WHITE OAK, MD 26 October 2011—Health care providers, patients, regulators and others frustrated by the growing problem of drug shortages urge all stakeholders to work toward a solution, despite the lack of consensus on what that solution may be.
"Despite the efforts of all the partners in the room, and particularly the FDA, our drug shortages are getting worse and not better," said Douglas Throckmorton, deputy director of FDA`s Center for Drug Evaluation and Research (CDER), during a September 26 public workshop on drug shortages held in White Oak, Maryland.
FDA officially acknowledged 178 new shortages of medically necessary drugs in 2010. Shortages this year have already surpassed that figure, said Edward Cox, who is part of the four-person team that constitutes CDER`s Drug Shortage Program.
According to FDA, recent shortages have involved cancer drugs, anesthetics, emergency medicine drugs, and electrolytes. The agency stated that shortages of older sterile injectable products have been increasingly common this year.
The University of Utah Hospital and Clinics Drug Information Service reported 211 new drug shortages in 2010 and 201 so far this year, said Erin Fox, the program`s manager. This year`s figures don`t include items first reported during 2010 that are still in short supply, she said.
Fox and her colleagues provide information on drug shortages for ASHP`s online Drug Shortages Resource Center.
In most cases, Fox said, the shortages she tracks are of unknown or undisclosed origin.
"We don`t really understand all of the reasons why shortages are happening," Fox said.
Cox said 54% of drug shortages in 2010 resulted from problems with product quality and deviations from good manufacturing practices. Examples include bacterial contamination of sterile products and the presence of glass particles or particulates in product vials.
FDA attributed 21% of last year`s shortages to "delay or capacity issues," including problems obtaining raw materials and limitations in the availability of production lines, Cox said.
He said just seven manufacturers produce "a very large percentage" of sterile injectable products and reuse manufacturing lines to make other medications under contract. Thus, a problem on a single manufacturing line can affect the availability of multiple products.
DeWayne Pursley, neonatologist-in-chief at Beth Israel Deaconess Medical Center in Boston, asked FDA to develop a list of critical medications and establish a federal stockpile of them and a fair and equitable method for distributing them.
"The current system is simply too passive," he said.
The patient`s perspective. Davria Cohen of Crofton, Maryland, has relied on total parenteral nutrient (TPN) solutions for survival since a car accident nearly 30 years ago resulted in the loss of most of her small and large bowel.
Over the years, Cohen has endured shortages of multivitamins that have necessitated the reformulation of her TPN solution.
This year, she said, calcium gluconate and magnesium sulfate additives have been in short supply, and their substitutes are not mutually compatible. So her usual daily nine-hour TPN infusion session is now followed by a three-hour session for the infusion of sodium phosphate.
In addition to worrying about product shortages and coping with the increased infusion time, Cohen fears that the increased use of her i.v. catheter will result in an infection.
"I depend on TPN to live," she said. "This is a life-threatening problem for those of us who cannot eat."
Other patients and clinicians described their experiences with drug shortages during cancer treatment. Typically, first-line regimens were unavailable, causing treatment delays or the use of agents that were less effective, less well-studied, or may cause serious adverse effects.
The burden on hospitals. Data from a 2010 ASHP–University of Michigan survey and a survey undertaken this year by the American Hospital Association (AHA) indicated that drug shortages are a universal problem for hospitals. Both surveys found that 99% of hospitals reported at least one drug shortage.
Nearly half of the respondents to the AHA survey reported 21 or more shortages during the first half of 2011.
"Drug shortages are occurring across all treatment categories," said Roslyne Schulman, director of policy development at AHA. "Over half of hospitals report that shortages are changing practices and compromising patient care."
Drug shortages are also costly for hospitals. The 2010 ASHP–University of Michigan survey estimated that managing shortages costs hospitals $216 million annually in labor costs, mostly from pharmacists and pharmacy technicians, and mostly using existing staff, said Burgunda Sweet, director of the University of Michigan Health System`s Drug Information Service.
Frustration. A common thread during the workshop was the need for better communication, especially from FDA and manufacturers, about when a shortage is expected and its likely duration.
Another common theme was the need for transparency about why shortages are occurring.
"The answer to the question, Why are we having a shortage?, `We don`t know,`—is just not acceptable," said Bona Benjamin, ASHP`s director of medication-use quality improvement.
Benjamin urged stakeholders to support the federal Preserving Access to Life-Saving Medications Act.
If enacted, the bill would require all manufacturers to promptly notify FDA of any problem in the manufacture of a drug that may result in a shortage. The bill would also require manufacturers to notify FDA six months in advance of discontinuing a product.
Under current law, manufacturers must warn FDA about product discontinuations only when they involve sole-source, medically necessary drugs.
Although FDA can ask a manufacturer to reconsider plans to discontinue a drug, the final decision is ultimately up to the manufacturer.
"No company is bound to continue making any drug no matter how medically necessary it is," Fox said.
