Late Breaking News
National Drug Shortages Plague VA; Pharmacy Officials Detail Response at Public Hearing Cont.
VA uses FDA’s national drug-shortage website to help predict where and when it will have difficulties. The agency also must do its own research, and, for some drugs, it is simply too difficult to predict when and where they will be needed to determine how much to preorder.
When a shortage occurs, VA helps coordinate sharing among its own hospitals and borrows from private facilities. “We have found situations where some private hospitals have excess stock during a shortage due to contracts or to the gray market. We don’t hold back in calling around,” Calabrese said.
The “gray market” refers to vendors selling questionably-obtained drugs to hospitals, usually at a large markup.
VA also has the option of rationing drugs, reducing prescription quantities from 90 days to 30 days during severe shortages. It also can consolidate dispensing to a single CMOP to increase efficiency.
Not relying solely on FDA, the agency also will put out its own shortages report in the form of a weekly pharmaceutical newsletter, Calabrese said. “We have to do additional work. We have to call the companies directly. We have to look at prime-vendor wholesalers to see what’s available.”
One possible solution during a shortage is to purchase from foreign countries. However, current regulations make that difficult. The Federal Acquisition Regulation (FAR) — the system of regulations that set out the purchasing rules for federal agencies — creates an additional layer of bureaucracy for VA to work through.
“These acquisition regulations make it difficult to purchase from foreign countries,” Calabrese said. “Also, our reaction time may not be fast enough. Sometimes we need to make a decision in days, or even hours.”
Calabrese recommended that FDA consider developing waivers for federal agencies during drug shortages, so they can take advantage of foreign purchasing.
Because shortages also occur when a manufacturer stops making a particular drug, Calabrese also suggested that FDA develop new market withdrawal regulations. If manufacturers were required to get approval from FDA before voluntarily withdrawing from the market, it would allow FDA to work with remaining manufacturers to adjust manufacturing to meet increased market demand.
It would also provide an early warning to the public and to VA to prepare for future shortages, he pointed out.