Background

Opioid analgesic drug use in the United States increased from 30 million in 2002 to 35 million in 2010. There is a concern that patients may misuse drugs within this class when not properly instructed by their healthcare provider and that unanticipated adverse events may occur as a result. In July 2012, the US Food and Drug Administration (FDA) called for a risk evaluation and mitigation strategy (REMS) program to ensure that the benefits of an extended-release or long-acting (ER/LA) opioid drug outweigh its risks, through manufacturer submission of a medication guide, communication plan, or other elements to ensure safe use. The overall goal of a REMS is to minimize the risk of opioid analgesics while facilitating patient access to this class of drugs.

Issue

As part of the implementation of REMS, all ER/LA opioid drug manufacturing companies will be required to provide continuing education (CE) programs for physicians and pharmacists about REMS and to provide information that prescribers can use when counseling patients about the potential risks and benefits of a drug. The FDA aims to implement the first official CE program in March 2013. However, the benefits of such a program are currently unclear and prescriber awareness of REMS is very low. The challenge for the FDA is to properly educate prescribers of opioid drugs on the benefits of REMS so that implementation of the REMS program will be more effective and so that physicians and patients can make more effective decisions when prescribing and taking these types of drugs.

Rule

If physicians are properly educated about the risks and pitfalls of drugs covered by a REMS, then the program will be much more effective in ensuring the safety of the public.

Analysis

Education of the people who will use a REMS most frequently is essential to the success of implementation of REMS. A prescriber education program on risk and safety use of a REMS currently exists, but the program is currently opt-in for physicians, and there is no way of telling whether or not the program or similar CE programs are effective. A recent survey suggests that about only 1 out of every 3 prescribers (35%) of opioid drugs are aware of REMS, falling far short of the FDA’s goal to educate at least 60% of prescribers. Therefore, the goals of a potential CE program are unclear and raise more questions than they answer.

What will the program entail and what are its objectives? Is there a deadline by which prescribers should be educated? What elements should be included in the CE program? What will the FDA do to get word out to prescribers about the CE program? Will it be a required course for all prescribers? To help answer some of these questions, the MedBiquitous Consortium has an initiative called MEM 2.0, a program that will allow CE providers to disseminate data about REMS-related CE.

CE accreditors from across the country are on board with the program, but it is hard to assess how much the program is being used or will be used once the program begins. Will it be mandatory? There is no clear data to tell if healthcare providers will learn what they need to know about REMS through participation. It is essential that prescribers are fully educated about the use of a REMS so that they can make more effective decisions when prescribing opioids, and so that patients can be better informed of the risks of this class of drugs, which can include serious adverse effects such as addiction, unintentional overdose, and death.

Conclusion

The implementation of REMS emerged out of a need to educate patients and prescribers of opioid drugs about the adverse effects of this class of drugs. CE, which is a mainstay of a healthcare practitioner’s career, can be an effective way of providing physicians and pharmacists with information they can use to educate their patients. Therefore, it is imperative that prescribers of opioid drugs be properly informed themselves about the risks and benefits of this class of drugs in order to help minimize the risks of opioid analgesic use and work collaboratively with other healthcare professionals and institutions. Only time and practice, however, will tell if a CE program will be effective in helping the FDA and manufacturers of ER/LA drugs reach their goals.

For more information on this issue, contact the Kulkarni Law Firm.