Transcript Slide 1
Essential Drugs for Public Health Programs Ideal Overlap of Regulated Product and Public Health Environments Regulated Pharmaceutical Product Environment • Regulators (FDA, etc) • Standards (USP, etc) • Pharmaceutical producers • Pharmaceutical distributors International Public Health Right Drug Intervention Environment Right Reason • Global policy and donor agencies (WHO, UNICEF, etc) Right Place Right Storage Right Time • Bilateral donors (USAID, etc) • Developing country MOHs • NGOs How drugs become available How drugs get used (with storage condition specifications) (ideally) Oxytocin for Prevention of Post Partum Hemorrhage Overlap has shrunk rather than grown in past couple years Regulated Pharmaceutical Product Environment • Regulators (FDA, etc) • Standards (USP, etc) Right Drug Right Reason Right Place • Pharmaceutical producers Right Storage • Pharmaceutical distributors Right Time International Public Health Intervention Environment • Global policy and donor agencies (WHO, UNICEF, etc) • Bilateral donors (USAID, etc) • Developing country MOHs • NGOs How Oxytocin becomes available How Oxytocin gets used (trend to more conservative storage conditions) (desire to extend use beyond clinics) Oxytocin for Prevention of Post Partum Hemorrhage Overlap has shrunk rather than grown in past couple years Regulated Environment Oxytocin Specific Events • USP changed Oxytocin for injection monograph storage conditions from 15-30C to 2-8C • Directly impacts USFDA, pharma producers selling in US • Major influence and impact in many other countries and pharma producers that adopt USP standards • More pharma producers will label their Oxytocin for injection “Store at 2-8C” Public Health Environment Oxytocin Specific Events • Global policy and donor agencies (WHO, UNICEF, USAID, FIGO, etc) focus on AMSTL to reduce a leading cause of maternal death--PPH • In AMSTL, a dose of an oxytoxic drug to be given to every woman giving birth • Oxytocin recommended as drug of choice for this use • More Oxytocin will ideally be used with women giving birth at home or in limited capacity facilities, where 2-8C drug storage conditions can not be achieved Big Picture Objective of Today’s Meeting? Identify how we all can take steps to increase the overlap (solution space) Public Health Environment Regulated Environment • Regulators (FDA, etc) Oxytocin • Standards (USP, etc) For PPPH • Pharmaceutical producers At Birth • Pharmaceutical distributors In Proper Conditions • Global policy and donor agencies (WHO, UNICEF, etc) • Bilateral donors (USAID, etc) • Developing country MOHs • NGOs How Oxytocin becomes available How Oxytocin gets used (trend to more conservative storage conditions) (desire to extend use beyond clinics) Possible Steps to Increase the Overlap? Regulated Environment Public Health Environment • Modify Standards (USP) that drive Oxytocin storage condition labeling • Global policy and donor agencies (WHO, UNICEF, etc) Questions: • Bilateral donors (USAID, etc) • How much change is realistic? • Developing country MOHs • How long would it take? • NGOs • What data is needed? How Oxytocin becomes available How Oxytocin gets used Possible Steps to Increase the Overlap? Regulated Environment Public Health Environment • Modify Oxytocin Formulation to further increase heat tolerance • Global policy and donor agencies (WHO, UNICEF, etc) • Questions: • Bilateral donors (USAID, etc) • How much change is realistic? • Developing country MOHs • How long would it take? • NGOs • Do producers have incentive? How Oxytocin becomes available How Oxytocin gets used Possible Steps to Increase the Overlap? Regulated Environment Public Health Environment • Modify Oxytocin Packaging to include heat exposure monitor • Global policy and donor agencies (WHO, UNICEF, etc) • Key Questions: • Bilateral donors (USAID, etc) • Would increased costs be tolerated? • Developing country MOHs • Would producers have incentive? • NGOs How Oxytocin becomes available How Oxytocin gets used Possible Steps to Increase the Overlap? Regulated Environment • Regulators (USFDA, etc) • Standards (USP, etc) • Pharmaceutical producers • Pharmaceutical distributors Public Health Environment • Improve Infrastructure with More Cold Chain Capacity Key Questions • Is this realistic? • Will it help when births occur outside of health facilities? • How long will it take? How Oxytocin becomes available How Oxytocin gets used Possible Steps to Increase the Overlap? Regulated Environment • Regulators (USFDA, etc) • Standards (USP, etc) • Pharmaceutical producers • Pharmaceutical distributors Public Health Environment • Educate and Inform with Guidelines, Recommendations Key Questions • How to harmonize with regulated labeling issues? • How much effort to overcome current (sometimes misguided) beliefs? • How long will it take? How Oxytocin becomes available How Oxytocin gets used What is possible? What should we prioritize? What have we missed? Regulated Environment Public Health Environment • Modify Standards • Improve Infrastructure • Modify Formulation • Educate and Inform • Modify Packaging