NABP e-News: April 3, 2008

April 3, 2008 12:00 am

California Board Delays Implementation of e-Pedigree Requirement
On March 25, 2008, the California State Board of Pharmacy voted unanimously to delay implementation of its requirement for electronic pedigrees originally scheduled to take effect on January 1, 2009. The new implementation date is January 1, 2011. The decision comes in response to the concerns of professional pharmacy organizations and drug companies regarding pharmacists’ ability to comply with the law if all of the pharmaceutical manufacturers were not in compliance with the regulation, as well as the potential cost of compliance. Upon implementation of the law, no wholesaler or pharmacy may sell, trade, or transfer a prescription drug at wholesale without providing an electronic pedigree, and no wholesaler or pharmacy may acquire a prescription drug without a pedigree. More information is available on the California Board Web site.

Indiana Legislation Requires Internet Pharmacies to Obtain VIPPS Accreditation
The state of Indiana is raising the bar for nonresident pharmacies conducting business over the Internet and shipping prescription medications to Indiana customers. Read more in the March 31, 2008 NABP news release posted on the NABP Web site.

Court Upholds Board’s Action against Pharmacist for Refusal to Dispense Birth Control
On March 25, 2008, the Third District Circuit Court of Appeals upheld the disciplinary action imposed by the Wisconsin Pharmacy Examining Board against a pharmacist who refused to fill a lawful prescription for oral contraceptives or to transfer the prescription. The patient testified that, as a result of the pharmacist’s actions, she missed the first dose of the medication. The Board determined that the pharmacist had engaged in unprofessional conduct which could have caused harm to the patient and, as a consequence, placed restrictions on the pharmacist’s license, requiring the pharmacist to inform all future employers in writing that he will not dispense birth control pills and outline the steps he will take to ensure a patient has access to this medication. The court upheld the Board’s action. The court ruling is available at www.wicourts.gov/ca/opinion/DisplayDocument.pdf?content=pdf&seqNo=32233.

FDA Identifies Products Requiring Risk Evaluation, Mitigation Strategy
Food and Drug Administration (FDA) has identified 25 drugs and biologic products for which it will require the manufacturers to submit a safety plan, called a Risk Evaluation and Mitigation Strategy (REMS). These products have been identified as beneficial to patients but especially dangerous if not used properly. Under the Food and Drug Administration Amendments Act of 2007, FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug, to help ensure that health care professionals prescribe the drug correctly and that patients use it safely. The manufacturers of the 25 drugs and biologic products identified must submit to FDA a proposed REMS by Sept. 21, 2008. More information, including the 25 drugs and biologic products identified, is available on the FDA Web site at www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.htm.

Minnesota Senate Approves Bill to Thwart Illicit Internet Drug Distributors
The Minnesota Senate has unanimously approved a bill intended to curb the operation of illicit Internet drug distributors in Minnesota. The bill (House File 2639 / Senate File 2941) was created in response to the 2006 prescription drug overdose of St. Cloud, MN resident Justin Pearson, who obtained a prescription for a controlled substance from an Internet drug distributor by filling out an online questionnaire without a medical evaluation. Dubbed "Justin's Bill," the legislation would require a face-to-face visit between the patient and the practitioner who prescribes a commonly abused prescription drug. The bill, available at www.revisor.leg.state.mn.us/bin/bldbill.php?bill=H2639.1.html&session=ls85, now goes to the state House of Representatives.

Heparin Contaminant Identified; FDA Recommends Purity Tests
FDA investigators have identified the contaminant found in some batches of recalled heparin as over-sulfated chondroitin sulfate. Investigators are now trying to determine whether the contaminant is to blame for the recent 21 deaths and more than 700 reports of serious side effects in heparin users, and whether it was introduced deliberately into heparin products. The contaminant reacts like heparin in many tests, which is why the traditional release tests did not detect it. To ensure a safe supply of heparin, FDA has released information on two other screening tests, proton nuclear magnetic resonance and capillary electrophoresis, that manufacturers and regulators can use to check for this contaminant. More information on these tests is available on the FDA Web site at www.fda.gov/cder/drug/infopage/heparin/default.htm.

CriticalPoint Offers Boards Free Web-Based Training on Aseptic Compounding
CriticalPoint, LLC is offering free Web-based training to acquaint state board of pharmacy inspectors with the revised compounding standards outlined in United States Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding - Sterile Preparations. The revised standards will become official on June 1, 2008. Registration is available by e-mailing Peter Cantor of CriticalPoint at pcantor@criticalpoint.info. CriticalPoint also offers an interactive Flash-based competency program on garbing and hand hygiene to ensure competency with USP 797 garbing requirements. More information is available on the CriticalPoint Web site at www.criticalpoint.info.

Seven Additional Facilities Awarded VAWD Accreditation
NABP recently accredited seven new facilities through its Verified-Accredited Wholesale Distributors^® (VAWD^®) program, bringing the total number of accredited facilities to 261 as of March 28, 2008. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

• Aurobindo Pharma USA, Inc manufactures generic pharmaceutical products and distributes its products to wholesale distributors, pharmacies, and hospitals throughout the United States. The company received accreditation for its Cranbury, NJ facility.
• Exel, Inc is a third-party logistics provider exclusively for the generic pharmaceutical drug manufacturer Sandoz. The company received accreditation for its Mechanicsburg, PA facility.
• McKesson Corporation, dba McKesson Drug Company, primarily supplies pharmaceutical products and over-the-counter items to other McKesson facilities nationwide. The company received accreditation for its Aurora, CO facility.
• Priority Solutions International, Inc, dba Distribution Solutions International, Inc is a third-party logistics provider that distributes prescription drug samples, over-the-counter and medical devices to pharmaceutical sales representatives and physicians. The company received accreditation for its Memphis, TN facility.
• VaxServe, Inc, a Sanofi Pasteur Company, distributes Sanofi Pasteur vaccines and other manufacturers’ prescription drug products to primary care physicians’ offices, community immunization providers, immunizing pharmacies, travel clinics, and corporations. The company received accreditation for its facilities in the following locations:
  • Kansas City, Mo
  • Sparks, NV
  • Taylor, PA