Medical Directives and the Delegation of Controlled Acts
Approved: October 2007; Revised: June 2014
- Model Standards of Practice for Pharmacists
- Model Standards of Practice for Pharmacy Technicians
- Documentation Guidelines
College Contact: Pharmacy Practice
This policy sets out the College’s expectations for members when considering delegation, and provides guidance on a member’s responsibility when performing delegated acts. The use of delegation is in accordance with the provisions of the Regulated Health Professions Act, and the Pharmacy Act.
- Delegation of a controlled act should only occur if it is clinically appropriate and in the patient’s best interests.
- The use of delegation is only appropriate to advance patient interests, not professional self-interest.
- Patient safety is paramount and a member should only accept delegation if he or she feels competent to perform the delegated act or procedure.
- A member is accountable for his or her performance and patient outcomes when accepting delegation.
Controlled acts are specified in the Regulated Health Professions Act, 1991 (RHPA) as acts which may be only performed by authorized regulated health professionals(1). A controlled act can be delegated by a regulated health professional with the authority to do so.
Delegation is a process whereby a regulated health professional authorized to perform a controlled act under a health profession Act (delegator/authorizer) confers that authority to someone (regulated or unregulated) who is not so authorized (delegate/implementer) (2). Any act or procedure can be delegated as long as delegation is not prohibited by legislation or organizational policy (e.g. by regulation, a pharmacy student is not permitted to delegate or accept the delegation of a controlled act) (3).
An order is a prescription for a procedure, treatment, drug or intervention and may take the form of either(4):
A. Direct Order — A direct order is an order to perform a controlled act for only one patient for a specific intervention. It may be verbal or written and only occurs after a direct assessment of the patient by the authorizer.
B. Medical Directive — A medical directive is a written order to perform a controlled act for any patient who meets the criteria set out in the medical directive. A medical directive can order a procedure or series of procedures under specific conditions without a direct assessment of the patient by the authorizer (e.g. authorizing a pharmacist to order INR testing for a patient receiving warfarin therapy). Ideally all health professionals involved in authorizing and implementing procedure(s) under medical directives participate in their development.
The regulated health professional conferring delegation will be referred to in this policy as the authorizer, and the person receiving the delegation will be referred to as the implementer. Delegation takes place through either a direct order or a medical directive. Delegation confers the legal authority to perform a controlled act, whereas an order provides instructions on how to perform it.
A member may delegate a controlled act subject to the terms, conditions and limitations of his or her certificate of registration (Appendix A). It is not considered delegation to authorize the initiation of a controlled act that is within the scope of practice of that health professional. It is also not considered delegation to refer a patient to another health professional for care.
A member must only delegate acts that he or she is personally competent to perform and which are a part of his or her regular practice. When delegating an act or procedure, the authorizer is responsible for ensuring that the act is performed competently, and that delegation is in the best interest of the patient. Accountability for the delegated act remains with the authorizer, who must be especially diligent in assessing the performance readiness of an implementer to ensure safe and effective care.
Sub-delegation, where a member delegates an act that was delegated to them, is not permitted.
If a member accepts delegation for an act or procedure in one setting, he or she cannot assume that delegation is transferable to another setting. A change in setting does not affect the competency of the member but does require assessment by both the member and authorizer to ensure the delegated act is appropriate given the conditions of the new setting.
In circumstances where a member is not named in a direct order (e.g. a prescription for a vaccine may include the order “pharmacist to inject”) the member should be confident, based on his or her communication with that authorizer, that the order was intended for him or her and that appropriate assessment of the member’s performance readiness has occurred.
Medical directives identify the health care professionals authorized by the order (e.g. all pharmacists at the Long River Family Health Team).
The Federation of Health Regulatory Colleges of Ontario (FHRCO) has developed An Interprofessional Guide on the Use of Orders, Directives and Delegation for Regulated Health Professionals in Ontario which contains templates for assessing performance readiness, developing a medical directive and education and competence assurance plan, and additional tools to assist with delegation. Members are encouraged to review the FHRCO guide and utilize the templates when developing a medical directive. In addition, FHRCO lists all controlled acts defined under the RHPA along with the health professionals authorized to perform each act.
Accepting a Delegated Act or Procedure
1. Patient Best Interests
Independent of the assessment by the authorizer, a member must use professional judgment when accepting delegation to evaluate the associated risks and determine whether delegation is in the best interest of the patient. Delegation should not occur solely for convenience and should never be accepted on the basis of professional self-interest. A member should have current knowledge of the patient’s condition and therapy and only accept delegation in the context of a member-patient relationship unless the patient’s best interests dictate otherwise (e.g. if a pharmacist orders lab work under a medical directive in an emergency department).
In accepting a delegated act or procedure, the implementer will:
- Assess the patient to confirm the patient’s need for the act or procedure;
- Consider the known risks and benefits to the patient, the predictability of outcomes, and the safeguards and resources available to safely manage outcomes; and
- Identify any other factors specific to the situation.
2. Assess Personal Competence
In every instance where a member considers accepting delegation the member will ensure that he or she has the appropriate knowledge, skill and judgment to competently perform the act or procedure, as well as safely manage all foreseeable outcomes. In addition, the setting in which the member practices must have appropriate facilities to perform the delegated act or procedure (e.g. there must be a clean, safe, private and comfortable area for administration of injections). A member will provide any information the authorizer may need to assess the member’s competence to implement the act or procedure.
Both the authorizer and implementer are accountable for self-evaluation of:
- Competence and capacity to perform the delegated act or procedure; and
- Ability to manage patient outcomes.
Upon accepting delegation a member is accountable for performing the act or procedure competently and for ensuring that any potential outcomes are managed appropriately.
4. Patient Consent
The implementer is required to provide the patient with appropriate information on the authority under which the act or procedure is being performed, and the patient must give informed consent. As required by the Health Care Consent Act the implementer must ensure that the patient understands that the authorizer has delegated the act or procedure to the member (5). Providing appropriate information to the patient includes the ability to answer questions regarding the risks and benefits of the act or procedure. If a member is unable to provide information that a reasonable person would request, the member should reconsider whether or not acceptance of delegation of the act or procedure is appropriate.
A member must document that he or she obtained informed consent from the patient to proceed with delegated act or procedure. A member is also required to document details of the delegated act or procedure performed under a direct order. Additionally, under a medical directive a member is required to document the results of the patient assessment as well as the rationale for performing the delegated act.
Members can refer to the Documentation Guidelines for more information.
Appendix A: Terms, Conditions and Limitations on a Member’s Certificate of Registration
- Can delegate
- Can accept delegation
- Can not delegate
- Can not accept delegation
- Can not delegate
- Can accept delegation
- Can not delegate
- Can accept delegation
* Terms, Conditions and Limitations on a Member’s Certificate of Registration are specified under the general regulation of the Pharmacy Act.
- Regulated Health Professions Act, 1991, S.O. 1991, c18, s. 27(1)(a,b)
- Federation of Health Regulatory Colleges of Ontario. An Interprofessional Guide on the Use of Orders, Directives and Delegation for Regulated Health Professionals in Ontario. Retrieved on January 31, 2014
- Pharmacy Act, 1991, O. Reg 202/94, s.12(5)
- College of Nurses of Ontairo. Authorizing Mechanisms (2014). Retrieved on March 21, 2014
- Health Care Consent Act, 1996, S.O. 1996, c. 2, Sched A, s.11(1)