Drug shortages eat up pharmacists’ time, budget; threaten patient safety
Providers sound call for more advance notice
Drug shortages were once an exception — until the last five or six months. "I’ve been a pharmacist for 30 years, and this has been the worst," says Charles Cancro, RPh, procurement specialist for the Ralph H. Johnson VA Medical Center in Charleston, SC. The medical center has had problems ordering drugs such as betamethasone acetate and betamethasone sodium phosphate (Celeston Soluspan), dexamethasone sodium phosphate for injection (Decadron), albuterol inhalants, methadone, and fentanyl.
Now Cancro spends much of his day chasing down drug supplies, trying to find alternative sources or medications, and informing patients of changes to their prescriptions. He feels the strain on his job, but also knows these shortages can affect patient outcomes. As an example, 344 pharmacists recently told the Institute for Safe Medicine Practices (ISMP) in Huntingdon Valley, PA, about their patient safety concerns during the fentanyl shortage. In the survey, they cited several disturbing possibilities:
- dosing errors due to unfamiliarity with substitute products;
- adverse drug reactions with higher potency opiates;
- ineffective pain control; and
- issues with contamination and drug diversion if using multiple-dose vials (or reusing single-dose vials to prevent waste).
What’s the problem?
Compliance problems were more often the cause of drug shortages throughout the early 1980s and early 1990s, say clinical coordinator Mark Goldberger, MD, MPH, and program manager Lisa Hubbard, RPh, both of the Drug Shortages Program at the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research. In a written statement to Drug Utilization Review, they say other factors have contributed to the recent shortages:
- limited or decreased number of bulk drug suppliers;
- corporate mergers and decisions to cut off the end-of-product line;
- less active pharmaceutical ingredient suppliers;
- packaging issues;
- failure to meet good manufacturing practices; and
- issues with natural disasters.
Indeed, many of the recent drug shortages can be traced to significant changes within the pharmaceutical industry, says Joe Deffenbaugh, MPH, professional practice associate for the American Society of Health-System Pharmacists (ASHP) in Bethesda, MD.
Because of pharmaceutical company consolidation through mergers and acquisitions, "fewer manufacturers are making the products these days," he says. "In fact, we have a number of products that are only manufactured by one company. If the company gets into a manufacturing practice difficulty, then no product is available." In the past, several manufacturers made essentially the same products, so the system had some cushion. (See news brief on tetanus booster availability, in this issue.)
Another factor related to the mergers and acquisitions are the business practices of what are now multinational conglomerates. "Most of the injectable products that are used in hospitals are relatively inexpensive on the purchase price side," Deffenbaugh explains. "But they are not necessarily inexpensive to make because sterile product manufacturing facilities are complex and are under rigorous quality controls and oversight by the FDA. The bottom line for these multinational conglomerates is that if a drug product is not making any money, then they won’t make it."
In addition, these large companies are receiving price pressure from many areas, he adds. "Everyone from government on down says drug products cost too much." The companies are told to reduce the price of drugs and to get more drugs available generically. "All these pricing influences have an effect on whether a manufacturer is willing to make these low-return or no-return drug products."
Hospitals’ purchasing methods can make them more vulnerable to drug supply interruptions, too, Deffenbaugh says. For example, many of the drug products used in pediatric hospitals have just a few sources. Because of this, a number of pediatric centers are backing away from using just-in-time inventory for critical drug products.
Cancro believes that many pharmaceutical companies struggle to stay in compliance with government standards. "I feel that the FDA has cracked down more on these companies," he says. Companies often give "unavailability of the raw product" as the reason for a shortage. But so many products can’t be unavailable at one time, asserts Cancro.
Always the last to know
Much of pharmacists’ frustration with drug shortages is finding out about them at the last minute — usually when they are trying to order the drug. "After four or five days, my supply tech will let me know she is having trouble getting a drug," Cancro says. "I’ll call the wholesaler directly and they will tell me [about the shortage]." Then he calls the manufacturer to make sure a shortage actually exists.
Pharmacists also hear about shortages when they receive a flyer from alternative distributors that specialize in providing drug products that are in short supply, Deffenbaugh says.
Both the FDA and the ASHP now offer information about drug shortages on their web sites, but few of the pharmacists surveyed by the ISMP said they checked them. (The FDA site is www.fda.gov/cder/drug/shortages and ASHP’s Drug Product Shortages Management Resource Center can be found at www.ashp.org/shortage.)
Pharmacists would prefer to hear about the shortages directly from the manufacturers — with advance notice. Some feel the FDA should encourage the information-distribution process. The FDA, though, has limited regulatory authority to intervene, says agency spokesperson Crystal Rice. "We serve as the liaison to inform the public about shortages, what shortages exist and to educate people about them."
The FDA focuses most of its attention on "medically necessary" drugs — those needed to treat or prevent a serious medical condition and that have no acceptable alternative product. In these cases, the FDA can work with alternative manufacturers, expedite the review of marketing applications from new suppliers, and use "discretionary enforcement" for regulations that do not compromise public safety, according to information Hubbard provided to ASHP. The FDA, however, cannot force a manufacturer to increase production of a certain drug. This situation leaves pharmacists scrambling on their own to learn about the drug shortages, to find other suppliers of the drug, or to find suitable alternatives, if possible.
The process is not only time-consuming but also expensive. The VA Medical Center in Charleston, for example, buys from specific manufacturers that offer a special price. If those manufacturers don’t have a drug, Cancro has to contact alternative sources, which can charge significantly higher prices. He has had to pay seven times the normal rate for additional supplies of the flu vaccine.
"When there is a shortage, alternative distributors offer the drug product but charge five to 100 times what [pharmacists] used to pay for it," Deffenbaugh says. "Hospitals are caught between a proverbial rock and a hard place. They have to have the drug to properly care for their patients and yet they have no way of recovering additional costs."
The pharmacists in the ISMP survey agree. They cite a negative financial impact due to purchasing drugs off-contract or through secondary markets, costly alternative drugs, same-day shipping costs, reactive overstocking practices, and clinical hours lost to activities relating to the drug shortages.
If Cancro can locate more of a drug that is in limited supply, he tries to take just what he needs for a short period of time. "I don’t want to keep other patients from receiving it," he says. He knows that some hospitals don’t always follow the same policy. "Sometimes when people hear about a drug having a short supply, they will buy tremendous amounts of it."
In several instances, the manufacturers only release the drug on a patient-by-patient basis. "The company wants the patients who absolutely have to have the drug to get it. But you as a pharmacist spend a considerable amount of your time trying to get the patient the medicine when you have other patient care responsibilities," says Thomas Worrall, RPh, ambulatory care clinical pharmacy specialist at the VA Medical Center in Charleston and chair-elect of the hospital and institutional practice section of the American Pharmaceutical Association’s Academy of Pharmacy Practice and Management.
In cases where the drug is not available at all, alternatives may be chosen that may not present optimal patient outcomes. "If you can’t get the drug that has the best outcomes, then you have to use the next best thing that is available. There isn’t anything you can do," Worrall says.
When alternative drugs are used, patients at the VA receive a letter informing them of the change, he says. "We’ll tell them that their medicine is being substituted with a similar drug that will provide them relief of their condition. If they have any questions, information on the letter tells them to contact their physician or their clinical pharmacist in their primary care treatment center."
Patients often call after receiving the letters. "Then you have to counsel them on their new medicine or explain to them why their other medicine is not available," Worrall says. Even if the situation isn’t life-threatening, not having the drug may affect their quality of life.
Staff also must be informed and educated about drug changes. The ISMP survey found that pharmacists did not always provide information about possible adverse effects of the substitute drugs to medical staff.
Try and preplan
Although many drug shortages are difficult to foresee, pharmacists can help themselves by looking at what drugs are essential at their facilities and then considering different "what-if" situations, Deffenbaugh advises.
The ASHP recently published comprehensive pre-planning guidelines on managing drug product shortages. The guidelines can be viewed at www.ashp.org/shortage/mgtguideline.pdf. (See "Manage drug shortages proactively too limit risks," in this issue, for recommendations made by the pharmacists in the ISMP survey.)
If pharmacists suspect a supply of a drug may become limited, they can send messages to physicians and ask them to restrict their use of the drug to patients whose treatment depends upon it, suggests Worrall. "If you know ahead of time, you can try to maintain the supply you have on hand now for the patients who will need it."
A look into the crystal ball may be needed for some time. "I don’t see the problem getting any better in the near future," Cancro says.
• Charles Cancro, RPh, procurement specialist for the Ralph H. Johnson VA Medical Center in Charleston, SC. Telephone: (843) 577-5011.
• Joe Deffenbaugh, MPH, professional practice associate for the American Society of Health-System Pharmacists, Bethesda, MD. Telephone: (301) 657-3000.
• Mark Goldberger, MD, MPH, clinical coordinator, and Lisa Hubbard, RPh, program manager, the Drug Shortages Program at the Food and Drug Administration’s Center for Drug Evaluation and Research, Rockville, MD. Web site: http://www.fda. gov/cder. Telephone: (301) 827-2127.
• Crystal Rice, FDA spokesperson, Rockville, MD. Telephone: (301) 827-6242.
• Thomas Worrall, RPh, ambulatory care clinical pharmacy specialist at the Ralph H. Johnson VA Medical Center in Charleston, SC, and chair-elect of the hospital and institutional practice section of the American Pharmaceutical Association’s Academy of Pharmacy Practice and Management. Telephone: (843) 577-5011. E-mail: email@example.com.