Much of the attention to the problem has centered on the shortage in cancer drugs, but rheumatology has seen its share of shortages, too, forcing patients to struggle in their search for medications, and sometimes adding to their pain and discomfort.
Drugs frequently prescribed by rheumatologists that were in short supply as of September 2011 include leflunomide tablets, injectable methotrexate, and metylprednisolone tablets. And there are many others in short supply now or that have been in short supply recently.
Kathryn Dao, MD, a rheumatologist at the Baylor Research Institute in Dallas and co-editor of the ACR’s Drug Safety Quarterly (DSQ), says it’s a worsening problem in rheumatology.
“We have been encountering more drug shortages lately,” she says. “Currently, it has been more of an annoyance than a problem, but I foresee this becoming a larger issue. We have been able to work around the shortages by finding appropriate substitutes that have similar efficacy, similar side effect profiles, and similar costs; however, I wonder how much longer we would be able to do this.”
John J. Cush, MD, co-editor of DSQ and director of clinical rheumatology at the Baylor Research Institute, says the shortages have been a source of headache for patient and physician.
“You have to find new ways to write for the drug, like different doses or use the original trade name to get the prescription filled,” he says. “It’s a major inconvenience for the patients and for the prescribing doctors.”
DSQ frequently lists drugs used in rheumatology that are in short supply.
Rheumatology Feeling the Lack
Dr. Cush emphasizes that drug shortages in rheumatology, while a serious problem, have not risen to a catastrophic level. He says that none of his patients has suffered permanent harm or damage due to a drug shortage, as has been seen with cancer patients.
“While there are certain patients who’ve been inconvenienced by this, I would not say this has been a show-stopper for rheumatology,” he says. “We have enough alternatives that short supply has not shut down patient care.”
Dr. Fudman says that, for many patients, there is only one optimal drug.
“There’s not such a wide variety of drugs in rheumatology that it’s easy to switch off of various things,” he says. “If somebody’s on methotrexate, they’re on methotrexate. If they’re on leflunomide, they’re on leflunomide. These are drugs that take a long time to build up their efficacy. It’s not something you can switch back and forth.”
The FDA says it confirmed 178 cases of drug shortages in 2010—a record number. That was up from 55 shortages five years ago.1
According to the University of Utah Drug Information Service, there were 120 shortages reported in the U.S. in 2001—but that number has risen to 211 in 2010.
Through September of this year, 200 shortages were reported.2
“In the past couple of years, it’s just been exponential,” says Diane Ginsburg, the immediate past president of the American Society of Health-System Pharmacists and clinical professor and assistant dean for student affairs at the University of Texas’ College of Pharmacy in Austin.
According to the FDA, 77% of the shortages in 2010 involved sterile injectable drugs.
“There are fewer and fewer firms making these older sterile injectables, and they are often discontinued for newer, more profitable agents,” FDA spokeswoman Yolanda Fultz-Morris says in an email. “When one firm has a delay or a manufacturing problem, it is extremely difficult for the remaining firms to quickly increase production.”
The biggest cause for the shortages in those drugs has been product quality issues, namely microbial contamination and newly identified impurities, according to the FDA. From January to October of 2010, 42% of drug shortages were due to quality problems.
Eighteen percent were due to product discontinuation by the manufacturer and another 18% were due to delays and capacity problems. Nine percent were due to difficulties getting raw materials and 4% of the sterile injectable shortages were due to increased demand because there was a shortage of another injectable medication—in other words, one shortage led directly to another.
Kevin Schweers, a spokesman for the National Community Pharmacists Association, says generic drugs, especially schedule II substances, have been in short supply. But there can be problems even when one generic is available to replace another generic.
An example, he says, is when a “new generic substituted in place of the old one is made by a different manufacturer and may come in a different color or shape. That can leave patients wondering and asking the pharmacist why their medication is different or if a mistake was made.”
Some healthcare professionals say patient safety has been affected, according to 1,800 healthcare practitioners who participated in a survey last year conducted by the Institute for Safe Medication Practices (ISMP), a nonprofit group. Twenty percent of the respondents said drug shortage–related errors were made, while 32% says they had “near misses” related to drug shortages. Nineteen percent said there had been adverse patient outcomes as a result of drug shortages.
The study noted two instances where patients died when they were switched to dilaudid because morphine was in short supply; both patients were given doses appropriate for morphine instead of doses adjusted for dilaudid.
Dr. Fudman says that the extent of the health effects on his rheumatology patients is pain and swelling if there is a delay in getting their medications. They also may have to take two pills rather than one, if a certain strength is in short supply, or get more frequent injections, as was the case when triamcinolone (Aristospan, Amcort, Aristocort) experienced a shortage.
“Aristospan is by far the best injectable steroid for joint injections, and the longest-lasting response,” he says. “When we don’t have that available, we inject with Kenalog or something else, and they don’t get as long lasting a response,” requiring another injection sooner.
Dr. Dao says one of the most potentially significant problems is with the shortage in the shingles vaccine, often given before a patient is started on biologic therapy to prevent that side effect.
“There are patients who would benefit from the shingles vaccine before they start biologic therapy,” she says. “Due to the unavailability of the vaccine, some have foregone the vaccine and started their biologics. It unclear whether this decision will significantly increase their risk for shingles in the future.”
Lack of Notice a Problem
Physicians in rheumatology and other fields say that they often are not notified about a drug shortage before their patients experience it themselves.
Dr. Fudman and others say that they get their information about shortages, including the cause and the expected date when the drug will again be easily available, from the American Society of Health-System Pharmacists website (www.ashp.org/DrugShortages/Current).
He does get e-mails about shortages from the ACR, but almost always after a patient has already told him about the shortage after he or she tried unsuccessfully to get a prescription filled, he says.
But, he says, he isn’t sure how useful advance notice would be anyway, because it probably wouldn’t affect what he prescribes—there’s a chance the drug would still be available on the shelf.
“Even if they told us that ahead of time, I’m not sure what we would do, other than tell patients, ‘If your pharmacy says they don’t have it, try another pharmacy,’ which is what we do anyway,” Dr. Fudman says.
Dr. Cush says that while he thinks the effects of shortages will continue to be felt mostly outside rheumatology, the overall problem isn’t likely to improve soon—because manufacturers have so much discretion in what they produce.
“The problem is it’s a free-wheeling environment when it comes to generics, in what they will make and what they won’t make,” he says. “I think it’s going to get worse before it gets better.”
Thomas Collins is a freelance medical writer based in Florida.
References
- U.S. Food and Drug Administration. Drug Shortages. Available at www.fda.gov/drugs/drugsafety/drugshortages/default.htm. Accessed September 21, 2011.
- American Society of Health-System Pharmacists. Drug Shortages: Current Drugs. Available at www.ashp.org/Drug Shortages/Current. Accessed September 21, 2011.
