The WHO constitution [49] defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. It goes on to state that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being, without distinction of race, religion, political belief, economic or social condition. The constitution also states that the health of all peoples is fundamental to the attainment of peace and security, and is dependent upon the fullest cooperation of individuals and states. Similarly, the Ottawa charter [50] outlines the link between health and broader social policy and health systems, highlighting the importance of actions at the health-system level.
These guidelines contain two levels of recommendations for action at the health-system level – “minimal” and “optimal”. Recommendations marked “minimal” are suggested for adoption in all settings as a minimum standard; they should be considered the minimal requirements for the provision of treatment of opioid dependence. Recommendations marked “optimal” represent best practice strategies for achieving the maximal public health benefit in the provision of treatment for opioid dependence.
4.1. International regulations
Nations operate within an international regulatory framework; and methadone and buprenorphine are medicines under international control. The Single Convention on Narcotic Drugs, 1961 (as revised by the 1972 protocol) and the Convention on Psychotropic Substances, 1971, outline specific control requirements for those substances (details of requirements of these conventions are given in Annex 7). The conventions also include the requirement to make treatment available for people who are dependent upon narcotic drugs or psychotropic substances. The two main objectives of these conventions are to make narcotic drugs and psychotropic substances (including opioids) available for medical and scientific purposes, and to prevent their diversion for other purposes.
Responsible authorities should familiarise themselves with the international and legal regulations for the procurement, distribution, storage and prescription of opioids. If a country does not have regulations concerning the dispensing of agonist maintenance medications and provision of interventions, then these should be developed in accordance with the relevant conventions. The laws and regulations should enable prescribed methadone and buprenorphine to be dispensed – either under supervision or as take-home doses – from accessible dispensing points, while preventing diversion for non-medical use.
Treatment providers should familiarize themselves with the national and subnational requirements, and ensure that the treatment provided is consistent with relevant laws and regulations.
International agreements that outline responsibilities for the protection of human rights are also relevant to opioid treatment (see ethical issues, below).
4.2. Opioid dependence as a health-care issue
Substance dependence per se should be regarded as a health problem and not a legal one. Given the multiple medical problems associated with opioid dependence and the nature of pharmacological treatment, provision of pharmacological treatment for opioid dependence should be a health-care priority. This is encouraged in the Single Convention on Narcotic Drugs, 1961, which encourages parties to give special attention to, and take all practicable measures for, the prevention and treatment of the abuse of narcotic drugs. The convention also stipulates that treatment may be made available as an alternative to conviction or punishment (or in addition to them) to those people with substance-use disorders who have committed punishable offences.
4.3. National treatment policy
When a treatment system is developed in any country, it should be planned as part of the community's overall resources for dealing with health and social problems (WHO Expert Committee 30th Report). [10, 50]
The policy should outline the approach to preventing and treating the problems of opioid dependence. It should be based on epidemiological data, the evidence for effectiveness of interventions, the resources of the country and the values of the society.
Estimating treatment need is important for planning treatment services, and for reviewing the accessibility of services to different population groups. Estimating the number of opioid-dependent people in a population from household surveys is difficult due to their under representation in large-scale epidemiological surveys. Alternative techniques that can be more effective are capture–recapture, back projection and multiplier methods [51]. WHO has produced guidance on how to estimate the number of opioid-dependent people [52].
Treatment need can also be estimated using systems that monitor treatment, including the demand for first-time treatment. However, some populations may be underrepresented in estimates of those seeking treatment; such groups include women, the young, street children, refugees, the poor and minority ethnic and religious groups.
Collecting data on the number of patients treated with each type of treatment can be useful. Data on numbers in opioid agonist maintenance treatment can be gathered from treatment centres or pharmacies dispensing methadone and buprenorphine, either in real time or on an intermittent basis. Gathering data on numbers of people treated for opioid withdrawal is more difficult, and requires coordination of data from residential facilities, outpatient specialist services and primary care. A relatively inexpensive way to evaluate long-term outcomes is to link data records with population registries (mortality).
A needs assessment is a formal systematic attempt to determine important gaps between what services are needed and those that are currently being provided. The assessment involves documenting important gaps between current and desired outcomes, and then deciding in which order those gaps should be closed.
When planning and developing pharmacological treatment for people with opioid dependence, the scope of present and potential public health problems associated with opioid dependence and current treatment coverage should be considered.
Recommendation (Best Practice)
A strategy document should be produced outlining the government policy on the treatment of opioid dependence. The strategy should aim for adequate coverage, quality and safety of treatment.
4.4. Ethical issues
4.4.1. COMPULSORY AND COERCED TREATMENT
In line with the principle of autonomy, patients should be free to choose whether to participate in treatment, unless another ethical principle overrides this. The principle of autonomy may be overridden, for example, when a person is incapacitated by a mental illness and can no longer care for themselves, or when a person poses a risk to others. Most countries have mental health legislation to this effect, which can be applied to patients with opioid dependence if necessary. However, in most cases, those who have lost control over opioid use are not necessarily considered to have lost the ability to care for themselves in other ways.
In situations where opioid-dependent individuals are convicted of crimes related to their opioid use, they may be offered treatment for their opioid dependence as an alternative to a penal sanction. Such treatment would not be considered compulsory unless the punishment for refusing or failing treatment were more severe than the penal sanction it replaced. Similarly, legal proceedings can be a delayed until after a period of treatment, so that the effects of treatment can be taken into account. Such programmes, which divert opioid-dependent patients away from the criminal justice system, can also be implemented on arrest or before trial. These programmes are sometimes called diversion programmes (the use of the term “diversion” here should not be confused with its use in “diversion of treatment medication”, which is described elsewhere). Evaluations of diversion programmes show high rates of successful treatment and low rates of recidivism [53, 54].
Recommendation (Minimum standard)
Psychosocially assisted pharmacological treatment should not be compulsory.
4.4.2. CENTRAL REGISTRATION OF PATIENTS
Patients should have the right to privacy. Confidentiality should be considered when contemplating setting up systems of central registration of patients. Central registration has advantages, in that it:
prevents patients from receiving methadone or buprenorphine from more than one source
can be used to limit access to other controlled medicines requiring central approval, such as other opioids
can provide more accurate data on treatment numbers than situations where central registration is not used.
However, central registration can facilitate breaches of privacy, and this may deter some patients from entering treatment. It can also delay the commencement of treatment.
Safe and effective treatment of opioid dependence can be achieved without central registration. Because such registration could cause harm if privacy is breached, it should only be used if government agencies have effective systems for maintaining privacy.
4.5. Funding
In each national situation, funding and equitable access to treatment should be assured for the treatment approaches that are appropriate. In general, this means making the most cost-effective treatment widely available and accessible.
The cost to patients of treatment for opioid dependence also influences the outcomes of treatment. If costs are excessive, treatment will not be accessible to disadvantaged populations. Many opioid-dependent patients have difficulty paying for treatment and are not covered by health-insurance schemes. Where patients have to pay for treatment, retention rates and health outcomes are worse than where treatment is free [55]. Even small financial costs for treatment can be a significant disincentive.
Costing mechanisms for treatment can have unintended consequences. For example, if higher doses of methadone and buprenorphine cost more than lower doses, patients may opt for too low a dose, resulting in poorer outcomes. In contrast, if patients pay the same price regardless of the dose, they may overstate their needs and sell their excess supply, which in turn may make staff reluctant to increase the medication dose when patients request it.
The cost of dispensing the medication is also relevant. If patients pay a dispensing fee to a pharmacist or clinic each time they collect their medication, they may collect their medication less frequently.
Although it is impossible to avoid all perverse incentives (i.e. those that have unintended and undesirable effects), making treatment both free and accessible will minimize them.
Where a country has a public universal health-care system, this should include access to opioid dependence treatment. Where a country has an insurance system, this should again include access to opioid dependence treatment, recognizing that long-term treatment will be needed in many cases.
Another aspect of treatment funding is sustainability. In many cases, pilot funding is used to launch treatment of opioid dependence. However, it is not appropriate to use short-term funding for long-term agonist maintenance treatment without a realistic prospect of people in treatment being able to access continuing pharmacotherapy at the end of the pilot phase.
The development and maintenance of opioid treatment services evidently needs to take place within the broader system of health-care financing and provision in a given country. An understanding of the way that health funds are raised and allocated in a country is therefore important for the appropriate planning of opioid treatment services. One particularly important potential barrier to treatment in many countries with relatively low resources is the reliance on private, out-of-pocket spending by households as the primary mechanism for paying for health care. Tax-based public health-insurance schemes provide a more equitable mechanism for paying for health services, as well as a more suitable basis for developing and sustaining opioid treatment services at the population level.
Determining the total resources and associated costs needed to initiate and maintain a treatment service for opioid dependence should be a key element of strategic planning. Although cost estimates have been produced for a range of opioid-dependence treatment programmes [56, 57, 58, 59, 60, 61, 62, 63], they are largely restricted to the context of high-income countries, where costs and levels of funding for health may differ markedly from those found in low and middle-income countries. For example, although estimates of required staff will figure prominently in any resource-planning exercise, the costs of this labour may not represent such a large component of total cost in low and middle-income countries (due to lower salary levels); in contrast, the costs of purchasing and distributing medication, and of fuel, utilities and equipment may take up a relatively greater share of costs in such countries. WHO has methods and tools that can be used to assist such resource planning and programme costing at the national level [64].
Recommendation (Minimum standard)
Treatment should be accessible to disadvantaged populations.
Recommendation (Minimum standard)
At the time of commencement of treatment services, there should be a realistic prospect of the service being financially viable.
Recommendation (Minimum standard)
To achieve optimal coverage and treatment outcomes, treatment of opioid dependence should be provided free of charge, or covered by public health-care insurance.
4.6. Coverage
Pharmacological treatment of opioid dependence should be accessible to all those in need, including those in prison (the efficacy of opioid agonist maintenance treatment is well documented in this setting) and other closed settings [65, 66, 67]. Interruptions to opioid agonist maintenance treatment while patients are moving in and out of custodial settings should be avoided.
Treatment programmes should be designed to be as accessible as possible; for example, programmes should be physically accessible, open at convenient times, have no undue restrictions on accessibility, and have the capacity to be expanded to accommodate likely demand. A programme should provide adequate facilities and should have opening hours that allow staff and patient confidentiality and safety, adequate and accessible dispensing facilities, and safe and secure storage of medications.
Recommendation (Minimum standard)
Pharmacological treatment of opioid dependence should be widely accessible; this might include treatment delivery in primary care settings. Comorbid patients can be treated in primary health-care settings if there is access to specialist consultation when necessary.
Recommendation (Best Practice)
Pharmacological treatment of opioid dependence should be accessible to all those in need, including those in prison and other closed settings.
4.6.1. PRIMARY CARE
Integration of opioid dependence treatment into primary care is one way to increase accessibility, although it may not be possible in all settings. Primary care practitioners will usually need support from the specialist system, through mentoring, training, consultation and referral. With such support, patients with quite complex comorbidity can be safely managed in primary care.
Opioid agonist maintenance treatment, opioid withdrawal services and relapse prevention services can all be provided in primary care settings, given the right conditions.
Several clinical trials of opioid agonist maintenance treatment have been conducted in primary care settings [68, 69, 70]. Use of general practitioners for opioid agonist maintenance treatment significantly increases the capacity of the service, and treatment numbers have increased rapidly in countries that have adopted this approach [71]. Treatment in primary care also has the advantage of integrating addiction medical and psychiatric services into mainstream services, reducing the stigma of addiction and the professional isolation of medical staff. Integration also reduces some of the problems that clinics can develop when large numbers of patients on opioid agonist maintenance are aggregated. Within the clinic setting, interaction between patients can lead to drug dealing and an antitherapeutic milieu. Outside the clinic, the congregation of drug users can become a visible target for members of the public who do not approve of opioid agonist maintenance treatment.
Opioid withdrawal and relapse prevention services can also be provided in primary care, with similar efficacy as specialist clinics but at lower cost [72, 73].
4.6.2. PRISONS
Prisoners should not be denied adequate health care because of their imprisonment. This would normally imply that the treatment options available outside prison should also be available in prison. Opioid withdrawal, agonist maintenance and naltrexone treatment should all be available in prison settings, and prisoners should not be forced to accept any particular treatment.
Opioid agonist treatment in prisons
The benefits of opioid agonist maintenance in prisons include less injecting drug use while in prison, increase in uptake of treatment on leaving prison, and reduction of rates of return to prison. Potential harms include diversion of medication, and spread of HIV through injection of diverted medication using contaminated injecting equipment. Because of these potential harms, unsupervised doses are generally not appropriate in prison settings. Rates of diversion of methadone are low, even in prison settings, and can be reduced further by diluting the methadone and by keeping methadone patients separate from other prisoners for 30 minutes after dosing.
Because it is a sublingual tablet that can take up to 15 minutes to dissolve, buprenorphine is difficult to supervise in prison settings, sometimes resulting in pressure on patients from other prisoners to divert their medication for injection [74]. Methods to increase the effectiveness of supervision include crushing the tablet, filming dosing, ensuring the hands remain behind the back of the patient during dosing and inspecting the mouth after dosing. If effective supervision of buprenorphine is difficult, it may be better to use methadone instead.
Policy makers and prison administrators should ensure appropriate links between prison health services and agonist maintenance treatment outside prison. Even small gaps in the continuity of treatment are distressing for the patient and risk the person relapsing to illicit opioid use. Therefore, opioid agonist maintenance treatment should be continuous on leaving prison. This means coordinating the day of discharge from prison with the day of commencement of opioid agonist treatment outside prison.
Patients not in treatment in prison should be given the opportunity to start methadone or buprenorphine in prison, even if they have only a short period of their sentence left to complete. Commencement of opioid agonist maintenance treatment in prison reduces the high risk of overdose and death on leaving prison, and reduces reincarceration rates.
4.7. What treatments should be available?
If countries are able to afford it, it is best to have both methadone and buprenorphine available for opioid agonist maintenance treatment. Having both treatments means that patients who experience adverse effects from one of the medications, or fail to respond, can try the alternative. This situation may increase the proportion of people with opioid dependence staying in opioid agonist treatment; it may also increase the effectiveness of treatment, through better matching of treatment and patient. The additional availability of alpha-2 adrenergic agonists for opioid withdrawal increases the options for those who wish to withdraw as quickly as possible or who wish to commence naltrexone after withdrawal. The availability of naltrexone after withdrawal is also a valuable additional option, because it gives a lower rate of relapse.
Recommendation (Minimum standard)
Essential pharmacological treatment options should consist of opioid agonist maintenance treatment and services for the management of opioid withdrawal. At a minimum, this would include either methadone or buprenorphine for opioid agonist maintenance and outpatient withdrawal management.
Recommendation (Best Practice)
Pharmacological treatment options should consist of both methadone and buprenorphine for opioid agonist maintenance and opioid withdrawal, alpha-2 adrenergic agonists for opioid withdrawal, naltrexone for relapse prevention, and naloxone for the treatment of overdose.
4.8. Supervision of dosing for methadone and buprenorphine maintenance
This section should be read with the section on opioid agonist maintenance treatment (Section 6.4). Without supervision of dosing, methadone and buprenorphine are likely to be diverted for illicit use, giving rise to problems of overdose, injection and spread of bloodborne viruses.
However, supervision of every dose is severely restrictive to patients, and limits the acceptability of treatment. Supervision of most doses is still onerous for patients, but is not necessarily detrimental to the individual in treatment; on the contrary, it may be of benefit in the early phases of treatment.
Regulations and laws describing the degree of supervision of methadone and buprenorphine maintenance should be in accordance with the relevant international treaties and reflect the balance between treatment acceptability and risk of diversion that is acceptable to the community. Programmes in which medicine is being diverted to the street market are not beneficial to patients and often not tolerated outside the health-care sector either. With guidance, treatment staff can select patients at lower risk of diversion, who can receive a lower level of supervision of dosing (Section 4.6).
In most cases, staff training, adequate take-home policies and normal legal restrictions on illicitly procured opioids can minimize diversion without the need for specific legislation. Programmes will be more sustainable if there are systems to prevent or minimize diversion of pharmacotherapy, and to monitor the benefits of treatment. As a minimum, this would include systems that monitor the extent of diversion (Section 5.7).
