VA Is Part of Group Looking at National Solutions

WASHINGTON—Drug shortages have plagued hospitals with their frequency, breadth and duration over the past decade, with more than 100 drugs in shortage as of mid-November, according to the U.S. Food and Drug Administration. Shortages increase the risk of patient harm, drive up pharmacy costs, and require untold hours for pharmacist and providers to manage.

The VA and military facilities are not exempt from the impact of disruptions in the drug supply chain. “VA experiences the same shortages as the private sector,” said Jennifer Zacher, deputy chief consultant of VA’s Pharmacy Benefits Management Formulary Management.

Shortages put veterans and military readiness at risk, often for months at a time. Shortages of acute care drugs last a median of 242 days, while non-acute care drugs remain in limited supply or unavailable for an average of 173 days, according to research in Health Affairs.1

Most drugs in shortage were experiencing supply disruptions, specifically quality issues. Source: FDA

A number of factors drive the continued shortages. Manufacturing quality problems account for nearly 40% of supply disruptions. A lack of raw materials and manufacturing delays and capacity issues are responsible for more than half of shortages together. 

Those quality issues have increased as manufacturers have adopted longer, more dispersed supply chains. Manufacturers now acquire much of their raw material and increasing produce drugs in China and India, where quality issues have regularly recurred.

Some legislators and advisors fear that relying on China for critical medications exposes the U.S. and our military to strategic disruption or contamination of the drug supply. In an article for Military Officer, Rosemary Gibson, the author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine, argued that “[d]uring conflicts, medicines could be weaponized by withholding them or degrading their potency.  This would ultimately be as devastating as an adversary’s military force.”

Gibson noted that the key component for vancomycin, a drug of last resort against multidrug resistant organisms, is made in China in a facility that at FDA inspection revealed could not provide accurate information on the quality of its product. 

A current example of the extent of the risk poor quality control creates can be seen in the broad recall over the last year of valsartan, a medication commonly prescribed for hypertension and heart failure. Changes in the manufacturing process in China led to contamination with NMDA, a potential carcinogen, which ultimately affected all manufacturers of the drug.

The head of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, recognized the danger at a hearing held by the House Committee on Energy and Commerce’s Subcommittee on Health in late October. “Lack of a reliable supply of critical medicines creates a significant risk for national security,” Woodcock told lawmakers. “Not just for our military, but for all our citizens.”

While hospitals and healthcare system such as the VA know that drug shortages will continue to occur, it is hard to predict what will be affected and when. 

“There is no advanced warning system for drug shortages. When one occurs, VA responds on a case-by-case basis,” Zacher told U.S. Medicine.

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