APhA continues OTC+ dialogue with AMA

Abstract

AMA House of Delegates opposes concept, but committee acknowledges ‘pharmacists are valuable members of health care team'APhA continues to work with the American Medical Association (AMA) to resolve differences and correct perceptions regarding FDA's OTC+ concept and pharmacists' collaboration with physicians in general.July meetings with AMA included discussion of recently passed AMA policy and continued work on messaging, consistent terminology that can be used by pharmacists and physicians, and mechanisms for pharmacists and physicians to collaborate to improve patient care, said APhA Senior Vice President of Professional Affairs Anne Burns, BSPharm.AMA adopts resolutionsIn June, the AMA House of Delegates adopted two of three resolutions in which pharmacy had engaged: resolution 235, Opposition to FDA's Rx to OTC Paradigm Shift, and resolution 218, Pharmacist Prescribing, as amended in lieu of resolution 240 (also named Pharmacist Prescribing), according to the AMA Reference Committee B report (www.ama-assn.org/assets/meeting/2012a/a12-refcomm-b-report.pdf).Pharmacy groups, led by APhA, had asked the committee to recommend that resolution 235 be adopted with a revised title and that resolutions 218 and 240 not be adopted, according to two Joint pharmacy letters sent June 1 and 15 and brief testimony on June 17 at the AMA meeting from APhA Senior Director of Government Affairs Marcie Bough, PharmD."We appreciated the opportunity to offer clarifications and appreciate that the report specifically recognized the value that pharmacists bring to the health care team," Bough said in reaction to the AMA actions. "We look forward to continued work with our medical colleagues and other stakeholders as any potential new drug paradigm evolves."Meeting in Chicago on June 16–20, the AMA House of Delegates included 504 physician delegates representing 177 state and medical specialty societies, according to AMA. It convenes twice a year.Pharmacy's positionAPhA's Bough testified on behalf of nine pharmacy organizations at the Reference Committee B meeting during the AMA meeting to offer clarifying remarks on what FDA is considering. FDA offered similar testimony about its potential new drug paradigm (OTC+) concept and the specifics of its proposal.Under FDA's OTC+ concept, medications that otherwise would be available only by prescription could be made available OTC with certain "conditions of safe use" such as interventions by a pharmacist or innovative technologies, and manufacturers could submit such an application for review by the agency. As explained in the FDA meeting notice announcing the new paradigm concept under consideration, the concept could address the public health problem of undertreatment of common conditions. APhA supports OTC+. (See page 60 of June Pharmacy Today.)Resolutions 218 and 240 inaccurately characterized the concept FDA is considering as enabling pharmacists to independently prescribe certain medications, according to the June 15 Joint pharmacy letter. "There is no intent to seek independent prescribing authority for pharmacists" as incorrectly described in the background material and "Resolve" language for resolutions 218 and 240, emphasized the letter.The pharmacy letter recommended adoption of resolution 235 in lieu of resolutions 218 and 240 but with "a revised title to better reflect the intent of the resolution, which supports AMA's continued dialogue on this issue."Joining APhA on the June 15 letter were eight colleague pharmacy groups. The letter served as the basis for Bough's testimony at the AMA hearing.Bough told Today that "pharmacy and medicine agree that we should have an opportunity to provide input as FDA reviews any manufacturer's application seeking to use a conditions of safe use if such a pathway exists in the future."Immunizations, other policiesAccording to the report's summary of discussions around resolution 218, Reference Committee B acknowledged testimony and concerns regarding pharmacist-provided immunizations, decided to discuss immunizations in a separate conversation, and urged those interested to submit a resolution addressing immunization issues at the next AMA meeting.Other pharmacy-related policies adopted by the AMA House of Delegates included a policy on drug shortages, a policy that pharmacies should have interpreter services, and a policy opposing the sale of tobacco in pharmacies. Several other drug-related policies were adopted. AMA House of Delegates opposes concept, but committee acknowledges ‘pharmacists are valuable members of health care team' APhA continues to work with the American Medical Association (AMA) to resolve differences and correct perceptions regarding FDA's OTC+ concept and pharmacists' collaboration with physicians in general. July meetings with AMA included discussion of recently passed AMA policy and continued work on messaging, consistent terminology that can be used by pharmacists and physicians, and mechanisms for pharmacists and physicians to collaborate to improve patient care, said APhA Senior Vice President of Professional Affairs Anne Burns, BSPharm. AMA adopts resolutionsIn June, the AMA House of Delegates adopted two of three resolutions in which pharmacy had engaged: resolution 235, Opposition to FDA's Rx to OTC Paradigm Shift, and resolution 218, Pharmacist Prescribing, as amended in lieu of resolution 240 (also named Pharmacist Prescribing), according to the AMA Reference Committee B report (www.ama-assn.org/assets/meeting/2012a/a12-refcomm-b-report.pdf).Pharmacy groups, led by APhA, had asked the committee to recommend that resolution 235 be adopted with a revised title and that resolutions 218 and 240 not be adopted, according to two Joint pharmacy letters sent June 1 and 15 and brief testimony on June 17 at the AMA meeting from APhA Senior Director of Government Affairs Marcie Bough, PharmD."We appreciated the opportunity to offer clarifications and appreciate that the report specifically recognized the value that pharmacists bring to the health care team," Bough said in reaction to the AMA actions. "We look forward to continued work with our medical colleagues and other stakeholders as any potential new drug paradigm evolves."Meeting in Chicago on June 16–20, the AMA House of Delegates included 504 physician delegates representing 177 state and medical specialty societies, according to AMA. It convenes twice a year. In June, the AMA House of Delegates adopted two of three resolutions in which pharmacy had engaged: resolution 235, Opposition to FDA's Rx to OTC Paradigm Shift, and resolution 218, Pharmacist Prescribing, as amended in lieu of resolution 240 (also named Pharmacist Prescribing), according to the AMA Reference Committee B report (www.ama-assn.org/assets/meeting/2012a/a12-refcomm-b-report.pdf). Pharmacy groups, led by APhA, had asked the committee to recommend that resolution 235 be adopted with a revised title and that resolutions 218 and 240 not be adopted, according to two Joint pharmacy letters sent June 1 and 15 and brief testimony on June 17 at the AMA meeting from APhA Senior Director of Government Affairs Marcie Bough, PharmD. "We appreciated the opportunity to offer clarifications and appreciate that the report specifically recognized the value that pharmacists bring to the health care team," Bough said in reaction to the AMA actions. "We look forward to continued work with our medical colleagues and other stakeholders as any potential new drug paradigm evolves." Meeting in Chicago on June 16–20, the AMA House of Delegates included 504 physician delegates representing 177 state and medical specialty societies, according to AMA. It convenes twice a year. Pharmacy's positionAPhA's Bough testified on behalf of nine pharmacy organizations at the Reference Committee B meeting during the AMA meeting to offer clarifying remarks on what FDA is considering. FDA offered similar testimony about its potential new drug paradigm (OTC+) concept and the specifics of its proposal.Under FDA's OTC+ concept, medications that otherwise would be available only by prescription could be made available OTC with certain "conditions of safe use" such as interventions by a pharmacist or innovative technologies, and manufacturers could submit such an application for review by the agency. As explained in the FDA meeting notice announcing the new paradigm concept under consideration, the concept could address the public health problem of undertreatment of common conditions. APhA supports OTC+. (See page 60 of June Pharmacy Today.)Resolutions 218 and 240 inaccurately characterized the concept FDA is considering as enabling pharmacists to independently prescribe certain medications, according to the June 15 Joint pharmacy letter. "There is no intent to seek independent prescribing authority for pharmacists" as incorrectly described in the background material and "Resolve" language for resolutions 218 and 240, emphasized the letter.The pharmacy letter recommended adoption of resolution 235 in lieu of resolutions 218 and 240 but with "a revised title to better reflect the intent of the resolution, which supports AMA's continued dialogue on this issue."Joining APhA on the June 15 letter were eight colleague pharmacy groups. The letter served as the basis for Bough's testimony at the AMA hearing.Bough told Today that "pharmacy and medicine agree that we should have an opportunity to provide input as FDA reviews any manufacturer's application seeking to use a conditions of safe use if such a pathway exists in the future." APhA's Bough testified on behalf of nine pharmacy organizations at the Reference Committee B meeting during the AMA meeting to offer clarifying remarks on what FDA is considering. FDA offered similar testimony about its potential new drug paradigm (OTC+) concept and the specifics of its proposal. Under FDA's OTC+ concept, medications that otherwise would be available only by prescription could be made available OTC with certain "conditions of safe use" such as interventions by a pharmacist or innovative technologies, and manufacturers could submit such an application for review by the agency. As explained in the FDA meeting notice announcing the new paradigm concept under consideration, the concept could address the public health problem of undertreatment of common conditions. APhA supports OTC+. (See page 60 of June Pharmacy Today.) Resolutions 218 and 240 inaccurately characterized the concept FDA is considering as enabling pharmacists to independently prescribe certain medications, according to the June 15 Joint pharmacy letter. "There is no intent to seek independent prescribing authority for pharmacists" as incorrectly described in the background material and "Resolve" language for resolutions 218 and 240, emphasized the letter. The pharmacy letter recommended adoption of resolution 235 in lieu of resolutions 218 and 240 but with "a revised title to better reflect the intent of the resolution, which supports AMA's continued dialogue on this issue." Joining APhA on the June 15 letter were eight colleague pharmacy groups. The letter served as the basis for Bough's testimony at the AMA hearing. Bough told Today that "pharmacy and medicine agree that we should have an opportunity to provide input as FDA reviews any manufacturer's application seeking to use a conditions of safe use if such a pathway exists in the future." Immunizations, other policiesAccording to the report's summary of discussions around resolution 218, Reference Committee B acknowledged testimony and concerns regarding pharmacist-provided immunizations, decided to discuss immunizations in a separate conversation, and urged those interested to submit a resolution addressing immunization issues at the next AMA meeting.Other pharmacy-related policies adopted by the AMA House of Delegates included a policy on drug shortages, a policy that pharmacies should have interpreter services, and a policy opposing the sale of tobacco in pharmacies. Several other drug-related policies were adopted. According to the report's summary of discussions around resolution 218, Reference Committee B acknowledged testimony and concerns regarding pharmacist-provided immunizations, decided to discuss immunizations in a separate conversation, and urged those interested to submit a resolution addressing immunization issues at the next AMA meeting. Other pharmacy-related policies adopted by the AMA House of Delegates included a policy on drug shortages, a policy that pharmacies should have interpreter services, and a policy opposing the sale of tobacco in pharmacies. Several other drug-related policies were adopted.