The harm in pharmacy misfills

It never occurred to Gwen Dalley that there was anything wrong with the prescription antibiotic pills she picked up at a Loganville pharmacy. But within a day of taking them, while driving her usual school bus route, she was so overcome with dizziness that she had to pull over and radio for a substitute driver.

As Dalley continued to take the pills, her symptoms got worse. She was nauseated, started having headaches and her vision blurred. She was briefly hospitalized, but doctors couldn’t figure out what was wrong.

Eventually she noticed that some of the pills in the pharmacy bottle were larger than others. It turned out most of them were not the antibiotic her doctor had prescribed, but an antidepressant with significant side effects, according to a complaint Dalley filed in January with the Georgia Board of Pharmacy.

Every year, dozens of Georgia consumers complain to state regulators about mistakes made at local pharmacies. Patients have received double, quadruple, even 10-times their prescribed dosages. They’ve been sent home with the wrong drugs: One patient was given the risky blood thinner warfarin – instead of a diabetes medication. Another was given diet pills instead of blood pressure pills. Still another was dispensed an Alzheimer’s treatment instead of sleeping pills, according to pharmacy board disciplinary records.

In response to the AJC’s questions, officials at several major pharmacy chains — including CVS, Rite Aid, Kmart and Kroger — issued statements saying that safety is their top priority and that they all have systems to ensure prescription accuracy.

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Yet mistakes still happen.

Nobody knows exactly how many because only a fraction are reported to regulators; most are handled privately by the pharmacies.

Some studies indicate that about 3 percent of the prescriptions dispensed by pharmacies have potentially harmful errors. The patient may be given the wrong drug, the wrong dosage or the wrong directions.

“That’s pretty big numbers overall,” said Michael Cohen, a pharmacist and president of the Institute for Safe Medication Practices, noting the billions of prescriptions Americans get filled each year. “You should be concerned enough to look at your medication, talk to the pharmacist and know what can go wrong in the pharmacy.”

Allie Fennell learned this lesson the hard way.

Fennell, 34, had taken a generic version of the popular allergy drug Allegra for years without problems. Then in May 2008 she picked up a refill from the CVS pharmacy at 1544 Piedmont Avenue in Atlanta that instead contained a psychiatric drug called nefazodone, according to a complaint she filed with the pharmacy board.

“I kept taking them every day and my allergies were getting worse,” Fennell said. On top of that, she began feeling like her brain was in a fog and she became nauseated. She eventually noticed a description of the pills on the label didn’t match the pills in the bottle.

Dalley, the school bus driver, said she’s still outraged about being given the wrong drug by a CVS pharmacy in Loganville in 2007. “What if I’d been driving down the road with 50 kids and passed out?” she asked.

CVS officials declined to comment on the incidents. Trent Speckhals, an attorney who represented Dalley and Fennell, said both women settled their cases confidentially.

Pharmacy regulators said they can’t confirm or deny whether the women’s complaints were ever received. Under Georgia law, the complaint process, as in most states, is mostly kept secret.

Only if the pharmacy board votes to publicly reprimand the pharmacist or pharmacy are any details available for review.

But many reprimands are delivered privately as letters of concern. The public is not allowed to see these. Board officials were unable to say last week how many of these private warning letters have been issued.

The AJC reviewed more than 200 public disciplinary documents issued by the pharmacy board since 2006 and posted on the Web at http://tinyurl.com/puborders . Many involved pharmacists with substance abuse problems or who had dispensed narcotics without valid prescriptions. Others involved pharmacists voluntarily surrendering their licenses without any details being given as to why. A few involved pharmacy employees preparing or dispensing medications without a licensed pharmacist being present to oversee the accuracy of their work.

About 50 public disciplinary actions involved medication mistakes. In most cases the pharmacist was fined $500 and required to take a medication safety course; the pharmacy they worked for usually received a similar fine.

After a mistake is made, one or two years may pass before the board issues the public reprimand, records show. The reasons for the delays are unclear due to the secretive nature of the process.

When pharmacy mistakes happen, fatigue and overwork are the main factors said Rick Allen, deputy director of the Georgia Drugs and Narcotics Agency, which serves as the board’s investigative arm.

Allen said his agency receives five to 10 complaints a month about misfilled prescriptions. Most of the complaints are valid, he said.

The pressure on retail pharmacists to crank out prescriptions can be intense, he said, with some overseeing hundreds of prescriptions a day.

“Most of the time they’re overworked. They let their technician do too much of the work and they’re not checking what the technician did,” Allen said.

Technicians’ training may be minimal, Allen said, which is why a licensed pharmacist is required to review each prescription being dispensed. Georgia pharmacists are only allowed to supervise the prescription-filling work of three technicians.

From 2004 through 2007, regulators found CVS pharmacies across the state making mistakes and often having too many technicians and not enough pharmacists, records show. In September 2007 the pharmacy board required CVS to pay a $75,000 fine.

CVS, which has 300 stores in Georgia, has the No. 1 market share of total drug store sales in the Atlanta area.

CVS/pharmacy spokesman Mike DeAngelis, in an e-mail, said: “We recognize that any process involving people is not immune from the possibility of error or accidental deviation from procedural controls,” noting that if an error occurs, the pharmacy works to learn what happened and what can be done to prevent it from happening again.

Regulators can only investigate the mistakes that are reported, and few are. Most consumers complain directly to the pharmacy, which usually handles the matter privately, Allen said.

“What we get is really a trickle of what’s happening,” Allen said. “Most stores do not report their misfills to us. ... It would be good if they were reported. If we’ve got a pharmacist with a problem, we need to know about it.”

But Allen admits that a flood of complaints could drown his shrinking staff of investigators.

“We’ve gone from 13 agents down to really nine because of furloughs and state layoffs,” Allen said. That’s less than the agency had 35 years ago, when there were half the number of pharmacies in the state and Georgians took a fraction of the prescription drugs they do now, he said.

Still, he said, “If a patient has been injured we try to get on to that and put everything else aside.”

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Mistakes take many forms

The Georgia Board of Pharmacy makes some of its reprimands -- called public board orders -- available for review on the Web. In many cases there is a significant lag time between when the mistake occurred and when action is taken.

● A 27-year-old woman who was prescribed an anti-anxiety medication for an allergic condition instead received a powerful heart drug from a Kmart pharmacy in Cartersville. The woman was hospitalized for three days after suffering a reaction to the drug. The board order was issued in September 2008; the prescription was misfilled in February 2007.

● Pharmacists at a Wal-Mart in Newnan misfilled a patient’s prescription for Quinamm, to treat malaria, with Quinapril, a blood pressure medication. And they did it three times. A board order was issued in January 2008; the incidents occurred in November 2005 and in June and July 2006.

● A CVS pharmacy on Jones Bridge Road in Alpharetta improperly refilled a 10-month-old child’s prescription for Zantac – needed to control stomach acid — with liquid Zyrtec, an allergy medication. Even though the child’s mother called the pharmacy to ask why the liquid smelled different, she “was assured by the pharmacist on duty that the correct drug had been given.” The child took the drug for a week before the mother noticed the pharmacy label was covering another showing the drug was actually Zyrtec. The board issued its order in July 2007; the incident occurred in May 2005.

● A Kmart pharmacy in Canton sent a patient home with a bottle of the antibiotic Levaquin that said to take the pills four times a day — instead of just once a day as the doctor prescribed. The patient followed the wrong instructions on the bottle and in August 2007 Kmart settled a claim over the misfill and notified the board. The board issued its order in December 2008; the incident occurred in 2005.

Source: Georgia Board of Pharmacy, public board orders. CVS and Kmart officials declined to comment on the specifics of these cases; Wal-Mart didn’t respond.

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Protecting Yourself

● Look in the bag: Before you leave the pharmacy counter, take a look at the label the pharmacy has put on your medication. Is your name spelled correctly? Is your doctor’s name correct? If not, you might have someone else’s prescription. Make sure the right drug and dosage are on the label.

● Talk to the pharmacist: Experts say many mistakes are caught when patients talk with the licensed pharmacist on duty — not a technician — about the drug they’re picking up. Tell the pharmacist what you’re taking the drug for. Tell the pharmacist about other medications you’re taking and any medical conditions. Ask how the drug should be taken and about potential side effects.

● Be wary: If pills you’ve been taking are a different color or shape, ask questions.

● Get more information: The Institute for Safe Medication Practices has more useful tips at www.consumermedsafety.org . To get updates about new safety alerts for the medications you take, go to www.consumermedsafety.org/medsafetyalert.asp

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Where to complain

● Georgia Board of Pharmacy: Complaints can be filed online at: http://tinyurl.com/soscomplaint . Or write to: Georgia Board of Pharmacy, 237 Coliseum Drive, Macon, GA 31217. Make sure to include your name and contact information.

Tell the AJC: The Spotlight column wants to know about complaints filed by consumers with the pharmacy board and whether any action was taken. If you’ve filed a complaint in recent years, tell us about your experience: 404-526-5041 or spotlight@ajc.com.

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Check our sources

Public reprimands involving pharmacies and pharmacists are posted on the Secretary of State’s Web site, http://sos.georgia.gov/plb/PublicOrders/

In most cases, however, the documents are listed in the name of the pharmacist, and the pharmacy’s name is mentioned within the document. Pharmacies are often identified by store number, not address.

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Got a tip?

Do you suspect government waste, a consumer rip-off or a threat to public safety? Tell us what you want investigated. E-mail spotlight@ajc.com or call 404-526-5041.

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