Many therapeutic drugs are in short supply — both nationally and in Rhode Island — and some say the problem has forced hospitals to switch to medications that are less safe and less effective.
“In the past 12 to 18 months, I’ve dealt with more drug shortages than I’ve seen in my 25 years of purchasing drugs for hospitals,” said Charles Mahoney, director of pharmacy management for Rhode Island Hospital, Miriam Hospital and Bradley Hospital. “I don’t think there’s a hospital in the country that’s been spared,” he said.
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The American Society of Health-System Pharmacists as of last week had a list of 13 drugs “of importance to hospitals” that are in short supply nationally.
The U.S. Food and Drug Administration counts 10 drugs that are in low supply and another 15 drug shortages that recently have been resolved. Both the FDA and ASHP have set up Web pages to alert doctors and hospital pharmacy managers of shortages.
The lists include some of the most widely used medications in U.S. health-care facilities.
For several months, hospitals have had to ration fentanyl, a narcotic used for anesthesia and analgesia, because of tight supplies.
Last month, health-care providers were warned of a national shortage of tetanus and diphtheria vaccines. A key tetanus manufacturer of the medicines, Wyeth-Ayerst, discontinued production earlier this year, leaving a smaller producer scrambling to meet demands.
In March, the FDA declared a shortage of naloxone, which is used to treat narcotics overdoses. Supplies of dexamethasone, an injectable steroid used primarily to treat inflammation, and bacitracin, an antibiotic for skin and eye infections, also are low.
Mahoney said Lifespan hospitals since Jan. 1 have counted 26 medications that are either in short supply or out of stock – 11 of which required physicians to switch to alternative medicines in order to treat patients.
While Mahoney says the problem has not negatively affected patient care, the shortages have grown into a huge clinical headache.
“You can switch to an alternative drug that produces the same clinical outcome,” Mahoney said. “But these medications look different, they’re administered differently, they have different dosages, they’re calculated differently. It’s a big problem and you’ve really got to educate people.”
Joseph Deffenbaugh, a professional practice associate at ASHP, says there is no doubt that the national drug shortages have negatively affected patient care, although there is no official data to support that claim.
“(Hospitals) tell us that a lot of in-patient surgeries and ambulatory procedures just don’t get done if the preferred drug products are not available,” Deffenbaugh said.
“Hospital medication-use systems are very complex and very vulnerable to errors under the best of circumstances. When a provider has to go to an alternative product, it raises the opportunities for something to go wrong,” he said.
Officials say several problems throughout the medicine supply chain have converged in recent years to create the string of shortages.
Troubles at manufacturing plants and raw-material shortages have been blamed. And some have said the FDA is partly responsible because it’s been overzealous in regulating drug manufacturers, forcing some to shut down altogether.
Although the FDA says it “works with all parties involved in drug shortages to make sure all medically necessary products are available,” Mahoney says the agency could do more to help offset shortages.
“(The FDA) can close down a facility and walk away, but they may have taken 50 percent of the supply offline and then we have to deal with it,” Mahoney said. “I’d like to see the FDA become more involved with not just correcting manufacturing problems but managing the entire supply chain.”
Health-care providers themselves also shoulder at least some of the blame, according to the ASHP. As more hospitals employ “just-in-time” delivery of materials to keep inventory costs low, “safety” or buffer stocks sometimes disappear.
But many shortages are the direct result of a drug company’s decision to discontinue a product line, which often cripples the entire supply chain.
The fentanyl shortage, for example, reportedly started when the drug’s main supplier decided to stop making the product because the company concluded it was no longer profitable to comply with the FDA’s good manufacturing practices (GMP) regulations.
Indeed, many of the scarce drugs are low-volume, low-profit medications that have been used in hospitals for decades. For large pharmaceutical companies that rely on blockbuster drugs to drive revenue growth, these medications have become expendable.
“With all the mergers and acquisitions in the pharmaceutical industry, the trend is for merged companies to reevaluate their product lines and discontinue products that don’t contribute to the bottom line,” the ASHP’s Deffenbaugh said.
Hospital administrators say the shortages ultimately drive up costs.
Rhode Island Hospital — a regional trauma center that commonly administers tetanus shots in its emergency room — borrowed tetanus shots from other hospitals and carefully rationed its limited supply when Wyeth-Ayerst cut back production.
But when the tetanus vaccine finally ran out last month, the hospital resorted to using tetanus immune globulin, which costs $100 per dose vs. the $4 tetanus shots, according to Mike Marcoux, a clinical pharmacist specialist at the hospital.
Bart Grimes, manager of the pharmacy department at Newport Hospital, agrees with Mahoney that the drug shortages have not hampered quality of care. But, Grimes added, “If we continue to have these problems, it’s fair to say it’ll have a profound effect on the industry.”
