The Scoop on Drug Shortages - Pharmaceutical Executive


The Scoop on Drug Shortages

Pharmaceutical Executive

Recent efforts to curb shortages

Many countries are now developing solutions to address drug shortages across Europe including Germany, Belgium, and France. A number of government and legislative actions, including an Executive Order from President Obama on October 31, 2011, are also ongoing. Recently three top manufacturers indicated that they would be expanding their capacity for manufacturing generic sterile injectables. Policymakers like the FDA; other regulatory agencies worldwide, including the European Medicines Agency and national authorities in Germany, Belgium, and France; and manufacturers have all been directed to derive new solutions and policies to prevent drug shortages or to more effectively manage them.

One hospital pharmacist noted that achieving sustainable solutions to drug shortages would only occur by involving physicians and patients in the process and by building awareness among various constituents within hospital settings. Another interviewee warned that "we need to change our policy and involve doctors and patients in this discussion—as well as start advocacy groups." In many cases, physicians and patients may not be fully aware of shortages or their magnitude.

Key industry associations, including the EAHP (European Association of Hospital Pharmacists), the ASHP (American Society of Health-System Pharmacists), are involved in efforts to raise awareness and to reduce the incidence of drug shortages. In addition, patient advocacy groups are now bringing much needed visibility to the issue of drug shortages and are attempting to empower patients via access to information on websites, special webinars, or through social media. Some patient advocacy groups, such as, make information about drug shortages available to patients and provide this information online. It provides detailed information about the shortage status of the heavily used drugs leucovorin and 5 FU (fluorouracil) on its website and also identifies alternative treatments and other critical "what to do" guidance for patients.

In our view, cooperation among all stakeholders will be needed to not only reduce the incidence of shortages, but to alleviate their unquestionably harmful effects on the patient population. Resolution of this problem will depend on government and industry leadership under a worldwide effort focused especially on anticipatory actions at the front line—by physicians, hospital staff, and patients.

Mary Jo Lamberti, PhD, is a Senior Project Manager at Tufts CSDD. She can be reached at
. Ken Getz, MBA, is a Senior Research Fellow and Director of Sponsored Research Programs at Tufts CSDD. He can be reached at


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