DOI: 10.1097/NUR.0b013e31824672b3

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PMID: 22336932

Issn Print: 0887-6274

Publication Date: 2012/03/01


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A Looming Threat—Increasing Drug Shortages in the United States: Resources for the Clinical Nurse Specialist

PATRICIA ANNE O’MALLEY

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Author Information: Nurse Researcher, Center of Nursing Excellence, Miami Valley Hospital, Dayton, Ohio, and Adjunct Faculty, Indiana University East, Richmond.

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On November 30, 2010, the House Oversight Subcommittee on Health Care (US House of Representatives Committee on Oversight and Government Reform) heard testimony regarding the rise in prescription drug shortages. Since 2005, the number of drug shortages has nearly tripled, and generic chemotherapeutic agents for children are increasingly becoming unavailable. The results have been unthinkable—children unable to receive curative treatment. Michelle Hudspeth, MD (chief, Division of Pediatric Hematology/Oncology), testified that “the war on cancer has been reduced to a mere skirmish with no weapons and no clear battle plan.”1 Cancer research is suffering as well. Participation in clinical trials has decreased significantly because access to chemotherapy agents is required for investigators to enroll subjects. Therefore, advances in cancer treatment are slowly come to a halt. Research groups watch monies spent for the regulation of clinical trials (required whether a subject is enrolled or not) disappear.1
The drug shortage not only affects patients and subjects. Nurses, physicians, pharmacists, information technology, and healthcare organizations scramble with each announcement of rationing and substitution. Every modification of prescribing practice related to shortage introduces significant risk of adverse events related to dosing errors. Particularly risky are chemotherapeutic drugs that have a narrow therapeutic index; small dose changes can result in a benefit or death. Education of staffs with every drug shortage and/or substitution costs organizations millions of dollars.1
Why the shortage? As with all explanations, simple reasons do not exist. Dr Hudspeth and Ted Okon (executive director of the Community Oncology Alliance) testified that the Medicare Modernization Act (MMA) of 2003 may be a significant explanatory factor for the current shortages. The MMA was designed to provide transparency in pricing and changed the reimbursement model from the average selling price including discounts to a percentage of the average wholesale price. As a result, generic prices decreased because of market competition and low limits on yearly price increases. Although the intention of the MMA was good and balanced Medicare payments to market rates, the act had long-term unintended consequences that include consolidation of oncology providers, mergers of clinics into hospitals, and reduction of the numbers of companies providing low-cost generic drugs.1,2
Okon2 described how cancer treatment is increasingly delayed, changed, or even discontinued because low-cost, life-saving generic intravenous cancer drugs are not available. Lag in reimbursement correction and downward pricing pressures have reduced incentives for manufacturers to produce a product. It is obvious that the drug shortage will require, in part, an economic solution.2
Scott Gottlieb, MD, a resident fellow with the American Enterprise Institute in Washington, DC, described the lived reality of current drug shortages; missed and delayed chemotherapy treatments, patients receiving inferior antibiotics, anesthetics and parenteral nutrition, waiting lists, rationing, errors, adverse events, and poor outcomes.3 Dr Gottlieb warned the committee not to confuse consequences and causes of drug shortages when defining root causes. Like Hudspeth and Okon, Dr Gottlieb testified that causes for drug shortages are unique, complex, and layered. Thus, solving the drug shortage problem will require unique, complex, and layered solutions.3
In addition, Kasey Thompson, vice president of Policy, Planning, and Communications for The American Society of Health-System Pharmacists, reported to the House Oversight Subcommittee findings from a 10-year collaborative study with the University of Utah drug information program regarding drug shortages. This analysis revealed that most shortages were related to quality issues in manufacturing and that pharmacists are increasingly spending more time finding a product rather than caring for patients.4
Gottlieb3 provided a starting point for problem solving by proposing that 3 categories of factors underlie the current drug shortages.
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