Prescription drug mistakes and overdoses are more common than reported.
Are you among the multitudes of Americans taking the blood-thinner Coumadin? Or insulin for diabetes? Or Propulsid for heartburn? Or cancer-fighting drugs?
If so, there’s not much room for error in your daily dose. One milligram too much of Coumadin, for example, and you can start hemorrhaging. One milligram too little and you can develop a blood clot that causes a stroke or heart attack.
Propulsid can be lethal when taken with certain antibiotic and antifungal drugs.
With more than 2 billion prescriptions written each year in the United States, the potential for adverse drug reactions is higher than ever. Anyone can make a medication error–doctors, nurses, pharmacists and patients. The results can range from insomnia and impotence to chronic mental illness and death.
And if you think the health-care system or government will protect you from medication errors, think again.
“Most people think the system is fairyland-perfect, that most every drug is a wonder drug, and that every bad drug is taken off the market,” says Stephen Fried, the Philadelphia-based author of the new book “Bitter Pills: Inside the World of Hazardous Drugs.” “But it’s a system with flaws.”
In fact, adverse reactions to prescription and over-the-counter medications kill more than 100,000 Americans each year–making it at least the sixth-leading cause of death after heart disease, cancer, lung disease, strokes and accidents, according to a study published in the April 15 Journal of the American Medical Association,
Many of these deaths could be prevented if patients educated themselves, Fried says: “People pay more attention to the food they eat and the cellular phones they talk on than to the drugs they take.”
At the very least, he says, patients should read the instruction sheet that many states require to be issued with every prescription. For more detailed information, they should read the package inserts provided by the drug’s manufacturer.
Fried also advises reading the most authoritative articles, contacting the best research institutions and surfing reputable Web sites.
“They’ve got to do the work,” he says. Otherwise, they’re just playing prescription roulette, a game they’re increasingly likely to lose.
The number of reported deaths each year from adverse reactions to legal drugs is 40 times that of the number of people killed by adverse reactions to heroin, cocaine and other illegal drugs, Fried estimates.
“That doesn’t mean we should stop spending money on the War on Drugs,” he says, “but that we should spend money on all drug problems in this country.”
The U.S. Food and Drug Administration spends only $140,000 a year to monitor drugs once they’re on the market. To identify problems, the agency relies on voluntary reports it receives through its MedWatch program.
Some of those reports come from health-care professionals, while others come from the Maryland-based U.S. Pharmacopeia, a non-profit organization that sets drug-purity standards.
Joanne Peterson-Falcone, an intensive-care nurse at Penrose Hospital, recently joined the U.S. Pharmacopeia’s 15-member advisory panel on medication errors.
She keeps herself up to date on medication errors with bulletins from the FDA, drug manufacturers and the Institute for Safe Medical Practices, a Pennsylvania-based non-profit watchdog group.
“Medical practice changes from minute to minute,” Peterson-Falcone says. “It changes so fast it’s unbelievable.”
All reporting is voluntary. Doctors, pharmacists and hospitals are not required by law to report even the medication errors that result in death. Such incidents usually come to light only when criminal charges are involved. Only drug companies are legally required to pass on complaints they receive about their products to the FDA.
Fried regrets that attempts to pass mandatory-reporting laws have repeatedly failed in Congress.
“It’s a big mistake,” he says. “The underreporting of adverse drug reactions is a tragedy all of us pay for.”
Diane Cousins, director of the U.S. Pharmacopeia’s voluntary medication-errors reporting program, fears the number of reports could decline if mandatory-reporting laws were passed, mostly because clever lawyers would find loopholes.
“Traditionally, there’s been a culture of fear in health care,” she says. “That culture needs to change so that people aren’t afraid to tell when they or someone else has made an error.”
Cousins sees signs that the industry is becoming less inclined to scapegoat individuals and more inclined to fix the systems that cause errors.
Fried, however, sees little evidence that the system wants to open itself to scrutiny.
