FDA Favors Blister Packs In Battle Against Opioids
Benefits of unit-dose blister packaging include safeguarding medication efficacy, improved supply chain security and aiding medication adherence.
In its most recent article, the HCPC reviewed how the FDA was looking at a variety of alternatives to stem the opioid epidemic. The HCPC has been involved in this effort by promoting the wide-ranging benefits of unit-dose blister packaging, from safeguarding medication efficacy to improved supply chain security and aiding medication adherence.
In January, the FDA issued letters to the manufacturers of OTC loperamide (branded as Imodium AD and also sold as private label/generic products) to be packaged in unit-dose packaging to limit the number of doses available for short-term use. This action was in response to an increase in purposeful misuse of loperamide by those suffering from opioid addiction. There has been a growing trend of abusers taking more than the recommended dose in order to alleviate opioid withdrawal symptoms or to obtain a euphoric effect. Overdosing on loperamide has resulted in serious heart problems and even death, according to the FDA. Thus, the agency seeks to limit the availability of the number of doses through blister packaging. As stated in the FDA communication, “Evidence suggests that package limitations and use of unit-dose packaging may reduce medication overdose and death.”
In addition to taking this definitive action, FDA Executive Director Scott Gottleib, M.D. supported the wider use of blisters as follows: “Since establishing the Opioid Policy Steering Committee in May, senior FDA leaders across the agency have been hard at work to ensure that we’re leaving no stone unturned in our efforts to combat this immense public health emergency. With 11.5 million Americans misusing prescription opioids in the past year and more than 40 people dying every day from overdoses involving prescription opioids, it has become abundantly clear that more vigilant action is needed from the FDA and others to get ahead of this crisis.
“At the FDA, we believe one of our key roles in addressing the opioid epidemic is to reduce new addiction. We’re exploring ways we can reduce exposure to opioids through our influence on prescribers, particularly through our Risk Evaluation and Mitigation Strategy (REMS) authorities. We’re also actively exploring how we can use changes in packaging as a way to give providers better options for tailoring how much they prescribe to the clinical need. This is especially true when it comes to immediate release formulations of opioid drugs like Vicodin and Percocet, which are typically meant for short-term use. If more immediate release opioid drugs, in particular, were packaged in three- or six-day blister packs; then more doctors may opt for these shorter durations of use. Additionally, provided the FDA concluded that there was sufficient scientific support for these shorter durations of use, this could provide the basis for further regulatory action to drive more appropriate prescribing.
“To illustrate the point, suppose the dental community developed an expert guideline that said no routine dental procedure should require more than a three- or five-day initial fill of an immediate-release opioid, and the FDA reviewed and determined that blister packs in these quantities were necessary to ensure safe use. If the drugs were then packaged in blister packs that comported with these durations of use, it could help reduce overall dispensing. More doctors might more readily opt to prescribe these blister packs instead of other treatment options.”
Since 1990, the HCPC has always expressed that blister packaging is not a silver bullet solution, but a helpful tool to help the patient, protect the drug and secure the product in the supply chain. Regardless of the type of drug, and in the sad case of opioid addiction and misuse, it can help save lives.
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