Pharmacists are concerned that several forms of penicillin are in shortage, including one used as the primary treatment for syphilis.
Penicillin G Benzathine, which comes in a pre-filled syringe known by the brand name Bicillin L-A, has been in shortage since spring. The medicine is the first-line treatment for syphilis, meaning that, although there are alternatives, it is highly preferred over other treatments.
Pfizer, the only producer of the drug, has put the product on allocation, meaning it is being distributed in limited quantities but is not available for usual ordering by pharmacists, according to federal and industry databases. Pfizer cites a manufacturing delay as reasoning for the shortage, which is a common issue for manufacturers of pre-filled syringes because they're very difficult to make without contamination or other safety issues.
Pfizer said in a statement that it's working to restore full supply by early November. An FDA database updated Monday said Pfizer's next round of allocated deliveries would come in late October 2016 with “supply improvement” late in the first quarter of 2017.
The drug is vital for pregnant women with syphilis because their treatment options are more limited. It's considered the “gold standard” for syphilis treatment, experts say, because a patient only needs one injection every week, unlike the secondary treatment, ceftriaxone, which must be given every day.
Many people with syphilis may be homeless or face other social factors that make treatment less consistent and reliable. Therefore, physicians will get "very uneasy" if they're forced to resort to an alternative that requires more frequent injections, said Eric Maroyka, an expert with the American Society of Health System Pharmacists.
“The concern is (whether) the patient is even going to come in at the right time to get their treatment,” said Maroyka, a former hospital pharmacy director. “(If) you get the shot every couple of weeks, we'll feel confident you're being treated.”
Pharmacists would exhaust all available measures, including paying more for the drug, before deciding to offer the secondary treatment, said Maroyka, who is director of ASHP's Center on Pharmacy Practice Advancement.
Dr. Aaron Glatt, hospital epidemiologist and chairman of the department of medicine at South Nassau Communities Hospital in Oceanside N.Y., said the hospital hasn't yet had trouble obtaining the drug, but acknowledged that a major shortage could be disruptive.
“If there are no alternatives, it's a disaster,” Glatt said. “If there are alternatives, it just makes it a bit more complicated.”
Also in shortage are Pfizer-made Penicillin injections used to treat high-risk patients with strep-throat, including brand name Bicillin C-R 900/300, a combination of the Penicillin Benzathine and Penicillin G Procaine, a once-a-day shot used to treat strep throat that is also in shortage.
The combination product is administered only once to treat a strep infection, so it's used for patients susceptible to rheumatic fever and heart valve disease, which can be caused by untreated strep. And like the primary syphilis drug, its one-time delivery is good for patients who might not adhere to their medication regimen, Maroyka said.
Experts have expressed concern that the need to devise solutions to an overwhelming amount of drug shortages can be a distraction from maintaining a safe and effective pharmacy. Some pharmacists have even gone beyond distributors and group purchasing organization contracts to purchase drugs directly from manufacturers.
It's unacceptable that such a common, vital medicine as Penicillin is in shortage, said Erin Fox, director of drug information at University of Utah Health Care in Salt Lake City. She pointed out in an email that the drug is listed as an “essential medicine” by the World Health Organization, meaning that it's needed for a majority of the world's population and must be kept in “in adequate quality, in sufficient quantity and at a reasonable cost.”
“Overall, it's good that Pfizer is prioritizing the most critically needed product, but I think it is absolutely ridiculous that we even have a shortage of penicillin,” Fox said. “Pfizer has taken big price increases – I don't know why they can't fix this issue more quickly.”