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 address diversion and abuse through a multidimensional approach that includes opioid educational efforts, monitoring for suspicious orders of controlled substances, drug take-back programs and research into abuse-deterrent technologies.
1. Abuse-Deterrent Formulations
As appropriate regulatory standards are developed and more research is undertaken, Mallinckrodt believes that abuse-deterrent formulations (ADFs) may prove to be one component of a comprehensive approach to combating opioid abuse. Abuse-deterrent formulations are designed to make it difficult for a medication to be manipulated, thereby making it more difficult to abuse.
Mallinckrodt has invested millions of dollars in research to explore the abuse-deterrent potential of its proprietary formulation technologies. Our goal is to develop abuse-deterrent formulations that will effectively make our branded and generic products less attractive to potential abusers, while at the same time provide patients who depend on our medicines with a variety of safe and affordable options.
Mallinckrodt is committed to developing abuse-deterrent formulations and has long sought clear, final and stable guidance from the U.S. Food and Drug Administration (FDA). Over the years, important progress has been made by the FDA in the development of final guidance. In 2013, the FDA released its draft guidance publication on the evaluation and labeling of abuse-deterrent opioids, and in 2014 a meeting was conducted with both branded and generic manufacturers to discuss ADF development.
With regard to final guidance on abuse-deterrent formulations, Mallinckrodt encourages the FDA to adopt a balanced approach that provides a meaningful and realistic pathway forward for both branded and generic manufacturers. Without that balanced approach, the development of the science of ADFs will stall, access to pain control will be impeded, and the cost of pain medications for government and other healthcare programs will increase sharply.
Mallinckrodt remains committed to working with the FDA on these issues and strongly supports ongoing dialogue among the agency, drug manufacturers and other stakeholders. Mallinckrodt has an active, robust research and development program, and we look forward to discussions with the FDA regarding the incorporation of abuse-deterrent formulations into both extended-release and immediate-release opioid products.
2. Risk Evaluation and Mitigation Strategies (REMS) and Mandatory Prescriber Education
In addition to our work on abuse-deterrent formulations, 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. Mallinckrodt plans to publish the results of the REMEDIES program in a peer-reviewed scientific journal.
3. 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.
As of January 2015, 49 states had enacted laws that established monitoring programs to track certain prescriptions, and Missouri is the only state still without such legislation. Mallinckrodt is currently working with a coalition of approximately 40 Missouri organizations to pass such a measure. Legislation is currently under active consideration by both the Missouri Senate and the House.
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.
4. 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.
5. 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. Although many organizations, including federal and state governments, have undertaken significant public education campaigns more can be done.
Since 2012, Mallinckrodt has been a Gold Sponsor of, and active participant in, The Medicine Abuse Project™ led by The Partnership at Drugfree.org. This initiative addresses prescription medicine abuse among young people and how to prevent it.
In 2013, Mallinckrodt collaborated with the American Academy of Family Physician’s National Research Network to validate an assortment of opioid risk assessment tools that would have an impact in clinical family practice. The study is ongoing and will be completed mid-2015.
And most recently, in 2014, Mallinckrodt released a revised version of their Drug Take-Back Toolkit to assist local communities with planning their own drug collection events, which provide the public a safe method to dispose of unused medications. The toolkit was developed in collaboration with multiple stakeholders and field tested by Community Anti-Drug Coalitions of America (CADCA).
6. Storage and Disposal
Mallinckrodt supports expanding programs that encourage appropriate storage and disposal of opioids, and we have been and continue to be involved in various take-back programs. Specifically, we have supported drug take-back days and drug drop boxes with local law enforcement agencies. 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.
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.