The Secretary of the 18Th Expert Committee on the Selection and Use of Essential Medicines

The Secretary of the 18th Expert Committee on the Selection and Use of Essential Medicines
Medicine Access and Rational Use (MAR)
Department of Essential Medicines and Pharmaceutical Policies (EMP)
World Health Organization (WHO)
20 Avenue Appia
CH-1211 Geneva 27
Switzerland

Date—February18,2011

Dear Committee Members:

I am writing this letter in support of the application for misoprostol to be added to WHO’s Essential Medicines List (EML) for the prevention of postpartum hemorrhage in section 22.01.00.00 “Oxytocics,” submitted by Gynuity Health Projects and Venture Strategies Innovations. As is well-evidenced in the international literature on maternal mortality and morbidity, postpartum hemorrhage (PPH) remains one of the largest contributors to maternal morbidity and mortality in low-resource settings and accounts for nearly one quarter of all maternal deaths worldwide. The addition of misoprostol to the EML for its PPH prevention indication will contribute to worthwhile efforts to achieve Millennium Development Goal #5 to reduce maternal mortality by three-quarters by the year 2015. The drug’s wide availability, low-cost, stability at room temperature and ease of use make it an ideal drug to add to the package of interventions available to prevent PPH in low-resource settings.

Several medical bodies support the use of misoprostol for PPH prevention in various circumstances—in particular when oxytocin is not available, including the WHO in itsWHO Recommendations for the Prevention of Postpartum Haemorrhage (WHO, 2007),6the International Federation of Gynecology and Obstetrics (FIGO), the Royal College of Obstetricians and Gynaecologists and the International Confederation of Midwives (ICM).

While several countries in Asia and Africa have already included misoprostol for the prevention of PPH in their list of essential medicines, other Ministries of Health find it difficult to include misoprostol for PPH preventionin their country’s Essential Drugs List because the product is not listed on theWHOEML for this important women’s health indication.Similarly, UN agencies and organizations active in emergencysituations are frequently unable to offer this medication because of its absence from the WHO EML. Listing misoprostol for its PPH prevention indication will break down this barrier.

I thank you for considering the addition of this very important medication to the WHO EML for the prevention of postpartum hemorrhage.

Sincerely,

Amanuel Gessessew

Obstetrician and Gynecologist

Ayder Referal hospital

Mekele

Tigray

Ethiopia

References

1) Mobeen N, Durocher J, Zuberi NF, Jahan N, Blum J, Wasim S, Walraven G, Hatcher J. Administration of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a randomised placebo-controlled trial. BJOG. in press.

2) Derman RJ, Kodkany BS, Goudar SS, Geller SE, Naik VA, Bellad MB, Patted SS, Patel A, Edlavitch SA, Hartwell T, Chakraborty H, Moss N: Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet 2006, 368:1248-1253

3) Høj L, Cardoso P, Nielsen BB, Hvidman L, Nielsen J, Aaby P. Effect of sublingual misoprostol on severe postpartum hemorrhage in a primary health centre in Guinea-Bissau: randomized double blind clinical trial. BMJ 2005;331(7519): 723.

4) Walraven G, Blum J, Dampha Y, Sowe M, Morison L, Winikoff B, Sloan N. Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial. British Journal of Obstetrics and Gynaecology 2005;112(9):1277.

5) Alfirevic Z, Blum J, Walraven G, Weeks A, Winikoff B. Prevention of postpartum hemorrhage with misoprostol. International Journal of Gynecology and Obstetrics 2007;99(Supplement 2): S198-S201.

6) WHO DoMPS. WHO Recommendations for the Prevention of Postpartum Haemorrhage.Geneva: World Health Organization, 2007.

Like many other developing countries, reduction of maternal mortality in my country of Ethiopia remains difficult to achieve. Recent estimates show that the maternal mortality rate is one of the highest in the world; at about 530 deaths per 100,000 live-births it is expected to be reduced to 230 in four years in accordance with MDG5. Considering the short period of time we are left between now and 2015, the goal will be difficult to attain unless it is supported by bold, practical and feasible policies.

One of the major steps taken by the Ethiopian government in this regard was the revision of the previous restrictive abortion law in 2005. Prior to that, unsafe abortion was one of the major contributors of maternal death and we are already seeing tremendous gains in the reduction of morbidity and mortality as a result of this policy.

As in many parts of the world, postpartum hemorrhage is another major cause of maternal deaths and disability in Ethiopia. This problem is easily preventable in health institution when the third stage of labor is managed actively. Institution delivery is also helpful for early treatment of postpartum hemorrhage with uterotonics and other medications. However 85% of our population lives in rural areas. Recent reports show that the vast majority of births— an incredible 95% take place at home. There are complex cultural, economic and social reasons why women deliver at home. These barriers are not easy to avoid in a short timeframe and despite concerted efforts underway to change this, the reality is we will need to wait decades until we get the accepted rate of institutional delivery in Ethiopia.

So what option do we have? [Pause] To treat the few mothers who come to health institutions and to leave the majority who deliver at home unassisted and to die as a result of postpartum hemorrhage? It is not difficult to imagine that no one accepts this option. Rather, we need to have an acceptable and effective strategy to help mothers at home where the majority of the deliveries take place. Various community-based studies, including a published study in Ethiopia, have unequivocally proved that the utilization of misoprostol in the prevention of postpartum hemorrhage is very effective and safe. Mothers should not be denied this opportunity while there is no strong reason and evidence to do otherwise.

In Ethiopia we have recognized the tremendous role misoprostol can have in increasing access for thousands of women to effective PPH management. We have trained over 1700 of our frontline government health extension workers—young women with a 10th grade education and 18 months of preventative and maternal and child health education—to distribute misoprostol to laboring mothers in their home and the rural health post/centers. Misoprostol is proving a viable, heat-stable, back-up option to oxytocin in our rural clinics where commodity security is a challenge in our vast country.

The direct causes of maternal deaths have been clear for a long time. What was not clear was an effective strategy that fits a particular setting, such as Ethiopia or many other developing countries. The years it took to revise the abortion law and approve task shifting of emergency surgery to non physicians are very good examples of how much time is wasted deliberating in the prevention of maternal mortality in Ethiopia. Thousands of mothers died because of disagreement by policy makers to make this very straight forward shift in policy.

Likewise, we should not wait until thousands of mothers die as result of postpartum hemorrhage while there is strong evidence that shows prevention is possible at home. Inclusion of misoprostol in the WHO EDL for the management of PPH will make it more available to women who need it, legitimizing its role to save lives and facilitating procurement and program implementation.Hundreds of thousands of women without a voice here today are waiting for our decision to help them.