Responding to Drug Shortages

JUNE 01, 2005
James C. McAllister III, MS, FASHP, Pharmacy TimesEditor, Health-Systems Pharmacy Section

Regrettably, almost all pharmacists have been forced to deal with drug shortages at an increasing rate in the past 2 years. Although such shortages sometimes result from understandable circumstances, are these circumstances truly unavoidable? If they are avoidable, is the appropriate organization held accountable? I know that our staff at the University of North Carolina Hospitals and Clinics and the affected patients feel helpless when products on which we have relied are not available. The negative impacts on productivity and efficiency are superseded by the angst created between pharmacists and physicians (who believe that we are responsible) and other health care providers and our patients.

Last week, we encountered a shortage of a "lifesaving" drug that required the institution to decide which patients got the limited amount of drug that was available to it. Despite a positive outcome and fantastic cooperation between the pharmacy and medical staffs, we were all forced to make uncomfortable decisions. This is just one dramatic example of the many shortages that impact hundreds of patients and providers every day.

If a shortage is due to a raw materials shortage, does the manufacturer change sources in order to ensure that a supply of raw materials is reliable? If the shortage results from FDA manufacturing interventions, has the manufacturer modified policies and procedures to avoid future problems of a similar nature? Is it appropriate for a manufacturer to cease production of a drug due to its lack of profitability unless it is available from alternative sources? If so, are patients and providers informed by the manufacturer, with enough time to migrate to an alternative treatment plan?

I believe that manufacturers should be held responsible for drug shortages and should be required to inform all those affected with as much lead time as possible, including telling them the reason for the shortage. We should encourage pharmacy leaders, P & T committees, medical staff, and patients to express their disappointment in writing to the manufacturers, and to send copies to their congressional representatives and the FDA.

Pharmacists have to be accountable if poor inventory management results in drug shortages at the local level. Why shouldn't manufacturers be held to the same standard? Pharmacists (and the organizations in which we practice) will continue to feel helpless until we are able to hold manufacturers publicly accountable for drug shortages.

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