Newswise — Peter Doukas, Ph.D., dean of Temple University School of Pharmacy, tells every new class, "There's a fine line between a drug helping and a drug harming."

Pharmacists, the health care professionals most equipped to draw this line, are increasingly leading efforts in hospitals and other health care facilities to insure medication safety. In 2001, under the direction of Patrick McDonnell, Pharm.D., assistant professor of pharmacy practice, and Michael Cohen, R.Ph., M.S., Sc.D., president of the Institute for Safe Medication Practices (ISMP), Temple University's School of Pharmacy became the first in the nation to establish a Drug Safety elective track for students who want to specialize in this growing field. McDonnell and Cohen are joined by professionals from the Food and Drug Administration (FDA), ISMP, and the School of Pharmacy in teaching the courses. Students then go on two rotations related to drug safety either at a hospital, a pharmaceutical company, ISMP or the FDA.

According to the Institute of Medicine's 1999 report "To Err is Human," medication errors, one type of drug safety issue, account for approximately 7,000 of the 44,000 to 98,000 deaths from medical errors annually.

Medication errors can be costly as well. McDonnell's most recent publication, in Hospital Pharmacy, describes the case of a man admitted to the hospital with a severe drug reaction to the tune of $181,000 for a 31-day hospital stay. The cause of this error was a well-known drug interaction that was most likely missed because there were two "prescribers" on the health care team who didn't communicate. Furthermore, the interaction was not detected by the patient's pharmacist.

"In class, we look at the systems in place that allow these mistakes to happen: bad handwriting, the placement of bottles on the pharmacy shelf and drugs that look alike or sound alike. These constitute errors of commission. I also try to convey to students that errors of omission, not asking patients about other drugs they are taking, and not stressing the importance of taking drugs as prescribed, can also occur," said McDonnell.

To understand how medication errors happen, it helps to look at medication use as a process, or a series of events, that starts with the drug company manufacturing the drug and extends to the patient taking the drug. At each step there is potential for mistakes, for instance when the doctor selects the patient's drug therapy, when the pharmacist fills the prescription, and when the patient takes the drug.

In the U.S., drug safety at the manufacturing and distribution level is scrupulously monitored and tightly regulated. By the time a drug reaches the pharmacy, it is usually safe in and of itself. As evident in recent news however, such may not always be the case when a drug is widely used within a large population over an extended time period.

"Over the past two decades, more and more new drugs have entered the market and some are being fast-tracked through the research and approval process. At this point, a critical phase in terms of drug safety is post-marketing surveillance, or monitoring the drug during and after the initial advertising push. All drugs go through clinical trials to evaluate safety and efficacy, but often out of economic necessity, many drugs come to market with fewer than 10,000 participants and at least 30,000 are needed to accurately determine safety," explained McDonnell.

McDonnell spends half of his time teaching at the pharmacy school and the other half at a hospital as a pharmacist preceptor where he guides pharmacy students on clinical rotation. His students analyze actual adverse drug events, with an emphasis on prevention, in class and then in clinical rotations.

"We study patients who are hospitalized because of drug-induced problems and conduct discharge counseling to make sure patients truly understand their medicines. Hospital re-admissions due to adverse drug events comprise 3-10 percent of all hospital admissions," said McDonnell. "One third of patients either don't understand or don't follow medication directions. A common failure is when patients take less of the drug than they're supposed to or stop taking the drug altogether."

According to the Institute of Medicine, patients, professionals and institutions can all play a part in improving drug safety. Hospitals and health care organizations can utilize "proven medication safety practices, such as automated drug-ordering systems."

Patients need to ask questions, raise concerns and understand the medicines they are taking. And pharmacists, says McDonnell, need to be more fully utilized as drug experts within the health care team.

"We're in the best position to prevent adverse drug events, first by interacting more proactively with patients and second by joining in the patient care process, for example by participating with the medical teams during hospital rounds," he said.

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