No Rx for Drug Shortages: What’s a Doc to Do?

When it comes to drug shortages, expensive sterile injectables, such as chemotherapy and anesthesia agents, seem to get the most attention. After all, they did represent nearly three-quarters of drug shortages reported last year, and they’re often used for seriously ill patients.

But doctors are also scrambling to find plain-Jane pills that cost pennies apiece. These drugs range from buffered aspirin and atorvastatin (generic Lipitor) to tetracycline and doxycycline. In some cases, the shortages are forcing physicians to prescribe more expensive and less studied medications.

“There are definitely some drug shortages that can affect primary care,” says Bona Benjamin, RPh, a pharmacist who serves as director of medication use, quality improvement, at the American Society of Health-System Pharmacists. Along with the FDA, Benjamin’s group maintains a list of current drug shortages.

Sandra Fryhofer, MD, a practicing general internist in Atlanta and a past-president of the American College of Physicians, says she’s never seen anything like the ongoing shortages. “I’ve written prescriptions for tetracycline and couldn’t get it,” Dr Fryhofer says. “Even for (postmenopausal) hormone therapy, we’re seeing lots of delays.”

Doxycycline can be used instead of tetracycline, but what are you supposed to do when the backup drug is in short supply? Plus, with temperatures heating up and folks spending more time outdoors, ’tis the season for tick-borne diseases, and for Rocky Mountain spotted fever, doxycycline is the first-line treatment. While doxycycline isn’t the only antibiotic used to treat Lyme disease, “the efficacy of drugs other than doxycycline for Lyme disease prophylaxis following a tick bite has not been tested,” according to a just-released CDC Health Advisory spurred by the doxycycline shortage.

Doxycycline is also the preferred drug for pelvic inflammatory disease and epididymitis, notes Doug Campos-Outcalt, MD, Chair of the Department of Family, Community and Preventive Medicine at the University of Arizona College of Medicine in Phoenix.

Dr Campos-Outcalt, clinical science analyst for the American Academy of Family Physicians’ Health of the Public and Science Division, also works at the Maricopa County Department of Public Health’s TB and refugee clinics, where doctors are having to cope with a shortage of isoniazid, or INH, 1 of the 4 drugs that make up the core for first-line TB treatment regimens. INH is also the recommended drug to prevent latent TB from becoming active disease.

Since the shortage began last November, Dr Campos-Outcalt and colleagues at public health clinics around the country have had to prioritize TB patients when deciding who gets INH; patients with active TB are first priority, even though INH is the top choice for patients with latent TB. An MMWR report released in late May suggests that the shortage could contribute to the spread of TB in the United States.

Like tetracycline, INH has been used for more than 6 decades. And, as has been the case with tetracycline, doctors have had to revert to a more expensive alternative, rifampin.

“It’s probably okay, but it hasn’t been tested as much,” Dr Campos-Outcalt says. And rifampin costs 10 to 20 times more than INH.

And that makes Drs Campos-Outcalt and Fryhofer suspicious about the many shortages of relatively inexpensive drugs. While one manufacturer cited a lack of raw materials for its tetracycline shortage, some other manufacturers, including 4 for INH, have offered no explanation for their shortages.

“It’s probably more complicated than it looks, but I can’t help but wonder whether economics is at work here,” Dr Campos-Outcalt says. “My view is somebody ought to look into this.”

The US Government Accountability Office is, but spokesman Chuck Young says its report on drug shortages won’t come out until next January. By then, 3 of 4 INH manufacturers say, back-ordered tablets should become available. But who knows what new shortages will crop up?