NABP e-News: July 08, 2009

July 8, 2009 12:00 am

OpSec Security Identifies Trends of Increased Illicit Drug Trade Online
A study by OpSec Security, Inc, reveals an increase in illicit sales of bulk pharmaceuticals and active pharmaceutical ingredients by trade board sellers over the Internet. The two-year study, released June 22, 2009, also shows an increase in illicit activity by Internet drug outlets that sell drugs directly to consumers. OpSec Security, an anti-counterfeiting and brand protection company, announced these findings in a June 22 news release, stating that these trends pose increased risks to patients who buy prescription medications and to companies that source pharmaceutical products online.

Informational Network Leads to Recovery of Stolen Pharmaceuticals
In the April 30, 2009 NABP e-News, NABP requested assistance from the boards of pharmacy in tracing a pharmaceutical cargo theft. Approximately 14 pallets/994 cartons/5,962 packs of Copaxone^® (glatiramer acetate) 20 mg were stolen in mid-April. The tractor-trailer was found empty at a rest stop on the New Jersey Turnpike on April 20. NABP recently learned that, on June 10, an unspecified portion (hopefully all) of the Copaxone that had been stolen was recovered in Newark, NJ. The product, which must be stored below 74 degrees, was ultimately located in an abandoned “sea container” that had no environmental controls. It is believed by many that the reason the stolen goods never left the northeast is because of the rapid and extensive spread of information about the theft. This informational network may have made the product difficult to market illicitly and ultimately may have caused the thieves to abandon it. NABP would like to thank the boards for their assistance in this successful effort.

EMEA Advises Withdrawal of Painkiller; Cites Risk of Death from Overdose
The European Medicines Agency (EMEA) has recommended that drug products containing dextropropoxyphene (known as propoxyphene in the United States) be withdrawn across the European Union. After reviewing the safety and efficacy of these products, EMEA concluded that their risks, “particularly the risk of potentially fatal overdose,” are greater than their benefits, EMEA stated in a June 25, 2009 press release. Propoxyphene is still marketed by a variety of generic-drug makers in the US, where Food and Drug Administration (FDA) is considering whether to withdraw it, the Wall Street Journal reported on June 26. Critics of the drug have claimed for decades that its risks outweigh its benefits and have called for its withdrawal from the US market.

FDA Takes Actions on Pain Medications Containing Propoxyphene
FDA announced in a July 7 news release that it will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. FDA also will require these manufacturers to provide a medication guide for patients stressing the importance of using the drugs as directed. In addition, FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action. In its July 7 denial of a citizen petition requesting a phased withdrawal of propoxyphene, FDA said that, despite “serious concerns . . . , the benefits of using the medication for pain relief at recommended doses outweighs the safety risks at this time.”

FDA Warns of Bacterial Contamination Risk in Clarcon Skin Products
Clarcon Biological Chemistry Laboratory Inc of Roy, UT, has voluntarily recalled some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. FDA is warning consumers not to use any Clarcon products and to dispose of them in household refuse. Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues, which may need medical or surgical attention and may result in permanent damage. More information and examples of affected products are available in the FDA news release.

Two Additional Facilities Awarded VAWD Accreditation
NABP recently accredited two additional facilities through its Verified-Accredited Wholesale Distributors^® (VAWD^®) program, bringing the total number of accredited facilities to 350 as of July 2, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

• Cardinal Health 110, Inc dba Cardinal Health 411, Inc distributes prescription drugs, over-the-counter products, and other health items to independent and chain pharmacies, hospitals, surgical centers, clinics, and practitioners’ offices. The company received accreditation for its Auburn, WA facility.

• Walgreen Company received accreditation for its Windsor, WI facility. This facility is the company's single collection point for all recalls, overstocks, returns, and items for destruction. Of these, only overstock items are re-distributed to company pharmacies.

Correction
The June 24, 2009 NABP e-News article “Arizona Health Associations Sue State for Regulatory Board Funding” incorrectly states that, under the new state budget plan, 100% of the state regulatory boards’ fees are earmarked for the general fund. It is 100% of the boards’ reserve balance (not fees) that was transferred to the general fund. Additionally, the Arizona Republic article cited was published on April 9, 2009.