Responsible Use Programs
Mallinckrodt is committed to helping healthcare providers treat patients in pain and fighting opioid misuse and abuse. Our key initiatives support a broad range of programs that encourage the appropriate use of pain medications and go beyond what is required by law. We take our responsibility as an opioid manufacturer very seriously.
1. A Prescription for America’s Opioid Epidemic: Six Integrated Policy Initiatives to Address Opioid Abuse and Misuse
As an industry pioneer in addressing the problem of prescription drug diversion and misuse and a strong and committed partner to those focused on addressing the problems of drug abuse, Mallinckrodt has developed a unique perspective on potential policy solutions to address the significant problem facing rural areas, towns and cities in virtually every state across the U.S.
For years, the company has worked with policymakers, law enforcement, patient groups and other stakeholders on the issue of opioid diversion and abuse, in particular, and will strongly advocate for public policies directed at prevention and treatment. The company believes that by implementing six integrated policy initiatives, summarized below, significant and measurable progress can be made in the fight against prescription drug abuse in America. Click here to read the full policy statement.
1. Use Opioids Sparingly: The preferred standard of care must be a balanced, multimodal approach to pain management. Mallinckrodt will advocate for incentives, policies and treatment guidelines that focus opioid use on cases where adequate pain management cannot be achieved with an alternative therapy, or where alternative therapies are not available or is inappropriate for a particular patient. Mallinckrodt and others offer such alternative medication options today and the company also supports creation of treatment guidelines to advance this approach.
2. Expand Access to Medication-Assisted Treatment: All patients with a substance use disorder should have access to appropriate treatment, including counseling, behavioral therapy and all relevant U.S. Food and Drug Administration-approved medications. Mallinckrodt will advocate for federal and state policies that eliminate barriers to treatment access.
3. Mandate Advanced Education for Healthcare Providers: Understanding and identifying the risks associated with opioids are critical to better ensuring that healthcare providers can prevent opioid abuse and misuse before it begins. Mallinckrodt has been a strong advocate for continuing medical education for physicians (including dentists and veterinarians), and education of pharmacists and hospital personnel on appropriate prescribing and warning signs of opioid abuse and diversion. The company will continue to advocate for strengthened state and federal policies that mandate such education.
4. Enhance Regulatory Standards and Data Usage to Prevent Diversion: Clarifying responsibilities for tracking opioids in the supply chain, generating better data on the nature of opioid abuse – from both legitimate opioid prescriptions and illicit opioid use – and aligning and strengthening prescription drug monitoring programs (PDMPs) across states are critical steps toward halting the diversion and improper use of opioids. Mallinckrodt has been a leading proponent of PDMPs, and will advocate for regulatory clarity and improved data generation and sharing at the federal and state levels.
5. Urge Safe Drug Storage and Disposal: Several national statistics reveal that home medicine cabinets are a primary source of diverted prescription opioids, and so it is critically important to form public and private partnerships to provide ways to safely and responsibly store medications and dispose of unused and unneeded medication. As one such solution, Mallinckrodt has donated approximately 1.5 million drug disposal pouches across the United States and will increase that number incrementally to 2 million by the first quarter of 2018. Some states have also purchased drug disposal pouches for their residents, and Mallinckrodt will advocate for funding to continue these efforts.
6. Fund Community-Based Education / Intervention: Education on opioid abuse and community interventions with youth and at-risk populations is critical to achieving healthy and drug-free communities. Mallinckrodt will continue to advocate for federal funding, made available through the Comprehensive Addiction and Recovery Act, and state funding to support community-based education and intervention programs.
2. Prescription Drug Monitoring Programs (PDMPs)
PDMPs are statewide electronic databases that collect data on substances dispensed in the state. PDMPs have proven to be an effective tool in reducing prescription drug abuse. Specifically, evidence exists that PDMPs reduce doctor shopping, shorten the time needed to conduct investigations, improve clinical decision making and lower overall rates of abuse and diversion. For example, a 2002 Government Accountability Office report found that Kentucky, Nevada and Utah reported less diversion of prescription drugs as compared to the level reported in previous years because of PDMPs.
For many years, Mallinckrodt has been a vocal advocate for the prescription drug monitoring program (PDMP) in Missouri, and has led a coalition of groups to pass legislation in Missouri to implement a PDMP. Read our statement commending Gov. Eric Greitens executive order to establish a PDMP in Missouri.
While PDMPs have been shown to be effective, Mallinckrodt believes there is significant room for improvement, including providing real-time data, incentives for utilization and interstate data sharing. We support modifying PDMPs to make easy-to-use, real-time data consistently available to pharmacies and prescribers. We urge the Medicare and Medicaid programs and other payors to offer financial incentives to prescribers and pharmacies that consistently use PDMP data as part of their prescription management practices. This incentive would address the costs associated with developing the capability to participate in PDMPs, reviewing data when prescribing and inputting prescription data into the system.
Furthermore, because experience has shown that abusers often will travel from one jurisdiction to another to secure opioids, it is critically important to make data available on a nationwide basis. In order to respect both the state and federal interests found here, Mallinckrodt advocates for the formation of a joint state and federal commission with the authority to set and implement uniform standards for data reporting and transparency to prescribers and pharmacies.
3. Anti-Diversion Program
At Mallinckrodt, we believe that a comprehensive anti-diversion program is an important component of addressing opioid abuse, and we have invested — and continue to invest — significant thought and resources in this area. Over the last several years, we have consistently and continually improved our innovative, industry-leading anti-diversion program and believe that it goes far beyond the requirements found in U.S. Drug Enforcement Administration (DEA) regulations regarding maintaining a system to detect suspicious orders of controlled substances.
This belief is supported by the fact that we have been contacted by wholesalers and other manufacturers wanting to learn about our anti-diversion program and have worked with a number of key players to provide them with best practices in this area.
Mallinckrodt believes that constructive dialogue between the DEA and manufacturers and wholesalers will help in the development of solutions to the prescription drug abuse problem. Accordingly, we have organized and convened an industry working group of manufacturers and wholesalers to engage on this important issue. While each of the participating companies maintains its own anti-diversion programs, we agree that our collective contributions can exceed what we are able to do individually — and that, by collaborating and exchanging ideas, we can take additional meaningful steps toward reducing diversion and abuse. In addition, we will continue to support clarification of DEA regulations in this area.
4. Public Education
Mallinckrodt believes public education is critical in the fight against prescription drug abuse, misuse and diversion. If used appropriately, opioid pain medications can be safe and effective; however, the risks associated with these medicines can be serious and challenging. Education for patients, caregivers, healthcare providers and the community is essential to build awareness on the responsible prescribing, use, storage and disposal of pain medication. Mallinckrodt will continue to advocate for federal funding, made available through the Comprehensive Addiction and Recovery Act, and state funding to support community-based education and intervention programs. We are also a proud and long-time supporter of the Community Anti-Drug Coalitions of America (CADCA) and its mission to make America’s communities safe, healthy and drug-free.
5. Storage and Disposal
Mallinckrodt supports expanding programs that encourage appropriate storage and disposal of opioids to prevent unused medications from ending up in the wrong hands. We have donated more than 1.5 million drug deactivation and disposal pouches to community groups, law enforcement, schools, patients and families across the United States and will increase that number to 2 million by the first quarter of 2018. We have also supported drug take-back days and drug drop boxes with local law enforcement agencies. A partnership in St. Louis, MO alone helps discard about 3,500 pounds of prescription drugs every quarter. We believe that local, state and federal agencies can do more to make these programs more effective, more readily available and more widely publicized. We stand ready to work with the government and other stakeholders in achieving these critically important objectives.
Past Mallinckrodt Donation Partnerships
6. Risk Evaluation and Mitigation Strategies (REMS) and Mandatory Prescriber Education
Mallinckrodt also supports a variety of initiatives to increase responsible prescribing of opioid pain medications. We support the classwide REMS program for extended-release and long-acting opioids, but we believe there is room for improvement. Specifically, we believe that the REMS program’s emphasis on educating a particular set and percentage of prescribers could be improved by adding education effectiveness measurements.
Mallinckrodt has invested over $2.5 million in the development of an innovative prescriber education program called REMEDIES (Risk Evaluation and Mitigation Strategies — An Employer-Driven CME Initiative for Efficacy and Safety). Through meaningful, ongoing, prescriber training utilizing live and online programs, the REMEDIES program’s ultimate goal is to improve the quality of care for opioid-tolerant pain patients. With this type of program, participating prescribers will be better able to:
- Develop individualized treatment plans that take a more holistic approach for patients with chronic pain, including patients with medical or psychiatric comorbidities
- Devise a rationale and clinical plan for the initiation, safe use, adjustment and appropriate rotation of opioid therapy in patients with persistent pain
- Demonstrate a current understanding of pain terminology, tolerance and related phenomena in opioid-based pain management (e.g., dependence, tolerance, addiction, misuse, abuse, diversion, pseudo-addiction)
- Synthesize a comprehensive understanding of how clinicians can implement the classwide extended-release/long-acting opioid REMS program into clinical practice to help assure safe and effective pain relief for patients
- Improve patient diagnosis and management through appropriate use of currently available treatments
A key component of the REMEDIES program is the ongoing performance improvement initiative that launched in November 2012 and ran until October 2014. This initiative allowed participating prescribers to better integrate what they learned into clinical practice.
Another important element of the REMEDIES program is anonymous screenings by employers of their employees’ worker compensation records to assess health improvements in patients with pain who are under the care of participating prescribers. Fully compliant with health privacy regulations, three such anonymous employer screenings have been conducted by the New England Truck Training Centers of America (Boston), MasTec Wireless Networks (Fort Lauderdale), and Canal Cartage (Houston).
The REMEDIES program has demonstrated a high level of success in achieving its educational goals with final outcome assessments showing meaningful changes in opioid prescribing behavior and improvements in pain-patient outcomes.
7. Substance Abuse and Treatment Programs
We commend federal, state and local governments for funding and, in many cases, operating, substance abuse prevention and treatment programs. Mallinckrodt believes that these efforts are an indispensable part of a solution to opioid abuse. Indeed, by focusing on the problem before it occurs and targeting known abusers for rehabilitation, these programs may be the most important and most direct means of addressing opioid abuse.
8. Abuse-Deterrent Formulations
We have made investments in our product lines to develop tamper-resistant and abuse-deterrent technologies.