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 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

Ergometrine injection is very unstable, sensitive to light, with much variation between brands

Recommended solutions: careful supplier selection; refrigerated storage; protect from light; check colour; do not use discoloured products

Methylergometrine is not more stable per se; some products are

Oxytocin injection is more stable than (methyl)ergometrine, and not sensitive to light. But oral oxytocin is even less stable than (methyl)ergometrine injection

Better stability and lower cost support clinical arguments that oxytocin is the drug of choice for AMTSL/prevention of PPH

3 Medicines Policy and Standards

Summary of new information since 1996

There is a more stable methylergometrine injection (1 year at 25°, and 6 months at 30°) – but one brand only (IDA)

Oxytocin brands are consistent in stability (IDA)

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)

Oxytocin has been included in set of "WHO policy advice", summarizing RH clinical evidence for national programmes

Oxytocin has been listed for inclusion in the WHO/UN prequalification project in 2006 (pending funding)

4 Medicines Policy and Standards

What is the problem?

Oxytocin is recommended drug of choice for AMTSL/PPPH; yet it is insufficiently been used at country level

No AMTSL done at all Ergometrine or misoprostol used instead Oxytocin not recommended in national guidelines Oxytocin listed but not supplied Oxytocin supplied but wrongly stored; Oxytocin use by some clinicians but not by all, not by SBAs Other non-compliance with clinical AMTSL procedures

There is much difference between countries; this implies the need for individual country approaches

5 Medicines Policy and Standards

Use clinical arguments, not stability data, to change behaviour

(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

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)

Advocate procurement of prequalified oxytocin only

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 Medicines Policy and Standards

www.who.int / medicines

Saving lives with the right (to) medicines