Decision on ethical issues in TPT implementation
What are ethical considerations and related actions for programme management of TPT?
Implementation considerations
In general, only about 5–10% of people infected with M. tuberculosis will develop TB disease at some point in their lifetime. The risk of TB infection progressing to TB disease is much higher for some groups, such as People with HIV, very young children and people who have just recently acquired infection. Treatment always carries some risk of adverse drug reactions, so understanding the individual risk versus benefit of taking TPT, helps to make an informed decision. TPT should be administered following an evaluation of benefits against potential harms to the individual. Routine testing and treatment should be limited to those groups with demonstrated risk of progression from TB infection to TB disease. Indiscriminate population wide TPT is not recommended.
TPT is given to people who are not ill and not infectious. This basic difference from treating TB disease alters the ethical obligations that are imposed when a condition threatens the health of the affected individual and the community (135). Whether or not to take TPT must therefore always be an individual choice, made with full information and without coercion. People offered TPT should feel empowered to opt out or to stop TPT once started. Provision of TPT must always be based on human rights and respect for persons (95). The absence of an immediate risk of transmission makes it unethical to restrict the movement of someone with TB infection who refuses treatment.
The WHO TB ethics guidance clearly states that taking TPT should never be compulsory. National programmes should strengthen counselling services for eligible persons to ensure effective and adequate communication around protective benefits, uncertainties and likely adverse events. The risks and uncertainties should be communicated in culturally appropriate messaging. Feedback should be invited regularly with the aim to adjust programme implementation. It is desirable to document and monitor counselling efforts and informed consent of TPT recipients systematically to ensure effective implementation. Proactive measures including routine clinical and laboratory (when indicated) monitoring should be made an integral part of PMTPT to ensure that those treated remain safe throughout TPT.
Informed consent
Explicit consent is generally required for TPT since the subject does not pose an immediate risk to others and the potential benefits are highly context specific and may be outweighed by risk of harm for some individuals. The provider usually has a professional obligation to do this. Whether this is documented in writing or not depends on local practice. Informed consent requires effective and adequate communication of the possible uncertainties, as well as prospects of risk reduction (often uncertain due to risk of reinfection). Nurses and other frontline health care workers can be trained to counsel people about TPT, the options of treatment and to interpret the results of testing for TB infection or for active TB disease. In addition to the benefits and risks for individuals, information should also be given on the implications of TPT on a person’s family and the community. National programmes should consider formulating appropriate TPT communication strategies, with special attention to communicating benefits, risks and uncertainties in a culturally and linguistically appropriate manner, by involving the community, people who have taken TPT and ex-TB patients.
Key point: Counselling before TPT is of paramount importance to safeguard human rights. National programmes should prominently factor in resources to strengthen the counselling component both in planning and fund allocation, to ensure that all individuals identified as eligible for TPT can make an informed choice between accepting or opting out of TPT, based on a clear understanding of the potential benefits and harms of taking treatment.
Ethical issues around TPT services
- In the absence of specific risk factors, most individuals having TB infection will NOT progress to TB disease.
- The poor predictive value of current tests in determining who will progress from TB infection to disease lowers the certainty of effectiveness of TPT at the individual level.
- There are currently no tests to establish that TPT has been successful for the individual.
- There is a risk of emergence, although very low, of drug resistance if TPT is given in the presence of TB disease.
- TPT carries a risk of adverse events, some of which are serious (such as hepatotoxicity). Considering that these reactions are provoked by a treatment given to someone who is usually healthy makes its occurrence more unfortunate.
- Apart from toxicity, TPT presents the added inconvenience of psychological burden and anxiety costs.
- TPT carries the risk of stigma and discrimination that is attached to TB.
- TPT carries a financial implication for the household for testing, adhering to treatment and care
- While TPT protects from disease there is always the risk of reinfection. Risk of TB disease is higher among groups who are already marginalized and furthermore likely to reside in crowded places with poor infection control. Access to TB screening and TPT for these groups should be prioritized to enhance equity, human rights and solidarity. Efforts must be made to address existing inequities in access to services and to uphold human rights, so that the vulnerability of target groups does not impede their access to screening and treatment or violate their rights. Any interventions for vulnerable groups, including those who are criminalized, those in prisons, and children, should include measures to minimize the risk of stigmatization, such as protecting confidentiality of personal data and informed consent. This may require providing support to cover social and economic costs associated with screening, treatment and interventions that minimize the burden on a person on TPT (such as requiring only one visit, access to shorter and safer TPT regimen).
Mandatory TB screening at borders and in at-risk groups:
- Migrants who are screened for TB disease, may also be automatically screened for TB infection. Screening for either condition should always be done with the intention to provide appropriate medical care, and never to deport or deny entry into the country. Since TB infection indicates a potential future risk to a small minority of people, excluding or deferring immigration on the basis of infection alone is unjustified and unethical. The individual’s status – testing positive for TB infection or receiving TPT – should not affect the immigration procedure. This should be reflected in existing laws or other policy regulations. People should be tested for TB infection and receive TPT in strict adherence to human rights and ethical considerations.
- Health care workers are at increased risk of acquiring TB infection and/or disease when infection control measures are not effective. Health workers have the right to work in a safe work environment but with the professional obligation to act in a way that minimizes risk of harm to persons under their care. Any consideration of mandatory screenings should take into account both the burden imposed on health care workers and potential risks for others. Policies should evaluate the likelihood of transmission (i.e. if health care workers are in a clinical or ambulatory setting with heightened exposure to them or their patients), and how likely are patients to suffer harm by developing TB disease (such as immunosuppressed patients). If health care workers are occupationally exposed to TB or even undergo screening and treatment, then there is a reciprocal obligation on the health system to alleviate the burdens imposed on them by infection as much as possible, through free screening and TPT, and importantly investing in improving infection control measures to reduce the risk to health care workers, patients and the wider community. Any decision to implement periodic screening for TB infection and/or TB disease among health care workers should always be based on high quality evidence of the risk of transmission, and the benefit to both health care workers and others potentially affected.
Community engagement: Affected communities often do not appreciate the value of preventive action, the need to protect community members from TB and what is TB infection versus TB disease. Community engagement and health education play an important role in ascertaining that individuals and communities can make informed choices regarding TPT.
In conclusion, policies should be evaluated by end-users from an ethical perspective and the views and experiences of affected populations gathered after implementation, both to consider possible unexpected effects and to ensure that the evidence on which they are based remains current and relevant. Person-centred TPT care entails, among others, that it is provided in an equitable fashion without placing marginalized and vulnerable populations at an added disadvantage. It focuses on human rights aspects of TPT interventions so that there are appropriate safeguards in law, policy and practice to minimize additional stigma, discrimination, violation of bodily integrity or restrictions on freedom of movement. People offered testing and treatment should understand the associated uncertainties well enough to be able to participate in decisions on care options. These guiding principles would best draw upon a set of established human rights principles, such as consent, noncoercion, confidentiality.
Key point: Ministries of health should consider formulating appropriate TPT communication strategies by involving people who have taken TPT from different target populations. A review of the adequacy of communication resources at their disposal and dissemination can enable individuals and communities to be more autonomous when making informed choices regarding TPT.