Wednesday, December 12, 2012

AWARxE Campaign: Initiative to Educate Middle School Students

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I hope everyone is enjoying their week! I had an excellent visit at the University of Minnesota College of Pharmacy last week on November 28th. The College is one of two finalists for the Lawrence C. Weaver Transformative Community Service Award. Several individuals were in attendance to present their initiatives to the American Association of Colleges of Pharmacy (AACP) team who was visiting and has the responsibility of deciding which of the finalists will receive this prestigious award. I attended all of the various presentations and supported Julie Johnson in her presentation focusing on advocacy efforts and the strong relationship between MPhA and the College. I spoke about the AWARxE campaign and our initiative to educate middle school students on the dangers of prescription misuse and abuse, the existence of rogue Internet pharmacies, the risk of acquiring counterfeit medications, as well as the approach student volunteers exploit while presenting to middle school students.

The AWARxE presentation is informal and the volunteers are encouraged to wear jeans and the AWARxE t-shirt to relate better with the students and avoid ‘preaching’ to them. The presentation facilitates a fun, relaxing atmosphere where students can learn about AWARxE and not be hesitant to ask questions or share stories. During the presentation, we provide a demonstration for the students to keep the crowd interested and engaged. This demonstration consists of displaying four containers on a table each containing a different ingredient such as milk, orange juice, and ginger ale. We then reveal a covered container that has the various ingredients combined with added oatmeal. After asking if any of the students would drink the mixture, and undoubtedly there are one or two eager students who agree to the challenge, we inquire if their agreement would be retracted knowing that syrup of ipecac was in the container. The purpose of this activity is to remind and educate students about the harmful effects that can result from participating in Skittles parties and consuming an unknown array of medications that can have fatal interactions or side effects.

The AACP team listened to my presentation on the AWARxE campaign and was impressed with the initiative middle schools are taking to use the College as a resource for educating their students about this important topic. Other presentations focused on transformative community partnerships and advocacy, service to rural regions and underserved urban areas, the College’s expansion to Duluth in an effort to improve access to care through graduating more students interested in rural pharmacy, as well as the multitude of community and public engagement initiatives taken by faculty and students. Student representatives from the Phillips Neighborhood Clinic (PNC), HOPE Clinic, Puebla Mexico trip, REACH Haiti group, and other entities were all present to provide the AACP team with examples of the College’s community engagement efforts and excellent outcomes. This was certainly a rewarding experience!

Melissa Katzenberger

Pharm.D. Candidate
University of Minnesota College of Pharmacy
Class of 2013

NECC Compounding Issue

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Thanks for tuning in! On December 27th, I had the opportunity to attend the Board of Pharmacy meeting focused on addressing the New England Compounding Center (NECC) issue, as well as participate in a webinar hosted by the National Association of Board of Pharmacy (NABP). After talking with the Attorney General’s Office and referencing the Data Practices Act, the Board has determined that all inactive investigational data and reports against a pharmacy are considered public documents, unless the material states that it is private and privileged. The media requested the release of this information, but the Board is concerned that the documents, although public, will not be accurately interpreted and potentially falsely reported. The Board fears that its relationship with the compounding pharmacies and pharmacists will be adversely impacted if data are made available to the media without proper communication. In addition, the Board has devised a working group consisting of two Board members and two or more staff members with the charge of updating the format of the surveyor form to clearly define areas where action is required, while separating the summary of information generally discussed and recommended where action is not required. This was a concern of compounding pharmacists, as it was difficult to differentiate between the two.

In response to the NECC compounding issue, all Boards of Pharmacy have been contacted by Congress and required to answer specific questions inquired by the Senate and House of Representatives. NABP is contracting with the Iowa Board of Pharmacy to conduct inspections at high-risk compounding pharmacies in Minnesota and other states that are licensed by the Iowa Board. Training on USP 797 will be completed by NABP representatives conducting the investigations, as well as offered to all Board surveyors. The first wave of investigations will occur between December 2012 and February 2013 to identify traditional versus non-traditional compounding pharmacies. The Board is challenging NABP’s definition ‘non-traditional’ compounding, which includes bulk and sterile compounding, and argues that only two practices exist: compounding and manufacturing. A second wave of investigations will be conducted between March 2013 and June 2013 to discover if the traditional compounding pharmacies identified are practicing sterile versus non-sterile compounding. Throughout this process, NABP will be ensuring that the pharmacies are abiding by the rules and regulations established in Iowa and their resident state. Any potential violations found will be confirmed with the resident Board of Pharmacy before charging disciplinary action to be completed. The Board is not in agreement with NABP conducting the investigations, and would rather report information after having our surveyors visit the indicated pharmacies. Ultimately, NABP will be collating the data and documents gathered from the investigations to create e-Profiles for each of the high-risk compounding pharmacies, which will be made available to all Boards of Pharmacy and the public, if the latter is requested. On December 19, state Board of Pharmacy executives and the FDA are invited to attend an inter-government meeting to discuss the recent NECC compounding issue and explore the best way to provide oversight moving forward. Change is in progress!

Melissa Katzenberger

Pharm.D. Candidate
University of Minnesota College of Pharmacy
Class of 2013