Ethics of prescribing psychiatric drugs to children and adolescents Prof Petrus J de Vries Sue Struengmann Professor of Child & Adolescent Psychiatry University of Cape Town Patient age: 11 years 9 months Patient Age: 13 years 2 months Ethics of prescribing 1. Cardinal principles of medical ethics 2. Related values 3. Off-licence/off-label prescribing and the ethical dilemma 4. Background to disorders in children & adolescents 5. So how do we manage prescribing in context of ethics principles? 6. Psychodynamics and prescribing 7. Tips for practice 1. Cardinal principles of medical ethics 1. Cardinal principles of medical ethics 1. Autonomy (Voluntas aegroti suprema lex) – patient’s right to choose or refuse treatment 2. Beneficence (Salus aegroti suprema lex)professionals to act in best interest of patient 3. Non-maleficence (Primum non nocere) – first, do no harm 4. Justice (Justitia) – fairness and equality of access to care and resources Related values 5. Respect for persons – patient (and treating clinician) has the right to be treated with dignity 6. Truthfulness and honesty – informed consent and conflicts of interest The Ethical Dilemma NONMALEFICENCE AUTONOMY SOLUTION??? BENIFICENCE JUSTICE RESPECT, TRUSTFULNESS, HONESTY Background to disorders in children & adolescents • We prescribe for a range of mental health and neurodevelopmental disorders • Children and adolescents may suffer from the same disorders as adults • May present more diffusely/atypically • May respond less predictably • Cumulative impairments may be more subtle (e.g. loss of skill vs never acquired a skill) • Very few drugs are licenced for use in children ‘Off-licence’ and ‘off-label’ • Used to be called ‘Product Licence’ • Now ‘marketing authorization’ (e.g. by FDA, EMA etc) • All products have a Manufacturers’ Summary of Product Characteristics (SPC) reflecting the authorization • As far as possible medicines should be prescribed within terms of marketing authorization • Many children require medication not specifically authorized (‘licenced’) for paediatric use • Prescribing outside authorization cannot be promoted, but it is not prohibited Adherence in children • • • • • • • • • Prescription not dispensed or collected Instructions for administration not clear Purpose of medication not clear Difficulty taking medication (e.g unable to swallow) Unattractive formula (e.g. taste, size, colour) Timing of administration (e.g. during school) Perceived lack of efficacy Real or perceived adverse effects Child/parents perception of risk and severity of effects/side effects may differ from that of clinician So, how do we manage prescribing and discussion of prescribing to children and adolescents within an ethical framework (autonomy, beneficence, nonmaleficence, justice, respect, trustfulness/honesty) Autonomy • Moved away from ‘doctor knows best’ • Individual’s right to have their own opinion, think for themselves, behave as they wish and make their own healthcare decisions based on their own values • In mental health need for autonomy may be greater given that psychiatrists can remove freedom of patients • Even if autonomy leads to decisions at odds with clinician recommendation it has to be respected • Clinician responsibility: not to overly influence choice and to educate and facilitate through accurate and upto-date information Autonomy (2) • Children may not be considered autonomous and may not be deemed to have capacity to consent (understand risks & benefits, weigh up consequences, make, and communicate decision). Parents/guardians often agents of autonomy • HOWEVER, it is part of our ethical duty to promote an environment within which the child’s physical, emotional and moral autonomy can develop • Great emphasis required on ASSENT/APPROVAL from child Consent to medical treatment (Section 129 Children’s Act 2005) • Over age 18 – presumed to have capacity to consent to treatment (we have to demonstrate that they do not have capacity to consent) • Over age 12 – may be mature enough to have capacity (but we have to demonstrate it) + assent from parent • Under age 12 – in law child not deemed to have capacity. Parent consents + assent from child Beneficence and non-maleficence • ‘Best interest’ and ‘first do no harm’ go hand in hand as risk-benefit ratios are considered • ‘Best interest’ requires clinician to have relevant and up-to-date knowledge/evidence about medications • ‘Non-maleficence’ – need to be familiar with adverse effects of medications • ‘Risk’ should not only include physical risk, but also consider social stigma, cost, inconvenience, family disapproval etc… Justice • Fairness or equitable treatment • Distributive justice – fair distribution of healthcare services in society • Access to quality health care, insurance cover, reimbursements, which drugs can be prescribed • Rates of prescribing often increase when there is limited access to non-pharmacological treatments • Patient Advocacy – lobbying for the rights of users – may be part of our ethical duty • Sometimes less than ‘textbook’ treatment is good enough, but sometimes not… Informed consent, decision-making, capacity/competence A) provision of information – in understandable language, nature of condition, nature of proposed treatments, probability of success, risks, potential benefits, alternatives, including choice of no treatment B) assess patients understanding of above C) assess capacity of patient/parent to make decision D) assure that patient/parent has freedom to choose among options/alternatives without coercion or manipulation Duty • To provide information that a ‘reasonable’ doctor would share and what a ‘reasonable’ patient/parent would want to know • NB to consider capacity of parent. When in doubt about parental capacity, seek 2nd opinion. Assent • Ethical and practical reasons to seek assent/agreement from child • The very process of assent leads to conversation that shows respect for the child and for their developing autonomy • Excellent vehicle to educate the child about illness, treatment & prognosis at a level appropriate to their developmental level • Opportunity to increase comfort about matters, improve therapeutic alliance, for child to ask questions important to them, give insight into family/contextual dynamics relevant to medication and adherence • This interpersonal, interactive process is JUST AS IMPORTANT as the content of discussion Steps in Assent 1. Help child achieve developmentally appropriate awareness of condition 2. Let them know what they can expect with tests/investigations and treatments 3. Make judgement of their understanding of situation, factors etc. 4. Get some expression of willingness to accept proposed care Psychodynamics and prescribing • The act of prescribing psychiatric medications has great psychodynamic significance to children, adolescents and families • Uncovering and appreciating the attributions given to medication can contribute to better understanding of psychopathology, development of alliance, adherence and treatment response Psychodynamics and prescribing • Even brief encounters with a doctor carries psychodynamic weight • Developmental expectations interact too – e.g. 6 year old versus 13 year old (autonomy, privacy, self-esteem) • Taking medication may be a constant reminder of being bad, flawed, not good enough • Does the family believe the condition is biologically determined? • Have others in family been treated with medications? Does the child remind them of these family members (positively or negatively)? • Does the child complicate family stress/divorce? Is the child blamed for the challenges? Does family feel pressured by school or others to take medication? • Does the doctor feel pressured to prescribe? The ongoing process.. • Once prescription started the role of the doctor should go beyond checking effectiveness, tolerability, adherence • Learn more about the child, the underlying condition for which prescribed, revisit basic information and supplement to see if early information was accurate, incomplete, or if changes have occurred • Non-compliance should not be seen as a problem to be fixed, but as a chance to get insight into the internal world of the child, psychodynamics of the family, and seen as an opportunity to strengthen the therapeutic alliance with the child, family and others Ten Tips for Ethical Prescribing to Children 1. Think: AUTONOMY, BENEFICENCE, NONMALEFICENCE, JUSTICE 2. Remember that many medications are not licenced for children and we therefore have to have good reason to recommend these medications 3. Therefore take care to get informed consent by giving accurate information in an understandable way, risks, benefits, alternatives, check they understand, seek their choice without pressure 4. Essential to get assent from child – educate, risks, benefits, alternatives, check what they understand, seek agreement Ten Tips for Ethical Prescribing to Children 5. Provide written information wherever possible. Certainly document that you had conversation around consent and assent 6. Where doubt or discomfort about parental capacity, seek 2nd opinion from senior colleague 7. Remember the process of prescribing comes with great psychodynamic significance to child/family. Respect their views and try to understand these Ten Tips for Ethical Prescribing to Children 8. Seek permission to share appropriate information with other adults, school, family members 9. Document discussions about medications, keep records up to date 10. In order to provide accurate information, we need to keep up to date with our knowledge in the field relevant to children/young people. 10 practical prescribing tips for children 1. Diagnosis can be difficult in children and comorbidities are common. Be clear not only about the diagnosis but also the specific symptoms medication will target. Therefore identify and clarify target symptoms for medicines. This will make it easier to agree when a medication is helping or not. 2. Use rating scales to monitor change in target symptoms/domains. This will help you and family to focus on change. 3. Begin with less, go slow, but be prepared to end with more 4. Monotherapy is ideal for children. However, combine with psychosocial treatments wherever possible 5. Allow time for adequate trial. May require longer treatment periods before adequate response – often 8-12 weeks 6. Wherever possible change one drug at a time (and one intervention at a time) 7. Document vitamins, herbs, over-the-counter medications – these can alter metabolism of psychotropic drugs 9. Do appropriate medical and laboratory investigations as required for different medications 10. Make patients and families partners in the process of prescribing. Educating them about medication is essential.