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.
5 Comments
Sounds like the prices are to low or someone would be making them. Or maybe no one now knows how to make them. Of course some of the companies got rid of all their senior staff who knew how to make these injectables to save money.
So...relying on cheap generic drugs cost Premier $78M in "shortage" losses. Isn't that interesting.
There is a simple solution to prescription drug shortages and it has nothing to do with drafting new legislation.
Instead of pharmacy departments driving down the prices for their already cheap generic drugs, they should be purchasing them at prices that make it profitable for manufacturers to maintain a continuous supply. All of the reasons given for the shortages could be resolved with an appropriate profit incentive.
Interesting that pharmacy departments are willing to pay "gray market prices" and even pay for more expensive therapeutic options when there is a shortage but otherwise they usually insist on the "cheapest."
I wonder how many of the Premier PharmD's would be at Premier if Premier decided to hire only the cheapest they could find? After all... a pharmacist is a pharmacist, is a pharmacist. I suspect there might be a shortage of applicants. www.PharmaReform.com
Thanks for posting Ed. I don't see this getting better any time soon. We have to compete with BRIC countries. In addition, biosimliars are likely going to be more profitable than a lot of the injectable drugs that are on shortage.
So, the response of the Congress and FDA to ongoing shortages of drugsis to require companies to notify the public when there's going to be a shortage? Pardon me, but how exactly is that going to help? What might help is some regulatory relief for the indusrty so we could afford to manufacture in this country again. Of course, that will never happen.
The scope of the problem was also suggested by a survey over 1,800 healthcare providers conducted last fall by the Institute for Safe Medication Practices. The survey found at least 1,000 medication errors affecting patient safety that were related to drug shortages.Thanks of sharing this post.