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8/14/2000

Drug Shortages Seem Plentiful, Frequent

Cheryl A. Thompson

Seemingly frequent shortages of drug products have placed health-system pharmacies on constant alert and pharmacists in the position of quickly formulating policies on therapeutic alternatives.

Faced with a potential lack of intravenous (i.v.) methylprednisolone at her seven-hospital system, Margo S. Farber, Pharm.D., coordinator of drug information services for Detroit Medical Center, had to plan for unpredictable, critical patient needs, such as acute treatment of spinal-cord injuries. The system's pharmacy and therapeutics committee readily accepted her proposal for automatically using another i.v. glucocorticoid if the inventory of methylprednisolone "falls below a critical level." 

With the exception of the neurologists, "the others were not that excited, Farber said. "We're so used to [shortages] now." 

At ASHP, Professional Practice Associate Joseph H. Deffenbaugh, M.P.H., monitors drug shortages as he hears about them from members. He ascribes inventory problems to four underlying factors: 

  • Adoption of just-in-time inventory systems by pharmacies, wholesalers, and manufacturers,  
  • Fewer companies making products,  
  • Violations of current good manufacturing practices, and  
  • Corporate decisions not to make an ingredient or product anymore.
Manufacturing and supply problems came into play with the recent shortage of i.v. penicillin G sodium, when the one FDA-approved supplier of sterile bulk drug decided to stop that business and the major manufacturer of finished product ran afoul of the government's manufacturing codes.

As part of an agreement ASHP recently made with FDA, Deffenbaugh tries to determine the reason for reports of an inadequate supply of a drug product. If the cause is a national shortage, not a regional distribution problem, FDA will then decide whether unavailability of the drug would cause a public health problem. "FDA has very tight criteria for whether they get involved, or not, in a drug shortage," Deffenbaugh said. 

Detroit Medical Center's Farber attributed her system's avoidance of a crisis to a pharmacy purchaser, a technician, who had a hunch that i.v. methylprednisolone might become hard to obtain and upped his orders. 

Deffenbaugh advises pharmacies to more diligently monitor changes in inventories and analyze the usage rates of critical drug products. For items with limited alternatives, pharmacists should "think seriously of how much you have on hand and expand that just-in-time inventory flexibility." 

In progress is an ASHP guideline on managing drug shortages. The writers will report their progress at Annual Meeting 2000 during a Wednesday afternoon session that also features an FDA representative, pharmacists' strategies for managing drug shortages, and a speaker on responding to the i.v. immunoglobulin shortage.