Laura J. Frye (Ed.)
Publication Date
November 1, 2011

Gynuity Health Projects

In March of 2011, Gynuity Health Projects convened a meeting "to clarify pathways for moving forward in accordance with scientific evidence to foster availability of misoprostol and its use for postpartum hemorrhage indications. This included discussion of what registration means, how it can be optimally pursued, where registration fits in the context of making misoprostol available to meet women’s and health systems needs, and how and when it might make sense to proceed without product registration." This document reports on the meeting.

Sessions included the following:

  1. Focus on product registration processes and product regulation, manufacturing and clinical practices, World Health Organization (WHO) prequalification, and WHO’s Model Essential Medicines List.
  2. Focus on misoprostol products' quality and accessibility. The participants learned about the "post-marketing activities that should be undertaken after product registration..."
  3. Focus on systems necessary for ensuring product availability, using examples of "oxytocin and dedicated emergency contraception products as models of drugs in which labeling and usage have not always been aligned."
  4. Focus on strategies for making misoprostol available globally. "By examining the UNFPA [United Nations Population Fund] and USAID [United States Agency for International  Development]  procurement processes, participants gained clarity on some of the possible routes for obtaining misoprostol and several organizations provided explanations of the strategies they have used and challenges they have faced in their efforts to obtain registration for misoprostol in various settings."
  5. Discussion on next steps for the Postpartum Hemorrhage (PPH) community to move forward towards achieving wider access to quality misoprostol products globally.


Communication-related planning included:

  • The investigator’s brochure is a "key document" for maintaining good clinical practice (GCP) when working with drugs not approved by governmental regulatory bodies for the purpose they are being studied. "The brochure contains a summary of the physical, chemical, and pharmaceutical properties and formulations, nonclinical studies, and effects in humans of the drug. It should be written by qualified staff and updated at least annually. Another essential document for maintaining GCP is a set of Standard Operating Procedures which should include sections on shipping and receiving the drug, drug storage, staff access, drug accountability, and dispensing products to participants."
  • To support the WHO prequalification process for pharmaceuticals (intended to boost or accelerate availability of essential medicines), "the Concept Foundation has completed a set of frequently asked questions and a primer on the program for manufacturers."
  • A challenge to marketing misoprostol: "An important marketing challenge is to combat the negative images of the drug among doctors due to the association with abortion," rendering it potentially unavailable in some countries.
  • The supply of pharmaceuticals depends, as stated here, on public sector demand, which includes management of medicines by procurers, some of whom are not trained pharmacists: "As a result, to strengthen the supply system [the PPH community] need[s] to tailor messages to non-trained procurers and to give them good reasons to order misoprostol and also encourage the adoption of standard operating procedures for procurement, dispensing and use of uterotonics....Promoting product availability requires identifying the barriers in the system and tailoring messages and advocacy efforts."
  • Using the example of emergency contraception (EC): "EC is prime example of how science can be far ahead of registration and regulation, and how many providers are quick to adopt evidence-based, off-label protocols."(An off-label use differs in indication, dose, route, or frequency from the label, which describes use that is common and sanctioned by some regulatory agencies.) "There was no registered or marketed emergency contraceptive pill until 1999, however spreading the word about EC off-label use began before there was a dedicated product. During the 1980s and 1990s there were advocacy and educational programs, and materials like instructional pamphlets that were made available to non-profits working worldwide. Social marketing organizations took on EC as a key issue, and the Emergency Contraception Website and Hotline emerged in the US and Canada providing instructions for use and a list of providers. Organizations focusing on service provision helped to make EC pills available ahead of need and addressed provider barriers, such as logistics and provider attitudes. A registered product was not needed to share information about EC....The use of EC off-label lead to the development of a dedicated product and provided the preconditions that demonstrated both the need and use worldwide. It showed the pharmaceutical industry that it was worthwhile to produce and market. Most of the marketing today is still done by non-pharmaceutical agencies."
  • Using the example of integrated marketing from Marie Stopes International (MSI): "The MSI branded misoprostol product is Misoclear, and this branding is intended to indicate a product of consistent quality and value and to differentiate the product from fake drugs. MSI distributes Misoclear through its clinics, outreach camps, trained social franchisees (BlueStar providers), as well as pharmacies. MSI also conducts a wide range of operations research to track customer profiles, product use, efficacy, and side effects in collaboration with partner agencies."
  • Using the example of Somaliland: Understanding local barriers in Somaliland showed the steps needed for product introduction where most births occur at home and where negative press on the abortion aspect of misoprostol preceded its rollout. "Together with its partners, PSI [Population Services International] worked with in-country champions and achieved Ministry of Health permission for importation and distribution of misoprostol for PPH. However, there was significant fear about use for abortion, including newspaper articles. PSI conducted a pilot study demonstrating tight monitoring of the drug and eventually the Ministry of Health allowed them to roll out distribution to clinics and health posts."
  • Participants suggested a database of research and regional efforts for approval by government ministries of health. A research template was suggested so that studies could be comparable. Joint advocacy was also suggested.

Click here to read the full text of this document online.


Gynuity website, October 2 2014. Image credit: Women Deliver website