NABP e-News March 21, 2007

March 21, 2007 12:00 AM

California Panel Issues Recommendations to Reduce Medication Errors
The California Medication Errors Panel issued a report on March 6, 2007 focusing on the causes of medication errors in the outpatient setting and recommending changes in the health care system to protect consumers from errors associated with prescription and over-the-counter medications. The Panel’s recommendations focus on the following areas:

• Communication – such as improving the legibility of handwritten prescriptions, setting a deadline for the implementation of electronic prescribing, requiring the intended use of medications to be included on all prescriptions and labels, and improving access to and awareness of language translation services;
• Consumer Education – to increase consumer awareness regarding the proper use, and the dangers of misuse, of prescription and over-the-counter medications;
• Pharmacy Standards and Incentives – to improve the quality and consistency of medication consultation provided by pharmacists, and establishing standards for medication therapy management programs and incentives for their implementation and ongoing use by pharmacists and other health care providers;
• Training and Education – creating continuing education requirements for pharmacists and other health care professionals that address safety practices, such as medication consultation and medication therapy management programs;
• Research – to obtain information about the incidence, nature, and frequency of medication errors in the community setting.

The full report is available at http://www.pharmacyfoundation.org/AM/Template.cfm?Section=Med_Errors.

NABP Discusses Pharmacy Compounding Issues at APhA Annual Meeting
NABP Executive Director/Secretary Carmen Catizone presented “Quality Standards and Practice Issues in Pharmacy Compounding: the NABP Perspective” on March 18, 2007 at the American Pharmaceutical Association Annual Meeting and Exposition in Atlanta, GA. Mr Catizone was a co-presenter with Eric Kastango, RPh, MBA, of Clinical IQ, LLC, in the continuing education session "Achieving USP 797 Compliance." Mr Kastango discussed compliance with United States Pharmacopeia (USP) Chapters 797 and 795, a subject he will also discuss at the NABP 103rd Annual Meeting during a special pre-meeting continuing education session targeted specifically to board of pharmacy investigators. This session will take place at 2 pm Saturday, May 19, 2007, at the Hilton Portland & Executive Tower in Portland, OR. Mr Catizone addressed the roles of the state boards of pharmacy and the Food and Drug Administration (FDA) as they relate to the regulation of pharmacy compounding; distinctions between compounding and manufacturing; the NABP Model State Pharmacy Act and Model Rules regarding compounding, including NABP's Good Compounding Practices; and the standards outlined in USP Chapters 797 and 795.

FDA Asks Manufacturers to Print Warnings on Labels of All Sleep Disorder Drugs
FDA has requested that all manufacturers of sedative-hypnotic drug products revise product labeling to include stronger language concerning potential risks. Adverse events could include anaphylaxis and angioedema, which can occur as early as the first time the product is taken, and complex sleep-related behaviors such as sleep-driving, making phone calls, and preparing and eating food (while asleep). Along with the labeling revisions, FDA has requested that manufacturers send letters to health care providers to notify them about the new warnings and develop Patient Medication Guides to be dispensed with the drugs to inform patients about the risks and precautions.

FDA: Stop Manufacturing and Distributing Unapproved Ergotamine Tartrate Products
FDA recently told 20 companies to cease marketing unapproved drug products containing ergotamine tartrate. Ergotamine tartrate products are used to treat vascular headaches, including migraines. As part of continued efforts by FDA to combat the marketing of unapproved drugs, FDA sent warning letters to eight manufacturers and 12 distributors warning them that they are subject to further enforcement action if they do not stop manufacturing and distributing these products. FDA urges patients who are using ergotamine products and have questions or concerns to contact their health care providers. This action does not affect FDA-approved products containing ergotamine, which will remain on the market.

Four Facilities Awarded VAWD Accreditation
NABP recently accredited four new facilities through its Verified-Accredited Wholesale Distributors^®(VAWD^®) program, bringing the total number of accredited facilities to 76. A full listing of VAWD facilities is available in the VAWD section of the NABP Web site.

• Bloodworth Wholesale Drugs, is an independent wholesale distributor of generic pharmaceuticals. The company received accreditation for its Tifton, GA facility.
• Kroger Limited Partnership II dba Peyton's Northern, is the wholesale distribution facility for Kroger, Fred Meyer, and Dillon stores in Indiana, Michigan, Ohio, and Kentucky. The company received accreditation for its Bluffton, IN facility.
• Metro Medical Supply Wholesale, Inc dba Metro Medical Supply Wholesale, Inc, provides medical products to customers with special medical needs. The company received accreditation for its Nashville, TN facility.
• Safco Dental Supply Company, distributes medical, dental, and optical equipment. The company received accreditation for its Northbrook, IL facility.