GLP-1如何改变了复合治疗.pdf

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1、2/16/20261How GLP-1s Have Changed CompoundingAmy Summers,PharmD,BCSCP,FAPCConsultantRestore Health Consulting,LLC20 Years Ago,Compounders WereAll 503A(no section 503B in existence yet)Made up of hospitals,infusion pharmacies,and“mom and pop”community pharmaciesPreparing mostly sterile-to-sterile CSP

2、s OR nonsterile CNSPs Largely using manual/legacy methods to prepare a compoundCommonly offering large formularies(hundreds to 1,000)at a practice sitePreparing batch sizes often for N=1 to 10 patientsSeeing a mix of cash pay and some insurance No board certification in existenceLess intense regulat

3、ory scrutiny122/16/20262What Events/Shifts Have Happened Since Then?2012 NECC Tragedy DQSA Section 503B+Increased Regulatory Scrutiny of Compounding2013 NABP Launches VPP AccreditationMid 2010s-Present HCPs Became Social Media Influencers of Healthcare Products Patients are interested in precision m

4、edicine and want to live well2019 Healthcare Marketing on Social Media(e.g.,Mucinex on TikTok)consumerization of healthcare2019 First BCSCP Class2020 COVID-19 telehealth use becomes mainstream+certain regulations relax(e.g.,DEA CS)2022-2025 Multiple GLP-1 National Drug Shortages 503As and 503Bs step

5、 up to assist patients in continuity of care2022 AI Boom 2023 USP Updates Increased quality expectations2025 New US Administration No added federal laws BUT FDA has been busy with Green List,HRT black box removal,and warnings on claimsHow Have GLP-1s Changed Compounding?1.Public Awareness&Perception

6、2.Big Pharmas Response3.Market Expansion&Evolution4.Regulatory Landscape5.Shift in the Business Model342/16/20263Public Awareness&Perception A national poll(1,222 U.S.adults,Feb 2025)found:42%of adults are familiar with pharmacy compounding.29%didnt know what compounding was,and another 29%were unsu