Fundamentals of Pharmacology. Группа авторов
Clinical Practice (GCP) principles (MHRA, 2012).
Despite these safeguards, there are notable incidences that have occurred in recent years related to the conduct of some clinical trials. For example, in 2006, volunteers in an early phase drug trial at the Northwick Park Hospital became seriously ill. The story became headline news after six participants reacted badly to the medication, suffering a severe immune response leading to organ failure and one participant requiring the amputation of his fingers. This led to a full investigation and the resulting report changed a number of practices in the running of drugs trials which sought to prevent this from happening again (Expert Scientific Group on Phase One Clinical Trials, 2006).
Fortunately, however, the ethical and legal frameworks which surround clinical research, limit these incidents and provide principles and guidance for the safe conduct of research and researchers.
Skills in practice: How to use medical ethics
Not all decisions are made easily, and, in some cases, there are multiple factors that influence decision‐making, such as personal experience, religion, regulatory codes, legal issues and so on. In practice, a practitioner will use a combination of all such factors to reach a decision; this is sometimes described as a systematic study of moral choices. In the first instance, the code of behaviour or conduct presented by a regulatory body is considered correct. Within healthcare, there are many examples of ethical decision‐making process which include varying numbers of steps to follow. Overall, there is the general adoption of principle‐based ethics to guide decision‐making practice within healthcare, which is evident in this example.
Step 1 – Ability to recognise an ethical issue. Ask yourself: could this scenario or decision cause harm or damage to someone or some group? Are there choices between different alternatives; for example, a good and bad alternative or, maybe, two bads or two goods? Is this situation bigger than what is efficient? Or what is legal? What are your initial gut reactions? By considering the scenario on an emotive level you can recognise your own assumptions, values and biases so that you can set them aside before analysing the situation critically.
Step 2 – Gathering the facts. What facts are already known? What other relevant facts need to be gathered? Who are the relevant stakeholders within this scenario and its outcome? Has everyone involved been consulted? Are some concerns more important than others?
Step 3. Evaluation of alternative options or actions. Includes questions from a range of approaches. From a utilitarian approach ask: which actions/option do the least harm and produce the most good? Considering the deontological approach – which actions/option best respects all stakeholder rights? From a nursing approach, which actions/option treat people proportionately or equally? Which actions/option best serve the whole community and not just some if its members? From a virtue approach, also consider which actions/option lead me based on the type of person I want to be?
Step 4. Make the decision. When all approaches have been considered, which actions/option best addresses the scenario? Which action/option is best based on all the stakeholder core values? Consider what others might say when you have shared your chosen actions/option, can you justify your choice?
Step 5. Carry out the actions/option chosen and reflect on the outcome. Plan how your decision can be implemented with the upmost care, pay attention to any concerns raised by all of the stakeholders. Implement your plan and evaluate. Reflect on the results of your choice of decision and what have you learned from this specific scenario. Consider how the ethical problem could be prevented in the future.
Episode of care
Paul is a 65‐year‐old man who has attended the walk‐in centre with a suspected oral infection. He is allergic to penicillin so is prescribed metronidazole 200 mg twice daily for seven days. However, he smells strongly of alcohol and it states in his previous notes that he has had multiple admissions with alcohol‐related injuries and has a chronic alcohol addiction. You as the nurse query this with the doctor who has prescribed the antibiotics, knowing that the British National Formulary (Joint Formulary Committee, 2019) indicates that alcohol and metronidazole are contraindicated and can cause a severe reaction. The doctor states that she has discussed this with Paul and he is aware that he must refrain from drinking alcohol for the course of the treatment. Consider this from an ethical perspective. While the treatment may be doing ‘good’ (beneficence), it has the potential to do harm (maleficence). It is imperative that health professionals discuss medication plans prior to treatment to ensure that patients are aware of the impact this will have on their daily activities. In Paul's case, it is highly unlikely that he will refrain from alcohol and could either take the metronidazole regardless, risking an adverse reaction, or he may decide to not take the antibiotics and risk further infection and possible sepsis. Key message? Ensure every decision made fully involves the patient and aligns with their own values and lifestyle.
Episode of care
Maya is an 85‐year‐old woman who lives alone. She is usually independent with all of her activities of living and, although she does not like to leave the house, she is usually in good physical and mental health. Her daughter visits her three times a week and has noticed some increased confusion over the past few days. Today she has visited and felt it necessary to call the GP as Maya is extremely confused and smells strongly of malodorous urine. The GP refers her to the acute admissions unit with a suspected Urinary Tract Infection (UTI). Further tests are undertaken in hospital, but the admissions team decide to prescribe intravenous (IV), broad‐spectrum antibiotics to treat the UTI as per the guidance from the National Institute for Health and Care Excellence (NICE NG109, 2018), which they hope will also alleviate the acute confusional state. However, Maya becomes very distressed when the nurse attempts to cannulate and Maya's daughter states that she does not consent to her mother receiving IV antibiotics. Maya has been assessed as an adult lacking capacity by health professionals. In accordance with the Mental Capacity Act (2005), she is cannulated and receives the IV antibiotics. Over the course of the next 24 hours her condition improves and her acute confusional state dissipates. The health professionals have acted in accordance with legal standards. They have also balanced their duty to respect Maya's autonomy with their duty of care in ensuring beneficence (doing good by giving the required treatment in Maya's best interests) and non‐maleficence (doing no harm by omitting care that was in her best interests).
Conclusion
This chapter has sought to outline the fundamental legal and ethical principles relating to pharmacology in healthcare. The three key components that underpin high‐quality decision‐making with and for patients in our care are related to the law, ethical principles and regulatory bodies. A variety of legislation has been discussed to offer an understanding and insight into how healthcare professionals manage and administer medicines within the confines of the law. The interplay of legislation, ethical principles and professional regulation is a fine balance that health professionals seek to strike in order to optimise the safety and efficacy of treatment.
Working in healthcare requires an acknowledgement of the areas of ambiguity and conflict that may be encountered; and while we seek to always ‘do good’, there are countless situations where this endeavour may be obstructed by other considerations such as patients' capacity or the wider public interest.
Acknowledgement of the issues that have been outlined within this chapter and a deeper understanding of how to apply the knowledge of ethical principles will ultimately improve practice and provide safer and higher quality patient care. It is incumbent upon all health professionals (and students) to act with integrity within these frameworks and to make individualised decisions which are in the patients' best interest and, wherever possible, fully informed.
References
1 Abortion Act (1967). Abortion Act. www.legislation.gov.uk/ukpga/1967/87/contents (accessed