Ethics of prescribing psychiatric medication to children and

Ethics of prescribing psychiatric
drugs to children and
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
4. Background to disorders in children &
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
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
Background to disorders in children &
• 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
• 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,
• 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
• 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
• HOWEVER, it is part of our ethical duty to
promote an environment within which the child’s
physical, emotional and moral autonomy can
• 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
• ‘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…
• 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
• 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,
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
B) assess patients understanding of above
C) assess capacity of patient/parent to make
D) assure that patient/parent has freedom to
choose among options/alternatives without
coercion or manipulation
• 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
• 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
• 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
• 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,
• 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
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
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
8. Seek permission to share appropriate
information with other adults, school, family
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
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
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
10. Make patients and families partners in the
process of prescribing. Educating them about
medication is essential.

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