Drug shortages ‘essential issue,’ state Del. Morhaim says -- Gazette.Net


Doctors at Anne Arundel Medical Center had a serious discussion last week about whether to keep their doors open over the weekend for surgeries. Their concern, according to one hospital official, was whether they had enough of a drug needed to revive patients from general anesthesia.

“We sometimes have to prioritize who will get a certain drug, which I think you’ll understand is another word for ‘rationing,’” said Dr. Barry Meisenberg, chairman of quality improvement and health systems research at Anne Arundel Medical Center.

Meisenberg and other Maryland doctors spoke at a hearing this week before the General Assembly’s Joint Committee on Health Care Delivery and Financing, outlining the severity of shortages of certain drugs, a problem affecting medical care nationwide.

“I’ve received an enormous stack of letter from doctors around the state,” said Del. Dan K. Morhaim (D-Dist. 11) of Owings Mills, co-chair of the committee and a physician. “The shortage is more shocking and more extensive than I thought.”

Morhaim and other legislators are looking for ways the state can ease the problem, including requiring more stringent reporting by drug wholesalers and pharmacies.

“I’m committed to generating some kind of legislation this year, and it may take more than one year [to pass], but this is an essential issue,” Morhaim said.

Based on a survey by the American Hospital Association, 80 percent of hospitals report delays in patient care due to drug shortages, 50 percent report that they could not provide the recommended treatment to some patients, and about 75 percent say they have had to ration certain medications. Most of the drugs affected are generic injectables, and include those for chemotherapy, antibiotics, anesthetics and electrolytes or nutritional drugs.

“There is no single predominant reason behind the shortages,” said Dr. Clarence Lam of Johns Hopkins School of Public Health, a consultant to the U.S. Food and Drug Administration on drug shortages. “We believe there is a confluence or perfect storm of circumstances.”

While occasional drug shortages have occurred in the past, frequent and persistent shortages started about two years ago, doctors and officials said.

According to an FDA study, about 60 percent of shortages are caused by issues in the manufacturing process. More than 70 percent of all generic injectables are produced by three manufacturers, meaning disruptions in production can widely affect the supply.

Exacerbating the problem, Lam said, is a group of pharmacies and wholesalers in Maryland and other states that sells scarce drugs to each other, marking up the price as the drugs move through the chain on what observers call the “gray market.”

U.S. Rep. Elijah E. Cummings (D-Dist. 7) of Baltimore plans to introduce legislation in Congress that would expand the powers of national and state agencies to oversee distribution of crucial drugs, said staffer Christopher Knauer.

According to an analysis by Knauer and Patricia Roy, an analyst at the Government Accountability Office, one chain of pharmacies and wholesalers in Maryland marked up prices from an initial $7 to $600.

Cummings’ legislation would create a national database of drug wholesalers and prohibit pharmacies from selling their stock to wholesalers. Currently, Maryland law allows pharmacies to sell 5 percent of their stock to other companies, rather than to individual patients or medical facilities. However, there are no requirements to report what percentage of a pharmacy’s stock is sold to each type of customer.

“Many were clearly exceeding those state limits,” Roy said. “Wholesalers were specifically asking [pharmacies] to sell shortage drugs, and some were sharing profits [from markups].”

In addition to the increase in expensive gray-market drugs, hospitals and doctors have to turn to more expensive brand-name medications for their patients as alternatives. Doctors say that some of those drugs are less effective or carry more risk of side effects. The cost differential could be as great as $2 for a generic pill and $42 for a brand-name pill, said Dr. Laura Pimentel, president of the Maryland chapter of the American College of Emergency Physicians.

“It’s progressing to the point where we not only don’t have the primary drug we use, but we don’t even have the secondary drug,” Pimentel said, noting that even a basic drug like sodium bicarbonate, used to treat aspirin overdoses, has been in such short supply that patients have received emergency dialysis for overdoses, a far more expensive and invasive procedure than simply administering a drug.

Morhaim and others said that it is time to review the state’s drug pedigree law, passed in 2007, which requires pharmacies and wholesalers to outline the history of the distribution of a drug. Certain provisions could be tightened, and others added to more closely monitor medicine coming from other states, Morhaim said.

“We are all in this, because of Medicare and Medicaid and the funds that the state matches,” said Sen. Delores G. Kelley (D-Dist. 10) of Randallstown, a member of the joint committee. “We are all paying marked-up prices. There’s not a citizen who’s being taxed that’s not being impacted.”