NABP e-News: September 16, 2009

Contact Test Security: NABP's Tip Site Accepts Reports of Testing Violations
NABP examinations are administered under strict security measures, and information on suspected examination irregularities, acts of unethical behavior, and breaches of security can be reported on NABP’s examination tip site. Incidents that compromise the content of any NABP examinations, including the NAPLEX, MPJE, and FPGEE, can be submitted anonymously; or, to further discuss the incident with NABP staff, include personal contact information when submitting the report or contact Customer Service directly at 847/391-4406. Reports of suspected irregularities are treated confidentially and are investigated fully in support of NABP's commitment to ensuring the integrity and reliability of its examinations. The tip site is accessible under the Examinations section of the Web site.

NABP Amendments to Model Act Focus on Improved Quality and Safety in Patient Care
NABP amended the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) in the interest of improved quality and safety in patient care, and as an outcome of task force and committee recommendations, which were approved by the NABP Executive Committee.

  • The Model Act’s Pharmacy Practice section was amended to include a new subsection on drug labeling requirements; the subsection mandates that labels emphasize critical information for patients.
  • The Patient Counseling subsection now includes the suggestion that pharmacists counsel patients on proper disposal methods of unused medication.
  • Further, the definition of valid patient-practitioner relationship has been clarified.
  • Finally, the definitions for certified pharmacy technician and pharmacy technician were clarified to explicitly list which activities they may perform and those that they are excluded from performing.

More information on the amendments to the Model Act, and images of example prescription labels, are available on page 171 of the September 2009 NABP Newsletter.The current Model Act can be accessed on the NABP Web site under Publications.

CDC Posts Updated Recommendations for Antiviral Treatments and Influenza Prevention
On September 8, 2009, the CDC posted “Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season” on its Web site. The document provides “updated guidance on the use of antiviral agents for treatment and chemoprophylaxis of influenza including 2009 H1N1 influenza infection and seasonal influenza" and assists "clinicians in prioritizing use of antiviral medications for treatment or chemoprophylaxis for patients at higher risk for influenza-related complications.” Generally, the CDC does not recommend treatment with antiviral drugs for patients who are not high risk and do not require hospitalization. Specific recommendations for patients who do require treatment with antiviral medications include considering writing prescriptions following telephone consultations for selected patients at higher risk for influenza-related complications. Dosage and treatment information for specific high risk populations, and information on antiviral resistance, adverse events and contraindications is also provided.

FDA Updates "Warning Letters" Web Page
FDA has reorganized and updated the warning letters page in the Inspections, Compliance, Enforcement, and Criminal Investigations section of the FDA Web site. In addition to improved formatting and page navigation, the page will now include additional information as follows:

  • Every Tuesday, the most recently issued warning letters now will be presented under Recently Posted with the date provided.
  • Effective September 1, the Close Out Date is now provided in the Warning Letters table and detailed information about the Warning Letters Close Out Program is provided.

FDA Seeks Assistance in Tracking Stolen Albuterol Sulfate Inhalation Solution
Food and Drug Administration (FDA) is seeking assistance in tracking a cargo theft of 35,760 cartons of Dey® brand generic albuterol sulfate inhalation solution that occurred on approximately August 6 in McKinney, TX. Each carton contains 30 3-ml single unit-dose vials of 0.083% albuterol sulfate inhalation solution, NDC number 49502-697-29, lot numbers 9G01 and 9FE2. FDA stresses that every carton of Dey brand generic albuterol sulfate manufactured with these lot numbers was subject to this theft and was never previously distributed, so none of this product should be in the legitimate pharmaceutical supply chain.

FDA is asking pharmaceutical drug distributors and pharmacies that may receive offers for the stolen drug products, or that may have been sold stolen product, to contact FDA's Office of Criminal Investigations (OCI) by phone at 800/551-3989 or on the OCI Web site. Boards of pharmacy are urged to share this information with their licensees and to encourage distributors and pharmacies to verify pedigrees they receive with any wholesale drug purchases.

Three Additional Facilities Awarded VAWD Accreditation
NABP recently accredited three additional facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 364 as of September 10, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

  • Foundation Care, LLC is a specialty pharmacy focusing on rare chronic respiratory conditions and diabetes treatment. The company received accreditation for its Earth City, MO facility.
  • National Pharmaceutical Returns, Inc processes the returns of controlled and non-controlled prescription drugs, either returning products to the manufacturer and obtaining credit for the owner, or submitting products to a destruction company for proper disposal. The company received accreditation for its Urbandale, IA facility.
  • PD-Rx Pharmaceuticals, Inc is a small wholesale distributor, carrying a complete line of brand and generic pharmaceuticals, and is licensed in all states. The company received accreditation for its Oklahoma City, OK facility.

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