By: Margaret A. Hamburg, M.D.
More than 15,500 people died in the United States in 2009 after overdosing on narcotic pain relievers. That’s a 300 percent increase over the last 20 years. And for each death, there are an additional ten treatment admissions, 32 emergency department visits and 825 nonmedical users of these drugs.
FDA is extremely concerned about the inappropriate use of opioids, which has reached epidemic proportions in the U.S., becoming a major public health challenge. While much of the problem is attributable to illicit use which can include sharing medication with family and friends or theft of the drug from home medicine cabinets, legitimate use of medications for pain may also lead to unnecessary adverse events, addiction, and death for some patients. Our nation’s front-line health care professionals, especially physicians and other prescribers can play an important role in efforts to reduce this trend.
FDA believes it is critically important to facilitate prescribers’ education about the best uses of opioids, including knowing when and for which patients they should be used.
Therefore, today, FDA issued an open letter to prescribers urging them to take advantage of educational programs designed to promote responsible opioid prescribing, improve pain management, and minimize prescription drug abuse and diversion.
And I’m pleased to announce that the American Medical Association (AMA), the American Academy of Family Physicians (AAFP), the American Academy of Physician Assistants (AAPA) and the American Academy of Pain Management (AAPM) have graciously agreed to distribute the open letter to their members. All are actively engaged in activities, including training, aimed at reducing the misuse and abuse of opioid medication, as are many others.
FDA will also distribute this open letter to our expansive health care news lists and urges all health care professionals to not only read, but also pass the letter along to all of their prescribing colleagues.
Prescriber training is one element of a risk management plan known as a Risk Evaluation and Mitigation Strategy (REMS) required by FDA, and approved in July 2012, to address the misuse, abuse, and addiction related to extended-release (ER) and long-acting (LA) opioid pain medicines.
New educational programs mentioned in the letter address ER/LA opioid prescribing. They are based on a blueprint developed by FDA with input from many stakeholders and will be provided at little or no cost through accredited continuing education activities supported by independent education grants from drug manufacturers. The first prescriber training program is available starting today and others will follow.
FDA sought the REMS for ER/LA opioids because these types of pain medicines have clearly emerged as those with the highest potential for harm from misuse, abuse, and unintentional overdose. These widely-used products often contain large amounts of opioids in a single dosage form, sometimes in sufficient quantity to be lethal, especially for a child, and they are a prime target of drug abusers. And that’s why it is so important for physicians and other prescribers to participate in these training programs to enhance their understanding of how to appropriately prescribe these powerful medications to patients that need them – while also keeping them out of the hands of those who could misuse or abuse them.
According to estimates, more than 320,000 prescribers who are registered with the Drug Enforcement Administration wrote at least one prescription for an ER/LA opioid pain medicine in 2011, so we have a lot of prescribers to reach. However, working together to ensure appropriate use of opioids, I am confident we can make great strides in reducing this epidemic.
Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration