Drug shortages worsen following pharmacy-related meningitis scare
■ Six products supplied by a company that closed due to the outbreak are on the FDA’s critical shortage list.
By Christine S. Moyer — Posted Dec. 10, 2012
Drug shortages are intensifying in some parts of the nation due to the recent closings of two specialty pharmacies in Massachusetts following a fungal meningitis outbreak.
During the outbreak that started in September, the New England Compounding Center and its sister company, Ameridose LLC, which was a major hospital drug supplier, recalled all of their unexpired products. NECC produced the injectable steroids that were linked to the ongoing meningitis outbreak in at least 19 states. More than 500 cases of the disease have been reported, and at least 30 deaths have occurred, said the Centers for Disease Control and Prevention.
In October, NECC and Ameridose halted production. Ameridose’s closure is temporary.
Hospitals and other medical centers that relied on the companies for thousands of medications each month are scrambling to identify new sources for drugs, including antibiotics, lifesaving medicine and pain medications.
Some hospitals are trying to boost their pharmacy capabilities so they can reconstitute and package drugs themselves rather than rely on specialty pharmacies that could have safety issues similar to those of NECC.
NECC and Ameridose “provided a service that many hospitals around the country were using,” said Anuj Goel, MPH, vice president of legal and regulatory affairs for the Massachusetts Hospital Assn. “But the impact in Massachusetts has been very severe, given the fact that [those companies are located in the state]. It was definitely a big hit.”
Boston-based Massachusetts General Hospital, which is New England’s largest hospital, is among the health centers that have been particularly hard-hit. About 17% of the nearly 400,000 doses of medication it uses each month were provided by Ameridose, said Padma Gulur, MD, the hospital’s director of inpatient pain services. A smaller amount of medication was produced by NECC.
“We have had to take [everything] in-house,” Dr. Gulur said. “Because obviously, in this environment, we’re not going to look for another manufacturer whose credentials we haven’t checked thoroughly.”
As a result, the hospital’s pharmacy, which once operated from 7:30 a.m. to 4:30 p.m., now functions around the clock. The pharmacy expanded its space to other sterile areas and is considering temporarily using one of the operating rooms, Dr. Gulur said.
Some new employees have been hired to help manage the increased workload. But most of the tasks are falling to existing staff, she said. For instance, nurses learned how to prepare certain injectable antibiotics, and anesthesiologists are reconstituting some of the medications they use.
Still, the hospital can’t produce all the medication it needs. So staff members are working to identify new sources for needed medications, Dr. Gulur said.
One challenge is that the closings of Ameridose and NECC come at the end of the year, when the nation’s supply of pain medication historically is low, Dr. Gulur said. The government limits the number of narcotics that can be manufactured for prescription medication each year.
Further complicating matters, six products supplied by Ameridose were on the Food and Drug Administration’s critical shortage list. That means the products were in short supply before Ameridose recalled its unexpired products and halted operation.
“The recall has the potential to exacerbate one or more of those shortages,” the FDA said.
The six products on the critical shortage list are:
- Sodium bicarbonate injection
- Succinylcholine injection
- Atropine sulfate injection
- Bupivacaine hydrochloride injection
- Lidocaine hydrochloride injection
- Furosemide injection
“Drug shortages are two words that no one wants to hear — not patients, not health care professionals and not me,” said FDA Commissioner Margaret A. Hamburg, MD. “However, drug shortages are still a serious problem, one that may be temporarily impacted by [Ameridose’s] voluntary recall of all its unexpired products.”
Steps to ease shortages
There have been shortages of more than 100 drugs in the U.S. this year, the FDA said. The problem peaked in 2011, when 251 medications were in short supply.
Contributing to the shortages are production delays and quality issues. The FDA said too few manufacturers are producing the older and widely used generic sterile injectables to meet the nation’s needs. Many companies choose not to produce these products because they are not as profitable as other drugs and manufacturing them is complex, health experts say.
Shortages of lifesaving medication, including benzodiazepine drugs to stop seizures, have led emergency medical workers in the Memphis, Tenn., area to rely on compounding centers to create those products, said emergency physician Joseph E. Holley Jr., MD.
“If there are less compounding facilities around, there will be less opportunities to have those drugs made for us,” said Dr. Holley, EMS medical director for Memphis and surrounding municipalities.
To help limit the impact of the closures on existing drug shortages, health professionals should consider keeping medication on their shelves for the maximum amount of time that is safe, the MHA’s Goel said. In some cases, drugs in hospitals are discarded after 10 days, but they could be used safely for up to 15 days, he said.
In Massachusetts, the Public Health Council adopted emergency regulations in November to allow hospitals to share safe, compounded drugs with other hospitals in times of need, said Lauren Smith, MD, MPH, interim commissioner for the Massachusetts Dept. of Public Health. The rules took effect Dec. 1. The council is an appointed board of clinicians, professors and public health advocates.
“Part of the Dept. of Public Health’s mission is to work with hospitals to ensure that they have a plan in place to respond to any unforeseen emergencies,” Dr. Smith said. “These regulations provide another tool at our disposal to respond to any urgent situations that may arise, so we may protect the public health and ensure patient safety.”