Purdue’s Efforts to Help Address the Crisis
While the company has made mistakes in the past, for close to two decades, Purdue has engaged in over 60 distinct initiatives to stem prescription opioid abuse in close collaboration with states, communities, industry partners, and law enforcement agencies.
In 2001 alone, Purdue’s activity included a range of important programs, such as providing free tamper-resistant prescription pads to 16,000 healthcare professionals, offering abuse detection and deterrence training to more than 70,000 law enforcement officials, launching a national education program on prevention drug diversion targeting 395,000 prescribers, and developing the Researched Abuse, Diversion and Addition-Related Surveillance (RADARS) program to detect and study abuse, misuse and diversion nationwide.
This commitment to prevention, diversion reduction, education and training, research, and recovery is important to the company.
We are proud to provide resources, grants, and expertise to healthcare providers and the most impactful organizations on a national, state and community level so that together we can accelerate the next generation of solutions. Our partners have included the National Association of Drug Diversion Investigators, Partnership for a Drug-Free America, Community Anti-Drug Coalitions of America, the Prescription Drug Safety Network, and Communities that Care.
Below, please find more information on just a few of the important steps we have and are taking to help address the crisis.
In an effort to make OxyContin more difficult to manipulate, Purdue spent years and hundreds of millions of dollars working to develop a reformulation of OxyContin that would continue to deliver pain relief to patients and be less attractive and more difficult for users to abuse or misuse. In 2010, Purdue became the first company to receive FDA approval for an opioid with abuse-deterrent properties. In 2013, based on laboratory and clinical data, the FDA granted OxyContin the first-ever label stating that the medication has properties that are expected to make it more difficult to abuse by certain routes. However, abuse by injection, intranasal and oral route is still possible, and all opioids, including those with FDA-recognized abuse-deterrent properties carry risks of addiction, abuse, and misuse, which can lead to overdose and death. Today, the FDA continues to encourage the development of opioid pain medications that are harder to manipulate and abuse.
Improving Prescription Drug Monitoring Programs
PDMPs provide healthcare professionals with access to prescription dispensing histories and are designed to help them identify emerging substance use disorders and potential doctor-shoppers. Purdue has a long history of supporting state efforts to develop and implement PDMPs. For example, Purdue provided funding in 2011 to help enable states to share PDMP data across state lines. Purdue is also part of a unique public-private partnership with the Commonwealth of Virginia to enhance its PDMP and integrate it with electronic medical records. Purdue also recently funded pilot projects through the National Association of Drug Diversion Investigators to enhance PDMP data and collection analytics.
Youth Education Programs
Purdue is a member of the Prescription Drug Safety Network, a public-private initiative created by EVERFI, a leading prevention education innovator. This coalition is empowering students with skills to help them make safe and healthy decisions about prescription use. With support from Purdue, EVERFI’s digital learning course will become available in approximately 245 high schools across the United States by 2019.
Increasing Access to Naloxone and Nalmefene
Naloxone and nalmefene are opioid antagonists used to reverse the effects of a life-threatening opioid overdose.
Purdue recently awarded a grant to Harm Reduction Therapeutics to advance the development of its low-cost, over-the-counter (OTC) naloxone nasal spray in the United States. Purdue also provided funding to the National Sherriff’s Association (NSA) for the purchase of naloxone kits and training of law enforcement officers on overdose reversal. Since November 2015, the NSA estimates it has distributed nearly 3,500 naloxone doses to 21 states and trained more than 1,000 law enforcement officers on administering naloxone to victims of a drug overdose.
On March 13, 2019, the FDA granted Fast Track designation to Purdue’s nalmefene hydrochloride injection for the emergency treatment of known or suspected opioid overdose. Because of the increasing number of deaths due to fentanyl and its even more potent analogues, nalmefene has the potential to serve as an important alternative for the treatment of opioid overdose. As part of Purdue’s commitment to advance meaningful solutions to address the opioid addiction crisis, the company will work to bring forward this option with the commitment not to profit from any future sales of this drug.
There is no guarantee that nalmefene HCl injection, an investigational agent, will successfully complete clinical development or gain FDA approval.
Increasing Access to Treatment
Purdue supports affordable, convenient, and timely access to Medication Assisted Treatment (MAT) and individualized recovery services for opioid use disorder. The company has provided funding and expertise to a range of programs, including recovery to the workplace models, community-based peer recovery programs, and capacity improvement projects.
Public Policies to Address the Opioid Addiction Crisis
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. 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 patients 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 addiction 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, including abuse, addiction, overdose, and death. Patients, their guardians, and caregivers need to understand the risks and anticipated benefits of opioid analgesics, and their 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
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.
Require Demonstrated Competence for Opioid Prescribing
Purdue supports requiring demonstration of competence in opioid prescribing as a condition for initial or renewed registration with the Drug Enforcement Administration to prescribe opioid analgesics. 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.
Purdue’s opioid analgesics are subject to the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics. A REMS is a program to manage known or potential serious risks associated with a drug product and is required by the FDA to help ensure that a drug’s benefits outweigh its risks. Purdue is also a member of the REMS Program Companies, a consortium of pharmaceutical companies formed to implement a single shared REMS for opioid analgesics.
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 the ability to obtain naloxone without a prescription.
Expand Access to Medication-Assisted Treatment for Opioid Use Disorder
Purdue supports affordable, culturally appropriate, convenient, and timely access to MAT. 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 can effectively treat opioid use disorder.39,40
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, such as insurers refusal to pay for prescription opioids with ADP. While the FDA has approved several opioids with ADP, the vast majority of opioids dispensed are generic and lack such properties. Development and use of opioids with ADP are part of a comprehensive approach to reduce the abuse of opioid analgesics. All opioids, including those with ADP recognized by the FDA, expose users to the risks of addiction, abuse, and misuse.