I’ve been losing sleep lately over drug shortages.
I worry mostly about how the overwhelming number and duration of drug shortages are affecting our patients. As of September, close to 200 unique product shortages had been reported to the ASHP Drug Shortages Web Resource Center. That number puts us well on track to reach the highest number of shortages reported since we started the web site about a decade ago. It’s a competition that I don’t want to win.
The patient safety concerns are significant. Use of new dosage forms and less familiar alternative therapies present opportunities to upset the careful system of checks and balances that health care facilities implement to prevent patient harm.
Drug shortages are also having a profound effect on patient outcomes. This has become increasingly apparent with the recent shortages of chemotherapy drugs, such as doxorubicin. As one ASHP member recently said, how can you tell a patient that he or she has a curable disease, but unfortunately we don’t have the drug needed to treat it. The idea that shortages may be affecting patient morbidity and mortality months, even years, after a shortage occurs causes me more distress than I can express here. We became pharmacists to improve patient lives. I find it unacceptable that we should not have the tools we need to fulfill that role.
I’ve also lost sleep ensuring that ASHP is doing all we can to meet members needs in this area. We’ve dramatically increased resources directed to this effort. The Society has worked closely with the Food and Drug Administration (FDA) on specific shortages, such as advising the Agency on importation of propofol. Working with the University of Utah Drug Information Service, we’ve also increased the frequency of updates and included more information about alternative therapies in the monographs posted on the ASHP web site.
On November 5, 2010, ASHP co-convened the Drug Shortages Summit in conjunction with the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices. A primary goal of the Summit was to develop an assertive action plan to stop patient harm and disruptions in care caused by drug shortages. Participants included representatives from health professional organizations, pharmaceutical manufacturers, and supply chain entities. Representatives of the FDA and the Centers for Disease Control and Prevention also attended portions of the meeting as observers.
Summit participants developed a broad range of recommendations to address drug shortages. For example, one recommendation is to seek additional authority for FDA that would require drug manufacturers to notify the Agency of their intent to discontinue a product, thereby allowing for better planning with alternative manufacturers. Another recommendation is to evaluate the need for an abbreviated approval pathway for unapproved drugs (i.e., those marketed prior to 1938 which have never received FDA approval) and other approaches that would incentivize manufacturers to produce critical therapies.
For next steps, ASHP will collaborate with our co-conveners and Summit participants to develop action plans to implement the Summit recommendations. Stay tuned for more detail, and more importantly, more action by ASHP.
ASHP wants to hear how shortages are affecting your practice and patients. We recently facilitated a member survey on resource utilization that was developed by our colleagues at the University of Michigan Health System. The Open Forum on Drug Shortages at the Midyear on Tuesday, December 7th from 5:15 pm – 6: 15 pm will provide an opportunity to share your experiences and suggestions. You can also submit comments at quality@ashp.org.
In taking these proactive steps, ASHP’s goals are many. Most importantly, we’ll address and, to the extent possible, correct the negative consequences that drug shortages have on patient care. We’ll also minimize what we know is a significant burden on pharmacies in terms of staffing and other resources used to manage drug shortages.
By accomplishing these goals, I also hope to sleep a little better.