Decision on Addition of Misoprostol to WHO EML for Treatment & Prevention of Postpartum Hemorrhage

May 19, 2011

Dear Colleagues:

It has been several months since you lent your support to add misoprostol for prevention and treatment of post-partum hemorrhage (PPH) to the World Health Organization’s (WHO) Model List of Essential Medicines. The 18th Expert Committee on the Selection and Use of Essential Medicines met in Accra, Ghana in March 2011 to review the applications for misoprostol to be added to the WHO’s essential medicines list (EML) for the prevention and treatment of PPH. There was a huge outpouring of support for the inclusion of misoprostol for both indications by international policy-making and programmatic agencies and outside expert reviewers that positively reviewed both applications.

On May 6th, the Expert Committee published its results which “add misoprostol to the [Essential Medicines] List, for the prevention of PPH in settings where parenteral uterotonics are not available or feasible.” Additionally the committee moved the drug from the complementary to the core list of essential medicines. The committee’s report cited a recently completed study from Pakistan, demonstrating that “there may be a benefit from use of misoprostol by traditional birth attendants or assistants trained on the use of the product at home deliveries. Unfortunately, the committee did not approve the inclusion of misoprostol for its specific PPH treatment indication at this time. The unedited draft report is available on the WHO website at: http://www.who.int/medicines/publications/unedited_trs/en/index.html.

Regarding misoprostol for PPH treatment, the committee expressed some concerns which led to their decision to withhold approval at this time. The major stumbling blocks noted by the committee appear to be concerns about the very limited (e.g. no) data to support the use of misoprostol for treatment of PPH among women who have previously received prophylactic misoprostol to prevent PPH as well as about possible side effects after 800 micrograms (mcg) of sublingual misoprostol. . The committee also indicated a worry that any recommendation to use misoprostol for both PPH prevention and treatment could reduce attempts to make oxytocin more available. It is important to underscore however, that the committee also noted in its report that WHO guidelines and other internationalguidelines recommend misoprostol for both the prevention and treatment of PPH due to atony, where parenteral uterotonics are not available.

We are pleased that the EML will now include the 200-mcg tablet of misoprostol for its PPH prevention indication, in addition to:

  1. a 25‐mcg vaginal tablet, for use in induction of labor;
  2. a 200‐mcg tablet to be used in combination with mifepristone, for termination of pregnancy (where legally permitted and culturally acceptable);
  3. a 200‐mcg tablet for the management of incomplete abortion and miscarriage.

Moreover, the addition of misoprostol to the Core List is a strong validation of the drug’s role in women’s health. Future research will address misoprostol use for PPH treatment after its use for PPH prevention. Such use of the drug is certainly already a reality in places where oxytocin is not yet available and/or feasible to use. These results and other supportive data will be submitted to the Expert Committee on the Selection and Use of Essential Medicines again for consideration in two years.

Many organizations, including Gynuity Health Projects and Venture Strategies Innovations, continue to support the addition of misoprostol to the Model List of Essential Medicines for its specific post-partum hemorrhage treatment indication and will continue to advocate for its inclusion in the future.

We thank you again for your support of this issue.

Sincerely,

 

Jennifer Blum, M.P.H., Gynuity Health Projects
Ndola Prata, M.D., M.Sc., Venture Strategies Innovations, Associate Professor in Residence, University of California, Berkeley
Kirsten Moore, Reproductive Health Technologies Project