Caring about others: Drug shortages
How do our clients recognize that we care? In the context of recent drug shortages, we have been exploring this question starting with the November 2011 issue. In December's column we focused on the causes and consequences of drug shortages. In the third part of this series, we are focusing on the pharmacists' and veterinarian's roles in identifying drug shortages and protocols to minimize drug-related adverse events.
Recall that a severe shortage of prescription drugs, including injectable anesthetic drugs, chemotherapy agents and antimicrobial drugs is endangering the welfare and lives of human and animal patients.
On Oct. 31, 2011, President Barack Obama asked the Food & Drug Administration (FDA) to reduce drug shortages which have been primarily caused by disruption in supplies (please see Part 2 of this four-part series in the December issue of DVM Newsmagazine).In summary, 1) the President's order asked the FDA to require manufacturers to provide six months advance notice of manufacturing-disruptions for certain drugs; 2) the FDA was asked to expedite regulatory reviews to help alleviate drug shortages; 3) the FDA was asked to communicate with the Department of Justice (DOJ) events related to discovery of drug stockpiling or price gouging.
While FDA has been working with manufacturers to minimize or prevent shortages, many root causes and potential solutions to the shortage problems are not within the authorities of FDA. The FDA prevents drug shortages primarily by expediting regulatory reviews of new manufacturing processes, sites and supplies. The FDA responds to drug shortages by requesting other manufacturers to increase production. By working with manufacturers to identify mechanisms to reduce drug-induced adverse events, delays in regulatory reviews are reduced.
FDA's report stated that the manufacture of sterile injectable drugs is more complex than the manufacture of oral drugs and therefore leads to greater problems of quality control.
Additional legislation is encouraged by President Obama, including:
1. The FDA should communicate to the Department of Justice (DOJ) any findings that drug shortages have led to stockpiling or sale of affected drugs at excessive prices. The DOJ shall then determine whether or not these activities are consistent with the law.
2. New legislation will require drug manufacturers to notify FDA of drug discontinuations or other supply disruptions that could potentially lead to shortages of many drugs that the FDA has approved for human use. Manufacturers of drugs likely to become unavailable must notify FDA six months in advance or as soon as possible after recognition of an impending drug shortage. New laws will allow FDA to impose monitory penalties on manufacturers that fail to adhere to the reporting requirements.
3) In response to these drug shortages, FDA sent letters to drug manufacturers notifying them of their current legal obligations to report product discontinuations in advance of the event. FDA also encouraged manufacturers to notify the agency of any potential disruptions in the supply of drugs.
Part 4 of this four-part series will focus on how to respond to elective and non- elective illnesses requiring the use of drugs in short supply.
Dr. Osborne, a diplomate of the American College of Veterinary Internal Medicine, is professor of medicine in the Department of Small Animal Clinical Sciences, College of Veterinary Medicine, University of Minnesota.
Dr. Nwaokorie recently completed his MS and is pursuing a PhD at the University of Minnesota.