Bartering, sharing, creativity in dealing with drug shortages

Roy Guharoy, professor of medicine at University of Massachusetts Medical School and chief pharmacy officer at UMass Memorial Health Care, called the drug shortage a national crisis that is expected to get worse.

“It’s a patient safety crisis,” he said.

“So far our patient care has not been compromised because of the shortage,” he said. But it’s a big challenge for local hospitals to keep ahead of the unpredictable supply that is expected to affect 300 drugs this year.

Mr. Guharoy credited the teamwork at UMass Memorial Health Care, which comprises five hospitals across six campuses, with responding to the crisis. Efforts involve an active patient-safety committee and weekly meetings with physicians, particularly those in the most affected fields, including oncology, anesthesiology, cardiology and critical care.

To safeguard against potential dosage errors that could result from substituting a drug such as the pain medication fentanyl, which is significantly more potent than the morphine for which it’s substituted, the hospital system invested a few years ago in “smart” infusion pumps. Smart pumps administer the appropriate, preprogrammed dose of an intravenous drug.

The hospital system has to be creative when facing drug shortages, Mr. Guharoy said. For instance, it may purchase a large supply of a particular drug — if that’s the only quantity available — and then apportion smaller dosages among its hospitals.

Mr. Guharoy said it takes a lot of manpower to manage the constantly changing shortages, which adds to health care costs. He said nationally, drug shortages cost the system over $240 million a year.

Paul Paladino, director of pharmacy at St. Vincent Hospital, said, “We spend at least two hours a day trying to make sure we have everything in stock for our patients.

“To date, we have not run out of anything.”

Both UMass Memorial Health Care and St. Vincent Hospital buy drugs only through licensed wholesalers that can track a drug’s “pedigree” each step of the way from manufacturing to distribution. Neither would consider buying drugs in short supply from the “gray market.”

But the hospitals may outsource to licensed, regulated compounding pharmacies when a particular drug is needed. Mr. Paladino said it can cost five to 10 times as much to buy from a compounding pharmacy as through the regular wholesaler, but the hospital is assured of the drug’s safety and the markups aren’t nearly as high as the thousand-fold increases peddled by gray-market vendors.

“We have an account that we have open all the time (with a compounding pharmacy) and we order every week,” Mr. Paladino said. “That assures us we have what we need.”

He also said the hospital ends up overstocking certain drugs to prevent emergency shortages, which also adds to costs. Occasionally, St. Vincent borrows from and lends drugs to other hospitals.

Since many of the shortages have occurred with emergency medications, and ambulance companies typically get their drugs from hospitals, hospital personnel have had to make sure paramedics are trained in the proper dosages for similar drugs that might be substituted for others.

“There is education any time you make a switch,” said Mark Miller, EMS quality improvement liaison at St. Vincent.

The state Office of Emergency Medical Services issued protocols for ambulance personnel about drug substitutions and dosages, but temporary substitutions have to be approved by the affiliated hospital’s medical and pharmacy directors. The OEMS regional offices plan to do more training on drug substitutions in the coming year.

“It means restocking, retraining. It’s a burden to some extent,” said Dr. Marc C. Restuccia, medical director for Central Mass Emergency Medical Systems and director of Life Flight, MDAccess and Worcester EMS at UMass Memorial Medical Center — University Campus.

“It’s not dangerous for patients at this point, but in an ideal world it’s not something you’d want to go through,” he said. The constantly shifting availability of drugs, with different protocols and storage requirements, he said, “increases the possibility for error.”

Mr. Guharoy said that two bills pending in Congress, HR 2245 and S 296, would require drug manufacturers to notify the federal Food and Drug Administration six months in advance of production or business situations likely to result in shortages. He urged support of these bills.

Dr. Restuccia said, “You assume that the drug supply in this country is safe and assured.”

The recent epic shortages, however, revealed that may not always be true.

Contact Susan Spencer by email at susan.spencer@telegram.com.