The ongoing shortage of prescription medicines continues to wreak havoc in the form of rising medication errors and are costing US hospitals an extra $200 million by forcing them to purchase more expensive generics or other therapeutic substitutes, according to a survey by the Premier alliance of hospitals and healthcare provideres.
Why is this happening? At least 42 percent of sterile injectable drug shortages last year were due to product quality problems, such as particulates, microbial contamination, newly identified impurities and stability changes. Another 9 percent were due to problems with raw materials and 5 percent were attributed to the shutdown of a manufacturing site. Keep in mind, Premier notes, that foreign markets are the source for up to 80 percent of the raw materials required to manufacture pharmaceuticals.
Other reasons: at least 18 percent of sterile injectable shortages in 2010 were due to product discontinuations; inceased FDA enforcement; leaner inventory levels; customer stockpiling; gray market price gouging and changes in clinical practice. In any event, providers are paying an average of 11 percent more for hard-to-find drugs, although Premier writes that the total economic impact is "likely much higher, since research excludes drugs purchased on the gray market, or those with therapeutic alternatives."
The survey of 311 pharmacy experts at 228 hospitals and other healthcare sites - such as infusion and surgery centers, retail pharmacies, and long-term care facilities - found 89 percent experienced shortages that may have caused a safety issue or error in patient care. And 53 percent reported six or more shortages. Meanwhile, 80 percent pointed to shortages that delayed or cancelled patient care. Consequently, 42 percent purchased a more expensive med from a 'gray market' vendor and 60 percent reported a pharmacist compounded a drug that should have been commercially available (here is the survey).
This is not the first time that shortages have been blamed for errors. A separate survey last year by the Institute for Safe Medicine Practices found that 35 percent of health care practitioners who work in hospitals reported facility experienced an error that could have led to patient harm during the past year thanks to a shortage. About one in four reported errors that reached patients and one in five reported adverse patient outcomes (see this).
As a result, drug shortages have gained considerable attention. Last month, two US Senators introduced a bill that they maintain would give the FDA the ability to require drugmakers to provide early notification when a shortage is anticipated. For instance, a drugmaker would have to tell the agency of an impending shortage due to changes made to raw material supplies, adjustments to production capabilities and such developments as mergers, withdrawals, or changes in output (read here and here).
Overall, there were more than 240 drugs either in short supply or completely unavailable last year, according to Premier, and more than 400 generic equivalents were backordered for more than five days. And 77 percent of those in short supply last year were sterile injectable products, which are mostly used in hospitals and clinics. Moreover, many of the drugs that were hard to find in 2010 remain unavailable or in short supply this year.