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Voluntary Guidelines Tackle Drug Product Shortages

Kate Traynor

The Healthcare Distribution Management Association (HDMA), representing pharmaceutical distributors, recently released voluntary guidelines (PDF) for handling—and minimizing—drug product shortages that affect patient care.

The guidelines were created to address inefficiencies in the drug product distribution system. In particular, the document emphasizes the importance of keeping all segments of the drug supply chain—including manufacturers, wholesalers, regulators, and purchasers—informed about supply issues.

"The document encourages earlier and more widespread communication about shortages and consistency of information," said David R. Witmer, Pharm.D., vice president of member services at ASHP. He noted that, from the pharmacy perspective, the guidelines are fairly broad in scope and discuss the management of shortages in "community chain practice settings as well as institutional settings."

Because the guidelines address supply problems at the manufacturer, distributor, and health care provider levels, Witmer said that the document can help pharmacists better understand "the complexities of the drug distribution system" and the reasons why shortages occur.

HDMA developed the guidelines with input from ASHP, other professional pharmacy groups, the American Medical Association, drug manufacturers and wholesalers, and the Food and Drug Administration (FDA).

The guidelines urge manufacturers and others to quickly report supply problems to ASHP so that the information can be disseminated through the Society's online Drug Product Shortages Management Resource Center.

Witmer emphasized that a true product shortage differs from a short-term back order of a medication.

"Pharmacists are not concerned about not getting something for a day," Witmer said of product back orders. "They're concerned when they actually have to start thinking about how they're going to treat a patient differently because they're not getting the drug over the long haul."

Patient-care problems identified in the document include the need to provide appropriate alternative therapy and for pharmacists to educate physicians and patients about available treatment options. Supplies of alternative therapies must likewise be available in sufficient quantities to meet patients' needs.

Among other recommendations, the HDMA report urges drug manufacturers to work with their customers to accurately forecast product demand throughout the year. When a product is in short supply, the report advises manufacturers to consider the implications for patient care of "unusually large" purchases of the product by wholesalers, distributors, and medication providers. The guidelines also note that factors such as end-of-the-year manufacturing slowdowns and the shipment of product to meet date-related sales goals can cause seasonal fluctuations in availability that must be communicated to customers.

The guidelines also call for upon manufacturers to develop "allocation programs" that rely on a "central pool of inventory" from which to ship critical products that are in short supply. During a shortage, manufacturers are urged to "collapse the supply channel" by shipping directly to health care providers or their institutions instead of sending material to wholesalers.

The document also urges drug manufacturers to provide at least 30 days' notice to FDA when any product is discontinued. At present, manufacturers are only required to notify FDA of a product's discontinuation if it is a sole-source material that is considered a life-saving product.

HDMA identifies wholesalers as a bridge between manufacturers and health care professionals and urges wholesalers to provide their customers with timely and complete information about shortages as they develop. The document encourages wholesalers to develop "accurate and timely product availability databases" to keep customers abreast of supply issues.

Witmer urged all segments of the drug supply chain to take responsibility for managing and preventing product shortages.

"There is a tendency for people to want to place all the blame on a specific part of the supply chain, such as manufacturers, the FDA, wholesalers, or even providers," he said. "But I think if we're going to solve this problem, people are going to have to begin to work together to address the root causes of drug shortages and improve communication throughout the supply chain when shortages do occur."