SELF AND COMMUNITY BASED OPIOID SUBSTITUTION AMONG OPIOID DEPENDENT POPULATIONS IN THE INDIAN SUB-CONTINENT

Presented by Jimmy Dorabjee, SHARAN, New Delhhi, India

Background

The phenomenon of 'traditional' drug use in Asia has been well documented since the presence of the British in the region. Substances such as cannabinoids and opioids have found their way to Western markets at substantial profit margins which resulted in International pressure for Supply Reduction and crop eradication measures.

In Asia traditional forms of opioids gave way to the manufacture of heroin in the Golden Crescent regions. The purity of the heroin manufactured in the SE Asian region, as well as the reduced availability of opium products, resulted in the switch to a more cost effective mode of use. Hong Kong (1950's) first saw a shift from smoking to injecting of heroin with Thailand (1960's), Laos (1970's) and North East India (1980's) following suit (Crofts et al, 1995.). The cruder products from the Golden Crescent region were more suited to ingestion through inhalation and cheap and abundant supplies of brown sugar flooded the Indian markets by the mid 1980's.

Introduction

Brown sugar was introduced into the Indian opioid market in the early 80's at a street cost of 30 Rupees (Rs) per gram (around US$2) and effectively displaced the opium and cannabis market. This resulted in traditional opium users succumbing to the aggressive marketing ploys of the National and International drug Mafia and by the mid 80's opium and cannabis dens in major cities turned into retain outlets for brown sugar. However, the introductory price soon doubled and kept rising making it unaffordable to the street using populations, with the resultant phobia of withdrawals due to the high tolerance levels.

The continuing price spiral led to an increase in criminal activities related to addiction and the demand for detoxification and treatment services. Some of these detoxification centres utilised buprenorphine in the management of heroin withdrawals and street wise drug users soon capitalised on its widespread availability in the 'grey market', where it was indicated as a post operative analgesic, available mainly in ampoule form.

By the late 80's and early 1990's, injectable buprenorphine gained popularity as an alternative among the heroin users and this mushroomed into epidemics of injecting in the larger cities of the India Subcontinent (Biswas et al, 1994; Panda, 1997; Kumar & Daniels, 1994; Dorabjee, 1994; Bharadwaj, 1995). While buprenorphine effectively managed opioid dependency, it also gave rise to the vulnerability of injecting related harms, especially HIV, HBV and HCV. The equipment and related information. Rampant reuse of unsterile equipment, high frequency of needle sharing and extremely poor health status, all contribute to potential epidemics of endemic proportions. The density of slum populations involved in injecting drug use (IDU) coupled with high frequency of sexual contacts raise the prospect of an explosive and uncontrolled epidemic of HIV ,which in turn threatens hard won public health gains.

By 1992, injecting drug use had filtered down to the smaller cities (Self Injecting of drugs gains popularity in Punjab, TOI, July 95) and injecting drug users (IDUs) began to 'cocktail' Buprenorphine with Pheniramine and Promthazine as well as with Diazepam, in an effort to enhance and prolong the effects (Biswas, 1994). A recent UNDCP report expressed concern that 'in India there are increased use of injecting techniques, a major factor contributing to the spread of HIV among drug users in that country'.

The rise in IDU in the cities has been attributed to price increase as well as the reduction in availability of heroin, mainly due to supply reduction efforts. In the North East, injecting of an opioid analgesic dextropropoxyphene, which is available in capsule form, has resulted in major health hazards (Eicher, 1996, pp 56-57). By 1995, reports of the spread of buprenorphine injecting, with the resultant public health concerns, were available from Nepal (Shreshtra, 1995) buprenorphine abuse in Nepal and Bangladesh (UNDCP, 1996) and received mention in the 1995 and 1996 Reports of the International Narcotics Control Board, which expressed concerns about "the serious consequences of the increased abuse of buprenorphine .... and the further spread of buprenorphine abuse in Bangladesh and Nepal, or even in India itself. In Bangladesh buprenorphine is abused by 90% of injecting drug users".

The positive aspects of injections of Buprenorphine are that it is cheaper than heroin, a 2 ml (0.6 mg) vial costing (Rs 12), around 1/5 the price of an average dose of heroin. Buprenorphine is also clinically safe, the ampoules are unadulterated and manufactured with strict quality controls, besides having little overdoes potential and are readily available in pharmacies. In light of this situation SHARAN began a pilot management of drug abuse and HIV prevention programme among opioid using populations in Delhi slums in early 1993. the low threshold intervention utilises between 2 & 6 mg sublingual buprenorphine among its street clients. Feedback from clients on the non-availability in pharmacies and chemists of sublingual tablets as compared to injectable buprenorphine in 0.3 and 0.6 mg doses is a matter of serious concern.

Research prior to development of the intervention showed that buprenorphine was available in sublingual form although far less easily than injectables. Literature review also showed that buprenorphine maintenance "reduces illicit opioid use, suppresses withdrawal symptomatology and retains clients in treatment in a manner comparable to methadone, providing an additional pharmaco-therapeutic tool to treat opioid addiction".

More specifically, buprenorphine:

· has been demonstrated to be acceptable to heroin addicts (Kosten et al 1993; Johnson, Jaffe & Fudala 1992; Fudala et al 1990; Jasinski, Pevnick & Griffith 1978);

· had few side effects (Lange et al, 1990);

· blocked the effects of subsequently administered doses of morphine (Bickel et al 1988; Pevnick & Griffith, 1978);

· binds tightly to the opioid receptors (Lewis 1985; Neil 1984);

· significantly diminishes the self administration of heroin (Mello, Mendelson & Kuehnle, 1982; Mello & Mendelson, 1980).

The Programme

In India few treatment services address the issue of IDU, the main focus being 'abstinence' and the 12 step NA Recovery programme for voluntary agencies and 'detoxification' for medical institutions. The SHARAN programme had already established contact with drug users and the community through periodic detoxification camps and later through AIDS awareness programmes that discussed the dangers of needle sharing. It was in the detoxification camps that the spread of injecting was documented and the need for substitution of injectables with sublingual medication was subsequently addressed.

Beginning in early '93 as an outreach and street delivery system, the programme encouraged discussion of substances being used and included focus group discussions on 'topping up'. Dosage of substitute medication was open to negotiation and the opinion of the clients was continually taken into consideration. Having received a positive response from the clients and the community in the pilot phase, we began to expand the reach from 30 to reach a target of 300. Feedback of some clients on withdrawals due to low dosages was accepted and, following a literature review, an increase in dosing up to 8 mg commenced. The medical officer associated with the programme relied on feedback and opinion of outreach staff when prescribing.

The focus of the programme, a drop in centre proving a non judgmental and safe environment was opened in the slum most affected by drug dependency which was also a major drug dealing and using area. A doctor visits the centre thrice weekly providing wider health treatments such as TB and this was also made available to family members of clients. Open 12 hours daily, the centre provides the following:

· Oral substitution therapy

· Medical Services

· Specialist health care referrals

· Individual and Family Counselling

· Detoxification through structured reduction of doses as well as in detoxification camps

· Health education

· Drug awareness programmes

· HIV/AIDS education (safe sex and drug use)

· HIV pre & post test counselling

· Free needles/syringes

· Free condoms and regular condom use demonstrations

· Recreational facilities (indoor games)

· Outreach support

· Weekly client group discussions

· Peer educator sessions

· Home/community based detoxification

Results

From February 1995 till January 1997 the programme has serviced 1320 clients of whom 315 regularly attend the drop in centre. 447 (34%) clients are IDUs injecting buprenorphine and cocktails, and 873 (66%) are heroin chasers and/or occasional IDUs. Out of 447 IDUs, 148 (33%) have stopped injecting while 158 (35%) have reduced the frequency of injecting and sharing of equipment. Hence, a positive impact has been made on 306 (68%) of the IDUs. Retention on the programme is more for older clients with a longer history of drug use and few detoxification attempts and in treatment clients frequently opt for detoxification/rehabilitation services, indicating a compatibility with other treatment methodologies.

Of clinical pharmacological relevance, we found that sublingually 2 to 6 mg buprenorphine was an effective dose for maintenance of IDUs using up to 3 mg buprenorphine daily and heroin inhalers using up to 2 gms per day. The heroin smokers suffered minimal discomfort in the switch from heroin to buprenorphine, while IDUs injecting buprenorphine cocktails reported a short period of anxiety before adjustment to sublingual. This maintenance dose is significantly lower than in reported clinical experiments where doses of upon to 16 mg have had the best results, and may be due to differences in client population profile.

Discussion

This intervention appears to impact severely stigmatised, criminalised (under the Narcotics Drugs and Psychotropic Substance Act 1985) and under served opioid users who have little or no access to treatment. Although buprenorphine is 1.5 the price dose for does of heroin, it is till too expensive to be sustainable as a substitution therapy in developing countries. However, there is still a considerable cost effective factor when considerations of public health and criminalisation are taken into account. Further, initiation and retention rates on the programme are high especially when compared with other treatment modalities.

Reports and informal assessments done in Bombay, Madras, Calcutta and Delhi indicate that the profile of clients on the SHARAN programme tallies with the all India client profile excepting that of the North Eastern States of Manipur, Mizoran and Nagaland. Over 95% are males from the lower socio-economic strata with little or no education, live in unsanitary, overcrowded conditions, suffer from respiratory conditions, have little HIV risk perception and are earning members of their families.

Self medication incorporating the injecting of crushed and partially soluble capsules of dextroproproxyphene in the North Eastern States has become prevalent due to pricing and no availability of heroin. Such substitution behaviour raises serious questions about uninformed legislation that affects the availability of buprenorphine for currently dependent populations. Inversely, sublingual buprenorphine substitution could well be can appropriate treatment to address hazardous self medication/substitution and injecting behaviours in the North Eastern States.

Conclusions

· Programmes using a similar methodology of buprenorphine substitution are attractive and acceptable to out of treatment opioid dependent populations.

· The immense need of the development and replication of the programme in the Indian subcontinent (Eicher, 1996 pp 66-67). to this effect evaluation of the cost effectiveness of sublingual buprenorphine therapy and the need for higher (2 mg to 4 mg ) than the present 0.2 mg doses is necessary.

· The alarming health risks including increased frequency of injecting episodes, swollen limbs which become gangrenous leading to amputation, occluded veins and the rapid deterioration in venous architecture, associated with self substitution of dextroproproxyphene in the Northwest (Eicher, 1996, pp 52-58) need to be considered and harm reduction efforts in this area are imperative.

· Sustainability of similar programmes is a key question especially in the context of behaviour change interventions and the need for such interventions to be considered on a long term basis is crucial to its success.

· The promotion of an alternative behaviours against one off intervention depends on:

1. Political commitment based on evaluation of the public health gains and decriminalisation;

2. the cost effectiveness factor in terms of higher does preparation, thereby reducing cost;

3. regular and widespread availability of sublingual tablets.

This paper was written by Jimmy Dorabjee and Luke J Samson

Acknowledgement

This programme has been made possible with financial assistance from The Commission of the European Communities. The view expressed in this paper are those of the authors and do not represent any official view of the Commission.

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