Challenges in the scale-up of opioid substitution treatment in India

Abstract

Opioids are one of the best known analgesics and euphoriants known to humankind. Their widespread use globally for such purposes has also led to opioids topping the list of “problem drugs.” In India, opium and its variants have been cultivated and used as household remedies, in medicinal preparations and as intoxicants for centuries. Advent of high potency, synthetic opioid preparations like heroin however, has changed the scenario drastically. Especially in the Northern and Northeastern parts of the country, the opioid use epidemic is well-established and opioid use disorders are among the commonest illicit-drug-related conditions, bringing patients to health care providers. Use of injectable opioids has added yet another grave dimension in the harms caused by opioids. In India, almost all injecting drug users (IDUs) are opioid dependent[1] and the prevalence of HIV among this group is the highest (more than 9%) among all the high risk groups.[2] For addiction treatment professionals, opioid use disorders present certain unique challenges. Short-term, stand-alone treatment of acute withdrawal symptoms (or “detoxification”) is almost invariably associated with relapse to opioid use.[3 4] Consequently most patients require a long-term, combined psychosocial and pharmacological approach for treatment. Two distinct approaches exist for the long term pharmacological treatment (1) agonist maintenance treatment or opioid substitution treatment (OST) and (2) antagonist treatment. The latter, involves long-term maintenance of opioid-dependent patients on an antagonist like naltrexone. This traditional approach is marred by poor evidence of its effectiveness. Naltrexone maintenance has been found to work in only a select sub-population of opioid dependence patients, mainly on account of poor compliance and retention in treatment.[5] As a consequence, and with emergence of stronger evidence-base, agonist treatment or OST, is now the universally accepted treatment modality. Consequently, most treatment guidelines, including those of the Indian Psychiatric Society (IPS), recommend OST as the preferable option for long-term pharmacological treatment of opioid dependence.[6] Globally, the most common treatment agents used for OST are methadone and buprenorphine. Methadone, as the agonist treatment option has existed for many decades and is widely used in many countries around the world, as compared to buprenorphine.[7] Curiously, in India, it is buprenorphine which has been available as an analgesic and maintenance agent for OST for a very long time while methadone has been introduced only recently.[8] Despite being available for around three decades, use of buprenorphine as OST has remained low in India. In this article, we discuss the reasons behind this and recommend certain steps, which would help in scaling-up this most evidence-based and effective treatment for opioid dependence in India. OPIOID SUBSTITUTION TREATMENT IN INDIA: EXISTING SITUATION Buprenorphine was launched as an analgesic in the late 1980s. Soon after the emergence of evidence regarding its effectiveness in international literature,[9] some academic institutes as well as nongovernmental organizations (NGOs) started using the low-strength, sublingual buprenorphine tablets for treatment of opioid dependence. Use of buprenorphine got a further boost in India with the launch of higher strength (2 mg) tablets in 1999 and subsequently launch of buprenorphine and naloxone fixed dose combination (FDC) in 2004–2005. A big turning point however, was inclusion of OST as one of the components of National AIDS Control Programme (NACP) in 2007. Since then, the National AIDS Control Organization has been scaling-up OST in the country as a measure to prevent HIV/AIDS. There are currently around 140-odd facilities providing free-of-cost buprenorphine tablets (only as daily observed treatment) to thousands of IDUs. Outside the AIDS program however, it is difficult to reliably estimate the extent of coverage of this intervention. Certain academic institutions have been implementing OST and gathering and disseminating their clinical and research experience, encouraging others to adopt this practice.[10 11 12] However, by all accounts, very few health facilities in India – either in the government sector or private – provide this treatment. The situation in Punjab provides an illustrative example of the poor penetration of OST. While it has been perceived (without any structured data) that a large number of psychiatric facilities in the private sector in Punjab provide OST to their patients using buprenorphine – naloxone, epidemiological data paint a different picture. As per the “Punjab Opioid Dependence Survey,” only about 15% of opioid dependent people in the state have received any form of medical treatment “ever” (including OST).[13] Indeed, a number of publications have been highlighting the inadequate coverage of OST in India.[7 8 14] SCALE-UP OF OPIOID SUBSTITUTION TREATMENT: CHALLENGES RELATED TO SERVICE PROVIDERS It is a widely accepted fact that availability of human resources for mental health care is pathetically low in India.[15] This shortage of trained professionals is even graver for the addiction treatment sector. In addition, even among the specialists (like psychiatrists) the exposure to OST during the training phase is grossly inadequate. This is not surprising, since very few teaching institutes offer this treatment and hence there are hardly any opportunities for the trainee psychiatrists to gain knowledge and skills on OST. The problem is further compounded by an attitude of looking at OST as “just substituting one addiction for another” – displayed unfortunately by some members of the psychiatric fraternity. It is also a misconception that only psychiatrists can deliver OST. The clinical and program-implementation experience in India is a testimony to the fact that even the nonspecialist physicians can be effectively trained to deliver OST.[16] Thus, one of the most formidable challenges in the country is related to inadequate number of professionals and inadequate capacities of existing professionals. SCALE UP OF OPIOID SUBSTITUTION TREATMENT: CHALLENGES RELATED TO LEGAL AND POLICY FRAMEWORK Medications used for OST can themselves be addictive. Consequently, world-over, including in India, their procurement, storage, trade and dispensing needs to be, and are, highly regulated. Of the two commonly used medications for OST – methadone and buprenorphine – the former (being a pure agonist at opioid receptors) has been categorized as a “narcotic” in the international regulatory framework. Buprenorphine on the other hand (being a partial agonist) has been placed in the list of “psychotropics” and thus is subject to less stringent regulations. Similarly, under the Indian regulatory framework, buprenorphine has been labeled as a psychotropic in the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. In addition, being a pharmaceutical product, it is also subject to regulations under the Drugs and Cosmetics Act, 1940 and Rules (1945). However, the FDC of buprenorphine-naloxone adds another layer of complexity to the regulatory framework. The Drug Controller of India had initially imposed a condition that these tablets be supplied only to certain specific facilities (in effect, “de-addiction centres” supported or authorized by the government). Unfortunately, the phrase “de-addiction centre” has not been adequately defined. In addition, the legal position of this additional condition imposed by the Drug Controller also remains doubtful. Involvement of a large number of enforcement agencies with little inter-department coordination, adds to the complexity. The complex regulatory regime has ensured that it is very difficult for health care providers (including psychiatrists) to procure, stock and dispense buprenorphine to their patients. These troublesome and sometimes contrary positions of regulatory authorities and service providers has led to some psychiatrists in Punjab being arrested and jailed for charges of stocking and dispensing buprenorphine.[17 18] While the cases remain sub-judice, it is worth noting that the existing legal and policy environment in India is not conducive to provide OST to the large population of untreated opioid dependent patients. Although one of the driving motives of legislation has been to prevent the illegal diversion of pharmaceutical opioids from the legal market, the present regulations have only led to the inadequate provision of treatment for needy patients.[19] The same legal and policy framework however, appears to be much less stringent for methadone, a pure opioid agonist, narcotic medication. The recent amendment to the NDPS Act (2014) has placed methadone in the category of “Essential Narcotic Drug,” paving the way for its smoother and easier availability with almost any registered physician choosing to provide it.[20] While such legal and policy reforms should be welcomed from an addiction treatment perspective, it appears strange that a pure agonist opioid is being subjected to much simpler regulations (aimed at promoting its wider and easier availability), while a safer partial agonist (buprenorphine) with documented effectiveness and safety in India has been placed under such stringent regulations. THE ROAD AHEAD India has a large number of people with opioid dependence, many of whom would need long term pharmacological treatment with agonists. As a signatory to the three UN Conventions and as enshrined in the NDPS Act (1985), the government needs to fulfill its commitment to curb the illicit use of drugs and at the same time make the relevant narcotic and psychotropic drugs available for legitimate medical and scientific use. To this end, we propose the following recommendations. 1. Enhancing the capacities of health professionals Professional associations (like the IPS) are mandated to assist and guide their members in providing evidence-based and effective treatments. At the same time, these societies are also expected to be a collective voice of its members when they are seen as being treated unfairly by the drug control/other enforcement authorities. It is high time that professional associations of psychiatrists in India take a lead in building capacities of their members on OST through designing and implementing professional development courses/training programmes. Indeed, creation of the Task Force on OST jointly by the IPS and Indian Association of Private Psychiatry (IAPP) on this issue is a welcome step. The document produced by this task force “OST using Buprenorphine: IPS-IAPP Task Force recommendations…” could prove to be a useful advocacy tool. For conducting training on OST, there are a number of experienced academic institutions in India which could be engaged. Besides conventional, in-person training programs, innovative use of information technology could make such initiatives reach a large number of participants very effectively. Some early initiatives such as the Virtual Knowledge Network of NIMHANS, Bengaluru[21] or the AIIMS-PHFI online OST Training Program[22] appear very promising. If such training programmes are accredited by the relevant authorities, these could also fulfil the procedural requirement for eligibility to provide OST. Since medications used for OST possess abuse liability and are regulated, it is imperative to have in place mechanisms to ensure their safe storage, dispensing and monitoring. There are models of “Standard Operating Procedures” and “Quality Assurance” mechanisms for OST developed under the NACP.[23] Such procedures and mechanisms must be developed and implemented for all the categories of OST providers. 2. Legal and policy reforms Sustained and persistent advocacy by the palliative care professionals played a key role in bringing about the necessary (and welcome) amendment to the NDPS Act (Amendment 2014), which would now result in easier availability of “essential” opioid narcotics as analgesics.[24] Such advocacy is also required on the part of psychiatrists, to bring about policy reforms, paving the way for easier and wider availability of buprenorphine as OST. Specifically, the drug controller should be requested to modify the special condition attached to buprenorphine; any qualified medical professional delivering addiction-treatment services irrespective of the type of setting, should be eligible to provide this treatment. Mechanisms need to be in place to ensure the compliance of the service providers with the standard procedures and regulations. It is also important to sensitize and orient the law enforcement officers to the benefits of providing OST to opioid dependent people. The evidence that OST brings about a reduction in criminality could bring about a sea change in perception of law enforcers to this treatment.[25] 3. Bringing ost into the mainstream of addiction treatment As of now, the only large scale health program in India providing OST is the NACP, which – true to its mandate – provides this treatment to only opioid dependent IDUs. A vast majority of opioid dependent persons in India use opioid through noninjecting route. Many of them would need to be brought under the treatment coverage. For this, the Drug De-addiction Programme of the Union Ministry of Health (for government hospitals) as well as the program for assistance to NGOs to implement Integrated Rehabilitation Centre for Addicts by Union Ministry of Social Justice and Empowerment, must make OST available at their respective addiction treatment facilities. Indeed, if the teaching institutes in the country adopt OST as one of the treatment strategies on an adequate scale, it would have a cascading effect, resulting in more trainee psychiatrists getting exposed to and trained in OST and then implementing it responsibly at their places of work. In addition, effectively communicating the principles of evidence-based addiction treatments, including harm reduction and OST to the public, treating professionals, policy makers and regulators will be needed to create acceptance and better uptake of this evidence-based approach which has the potential to save lives and make opioid dependent individuals functional members of our society. CONCLUSION India has a rich clinical, research and programme-level experience of implementing OST. Unfortunately this experience and expertise has remained concentrated at a few institutions and with a few professionals. There are a number of attitudinal and policy-level hurdles blocking the way of providing this treatment on an adequate scale. “Science,” “Evidence,” “Health” are key operative words on which drug policies should be based. A concerted effort by the professionals, activists and consumers is needed in these areas to advocate for the reforms which could make OST available, affordable and accessible to the large number of opioid dependent persons in India.