Regulated Pharmaceutical Product Environment Regulators (FDA, etc) Standards (USP, etc)

Essential Drugs for Public Health Programs Ideal Overlap of Regulated Product and Public Health Environments • International Public Health Intervention Environment • Global policy and donor agencies (WHO, UNICEF, etc) • Bilateral donors (USAID, etc) • Developing country MOHs • NGOs • Regulated Pharmaceutical Product Environment • Regulators (FDA, etc) • Standards (USP, etc) • Pharmaceutical producers • Pharmaceutical distributors Right Drug Right Reason Right Place Right Storage Right Time How drugs become available (with storage condition specifications) How drugs get used (ideally)

Oxytocin for Prevention of Post Partum Hemorrhage Overlap has shrunk rather than grown in past couple years • International Public Health Intervention Environment • Global policy and donor agencies (WHO, UNICEF, etc) • Bilateral donors (USAID, etc) • Developing country MOHs • NGOs • Regulated Pharmaceutical Product Environment • Regulators (FDA, etc) • Standards (USP, etc) • Pharmaceutical producers • Pharmaceutical distributors Right Drug Right Reason Right Place Right Storage Right Time How Oxytocin becomes available (trend to more conservative storage conditions) How Oxytocin gets used (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 • Global policy and donor agencies (WHO, UNICEF, etc) • Bilateral donors (USAID, etc) • Developing country MOHs • NGOs • Regulated Environment • Regulators (FDA, etc) • Standards (USP, etc) • Pharmaceutical producers • Pharmaceutical distributors Oxytocin For PPPH At Birth In Proper Conditions How Oxytocin becomes available (trend to more conservative storage conditions) How Oxytocin gets used (desire to extend use beyond clinics)

Possible Steps to Increase the Overlap? • Public Health Environment • Global policy and donor agencies (WHO, UNICEF, etc) • Bilateral donors (USAID, etc) • Developing country MOHs • NGOs • Regulated Environment • Modify Standards (USP) that drive Oxytocin storage condition labeling • Questions: • How much change is realistic? • How long would it take? • What data is needed? How Oxytocin becomes available How Oxytocin gets used

Possible Steps to Increase the Overlap? • Public Health Environment • Global policy and donor agencies (WHO, UNICEF, etc) • Bilateral donors (USAID, etc) • Developing country MOHs • NGOs • Regulated Environment • Modify Oxytocin Formulation to further increase heat tolerance • Questions: • How much change is realistic? • How long would it take? • Do producers have incentive? How Oxytocin becomes available How Oxytocin gets used

Possible Steps to Increase the Overlap? • Public Health Environment • Global policy and donor agencies (WHO, UNICEF, etc) • Bilateral donors (USAID, etc) • Developing country MOHs • NGOs • Regulated Environment • Modify Oxytocin Packaging to include heat exposure monitor • Key Questions: • Would increased costs be tolerated? • Would producers have incentive? How Oxytocin becomes available How Oxytocin gets used

Possible Steps to Increase the Overlap? • 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? • Regulated Environment • Regulators (USFDA, etc) • Standards (USP, etc) • Pharmaceutical producers • Pharmaceutical distributors How Oxytocin becomes available How Oxytocin gets used

Possible Steps to Increase the Overlap? • 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? • Regulated Environment • Regulators (USFDA, etc) • Standards (USP, etc) • Pharmaceutical producers • Pharmaceutical distributors How Oxytocin becomes available How Oxytocin gets used

What is possible? What should we prioritize? What have we missed? • Public Health Environment • Improve Infrastructure • Educate and Inform • Regulated Environment • Modify Standards • Modify Formulation • Modify Packaging

Regulated Pharmaceutical Product Environment Regulators (FDA, etc) Standards (USP, etc)