The medicine cabinets at Northeast Ohio's hospitals are sparse these days, and while it's no fault of their own, a nationwide drug shortage has forced pharmacists to come up with creative ways to make supplies of medications last. Although the federal government has offered a few tools to ease the burden, local hospital pharmacists say the shortages show few signs of easing. More than 200 drugs are in short supply or unavailable entirely; the bulk of these are generic injectable drugs. Alternatives, if they exist, often are sold at high markups. One hard-to-come-by pain medication typically costs the Cleveland Clinic 10 cents a dose. But, given the difficulty in securing
the drug, the health system instead purchases an alternative that costs upwards of $10 a dose, according to Scott Knoer, the system's chief pharmacy officer.
“Every hospital is working on this, and most of the public never even knows how much work goes into handling the problem,” said Mr. Knoer, who has a full-time staff mem-ber devoted to managing the issue.
The reasons for the drug shortages are wide-ranging. Several drug manufacturers have closed or consolidated operations in the face of shrinking profit margins, a trend health care observers say has suffocated the supply chain.
In addition, the U.S. Food and Drug Administration contends more than half of the shortages are a result of quality issues that forced regulators to shutter, either permanently or temporarily, drug manufacturing plants. That was the case at Ben Venue Laboratories Inc., which last year halted production operations at its headquarters in Bedford after multiple inspections turned up dozens of quality control issues.
Ben Venue's shutdown led to a critical shortage of injectable methotrexate, a drug used to treat leukemia in children and rheumatoid arthritis in adults.
“It's going to take a long time to figure this out,” said Dr. Michael Anderson, chief medical officer at University Hospitals Case Medical Center, in talking about how to address the shortage. “It'll take a long time to find the right balance between the needs of companies and the needs of patients.”
A lobbying effort
It wasn't until this summer — thanks to a lobbying effort in Congress led by the Cleveland Clinic — that larger health systems by law could repackage certain drugs into smaller doses and share them among hospitals within their system. Previously, the Clinic only could repackage drugs and share them on its main campus; it was barred, for example, from sharing them with Hillcrest Hospital, just 10 miles east in Mayfield Heights.
Still, the Clinic's Mr. Knoer estimates the repackaging legislation will help extend the life of only about 10% of the drugs on short supply. The new provision doesn't apply to controlled substances. It's also unclear how the provision might affect hospitals loosely affiliated with one another, instead of those that are wholly owned.
On the plus side, the FDA now requires drug manufacturers to provide six months' advance notice of decisions to discontinue certain drugs, so that hospitals and the market can react accordingly. Such disclosures in the past were voluntary.
“This has been a problem that's been brewing for a while,” UH's Dr. Anderson said. “It's reassuring to me as a leader to see the FDA and Congress taking it seriously.”
Locally, the Center for Health Affairs, an advocacy group for Northeast Ohio hospitals, has decided to step up its lobbying efforts at the state level after surveying its member hospitals to gauge the breadth of the problem.
“The hospitals basically validated that they felt the shortage was somewhat severe,” said Lisa Anderson, a registered nurse and the Center for Health Affairs' vice president of member services. “Years ago, it was sporadic. Now it's more of a chronic problem.”
The group is looking to ease restrictions on drug compounding — the method by which drugs are concocted from raw materials at hospitals' in-house pharmacies. At present, the Ohio State Board of Pharmacy permits hospitals to compound drugs on a patient-by-patient basis, rather than stockpile compounded drugs in anticipation of need. State regulations also limit the transfer of compounded drugs between a health system's member hospitals.
The Center for Health Affairs also plans to lobby state lawmakers in support of legislation that would forbid pharmacies from selling drugs in short supply to wholesalers, who in turn resell them to hospitals at high markup.
The new normal?
Hospital officials say it's still too early to tell whether measures to curb the problem will have a lasting impact. Wiggle room, maybe, but a cure-all appears nowhere in sight.
“It's bad,” said Stacey Zorska, director of pharmacy at Southwest General Health Center in Middleburg Heights. “It's a daily struggle, and we really can't anticipate what the next crisis is going to be. I think our team has gotten very good at what to do no matter what the shortage is, but it's a struggle.”
Kevin Zupancic, director of pharmacy at Parma Community General Hospital, said he's reminded of the shortage daily. He has had to buy a second dry-erase board to keep track in his pharmacy of the mounting list of drugs on short supply.
Local hospital officials acknowledge the drug shortages often force them to tweak patients' treatment plans. They said patients haven't been hurt, but the prospect of opting for backup drugs so regularly is a concern.
Article found at Crain's Cleveland Business at this page.
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