The nationwide drug shortage that has led to patients deaths and forced hospitals to buy marked-up meds or look for alternative treatments will require several solutions to fix the problem, healthcare providers told the U.S. Food and Drug Administration yesterday.
With various reasons cited for the shortages--including abandonment of generics due to lower than expected profit margins, discontinuations, and raw material issues--providers say regulatory and manufacturing changes must be made, reports MedPage Today.
For example, requiring manufacturers to warn the FDA of pending drug shortages could help alleviate the drug shortage crisis. "If single-source producers are required to give a six-month notice before they stop manufacturing, why can't all manufacturers do that?" Dr. Laura Porter, patient advocate and medical consultant with the Colon Cancer Alliance, asked the FDA panel.
Other industry executives suggested the creation a national stockpile of critical dugs. Dr. DeWayne Pursley, chief of neonatology at Beth Israel Deaconess Medical Center, who represented the American Academy of Pediatrics, recommended the agency develop the list of critical meds and decide how much of each should be readily available to handle a shortage.
Drugs in short supply should be imported in time- and quantity-limited amounts, he added.
Meanwhile, Dr. Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, emphasized better information--about shortages and available options--as the first step to solving the problem.
Implementing these various solutions to ease widespread drug shortages could help hospitals avoid buying marked-up drugs from unauthorized "gray market" vendors.
- check out the MedPage Today article