NACO has recognised the critical importance of providing opioid substitution therapy (OST) — both for prevention and to improve adherence to treatment. According to the country’s ART guidelines, “OST is the most effective treatment for opioid dependence, and results in substantially higher retention rates, suppression of drug use and improved psychosocial functioning. Its use in the context of HIV treatment has been associated with improved adherence to and outcomes of treatment. Detoxification and abstinence-based programmes are unlikely to achieve similar levels of clinical effectiveness and may prove counterproductive in the context of ART. If possible, stabilization of substance use with substitution treatment is recommended prior to the commencement of ART.”33
A buprenorphone-based system
But scale-up has been slow, especially considering that the first substitution therapy pilots, using buprenorphine, were launched in 1997.34 During the next ten years, access to OST was increasingly offered by CBO/NGO’s working with IDUs — but a little over a year ago, NACO took on OST as a national programme. At present, however, OST is still based on buprenorphine — methadone is not yet available.
“At the time when our proposal for OST was passed by all of the ministries, when it got the clearance from the Expenditure Finance Committee — in June 2008 — methadone had not yet been approved by the government,” said Ms Khumukcham. “Plus, we had experience with buprenorphine, so we started with that.”
Indian guidance on delivering OST services
The TI guidelines list some of the basic steps required to set up an OST site, but NACO has also published separate, more detailed guidelines on delivering OST. These deal with how to assess clients, staffing requirements, how to administer the drug and provide follow-up. The guidelines include standardised intake forms, consent forms, prescription forms, a checklist for side-effects, and referral forms.
There are also standardised forms to keep track of the medication, with a simple client dose sheet, a dispensing register and daily stock register to be maintained by the nurse, and a central stock register kept by the project coordinator noting when stock comes in and when he gives it to the nurse. The guidelines note that there needs to be “storage space for drugs, e.g., cupboard for OST, STI drugs, and other material,” but do not demand secure vaults and alarm systems as in some countries.
However, not all of the NGOs that were dispensing OST when NACO took over the programme have been able to continue. Previously about 63 sites were distributing OST to 6000 clients, but after government inspection only 47 were accredited. This has since increased to 50 delivering OST to 4800 clients but is well below the 40,000 target for the end of 2012.
Challenges in scaling up OST in India
“The issue is: can we scale it up?” said Dr Neeraj Dhingra, the Assistant Director General of NACO. “To scale it up more quickly, can we engage the many government hospitals which are already acting as de-addiction centres?”
There are several hundred centres run by the MoSJ and the Ministry of Health in India, offering detoxification, de-addiction and rehabilitation, but these abstinence-oriented services are underfunded, and the services they offer are minimal.35
There are referral linkages between OST sites and de-addiction centres — in fact, the stated goal of OST in India is to wean people off drugs within a year. It is not clear how strictly the programme will insist on this — according to Mr Gasper, complete abstinence is rarely achieved quickly, and when it is, "it is usually followed by a relapse shortly afterwards then we have to start all over again at a higher dose.”
Another concern is that treatment of the drug user can be poor at some ‘detox and de-addiction’ sites.
“So many drug users have been put in inhuman conditions i.e. they are chained, beaten up. And in fact we have filed a case against one of the detox centres in Punjab because of the death of a drug user,” said Ms Singh. “The other thing is that this only works when you have the involvement of drug users in the programme. Even if they put OST into government facilities they are going to have to factor in the community somehow. Only the community can draw these people in for services. Nobody else can.”
“We have been struggling with whether this government facility will be able to give OST respecting the client's privacy, with the good attitude and the type of services that are at the [Targeted Intervention],” said Dr Dhingra. “So we have planned a feasibility study first — we would like to see how many of the government institutions, which are in proximity to the IDUs, can really take it on.”
Some outside experts believe that if the programme started using methadone — and a pilot is being planned — NACO would be able to scale up OST more rapidly. But not everyone in India is convinced. One issue is that NGOs have a proven track record delivering buprenorphine but there is perception that methadone will be more complicated for them to deliver.
“We have quite a lot of people on a waiting list. The supply of buprenorphine is not the problem. Ever since the government has taken over the procurement of buprenorphine, the centres are flooded with medicine. But what is not in place and what is not there is the money or the funds to run the OST sites,” said Shalini Singh, who works for Sharan, the first NGO to provide OST. “The challenge is getting the qualified staff - say, nurses or doctors. Doctors are so poorly paid — and the prime time for a medical doctor to earn is the morning time. That’s when you require the doctor’s presence at the drop-in centre. And when you have such a low budget, you can’t get them.”
Workers at the OST sites visited for this report, agreed that the chief barriers for CBOs scaling up OST were the staffing requirements — particularly the difficulty recruiting qualified staff at the low rates the government is paying — and the need to set up drop-in centres convenient to IDUs, who are often in other districts.
“We have 100 clients on OST, and probably provide OST to another 100 clients in Chennai,” said Mr Gasper. “The problem is the distance. Access to a drop-in centre should be one to two kilometres so they can walk to it. If we could set up a drop-in centre like this in south side or in central Chennai, more IDUs will have access to services. Travelling is the problem — from there to here, they have to spend 20 to 25 rupees a day. For that money they can go for one shot of heroin.”
The debate over methadone-based OST
Ms Singh acknowledged methadone might be cheaper than buprenorphine, but that it comes with other costs. “Methadone requires more monitoring, buprenorphine is an easier, safer drug, that doesn’t have such significant interactions with ART and rifabutin. And leading advocates who are drug users in other countries prefer to take buprenorphine themselves — people need to listen to what the drug users want.”
Rifampicin, a key drug used in TB treatment, reduces methadone levels. Efavirenz, nevirapine and some of the protease inhibitors may also reduce methadone levels, and rifampicin also reduces levels of nevirapine and protease inhibitors, leading to the recommendation that efavirenz is the preferred third agent in antiretroviral therapy for TB patients.
WHO's 2006 antiretroviral treatment guidelines recommended that if an NNRTI is being used in combination with methadone, the methadone dose should be increased by 5-10mg every 1-2 days in a step-wise fashion until withdrawal symptoms cease, with methadone dosage adjustment likely to be required seven days after starting ART.
This complex web of potential drug interactions in patients with TB/HIV coinfection, which requires close monitoring of opiate withdrawal symptoms in OST patients and prompt dose adjustment by clinicians with a good understanding of the drug interactions, is difficult to manage in any setting, especially where patients have a long journey to a clinic. The response to withdrawal symptoms in this situation is more likely to be an attempt to self-manage by resuming injecting drug use.
Buphrenorphine has no clinically significant interactions with NNRTIs, but levels may be reduced by rifampicin, requiring a dose adjustment if opiate withdrawal symptoms occur.
As an alternative, rifabutin can be used instead of rifampicin, since this drug does not reduce methadone levels.
NACO also has concerns with safety— and whether India’s drug control agencies will insist on prohibitively restrictive control of the drug.
“If the dosage is not properly regulated in methadone it can create problems. If there is even one problem, it could just destroy the whole OST programme. We need to be very careful of that,” said Dr Dhingra. “The second issue is: are our NGOs capable of giving methadone without secure dispensaries? If they can, we will do it with the best ones that we have got. But we need to be very sure what systems and what procedures need to be set in place for methadone. My gut feeling is that, if buprenorphine is giving the desired effect, why do we want to waste our time in setting up another system?
"It takes time for us to set up in India – it’s a huge country. With buprenorphine we’ve already institutionalised a system. It's one thing if we find methadone can be easily incorporated into the existing without major changes. But if you ask me to change that whole system, I’ll do it only if I’m convinced that methadone has much stronger beneficial effects than buprenorphine.”