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Drug Information Leaflets for Consumers Need Improvement, FDA Says

Kate Traynor

A study commissioned by FDA indicates that, although 89% of newly filled prescriptions come with written drug information for consumers, much of that information is incomplete and of limited use to patients.

The study, which was led by researchers from the University of Wisconsin School of Pharmacy, examined more than 1300 pharmacy-generated drug information leaflets for atenolol, glyburide, atorvastatin, and nitroglycerin.

Using predetermined evaluation criteria, a panel of 16 pharmacy professionals concluded that 51% or fewer of the leaflets provided adequate information about contraindications to the prescribed drug. No more than 53% of the leaflets provided sufficient warning of important precautions patients should take when using the drugs.

For example, less than 1% of the leaflets fully explained the need for patients who take atorvastatin to undergo liver function tests before and during medication use. Only a third of the leaflets adequately warned patients that taking sildenafil with nitroglycerin can be fatal.

The expert opinions were supplemented by the views of consumer panelists who were asked to examine and rate the leaflets. The most common problem noted by the consumers was illegibility of the drug information—a problem also cited by the expert panel. The consumers gave a third of the leaflets a score of 1 or 2 out of 5 possible points for print size, print quality, line spacing, and ease of reading.

Based on the study’s findings, FDA’s Drug Safety and Risk Management Advisory Committee concluded during a July 17 open hearing in Gaithersburg, Maryland, that the leaflets produced by the private sectors do not comply with Public Law 104-180. That law, which was enacted in 1996, required 75% of new prescriptions to include "useful written information" about the products by the year 2000. By 2006, 95% of newly dispensed prescription drugs must be accompanied by useful written information.

Failure to comply by 2006 could subject the leaflets to FDA regulation—a course of action that the advisory committee seemed reluctant to embrace.

The advisory committee recommended that FDA convene a workshop to identify specific ways to bring the leaflets into compliance.

Committee member William H. Campbell, dean of the University of North Carolina School of Pharmacy in Chapel Hill, said that workshop participants should include ASHP and other professional organizations holding a stake in drug safety and risk management. ASHP is also a producer of the leaflets.

The committee also recommended that an oversight group be appointed and that the group have some unspecified ability to enforce compliance with Public Law 104-180.

FDA had noted in a June 18 statement that the agency "sees progress" in meeting the so-called "Keystone criteria" used to evaluate the leaflets. In particular, 95% of the leaflets were deemed by the expert panel to be up-to-date, scientifically accurate, and nonpromotional. The drug information leaflets were also evaluated to determine whether they

  • Contained the drug’s names and indications,
  • Listed contraindications and what to do if the patient has one,
  • Described how to use the drug, monitor its use, and best benefit from the medication,
  • Listed precautions and told how to avoid harm,
  • Described serious or frequent adverse events associated with the drug’s use and what to do if such an event occurs,
  • Provided general information and encouragement to ask questions about the drug, and
  • Were legible and comprehensible at a sixth- to eighth-grade reading level.