NABP e-News: March 03, 2010

March 3, 2010 12:00 am

Iowa Board of Pharmacy Recommends Classifying Marijuana as Schedule II Drug
Following a unanimous vote at a special meeting held February 17, the Iowa Board of Pharmacy recommended to the Iowa state legislature that marijuana be reclassified as a Schedule II controlled substance, which could allow medical uses of the drug. The Board further advised that a task force of patients, medical professionals, and law enforcement officers should create guidelines for safely implementing a medical marijuana program, as reported by the Des Moines Register. The Board’s decision was informed by a series of public meetings held in 2009, as well as by research and public comments. Bills relating to the creation of a medical marijuana act in Iowa were introduced to the legislature, but were either referred to committee or died during the current session. Thus, while the Iowa legislature will likely not act on the medical marijuana issue this session, the Board’s recommendation could impact the outcome of future bills.

Canadian Internet Pharmacy Owner Loses License for Illegally Dispensing to US Consumers
The Canadian pharmacist who owned and operated a highly profitable Internet pharmacy complied with the decision of the Manitoba Pharmaceutical Association to have his name removed from the Register of Pharmacists. At disciplinary hearings in 2009, the pharmacist was charged with dispensing prescription drugs supplied from a business in the Bahamas to patients in the United States; allowing dispensed drugs to be shipped through other countries before entering the US, which concealed the drug source from consumers; allowing his pharmacy’s name to appear on prescription labels of the drugs, which gave the appearance they were dispensed in Canada; and dispensing prescription drugs that were past or close to the expiration date and drugs not approved by the Canadian regulatory agency, Health Canada. The charges followed a three-year investigation initiated by US Food and Drug Administration (FDA) allegations that his pharmacy dispensed counterfeit medicines to US consumers.

Florida Man Convicted for Diverting Prescription Drugs, Sentenced to 70 Months
The United States Attorney’s Office for the Southern District of Florida announced on February 18, 2010, that a Florida man who operated as a prescription drug wholesaler has received a 70-month prison sentence following a conviction for conspiring to divert prescription drugs through interstate commerce. Through two Miami-based prescription drug wholesale operations, one of which was unlicensed, the man ordered from unlicensed California-based human growth hormone suppliers who regularly shipped hundreds of boxes of Serostim and Nutropin AQ from 2000 to 2001. Further, the man distributed counterfeit Nutropin AQ, which entered the US drug supply chain and caused harm to a child. The wholesaler broke laws related to the Prescription Drug Marketing Act, which prohibits wholesale distributors from interstate commerce without a license in an effort to combat diversion and counterfeiting. NABP established the Verified-Accredited Wholesale Distributors^CM (VAWD^CM) program in 2004 to help further protect the public from the threat of counterfeit drugs. VAWD accreditation provides assurance that a wholesale distribution facility operates legitimately, is validly licensed in good standing, and employs security and best practices for safe distribution.

FDA Notice Regarding Stolen Prescription Drugs and Health Products
As reported in an FDA noticesmall portions of several GlaxoSmithKline product lots were stolen while the products were in transport from the distributor to wholesalers in the Bayamon district of Puerto Rico on January 29, 2010. The FDA notice provides a list of relevant product lots. Small portions of lots of consumer health care products, including Tums, Sensodyne toothpaste, Poligrip Denture Adhesive, and Ecotrin aspirin were also stolen. GlaxoSmithKline, FDA, and local authorities are investigating the theft. Information regarding this theft or suspicious or unsolicited offers for the products in question should be reported to the FDA Office of Criminal Investigations at 800/551-3989 or by visiting the OCI Web Site.

Maalox Product Name Can Lead to Mix-Ups and Serious Side Effects, FDA Warns
FDA advises consumers and health care professionals to carefully check the labels of Maalox products to ensure that the appropriate product is selected, due to the potentially confusing name, Maalox Total Relief. Maalox Total Relief treats upset stomach and is an anti-diarrheal medication, while traditional Maalox liquid products, such as Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength, are antacids. Bismuth subsalicylate, the active ingredient in Maalox Total Relief, can lead to serious side effects in some individuals. Specifically, patients with a history of gastrointestinal ulcer disease, children and teens recovering from viral infections, and patients taking certain prescription medications should not use the product. The manufacturer is working collaboratively with FDA and will be changing the name of Maalox Total Relief to avoid further confusion. The renamed product should be available by September 2010, according to an FDA news release.

Sublethal Doses of Antibiotics Lead to Multidrug Resistant Bacteria
Research published in Molecular Cell demonstrates that sublethal doses of an antibiotic can lead to bacteria that are resistant to multiple additional antibiotics, even while the bacteria may remain susceptible to the original antibiotic. Experimenting on strains of E.coli and Staphylococcus, the researchers studied the biomolecular process that produces drug resistance in bacteria. The new research further stresses the importance of awareness efforts such as Centers for Disease Control and Prevention’s Get Smart program, which advises patients on the appropriate use of antibiotics, including not taking antibiotics for viral infections, and making certain to complete entire courses of prescribed antibiotics.