Medication shortages: ‘Truly a public health crisis’


The Philadelphia Inquirer

Rationing medical care is denounced as immoral in the United States, yet it goes on daily in hospitals, clinics, nursing homes, ambulances and pharmacies.

Since 2006, this country has had worsening shortages of sterile generic injectables — drugs given by shots or intravenously. Currently, more than 300 medicines crucial to treating cancer, infections, cardiac arrest, premature infants, pain and more are in short supply.

The reasons for this predicament are complex, and the fixes, elusive. The scope, however, is clear from surveys of medical and trade groups. The latest, a University of Pennsylvania poll of oncologists released last month, found 83 percent had dealt with shortages by delaying cancer treatments, omitting doses, using second-choice drugs or sending patients elsewhere.

“Oncologists are facing wrenching decisions about how to allocate lifesaving drugs,” said cancer specialist Keerthi Gogineni, who led the Penn survey.

Why aren’t patients and families up in arms?

They may not realize their care was compromised or complicated by a shortage unless their caregivers are unusually candid.

“Patients in an intensive care unit often don’t know they’ve been impacted,” said pharmacist Erin Fox, who tracks shortages as manager of the University of Utah’s drug-information service. “And the hospitals don’t want folks to talk about it. They don’t want to admit, ‘We had a patient who died because we didn’t have this drug.’ ”

The secret human toll is rising. In the last three years, dozens of deaths because of contaminated drugs have been linked to producers and vendors who have capitalized on shortages. The Institute for Safe Medication Practices (ISMP) in Horsham, Pa., received hundreds of reports of medication errors, near-disasters, and 15 deaths related to shortages when it surveyed 1,800 health-care practitioners in 2010.

“This is the worst I’ve ever seen in over 40 years as a pharmacist,” said Michael Cohen, ISMP president. “It’s truly a public health crisis.”

Though shortages occur in other developed countries, the U.S. is especially vulnerable, experts agree.

In a recent analysis, Food and Drug Administration officials cited a root problem: U.S. factories that make sterile injectables are few, aging and inadequate, and manufacturers have no economic incentives to upgrade. When equipment breaks or inspectors find problems, it’s often easier to quit making the injectables — which have high production costs and low profit margins — and divert the capacity to more lucrative products.

Only seven companies now make virtually all sterile injectables in the U.S., their plants running round the clock. Six have received repeated FDA warnings about safety lapses.

Experts cite other factors behind shortages, including hospital group purchasing contracts that drive down prices; hoarding; and low insurance reimbursements.

“In Britain, prices are more regulated,” said Michael Link, a Stanford University pediatric oncologist. “The reimbursement rate for generics is higher, and on-patent drug reimbursement is lower.”

The FDA cannot order firms to make drugs, but recent legislation and a presidential order gave the agency more muscle. Last year, it began requiring companies to give early warnings of permanent and temporary drug discontinuations.

The agency also allowed temporary importation of a key ovarian cancer chemotherapy, as it did the year before for a leukemia drug.

But importation is not ideal. Many foreign factories do not meet FDA standards. And global transport of heavy glass vials adds to costs.

Last month, an industry group, the International Society for Pharmaceutical Engineering, released the first global survey of companies and others. The intent was to see if steps already taken by industry and regulators were working.

The answer was not so well. Of 142 respondents with a shortage-prevention program, more than half said “the company was still unable to prevent a drug shortage.”

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