Informed Consent is the agreement to any medical or mental health treatment (such as a medication, service or procedure) given after the child, parent, and/or legal custodian has had the opportunity to receive sufficient information about its risks and benefits. Consent or denial must be given, after receiving all necessary information, based upon what is in the best interests of the child. To ensure that consent is informed and legally valid, the case manager should collect, either verbally or in writing from the prescriber, information about the following factors, and understand and consider their impact upon the child:
- Nature and purpose of the recommended treatment; what are the prescriber’s reasons for this particular recommended course of treatment?
- Diagnosis; what is the specific condition to be treated?
- Dosages of any medications and the beneficial effects on the condition expected from the medications
- Whether recommendation is for “off-label” use. “Off-label” means that if a drug has been approved for one use, dosage or age group, prescribers may choose to use this same drug for other reasons, if they believe it may be helpful
- Possible side-effects, including probable clinically significant side effects and risks associated with the medications
- Required follow-up or monitoring
- Availability of alternatives, including generally accepted alternative medications and/or non-pharmacological interventions, if any
- Prognosis without an intervention, including the probable physical and/or mental health consequences of not consenting to the recommended treatment, including medication