• 04
  • May
    2011

In our last post, we began looking at a recent Wall Street Journal article discussing current efforts in the pharmaceutical industry to simplify consumer instructions and warnings related to prescription medications.

As the article points out, sometimes medication problems arise from clinician error or unexpected reactions. According to the Agency for Healthcare Research and Quality, between 2004 and 2008, the number of Americans who were injured or became ill from taking prescription medications rose 52 percent. In 2008, the number was 1.9 million. Over half of the increase can be blamed on corticosteroids, blood thinners, and sedatives and hypnotics. Another 838,000 other patients were taken to the ER with medication problems from painkillers, antibiotics, insulin, and cardiovascular medications, and hormones used in the treatment of various diseases.

But according to the FDA, poor literacy skills are another important cause of medication errors. A 2006 study showed that out of 70% of patients who had low literacy skills who could correctly recite the instruction "take two tablets by mouth twice daily," 34% could then proceed to demonstrate the actual number they should take. According to the National Consumers League, over one third of hospital admissions brought about by medication happen because of poor medication adherence. And as the National Community Pharmacists Association says, as much as 75% of Americans report that they do not take their prescription medications as directed.

One research professor cited by sources said that over half of adults misunderstand at least one common prescription warning or precaution. He also said that patients generally better understand instructions that are direct and explicit, and patients who have low literacy skills often benefit from picture instructions. Another study performed by that same researcher found that important warnings are often simply not present on labels.

Food and Drug Administration is currently working on replacing instruction inserts and medication guides, which are widely used in retail pharmacies, with single page consumer information sheets. A pilot test is currently waiting for funding to get the project underway, and sources said a final rule may be five or six years out. While supporters feel that consumers are more likely to avail themselves of one sheet's worth of warnings concerning a medication, opponents of the idea say that a one page printout is inadequate to properly warn consumers about certain medications.

Whatever ends up happening in the regulatory world, it is clear that something needs to be done to better inform consumers about the medications they consume, as well as to prevent doctors from making medications errors with their patients.

Source: Wall Street Journal, "'Use Only as Directed' Isn't Easy," Laura Landro, 26 April 2011.