This past summer we completed an evaluation of the long-term use of misoprostol for treatment of PPH at the community-level. Overall, misoprostol acceptance is very high among women surveyed in both intervention villages (where misoprostol has been in use by TBAs) and control villages where TBAs do not have misoprostol to control the life-threatening bleeding that can occur after delivery. More than four out of five women surveyed, reported they would recommend misoprostol to a friend or take it again if they experienced PPH.
In the villages where researchers visited, the overwhelming response was, "Bring more! Bring more tablets!"
Over the past year, Venture Strategies has been steadily working with the Tanzanian government towards registering the drug misoprostol to control postpartum hemorrhage (PPH). Since our Medical Director's groundbreaking operations research demonstrating misoprostol is safe to use at home births in Tanzania, and substantial policy and advocacy efforts, this lifesaving drug is poised for registration pending approval of the regulatory dossier.
To date we have facilitated a partnership between a high quality generic pharmaceutical manufacturer and a Tanzanian distributor, ByTrade, to submit the regulatory application to register and import misoprostol for use in controlling PPH. Additionally, Venture Strategies and our colleagues at the School of Public Health, UC Berkeley provided technical expertise to draft the regulatory dossier, which has been submitted to the Tanzanian Food and Drug Authority.
In preparation for misoprostol's forthcoming regulatory approval, we are co-hosting an expert technical meeting in October 2007 to discuss the integration of new misoprostol clinical guidelines and plans for implementation of misoprostol at the community level.
In the year since Dr. Ndola Prata published her landmark study demonstrating that misoprostol can be used safely and effectively to save mother's lives from excessive bleeding after childbirth by illiterate traditional birth attendants, significant strides have been made towards making this life-saving drug available to all Tanzanian women who die needlessly in childbirth.
In May 2006, a group of technical officials from the Ministry of Health and regulatory agency met in Tanzania's capitol city in a closed-door session to discuss potential additions to the country’s essential drug list.
The essential drug list is comprised of medicines considered so important to the population that they are given a special status.
The topic of generic-drug misoprostol was raised, and the group began to discuss. One participant raised a piece of paper with a description of the progress being made in neighboring country Ethiopia. The paper was an email announcement sent by our organization, Venture Strategies.
“Ethiopia has added this drug to their list. Women are dying in Ethiopia of this condition, and they are dying here in Tanzania. We need this drug.”
That day, the group decided to add misoprostol to their national drug list for the purpose of controlling postpartum hemorrhage, the leading cause of maternal death. Adding it to the list for this purpose has a secondary benefit – it authorizes health providers to use the drug for this important off-label purpose. This first step helps significantly to clear the way for making misoprostol widely available.
We are proud of the Tanzanians for taking this bold historic step and are pleased to be able to support them at this critical time for the country’s mothers.
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