Supervised monthly doses of rifampicin-ofloxacin-minocycline (ROM)...........Rifampicin to be swallowed in front of a health worker (best on an empty stomach or at least 2 h after a meal; a total of 6 doses [6 months]) Ofloxacin to be swallowed in clinic once monthly – 6 doses Minocycline to be swallowed in clinic once monthly – 6 doses Dapsone once daily for 6 months. This treatment is likely to work even if the patient fails to take the daily doses of dapsone. More than three skin patches (MB) or if the skin smear was positive (if there are more than three patches, give this treatment even if the skin smear was negative): Give the same treatment as mentioned above, but also give clofazimine monthly to be swallowed in the clinic and a daily clofazimine dose as in

Suggested protocol for the management of leprosy by primary health-care clinicians

Rajkumar Ramasamy
KC Patty Primary Health Centre, Kodaikanal, Tamil Nadu, India

Date of Web Publication

16-Jul-2019

Correspondence Address:

Dr. Rajkumar Ramasamy
KC Patty Primary Health Centre, Kodaikanal, Tamil Nadu,
India

Source of Support: None, Conflict of Interest: None

Abstract

The new WHO guideline for the management of leprosy may not address all the grass roots realities of treating and preventing leprosy effectively in India. I suggest the addition of supervised doses of ROM as a part of addressing these problems.

Keywords: Primary care management of leprosy, rifampicin-ofloxacin-minocycline, WHO standard treatment

How to cite this article: Ramasamy R. Suggested protocol for the management of leprosy by primary health-care clinicians. Curr Med Issues 2019;17:6-9

How to cite this URL: Ramasamy R. Suggested protocol for the management of leprosy by primary health-care clinicians. Curr Med Issues [serial online] 2019 [cited 2019 Jul 17];17:6-9. Available from: http://www.cmijournal.org/text.asp?2019/17/1/6/262825

Case Histories

1. A 38-year-old Adivasi man living in a remote village presented with clinical features of multibacillary (MB) leprosy confirmed by split skin smear examination in the field, which showed a high bacillary index (BI) and morphology index (MI). He was started on the WHO MB treatment (MBT) and monthly supervised doses of ofloxacin and minocycline in addition to his monthly supervised rifampicin already in the WHO MBT pack (rifampicin-ofloxacin-minocycline [ROM] treatment). He was erratic in collecting the medications which sometimes had to be delivered as far as possible in his village by health workers. After 6 months of treatment, he felt “God had healed him” and refused the WHO treatment but continued the ROM another 2 months and defaulted refusing treatment altogether. Six years later, an opportunistic split skin smear examination taken in his village was negative. Evidently, his belief that God had healed him was correct although we would feel that God worked through ROM
2. A 40 year old Adivasi man was diagnosed to have MB disease with a high BI and MI on split skin smear examination. He lived in a remote village and was struggling to bring up his 3 daughters and son. He was started on WHO MBT and supervised monthly doses of ROM. Personal difficulties made it hard for him to be regular collecting his medications and he needed repeated home visits by the primary care team to encourage him. Over 2 years he collected a total of 14 months treatment eventually having skin smears with BI and zero MI when treatment was stopped. His family were screened and one teenage daughter needed treatment for PB leprosy. The other children were given 3 doses of ROM as prophylaxis.

Introduction

Leprosy is much less common than before, but new cases of leprosy including multibacillary (MB) and more contagious forms of it will continue to do occur because of the very long latent period of this disease.

With dismantling of many leprosy control programs, leprologists and dermatologists experienced in the management of leprosy, and health workers specializing in leprosy have become fewer especially in rural areas. Most patients with early lesions of leprosy will present to family physicians usually without realizing the nature of the illness they have. The recognition of early lesions, especially the paucibacillary (PB) forms, remains primarily a clinical diagnosis and is within the scope of well-trained family physicians who must be at the forefront of controlling this disease today. They will often have to do so without the support of leprosy program health workers who helped compliance with treatment in the past.

The WHO have had a guideline for the management of leprosy,^[1] and there is a proposal to introduce a new protocol.^[2] The use of supervised monthly doses of rifampicin-ofloxacin-minocycline (ROM) has been available as a treatment option for leprosy for years, and the efficacy of ROM and its safety have been tested in many studies.^[3],[4] Nevertheless, the WHO still has no clear role for it except recommending it as a single-dose option in those with a single skin lesion in the current protocol and apparently no mention of it in the proposed new protocol.

We believe that in primary health-care, the addition of ROM to MB treatment can play a crucial insuring role in the treatment of leprosy for the following reasons:

• It presents a practical way to give supervised pulse doses through planned or opportunistic contact to reluctant patients on treatment
• The diagnoses and classification of leprosy especially based on the recognition of the number of skin lesions present are practically often difficult. The number of microbiologists able to reliably interpret skin smears is becoming less common. Therefore, it is quite possible for MB leprosy to be classified as PB leprosy. Combination treatment offers better chances of curing these patients
• Default from treatment completion is high all over the world,^[5] and there is no clear definition in the WHO protocol of who defaulters are and what action should be taken in modifying treatment for defaulters in existing protocols. Combination treatment offers better chances of treating defaulters more effectively
• The new WHO proposed protocol for the prophylactic treatment of close contacts of those with MB leprosy patients suggests that those living and eating in the same household of MB cases for >6 months should receive a single dose of rifampicin which will reduce the incidence of later leprosy in contacts given this treatment by 57%. However, since the risk of disease in close contacts of leprosy is possibly even up to 5.5% a year in the initial stages,^[6] the reduction of 57% is unacceptably low. This fact is even more important given that leprosy symptoms and signs may occur many years later when a grown-up child contact may well have forgotten the disease of the index case. The aggressive treatment of close contacts with ROM is essential for the eradication of this disease
• In addition, the reliance on a single dose of ROM for PB disease in the existing protocol is dangerous especially when drug supplies are erratic and quality and storage uncertain and doses can be miscalculated. Further vomiting of odd doses of ROM medications is not uncommon after swallowing the drugs observed.

It appears that the reliance on the WHO Standard MB Leprosy Treatment in India is partly because these packs are given free by the WHO. However, the addition of ROM as a safeguard will only add about Rs. 150 per month and is a relatively negligible cost.

The management guidelines for leprosy developed over the years in KC Patty Primary Health Center (KCPPHC) covering remote villages in the lower Kodaikanal hills of Tamil Nadu attempts to address these factors. It combines the current WHO recommended treatment with ROM to ensure that those diagnosed as likely to have leprosy receive the most effective treatment that considers practical problems in the field. It is presented as an attempt to stimulate discussion and device recommendations that lead to a pragmatic protocol for the management of leprosy for primary-care physicians at the forefront of managing leprosy.

KC Patty Primary Health Center: Leprosy Management Protocol for Health Workers and Medical Staff

This protocol does not focus on the diagnosis of leprosy, but we would like to stress that:

• The best way to find leprosy early is to teach your target community using color pictures that any new patch on their skin which has been present more than 3 months can be leprosy. If they have such a lesion, they need to see a doctor. If it was leprosy, treating it at this stage will prevent later horrific deformities
• Look for skin lesions all over the body in good light and test for sensation properly. It usually will have reduced sensation and may have been present for months. A doctor should confirm the diagnosis. If you are not sure that a skin lesion is due to leprosy, then enter the name in a short-term follow-up register and recheck the patch for 3 months. Skin lesions suggestive of leprosy that remain after 3 months or those associated with nerve thickening are more likely to be due to leprosy
• If you think a person could have leprosy, then they need to be seen by a doctor and have skin smears sent to a reliable laboratory. However, if a doctor does not have access to a reliable laboratory or it is not possible to do a skin smear, do not delay treatment.

In KCPPHC, we use the standard WHO treatment combined with ROM treatment to ensure that the patient stands the best chance of cure even if they do not complete treatment.

1. If one or two leprosy skin lesions present (PB) and the skin smear (if done) is negative. Treat with [doses in [Table 1]:

Table 1: Drug doses Click here to view




• Rifampicin to be swallowed in front of a health worker (best on an empty stomach or at least 2 h after a meal; a total of 6 doses [6 months])
• Ofloxacin to be swallowed in clinic once monthly – 6 doses
• Minocycline to be swallowed in clinic once monthly – 6 doses
• Dapsone once daily for 6 months.


This treatment is likely to work even if the patient fails to take the daily doses of dapsone.


2. More than three skin patches (MB) or if the skin smear was positive (if there are more than three patches, give this treatment even if the skin smear was negative): Give the same treatment as mentioned above, but also give clofazimine monthly to be swallowed in the clinic and a daily clofazimine dose as in [Table 1].

This treatment is given for 12 months and sometimes for 24 months if a skin smear repeated at 12 months shows no improvement in the morphology index (MI). This treatment is also likely to work in an uncooperative patient who will not take the daily clofazimine or dapsone (Information for doctors – the skin smear need not show the absence of bacilli, i.e., bacillary index need not become zero at 12 months, because the clearance of dead bacilli in smears may take years despite effective treatment. In KCPPHC, we recommend that the treatment is continued 2 years only if the MI in smears at 1 year has not shown a marked improvement, but microbiologists able to give a reliable MI are becoming uncommon even in India).

Complications of treatment

If patients (especially the MB group) who are taking treatment get painful joints, weakness of hands or feet, or fever with increased rash, they may have a reaction to treatment. Refer them immediately to a specialist experienced in the management of leprosy. If there is a delay in referral, start prednisolone 40 mg/day in adults or 1 mg/kg/day in children and leprosy treatment should be continued. Patients who get these reactions on treatment may get discouraged and not take treatment. Encouragement and reassurance are needed that only with continued treatment, they can triumph over this disease.

Follow-up and patient/family education

Patients with leprosy should be put on the follow-up register. You need to explain to them what the disease is, what harm it can do, and that it can be cured. Please make sure that they understand how long treatment is needed. Family members and especially children must be screened for leprosy (refer treatment of close contacts). It is essential to find out what the family and patient's belief is about what causes leprosy and their feelings and fears about whether it can be cured. Start from where they are and help them believe that it is not due to any fault of their own and that it can be cured. This step is crucial to treatment success.

What if patients come late to collect leprosy drugs – Do you need to restart treatment from the beginning?

In the 6-month regimen for those who have one or two skin lesions or PB leprosy, even a single dose of ROM treatment may cure the disease, so there is no need to restart treatment from the beginning. In KCPPHC, we try to ensure that 6 months of total treatment is given eventually whatever the gaps between doses.

In those with more than three skin lesions or MB leprosy, treatment will need to be restarted for another 12 months if there is more than 3 months delay in the first 6 months of treatment. If there is <3 months delay or delay after the first 6 months is over, then continue with the treatment from where it was left off (There is no clear evidence to back these statements! [Even though the National Leprosy Eradication Program (NLEP)^[7] tries to address the issue, What to do in default needs to be addressed – this statement is based on the logic that in early default in MB leprosy at a time when the bacterial load is still high, default has more serious consequences]).

Those patients already having damaged nerves and loss of sensation must understand that the treatment will prevent new damage to nerves, but already damaged nerves will not recover fully. Limbs that cannot feel properly due to damaged nerves need protection.

• Wear correct footwear that protects their feet. Hawaii slippers are of no use
• Treat any wounds or ulcers early with a doctor or health worker's help
• Be careful when touching hot objects to not burn the hands
• If blinking is reduced due to damaged nerves around the eye, the eyes need protection from drying up – special eye drops (methyl cellulose) may be needed. Protect them from dust and dirt by wearing glasses and see a doctor immediately if eyes become red
• Severe nerve damage may need the help of specialist teams including physiotherapist and surgeons to whom referrals should be made wherever possible.

Managing contacts

Always screen the rest of the family for leprosy. Even if there are no signs of skin patches suggesting infection in other family members now, they could get signs years later. Tell them about checking their skin for early signs of leprosy every 3–6 months when bathing and to seek a doctor's help if any suspicious skin patches occur even years later. Use color pictures to show a variety of skin lesions of leprosy that they need to look out for.

In KCPPHC, all household contacts and especially children of those with MB leprosy patients should receive 3 months of ROM treatment (i.e., 3 supervised doses) even if they have no skin lesions. Household contacts are defined as any person who has lived with the leprosy patient for >6 months.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 

References

1.	World Health Organization. Model Prescribing Information: Drugs Used in Leprosy. World Health Organization; 1998. Available from: http://apps.who.int/medicinedocs/en/d/Jh2988e/5.html. [Last accessed on 2019 Jun 19].
2.	World Health Organization. Guidelines for the Diagnosis, Treatment and Prevention of Leprosy. Executive Summary. Available from: http://www.searo.who.int/entity/global_leprosy_programme/approved-guidelines-leprosy-executives-summary.pdf?ua=1. [Last accessed on 2019 Jun 19].
3.	Setia MS, Shinde SS, Jerajani HR, Boivin JF. Is there a role for rifampicin, ofloxacin and minocycline (ROM) therapy in the treatment of leprosy? Systematic review and meta-analysis. Trop Med Int Health 2011;16:1541-51.
4.	Kumar A, Girdhar A, Girdhar BK. A randomized controlled trial to compare cure and relapse rate of paucibacillary multidrug therapy with monthly rifampicin, ofloxacin, and minocycline among paucibacillary leprosy patients in Agra district, India. Indian J Dermatol Venereol Leprol 2015;81:356-62.   [PUBMED]  [Full text]
5.	Kumar A, Girdhar A, Chakma JK, Girdhar BK. WHO multidrug therapy for leprosy: Epidemiology of default in treatment in Agra district, Uttar Pradesh, India. Biomed Res Int 2015;2015:705804.
6.	World Health Organization. Transmission of Leprosy. Available from: http://www.who.int/lep/transmission/en/index4.html. [Last accessed on 2019 Jun 19].
7.	National Leprosy Eradication Program: Classification and Management of Leprosy. Ch. 7. Available from: http://nlep.nic.in/pdf/Leprosy%20manual.pdf. [Last accessed on 2019 Jun 19].

Drug doses