WHO Adds Misoprostol to Model List of Essential Medicines

After years of clinical trials, the World Health Organization agreed to add misoprostol to its Model List of Essential Medicines in April of this year. This is due to the efforts of numerous advocates and stakeholders, including an initiative of Gynuity Health Projects and Family Care International to evaluate misoprostol as an alternative medicine for prevention and treatment of post-partum hemorrhaging.

As a safe and efficient drug for the treatment of incomplete abortion and miscarriage, misoprostol is a necessity to help prevent the 500,000 deaths that occur each year due to childbirth and pregnancy related complications, and ultimately to reach MDG 5, reducing maternal mortality by 75%.

Excessive bleeding, (also referred to as post-partum hemorrhage or PPH) is the leading cause of maternal mortality, killing more than 150,000 women every year. Women who suffer from PPH can die very quickly, often within 2 hours, if immediate and appropriate medical care is not available. Many women in developing countries often deliver at home, and are unable to recognize the signs of excessive bleeding in time to seek care. Those who do realize the serious repercussions may still find that there is not available transport or sufficient time to reach the nearest hospital, and even if they were to make it there in time, many facilities are often under supplied and unequipped to handle such emergencies.

The standard drug used in recent years to stop PPH has been oxytocin, but after conducting extensive clinical trials, misoprostol has increasingly demonstrated potential in preventing and treating post-partum hemorrhaging, based on its ability to stimulate uterine contractions and stop bleeding. In addition, misoprostol offers many advantages over the standard treatment; it can be given via a variety of routes (oral, rectal, sublingual, vaginal), it does not require refrigeration, it has a long shelf life, is stable at high temperatures, is inexpensive ($1 per dose) and has relatively few side effects (Lancet source: http://www.thelancet.com/journals/lancet/article/PIIS0140673606695226/fulltext). Due to these characteristics, misoprostol is particularly well suited for developing countries, as it can be used by a wide range of health care providers in low resources settings as well as by midwives and traditional birth attendants in remote villages.

In order to reach MDG 5, reducing maternal mortality by 75% by 2015, we must continue to support organizations and initiatives to gain approval for drugs such as misoprostol. Venture Strategies, a nonprofit organization created to improve the health of low income people in resource-poor settings, and a partner of PPD, has been working to get misoprostol registered in a number of African countries. Due to the efforts of Venture Strategies and partners, in January 2006, Nigeria was the first country in the world to register misoprostol for postpartum hemorrhage. In the past few years misoprostol has also been registered or approved for obstetric/gynecologic indications in several countries, including Ghana, Sudan, Ethiopia, Kenya, South Africa, Tanzania, Uganda, and Zambia.

As the World Health Organization (WHO) has now acknowledged this new drug on its essential medicines list, it is the PPD ARO's hope that significant strides toward reducing maternal mortality will soon be made. Each day more than 350 women die due to severe bleeding, and the creation of a drug that is both effective and actually able to be used in most communities is a huge step in preventing the many unnecessary deaths that occur worldwide.

To learn more about Postpartum Hemorrhage and the use of misoprostol you can access information from Family Care International in English and French at http://www.familycareintl.org/en/resources/publications/21

To review WHO information on misoprostol, including letters of support from various interest groups, please visit
http://www.who.int/selection_medicines/committees/expert/17/application/misoprostol/en/index.html

Medical guidelines and research reports are available at: http://www.misoprostol.org/

And read a recent (April 2009) article on global availability (including details on licensing and distribution in each country) from the International Journal of Gynecology and Obstetrics: http://tinyurl.com/misoavail