Physicians who rely on these medications to treat specific diseases are worried
February 24, 2013 5:00 AM
Nancy Hagen-Liddle of Oakmont said her standby antibiotic, Vibramycin, mysteriously became unavailable last month.
By Steve Twedt Pittsburgh Post-Gazette
Shortly after the New Year, Nancy Hagen-Liddle, a semiretired nurse living in Oakmont, developed a sinus infection, then bronchitis. These upper respiratory problems have dogged her most of her adult life, but usually a short course of antibiotics took care of them.
This time, however, she ran into an unexpected problem -- her doctor said she could not write a prescription for doxycycline, sold under the brand name Vibramycin, because of a shortage of the stalwart medication that's used to treat a variety of bacterial infections as well as Lyme disease.
"She said, 'There's a weird thing happening. I can't get it anywhere,' " Ms. Hagen-Liddle remembers.
What is happening -- and not just with doxycylcine -- is a continuing problem of shortages among formerly common medications. The U.S. Food and Drug Administration website, www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm, currently lists more than 100 medications in short supply.
Fortunately, the local doxycycline shortage was short-lived, at least this time. After three weeks, during which she tried a different -- and less effective -- antibiotic, a supply of Vibramycin came in and Ms. Hagen-Liddle started feeling better in a week.
But such shortages, however brief, remain a real worry for physicians who rely on these medications to treat specific diseases.
Pediatrician Andrew Nowalk, who specializes in treating infectious diseases at Children's Hospital, says doxycycline is the drug of choice for treating Lyme disease, a tick-borne illness that causes fever, headache, fatigue and a characteristic "bull's-eye" skin rash. Left untreated, it can affect a person's joints, heart and nervous system.
While Children's Hospital has not faced a doxycycline shortage yet, Dr. Nowalk noted the number of children contracting Lyme disease locally has increased from about 10 cases in 2005 to more than 200 last year, with new cases typically peaking during the summer months.
If the number of new infections continues its upward trend and demand for doxycycline grows, he said, a shortage may force doctors to turn to other medications, which cost more and may not be quite as effective.
The causes behind drug shortages are many and varied. In some cases, it's simply due to increased demand, sometimes a manufacturer goes out of business or stops making a particular drug, or perhaps a quality issue at a production plant will disrupt the supply.
Mary Beth Lang, who heads pharmacy services for UPMC, said she's also noticed that "over time, vendors are finding it's not as profitable to make the older drugs, so we are seeing drugs drop out of the market."
Ms. Hagen-Liddle can attest to that: While her co-payment for doxycycline was never more than $10, she had to pay $45 for the less effective substitute.
The problem of drug shortages has emerged only in recent years. In November 2011, President Barack Obama issued an executive order addressing the shortages. The order encourages pharmaceutical companies to alert the FDA when they foresee a shortage and also increased staffing in the FDA's Drug Shortages Program.
The FDA, for its part, will ask other firms to increase production when a company forecasts a shortage, and will expedite regulatory reviews. Last spring, FDA Commissioner Margaret Hamburg reported a sixfold increase in early notifications by manufacturers, reducing the number of new shortages from 90 drugs to 42.
Despite federal efforts to address shortages, they still persist.
Ms. Lang said UPMC now designates a pharmacist at each of its facilities whose duties include "managing" drug shortages -- tracking current supplies and possible shortages -- while two to three central staff might work with vendors to prevent or limit the impact of a shortage.
"Unfortunately, we've become desensitized because we have so many shortages in the industry. There are some studies that estimate it costs a hospital $36,000 annually for personnel time to manage shortages," Ms. Lang said.
The FDA's Ms. Hamburg acknowledged as much in a newsletter last May. Despite some successes in preventing some drug shortages, she wrote, they "remain a serious, complex problem and the agency remains extremely concerned about all current and potential drug shortages."