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