Drug Shortage Crisis Plagues Pharmacists

By Wechsler, Jill | Drug Topics, March 2012 | Go to article overview

Drug Shortage Crisis Plagues Pharmacists


Wechsler, Jill, Drug Topics


Support grows for legislation that would require manufacturers to prenotify FDA of looming production changes

The outcry from physicians, pharmacists, and patients over disruptions in supplies of vital medications continues to draw attention on Capitol Hill and throughout the healthcare system. Oncologists can't obtain widely-used chemotherapies to treat seriously ill patients. Doctors struggle to provide vital parenteral products for premature babies. Pharmacists have to search for alternate sources of important medications and home-infusion products. Surgeons are postponing operations because key anesthetics and pain medications are not available.

While there always have been periodic drug shortages, the problem has become much more acute in the last 2 years. The University of Utah Drug Information Service recorded more than 260 prescription drug shortages in 201 1, topping 21 1 in 2010 and much more than in previous years when totals usually were well below 100 (Table 1, page 48), The vast majority involves sterile injectables, including many widely used generic analgesics, antibiotics, and chemotherapies (Table 2, page 48), A survey by the American Hospital Association last June found that virtually all hospitals experienced at least 1 drug shortage last year, and multiple supply problems were common.

More recently, reports have surfaced of patients desperately asking pharmacists for medications to treat attentiondeficit hyperactivity disorder (ADHD), 1 of the more severe shortage situations affecting retail pharmacies. Manufacturers blame government policies that limit production of controlled drug substances to prevent illegal diversion, while the regulators point to brand drug companies curbing production of low-cost generics to build sales of more expensive therapies. Patients forced to try alternative ADHD therapies run the risk of adverse reactions and reimbursement problems,

Multiple factors

As the drug shortage crisis has made headlines, Congress has expanded investigations into the causes and responses to pharma supply chain difficulties. Some observers charge that too-strict oversight of manufacturing processes by PDA aggravates the problem - while others blame manufacturer negligence and business practices that lead to production errors that put the public health at risk. Some point a finger at government policies that drive down reimbursement for old-line generics, which discourages pharmaceutical industry investment in low-profit therapeutic categories that are difficult to produce.

In fact, a long list of underlying factors appears responsible for the manufacturing failures that have generated many short-supply situations. These include drug industry consolidation, limited raw material supplies, changes in inventory and distribution practices, production delays, increases in demand, and business decisions to close a manufacturing site or discontinue production (Table 3, page 48), When there are only 1 or 2 sources for a critical drug, a small shift in production lines, plus just-in-time inventory controls at hospitals, make it hard to buffer the impact, explained pharmacist Richard Paoletti of Lancaster (Pa.) General Health at a September 2011 hearing on Capitol Hill,

An PDA public workshop that same month provided a forum for physicians, pharmacists, patient advocates, drug distributors, and manufacturers to air concerns and propose remedies for short-supply situations. Several Congressional committees held hearings last fall on the growing crisis. The outcry prompted the Obama administration to unveil a drug shortages initiative in October 201 1, and to issue an executive order for PDA and the Department of Justice to crack down on stockpiling and exorbitant pricing of lowsupply drugs. The White House voiced support for legislation that expands advance reporting by manufacturers to FDA regarding production issues likely to lead to shortages,

A main problem is that PDA often does not know about looming drug supply problems because, under current law, only sole-source manufacturers of critical medications have to notify the agency when they anticipate product discontinuation. …

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