Inside Tomorrow's Pharmacist (2001)

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Clinical pharmacy: autonomy, informed consent and concordance

Clinical pharmacy: autonomy, informed consent and concordance by Ailsa Benson

I am sure that you will be the first to agree that your degree course has covered quite a range of topics, some of which you will have enjoyed more than others. But — and I realise that I am guessing here — many of you will feel that your contribution to health care will be in the use of your clinical pharmacy skills and knowledge.

Clinical pharmacy activities have been said to influence the correct use of medicines at three levels — before, during and after the prescription is written.1 But, as Nick Barber has pointed out,2 there is an all-important fourth aim — that of respecting patient autonomy.

Remember your ethics lectures? Autonomy is the capacity to think, decide and act freely and without let or hindrance. But we need to be sure that we recognise that there is a difference between respecting and creating autonomy, which is why in this article I am also going to discuss informed consent.

We need to see the patient as a human being with their own decision making capabilities, and inform them of the risks and benefits of their actions to do with drugs.2 But even this, in and of itself, is not enough. Concordance is our aim in talking with patients about their drug therapy and the article will conclude with this topic and how you can, with three questions:

• Help to create autonomy

• Demonstrate respect for it

• Aid informed consent

• Achieve concordance

In so doing, you will be truly delivering a clinical pharmacy service.

It is not uncommon for us all to use one word to embrace many different concepts. Unlike the Inuit who have numerous words for snow! So too with autonomy. We all have a shared understanding of the general intent behind the word, but have you ever thought about the important distinction I highlighted above? Which do you think comes first — respecting or creating autonomy? If we think about it, it is probably true to say that practical work for health has always been carried out with the intention of creating autonomy.3

In pharmacy, the medication we are supplying is intended either to alleviate symptoms or to cure the problem. By providing such pharmacological interventions we are helping to create autonomy. A health problem can make us tired, damages our body in one or more ways and clearly destroys autonomy.4 But we start to respect autonomy when we accept a patient's decision about the what and how of using medicines and other treatments.

The responsibility for ensuring that any such autonomous decision is the result of properly created autonomy is one that we should not treat lightly. If someone decides not to use the medication appropriately, we need to try and understand the reasons behind this. We have a professional responsibility to do our utmost to ensure that their decision is based on a proper understanding of the circumstances, an ability to make a rational choice and, of course, the ability to act on that choice.5

You will, I am sure, make the connection between that and the concept of informed consent. Informed consent means more that just telling or disclosing information to the patient; it brings with it a key responsibility to ensure the patient's understanding and consent. The classic tests for informed consent are:

1. Competence (to understand and decide)

2. Disclosure (of material information)

3. Understanding (of the information)

4. Voluntariness (in deciding what to do)

5. Consent (to the intervention)6

You might like to consider who is the driver for each of these — you, the patient, or both of you together.

Doing things to other people without satisfying these tests is both to override their autonomy and to fail in helping to create it. So every time you hand a customer her tablets and say: "here they are, take one three times a day," you are not ensuring that there is informed consent. Nor are you really practising clinical pharmacy. Taking medicines amounts to a medical intervention and any individual needs sufficient information in order to accept this choice.7

Now we know that many customers are happy to take the tablets, but we do have a responsibility to ensure that they understand the implications. Side-stepping questions about what they are with a bland statement, such as: "well, the same tablet can be used for many different things so you need to ask your doctor", are not supporting the concept of informed consent — and certainly doing nothing for either the creation or respecting of autonomy.

Since some 50 per cent of people with chronic medical conditions are unable or unwilling to take the medication prescribed for them in optimum doses,8 it is not surprising that the term compliance has fallen out of favour. Perhaps a greater understanding is now been given to what we really mean about the consent component of informed consent and the creation of autonomy. So a new term "concordance" has been born. This is an agreement reached after negotiation between a patient and health care professional that respects the beliefs and wishes of the patient in determining whether, when and how medicines are to be taken.8

Interestingly — and importantly — this term acknowledges that there is a two way relationship between health care professional and patient and is a tacit acknowledgement of the need to respect the autonomy of the health care professional too.

The two key factors which are key components to the understanding — and hence creation of — autonomy are to do with the patient's idea of the need for therapy and any worries about the risks involved, not just side effects but also about dependence and addiction. So asking patients: "what would you like to know about your medicines" and "what do you understand about your health problem" provide the opportunity to help a patient understand why the medicine is necessary. This gives you the opportunity to explain the benefits based on evidence; it helps them to make an informed risk assessment.

But to maintain autonomy and concordance, we need to provide the opportunities for patients to feedback on experiences and concerns. We can do this proactively by asking people when they return with repeat prescriptions, and even by saying something like: "please remember that whenever you have questions about your medicine I would be happy to answer them."

Mrs Benson is head of training, National Pharmaceutical Association