The Standards of Practice for Pharmacy Managers came into effect July 1, 2005, replacing the existing Standards for Designated Managers and the Standards for Pharmacists Supervising Hospital Pharmacies.
For a printable PDF file of the following Standards, click here
Overriding Principles:
For purposes of this document, a “manager”:
1. is a pharmacist licensed in Part A of the register who is designated by the proprietor of the pharmacy or administrator of the hospital to be responsible for the operation of the pharmacy.
"Designated manager" means the pharmacist identified by the owner of the pharmacy, in information provided to the College, as the pharmacist responsible for managing the pharmacy. This pertains to the Drug and Pharmacies Regulation Act (D.P.R.A.) definition of the designated managers in pharmacies accredited by the College since the practice of pharmacy in hospitals is exempt from this Act.
2. has authority over decisions affecting the operation of the pharmacy.
3. shall ensure adherence to the requirements defined by legislation and policy governing the practice of pharmacy.
4. must actively and effectively participate in the day-to day management of the pharmacy.
Although some areas appear in the Standards of Practice for all pharmacists, this document is intended to reinforce the importance of these Standards as well as the higher expectations of the designated manager. They do not absolve individual pharmacists of their professional responsibilities.
The legislation that forms the foundation of these standards is the Drug and Pharmacies Regulation Act (DPRA), Section 166, definition:
Responsibility of owner and manager
166. (1) Every owner or manager of a pharmacy is liable for every offence against this Part committed by any person in the employ of or under the supervision of the owner or manager with the owner's or manager's permission, consent or approval, express or implied, and every director of a corporation operating a pharmacy is liable for every offence against this Part committed by any person in the employ of the corporation with the director's permission, consent or approval, express or implied. R.S.O. 1990, c. H.4, s. 166 (1).
Idem
(2) Where any person operates a pharmacy contrary to this Part or the regulations, the owner and manager of such pharmacy, or either of them, or any director of a corporation operating a pharmacy, may be proceeded against, and prosecution or conviction of any of them is not a bar to prosecution or conviction of another. R.S.O. 1990, c. H.4, s. 166 (2). "
The manager is responsible for the overall operation of a pharmacy including:
1. Professional Supervision of the Pharmacy
2. Facilities, Equipment, Supplies, and Drug Information
3. Record Keeping and Documentation
4. Drug Procurement and Inventory Management
5. Training and Orientation
6. Safe Medication Practices
7. Accountability for Managers of Accredited Pharmacies
STANDARD 1
Professional Supervision of the Pharmacy
Pharmacy Act, 1991
Authorized acts (S.O. 1991, c. 36)
4. In the course of engaging in the practice of pharmacy, a member is authorized, subject to the terms, conditions and limitations imposed on his or her certificate of registration, to dispense, sell or compound a drug or supervise the part of a pharmacy where drugs are kept. 1991, c. 36, s.4.
1.1 The manager shall ensure that only pharmacists registered with the Ontario College of Pharmacists, or registered students or interns under the supervision of a pharmacist, are allowed to perform the controlled acts of a pharmacist. No person except a pharmacist is permitted to direct, influence or control any action defined under the Standards of Practice.
1.2 The manager shall ensure that pharmacists can be clearly distinguished by the public from other pharmacy support staff and other staff.
1.3 The manager is responsible for ensuring that any delegation protocols permitted in the pharmacy are in compliance with OCP policies.
1.4 The manager is responsible for determining and maintaining the appropriate staffing levels required to satisfy patient care needs unique to their practice site and allow full compliance with the College's standards of practice.
1.5 The manager shall ensure that a registered pharmacist is on duty during all hours of operation*
Hospital pharmacy is exempt from the DPRA, however,
• Hours of pharmacy services shall meet the needs of hospital clients; arrangements shall be made for after hours provision of medications;
• After hours access to a hospital pharmacy for obtaining medications shall only be by the pharmacist or delegated personnel under authority and guidance of the pharmacist.
1.6 A policy shall be established for an emergency situation, when the pharmacy is closed, which necessitates immediate access by designated non-pharmacy personnel. Access shall be documented and communicated to the manager as soon as possible. Examples of emergency situations would include fire, flood or security breach.
1.7 All advertising is compliant with the current regulations, policies or guidelines*.
* hospital pharmacy is exempt from the DPRA
STANDARD 2
Facilities, Equipment, Supplies, and Drug Information
2.1 The manager shall ensure that there is sufficient space, facilities, equipment, information resources and supplies which are of the type, quality and quantity to:
2.1.1 Support the principal functions and related processes, goals and objectives; and
2.1.2 Ensure a safe working environment for pharmacy staff (e.g., consideration for handling antibiotic, cytotoxic, biological and hazardous products, staff and patient security, etc.)
2.1.3 Comply with section 72 and 73 of Reg. 551 under the DPRA (physical conditions/image of the pharmacy)*.
*hospital pharmacy is exempt from the DPRA
2.2 The manager is responsible for ensuring that any specialized function undertaken at the pharmacy follows established OCP and/or CSHP guidelines/procedures/policies relevant to that function and that the appropriate space and
equipment is available and maintained in good working order (e.g., custom compounding, sterile compounding,
long-term care, methadone).
2.3 The manager shall ensure that
• Library requirements (as per DPRA Reg. 551 s.73(k) for accredited pharmacies or the Canadian Society of Hospital Pharmacists (CSHP) Standards for Hospital Pharmacies) are met and that relevant references regarding specialized practice are available, and
• There is access to a drug information service that meets OCP and/or CSHP criteria.
2.4 The manager shall ensure that if operating a lock & leave area of an accredited pharmacy, all specific requirements for that type of operation are met.
STANDARD 3
Record Keeping and Documentation
3.1 The manager shall ensure that there are policies and procedures in place for consistent record-keeping and documentation.
3.2 The manager shall ensure that the software systems used are capable of complying with all relevant record keeping requirements, guidelines, and standards of practice.
3.3 The manager shall ensure that written procedures are established to ensure that privacy of personal health information is protected.
STANDARD 4
Drug Procurement and Inventory Management
4.1 The manager shall ensure there is an adequate inventory control system to:
a) Detect, segregate and dispose of outdated, deteriorated, recalled, obsolete or hazardous drugs, according to
environmentally sound methods;
b) Ensure that medication storage, including investigational drugs, within the pharmacy and, where applicable, throughout the institution is the responsibility of pharmacists;
c) Ensure that all medications are stored under proper conditions of sanitation, temperature, light, humidity,
ventilation, regulation, security, and safety; and
d) Restrict access to medication storage areas to designated personnel.
4.2 The manager shall ensure that a physical count of all narcotic, controlled drugs and targeted substances is conducted at least once every six months. The results of the inventory must be retained for a two-year period in a readily retrievable format in the pharmacy. An inventory of all narcotic, controlled drugs and targeted substances must be conducted whenever there is a change of designated managers or after any break and enter or theft from the pharmacy premises.
4.3 The manager is responsible for ensuring that all losses of narcotics, controlled drugs and targeted substances are reported, as required by law, to the appropriate authority.
4.4 The manager shall make recommendations and provide direction to ensure that all medications purchased for use or sale are of acceptable standard and quality.
4.5 The manager shall ensure that there are procedures in place for obtaining supplies of medications in an
urgent situation.
STANDARD 5
Training and Orientation
5.1 The manager is responsible for ensuring that all staff in the pharmacy is competent to perform duties defined by their position including specialized functions. Certification of staff may be required for some specialized functions.
STANDARD 6
Safe Medication Practices
6.1 The manager shall ensure that all new, professionally relevant information (e.g., drug recalls, warnings) directed to the pharmacy is immediately available to the staff pharmacists.
6.2 The manager is responsible for ensuring that the medication processing systems (e.g., preparation, distribution, repackaging, returns, compounding, dispensing, etc.) used by the pharmacy are designed to minimize errors, protect the public, and enable staff pharmacists to satisfy their obligations under the Standards of Practice. Consideration should be given to staffing levels, space, environment, information systems, and resources.
6.3 The manager is responsible for ensuring that a system of communicating and documenting patient and drug information is in place in order to provide consistency of care. (Please refer to Documentation Guidelines for Pharmacists 2004.)
6.4 The manager is responsible for ensuring that a system is in place for the implementation/maintenance of a medication error follow-up and reporting protocol.
6.5 The manager shall ensure that there are processes in place to evaluate the quality of the pharmacy services provided and to make the necessary changes to improve practice.
STANDARD 7
Accountability for Managers of Accredited Pharmacies
7.1 The manager must submit to the College an acknowledgement letter outlining that he/she has read and accepts the responsibilities of their position.
7.2 The manager shall respond in writing to the Registrar’s queries regarding pharmacy practice situations and, where applicable, identify the member involved in any matter under review.
7.3 The manager is responsible for developing and submitting any action plans that may be directed by the College.