Friday, May 25, 2012

Overcoming the drug shortage challenge: a call to action

For providers working in hospital and health-system settings, drug shortages have become an unfortunate reality of every day practice.  While the lay media has placed much of its emphasis on cancer chemotherapy and other drugs used in oncology practice, cardiology and critical care medicine are two areas that have been hit especially hard by drug shortages. In the last six months, the following intravenous medications have been subject to extended periods of limited to no availability:
  • Analgesics (fentanyl, morphine)
  • Antibiotics (aminoglycosides, fluoroquinolones)
  • Antihypertensives (hydralazine)
  • Antiarrhythmics (lidocaine, procainamide)
  • Beta blockers (labetalol, metoprolol)
  • Benzodiazepines (diazepam, lorazepam, midazolam)
  • Calcium channel blockers (diltiazem)
  • Loop diuretics (furosemide, bumetanide)
  • Nutrition and electrolytes (magnesium, phosphate, sodium bicarbonate)
  • Vasopressors (epinephrine, vasopressin)
  • ... and many more (antiemetics, other sedatives)
The underlying reasons for these critical drug shortages are complex and multifactorial, and which ones deserve the most blame are largely subject to one's political and economic views. Some have argued that the shortages are a result of failures in the free market, i.e., when a manufacturer decides that a product is no longer profitable, they can cease production without regard to whether patients depend on it or not.  Others argue that the regulatory environment enforced by the US Food & Drug Administration (FDA) is too strict and has made it challenging for companies to stay competitive. The truth is probably somewhere in between, but no matter how you feel about the issue, the consequences are the same: drug shortages significantly impact patient care.

On Thursday, the Senate passed the Food and Drug Administration Safety and Innovation Act of 2012 (S.3187), which reauthorizes the Prescription Drug User Fee Act (PDUFA) and includes several provisions designed to help alleviate drug shortages, including:
  • Expedited review of generic drug approvals;
  • Incentives for new generic drug manufacturers to enter the market; and,
  • Early notification to FDA if an interruption in production is anticipated or production is being discontinued altogether.
The House is expected to vote on their version of the bill next week.  In the meantime, I encourage you to contact your representatives and urge their support for PDUFA, including those provisions specifically designed to address drug shortages.  If you are unsure who these individuals are for your area, please use this free resource developed by the American Society of Health-System Pharmacists (ASHP). Also, for general information and tips for political advocacy, see this toolkit developed by the American Pharmacists Association (APhA).

No comments: