Advisory Committee and Public Workshop Notices

*Also Submitted as a PDF File* VIA Electronic Submission March 30, 2009 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Chain Pharmacy's Recommendation to Improve Written Prescription Information, Docket No. FDA-2008-N-0038 Dear Sir or Madam: Thank you for the opportunity to submit our comments on the above referenced docket. As the Food and Drug Administration (FDA) considers ways to improve the quality and delivery of written prescription information distributed to patients, the National Association of Chain Drug Stores (NACDS) recommends the creation and use of a single, FDA-approved plain language document to replace all existing written prescription information distributed by pharmacies. NACDS has been pleased to work with the FDA over the years to address issues related to written prescription information and is prepared to assist the FDA and members of the FDA Risk Communication Advisory Committee to help implement this patient-friendly solution. We understand that many patients rely on the written prescription information distributed by their pharmacies. These written materials are intended to provide patients with information about their medications, such as why they are on the medication, what they should expect from the medication, including any possible adverse event(s), and how to use the medication properly to best adhere to their doctor's instruction(s). These are typically the questions most patients ask and information they seek when they pick up a prescription from the pharmacy. Pharmacists are trained to convey this information in a succinct manner using layman's terms. Any written prescription information provided to patients should complement verbal communication and be presented in a similar manner to achieve optimum understanding by the patient or caregiver. The Current System Overwhelms Patients Unfortunately, the current system does not afford patients with succinct, easily comprehendible information and unintentionally creates barriers to the proper use of the information received by patients. Patients are overwhelmed with too much information under the current programs. For example, a patient who has received a prescription for an anti-depressant may receive consumer medication information (CMI), patient package insert (PPI), and medication guide (MedGuide) with their medication, which could amount to several pages with potentially conflicting information. In more extreme cases, MedGuides alone could amount to 15 or more printed pages. Furthermore, there are other documents that patients could receive in addition to these such as additional messages from the manufacturer that accompany the drug product. A patient could easily leave the pharmacy with a multitude of information from different sources varying significantly in content and complexity. Even if there is critical information to be conveyed such as the risk of certain adverse events, repeated presentation of that information in multiple documents with inconsistency in coverage, tone or sense of importance may unnecessarily discourage the patient from taking the drug. The problems created by the volume and length of information are only the first challenges to patient acceptance. As the CMI survey results point out, the difficulty in comprehending CMIs continues to hinder the program and contributes to the difficulties patients experience in acceptance and understanding of materials distributed to them. The complexity is also a problem with other written information provided to patients such as MedGuides and PPIs. Another challenge is the type of information that must be communicated is inherently difficult to convey. Complex clinical information is not easily translated to simple layman's terms. In addition, as clinical knowledge about a drug or therapy expands, these materials are updated to account for the new information. Under the current system, it…