Sen. Lamar Alexander, R-Tenn., wants to help Food and Drug Administration Commissioner Scott Gottlieb fulfill his pledge to reduce Americans' exposure to opioids by requiring makers of certain products to package their pills in limited quantities.
The so-called unit-dose blister packs would make it simpler for doctors to write prescriptions for smaller numbers of opioids, such as for a seven-day supply, said Alexander, who unveiled legislation on March 26 proposing his idea. Blister packs would also make it easier for pharmacists to fill the prescription and could help prevent overprescribing, as well as diversion of unused medicine, he added.
The move is an attempt to help curb the U.S. opioid epidemic, which is responsible for about 115 deaths each day, according to the Centers for Disease Control and Prevention, or CDC.
Alexander's legislation comes on the same day the American Dental Association, or ADA, disclosed a new policy recommending a seven-day limit on prescriptions of opioids to treat patients in severe pain following tooth extraction or root canals. Another new ADA policy calls for requiring dentists to complete continuing education about prescribing opioids and other controlled substances.
In addition, the ADA said dentists should register with and use state prescription drug monitoring programs to promote the appropriate use of opioids and deter misuse and abuse.
"I call upon dentists everywhere to double down on their efforts to prevent opioids from harming our patients and their families," ADA President Joseph Crowley said in a March 26 statement.
Support for blister packs
Gottlieb has often talked about possibly imposing a blister-pack requirement for immediate-release formulations of opioids to help ensure providers dispense only the amount needed for the common, short-term uses for which those medicines are often intended.
"I believe that this merits consideration through a careful, science-based process," he said during a Feb. 15 public workshop on opioid prescribing held at the National Press Club in Washington.
More doctors may opt for shorter durations of use with the availability of blister packs, Gottlieb said. "This would reduce overall exposure and the rate of new addiction," he said. "Moreover, provided 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."
Gottlieb reiterated those thoughts during a March 21 hearing convened by the House Energy and Commerce Health Subcommittee, which is currently examining 25 separate pieces of legislation aimed at providing solutions to the opioid crisis.
On March 1, the FDA chief asked certain online retailers, like Amazon.com Inc. and Walmart Inc., to stop selling bundled packages of Imodium — an over-the-counter anti-diarrheal product people have been using in large doses to get high — and to provide only one package at a time per customer.
Gottlieb noted that the FDA was working with Imodium manufacturers to limit the number of pills by putting the product into blister packs of eight tablets.
The Pharmaceutical Research and Manufacturers of America, or PhRMA, last fall threw its support behind the seven-day limit for opioids.
"Too often, individuals receive a 30-day supply of opioid medicines for minor treatments or short-term pain," PhRMA President and CEO Stephen Ubl said during a Sept. 27, 2017, meeting of the White House opioids commission.
He emphasized the move was "unprecedented" for PhRMA because it has "always supported physician autonomy."
"But given the scope of this crisis, we believe it's the right thing to do," Ubl told the White House commission.
A week earlier, CVS Health Corp. said it would start limiting the supply of opioids dispensed for certain acute prescriptions to seven days and the daily dosage of a treatment based on the strength of the drug. It is also requiring the use of immediate-release formulations of opioids before extended-release opioids are dispensed.
Stopping fentanyl, illicit drugs at the border
Alexander also unveiled a second bill aimed at ensuring the FDA can spend the $94 million from the $1.3 trillion omnibus spending legislation, signed March 23, to upgrade the agency's detection technology, laboratory capacity and import facilities to better identify illegal drugs, including synthetic opioids, like fentanyl, at the border.
The CDC blamed fentanyl and its synthetic analogues for much of the recently reported 30% increase in emergency room visits in the U.S.
The omnibus funds are intended to support additional trained canine units at U.S. import facilities, which would increase detection and screening capabilities, Alexander said in a March 26 statement.
The facility, laboratory and equipment upgrades are meant to improve the FDA's capacity to examine and detect illegal opioids at international mail facilities, the Tennessee lawmaker added.
At the March 21 House hearing, Gottlieb noted the FDA was up against a "numbers game" in confronting the thousands of packages of illicit drugs that are coming into international mail facilities in the U.S., acknowledging that "They simply overwhelm our system with volume."