Prescriber Education:
Risk Evaluation
Risk Evaluation & Mitigation Strategy (REMS)
We’re sorry about all the acronyms, but that’s how the Feds do it. Anyway, if you are prescribing long-acting or extended release pain killers, you should be familiar with the following:
The FDA used its authority under the Food and Drug Administration Amendments Act of 2007 to require drug manufacturers to develop a Risk Evaluation & Mitigation Strategy (REMS), if they market a opioid analgesic in a particular class, to help ensure that the drug's benefits outweigh its risks. This affects more than 30 drugs made by about 20 companies called Extended-Release and Long-Acting (ER/LA) opioids. The FDA has also constructed a REMS for transmucosal immediate-release fentanyl (TIRF) drugs, like fentanyl lozenges. The next step will probably be a REMS for short-acting opioid agents. Questions & Answers about the REMS, along with a list of ER/LA drugs can be found here.
The ER/LA opioid analgesics REMS is part of President Obama’s 2011 national prescription drug abuse plan to combat prescription drug abuse. A 2000 national survey of medical residency programs found that only 56% required 3-13 hours of training in substance abuse education. The Obama Plan targets prescribers who only occasionally and/or briefly use these interventions, especially for minor conditions, with the goal of reducing the amount of unused medications sitting in medicine cabinets in homes across the country. Non occasional users (like pain clinics) should certainly attend to the Plan. The Plan also seeks to “Increase the use of Screening, Brief Intervention, and Referral to Treatment (SBIRT) programs to help healthcare providers identify and prevent prescription drug abuse problems” (p. 6).
The 20+ companies manufacturing the drugs covered by the REMS currently in effect must provide educational materials to both prescribers and patients in an effort to promote their safer use; i.e. reduce addiction risk.
For Patients
The REMS mandated requires drug manufacturers to provide educational resources to patients, these are typically nonpromotional guides–essentially they are warnings on package inserts typical for all drugs. Such medication guides have generally proven ineffective at educating patient about medication risks
The pamphlet Chronic Pain and Opioids–Debunking the Myths is included here as an example of a more extreme point of view; i.e., that opioid addiction is not as common as the government says and this has “scared” doctors from prescribing. The latter point is certainly true. This pamphlet (which appeared as a public service advertisement in libertarian news media) represents the Cato Institute’s view that personal freedom includes having the right of drug choice. As this website provides education about all options we include the pamphlet for your review.
For Prescribers
The FDA does not require specialized training in opioid prescription for physicians, nurse practitioners or physician assistants. They believe requiring this would duplicate the Drug Enforcement Administration (DEA) registration system as well as they would then need some method of assessing and tracking that education, which was considered overly burdensome to practitioners. But, the FDA expects prescribers to voluntarily take advantage of the REMS training that pharmaceutical companies must pay for.
There are approximately 320,000 prescribers of ER/LA opioid analgesics in the United States, and the FDA expects drug companies to help train 25% of these prescribers at the end of the REMS’ first year, 50% after two years, and 60% of them within four years from when the training became available. The first continuing education activities under the REMS were made available to prescribers as of March 1, 2013, with others to follow.
Drug companies honor their requirement to provide educational opportunities for prescribers most often by offering grants, typically to universities and medical schools, to develop REMS educational programs that offer CEs. The is formally called the Grant Management System (GMS). Here is a list of approved CE educational programs created for providers under the GMS. There was concern about bias in these programs due to the funding by the pharmaceutical industry; however, the GMS has done a good job and this writer feels the programs listed in the above link are good, solid learning experiences from independent sources. You’ll want to be among the first to receive such education, if you use opioid treatments.
By the way, If you have the experience and training, consider developing an educational program, yourself, that offers CE’s to other providers–here are questions & answers about applying for your own grant under the GMS to share your knowledge by developing a CE program.
The FDA provides a blueprint for the content of these CE programs, which is available in PDF format–it describes the educational points the FDA believes important to prescribers–FDA Blueprint for Prescriber Education. The FDA’s Blueprint makes clear its expectation that:
Prescribers should assess each patient’s risk of abuse, including substance use and psychiatric history. Which means they: Understand and appropriately use screening tools for addiction or abuse to help assess potential risks associated with chronic opioid therapy and to help manage patients using ER/LA opioid analgesics…
TestSTAT can help you with abuse/addiction risk assessment tools, alternative treatment options, education and the latest news regarding FDA expectations for good clinical practice with opioid medication.