NABP e-News: April 30, 2009

Health Care Community on Alert as Swine Flu Concerns Rise in US
The federal government has declared a public health emergency, as the number of confirmed human cases of swine influenza A (H1N1) in the United States has risen to at least 109, including one death, with additional cases suspected. H1N1 is not prevented by the current flu vaccine, and it is resistant to two of the four antiviral drugs licensed in the US for treatment of influenza, amantadine and rimantadine. It is sensitive, however, to oseltamivir (Tamiflu®) and zanamivir (Relenza®). Centers for Disease Control and Prevention (CDC) has developed a genetically matched “seed stock” for the strain, which would be needed if vaccine production is necessary.

The Food and Drug Administration (FDA) Office of Criminal Investigations (OCI) anticipates increased counterfeiting and diversion of flu treatment products and increased marketing of fraudulent and unapproved drugs (especially over the Internet) purported to prevent and treat H1N1. Any suspected fraudulent products and criminal schemes should be reported to Special Agent Gregg Goneconto or Special Agent Nancy Kennedy at OCI headquarters (800/551-3989), or via the OCI Web page at http://www.fda.gov/oci/contact.html.

Rx Response is working with local, state, and federal health authorities to help ensure the continued efficient functioning of the nation’s pharmaceutical supply chain in response to this public health threat.

NABP Asks Boards’ Help in Tracing Pharmaceutical Cargo Theft of Copaxone
The FDA OCI has notified NABP of a recent theft of the pharmaceutical Copaxone®. Approximately 14 pallets/994 cartons/5,962 packs of Copaxone (glatiramer acetate) 20 mg, a non-controlled substance with Batch/Lot #P53159 and an expiration date of January 2011, were stolen during the week of April 13-17, 2009. The tractor-trailer was recovered at a rest stop on the New Jersey Turnpike on April 20. Unfortunately, its contents were emptied. Corporate security from TEVA indicated that the remainder of the specific Batch/Lot #P53159 was recalled so that if that particular product with Batch/Lot #P53159 is being distributed, offered for sale, or dispensed, it would be the stolen product.

Copaxone is a unique product and is used only to treat patients suffering from multiple sclerosis. If the product is not stored below 74 degrees and out of the sunlight, it becomes ineffective and the product may not be safe for use.

NABP requests that the boards of pharmacy provide this information to the pharmacists in their states and ask them to immediately notify the FDA OCI if they are contacted by individuals offering to sell this product or if they have purchased this product or know of anyone who may be involved with this theft and the distribution of this product. 

Any information should be provided to Special Agent Gregg Goneconto or Special Agent Nancy Kennedy at OCI headquarters (800/551-3989), or via the OCI Web page at http://www.fda.gov/oci/contact.html.

NABP Seeking Pharmacists in All Practice Areas to Take Survey
The expertise of pharmacists in all areas of pharmacy practice is needed for an online survey NABP is conducting as part of a full pharmacy practice analysis. The survey, which is available at http://www.zoomerang.com/Survey/?p=WEB228YSHUR9UR, will run from April 1 to June 30, 2009. Survey results will furnish data necessary to update and validate the current North American Pharmacist Licensure Examination® (NAPLEX®) competency statements, which are scheduled to be revised and implemented into the 2010 blueprint.

NABP conducts a pharmacy practice analysis at least every five years in accordance with standard testing industry examination development and revision guidelines. The analysis allows NABP to ensure that the NAPLEX competencies are in line with the existing pharmacy practice standards and that they accurately reflect the current knowledge, skills, and abilities of entry-level pharmacists seeking licensure. Questions regarding the survey may be directed to custserv@nabp.net or 847/391-4406.

Pharmacies Agree to Provide Prescription Medication Instructions in Other Languages
Several large retail chain pharmacies, including Wal-Mart, Target, and Costco Wholesale Corporation, have agreed to provide New York customers with prescription medication instructions in their primary language. New York Attorney General Andrew M. Cuomo announced the agreement in an April 21, 2009 statement. Under the terms of these agreements, the companies will counsel all pharmacy customers about prescription information in their own language and provide written translations in Spanish, Chinese, Italian, Russian, and French.

DEA Issues Interim Final Rule on Internet Pharmacy Regulations 
Drug Enforcement Administration (DEA) has issued an interim final rule to implement the Ryan Haight Online Consumer Protection Act. Enacted in October 2008, the Ryan Haight Act amended the Controlled Substances Act and Controlled Substances Import and Export Act by adding several new provisions to prevent the illegal distribution and dispensing of controlled substances over the Internet. Except for a few subsections, including the definition of telemedicine, this interim rule took effect on April 13, 2009. Among other requirements, the Ryan Haight Act requires online pharmacies selling controlled substances to obtain modified DEA registration. DEA is accepting comments on these interim regulations through June 5. More information is available in the April 6 Federal Register. 

Eight Additional Facilities Awarded VAWD Accreditation
NABP recently accredited eight additional facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 328 as of April 24, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

  • Graceway Pharmaceuticals, LLC distributes a product line of approximately 15 specialty prescription products nationwide. Products are purchased directly from manufacturers. The company received accreditation for its Piney Flats, TN facility.
  • InSource Inc is a distribution center for pharmaceutical medications, repackaged medications, and Schedule III-V controlled substances to customers in all 50 states. The company received accreditation for its Bastian, VA facility.
  • Integrated Commercialization Solution, Inc is a third-party logistics provider sharing warehouse and administrative space with ASD Specialty Healthcare, Inc and Besse Medical. The company received accreditation for its KY facility.
  • McKesson Corporation, dba McKesson Drug Company, distributes over-the-counter products and prescription drugs to community and chain pharmacies, hospitals, and clinics. The company received accreditation for its Cape Girardeau, MO facility.
  • McKesson Medical-Surgical Inc distributes medical and non-medical supplies, products, and pharmaceuticals to hospitals, surgical centers, physician offices, and medical centers in California and Nevada. The company received accreditation for its Ontario, CA facility.
  • Patterson Logistics Services, Inc supports more than 70 sales branches across the US. The company received accreditation for its Dinuba, CA facility, which distributes dental, veterinary, and medical supplies to practitioners and clinics in eight western states.
  • Q Logistics Inc serves as a third-party logistics provider to distribute prescription drug samples, literature, and products for patient assistance programs in 50 states. The company received accreditation for the following two facilities:
    • Cedar Knolls, NJ
    • Florham Park, NJ

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