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Public Citizen finds fault with the patient leaflets pharmacists distribute to consumers at the time of dispensing.
Are patients getting sound written drug information with their new prescriptions? This issue has been at the center of a contentious debate for more than 20 years. The divisions have been along ideological lineswith pharmacists and their associations favoring a "marketplace for information" and consumers preferring a government-regulated program with quality standards and oversight.
The issue dates back to 1979, when the Food & Drug Administration proposed the first plan. It was killed in the early days of the Reagan Administration. In 1982, the National Council on Patient Information & Education (NCPIE) was formed, pledging to meet patients' information needs.
In 1995, the FDA proposed the Medication Guide rule. The same ideological forces that divided the FDA's 1979 plan greeted this proposal. A compromise was struck over the Medication Guide rule with the passage of Public Law 104-180 in 1996. This law called for the FDA to assess the effectiveness of current private-sector approaches to providing patients with drug information. If 75% of patients receiving new Rxs did not receive useful written information by the year 2000, the Department of Health & Human Services would be required to explore other initiatives. The HHS Secretary accepted the "Action Plan," as it was known, on Jan. 13, 1997. The Action Plan stated that drug leaflets to patients should be accurate, unbiased, sufficiently comprehensive, understandable, timely, and useful.
Next, the FDA granted a contract to the University of Wisconsin School of Pharmacy to conduct a national assessment of patient information leaflets. In June 2002, the FDA released the results of this assessment, which covered about 1,300 leaflets distributed nationally by pharmacists for atenolol, atorvastatin, glyburide, and nitroglycerin. The survey found that while 89% of patients received some written information, the information was only about 50% useful.
To Public Citizen, the concept that drug information can be 50% useful is unfathomable. Drug information that contains only half of what it should is misleading, and misleading drug information is potentially dangerous.
Based on the survey results, FDA concluded that progress has been made in meeting the goals set under the law. The agency said it would continue to work with private sector partners to improve the usefulness of patient information and meet the goal for the year 2006, which calls for 95% of patients obtaining new prescriptions to receive useful written drug information at the time of dispensing.
Following the FDA's decision to delay action until 2006, Public Citizen's Health Research Group filed suit against the agency this past February, challenging the FDA's failure to seek public comment as required by the law. Negotiations began almost immediately, and the suit was settled in April. In the settlement, the FDA agreed to hold a public meeting this month and to open a docket to seek public comment. It is expected that some at this meeting will raise the issue of pharmacist counseling and oral information provided by health professionals.
Consumer groups are strongly supportive of verbal interactions between healthcare professionals and consumers, but given the limited amount of drug information that can be communicated to and retained by a consumer in this type of interaction, we continue to believe that FDA-approved written information provides patients with the best opportunity to avoid preventable adverse drug reactions. An August 1997 Office of Inspector General report found that enforcement of patient counseling laws by state pharmacy boards has been minimal, underscoring the need for mandatory distribution of FDA-approved written drug information.
Several professional trade organizations, including some representing pharmacy, have consistently supported the distribution of high-quality drug information for consumers. However, these same organizations also oppose FDA oversight of quality guidelines such as those contained in the Action Plan. Claiming support while opposing regulatory oversight is disingenuous and does nothing for the image of pharmacy as a health profession. The results of the University of Wisconsin survey clearly show the poor quality of drug information that consumers can expect without active FDA oversight of quality guidelines.
With the settlement of the Public Citizen lawsuit, patient information leaflets will once again come up for public debate. Pharmacy could cultivate smarter patients by remembering that voluntary programs have failed for 20 years and by supporting the only viable alternative availablean FDA-regulated program.
Larry Sasich. Useful drug information: 20 years and still waiting. Drug Topics Jul. 7, 2003;147:17.