- Canada is facing an EpiPen shortage due to a supply interruption at Pfizer Inc., which helps manufacture the product for Mylan N.V.
- Pfizer predicts it won't have any inventory of the 0.3 mg EpiPen until early or mid-February, according to a Jan. 18 statement from Health Canada, the country's national health department. The interruption shouldn't affect the supply of EpiPen Jr.
- A drug shortage report from Mylan estimates the supply will be revitalized by March 2. In the meantime, Pfizer intends to get the available supply of EpiPens out faster to prevent stores from running out.
Pfizer's had a rough time producing EpiPen (epinephrine) over the last year. In March, Mylan voluntarily recalled batches of the drug in Australia, Europe, Japan and New Zealand after a couple of auto-injectors were found to have defective parts.
Meridian Medical Technologies Inc., a Pfizer subsidiary, manufactured the batches originally, and later expanded the voluntary recall to include products distributed in the U.S. and other markets in Asia, Europe, North America and South America.
At the same time, Pfizer was seeing weaker returns from EpiPen. Revenues from the drug brought in $81 million for the big pharma in the first quarter of last year, down 16% from the same period in 2016. The trend continued over the first nine months of 2017, with year-over-year sales still down 16% to $253 million.
It's unclear what effect, if any, last year's issues are having on the EpiPen shortage in Canada; Mylan didn't include many details in its report, other than noting the shortage stemmed from a "disruption of the manufacture of the drug."
Still, the latest snafu illustrates that Pfizer has manufacturing issues left to tackle.
"Ensuring continuity of the supply of our medicines is paramount, and this temporary supply interruption does not indicate an impact on the quality, safety or efficacy of EpiPen auto-injectors currently available on the Canadian market," the company wrote in its Jan. 11 statement.
According to Health Canada, Pfizer is requesting pharmacists be mindful of their EpiPen 0.3 mg prescriptions until inventories are rebuilt.
"In general, it is recommended that individuals have more than one auto-injector with different expiry dates to avoid being in the situation of only having an expired auto-injector," the department said in a Jan. 18 statement. "However, in this shortage situation, if an individual is experiencing an anaphylactic reaction, Health Canada advises Canadians to use the expired product and immediately contact 911."