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Right Drug, Wrong Patient

 

by Andrea Rock

 

As a rule, the pharmacy's proficiency and authority is little doubted. But the rate of pharmacy errors is much higher than people think. Imagine what would happen if the drug dispensed to you were not the proper one. The following article tells us more about pharmacy errors. 

 

At breakfast, seven-year-old Gabrielle Hundley took the first of two pills that would change her life. The new prescription that her mother, Peggie, had gotten filled at the Rite Aid in Rock Hill, S.C., was for Ritalin, a drug used to treat attention deficit-hyperactivity disorder.

In an emergency room later that day, February 21, 1995, doctors discovered that the little girl hadn't taken Ritalin at all, but a high dose of Glynase, a diabetes medication. In court the next year, the Hundleys' attorney argued that the pills were incorrectly dispensed, and contained 16 times the normal starting dose for adult diabetics, causing Gabrielle's blood-sugar level to plummet so severely that she suffered permanent brain damage. The jury awarded the Hundley family $16 million. Rite Aid is appealing the verdict.

Pharmacy transactions seem so straightforward. How often could they go awry?

While there are no definitive national statistics, there is evidence suggesting that drug-dispensing mistakes are more common than you think. In a 1997 nationwide survey conducted by the trade publication Drug Topics, 53 percent of pharmacists admitted having made errors in the preceding two months. A June 1996 survey of 3361 pharmacists in California and Oregon revealed that errors occurred at an annual rate of 324 per pharmacy—nearly one a day.

"Ten years ago, an acceptable error rate was considered one per year per pharmacy," says Ralph Vogel, president of the Guild For Professional Pharmacists, a union representing 2000 pharmacists. "What we're seeing today is the chaos that comes from understaffing and other new stresses in the pharmacy. "

The pharmacy industry insists that worries over error rates are overblown. Nevertheless, many state regulators, consumer advocates and pharmacists contend that a revolution in the retail drug business is causing problems by increasing workloads.

They point to two factors: First, overall prescription volume keeps rising─up 30 percent between 1992 and 1997, according to IMS Health, a health care information company. Second, the percentage of prescriptions paid for by insurance or HMOs has risen from 28 percent in 1991 to 60 percent in 1997. These third-party payers are imposing ever-lower reimbursement rates on pharmacies, which must churn out a high volume of prescriptions to keep profit margins up. Even the Big Four chains—Rite Aid, CVS, Eckerd and Walgreens─are affected.

Against this backdrop, too many people are taking the prescription transaction for granted. Indeed, for the past nine years, Americans responding to Gallup Polls have ranked pharmacists as the country's most honest and ethical professionals ahead of clergy members. No wonder so many people assume nothing can go wrong. "I had blind faith," says Peggie Hundley.

Here's what you need to know to protect your family:

You can't rely solely on your doctor. Most physicians get only one year of formal training in medical school on the use of prescription drugs. And, generally, continuing education on medications is not required.

In contrast, many states require pharmacists to complete an average 15 hours of continuing education each year. And there's no dearth of homework: new drugs are pouring into the market, stimulated by a 1992 program shortening the FDA 's drug-approval times. In the past two years, 92 new drugs hit the market—compared with 125 approved for the previous five years.

So don't assume you would never leave your doctor's office with a problem prescription. Ruth Paxton, 44, of Dayton, Nev., trusted her doctor implicitly when she sought treatment for a sinus infection in July 1992.

Years earlier, Paxton had experienced severe allergic reactions to the antibiotics penicillin and Keflex. Unaware of the severity of her past reactions, her doctor prescribed the antibiotic Ceftin, which can cause life-threatening allergic responses in people with extreme sensitivities to either of the other two drugs.

Within 20 minutes of taking Ceftin, Paxton's throat began to swell, making it difficult to breathe. Swift self-treatment with an anti-histamine stopped the reaction.

Nevada's board of pharmacy reprimanded Paxton's pharmacist, saying he should have warned her of the potential for allergic reaction.

A white coat does not a pharmacist make. The burden of knowing about potentially dangerous drug reactions is one reason pharmacists must complete five or six years of academic training. Yet increasingly, the white-coated person who dispenses medicine isn't a pharmacist at all but a pharmacy technician. Depending on the state, such techs may have nothing more than a high school degree and on-the-job training.

As pharmacy chains face squeezes on profit margins, the use of techs is growing. Why? Techs typically earn $5 to $12 an hour─compared with the average of $30 to $39 an hour for registered pharmacists.

Of course, pharmacists are supposed to check technicians' work. Failure to do so was cited as a major cause of dispensing errors by nearly a third of pharmacists in the Drug Topics survey.

You could get the right drug, but the wrong dose. Hazel Van Hattem of Crete, Ill., says there were two pharmacists and three technicians on duty on May 30,1995, when she picked up a refill of Coumadin, a powerful blood-thinning medication, for her husband, Ernest. "At the trial, they said they couldn't be sure who filled the prescription," says Hazel, referring to her lawsuit against Kmart. Her attorney argued that whoever filled the prescription did so with pills containing 5 mg. of Counmadin rather than Ernest's usual 2 mg.—an overdose that caused massive bleeding and led to his death. A jury levied an $810 000 judgment against the pharmacy. A Kmart spokesperson says the company is appealing.

Some dispensing errors can be attributed to unreasonable workloads. Three medical studies conducted over an 11-year period found a correlation between pharmacists' workloads and error rates :"There does appear to be a greater risk of errors when a pharmacist is expected to fill more than 24 prescriptions per hour," says Elizabeth Allan Flynn of Auburn University's School of Pharmacy. Increasingly, pharmacists say, pushing beyond that rate is not unusual.

The safety net has holes. Most pharmacies rely on computer setups that are supposed to be updated regularly with information about new drugs or new risks for existing drugs. But these systems don't always work.

In a study reported in the Journal of the American Medical Association in 1996, Raymond Woosley, chairman of the department of pharmacology at Georgetown University Medical Center, and his colleagues presented two prescriptions for the same patient to 50 pharmacists in the Washington, D.C., area. One was for the antihistamine Seldane; the other was for the antibiotic erythromycin.

Since 1992 the FDA and the drug manufacturers have issued warnings that mixing the two drugs could be fatal. Still, 32 percent of the pharmacies filled the prescriptions. Of the 48 pharmacies using computers to flag adverse interactions, 29 percent had programs that failed to issue an alert. In some cases, Woosley says, pharmacists had shut down the systems or overridden them.

And what about the patient information leaflets stapled to prescription bags at most pharmacies? These are also designed to give added protection against drug interactions or side effects. They usually aren't prepared by pharmacists or physicians—but by commercial vendors. And they're often vague or out-of-date.

Little watchdog oversight exists. Most state boards don't require pharmacies to report dispensing errors. And national error-reporting programs such as one run by U.S. Pharmacopeia (a nonprofit group that sets drug-manufacturing quality standards) are voluntary.

Drug chains, however, usually require pharmacists to submit error reports to management. But even those internal reports don't always prevent future errors.

Malvina Holloway, 59, of Mobile, Ala., received a bottle filled with Tambocor, a dangerous heart-rhythm-altering medication, rather than the breast-cancer drug Tamoxifen that her oncologist had prescribed. Holloway didn't discover the mistake until five months and two refills later.

Luckily, she did not experience any adverse reactions to the heart drug, but Holloway was distressed that her cancer treatment was delayed. She sued Harco Drugs, Inc., the regional chain where the mistake was made. Her attorney presented 233 incident reports that had been submitted to Harco management, the majority involving dispensing errors at their stores over the preceding three years. Holloway won a $255 000 jury award.

Such awards have motivated chains to improve internal procedures on error reports. But Carmen Catizone, executive director of the National Association of Boards of Pharmacy, which represents state licensing boards across the country, argues for greater oversight: "We are proposing that each individual pharmacy be required to report serious dispensing errors to the state board."

The ultimate responsibility of protecting himself, though, rests with the consumer. In most states, pharmacists are required by law to counsel customers about new prescriptions. Nevertheless, most customers turn down offers for a "show and tell."

Says Stephen Giroux, a pharmacist in Middleport, N.Y. "If people understood the harm that could be done to them by a dispensing error, they wouldn't treat going to a pharmacy like going to a fast-food store."

 

How to Protect Yourself

* Take Notes: At your doctor's office, write down the generic and brand names of your prescribed medicine, along with its purpose and the dosage. That way you can double-check the medication the pharmacist hands you.

* Inform Everyone: Remind both your doctor and your pharmacist of any drug allergies you have, as well as any other medications you're taking.Include over-the-counter pain or cold remedies, vitamins and herbal supplements.

* Check Refills: Make sure the pills are the same color and size you usually get. If they're different, assume they're wrong until a pharmacist examines them.

* Shop Off-Peak: Avoid getting prescriptions filled on a Monday, traditionally a pharmacy's busiest day. Call in refills a day or two ahead to lessen chances that your prescription will be filled during busy hours. If you get your prescriptions by mail, order them at least two weeks before you need a refill. Most importantly, if you feel sick after taking a newly prescribed drug, call your physician immediately.

                                                             —A.R.

    (1 645 words)

    (From Reader's Digest,Sept., 1999 )

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