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