Preventable Drug-Induced Injury: What is the Last Line of Defense?

A study published in the October 3, 2001, Journal of the American Medical Association reveals the extent of inappropriate prescribing by physicians and the equally inappropriate dispensing by pharmacists of cisapride (PROPULSID), a dangerous nighttime heartburn drug that was removed from the market in March 2000 because of fatal heart rhythm disturbances (see the March 2000 issue of Worst Pills, Best Pills News).

The researchers examined prescription claims data from several preferred provider and health maintenance organizations for all patients with cisapride prescriptions between July 1993 and December 1998. The study involved the records of 38,757 pediatric and adult patients who had received a total of 131,485 prescriptions for the drug after warnings about the drug and contraindications against its use, mandated by the Food and Drug Administration (FDA), began appearing in cisapride’s professional product labeling. Of these prescriptions, 4,414 (3.4 percent) were identified as being prescribed with at least one drug contraindicated in the labeling.

Of all of the cisapride prescriptions identified as being prescribed with a contraindicated drug, 2,190 (50 percent) were by the same doctor, 3,908 (89 percent) were by the same pharmacies, and 765 (17 percent) were dispensed on the same day. These results actually underestimate the extent of cisapride misprescribing and misdispensing because the study did not look at patients with a long list of medical conditions in which cisapride was also contraindicated. In the October 2001 issue of Worst Pills, Best Pills News we wrote about the failure of FDA-mandated safety labeling changes and “Dear Health Care Professional” letters to protect patients from preventable drug-induced injury or death. One of the studies we cited involved cisapride and was published in the December 20, 2000, issue of the Journal of the American Medical Association. In this study, in one state Medicaid program, in the year prior to the strengthening of the black box warning in cisapride’s labeling, 60 percent of patients were receiving the drug when it was contraindicated. In the year after the appearance of the black box and a “Dear Health Care Professional” letter the proportion of patients receiving the drug in a contraindicated manner had hardly decreased at all—only from 60 to 58 percent.

The December 2000 study reinforces a broad belief that FDA regulatory actions have a minimal effect on decreasing potential drug-induced injury and death. The October 2001 study shatters two widely held myths about drug safety: 1) going to one doctor instead of more than one will protect you from dangerous drug interactions and the prescribing of contraindicated drugs; and 2) using only one pharmacy will have the same effect.

The answer to the question asked in the title of this article is certainly not the doctor or the pharmacist based on recent published research—it is you. In our crazy-quilt, market-based, so-called “health care system,” as the profits of entrepreneurs (doctors, pharmacists) are squeezed, more responsibility for managing the risks of prescription drugs is transferred to the people who will use them.

What You Can Do

Before using a new prescription drug, ask your pharmacist for the drug’s professional product labeling or “package insert.” Pay particular attention to the “Contraindications” section, which will tell you what drugs should not be used in combination with the one that has been prescribed, and which medical conditions make it inadvisable to use the prescribed drug. Also, the “Drug Interactions” section of the package insert contains information that can be life saving.