June 3, 1999-The boom in medication brings rise in fatal risks
Helen McLaughlin was 73 years old when, relatives say, a mix-up in prescription drugs took her life. In death, she became a statistic that is causing increasing anxiety among health care experts and Federal regulators: the tens of thousands of Americans who are killed each year not by illness, but by medication intended to treat it.
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. Mr. 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 Mr. 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."
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 FDA 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. 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. FDA 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
That medications pose a threat to public health is, in a sense, testimony as much to medicine's success as its failure. As Dr. Leape put it, "Adverse drug events are a disease of medical progress." 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 Mr. 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
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 FDA 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 FDA 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 FDA. and Rezulin's manufacturer, Parke-Davis, a division of the Warner-Lambert Company of 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 FDA 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 FDA 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 FDA 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.' "
The Drug Stores: Pharmacists Say They're Overworked
Perhaps no one in health care is more acutely aware of the potential harm of prescription drugs than pharmacists. Yet, pharmacists say little attention is paid to the difficulties they face in today's complex health care environment.
The Leesburg Pharmacy in Leesburg, Va., is a case in point. On a recent afternoon, half a dozen patients were lined up behind the counter waiting for their prescriptions to be filled; others milled about the store. A series of bins with prescription slips and medications formed a queue along the green formica countertop. Forty-nine prescriptions were in one stage or another of preparation. "And this," said Greg Chase, the chief pharmacist, "is a slow day."
Leesburg is an independent pharmacy and, like pharmacies around the country, its profits are being squeezed by lowered reimbursements from managed care companies. So it makes up the difference in volume. The pharmacy fills about 300 prescriptions every day, a 50 percent increase over that of three years ago, said the store's owner, Bruce Roberts. He said that leaves little time for pharmacists to talk to patients about how to take their medication, something experts say is essential if drugs are to be used safely. "The medications have become much more complex, and the interactions among these complex drugs is greater than it was in years gone by," Mr. Roberts said. "With managed care and pharmacists being stretched to the limit, there is just no way that you can provide the service that we really need to be able to educate the populace as to the dangers of drugs." Still, Mr. Roberts is trying. He has set up a private consultation counter for patients who have questions. He has purchased a robot, at a cost of $175,000, that can dispense the 200 most commonly prescribed medications, a system that not only allows pharmacists to do more counseling but can also cut down on mistakes. And he has diversified, selling gifts and offering lactation consulting and other services so that he can afford the salaries of his three full-time pharmacists.
That is a relief to Mr. Chase; he came to Leesburg Pharmacy two years ago from a chain drug store, CVS, where three pharmacists filled 600 prescriptions every day, and often worked 12 consecutive hours to do it. "You've gone four to five hours without even a chance to go to the restroom," he said, echoing the complaints of his colleague, Mr. Joseph, who previously worked at the Rite Aid chain. "Your mind is fried."
Officials at CVS, which owns 4,100 drug stores in the United States, and Rite Aid Corporation, which owns 3,800 stores, say they have no evidence that more mistakes are being made. But they are concerned about workplace pressures, and are taking a number of steps, including greater use of robots, to ease the burden. As members of the National Association of Chain Drug Stores, the companies are also sponsoring research by a psychology professor at the University of Cincinnati who is examining ways to reduce pharmacy errors.
The professor, Tony Grasha, said in an interview that mistakes occur when psychosocial factors, such as stress at home, combine with a higher workload. Dr. Grasha said his studies show that errors are rare, about one-half of 1 percent of all prescriptions filled, and that those that pose a danger to patients are rarer still. But, he added, with the number of prescriptions growing, mistakes are a serious concern. "It is a tiny fraction percentagewise," Dr. Grasha said, "but when you are filling three billion prescriptions a year and are anticipating four billion by the year 2005, then even a very small percentage is a lot."
Some state pharmacy officials are also worried. In addition to the action against Rite Aid in Washington State, officials in another state, North Carolina, are trying to force drug stores to cut back on pharmacists' hours and to require lunch and bathroom breaks in an effort to improve safety. The North Carolina Board of Pharmacy has also decided that when a pharmacist who fills more than 150 prescriptions in a day makes an error, both the pharmacist and the store will be held liable, and will face a possible license suspension or revocation.
"Our discipline actions are going up," said David Work, the board's executive director, "and errors are a part of that." Computers are an important part of the pharmacy safety net, but they have limitations. When Mr. Chase typed in the name of a 23-year-old patient who had been prescribed an anti-psychotic medication, his computer issued a warning that the drug could be dangerous in combination with another prescription in the patient's file.
But the system presumes that a patient goes to the same pharmacy every time. And the computers raise so many red flags, without distinguishing the serious from the benign, that pharmacists grow weary of them and start to ignore them. In the Rite Aid case in Washington, one pharmacist dispensed a drug with instructions for the patient to take triple the proper dose, an order that, state officials said, would have resulted in a computer alert. The message was apparently ignored.
"It's like crying wolf," said Susan Winckler, director of policy and legislation for the American Pharmaceutical Association, which represents 52,000 pharmacists. "Some pharmacists call it 'the right-hand syndrome.' You just hit the return key when you see the message."
Mr. Cohen, of the Institute for Safe Medication Practices, says most pharmacy computer systems need serious improvement. In a recent study, he asked 307 hospital pharmacies to fill 10 different drug orders that had killed patients in 1998. Some contained an overdose. Others called for two drugs that were deadly in combination.
"The results were outrageous," he said. Only four of the 307 pharmacies detected all 10 unsafe orders. Deaths and injuries from drugs are vastly underreported, experts say, in part because doctors fear civil lawsuits or, worse, prosecution. When Miguel Sanchez died, the district attorney in Adams County, Colo., Bob Grant, brought charges of criminally negligent homicide against three nurses who cared for the baby. Two pleaded guilty in exchange for two years' probation; another was acquitted at trial.
"They failed to perceive a substantial risk that the death of a child would occur," Mr. Grant said. "That's criminal negligence." Mr. Cohen, of the Institute for Safe Medical Practices, disagrees; after Miguel's death, he said, he uncovered 54 procedural shortcomings that contributed to the mistakes that killed the boy, from a hospital pharmacist who lacked training in how to properly dose drugs for infants to unclear labeling on the syringe to the textbooks that lacked crucial warnings. Had any of the shortcomings been corrected before Miguel's birth, he said, the boy might be alive today.
Ms. McCadden, the hospital's risk manager, acknowledged the flaws and said that, under Mr. Cohen's guidance, the hospital had taken a variety of steps: "Any medication going to the nursery is now checked by two pharmacists. Two nurses in the nursery will also double-check the medication." The hospital also hired a pediatric pharmacist, ordered new textbooks and conducted educational sessions for its staff. And Ms. McCadden and the three nurses have told their story to other hospitals and at conferences in an effort to educate other professionals. "We've done a lot of talking," Ms. McCadden said.
Easing the Burden With Technology
The idea that the health care system can be designed to minimize mistakes and drug dangers is one that has been promoted heavily by Dr. Leape. "Errors," he says, "are symptoms of a sick system, not a sick person. Humans make mistakes. To the extent you can redesign around that, you can get rid of it."
For example, he said, the FDA could require pharmaceutical companies to standardize their drug labels for easy reading. Medicines could come with bar codes, so that pharmacists could use scanners to check for the correct name, the same way a grocery clerk scans a jar of pickles. Doctors could trade in their prescription pads for computers.
These ideas are beginning to catch on in some unlikely places. Two years ago, Dr. Kizer, of the Veterans Administration, began a major patient safety initiative designed, in part, to minimize prescription drug errors at the nation's 172 veterans hospitals and clinics. Over the next two years, the department intends to spend $40 million on technology that will allow doctors to use computers to write their prescriptions.
At the Veterans Administration Medical Center in Providence, a stately brick building that looks anything but high technology, the results are already in evidence. Doctors still walk around with prescription pads in their laboratory coat pockets, but only out of habit. They have not used them since December except to prescribe narcotics. A computer terminal is in every examining room. Wireless portable units (the hospital has installed optic fiber cables in the ceiling) are on rolling carts in the hospital corridors. When a doctor enters a prescription into the computer, it is checked and double-checked. The machine rejects spelling errors, or overdoses, and scans the patient's medical record for potentially dangerous interactions with drugs prescribed by other doctors. The computer then sends the order electronically to the pharmacy.
In an analysis of a similar system at the Brigham and Women's Hospital in Boston, Dr. Leape found that medication errors were reduced by 80 percent. But hospitals have been slow to get rid of prescription pads; according to Mr. Cohen, 12 percent of the nation's hospitals have the capability for computerized prescription writing, but only 6 percent use it. That is partly because not all doctors are enthusiastic about the system. When Dr. Chirico-Post, the chief of staff at the Providence V.A. center, announced that her hospital would be among the first in the Veterans Health Administration to switch to computers, some doctors complained that they did not know how to type. Others said it would take too much time. And even those who like the system said it had its drawbacks.
Dr. Dawna Blake, chief of the hospital's primary-care practice, says she welcomes the warnings the system issues when she is writing a prescription. "It gives you a lot of nice reminders," she said. But the machine does slow her down, she said. She still takes patient notes by hand and then enters them into the computer at the end of the day. "I can't sit there and enter my notes when the patient is in the room," she said. "To me, that's a distraction."
Those arguments did not deter Dr. Chirico-Post. With a hospital pharmacy filling more than 500,000 drug orders for inpatients each year, she said, and another 500,000 outpatient prescriptions, the potential for errors and dangerous interactions is too great to ignore. "Outside of working in the operating room," she said, "dispensing a drug, giving a drug to the patient, is one of the most dangerous things we do."
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