For A Responsible National System Of Balanced, Evidence-Based, And User-Friendly Drug Information

In a health care system that rewards quantity over quality, rushed clinical encounters with physicians and pharmacists leave too little time to review drug risks and benefits says Jerry Avorn [Communicating Drug Benefits and Risks Effectively: There Must Be a Better Way. Jerry Avorn, MD, and William H. Shrank, MD, MSHS 21 April 2009 | Volume 150 Issue 8 | Pages 563-564]

This is not to mention a problematic mix of overpromotion, undercommunication, and inadequate regulation which has left many patients bewildered and mistrustful of prescriptions.

Avorn makes the case that as lay people and physicians increase their demands for coherent, evidence-based, unbiased drug information, we would all be well served by a comprehensive program to replace our current patchwork of bad communication and excessive promotion with a responsible national system of balanced, evidence-based, and user-friendly drug information.

Neither the package inserts nor the container labels offer as much help as they should says Avorn. Much discussion about drug information for lay people has focused on the package inserts; however, these documents are primarily written for physicians, not patients, and they are rarely inserted in the packages patients actually receive. Another source is the label affixed to the medication bottle. These communicate the name of the pharmacy in large type but vary greatly in their reporting of warnings (3) and instructions (4). When communicating essential safety information, container labels often use a font too small for many patients to read, and they often emphasize information more relevant to the pharmacist than the patient.

This reappraisal should not stop with evaluating patient-directed materials. Physicians need to learn about benefit and safety data through sources that are more useful than the tiny-print overkill that now constitutes these official documents (12–14). But as the work of Schwartz and colleagues points out, more than reformatting will be needed to create educational materials that guide physicians and patients in the right direction.

Using a Drug Facts Box to Communicate Drug Benefits and Harms-Two Randomized Trials Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS; and H. Gilbert Welch, MD, MPH 21 April 2009 | Volume 150 Issue 8 | Pages 516-527

Two randomized, controlled trials were conducted between October 2006 and April 2007 by Lisa M. Schwartz et al. This was a symptom drug box trial using direct-to-consumer ads for a histamine-2 blocker and a proton-pump inhibitor to treat heartburn, and a prevention drug box trial using direct-to-consumer ads for a statin and clopidogrel to prevent cardiovascular events.

In the symptom drug box trial, 70% of the drug box group and 8% of the control group correctly identified the PPI as being "a lot more effective" than the histamine-2 blocker (P < 0.001), and 80% and 38% correctly recognized that the side effects of the 2 drugs were similar (P < 0.001).

When asked what they would do if they had bothersome heartburn and could have either drug for free, 68% of the drug box group and 31% of the control group chose the proton-pump inhibitor, the superior drug (P < 0.001).

In the prevention drug box trial, the drug box improved consumers' knowledge of the benefits and side effects of a statin and clopidogrel. For example, 72% of the drug box group and 9% of the control group correctly quantified the benefit (absolute risk reduction) of the statin (P < 0.001). Most of the control participants overestimated this benefit, and 65% did so by a factor of 10 or more.

A drug facts box improved U.S. consumers' knowledge of prescription drug benefits and side effects. It resulted in better choices between drugs for current symptoms and corrected the overestimation of benefit in the setting of prevention.