Concept Foundation Concept Foundation & &

MTP Registration AdvocacyMTP Registration AdvocacyThailandThailand

Presented byPresented byWanapa Naravage, Ph.D.Wanapa Naravage, Ph.D.

Program Manager, Concept FoundationProgram Manager, Concept Foundation1111thth March 2012 March 2012

ICMA and WoW MeetingICMA and WoW Meeting

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Concept FoundationConcept Foundation

An international not-for-profit organization working in An international not-for-profit organization working in the field of reproductive health. the field of reproductive health.

Established by the WHO/HRP, World Bank, UNFPA in Established by the WHO/HRP, World Bank, UNFPA in 19881988 to help to help increasing access to health-improving increasing access to health-improving medicines and technologies.medicines and technologies.

Concept Foundation’s goal to: Concept Foundation’s goal to:

““Provide access to products for reproductive Provide access to products for reproductive health of assured quality to the public sector of health of assured quality to the public sector of

lower and middle income countries at the lowest lower and middle income countries at the lowest possible pricepossible price.”.”

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Conditions of agreement between WHO and Conditions of agreement between WHO and Concept FoundationConcept Foundation

Under its collaborative agreement with WHO, agreed to:Under its collaborative agreement with WHO, agreed to: Price – Co-packaged product with preferential price to public sector, making Price – Co-packaged product with preferential price to public sector, making

it affordable to many more women. it affordable to many more women.

Quality - Manufactured in USFDA/EMEA compliant facility, meeting Quality - Manufactured in USFDA/EMEA compliant facility, meeting international current Good Manufacturing Practice (cGMP).international current Good Manufacturing Practice (cGMP).

Regulatory issues – Misoprostol used “off-label”, regulatory agencies Regulatory issues – Misoprostol used “off-label”, regulatory agencies welcome formal registration of misoprostol for use in medical abortion; welcome formal registration of misoprostol for use in medical abortion; clinical part of registration dossier based on WHO clinical trials. clinical part of registration dossier based on WHO clinical trials.

Ease of use – Ease of use – co-packaged product easier for both provider and woman.co-packaged product easier for both provider and woman.

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BackgroundBackground

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To terminate pregnancyTo terminate pregnancy Law restrictionLaw restriction Regulation under medical council is ambiguous, Regulation under medical council is ambiguous,

therefore doctors are reluctant to carry out abortiontherefore doctors are reluctant to carry out abortion Attitude of providersAttitude of providers Social stigmaSocial stigma Limited safe abortion services Limited safe abortion services

To continue pregnancyTo continue pregnancy Lacking or inadequate support health service systemsLacking or inadequate support health service systems Social stigma Social stigma

Situation of Abortion Situation of Abortion (1)(1)

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Abortion Laws and RegulationAbortion Laws and Regulationss (2)(2)

Criminal code 305 (1) (2), 276, 277, 282, 283, 284 and Medical council regulation 2005 - medical doctors can perform abortion legally in order to:

Save a woman’s life and preserve physical health Preserve mental health Rape Women under 15 years of age Baby malformation

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Situation of Unsafe AbortionSituation of Unsafe Abortion (3)(3)

Surgical technologiesSurgical technologies Dilatation and Curettage (D & C) by sharp curettageDilatation and Curettage (D & C) by sharp curettage Manual Vacuum Aspiration (MVA) Manual Vacuum Aspiration (MVA)

Medical abortionMedical abortion Mifepristone (not legally available in Thailand)Mifepristone (not legally available in Thailand) Misoprostol (available for gastric ulcer, only doctors in Misoprostol (available for gastric ulcer, only doctors in

hospitals can administer)hospitals can administer) Easily purchased from internet and black market Easily purchased from internet and black market

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Situation of Unsafe AbortionSituation of Unsafe Abortion (4)(4) In Thailand, 200,000* abortions per year are quoted but no hard In Thailand, 200,000* abortions per year are quoted but no hard

data is available.data is available.

A study carried out in 1999 demonstrated that 28.8%** A study carried out in 1999 demonstrated that 28.8%** of the of the 13,090 induced abortion cases resulted in serious complications i.e. 13,090 induced abortion cases resulted in serious complications i.e. uterine perforation, infection and death.uterine perforation, infection and death.

Cost per visit for treatment of complication was 90 US$. In case of Cost per visit for treatment of complication was 90 US$. In case of severe complication, it would cost around 700 US$ per case**.severe complication, it would cost around 700 US$ per case**.

84% of young people age between 13-22 experienced unplanned 84% of young people age between 13-22 experienced unplanned pregnancy, of which 53% had induced abortions***.pregnancy, of which 53% had induced abortions***.

Ref: * Boonlert Lieoprapai, Population and Social Research Institute, Mahidol University (Bangkok post 15 March, 1978)**Suwanna Warakamin and Nongluk Boonthai. Situation of induced abortion Thailand, 2000.*** Nartruedee Dendoung, 2010.

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Develop of an Advocacy Develop of an Advocacy StrategiesStrategies

Step 1: Face –to-face meeting with the Step 1: Face –to-face meeting with the stakeholders (GO, NGO and WHO)stakeholders (GO, NGO and WHO)

Step 2: Form an advocacy group (working Step 2: Form an advocacy group (working group)group)

Step 3: Select theme for advocacyStep 3: Select theme for advocacyStep 4: Assess the situationStep 4: Assess the situationStep 5: Develop the modelStep 5: Develop the modelStep 6: Scale upStep 6: Scale up

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Four Key Principles for all StepsFour Key Principles for all Steps

Systems thinkingSystems thinking – bringing inter-relationships and the – bringing inter-relationships and the bigger picture into view.bigger picture into view.

A focus on A focus on sustainability.sustainability.

Understanding the Understanding the determinants of the pilot model determinants of the pilot model program and scaling-up success program and scaling-up success and use of this and use of this understanding to shape the scaling-up strategy.understanding to shape the scaling-up strategy.

Maintaining a focus Maintaining a focus on human rights, participation, on human rights, participation, gender equity, equitable access to quality of care, and gender equity, equitable access to quality of care, and ownership.ownership.

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Theme: “Making MTP Available, Accessible, Theme: “Making MTP Available, Accessible, Affordable Products of Assured QualityAffordable Products of Assured Quality ””

ByByWorking Group & SCWorking Group & SC

Department of Health, MoPHDepartment of Health, MoPHSiriraj Medical SchoolSiriraj Medical School

Ramathibodi Medical SchoolRamathibodi Medical SchoolChulalongkorn Medical SchoolChulalongkorn Medical School

MCH HospitalMCH HospitalWHO/ThailandWHO/Thailand

PATH/Thailand (Choices Network)PATH/Thailand (Choices Network)Concept FoundationConcept Foundation

SCSCRTCOG, Medical Council, Medical AssociationRTCOG, Medical Council, Medical Association

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Choices Network (58)

• prevention• options counseling • advocate for early

seeking help• refer cases

ResourceTeam (WG)

Lessons LearntScaling-up

Pilot MTP models

university hos• MCH hos

MTPMaking Available, Accessible, Making Available, Accessible,

Affordable Products of Assured Affordable Products of Assured QualityQuality

Planning Pilot Program: Planning Pilot Program: Conceptual FrameworkConceptual Framework of Strategic Approach (2)of Strategic Approach (2)

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Planning Pilot Program: Planning Pilot Program:

Conceptual FrameworkConceptual Framework of Strategic Approach (1)of Strategic Approach (1)

Making MTP Available, Accessible, Affordable Products of Making MTP Available, Accessible, Affordable Products of Assured QualityAssured Quality

Phase IStrategic Assessment

& Advocacy2010-2011

Phase IITesting

Interventions2011-2012

Phase IIIScaling up &Expansion 2012-onward

Resource Team

External Environmentunderstanding norms, values, laws & regulations and help or health seeking patterns of the UP women

source: Adapted from R. Simmons. ExpandNet and WHO, Presented at DoH, MoPH, Thailand, 17 Jan 2011

Process of product registration

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Phase I: Phase I: Strategic AssessmentStrategic Assessment & Advocacy& Advocacy

ObjectivesObjectives

Assess opportunities and constraints in the political, Assess opportunities and constraints in the political, policy and health sectors structurepolicy and health sectors structure

Assess capacity levels of supportive health systems, Assess capacity levels of supportive health systems,

health care facilities and health care personnelhealth care facilities and health care personnel

Advocate policy and decision makers on evidence Advocate policy and decision makers on evidence based on MTPbased on MTP

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Phase I: Phase I: Strategic AssessmentStrategic Assessment & Advocacy& Advocacy

Generation of a working group (resource team) and Generation of a working group (resource team) and steering committee i.e. OB & Gyn experts from Siriraj, steering committee i.e. OB & Gyn experts from Siriraj, Chula, Rama, RTCOG, Medical Association, Medical Chula, Rama, RTCOG, Medical Association, Medical Council, trainers/educators, decision makers from DoH, Council, trainers/educators, decision makers from DoH, representatives of WHO, PATH and Concept representatives of WHO, PATH and Concept Foundation. Foundation.

Has formally and informally met with the Thai FDA Has formally and informally met with the Thai FDA senior management team regarding MTP registrationsenior management team regarding MTP registration

Identified a local pharmaceutical distributor submitting of Identified a local pharmaceutical distributor submitting of the MTP product dossier for registration. the MTP product dossier for registration.

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Phase I:Phase I:Strategic AssessmentStrategic Assessment & Advocacy& Advocacy

Abortion and MTP remain sensitive issues. Therefore, Abortion and MTP remain sensitive issues. Therefore, the project organized meetings with stakeholders the project organized meetings with stakeholders nationwide and Choice Network Members to consult on nationwide and Choice Network Members to consult on making MTP available and accessible in Thailand. Also, making MTP available and accessible in Thailand. Also, evidence based on MTP from multi nation experiences evidence based on MTP from multi nation experiences had been presented in the meetings.had been presented in the meetings.

Develop an innovative project based on each health Develop an innovative project based on each health facility setting and system.facility setting and system.

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MTP Registration:MTP Registration:Concerns and Needs from the Concerns and Needs from the

Thai FDAThai FDA Study needs to demonstrate measures to

assure that:

the product is distributed to the hospital and prescribed by medical doctors

prescription MTP for the cases based on the law and regulations

Collaboration from medical society to control the drug in order to use based on the registration purpose as an dedicated product for early MTP

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Phase II: Phase II: Testing InterventionTesting Intervention

Project Goal and ObjectivesProject Goal and Objectives

The goalThe goal is to prepare for the provision of quality and is to prepare for the provision of quality and accessible Medical Termination of Pregnancy (MTP)accessible Medical Termination of Pregnancy (MTP)

The objectives:The objectives: To develop a service delivery model for MTPTo develop a service delivery model for MTP To develop a strategy for scaling up the accessibility To develop a strategy for scaling up the accessibility

and availability of MTP based on the findings and availability of MTP based on the findings

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What is a supportive health What is a supportive health system?system?

Drugs for medical abortion can be provided by trained medical Drugs for medical abortion can be provided by trained medical doctors but, in the few cases of incomplete abortion, there is need for doctors but, in the few cases of incomplete abortion, there is need for access to referral services.access to referral services.

The health systems must ensure access to a provider trained in the The health systems must ensure access to a provider trained in the use of manual vacuum aspiration (MVA) and to blood transfusion use of manual vacuum aspiration (MVA) and to blood transfusion services. services.

The health system must be prepared to provide training of all levels The health system must be prepared to provide training of all levels of health care providers and values clarification with providers.of health care providers and values clarification with providers.

Abortion remains a sensitive issue in our country and there is a Abortion remains a sensitive issue in our country and there is a continuing need for advocacy with providers as well as the broader continuing need for advocacy with providers as well as the broader society. society.

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Phase II: Phase II: Testing InterventionTesting Intervention ( (11))

Selection of health facilities to perform MTPSelection of health facilities to perform MTP

Adaptation of international MTP training curricula to the Adaptation of international MTP training curricula to the needs of the Thai health service systemneeds of the Thai health service system

Adaptation of values clarification and options Adaptation of values clarification and options counseling materials to the needs of the Thai health counseling materials to the needs of the Thai health service system service system

Training of health care providers at the selected study Training of health care providers at the selected study sites in the provision of MTP services including values sites in the provision of MTP services including values clarification and options counseling.clarification and options counseling.

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Phase II: Phase II: Testing InterventionTesting Intervention ( (2)2)

After training, sites will be provided with combination After training, sites will be provided with combination packages of Mifepristone and Misoprostol.packages of Mifepristone and Misoprostol.

Development of a service protocol for MTP using Development of a service protocol for MTP using international guidelinesinternational guidelines

Development and testing of IEC materials for Development and testing of IEC materials for providers and womenproviders and women

Development of a record-keeping system that can be Development of a record-keeping system that can be used for the study and provide insights for record-used for the study and provide insights for record-keeping in routine service delivery keeping in routine service delivery

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Phase II: Phase II: Testing InterventionTesting Intervention ( (3)3)

Collection of data on service provision and outcomes of Collection of data on service provision and outcomes of the treatment including adverse eventsthe treatment including adverse events

Provision of MTP using practical guidelinesProvision of MTP using practical guidelines

Interviewing of providers and women who have used Interviewing of providers and women who have used MTP on their opinion of MTP serviceMTP on their opinion of MTP service

Assessment of how provision of MTP affects services Assessment of how provision of MTP affects services

and costs and costs

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Phase II: Phase II: Testing InterventionTesting Intervention ( (4)4)

Reporting of the outcomes of MTP including rates of Reporting of the outcomes of MTP including rates of complete and incomplete termination of pregnancies, complete and incomplete termination of pregnancies, failures and any complications failures and any complications

Review of the experience of MTP provision in a Review of the experience of MTP provision in a participatory process with key stakeholders, for the participatory process with key stakeholders, for the development of a strategy to make MTP more widely development of a strategy to make MTP more widely availably and accessible in Thailandavailably and accessible in Thailand

Organization of a dissemination workshopOrganization of a dissemination workshop

Preparation of scientific papers on the resultsPreparation of scientific papers on the results

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Phase II: Phase II: Testing InterventionTesting Intervention

The Regimen for MTP to be usedThe Regimen for MTP to be used

The regimen for MTP used in the study consists of:The regimen for MTP used in the study consists of: 1 tablet of 200 mg mifepristone1 tablet of 200 mg mifepristone taken orally taken orally

followed 24 hours later by; followed 24 hours later by; 4 tablets of 200 μg misoprostol4 tablets of 200 μg misoprostol each (800 µg) is each (800 µg) is

administered vaginally (or sublingually). administered vaginally (or sublingually). This protocol is based on the recommended MTP This protocol is based on the recommended MTP

regimen by WHO and the UK Royal College of regimen by WHO and the UK Royal College of Obstetricians and Gynaecologists: Obstetricians and Gynaecologists:

This regimen can be used until 63 days of pregnancy This regimen can be used until 63 days of pregnancy and has shown the highest efficacy of all clinically and has shown the highest efficacy of all clinically proven regimensproven regimens

Follow up 14 days after the first visitFollow up 14 days after the first visit

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Medabon®Medabon®

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The Need for InformationThe Need for InformationPATH, Ipas and Concept have produced materialsPATH, Ipas and Concept have produced materialsfor health care providers and programme managers who arefor health care providers and programme managers who areworking to introduce Medabon®. They are also intended toworking to introduce Medabon®. They are also intended toreach policy makers and the media and include:reach policy makers and the media and include:

Medical Abortion & Medabon®: Key Talking PointsMedical Abortion & Medabon®: Key Talking Points Medabon®: Frequently Asked Questions (FAQ)Medabon®: Frequently Asked Questions (FAQ) Medabon®: What You Need to Know (sample patient brochure)Medabon®: What You Need to Know (sample patient brochure) Medabon®: Medical & Service Delivery GuidelinesMedabon®: Medical & Service Delivery Guidelines Medabon®: Background for Providers of Emergency CareMedabon®: Background for Providers of Emergency Care Medabon®: A Framework for IntroductionMedabon®: A Framework for Introduction Medical Abortion: Selected ReferencesMedical Abortion: Selected References

Can be downloaded from Can be downloaded from www.medabon.infowww.medabon.info

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Phase III: Phase III: Scaling up & Expansion Scaling up & Expansion

Participatory Development of Scaling – up Strategy and Participatory Development of Scaling – up Strategy and DisseminationDissemination

At the end of pilot project the Department of Health, steering committee, the principal investigators and members of WHO, PATH and Concept Foundation will develop a strategy for expanding the availability and accessibility of MTP within Thailand.

Strategy development will be based on review of findings and study experience

Study results will be disseminated through a variety of appropriate channels within Thailand e.g. a dissemination workshop and scientific papers.

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Conclusion Conclusion MTP: Key Information/MessagesMTP: Key Information/Messages Decision makers and regulatory authority:Decision makers and regulatory authority:

Safety Safety EfficacyEfficacy Acceptability Acceptability

Service providers and users:Service providers and users: Regimen Regimen TimingTiming Route Route Expected side effectsExpected side effects

‘This option and will be prescribed under existing law and regulation’

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Conclusion Conclusion MTP: Advocacy StrategiesMTP: Advocacy Strategies

Face – to – face meeting with the decision makers and regulatory Face – to – face meeting with the decision makers and regulatory authorityauthority

Set up working group by involvement of the relevant government Set up working group by involvement of the relevant government sectors, academic and NGO sectors, academic and NGO

Organize meeting regularly with the WG to ensure effective Organize meeting regularly with the WG to ensure effective collaboration and trouble shootingcollaboration and trouble shooting

Seminar/workshop for sharing solid evidence based model programSeminar/workshop for sharing solid evidence based model program

Avoid using of mass media campaign to prevent attack by the Avoid using of mass media campaign to prevent attack by the opponents opponents

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Visit www.conceptfoundation.organd www.medabon.info