Drugs & Adverse Effects / Death by Prescription

submitted by Dr. Gary Farr Last Updated November, 29, 2001

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Death by Prescription

By Sheryl Gay Stolberg

In March 1997, Mrs. McLaughlin, a widow who lived with her two daughters in Elizabeth, N.J., walked into the pharmacy department of her local Shop-Rite supermarket to fill a prescription for chlorpromazine, an antipsychotic medication. She walked out, according to her son, Charles, and a lawyer, Michael S. Smith, who is suing Shop-Rite on behalf of her family, with a drug that has a nearly identical name, chlorpropamide, which is used by diabetics to lower their blood sugar.

It was, said the lawyer, a particularly serious mistake. Mrs. McLaughlin suffered from diabetes, and was already taking medication for it. She took the new drug in addition to her regular pills for three weeks when she was admitted to Elizabeth General Medical Center with dangerously low blood sugar. Smith said her weakened condition precipitated a cascade of health problems: respiratory failure, intestinal bleeding, two ulcers and a drug-resistant bacterial infection that she acquired during her hospital stay. Mrs. McLaughlin died on May 20, 1997.

Citing the lawsuit, officials at Shop-Rite, a subsidiary of the Wakefern Food Corporation, declined comment. But McLaughlin, who works as an ultrasound technician at Montefiore Medical Center in the Bronx, said he finds it difficult to comprehend that his mother died from a medication she did not need, or ask for.

"I work in a hospital," he said.

"I know that errors occur. But on the other hand, there has to be some sort of fail-safe system to prevent things like this."

Click for larger image

Of a study of 732 elderly patients brought to a hospital in Norway, 133 (18%) died as "either indirect or direct fatal reactions to the drugs they were given."

But there is no fail-safe system, a fact that is becoming increasingly apparent to officials of the Food and Drug Administration, as well as to independent experts on drug safety. They say Mrs. McLaughlin's death highlights a pervasive and dangerous problem: with more medications on pharmacy shelves than ever before and with more prescriptions being written, the nation's health care system is overwhelmed, creating a growing risk that patients will be killed or injured by adverse reactions or mistakes.

Regulators, even after approving a new drug, cannot always predict all potential side effects or toxic interactions. Many pharmacists are overworked, filling more prescriptions with less help. And with as many as a dozen medications available for any one ailment, doctors are having a difficult time keeping abreast of F.D.A. warnings about possible risks.

"There are just so many new drugs available," said Dr. Kenneth W. Kizer, Under Secretary for health in the Department of Veterans Affairs. "And keeping current with the information that goes with each drug has become almost impossible. The system is just not designed to help the practitioner."

The true scope of the problem is unknown, in part because hospitals and doctors are not required to report it.

But recent studies lead scientists to think that prescription drugs are killing and injuring far more people than previously believed, and experts estimate that two-thirds of the deaths and injuries could be prevented. A study published last year in the Journal of the American Medical Association estimated that 106,000 hospital patients die and 2.2 million are injured each year by adverse reactions to prescription drugs, not including cases where errors are involved. (Emphasis added) The estimate was the first of its kind.

In another study, made in 1995, Dr. Lucian L. Leape, a health policy analyst at the Harvard School of Public Health, found that 6.5 percent of patients at two teaching hospitals in Boston had been injured by their medicines, and one-third of these cases involved mistakes.

F.D.A. officials are convinced the danger is growing. In a 150-page report made public last month, they called for pharmacists, doctors, hospitals and drug companies to work together to create "a new framework" for cutting down on the risks from the drugs the agency approves. And on Tuesday, the agency put a new rule into effect that requires manufacturers of some especially risky drugs to distribute explicit warning pamphlets to patients.

"People are being harmed and some of the harm is preventable," said Dr. Janet Woodcock, director of the F.D.A.'s Center for Drug Evaluation and Research. "All of these things are raising alarm bells in people's minds that there is a potential for even more serious problems. And the problem is pretty serious right now."

The Pressures--So Many Drugs, So Little Time

Pharmaceutical manufacturers are discovering new ways to treat more diseases and conditions, from impotence to diabetes. The F.D.A., long criticized as moving too slowly on drug applications, is now approving products at a record-setting pace. And patients are living longer with illnesses that could not be treated before.

More prescriptions are being written, not only because there are more drugs but also because the population is aging; elderly people take more than one-third of all drugs that are prescribed. The National Association of Chain Drug Stores said that in 1992, 2.03 billion prescriptions were dispensed in retail pharmacies; the figure was up to 2.78 billion last year. By the year 2005, the association estimates, it will be 4 billion.

Pharmacies, pressed by the cost controls of managed care, are struggling to fill the higher volume of prescriptions in less time, and with less help. "I worked 12-hour days, and if you get to the bathroom once a day you're fortunate," said Adle Joseph, a pharmacist in Leesburg, Va., who spent 35 years with the Rite Aid chain before retiring last year to join a slower-paced, independent store. "The conditions are just not conducive to good safety."

In Washington State, for example, an investigation turned up numerous prescription errors and lax safety procedures at Rite Aid stores last year; documents provided by the state Board of Pharmacy show that pharmacists complained that "long work hours and inadequate staffing" contributed to their mistakes. The company said only a few of the errors posed any danger to patients; it settled the administrative charges with a $50,000 payment and promised to make sure its procedures followed state law.

Doctors, too, are overloaded. Two decades ago, physicians familiarized themselves with a relatively small pharmacopeia and prescribed the same drugs again and again. Today, the choice of medicines rests not only with doctors, but also with managed care companies, which buy drugs in bulk to reduce costs and list them on formularies that can change each month.

At the Veterans Administration Medical Center in Providence, R.I., Dr. Jeannette Chirico-Post, the hospital's chief of staff, expressed concern about how complicated prescribing drugs has become.

"We have more drugs at our fingertips," she said, "and the potential for drug-drug interaction is far greater than we saw 10 or 15 years ago."

And while computer technology is available to help doctors avoid mistakes and screen for dangerous combinations of drugs, few hospitals and even fewer private doctors have it. Those that do say the systems can produce so many false alarms that they are nearly impossible to work with.

"We are using medications in ways that we never used them before," said Michael Cohen, president of the Institute for Safe Medication Practices, a nonprofit organization that investigates prescription drug errors. He said the mistake in Mrs. McLaughlin's case could have been avoided with clearer labeling.

"Pharmaceutical companies aren't keeping up with the times and labeling their products as safely as they need to," he said. "We haven't developed the technology to prevent patient harm, or we are not incorporating it because we say it's too expensive. We are not investing the resources that we need to protect patients."

Miguel Sanchez lost his life because of a lack of such safeguards. He was a healthy baby when he was born on Oct. 15, 1996, in a community hospital in a suburb of Denver. His mother had a history of syphilis, however, and a neonatologist prescribed a long-acting form of penicillin to keep the baby from becoming infected. But a series of mistakes, uncovered by Cohen's institute, which examined the death at the hospital's request, claimed Miguel's life.

A pharmacist misread the doctor's handwriting and delivered 10 times the proper dose, leading the nurses to confuse the medicine with a newer generation of drugs that are administered differently. Miguel's medication, a milky white suspension, was supposed to be injected in the thigh muscle; typically, only clear liquids are given in the veins. But the baby's nurses worried that such a huge injection into a muscle would hurt the infant.

To complicate matters, some new opaque suspension drugs had been approved by the Government for intravenous use. The nurses checked two medical texts to see if the drug could be given intravenously, and found no warnings against it. So they injected the penicillin into the baby's arm. Miguel had a heart attack and died an hour later.

"It was devastating," said Pat McCadden, the risk manager at Centura St. Anthony North Hospital in Westminster, Colo., where Miguel spent his brief life. "Everybody had a hard time believing this could happen, because these were very knowledgeable, experienced nurses."

The Errors Medication Threat Often Lies in Use The Errors Medication Threat Often Lies in Use

There are a variety of ways that people can be killed or injured by their medicine. Outright mistakes, like the one that occurred with Miguel, is one way; some experts say these medication errors account for one-third to one-half of all cases. Known side effects, including dangerous interactions between drugs, are another. Unforeseen side effects, which do not turn up in testing but become apparent after a drug comes into widespread use, are a third.

Collectively, these are known as "adverse drug events," and in recent months the F.D.A. has been troubled by a series of them, including these:

• Posicor, a drug for high blood pressure, was withdrawn from the market last year, but not because it was harmful on its own. Rather, Posicor became lethal in combination with a number of other drugs, so many that the F.D.A. believed that doctors and consumers could not keep abreast of the risks. Agency officials said that 24 people taking Posicor in the 11 months it was on the market had died, and that two or three of those deaths were directly linked to Posicor, although a spokeswoman for Roche Laboratories of Nutley, N.J., the drug's manufacturer, has said "no causal link" was demonstrated.

• The diabetes drug Rezulin, approved two years ago, can cause liver damage, which prompted the F.D.A. to issue repeated warnings to doctors to closely monitor patients taking it. But an agency investigation found that doctors were not listening; only 2.7 percent of patients taking Rezulin for three months were being monitored the way the agency had recommended. At a hearing in March, the F.D.A. and Rezulin's manufacturer, Parke-Davis, a division of the Warner-Lambert Company of Morris Plains, N.J., agreed that 43 people had suffered acute liver failure that was possibly due to the drug; of these, 28 died. A panel of independent scientific experts has recommended that the drug be prescribed only to patients who do not respond to other therapy.

• The arthritis drug Celebrex, which was approved by the F.D.A. in January and has already been prescribed to more than two million people, is repeatedly being confused by doctors and pharmacists with two other drugs: Cerebyx, an anti-seizure medication, and Celexa, an antidepressant. The agency has already received 41 reports of the wrong prescription being filled; in one, an 81-year-old woman wound up taking two antidepressants for a month.

"We haven't had any serious injuries, thank goodness," said Dr. Jerry Phillips, the F.D.A. official who keeps tabs on medication errors, referring to Celebrex. He is trying to persuade the Monsanto Company, which manufactures the drug, to change Celebrex's name, a difficult task given that the company has spent tens of millions of dollars advertising and promoting the medication.

At the same time, Dr. Phillips said, the food and drug agency is planning to install computer software that will analyze proposed drug names to avoid such confusion in the future. But at least one expert, Dr. Leape of Harvard, said it should have taken that step years ago.

"The F.D.A. has essentially focused on the safety of the product, whereas the major threat has to do with safety of use and misuse," Dr. Leape said. "Their point of view has been that it is safe and effective when used as directed, and the directions are on the label, so read it. We have come to them repeatedly and said; 'That is not enough. People make mistakes, even when it is all there."