Two items today. A nationwide recall of three lots of injectable epinephrine that every pharmacy and infusion site should check against its own stock, and a look at what happens when a drug clears FDA before insurers are ready to pay for it.
American Regent recalls three lots of epinephrine injection over cracked vials and particulate matter
American Regent announced a voluntary nationwide recall on September 3 covering three lots of Epinephrine Injection, USP, 30 mg/30 mL (1 mg/mL) multi-dose vials, NDC 0517-3030-01. The affected lots are 25128L1C0, 25280L1C0 and 26108L1C0. Customer complaints described leaking and cracked vials, and the company investigation found particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass. The stated risk is serious. Particulate injected intravenously can block and clot blood vessels, and a cracked vial means sterility can no longer be assured. No adverse events had been reported at the time of the announcement. Distributors, retailers and healthcare facilities are told to stop using the product and return it to the place of purchase or discard it. This is worth a same-day check of physical stock, and of emergency kits in particular, because epinephrine usually sits in a crash box instead of on an active dispensing shelf, and stock nobody has touched in months is exactly the stock that gets missed. Read more at FDA →
A newly approved cancer drug shows the gap between FDA approval and insurance coverage
STAT reports on patients with pancreatic cancer caught between the approval of a new drug and the point at which insurers were ready to cover it. The drug nearly doubled median survival in its key trial. The expanded access programs that had been supplying it closed as soon as FDA approved, and coverage was not yet in place, so some patients waited weeks with nothing to bridge them. The reported cost is close to $40,000 a month, and one family paid more than $9,000 for a seven day supply while an approval worked its way through. The pattern is not unique to this drug. It repeats on most specialty launches, and the pharmacy or infusion provider is usually the one standing in front of the patient when it happens. Anyone building a specialty or infusion service should settle in advance how a launch-window gap gets handled, including who talks to the patient about cost and what the site is willing to supply at risk. Working that out for the first time with a patient waiting is the worst version of it. Read more at STAT →
This update is general information about developments in pharmacy law and regulation. It is not legal advice, it does not create an attorney-client relationship, and it should not be relied on as a substitute for advice about your own situation. Prior results do not guarantee a similar outcome. If you have a specific question about your pharmacy, call or write and we will talk about it properly.
Law Office of Bhavesh Desai | Bhavesh Desai, Pharm.D., Esq.
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