Addressing Prescription Abuse Through Regulation and Education

All interests must collaborate to combat public health crisis
by Herbert Neuman, MD

Prescription drug abuse and misuse is a serious and rapidly growing public health issue. Previous articles in Addiction Professional and the countless personal stories you likely hear in your professional practice have shown this is a widespread issue affecting communities across the country.

States such as Kentucky, West Virginia and Florida are seeing record high reports of abuse and misuse, especially among teens and young adults. In West Virginia, nine out of 10 drug deaths are from prescription medications. A recent ABC News investigation showed that Florida has more pain clinics than fast food restaurants. To combat abuse and misuse, states are putting in place legislation to monitor powerful prescriptions and are creating prevention and awareness programs. One example is Ohio Gov. John Kasich’s commitment to build a prescription drug task force and his recent allocation of $100,000 to boost an effective private drug treatment program.

At the federal level, both the Office of National Drug Control Policy (ONDCP) and the Food and Drug Administration (FDA) are investing time and resources to address this significant issue. ONDCP in April announced an action plan to address prescription drug abuse. The plan’s framework focuses on four distinct issue areas: education, monitoring programs, drug disposal, and enforcement efforts to reduce the prevalence of “pill mills” and doctor shopping.

The FDA recently finalized its guidance on a class-wide Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioid pain medications. The Food and Drug Administration Amendments Act of 2007 gave the FDA authority to require such strategies from manufacturers of certain products to ensure that the benefits of a drug outweigh its risks. More than 80 products on the market today have these requirements, and the FDA’s latest guidance requires manufacturers of extended-release and long-acting opioid medications to develop and share educational materials for prescribers and patients.

Since introducing a branded extended-release opioid in April 2010, Covidien, a healthcare products company, has implemented a comprehensive REMS for that product that aligns closely with the FDA’s latest guidance. We look forward to working with the FDA to ensure compliance.

Leveraging existing resources
While action is being taken on the state and federal level, questions remain about how best to arm addiction professionals and consumers with resources so that they can help prevent abuse and misuse of powerful painkillers. As the chief medical officer for the pharmaceuticals business within Covidien, I want to ensure that you are aware of the range of useful tools that exist.
The American Pain Foundation has created PainSAFE (Pain Safety & Access for Everyone), an educational resource that provides information about the safe use of pain therapies. PainSAFE resources include information about pharmacotherapy and a “Frequently Asked Questions” section about opioid safety. Similar tools are available from the American Pain Society and the American Chronic Pain Association. There is also a relatively new initiative, The Zero Unintentional Deaths campaign, which offers guidance for patients, parents and prescribers around the safe use of prescription painkillers.

Collaboration is key
To complement existing addiction prevention resources, Covidien recently launched the C.A.R.E.S (Collaborating & Acting Responsibly to Ensure Safety) AllianceSM, a growing consortium of five national medical, patient safety and anti-drug diversion organizations focused on responsible prescribing and safe use of opioid pain medications. The C.A.R.E.S Alliance ( seeks to reduce opioid pain medication misuse and abuse by collaboratively developing and sharing tools and resources for healthcare professionals, patients, and community and healthcare organizations.

Via the website, patients and their families find tips for the safe use and handling of their medications, and healthcare professionals receive tools for prescribing and for screening and assessing patients.

It’s important to remember that the issue of prescription drug abuse can be solved only if we all work together. Addiction professionals, regulatory bodies, caregivers and consumers all have a responsibility to patient safety and should seek out available tools and resources to ensure the safe use of prescription painkillers. Through collaboration at the national, state and local levels, we all can play a key role in ending this burgeoning public health crisis. I know this is a cause we can all champion.

Herbert Neuman, MD, is Vice President of Medical Affairs and Chief Medical Officer-Pharmaceuticals for Covidien, a healthcare products company and a supplier of opioid pain medications in the U.S. Covidien sponsors the C.A.R.E.S. Alliance

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