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No Shortage of Blame

Harold E. Cohen, RPh
Editor-in-Chief



9/20/2011
US Pharm. 2011;36(9):2. 

Amid all of the problems facing the profession of pharmacy today, one stands out that we haven't heard much about until recently, although it's been festering for years. Drug shortages have silently, but steadily, risen to critical levels, much like an overheated core in a nuclear reactor that is about to blow. 

Severe drug shortages, particularly at hospitals and cancer centers, are causing critically ill patients to go without potentially life-saving drugs, driving up health care costs astronomically and creating an underworld of “gray market” drugs. While conspiratorial theories about the shortages run rampant with unabated finger pointing, it is sad that the profession of pharmacy apparently cannot clean its own house on this issue. With this failure to come to terms with the problem and find a solution, drug shortages continue without letup. 

And make no mistake about it. These shortages are real, a fact that was validated by no less than two well-respected professional associations and a nonprofit alliance of hospitals. According to a survey recently completed by the American Society of Health-System Pharmacists, the labor costs associated with managing shortages translates to an estimated impact of $216 million nationally. And the American Hospital Association released data from a survey it conducted that revealed that nearly 100% of the hospitals participating in the study reported having experienced at least one drug shortage in the last 6 months, with nearly half reporting 21 or more shortages in the last 6 months. According to a survey by Premier Healthcare Alliance, drug shortages have nearly tripled since 2005. Last year alone, over 240 drugs were either in short supply or completely unavailable, with more than 400 generic equivalents being back-ordered for more than 5 days. And while any drug shortage can be catastrophic for patients, many of the drugs in short supply were for sterile injectable products used to treat critically ill patients.  

Although there is a shortage of drugs, there is no lack of explanations as to why there is a shortage in the first place. The blame is being spread throughout the industry and includes items like the poor quality of the raw materials needed to manufacture the drugs, tough economic times leading some manufacturers to delay investing in their products, the FDA's risk-averse approach to new drug approvals, leaner inventories, stockpiling by hospitals and other dispensers of these hard-to-get drugs, and discontinuance of older products as their profitability plummets. 

The problem is so pervasive that it goes well beyond the FDA's core competencies. Unfortunately, it appears that there is no end in sight for the shortages, and pharmacists, not the FDA, are the ones who have to face patients and let them know their potentially life-saving drugs are not available. 

A coalition of health care groups has suggested some legislative and regulatory steps in addressing the drug-shortage crisis. Among them are creating an early drug-shortage warning system, streamlining the FDA's approval process, improving communications between stakeholders, and exploring incentives to encourage drug manufacturers to stay in, or re-enter, the market. It's a good start, but since pharmacists are on the frontline in communicating with patients every day and are one of the most trusted health care professionals, I encourage them to contact their state and federal elected officials and ask them to get involved. Reducing drug shortages is vital to this nation's health care, and pharmacists should, and can, play an active role in voicing their opinions. 

To comment on this article, contact editor@uspharmacist.com.

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