Anti TB Draft (Consensus)

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CONTENT

?The preamble.

?The principles of treatment of tuberculosis.

?Classification of cases and proposed treatment regimen.

?Issue of referring a patient : when?

?What are the problems for the primary care physicians.

?What is expected from the Government.

We extend our heart felt thanks and gratitude to all the members of the consensus team and our colleagues who joined voluntarily in the subsequent meeting and contributed actively to make this draft possible.

We extended thanks to all our staff members and people who supported us selflessly to prepare and publish the draft.

This consensus draft is published by : Institute of Pulmocare & Research on 24th March, 2010

The draft has been made for public interest to strengthen the existing anti TB campaign

The draft has already been forwarded to different authorities as the Govt. of India (Health & Family Welfare department, Human RD), WHO, RNTCP etc.

The concept, the credit (if any), the copyright (if applicable) shall go to the Institute of Pulmocare & Research, Kolkata.

This printed version is published for free of cost distribution amongst the colleagues and concerned people.

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LIST OF DOCTORS CONTRIBUTING IN MAKING THE DRAFT

Consensus members :

1. Dr. Dhiman Ganguly

2. Dr. Rupak Ghosh

3. Dr. Saikat Nag

4. Dr. Sujan Bardhan

5. Dr. Saibal Ghosh

6. Dr. Angira Dasgupta

7. Dr. Malay Maitra

8. Dr. Abhijit Mukherjee

9. Dr. Somnath Mitra

10.Dr. Parthasarathi Bhattacharyya

Members who have attended the presentation along with the consensus members :

1. Dr. PDO Davies (as an observer)

2. Dr. Amit Podder

3. Dr. Anirban Sarkar

4. Dr. Ansuman Mukherjee

5. Dr. Debajyoti Pal

6. Dr. Dhrubajyoti Roy

7. Dr. J. L. Ghosh

8. Dr. M L Gupta

9. Dr. Monotosh Khanra

10.Dr. Pawan Agarwal

11.Dr. Ranjan Das

12.Dr. Shankar Saha

13.Dr. Subhasish Chakraborty

14.Dr. Sumita Basumallik

15.Dr. Supriya Sarkar

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THE PREAMBLE

Although TB is a global emergency and RNTCP is a very well organized anti tuberculosis campaign in India, treating TB appears at times difficult for several reasons and the provided guideline is often found inadequate to help in the ground situations. RNTCP has been a bold and effective campaign in this regard and, incidentally, it caters to about 50% of the diseased population in the country although it covers 100% of the geographical areas. The rest 50% of patients are treated outside RNTCP and there is hardly any control on the treatment of this segment of patient population. Naturally, without a database regarding the treatment of about half of the patients, the claimed success of the RNTCP program is doubted and certainly diluted. Incidentally, the so called PPM (private public mix) in anti TB campaign is still in its infancy and many of us appreciate that there is a huge communication gap between people working in RNTCP and those working outside the programme regarding the treatment of the patients. There are often questions about the scientific rationale of some of the RNTCP recommendations too. Amidst this scenario, we have been observing an increased trend of development of drug resistant disease (especially MDR) and advent of XDR tuberculosis globally. In India, prevalence of MDR disease is rising and an estimated prevalence is about 3% in new cases and 17% in patients who has received anti tubercular treatment earlier. The situation may turn worse if emergency measures are not taken to tackle the scenario. Each of us feel that there is more scope for improvement in making the anti-TB campaign more effective especially in a situation of growing drug resistance and increasing prevalence of HIV co-infection. Therefore, we decided to come out with a bunch of proposals to add momentum in the success of the anti TB campaign of the country through RNTCP.

As with all our friends facing TB in their practice, we are concerned about the developments and the difficulties of treating the disease. We, in our limited resources, therefore decided to publish our views to help the campaign.

While making the draft, we have appreciated the lacunae in providing evidence through generating operational data in many areas despite the good work being done by the RNTCP and other authorities. We have, therefore, adopted a policy to form a consensus of opinion that may have a significant role to play in any humane activity amidst the dearth of evidence from scientific and tangible operational research. Since, we are essentially treating physicians and not full time paid TB specialist or researcher, our approach may appear more logical and feasible but may seem, at times, not well supported by scientific evidence especially when there is a real dearth of database. We believe that an honest consensus with people thoroughly involved in an issue of human interest can largely overcome problems from dearth of data to help making a decision and an effective solution of an emergency issue to a large extent. We, therefore, leave our thoughts and the draft to the global medical intelligentsia to carry forward our opinion formed out of experience and possibly realizations to bring forth a more effective anti-TB campaign in future. This effort is no way to criticize anybody or to invite any controversy; it is sincerely meant to strengthen the global anti TB campaign.

The present draft is just the outline of our opinion pool which is meant to bring forth the background for a more detailed and effective interactions and operational research to form an acceptable consensus in future. There is enough room for discussion, modification, improvisation and completion of the draft. Certain areas are not elaborated in order to avoid controversy and avail more time for development of a better insight to do so.

Time and logistic constraints have appeared important hurdles for us to make the draft. We wish that the initial draft will be circulated well across the country and the globe and will ignite positive criticism to enable the right people to come forward with a better and an acceptable statement in near future with involvement of our colleagues from all across the country and abroad in an ideal private-public mix.

We wish inputs regarding our efforts from all concerned; kindly mail your views to IPCR by mail ([email protected]) or by logging on to www.pulmocareindia.org

Let us all add the little of our best to treat TB and help humanity.

IPCR Initiative - 2010

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ABBREVIATIONS USED IN THE DRAFT ARE GIVEN BELOW :

RNTCP : Revised National Tuberculosis Control Program.

TB : Tuberculosis.

ATD : Anti Tubercular Drugs

NTM : Non Tubercular Mycobacteria.

MT : Mantoux Test.

PCR : Polymerase Chain Reaction.

QFT-G : QuantiferonGold Test.

API : Association of Physicians of India.

IMA : Indian Medical Associations.

PPM : Private Public Mix.

OTC : Over the Counter.

EATD : Empirical Anti Tubercular Drugs.

MDR-TB : Multi Drug Resistant Tuberculosis.

XDR-TB : Extensive Drug Resistant Tuberculosis.


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THE PRINCIPLES OF TREATMENT OF TUBERCULOSIS

The preamble :

DOTS is a great success and RNTCP is a great campaign. However, amidst phenomenal input and claimed success by the RNTCP, certain lacunae in the program are being detected by the concerned people and, incidentally, there has been simultaneous reports of increasing prevalence of drug resistance and multi-drug resistant disease.

It is a fact that despite almost complete coverage of the country under RNTCP and that despite the best possible efforts, about 50 % of the TB patients of our country are not treated by the RNTCP. Therefore, one needs to know the factors for adherence by such huge population to the non RNTCP treatment and simultaneously, take care to ensure the best quality treatment in this non RNTCP private sector. This demands immediate and intense operational research.

Hence, it is an urgent need to take both the private (non-RNTCP) and public (RNTCP) sector treatment under uniform principles and practice of therapy. The present draft is prepared keeping this fact in mind.

We are sure that there are many other issues not incorporated in the draft; some areas are already taken care by the RNTCP and there may be difference of opinion on the draft as well. We appreciate that an upsurge of differences and questions about the logistic issues related to the implementations of the principles are likely after the publication of the draft as we have already experienced it in our mini consensus meetings. We like to say that this is a set of principles only and in forming principles we felt that we must remain as close as possible to the ideal. Any point in the draft may be discussed and argued and any proposal may be scrutinized thoroughly and discussed widely to make it operationally feasible. We would love to see wide scale discussion and debate with involvement of the intelligentsia in a private-public mix. TB is a national issue and the draft is an outcome of our concern about the national health.

The principles of treatment are outlined in different categories as follows.

Administrative :

?TB should be declared as an emergency issue for the nation (National Health Emergency).

?All TB patients will have to be notified and treated. Notification of TB cases shall be mandatory for both the private sector and the public sector authorities.

?Everybody should not treat TB: doctors will be specified for treatment (different levels of doctors will be designated (as a) Level 1= grass root level doctors, Level 2= specialists, and Level 3 = referral level doctors) and the role of each level has to be specified.

?The regimen for a patient should be initiated by specified doctors.

?The regimens are to be defined as standard by the experts in PPM and a uniformity of treatment has to be followed. If there is any deviation at any point of time, it has to be done through the level 2 or level 3 TB treating doctors and this should also be notified and treated. There should be flexibility in offering extra treatment in certain situations; this decision has to be through consultation of level 2 or level 3 doctors and it has to be documented and notified.

?Specialists should be marked for referral in specific situation.

?Specific situations for referral / evaluations and admissions shall be clearly noted.

?Regular training and appraisal is a must for all categories of workers under the guidance and control of RNTCP

?TB clinics should be specified with bare minimum facilities both for the Govt. and the private sector (the basic minimum requirements are to be qualified and all the centers shall work only upon RNTCP certification; they will be under monitoring by the RNTCP and the details of the facilities (including the


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infrastructure, manpower, capabilities etc) shall have to be available on internet for verification by the public). This is to ensure the uniformity of the standard across the country.

?All investigations will be RNTCP guided or guided and funded.

?Laboratory and other facilities should be RNTCP arranged or certified and all of them should be under quality check up by RNTCP ( by team of experts from the country and , if necessary abroad).

?RNTCP centers or RNTCP certified centers / pharmacies should have universal coverage for supply of drugs.

?Follow up responsibility will stay with the RNTCP and the treating physician with involvement of the NGOs.

?All activities (including monitoring by RNTCP) are to be recorded for publications and verifications; all data are to be uploaded in appropriate software that will enable access in internet so that the client and everybody interested can verify it.

?There will be good incentive (fees as per the local standard and other facilities) for private sector workers (doctors and others) for being selected in the TB campaign but non-adherence / poor performance on their part will lead to blacklisting them and striping off the power of treating TB in future.

?There shall have to be some incentive for good compliance and completion of the treatment by the patient as well (for example, extra allocation of sugar or kerosene oil from the local ration shop at subsidized price etc).

?Apart, they can be given certificate of completion in local social programs. The details of the social reward have to be decided locally by the treating team. There should be a system to bring the defaulters back to treatment with counseling etc.

?The domiciliary treatment has to be restricted for selected categories of patients and the neglected / dying TB hospitals and sanatoriums are to be rejuvenated at the earliest with adequate modernization for provision of evaluation, admission, and supervised treatment of the appropriate cases.

?Adequate arrangements are to be made by the RNTCP for admission of all infective cases when domiciliary isolation for a stipulated period is not possible or there is chance of drug resistance. The isolation should be continued till a patient becomes sputum negative. Sanatorium treatment for all infective MDR, XDR, and treatment failure cases should be a must. These three categories of patients will stay in three different areas in a sanatorium with restricted intergroup mixing.

?The supply of quality medicine has to be assured with random checking of the bioequivalence; the quality control has to be strict and TB drug manufacturing license has to on the basis of strict quality assurance.

?Selected retired experts from both private and public sectors who have direct contributions in anti-TB campaign with a non controversial track record shall be selected in the monitoring team and very selected retired and existing experts shall have extra power to exercise in the campaign especially in the role of ‘watch dog’ and everything has to be evidence based as far as possible and will have to be available on record (especially on internet) for verification. Some selected persons will be entrusted with the ‘think tank’ responsibility in the whole campaign. There shall be regular updating and appraisal of the efforts. Any problem in implementation shall have to catch quick attention of appropriate authority and the think tank.

?Operational research shall have to be highly encouraged.

?Monitoring on the foreign national infiltration and normal traffic has to be ensured to prevent dilution in the performance and success of the campaign.


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Scientific :

?

?The drug regimens has to be specified with certain flexibilities on involvement of the referral doctors.

?The prescription of second line drugs will be restricted to be done by the second line doctors only.

?Chance of resistance increases on premature withdrawal / non compliance.

?DOTS is the best policy so far to ensure compliance.

?It is better to over treat the disease than under treating TB.

?Appropriate referral and hospitalization is necessary for successful anti-TB campaign.

?There should not be any role of treating latent tuberculosis or offering INH chemoprophylaxis in high prevalent society as ours. The issue should be discussed thoroughly at the appropriate level. Pending evidence, all such cases merit a discussion in a clinical board with at least two level II (two) TB treating doctors and as the next course of action full treatment according to the existing Category I may be considered. Appropriate research should be initiated to generate evidence for the best course of action at the earliest.

Legal :

?Delay / non compliance is a social crime on the part of the patient.

?Detection of vested interest at any level by anybody in the anti-TB campaign is a criminal offence and a liability for punishment. Similarly, lethargy or any callous act imparting difficulty in the process of anti –TB campaign is as serious as a criminal offence and makes one liable for legal action and punishments.

Clarification :

1. RNTCP certification : RNTCP shall be the main body (with the help of the think tank, experts, and other people) to certify TB treating a) doctors, b) HCWs, c) NGO, d) hospitals (Private and public), e) clinics, f) drug dispensing centers, g) referral and hospital facilities, and others in the TB treating campaign. The RNTCP decisions shall be published in the internet and they should be displayed locally at the block and panchayet office, local schools and colleges, local police station, and local health centers and also in all the RNTCP selected clinics, drug stores etc.).

2. Social punishment : the defaulters will be supported with adequate counseling and reward etc. to bring them back to treatment. On failure, when a defaulters name will displayed openly at all the places as mentioned above with a note that the person has been doing harmful activities for the society he or she will be under pressure in the community to observe the directions from the treating authority. As a bi-product, there will be good social awareness in turn and it will be easy to mobilize mass support in favor of the campaign.

3. Involvement of NGOs : it will mostly be restricted to ensure adherence and monitoring for which it will be paid from a different department (viz. HR ministry) but RNTCP and both RNTCP and HRM shall have the right to monitor the activities of the NGOs. Local feedback facility has to be developed to ensure assistance and surveillance on the NGOs. Any NGO willing to treat TB or do something beyond the stipulated activities in anti-TB campaign have to have RNTCP certification. Any institute having existing anti-TB activities (as institutes like Ramakrishna Mission, Ranchi that is running a TB hospital effectively for a long time) shall be allowed with RNTCP certification and all possible logistic assistance.

4. Data keeping : a mega software can be prepared with the help of the experts that will enable all the activities to be uploaded with provisions for verification, monitoring, emergency actions, decisions regarding punishment, and continuous operational appraisal and research. A system of continuous and effective back up has to be evolved at the central and local level. Data keeping shall be a must for both the public and private sectors.

TB needs prolonged treatment with multiple drugs.


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CLASSIFICATION OF CASES AND PROPOSED TREATMENT RE GIMEN :

The background : TB is a global challenge and the rising prevalence of MRD TB is going to be a global threat. With the existing variable but essentially very high level of initial resistance to different anti-tubercular drugs, and our experience of rising prevalence of the MDR disease, we feel that some rethinking on the classification and the recommended treatment regimens is necessary. We appreciate that there are some conceptual and logistic problems related to the existing RNTCP categorization of the disease and the recommended therapy and they need to be addressed. To our mind, it is the right time to try so with positive intellectual feedback, appropriate pilot studies, and consensus formation. We feel again that bare classification and recommendation of treatment is not enough to enforce or implement a treatment regimen successfully. To us, there shall be rooms to guide in difficulties and there should be adequate flexibilities when a situation demands. To us again, especially in face of rising prevalence of resistance to the anti TB drugs by the bug, the concept of de-escalation of therapy with the appropriate use of culture sensitivity tests (whenever possible) should be the approach especially when there is relapse or treatment failure.

For the time being, the members agree that, by and large, the RNTCP guideline has to be followed although they feel that the RNTCP categorization of patients and treating them accordingly needs modification, and deviations may be allowed in selected situations through the decision of a board meeting or consensus of opinions (at least by two experts) in an individual case whenever necessary.

Although the consensus group appreciates its limitations of formulating a treatment regimen right now, it wishes to forward the proposal of an alternate regimen (as given below) to the Govt. and the RNTCP to consider it for a pilot study. Similar other regimens may also be formed on consensus for pilot study again. To us, it is easy to say that one needs evidence to make or formulate a regimen, but it is actually very difficult to find or generate the evidence overnight where the mycobacteria appears more smart than us by way of becoming resistant to different drugs. Therefore, even if there is serious effort to generate evidence, it will take a long time and meanwhile the situation may turn further difficult to tackle. Therefore, the consensus body feels that there should be efforts to make pilot studies with one or two regimens for different categories of patients alongside simultaneous appropriate research to generate the necessary evidence and in the process the best possible PPM should be encouraged.

The consensus group further wishes a widespread discussion and a systematic review of these issues in private, public and PPM to finally come out with an acceptable solution and it feels that the present draft may go a long way in this direction.

The proposed new classification :

?Group 1 : Tuberculosis first time in life without h/o exposure to possible MDR patient or situations:

?Group 2 : Relapse and treatment failure cases

a) relapse cases : when a patient relapses after a complete or incomplete treatment

b) treatment failure cases : when there is no response to a good regimen of treatment given for at least 3 months

We have omitted the discussion with “defaulter” group to make the grouping simple

?Group 3 : Extra-pulmonary tuberculosis

?Group 4 : TB in immunocompromised host: (HIV disease, patients on chemotherapy, patients with immunosuppression from other causes and patients on immunosuppressive dose of steroid)

?Group 5 : TB in special situations as CRF, Chronic liver disease, pregnancy, others including tuberculosis in children**, diabetes mellitus***, and ATD toxicities ***. (group 4 and 5 may be clubbed together)


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?Group 6 :

a) relapse after treatment of group 2 patients and

b) relapse after treatment of MDR tuberculosis

* There should not be, in general, any room for the treatment for latent tuberculosis at present.

Alongside, any single drug chemoprophylaxis in a high prevalent society as ours (with high prevalence of initial resistance to the first line drugs) is not recommended. If the situation demands, the prophylactic regimen needs to be decided on consensus. The consensus members feel that full anti-tuberculosis treatment can be offered as per the treatment regimen of the proposed group 1 for any situation where the prophylaxis is deemed necessary. Such a decision, however, has to be taken through a meeting / board with the presence of at least one / two level 2 TB treating physicians.

** A draft has to be prepared on consensus for the diagnosis and treatment of tuberculosis in children. This is an important but neglected area especially in Indian scenario. The members have observed that probably because of the fear of toxicity, ethambutol is avoided and there is lethargy in using pyrazinamide. As a result, in many occasions, the treatment ends up with two drugs as INH and rifampicin. It is also observed that anti TB drugs have been prescribed in children even for non-specific reasons without evidence of the disease; the members propose RNTCP to take into view the opinion of the pediatric associations and form an uniform, acceptable, and evidence based (as far as possible) criteria for the diagnosis and treatment of tuberculosis in children. Experts may be identified from the pediatricians also to help the treatment of doubtful and difficult situations.

*** With progressively higher prevalence and incidence of diabetes along with demand of insulin in many occasions and for other difficulties of treatment. We feel that the co presence of diabetes with TB needs special mention and guidance. Similarly, anti-tubercular drug toxicities often pose problem to treat the disease; we feel that they too need special attention. Separate treatment guideline may be formed on consensus in these two important areas.

**** Quinolones need to be regarded as first line equivalent drug and it should be preserved for the treatment of resistant disease and in intolerance to first line drugs.

Recommended regimen of treatment for the patients according to the alternate classification :

Group 1 : Tuberculosis first time in life without h/o exposure to possible MDR patient or situations :

6 RHEZ

?An injectable (viz. streptomycin) or a quinolone may substitute any one or two particular agent in case of resistance or toxicity. The regimen should be changed upon availability of the culture sensitivity report, if sent. In cavitary disease extra care must be sought for isolation of the patient for at least 2 weeks. Any modification needs to be done on consultation with a level 2 doctor and this has to be notified properly.

One level 2 doctor should preferably be involved to decide the initial regimen

Group 2 : Relapse and treatment failure cases

2a) Relapse case

6RHEZ Þ 3 HRE

?Sputum (preferably paired samples) must be sent for mycobacterial culture and sensitivity before starting treatment and the regimen should be changed subsequently according to the culture sensitivity report.

?The sensitivity tests should be sought for at least nine (R, H, E, Z, Sm, Kana, Ciprofloxacin,


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ethionamide and cycloserine) and if necessary for more drugs.

?The treating physician has to bring the previous treatment history (in details) and take into account the co morbid factors (medical and social) into account to decide the regimen and also to make the appropriate strategy to ensure DOTS.

?The treatment has to be on daily regimen and, if necessary, the patient has to be admitted.

?A quinolone or an injectable (strepto/ kana/ amika) may substitute any particular agent in case of known resistance or toxicity.

?Any modification in the treatment has to be notified.

One level 2 doctors must be involved to decide the initial regimen

2b) Treatment failure cases :

6RHEZQ SM/ Kana and ethionamide Þ 6 RHE+Z/Q and ethionamide

?Sputum (preferably paired samples ) must be sent for mycobacterial culture and sensitivity and the regimen should be changed according to the culture sensitivity report.

?The sensitivity tests should be sought for at least nine (R, H, E, Z, Sm, Kana, cipro, ethionamide and cycloserine) and if necessary for more drugs.

?The treating physician has to bring the previous treatment history (in details) and take into account the co morbid factors (medical and social) into account to decide the regimen and also to make the appropriate strategy to ensure DOTS.

?The treatment has to be on daily regimen and, if necessary, the patient has to be admitted.

?A quinolone or an injectable (strepto/ kana/ amika) may substitute any particular agent in case of known resistance or toxicity.

?Any modification in the treatment has to be notified

?The patients should be isolated till they turn smear negative.

To start the treatment as MDR TB and modify/ deescalate the treatment after 6 to 8 weeks upon the availability of the culture sensitivity report should be the protocol in this group of patients. The treatment of MDR disease may be done as per the existing RNTCP guideline.

One or preferably two level 2 doctors must be involved to decide the initial regimen

Group 3 : Extra-pulmonary tuberculosis : should be treated on individual merit to a large extent upon consultation with at least one (preferably more) level 2 doctor/ doctors. The duration of treatment will vary in each type according to the degree of response; pericardial, meningeal, and bone TB should be treated for prolonged period. Particularly for CNS tuberculosis, pyrazinamide has to be continued for the full length of therapy since the CNS penetration of the drug is good. Consultation / collaboration of a specific subspecialty expert (cardiologist, orthopedician, etc.) shall have to be done whenever felt necessary. RHEZ may be started and continued for prolonged duration as per the discretion of the physician concerned in consultation with level 2 or 3 specialist. The treatment should be stopped on satisfaction of the treating physician as ‘cure’ is achieved and in the process level 2 or 3 doctors may be consulted in any doubt / difficulty.

Group 4 : TB in immunocompromised host :

?If there is no risk factor or suspicion of drug resistance: the patients should be treated as group I

?If there is risk factor of drug resistance: the patient should be treated as MDR-TB keeping R and H and changing the regimen subsequently according to the CS report.


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?Concomitant treatment of the immunocompromised state has to be done.

?Involvement of appropriate sub-specialty doctors will be done as per the demand of the situation

One (preferably more) level 2 doctors must be involved to decide the initial regimen, follow up schedule, duration of the treatment in collaboration with an expert from the required sub-specialty.

Group 5 : TB in special situations as CRF, Chronic liver disease, diabetes, pregnancy, others : the regimen has to be decided by level 2 doctors on consensus and the treatment should be done as per the existing RNTCP guideline with or without modification. A draft need to be to be prepared with experts upon consensus. One (preferably more) level 2 doctors must be involved to decide the initial regimen, follow ups, duration of the treatment in collaboration with an expert from the required sub-specialty.

Group 6 : Relapse after a) category 2 treatment and b) MDR tuberculosis : to individualize the regimen using multiple drugs not used earlier; the treatment should be done through by board formation including more than one level 2 and level 3 doctors.

+ The Government is proposed to mark quinolones for tuberculosis treatment and not meant for routine general use as an antibiotic with immediate effect. The drug needs to be preserved for treatment of resistant TB only.

** Indications of steroid with dose and duration shall be specified.


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10IPCR Initiative - 2010

Tuberculosis first time in life without h/o exposure to possible MDR patient or situations (Group 2 patients) :

6RHEZ or 3RHEZ

Þ5RHE

One level 2 doctor should preferably be involved to decide the initial regimen

yes, when sick and home isolation not possible

An injectable or a quinolone may substitute

any particular agent in case of resistance or

toxicity. The regimen should be changed

upon availability of the culture sensitivity

report, if sent. In cavitary disease extra care

must be sought for isolation of the patient

for at least 2 weeks. Any modification

needs to be done on consultation with a 2nd

level (level 2) doctor and this has to be

notified properly.

CommentsGroup Details Regimen Involvement of experts Isolation Admiss-ion

1

Sputum (x 2) must be sent for mycobacterial culture and sensitivity and the regimen should be changed according to the culture sensitivity report. The sensitivity tests should be sought for at least eight ( R,H,E, Z, Sm, Kana, Cipro, ehionamide) and if necessary for more drugs.The treating physician has to bring the previous treatment history in details and also to take into account the co morbid factors (medical and social) in to account to decide the regimen and make the appropriate strategy to ensure directly observed therapy.The treatment has to be on daily regimen and, if necessary, the patient has to be admitted.a quinolone or an injectable (strepto/ kana/ amika) may substitute any particular agent in case of known resistance or toxicity.any modification in the treatment has to be notified

yes, when sick and home isolation not possible

yes for 2 weeks

yes, till they turn sputum negative

One level 2 doctors must be involved to decide the initial regimen

one or preferably two level 2 doctors must be involved

6RHEZ

Þ3 HRE

6RHEZQ SM/Kana and ethionami

de Þ6 RHE+Z/Q and ethionamide

Relapse case

Treatment failure cases

1

2b

should be treated on individual merit to a large extent. The duration of treatment will vary in each type according to the degree of response; pericardial, meningeal, and bone TB should be treated for prolonged period. Consultation / collabotation of a specific subspeciality expert (cardiologist, orthopedician, etc.) shall have to be done whenever felt necessary

yes, when required

consultation with at least one (preferably more) level 2 doctor/ doctors is recommended

Extra-pulmonary tuberculosis

3

no risk factor or suspicion of drug resistance: start as Category 1risk factor of drug resistance : start as MDR keeping RH and change the regimen subsequently according to the CS report.concomitant treatment of the immunocompromised state involvement of appropriate sub-specialty doctors will be done as per the demand of the situation

yes, when required

One (preferably more) level 2 doctors must be involved to decide the initial regimen, follow ups, duration of the treatment in collaboration with an expert from the required sub-specialty.

TB in immunocompromised host

4 yes for 2 weeks

to be decided by level 2 doctors as per

consensus should be done as per the

existing RNTCP guideline with or without

modification. A draft need to be to be

prepared with experts upon consensus.

yes, when sick

One (preferably more) level 2 doctors must be involved to decide the initial regimen, follow ups, duration of the treatment in collaboration with an expert from the required sub-specialty.

TB in special situations as CRF, Chronic liver disease, diabetes, pregnancy, others

5

the treatment should be done through by

board formation including more than one

level 2 and level 3 doctors.

yesthe treatment should be done through by board formation including more than one level 2 and level 3 doctors.

Relapse after a) Gr. 2 treatment and b) MDRTB

6 yes till sputum negative

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ISSUE OF REFERRING A PATIENT : WHEN?

We understand that treatment of TB is not an easy job and, therefore, we have proposed to specify the TB treating doctors officially. By virtue of widespread observation of DTCD and MD (pulmonary medicine) curriculum in different universities, and a lot of MBBS doctors with inclination and vast experience in treating TB, the country has a very good human resource for making level 2 and level 3 TB treating physicians. However, they are to be trained for adhering to an uniform course of action and offer collective response to a particular situation (opinion pool of two or more TB treating doctors).

A certificate course may be opened to train interested doctors to make them capable of joining the anti-TB campaign.

We feel that there should be a laid down guidelines for seeking referrals in treating TB. This, to our mind, will help to reduce defaulters and treatment failures.

Consultation recommended as :

a) mandatory

1. tuberculosis in special situations

2. tuberculosis in HIV co-infection

3. any relapse and treatment failure case

4. any suspected drug resistant disease

5. non lymph-node extra-pulmonary tuberculosis

6. no response/ no response to chemotherapy for 2 months

7. H/O contact with drug resistant tuberculosis

8. any untoward ATD toxicity

9. suspected NTM infection

b) optional and recommended

1. lymph-node tuberculosis

2. poor response to chemotherapy for over one month

3. no strong evidence for TB but it seems necessary for EATD trial

4. h/o family member dying of tuberculosis

5. H/o successful anti-tuberculosis therapy in past

6. tuberculosis in children

c) optional

1. tuberculosis in HCW

2. tuberculosis in hostels/ camps/ confinements

3. suspected cases of PUO from tuberculosis

There can be debate / discussion on the points jotted down as above and many of them needs elaboration (like what are the untoward effects of ATD or what are the situations to suspect NTM). These all may be addressed in a revised version of the draft in future.


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WHAT ARE THE PROBLEMS FOR THE PRIMARY CARE PHYSICIANS?

This is an issue of immediate operational research. We have to know the problems categorically to implement the anti-TB campaign more effectively. This important area should not be overlooked and should be addressed with a strong zeal. We have tried to innumerate a few to initiate awareness and actions.

?Problem to access the existing knowledge base

?Problem to access the RNTCP facilities

?Problem to come out from the old mindset (a few are charted below)

a) chest x-ray is enough to diagnose tuberculosis.

b) that Mantoux test can diagnose TB

c) that immunological tests are good to start ATD

d) the PCR based testes are confirmatory

e) the poor access to TB culture

f) costly and the latest tests are the better ones

g) any fever over 2 weeks is likely TB

h) any shadow persisting in X-rays and not resolving to antibiotics merits ATD

i) one can prescribe any regimen he or she wishes

j) fixed dose regimens are ‘all cure’; do not bother for any dose adjustment

k) pyridoxine is not essential in treating with INH containing regimen

l) one can add a single drug to the failing regimen

ndm) there is no problem to start 2 line drugs without evidence of resistance

n) there is no need to refer a patient to RNTCP

o) there is no need to refer a patient to experts

?Problem to access to evaluate TB properly

a) evaluation with less useful tests (serology/ QFT –G)

b) poor access to TB culture


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WHAT IS EXPECTED FROM THE GOVERNMENT ?

The Government needs to act as a facilitator for the treatment and control of TB. Infact, to our opinion, a little modification in the policy will help in a long way to fight TB in our country. With the advent and assess to modern information technology, the job appears possible without much difficulty. We have broadly outlined the expectations from the Govt. and have also given an outline of the modus operandi. There is room for significant modification and improvisation of the draft based on consensus and operational research.

General expectations :

?The state shall declare the TB as a state of emergency and all the TB cases shall have to be notified with RNTCP.

?The state shall accept the principles of treatment officially and will endorse all treatments matching the principles.

?The right of treating TB has to be withdrawn from everyone and the TB treating doctors shall have to be identified and fixed for the purpose. They should be trained appropriately for performing the job. RNTCP may take the charge of training with the help of different individuals, institutes and professional bodies as API, IMA etc. Any modification of treatment has to come through the specified experts and to be notified again.

?The OTC availability of ATD has to be stopped and the drugs should be dispensed through the RNTCP centers or selected and licensed drug stores.

?TB PCR and serological tests should be restricted for research purpose and to the use by experts only in very selected situations.

?The RNTCP centers should be more in number.

?AFB detection centers (smear and culture-sensitivity) shall be increased sharply under RNTC. More number of accredited laboratories are to be set up – at least one in each rural medical college and preferably one in each district headquarters. If this is not possible selected private centers shall be recognized as reference laboratories for the purpose (as a firm step in PPM). Any sample tested in these labs on order by the selected TB treating doctors will be financially reimbursed by the RNTCP. The RNTCP shall monitor the quality and performances of the labs.

?Arrangements are to be done so that non govt. care givers and recipients find some easy and effective accessibility to administration.

?All Govt. policies, actions, allocations, expenditures, and resources should be available to access by any body on internet on request and all databases should be available online.

?All the actions at micro (individual) level to macro level should be entered in a mega-software programme and all collected data has to appear within 3 (three) days of collection so that anybody on request should be allowed to access the data.

?There should be a provision of interaction online with registration of grievances, suggestions and any knowledge input.

?There should be an independent and autonomous operational research cell funded by RNTCP. One or more NGOs may be entrusted for the activities independently and under co-ordination by the said research cell.

?The sanitaria should be modernized to admit MDR & XDR TB cases.

?To implement the anti-TB campaign in a PPM the efforts should start from the top with steps to


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a) identify the resource persons from private sector along with that from public sector; make a mix for uniform strategic activities.

b) identify the treating physicians: specialists should be marked for referral in specific situation.

c) identify the institutions that will cater to anti TB campaign by way of providing the necessary infrastructure facilities for AFB culture etc.

d) identify the modes of operation for TB detection and treatment effectively.

?To identify and recognition of TB treating doctors the proposed mode of selection may be considered :

a) through the involvement of the resource persons in action of selection.

b) to take into account the qualification / training / inclination.

c) arrange a basic training and make new members with willing physicians.


Anti TB Draft (Consensus)

Documents

Transcript of Anti TB Draft (Consensus)