As Pharmaceuticals Boom, So Do Drug Errors

Parham Jones stood behind a Rite Aid prescription counter at the crossroads of suburban and rural South Carolina, wrapping up a 12-hour shift and a 60-hour workweek.

It was Feb. 20, 1995--Monday, a pharmacist’s busiest day. With phones ringing and customers clamoring, Jones handed the mother of Gabrielle Hundley a bottle labeled “Ritalin,” a drug for hyperactivity.

But the bottle contained Glynase, a drug diabetics use to lower blood sugar--at 16 times an adult dose.

Just two pills sent 8-year-old Gabrielle into a coma. Her blood sugar sank so low that her brain, starved for fuel, began consuming its own tissues. Five years later, her IQ remains in the retarded range.

Americans have doubled their prescription drug use since 1989, while the number of druggists has remained about the same. That gives each pharmacist twice as many chances to make a mistake. It also increases the chances that Gabrielle--or any other consumer--will become the victim of a pharmacist’s error.

Federal oversight of prescription drug manufacturers has never been more intense. Yet the pharmacies that dispense 3 billion prescriptions a year are overseen by state, not federal, regulators.

The difference is dramatic.

Under federal regulation, a drug manufacturer that learns its medication has seriously harmed a patient must report the incident to regulators--or face possible criminal charges.

But just two states require pharmacies to report dispensing errors, and only in extreme cases. Georgia requires reporting of errors that cause a patient “significant” harm; North Carolina requires reporting when errors result in death.

In no other state are pharmacies even required to report errors. When consumers point out mistakes, regulators discipline few druggists and drugstores. The usual punishment: a written reprimand.

In an investigation into safety and oversight in the nation’s pharmacies, the Associated Press examined court records of pharmacy malpractice cases and conducted hundreds of interviews with pharmacists, regulators and pharmacy officials. Because there is no comprehensive database of state disciplinary actions against pharmacists, disciplinary information for 1998 was gathered through AP requests for public records, completed by all 50 states.

No one knows exactly how many patients have received the wrong prescriptions, but state regulators know the problem has grown worse over the last decade.

The number of prescription drug-related deaths reported in North Carolina rose from 14 in 1992 to 36 in 1999. North Carolina officials say they know many deaths aren’t being reported.

Although few states ask drugstores about errors, most state pharmacy boards compile records of complaints by consumers and by the state inspectors who sometimes notice problems during their infrequent visits.

In nearly every state, the number of complaints has risen substantially in recent years. Annual complaints in Florida nearly doubled from 1995 to 1999 alone, from 387 to 736. In North Carolina, complaints jumped from 217 in 1997 to 370 in 1999.

The keepers of those statistics say those numbers are a fraction of the total.

“We can only track those that come to us,” said Lawrence Mokhiber, executive secretary of the New York Board of Pharmacy, which regulates pharmacists in the state.

Pharmacy errors are part of the larger problem of medical errors. The National Academy of Sciences estimates that medical errors in the nation’s hospitals--from medication to surgical mistakes--kill 44,000 to 98,000 Americans a year, more than breast cancer or highway accidents.

No comparable figure exists for pharmacy errors.

“I don’t know what the right number is, but even if it’s one-tenth of that number, it’s a very serious problem,” said Dr. Raymond Woosley, head of pharmacology at Georgetown University Medical Center.

Medical researchers have found varying error rates--all suggesting millions of Americans become victims each year.

A 1996 study, published in the journal Human Factors, found 3.2% of prescriptions were filled in error. Researchers spent 23 days double-checking 5,072 prescriptions and found 164 mistakes. They ranged from typing the wrong instructions to putting the wrong drug in the bottle.

University of Cincinnati psychologist Anthony Grasha estimates that 1.5% of prescriptions contain an error that goes undetected until the customer leaves the store and 0.5% to 0.75% go unnoticed by everyone, including the customer.

“More people check their photographs at a one-hour photo mart than check their prescriptions at a pharmacy,” he said.

Grasha says about 3% to 5% of the errors that reach customers are clinically significant. He bases his estimates on other research and his own studies of pharmacists who monitor their own errors. Grasha’s research was funded in part by chain drugstores.

The most reliable estimates range from 2% to 3%, according to Michael Cohen, president of the Institute for Safe Medication Practices. The nonprofit group studies trends in errors and advises health care officials on how to minimize them.

Even with an error rate as low as 0.5%, a small drugstore dispensing 200 prescriptions daily would average an error a day. Nationwide, pharmacies would make 15 million mistakes this year.

Pharmacists acknowledge a problem. In a 1997 survey of 206 pharmacists by Drug Topics magazine, more than half admitted making at least one dispensing error in the previous two months.

“If a pharmacist tells you he hasn’t made a mistake, he’s lying,” said Larry Sasich, a pharmacist with Public Citizen, a consumer advocacy group based in Washington, D.C.

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Millions of errors cross drug counters each year, and some--like Gabrielle’s prescription--cause harm. This points to thousands of error reports that regulators simply don’t receive.

Drugstore companies report at least some of their errors to their insurers. Internal pharmacy records, found in court records obtained by the AP, offer a rare glimpse into the errors that pharmacies never report to regulators.

In a Texas lawsuit, Eckerd Drugstores said it received 9,826 claims of errors in the 6 1/2 years ending in July 1991. That’s an average of 1,512 per year. Asked about the report, the nation’s third-largest drug chain responded with this statement: “Eckerd is committed to reducing already minuscule error rates even further.”

In a Florida lawsuit, Walgreen & Co., the nation’s top-selling chain, fielded 6,147 reports of dispensing errors over two years ending in 1994. The allegations triggered 223 lawsuits.

Both Eckerd and Walgreens note that those figures represent fewer than one error for every 40,000 prescriptions filled. Eckerd filled 418 million over the 6 1/2 years. Walgreens filled 248 million prescriptions over the two years reported.

But those figures don’t include all the errors their druggists make.

They don’t include cases in which customers accepted small payments to resolve the dispute.

An internal guide called “Handling Prescription Errors” advises Walgreens pharmacists that “all pharmacy supervisors have $500 settlement authority when trying to conclude a prescription error claim before contacting Travelers,” Walgreens’ insurance company. If the claim can be resolved, the guide advises, “do not call Travelers.” In those cases, the report goes no further than the pharmacy manager.

Sometimes customers never point out the error. Even when they do, many druggists interviewed said, they often don’t even tell their managers.

“We’d report the ones that we expect to have repercussions. . . . Maybe one out of 30,” said pharmacist Joe Grant. He took medical leave from Philadelphia Rite Aid after what he described as a physical breakdown brought on by an excessive workload.

Fewer Stores Filling More Prescriptions

Many pharmacists blame mistakes on a workload that they say grows more unmanageable each year. Data from the National Assn. of Chain Drug Stores and the U.S. Department of Labor reveal that druggists are dispensing more prescriptions than ever.

In 1989 Americans bought 1.5 billion prescriptions at drugstores. In 1999 they bought 3 billion, according to NACDS. Over the same period, federal figures show the number of pharmacists dispensing them rose just 5%, from 171,000 to 180,000.

In the case of Gabrielle Hundley, an outside pharmacist testified that the store was understaffed and Jones was overworked. Rite Aid appealed a $16-million verdict for Gabrielle’s family in 1998, stating: “The company believes there is no evidence to prove that workload played any role in this case.” The appeal is pending.

The workload crunch is likely to get worse. The industry association predicts that by 2005, the number of prescriptions will jump by at least one-third, to 4 billion, while the number of pharmacists will increase 6%.

The rising volume of prescriptions was prodded by managed care insurers.

Insurers helped to drive up drug use, especially among aging baby boomers, by encouraging doctors to use medications rather than more expensive treatments requiring hospital visits. Then insurers cut the fees they paid to pharmacies.

The result was more and bigger chain stores--and fewer mom-and-pops.

Lower Profits, Higher Volume

Chains made up for lower drug profits by raising volume. They bought rival stores and made existing stores bigger. One in three independents has gone out of business since 1990. The total number of drugstores dropped from 59,000 to nearly 52,000 during that time. Chains, which were outnumbered by mom-and-pops in 1991, now dominate them by a 3-to-2 margin. Chain drugstores sell 6 of every 10 prescriptions.

“You’ve got fewer stores filling more prescriptions,” said Bill Ward, director of the drug control division of Connecticut’s Department of Consumer Protection. “When you think about that, it just begs for errors.”

Pharmacies are trying to ease the workload. To shoulder much of the pharmacist’s burden, they’re hiring more technicians and assistants--a total of 129,000 nationwide, at cheaper rates, with less education. Companies also have upgraded computer systems to track more than 5,000 prescription drugs on the market, identify those that don’t mix and guard against bad reactions.

“There is more business coming into the pharmacy, no doubt about that,” said Walgreens spokesman Michael Polzin. “But we’ve made a very concentrated effort to deal with that workload efficiently.”

Critics say it’s not enough.

“The system is flawed, and too little is done to correct the problem,” Douglas Hepler, a University of Florida professor, told a conference of the nonprofit Joint Commission of Pharmacy Practice in October. “The system has moved from a scientific and professionally driven enterprise to a market-driven enterprise, yet managers don’t see safety as a market commodity.”

When errors occur, they often involve pharmacists dispensing the wrong drug, as in Gabrielle Hundley’s case. But giving the wrong dosage can be just as serious.

Jill Cabanillas has lived with the results of such an error since Aug. 23, 1994. That day she heard her daughter, 6-year-old Bryn, speak her last words: “Mommy, it’s cold.”

Bryn’s eyes rolled back in her head and she suffered a two-hour seizure, racked by spasms.

Emergency room doctors discovered why: The pharmacist had given her 100-milligram pills of the barbiturate phenobarbital--six times the dose her doctor ordered.

Bryn still cannot speak or walk. The overdose, from a Thrifty drugstore in Costa Mesa, caused repeated spasms that exacerbated a mild case of cerebral palsy. Now a pump implanted in her abdomen delivers anti-spasm medication to her spine. Her parents hope an operation will eventually allow her to stand upright.

The family won a $30-million verdict against Rite Aid, which bought the Thrifty chain. The lifetime award--which surpassed the Hundley verdict as the largest pharmacy malpractice award on record--was later settled for a smaller amount in cash.

“I would have thought that there were enough checks and balances” in the pharmacy, Jill Cabanillas said. “Whatever they’re doing isn’t working.”

A Crazy Quilt of State Laws

The nation’s drug distribution system is overseen by pharmacy boards, dominated by fellow pharmacists and governed by a patchwork of 50 state laws. Practices that are legal in one state--such as letting pharmacy technicians take refill orders over the phone--are outlawed in the next. Punishment for the same violation can range from a reprimand to a revoked license.

Even many of those who make the rules concede the system doesn’t make a lot of sense. David Work, executive director of North Carolina’s board, calls it “bizarro world.”

Regulators discipline few pharmacists and fewer pharmacies.

No regulatory agency keeps a record of disciplinary actions in all states. The AP filed public records requests with each state, asking for each disciplinary case in 1998.

According to that data for all 50 states, druggists and their employers were disciplined 1,454 times in 1998. The violations range from drug addiction to failing to keep proper records on narcotics. They exclude cases in which failing to keep up with annual education requirements was the only violation.

State regulators punished druggists or their employers just 357 times for dispensing errors in 1998. Most came to their attention when consumers complained. In two out of every three cases, the pharmacist was let go with a reprimand. Fines are rare and usually less than $300.

But there are some dramatic differences in the way states enforce their laws. Arizona officials, for example, met informally with dozens of pharmacists to talk about their mistakes, but disciplined none.

Janna Schwehm faced harsher discipline in Washington state.

When the druggist mistakenly doubled a patient’s dosage of the painkiller Fentanyl and then failed to respond to investigators in time, the board revoked her license for 10 years. She was not available for comment.

“You’ve got all ends of the spectrum in enforcement,” said Fred Mills, who retired in December as executive director of Louisiana’s board. “There’s no consistency.”

The types of violations and punishment in a given state bear little relationship to the state’s size. Florida, with 15 million residents, disciplined one pharmacist for a dispensing error in 1998. Washington, with 5.8 million, disciplined 64 pharmacists and pharmacies for errors--more than any other state--and warned 77 more.

Regulators widely view North Carolina as the nation’s most aggressive pharmacy watchdog. Besides requiring mandatory death reports, the board makes pharmacy owners share blame for errors by especially busy pharmacists.

North Carolina is different because the board is elected by pharmacists, Work said.

“Every other board has political appointees,” he said. “We are relatively immune from politics.”

Political hurdles are part of the reason no other state requires drugstores to report fatal mistakes, said Carmen Catizone, president of the National Assn. of Boards of Pharmacy.

Regulators created the nonprofit trade group to coordinate laws among states. The association formally supports new laws requiring drugstores to report errors. But members who favor the requirement have failed to override opposition from drugstore executives, who fear that error reports could be used against them in court.

“Even the good ideas--like mandatory reporting--are often defeated by special interests,” Catizone said.

The California State Board of Pharmacy voted not to support a popular 1998 bill to study errors. Gov. Pete Wilson, elected with support from managed care insurers, later vetoed it.

The cost of not knowing is high, said Rep. Bill Coyne (D-Pa.), who has unsuccessfully sought mandatory disclosure at the federal level. “I am concerned that medication errors that could be avoided are being repeated over and over again because those mistakes have not been identified and prevented.”

The result is that pharmacy boards get scant information on the industry they regulate. New Jersey receives some reports of pharmacy malpractice cases from insurers-- but only after legal disputes are resolved and only if they are settled without confidentiality agreements, New Jersey board member Sophie Heymann said.

“We just got a case from 1993,” Heymann said in a 1998 interview. “What do you do with a pharmacist that’s been on duty from 1993 to 1998 after an error was committed in 1993?”

Some pharmacists have used that confusion to their advantage. Disciplined in one state, they cross a border and practice until the next state catches on.

Fifty druggists were disciplined in 1998 after regulators in one state learned of violations in another, according to disciplinary records.

The National Assn. of Boards of Pharmacy acts as a clearinghouse for states to check the pasts of such druggists. But the nation’s most populous state, California, doesn’t participate.

Texas regulators suspended a Houston druggist’s license in 1994 when he was accused of stealing morphine. By then he was working in California. State officials there eventually discovered the Texas discipline and revoked his license in 1998. By then he’d held a California license for four years.

Even in states that do run candidates’ names through the national background check, a pharmacist sometimes eludes detection.

Jerry Cavalier apparently had no problem working in Nevada. But when he applied to work in Washington, investigators there found that he had also worked in Ohio-- where his license had been revoked 20 years earlier after a felony conviction for drug-trafficking.

Washington regulators denied him a license for 10 years, but they couldn’t find him to tell him so.

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NEXT WEEK: Overworked pharmacists prone to errors and severe stress.