mortality in New York City. Public Health Reports, 122(3), 393–397.

McAuley, A., Best, D., Taylor, A., Hunter, C., & Robertson, R. (2012). From evidence to policy: The Scottish national naloxone programme. Drugs: Education, Prevention and Policy, 19(4), 309–319.

National Alliance for Model State Drug Laws. (2015). Naloxone access: Status of state laws map. Retrieved from https://namsdl.org/wp-content/uploads/Naloxone-Access-Status-of-State-Laws-Maps.pdf

U.S. Department of Health and Human Services. (2013). Addressing prescription drug abuse in the United States: Current activities and future opportunities. Retrieved from https://www.cdc.gov/drugoverdose/pdf/HHS_Prescription_Drug_Abuse_Report_09.2013.pdf

 

Multi-component Strategies

Multi-component Strategies Peggy Kelley Thu, 10/25/2018 - 02:51 PM EDT

Multicomponent programs involve implementing more than one strategy simultaneously or in tandem. These varying components work together simultaneously to address various factors that prevent NMUPD. In general, in order to be successful, multicomponent programs:

  • Incorporate multiple levels of influence. A widespread approach targeting multiple risk and protective factors across multiple levels of influence may achieve the greatest impact. For example, the Harmful Legal Product Prevention Project incorporates intervention at the family level, the school setting, and the broader community; and when strategies are implemented together, research demonstrates increased community readiness1, increased parental locking up of prescription drugs2, and decreased harmful legal product use for youth.3 Similarly, Project Lazarus intervenes with the general community to change community norms, and with prescribers to change prescribing practices and when activities occur together, outcomes have been linked to decreases in overdose death rates.4
  • Require successful collaboration. They include engagement of stakeholders from different community sectors (e.g., public health, education, business, law enforcement) to design, raise awareness of, and/or implement program activities. All multi-component programs listed involve formal or informal collaborative arrangements among groups or organizations where everyone is working together toward a common goal. For example, Drug-Free Community Coalitions require formal collaboration and have demonstrated success in reducing substance use.5
  • Are strategic and data-driven. The programs are grounded in understanding local assessment data and community readiness for identifying priorities and selecting relevant strategies. They also utilize current prevention science to guide practice. For example, Promoting School-Community-University Partnerships to Enhance Resilience (PROSPER) uses collaboration with the local land-grant universities to leverage expertise on prevention science and Project Lazarus utilizes assessment data to target areas of high risk.

Multi-Component strategies, summarized here, include the following:

1 Ogilvie, K. A., Moore, R. S., Ogilvie, D. C., Johnson, K. W., Collins, D. A., & Shamblen, S. R. (2008). Changing community readiness to prevent the abuse of inhalants and other harmful legal products in Alaska. Journal of Community Health, 33(4), 248–258.

2 Collins, D. A., Johnson, K. W., & Shamblen, S. R. (2012). Examining a home environmental strategy to reduce availability of legal products that can be misused by youth. Substance Use & Misuse, 47(12). doi:10.3109/10826084.2012.716481. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3884673/

3 Johnson, K. W., Shamblen, S. R., Ogilvie, K. A., Collins, D., & Saylor, B. (2009). Preventing youths’ use of inhalants and other harmful legal products in frontier Alaskan communities: A randomized trial. Prevention Science, 10(4), 298–312. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3735174/

4 Albert, S., Brason II, F. W., Sanford, C. K., Dasgupta, N., Graham, J., & Lovette, B. (2011). Project Lazarus: Community-based overdose prevention in rural North Carolina. Pain Medicine, 12, S77–S85. Retrieved from http://prescribetoprevent.org/wp-content/uploads/2012/11/pm2011albert.pdf

5 Office of National Drug Control Policy. (2014). Drug-Free Communities Support Program: 2013 National Evaluation Report.

Office of National Drug Control Policy. (2015). Drug-Free Communities Support Program: 2014 National Evaluation Report.

Drug-Free Community Coalitions

Drug-Free Community Coalitions Peggy Kelley Thu, 10/25/2018 - 02:52 PM EDT

Description

Drug-free community coalitions are formal collaborative arrangements among groups or organizations within a community that are formed or expanded to prevent and reduce youth substance use, including prescription drug abuse, within the community. In a community coalition, each member maintains its independent status while agreeing to work collaboratively to achieve a common goal (Community Anti-Drug Coalitions of America [CADCA], 2012).

Objective(s)

To harness and maximize multi-sector resources for the purposes of designing or selecting and implementing activities that are likely to prevent or reduce youth substance use, including prescription drug abuse

Typical Elements

Since 1997, SAMHSA and the Office of National Drug Control Policy (ONDCP) have offered Drug-Free Communities (DFC) grants to support community coalitions established to prevent youth substance abuse (ONDCP, 2015). In addition, CADCA offers technical assistance to community coalitions (CADCA, 2012), which typically includes the following:

  • Assistance in determining the coalition type (CADCA, 2010):
    • Activity/Event Coalitions focus on providing information and service referrals to the general public
    • Service/Program Delivery Coalitions focus on developing and providing individual or indicated-level prevention programs and services
    • Community Mobilization Coalitions focus on mobilizing the community to support specific prevention actions (for example, implementing drug-free zones)
    • Comprehensive Community Coalitions focus on implementing universal and/or selective prevention programs and services
      • Note: Coalitions can change their focus over time or choose to focus on multiple facets of prevention simultaneously, as the community situation and resources warrant (CADCA, 2010).
  • Assistance in selecting coalition activities (CADCA, 2012), for example:
    • Assessment: Collecting and assessing data to define the scope of the problem (for example, the rates of prescription drug abuse), currently available resources to address the problem, areas in need of improvement, etc.
    • Capacity: Developing the community’s ability to address the problem
    • Planning: Creating a plan to address the problem, selecting activities and other strategies for implementation
    • Implementation: Implementing the chosen prevention strategies and activities
    • Evaluation: Evaluating the impact of the implemented strategies
      • Note: Community coalitions generally center their activities on one of these five elements, the names of which are taken from SAMHSA’s Strategic Prevention Framework (CADCA, 2012).
  • Assistance in selecting coalition members who represent 12 key sectors (SAMHSA, 2014): youth; parents; business; media; education; youth-serving organizations; law enforcement; religious organizations; civic or volunteer organizations; healthcare organizations; state, local, or tribal agencies involved in the substance abuse field; and other organizations involved in the substance abuse field
  • Assistance with implementing promising or effective prevention programs, for example:

Populations

Communities

Outcomes

  • In communities where a coalition received a DFC grant, middle and high school students have shown reductions in their use of tobacco, alcohol, and marijuana (ONDCP, 2014, 2015).
  • Prescription drug abuse was added as one of the four DFC core substance abuse outcomes in 2012, and only baseline data have been collected thus far (ONDCP, 2014).

Guidelines

Drug-Free Communities Support Program, Request for Applications No. SP-14-002: 2nd Modified Announcement. 

Capacity Primer: Building Membership, Structure and Leadership. 

Handbook for Community Anti-Drug Coalitions. 

Acknowledged by

Office of National Drug Control Policy. Drug-Free Communities Support Program. 

Community Anti-Drug Coalitions of America. Drug-Free Communities Program. 

References

Community Anti-Drug Coalitions of America. (2010). Capacity primer: Building membership, structure and leadership. Retrieved from https://www.cadca.org/sites/default/files/resource/files/capacityprimer.pdf

Community Anti-Drug Coalitions of America. (2012). Handbook for community anti-drug coalitions. Retrieved from https://www.cadca.org/sites/default/files/resource/files/coalitionhandbook.pdf

Dublin A.C.T. Coalition. (2011). Who we areOverview. Retrieved from http://dublinact.org/

Good Drugs Gone Bad (GDGB). (n.d.). About Us. Retrieved from http://www.gooddrugsgonebad.com/find_us/

Office of National Drug Control Policy. (2015). Drug-Free Communities Support Program: 2014 National Evaluation Report. Retrieved from https://obamawhitehouse.archives.gov/sites/default/files/DFC2014Interim%20ReportExecutiveSummaryFinal.pdf

Substance Abuse and Mental Health Services Administration. (2014). Drug-Free Communities Support Program, Request for Applications No. SP-14-002: 2nd Modified Announcement. Retrieved from https://www.samhsa.gov/sites/default/files/grants/pdf/sp-14-002-modified2.pdf

Harmful Legal Product Prevention Project

Harmful Legal Product Prevention Project Peggy Kelley Thu, 10/25/2018 - 02:53 PM EDT

Description

The Harmful Legal Product Prevention Project was part of a National Institute on Drug Abuse pilot project. From 2004 to 2008, researchers, community coalitions, and schools collaborated to implement three primary prevention strategies—the Community Readiness Model, the Home Environmental Strategy, and Think Smart—in rural/frontier Alaskan communities. The strategies were implemented in tandem, though each could be implemented on its own (Gruenewald, Johnson, Shamblen, Ogilvie, & Collins, 2009).

Objective(s)

To assess and improve community readiness to address prescription drug abuse, youth prescription drug, and youth harmful legal product (HLP) abuse; to strengthen parent-child communication, parents’ efficacy to modify home environments in order to limit access to HLPs, and youth skills to resist drug offers; and to decrease youth’s motivation to use drugs and their vulnerability to social influences to use drugs

Typical Elements

  • The Community Readiness Model (CRM) determines community readiness across six dimensions and provides guidance on using survey results to create an action plan to improve community readiness (Colorado State University, 2011). The CRM is based on the Stages of Change Model (Prochaska & Di Clemente, 1982) of how individuals process and experience change, both on their own and in formal settings (Oetting et al., 2014). The steps of CRM implementation are as follows:
    • Step 1: Identify and clearly define the issue
      • Note: In addition to addressing prescription drug abuse, the CRM can be adapted to address underage drinking, binge drinking, illicit drug use, or non-substance-related issues, such as breast cancer prevention (Oetting et al., 2014).
    • Step 2: Identify and clearly define the community you wish to assess and improve (for example, by geographic areas, population subgroups, occupation subgroups, public systems, organizations, or departments within organizations)
    • Step 3: Determine the key dimensions you wish to assess
      • Note: The six dimensions assessed by the CRM are Community Efforts, Community Knowledge of the Efforts, Leadership, Community Climate, Community Knowledge About the Issue, and Resources Related to the Issue (Colorado State University, 2011).
    • Step 4: Prepare survey questions
      • Note: Survey questions should be succinct. They should define the issue of concern and any technical terms used (Oetting et al., 2014). The CRM guidelines contain a standardized format for survey questions (Colorado State University, n.d.).
    • Step 5: Determine how you will score interview responses, in terms of community readiness
      • Note: The CRM identifies nine stages of community readiness:
        • Stage 1: Community tolerance / no knowledge
        • Stage 2: Denial
        • Stage 3: Vague awareness
        • Stage 4: Pre-planning
        • Stage 5: Preparation
        • Stage 6: Initiation
        • Stage 7: Institutionalization/stabilization
        • Stage 8: Confirmation/expansion
        • Stage 9: Professionalization (Colorado State University, 2011)
    • Step 6: Select key respondents for the survey from pools of individuals who are involved in the community and are aware of any efforts to address the selected issue
      • Note: For example, school personnel, law enforcement personnel, court system personnel, city/county/tribal government employees and officials, health system personnel, social service providers, behavioral health treatment providers, spiritual/religious leaders, and community members at large.
    • Step 7: Conduct the interviews
      • Note: The CRM suggests conducting 6 to 12 interviews, although smaller or homogenous communities may only need as few as 4 interviews (Oetting et al., 2014).
    • Step 8: Score interview responses across the key dimensions, using the predetermined scale (Oetting et al., 2014)
    • Step 9: Average scores from each interview to develop overall community scores for each dimension
    • Step 10: Develop and implement an action plan to improve community readiness
    • Step 11: Set goals for improvement based on the dimensional scores
    • Step 12: Create working groups to identify and implement the action plan and activities for improvement
      • Note: In the Alaskan communities, the initial interview responses showed that most students (48% to 91%, depending on the community) thought that it would be “sort of easy” or “very easy” to obtain four types of HLPs. However, the communities received a score of “2” (denial/resistance) or “3” (vague awareness) on their level of knowledge about the issue. The HLP Prevention Project stakeholders identified and developed improvement activities to increase community readiness while also implementing the Home Environmental Strategy and Think Smart (Johnson et al. 2007, p. 9).
  • The Home Environmental Strategy is intended to reduce children’s misuse of HLPs, such as prescription drugs, by removing unnecessary HLPs from the home and locking up and monitoring any HLPs that must remain (Collins, Johnson, & Shamblen, 2012).
    • Note: This model calls for parents to consider substituting HLPs with other products when possible, particularly for HLPs such as markers or glues (Johnson et al., 2007).
    • An important first step in implementing this strategy is to develop and offer Family Night events for parents of school-age children. The goal of Family Night is to increase parental norms related to HLP misuse (such as parental disapproval of children’s HLP misuse, and family rules that reduce the availability of HLPs).
      • These events should last approximately two hours, be held at the school, and occur multiple times over a series of months
      • At the events, provide information to parents on the potential dangers of HLPs and guidance on how to prevent children’s misuse
      • Encourage parents to clearly communicate the dangers of HLP misuse to their children
        • Note: For example, parents might link their HLP message to their own values and beliefs, establish rules and consequences related to HLP misuse, and provide positive reinforcement to children who adhere to family rules regarding HLPs (Johnson, Shamblen, Ogilvie, Collins, & Saylor, 2007).
      • Ask parents to identify and inventory all HLPs in the home
      • Persuade parents to control the availability of HLPs in the home (for example, by locking up and monitoring them)
      • Support other parent-focused prevention efforts, including informal parent-to-parent support
      • Identify parents who may be interested in participating in or supporting community-wide prevention strategies
        • Note: In the Alaskan communities, the Home Environmental Strategy focused on parents of fifth-, sixth-, and seventh-graders. The strategy consisted of a series of Family Night events held over the course of 10 months. Parents were invited to participate through letters and telephone calls, and additional events were held in areas where the first events had low turnout.
  • Think Smart is a weekly interactive school-based program developed for the HLP Prevention Project and derived from the Life Skills Training program for Native American communities; it has been modified to focus on HLPs and for frontier Alaskan communities. However, the strategy is not designed solely for Alaska Natives; it is intended for all frontier Alaskan communities (Johnson et al., 2010). Community coalitions interested in Think Smart may need to modify the program to suit their communities.
    • The Think Smart program (Johnson et al., 2010):
      • Includes 12 weekly core lessons of 45–60 minutes (three booster lessons are implemented two to three months after the core lessons are complete)
      • Is provided by teachers in a classroom setting
      • Draws from behavioral models that “emphasize teaching drug refusal skills, anti-drug norms, personal self-management skills, and general social skills in an effort to resist drug offers, decrease the motivations to use drugs, and decrease vulnerability to drug use social influences” (Johnson et al., 2009, p. 3)
      • Presents stereotypes about drugs (including peer norms and cultural identity), teaches facts about drugs, and then introduce and practice a problem-solving model known as S.O.D.A.S. (Stop, Options, Decide, Act, Self-Talk), which emphasizes refusal and self-assertiveness skills.
    • Before implementing Think Smart, the group or organization should determine the need for additional school-based prescription drug prevention programming and whether the Think Smart program is applicable. Next steps:
      • Obtain program materials, including curricula and “a complete teaching kit with all the items necessary to implement the interactive curriculum (e.g., laminated role play cards, timers)” (Johnson et al., 2010, p. 6)
      • Partner with an intervention agency to provide a two-day onsite training for teachers
      • Offer schools technical assistance throughout the program
      • Schedule weekly sessions for teachers to implement the curriculum
      • Obtain parental consent, if necessary

Populations

Local community members, parents of school-age children, school-age children

Outcomes

  • As part of the HLP Prevention Project, CRM was linked to an average increase in community readiness, as measured by the combined score of all six dimensions (a combined score of 32 pre-action plan implementation, and 34 post-action plan implementation). The largest average increases were in the dimensions of “community knowledge about the issue” and “community resources available to address the issue” (Ogilvie et al., 2008).
  • The Home Environmental Strategy has been linked to parents statistically significantly becoming more likely to lock up prescription drugs (Collins, Johnson, & Shamblen, 2012).
  • The rates of past-30-day HLP use of Alaska students who participated in Think Smart were eight times lower than the rates of students who did not participate, according to a two-group, randomized, matched-control trial (Johnson et al., 2009).

Guidelines

Community Readiness for Community Change.

Acknowledged by

No acknowledgements have been found regarding the role of any HLP prevention project in preventing the nonmedical use of prescription drugs and/or its consequences.

References

Collins, D. A., Johnson, K. W., & Shamblen, S. R. (2012). Examining a home environmental strategy to reduce availability of legal products that can be misused by youth. Substance Use & Misuse, 47(12). doi:10.3109/10826084.2012.716481. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3884673/

Colorado State University. (2011). Community Readiness. Tri-Ethnic Center for Prevention Research. Retrieved from http://www.triethniccenter.colostate.edu/community-readiness-2/

Gruenewald, P. J., Johnson, K., Shamblen, S. R., Ogilvie, K. A., & Collins, D. (2009). Reducing adolescent use of harmful legal products: Intermediate effects of a community prevention intervention. Substance Use & Misuse, 44(14), 2090–2098.

Johnson, K., Courser, M., Holder, H., Miller, B., Ogilvie, K., Moore, R., . . . Saltz, B. (2007). A community prevention intervention to reduce youth from inhaling and ingesting harmful legal products. Journal of Drug Education, 37(3), 227–247. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2443954/

Johnson, K. W., Ogilvie, K. A., Collins, D. A., Shamblen, S. R., Dirks, L. G., Ringwalt, C. L., & Norland, J. J. (2010). Studying implementation quality of a school-based prevention curriculum in frontier Alaska: Application of video-recorded observations and expert panel judgment. Prevention Science, 11(3), 275–286. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3569516/

Johnson, K. W., Shamblen, S. R., Ogilvie, K. A., Collins, D., & Saylor, B. (2009). Preventing youths’ use of inhalants and other harmful legal products in frontier Alaskan communities: A randomized trial. Prevention Science, 10(4), 298–312. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3735174/

Oetting, E. R., Plested, B. A., Edwards, R. W., Thurman, P. J., Kelly, K. J., Beauvais, F., & Stanley, L. (2014). Community readiness for community change. Fort Collins, CO: Tri-Ethnic Center for Prevention Research, University of Colorado. Retrieved from https://www.coursehero.com/file/15527087/Community-Readiness-Handbook-2014/

Ogilvie, K. A., Moore, R. S., Ogilvie, D. C., Johnson, K. W., Collins, D. A., & Shamblen, S. R. (2008). Changing community readiness to prevent the abuse of inhalants and other harmful legal products in Alaska. Journal of Community Health, 33(4), 248–258.

Prochaska, J. O., & Di Clemente, C. (1982). Trans-theoretical therapy: Toward a more integrative model of change. Psychotherapy: Theory, Research, and Practice, 19(3), 276–288. Retrieved from https://www.researchgate.net/publication/232461028_Trans-Theoretical_Therapy_-_Toward_A_More_Integrative_Model_of_Change

Project Lazarus

Project Lazarus Peggy Kelley Thu, 10/25/2018 - 02:54 PM EDT

Description

Project Lazarus addresses drug overdose deaths, with a focus on prescription drug overdoses. Its four-component overdose prevention program was initiated in Wilkes County, North Carolina, but has since been expanded statewide.

Objective(s)

To raise awareness of prescription drug abuse, address dangerous prescribing practices, and increase community efficacy to address prescription drug abuse and reduce overdose deaths

Typical Elements

Project Lazarus is a prevention model comprising four components, each of which is intended to work in conjunction with the others (Project Lazarus, n.d.a):

  • The first component is community activation and coalition building (Albert et al., 2011, p. 77). Coalitions can include representatives from organizations identified as important to health promotion—including health departments, schools, governmental agencies, hospitals, primary care clinical practices, churches, and newspapers—who together engage in prevention activities, for example:

    • Holding a town hall meeting focusing on overdose deaths
    • Creating special task forces to examine topics relevant to overdose deaths (such as prescribing rates)
    • Developing community leadership
    • Gathering input for an educational toolkit
    • Holding community training events that raise awareness of overdose deaths (Community Care of North Carolina [CCNC], n.d.)
    • Developing social marketing media campaigns
    • Creating school education events, such as classroom-based education, or pledge cards
  • The second component, monitoring and epidemiological surveillance (Albert et al., 2011), involves gathering and analyzing various types of data to describe and characterize overdose deaths occurring in the community, for example:
    • The number of emergency department (ED) visits for substance abuse and accidental poisonings
    • The amount of controlled substances dispensed to outpatients
    • The number of “fatal accidental poisonings” (Albert et al., 2011, p. S80)
    • Vital statistics from the state health agency
      • Note: For example, Project Lazarus determined that overdose deaths in Wilkes County were due “almost exclusively to prescription opioid pain relievers” (Albert et al., 2011, p. S77).
  • The third component, prescriber, patient, and law enforcement training and education (Albert et al., 2011), includes activities such as the following:
    • Developing an educational tool kit for prescribers and patients, including, for example, pain management guidelines, opioid risk assessment tools, universal precautions for opioid prescribing, a sample patient-prescriber agreement, defensive prescription writing materials, patient education materials, and information on screening, brief intervention, and referral to treatment (Albert et al., 2011, p. S81)
    • Providing individual education and training to prescribers on pain management and overdose prevention
    • Supporting continuing medical education on pain management and overdose prevention
    • Informing prescribers about actions the state medical board can take against prescribers who violate state regulations
    • Inspecting local pain clinics
    • Promoting use of Prescription Drug Monitoring Programs (PDMPs)
      • Note: PDMPs can have different names by state—for example, North Carolina’s is called the Controlled Substance Reporting System.
    • Modifying hospital ED policy on dispensing opioids (such as mandating PDMP use and limiting the amount of opioids that can be dispensed at one time)
    • Holding medication takeback events and establishing permanent medication disposal sites
    • Training specialized drug diversion law enforcement officers
    • Mandating the use of patient-prescriber agreements when pain medications are prescribed
    • Creating support groups for patients with chronic pain
    • Assigning ED case managers to patients with chronic pain
  • The fourth component, overdose reversal medication (Albert et al., 2011), encourages the establishment of procedures that enhance naloxone access to populations at risk of overdose (Harm Reduction Coalition, n.d.), for example:
    • Training prescribers to identify patients at risk of an overdose
    • Asking at-risk patients to participate in the initiative
    • Showing participating patients a 20-minute video that “covers patient responsibilities in pain management, storage, and disposal of opioid medications, recognizing and responding to an opioid overdose, and options for substance abuse treatment” (Harm Reduction Coalition, n.d., p. 1)
    • Giving participating patients a prescription for a free naloxone kit
    • Supporting efforts to expand the capacity of inpatient detox programs, for example, securing funding for additional beds at existing programs, increasing awareness of existing programs, and establishing new programs

Populations

Prescribers, patients at risk of overdose, community members

Outcomes

In Wilkes County, North Carolina, Project Lazarus has been linked to the following outcomes (Albert et al., 2011; Project Lazarus, n.d.b):

  • A 69% reduction in the overdose mortality rate from 2009 to 2011
  • A reduction (from 82% in 2009 to 0% in 2011) in the percentage of overdose patients whose death was caused by a prescription issued by a prescriber operating in the county
  • A 15% reduction in the number of ED visits for overdoses or substance abuse from 2009 to 2010
    • Note: Statewide, North Carolina saw a 6.9% increase in the number of ED visits for overdoses or substance abuse.
  • A percentage of prescribers who registered with the state PDMP, as of 2010, that is almost three times higher than the statewide average (70% and 26%, respectively) (CCNC, n.d.)

Guidelines

Project Lazarus [Website]

Acknowledged by

Office of National Drug Control Policy. A Public Health Approach to Overdose Prevention: Director’s Remarks at Project Lazarus, Wilkes County, North Carolina. 

References

Albert, S., Brason II, F. W., Sanford, C. K., Dasgupta, N., Graham, J., & Lovette, B. (2011). Project Lazarus: Community-based overdose prevention in rural North Carolina. Pain Medicine, 12, S77–S85. Retrieved from http://prescribetoprevent.org/wp-content/uploads/2012/11/pm2011albert.pdf

Community Care of North Carolina. (n.d.). Project Lazarus: A community-wide response to managing pain. Retrieved from https://www.slideserve.com/rivka/project-lazarus-a-community-wide-response-to-managing-pain

Harm Reduction Coalition. (n.d.). Project Lazarus: Case study. Retrieved from http://harmreduction.org/issues/overdose-prevention/tools-best-practices/naloxone-program-case-studies/project-lazarus/

Project Lazarus. (n.d.a). The Project Lazarus model. Retrieved from https://www.projectlazarus.org/the-model

Project Lazarus. (n.d.b). Project Lazarus results for Wilkes County. Retrieved from http://projectlazarus.com/project-lazarus-results-wilkes-county

Promoting School-Community-University Partnerships to Enhance Resilience (PROSPER)

Promoting School-Community-University Partnerships to Enhance Resilience (PROSPER) Peggy Kelley Thu, 10/25/2018 - 02:55 PM EDT

Description

Promoting School-Community-University Partnerships to Enhance Resilience (PROSPER) is a prevention services delivery system that links land-grant university researchers and experts with community organizations to develop and support youth substance abuse prevention programming, including prescription drug misuse and abuse programs. PROSPER is not a specific prevention strategy; rather, it is a process designed to improve the quality of community-implemented strategies.

Objective(s)

To improve the quality and fidelity of community-implemented evidence-based prevention programs

Typical Elements

The PROSPER system is implemented in four stages: initial organization, initial operations, ongoing operations, and long-term stability.

  • Eight to 10 community members form a community team, which is co-led by a county-based member from a land-grant university system’s cooperative extension program and a representative from the local school district (PROSPER Partnerships, n.d.).

    • The team leaders are expected to spend 25–30% of their full-time work responsibilities on community team activities.
    • The community team should include members who represent a diverse cross-section of the community, including healthcare providers, social service providers, and representatives from law enforcement, parent and youth groups, businesses, and faith-based organizations.
      • Note: Factors influencing the success of community teams include the rates of community poverty, and perceptions of community readiness; therefore, in low resource and ready communities, greater focus may need to be given to building capacity by increasing team building and cross-agency understanding prior to moving into implementation (Greenberg, Feinberg, Meyer-Chilenski, Spoth, & Redmond, 2007).
  • The State Management Team, comprising of Extension administrators and university faculty, is led by a State Partnership Director, who is supported by land-grant university prevention researchers and experts who coordinate PROSPER implementation across the state (PROSPER Partnerships, n.d.). This team does the following:
    • Communicates the most recent prevention research findings and other information to prevention coordinators
    • Develops community team action plans, based on information provided by prevention coordinators
    • Engages with state-level agencies to further support prevention programming
    • Oversees evaluations at all levels of the system
    • Receives technical assistance and expert support from the National Network Team (see below)
  • The land-grant university system hires an expert prevention coordinator, who receives oversight and coordination support from the State Management Team. The coordinator’s responsibilities include the following (PROSPER Partnerships, n.d.):
    • Attending community team meetings, and providing support as necessary
    • Holding bi-weekly meetings with the community team co-leaders
    • Maintaining regular contact with other prevention coordinators to share information and best practices
    • Organizing training and professional development activities for community team members
    • Providing specific technical assistance to community teams on planning, recruiting for, and implementing the family-focused and school-based programs (see below), maintaining productivity, and securing sustained funding for the programs
    • Facilitating the flow of information between the community team and the State Management Team by attending regular meetings with the State Management Team to report on community team activities and progress
  • A National Network Team consists of trainers, technical assistance providers, prevention scientists, and evaluation specialists who coach and support the State Management Team. The National Network Team is established to address four key goals, set in conjunction with federal funding partners (PROSPER Partnerships, n.d.):
    • Learn how to identify state land-grant university systems that have the capacity and ability to adopt PROSPER
    • Learn how to work with adoption-ready state systems to build the infrastructure necessary for successful implementation
    • Learn the most effective ways to implement PROSPER at the community level
    • Develop a team capable of providing ongoing training and technical assistance to State Management Teams
  • From a “menu” of pre-approved evidence-based programs (EBPs), one family-focused EBP, targeting sixth-graders, and one school-based EBP, targeting seventh-graders, is selected and implemented by the community (Spoth, Guyll, Redmond, Greenberg, & Feinberg, 2011).
    • Note: Family-focused programs implemented in PROSPER evaluation studies include the Strengthening Families Program: For Parents and Youth 10–14, and Guiding Good Choices. School-based programs include All Stars, LifeSkills Training, and Lions Quest.
    • Families are recruited to participate in the family-focused program
    • The implementation of both programs is monitored with support from land-grant university researchers
    • Funds are raised to support the programs’ implementation by the Community Team
    • The prevention coordinator offers technical support
      • Note: The National Network Team works with states to build their infrastructure as needed to support implementation of the EBP that is most appropriate for their community.
  • Community team’s work with the State Management Team, through the prevention coordinators, to ensure that two primary sustainability goals are met annually: (1) sustaining the growth and quality of the EBPs, and (2) sustaining each well-functioning community team.
    • Note: As of March 2015, PROSPER had not developed an open system to initiate implementation of its model in all states. Its initial land-grant university systems were specifically selected to participate in the pilot program, while additional land-grant university systems applied to participate through a one-time National Institutes of Health funding opportunity (PROSPER Partnerships, n.d.).

Populations

Youth, families, schools, the community at large

Outcomes

  • Using a randomized controlled trial study, follow-up data six years after program exposure showed that participating youth had a lifetime prescription drug misuse rate of 27.3%, compared to 32.2% among non-participating youth (Coalition for Evidence-Based Policy, 2014).
  • Using a randomized controlled trial study, follow-up data 18 months after program exposure showed that participating youth were significantly less likely to initiate any form of substance abuse, compared to non-participating youth (Spoth et al., 2007).
  • PROSPER has been linked to communities maintaining an ongoing adherence rate to EBP models that is near 90% (Spoth et al., 2011).

Guidelines

All Stars. 

Guiding Good Choices

LifeSkills Training. 

Lions Quest

PROSPER Partnerships: We’ve got prevention down to a science

Strengthening Families Program

Acknowledged by

U.S. Centers for Disease Control and Prevention, Grant DP 002279.

National Institutes of Health, National Institute on Drug Abuse, Grant DA 028879.

References

Coalition for Evidence-Based Policy. (2014). Top tier evidence initiative: Evidence summary for Promoting School-Community-University Partnerships to Enhance Resilience (PROSPER). Retrieved from https://evidencebasedprograms.org/document/prosper-evidence-summary/

Greenberg, M. T., Feinberg, M. E., Meyer-Chilenski, S., Spoth, R. L., & Redmond, C. (2007). Community and team member factors that influence the early phase functioning of community prevention teams. Journal of Primary Prevention, 28(6), 485–504. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2848438/

PROSPER Partnerships. (n.d.). How it works. Retrieved from http://helpingkidsprosper.org/how-it-works

Spoth, R., Guyll, M., Redmond, C., Greenberg, M., & Feinberg, M. (2011). Six-year sustainability of evidence-based intervention implementation quality by community-university partnerships: The PROSPER study. American Journal of Community Psychology, 48(0), 412–425. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3727665/

Spoth, R., Redmond, C., Shin, C., Greenberg, M., Clair, S., & Feinberg, M. (2007). Substance-use outcomes at 18 months past baseline: The PROSPER community-university partnership trial. American Journal of Prevention Medicine, 32(5), 395–402. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2869212/

 

Glossary of Terms

Glossary of Terms Peggy Kelley Thu, 10/25/2018 - 02:57 PM EDT

Aversion formulations: Alterations to a prescription drug’s formula to reduce its abuse potential. These alterations can include changes to a drug’s delivery method, chemical consistency, or physical properties.

“Closed system”: Refers to the DEA’s process for ensuring that all individuals and organizations who handle controlled substances, including manufacturers, distributers, prescribers, and pharmacies, are registered with the DEA. Individuals and organizations must meet certain requirements to obtain and maintain this registration, including tracking all controlled substances they handle.

Controlled prescription drugs: Prescription drugs that contain at least one DEA Schedule controlled substance. Prescribers and pharmacies must meet certain requirements (including licensing) to prescribe and dispense these prescription drugs.

Declaratory judgments: A court decision in a civil dispute that is legally binding and precludes any arbitration, negotiation, or settlement between the parties in dispute. It can be a standalone order or attached to an injunction or awarding of damages.

Formulary: The list of prescription drugs covered by a health insurance plan. It can include criteria that determine when certain drugs are covered.

Good Samaritan laws: Laws that provide legal protections to individuals attempting to assist an individual in danger. These laws can contain provisions for assisting individuals overdosing from prescription drugs, including administering naloxone or contacting emergency personnel.

Indicated prevention programs: Prevention programs intended to identify and serve individuals at risk for a substance use disorder (e.g., a student with recent increased delinquency).

Land-grant university: Universities that receive federal benefits under the Morrill Acts of 1862 and 1890. To qualify, universities must meet certain requirements, including a mission to focus on agriculture, science, engineering, and certain other technical studies.

Long-acting opioid analgesic: Opioid-based pain reliever prescription drugs intended to manage chronic pain. These drugs have high dosages of opioids and patients are directed to take them at regular intervals, not “as needed.” Also known as extended release opioid analgesics. Contrast to short-acting or immediate release opioid analgesics.

Morphine milligram equivalents: Measurement system used to calculate the strength of opioid medications.

Narcotic analgesics: Pain relievers that contain opioids. They are used to treat moderate to severe pain and vary in potency and risk of causing dependency or addiction.

Non-narcotic analgesics: Pain relievers that do not contain opioids. They are primarily intended to treat mild pain and are usually available over-the-counter at lower doses (e.g., acetaminophen).

Pay-for-performance: Health care payment model that links provider payments to patient outcomes. Alternative to fee-for-service models, where provider payments are linked only to the quantity of services provided.

Pharmacy hopping: Patients attempting to fill the same prescription at multiple pharmacies to obtain more medication than the prescribed dosage.

Physicochemical barriers: A type of aversion formulation to reduce a prescription drug’s abuse potential. These barriers can be designed to make it more difficult to dissolve, crush, chew, or otherwise modify the prescription drug.

Polypharmacy: The concurrent use of four or more medications to treat various health conditions.

Pseudoephedrine: A nasal decongestant found in many over-the-counter and prescription medications. It is also a key precursor chemical in several of the most common methods used to produce methamphetamine.

Schedule I or II substances: Schedule I controlled substances are those defined as having no accepted medical uses and a high risk for abuse or dependency, and, as such, there are no Schedule I prescription drugs. Legal manufacture of Schedule I controlled substances is permitted for certain research purposes. Schedule II controlled substances are those defined as having accepted medical uses and a high risk for abuse or dependency. Due to their high risks, the DEA has placed additional requirements on the storage, transportation, and tracking of Schedule I and II controlled substances.

Schedules of Prescription Drugs: Prescription drugs that contain controlled substances are classified along the U.S. Drug Enforcement Administration’s Controlled Substances Act Scheduling system according to their acceptable medical uses and risk for abuse or dependency. The Schedule runs from I (highest classification) to V (lowest classification).[1]

Screening, brief intervention, and referral to treatment (SBIRT): Strategy to deliver services to individuals at risk for or with substance use disorders, focusing on a short screening, immediate services, and referral to more comprehensive services.

Selective prevention programs: Prevention programs intended to reach vulnerable groups within a population considered at risk for a substance use disorder (e.g., children of parents with a substance use disorder).

Tramadol: A long-acting opioid analgesic for treating moderate to severe pain. Contrast to oxycodone.

Uncontrolled prescription drugs: Prescription drugs that do not contain any DEA Schedule controlled substances. Prescribers and pharmacies must meet fewer requirements to prescribe or dispense these prescription drugs. Examples include medications to treat high blood pressure or bacterial infections.

Universal precautions: Steps that prescribers can take to reduce the likelihood of prescription opioid misuse among patients, such as ensuring patient informed consent about opioid use or developing a treatment agreement.[2]

Universal prevention programs: Prevention programs intended to reach an entire population (e.g., all students in a school, all residents in a community, etc.), without regard to individual risk factors.

[1] U.S. Drug Enforcement Administration. (n.d.). Drug scheduling. Retrieved from https://www.dea.gov/drug-scheduling

[2] Benedict, D. G. (2008). Walking the tightrope: Chronic pain and substance abuse. Journal for Nurse Practitioners, 4 (8), 604 – 609.