Protocol for Delegating Dispensing & Compounding in Health Care Facilities
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PROTOCOL FOR DELEGATING DISPENSING AND COMPOUNDING IN HEALTH CARE FACILITIES

Approved by June 1995 Council


DEFINITIONS

“Pharmacist”: refers to a person registered as a pharmacist with the Ontario College of Pharmacists

“Accredited Pharmacy”: refers to a pharmacy accredited by the Ontario College of Pharmacists to dispense and sell drugs to the public.

“Delegation”: refers to the transfer of authority to a person who is not otherwise authorized to perform a procedure within a controlled act.

PURPOSE

The purpose of this protocol is to outline the mechanism by which a pharmacist may delegate, to non-pharmacists in health care facilities, specified tasks within the controlled acts of “dispensing”, and “compounding” drugs.

CONTROLLED ACTS

Under the Regulated Health Professions Act, only specified health professionals can perform a “controlled act” as defined in Section 27 in the Act. There are thirteen controlled acts, many with several subcomponents. the most relevant of these acts to pharmacists is Controlled Act #8:

      “prescribing, dispensing, selling or compounding a drug as defined in subsection 117(1) of the Drug & Pharmacies Regulation Act, or supervising the part of a pharmacy where such drugs are kept.”

AUTHORIZED ACTS

The subcomponents of the controlled acts that can be performed by pharmacists are called “authorized acts” and are outlined in the Pharmacy Act:
      “In the course of engaging in the practice of pharmacy, a member is authorized...to dispense, sell or compound a drug or supervise the part of a pharmacy where drugs are kept.”
      (Note that the “prescribing” subcomponent of the controlled act has not been authorized to pharmacists.)

Like pharmacists, physicians also have the authorized acts of dispensing and compounding a drug, while dentists have the authorized act of dispensing a drug in their respective professions’ legislation.

The Regulated Health Professions Act and its companion pieces of legislation do not allow any person other than the ones authorized above to autonomously perform these acts. Therefore, pharmacy technicians, registered nurses (RN), registered practice nurses (RPN), etc. are not authorized to perform these acts independently, regardless of their practice sites.

DRUG AND PHARMACIES REGULATION ACT

In an accredited pharmacy, the distribution of drugs to the public is further restricted by the Drug and Pharmacies Regulation Act (DPRA). Thus, in community pharmacies the full provisions of the DPRA apply, including Section 149, which states,
      “no person other than a pharmacist or an intern or a registered pharmacy student acting under the supervision of a pharmacist who is physically present shall compound, dispense or sell any drug in a pharmacy.”

The DPRA does not allow this authority to be transferred to any other person.

In the health care facility setting, Section 118 of the DPRA exempts hospitals and other health institutions from its provisions. This exemption, however, does not extend to the Regulated Health Professions Act and its controlled acts. Therefore in the institutional setting, although the provisions of the DPRA do not apply, the controlled acts (including dispensing, selling and compounding of drugs) DO apply and remain restricted to those health professionals authorized under the Regulated Health Professions Act.

DELEGATION IN THE INSTITUTIONAL SETTING

There is a process outlined in the Regulated Health Professions Act by which authorized acts can be delegated to non-authorized persons, provided the delegation is in accordance with any applicable regulations under the Health Professions Act governing the member’s profession. Thus, pharmacists can delegate dispensing and compounding of drugs to non-pharmacists in hospitals and other health care facilities.

If the person accepting the delegation is also a regulated health professional (e.g., RN, RPN), the acceptance of delegation must also be done in accordance with any applicable regulations established by that profession’s College.

WHAT A PHARMACIST MAY DELEGATE

The processes of dispensing and compounding drugs consist of technical functions in combination with cognitive functions. It is the College’s position that only the technical aspects of the medication process can be delegated. For example, tasks not appropriate for delegation would include: assessing the therapeutic appropriateness of a prescription and making a recommendation to a prescriber, developing the compounding formula for an extemporaneously prepared pharmaceutical, etc.

This is not to imply that other health professionals (e.g., registered nurses) cannot perform similar cognitive functions within their own scope of practice. However, their performance will be according to their own profession’s expectations and standards and not according to a pharmacist’s training and standards. It is not appropriate for a pharmacist to attempt to delegate the cognitive aspects of dispensing or compounding, as they would be done by a pharmacist.

This protocol therefore only addresses and permits delegation of the technical aspects of dispensing, and compounding drugs.
      1. Delegating “Dispensing a Drug”
        The tasks within “dispensing a drug” which can be delegated are:
        - receiving a written prescription
        - interpreting (i.e., reading) a prescription
        - adjusting an order according to an approved policy (e.g., therapeutic interchange)
        - order entry
        - selecting the drug (i.e., determining product to dispense)
        - reconstituting a product
        - determining expiry date of product
        - repackaging medications (into vial, unit-dose package, syringe, etc.)
        - labeling a product
        - final physical check for accuracy of finished product
        - maintaining (not interpreting) patient profiles
        - maintaining, preparing and operating equipment
      2. Delegating “Compounding a Drug”
        Drugs which may be “compounded” include non-sterile topical and oral preparations as well as IV admixtures and other sterile preparations. The tasks within “compounding a drug” which can be delegated are:

        - selecting ingredients
        - performing calculations of quantities
        - determining equipment to be used
        - physically preparing product according to approved formula and protocol
        - carrying out established quality control assessments on product
        - final physical check of finished product

COMPOUNDING/DISPENSING VERSUS ADMINISTRATION

It can be seen that there is an overlap between what may be deemed to be compounding/dispensing and administration. For example, the reconstituting of an injectable product by a pharmacist is considered part of compounding /dispensing. The reconstitution of the same product by a nurse immediately prior to the drug being administered to the patient is part of administration which falls within a nurse’s scope of practice. It would not therefore be necessary to delegate this procedure to an RN or RPN.

REQUIREMENTS OF THE DELEGATING PHARMACIST

The delegation of dispensing or compounding a drug must be done by a pharmacist who possesses a certificate of registration from the Ontario College of Pharmacists. The delegation may be done by either the Director of the pharmacy service or by a pharmacist so designated by the facility. It is not necessary for the pharmacist to be an employee; however, there should at least be a documented relationship between the facility and the pharmacist wherein the authority and accountability of the pharmacist is outlined (e.g., in a contracted “consultant” capacity.)

The pharmacist must have sufficient knowledge and expertise to ensure that the delegation is done safely and effectively. Any pharmacist who is asked by a facility to delegate a function with which he or she is uncomfortable has the right to refuse to delegate.

DELEGATING TO AN INDIVIDUAL

The pharmacist may delegate to any health professional regulated by the Regulated Health Professions Act (e.g. RN, RPN); however the professional accepting the delegated function must do so in accordance with his/her own College’s regulations. The pharmacist may also delegate to an employee who is not a regulated health professional, such as pharmacy technician, provided this individual is capable and accepts the delegation.

In either case, there should be a mechanism to assess the competence (i.e. knowledge and technical skills) of the person to whom tasks are being delegated. As the level of task complexity and independent activity increases, so should the level of ability. Factors which may be taken into consideration could include educational background, training and experience.

An individual to whom a specific task is delegated should retain the right to refuse to perform that task if she/he believes that additional training is required to allow proper task performance.

Individuals who are registered with the College as registered pharmacy student or interns are not required to have formal delegation of compounding or dispensing, since they are permitted to perform these controlled acts as long as they are supervised in a manner consistent with the College policy for student and interns.

DELEGATION PROCESS

Tasks being delegated should be outlined in policies and procedures developed within the facility and approved by the delegating pharmacist. In approving the policies and procedures, the pharmacist accepts responsibility for ensuring the procedures are in accordance with standards acceptable to the profession of pharmacy.

The pharmacist and the facility should also establish policies and procedures for the delegation process. They should outline who may be delegated specific aspects of the dispensing, and/or compounding functions and how this delegation should take place. The policies should ensure that there is a mechanism for assessing competence initially and on an ongoing basis. It is recommended that quality assurance components be incorporated, to determine if the delegation process is effective and to monitor the need for improvements.

The pharmacist should establish a mechanism for ensuring the person accepting delegation is fully knowledgeable of the policies and procedures and is competent to perform them as outlined. The mechanism may include a “certification” process or another system which assesses and documents training, knowledge, skills and performance. A practical and/or written test may be a component of the process. A process for monitoring and maintaining competency should also be in place (e.g., performance appraisals and/or quality assurance audits, followed by retraining and recertification/retesting process if necessary).

DOCUMENTATION

All policies and procedures relating to the delegation authority, the delegation process, and the delegated tasks should be kept in a readily retrievable format according to the system established by the facility.

There should be a mechanism for documenting which personnel have been delegated which tasks and by whom. The pharmacist delegating the tasks and the person accepting the delegation should both be signatories. The documentation should be kept in a readily retrievable format, such as the employee’s personnel file or designed departmental files or binders. All such documentation should be subject to periodic audits for accuracy and completeness.