Ethics & Compliance
Public Policies to Address the Opioid Crisis
The nation is experiencing a public health crisis involving licit and illicit opioids.1,2 Purdue endorses the following policies that support a comprehensive approach to reducing addiction, abuse, diversion, and overdose related to opioids.
Wider Dissemination of FDA-Approved Medication Guides for Opioid Analgesics
Purdue supports policies that ensure every patient who is prescribed an opioid analgesic is aware of and receives that drug’s FDA-approved Medication Guide.3 Medication Guides contain important safety information for patients and caregivers. Medication Guides for opioid analgesics contain information about common side effects, serious side effects, and risks associated with taking opioids, including addiction, abuse, and misuse, that can lead to overdose and death. Medication Guides also tell how to take the medicines, how to store them, and how to safely dispose of them when they are no longer needed.
Public Education to Promote Safe Handling, Storage, and Appropriate Disposal of Medications, Particularly Controlled Substances
Purdue supports programs to educate patients on the proper handling, storage, and disposal of medications, and the risks of accidental exposure or diversion of medicines that are not stored securely. Information about removal and disposal options in the local community and recommendations for disposal from the FDA are important tools for the public and should be part of public education addressing the opioid crisis. Prescribers, dispensing pharmacies, health plans, and federal health care programs should include messages about safe handling, storage, and appropriate disposal whenever they interact with patients who are receiving medications by prescription.
Obtain Informed Consent
Purdue supports clinicians obtaining informed consent prior to initiating treatment with an opioid analgesic. While opioid analgesics can help manage pain when appropriately prescribed, these medications expose patients to risks as well. Patients, their guardians, and caregivers need to understand these risks, even when taken as directed, their anticipated benefits, and recognized alternatives.
Use Electronic Prescribing for Controlled Substances
Purdue encourages the use of electronic prescribing for controlled substances because it can reduce medication errors caused by illegible prescriptions or oral miscommunication. It may also reduce diversion by making forging or altering prescriptions difficult, and reduce theft of written prescriptions and prescription blanks. To prevent disruptions in patients’ access to prescribed medications, policies to reduce the known barriers to adoption and use of electronic prescribing should be implemented prior to requiring electronic prescribing for controlled substance medications.
Limit the Duration of the First Opioid Prescription
Purdue supports medically appropriate limits on the duration (days’ supply) of the initial opioid prescription during a course of treatment. Such limits can improve prescribing practices and reduce the number of unused opioids in the community.
Use Prescription Drug Monitoring Programs (PDMPs)
Purdue encourages prescribers to register and use PDMPs. Further, Purdue supports improved PDMP utility for clinicians, such as accessing data across state lines, allowing use by a prescriber’s delegate, and integrating information into the clinical workflow. Evidence shows PDMPs are effective in supporting appropriate clinical decision-making, reducing “doctor shopping,” and preventing prescription drug abuse and diversion.4
Require Demonstrated Competence for Opioid Prescribing
Purdue supports required demonstration of competence in opioid prescribing as a condition for initial or renewed registration with the DEA to prescribe opioid analgesics.5 Prescribers can demonstrate competency by completion of specific training on the risks and appropriate use of opioids or by certification from a relevant specialty board. Healthcare professionals who possess current and accurate knowledge of opioids are more likely to make appropriate prescribing decisions, thereby reducing risks to the individual and to the public.
Expand the Use of Naloxone
Purdue supports increased access to naloxone, an opioid reversal agent, to reduce deaths from opioid overdose. Policies to expand use include greater availability of naloxone for use by law enforcement and other first responders; appropriate civil immunity to persons aiding in a potential overdose situation (“Good Samaritan” laws); and ability to obtain naloxone without a prescription.6,7
Expand Access to Medication-Assisted Treatment (MAT) for Opioid Use Disorder
Purdue supports affordable, culturally appropriate, convenient, and timely access to MAT.8,9 Policies to expand access to MAT include increasing workforce capacity, improving insurance coverage, and reducing stigma. Evidence shows that combining the judicious use of medications approved by the FDA specifically for use in managing opioid addiction with counseling and behavioral therapies effectively treats opioid use disorder.
Encourage Adoption of Abuse-Deterrent Formulations
Purdue supports removing barriers to the appropriate clinical use of opioid analgesics with abuse-deterrent properties (ADP) as recognized by the FDA. While the FDA has approved several opioids with ADP, the vast majority of opioids dispensed lack such properties.10,11 Development and use of opioids with ADP are part of a comprehensive approach to reduce the abuse of opioid analgesics.12 All opioids, including those with abuse-deterrent properties recognized by the FDA, expose users to the risks of addiction, abuse, and misuse.
- Substance Abuse and Mental Health Services Administration. (2018). Key substance use and mental health indicators in the United States: Results from the 2017 National Survey on Drug Use and Health (HHS Publication No. SMA 18-5068, NSDUH Series H-53). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from: https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHFFR2017/NSDUHFFR2017.htm.
- Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018;67(5152):1419-1427.
- Food and Drug Administration. For Consumers. Consumer Updates: Medication Guides for Certain Prescription Products. Available at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107825.htm. Accessed June 26, 2018.
- Worley, J. Prescription Drug Monitoring Programs, a Response to Doctor Shopping: Purpose, Effectiveness, and Directions for Future Research [published online April 30, 2012]. Ment Health Nurs. 2012;33(5):319–328. doi:10.3109/01612840.2011.654046.
- Office of National Drug Control Policy. Epidemic: Responding to America’s Prescription Drug Abuse Crisis. Healthcare Provider Education, p3, bullet 1. https://obamawhitehouse.archives.gov/sites/default/files/ondcp/policy-and-research/rx_abuse_plan.pdf. Published 2011. Accessed July 25, 2017.
- Department of Health and Human Services, Assistant Secretary for Planning & Evaluation. Opioid Abuse in the U.S. and HHS Actions to Address Opioid-Drug Related Overdoses and Death. ASPE Issue Brief. https://aspe.hhs.gov/system/files/pdf/107956/ib_OpioidInitiative.pdf. Published March 26, 2015. Accessed July 25, 2017.
- State Naloxone and Good Samaritan Legislation. ONDCP. https://obamawhitehouse.archives.gov/sites/default/files/ondcp/Blog/naloxonecirclechart_november2014.pdf. Published December 1, 2014. Accessed July 25, 2017.
- Lipari RN, Park-Lee E, Van Horn S. Substance Abuse and Mental Health Services Administration (SAMHSA). America’s Need for and Receipt of Substance Use Treatment in 2015. The CBHSQ Report. https://www.samhsa.gov/data/sites/default/files/report_2716/ShortReport-2716.html. Published September 29, 2016. Accessed July 25, 2017.
- Department of Health and Human Services, Assistant Secretary for Policy & Evaluation. Opioid Abuse in the U.S. and HHS Actions to Address Opioid-Drug Related Overdoses and Death. ASPE Issue Brief. https://aspe.hhs.gov/system/files/pdf/107956/ib_OpioidInitiative.pdf. Published March 26, 2015. Accessed July 25, 2017.
- U.S. Food and Drug Administration. Opioid Medications: Abuse-Deterrent Opioid Medications. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/abuse-deterrent-opioid-analgesics. Updated August 21, 2017. Accessed August 28, 2017.
- IMS Health NPA and NSP. Data on file. Prescriptions for opioid analgesics with ADP labeling as percentage of total prescriptions for opioid analgesics for the 12-month period ending December 2016.
- U.S. Food and Drug Administration. Fact Sheet – FDA Opioids Action Plan. Bullet 5. https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm484714.htm. Updated July 11, 2017. Accessed July 25, 2017.