Pharmaceutical companies will be required to provide additional opioid training for prescribers

medical-doctor-1314902-mThe FDA has announced that it will begin requiring opioid manufacturers to provide more training for healthcare providers.  At present, manufacturers must provide training about long-acting, extended release opioids to prescribers.  In the future, the manufacturers of short-term and immediate release opioids will also be required to provide the same type of training.  The training will be available to physicians, nurses, and pharmacists.

This change was brought about by the continuing high rate of drug overdose incidents by prescription drug abusers, particularly those abusing opioid painkillers.  The training was previously only required by makers of long-acting opioids.  However, the FDA stated statistics show that today the vast majority, 90% to be exact, of opioid pain medication prescriptions are for the short-acting variety.  It has been found that abusers of opioids are misusing the short-acting, immediate release versions as well as the long-acting types.  After becoming addicted to the commonly prescribed short-acting versions of the medication, most abusers graduate to higher doses of the prescription drugs or move to illegal drugs, which present a lower cost alternative.

The FDA also cautioned prescribers that the new abuse-deterrent version of some of these drugs should still be prescribed with great caution.  These drugs are less susceptible to manipulation through crushing, snorting or injecting, but can still lead to, or contribute to, addictions.  The potential for abuse of even these formulations should not be underestimated.

The content of the opioid training will also be expanded.  Initially, the training covered topics such as: which patients are viable candidates for opioid painkillers and how to manage those patients; starting, changing and ending use of the drugs; monitoring patients; and recognizing misuse and addiction.  The updated training will also include a component regarding non-opioid pain management techniques. The goal of the training is to make sure that opioid painkillers are only being prescribed to appropriate patients and under the correct circumstances.

While pharmaceutical companies will be mandated to provide such additional training, utilizing the training offered will still be optional for physicians–for now.  FDA Commissioner Scott Gottlieb stated that he was continuing to look into the possibility of making physician training mandatory.  As long as a year ago, an FDA panel recommended that prescriber training be made mandatory.  However, mandatory training for doctors has been opposed by several physician groups as being a “one size fits all approach” that is not effective.

Hamil Little PC

We advise and represent hospitals, medical practices, physicians and other healthcare providers. If you have questions about this post, contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com.

 

** Disclaimer: Thoughts shared here do not constitute legal advice. Please consult with an attorney to discuss your legal issue.

 

Sources:

FDA to require expanded training on opioids” Nadia Kounang, CNN (July 11, 2017)

FDA chief to impose tougher doctor-training rules on opioid manufacturers” Laurie McGinley, Washington Post (July 10, 2017)

FDA Panel: Physician opioid training should be mandatory” Editor, Texas Chiropractic Association (Jun 3, 2016)

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