Responding to Drug Shortages

Regrettably, almost all pharmacistshave been forced to dealwith drug shortages at anincreasing rate in the past 2years. Although such shortagessometimes result fromunderstandable circumstances,are these circumstancestruly unavoidable?If they are avoidable, is theappropriate organizationheld accountable? I knowthat our staff at the Universityof North CarolinaHospitals and Clinics andthe affected patients feelhelpless when products onwhich we have relied arenot available. The negativeimpacts on productivityand efficiency are supersededby the angst createdbetween pharmacists andphysicians (who believethat we are responsible) andother health care providersand our patients.

Last week, we encountereda shortage of a "lifesaving"drug that requiredthe institution to decide whichpatients got the limited amount ofdrug that was available to it. Despite apositive outcome and fantastic cooperationbetween the pharmacy and medicalstaffs, we were all forced to makeuncomfortable decisions. This is justone dramatic example of the manyshortages that impact hundreds ofpatients and providers every day.

If a shortage is due to a raw materialsshortage, does the manufacturerchange sources in order to ensure thata supply of raw materials is reliable? Ifthe shortage results from FDA manufacturinginterventions, has the manufacturermodified policies and proceduresto avoid future problems of asimilar nature? Is it appropriate for amanufacturer to cease production of adrug due to its lack of profitabilityunless it is availablefrom alternative sources? Ifso, are patients and providersinformed by the manufacturer,with enough timeto migrate to an alternativetreatment plan?

I believe that manufacturersshould be held responsiblefor drug shortages andshould be required to informall those affected with asmuch lead time as possible,including telling them thereason for the shortage. Weshould encourage pharmacyleaders, P & T committees,medical staff, and patients toexpress their disappointmentin writing to the manufacturers,and to sendcopies to their congressionalrepresentatives and the FDA.

Pharmacists have to beaccountable if poor inventorymanagement results indrug shortages at the local level. Whyshouldn't manufacturers be held to thesame standard? Pharmacists (and theorganizations in which we practice)will continue to feel helpless until weare able to hold manufacturers publiclyaccountable for drug shortages.