Leprosy Mailing List – June 3, 2017
Ref.: (LML) Unseen problems in leprosy control in rural areas of Western Maharashtra: the current scenario and its policy implications
From: V.P. Shetty, Shubhada Pandya, N.F. Mistry. The Foundation for Medical Research, Mumbai, India
Dear Pieter,
The World Health Assembly Resolution, 1982 endorsed Multidrug Therapy (MDT) as the key to leprosy elimination world-wide. [1]
After fixed duration treatment i.e., 12 months MDT for Multibacillary (MB) and 6 months for Paucibacillary (PB) leprosy, the person is declared ‘cured’ and removed from the registers.(2)
The Resolution further stated that because the risk of relapses after the completion of the WHO MDT regimen has been ‘negligible’, active post –MDT surveillance was not necessary. Instead, patients should be instructed, at the time of Release From Treatment (RFT), about early signs of possible relapse or reaction and to report promptly to the Primary Health Centre (3). In light of field experiences and observations in our country this appears to be an unreasonable expectation.
Where do we stand today:
Firstly, contrary to expectations, MDT usage in disease endemic pockets has not made a major dent in the Annual New Case Detection Rate (ANCDR) or in the Child Rate (both of which are the parameters of continuing disease transmission).
Secondly, the proportion of MB leprosy patients and patients presenting with deformity / nerve function impairments (both of which are indicators of delay in diagnosis) have almost doubled since December 2005 (when leprosy was officially declared ‘eliminated’ from India, and there after integrated into general health services). Raigad District in Western Maharashtra is an example. It records the third highest number of leprosy cases in the country with more than 54% MB cases and > 7% with visible (Grade 2) deformity. [4, 5]
In the integrated set-up, the main focus indeed is to detect and treat new cases. However, the encouragement of self-reporting by patients under Information, Education and Communication (IEC) activities has not been very successful for several reasons. In two studies conducted by us in rural areas of Western Maharashtra(6,7) it was found that: only ~25% of the patients were aware of the disease for which they were being treated, although > 80% had been explained about the duration of the treatment.
The only occasion that a patient was seen by the doctor (if at all) was at the time of diagnosis. Once the patient was registered, MDT was initiated and delivered at his/her home by the multi-purpose workers (mainly ASHA workers). This was intended to facilitate compliance and treatment regularity.
In the National Leprosy Control Programme {NLCP} the treatment compliance rate is reported as >96% (5), which was not substantiated in our studies. In about 20% of patients shown as RFT in the treatment register, on verification / as per patient’s narrative, had not completed their course of treatment. The reasons proffered by the patients were, drug side effects, ‘reaction’, lesion disappearing, discoloration of skin or drug packet not being delivered by the multipurpose workers.
Another drawback of the approach is the lost opportunity for the doctors to learn about the disease and its management, and the lost bond between the patient and the doctor. A lesson learnt here is that better communication and more frequent interaction between the treating doctors and the patients could have helped in resolving these issues in a timely manner. It is important to be aware of these lacunae to determine the implications for post RFT events and for taking corrective measures.
The definition of end-point in leprosy solely based on MDT duration is over simplistic. (2) Bacteriological and clinical examinations are neither conducted nor deemed important. Firstly Neuropathy/ nerve function impairments does not get assessed or attended to, as paramedical workers are not trained. Patients are ultimately deprived of proven benefits of timely detection of NFI and appropriate treatment with immuno-suppressive drugs (8). Secondly sooner or later the emergence of bacterial resistance to components of MDT is inevitable.
Following integration in the year 2005, Leprosy Referral Centers (LRCs) were introduced to deal with special care needs such as difficult to diagnose cases, reaction management and Deformity Prevention and Medical rehabilitation (DPMR). During the course of our study it was observed that most LRCs based in Raigad district were nonfunctional mainly due to dearth of trained human resources and infrastructure.
Post- RFT events and relapse following MDT are not negligible:
Post -MDT deleterious events such as reaction, neuritis, persistence of lesion and relapse have not so far been fully documented or appreciated due to lack of attention to post- MDT surveillance. Timely detection and proper management of post MDT events are important as they impinge on the success of the NLCP.
Our recent study made an effort to gauge the magnitude of these problems in 6 primary health centers in Panvel block in Raigad district, in patients RFT between April 2005 and March 2010. Of the 406 patients examined in 3 annual visits (2012-2015) a total of 76 (18.7%) were detected with deleterious events requiring medical attention. (7)
The rate of disease relapse after cessation of chemotherapy in this study was 54/406=13.3%, the majority being Borderline Tuberculoid (BT) cases classified as MB (WHO operational classification) and receiving 12 months of MB-MDT. This proportion by no means is low and raises concern about the efficacy of the current MDT regime
Burden of leprosy related deformity after release from treatment
As per 2011 NLCP estimates, there are about 1 million leprosy patients living with disease related deformity in India, with a few thousand added annually . Grade 2 deformity in new cases is on the rise showing that early detection is not happening. (9)
In a small sample survey we assessed the deformity status of RFT patients in a village composed generally of Kolis (Fisher folk) in Panvel taluka of Raigad District (unpublished).
In a population of 1875, there were 31 leprosy patients who had been released from treatment; 19(60%) had multiple Grade2 and/or Grade 1 deformity. Plantar ulcers (6 cases), foot-drop (3 cases), ulnar claw hand (4 cases), median claw-hand (4cases) eye complications (3 cases) were seen. Perceived stigma and a significant lack of confidence in the public health system were found to be some compounding factors. Co-morbidities due to lymphatic filarisis (2 cases), mental depression (3cases), hypertension (2 cases) and other skin diseases (6 cases) were also seen among leprosy patients making a strong case for considering a ‘Comprehensive Health Care’ need/approach.
Implications for policy:
While revival of active survey and contact examination by the NLCP to detect and treat cases early are indeed a move in right direction, post RFT surveillance remains a neglected area.
§ There is a large and a growing number of People Affected with Leprosy released from treatment requiring continued and comprehensive medical care.
§ 10 years of post-RFT Surveillance conducted at least 6 monthly are needed for MB cases and for 5 years for PB cases.
§ Closer and regular interaction between patient and the medical officers of PHC is highly desirable to improve the quality of service.
§ Efficacy of MDT must be assessed with defined treatment end-points including a) examination and certification of each patient by a NLCP- appointed expert at RFT; b) Slit skin smear and c) Molecular based tests to score for the presence of live bacteria are advisable and doable.
§ Paramedical workers should be trained and encouraged to carry out nerve function assessments.
§ Nerve function impairment (NFI) assessment should be conducted and recorded at regular intervals, pre as well as post RFT.
§ Early detection of NFI and anti-inflammatory drug treatment with proven benefits should be part of standard treatment guideline as part of Prevention of disability.
§ All the patients with residual NFI should be identified as a high- risk group in a long term Deformity Prevention and Medical Rehabilitation (DPMR) plan.
§ At RFT all the patients should be screened for co-morbidities such as diabetes, hypertension, latent tuberculosis, cataract, alcoholism etc.
§ The Leprosy Referral Centers (LRCs) must have trained personal to provide quality care and treatment for reaction, neuritis, plantar ulcers, other disability management and laboratory facility for biochemical and micro-biological investigations. A system with guidelines should be in place for upward/ downward referrals.
§ Every patient could be given a health card with appropriate guidelines for DPMR
Above short- comings need priority redressal failing which, the community will be faced with an even increasing numbers of patients with gross morbidities and reduced quality of life.
Speaking for ourselves.
Regards,
Dr VP Shetty, Dr S.S. Pandya, Dr N.F. Mistry.
Correspondence: Dr VP Shetty
The Foundation for Medical Research
84A, R.G.Thadani Marg
Worli, Mumbai 400 018, INDIA
Tel : +91 22 24934989 / 24938601
Fax: +91 22 24932876
E-mail: fmr@fmrindia.org / fmrmum@gmail.com
Website: www.fmrindia.org
References:
1) Chemotherapy of Leprosy for Control Programmes; report of a WHO study group. Geneva, World Health Organization, 1982 WHO technical report series, No. 675 1982
2) A guide to Eliminating Leprosy as public health problem. Action plan for the Elimination of leprosy, WHO Geneva 1995
3) www.who. int/lep/mdt/duration/ en/index1. html )
4) ILEP Technical Commission discussion document. A review of evidence on MB relapse rate after MDT 2005.
5) WHO 2014 global leprosy update 2013, reducing disease burden. Weekly epidemiological record 89: 389-400
6) SR Atre, SG Rangan, VP Shetty, et al. Perceptions, Health seeking Behavior and access to diagnosis and treatment initiation, Leprosy Review, 82: 2011; 222-234
7) VP Shetty, Shubhada Pandya, Swaran Kamble et al. Post RFT deleterious events including relapse over period of three years in 577 leprosy patients in western Maharashtra. Indian Journal of Leprosy 2017 (submitted/under review)
8) Croft RP et al The treatment of acute nerve function impairment in leprosy: results from a prospective cohort study in Bangladesh .Lepr Rev.2000. 71 (2): 25-33
9) NLEP (2012) Disability Prevention and Medical rehabilitation: Guidelines for Primary, Secondary and Tertiary level care. National Leprosy Eradication Programme. New Delhi: Central Leprosy Division, Directorate General of Health Services. Available from: http://nlep.nic.in/pdf/Guidelines [Last accessed on 2017 May 3]
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