The Policy Regarding the Use of Medical Directives and Delegation by Pharmacists is to be considered in conjunction with the Standards of Practice, the Standards of Practice for Pharmacy Managers, the Standards for Pharmacists Providing Pharmacy Services to Licensed Long-Term Care Facilities, the OCP Documentation Guidelines and the Code of Ethics.

In order to delegate or to accept delegation, pharmacists must ensure that the following principles are met:

The procedure being directed or delegated is clinically appropriate and in the patient’s best interest;

• In making the decision to delegate or accept a delegated task, pharmacists should keep in mind that the establishment of directives or delegation or the performance of practices beyond principal expectations should only occur in order to address patients’ best interests.
• Delegation is only acceptable when the resulting care is consistently the same or better than it would be without the directive, delegation or practice. Entering into an agreement in order to advance professional or personal self-interest, or for convenience, is unacceptable.
• Practice feasibility should be considered; delegation should not result in negative impacts to other parts of the care delivery system.
• The authorizer must have an established or anticipated professional relationship with the patient.

The delegator (authorizer) and the delegate (implementer) have the competency (knowledge, skills and judgment) to perform the acts or tasks;

• In assessing performance readiness, the authorizer and implementer need to ensure that the procedure will be performed competently (i.e., safely, effectively and efficiently) and that the outcomes will also be managed appropriately. Initial education and continuing competency plans may need to be established, particularly for practices beyond principal expectations. A specific form (see Interprofessional Guide/Templates - www.medicaldirectives-delegation.com) may be used (template for establishing performance readiness available).
• Both the authorizer and the implementer are accountable to the patient for their decisions and actions. The authorizer must analyze the potential harm associated with the performance of the delegated act and be satisfied that the risk to the patient is not increased by delegation. The implementor, in turn, only accepts the delegation if (s)he knows that (s)he actually has the knowledge, skills and judgement to safely perform the task.

Patients have consented to receive care by the delegate, under the directive or delegation;

• Pharmacists are advised to ensure that patients understand under what authority an action is being contemplated and performed.
• The medical directive should include provisions for ensuring that the patient accepts the model of care being considered, by identifying how informed consent will be obtained and by whom.

There is a process for documentation of the care provided and for communication of the care to the authorizer;

• Pharmacists are expected to document in a readily retrievable format, action taken under such a protocol, by what authority (for example, the name of the medical directive), and that the action has been communicated to the appropriate health care provider.
• The authorizer and implementer(s) should identify how and where (e.g., on the patient’s health record) performance of the procedure and patient’s response will be documented, and when and to whom it will be communicated.

The above considerations are documented in a readily retrievable format which also includes:
a) A process for regular review of the directive or delegation;

• This is necessary so that all questions and concerns arising from implementation are addressed and should ensure that all appropriate stakeholders have been consulted.

b) The signatures of all authorizers and implementers are on the directive or delegation.

• The medical directive or delegation must include details about how it will be performed, by whom and under what circumstances (template for establishing a medical directive available, see Interprofessional Guide/Templates - http://www.mdguide.regulatedhealthprofessions.on.ca/templates/default.asp).
• The degree of detail provided in each medical directive depends on the circumstances of the situation and on the expectations of the signatories.

Re-delegation of the delegated act(s) is not permitted;
• The implementer cannot further delegate the task/act(s) that was delegated to him/her as re-delegation would compromise accountability.

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Frequently Asked Questions about the Use of Directives and Delelgation

The Federation of Health Colleges of Ontario has developed “An Interprofessional Guide on the Use of Orders, Directives and Delelgation” for regulated health professionals in Ontario.
This guide and templates for medical directives can be found at http://www.mdguide.regulatedhealthprofessions.on.ca/templates/default.asp
Frequently asked questions for pharmacists:

Understanding directives and delegation looks rather complicated. There seems to be a lot of information. Can I simply use the templates?

Understanding directives and delegation can appear rather complicated because of the different points of view that exist depending on the profession, setting and applicable health legislation. Reconciling the apparent contradictions and reaching consensus across all points of view is essential to enabling multi-professional care in any setting, and the information required to achieve this can seem rather extensive.

The templates are tools for establishing both directives and delegation. They incorporate the information identified in the guidelines and apply to all settings and professions, so you may use them on their own if you wish, referring to the guidelines for backup if necessary. In addition to being used for directives and delegation, the templates may also be used to assist with making decisions regarding performing procedures that may not require a directive or delegation, but are beyond principal expectations of practice for proposed implementers. The templates may be used as documents themselves, or they may serve as a guide to assist with decision making or for developing setting specific documents.

At our clinic, the physicians have approved a directive for medication adjustments, diagnostic imaging, and blood tests and team members are completing prescriptions and requisitions pursuant to it. Some of our patients live out of town and will have the prescriptions filled and tests completed by the health professionals in their hometown. How can we be sure those professionals will recognize the prescriptions and requisitions as proper so that the patients will receive the care they need?

Under these circumstances, it is essential to use agreed upon formatting to signify that the prescriptions and requisitions are a physician's order, enabling the relevant professionals (in this example pharmacists, medical radiation technologists and medical laboratory technologists) to practice in accordance with their legislative requirements for orders. Any prescriptions or requisitions completed pursuant to a directive must specifically identify the medical directive (name and number), the individual responsible for implementing the directive (name and signature), and the name of the prescribing physician, along with contact information to clarify any questions. As desired, a copy of the medical directive may be forwarded to further demonstrate the integrity of the order.

The process for developing a directive seems quite involved. Are there other less involved ways to authorize and implement best practices?

It is true that developing a directive can be involved but it is necessary to assure appropriate, coordinated care and patient safety, particularly in larger settings. There are other ways to authorize and implement best practices that are less involved because the decision to implement the order remains solely with a physician or appropriate authorizer and thus does not require the same degree of pre-planning to ensure coordination and appropriateness.

How do I know if I am competent to perform a delegated procedure or any procedure that is beyond my principal expectations of practice? How does an authorizer know I'm competent?
You know you are competent when under the circumstances in the situation, you can reliably demonstrate the knowledge, skills and judgment necessary to perform and manage the outcomes of performing a procedure safely, effectively and ethically in accordance with current best practices and standards of practice for your profession. You may verify competence through consultation with the literature and experts, through successful completion of relevant courses and through supervised practice where a competent practitioner observes and gives feedback on your performance. In the event you are told you are competent, yet you do not believe you are, you would be expected to take the appropriate action to address patient best interests.

Prior to authorizing performance of a procedure, authorizers are responsible for taking reasonable measures to assure that implementers are competent to perform the procedure given the circumstances in the situation. If regulated implementers hold themselves out as competent, authorizers may rely upon this unless there is evidence to suggest an implementer is not competent. Other reasonable measures by which an authorizer may affirm your competence may include directly observing your practice, affirming completion of relevant courses that indicate achievement of competence or accepting an employer's appropriate assurances of your competence.

See 'How Does Accountability Work?' for information on what accountabilities for competence are.

Once I've been authorized to perform a delegated controlled act in one setting, can I perform it in another setting, or do I have to be authorized again?

If you change settings, you do not lose your competencies. However, you and the authorizers and manager responsible for care in another setting do need to be sure that performing the delegated act is appropriate given all the circumstances in the new situation, be it a new organization or a new team within the same organization. This includes assuring that the appropriate authority is in place, for example that the applicable authorizers have signed off on the practice prior to going ahead with performance.

Who needs to be involved in developing a directive? Who needs to approve?

Anyone who is affected by a directive needs to be involved in its development. This includes authorizers, implementers, co-implementers (where two implementers are involved in implementing a directive, for example when a respiratory therapist decides to implement a physician's order for a lab test and a medical laboratory technologist performs the test) and individuals and groups with administrative responsibilities for practice. In smaller settings, this may be a very small number of people, for example a physician and nurse. In larger settings, the numbers would likely be much larger, and may extend to administrative groups. The extent of involvement of each party to the directive may vary depending on the nature of their responsibilities pursuant to it.

Directives must have the integrity of a direct order, thus all physicians or authorizers potentially responsible for patients who may receive care under a directive must approve it. Because physicians or authorizers derive their authority to give orders in part based on their professional relationship with a patient, only those with a professional relationship or anticipated relationship may approve it.

Larger settings with multiple physicians or authorizers may wish to consider how to best facilitate sign-off. Clarifying which physicians or authorizers are responsible for patients receiving the care that a directive applies to can be a starting point. For example, all Emergency Department (ED) physicians would be required to sign a directive applying to ED patients, and surgeons consulting to the ED who may become responsible for ED surgical patients may be involved, however an ED physician would not likely be required to sign a directive pertaining to surgery. Options for sign-off include:

• Enabling physicians who are doing locums to sign off at the outset of the locum, or who are trainees (for example residents) to sign off during the orientation to their clinical rotation may be considered. In such instances, a review of all applicable directives with a signature on one master listing all may be sufficient.
• For cross-hospital directives that every physician or authorizer is directly responsible for, obtaining sign-off as part of privilege renewal may be an option, as long as the timing for directive approval or renewal coincides with that for privilege renewal.
• Implementers may sign-off on the directive, or may indicate their agreement upon implementation of it in practice. Larger settings with multiple implementers may wish to consider how to best facilitate sign-off where it is indicated. One option may be to have representative implementers sign off directly, and individual implementers may sign off upon successful completion of a program of qualification.
• Other stakeholders to a directive may be required to sign off, depending on applicable legislation and policy governing clinical practice.
• Involvement in and approval of a directive is addressed throughout the Guidelines and Templates, including in:
• 'What are the Overall Steps For Approving Directives and Delegation Across the Continuum of Settings',
• The Templates:
  • Section 11 of the Performance Readiness Assessment Instruction Template, 'Those Consulted for Input' and the 'Authorized Implementer(s)' and 'Approving Authorizer(s)' section of the Medical Directive and/or Delegation Template both identify who and how to approve a directive, and
  • The Implementer Approval Form and Authorizer Approval Form can be used to facilitate sign-off, along with the Implementer Performance Readiness Forms - Individual and Group.

When working with directives and delegation, what are authorizers and implementers accountable for?

When working with directives and delegation, both authorizers and implementers are accountable for fulfilling the preconditions identified in the Guidelines 'What Are the Steps for Authorizing and Implementing any Procedure?' and for decisions and actions taken individually and as members of team.

For further information see 'How Does Accountability Work from a Regulatory Perspective' and 'What Are the Steps for Authorizing and Implementing any Procedure?'. The question immediately above on resolving confusion about when a delegation is required and what it looks like also addresses relevant information.

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Recommended Format for a Prescription or Requisition Completed Pursuant to a Directive

A prescription or requisition for diagnostic imaging or laboratory specimen analysis pursuant to a directive must identify the:

• Name and number of the medical directive
• Name of authorizer, and
• Name and signature of the implementer

The following sample illustrates the recommended format for including this information. The format readily signifies to pharmacists that they have a proper order, permitting them to dispense the prescribed medication in accordance with legislative and regulatory requirements. Should there be questions about the prescription, the pharmacist would contact the implementer, in this case, R.F. Janes. If the questions cannot be resolved, the physician or authorizer would be contacted for clarification. The physician or authorizer is recorded as prescriber. Where requested, a copy of the directive may also be forwarded to the pharmacist. The sample prescription is appended to the directive.

The same conventions would apply to requisitions received by medical laboratory technologists and medical radiation technologists that are completed pursuant to a directive.