NABP e-News February 07, 2008

February 7, 2008 12:00 am

USP Hosts Free Webinar on Revised Chapter 797 Compounding Standards
United States Pharmacopeia (USP) will host a free Webinar at 11:30 am EST (GMT -05:00, New York) on February 20, 2008 to acquaint state board of pharmacy inspectors and surveyors of the Pharmacy Compounding Accreditation Board with revised compounding standards. The revised USP General Chapter 797 Pharmaceutical Compounding - Sterile Preparations will become official on June 1, 2008. The Webinar will provide direct dialogue with two compounding experts who serve on the USP Expert Committee responsible for the standards and will include time to address questions. Instructions for connecting to the Webinar are available on the NABP Web site. USP also has scheduled several fee-based Webinars and workshops. More information on these events is available on the USP Web site.

CMS to Suspend Medicare Disease Management Pilot Project
Phase I of the Medicare Health Support (MHS) program will end in July 2008, after three years of operations by five Medicare health support organizations, according to Centers for Medicare and Medicaid Services (CMS). The MHS program was established by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 as a two-phased initiative. Phase I is a pilot program designed to test a variety of care management interventions for some 68,000 fee-for-service Medicare beneficiaries with heart failure or diabetes. CMS will determine whether to expand the MHS program for Phase II based on the results of an independent evaluation, which will assess whether the program has improved clinical quality and beneficiary satisfaction, and achieved savings targets. Preliminary evaluations indicate that Phase I of the program is not meeting these criteria. More information is available on the CMS Web site at www.cms.hhs.gov/CCIP/downloads/EOP_Fact_Sheet_FINAL_012808.pdf.

Nine Miami-based DME Sellers Convicted for Defrauding Medicare
The owners of nine Miami, FL-based health care corporations were convicted of Medicare fraud and sentenced to prison terms in mid-January 2008, the Department of Justice (DOJ) announced. The nine defendants were charged with filing a collective total of $56.6 million worth of fraudulent Medicare claims for unnecessary durable medical equipment (DME) and infusion therapy. According to data from CMS, Miami-Dade County alone accounted for more paid DME claims than 44 other states. The full press release is posted on the DOJ Web site.

NABP Joins Supply Chain Safety Discussion at PhRMA Briefing
NABP staff participated in the January 2008 briefing of the Pharmaceutical Research and Manufacturers of America (PhRMA). Each month, PhRMA hosts a briefing on a current topic of interest to patient advocacy groups, consumer groups, and health care professionals. The January briefing, “From Production to Patient: An Examination of the Supply Chain and the Protective Measures Used to Keep it Safe for US Consumers,” took place on January 30 at PhRMA headquarters in Washington, DC. NABP discussed prescription medication counterfeiting, how these fake drugs enter the supply chain via Internet and wholesale drug distributors, and what the boards of pharmacy and NABP are doing to address this problem.

FDA Moves Forward with Plans to Establish Permanent Offices Abroad
Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach recently announced that FDA is moving forward with plans to establish permanent offices outside the United States. By stationing personnel in US embassies, FDA hopes to be in a better position to improve the safety of food and medicines coming into the US. Von Eschenbach named five regions where FDA inspectors and technical advisers potentially could be staffed: China, India, Europe, Central and South America, and the Middle East. Funding for the program, dubbed “FDA beyond Our Borders,” reportedly will be incorporated into FDA’s budget request for fiscal year 2009.

Nine Additional Facilities Awarded VAWD Accreditation
NABP recently accredited nine new facilities through its Verified-Accredited Wholesale Distributors^® (VAWD^®) program, bringing the total number of accredited facilities to 243 as of February 1, 2008. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

• Fresenius USA Manufacturing, Inc, dba Fresenius Medical Care North America, distributes dialysis products and equipment to clinics and home patients in seven states. The company received accreditation for its Perrysburg, OH facility.
• JOM Pharmaceutical Services, Inc, a subsidiary of Johnson & Johnson, distributes prescription drug products manufactured by its own companies, eg, Ortho-McNeil and Janssen. The company received accreditation for its Shepherdsville, KY facility.
• McKesson Corporation, dba McKesson Drug Company, distributes pharmaceutical and over-the-counter (OTC) products to pharmacies nationwide. The company received accreditation for four of its subsidiaries in the following locations:
  • Salt Lake City, UT
  • Wilsonville, OR
  • Aurora, CO
  • Little Canada, MN
• Perrigo Pharmaceuticals Company is a global health care supplier and manufacturer of OTC, pharmaceutical, and nutritional products for the store brand market. The company received accreditation for two of its distribution facilities in the following locations:
  • Greenville, SC
  • Allegan, MI
• Wal-Mart Stores East, LP, dba Wal-Mart Pharmacy Warehouse #46, supplies pharmaceutical products, including Schedule III-V controlled substances, and general merchandise to Wal-Mart Stores and Sam’s Clubs in 17 states. The company received accreditation for its Williamsport, MD facility.