Role of Pharmacy Licensee Flashcards
Licensee Requirements
● Licensee applicant must be in good standing with ACP
● Submit Enhanced Police Information Check
● Any pharmacist applying to be a licensee must complete Part A & B of the Licensee Education Program
● Demonstrate qualifications / experience (meet at least two of the following):
○ The applicant has been registered on ACP’s clinical pharmacist register or as a pharmacist in
another Canadian jurisdiction for the past two consecutive years or more.
○ In the past five years, the applicant has served as a licensee or the equivalent in a Canadian
jurisdiction for at least one year, without being subject to discipline proceedings.
○ In the past 10 years, the applicant has served as a proprietor of one or more pharmacies in
Alberta for at least two consecutive years, where there have been no discipline proceedings.
○ The applicant will be practising in a licensed pharmacy where the proprietor’s agent is a
regulated member in good standing with ACP.
If the licensee and proprietor’s agent are different people:
○ The applicant will be practising in a licensed pharmacy where, in the past five years, the
proprietor’s agent has served as a licensee in Alberta for at least one year, without being
subject to discipline proceedings.
○ The applicant will be practising in a licensed pharmacy where, in the past 10 years, the
proprietor has owned one or more pharmacies in Alberta for at least two consecutive years,
where there have been no discipline proceedings.
Proprietor / Proprietor’s Agent
● Owns the pharmacy OR represents the owner(s) of the pharmacy
● Oversee / directs the operations of the pharmacy - “significant degree of control over”
○ the management and policies of the licensed pharmacy, or
○ the conduct of the regulated members who are employed by the licensed pharmacy;
● Hiring / firing
● Budgeting
● Policies and procedures
● Infrastructure / equipment
May be the same individual as the licensee
Appropriate Licence for the Pharmacy (5 types)
only pharmacies can bill through programs
● Community Pharmacy
○ For provision of pharmacy services to a patient / patient agent (e.g. drug dispensing related
services)
● Compounding and Repackaging Pharmacy
○ Compounding and repackaging and subsequent sale to a pharmacy with a community
pharmacy license, cannot release directly to pt (a pharmacy can have 2 licenses)
● Mail Order Pharmacy
○ For provision of pharmacy services when the patient (or their agent) does not regularly attend
the pharmacy AND the pharmacist does not personally assess the patient on a regular basis
● Satellite Pharmacy
○ Remote location from the community pharmacy - operates at specific times
● Combinations of licences as required
Pharmacy Licensee
Staffing Hours Report proprietor that
directs management of the
pharmacy that contravenes
Physical requirements Equipment and systems standards or legislation
Resources Records Privacy policies (HIA)
Quality assurance processes Website Comply with legislation and
ACP requirements
Pharmacy Licensee Obligations
● New Pharmacy ○ Opening a Licensed Community Pharmacy ● Renewal of pharmacy license (including the signing of statutory declaration) ● Cooperate with practice visits (ACP) ○ Routine Assessment ■ Self-assessment (Licensee) ■ On-site assessment (any pharmacy team member) ■ Reporting and deficiency correction ○ Investigations
can walk in anytie
standard 1
○ Compliance with the law ■ Pharmacy and Drug Act ● Pharmacy and Drug Regulation ■ Health Professions Act ● Pharmacists and Pharmacy Technicians Profession Regulation ■ Code of Ethics ■ Government Organization Act (Sch. 7.1 - restricted activities) ■ Food and Drug Act ● Food and Drug Regulations ■ Controlled Drugs and Substances Act ● Narcotic Control Regulations ■ Health Information Act ■ Animal Health Act
licensee telling a pharm twhen they can do one on one pt interview
this does not impair professional independence
managing when they can happen (not saying you can or cannot do it)
Standard 2
Professional independence
■ Must not practice in conditions where that is compromised
■ Must not impose conditions that will compromise it
Standard 3
Proper staffing
■ Adequate staffing (using judgement)
■ Identify staff (name tag) - pharmacist, student pharmacist, pharmacy technician,
non-regulated - titles that can be used are specified (3.3)
■ Training / appropriate orientation
■ Supervision - including initial evaluation
Supervision - direct
● Direct ○ Supervisor must be present when the restricted activity is being performed ○ Be able to observe and intervene or stop the actions of the supervised individual ● Who? ○ Pharmacy interns ○ Provisional pharmacy technicians ○ Pharmacy students ○ Pharmacy assistant
Supervision - indirect
● Indirect
○ Supervisor must be readily available
○ Supervisor must ensure compliance with P&Ps
● Who?
○ Pharmacy interns who completed SPT
○ Provisional pharmacy technicians who completed SPT
can a student pharm admiister a drug by inj without RPh looking over your shoulder
able to intervene at any time during injection
no
Standard 3
○ Restricted activities - pharmacy technicians
■ Policies and procedures (3.11)
■ Compliance check of P&P
■ Pharmacist to provide direction to the pharmacy technician
● Same pharmacy but not necessarily on the same shift
○ (3.15) “…any drug or health related request or issue that requires therapeutic knowledge,
clinical analysis or assessment, to a clinical or courtesy pharmacist”
Standard 4
○ Physical space
Ensure a suitable environment for practice ○ Environmental conditions ○ Security ○ Signage ○ Equipment ○ Library ○ Confidentiality - sound and sight
not acceptable if you can overhear
Standard 5
○ Drug supply
■ Receipt of product
■ Storage / security
● Temperature monitoring (refrigeration / frozen)
● External / Internal / Injectable
● Human vs Veterinary use
● Narcotic and Controlled Drugs - metal / time delayed safe (5 minute delay
minimum)
■ Packaging / transportation
■ Disposal
do you have to accept expired meds and sharps from pt?
required from COE and SOP
accept appropriately
Standard 6
● Standard 7
Standard 6
○ Quality assurance program (includes error management)
● Standard 7
○ Patients must have access to compounding services
■ Referral or an agreement with a “Compounding and Repackaging Pharmacy”
snessure there is way for pt to get it
Standard 8
○ Comprehensive record keeping
● Creation, storage and retrieval of required records
○ Offsite storage permitted (if approved by Registrar)
● Prescriptions, transactions records, compounding and repackaging records -
2 years past completion of therapy OR 42 months from date of first fill (whichever is greater) - exception - implants - 2 years past date therapy iscompleted
● Patient records - 10 years past last pharmacy service (or two years past ageof majority - whichever is
greater)
can be stored offsite (need ACP approval)
6 yrs 0 how long ti stire record
2 years past age of majority
14
Standard 9
○ Compounding and repackaging pharmacy requirements
● Standard 10
○ Mail order pharmacy requirements
■ Include records related to any arrangement or agreement related to how patients are
referred to the mail order pharmacy
● Standard 11
○ Satellite pharmacy requirements
● Standard 12
○ Remote dispensing - This is BLANK currently
read
Standard 13
○ Closure of a pharmacy
● Inform ACP immediately:
○ Date of closure ○ How drugs are disposed of ○ How patient records are disposed of ○ How patients can access their records ○ Narcotic and controlled drugs transfer records
● Standard 14
○ Proprietor obligations
■ Proprietor is defined as: A person who owns, manages or directs the operation of a
facility in which a licensed pharmacy is located and exercises a significant degree of
control over
i. the management and policies of the licensed pharmacy; or
ii. the conduct of the pharmacists and pharmacy interns, if any, who are employed by the licensed
pharmacy
○ Licensee capability
○ Support and resources
read
Pharmacy License / Website
● Licensee responsible to ensure correct information is displayed on websites
promoting the pharmacy
● Copy of the pharmacy license (displayed in the pharmacy and on website)
● Address / email phone number of the pharmacy
● Name / practice permit number / business address of licensee
● A statement that the licensee is required to provide, on the request of a
patient, the name and practice permit number of any regulated member who
provides a pharmacy service to the patient or who engages in the practice of
pharmacy with respect to a patient.
● Name and business address of the proprietor (and representative)
● Copy of patient concerns poster
