The US Food and Drug Administration (FDA) is looking into improved packaging, storage and disposal strategies to address the opioid abuse epidemic in the United States. In a statement released at the end of October, FDA Commissioner Scott Gottlieb, MD, reaffirmed the regulatory body's commitment to addressing the crisis, including looking into ways to reduce exposure to opioid drugs and ensuring only properly indicated patients have access to prescribed medication.
Among the strategies being explored by the FDA are ways to improve the packaging, storage and disposal of opioid medication, for example, OxyContin (oxycodone) or Percodan (oxycodone-aspirin). "The FDA is committed to exploring our existing authorities to find new and impactful ways of regulating these product features to improve patient safety," Gottlieb asserted.
In May 2017, the FDA set up the Opioid Policy Steering Committee to examine steps the agency could take to improve the packaging of opioids to improve the current prescribing practice. A task force was also set up to conduct further research to inform future policymaking. According to the 2015 National Survey on Drug Use and Health by the Center for Behavioral Health Statistics and Quality, more than 90 Americans day each day as a result of an opioid overdose. The study also revealed a fourfold rise in the number of prescription opioids sold between 1999 and 2010.
Opioid medication, such as oxycodone and codeine, may soon be packaged in a manner limiting the number of pills dispensed, for example via a blister pack with a defined expiration period, Gottlieb suggested. Another possible solution is the use of packaging to make it easier to track the number of doses taken. Improving storage and disposal of drugs could also make it harder for unused or leftover medicines to fall into the hands of third parties for whom the drugs are not prescribed, he added.
"We believe that innovation in packaging, storage, and disposal could have a meaningful impact on preventing or deterring misuse, abuse, or inappropriate access to prescription opioids - especially when coupled with additional efforts that the FDA and others are undertaking to reduce the scope of the opioid epidemic," the commissioner asserted.
This is not the first FDA statement in recent weeks on the subject of tackling opioid abuse in the United States. The agency is also looking into the development of opioid formulations to deter abuse. A number of medications of this sort are already available in US pharmacies, such as Hysingla ER (hydrocodone bitartrate), which has properties to make it harder to snort or dissolve for injection, and Embeda (morphine sulphate and naltrexone hydrochloride), which contains an agent to block the opioid high.
