Drug Topics - March 10, 2008 - (Page 72) 72 DRUG TOPICS MARCH 10, 2008 www.drugtopics.com CONTINUING EDUCATION An ongoing CE program of The University of Florida College of Pharmacy and DRUG TOPICS CE The University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education ACPE # 012-99908-032-H03-P ACPE # 012-999-08032-H03-T Pharmacist responsibilities regarding Medication Guides Kimberly Burns, R.Ph., J.D., Assistant Professor, Lake Erie College of Osteopathic Medicine School of Pharmacy, Erie, Pa. Introduction very year, millions of Americans take prescription drugs without being fully informed by their healthcare providers about associated risks, contraindications, and adverse effects.One way to help inform patients about their prescription medications is through the provision of written information, available in various forms, regarding the prescribed drugs. Pharmacists, particularly in outpatient practice settings, have a vital role in ensuring that patients receive available written information. There are currently a number of public and private-sector initiatives that have the goal of providing patients with access to useful, scientifically accurate written drug information. The Food & Drug Administration Medication Guide program, which began in 1998, is one example of written drug information available for patients. Medication Guides are consumer-oriented FDA-approved written medication information sheets, more commonly known as “MedGuides.” The FDA requires distribution of Medication Guides to patients for the safe and effective use of select prescription drugs that have been determined to pose a “serious and significant public health concern.” Under the Medication Guide program, authorized dispensers (e.g., pharmacists and dispensing practitioners) are required to directly provide Medication Guides to the patient, meaning that pharmacists have the primary responsibility for meeting this requirement. However, pharmacist compliance with providing Medication Guides to patients may be very low, creating a concern as to whether patients are receiving useful, scientifically accurate information that the FDA has determined is important to ensure the safe and effective use of medications. Therefore, to help inform patients about their prescription medications, and to minimize potential liability, pharmacists should be educated on and aware of their responsibilities regarding the Medication Guide program. E This lesson is no longer valid for CE credit after 3/31/10. To obtain immediate CE credit, take the test online at www.drugtopics.com. Just click on the “Continuing Education” box on the Drug Topics home page, which will take you to the CE site. Log in, find and click on this lesson, and follow the three simple steps. Test results will be displayed immediately and you can print the certificate showing your earned CE credits. The author discloses that she has no financial relationship with any manufacturer in this area of medicine. Types of written patient information Medication Guides represent only one example of written patient information. The various types of written patient information available, as well as their differences, can easily confuse healthcare professionals. The following descriptions provide important information for pharmacists on the most common sources of written patient information available. Non FDA-approved written patient information Consumer Medication Information (CMI): Consumer Medication Information (CMI) is written information about prescription drugs developed by organizations other than a drug manufacturer that is intended for distribution to consumers at the time of dispensing. CMI is also known as voluntary pharmacy leaflets, which are computerized printouts that are attached to or placed in the prescription bag at the pharmacy. Although CMI is currently the most common form of written patient information received and relied upon by consumers, it is not approved by the FDA or drug manufacturers. However, in 2006 the FDA provided industry guidance to assist organizations in developing useful CMI. In addition, there are quantitative and qualitative goals regarding CMI’s distribution and usefulness to patients that generate from Public Law 104-180, which led to the development of the Keystone Guidelines. The Keystone Guidelines require that private- For questions concerning PRINT CEs, call (352) 273-6275. For questions concerning ON-LINE CEs, call (866) 261-3558. http://www.drugtopics.com http://www.drugtopics.com
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