NABP e-News: October 28, 2009

October 28, 2009 12:00 AM

NABP 2009 Symposium Addresses Legalization of Medical Marijuana and the Benefits of Public-Private Partnerships
The NABP 2009 Symposium, to be held December 3-4, 2009 in Tucson, AZ, will bring attendees together to discuss the legalization of medical marijuana, a timely topic in view of the recent change in White House drug policy. Speakers include Office of National Drug Control Policy drug policy expert Kevin Sabet, and Lloyd Jessen, Iowa Board of Pharmacy executive director, who will speak on his board's activities and its upcoming recommendation to the Iowa legislature regarding the use of medical marijuana. Participants will also learn about the benefits of public-private partnerships. More than 15 presenters, including representatives from state and federal agencies and other experts from government, academic, and various medical and pharmacy practice settings, will speak. 11.25 hours continuing pharmacy education credit may be earned. For more information and to register, visit the Meetings section of the NABP Website.

FDA Reopens Comment Period for REMS for Certain Opioid Drugs 
As of October 19, 2009, Food and Drug Administration (FDA) reopened the comment period to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. Opioid drugs formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone will be affected by the developing REMS. FDA emphasizes that “[a] REMS that will adequately manage the risks of these products without unduly burdening the health care system or reducing patient access to these medications must be carefully designed.” Thus, the comment period will remain open until October 19, 2010, and interested parties can submit written or electronic comments to FDA through the Regulations.gov Web site using docket number FDA-2009-N-0143.

FDA and FTC Join to Warn Owners of Web Site Marketing Fraudulent H1N1 Supplements 
FDA and Federal Trade Commission (FTC) issued a warning letter, the first to be issued jointly by the agencies, to a Web site marketing fraudulent products claiming to prevent and treat 2009 H1N1 influenza. The letter gave the Web site owners 48 hours to provide the agencies with a plan to discontinue fraudulent marketing. Andrew Weil, the site owner, defended the postings on his Web site, but also states that he had the content in question removed. He claims, “I fully support the FDA/FTC task force in its efforts.” More information can be found on the FDA Web site.
FDA also posted a news release warning the public about fraudulent H1N1 products. Further, FDA maintains a “Fraudulent 2009 H1N1 Influenza Products List." Body wash, teas, masks, hand sanitizers, and test products are among the fraudulent items listed.     

McAfee Reports High Level of Pharmaceutical Related Spam in September 2009
Spam e-mail messages advertising and linking to supposedly “Canadian” online pharmacies account for more than 70% of global spam volume in September 2009, according to the October 2009 Spam Report from McAfee, an Internet and network security solution provider. Spammers take advantage of consumer trust in authentic Canadian pharmacies and prey upon their desire for discount drugs. In actual fact, the spam messages do not originate from Canada, nor are the Web sites they lead to located in Canada. Therapeutic Research Center in Stockton, CA, the AARP, and Liberty Medical Supply have suffered similar abuse, in smaller volumes, by spammers who send messages claiming the endorsement of these organizations. The McAfee report explains how spam is propagated through personal computers infected with bot software through such sources as online games, and describes how spam is often part of phishing schemes that attempt to obtain users’ information.

Tamiflu Oral Suspension Dosing Error Risk Related to Concentration of Emergency Compound
The Institute for Safe Medication Practices (ISMP) issued an alert to all health care professionals regarding a risk of dosing errors related to the concentration of pharmacy-compounded Tamiflu (oseltamivir phosphate) oral suspension being dispensed due to shortages of the manufacturer’s oral suspension. The base concentration for the commercially manufactured Tamiflu oral suspension is 12 mg/mL. The directions for emergency compounding of Tamiflu oral suspension from Tamiflu powder capsules result in a 15 mg/mL oseltamivir base concentration. Incidents have occurred resulting in too large of a dose being dispensed to children. ISMP advises that prescribers communicate suspension doses in milligrams rather than by volume, and that, if experiencing shortages of commercial Tamiflu oral suspension, pharmacists communicate with area medical practices regarding the dosage error risk. More information may be found at the ISMP Web site.

Washington Pharmacists Authorized to Prescribe Antiviral Drugs if Influenza Outbreak Declared
Following the protocol detailed in a new Collaborative Drug Therapy Agreement (CDTA), pharmacists in Washington state will be authorized to prescribe antiviral medications if the local health officer determines this action necessary to respond to an influenza outbreak. The CDTA was developed by a team from the Northwest Center for Public Health Practice, the Washington State Pharmacy Association, and Public Health – Seattle & King County, in consultation with physicians and emergency managers, and with support from Centers for Disease Control and Prevention pandemic preparedness funds. The CDTA was developed under a contract with the Washington State Department of Health. If the protocol is put into effect, pharmacists will be authorized to evaluate patients using local public health guidelines to determine whether antivirals should be dispensed.