NABP e-News: May 15, 2008

May 15, 2008 12:00 AM

Hospitals Continue to Administer Recalled Heparin Products to Patients; FDA Urges Removal
Despite 81 deaths in the United States associated with contaminated heparin and at least five recalls of various heparin dosage forms in the last several months, hospitals continue to administer the recalled drugs to patients. During the week of April 22, 2008, the California State Board of Pharmacy initiated specialized inspections of all hospital pharmacies to determine (1) if the recalled heparin remains on the shelves, (2) where the pharmacies are obtaining heparin, and (3) where the wholesalers are getting the heparin. As of May 5, after having inspected some 220 hospitals (of 500), the Board found recalled heparin in 32 of these hospitals. In 11 of the hospitals, the Board identified cases in which patients had received the recalled heparin. On May 2, the state Department of Public Health initiated inspections of the 500 California dialysis clinics they license to ensure these clinics are not using recalled heparin on patients. Food and Drug Administration (FDA) has issued a request asking health professionals to examine all storage areas to ensure that all of the recalled heparin products have been removed and are no longer available for patient use. More information is available on the FDA Web site at www.fda.gov/cdrh/safety/heparin-healthcare-update.html.

Florida Legislature Passes Bill Requiring Registration of Pharmacy Technicians
Under a bill passed recently by Florida legislators, pharmacy technicians would need to register with the Florida Board of Pharmacy by 2010. Starting in 2011, the legislation would require them to complete one of the following: a board-approved training program, 1,500 hours of work as a technician under a Florida licensed pharmacist, or certification by a program accredited by the National Commission for Certifying Agencies. The bill is posted on the Web site of the Florida Senate at www.flsenate.gov/data/session/2008/Senate/bills/billtext/pdf/s1360er.pdf.

Maryland Passes Legislation for Comprehensive PBM Oversight
The Maryland General Assembly passed a comprehensive legislative package on April 17, 2008, providing regulatory oversight of pharmacy beneficiary managers (PBMs). The bills require all PBMs to register with the state, disclose certain information before switching a prescription, provide fee schedule information to pharmacies, and ensure that any person responsible for making prescription decisions is authorized to do so. Approximately 95% of all patients with prescription drug coverage receive benefits through a PBM. PBMs manage an estimated 70% of prescription drugs dispensed through retail pharmacies that are covered by private third-party payers.

Debate Continues over Pharmacists’ Conscientious Objections in Wisconsin
The March 25, 2008 appellate court decision to uphold disciplinary action imposed by the Wisconsin Pharmacy Examining Board against a pharmacist who refused to dispense birth control may be subject to the scrutiny of the Wisconsin Supreme Court. A law firm recently asked the state’s high court to hear an appeal of the disciplinary action, claiming the pharmacist is being punished unjustly for refusing to compromise his religious beliefs. The supreme court justices will vote to determine whether to hear the case.

FSMB Mulls Model Policy to Require Demonstrations of Continuing Competence for Re-licensure
The Federation of State Medical Boards’ (FSMB) House of Delegates is considering the adoption of a model policy to assist states in requiring physicians to demonstrate their continuing competence as a condition of re-licensure. The House of Delegates recently endorsed a recommendation for additional research into the potential impact the model policy, currently in draft form, might have on state medical boards, licensed physicians, and other stakeholder organizations. The draft model policy suggests that state medical boards require physicians to take part in ongoing self-assessment and tailored educational activities, and to demonstrate continuing competence in their areas of practice. More information is available on the FSMB Web site at www.fsmb.org/m_mol_faqs.html.

Three Additional Facilities Awarded VAWD Accreditation
NABP recently accredited three new facilities through its Verified-Accredited Wholesale Distributors^® (VAWD^®)program, bringing the total number of accredited facilities to 268 as of May 9, 2008. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

• Nationwide Medical/Surgical, Inc offers a full line of prescription drugs including controlled substances to pharmacies, hospitals, clinics, and physicians. The facility also provides wholesale distribution services to customers in Europe and Asia. The company received accreditation for its Van Nuys, CA facility.
• Schnucks Pharmacy Service Center is the primary supplier of pharmaceutical and other goods for the 90-plus Schnuck Market Pharmacies located in Indiana, Illinois, Iowa and Missouri. The company received accreditation for its Bridgeton, MO facility.
• Stericycle, Inc is a full-service reverse distributor serving customers in 43 states. Stericycle also provides recall management consulting and execution services. The company received accreditation for its Indianapolis, IN facility.