About the Author(s)
Recent Developments

FDA Drug Shortage Crisis
Rachel Brent


Abstract:
The rising drug shortage is forcing hospitals to delay or alter treatments. Although a proposed drug shortage notification system awaits legislation, pharmacists and hospitals are concerned with increased costs due to drug hoarding and gray-market vendors.
Keywords: drug shortage, drug production, gray-market, patient safety


Published: 16 August 2012
Cite as: Brent R. FDA Drug Shortage Crisis.
Bull Health L Policy. 2012;1(1): e11.

Introduction

In recent years, the United States has seen a dramatic spike in the number of reported drug shortages. This is “a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”
1 Impacted parties include hospitals, pharmacies, assisted living facilities, and individual consumers.2 In 2010, 178 drug shortages were reported to the FDA; 2011 has already exceeded this number.3 Drug shortages arise from regulatory and/or manufacturing issues, recalls of the affected or related products, limited availability of raw or bulk materials, and/or changes in product formulations.4 Medical facilities and pharmacists impacted by a shortage must carry on without the medication or resort to alternatives often without sufficient warning, leading to significant safety and patient care implications.5

Issue: Drug Shortages and Medical Community Reaction

The most common drugs in short supply are older generic therapies whose profits tend to be smaller.
6 Drugs that are still patented and thus more expensive, tend to have a greater profit margin providing drug manufacturers with incentive to make sure there is an ample supply.7 Of those generics in short supply, injectable medications are the most affected.8 Injectable drugs are harder to manufacture, store and ship, and must be kept sterile unlike pills and tablets.9 These include medications for cancer treatment, anesthesia, surgery, and intravenous feeding.10 Where hospitals do not have enough of a particular drug they have been forced to delay treatment, postpone surgeries, or manage the shortage with less effective and/or costlier substitutes.11 In a 2010 survey of 1,800 health care practitioners conducted by the Institute for Safe Medication Practices, approximately 1/5 of the pharmacists and 1/3 of the physicians reported having knowledge of adverse effects as a result of the shortage.12

If a hospital is able to track down a drug, they are often forced to spend up to ten times what they normally would spend for a medication not in short supply.
13 Vendors in the “gray-market,” a secondary wholesaler market where 10 percent of the nation’s drugs are sold, are among the medical community’s deepest concerns with the onset of a severe drug shortage.14 Gray-market vendors buy and sell drugs, particularly those in short supply, from hospitals, pharmacies, wholesalers, and manufacturers and then re-sell them at a higher price.15 The quality and safety of gray-market products have also been called into question,16 as have other sources considered to address drug shortage concerns, such as purchasing over the Internet.17 However, concerns with delaying a patient’s treatment has led many hospital providers to nevertheless purchase drugs from gray-market distributors.18

Organizations have proposed in-house plans to reduce the impact of a drug shortage.
19 The American Pharmacists Association recommends an infrastructure to address shortages which includes developing policies and procedures, defining the roles and responsibilities of each department, creating a plan for communicating a shortage, and designating a decision-maker for the use of an alternative treatment in the event a shortage does occur.20 Other hospitals have developed internal conservation strategies for the drugs at risk.21 The Generic Pharmaceutical Association has also suggested that Congress provide incentives such as tax credits to manufacturers who will produce “medically necessary” drugs.22

Conclusion
The drug shortage is creating significant patient safety risks due to access issues and gray market sales. Additional focus on private and public solutions is necessary to address this growing concern.

Competing Interests:
None reported
Acknowledgments: None reported

References (Bluebook)
1. Rola Kaakeh et al., Impact of Drug Shortages on U.S. Health Systems, 68 Am. J. Health-Sys. Pharmacy 1811, 1811 (2011).
2. Melissa Skelton Duke et al., Mitigating the Impact of Medication Shortages on Public Health, 51 J. of the Am. Pharmacists Ass’n. 574, 574 (2011).
3. Joyce Frieden, No Easy Fix for Drug Shortage Crisis, MedPage Today, Sept. 26, 2011, available at http://www.medpagetoday.com/tbprint.cfm?tbid=28749 (last visited Nov. 6, 2011).
4. See Kaakeh, supra note 1.
5. See Frank A. Federico et al., Drug Shortages: A Patient Safety Crisis, Healthcare Executive 80, 80 (2011).
6. Liz Szabo, Drug Supplies Run Short, Endangered Patients; Hospitals Report Delayed Care, USA Today, Aug. 16, 2011, § LIFE, at 2D.
7. Id.
8. Howard Larkin, Drug Shortage May Be Worst in 30 Years, Hosp. & Health Networks Mag., Feb. 2011, at 28, 28 available at http://www.hhnmag.com/hhnmag_app/jsp/articledisplay.jsp?dcrpath=HHNMAG/Article/data/02FEB2011/0211HHN_FEA_pharmaceuticals&domain=HHNMAG.
9. Editorial, The Shortage of Vital Drugs; The Market Has Failed, So The Government Needs to Step In, N.Y. Times, Aug. 26, 2011, § A, at 26.
10. Szabo, supra note 6, at 1D.
11. Id.
12. Editorial, supra, note 9.
13. Szabo, supra note 6, at 1D.
14. Jaimy Lee, Providers Fuel ‘Gray Market’; Some Sell While Others Buy During Drug Shortage, 41 Mod. Healthcare 8, 8 (2011).
15. Id.
16. Bryan A. Liang, Fade to Black: Importation and Counterfeit Drugs, 32 Am. J. L. & Med. 279, 279-323 (2006).
17. Bryan A. Liang & Timothy K. Mackey, Vaccine Shortages and Suspect Online Pharmacy Sellers, Vaccine (2011) doi:10.1016/j.vaccine.2011.11.016, at 1, 2 available at http://www.sciencedirect.com/science/journal/aip/0264410X (select articles in press).
18. Lee, supra note 14, at 9.
19. Skelton, supra note 2.
20. Id. at 574-75.
21. Larkin, supra, note 8.
22. See Szabo, supra note 6, at 2.

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