In an effort to combat the surging opioid epidemic in the U.S., the FDA is proposing blister packs for prescription opioids as well as OTC loperamide.
According to the Scott Gottlieb, MD, FDA commissioner, loperamide abuse has been increasing in the United States. It is used by some at “extremely high and dangerous doses” as an opioid alternative, either to manage withdrawal symptoms or to achieve the same euphoric effects of opioid use.
The maximum approved daily dose for adults is 8 mg/day for OTC use and 16 mg/day for prescription use. “Loperamide is safe at these approved doses. But, when higher than recommended doses are taken, we’ve received reports of serious heart problems and deaths with loperamide, particularly among people who are intentionally misusing or abusing high doses,” Gottlieb says.
As a result, FDA is requesting that OTC loperamide manufactures—including generic and store brand loperamide—produce packages that contain “a limited amount of loperamide appropriate for use for short-term diarrhea, according to the product label,” Gottlieb says. He gave the example of a single retail package containing eight 2 mg capsules in blister packaging.
Meanwhile, Gottlieb is also suggesting similar blister packs for prescription opioids — an initiative that the Institute for Safe Medication Practices (ISMP) has been pushing for years. “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,” Gottlieb says.
For example, the dental community might develop an expert guideline, saying that no routine dental procedure should require more than a three or five-day initial fill of an immediate-release opioid, Gottlieb adds.
“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,” Gottlieb explains.
However, the FDA stopped short of promulgating specific regulations or guidelines for opioid manufacturers.
Michael R. Cohen, RPh, president of the ISMP and a member of the Drug Topics editorial board, is pleased FDA is proposing blister packs for prescription opioids. “Is it going to totally eliminate the deaths we have seen? No, but it will cut into it,” Cohen tells Drug Topics. “It would prevent abuse, diversion, and even addiction.”
For example, dentists would be more likely to prescribe one or two painkillers in a blister pack, instead of around 30 loose tablets, which currently occurs in some cases. “The patient starts taking it long term when they don’t really need to,” Cohen said.
Blister packs would also prevent children from accidentally taking prescription opioids, Cohen adds.