1. Promoting the use of oxytocin for the prevention of PPH Hans V. Hogerzeil, MD, PhD, FRCP Edin Director, Medicines Policy and Standards World Health Organization

2. 2 Medicines Policy and Standards Summary of stability studies 1988-1996 Hogerzeil HV, Walker GJA. Instability of (methyl)ergometrinein tropical climates: an overview. Eur J Obs Gyn Reprod Biol 1996; 69: 25-29 n Ergometrine injection is very unstable, sensitive to light, with much variation between brands ä Recommended solutions: careful supplier selection; refrigerated storage; protect from light; check colour; do not use discoloured products n Methylergometrine is not more stable per se; some products are n Oxytocin injection is more stable than (methyl)ergometrine, and not sensitive to light. But oral oxytocin is even less stable than (methyl)ergometrine injection n Better stability and lower cost support clinical arguments that oxytocin is the drug of choice for AMTSL/prevention of PPH

3. 3 Medicines Policy and Standards Summary of new information since 1996 n There is a more stable methylergometrine injection (1 year at 25°, and 6 months at 30°) – but one brand only (IDA) n Oxytocin brands are consistent in stability (IDA) n Heat-stable oxytocin has been recognized by WHO as a "missing essential medicine", inviting product development (Priority medicines – a public health approach to innovation. WHO, 2004) n Oxytocin has been included in set of "WHO policy advice", summarizing RH clinical evidence for national programmes n Oxytocin has been listed for inclusion in the WHO/UN prequalification project in 2006 (pending funding)

4. 4 Medicines Policy and Standards What is the problem? n Oxytocin is recommended drug of choice for AMTSL/PPPH; yet it is insufficiently been used at country level ä No AMTSL done at all ä Ergometrine or misoprostol used instead ä Oxytocin not recommended in national guidelines ä Oxytocin listed but not supplied ä Oxytocin supplied but wrongly stored; ä Oxytocin use by some clinicians but not by all, not by SBAs ä Other non-compliance with clinical AMTSL procedures n There is much difference between countries; this implies the need for individual country approaches

5. 5 Medicines Policy and Standards Use clinical arguments, not stability data, to change behaviour n (Re)formulate WHO clinical guidance on AMTSL; involve and get support from important professional associations; present counterarguments to common objections; adapt / strengthen WHO policy guidance for national programmes n Get oxytocin included in national clinical guidelines and training programmes, and on national essential medicines lists; use Human Rights arguments (right to health, right to life) n Advocate procurement of prequalified oxytocin only n Develop individual country programmes to change behaviour: (1) survey / analyse situation, (2) identify reasons, (3) develop intervention with national opinion leaders, (4) monitor effect with self-monitoring systems (5) report good impact

6. 6 Medicines Policy and Standards www.who.int / medicines Saving lives with the right (to) medicines