NABP Headlines                                                                                         

Programs in Iowa and New Jersey Help Residents Properly Dispose of Unused Medications
Iowa’s state-wide TakeAway Program, and Operation Medicine Cabinet in New Jersey, enable residents to dispose safely of most unused medications in efforts to curb prescription drug abuse and promote environmentally sound medication disposal. The TakeAway pilot program in Iowa provides two 20 gallon systems to more than 300 participating pharmacies for collection of unused medications, which are then shipped to the partner, Sharps Compliance Corporation, for approved disposal. The pilot program is funded through a state grant and is the product of 2009 legislation calling for a community-based medication disposal program. In New Jersey, police departments and public offices in more than 400 communities provided no-questions-asked drop-off stations for unused medications on November 14. Organizers of New Jersey’s Operation Medicine Cabinet hope this will become an annual event. More information can be found on the TakeAway Web site and the Operation Medicine Cabinet Web site.

Voluntary Recall of Tylenol Arthritis Pain Caplets by Manufacturer
Several lots of Tylenol® Arthritis Pain Caplet 100 count bottles have been recalled as a precaution by McNeil Consumer Healthcare in consultation with the Food and Drug Administration (FDA), as announced on the manufacturer’s Web site on November 9, 2009. The recall was initiated due to an unusual smell or taste associated with these lots that led to a small number of people reporting nausea and related symptoms. The product is easily identified by the distinctive red EZ-OPEN CAP. The affected Tylenol Arthritis Pain Caplet 100 count product lot numbers are as follows:

• 08BMC013, 08BMC020, 09BMC034, 09CMC036, 09CMC040

Information on how to return or dispose of the product can be obtained on the McNeil Web site or by calling 1-888/222-6036.

FDA Commissioner’s Letter to Health Care Practitioners Includes H1N1 Vaccine Development and Safety Information
On November 10, 2009, Dr Margaret Hamburg, Commissioner of Food and Drugs, sent a letter to America’s health care professionals thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on the safety of the 2009 H1N1 vaccines. In order to help practitioners answer patient questions regarding the safety of the 2009 H1N1 vaccines, the letter provides details about how the vaccines were developed, tested, and approved. The letter explains that for the first time in history a vaccine is available at the time of the influenza outbreak due to the work of hundreds of scientists across the world. Practitioners are also reminded to report any adverse effects related to the 2009 H1N1 vaccine to the Vaccine Adverse Event Reporting System.

Kansas Pharmacy Owners Convicted for Internet Prescription Sales Crimes
Two pharmacy owners in Kansas were found guilty of several charges related to Internet distribution of prescription medications to customers who did not have valid prescriptions and who did not receive consultation. Special agents from the Attorney General’s office in Kansas closed the pharmacy in March 2008, and the pharmacist was tried and found guilty for his role in May 2009. On November 2, Attorney General Steve Six announced the convictions against the pharmacy owners. One owner was found guilty of computer crime, conspiracy to commit computer crime, and commercial bribery. The other owner was found guilty of misdemeanors for violating the Pharmacy Act of Kansas and for violating the Kansas Food, Drug and Cosmetic Act.

FDA’s Safe Use Initiative Aims to Reduce Preventable Harm from Medication Use
On November 4, 2009, FDA announced the launch of the Safe Use Initiative, a program designed to reduce the likelihood of preventable harm from medication use. The report, “FDA’s Safe Use Initiative – Collaborating to Reduce Preventable Harm from Medicines,” describes the program in detail. Through the program, FDA aims to collaborate with health care professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm, and to develop, implement, and evaluate cross-sector interventions to reduce harm. To further advance the Safe Use Initiative, the FDA intends to hold a series of public meetings to gather feedback and will open a public docket to receive comments on the report and proposed candidate cases. FDA also released a new draft guidance document for industry, “Dosage Delivery Devices for OTC Liquid Drug Products,” for advanced viewing; the guidance is one example of a step that helps ensure safer medication use.

CDC Alerts Practitioners to Key Issues Concerning Treatment With Antivirals
Centers for Disease Control and Prevention (CDC) reports that while use of influenza antiviral drugs has increased, not all people recommended for treatment are receiving it. CDC emphasizes that treatment with oseltamavir or zanamavir can be beneficial for the following groups of people, even if begun more than 48 hours after onset of symptoms:

• Hospitalized patients with suspected or confirmed 2009 H1N1
• Outpatients, particularly those at risk for severe illness, or those who appear to be getting worse
• Some people without risk factors for severe illness

CDC reminds practitioners that there are ample supplies of children’s oseltamavir capsules, which can be mixed with syrup at home. Also, pharmacists can compound adult oseltamavir capsules into a suspension for treatment of ill infants and children. Finally, CDC stresses that treatment with antivirals for 2009 H1N1 influenza should not be delayed while waiting for laboratory confirmation. Additional updated information can be found on CDC's Web site.