Thursday, October 25, 2007

Fatal prescription errors becoming more common


When Chanda Givens found out she was pregnant, she did what most expectant mothers would do: She went out to fill her prescription for prenatal vitamins.

When she miscarried within a few weeks of taking the drug, Givens said it never occurred to her the prescription might be the cause. She later learned that instead of being given a prescription for Materna, a prenatal vitamin, she received one for Matulane, a chemotherapy drug used to treat Hodgkin's disease, according to a lawsuit filed this month in federal court.

The drug is intended to interfere with cell growth and DNA development, according to the lawsuit.

Givens said her prescription was filled at a Walgreens pharmacy near her suburban St. Louis, Missouri, home. Walgreens said it's reached a resolution with the family and declined further comment.

Every year in the United States, 30 million dispensing errors out of 3 billion prescriptions occur at outpatient pharmacies, according to the National Patient Safety Foundation. Some errors are minor. Some patients catch easily. But others can be serious.

"There's been a tremendous increase in fatal pharmacy errors over the past 20 years," said David Phillips, a sociology professor at the University of California-San Diego who has studied this issue. "And the increase is much bigger for outpatient pharmacies than for inpatient pharmacies."

Why the increase? Phillips said more health care is happening outside hospitals, putting more of a burden on outpatient pharmacists. Here, from Phillips and other experts, are ways to avoid becoming a victim:

* Don't get a prescription filled at the beginning of the month.

Phillips' research shows that in the first few days of each month fatalities due to medication errors rise by as much as 25 percent above normal. The reason: Social Security checks come at the beginning of the month.

"Quite a number of people can't afford to get their medicines until the Social Security check comes in, so at the beginning of the month they turn up in abnormally large numbers and swamp the pharmacists," Phillips said. "When pharmacists are busy, they make more mistakes."

Of course, it's not always possible to wait a week or two to get a prescription, but Phillips advises to do so if you can.

* Open the bottle at the pharmacy.

Mitch Rothholz, a spokesman for the American Pharmacists Association, said pharmacy errors aren't common, but that there are things patients can do to make sure the medicine inside a bottle is the right drug.

He said opening the bottle right at the pharmacy and showing the pills to the pharmacist is one safeguard. Another: If it looks different than the medicine you've taken before, or you have any questions, don't be afraid to ask the pharmacist.

* Don't be in a rush.

"When picking up drugs, patients want to get in and out quickly," said Hedy Cohen, a spokeswoman for the Institute for Safe Medication Practices. "We care if our food has butter or margarine on it. We really should be much more careful about the medications we put in our mouths."

Cohen said patients should take the time to get detailed instructions about how to take a drug. Errors happen not just when the wrong medicine is dispensed, but when the right medicine is taken at the wrong dosage.

Cohen added that pharmacies can take additional steps, too. For example, many drug names look alike.

Cohen suggests writing in capital letters the portions of drug names similar to other medications to make distinctions more clear and to prevent errors. Commonly confused drugs

The Institute for Safe Medication Practices has suggestions for making abbreviations clearer, too. For example, when a doctor writes "q.o.d." on a prescription, that means the pharmacist should instruct the patient to take the medicine every other day. That abbreviation could be mistaken for "q.d.", which means daily. The solution: Physicians should write out "every day" or "every other day."

Source: CNN, 10/25/07

Thursday, October 18, 2007

Ahead of the Bell: Cold medicine makers


One week after the nation's largest over-the-counter drug makers pulled cold medicines designed for infants off the market, companies will make the case Thursday that the treatments are safe and effective for toddlers.

The Food and Drug Administration will ask a panel of outside experts Thursday and Friday whether popular cold medicines are medically appropriate for young children. After a review of data, FDA scientists recently said the treatments should not be given to children under two because of the risk of accidental overdose. The agency will ask its advisers whether current labeling advising parents to "consult your physician" should be replaced with the instructions "do not use in children under two."

In response to the safety concerns, Johnson & Johnson, Wyeth and others withdrew products last week that target infants. However, public health advocates are expected to tell FDA that the companies haven't gone far enough.

The American Academy of Pediatrics, whose president will speak at the meeting, has said there is no evidence cold medicines are effective in children up to six years old -- and product labeling should state that. The pediatrics group and others also want FDA to prohibit companies from using images of toddlers to market their cold medications.

Scientists from Johnson & Johnson and other industry representatives are expected to argue that the treatments are effective in toddlers, while acknowledging that additional studies are needed to prove this.

FDA agreed to have its panel of experts review data on cold medicines at the request Baltimore city officials, who reported 900 Maryland children under four overdosed on the products in 2004.

FDA is not required to follow the recommendations of its panelists, though it usually does.

Source: Business Week, 10/18/07

Monday, October 1, 2007

FDA: Kids' Medicines NOT Recommended


They are widely available in drugstores across the country -- over-the-counter cold and cough remedies, with fruity flavors specifically marketed for kids.

But, there's a growing consensus that these medicines may not always be safe — and for young children, aren't worth the risks.

In a report released last week, safety experts within the Food and Drug Administration said they would recommend NO level of dosage for children under the age of two, "due to the lack of evidence of efficacy and safety concerns."

"There are a variety of problems that can occur, and there have been some deaths associated with cough and cold preparations," says Dr. Janet Serwint, who signed a petition, asking the FDA to warn parents about the dangers of these medicines.

Even more amazing, the industry itself — while insisting its medicines are safe — now agrees they should not be given to very young children.

"Parents should not use these products for children under 2," says Linda Suydam, president of the Consumers Healthcare Products Association.

Suydam says the real problem is "misuse" and "overdose." The labels on most boxes suggest that parents "consult with a doctor" about the appropriate dosage for children under the age of 2. The FDA review called that warning "confusing," and said it appeared to be contributing to "medication errors, which can result in fatal overdoses."

Overall, the review found 54 reported deaths from decongestants over the past four decades, most in children under the age of 2.

Experts say they believe the FDA may finally take action when it meets to discuss the matter next month.

Josslyn Goldner knows how dangerous over-the-counter medication can be. Her son, Max, wound up in the emergency room after he took the prescribed dose of a popular kids' medicine — one that isn't even under FDA review.

She says she has learned to be wary.

"I'm trying to be a little bit more selective and proactive, and not assume that companies that are in the business to make money, are going to actually be worrying so much about my child," Goldner says.

Source: ABC News, 9/30/07