Pharmacy Licensee Flashcards

1
Q

Licensee
- Responsibility

A

Personally manages controls and supervises the pharmacy
- Staffing and practice
- Physical site
- ACP reporting

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2
Q

Licensee
- Who can be

A
  • Only a pharmacist can be a licensee
  • Must be actively present in the pharmacy
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3
Q

Proprietor’s
- Responsibility

A

Owns/Represents the pharmacy

Oversees and directs the operations of the pharmacy
- Number of staff
- Hiring, Firing
- Hours of operation
- Budgets, Policys
- Marketing

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4
Q

Proprietor
- Who can be

A

Can be the licensee

Can also be represented by A Proprietor REpresentative who represents the owners of the pharmacy

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5
Q

Licensee
- General Requirements

A
  • Good standing with ACP
  • Submit police information check (last 6 months)
  • Complete Part A and B of Licensee Education Program
  • Demonstrate qualifications and experience
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6
Q

Licensee
- Requirements

A

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

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7
Q

Licensee and Proprietor
- Relationship

A

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

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8
Q

Licensee and Proprietor
- Records

A

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

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9
Q

Kinds of Pharmacy Licensees

A

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

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10
Q

Pharmacy Licensee
- Obligations

A
  • 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
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11
Q

Pharmacy Licensee
- Routine Assessment

A
  1. Self assessment
  2. On-site assessment
  3. Deficiencies defined and corrected by licensee
  4. Reported back to ACP
  5. Continue making improvements to operations and practice
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12
Q

What does a Pharmacy Website require?

A

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

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13
Q

What changes in a pharmacy require ACP Approval

A
  • 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
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14
Q

Change of Licensee
- ACP Notification

A

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

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15
Q

Change of Proprietor
- ACP Notification

A

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

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16
Q

Off Site-Records
- ACP Notification

A

Have to notify ACP, location also must be approved

17
Q

Lock and Leave
- ACP Notification

A

Can not perform restricted activities in a pharmacy without a pharmacist being on site
- No sales of schedule 1,2,3 products

18
Q

Regulated Staff Change
- ACP Notification

A

Inform ACP of start and stop dates

Inform on addition of narcotic signing authority
- Pharmacist can only have narcotic signing authority at one pharmacy

19
Q

Permanent or Temporary Closures
- ACP Notification

A

Maximum of 14 days for temporary closure

20
Q

Licensee
- Additional Considerations

A

SOP Sexual abuse and misconduct

SOP Lab and POCT

NAPRA Sterile

Non-Sterile

HIA

Netcare

Occupational Health and Safety Act

Foundational Requirements

21
Q

Licensee Additional Considerations
- SOP Sexual abuse and misconduct

A

Duty to report any sexual abuse or sexual misconduct

22
Q

Licensee Additional Considerations
- SOP Lab and POCT

A

Duty to develop, implement, and manage POCT program

23
Q

Licensee Additional Considerations
- NAPRA Model Standards for Compounding Hazardous and non-Hazardous Sterile Compounds

A

High Risk = Inspect every 18 months

Sterile = Inspect every 3 years

24
Q

Licensee Additional Considerations
- Health Information Act

A
  • Mandatory breach reporting
  • Privacy impact assessments
  • Licensee is the custodian
25
Q

Licensee Additional Considerations
- Netcare

A
  • Privacy and security provisions
  • Information manager agreement
26
Q

Licensee Additional Considerations
- Occupational Health and Safety Act

A
  • Employee safety
  • Hazard assessment
  • Policies and procedure
27
Q

Licensee Additional Considerations
- Foundational Requirements

A

Used when opening a licensed pharmacy