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The FDA’s REMS Misstep

Harold E. Cohen, RPh
Editor-in-Chief

9/19/2012

US Pharm. 2012;37(9):1.

As someone who takes prescription medication on a regular basis, I am grateful for the FDA’s drug approval process, which has kept this country’s drug supply relatively safe over the many years it’s been in place. The enforcement of such a process continues to support a longer and more fulfilling life span for many Americans. While the FDA’s stringent drug approval system may at times be a thorn in some pharmaceutical manufacturers’ sides, ultimately the results are worth the extraordinary efforts made by both the pharmaceutical industry’s R&D teams and the FDA reviewers. And oftentimes, the FDA’s responsibility for, and dedication to, keeping drugs safe in this country extends beyond the drug approval process through the establishment of safety programs that serve the needs of both the professional community and consumers.

One such safety initiative is the risk evaluation and mitigation strategy program, better known as REMS. According to the FDA, REMS is designed “to address the prescription drug abuse, misuse, and overdose epidemic” in a number of therapeutic categories where such responses to medication are most prevalent. The agency’s latest foray into the world of REMS was the approval of a strategy for extended-release and long-acting opioids, a therapeutic category of drugs for patients who may need to be treated with potent and potentially addictive analgesics for prolonged periods. And while I applaud the FDA for launching such a program, I take issue with the fact that the provisions in the new REMS do not directly address pharmacists taking a more active role in disseminating this vital information to their patients by way of face-to-face patient consultation. Instead, the new strategy requires that pharmaceutical manufacturers make available “FDA-approved patient education materials on the safe use of these drugs” and make continuing education programs available to prescribers “based on an FDA Blueprint,” but stops short of mentioning that pharmacists should take a more aggressive role in the process other than simply handing out a one-page medication guide (known as a MedGuide) for each product prescribed. To give you some idea of what is involved, by the FDA’s estimate this REMS “will affect more than 20 companies that manufacturer these opioid analgesics.”

Given the fact that, by FDA Commissioner Margaret Hamburg’s own admission, the major purpose of the REMS “is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs,” it is obvious to me that Dr. Hamburg and her team have no conception of how valuable pharmacists are to the health care system by counseling patients on “how to safely use these drugs.” To essentially ignore pharmacists’ intimate involvement in the REMS process was a serious misstep for the FDA, and it should not go unnoticed by pharmacists.

For all the accolades I’ve given the FDA, as a pharmacist this one really hurts. Not only is this oversight disrespectful to our profession, it makes little or no sense from a health-safety point of view. The pharmacist is, and will continue to be, in the best position to counsel patients on “how to safely use drugs,” not the physician. It’s time the FDA paid serious attention to the profession of pharmacy and its role in patient counseling and medication therapy management. As a group, we cannot let the FDA ignore our efforts. Tell the FDA what you think so that its next steps for the profession are forward and not backward.

To comment on this article, contact editor@uspharmacist.com.
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