INT J TUBERC LUNG DIS 18(11):1353–1356 Q 2014 The Union http://dx.doi.org/10.5588/ijtld.13.0836

Extending tuberculosis notification to the private sector in India: programmatic challenges? S. B. Nagaraja,* S. Achanta,† A. M. V. Kumar,‡ S. Satyanarayana§ *Employees’ State Insurance Corporation Medical College and Postgraduate Institute of Medical Sciences and Research, Bangalore, †World Health Organization Country Office for India, New Delhi, ‡International Union Against Tuberculosis and Lung Disease, South-East Asia Regional Office, New Delhi, India; §Department of Epidemiology, McGill University, Montreal, Quebec, Canada SUMMARY

In May 2012, the Government of India declared tuberculosis a notifiable disease, requiring all public and private health sectors throughout the country to report all cases. Until then, TB disease was notifiable only by public authorities. In India, the private sector dominates anti-tuberculosis treatment, and poorly managed cases lead to severe forms of TB. Several challenges need to be addressed for effective implementation, including the creation of an electronic case-based web-

based mechanism for TB notification. Stricter enforcement backed by regulation and punitive measures for non-compliance, along with vigilant mechanisms in place to monitor private health facilities, is required. Massive campaigns and advocacy programmes for a notification drive may be the way forward. K E Y W O R D S : case notification; private sector; tuberculosis

A LANDMARK DECISION declaring tuberculosis (TB) a notifiable disease was announced by the Government of India on 7 May 2012. This decision requires all public and private health providers in the country to notify all TB cases that they diagnose and/ or treat.1 Until this time, TB disease was notifiable by public authorities under the Revised National TB Control Programme (RNTCP) and by those private health facilities involved in RNTCP public-private mix (PPM) schemes. In the present paper, we describe the reasons for making TB a notifiable disease, mechanisms for the notification of TB and the gaps in the notification procedure that preclude the realisation of the full benefits of notification.

true denominator of TB burden in the country. TB is an infectious bacterial disease that can be cured through effective treatment and close monitoring. Privately treated cases with susceptible, multidrugresistant TB (MDR-TB, defined as TB resistant to at least isoniazid and rifampicin) and extensively drugresistant TB (XDR-TB, defined as MDR-TB plus resistance to fluoroquinolones and one of the three injectables) are often unknown to the programme; mandatory notification will enable the country to quantify its TB problem and help in the proper planning and implementation of TB control strategies. Despite this, in India nearly 2.2 million individuals develop TB every year and 280 000 die of TB.3 In addition, poorly managed TB fuels drug resistance, which is more difficult to treat and is 20–40 times more expensive to manage. The 100 000 MDR-TB cases that emerge every year represent a serious threat to public health, as infectious persons will continue to spread infection if left untreated. Poorly managed MDR-TB may lead to XDR-TB, which is virtually incurable. Recent episodes in Mumbai have drawn attention to the growing threat of XDR-TB resulting mainly from non-standardised and incorrect treatment practices in the private sector. 4 These episodes may be repeated anywhere in the country, given the current

ASPECT OF INTEREST Why TB should be notifiable in India Notification is a statutory requirement common to diseases of public health importance; TB notification is a recognised standard of international TB care.2 Of the BRICS (Brazil, Russia, India, China and South Africa) countries, India has been the last to effectively implement TB notification. Notification aims to establish a local TB surveillance system that documents all cases of TB reported by both the private and public sectors to estimate the

Correspondence to: S B Nagaraja, Department of Community Medicine, ESIC Medical College and PGIMSR, Rajajinagar, Bangalore 560 010, India. Tel: (þ91) 080 2343 4156. e-mail: [email protected] Article submitted 19 November 2013. Final version accepted 17 June 2014.

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situation: 1) the private sector dominates health care services and in particular anti-tuberculosis treatment;4,5 2) prescribing practices among private providers are extremely poor, often with inappropriate and inadequate regimens;6,7 3) considerable quantities of anti-tuberculosis drugs are sold in the private sector, often with irrational prescriptions;6 4) there is unrestricted access to anti-tuberculosis and anti-MDR-/XDR-TB drugs without prescription;8 5) TB and MDR-/XDR-TB drugs are available at high cost for privately treated patients, which leads to interruptions and inadequate treatment;3 6) treatment in the private sector is unsupervised, without necessary patient support for ensuring treatment adherence;8 7) there is unreliable information on the number of TB cases diagnosed or treated in the private sector; 8) the private sector is profit oriented, and 9) the Government has little or no control over the quality of the TB care being offered in the private sector. Mechanisms for TB notification Notification under the RNTCP is done through an electronic-based reporting system, and recently a dedicated online website called ‘Nikshay’ has been developed. Several mechanisms have been developed to enable private providers to notify TB cases; these include submitting paper-based reports, e-mailing information and entering information directly into the Nikshay website. Use of mobile phone technology, such as text messaging and phone-based information systems, are being envisaged by the programme (Appendix).

DISCUSSION The challenges to TB notification faced by the private and public sector differ. In the private sector: 1) Creating awareness regarding notification among private practitioners and the general public is a challenge. A massive nationwide campaign to create awareness, build advocacy, and garner administrative and political support is a prerequisite. 2) Not all private practitioners are equipped with the tools required to notify cases. A list of options may be made available to practitioners:  Simple, web-based applications compatible with all computers and mobiles  Text messages to a dedicated number assigned for documenting TB notification  A toll-free number with interactive voice response services, allowing the caller from telephone or mobile phone to be guided by automated voice instructions

Paper-based reporting, collected periodically by a dedicated person entrusted with this task. 3) It is difficult to convince private practitioners of the additional benefits of notifying TB patients. There is a perception in the private sector that TB notification might attract unnecessary scrutiny of routine activities, resulting in the loss of independence in patient management and, eventually, loss of patients to the programme. Constant reassurance of private practitioners by programme staff is required. 4) Securing the continued trust of the private sector is a daunting task for the programme. The confidence of the private sector needs to be won over on various issues such as continuous drug supplies and appropriate treatment regimens, and timely payment of incentives and solving grievances will help in complying with TB notification. 5) Ensuring TB notification without legal back-up and punitive action is difficult. The requirement for notification therefore has to be accompanied by strong regulatory and punitive measures in case of non-compliance. Incentives can also be envisaged for those who comply. A carrot and stick approach may be the best approach. 

In the public sector, TB notification is already in place; further improvements are envisaged through case-based web-based notification. However, there are challenges in the implementation of a case-based web-based notification system: 1) Field-level data entry into the electronic based system is a challenge; the primary responsibility of peripheral health staff is to supervise and monitor TB cases. There are serious concerns about the availability and capacity of peripheral field staff from general health system to cope with the additional laborious data entry; there remains an apprehension of malpractice that may lead to poor quality of data if responsibility is imposed without considerable support. RNTCP programme managers should be adequately empowered to hire data entry operators or outsource data entry to private agencies in the at least 20–30% of health facilities with poor infrastructure and limited human resources. 2) Providing basic infrastructure for data entry remains a challenge. The peripheral health centres should be equipped with functional computers, uninterrupted power supply and internet connectivity. The best solution would be to provide handheld devices, possibly at the primary health centres, or solar powered fixed-touch screen electronic devices.9 Similar devices are being used successfully in India in the transportation, hotel, aviation and power sectors.

TB notification in India

Past experiences with the National AIDS Programme and Maternal and Child Tracking System suggests that case-based tracking of patients faces many challenges, such as data entry issues at the point of entry, validation of data entered, failure to forecast logistics for routine implementation, programme administrators being hesitant to rely on the indicators generated by this software and inflexibility of programme software to accommodate more variables. Similarly, case-based tracking for TB patients may not be successful without appropriate infrastructure and a robust mechanism in place. However, there is always scope for innovation and adaptation to improve the programme.

CONCLUSION The RNTCP should provide a simple, user-friendly platform for notification linked to a strategy to encourage the private health sector to prompt action. Regulations for monitoring TB notification among the private health sector should be strictly imposed by the Government of India. There is a need for a TB notification drive in the country and the necessary momentum could be garnered by massive campaigns and advocacy programmes. Conflict of interest: none declared.

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References 1 Government of India, Ministry of Health and Family Welfare. TB notification. New Delhi, India: Government of India, 2012. http://www.tbcindia.nic.in/pdfs/TB%20Notification%20Govt% 20%20Order%20dated%2007%2005%202012.pdf 2 Tuberculosis Coalition for Technical Assistance. International Standards for Tuberculosis Care. 2nd ed. The Hague, The Netherlands: TBCTA, 2009. 3 World Health Organization. Global tuberculosis report, 2013. WHO/HTM/TB/2013.11. Geneva, Switzerland: WHO, 2013. 4 Udwadia Z F, Amale R A, Ajbani K K, et al. Totally drugresistant tuberculosis in India. Clin Infect Dis 2012; 54: 579– 581. 5 Satyanarayana S, Nair S A, Chadha S S, et al. From where are tuberculosis patients accessing treatment in India? Results from a cross-sectional community-based survey of 30 districts. PLOS ONE 2011; 6: e24160. 6 Wells W A, Ge C F, Patel N, et al. Size and usage patterns of private TB drug markets in the high-burden countries. PLoS ONE 2011; 6: e18964. 7 Udwadia Z F, Pinto L M, Uplekar M W. Tuberculosis management by private practitioners in Mumbai, India: has anything changed in two decades? PLoS ONE 2010; 5: e12023. 8 Bhargava A, Pinto L, Pai M. Mismanagement of tuberculosis in India: causes, consequences, and the way forward. Hypothesis 2011; 9: e7. 9 Douglas G P, Gadabu O J, Joukes S, et al. Using touchscreen electronic medical record systems to support and monitor national scale-up of antiretroviral therapy in Malawi. PLOS Med 2010; 7: 1–6.

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APPENDIX Table Tuberculosis (TB) notification, reporting mechanisms and the progress of TB notification in India in both the public and private sector Tuberculosis cases: 1)

2) Drug-resistant TB cases: 1)

Reporting mechanisms: 1)

2)

3) Actual progress: 1) 2) 3)

Prior to the Government announcement in May 2012, only those TB cases detected by the RNTCP public sector and by private practitioners or non-governmental organisations (NGOs) involved with the RNTCP through structured schemes were notified. However, under the RNTCP, the involvement of private practitioners/NGOs was minimal and their contribution to the total number of notified cases insignificant. A community-based survey reported that 46% of the TB patients in India take their anti-tuberculosis treatment from ‘outside RNTCP’1 (private sector) and are thus missed by the RNTCP. An estimated 3 million TB cases are missed by national notification systems globally, to which India contributes around 30%.2 Since May 12, notification by both the public and private health sectors, irrespective of their involvement under the RNTCP, is compulsory. India achieved complete coverage of programmatic management of drug-resistant tuberculosis (PMDT) in 2013. Drug-resistant TB requires a laboratory diagnosis, and only those cases diagnosed under the RNTCP are notified. There is limited information on the number of ‘missed’ drug-resistant TB cases in the country. We believe that the majority of cases are not detected due to the complexity of diagnosis, and that those diagnosed in the private sector are not notified to the RNTCP. Before May 2012, the tuberculosis unit (TU) covering a population of 250 000–500 000 formed the basic RNTCP unit for reporting. All TB and drug-resistant TB cases diagnosed and treated by the various public health facilities are routinely registered and notified by a RNTCP senior treatment supervisor. The aggregate numbers of cases in different TUs are compiled at the district level and are reported to the state level by an RNTCP district programme manager. The programme envisaged using ‘Epicentre’ software for reporting . Since May 2012, the RNTCP has emphasised case-based web-based reporting system for notifying TB and drugresistant TB cases. This online reporting system, ‘Nikshay’, uses the health facility (public or private) as the basic reporting unit. Complete details of the patient and the basis for diagnosis are reported. The senior RNTCP treatment supervisor facilitates data entry in the health facilities. Currently, Nikshay allows the registration of hospitals and allopathic practitioners; only cases notified by these are reported. The RNTCP has opted to use both Epicentre and Nikshay for reporting until the latter reporting mechanism is strengthened. A total of 57 532 private health facilities are registered; this includes private laboratories, private registered patients and private hospitals. The number of patients notified through these facilities since 2012 is 41 702 cases, in addition to the ~5000 cases notified by the public sector being treated outside the RNTCP.3 The total number of TB patients registered for treatment under the RNTCP in the past 4 years is 1 522 147 (2010); 1 515 872 (2011);1 467 585 (2012) and 1 410 880 (2013).3 There has been no increase in the number of TB cases detected since notification was generalised in May 2012. The number of TB cases notified outside the RNTCP and private sector was captured from 2012 onwards: the total number of TB cases notified outside the RNTCP was 441 in 2012 and 4555 in 2013. The total number of TB cases notified by the private sector was 3016 in 2012 and 38 596 in 2013.3

References 1 Satyanarayana S, Nair S A, Chadha S S, et al. From where are tuberculosis patients accessing treatment in India? Results from a cross-sectional community-based survey of 30 districts. PLOS ONE 2011; 6: e24160. 2 World Health Organization. Global tuberculosis report, 2013. WHO/HTM/TB/2013.11. Geneva, Switzerland: WHO, 2013.

3 Central TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare. Revised National TB Control Programme. TB India 2014. Annual status report. New Delhi, India: Ministry of Health and Family Welfare, 2014.

TB notification in India

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RESUME

En mai 2012, le gouvernement d’Inde a d´eclar´e que la tuberculose (TB) e´ tait une maladie a` de´ claration obligatoire nationale pour tous les services publics et priv´es ; jusque-la, ` la TB n’´etait d´eclar´ee que par les autorit´es publiques. Or le secteur priv´e domine le traitement de la TB, et les cas mal pris en charge aboutissent a` des formes graves. Il y a donc plusieurs de´ fis a` relever pour une mise en œuvre efficace,

notamment grace ˆ aux syste` mes e´ lectroniques et a` l’internet. Une application plus stricte, appuy´ee sur un r`eglement et des sanctions en cas de non adh´esion, en mˆeme temps que des m´ecanismes vigilants de suivi des structures de sant´e priv´ees, constituent le besoin du moment. Des campagnes massives et des programmes de plaidoyer en faveur de la de´ claration pourraient constituer une bonne solution. RESUMEN

En mayo del 2012, el Gobierno de la India definio´ la tuberculosis (TB) como una enfermedad de declaracion ´ obligatoria en todo el pa´ıs, lo cual exige su notificacion ´ a los sectores de salud publico ´ y privado. Hasta ese momento, solo las autoridades publicas ´ notificaban la enfermedad tuberculosa. El tratamiento antituberculoso es ma´s frecuente en el sector privado y los casos con un tratamiento inadecuado terminan en formas graves de la enfermedad. Existen diversos obsta´culos que se deben resolver a fin de lograr una aplicacion ´ eficaz de la

medida, entre ellos la introduccion ´ de un mecanismo electronico ´ de notificacion ´ de la TB accesible en internet. En la actualidad, se precisa una aplicacion ´ reforzada mediante medidas normativas y punitivas en caso de incumplimiento, adema´s de mecanismos de vigilancia activos que supervisen los centros de salud del sector privado. Una forma de avanzar podr´ıa ser la realizacion ´ de campanas colectivas y programas de ˜ sensibilizacion ´ destinados a impulsar la notificacion. ´

Extending tuberculosis notification to the private sector in India: programmatic challenges?

In May 2012, the Government of India declared tuberculosis a notifiable disease, requiring all public and private health sectors throughout the countr...
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