STS: Private sector Engagement

The System for TB Elimination in Private Sector (STEPS) model evolved as a solution to address gaps in the quality of care for patients in the private sector by ensuring standards of TB care in India (STCI). STEPS is envisioned as an equal partnership between the public and private sectors for the benefit of society with TB elimination as the outcome.

The primary objective of STEPS is to address gaps in the quality of care for patients in the private sector by ensuring standards of TB care in both sectors to all citizens in a patient-centric manner.

Components of STEPS

1. Establish STEPS centre in each private hospital: These centres act as a single window for notification, linkage for social welfare measures, contact investigation, chemoprophylaxis, direct benefit transfers and treatment adherence support.
2. Consortium of private hospitals: Provides policy and resource support, and reviews the centre's performance.
3. Coalition of all professional medical associations: Sensitizes and supports specialists and doctors, and advocates with doctors for standards for TB care.

Establishing STEPS Centres

• In January 2019, the STEPS model was initiated and piloted in 14 districts in Kerala.
• Establishing STEPS centres at all private and cooperative hospitals is the heart of private sector engagement in Kerala. 
• STEPS centres are single window mechanisms at private hospitals to help doctors and to ensure that all TB patients diagnosed that particular hospital receive high standards of TB care.
• The STEPS centre will coordinate notification and follow up patients till the end of treatment, ensure all public health actions and link them to social welfare measures. 
• Patients will be followed up through an ‘after sales service model’ which is based upon a blend of self-initiated business promotion and customer loyalty blended with the social responsibility of private sector

Functions of STEPS Centres

1. To act as a single window mechanism for all TB-related services in the hospital
2. Notify in Nikshay all TB cases diagnosed in the hospital
3. To guide, support and arrange for:

• Universal Drug Susceptibility Testing (UDST)
• National TB Elimination Programme (NTEP) drugs if required
• Direct Benefit Transfer (DBT) of Rs 500 per month during treatment 
• Provisions for airborne infection control (AIC) kit
• Mobile based adherence monitoring system (99 DOTS) in case of NTEP drugs
• Offer HIV counselling and testing

4. To educate on TB and counsel the patient and family members on the need for completing treatment
5. To educate the patient and family members on AIC, adverse drug reactions (ADRs) and smoking cessation
6. To follow up the patient periodically over the phone to motivate the patient to continue treatment, detect any ADRs, remind about follow up investigations and scheduled clinical visits
7. Update details of bank account, UDST, treatment initiation, co-morbidity and outcome in Nikshay
8. Fast tracking patients with infectious TB as a step to ensure AIC in health facility
9. Ensuring other public health actions including contact tracing, chemoprophylaxis either directly or linking those patients willing to be followed up by the government field staff to local primary health care team
10. Document all activities and submit monthly report to the Private Hospital Consortium

Figure: Schematic Representation of STEPS Center Within a Hospital; Source: STEPS: A Solution for Ensuring Standards of TB Care for Patients Reaching Private Hospitals in India; Shibu B et al. 2021

Forming a Private Hospital Consortium

In every district, a consortium of private hospital owners provides policy and resource support for STEPS centers and reviews the STEPS centres' performance. Consortium members select one of the hospitals to serve as chair for a fixed term. The district program manager of NTEP serves as member secretary. The consortium meets once in 3 months to review the performance of STEPS centers and suggest corrective actions if required.

Create a Coalition of Professional Medical Associations

• In all districts, a coalition of professional medical associations advocates with medical practitioners and sensitizes them on STCI and STEPS.
• In addition to the Indian Medical Association, members of the coalition include associations of chest physicians, pediatricians, general physicians, geriatrics, family medicine, nephrologists, general surgeons, orthopedic surgeons, and radiologists.
• The coalition meets every 3 months to plan and review the activities as per the plan.

Initial Results of STEPS

• Since its pilot, TB patient notification to NTEP from the private sector in Kerala has increased. Also, public health actions, such as Direct Benefit Transfer (DBT), Universal Drug Susceptibility Testing (UDST), HIV testing, etc., for patients diagnosed from the private sector has increased.
• STEPS led to a shift from using private anti-TB drugs to NTEP-supplied drugs, leading to 2,000 additional cases being put on NTEP-supplied drugs. Overall, 70% of all cases notified from the private sector in 2019 were treated with NTEP-supplied drugs.
• Data officially collected by the state drug controller showed that the sale of anti-TB drugs decreased from 1.6 million rifampicin units in 2018 to 0.5 million rifampicin units in 2019 after the establishment of the STEPS model.
• Qualitative feedback also showed that STEPS was an acceptable model to all stakeholders, and patients were satisfied with the services received. During COVID-19, STEPS was resilient enough to ensure TB patient services and facilitate partnerships for COVID-19 management.

Resources

• Guidance Document on STEPS (System for TB Elimination in Private Sector) in Kerala.
• STEPS – A Patient-centric and Low-cost Solution to ensure Standards of TB Care to Patients Reaching Private Sector in India, Rakesh, P.S., Balakrishnan, S., Sunilkumar, M. et al, BMC Health Services Research, 2022.
• STEPS: A Solution for Ensuring Standards of TB Care for Patients Reaching Private Hospitals in India, Shibu Balakrishnan, Rakesh PS, et al., Global Health: Science and Practice, June 2021.

Assessment

To achieve universal Tuberculosis (TB) care for all notified TB patients, the National TB Elimination Program (NTEP) has initiated the Patient Provider Support Agency (PPSA) initiative.

PPSA is a model under which a third-party agency/non-governmental organization is selected by a state/ city/district NTEP unit to engage private-sector doctors treating patients of TB and provide end-to-end services, such as diagnosis, notification, patient adherence and support, and treatment linkages. 

The third-party agency is selected as per the contracting procedures laid down by the respective State National Health Missions (NHM).

PPSA follows a multipronged approach to engage private providers engaged in TB care to patients that includes:

1. Mapping private-sector providers (formal and informal), laboratories and chemists
2. Increasing engagement of private-sector providers through in-clinic visits and continuing medical education (CME)
3. Linking NTEP-provided diagnostic services (sputum microscopy, X-ray, cartridge-based nucleic acid amplification test, sputum collection and transport) and fixed drug combinations (FDCs)
4. Facilitating and updating TB notification and other relevant information in Nikshay
5. Facilitating incentives given by NTEP to the private-sector doctors and patients
6. Counseling the patients to ensure treatment adherence
7. Facilitating linkages for drug resistant-TB treatment and HIV services, as required.

Resources

• Patient Provider Support Agency: A Toolkit to Implement Patient Provider Support Agency in Your Region, PATH.

Kindly provide your valuable feedback on the page to the link provided HERE

The private-sector health facilities have experts and infrastructure to manage TB cases. Under the direct engagement partnership model, the programme manager directly engages private-sector health facilities which provide TB services to ensure that standards of TB care reach all the patients in that facility.

In a region where there is no dedicated Patient Provider Support Agency (PPSA), the National TB Elimination Programme (NTEP) can directly empanel and engage a private/ corporate/ trust hospital and designate them as “TB Treatment Centres”.

Services that can be provided under this model are:

1. Identifying presumptive TB cases and testing them for TB with reimbursement of testing cost to the laboratory.
2. Notifying and managing drug-sensitive TB with reimbursement of medicine cost to the disbursing chemist.
3. Managing ambulatory treatment support of Drug-resistant TB (DR-TB) as per need.
4. Bundling treatment services with public health actions by engaging facilities which can do both directly or who can engage another service provider to ensure complete coverage of public health actions for patients treated in their facility.
5. Providing specialist consultation when the NTEP does not have enough specialist doctors to manage patients or requires additional specialist doctors.

Covering Private Sector TB Patients through Public Health System: The Mehsana Model of Universal Access to Free TB Care, Gujarat

• Mehsana is a town in Gujarat implementing India’s first pilot allowing for universal free anti-TB drugs in India.
• The programme is managed by the district TB office, supported by technical partners, and has engaged a large proportion of private providers.

Overview of the Mehsana Model

1. The patient goes to a Private Provider (PP)/ chemist/ pharmacist.
2. PPs/ chemists refer presumptive TB cases for chest X-rays or smear tests.
3. The patient is provided with a unique number (i.e., a voucher) when prescribed a diagnostic test. The e-voucher links the patient with NTEP.
4. A call centre operated by an NTEP staff member generates and tracks this e-voucher and reimburses the diagnostic facilities for the test.
5. If the initial test is positive, the provider refers the patient to a formal provider for Drug Susceptibility Testing (DST). Costs of these tests are also reimbursed via the e-voucher.
6. The PP also notifies the case, and incentives for notification are sent to the PP/ chemist.
7. Monthly prescriptions come with an e-voucher, which patients can use to obtain medications (from a list of approved anti-TB drugs) from any local chemist who participates in the initiative

Over the entire course of the treatment process, the TB programme in Mehsana deploys field workers to monitor and facilitate drug compliance via home visits.

All the chemists and doctors in Mehsana were mapped and engaged. Doctors were trained to help them tailor prescription practices. NTEP offered no financial incentive to the doctor and only offers a minor overhead charge to the pharmacists.

In the end, the programme provides a win-win situation for all: the chemist acts as a referral point, the patient gets the right diagnosis and free drugs, and the private physician retains his or her patients.

Key Results

Of all the patients who initiated anti-TB treatment through the initiative, 72% successfully completed their regimens.

Lessons Learned from the Mehsana Model

Mehsana helped demonstrate proof of concept for a model that directly engages private healthcare providers to diagnose, notify, and treat TB cases and to strengthen adherence to the TB treatment regimen.

• Since PPs are often the first point of contact for patients, it is important to directly engage them by offering the right incentives to promote standard TB care.
• Information, Communication and Technology (ICT) tools were used at various stages (during the mapping exercise and the use of e-vouchers) of the initiative. Thus, the role of technology in existing partnership options must not be discounted.

Resources

• NTEP Training Modules (5-9) for Programme Managers & Medical Officers, NTEP, 2020.
• Mainstreaming Private Healthcare Systems for Tuberculosis Control, The Bridgespan Group, 2018.
• Ending Tuberculosis in India: A Political Challenge & an Opportunity, IJMR, 2018.

Assessment

The System for TB Elimination in Private Sector (STEPS) model evolved as a solution to address gaps in the quality of care for patients in the private sector by ensuring standards of TB care in India (STCI). STEPS is envisioned as an equal partnership between the public and private sectors for the benefit of society with TB elimination as the outcome.

The primary objective of STEPS is to address gaps in the quality of care for patients in the private sector by ensuring standards of TB care in both sectors to all citizens in a patient-centric manner.

Components of STEPS

1. Establish STEPS centre in each private hospital: These centres act as a single window for notification, linkage for social welfare measures, contact investigation, chemoprophylaxis, direct benefit transfers and treatment adherence support.
2. Consortium of private hospitals: Provides policy and resource support, and reviews the centre's performance.
3. Coalition of all professional medical associations: Sensitizes and supports specialists and doctors, and advocates with doctors for standards for TB care.

Establishing STEPS Centres

• In January 2019, the STEPS model was initiated and piloted in 14 districts in Kerala.
• Establishing STEPS centres at all private and cooperative hospitals is the heart of private sector engagement in Kerala. 
• STEPS centres are single window mechanisms at private hospitals to help doctors and to ensure that all TB patients diagnosed that particular hospital receive high standards of TB care.
• The STEPS centre will coordinate notification and follow up patients till the end of treatment, ensure all public health actions and link them to social welfare measures. 
• Patients will be followed up through an ‘after sales service model’ which is based upon a blend of self-initiated business promotion and customer loyalty blended with the social responsibility of private sector

Functions of STEPS Centres

1. To act as a single window mechanism for all TB-related services in the hospital
2. Notify in Nikshay all TB cases diagnosed in the hospital
3. To guide, support and arrange for:

• Universal Drug Susceptibility Testing (UDST)
• National TB Elimination Programme (NTEP) drugs if required
• Direct Benefit Transfer (DBT) of Rs 500 per month during treatment 
• Provisions for airborne infection control (AIC) kit
• Mobile based adherence monitoring system (99 DOTS) in case of NTEP drugs
• Offer HIV counselling and testing

4. To educate on TB and counsel the patient and family members on the need for completing treatment
5. To educate the patient and family members on AIC, adverse drug reactions (ADRs) and smoking cessation
6. To follow up the patient periodically over the phone to motivate the patient to continue treatment, detect any ADRs, remind about follow up investigations and scheduled clinical visits
7. Update details of bank account, UDST, treatment initiation, co-morbidity and outcome in Nikshay
8. Fast tracking patients with infectious TB as a step to ensure AIC in health facility
9. Ensuring other public health actions including contact tracing, chemoprophylaxis either directly or linking those patients willing to be followed up by the government field staff to local primary health care team
10. Document all activities and submit monthly report to the Private Hospital Consortium

Figure: Schematic Representation of STEPS Center Within a Hospital; Source: STEPS: A Solution for Ensuring Standards of TB Care for Patients Reaching Private Hospitals in India; Shibu B et al. 2021

Forming a Private Hospital Consortium

In every district, a consortium of private hospital owners provides policy and resource support for STEPS centers and reviews the STEPS centres' performance. Consortium members select one of the hospitals to serve as chair for a fixed term. The district program manager of NTEP serves as member secretary. The consortium meets once in 3 months to review the performance of STEPS centers and suggest corrective actions if required.

Create a Coalition of Professional Medical Associations

• In all districts, a coalition of professional medical associations advocates with medical practitioners and sensitizes them on STCI and STEPS.
• In addition to the Indian Medical Association, members of the coalition include associations of chest physicians, pediatricians, general physicians, geriatrics, family medicine, nephrologists, general surgeons, orthopedic surgeons, and radiologists.
• The coalition meets every 3 months to plan and review the activities as per the plan.

Initial Results of STEPS

• Since its pilot, TB patient notification to NTEP from the private sector in Kerala has increased. Also, public health actions, such as Direct Benefit Transfer (DBT), Universal Drug Susceptibility Testing (UDST), HIV testing, etc., for patients diagnosed from the private sector has increased.
• STEPS led to a shift from using private anti-TB drugs to NTEP-supplied drugs, leading to 2,000 additional cases being put on NTEP-supplied drugs. Overall, 70% of all cases notified from the private sector in 2019 were treated with NTEP-supplied drugs.
• Data officially collected by the state drug controller showed that the sale of anti-TB drugs decreased from 1.6 million rifampicin units in 2018 to 0.5 million rifampicin units in 2019 after the establishment of the STEPS model.
• Qualitative feedback also showed that STEPS was an acceptable model to all stakeholders, and patients were satisfied with the services received. During COVID-19, STEPS was resilient enough to ensure TB patient services and facilitate partnerships for COVID-19 management.

Resources

• Guidance Document on STEPS (System for TB Elimination in Private Sector) in Kerala.
• STEPS – A Patient-centric and Low-cost Solution to ensure Standards of TB Care to Patients Reaching Private Sector in India, Rakesh, P.S., Balakrishnan, S., Sunilkumar, M. et al, BMC Health Services Research, 2022.
• STEPS: A Solution for Ensuring Standards of TB Care for Patients Reaching Private Hospitals in India, Shibu Balakrishnan, Rakesh PS, et al., Global Health: Science and Practice, June 2021.

Assessment

To achieve universal Tuberculosis (TB) care for all notified TB patients, the National TB Elimination Program (NTEP) has initiated the Patient Provider Support Agency (PPSA) initiative.

PPSA is a model under which a third-party agency/non-governmental organization is selected by a state/ city/district NTEP unit to engage private-sector doctors treating patients of TB and provide end-to-end services, such as diagnosis, notification, patient adherence and support, and treatment linkages. 

The third-party agency is selected as per the contracting procedures laid down by the respective State National Health Missions (NHM).

PPSA follows a multipronged approach to engage private providers engaged in TB care to patients that includes:

1. Mapping private-sector providers (formal and informal), laboratories and chemists
2. Increasing engagement of private-sector providers through in-clinic visits and continuing medical education (CME)
3. Linking NTEP-provided diagnostic services (sputum microscopy, X-ray, cartridge-based nucleic acid amplification test, sputum collection and transport) and fixed drug combinations (FDCs)
4. Facilitating and updating TB notification and other relevant information in Nikshay
5. Facilitating incentives given by NTEP to the private-sector doctors and patients
6. Counseling the patients to ensure treatment adherence
7. Facilitating linkages for drug resistant-TB treatment and HIV services, as required.

Resources

• Patient Provider Support Agency: A Toolkit to Implement Patient Provider Support Agency in Your Region, PATH.

Kindly provide your valuable feedback on the page to the link provided HERE

The private-sector health facilities have experts and infrastructure to manage TB cases. Under the direct engagement partnership model, the programme manager directly engages private-sector health facilities which provide TB services to ensure that standards of TB care reach all the patients in that facility.

In a region where there is no dedicated Patient Provider Support Agency (PPSA), the National TB Elimination Programme (NTEP) can directly empanel and engage a private/ corporate/ trust hospital and designate them as “TB Treatment Centres”.

Services that can be provided under this model are:

1. Identifying presumptive TB cases and testing them for TB with reimbursement of testing cost to the laboratory.
2. Notifying and managing drug-sensitive TB with reimbursement of medicine cost to the disbursing chemist.
3. Managing ambulatory treatment support of Drug-resistant TB (DR-TB) as per need.
4. Bundling treatment services with public health actions by engaging facilities which can do both directly or who can engage another service provider to ensure complete coverage of public health actions for patients treated in their facility.
5. Providing specialist consultation when the NTEP does not have enough specialist doctors to manage patients or requires additional specialist doctors.

Covering Private Sector TB Patients through Public Health System: The Mehsana Model of Universal Access to Free TB Care, Gujarat

• Mehsana is a town in Gujarat implementing India’s first pilot allowing for universal free anti-TB drugs in India.
• The programme is managed by the district TB office, supported by technical partners, and has engaged a large proportion of private providers.

Overview of the Mehsana Model

1. The patient goes to a Private Provider (PP)/ chemist/ pharmacist.
2. PPs/ chemists refer presumptive TB cases for chest X-rays or smear tests.
3. The patient is provided with a unique number (i.e., a voucher) when prescribed a diagnostic test. The e-voucher links the patient with NTEP.
4. A call centre operated by an NTEP staff member generates and tracks this e-voucher and reimburses the diagnostic facilities for the test.
5. If the initial test is positive, the provider refers the patient to a formal provider for Drug Susceptibility Testing (DST). Costs of these tests are also reimbursed via the e-voucher.
6. The PP also notifies the case, and incentives for notification are sent to the PP/ chemist.
7. Monthly prescriptions come with an e-voucher, which patients can use to obtain medications (from a list of approved anti-TB drugs) from any local chemist who participates in the initiative

Over the entire course of the treatment process, the TB programme in Mehsana deploys field workers to monitor and facilitate drug compliance via home visits.

All the chemists and doctors in Mehsana were mapped and engaged. Doctors were trained to help them tailor prescription practices. NTEP offered no financial incentive to the doctor and only offers a minor overhead charge to the pharmacists.

In the end, the programme provides a win-win situation for all: the chemist acts as a referral point, the patient gets the right diagnosis and free drugs, and the private physician retains his or her patients.

Key Results

Of all the patients who initiated anti-TB treatment through the initiative, 72% successfully completed their regimens.

Lessons Learned from the Mehsana Model

Mehsana helped demonstrate proof of concept for a model that directly engages private healthcare providers to diagnose, notify, and treat TB cases and to strengthen adherence to the TB treatment regimen.

• Since PPs are often the first point of contact for patients, it is important to directly engage them by offering the right incentives to promote standard TB care.
• Information, Communication and Technology (ICT) tools were used at various stages (during the mapping exercise and the use of e-vouchers) of the initiative. Thus, the role of technology in existing partnership options must not be discounted.

Resources

• NTEP Training Modules (5-9) for Programme Managers & Medical Officers, NTEP, 2020.
• Mainstreaming Private Healthcare Systems for Tuberculosis Control, The Bridgespan Group, 2018.
• Ending Tuberculosis in India: A Political Challenge & an Opportunity, IJMR, 2018.

Assessment

Partnership options refer to the different modalities utilised by stakeholders of the National TB Elimination Programme (NTEP) to engage with a private-sector partner to improve the availability and quality of service delivery for TB patients.

The table below shows the partnership options that are currently available. The programme manager, based on the findings of the needs assessment, can identify the relevant partnership options that they can implement in their region.

Table: Available Partnership Options and their Scope of Services

The partnership options stated above are those which are currently identified and recommended in the NTEP Guidance Document on Partnerships.

A programme manager can innovate new partnership options which suit the local context, e.g., hiring a service provider for airborne infection control, facility-risk assessment, rehabilitation of DR-TB patients, or alcohol de-addiction programmes for people with TB, etc.

In scenarios where multiple systemic gaps have been identified during the needs assessment, the programme manager may consider using more than one partnership option, via bundling. Bundling refers to combining a series of partnership options in a logical and sequential manner to ensure that no patient is left out at any point in the care cascade.

Resources

• Guidance Document on Partnerships, RNTCP, 2019.

Assessment

TB is a notifiable disease in India, and TB notification has been made mandatory at the point of diagnosis since May 2012. This means that when a case of TB is diagnosed and/or put on treatment it is to be reported to the  NTEP.

• Every healthcare provider, i.e., clinical establishments run or managed by the Government (including local authorities), private or NGO sectors and/or individual practitioners, need to notify diagnosed or treated TB patient’s. 
• Reporting is to be done on the online reporting system called Nikshay and should include details of patient identification, and TB diagnosis.
• This, apart from enabling essential public health actions such as Treatment initiation, and Contact Tracing, chemoprophylaxis, but also enables provisions of Direct beneficiary transfer for Nikshay Poshan Yojana

Points to Note:

As per MCI code of ethics a registered medical practitioner giving incorrect information on his name and authority about notification amounts to misconduct and such a medical practitioner is liable for deregistration. It is the duty of the registered medical to divulge this information to the authorized notification official as regards communicable and notifiable diseases. 

Resources

• TB Notification Letter from GoI, 7 May 2012.
• TB Notification Amendment, 21 July 2015, MoHFW.

As a public health responsibility to prevent transmission of TB infection and development of drug resistance it is essential to engage both the public and private sectors for effective TB prevention and control. A total of seven standards related to Public Health Actions (PHA) (Standard 12 to Standard 18) have been mentioned in the Standards for TB Care in India (STCI)-2014.  All patients notified from the private sector also need to be offered all public health actions. 

This could be achieved in collaboration with the local public health services and/or other agencies.  

1) Provide Access to Correct and Complete Diagnosis for Private Sector Patients

• In this regard all private providers must be sensitized, and their capacities must be built with respect to early diagnosis, prompt referral for sputum smear examination to the National TB Elimination Programme (NTEP) diagnostic facilities / NTEP accredited private labs.
• All private providers and chemists/pharmacists must mandatorily notify the TB patients to the local health authorities – District Health Officer / District TB Officer.

2) Provide Support for Treatment Adherence 

• A treatment support plan must be developed at the time of treatment initiation for all patients in the private sector too, in mutual consultation with patient and private provider.
• All patients receiving treatment from the private sector must also be eligible to receive counselling services and upon consent, home visit counselling sessions (or at the location convenient to the patient) may be provided to patients and their caregivers under the NTEP’s Public Private Mix (PPM) or in association with partner agencies providing counselling services under NTEP.
• Any instance of treatment interruption must be reported at the earliest through Ni-Kshay.
• The patients may also be linked to Ni-Kshay call-centers for adherence support. 
• The NTEP has also partnered with Patient Provider Support Agency (PPSA) / Patient Provider Interface Agency (PPIA) wherein vouchers were provided to private sector TB patients for utilizing subsidized TB diagnostic and follow up investigation services and can be scale up in high burden districts across the country with support from state governments/ Corporate Social Responsibilities (CSR) agencies.

4) Contact Tracing and TB Preventive Treatment

• All private providers must hold a responsibility to ensure that persons in close contact with patients who have infectious tuberculosis are evaluated at the earliest and managed in line with NTEP recommendations. The district health officers and district TB officers must be responsible to ensure this is being done on a regular basis.
• Eligible contacts should also be counselled for initiation of TB preventive treatment.

5) Linkage to Social Welfare and Protection

• Upon notification by the private provider and initiation of appropriate TB treatment, all patients seeking treatment under the private sector become eligible to receive direct benefit transfer (DBT) under the government of India's Nikshay Poshan Yojana (NPY)
• In districts where PPSA is available, PPSA staff may perform the linkage of private sector patients to DBT services and in districts where PPSAs are not available, the TB Health Visitor/ Senior Treatment Supervisor (STS) needs to undertake the public health action under the supervision of the PPM Coordinator.
• The patients may also be guided and linked to various other social protection and welfare schemes available under central and state governments. The partner agencies with expertise in referral linkages shall help the NTEP in achieving this.

6) Liaison with Professional Bodies

• Professional bodies such as Indian Medical Association and Indian Pharmaceutical Association must be involved for advocacy regarding the services available under public health actions of NTEP for the private patients.
  

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, GoI, 2021.
• Mandatory TB Notification Gazette for Private Practitioners, Chemists and Public Health Staff, RNTCP, 2018.
• Notification of TB Cases: Amendments, MoHFW, GoI, 2015.
• TB Notification Order, MoHFW, GoI, 2012.
• National Strategic Plan for Tuberculosis Elimination 2017-2025, RNTCP, CTD, MoHFW, 2017.
• Standards for TB Care in India, WHO, 2014.

Assessment

TB notification rate is the number of TB cases notified over a specified time period for a specified population, usually per lakh. It indicates how many cases have been diagnosed and informed to the National TB Elimination Program.

It is mostly calculated annually, and the calculation formula is as follows: 

Figure: Deriving the Annualized TB Case Notification Rate

The National TB Elimination Program calculates TB notification rates based on TB cases notified using the digital surveillance system called Nikshay. Each state/district is provided with an annual target for TB case notification, the progress of which is measured periodically to understand efforts taken for the detection of TB cases.

Example

If the number of TB patients diagnosed in District X one year is 1000, and the mid-year population of District X is 10,00,000, then the annualized TB case notification rate is calculated as follows: 

100 cases/100 000/year

Resources

• NTEP training module for medical officers 5-9
• TB Notification Rate, TB Indicators WHO 2014

Under the Drugs & Cosmetics Rules 1945, drugs specified under Schedule H are required to be sold by retail on the prescription of a Registered Medical Practitioner (RMP) only.  At present, Schedule H contains 510 drugs.  

Recently, a new Schedule H1 has been introduced through gazette notification GSR 588 (E) dated 30-08-2013, which contains certain third and fourth-generation antibiotics, certain habit-forming drugs and anti-TB drugs.

These drugs are required to be sold in the country under the following conditions: 

(1) The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.

(2) The drug specified in Schedule H1 shall be labelled with the symbol "Rx" which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labelled with the following words in a box with a red border:

List of anti-TB drugs included in Schedule H1

1. Ethambutol hydrochloride
2. Ethionamide
3. Isoniazid
4. Levofloxacin
5. Moxifloxacin
6. Pyrazinamide
7. Rifabutin
8. Rifampicin

Obligations of Chemists with Regard to Sales of Anti-TB Drugs Under Schedule H1

• Mandatorily keep a copy of the prescription of drugs covered under Schedule H1 in a separate record and such record should be maintained for three years and be available for inspection.
• The supply of a drug specified under schedule H1 shall be recorded in a separate register at the time of supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such record shall be maintained for three years and be open for inspection (Annexure IV).

Table: Annexure IV – Schedule H1 Drugs Record Format; Source: Frequently Asked Questions on Gazette on Mandatory TB Notification for Chemists/ Pharmacies. tbcindia.gov.in.

Resources

• Rules for Selling of Drugs Under Schedule H1, Press release by MoHFW, 2013.
• The Drugs & Cosmetics Act and Rules, Ministry of Health & Family Welfare, Government of India, 2016.
• Frequently Asked Question on Gazette on Mandatory TB Notification for Chemists/ Pharmacies, Central TB Division.

Assessment