The medical profession subscribes to a strict code of ethical conduct; breaching any of its principles may attract disciplinary penalties from the Council, but we focus here on three main areas:
- respect for patient autonomy (informed consent, shared decision-making)
- respect for patient confidentiality
Respect for patient autonomy
This section contains only a brief overview of consent issues, which can be complex. You will find more detailed advice in the MPS booklet, Consent to Medical Treatment in South Africa. An MPS Guide.
There is a very good practical reason for seeking informed consent – it may prevent claims and complaints about you if the outcome of treatment is less than optimal
Quite apart from the legal and ethical requirement to do so, there is a very good practical reason for seeking informed consent – it may prevent claims and complaints about you if the outcome of treatment is less than optimal. Many claims and complaints are brought, not because a doctor has been negligent, but because the patient’s expectations have been disappointed.
If you discuss openly with your patients what is and is not possible, they will have more realistic expectations and are therefore less likely to feel disappointed when an otherwise successful treatment leaves them with residual problems, or when it doesn’t bring about a hoped-for improvement.
Those who have researched the subject seem to agree that the most appropriate situations for adopting shared decision-making are when one or more of the following apply:
- the patient prefers to be involved in decision-making
- there is a degree of uncertainty about the outcome of treatment options
- two or more options with similar potential outcomes are available
- the risks and benefits of the proposed treatments are high
- the patient has a chronic illness.
If you discuss openly with your patients what is and is not possible, they will have more realistic expectations
If you discuss treatment options with a patient and duly note the substance of the discussion in the patient’s notes, it may be much easier to defend your position if an allegation of negligence following the development of a non-negligent complication is later made against you.
Consent to treatment
The healthcare provider concerned must, where possible, inform the user ... in a language that the user understands and in a manner which takes into account the user’s level of literacy
As stated earlier, a patient’s right to autonomy is enshrined in the Constitution and is therefore an ideal that carries the force of law. In particular, the Health Act of 2003 (Chapter 2, sections 1 and 2) explicitly obliges healthcare providers to inform a health service user of:
- “the user’s health status except in circumstances where there is substantial evidence that the disclosure of the user’s health status would be contrary to the best interests of the user;
- the range of diagnostic procedures and treatment options generally available to the user;
- the benefits, risks, costs and consequences generally associated with each option; and
- the user’s right to refuse health services and explain the implications, risks, obligations of such refusal.
“The healthcare provider concerned must, where possible, inform the user ... in a language that the user understands and in a manner which takes into account the user’s level of literacy.”
Consent is not something that only applies to invasive surgical procedures. Technically, any bodily contact with a patient is an assault if the patient did not consent to it. Clearly, it would be ludicrous to obtain formal consent before performing every little act, such as measuring blood pressure or feeling a pulse, so the law allows healthcare practitioners to carry out much of their work on the basis of implied consent. If patients co-operate with your actions (for example, rolling a sleeve up for the sphygmomanometer cuff), you may assume their consent.
Even so, a short explanation of what you intend to do, and why, is still advisable – especially if it entails examining genitals or breasts. Even an examination of the fundus of the eye with an ophthalmoscope or palpating the glands in the neck can feel threatening to patients if they don’t know what to expect.
Consent is also needed for non-interventional treatments such as drug therapy, and for investigations and tests. Although it might seem that you have implied consent if the patient co-operates by taking the medication prescribed or by allowing you to take a blood sample, if the patient is unaware of the possible side-effects of the drug, or doesn’t know what blood tests you’re going to request, the consent is invalid because the patient could not make an informed decision in the absence of all the information.
The law allows healthcare practitioners to carry out much of their work on the basis of implied consent
To be considered valid, consent to a medical intervention must meet three criteria:
- Information: The patient must be informed about the material risks and benefits of the proposed intervention.
- Capacity: He or she must be capable of taking in the information, weighing it in the balance and arriving at a decision.
- Non-coercion: The patient must be free of undue pressure or coercion in making his or her decision.
The information that should be given to patients so that they may make an informed decision is listed in Box 4. Just presenting patients with information sheets or briskly rattling off a list of possible side-effects of a drug is not sufficient, however. The information must be tailored to the needs of the individual – it must therefore be presented in a form the patient can understand and in the context of his or her particular preferences and circumstances.
When providing information, health care practitioners must do their best to find out about patients’ individual needs and priorities
The Council offers this guidance regarding the context in which the information should be presented:
“When providing information, health care practitioners must do their best to find out about patients’ individual needs and priorities. For example, patients’ beliefs, culture, occupation or other factors may have a bearing on the information they need in order to reach a decision. Health care practitioners should not make assumptions about patients’ views, but discuss these matters with them and ask them whether they have any concerns about the treatment or the risks it may involve.”1
These are important considerations as each patient will take a different view on the implications of the risks and benefits, depending on his or her personal priorities. A patient who earns his living as a professional driver, for example, is likely to be reluctant to take medication that causes drowsiness.
Box 4: Information the patient should be given in the consent process
- “Details of the diagnosis, and prognosis, and the likely prognosis if the condition is left untreated.
- Uncertainties about the diagnosis, including options for further investigation prior to treatment.
- Options for treatment or management of the condition, including the option not to treat.
- The purpose of a proposed investigation or treatment; details of the procedures or therapies involved, including subsidiary treatment such as methods of pain relief; how the patient should prepare for the procedure; and details of what the patient might experience during or after the procedure, including common and serious side effects.
- For each option, explanations of the likely benefits and the probabilities of success; and discussion of any serious or frequently occurring risks, and of any lifestyle changes which may be caused or necessitated by the treatment.
- Advice about whether a proposed treatment is experimental.
- How and when the patient’s condition and any side effects will be monitored or re-assessed.
- The name of the doctor who will have overall responsibility for the treatment and, where appropriate, names of the senior members of his or her team.
- Whether students will be involved, and the extent to which students may be involved in an investigation or treatment.
- A reminder that patients can change their minds about a decision at any time.
- A reminder that patients have a right to seek a second opinion.
- Where applicable, details of costs or charges which the patient may have
(HPCSA, Seeking Patients’ Informed Consent: The Ethical Considerations (2007), para 3.1.3.)
Even if you do explain your intentions to the patient, you will also need to check that he or she understands what you’ve been saying, otherwise you will fall at the second fence (the patient’s capacity to understand and weigh choices in the balance). (See Appendix 2 for a guide to assessing decisional capacity.)
Mr H is a plasterer in his late 40s. He has been experiencing pain in his left knee, on and off, for several years, but it has become more intense and is affecting his ability to work. His GP refers him to the orthopaedic outpatient’s clinic at the local hospital where he is seen by Dr J.
Dr J examines Mr H’s knee and recommends an intra-articular steroid injection. He is aware that Mr H is self-employed and needs to be able to return to work as soon as possible, so he suggests that he administer the injection there and then. Mr H is doubtful about having an injection straight into the joint, but Dr J brushes aside his doubts, saying that it will get him “up and running in no time”. He points out that it is unlikely he will get another clinic appointment for another two weeks, which will only delay his recovery.
Mr H reluctantly acquiesces, and allows Dr J to administer the injection. Unfortunately, he subsequently develops septic arthritis in the joint. Although this is successfully treated with antibiotics, he loses several more weeks of work and decides to sue Dr J for compensation. His claim alleges invalid consent, not only because he had not been warned about the small risk of infection, but because he had felt coerced into making a hasty decision.
Mr H is doubtful about having an injection straight into the joint, but Dr J brushes aside his doubts, saying that it will get him “up and running in no time”
Lastly, you should not put patients under pressure to agree to a particular intervention (and you must be particularly scrupulous in this regard if you have a financial interest in a facility you wish to refer the patient to).
As a doctor, you have a duty to give your patients the benefit of your expert opinion, so there is nothing wrong with advising them and letting them know what your preferred course of action would be if you were in their shoes, but be careful not to let your advice cross over into pressure or coercion. See the scenario above for an example of how easily an attempt to allay a patient’s concerns may develop into coercion.