Well-being/Utility | The benefits of the prophylaxis must outweigh the harms |
Safety | Apart from direct side effects, consideration must be given to the potential risks of the prophylaxis, for example, consequences of imperfect adherence. |
Parameters of use | If data on safe and effective use are limited, prophylaxis must only be used within the limits of these data, that is, generalisability to different populations or uses must not be assumed. |
Risk behaviours | Steps must be taken to educate recipients about avoidance of risk compensation and to monitor changes in risk-related behaviour. |
Stigma | Consideration must be given to how others may perceive those receiving prophylaxis, for example, difficulties obtaining insurance. |
Diversion | In resource-poor settings, there is a possibility that drugs that can be used to treat extant conditions are diverted to prevent the same or other conditions. |
Equity/Justice | There should be a fair distribution of risks and benefits among the relevant population. |
Access | Prophylaxis must be acceptable to the population at risk. This includes both the formulation of the treatment and the system of provision. |
Competing priorities | Consideration must be given to how to distribute risks and benefits fairly. What ‘fairness’ means may change over time and depends on available resources, risk environment and societal norms. |