Misoprostol in resource poor countries

Abstract

Is cheap and effective, yet its availability remains restricted

An evidence based guideline on the use of misoprostol for women’s reproductive health has recently been published.¹ It underlines the value of misoprostol for specific clinical indications in obstetrics and gynaecology despite the remarkable absence of marketing efforts by producers. Misoprostol is a prostaglandin E₁ analogue, which is effective, cheap, and can be used safely for a variety of obstetric and gynaecological indications.² It is rare that a new drug can potentially save tens of thousands of maternal lives, particularly in the poorest countries in the world.

The uterotonic action of misoprostol was discovered as a side effect of its main intended use of treating peptic ulcer.³ For more than 20 years it has been a focus of global interest among obstetricians and gynaecologists, although the patent holder consistently refuses to acknowledge its tremendous potential value for women in the poorest countries. The reasons for this refusal seem to be related mostly to its wide use for induction of abortion. Threats of boycott activities from antiabortion groups have allegedly prevented it being marketed for use in gynaecology.

The uterotonic properties of misoprostol can reduce mortality in two ways. Firstly, the drug can be used to terminate unwanted pregnancies.⁴ Secondly, it can reduce the risk of life threatening postpartum haemorrhage.⁵ About 15% of maternal deaths globally are caused by unsafe abortions,⁶ and around 30% are caused by postpartum haemorrhage.⁷

About 42 million pregnancies are terminated annually worldwide. Reasons include lack of access to adequate information and a failure of contraception. Even if all women and men used contraceptives perfectly, nearly six million unwanted pregnancies would occur each year.⁸

Unsafe abortions kill an estimated 67 000 women annually.⁶ In addition, 5 million women each year experience temporary or permanent disability as a result of complications of unsafe abortions, including haemorrhage; sepsis; peritonitis; and trauma to the cervix, vagina, uterus, and abdominal organs.⁸ Such complications are entirely preventable when abortions are performed safely.

An induced abortion is associated with minimal morbidity and a negligible risk of death when performed by trained healthcare providers with proper equipment, the correct technique, and sanitary standards.⁹ Misoprostol can be used for medical abortion, cervical ripening before surgical abortion, and evacuation of the uterus for various medical reasons, including incomplete abortion and missed abortion. It can be used in oral, sublingual, or vaginal form.¹

The main cause of postpartum haemorrhage is uterine atony, which can usually be prevented by the use of conventional uterotonic drugs. Oxytocin is generally preferred but seldom available outside hospital based settings. One randomised controlled trial in resource poor communities found that misoprostol is effective for preventing postpartum haemorrhage in the active management of the third stage of labour. However, it is not yet standard care in such settings.⁵

Because parenteral oxytocin is not available in resource poor settings, it is important for alternative drugs to be made available. The simplified administration of oxytocin using the prefilled disposable UniJect device has been tried in Angola, but it requires refrigerated storage and is most appropriate for hospital settings.¹⁰ For these reasons, misoprostol holds great promise for the prevention of postpartum haemorrhage, but it will certainly not completely eliminate abundant postpartum haemorrhage.

Misoprostol is a cheap and effective drug for terminating unwanted pregnancies and preventing potentially fatal postpartum haemorrhage. It has the benefit of being a heat stable tablet that does not need to be injected but can be taken orally, sublingually, or vaginally. Tragically, because of resistant attitudes among companies marketing the drug, it is not yet an essential drug in many countries, although it is readily available on the black market. The end of the original producer’s global patent might improve its availability among the most deprived women in the poorest countries.