U.S. FDA Reports Drug Shortages Have Caused Delay in Life Saving Treatments

September 5, 2011--

As far back as May of this year reports of drug shortages to treat serious illnesses were being reported.

FairWarning.com sounded an alarm that U.S. Hospitals were facing serious shortages of medications used to treat illnesses like cancer and heart disease. Cheaper drugs were being used instead, which many times are not as effective.

A survey conducted by the American Hospital Association found that of the 820 hospitals surveyed almost all had run out of important drugs and 80% said they had to delay patient treatments because of drug scarcity in the previous six months.

“It’s just a matter of time now before we call for a drug that we need to save a patient’s life and we find out there isn’t any,” said Dr. Eric Lavonia of the American College of Emergency Physicians, stated to Associated Press.

Fair Warning stated last year there were 211 medications in short supply, triple the number five years ago. Although some of those shortages have been resolved, another 89 drugs were added to the list during the first three months of this year, according to the University of Utah’s Drug Information Service.

Most of the shortages involve injectable medications used in emergency rooms, intensive care units and cancer wards. The supply problems can last weeks or even months, and there aren’t always good substitutes. Other countries are reporting similar problems.

The shortages can be life threatening. At Miami Children’s Hospital, 14-year-old Caroline Pallidine had to wait a month for her last round of chemotherapy because of a prolonged shortage of cytarabine, a vital drug in the treatment of her leukemia.

“There’s always a fear, if she’s going so long without chemo, is there a chance this cancer’s going to come back?” said her mother, Marta Pallidine.

A number of factors are to blame, including contaminated vials, problems importing raw ingredients, high demand or factories that temporarily shut down to work on quality-control issues.

More expensive brand-name drugs are normally plentiful. But the Food and Drug Administration says that cheaper generic drugs often are harder to find, because of the limited numbers of manufacturers producing them.

While the number of patients harmed has not been tracked, the nonprofit Institute for Safe Medication Practices said it received two reports of patients who died after receiving the wrong dose of a morphine substitute.

FDA Enlists Assistance From Foreign Drug Makers

To address the problem, the FDA is asking some foreign drug makers to temporarily send to the U.S. versions of scarce drugs that aren’t normally sold here. That measure boosted supplies of propofol, an important anesthetic, and the transplant drug thiotepa.

But the Generic Pharmaceutical Assn. says manufacturers are not always to blame, citing issues such as FDA inspections and stockpiling.

In a recent report, The Food and Drug Administration states the shortages of these life saving drugs are raising concerns because regulators have to race to find replacement drugs.

It’s a case of supply and demand because the number of medication treatments that are difficult to find have tripled from 61 to 178 between 2005 and 210. Most of these medications are for hospital use. A spokesperson for the FDA said they fear for patients and will continue to address the shortages within their powers.

Congress is considering solutions. Sen. Herb Kohl, D-Wis., wants the Federal Trade Commission to weigh the potential impact of drug company mergers on shortages.

Legislation also is pending to require manufacturers to notify FDA in advance of problems that might trigger a shortage. The FDA prevented 38 potential shortages last year by accelerating approval of manufacturing changes or urging competing companies to ramp up production to meet demand.

Drug Companies Consolidate

Generic drugs are less profitable; therefore, there is no economic incentive to produce them. Cynthia Reilly of the American Society of Health System Pharmacists says “she and other advocates believe new legislation to allow the FDA to force companies to alert it six months in advance of closing a production line would be helpful, as it would give the agency more time to find a substitute. Currently the FDA has no power to force the drug companies.

Gray Market

There are two bills with broad support in Congress addressing the problem of the so-called “gray-market.” This is when distributors buy out rare drugs and then charge hospitals exorbitant rates for them. Some drugs are reportedly getting up to 1,000 times the normal price.