Addiction Treatment Blog

Over the past two decades there appears to have been a shift within health care from an expectation that patients with medical problems should entrust themselves passively to the care of physicians to an expectation that they should co-operate in their own care and indeed have some responsibility for the outcome of medical procedures they undergo. The changes are reflected in the terms we used; the word patient, which means someone who endures, is being replaced by terms such as client or consumer, which suggest a more active and discriminating participant in the medical process.

Nowhere is this shift more clear than when it comes to the question of what is known as informed consent. Informed consent was not an issue in medical practice 20 years ago. Today it forms a central issue in a number of ethical codes from the Nuremberg Code to the Helsinki Code as well as Codes originating from the Food and Drugs Administration (FDA) in the United States and the US Department of Health.

It may seem immediately clear what informed consent is but a moment’s reflection is likely to dispel this illusion. In a recent study (1), volunteers were asked to participate in a study which a drug was being investigated and they would be paid for participation in the study. They were then given varying amounts of information about the drug’s properties and expected side effects. It was found that the more information they were given the less likely were they to take the drug, despite being offered money. They were subsequently informed that the drug being investigated was aspirin. Despite now knowing more about the potential problems associated with taking aspirin, most subjects said that what they now knew would not influence how likely they were to take aspirin when they went home, should they have a headache or some other reason for taking it.

Despite its name, therefore, there seems a sense in which informed consent cannot be about being fully informed. Too much information can prejudice valid consent jut as readily as too little. Rather than meaning fully-informed consent, it would seem that informed consent must mean something more like valid consent or voluntary consent.

If we look at the problem in terms of valid consent, then a number of different aspects emerge (2). One is the question of voluntary consent. Another is the issue of adequate or appropriate information; in practice this cannot be separated from the question of comprehension on the part of the person being informed. And finally, there is an issue of legal competence. I will deal briefly with each of these in turn.

Table of Contents

• Voluntary Consent
• Information and Comprehension
• Legal Competence
• Compliance
• Prescribing
• References
• Drug Addiction and Depression Treatment
• Do You Need Help?

Voluntary Consent

When an individual attends for a consultation, there is an implicit assumption that they are seeking help and will take the advice offered by the doctor, psychologist or community nurse. In this regard, a prescription often seems to function in two ways – on the one hand as a treatment for a particular condition but on the other as a symbol of advice being offered. There is a belief that patients are happier when they take a little piece of paper away with them from the surgery than if they leave empty-handed.

Arguably, however, the question of informed consent has come to prominence in recent years, precisely because we generally do not accept this as a proper and fitting way of going about things. We do not voluntarily consent to current practice. There is a problem, however, in that a surgery or outpatient setting is not one conducive to any of us being able to articulate our concerns. In the first instance, we may be worried by the condition that has led us to seek help. Secondly, we may be anxious when faced with the doctor, nurse, psychologist or whoever. Thirdly. we may be aware of the queue of others after us, who need to be seen, and accordingly, we may feel that it would be better in the interests of others to keep our consultation brief. Once the allotted appointment time of 10-15 minutes is up, it is often very clear that the doctor is wondering whether they are likely to get to lunch or to get home if all consultations during this session are going to take as long.

For these and other reasons, we often take the script. But current evidence suggest that most people being treated with antidepressants do not take them beyond 4 weeks, despite recommendations that they are taken for 3-4 months. It seems likely that one reason for this behaviour is that many people being  treated with psychotropic medication do not voluntarily consent to that treatment and, once away from the pressures generated in clinical settings, withdraw consent.

I would argue, however, that the lack of consent involved here does not reflect and opposition to drug treatment so much as an opposition to a style of treatment delivery, in which an authoritarian doctor decides what is best for a patient and issues instructions. Implicit in this approach is the idea that medical science has developed such an extent that there is something approaching certainty regarding the proper management of most conditions and the idea that the practitioner being consulted is an authority or at least knows better than the patient what they should be doing.

In contrast, a cogent case has been argued by a number of commentators in recent years (3,4,5) that medical care should involve an explicit acknowledgement of ignorance or uncertainty on the part of the practitioner and an invitation to collaboration or co-operation. According to this approach, treatment would be a matter of negotiation rather than one of instruction. A negotiation that would recognise that an illness is one event within the drama of someone’s life and that for a variety of reasons, rigid adherence to a treatment regime, with all of the side effects that may be entailed, may not be that person’s top priority.

From this perspective, the issue of voluntary consent becomes a matter of good clinical practice. This is not something that can be properly defined by the law. Even signed pieces of paper, in certain circumstances, may not be interpreted by a court as indicating valid consent, while on the other hand the lack of a signed consent will not necessarily be taken to indicate a lack of consent should someone apply for legal redress for a claimed injury.

The law is only a blunt instrument. But it is one to which, increasingly, many treated by the health services appear to be turning. Ideally. a profession should set its own standards. By this I mean there should be some indications about what the profession thinks generally on certain key issues. In this case, drugs and what their role is in the management of nervous disorders. The problem in mental health work lies in getting the various different professionals comprising a mental health team to come to some agreed form of words regarding the treatments they deliver. On a national scale it would be equally difficult if not even more difficult to get all psychiatrists for example to agree amongst each other on a common form of words. In the absence of such agreements, however, patients who are exposed to a number of different mental health professionals are all too likely to get quite different, if not actually contradictory, views on the nature or purpose of their treatment. The possession of a blog such as this perhaps in some way can redress this problem, in that it at least gives its possessor a relatively clear set of statements, with which their therapist may agree or disagree and in the process reveal something of their likely approach to therapy.

Better practice, by which I mean the kind of co-operative practice that is more likely to result in valid consent to taking the risks involved in any act of health care, in my opinion, hinges on ability of health care professionals to live with explicit ignorance about the likely outcome of particular interventions in the circumstances of their parent’s life. The acknowledgement of ignorance and the sharing of knowledge and power that such an approach advocates is not one that all health care professionals agree is appropriate in all circumstances, or one that all can live with easily given in limited circumstances. This blog, however, has been written in the belief that such an approach is necessary.

Information and Comprehension

As regards the act of informing someone about the risks and benefits of treatments, there is considerable dispute about how much information needs to be on offer. Most commentators appear to come down in favour of informing the taker of a drug of the significant risks associated with treatment rather than making them aware of every possible risk. There a number of issues here.

One is the question being able to make an informed judgement of whether to consent to treatment or not. A bald list of side effects or complications is to unlikely to help any of us to make up or minds. In contrast, meeting someone or a number of people who are taking the drug or have undergone the treatment in question is more likely to offer a tangible example of the issues involved.

The issue of a real-life flesh and blood example rather than abstract lists also brings home the fact that, in making decisions, there is often a question of isolation involved. It is not an easy matter for anyone to be faced with ‘facts’ in clinical settings, which often bring with them implicit requests to make our minds up soon, without the benefit of any prior knowledge of the issues involved. Where psychotropic drug taking is concerned, such isolation and the disempowerment that it brings about could be managed to some extent by encouraging prospective drug takers to visit local user groups or MIND branches.

To some, such a referral to groups like MIND will seem somewhat quixotic, as often these agencies or groups are seen as hostile to medical practice. Where indeed they are hostile, caution is indicated, but even there a pattern of more frequent referral might encourage such groups to take a more collaborative approach to these issues. This could only be good for the community in general, the role of which in accepting medical practices is often overlooked. A century ago, there was much more commonality of understanding and interest between medical practitioners and those they sought to treat. With the relentless progress of technical developments, in the latter half of this century, this commonality of understanding has all but disintegrated. It is not clear what the consequences would be were it to vanish entirely.

On the question of imparting information, a further point of equal importance to any information that is given is an implicit or explicit giving of permission to return with further concerns and queries at a later date or even the permission to consult another. In this case the privileges of the wealthy who would think nothing of seeking further advice elsewhere if they are not happy with what they have paid for contain a pointer to the state of affairs that would be desirable for all.

Finally on the question of information, there is the issue of comprehension. Again it must be noted that clinical settings are often very stressful and there is a good deal of research to suggest that only half of the information imparted is retained afterwards. In order to combat this, the team which I work have a policy of sending copies of the letter to the patients’ general practitioner, detailing what has happened at the consultation, and to the patient also. One purpose of this is to give the patient an opportunity to remind themselves of the recommendations that were made but another is to give them a chance to review these recommendations in a less stressful setting (6,7).

Regarding any recommendations made, the actual language used in making a recommendation may be a considerable problem. The practice of medicine as with the practice of anything else involves the mastery of a jargon. This jargon becomes so commonplace in practice that practitioners often forget that the terms they use may be effectively meaningless to the person they are seeing. A term such as schizophrenia, for example, is likely to suggest something a condition in other words that would not on the face of it appear to be appropriately treated with drug therapy.

In the case of drug trial work, for example, I have regularly found that despite what have seemed to me to be clear instructions, a patient may simply not grasp that of the two pills they are taking, only one is active. Another issue is the question of antidotes. Many patients do not seem to appreciate that the anticholinergic drugs they are taking (see The Management of Side Effects article), for instance, are actually reversing changes brought about the neuroleptic drugs that they are also taking.

Legal Competence

Where mental health matters are concerned the question of legal competence, in the UK, resolves around the issue of whether the person has been detained compulsorily in a hospital and for treatment against their wishes. Detention under this provision of the mental health act assumes that the patient is not, at the time of detention, capable of validly consenting to what appears to be the best available treatment for their condition.

All too often, the interpretation that is put on the status of a patient, whether they are voluntary or detained, is that voluntary patients must consent to treatment, before it can be given, but detained patients can be forced to take whatever is decided by the treating team. This is not the case. The forcible administration of medication, whether the individual is a voluntary or detained patient, may provide the basis for a legitimate claim of assault. Conversely, in circumstances where it is clear that there is an emergency – someone has been violent or is clearly threatening injury to themselves or others, this assault may be justifiable, whether or not the individual has been detained under the mental health act.

The grey area is where mental health staff suspect that problems may be brewing up; that a patient may soon become violent. A concern about potential trouble is more likely to lead to an earlier intervention with medication in circumstances in which there are staff shortages or where staff training is such that there is little confidence in non-pharmacological methods of managing difficult behaviour. The forcible administration of medication in these latter circumstances may well amount to an assault.

Far from permitting such assaults, the spirit of detention under Section 2 or Section 3 of the Mental Health Act is such that patients thereby detained should be treated as though their relatives were constantly present. The treatment should be such that a relative would be likely to approve were they present to witness what was happening. The act was, after all, made to protect individuals rather than to legalise assault in certain circumstances.

Having said this, it should be recognised that what actually happens often depends on the persuasive skills of staff members. Many individuals have considerable skill at persuading others to go along with a sensible course of action. There are probably a number of components to such skills ranging from sheer physical presence and/or force of personality to a number of other tricks of the trade. To some extent such skills appear to me at least to be in danger of being lost. An over-reliance on pharmacological methods of treatment tends to militate against the development of such skills. The heavily prescriptive nature of the 1983 Act, with its Code of Practice, may also be having an effect on the confidence of staff to act in the best interests of patients, because of an uncertainty regarding the legal consequences of doing what seems spontaneously best at the time.

Compliance

There is a very considerable overlap between the areas of consent and compliance. Those who do not consent to treatment are unlikely to comply with it afterwards. Many people when they consent only do so provisionally. For instance, a consent to antidepressant treatment will often only involve an agreement to take the medication until some improvement appears, it will not in the first instance have meant to the patient an agreement to go on taking medication for months and years.

In response to indications of poor compliance with antidepressants, the pharmaceutical industry has gone some way down the road to provide the simplest possible regimes – one pill a day in the case of some of the SSRIs. This, however should not be thought of as the answer to problems with compliance – the issues involved in non-compliance hinge primarily on relationships and education. Current research suggests that the greatest single determinant of compliance is the quality of the relationship between the patient and his key worker or prescriber. This is caught best by William Osler’s famous quip that the distinguishing feature of human beings is their propensity to self-medicate – in other words patients often have much more faith in their pills than in their therapists. It may speak volumes for their relationship with their therapist, if against this background, they chose to give up treatment.

Another important element in the equation is an individual’s personal situation. Becoming a patient, may be just one more episode in a personal drama, a drama that may involve getting or holding a job, sexual relations, driving safely and so much more (3). Nursing staff and other mental health key workers may be much more aware of this than their medical colleagues and could probably do a great deal to minimise compliance-associated confrontations by a judicious imparting of information.

Prescribing (8)

The role of prescribing in issues of compliance and consent also needs to be considered. A prescription initially was an order to a pharmacist to dispense a particular medication. But until quite recently it was not only way a patient could get medication. Most drugs, including thalidomide for example, were sold over-the-counter (OTC). Alternatively based on prescription, a patient could go back to their pharmacist for virtually endless repeats.

The situation effectively changed following the thalidomide disaster and the amendments to the Food and Drugs Act in the US in 1962. Before 1962, there had been resistance to the idea that FDA should have the power to declare new drugs prescription-only. The prescription-only category had been introduced in 1912 to control the availability of drugs like cocaine and the opiates. In 1951 it was extended to restrict the availability of the first really effective agents, the new antibiotics, which could only be got on prescription. This seemed odd to many. But the horrors of thalidomide copper-fastened the position that all new drugs would be available only on prescription in the first instance. As a consequence, since 1962 all of us have, in certain respects at least, been effectively forced to hand over control of our health care to professionals in a way we didn’t have to before.

In recent years some of the new wonder drugs have gone OTC – the H-2 blockers such as cimetidine and ranitidine for instance. Is there any reason why the SSRIs or neuroleptics couldn’t also go OTC? As far as safety and possible interactions with other drugs goes the SSRIs are at least as safe as the H-2 blockers. If chlorpromazine had been available OTC it seems a safe bet that it would never have been prescribed by users to themselves in the huge doses that it was during the 1960s, 70s and 80s. The principal hazard stemming from its use – its intramuscular use in large quantities – is also something that users would seem unlikely to have inflicted upon themselves. In fact the regime that users seem likely to have opted for would probably have been pretty close to what medical opinion 40 years later seems to be coming around to recommending as optimal.

Sold over the counter, the antidepressants would seem likely to have been marketed as tonics rather than antidepressants – they improve sleep, appetite, energy etc. Seen in this light they might be far more acceptable to many people. Part of the appeal behind alternative medicine and the use of health foods is that this kind of management leaves control of health in one’s own hands and there aren’t the same disease implications.

The prescription question is bound up with the question of disease. In 1962, the FDA were attempting to minimise the adverse consequences of drug taking by making any new drugs safer but also by restricting the use of drugs to those who were genuinely ill, so that any risks brought about by a drug would be weighed in the balance of clear benefits also produced. In the case of depression, it would seem that many people simply don’t accept a disease model of depression – they don’t consent to treatment on these premises and as a consequence very often don’t comply.

References

1. Epstein LC, Lasagna L: Obtaining informed consent: form or substance. Arch Int Med 1969, 123:682-688.
2. Levine RJ: Ethics and regulation of clinical research. New Haven: Yale University Press; 1986.
3. Kleinman A: The illness narratives. New York: Basic Books; 1988.
4. Bursztajn HJ, Feinbloom RI, Hamm RM, Brodsky A: Medical choices: medical chances. London: Routledge; 1990.
5. Seedhouse D: Liberating medicine. Chichester: John Wiley and Sons; 1991.
6. Fitzgerald F, Healy D, Williams B: Shared care. Some effects of patient access to medical communications. J Ment Health 1996 5 [in press].
7. Healy D: Involving users in mental health services in the era of the word-processor and the database. In Community care: evaluation of the provision of mental health services. Edited by Crosby D, Barry M. Aldershot: Avebury Press; 1986:209-231.
8. Healy D: The antidepressant era. Cambridge MA: Harvard University Press; 1997.

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