Shortages of drugs – including injectables – are cropping up unannounced more than ever.  

The issue has become serious enough to capture the attention of federal lawmakers, who have proposed legislation that would give the market a heads-up when shortages occur or are anticipated. Repertoire covers this issue in-depth in its August issue.

“Everybody has been affected by [shortages] one way or another,” says Chris Rogers, director of pharmaceutical programs, McKesson Medical-Surgical. “It’s something we’ve had to manage.” And although non-acute-care distributors and their customers may feel the sting primarily with regard to sterile injectables, shortages have been reported in other pharmaceutical product categories, including vaccines and OTC drugs.

Impact on providers

Hospitals are feeling the pinch. A Premier healthcare alliance survey of 311 pharmacy experts representing 228 hospitals and other healthcare sites from July to December 2010 showed that:

  • 89 percent experienced shortages that may have caused a medication safety issue or error in patient care.
  • 80 percent experienced shortages that resulted in a delay or cancellation of a patient care intervention.
  • 98 percent experienced shortages that resulted in an increase in costs.

 

“Providers are paying an average of 11 percent more for shortage products, although the total economic impact is likely much higher, since research excludes drugs purchased on the ‘gray market,’ or those with therapeutic alternatives,” said the Premier report, which was published in March. “The research also does not include indirect costs, such as added labor needed to manage shortages and secure alternative supplies, as data on these areas does not exist.”

In September 2010, the Institute for Safe Medication Practices, Horsham, Pa., released the results of a survey of more than 1,800 healthcare practitioners, 68 percent of whom were pharmacists. During the prior 12-month period, more than half of the respondents reported “frequently” or “always” encountering the following difficulties associated with drug shortages:

  • Little or no information available about the duration of a drug shortage (85 percent).
  • Lack of advanced warning from manufacturers or FDA to alert practitioners to an impending drug shortage and suggested alternatives (84 percent).
  • Little or no information about the cause of the drug shortage (83 percent).
  • Substantial resources spent investigating the shortage and developing a plan of action (82 percent).
  • Difficulty obtaining a suitable alternative product (80 percent).
  • Experience a significant financial impact (78 percent).
  • Lack of a suitable alternative product (70 percent).
  • Substantial resources spent preparing and/or administering the alternative products (69 percent).
  • Risk of adverse patient outcomes (64 percent).
  • Internal hoarding of medications associated with impending shortages (58 percent).
  • Physician anger toward pharmacists/nurses/hospital in response to a drug shortage (55 percent).

 

Nothing new

Critical drug shortages have affected healthcare providers for years, says Erin Fox, manager, Drug Information Service, University of Utah Hospitals & Clinics. In fact, 10 years ago, the University of Utah entered a partnership with the American Society of Health-System Pharmacists (ASHP) and the group purchasing organization Novation to provide drug shortage information for their websites.

The market saw quite a bit of consolidation 10 years ago, notes Fox. “You might have had eight or 10 companies making a drug, then it went down to two or three. And that trend has continued.”

At the time, the Food and Drug Administration website was the only place the industry could get up-to-date information on shortages, says Fox. “That website was OK, but limited in what they could put up there.” Essentially, the FDA was only publishing information the drug companies provided them. And companies weren’t required to provide anything at all, not even information on why the shortage had occurred or when it would be resolved.

 “Since we’re pharmacists, we can provide information about therapeutic alternatives and how to manage a shortage,” including discussions about which patients might be most severely affected and how the provider should compensate for that, says Fox.

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