By: Margaret A. Hamburg, M.D.
Powerful prescription drugs called opioids make life tolerable for terribly ill patients who are wracked with pain. How ironic, and sad, that those same medications increasingly are misused and abused, thus causing pain, rather than relieving it.
In fact, abuse, misuse and addiction to opioids is a public health crisis of enormous, and devastating, proportion. In 2010, an estimated 16,651 peopled died because of inappropriate use of prescription opioid drugs, a 313 percent increase over the past decade.
Yesterday, while speaking at the National Rx Drug Abuse Summit, I found renewed faith that together we can turn the tide. More than 800 people from communities across the country, representing all levels of government, philanthropic organizations and the private sector, came with a commitment to do their part.
I told the Summit that FDA is certainly striving to do its part. Our multi-pronged approach is targeted at critical points in the lifecycle of an opioid product.
This comprehensive approach includes:
- Encouraging basic research about the science surrounding pain including the development of effective and appropriate treatment.
- Facilitating and incentivizing the development of abuse-deterrent formulations. We’ve issued a draft guidance document to assist industry in developing opioids that could, for example, be more difficult to crush and inhale, or dissolve and inject.
- Modifying opioid labeling for safety, accuracy, and clarity. FDA has made many changes to opioid medication labels in an effort to improve their use, and today they contain some of the most restrictive language that can be found in a drug label. But we recognize that some are calling for further limitations on the use of these products, particularly in the context of non-cancer pain, including limiting the recommended duration of treatment; setting a maximum daily dosage limit; and restricting the use of these drugs to patients with severe pain (as opposed to “moderate to severe” pain). If additional improvements could make the labels more effective, it’s important we explore them as part of our overall efforts to improve the safety of opioids. We recently held a public meeting to get input on opioids labeling and we’re currently considering potential changes.
- Working to achieve greater prescriber education and patient education. We required manufacturers of extended-release and long-acting opioids—those with the highest potential for abuse—to offer training for all U.S. licensed prescribers. The first training programs came on line on March 1, 2013, based on a syllabus that FDA created. Manufacturers are also providing prescribers with educational information to give to their patients.
- Supporting mandatory training of prescribers before they register with the Drug Enforcement Agency and receive their license to prescribe a controlled substance, and hoping to see passage of necessary legislation to support that goal.
- Addressing innovative ways to package and store opioids to prevent diversion, and;
- Improving the availability of products that treat abuse and overdose. Emergency medical personnel are trained to administer naloxone, an injectable medicine that can rapidly reverse an opioid overdose. We know there is widespread interest in exploring the broader uses of this product and are currently encouraging new technology such as intranasal or autoinjector formulations that would be easier to use in non-medical settings such as the home.
We are also open to working with outside groups on these challenging issues. For example, we are working with Brandeis University to determine how to analyze data on problematic prescribing patterns, which among other things could help identify doctors working for “pill mills.”
And we do all of this keeping in mind that we must strike a balance between the risks associated with misuse, abuse and addiction and the potential benefits of these products in helping patients who suffer from pain.
There can be no doubt that there is much to be done…and we must act now. These are not simple issues and there are no easy answers. Given the complexity of the issues surrounding the abuse, misuse and addiction to prescription painkillers, real progress will require dedication, persistence and the full engagement of all parties. We can, and must, do better.
Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration