Psychopharmacology and Pregnancy: Treatment Efficacy, Risks, and Guidelines 2014

2. The Process of Obtaining Informed Consent When Prescribing Psychopharmacology in Pregnancy

Martien Snellen , Geoff Thompson2 and Neill Murdoch3

(1)

Mercy Hospital for Women, Heidelberg, Australia

(2)

Private practitioner, Melbourne, Australia

(3)

Victorian Bar, Melbourne, Australia

Martien Snellen

Email: msnellen@iprimus.com.au

2.1 Beneficence

2.2 Autonomy

2.3 What Is “Informed Consent”?

2.4 Requirements of the Law and of Ethical Practice

2.5 Principles of Informed Consent

2.6 Competence

2.7 Voluntariness

2.8 Disclosure and Recommendation

2.9 Understanding

2.10 Decision and Authorisation

2.11 What to Make of It All?

References

Abstract

As with most things, in order to understand a modern concept it is useful to have knowledge as to its historical evolution. To comprehend fully the ethical and legal principle of informed consent in the context of the provision of psychopharmacological treatment in pregnancy this is essential. It is a story of transformation that began with the Beneficence model that is characterised by maximum physician discretion, and ends with the Autonomy model that emphasises increased patient involvement.

Keywords

Informed consentPsychopharmacologyPregnancyGuidelines

As with most things, in order to understand a modern concept it is useful to have knowledge as to its historical evolution. To comprehend fully the ethical and legal principle of informed consent in the context of the provision of psychopharmacological treatment in pregnancy this is essential. It is a story of transformation that began with the Beneficence model that is characterised by maximum physician discretion, and ends with the Autonomy model that emphasises increased patient involvement.

The current approach to decision-making in medicine is governed by the informed consent doctrine that aims to philosophically and legally preserve a patient’s right to self-determination. It was once considered ill-advised to include patients in treatment decision-making: now it is mandatory. The history of the concept of informed consent is also the history of the nature of the doctor–patient relationship and discloses a shift in the focus of control from one to the other.

The evolution of the modern doctrine of informed consent began with the idea that the medical profession should determine what information regarding the risks of any proposed treatment is sufficient. The irony here was that the law had started to recognise that doctors were obliged to inform their patients as to the relevant risks, but left the question of whether that obligation had been complied with in the sole hands of the medical profession itself. Thus, the decision as to what course to follow might have been the patient’s, but that decision could only be made on the basis of the information that a doctor thought reasonable to provide in accordance with contemporary medical standards. This situation continues in the UK (Bolam v Friern Hospital Management Committee 1957; Sidaway v Board of Governors of Bethlehem Royal Hospital 1985) and elsewhere, including many states in the USA (Wear 1998; Faden and Beauchamp 1986). In other places, including a number of other states in the USA (Canterbury v Spence 1972), Canada (Reibl v Hughes 1980), South Africa (Castell v De Greef 1994) and Australia (Rogers v Whitaker 1992), the courts determined what amount of imparted information should be considered sufficient by reference to a notional standard of a reasonable person in the position of the particular patient. Further, in some jurisdictions like Australia, a subjective element has been added as an alternative so that it is the particular patient who determines sufficiency, at least to the extent that the doctor knows or ought to know of that person’s views.

2.1 Beneficence

Until the middle of the last century the prevailing doctrine that informed medical practice was that of Beneficence which emerged from the Hippocratic tradition and its requirement for doctors to have an ethical obligation to act, to the best of their judgment, for the medical benefit of their patients, whilst at the same time doing no harm. In this tradition doctors were encouraged to exercise authority over obedient patients, albeit in a benign and paternalistic way. It was very much a situation where doctor knew best and patients, if they wanted to continue to be treated, acted accordingly. Essentially, at a time where therapies were often of limited benefit and the reliance on the placebo effect was great, it was considered that benevolent deception was a moral and justifiable act. Should the withholding of information be deemed by the doctor to be potentially beneficial for the patient it was considered clearly justifiable. As the word itself conveys, beneficence was the practice of one person doing good for, or acting for the benefit of, another. The “other” in this sense, being the patient, had a purely passive role and barely participated in the decision-making process. What was sought was consent for treatment that was implied by the very act of consulting a doctor.

During the Enlightenment, under the tutorage of such men as Benjamin Rush in America and John Gregory in Scotland, it was advocated that doctors have a duty to be truthful in their disclosures to patients. They introduced a sentiment that improved medical outcomes would emerge from greater patient understanding; however, they did not consider that doctors should deviate from their requirement that patients act exactly as they suggested. It was, in fact, the patients’ ability to share in their doctor’s wisdom that was thought to contribute to overall medical prognosis and thus to be beneficial. Thomas Percival’s Medical Ethics (1803) continued to support this tradition (Percival 1803) and it was not until 1980 that the American Medical Association amended their code of conduct to remove much of this ethic.

2.2 Autonomy

The term informed consent was first used in a legal context by a Californian court in 1957 (Salgo v Leland Stanford Junior University Board of Trustees 1957) and it was not until the 1970s that the informed consent doctrine was broadly developed by bioethicists and lawmakers and widely applied within medical practice (Dolgin 2010). The driving force behind this transformation was the emergence of the right to self-determination in the context of litigation in the USA addressing a constitutional right to privacy (Griswold v Connecticut 1965). The right to self-determination was equated to personal autonomy, itself a concept familiar to the common law where it reflects the “central tenet” that a person is legally responsible for their choices, as a corollary of which that person is entitled to make those choices free from unjustifiable interference from others (McHugh 1999) The development in the law of express notions of self-determination and autonomy in informed consent was associated with the promotion of these ideas in moral theory and, most relevantly, clinical practice (Faden and Beauchamp 1986).

It was determined that patients have the right to protect their bodily integrity, which entitles them to evaluate the different risks and dangers associated with each medical decision prior to giving consent (Beauchamp and Childress 2009). Associated rights include the rights to receive information, to consent to or refuse treatment and to have confidentiality and privacy maintained. At the same time the obligation of beneficence has been maintained.

It has been asserted that the initial imperative to seek consent for medical treatment emerged in the early twentieth century as a response to lawsuits rather than a moral imperative to respect patient autonomy (Will 2011). In the second half of the century the bioethics movement gained momentum in its endeavour to address the imbalance of knowledge within the doctor–patient relationship. In a seminal American case the right to self-determination was expanded when a judge considered that “true consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available” (Canterbury v Spence 1972). The Autonomy model is founded on the assumption that a patient will be able to make an informed decision consistent with their subjective sense of well-being so long as they are given adequate information.

In most cases the doctor’s ethical duty to act in the patient’s best interests and, above all, to do no harm will coincide with both the legal duty to exercise reasonable care and skill in the management of that patient’s condition and with the patient’s right to determine what course that management should take. However, there will be some cases where these principles conflict. What is still not universally accepted by the medical profession is the notion that the patient’s right to autonomy overrides the doctor’s view of what is best for the patient. To respect patient autonomy is to accept that the patient has the right to make bad decisions. In these circumstances the doctor’s ethical and legal obligations are discharged in most jurisdictions by providing the patient with all relevant information as to the patient’s options, including the risks and benefits of each, advising the patient as to what the doctor considers to be the best course to follow, thereby giving the patient the benefit of the doctor’s expertise and experience and then allowing the patient to decide what to do.

Informed consent is now considered to be given when a patient agrees to a proposed treatment based on their participation in a risk: benefit analysis. For this to occur a patient acting autonomously must be competent to understand and decide for themselves, be free of any third party coercion and be provided with all of the relevant facts needed to make a decision. The informed consent principle is still one that exists in evolution with the medical and legal professions, and bioethicists and philosophers exerting influence on the fine-tuning. This is so despite the relative lack of change in the law over the last two decades in most of the common law world.

In the area of perinatal psychiatry there is a potential for the unborn child to come to harm secondary to any proposed treatment. A mother will, in effect, be consenting on its behalf. This raises difficult questions. Plainly, the unborn (or yet to be conceived) foetus is not an autonomous being. It cannot make any determination for itself and is wholly dependent on its mother. In many legal systems it has no legal status at all until it is born alive. In others, legislatures have intervened to create legal personality in the foetus, usually for the purposes of the law in relation to abortion.

It is well accepted that, once born, a person may sue a third party for injuries caused in utero. For the doctor considering the prescription of medication to a woman considering pregnancy this confirms the need for the interests of the unborn to be given due weight. There will be circumstances where the interests of the mother and her foetus will not coincide: where the mother’s mental illness requires treatment without which her life may be in danger but where that treatment will endanger the health of the foetus. Informed consent in such a case will be of the greatest importance, for the psychiatrist treating the mother will have to do so while owing duties both to her and the unborn child.

2.3 What Is “Informed Consent”?

Much has been written about what is meant by the expression “informed consent” and we do not propose to add greatly to it. It has come to be used as a term of art, although plainly it means different things to different people. We regard it as a useful shorthand expression for a complex and critically important clinical tool with important legal ramifications. However, the law has disparaged the phrase as “somewhat amorphous” (Rogers v Whitaker 1992) and “apt to mislead” (Rogers v Whitaker 1980). In the legal context this may be so, as the phrase does not reflect the fundamental precepts of the law of negligence, in which so many of the cases have arisen that require there to be a duty to take reasonable care, a breach of that duty and damage as a result.

Even in the clinical context the phrase has its limitations, as it must cover situations where, by way of example, there is no consent but refusal. The fact is that the phrase is too well established in different disciplines now to be avoided. As with any other such convenient expression, it must be used with care.

We use it to refer to the process whereby a clinician secures the authorisation of their patient to follow a particular course of medical management, having disclosed to the patient the important features and risks of that course, together with the features and risks of any alternative course open to the patient so that the patient’s decision can be regarded as relevantly informed. The requirements of this broad definition are a different matter and it to them we now turn.

2.4 Requirements of the Law and of Ethical Practice

The relevant legal requirements are principally derived from the law of negligence. That is to say, the relevant requirements did not arise from any ethical obligation or clinical practice but from the content of the duty owed by the medical practitioner to a patient where a breach of that duty causes injury.

It is the medical practitioner’s duty to communicate to a patient who is considering a medical intervention the material risks of the proposed intervention. The High Court of Australia (Rogers v Whitaker 1980) has held that a risk inherent in the proposed treatment is material if, in the circumstances of a particular case, either:

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They later added that it is in every case, barring emergency or necessity, the choice of the patient whether to undergo particular medical treatment and that the choice is meaningless unless it is made on the basis of relevant information and advice.

As to the materiality of the risks which may be entailed in the proposed treatment, Australian law requires that the doctor must consider reasonably foreseeable risks, being those which are not farfetched or fanciful, even though they may be extremely unlikely to occur; the precise and particular character of an injury or the precise sequence of events leading to an injury need not be foreseeable. It is sufficient if the kind or type of injury was foreseeable (Rosenberg v Percival 2001). In considering the materiality of a risk, however, some reference must be made to particular rather than general risks if accurate information is to be conveyed concerning the severity of the potential injury or the likelihood of its occurrence.

The situation, which pertains in Australia, is to be contrasted with the law in the UK. There, the House of Lords have determined that a doctor is not negligent if he acts in accordance with a practice accepted at the time as proper by a responsible body of medical opinion even though other doctors adopt a different practice. In short, the law imposes the duty of care, but the standard of care is a matter of medical judgment (Sidaway v Board of Governors of Bethlehem Royal Hospital 1985). This is the so-called Bolam principle (Bolam v Friern Hospital Management Committee 1957). The only requirement imposed on the body of professional opinion supportive of the doctor’s position is that it be, variously, respectable, responsible or reasonable in the sense of not being illogical (Bolitho v City and Hackney Health Authority 1998).

The contrast between the two approaches is clear: in the former, the question of what information must be conveyed is determined by reference to the patient and their perspective. In the latter, the question is determined by reference to a body of responsible professional opinion.

It has been the complaint of the medical profession that while the law has imposed a set of mandatory requirements it has made no attempt to inform as to how compliance with those requirements can be achieved.

A different perspective is indicated. Informed consent should not be seen as onerous compliance with minimum legal requirements but as means of ensuring good communication with patients which is positively beneficial in its own right, through increasing patient understanding, managing expectations, improving compliance and fostering a sense of empowerment and control. This perspective requires consideration of what the doctor is engaged in and trying to achieve.

2.5 Principles of Informed Consent

The bioethicists Beauchamp and Childress (2009) suggest that there are seven key elements that constitute the principle of informed consent: threshold elements (competence and voluntariness), transformation elements (disclosure, recommendation and understanding) and consent elements (decision and authorisation). These will be considered with specific reference to the prescribing of psychopharmacological medicines during pregnancy.

2.6 Competence

In general, a patient is considered to be competent if they can understand a treatment option, deliberate regarding its risks and benefits, form a decision based on this deliberation and communicate their decision adequately. Whilst competence may be easy to define, incompetence is not. A patient may be competent in that they meet these criteria but may be a minor according to the law of the land and incompetent for that reason. Similarly, a person committed for involuntary treatment may lawfully be so treated even though they express an unwillingness to be treated. There is great variation across legal jurisdictions as to what age a person must be before they are allowed to make certain autonomous decisions and the extent of mental and psychological disturbance of capacity required before a third party or surrogate is able to make decisions on their behalf. As a general principle all adults are presumed competent to consent and all children are presumed to be incompetent. In practice, the process of obtaining informed consent may not differ where the patient is incompetent but not lacking the capacity to understand, deliberate, decide and communicate. Their involvement in discussions and agreement to what is proposed should be obtained.

Competence can be seen in absolute terms: it either exists or it does not. Capacity in the competent is to be distinguished: it exists on a spectrum between the highly educated, materially well off, physically and mentally unimpaired mature adult to the illiterate, poor, physically unwell, depressed, brain injured person suffering chronic pain and under the influence of medication or other substances. Capacity in this way overlaps to a large extent with the voluntary nature of the process.

2.7 Voluntariness

Voluntariness is a key element of the greater principle of autonomy. It refers to the idea that a person acts voluntarily if they will an action in the absence of external constraints and coercions. However, in many jurisdictions surrogate decision makers are authorised to treat patients when they are deemed to lack the competence to make decisions on their own behalf that are conducive to their best health outcome. The involuntary treatment of psychosis and depressive suicidality sit as prime examples.

Coercion may involve the making of a threat that will, if carried out, be to the perceived detriment of the patient. A doctor who informs a patient that they will commit them to involuntary treatment unless they take their medication is acting in a coercive way, even though their goal is in the patient’s interests. The same result may be achieved in another more acceptable way, if the doctor were to explain to the patient that the patient needs to continue to take their medication lest they become so unwell that they require hospitalisation.

Perceptions are important in considering how a doctor’s disclosure of information is to be regarded. There is an imbalance of knowledge and authority between doctor and patient, not least in a mental health setting. This imbalance may create a perception in the patient that they have no real choice but to comply with the doctor’s suggested course of action. If the patient’s will is in fact overborne the authorisation given by the patient to the doctor is not valid.

Others may inappropriately influence a patient, including family members. Partners and spouses of pregnant women are relevant here. Care must be taken to see that it is the patient who makes the relevant decision, and that the patient takes it freely, rather than at the behest of or to please someone else. Mostly, putative fathers of unborn children do not have legal rights in relation to those children although they may have, with the agreement of the patient, an important supportive role to play in obtaining informed consent.

2.8 Disclosure and Recommendation

Disclosure refers to the provision by a doctor to a patient of relevant information regarding the condition from which the patient suffers, any investigations required, its prognosis, the possibilities for management, a recommended course of management together with information as to the material risks and benefits of a proposed course and such alternative courses of management which might be open (which may include doing nothing).

Disclosure is about communication between doctor and patient. It is made in furtherance of the patient’s autonomy, which is achieved by increasing the patient’s understanding of their situation. Like all forms of communication, disclosure has to be tailored to the circumstances in order to be effective.

As a matter of general principle, the following must be considered in relation to disclosure of risks:

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As a result of legal proceedings within courtrooms across the globe three basic standards of disclosure have emerged: the proper professional practice standard, the reasonable person standard and the subjective standard.

The first two of these standards have been discussed above. The third, which requires the informational needs and concerns of each patient, no matter how idiosyncratic, to be ascertained and addressed by their doctor in order for the informed consent process to be properly completed, is not legally required practice everywhere. The difficulties of complying with such a standard are obvious. What the patient regards as relevant is deemed to be so regardless of the doctor’s views as to its importance. It may objectively be unimportant. With subjectivity comes the dilemma as to how can a doctor know what is important to any particular patient? Good practice, and to some extent legal requirement, indicates an investigation into what the particular patient is worried about. Legal requirement, in Australia, renders necessary a simple question of the patient, at an appropriate stage in the process, as to what their concerns are.

Many cases present an obvious path to follow: some less so. Some involve insoluble dilemmas—notably in this area where a medication necessary to treat a maternal mental illness creates an adverse risk to the foetus of such magnitude and probability that either the mother takes a chance by not taking the medication (to her own detriment and thereby that of the foetus), or by taking the medication (to the risk of the foetus’s well-being and thereby the mother later on) or there is no pregnancy. Where the decision involves these considerations the ethical implications for the advising doctor are great.

Disclosure is not exclusively a matter of substance. It cannot be achieved solely by dissemination of written information. Where, when and how it occurs, the type of language used and the patient’s underlying cultural beliefs all affect the effectiveness of the doctor’s attempts to communicate.

When it comes to the prescription of psychopharmacological medicines during pregnancy both doctors and patients are inevitably required to tolerate many uncertainties. The knowledge base regarding the full implications for both mother and child are incomplete at best. However, decisions need to be made and actions taken in order to relieve the suffering of the mentally ill. As data accumulates recommendations and standard practice may change. What can be considered reasonable practice at one particular point in time can be considered to be ill-advised at another.

One issue that causes a struggle at the interface between medicine and the law relates to the degree of certainty regarding research. A difference exists between what is established and what is speculated. As we will see in the next chapter methodological issues frequently make it difficult to advise regarding risk with any certainty. The courts and patients alike frequently find it difficult to distinguish between evidence-based risk and reports that suggest an association between exposure and outcome.

Unfortunately this has often resulted in the “knee jerk” response to cease all prescribing of psychotropic medications in the perinatal setting. If it becomes a choice between the doctor being held to account or the illness itself being held to account for any adverse outcome many doctors feel that it is legally safer to expose the patient to the latter risk. All in all there have been far fewer lawsuits filed as a consequence of non-treatment than there have been for negative outcomes associated with treatment. Such defensive medicine can but only lead to a lowering of health-care standards. Thus balancing the risk of foetal exposure with the risk of untreated psychiatric disorder places the clinician “between a teratologic rock and a clinical hard place” (Cohen et al. 1989).

2.9 Understanding

The concept of understanding is a vexed issue. It cannot be presumed that the provision of medical information results in any particular patient appreciating the full nature and implications of any proposed treatment. Studies have consistently revealed that following any medical consultation only around 20–60 % of the disclosed information is actually retained by the patient, the greater the amount of information presented the lower the proportion correctly recalled, and almost half of the information that is recalled is incorrect (Kessels 2003).

It is the doctor’s obligation to ensure that his or her patient has understood the information that has been disclosed. This may be done by discussing the information with the patient, asking that the information be repeated in summary by the patient and asking questions of the patient as to what they think is likely to happen to them (and their baby) and why. Again, the language used is critical.

In order to enhance a patient’s right to exercise autonomy they need to be given the best opportunity possible to understand the information that is given to them. Being provided with written material and time before a decision is made to adopt any particular treatment certainly increases the chances that a patient is able to offer informed consent. We advise that whenever possible the prescribing of psychopharmacological treatment in the perinatal context be separated in time from the consultation that offers opinion and recommendations, that patients are encouraged to explore with their doctor any uncertainties or lack of understanding and that this always occurs in a setting conducive to good communication.

2.10 Decision and Authorisation

Once again, it needs to be stated that for informed consent to be obtained any decision made by a patient to accept treatment needs to be free of coercion, undue persuasion, manipulation by misinformation or otherwise and maleficence. The principle of autonomy requires that a patient is able to not only give consent to any proposed treatment, but they are also allowed to withhold such consent either temporarily or permanently, or to change their position, and to do any of these things without incurring the wrath of their doctor or to find the therapeutic relationship ended.

Once a joint decision is made to embark on any particular treatment this action needs to be authorised. For this to be achieved the patient must unequivocally inform the doctor as to their decision—as to what course of management is to be followed. How this is to be evidenced is a matter of no clinical importance but may be forensically significant. In surgery this action has been enshrined in the signing of a consent form, a practice that has come to be synonymous (wrongly) with obtaining informed consent. In psychiatry consent forms are not much used outside of the context of Electroconvulsive Therapy, although there is no particular reason why this is so. When it comes to the prescribing and administration of medicines in psychiatry the patient’s authorisation is given orally in the course of a consultation with their doctor.

We have described the obtaining of informed consent as a process for good reason. It should not be seen as a one-off event to be attended to in the course of a single consultation. We envisage that the necessary steps—consultation, investigation, diagnosis, disclosure, recommendation, discussion, understanding, consideration, further discussion if need be, followed by decision, authorisation and communication—may take place over a number of consultations each taking some time.

2.11 What to Make of It All?

Doctors frequently find themselves in the uncomfortable position of having to treat a woman with mental illness who is either pregnant or planning to become pregnant. The issue is further complicated by the fact that more than half of the pregnancies in this population group are unplanned and exposure to psychotropic medications may have already occurred during the formative first trimester before they become aware of the fact of pregnancy. As a further complication the statute of limitations in many jurisdictions allows for the filing of civil lawsuits for medical malpractice related to pregnancy and birth for many years after exposure to any prescribed medication and any proposed injury. The net result is that fewer doctors may be willing to treat women with mental illness during the reproductive years, thus rendering more vulnerable an already vulnerable patient population (Einarson and Koren 2007). In the absence of established clinical guidelines for the prescribing of psychotropic medications during pregnancy each doctor and patient is forced to run a medico-legal gauntlet.

It needs to be remembered that the baseline risk for malformation in the general population is 2–4 %. When a birth defect or negative pregnancy outcome occurs it cannot be automatically assumed that any prescribed medication was the causative agent. As will be discussed in other chapters untreated mental illness in itself has been shown to adversely affect many pregnancy- and birth-related outcomes.

In order to provide optimal patient care and reduce overall medico-legal risk we wish to propose the following:

Guidelines for obtaining informed consent for psychopharmacological treatment in pregnancy

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References

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Bolam v Friern Hospital Management Committee. 1 WLR 582. 1957.

Bolitho v City and Hackney Health Authority. AC 232. 1998

Canterbury v Spence. 464 F. 2d. 772. 1972.

Castell v De Greef. (4) SA 408 (C). 1994.

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