As more women choose the patch, keep an eye out for counterfeits

FDA shuts down four Internet sites for distributing fake contraceptive

A quick review of your clinic’s dispensing habits tells the tale: More women are moving to use of the transdermal contraceptive (Ortho Evra; Ortho-McNeil Pharmaceutical, Raritan, NJ). The contraceptive patch is now the favorite nonoral contraceptive method in the United States, according to IMS Health, a Fairfield, CT-based supplier of pharmaceutical industry market research.1

With a rise in popularity comes a risk in counterfeiting. The Food and Drug Administration (FDA) has taken action against four foreign Internet sites found to be selling counterfeit contraceptive patches that contain no active ingredients. While counterfeiting is not yet widespread in the U.S. drug market, and no pregnancies have been reported, the FDA is investigating a growing number of such cases.

The regulatory agency has just released a new report detailing its efforts to keep the U.S. drug supply secure against the introduction of counterfeit drugs. (Review an online version of the publication, The FDA Counterfeit Drug Task Force Final Report, at www.fda.gov/oc/initiatives/counterfeit/.)

As more consumers seek the convenience of on-line pharmaceutical ordering, what do you need to know to make sure your patients are getting safe, effective contraception?

A call to the Ortho Customer Care Center telephone hotline was the first tip-off regarding the counterfeit patches, says Mona Terrell, Ortho-McNeil spokeswoman. The call came from an anxious woman who had ordered a supply of the patches from the Internet. When she received her order, the woman noticed a distinct difference in the appearance and packaging of the product, says Terrell.

The patches did not look the same as the Ortho product, she explains. Also, they were packaged loosely, without identifying materials, lot numbers, expiration dating, or any other labeling information needed to safely and effectively use the prescription product. (See pictures of the counterfeit patches; go to the product web site, www.orthoevra.com; click on "Breaking News: Ortho Evra Counterfeit Patch Alert." The site has photographs of pharmacy product packaging so women can see the correct product. The FDA also has photographs of the counterfeit patches at its web site, www.fda.gov/bbs/topics/news/photos/contraceptive/counterfeit.html. If consumers cannot access the Internet to review the information on the Ortho Evra web site, they can call the toll-free Ortho-McNeil Customer Care Center telephone number, (800) 682-6532.)

Ortho immediately contacted the FDA, says Terrell. Since that time, the FDA has shut down the following four Internet web sites for distributing the counterfeit patches:

  • www.rxpharmacy.ws;
  • www.usarxstore.com;
  • www.europeanrxpharmacy.com;
  • www.generic.com.

The sites also were selling other products that purported to be versions of FDA-approved drugs. FDA’s Office of Criminal Investigation is working with Johnson & Johnson, Ortho-McNeil’s parent company, and the Department of Homeland Security’s Bureau of Immigration and Custom Enforcement’s Cyber Crimes Center to track any further counterfeiting efforts.

On-line orders catch on

Internet buying of prescription drugs is on the rise as more Americans look to the convenience of on-line ordering or wish to find less expensive medicines.2 According to the FDA, consumers who want to buy drugs via the Internet only should purchase from sites bearing the Verified Internet Pharmacy Practice Sites (VIPPS) seal issued by the Park Ridge, IL-based National Association of Boards of Pharmacy (NABP).

Internet-based pharmacy practice sites that wish to display the VIPPS seal must submit a detailed application to the NABP, including the pharmacy’s policies and procedures. Licensure information is verified with applicable state boards of pharmacy, then a review is performed of the pharmacy’s application, policies, and web site, along with an on-site inspection of the pharmacy’s facilities.

According to the NABP, it does not regulate on-line pharmacies. Regulation of pharmacy practice is primarily the jurisdiction of the state boards of pharmacy with some federal oversight, the organization states. The NABP began developing the VIPPS program in 1999 after consumers contacted several state pharmacy boards to complain about illegal Internet prescribing and dispensing sites posing as legitimate pharmacies. The VIPPS program is one way for the public to distinguish between legitimate and illegitimate on-line pharmacy practice sites, according to the organization.

On-line sites located outside the United States pose the greatest challenges for state and federal regulators. Cooperation with other nations and their regulatory agencies is key to regulating on-line international pharmacy sites. The NABP says it is working with a number of international regulatory agencies to establish VIPPS programs for their on-line pharmacies.

The NABP just has issued a list of susceptible products that are particularly prone to adulteration, counterfeiting, or diversion. The list of 31 drugs is seen as a starting point by which state boards of pharmacy can begin to take a closer look at possible suspect drugs. The NABP has formed a drug advisory coalition to maintain and update the list. Family planning clinicians will be familiar with two of the drugs on the list: Diflucan (fluconazole, Pfizer, New York City ) and Rocephin (ceftriaxone, Hoffman-La Roche, Nutley, NJ).

Federal and state regulators and the wholesale drug industry are working together to make sure that the American pharmaceutical delivery system is secure. The NABP has developed model rules for adoption by state boards of pharmacy to help provide national and uniform regulation for the licensure of wholesale drug distributors.

Consumers who buy prescription drugs from unlicensed, uncertified pharmacies put themselves at risk of serious illness, says Terrell. Consumers always should consult a physician first if they are interested in prescription contraceptives; prescriptions only should be filled at a retail pharmacies, through legitimate mail order programs, or through on-line pharmacies certified by the NABP, she states.

References

1. Lagorce A. Schering AG storms birth control market. Forbes; July 11, 2003. Web site: www.forbes.com/2003/07/11/cx_ad_0710shr_print.html.

2. Cable News Network. FDA: Web site ships fake birth control. Feb. 4, 2004. Web site: www.cnn.com/2004/HEALTH/02/04/fake.contraceptives.ap/index.html.