Pharmacies have until 2006 for their patient leaflets to pass muster


If pharmacies don't beef up their patient leaflets by 2006, FDA will pass regulations, instead of relying on the private sector, to get the job done



Pharmacies have until 2006 for patient leaflets to pass muster

Community pharmacists have until 2006 to make sure they are providing useful written drug information to consumers with their prescriptions. At that time, if less than 95% of consumers are getting quality patient leaflets with their Rxs, the Food & Drug Administration will step in with federal mandates pharmacies must meet, rather than rely on the private sector to get the job done.

So warned Leslie DeLaPena Wheelock, the FDA's associate director for communication, at the recent National Association of Chain Drug Stores' Pharmacy & Technology Conference in Philadelphia. She told the audience that the FDA would conduct a study in 2007 to assess whether this goal is met.

The rationale for this initiative is a law passed in 1996, calling for 75% of consumers to receive quality information by 2000 and 95% by 2006. Wheelock said a study commissioned by the FDA and presented in 2001 found that out of 384 pharmacies surveyed, 11% gave out no written information to patients and 13% offered only scanty information. So there's clearly room for improvement out there. She added that cultivating well-informed consumers is one of the highest priorities for the new FDA commissioner Mark McClellan.

Disturbing findings were uncovered by another survey—this one obtained responses from 13 computer companies representing 20,000 pharmacy system installations in the country. Conducted last August by William Lockwood, executive director of the American Society for Automation in Pharmacy, the survey found that aside from using hard-to-read type sizes, some computer vendors eliminated black box warnings from their monographs, while others dropped disclaimers stating that the monograph is not intended to cover all possible uses, precautions, drug interactions, etc. These omissions are "a major liability exposure not just for the computer vendor but also for the pharmacist distributing the information," Lockwood cautioned.

One patient leaflet provider has taken steps to redress this problem. James L. Wilson, executive president and CEO of First DataBank, revealed that his firm has appended a black box warning to all of the company's patient leaflets that require it. This meant affixing the warning to more than 420 out of the 2,100 leaflets in its database. Wilson added that its contracts with customers do not allow them to leave out any content presented in the leaflets. Armed with five pharmacists and five pharmacy techs to handle patient education, First DataBank is working with the University of California, San Francisco, to review all of its 2,100 leaflets to make sure the company is ready to meet the 2006 deadline, he said.

Representing the pharmacists' side, Stephen Mullenix, VP for professional and industry relations at Medicap Pharmacies, said that practitioners want leaflets that are balanced without scaring patients with so much adverse event information that they stop taking their drugs. At the same time, they prefer leaflets that are simple, one page in length, low in cost, easily reproducible, and that won't add to their workload burden.

The challenge is clear: The private sector has until 2006 to get its act together, said John Coster, VP of policy and programs at NACDS. He urged pharmacists to go back and review their patient leaflets to see whether they meet FDA standards. He pointed to the FDA survey, which found that almost one-quarter of consumers receive either no information or barely any. The large chains can get up to speed on this initiative quickly, but how do you reach "the small pharmacies and small software vendors, which still constitute a significant part of the market?" he asked. "Help us avoid federal regulation of what you provide to consumers," he pleaded, adding that NACDS has produced a self-assessment guide to help pharmacists evaluate their leaflets.

Judy Chi

What to look for

Here are the eight criteria the Food & Drug Administration is using to evaluate patient leaflets. Pharmacies should compare their leaflets against this list to see how they match up.

  • Display drug name and indications for use.

  • State contraindications and what to do if you have them.

  • Talk about how to use the drug, monitor its safety, and get the most benefit from the product.

  • Give precautions and how to avoid them.

  • Present adverse events and what to do.

  • Offer general information and encourage consumers to ask questions.

  • Provide information that is scientifically accurate, nonpromotional, and up to date.

  • Be comprehensible, legible, and readable at the sixth- to eighth-grade level.

Judy Chi. Pharmacies have until 2006 for their patient leaflets to pass muster.

Drug Topics

Oct. 6, 2003;147:43.

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