Pharmacy Licensee Flashcards
Licensee
- Responsibility
Personally manages controls and supervises the pharmacy
- Staffing and practice
- Physical site
- ACP reporting
Licensee
- Who can be
- Only a pharmacist can be a licensee
- Must be actively present in the pharmacy
Proprietor’s
- Responsibility
Owns/Represents the pharmacy
Oversees and directs the operations of the pharmacy
- Number of staff
- Hiring, Firing
- Hours of operation
- Budgets, Policys
- Marketing
Proprietor
- Who can be
Can be the licensee
Can also be represented by A Proprietor REpresentative who represents the owners of the pharmacy
Licensee
- General Requirements
- Good standing with ACP
- Submit police information check (last 6 months)
- Complete Part A and B of Licensee Education Program
- Demonstrate qualifications and experience
Licensee
- Requirements
Registered on ACP clinical pharmacy register for past two consecutive years
OR
Proprietor agent is a regulated member with good standing with ACP
Last 5 years: Licensee/Proprietor has managed a pharmacy without being in a discipline
proceeding for 1 year
Last 10 years: Licensee/Proprietor has owned at least 1 or more pharmacies without
being in a discipline proceeding for 2 consecutive years
Licensee and Proprietor
- Relationship
Licensee reports to the Proprietor
- Licensee is responsible for pharmacy practice
- Proprietor supports and provides the Licensee with the resources needed to meet their obligations
Licensee and Proprietor
- Records
Proprietor is responsible with providing any records from the licensed pharmacy if requested by the licensee
- Health information is protected by licensee
If Proprietor is not a registered member they can NOT access patient records
Kinds of Pharmacy Licensees
Comminity Pharmacy
- Allows service to patients
Compounding Pharmacy
- Sells products to community pharmacy
- If they have a community pharmacy licence then they can also dispense to patients
Mail Order Pharmacy
- Provides service to patients who reguarly do not attend the pharmacy and are not monitored on a regulat basis
Satellite Pharmacy
- No pharmacy in a location so we provide pharmacy services through other means, MUST be linked to another community pharmacy
Pharmacy Licensee
- Obligations
- Opening new Pharmacy
- Renewal of pharmacy license
- Cooperating with practice visits (ACP)
a. Self assessments (By licensee)
b. On-site Assessment (By pharmacy team member)
c. Reporting and deficiency correction
Pharmacy Licensee
- Routine Assessment
- Self assessment
- On-site assessment
- Deficiencies defined and corrected by licensee
- Reported back to ACP
- Continue making improvements to operations and practice
What does a Pharmacy Website require?
Licensee must include:
- Copy of pharmacy license
- Address, email, phone number of the pharmacy
- Name, practice permit number and business address of licensee
- Name and business address of proprietor (and representative)
- Statement that licensee is required to provide name and practice permit of any regulated member who provides a pharmacy service upon request
- Copy of patient concerns poster
What changes in a pharmacy require ACP Approval
- Change of Licensee
- Change of Proprietor
- Keeping any records Off–Site
- Lock and Leave
- Relocation of Pharmacy
- Adding to a Community Pharmacy License
- Hours of Operations
- Regulated Staff Change
- Permeant or Temporary Closure
Change of Licensee
- ACP Notification
Licensee and Proprietor advise ACP
- Pharmacy can run for 90 days max with a temporary pharmacist in charge
- Have to close down pharmacy if a licensee is not found
Change of Proprietor
- ACP Notification
Owner and Major Shareholder (20% or more voting shares in a corporation), and Proprietor’s representatives are included
If a significant change in shareholder agreement occurs ACP should be notified
Off Site-Records
- ACP Notification
Have to notify ACP, location also must be approved
Lock and Leave
- ACP Notification
Can not perform restricted activities in a pharmacy without a pharmacist being on site
- No sales of schedule 1,2,3 products
Regulated Staff Change
- ACP Notification
Inform ACP of start and stop dates
Inform on addition of narcotic signing authority
- Pharmacist can only have narcotic signing authority at one pharmacy
Permanent or Temporary Closures
- ACP Notification
Maximum of 14 days for temporary closure
Licensee
- Additional Considerations
SOP Sexual abuse and misconduct
SOP Lab and POCT
NAPRA Sterile
Non-Sterile
HIA
Netcare
Occupational Health and Safety Act
Foundational Requirements
Licensee Additional Considerations
- SOP Sexual abuse and misconduct
Duty to report any sexual abuse or sexual misconduct
Licensee Additional Considerations
- SOP Lab and POCT
Duty to develop, implement, and manage POCT program
Licensee Additional Considerations
- NAPRA Model Standards for Compounding Hazardous and non-Hazardous Sterile Compounds
High Risk = Inspect every 18 months
Sterile = Inspect every 3 years
Licensee Additional Considerations
- Health Information Act
- Mandatory breach reporting
- Privacy impact assessments
- Licensee is the custodian
Licensee Additional Considerations
- Netcare
- Privacy and security provisions
- Information manager agreement
Licensee Additional Considerations
- Occupational Health and Safety Act
- Employee safety
- Hazard assessment
- Policies and procedure
Licensee Additional Considerations
- Foundational Requirements
Used when opening a licensed pharmacy