August 18, 2010—Safety-net hospital pharmacies nationwide are reporting severe shortages of widely used pharmaceuticals, including pain medicines, emergency drugs and some oncology treatments.
In late July, the Institute for Safe Medication Practices (ISMP), a nonprofit group devoted to medication-error prevention, described the recent rash of critical medication shortages as unprecedented. The problem appears to be most acute for generic injectable products.
“In 33 years, this is the worst I’ve seen drug shortages,” says David Smeenk, associate director of pharmacy for The Ohio State University Medical Center. “The industry is evaluating a number of legacy generic injectable products for profitability and discontinuing them.”
“The drug shortages encountered over the past six months have been inexcusable,” adds Raymond Goellner, pharmacy director of Gila Regional Medical Center in New Mexico.
Medication-Error Risks Heightened
They and other safety-net hospital pharmacy officials contacted in early August say they had or almost had depleted their stocks of the pain drugs morphine, hydromorphone and fentanyl in pre-filled syringes of various sizes. Pre-filled syringes of the emergency drug epinephrine were also reported to be unavailable or in short supply, as were various containers and volumes of heparin, dextrose, calcium chloride, lidocaine and furosemide. Cisplatin and a number of other generic injectable oncology drugs were also said be scarce.
“Frustrations are high, as health care providers experience frequent stock depletion of critical drugs, often without prior notice, and then scramble to devise acceptable and safe alternatives,” ISMP reported in its newsletter. Switching medications, dosage strengths or dosage forms, it continued, increases the risk of potentially fatal medication errors.
The institute notes that the reasons for shortages are varied and not always clear. “Whatever the cause … the urgency of this situation suggests that the current ‘business as usual’ approach is woefully inadequate in every respect,” it says. “This issue requires a disaster-type response.”
Health Care Reform’s “Must Sell” Language
The nation’s new health care reform law, the Affordable Care Act (ACA), requires drug manufacturers to sell their products to 340B providers if the same products are “made available to any other purchaser at any price.” Hospital advocates had pressed for the language’s inclusion to guard against discrimination against 340B providers when drugs are in short supply.
Earlier this summer, the U.S. House passed an employment and tax bill, since then heavily revised, with even stronger 340B “must sell” language. That provision, which was dropped from the final bill that President Obama signed on Aug. 10, stated that “if the supply of a covered inpatient drug is insufficient to meet demand, then the manufacturer may use an allocation method that is reported in writing to, and approved by, the (Health and Human Services) Secretary and does not discriminate on the basis of the price paid by covered entities or on any other basis related to the participation of an entity in the (340B) program.”
The language was part of a broader provision in the bill, also dropped, that would have established a limited inpatient drug discount program called 340B-1.