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

Regulated Pharmaceutical Product Environment Regulators (FDA, etc) Standards (USP, etc) Pharmaceutical producers Pharmaceutical distributors 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 (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 Right Drug Right Reason Right Place Right Storage Right Time

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 Oxytocin for Prevention of Post Partum Hemorrhage Overlap has shrunk rather than grown in past couple years

Regulated Environment Regulators (FDA, etc) Standards (USP, etc) Pharmaceutical producers Pharmaceutical distributors Public Health Environment Global policy and donor agencies (WHO, UNICEF, etc) Bilateral donors (USAID, etc) Developing country MOHs NGOs How Oxytocin becomes available (trend to more conservative storage conditions) How Oxytocin gets used (desire to extend use beyond clinics) Big Picture Objective of Today’s Meeting? Identify how we all can take steps to increase the overlap (solution space) Oxytocin For PPPH At Birth In Proper Conditions

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? Public Health Environment Global policy and donor agencies (WHO, UNICEF, etc) Bilateral donors (USAID, etc) Developing country MOHs NGOs How Oxytocin becomes availableHow Oxytocin gets used Possible Steps to Increase the Overlap?

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? Public Health Environment Global policy and donor agencies (WHO, UNICEF, etc) Bilateral donors (USAID, etc) Developing country MOHs NGOs How Oxytocin becomes availableHow Oxytocin gets used Possible Steps to Increase the Overlap?

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

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