National Drug Shortages, 1980-2001
The number of drug and vaccine shortages skyrocketed in the past 20 years. No one kept an accurate track of the number of shortages until 2000 when the University of Utah's Drug Information Service began compiling Drug Product Shortages Bulletins in 2000. The U.S. Food and Drug Administration (FDA) also maintains a web site detailing the "medically necessary" drugs that are in short supply.38 The number of drugs on these two lists varies because of the "medically necessary" condition imposed by the FDA. As of September 2002, the FDA lists 7 drug shortages and 5 drugs that have a limited distribution. In some parts of the country, the situation is worse. Tony Czaplicki, pharmacy director for Montclair Baptist Medical Center, maintains a list of 3,600 back-ordered drugs.
The most recent shortages? Anti-inflammatory steroid injections, antibiotics, and vaccines.39
All the data in the graph on the previous page are from the Drug Information Service (DIS) at the University of Utah Hospitals and Clinics in Salt Lake City. Data before 2000 are estimates given by Dr. Linda S. Tyler, pharmacy manager at DIS. The data includes drugs and vaccines.
Why the shortages? Manufacturing problems, supplier problems, shortage of active pharmaceutical ingredients, enforcement of FDA regulations, natural disasters that destroy raw materials, packaging difficulties, and corporate decisions to discontinue drugs all contribute to drug and vaccine shortages. Another contributor: just-in-time inventories.
Many hospitals used to keep two-week supplies of drugs. But with health care plans limiting the list of "acceptable" drugs and hospitals cutting funds for the purchase of (high cost) drugs, most hospitals only keep a three or four day supply. Some drugs have to be ordered on demand. In 2002, when a doctor at Long Island Jewish Medical Center prescribed a cancer drug for a patient undergoing a bone marrow transplant, the pharmacist, James Abberton, had to fill out a form and fax it to the drug company. "'Five years ago, I could buy 400 bottles and keep them on supply. Today, I can only get it for one patient at a time,' states Abberton." (Talan). And, that patient is lucky. In some cases, the drug that is needed is not available. As of April 2002, intravenous ganciclovir (used to treat severe infections in AIDS patients) could not be obtained.40
In some cases, drug manufacturers discontinue old products and replace them with new ones. Why do manufacturers discontinue effective drugs? When drug companies merge, the new corporations often trim their product lines. Also, shareholder pressures may lead executives to discontinue products that do not generate profits.
Meanwhile, the doctor, pharmacist, and patient are left to find alternatives (if they exist). Unfortunately, "certain well-established drugs have safety profiles that are just better than the alternatives," according to Joseph Deffenbaugh, professional practice associate at the American Society of Health-System Pharmacists. And switching drug therapies can have adverse effects on the patient's health. Doctors may have to use unfamiliar drugs and as a result, run the risk of giving the patient the improper dosage. The patient has to be monitored more closely to determine the alternative drug's effectiveness (and any side- effects). Then, when the original drug comes back on the market (if it wasn't discontinued), the doctor must monitor the patient's health closely in the transition back to the original drug. In some cases, patient deaths can occur when drugs and vaccines are taken off the market. In 2000, Wyeth Laboratories decided to stop production of the adenovirus vaccine. That year, two U.S. Navy recruits died of adenovirus infections and thousands of others were sickened. This virus is common in boot camp barracks — but until that year every recruit was vaccinated against the illness.
And, yet, some suppliers are getting the drugs that are (supposedly) in short supply. When hospital pharmacies cannot get a drug from their usual wholesaler, and the manufacturer does not tell them when (or if) the drug will become available again, some pharmacists buy the drug from other wholesalers and distributors. And pay top dollar. In some cases, these suppliers seek out the pharmacists. Brian D. Benson, pharmacy manager for Iowa Lutheran Hospital in Des Moines, receives telephone calls and faxes from secondary wholesalers that advertise "products that are generally unavailable and have a 200% markup on the price." Benson suggests that state boards of pharmacy investigate these wholesalers "to see if hoarding is a regular practice for some companies." Unfortunately, most states do not have a lot of idle investigators just sitting around. Iowa employs only three investigators for the entire state.41
Can anything be done about the shortages? "The government, and specifically the FDA, cannot tell the unregulated drug companies what to do or what to produce." (Everett). In some cases, when the FDA enforces regulations governing manufacturing practices (quality control is under the FDA jurisdiction) more shortages occur. "On May 18, 2002, the FDA fined Schering-Plough $500 million for poor manufacturing practices in 90% of its drug products since 1998. The FDA fine covered 125 prescription and non- prescription drugs…. As a part of the settlement, the company was to pay an additional $175 million if it failed to improve manufacturing practices at all four of its plants. Rather than upgrade its laboratories and factories, Schering-Plough simply decided to suspend production of 73 products. As with the suspension of influenza vaccine production by two makers last year, the result is instant shortages" (Everett).
Sources: Maguire, Phyllis. "Drug shortages raise new fears about patient care." ACP-ASIM Observer, December 2001. Retrieved September 18, 2002 from http://www.acponline.org/journals/news/dec01/drug_shortage.htm. Drug Shortages Management Resources Center. University of Utah. "Drug Product Shortage Bulletins." Retrieved September 18, 2002 from http://www.ashp.org/shortages.Center for Drug Evaluation and Research. U.S. Food and Drug Administration. "Definition of a Medically Necessary Product" and "Drug Shortages." Retrieved September 18, 2002 from http://www.fda.gov/cder/drug/shortages/. Jamie Talan. "Doctors encounter drug shortages." The Detroit News, April 14, 2002. Retrieved September 18, 2002 from http://www.detnews.com/2002/health/0204/17/a03-464741.htm. Donna Young. American Society of Health System Pharmacists. "Drug Shortages Frustrate Health Care Providers," April 4, 2002. Retrieved September 18, 2002 from http://www.ashp.org. Kelly McClurg. "Pharmaceutical prices are up, availability down," Birmingham Business Journal, July 12, 2002. Retrieved September 18, 2002 from http://birmingham.bizjournals.com/birmingham/stories/2002/07/15/story3.html. Centers for Disease Control. "Notice to Readers: Shortage of Varicella and Measles, Mumps and Rubella Vaccines and Interim Recommendations from the Advisory Committee on Immunization Practices." MMWR, March 8, 2002. Retrieved September 18, 2002 from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5109a6.htm. Linda Everett. "U.S. Hospitals Face Critical Drug Shortages." Executive Intelligence Review, August 9, 2002. Retrieved September 19, 2002 from http://www.larouchpub.com/other/2002/2930drug_shtge_ii.html.
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