Mike McClave is a foreman for the CSX railroad in Virginia. If one of his workers is injured, he has to tell the federal government. If a train slips off the tracks, he files a report. And when an engineer has worked for 12 hours, he rests.
So when McClave's 8-year-old daughter, Megan, died six years ago after a pharmacy gave her the wrong medication, McClave was shocked to learn that pharmacists in most states don't have to report their mistakes to anyone. He couldn't believe that they have no limits on the lengths of their shifts and that technicians who help fill prescriptions don't have to be certified in most states.
''If one wheel slips off the rail, we have to report it to the federal government,'' McClave said. ''Here's a whole industry that has much more of a direct impact on the public's health, and they're not subject to reporting. I think it gives a false sense of security about how safe it is.''
Pharmacy safety is again being questioned since 5-year-old Brendan Ward died recently from an improperly filled prescription. His death sheds light on an industry that has little oversight and is struggling to keep up with billions of new prescriptions for a confusing array of new drugs. It also shows how slowly states and the federal government have reacted to the surging numbers.
Bruce Roberts, owner of the Leesburg, Va., pharmacy that prepared Brendan's medicine at five times the prescribed dosage, said the boy's death should serve as a warning to his industry.
''Obviously, we're the cause of this child's death, and we're devastated,'' Roberts said. ''My hope is we'll be able to create a national dialogue to talk about this issue. In my mind, we've got a system that's broken.''
For McClave, the scrutiny is too late. He has been pressing for change since a Hampton Roads pharmacy dispensed Roxanol, a brand of morphine, instead of the prescribed Demerol after Megan's tonsillectomy.
McClave said that when he learned of Brendan's death, ''there was a pain in the pit of my stomach. We're still out there arguing about these things, and there are children dying.''
The crux of the problem, experts say, is that no one is keeping track of the errors. Only North Carolina and Georgia require drugstores to report mistakes, and even there only in grave circumstances: Georgia's pharmacists must alert the state when there's a ''significant adverse drug reaction,'' and North Carolina's pharmacists must report only deadly errors.
Last year, pharmacists nationwide filled about 3 billion prescriptions and likely will fill 4 billion by 2004, said Carmen Catizone, executive director of the Illinois-based National Association of Boards of Pharmacy. Although the number of prescriptions has grown rapidly, the number of pharmacists has risen by only about 10 percent over the past five years.
State pharmacy boards estimate that 2 percent to 5 percent of the prescriptions filled in 1999 included some sort of error, from simple misspellings to more serious dispensing or instruction mistakes.
''Nobody's actually quantified this, which is a very big problem,'' Catizone said. ''That's really the first step. We're missing the key data to fix the system.'' That data, Catizone and others say, would help the industry and government regulators attack the causes of common mistakes.
Industry groups point out that millions of prescriptions are safely filled each day. Pharmacies frequently review their own methods, have developed computer software to check a prescription's reaction with other medication, and even catch errors made by doctors.
Just last week, Florida authorities said, vigilant pharmacists probably saved lives by questioning a family physician who allegedly over-prescribed pain medication to patients.
''We did have pharmacists who questioned the frequency of the prescriptions and called the doctor,'' who is charged with four counts of manslaughter, said Santa Rosa County sheriff's spokesman Jim Lyle. ''Several did not fill the prescriptions.''
Phil Schneider, spokesman for the Alexandria, Va.-based National Association of Chain Drug Stores, said pharmacists go the extra mile to avoid errors.
''Pharmacies have well-established operating procedures to monitor the dispensing process in an effort to make sure it is done as accurately and safely as humanly possible,'' he said.
But in drugstores nationwide, the rising number of prescriptions and a shortage of qualified pharmacists are creating working conditions that have some experts fearful of increasing mistakes. Many pharmacists are working long hours with few breaks and spending more time haggling with insurance companies, they said.
''The whole process is very checks-and-balances oriented, but it's being strained,'' said Todd Dankmyer, spokesman for the National Community Pharmacists Association, which represents 24,000 independent pharmacies. ''It's being strained by an increase in volume, a shortage of pharmacists and a managed-care marketplace that has put us in a position where we are being forced to move even faster.''
Some in the industry think government regulators should have reacted sooner.
''These concerns have been known for years,'' said pharmacist Michael R. Cohen, president of the Pennsylvania-based Institute for Safe Medication Practices, a nonprofit educational organization. ''Our state boards and our regulatory authorities are in control of whether errors take place. Why doesn't someone look at these errors and see what needs to be done?''
Efforts to guard against prescription mistakes and other medical errors have stepped up nationwide only in recent months, largely in response to a 1999 Institute of Medicine report about deaths caused by medical mistakes of physicians, pharmacists and other health care professionals.
Last month, competing bills were introduced in the U.S. Senate to address the broader issue of medical errors. Both call for voluntary reporting that would include prescription mistakes.
Said Cohen: ''There are many more prescriptions that are being presented, and less pharmacists to fill them. Something's got to give, and it's creating havoc.''
And because new drugs are stronger than ever, mistakes are increasingly likely to have harmful consequences.
''Any error that's made now can be a serious error, because the drugs we use are extremely potent,'' said George E. Downs, dean of pharmacy at the University of the Sciences in Philadelphia.
Most state boards of pharmacy learn about errors only through consumer complaints or routine pharmacy inspections.
Last year, for example, the Virginia Board of Pharmacy disciplined 82 pharmacists, state officials said. From January through June, the board issued sanctions 29 times for mistakes including dispensing the wrong medication and providing the correct medication at the wrong dosage, or to the wrong customer.
One pharmacist dispensed Tofranil, an antidepressant, instead of the prescribed Topamax, an anti-epilepsy drug. Another filled a prescription for Prilosec, a heartburn medication, with Paxil, which is used to treat anxiety disorders. And a Richmond pharmacist instructed a patient to take four pills per day instead of the prescribed four tablets per week.
Jones said that when he heard about Brendan Ward's death, he planned a meeting with his employees to talk about the potential for life-threatening errors. ''When something like this occurs, any pharmacist will tell you it just gives them a sick feeling inside,'' he said.
In Brendan's case, a technician at Leesburg Pharmacy prepared a syrup that contained 250 milligrams of imipramine per teaspoon instead of the prescribed 50 milligrams, Roberts said. Pharmacist Gregory C. Chase dispensed the medication but didn't catch the error.
Brendan's mother, Kellie Ward, gave the boy two teaspoons of the syrup before putting him to bed April 5, state officials said. When she checked on him about 7 the next morning, he was dead.
According to a letter to Chase from the Virginia Board of Pharmacy, Chase did not document that he had verified Brendan's prescription. Scheduled to appear before the board in August, Chase could face sanctions ranging from a reprimand to the loss of his license. Chase was reprimanded by the state in October 1995 after dispensing the wrong tablets. He declined comment.
But no matter what regulations are put in place, medical experts say, no system is foolproof, and consumers must ask questions of their doctors and pharmacists.
It's advice Mike McClave learned the hard way. Ever since Megan's death, he asks a barrage of questions about any prescription medication. And he tells his friends to do the same.
''I never really wanted it to be a cause, but I couldn't sit back and not speak out,'' he said.
Brainerd Dispatch ©2013. All Rights Reserved.