FDA Sets New Standards for Opioids to Prevent Addiction

FDA Sets New Standards for Opioids to Prevent AddictionIn an attempt to slow the rising tide of prescription drug abuse, the U.S. Food and Drug Administration is taking steps to limit access to a class of highly addictive painkilling substances. Effective immediately, the extended-release and long-acting versions of popular opioids such as oxycodone, fentanyl and morphine sulfate will no longer be sanctioned for use by patients suffering from moderate levels of chronic pain.

Doctors will be discouraged from prescribing these powerful drugs as routinely as they did in the past, and from now on drug manufacturers who sell ER/LA pain medications will be required to add a label to their products recommending that they be used exclusively "for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.”

Additionally, a boxed warning will be added to medication packages informing users that long-term maternal use of these substances can lead to neonatal opioid withdrawal syndrome, a potentially fatal condition.

To some extent, the experience of pain is of course relative, so these new standards will still rely on the testimony—and honesty—of patients. But to give these new recommendations some teeth, physicians are going to be encouraged to discuss alternative forms of treatment with pain sufferers before prescribing opioids in every instance, even as they make sure their patients truly understand the risks associated with over-reliance on these addictive medications. It is hoped that if doctors open up a frank dialogue with those who are in need of treatment for pain, many will choose non-opioid routes rather than rely exclusively on pharmaceuticals.

The decision by the FDA to move to more restrictive standards for opioid prescriptions came in response to the calls for change from a group of clinicians, including many addiction specialists, who call themselves the Physician’s Committee for Responsible Opioid Prescribing, or PROP. The physicians who organized this coalition have had long-standing concerns about the problem of opioid addiction and about the casual way that some doctors have prescribed these medications, and they have been pushing the FDA to reclassify opioids as inappropriate for the treatment of moderate pain.

While the physicians from PROP have expressed some satisfaction with the FDA’s decision, they see it as only a start and believe much more must be done to curb opioid abuse. They are especially disappointed that the government’s drug regulatory agency did not accept their recommendations to lower permitted maximum dosages for opioid medications and to set a 90-day limit for long-term consumption of these drugs in all circumstances in which they have been prescribed. Both of these changes would undoubtedly reduce the likelihood of medical patients slipping into an opioid addiction, but the government’s medical experts believe more study is needed before any more limits are placed on opioid availability. Fortunately, the FDA is serious about its desire to see more research performed, and in the coming years it will require pharmaceutical companies that plan to continue manufacturing and distributing opioid pain medications to carry out extensive studies and clinical trials to further evaluate the risks that are known to accompany regular opioid usage, including addiction, hyperalgesia, overdose and sudden death.

It should be noted that the FDA’s new standards will not prevent drug companies from manufacturing immediate-release opioids and marketing them to medical patients whose moderate levels of pain are considered short-term and are not expected to require continuous intervention. This means that many moderate pain sufferers will still have access to a few forms of these drugs, even if the longer release versions will no longer be as widely prescribed. The risk of addiction with immediate-release opioids is generally not as great because they are not normally used for long periods of time, but like any other type of the drug, they can become addictive if they are intentionally misused or abused.

Putting the Genie Back in the Bottle

While government regulators are usually willing to change course when the preponderance of the evidence suggests that past medical practices were in error, the wheels of change often turn quite slowly because of bureaucratic inertia and industry resistance. The FDA’s actions represent a positive first step in trying to control a type of drug addiction that skirts the line of legality without actually crossing over it, which inevitably complicates most efforts to combat the problem. And if the FDA stays true to its word and does indeed force drug manufacturers to do honest and comprehensive studies on opioid use and addiction, it is likely that these addictive and potentially dangerous substances will face even greater restrictions on their use in the not-too-distant future.

Posted on September 27th, 2013
Posted in Drug Policy

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