Prior to administering a treatment – whether for therapeutic, preventative, diagnostic or other health-related purposes – informed consent must be obtained from the patient in accordance with O. Reg 202/94 under the Pharmacy Act, the Health Care Consent Act (HCCA) and the Code of Ethics.
The province’s Personal Health Information Protection Act (PHIPA) is not discussed in this article, as consent in PHIPA is related to the collection, use and disclosure of personal health information by health information custodians.
Pharmacy professionals should be familiar with key elements of the legislation governing informed consent to treatment that are most relevant to the provision of pharmacy services and patient care. This article provides an overview of these elements, and registrants are reminded to refer to the legislation for full details. Where applicable, Standards of Practice and principles from the Code of Ethics are also included.
1. Informed Consent
O. Reg 202/94 under the Pharmacy Act requires a pharmacy professional to receive an informed consent from the patient, prior to administering a substance by injection or inhalation or performing a procedure on tissue below (piercing) the dermis.
The Health Care Consent Act sets out the requirements for a patient’s consent to treatment to be informed. Accordingly, the pharmacy professional must first provide information to the patient about the:
- Nature of the treatment.
- Expected benefits of the treatment.
- Material risks of the treatment.
- Material side effects of the treatment.
- Alternative courses of action.
- Likely consequences of not having the treatment
The extent of information provided is a matter of professional judgement, based on what a “reasonable person in the same circumstances would require in order to make a decision about the treatment.” The pharmacy professional should confirm the patient’s understanding and respond to any requests for additional information. Confirmation that informed consent was received must be noted in the patient record in accordance with the regulations and Documentation Guidelines.
It is a Standard of Practice for pharmacists to give patients the information they need to make decisions about their care in a way they can understand and to respond to patient’s questions.
Similarly, technicians who provide patient education should respect the patient’s right to make their own, informed, decisions about their care.
To support the patient’s informed decision-making, the Code of Ethics expects pharmacy professionals to provide relevant and sufficient information regarding the potential risks and the most frequent/serious side effects associated with the medication therapy or pharmacy service.
2. Elements of Consent
According to the Health Care Consent Act, for a patient to consent to a proposed treatment, the consent must:
- Relate to the treatment
- Be informed
- Be given voluntarily
- Not be obtained through misrepresentation or fraud
The Code of Ethics expects registrants to respect the patient’s autonomy and their right to be an active decision-maker in their care. Registrants must be honest in dealing with patients and not influence, persuade or pressure them to accept pharmacy services.
3. Express or Implied Consent
Consent to treatment may be express or implied. Express consent is explicitly and clearly provided, either verbally (orally) or in writing. Alternatively, a pharmacy professional may determine that implied consent is provided, based on the patient’s action(s) or inaction in the circumstances at hand. When consent is implied or given verbally, the pharmacy professional should document this on the patient record.
4. Capability and capacity
The capability of a patient to give consent is contingent on their mental capacity to understand why and for what the consent is for, and depends on particular treatment and/or point in time. Pharmacy professionals can rely on the presumption of capacity unless they have reasonable grounds to believe otherwise. Subsequently, there is no minimum age of consent in Ontario
Pharmacy professionals have an ethical obligation to respect the right of a competent minor to provide informed consent and make decisions about their healthcare.
5. Withdrawal of Consent
A patient may refuse to give, or withdraw, their consent at any time. Otherwise, pharmacy professionals can presume that consent to a treatment includes consent to the continuation of, or adjustments in, the treatment, if the above factors do not significantly differ.