Weathering the Storm: The Drug Shortage Crisis
Marty Kochevar, MS, RPh, BCNSP, Clinical Practice Consultant, A.S.P.E.N.
In October of 2010, the Institute for Safe Medication Practices (ISMP) published an article discussing the drug shortage crisis in the United States. They noted, “All healthcare organizations have disaster plans in place that they practice and refine in preparation for an unexpected crisis. These plans are not developed ‘on the fly’ because healthcare providers recognize the value of planning for the unexpected and the necessity of minimizing potentially life-saving interruptions in care. The ongoing problem with drug shortages in our nation is rising to the level of ‘disaster’ status. Drug shortages continue to take an enormous toll on healthcare providers who must deal with the problem on a daily basis, and on patients who are on the receiving end of the shortages.”
Drug Shortages Summit
In November of 2010, the ISMP along with the American Society of Health-System Pharmacists (ASHP) and two other professional organizations co-convened a Drug Shortages Summit. The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) sent representatives to this summit. Other summit participants included representatives from health professional organizations, drug manufacturers, and supply chain entities. Representatives of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention also attended portions of the meeting as observers.
The summit noted that new drug shortages have increased every year from 58 per year in 2004, to 129 per year in 2007, to 168 in 2010. The reasons for the drug shortages are quite variable. They include:
Mergers in the drug industry
Raw materials supply
Supply chain (drug distribution) issues
Manufacturing / regulatory issues
Changes in clinical practice
Unknown (most frequent reason!)
The Drug Shortages Summit published a number of recommendations in its Summary Report. One of these included, “Improve communication to, among, and from product manufacturers and FDA, including detailed information on reason and anticipated duration of shortage. Also enhance communication to supply chain entities and health care providers (e.g., Dear Provider letters).”
This recommendation and others have been formulated into U.S. Senate bill S. 296, the Preserving Access to Life-Saving Medications Act, by Senators Amy Klobuchar (D-MN) and Robert Casey (D-PA). This legislation directs the FDA to address drug shortages by requiring manufacturers to notify the FDA about manufacturing problems or when a drug is to be discontinued. The bill also requires that the FDA maintain an online list of drugs in shortage situations, and revises the agency’s definition of “medically necessary.”
A.S.P.E.N. leaders and several Oley members participated in the Digestive Diseases National Coalition (DDNC) Public Policy Forum (also called Capitol Hill Day) on March 6–7, where attendees made Congressional visits. This forum allows the attendees to encourage legislators to sign on to legislation like U.S. Senate bill S. 296.
Health professionals and consumers are urged to write their senators in support of this bill. A.S.P.E.N. has created a Support Letter template that will help you. I
For further information on bill S. 296, review the at www.ashp.org (search for S. 296). Or read the full bill on the Thomas Legislative Information Web site, http://thomas.loc.gov/ (type in “S. 296”). To find your Senator and his or her contact information, visit www.congress.org.
While drug shortages involving home parenteral nutrition (HPN) are a small part of the overall drug shortage situation, it certainly affects us significantly. In the past we have experienced shortages of IV multivitamins, IV fat emulsions (i.e., lipids), and IV amino acids. Currently, we are experiencing shortages of IV electrolytes, minerals, and trace elements that are necessary for the compounding of HPN formulations. These include: sodium chloride (NaCl, salt), potassium chloride (KCl), calcium gluconate, and zinc chloride, among others. For the most comprehensive listing of drug shortages, see the ASHP Drug Shortage Resource Center at www.ashp.org/shortages.
A.S.P.E.N. has been and is proactive regarding HPN drug shortages for our members and their patients. We actively monitor the situation and publish news articles including PN drug shortage recommendations (e.g., IV multivitamins, IV fat emulsions, and IV amino acids). We are currently actively engaged in the IV electrolyte and mineral drug shortages. With everyone’s input and cooperation, we are hopeful we will “weather this storm” and hopefully avert future ones.
LifelineLetter March/April 2011