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Drug shortages continue to pose patient safety risks, price gouging attempts; Rapid solutions sought by stakeholders
The escalating increase in
the shortage of drugs vital to patient care has prompted numerous initiatives by healthcare and government organizations, as well as Congressional hearings – all focusing on finding rapid solutions.
The University of Utah reported a record high of 180 differing drugs in short supply over the first half of 2011. It is estimated that 360 products will be unavailable by the end of 2011.
A number of organizations including the American Hospital Association (AHA), the American Society of Health-System Pharmacists (ASHP), the Institute for Safe Medication Practices (ISMP), the University of Michigan Health System, and the Premier healthcare alliance, all found that the majority of hospitals are experiencing shortages of medicines, adversely affecting patient care. When shortages occur, the use of alternative drugs, dosage strengths, or dosage forms increases the risks of errors because the alternatives often require different dosing and administration considerations.
Reasons for drug shortages
Many trends have contributed to the drug shortage, including quality of active pharmaceutical ingredients, drug recalls, industry consolidation, offshore production, just-in-time inventories, stockpiling by end users, and changes in clinical practices.
Drug shortages impact safety, cost of care
According to a March 2011 Premier analysis,
Navigating Drug Shortages in American Health, pharmacy experts representing 228 hospitals and other care sites found:
Many of these medicines are essential to patient care, and include those used in chemotherapy, sedation drugs needed to conduct surgeries, and drugs needed to provide emergency treatments to heart attack patients.
Shortages are also taking a financial toll on providers.
It is estimated that the shortage could cost U.S. hospitals at least $415 million annually through the purchase of more expensive generic or therapeutic substitutes and enhanced labor costs.
Gray market presenting safety, cost concerns
Some “gray market” vendors are putting profits ahead of patients, offering drugs desperately needed at exorbitant price mark-ups. And in certain cases, the drugs being offered may be counterfeit, stolen, ineffective or unsafe.
An August 2011 Premier study,
Buyer beware: Drug shortages and the gray market, describes unsolicited sales offers made by gray market vendors to hospitals, showing that the average mark-up for shortage drugs was 650 percent. The highest single recorded mark-up offered was 4,533 percent for Labetalol, a drug used to treat high blood pressure.
Premier recommendations for safe drug purchases
To assist healthcare providers nationwide in avoiding gray market vendors and identifying safe, legitimate buying opportunities, Premier developed
this series of recommendations. When considering the use of a new supplier, hospitals should, at a minimum, follow these purchasing guidelines to help protect the hospital and patients from unintended harm.
What are the FDA and professional organizations doing about the drug shortage?
The ASHP in conjunction with the American Society of Anesthesiologists, American Society of Clinical Oncology, and the ISMP hosted a Drug Shortage Summit on November 5, 2010. Pharmaceutical manufacturers, wholesalers and distributors, the FDA, the University of Utah Drug Information Service, Premier, and others participated in the summit. Twenty-one recommendations were provided in the
Summit Summary Report for improving communication among stakeholders and removing barriers faced by FDA and drug manufacturers. Congressional hearings and an FDA workshop were also held in September, 2011. Stakeholder organizations are collaborating together and working with legislators to address key drug shortage situations in federal legislation.
Tools and resources to address drug shortage
Visit the Premier Drug Shortage website for resources to address drug shortages, including:
- Links to stakeholder organizations
- Research, white papers, sample policies
- Updates, status on specific drug shortages
- Workshops, summit proceedings
- Proposed legislation and testimony