NABP e-News: February 03, 2010

Prescription Warning Label Research Reveals Elements That Increase Patient Understanding
Researchers evaluating prescription warning labels concluded that warnings written in simplified text increase patient understanding, and the addition of icons increases understanding for adults with lower literacy skills. The study,led by researchers at Northwestern University’s Feinberg School of Medicine and conducted in four clinics in two cities, evaluated patients’ ability to understand drug warning labels with current standard text, simplified text,and simplified text with an icon. The rate of correct interpretation of the standard warning labels was 80% compared with 91% for the simplified text labels and 92% for the simplified text and icon labels. The study also demonstrated that fewer warning labels – no more than two – are more effective, as indicated in a Northwestern news article. Moving forward, the researchers will join NABP and other experts working on the United States Pharmacopeia Advisory Panel on Prescription Container Labeling.

Medicines and Medical Supplies Donated to Haiti Relief Efforts, Pharmacists Volunteer to Help
Through the guidance of Rx Response and the coordination of the Red Cross and several other aid organizations and government agencies, pharmaceutical companies have donated over $35 million in medicines, medical supplies, and cash to relief efforts in Haiti. As noted in a news release, Rx Response provided information on the most effective methods for donating medical products. In addition, over 2,500 pharmacists have offered to volunteer for two weeks at aid centers in the Dominican Republic,in response to an American Pharmacists Association (APhA) call to action. The organization asks patience of those waiting for a response to volunteer applications and provides updates and a link to the volunteer form on the APhA Web site. The Global Action Foundation Web site also provides more information for pharmacists wishing to volunteer in Haiti relief efforts.

FDA Transparency Initiative Launched with “FDA Basics” Web Site Resource
On January 12, 2010, US Food and Drug Administration (FDA) launched the FDA Basics section of its Web site, as the first phase of the agency's Transparency Initiative, which aims to provide useful and understandable information about FDA activities and decision making to the public in a timely manner and in a user friendly format. FDA Basics is focused to help the public better understand what the agency does, and includes questions and answers, short videos, and conversations with agency personnel about the activities and work of the agency. Various Centers and Offices in the FDA will also be hosting webinars on specific topics.

FDA Updates Warning Regarding Counterfeit Alli
FDA has updated a public health alert regarding counterfeit Alli 60 mg capsules sold over the Internet. On January 18, 2010, FDA warned that manufacturer testing of Alli, an over-the-counter weight-loss product, revealed that the counterfeit Alli does not contain orlistat, the active ingredient in Alli, but contains sibutramine, a controlled substance that should not be used without physician oversight. Further FDA tests have shown that the counterfeit drug delivers up to three times the usual daily dose of sibutramine,which can cause anxiety, nausea, heart palpitations, a racing heart, insomnia, and small increases in blood pressure. A description and pictures of the counterfeit Alli product are included in the FDA news release. Consumers who discover they have been taking the counterfeit drug should stop taking it, and contact the FDA's Office of Criminal Investigations (OCI) by calling 800/551-3989 or visiting the OCI Web site.

ISMP Provides Tools to Improve Medication Safety in Pharmacies
The Institute for Safe Medication Practices (ISMP) has made available two tools for use in improving medication safety in community pharmacy. The manual, Improving Medication Safety in Community Pharmacy: Assessing Risk and Opportunities for Change, includes materials and tools that will pinpoint specific system weakness in the medication-use processes and provide a starting point for successful organizational improvements to help prevent risk, patient harm, and medication errors. In addition, the ISMP Medication Safety Self Assessment® for Community/Ambulatory Pharmacy, can help staff assess the safety of pharmacy medication practices and identify opportunities for improvement. The tool includes an assessment booklet and the ability to enter results online and access preliminary aggregate data.

Four Additional VAWD Accreditations
NABP recently accredited four additional facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 399 as of January 27, 2010. A full isting of VAWD facilities is available under Accreditation Programs on the NABP Web site.

  • Genentech USA, Inc
    Hillsboro, OR
  • Genentech USA, Inc
    Louisville, KY
  • Hospira Worldwide, Inc
    Farmers Branch, TX
  • LifeScience Logistics dba LifeScience Logistics, LLC
    Louisville, KY

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