Last year, over 240 drugs were either in short supply or completely unavailable throughout the US, and data suggests that the problem is getting worse, says a new study.
Many of these 240 products are still hard or impossible to obtain, according to the report, which is published by the Premier healthcare alliance and estimates that the shortages are costing hospitals $200 million a year at the very least. "The frequency and impact of drug shortages have risen to critical levels, more than tripling since 2005 and affecting all segments of health care," it says.
Also in 2010, more than 400 generic equivalents were backordered for greater than five days, and 77% of the drugs in short supply were sterile injectable products, which are critical in the acute care setting. At least 42% of the shortages here were due to product quality situations such as presence of particulates, microbial contamination, newly-identified impurities and stability changes, it notes.
Another major contributor to the problem is manufacturers delaying or discontinuing investments, as pressures mount on them to offset profit reductions. Companies are not required to report plans for product discontinuations to the Food and Drug Administration (FDA) unless they are the sole manufacturer of a life-supporting or life-sustaining medication, or one which is used to prevent a debilitating disease or condition, says Premier. Nevertheless, “even with these limited requirements,” early notification prevented at least 24 product shortages in 2010, it says.
Other contributory factors include drug recalls, industry consolidation, offshore production, stockpiling by end-users, changes in clinical practice and emergency situations, "just-in-time" inventories and "price gouging" by grey market distributors. These latter operators buy up available drug supplies during times of shortage and offer them to end-purchasers at prices which can be as much as 335% higher, creating not only "huge profits" for themselves but also concerns over drug integrity, it adds.
A survey conducted by Premier of pharmacy experts representing hospitals and other healthcare sites during July-December 2010 found that: - 89% had experienced product shortages that may have caused a medication safety issue or error in patient care; - 80% had experienced shortages that resulted in a delay or cancellation of a patient care intervention; and - 98% had experienced shortages that resulted in an increase in costs.
The study estimates that the financial impact of drug shortages for which generic equivalents are available is at least $78 million a year, with the highest impact being felt in infectious disease ($22.5 million), surgery ($12 million), oncology ($10.5 million) and cardiovascular therapies ($8.5 million). More than $66 million (85%) of this financial impact last year was felt within the acute sector alone, it adds.
The analysis suggests that drug shortages could be costing US hospitals at least $200 million annually, through the purchase of more expensive generic or therapeutic substitutes, says Premier. However, while providers are paying an average of 11% more for shortage products, the total economic impact is likely to be much higher, since the research excludes drugs purchased on the grey market and those with therapeutic alternatives. Nor does it include indirect costs such as that of added labour needed to manage shortages and secure alternative supplies, as data on these areas does not exist, it notes.