Drug Shortages - What You May Not Know
by Ann Jankiewicz, ICHP President
June 5, 2008
One of the
responsibilities of the ICHP Professional Affairs Division is to review
ICHP’s Position Statements on a regular basis. As a member, I was
assigned to review the ICHP Position Statement on Manufacturer Drug
Shortages. In my research to do this review, I found that I did not
know everything there was to know about drug shortages and their
management. Since many of us have been affected by the recent heparin
shortage (among others), I thought it might help to review this topic.How do we find out about drug shortages? The most common resources for information are the manufacturing companies, FDA and ASHP. The FDA’s Drug Shortage Program is part of the Center for Drug Evaluation and Research (CDER) (www.fda.gov/cder/drug/shortages). The FDA has four other Centers including the Center for Biologics Evaluation and Research (CBER) (www.fda.gov/cber/shortage/shortage.htm,). The CDER helps manage shortages for prescription, over-the-counter and generic drugs; biologicals and vaccines are managed through the CBER. Manufacturers are not required by law to report potential or current shortages to the FDA, but they often do. FDA limits its work with shortages to products that are deemed medically necessary (products used to treat or prevent a serious disease or medical condition for which there is no other source or acceptable alternative). The most common causes of drug shortages include: manufacturing issues, limited production capability and raw material availability. FDA may help with some of these issues by encouraging other manufacturers to supply a product, helping to identify other sources of raw materials, helping with technical issues so that a manufacturer can meet inspections, and by expediting reviews and approvals of new or generic drugs. The FDA website lists drug shortages, possible alternate sources, links to manufacturer information on recalls, and allows you to report a shortage. It does not list alternative therapies.
ASHP has partnered with Novation and the University of Utah Drug Information Center to create the ASHP Drug Product Shortages Management Resource Center on the ASHP website (www.ashp.org). If you click on Drug Shortages in the Popular Links section of the home page, you will be taken to a page that includes current shortages, resolved shortages, and links to more information on managing drug shortages. Clicking on Current Shortages takes you to the Resource Center where you will find a list of drugs in short supply. When you click on the drug you are interested in, you find information that includes: affected products, reasons for the shortage, expected length of shortage, safety issues, and alternative therapies with references. You may not find alternate therapies for all drugs listed or there may be a delay in posting of alternate therapy recommendations. This requires revisiting the site for updates. The website also provides the opportunity to report shortages.
Frustrations surrounding the management of drug shortages include utilization of resources, communication, financial impact and the impact to patient care. Shortages put a strain on the staff. Staff is needed to research alternative sources, alternative therapies and to communicate the action plan outward. Shortages may increase costs due to use of a more expensive alternate therapy or paying more for an alternative source because it is off contract. Using alternatives may cause a safety risk due to unfamiliarity with the product on the part of the pharmacist, nurse or patient.
The ASHP Guidelines on Managing Drug Shortages is a good resource to help plan ahead for drug shortages. The guidelines say that “Although it is often not possible to predict wh