Birmingham-area hospitals and pharmacies are facing critical shortages of drugs used to combat cancer and other serious diseases, a situation that poses risks for patient health and could boost costs. Drug shortages in Alabama and across the nation are forcing doctors and pharmacists to find alternative drugs or tell patients they can't be treated on time. And even if they find a different medicine that works, studies show that the shortages can increase the risk of errors, near mistakes or adverse drug effects.
"It just puts clinicians in a quandary because they can't effectively manage their patients," said Maisha Kelly Freeman, professor of Samford University's McWhorter School of Pharmacy and director of the school's Global Drug Information Service.
The shortages are being caused by a variety of factors such as raw material quality concerns, drug recalls, natural disasters and regulatory issues, Freeman said. Shortages vary, and while some are medicines for attention deficit disorders or high blood pressure, others are used in chemotherapy.
According to a study by Premier, a Charlotte-based alliance of health care providers, more than 240 drugs were in short supply or completely unavailable in 2010 -- more than triple the number in 2005.
According to the U.S. Food and Drug Administration, about 180 drugs are in short supply this year. That includes antivenin for black widow spider bites and a vaccine for hepatitis B. Others include the muscle relaxant succinylcholine used in surgery and an epinephrine injection used in cardiac emergencies.
Last month, UAB Hospital received word from Johnson & Johnson that the manufacturer wouldn't be shipping Doxil, a medicine used to treat ovarian and breast cancer, on time. The hospital said it had been able to find the drug when other large academic medical centers couldn't, but it informed the 19 patients in various stages of treatment that it wouldn't have the drug available as of Aug. 29.
The FDA says Doxil is in short supply because of manufacturing delays, and a distributor of the drug said it will be more widely available in the last three months of this year. UAB said "careful purchasing and prescribing practices" allowed it to continue treating patients on Doxil after Aug. 29.
"We will continue to work with our medical suppliers, manufacturers and the Food and Drug Administration to ensure patients receive proper care," UAB Hospital Chief Executive Officer Michael Waldrum said.
On Aug. 5, a unit of Johnson & Johnson issued a "Dear Healthcare Provider" letter advising physicians of the Doxil shortage. The letter explained that the remaining medicine will go to patients already using Doxil.
"We continue to recommend that you do not start any new patients on Doxil until adequate supply becomes available," the letter said.
Other hospitals have faced similar problems. Alabama Hospital Association Executive Director Rosemary Blackmon said she's heard of shortages of various medicines around the state, including a situation where a person went in for chemotherapy but was sent home until the hospital could find more of the drug.
"What we found is that the pharmacists at hospitals have done a really great job of networking with each other," she said.
According to a recent survey of 820 hospitals by the American Hospital Association, almost all reported shortages in the past six months, and nearly half reported at least 21 shortages during the same period.
Hospitals in Birmingham including UAB, Trinity Medical Center and Children's of Alabama say they're taking creative routes to get patients what they need, such as borrowing and lending drugs among each other.
Patients affected by the drug shortages declined to be interviewed.
And while some hospitals say they haven't had to pass on costs to patients, it can be an economic issue. According to a survey by the American Society of Health-System Pharmacists and the University of Michigan Health System, labor costs associated with shortages equate to about $216 million nationally. Labor costs include staff time needed to find and research alternate drugs and determine proper dosages.
As doctors scramble to treat patients, third parties are racing to turn a profit. These groups, known as "gray market vendors," buy up drugs in short supply and sell them at "exorbitant price mark-ups," according to a report last month by Premier.
"And in certain cases, the drugs being offered may be counterfeit, stolen, ineffective or unsafe," the report said.
Premier said the highest mark-up from these "gray markets" was 4,533 percent above one drug's normal cost. In that case, Labetalol, a medicine used to treat high blood pressure, that normally cost $25.90 was offered for $1,200. In an analysis of 1,745 unsolicited offers from "gray market" vendors to hospitals, the average mark-up was 650 percent for drugs to treat critically ill patients, according to the report.
Birmingham-area retail pharmacies are also frustrated by the shortages.
Johnny Brooklere, partner and pharmacist at Brooklere Pharmacy in Alabaster and Adamsville Pharmacy in Adamsville, said drugs typically readily available can be hard to find these days. Brooklere, who's been in the pharmacy business since 1985, said the situation is the worst he's seen.
"It's been unusual," Brooklere said. "Usually if anything's short it's kind of an odd medication or things that are not so popular, but this year it's some very popular things and in multiple strengths. It's just wreaking havoc. I've never seen anything like it."
For the Bessemer-based American Pharmacy Cooperative Inc., which has about 1,600 pharmacies in 23 states, shortages have forced the organization to pay more for rare or alternative drugs. Moreover, insurance companies have been slow to change their pricing models to accommodate drug switches, which slows reimbursements to the pharmacists.
That creates a "huge cash flow issue" for pharmacies, with the end result being higher prices for patients, said Kenny Sanders, APCI's vice president for professional affairs.
There are some things the FDA says its can do to mitigate shortages and help doctors manage their medicines. When a shortage is discovered, the FDA can work with the manufacturer to address risks to patients and restore supplies, the agency said on its website.
Bipartisan bills in the U.S. House and Senate would, if passed, create an early warning system to alert the FDA about manufacturing problems or when a drug will be discontinued. However, right now the FDA can step in only if the manufacturer is the sole company producing a certain drug, said Melanie Smith, director of pharmacy at Children's of Alabama.
With a record number of shortages in 2010 and a higher amount this year, Smith said there doesn't seem to be a clear solution.
"It's been trending worse over the year," she said.
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