Comprehensive approach needed to end drug shortages

AMA delegates call on the Association to advocate that manufacturers be required to develop a plan for continuity of drug supply to avoid production shortages.

Posted Dec. 12, 2011.

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A lack of neuromuscular blockers has led to the cancellation of surgeries and other procedures. Chemotherapy treatments have been delayed or modified to less-than-optimal regimens because of drug shortages. Even when alternative drugs exist, patients have been harmed by administration errors tied to the substitution.

This is some of the impact -- with at times fatal results -- of a worsening drug shortage problem. The Food and Drug Administration says drugs classified as being in shortage tripled from 61 in 2005 to 178 in 2010, and that figure is now at about 200 drugs. The majority are injectables, which are more susceptible to manufacturing problems. Sixteen percent are oncology drugs, according to the IMS Institute for Healthcare Informatics.

Very often, drug shortages have been due to manufacturing quality problems. Other reasons observers have cited include drug industry consolidation and business decisions to discontinue production. In many situations, there's a clear window of opportunity for drugmakers to send news of a potential shortage further down the supply chain.

A 2010 survey of 1,800 health care professionals found that more than 80% of the time, they received no warning that a drug would be in short supply. When alternatives are used, unfamiliarity with these drugs raises the likelihood of errors or adverse outcomes, according to the Institute for Safe Medication Practices, which conducted the survey. About one in four respondents reported errors due to drug shortages in the past year, and one in five reported adverse patient outcomes because of shortages.

A comprehensive approach is needed to resolve the shortage situation, one that provides systematic changes and offers an early warning system when drugs grow scarce. Along those lines, an AMA Council on Science and Public Health report on the national drug shortage was put before the House of Delegates at the Interim Meeting in November. The report detailed the scope of the shortages, which delegates declared to be a national public health emergency.

Delegates directed the AMA to advocate that the FDA or Congress require drug manufacturers to create a continuity plan to supply vital and life-sustaining medications and vaccines. The same policy adopted by the AMA house supports 19 other recommendations developed at a 2010 summit of organizations representing anesthesiologists, oncologists, pharmacists and others. Those recommendations include requiring a year's notice before market withdrawals and offering tax incentives to manufacturers of critical drugs. The policy says the AMA will work with other stakeholders to implement the changes in an urgent fashion.

The new AMA policy supports drug shortage legislation such as HR 2245 and S 296 -- bills in the House and Senate that would require manufacturers to notify the FDA of any anticipated drug supply disruptions at least six months in advance. At the same time, delegates directed the AMA to express its appreciation to President Obama for issuing an executive order on Oct. 31 that directed the FDA to ask drugmakers voluntarily to provide information about delays, interruptions or other problems that might lead to shortages.

Early notification is an especially important and effective action. In 2010, such early notice to the FDA stopped nearly 30 shortages. Drugmakers and the FDA also need to work together to ensure that adequate production prevents a shortage.

The Council on Science and Public Health will report on the progress of preventing drug shortages at the AMA Annual Meeting in June 2012. The AMA and others have spelled out the actions that could have a significant impact even in that time frame. A good start is when drugmakers, who are in a position to be the first to anticipate a shortage, notify the FDA so the medical community need not be the last to know.

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