According to the US Food and Drug Administration (FDA), the increase in the shortage of critical drugs could potentially become a major public health emergency.
According to the US Food and Drug Administration (FDA), the increase in the shortage of critical drugs could potentially become a major “public health emergency.” The number tripled from 2005 to 2010 and this disruption in drug treatment supplies caused an increase in healthcare costs, delays in medical procedures, and cancelled drug studies. At the Academy of Managed Care Pharmacy (AMCP) 24th Annual Meeting, Senior Drug Information Specialist, Sherry Andes, PharmD, BCPS, BCPP, PAHM, from informedRX Inc (a subsidiary of SXC Health Solutions Inc), and Joseph Hill, MA, Director, Federal Legislative Affairs, American Society of Health-System Pharmacists, led the session, “Drug Shortages and the Impact on Managed Care Pharmacy” discussing the cause, effects, and potential solutions for addressing this concern.
The following 4 drug classes have been affected the most by the shortages: the central nervous system, antibiotics, chemotherapy, and cardiovascular. According to the University of Utah Drug Information Service 60% to 70% of the reported shortages were injectable therapies. As reported by the FDA Drug Shortage Program, the largest reason for the shortages was the quality of product (42%). Other reasons were production/capacity and product discontinuation issues, as well as unavailability of raw materials and other components. Time is also spent managing the drug shortage issue, with pharmacists losing up to 9 hours per week and pharmacy technicians 8 hours per week.
Potential solutions for these drug shortages involve legislation with bipartisan bills introduced to Congress in 2011. New legislation to establish early warning systems would force manufacturers to notify the FDA of an interruption in production and require them to establish a contingency plan. According to the FDA, in 2011, 195 additional shortages were prevented when manufacturers provided confidential and advance notice of pending shortages. There is significant interest in addressing this issue by Congress.
For more information on this and other sessions, please visit www.amcp.org.