By: Margaret A. Hamburg, M.D.
The recent attention paid by state policy makers around the serious public health problem of misuse, abuse, addiction, and overdose of prescription opioid painkillers is commendable. These efforts reflect the strong desire on the part of states where communities have been devastated by opioid addiction and overdose to prevent further tragic loss of life. However, it is important that such efforts comprehensively address the real root causes of the problem, are grounded in science, and will make a real and lasting difference.
The most recent state actions in Massachusetts and Vermont would require healthcare providers to take certain steps such as screening for abuse risk and documenting medical need before prescribing the opioid Zohydro ER. They would also require prescribers to participate in and regularly check state databases that track how often the drug is prescribed to a given patient – a measure that can help identify misuse.
Such requirements are consistent with the essential tenets of numerous medical society guidelines on appropriate pain management and – simply put – are precisely what responsible physicians should be doing. As the entities with responsibility for overseeing the practice of medicine, the states have an important role to play in addressing a critical driver of opioid abuse – inappropriate prescribing practices.
However, we can’t just focus on one drug, Zohydro, alone. These requirements would not apply to the prescribing of any of the other opioids on the market that account for some 250 million prescriptions and 18 billion tablets each year. Unfortunately, to date considerable misinformation appears to be diverting attention from more comprehensive policy solutions that apply to all opioids.
Last October, FDA approved Zohydro as a new treatment option for the management of pain severe enough to require daily, around-the-clock, long-term treatment, and for which alternative treatments options have proved inadequate. We have heard from many people who must cope with often severe pain on a daily basis. These are people who need a variety of therapies to have any hope for a quality life. And, importantly, Zohydro does not include the liver toxin acetaminophen, as many hydrocodone products (e.g., Vicodin) do.
Despite claims to the contrary, the fact is that the top dose of Zohydro is no more potent than the highest strengths of other extended-release opioids like Oxycontin and extended-release morphine. And since Zohydro is a Schedule II controlled substance, it is already subject to Drug Enforcement Administration prescribing restrictions. These include requiring patients to have a written prescription from their doctor instead of one provided to the pharmacist over the phone, and the prohibition of refills.
Moreover, the approval of Zohydro is not likely to significantly change overall opioid prescribing and use by patients suffering from pain. Rather, the most likely patients for this medication are those who are currently taking an immediate release hydrocodone product chronically, or people taking another extended-release/long-acting (ER/LA) opioid. And this drug is unlikely to increase the number of people abusing opioids.
Some have asserted that this drug’s approval should have been delayed until it had an abuse-deterrent formulation. Unfortunately, this puts too much faith in the current state of abuse-deterrent technology, which is still in its infancy and has yet to be fully tested in actual market or use conditions. Even the abuse deterrent properties of Oxycontin, the only opioid with an abuse-deterrent claim in its labeling that is consistent with the approach described in FDA’s 2013 draft guidance on this topic, are limited. For example, while the formulation is designed to make abuse by injection more difficult, it doesn’t prevent it and there is nothing barring someone from taking more Oxycontin pills by mouth – the most common form of opioid analgesic abuse.
Addressing the opioid crisis by focusing on a single opioid drug will simply not be effective. Instead, we must focus our collective attention and energy on the key drivers of the problem, which include excessive prescribing, illegal activity by a small number of providers, improper disposal of unused medications, and insufficient prescriber and patient education.
FDA has a critical role to play in combatting misuse and abuse of all opioids. That includes our requiring pointed warnings in the labeling of every ER/LA opioid analgesic drug and revising them to incorporate evolving scientific knowledge of risks and benefits. That also includes FDA requiring all manufacturers of ER/LA opioid analgesics to make available prescriber training and to conduct post-market studies to assess the long-term abuse risks of these products. As an agency, we will be evaluating the success of the risk management steps required of manufacturers of ER/LA opioid analgesics, including Zohydro. And we intend to monitor the utilization of all opioids to identify any emerging abuse issues.
Also critical are the development of non-opioid pain medications, treatments for opioid addiction and products that reverse opioid overdose. Just in the past few weeks, for example, FDA approved a major new advance in the treatment of opioid overdose – an auto-injector formulation of naloxone, and we will continue to review new treatments for drug abuse.
Let me say, in no uncertain terms: the prevention of prescription opioid abuse is of the highest priority for the FDA. Nothing can erase the tragedy so many people have had to face as a result of abuse, addiction, or misuse of opioids. But we can make meaningful progress to reduce and prevent our nation’s prescription drug crisis. FDA is committed to reducing abuse of opioids and ensuring appropriate access to pain medicines for patients in need.
But it is critical that we all play a role in developing and implementing smart policies that will result in real change. We urge those states with active prescription drug monitoring programs, as well as insurers and pharmacy benefit managers, to help identify and halt inappropriate prescribing. And we urge all states to consider requiring common sense, responsible pain management prescribing practices for all opioids.
Our nation’s front-line health care professionals, especially physicians and other prescribers, play a key role and have a responsibility to ensure that they are treating patients based on their individual needs. We need to be sure they receive adequate proper training and education and that they practice responsible opioid prescribing in order to improve pain management and minimize prescription drug misuse and abuse.
At the end of the day, the complex public health challenge of opioid abuse requires a comprehensive and science-based approach involving federal and state governments, public health experts, opioid prescribers, addiction experts, patient groups and industry. Then, and only then, will we truly solve this problem and protect the public health.
Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration