NABP e-News: July 22, 2009

NABP Position Statement Provides Guidelines for Medication Collection Programs
NABP has issued a position statement to provide guidelines to assist the boards of pharmacy in developing medication collection programs. The statement addresses the question of whether prescription medications, in the community pharmacy setting, can be safely returned and reused. Such programs are permissible, NABP maintains, “when it is demonstrated that integrity and stability of the medication is maintained, that the medication has not been tampered with, and the process results in the dispensing of safe medication to patients.” The statement provides elements for inclusion in a safe return and reuse protocol for medication collection programs in community pharmacies. The “Position Statement on the Return and Reuse of Prescription Medications in the Community Pharmacy Setting” is posted under News on the NABP Web site.

Pharmaceutical Cargo Theft: FDA Seeks Assistance in Tracking Stolen Medications 
Food and Drug Administration (FDA) is seeking assistance in tracking down several Sanofi-Aventis drug products that were stolen in a tractor trailer on July 9, 2009. If the stolen medications (listed below) are improperly stored and handled, they may be dangerous for patients to use. FDA is asking pharmaceutical drug distributors and pharmacies that may have received any suspicious or unsolicited offers for these drugs after July 9, 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.

  • Lovenox® 120 mg - batch/lot numbers: 12210, 12221, and 12218
  • Lovenox 30 mg - batch/lot number: 29395
  • Lovenox 80 mg - batch/lot number: 28534
  • Xyzal® 5 mg - batch/lot number: 8047787
  • Nasacort® AQ 16.5 g - batch/lot number: N09108A
  • BenzaClin® Gel 50 g Pump - batch/lot number: 8047564

Public Workshop to Address Written Prescription Drug Information for Consumers 
In the July 10, 2009 Federal Register, the FDA Center for Drug Evaluation and Research, in collaboration with FDA’s Office of the Commissioner, announces a public workshop entitled ‘‘Providing Effective Information to Consumers About Prescription Drug Risks and Benefits.’’ The workshop, to be held September 24 and 25 in Gaithersburg, MD, is “intended to explore potential approaches that will result in written prescription drug information for consumers that is comprehensible, accurate, and easy to access.” Written comments on Docket No. FDA-2009-N-0295 may be submitted to the Division of Dockets Management. A transcript of plenary sessions will be available for review at the Division of Dockets Management and online at www.regulations.gov approximately 30 days after the workshop.

Investigation of Two Internet Drug Outlets Leads to 26 Convictions, $7 Million Forfeiture
A nationwide federal investigation of two Internet drug outlets has resulted in the conviction of 26 people – “the most defendants ever convicted in an Internet pharmacy case in the United States” – and the forfeiture of more than $7 million in assets, according to a Drug Enforcement Administration news release. The investigation began in March 2003, when Union Family Pharmacy (now under different ownership) in Dubuque, IA, dispensed 90 diet pills to a California woman based upon an Internet prescription from a doctor in Mississippi. In September 2003, the Iowa Board of Pharmacy took emergency disciplinary action against the pharmacy and two pharmacists. This case led to a six-year criminal investigation, which revealed that the pharmacy had unlawfully dispensed more than 1.1 million prescription pain, diet, and psychiatric pills over a six-month period for two Internet companies, Pharmacom International Corporation and Medical Web Services.

Senate Votes to Permit Importation of Medications from Canada
The United States Senate has approved a plan that would allow patients in the US to obtain prescription medications from Canada over the Internet, the Associated Press (AP) reported on July 9, 2009. Sponsored by Louisiana Republican David Vitter, the plan was approved 55-36. These provisions were included in a bill funding the Customs Department and other homeland security agencies, a final version of which is pending, AP reports. Opponents of the idea say it will exacerbate the problem of illegally operating Internet drug outlets, many of which call themselves “Canadian Pharmacies” but are not licensed and do not adhere to Canadian safety regulations. FDA has warned for years that medications purchased from unapproved foreign sources are not subject to FDA safety and efficacy standards and, as such, their authenticity, purity, and safety are unknown.

Colorado Physician Jailed for Internet Prescribing
A Colorado physician was sentenced to nine months in jail for prescribing antidepressants over the Internet to an out-of-state patient whom he had never examined, American Medical News reported on June 1, 2009. The 19-year-old California patient for whom he prescribed the fluoxetine later committed suicide. Dr Christian Hageseth III was charged in San Mateo County, CA, with one felony count of practicing medicine without a valid California medical license. The dispensing pharmacy was located in Biloxi, MS.

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 352 as of July 17, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

  • Exel, Inc is a third-party logistics provider for Bayer Healthcare, Inc. While the facility does not handle prescription drugs, it does handle precursor products (ie, pseudoephedrine and ephedrine). The company received accreditation for its Ontario, CA facility.
  • Hygen Pharmaceuticals, Inc distributes generic prescription and over-the-counter products to independent and small chain pharmacies, clinics, and other wholesale distributors in 35 states, including Puerto Rico. The company received accreditation for its Bellevue, WA facility.
  • Nelson Laboratories LLC dba Nelson Laboratories is a wholesaler of animal health products to licensed veterinarians. The company’s product line includes pharmaceuticals, biologicals, and instruments. The company received accreditation for its Sioux Falls, SD facility.

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