Wednesday, March 13, 2013

Letter from U.S. FDA to All Opioid Prescribers

FDAIn early March, 2013, U.S. Food and Drug Administration (FDA) commissioner, Margaret A. Hamburg, MD, sent e-mail to select members of Congress assuring them that the “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.” She noted that, “While much of the prescription drug abuse 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.”

Dr. Hamburg asserted the agency’s view that front-line healthcare professionals, especially physicians and other prescribers of opioid analgesics, can and should play an important role in efforts to reduce the adverse trends. In that regard, she issued an open letter to all prescribers, urging them to take advantage of educational programs and other actions designed to “promote responsible opioid prescribing, improve pain management, and minimize prescription drug abuse and diversion.”

Following is the text of the FDA’s letter to opioid prescribers, including active links (opening in separate browser windows) to the websites and documents that are referenced.


Attention Prescribers: FDA seeks your help in curtailing the U.S. opioid epidemic


  • In light of the expanding opioid epidemic in the U.S., FDA urges prescribers to take advantage of training on opioid prescribing, available as of March 1, 2013. This voluntary training will be provided at little to no cost through accredited continuing education activities supported by independent education grants.

  • Taking advantage of training opportunities on opioid therapy, now and in the future, is one of three key roles that FDA sees for prescribers in helping to curtail this pervasive problem. The other two are: knowing the content of the most current drug labels for the opioids they prescribe, and educating patients about the appropriate use of opioids, their potential risks, and proper disposal techniques.

  • FDA-approved drug labels are frequently updated based on additional science, new benefit-risk information, or public health implications regarding the medication. Labels of extended release and long-acting opioid drugs were changed in July, 2012.


Misuse and abuse of prescription opioids has reached epidemic proportions in the U.S. While much of the problem is attributable to illicit use, appropriate use of medications for pain may also lead to unnecessary adverse events, addiction, and death for some patients. No group can be more effective in reducing this trend than our nation’s front-line health care professionals, especially physicians and other prescribers.

FDA sees three key roles for prescribers in curtailing the U.S. opioid epidemic, 1) ensuring that they have adequate training in opioid therapy, 2) knowing the content of the most current opioid drug labels, and 3) educating patients about the appropriate use of opioids, their potential risks, and proper disposal techniques.

Take advantage of important training opportunities

As the opioid epidemic has evolved in recent years, extended-release (ER) and long-acting (LA) (ER/LA) opioids have clearly emerged as products with the highest potential for harm, misuse, and abuse. These products contain large amounts of opioids in a single dosage form, sometimes in sufficient quantity to be lethal, especially in children, and they are a prime target of drug abusers.

In July of 2012, FDA approved a Risk Evaluation and Mitigation Strategy or REMS for these products. A REMS is a risk management plan for a manufacturer to implement that goes beyond the requirements in the drug prescribing information to manage serious risks associated with a drug.

An important element of this REMS is the availability of voluntary ER/LA opioid training programs, at little to no cost, to all U.S. licensed prescribers. The first of these programs is available as of March 1 and more will become available. Although the programs will be funded by opioid product manufacturers, the content will be objective and independent.

The programs will be offered by independent providers of continuing medical education (CME) and based on an FDA blueprint that was developed with input from a wide range of stakeholders. Included will be information on weighing the risks and benefits of opioid therapy, the appropriate choice of therapy for each patient, and managing and monitoring patients and counseling them on the safe use of these drugs.

The program also will include learning to recognize potential for, and evidence of, opioid misuse, abuse, and addiction, as well as general and drug-specific information about ER/LA opioid analgesics. FDA encourages all opioid prescribers to take advantage of this valuable training to help ensure they have adequate and up-to-date training in opioid therapy.

More information can be found at, which will be updated as additional opportunities become available.

Review and know the most current opioid drug labels

The July 2012 REMS for ER/LA opioids also included significant changes to the FDA-approved drug labels for these products. The revisions focused on making the labeling consistent among ER/LA products, and on increasing the prominence of information available regarding risk and precautions, such as those for abuse and misuse, respiratory depression, and accidental exposure.

The drug label, or package insert, that accompanies all FDA-approved medications is the most complete source of information on the drug. Drug labels provide important safety and efficacy information and clinical data to prescribers on the benefits, risks, and appropriate use for all FDA-approved drugs. The FDA-approved drug label is one of the most useful tools prescribers have for providing safe and effective opioid therapy to their patients.

As with all FDA-approved drugs, each ER/LA opioid product label has information unique to its own chemical compound and formulation. However, ER/LA opioid labels also share many important similarities. Therefore, maintaining a thorough knowledge of the drug labels can help prescribers inform their decision-making to ensure safe, appropriate, and effective use.

Labeling for all FDA-approved opioids can be found on the Drugs@FDA website, as well as at pharmacies and on many manufacturers’ websites. Labeling is also the root source of information prescribers receive from a wide variety of commercial online reference products and other resources educating prescribers about the safe and effective use of FDA-approved drugs.

Keep up with changes to drug labels. It is important to know that drug labels may change as new information on any FDA-approved products becomes available and that these changes occur frequently. We encourage prescribers to regularly review these changes. FDA’s MedWatch site provides easy access to safety labeling changes for FDA-approved drugs. This resource clearly identifies the parts of the label that have changed.

Help educate patients to use opioids safely and effectively

Patient education is vital to safe and effective opioid use. FDA urges all prescribers to ensure patients using opioids are appropriately informed of the risks and benefits of these drugs and fully understand directions for their use. The opioid drug labels also provide prescriber information related to patient education.

FDA-approved Medication Guides are key patient education tools. Pharmacies are required to provide them to every patient who receives an ER/LA opioid. Prescribers can also download all available Medication Guides for use in their offices. Among other valuable information, Medication Guides for ER/LA opioids inform the patient on safe disposal of their unused medication. FDA has also created a patient counseling document that prescribers can use to help educate patients on the safe and effective use of opioids.


FDA remains committed to making sure that patients in need have continued access to appropriate pain medications, while also ensuring that all opioid products are used as safely and effectively as possible under the supervision of prescribers armed with sound information and training. Prescribers are critical to successfully curtailing this national problem.


COMMENTARY: Attached to the letter, as examples, Dr. Hamburg provides specific information available in the FDA-approved labeling for two opioids — OxyContin® (oxycodone controlled release) and Dolophine® (methadone) — that the FDA considers to have exerted a “particular impact on the epidemic.” That information can be accessed [here].

The FDA appears to be under increasing pressure from Congress to do something about problems associated with opioid analgesics, especially overdoses and deaths that have been sensationalized in the news media. In a great many cases, reporters have focused unilaterally on tragic outcomes among persons who have misused or abused these medications in some way, without any equal balance on the millions of patients with pain who need opioid analgesics on a daily basis to thrive and survive, and are compliant with instructions for safe use of the drugs.

It is interesting that Dr. Hamburg places much emphasis on prescribers knowing and following information on FDA-approved product labeling — which is appropriate. However, the agency also is facing making a decision regarding a petition from last summer submitted by PROP (Physicians for Responsible Opioid Prescribing, most recently discussed in an UPDATE here) that would significantly change opioid-product labeling in terms of indication, dose, and duration of therapy.

Thus far, the FDA has exhibited admirable restraint in not leaping to judgments or making changes based on the weak, biased, or deficient evidence that is available to support the petition. Agency staff have patiently listened to testimony, gathered comments, and (we assume) are evaluating all input from objective, evidence-based perspectives.

Meanwhile, the new ER/LA-Opioid REMS — for extended-release and long-acting products — is still in a start-up phase, and the FDA is wise in giving that program a chance to take hold. Prescriber education is a critical component of the new REMS; although, as of this date (3/13/2013), few accredited programs are available and only one continuing education course was listed at the industry-supported website [here].

As for patient education, which is also deemed critical for reducing opioid-related problems, the selection of available materials is sparse. The patient counseling document mentioned in the FDA letter is brief, one page, and lists some essential “do and don’t” admonitions, but it does not provide a proper understanding of opioid risks and safe use, how to recognize adverse reactions or other problems, and being prepared for what to do in an emergency. For that sort of patient (and caregiver) education we recommend our Opioids911-Safety program available at

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