Lecture 12: Provincial Juris Cont'd Pharmacy and Drug Act

Question 1

Pharmacy and Drug Act

what aspects may be connected to pharmacy practice?

Answer 1

Community/ Institutional pharmacies connected to Mfr, wholesaler, compounding and repacking and the patient
- Need to make sure drugs come from a safe place and reputable source

Question 2

name 4 pharmacy licenses

Answer 2

Community Pharmacy License

Compounding and Repackaging License: can be given to a licensee owner strictly for purposes of compounding and repackaging, independent of comm pharmacy license

Satellite Pharmacy License: type of license that is provided at discretion of registrar

• Very unique services for a particular population
• Only have 1 or 2 in Alberta
• Physicians coming in once or twice a week for a short period of time to have small pharmacy office

Mail Order Pharmacy License: meds mailed to a pt
- dependent on a community pharmacy license existing as with satellite pharmacies

Question 3

define pharmacy service

Answer 3

the storing, compounding, dispensing or selling of drugs

Clinical services don’t need to be in pharmacy but need to access pt records which are in pharmacy

Question 4

do institutional pharmacies need a pharmacy license?

what services can an institutional pharmacies provide?

Answer 4

• Institutional pharmacies are operated by public sector, Alberta Health Services
• must hold a community pharmacy license if it charges for or bills a third party carrier for any other pharmacist services that it provides.
• If services or drugs are charged, they have same licensing requirements as community
• may dispense, compound, provide for sale, sell home parenteral therapy, special access drugs, a drug not readily available in a community pharmacy to a client of the facility, or a client being cared for
  in an entity affiliated with the facility;

Question 5

who can own a pharmacy? who can have a license?

Answer 5

Anyone can own a pharmacy but a license can only be provided to a pharmacist on the clinical reister who is licensee
• Unrestricted ownership,
• License provided to an individual registered on the
clinical register (licensee),
• Equipment is defined in operational standards,
• Is requisite for mail order** and satellite licenses

Question 6

What are the parts to the structure of a pharmacy

Answer 6

Broader area is called an establishment
Dispensary: prescription department
Patient services area: adjacent to the dispensing area with certain scheduled drugs and can monitor patients and engage with them
Public area: outside area doesn’t apply to licensing process (May need for small pharmacies that need a min size requirement)
Shoppers - only a finite portion of the total area is licensed

applying for Community Pharm License S5 act addresses high level info required

• s3 addresses additional info
• s10 physical requirements

Question 7

what can help a licensee and prospective pharmacy owner to make sure their application is readyÉ

Answer 7

GUIDANCE DOCUMENT FOR OPENING A

LICENSED COMMUNITY PHARMACY which is a common document

Question 8

what conditions can the registrar prescribe on a pharmacy license?

Answer 8

– Public safety,
– Quality pharmacist practice,
– Integrity of drug distribution system
decisions may be reviewed by a committee of council

Question 9

what are the responsibilities of licensee?

Answer 9

• Personally manage, control, and supervise the practice of pharmacy in the pharmacy
• Comply with the Act, any condition imposed on the
license, any order made under the Act, the code of
ethics, and the standards for the operation of licensed
pharmacies
– This includes compliance with standards of practice
– Readiness of licensee determines quality of services

Question 10

When can there be exemptions to the Mail Order License

Answer 10

• service provided for which neither the pt or pt agent attends the pharmacy to receive service
• exemptions:
• regular pt but unable to attend pharmacy for inordinate reasons such as illness, travel, work
• if a pharm regularly attends personally on the pt to assess the pt and monitor the pt’s response to drug therapy
• general health emergency or crisis
• state of public emergency (local state)

Question 11

do you need a community license to get a compounding and repackaging license?

Answer 11

no - may be provided to an individual on clinical register who does or doesn’t have a community license

• permits facility to compound or repackaged drugs for redistribution through licensed pharmacies
• unless entity holds a community pharmacy license, they cannot dispense drugs directly to public

Question 12

when is a satellite pharmacy license granted?

Answer 12

An individual holding a community pharmacy license may hold one or more satellite pharmacy licenses

The provision of a satellite pharmacy license is at the
discretion of the registrar
– Geographic need
– Demographic need

Question 13

Licensee Education Program purpose?

Answer 13

• designed to help pharmacists, licensees, and proprietors
• articulate the licensee’s and proprietor’s legal responsibilities, and ACP’s expectations when operating a pharmacy, particularly regarding the
authority, responsibility, and accountability of
licensees, in context with current legislation;
• use relevant resources to update and maintain knowledge about legislation and standards for operating a pharmacy; and
• develop understanding about the pharmacy licensee’s
role: leader, manager, professional, and clinician.

Question 14

Licensee Education Program

what is Part A and Part B?

Answer 14

Part A includes readings, peer conversation and
reflection, and an online module (Chapters 1- 5). Part A of the program has been CCCEP- accredited for six continuing education units (CEUs).

Part B includes an online module and resources
(Chapters 6-7) and a self-assessment (Chapter
8). Part B has been CCCEP-accredited for
four CEUs

Oct 2020- pharmacists applying as licensee for a new or existing pharmacy must complete Parts A and B of the Licensee Education Program before a pharmacy license will be issued.

All licensees must complete Part B of the
program before applying to renew their
pharmacy license in 2021 (deadline May 31 2021 and encouraged to complete Part A of the program

Question 15

are specialized pharmacies allowed?

Answer 15

7(1) Neither a licensee nor proprietor shall hold
out that a licensed pharmacy offers specialized
pharmacy services unless the licensed
pharmacy is designated under subsection (3).
(2) A licensee may apply to the registrar to
designate a licensed pharmacy as a pharmacy
that offers specialized pharmacy services.

not recognized currently

Question 16

drug schedule promotion

Answer 16

Pharmacists cannot advertise Schedule 1 drugs at all, but can have name, price, and qty for Sch 2 and 3 pdts

If pharmacy is part of larger establishment which is open longer than pharmacy, the Sch 3 products need to be locked - pharmacist must be present

Question 17

what is the Protection of Students with Life

Threatening Allergies Act (2019)?

Answer 17

Standard 1.23 - Subject to the directions of Council, a
pharmacist or a pharmacy technician practicing with the
pharmacist may sell epinephrine auto-injectors to an
individual authorized by a school board* to purchase
epinephrine auto-injectors to be maintained in a school
under the Protection of Students with Life Threatening
Allergies Act despite the requirements in these standards respecting identification, assessment, communication, documentation and record keeping on a patient specific basis.

Question 18

Health Information Act purpose?

Answer 18

• protect privacy of individuals for health info and confidentiality
• enable health information to be shared and accessed,
  where appropriate
• to prescribe rules for the collection, use and disclosure of health information,

Question 19

what is the diff b/w privacy and confidentiality?

Answer 19

Privacy includes a broader system of considerations
Confidentiality is very specific in context when you’re caring for patients
Maintaining privacy means more than just safeguarding confidentiality—it is an ongoing program that involves accountability, control of information flow, right of access procedures, and security measures.

Question 20

General rules for privacy (5)

Answer 20

• Only collect, use or disclose what is needed to do the job, no more.
• Collect directly from the individual whenever possible.
• Only provide information to those with a need to know.
• Provide anonymous information whenever possible.
• Safeguard the health information you hold

Question 21

what are 2 types of health info?

Answer 21

• diagnostic, treatment, and care information
• registration information

Health information links an identifiable individual
with information about
• their physical or mental health, including drugs
prescribed;
• the health service provider; and
• their contact and billing information.

Question 22

can individuals see their own health info?

Answer 22

• Individuals have a legal right to see or obtain copies of their personal health information without being asked why.
• Custodians have a duty to help individuals with
their requests.
• In some circumstances, custodians can refuse
access (e.g., when access may cause harm).
• Custodians have to respond to access requests
within 30 days

Question 23

Custodians vs Affiliates

Answer 23

The pharmacy licensee is the custodian of this
health information and other pharmacy
professionals or administrators who work for this
person are affiliates.

Each registrant of the Alberta College of Pharmacy is a custodian under the HIA, except when they are an employee/agent or affiliate of another custodian (e.g., a
staff pharmacist at a community pharmacy or AHS, nursing home, is considered an affiliate).

Question 24

what is the guiding principle for Circle of Care

Answer 24

The guiding principle for exchanging information within the circle of care for these purposes is that the least amount of health information with the highest degree of anonymity should be shared among custodians.

For disclosure to non-custodians and others who are not part of the circle of care, and/ or for purposes that are not authorized, Part 5 of the HIA outlines specific circumstances where use and disclosure may be allowed.

Question 25

how can consent be obtained?

Answer 25

A pharmacy professional can obtain the consent of
the individual to disclose health information, but it
must be written, explicit, and include all the
prescribed elements.

Question 26

what happens when there is a breach of privacy?

Answer 26

a custodian must, as soon as practicable, give notice
in accordance with the regulations of a loss of, any
unauthorized access to, or disclosure of individually
identifying health information in the custody or control of the custodian if there is a risk of harm to an individual because of the loss, unauthorized access, or
disclosure. As soon as practicable, in the context of
section 60.1 of the HIA, means as soon as the affiliate
or custodian becomes aware of the loss, unauthorized
access, or disclosure, and has the information that is
necessary to properly execute the notice.

Question 27

Offense for health information

what is considered an offense (2)?

Answer 27

1. Custodians and affiliates are subject to offence
   penalties for failure to meet their duty to notify.
2. Custodians are also subject to an offence for
   failure to take reasonable steps in accordance with
   the regulation to maintain administrative, technical,
   and physical safeguards that will protect against
   any reasonably anticipated threat or hazard to the
   security or integrity of health information and
   against any loss of health information.

eg. wrong packaging and giving wrong med to the person