Leprosy in post-elimination era in India: difficult journey ahead.

Leprosy is a chronic inflammatory disease of skin and peripheral nerves. Elimination of leprosy as a public health problem was reached at the global level in the year 2000 and by India on 31(st) December, 2005. Thereafter, leprosy services in India have been integrated with General Health-Care System resulting in reduced focus and funds. Sustaining the gains made so far in controlling leprosy is a big challenge and there is no time for complacency. Pockets of high endemicity with prevalence rate of > 1 still exist in many states. Our data from a tertiary care center indicates poor epidemiological control and ongoing disease transmission. To combat this, dermatologists all over India should continue to play a central role in capacity building and training of undergraduate and post-graduate students, medical officers, and field workers.

What was known?

India achieved statistical elimination of leprosy on 31st December, 2005 as a public health problem with a national prevalence rate of 0.96. As a result, leprosy services have been integrated with the General Health-Care System from the erstwhile vertical system.

Introduction

Leprosy, a chronic inflammatory mycobacterial disease chiefly involving skin and peripheral nerves and occasionally other organ systems, has afflicted mankind since time immemorial. It is almost world-wide in distribution, though certain countries have higher prevalence of the disease such as India, Brazil, Nepal, Myanmar, Indonesia, and Bangladesh.

The goal of elimination of leprosy as a public health problem as defined by the World Health Assembly i.e., attaining a level of prevalence of less than one case per 10,000 population, was reached at the global level in the year 2000.[1] This was followed by the “Strategic Plan for Leprosy Elimination 2000-2005” and the “Global Strategy for Further Reducing the Leprosy Burden and Sustaining Leprosy Control Activities 2006-2010” with the main intention of ensuring program sustainability by reducing reliance on vertical infrastructure and promoting integration within the General Health-Care System (GHS). The “Enhanced global strategy for further reducing the disease burden due to Leprosy: 2011-2015” also focuses on sustaining the gains made so far.[1]

Post-elimination: No time for complacency

Though the number of newly detected patients globally has shown a continuous falling trend since the inception of leprosy elimination (further reported reduction of 6.6% from 2009 to 2010), we need to understand the limitations of interpretation of global figures. Lack of reporting from all countries, reliability of the data reported by the countries, and possibility of under-diagnosis need to be taken into account.[2] Seventeen countries reported more than 1,000 new cases in 2010 and these contribute to 94·4% of the global detection figures.[2]

Trend of epidemiological indicators

The proportion of cases with multibacillary (MB) leprosy among new cases remains high in many countries like Democratic Republic of Congo (72%), Indonesia (81%), Cuba (83%) and Kenya (99%).[3] The proportion of children among new cases of leprosy (an indicator of active transmission) also remains high (>20%) in countries like Liberia, Dominican Republic, Indonesia. In fact, it has shown increases of up to 5% in Nepal and Sudan in the past few years and continues to remain high in India.[34] The proportion of new cases with grade-2 disabilities (indicator of late detection) has shown high levels in Madagascar, Sudan, and China. It is also rising in nine of the 17 countries including India (from 2·2% in 2006 to 3·1% in 2010).[3]

Difficulties in sustainability

The global strategy (2006-2010) defines sustainability as the capacity of a program to maintain quality and coverage of services at a level that will provide continuing control and further reduction of a health problem at a cost that is affordable to the program and the community.[5] Sustainability is a common problem for all successful elimination and eradication programs which face a tough end game as the problem appears to get smaller, polio eradication being a good example.[6] With a shift from a well-supported, high priority specialized program to one integrated with GHS, leprosy elimination is also facing problems of sustainability. After elimination of leprosy as a public health problem, other diseases tend to become relatively more important for national health administrations with reduction in focus and funds for leprosy control.

Unlike other infections, the impact of control programs for leprosy is limited due to many factors. Owing to its long incubation period, individuals incubating the disease may already harbor many bacilli, and these individuals might have transmitted Mycobacterium leprae to others (especially house-hold contacts) long before their disease becomes clinically detectable. Other factors are carriage of infection in the nose, persistence of M. leprae in the soil and even in animal reservoirs.[7]

Indian scenario

India shares more than half of the total global leprosy burden till date. Of the total 219075 new leprosy cases detected world-wide in 2011, India contributed to 58.1% of the global disease burden. The National Leprosy Eradication Program (NLEP) was launched in 1983 with the World Health Organization (WHO) goal of eliminating the disease by 2000. Through a series of aggressive NLEP activities, Government of India declared elimination of leprosy on 31st December, 2005 as a public health problem with a national prevalence rate (PR) of 0.96. A total of 1.27 lakh new cases were detected during the year 2011-2012, which gives a marginal reduction (1.24%) of Annual New Case Detection Rate from 10.48/100,000 population in 2010-11 to 10.35/100,000 population in 2011-12.[8] A total of 0.83 lakh cases were on record as on 1st April 2012, giving a PR of 0.68/10,000 population. One state (Chhattisgarh) and one U.T. (Dadra and Nagar Haveli) still have PR between 1/10,000 and 3/10,000 populations, as per NLEP monthly progress report for the year 2011-2012. The state of Manipur has the least PR (0.06/10,000).

Out of total 642 districts in India, 543 have declared leprosy elimination by March 2012.[8] Seventy two districts have prevalence of 1-2 and 27 have PR between 2 and 5.[8] Only single district of New Delhi from capital of India, has recorded PR between 5/10,000 and 10/10,000 population.

As a consequence of attaining this important milestone, leprosy services were integrated with the GHS from the erstwhile vertical system. However, pockets of high endemicity are still prevalent in few states. The present aim is to achieve elimination of leprosy at district level during the 12th Plan (2012-2017).

Our experience

Analysis from database of leprosy patients registered at our Leprosy Clinic (Guru Teg Bahadur Hospital and associated University College of Medical Sciences, Delhi). has revealed important facts [Table 1]. This institution is a tertiary-care teaching hospital catering to a large population of north-east district of Delhi including the native population as well as a large number of migrants from adjoining states of Uttar Pradesh, Uttarakhand, Bihar and Haryana.

Table 1

Important parameters of leprosy patients over a decade (2002-11)

Proportion of MB cases: It is clear that there is an increasing trend towards MB leprosy in past one decade, such patients being more likely to present with deformities

Presentation with deformities: 37% patients had grade-2 deformities at the time of presentation in the past 5 years

Lepra reactions: We noticed high incidence of patients presenting with reactions at the time of diagnosis (34.9%) or following multi-drug therapy MDT. In our experience, the standard WHO guidelines on the use of steroids for management of leprosy reactions seem to be oversimplified and are not effective in a significant proportion of our patients. They either need prolonged courses of steroids, or additional/alternative immunosuppressant. The dose and total duration of steroid and/or immunosuppressant treatment was variable. In our experience, thalidomide, though not recommended by WHO is an effective treatment for severe type II reactions

Childhood proportion: It has remained consistent within the range of 8-10%. As an indicator of recent transmission of the disease, a persistently high childhood proportion signifies ongoing transmission in general population.

The high MB proportion, proportion of new cases with grade-2 deformity, and childhood ratio are clearly indicating ongoing leprosy transmission in the population even in the post-elimination phase. Lepra reactions not only result in increased morbidity, but are also a known cause of defaulting from treatment.

Problems of integration of leprosy control activities with GHS

Integration of leprosy control activities with GHS has its own problems. Variations in health and socio-economic situations across states in India influence its implementation. Results from a follow-up operational research study from India undertaken in 2006-2007 to assess the level of integration on leprosy services established wide variations across the provinces.[9] Low training levels of medical officers and lower training levels of multi-purpose workers compared with previous years reported in the study is a cause for concern. This may be due to a lower resource allocation for leprosy in favor of other emerging, and more important health issues.

While integration of leprosy control with GHS is resulting in attainment of the program's needs, needs of the patients are not fulfilled as some cases are not being able to be picked up by the General Health Services Medical Officers. Such left out patients, if MB may be a cause of problem in the future. The Peripheral Health Center (PHC) Medical Officers should be able to suspect leprosy in such cases, but should refer them to the district hospital where a dermatologist or medical specialist with expertise in handling such cases can examine and manage them.

Importance and lacunae in training of personnel

In the context of a declining disease burden, capacity development becomes important due to declining clinical expertise in leprosy.[10] Adequate training of staff, an effective referral network, and supportive supervision are essential for timely and effective diagnosis and treatment of the disease and its complications. In the post-integration phase, leprosy is taking a back seat due to passing on the baton of managing the disease to general physicians, who have other “important” diseases to cater to.[11] However, dermatologists, due to their more experience, awareness, and vigilance about leprosy and management of its complications would always remain engaged as an essential link in continuing leprosy control activities.

The contribution of dermatologists in the success of leprosy elimination is well-recognized, but their continuing role in sustenance of gains in the “post-elimination era” needs to be emphasized upon. Dermatologists would continue to play an indispensable role in the current setting by:

Acting as a “safety-net” for patients “missed” by other health services

Providing technical support to referral and support services in leprosy management

Managing of lepra reactions and other complications

Teaching and training of health service staff about leprosy detection, treatment and referral system for more efficient management at peripheral level.

Leprosy is an integral component of post-graduate dermatology training program and participation in the NLEP by all teaching institutes is mandatory for the approval of the course by Medical Council of India (MCI). Exclusive MD course in Leprosy was available only in two southern states and doesn’t exist anymore. India has 355 MCI approved medical colleges, of which 178 run MD course in Dermatology, Venereology, and Leprosy of 3 years training duration and offer 453 seats annually. Of these 178 departments, 72 are awaiting MCI recognition for 145 seats. In addition, 84 colleges offer 132 diploma seats of 2 years training duration.[12] Of the many challenges facing leprosy elimination, the struggle to maintain the pool of the most skilled leprosy workers, i.e., the dermatologists is most important. Ironically, number of medical institutes in the 16 states with areas of PR > 1 are 100, that produce 142 qualified dermatologists each year. This may lead to compromised leprosy care enforcing patients to rush to metropolitan cities around like Delhi, Mumbai, Kolkata, etc., for their disease management. Delhi acts as a major catchment area for migrant population especially, from Bihar, Haryana, Uttar Pradesh, Uttarakhand, Chhattisgarh, and Jharkhand. Poor socio-economic status, limited job opportunities coupled with inevitable difficulties encountered to sustain day to day life here results in migration of these patients back to their home town abandoning treatment midway. This leads to poor treatment compliance, high drop-out rate raising defaulter rates and possible emergence of drug resistance.

Dermatologists are generally the points of first contact for a patient of leprosy with skin lesions. Opinion of the dermatologists in policymaking, training health workers, developing training curricula, and methodology, research, testing efficacy of newer drug/regimens, management of reactions, and their complications, has been considered important in the past and will continue to be so in the future.[13]

Role of private dermatologists

More than 70% of primary health delivery in India is by private health providers. Rapid urbanization and migration of the rural population to urban and semi-urban areas is further increasing demands on private health sectors. As is the trend worldwide, a significant number of dermatologists in India are urban based, working in private sector hospitals or their own clinics. Similar to the strategy adopted in the Directly Observed Treatment, Short course (DOTS) program for tuberculosis, Public–Private Partnership Initiatives enhance detection and treatment of new cases of leprosy from the private sector. The participation of dermatologists in private sector has been significant in leprosy diagnosis and management. Government of India arranged orientation program and provided MDT blisters and technical assistance to the private practitioners through Indian Medical Association in the year 2004-05.[1415] Bombay Leprosy Project, a Non-Government Organization in Mumbai, through Indian Association of Dermatologists, Venereologists, and Leprologists has been promoting orientation and motivation of dermatologists both from the medical colleges and private sectors for more than three decades now.[16] Dermatologists in private sector do contribute to the qualitative care in dealing with the remaining leprosy problem, though, concerns exist about the knowledge of private dermatologists in prescribing proper, uniform, and latest drug regimens. Latter is taken care by organizing sessions for regular updates in the field of leprosy during zonal, regional, and national conferences. In addition, they may be provided with latest guidelines and strategies of the program from district and state leprosy officers.

Conclusions

Though, the burden of leprosy is declining globally, efforts to sustain the current decline in endemic countries like India, by national leprosy programs along with continued support from international partners, is the need of the hour and there is no scope for complacency.

The enhanced global strategy emphasizes reducing grade-2 disabilities among new cases; thus, it is important that cases are detected early and treated effectively to attain cure with a complete course of MDT and management of complications. To achieve this, in addition to building the medical task force and strengthening the existing one, increased community awareness utilizing Information, Education and Communication (IEC) activities at all levels and in all states with more emphasis on endemic states should be launched. The message should be in local language to be more effective. In addition, issues relating to stigma, discrimination and rehabilitation need to be tackled in a more integrated and inclusive manner to realize the dream of leprosy-free India.

What is new?

Pockets of high endemicity are still prevalent in few states in India. Out of total 642 districts, 99 districts in 16 states have PR of > 1 indicating ongoing disease transmission. Dermatologists all across the country should try to consolidate the achievements made so far by building the medical task force and strengthening the existing one.