ACORNS - POLICY - QUEEN

All of the scenarios in the policy suit should be considered from the perspective of a health professional in a staff appointment as the lead officer for medical policy within a Ministry of Defence (rank equivalent of OF4/Commander/Lieutenant Colonel/Wing Commander).

Step 1 – IDENTIFY THE PROBLEM(S)

• Briefly state the Scenario: Military commanders want to use a new drug that protects against travellers' diarrhoea. There is disagreement between the adviser in medicine and the adviser in microbiology as to whether the drug is effective. Can the drug be introduced?
• List the Issues that arise from the scenario.
• Identify Critical Information required and Assumptions to be made:

This scenario covers the ethics and law regarding the introduction of a new drug and indication to the formulary of the armed forces. Many health systems use formularies to guide clinicians in the selection of drugs and to control costs by limiting the range of drugs that can be prescribed within the health system. These restrictions may also limit the indications for use. This is often separate from the process for approval of drugs for use within a country. In the UK this is reflected in the separation of function between the National Institute for Health and Care Excellence and the Medicines and Healthcare products Regulatory Agency (MHRA). Many armed forces have additional protocols or policies for the prescription of drugs for predictable indications of particular importance for the military population. Traveller’s diarrhoea is a particular challenge for armed forces personnel on deployment away from their home base or to areas with poor sanitation or food hygiene practices. In this scenario, two senior clinical advisers with an interest in the same topic have a disagreement. You might do a search of the medical literature to get your own understanding of the issue.

Step 2 – ANALYSE

Patient: your first duty to do no harm to patients through policy, but also to provide ‘beneficence’ if there is an appropriate healthcare intervention.

Clinical: each clinician may have a valid justification for their argument based on their perspective – from your knowledge of the topic what might these be? You should consider your ethical duties to practice within your area of competence, to consult with other clinicians, to use health resources prudently – WMA International Code of Medical Ethics https://www.wma.net/policies-post/wma-international-code-of-medical-ethics/

Legal: the new drug must be licenced for use in your country, and ideally must have this use as a recognised indication. If not, you will need to consider if the drug could be prescribed ‘off-label’, or this indication could be evaluated as part of a research project.

Societal/Military: you might consider the nuances of the military benefit to prevent traveller’s diarrhoea, would this apply to everyone, deploying everywhere, for how long etc.

Step 3 – FUSE

• Summarise conclusions
• Insert citations to key reference sources for your analysis
• Determine the exact Decision(s) to be made

This scenario covers a deep technical subject. You need to consider whether you have sufficient technical/professional knowledge to make such a decision or whether you need to be presented with a series of recommendations through a consultation process.

Step 4 – DECIDE

• What is your Decision?
• Why (can you justify it)?
• Residual uncertainly, need for review?

You would wish to avoid making the decision yourself unless your technical expertise is at least the same level as your advisers. You might speak to each adviser and ask for a written briefing of their position. Is there a committee or senior clinical expert whose role is to manage such a discussion? You might need to give this person/committee a specific task and suite of situations in which such a policy might be used (e.g. small numbers of personnel to a high priority/short duration task; senior officer diplomatic visit; rapid deployment for military emergency; isolated military expedition; etc).

Examples from the UK are the role of the Medical Director as the senior ‘expert’ clinician in advising the Surgeon General and the Advisory Group on Military and Emergency Response Medicine (https://www.gov.uk/government/organisations/advisory-group-on-military-medicine)    

Contributor – Air Vice Marshal (Rtd) Alastair Reid CB FFOM, Surgeon General UK Defence Medical Services 2019-2021.