RX drug shortages becoming more common

The frequency of drug shortages in 2010 more than tripled since 2005, increasing health care costs and posing medication safety issues for patients, according to an analysis released this week by Premier Healthcare Alliance – with many of the affected drugs expected to be in short supply through 2011.

“The public expects hospitals to have the necessary supplies and medications ready when needed, but at times we aren't able to meet that expectation,” Martin Caponi, RPh, pharmacy director at Sacred Heart Medical Center in Eugene, Ore., said in a press release. “Stepped up efforts and new measures are needed to address this issue.”

Caponi is also chair of the National Pharmacy Committee at Premier – a performance improvement alliance made up of more than 2,500 U.S. hospitals.

Researchers from the alliance surveyed 311 pharmacy experts from 228 health care organizations, including hospitals; infusion, oncology and surgery centers; outpatient and retail pharmacies and long-term care facilities.

They found that nearly 90% of respondents had experienced a drug shortage between July and December 2010, with more than half experiencing six or more shortages. As a result, 80% of respondents indicated that it was necessary to delay or cancel patient care.

Sterile injectable products were the most common drugs affected (77%), with the majority needed for sedation, emergency care and chemotherapy.

Problems with product quality — including the presence of particulates, microbial contamination, newly identified impurities and stability changes — accounted for at least 42% of these shortages, according to the report. Other causes included problems with raw material supplies and manufacturing site closures.

Fewer prescription drug manufacturers and the growing number of those that are ceasing generic drug production due to small profit margins, have also contributed to the problem, the researchers wrote.

Shortages cost U.S. hospitals at least $200 million last year, as facilities purchased more expensive or generic therapeutic substitutes. Most of the excess cost is attributable to “gray market” distributors who buy up existing drugs and resell the products during shortages at inflated prices — as much as 335% more, according to the report.

On average, providers indicated that they paid 11% more for shortage products, with 42% indicating that a purchased a more expensive product from a gray market vendor.

Current regulations do not require manufactures to notify the FDA or health care providers of drug shortages, unless the product in question is a life-supporting or life-sustaining medication or one that prevents a debilitating disease. Many believe this policy exacerbates the problem.

“Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available,” Sen. Amy Klobuchar (D-Minn.) said in a press release.

She has proposed a bill that would require prescription drug manufactures to notify the FDA if an incident occurred that could potentially lead to a drug shortage. The bill would also require the FDA to reinspect manufacturing sites that have been shut down within 90 days of when the manufacturer notifies the agency that the problem has been corrected.

“As we move forward, it is important that we have better coordination between the pharmaceutical industry, the FDA and healthcare providers so patients don't lose access to the medications they depend on,” Kobuchar said.

In the meantime, survey respondents indicated they have developed several key tactics to limit the negative impact of drug shortages. These included formulary changes in the way drugs were allocated such as rationing and restrictions, and improved communication strategies such as conducting regular internal meetings to present the impact of the shortage to the staff, hospital executives and medication suppliers, among others.

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