HDMA Product Availability Guidelines Advise Maintaining A Pool Of Inventory

Manufacturers should consider maintaining a central pool of inventory for products susceptible to shortages, the Healthcare Distribution Management Association recommends in guidelines on ensuring product availability.

"Manufacturer allocation programs should consider the potential benefits of maintaining a central pool of inventory," ¹ HDMA's guidelines state.

The guidelines suggest that, from the central pool, "product may be shipped to medication providers via direct or drop ship," and "may be held for emergency shipment."

HDMA created a Drug Availability Task Force a year ago to develop industry guidelines to alleviate drug shortages.

The task force included representatives from the Pharmaceutical Research & Manufacturers of America, individual manufacturers and FDA. Distributors, pharmacists, pharmacies and group purchasing organizations also are represented (² (Also see "FDA/Industry Drug Shortage Proposal: Early Notice On Discontinuations" - Pink Sheet, 16 Jun, 2003.), p. 36).

By compiling "best practices," the task force aimed to educate manufacturers unfamiliar with shortage procedures on ways to appropriately prepare for and handle drug shortages.

Problems associated with shortages are often exacerbated through poor communication, the guidelines indicate.

"There is no industry standard for communicating supply chain product availability issues, which has resulted in confusion among some manufacturers about what to do and how to communicate in the event of a shortage," the guidelines state.

"Communications about product shortages should be accurate, concise and clear in order to support the customer and the supply channel [to] the best of the manufacturer's ability given existing information."

According to the guidelines, shortfalls of the current communication process from manufacturer to wholesaler include: providing incomplete information; poor timing of communication; reluctance to provide detailed information regarding the shortage; providing inconsistent information to internal staff; and not suggesting alternatives to product in short supply.

"Alternative therapy(ies) for the unavailable product need to be carefully researched, therapeutically and clinically matched, and selected with proper communication to pharmacists at the store level," the guidelines state.

To keep wholesalers and pharmacies apprised of shortages, manufacturers should "create websites that are updated regularly," the guidelines suggest.

"Communications should be made on a weekly basis through e-mail to wholesalers, or via a website," the guidelines advise.

Antitrust concerns dissuaded the task force from recommending use of a central website for all manufacturer product shortage information.

However, the guidelines recommend passing information along to websites controlled by FDA and the American Society of Health-System Pharmacists.

HDMA seems to prefer the ASHP website over FDA's.

The guidelines note that ASHP uses the same definition of shortage recommended by HDMA: "supply does not meet demand for a drug on a nationwide or regional basis for a period of time that necessitates changing the practice of treating the patient."

Also, product shortage bulletins on the ASHP website "are developed when product unavailability is anticipated to be prolonged, requiring changes in patient care."

"The FDA website lists shortages of 'medically necessary' products that may be reported by groups within FDA, manufacturers, patients, consumers or health care professionals," the guidelines say.

ASHP recently announced an update to its website that allows users to "choose to search current drug shortages bulletins by generic name, therapeutic class or most recent update."