Report & Recommendations
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Issue-6 : Monitoring of Medical Abortion Programme

Bacckground

Monitoring of any health programme is essential for its safe and successful implementation. Monitoring can be defined as a process of measuring, recording, collecting and analyzing data on actual implementation of the programme and communicating it to programme managers, so that any deviation from the planned operations may be detected, the reasons identified, and suitable corrective actions taken. The purpose of health programme monitoring is to indicate to those concerned whether the operation and performance of programme is "on course". If it indicates inadequate performance, programme manager has to rectify the situation. Thus, monitoring helps in setting norms and measuring level performance. As with all health services, abortion services should be subject to qualitymonitoring and evaluation. If baseline data on morbidity and mortality from unsafe abortion are available and basic service statistics are ccurately kept, programmes will be able to evaluate the extent to which full access to legal services reduces maternal morbidity and mortality.  

QUESTIONS TO BE ANSWERED

A. What are the types of monitoring?
B. What to monitor?
C. How should the record-keeping and reporting to authorities be done?
D. Who will monitor and how often?
E. What should be the qualification of the provider and how accreditation is to be done?

VIEWS OF THE GROUP

The group needed to decide on as to how to monitor the medical abortion programme.

A. Types of Monitoring

The monitoring systems for MTP must be built on existing monitoring systems and must be within the context of the RCH programme. The service-providers should routinely report to the authorities. There shouldbe periodic monitoring of infrastructure, services and their quality. The issue of baseline assessment of service readiness and needs before introduction of medical abortion in the country was also debated but consensus was not reached. Monitoring should be decentralized to the district level.

B. What to monitor?

At the healthcare facility level, processes and mechanisms for monitoring services include case reviews, log book reviews, observation, checklists, facility surveys and maternal morbidity and death audits, all of which can be used to improve quality of care.

1. Routine monitoring should include :

Infrastructure : The monitoring of infrastructure including the number and location of licensed and functional facilities.

Provider : The emphasis would need to shift from monitoring of places to monitoring of providers and his or her access to emergency care medical facilities.

Services : Services to be monitored include reporting of cases, their segregation by methods and gestational age. It is needed to decide on the time-point at which a medical abortion is counted as a case i.e. when process starts or when abortion is complete.

Adverse events : Including failure to follow-up, need for surgical evacuation, serious side-effects, reporting and monitoring of complications and may be even monitoring of media reports.

Quality : Inclusion of non-numeric qualitative assessments of quality i.e. counseling and choice Training : Monitoring the quality and adequacy of training being provided.

Training : Monitoring the quality and adequacy of training being provided.

Progress : Assessment of progress to remedy problems identified in routine monitoring

2. Registration and Approval of Place

• Any level of health-care facility including primary health centre, clinic or hospital based set-up may be recognised for medical abortion, provided there is adequate arrangement for management of complications and referral (see below).
• It is desirable to ensure that misoprostol is administered at the clinic and patient remains under observation for 3-4 hours thereafter.
• Inspection of the place -

    a. The place approved should be inspected by the Chief Medical Officer of the District, as often as may be necessary with a view to verifying whether termination of pregnancies is being done therein under safe and hygienic conditions.

    b. If the Chief Medical Officer has reason to believe that there has been death of, or injury to, a pregnant woman at the place, or that termination of pregnancies is not being done at the place under safe and hygienic conditions, he may call for any information or may seize any article, medicine, ampoule, admission register or other document, maintained, kept or found at the place.

    c. The provision of the Code of Criminal Procedure, 1973 (2 of 1974), relating to seizure shall [so far as may be] apply to seizures made under sub-rule(2).

    d. At initial prescription and counseling make available the information about emergency access facilities and telephone numbers.

    e. Back-up facility to be identified and linkages created and formalized with addresses available for referral.

    f. Identify emergency and round the clock public and private hospital facilities with availability of blood transfusion for transfer of complications.

C. Record-keeping

The entire process needs to be recorded i.e. medical abortion number, date of registration, date of the first dose, the second and the follow-up visit, name of patient and her husband/father/guardian, age, religion, address, marital status, education, duration of pregnancy, reason for termination, obstetric history, significant past medical/ surgical history, findings of general/systemic and pelvic examination and relevant investigations done. Also, the side-effects and outcome of medical abortion, numbers lost to follow-up and the numbers requiring surgical evacuation should be
recorded.

All medical practitioners performing medical abortion should maintain an admission register for recording particulars of the women who receive medical abortion. The forms need to be made more gendersensitive. An informed written consent of the woman is mandatory.

The admission register should be a secret document and the particulars of the pregnant woman should not be disclosed to any person except under authority (as defined by MTP Regulations, 1975 Section of MTP Act 1971). The entries made in case sheet, OT register, follow-up card or any other document or register should not disclose the identity of the pregnant woman in any way.

A record of complications and serious side-effects pertaining, especially, to heavy bleeding ,necessitating the use of intravenous fluids, blood-transfusion or curettage, sepsis, incomplete abortion, continuation of pregnancy, adverse drug reactions, etc, should also be maintained. Monitoring and reporting of complications should be done irrespective of where abortion was initiated.

Reporting to authorities

Every head of the hospital or practitioner must send a monthly record of medical abortion to the Chief Medical Officer (CMO) of the State in form II. The record should include the name and address of the practitioner, the completed consent forms and adverse drug reactions, if found. Morbidity and mortality should be informed to the authorities immediately.

Confidentiality should be maintained. The CMO of the State should, in turn, send a report to the MOHFW.

D. Who will monitor and how often?

Monitoring should be decentralized to the district level. One representative each from the districtmonitoring cell, FOGSI, private sector, women’s representative of Panchayati Raj and social scientist should be included in the monitoring team. Data analysis should be done at the local level with review every 6 to12 months.

E. Qualification and Accreditation of the provider

Accreditation should be at the district level and the accreditation body should include a member of the professional body like FOGSI and must also have the power of delicensing. Remedial measures need to be clearly spelt out. One time accreditation is not adequate and licence-renewal should be done every 3-5 years.

The qualification and registration of providershould be verified by the Chief of the Centre that has been recognised for providing abortion services and reported to CMO of the district. A registered medical Practitioner (RMP) as prescribed by MTP Act, will only be authorized to prescribe medical abortion according to Definition 2(d), Section 2 and MTP Rule 3.

A Registered Medical Practitioner shall have one or more of the following experience or training in gynaecology and obstetrics :

a. Before commencement of the Act, experience in the practice of Obstetrics and Gynaecology for not less than 3 years.

b. After the date of commencement:

    i. 6 months of housemanship in Obstetrics and Gynaecology.

    ii. Experience at any hospital of not less than one year in the practice of Obstetrics and Gynaecology.

    iii. If assisted, an RMP in the performance of 25 cases of MTP in a hospital established or maintained, or a training institute approved for the purpose by the Govt.

c. Post-graduate degree or diploma in Obstetrics and Gynaecology.

Prescription for medications should bear doctor’s qualification and State Medical Council Registration Number. RMPs with MBBS should include inscription ‘certified to perform MTPs’. In order to expand access, MBBS, paramedics and those trained in ISMs may also, in future, be accredited for provision of medical abortion services.

Thus, ongoing comprehensive monitoring of legally-induced abortions is essential to track changes in the patterns and practices of abortion services that will result with the introduction of these new methods.

Recommendations

1. The MTP monitoring systems must be within the context of RCH programme.
2. The system of licensing the infrastructure and facilities needs to be simplified.
3. The facility as well as abortion-delivery services need to be monitored.
4. Medical practitioners should maintain an admission register for recording the particulars of the women undergoing medical abortion.
5. A record of side-effects, adverse events and serious adverse events need to be maintained.
6. A monthly record of medical abortion should be submitted to the CMO of the State.
7. At the district level, monitoring should be done every 6 to 12 months.
8. The State monitoring team should include a wider representation of stakeholders.
9. The qualification and registration of the provider must meet the requirements as per the Indian MTP Act, 1971.
10. Modifications are needed to shift the emphasis on provider, access and functioning counseling, appropriateness of protocol, etc) rather than the place.

 

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Introduction | Overview of the Consortium
Current Status of Medical Abortion | Consensus Issues & Recommendations
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