Jurisprudence Flashcards
1
Q
What is the Regulated Health Professions Act (RHPA)?
A
- regulation of health professions in Ontario
- 2 parts - topics external to regulatory colleges & Health professions procedural code
2
Q
What is the Pharmacy Act (PA)?
A
- deals w/ topics specific to the Ontario College of Pharmacists
- permits college to make regulations relating to prescribing, dispensing & administration of drugs
3
Q
What is the Drug and Pharmacies Regulations Act (DPRA)?
A
- accreditation, inspection, ownership, & operation of pharmacies
- deals w/ the rules for dispensing drugs
4
Q
What are the 4 Registration Classes?
A
- Pharmacist *
- Registered pharmacy student
- Intern
- Pharmacy technician *
- protected titles
5
Q
Pharmacist Registration Regulations
A
- Requires meeting the entry-to-practice requirements & maintaining continuing competency requirements
- Part A - only a pharmacist can practice pharmacy & provide patient care
-
Part B - have TCLs:
○ Cannot provide patient care
○ Cannot sell, dispense or compound drugs
○ Cannot supervise a pharmacy
○ Cannot be a designated manager
○ Cannot supervise the practice of pharmacy of a registered pharmacy student, intern or pharmacy tech
○ Must identify as a pharmacist listed in Part B of the register when working in a pharmacy or patient care envmts
6
Q
Registered Pharmacy Student Regulations
A
- Must meet registration requirements outlined on the OCP website in order to register as a student
- A certificate of registration has TCLs:
○ Only engage in practice if completing an education program or training as set out in the registration
○ Only engage in practice while under direct supervision of a pharmacist or other health care professional if completing a rotation for an approved education program
○ Cannot dispense, compound or sell drugs unless under the direct supervision of a pharmacist
○ Cannot supervise a pharmacy
Cannot delegate or accept delegation of a controlled act
7
Q
Pharmacy Intern Registration Requirements
A
- Must meet registration requirements outlined on the OCP website in order to register as an intern
- A certificate of registration has TCLs:
○ Only engage in the practice of pharmacy when:
- Practicing in a pharmacy to which Drug an Pharmacies Regulation Act applies while under direct supervision of a Pharmacist or
- In all other cases, while under the supervision of a Pharmacist
○ Cannot supervise a pharmacy
○ Cannot delegate a controlled act
- Can accept delegation of a controlled act as long as proper protocol is followed
8
Q
Pharmacy Technician Registration Requirements
A
- A certificate of registration has TCLs:
○ Must practice under the direct supervision of a pharmacist in an accredited pharmacy (other than a remote dispensing location) & in all other cases under the supervision or direction of a pharmacist
○ Cannot supervise the pharmacy
○ Cannot delegate a controlled act
○ Cannot provide info/education relating to drug use, to or for a patient, where it requires therapeutic knowledge, clinical analysis or assessment - Can ensure the technical accuracy of all prescriptions and are able to independently check (take responsibility for) the technical component while the pharmacist remains responsible for the therapeutic component
9
Q
Temporary Registration Classes - Emergency Assignment
A
- Gvmt of Ontario requires more pharmacy professionals to maintain sufficient access to pharmacy services for the public
- Issue emergency assignment (EA) certificates of registration for Pharmacists and/or Pharmacy technicians
- Registrar issues these EA certificates of registration as temporary w/ a 2 month expiry (may be extended as needed)
-
Pharmacist (EA) TCLs:
○ Must be supervised by a Pharmacist in Part A
○ Cannot be the designated manager of a pharmacy -
Pharmacy Technician (EA) TCLs:
Must be supervised by a pharmacist in Part A
10
Q
What is the Public Register?
A
- Known as “Find a Pharmacy or Pharmacy Professional” on College’s website
- provides info on registered Pharmacies and Pharmacy Professionals in Ontario to help pts make informed decisions
- College is required by law to maintain this register
11
Q
What is the Controlled Acts Regulation?
More broad idea
A
- identifies which classes can perform a controlled act & which requirements must be met
- Ex. Administration of the Influenza vaccine (for pts 2 years or older & w/ approved injection training) under Ontario’s Universal Influenza Immunization Program can be performed by:
○ Part A Pharmacists
○ Pharmacy interns & pharmacy students
○ Pharmacy techs - Valid CPR & 1st aid is required for pharmacists, students & interns, recommended for techs
12
Q
What is the Quality Assurance Regulation?
A
- Describes the components of the quality assurance program & the procedures that to be followed by the College
- To help ensure competency of Pharmacists & pharmacy techs to protect the public
13
Q
What is the Professional Misconduct regulation?
A
- In addition to definitions already in the RHPA (ex. Sexual abuse)
- Professional misconduct includes:
○ Failing to maintain the standard of practice of the profession
○ Conflicts of interest
○ False billing
○ Misrepresentation of qualifications
○ Failing to cooperate w/ the college - “catch all” clause that makes it professional misconduct to act in a disgraceful, dishonourable or unprofessional manner
14
Q
What are By-laws?
broad idea
A
- Some acts, like the RHPA authorize the making of by-laws
- By-laws are usually about internal or administrative matters
- By-laws are made by the College & are NOT subject to gvmt approval
- Ex. Banking & audit arrangments, council election, professional liability insurance
15
Q
What are Standards of Practice and Code of Ethics
very broad
A
- Set the minimum expectations & behaviour of the profession
- College committees apply standards of practice when dealing w/ members of the pharmacy profession
- Supplemental standard of practice (sSOP) provides expectations surrounding medication safety as it pertains to the AIMS (assurance & improvement in medication safety) program
- College has adopted the following by NAPRA:
- Model standards for Pharmacy Compounding of Sterile Preparations (non-hazardous & hazardous) & non-sterile preparations
- Supplemental standards of practice for Schedule II & Schedule III drugs
16
Q
Models of Regulation - No Regulation
A
- allows the market to determine which activities or practitioners will be chosen
17
Q
Models of Regulation - Consumer Protection Regulation
A
- ex. The sale of time shares & fitness centre memberships is governed by Ontario’s Consumer Protection Act
18
Q
Models of Regulation - Direct Government Regulation
A
- provincial gvmt could have the Ministry of Health & Long-term care regulate the pharmacy profession
19
Q
Models of Regulation - Self-regulation
A
- provincial gvmt can delegate to a profession under an act the authority to regulate itself (ex. Pharmacy profession in Ontario)
- Ontario govmt has chosen self-regulation model for health professions
20
Q
Registration Models vs. Licensure Models
A
-
Registration Models - regulate registered individuals or places that choose to become registered, but do NOT require the individuals or places to become registered
- they can use a protected title
-
Licensure Model - prohibit people or places from doing certain activities unless they hold a license
- Ex. Operating a pharmacy
21
Q
OCP - Publict Interest Mandate
A
- College has a mandate under RHPA to serve & protect the public interest
- Duty to report to the Minister of Health & Long-Term care
- gvmt has to approve any regulations proposed by the college before they take effect
- Decisions in discipline & fitness to practice can be appealed to the courts
- Meetings of the Council & College and discipline hearings are open to the public
- College is required to publish its discipline decisions & other relevant info about members of the pharmacy profession on the Public register
- College must have a website setting out its roles, responsibilities, & regulatory activities
22
Q
Scope of Practice Statement
What is it?
A
- Helps the public & the profession understand what members do
- College uses the statement to identify where it should focus its regulatory activities
- NOT exclusive, other professions do portions of these activities
- Members of the pharmacy profession are not prohibited from doing activities outside of this scope of practice statement
- However they cannot call themselves a member while doing so
23
Q
Scope of Practice of Pharmacy
4 main areas in scope of practice
A
- (a) the custody, compounding, dispensing & prescribing of drugs
- (b) the provision of health care aids & devices
- (c) the provision of info & education related to the use of anything mentioned in (a) & (b)
- (d) the promotion of health, prevention & treatment of disease, disorders & dysfunctions through monitoring & management of medication therapy
24
Q
Explain the Controlled Acts Model
what can the gvmt prohibt?
A
- can prohibit anyone who is not registered w/ the college from using a protective title
- prohibit anyone who is NOT registered w/ the college from practising pharmacy
- created a list of acts that are considered inherently harmful if not performed by competent, authorized individuals
- Same controlled act can be performed by more than 1 profession (ex. nurse, physicians)
- Dispensing, selling or compounding a drug, or supervising the part of a pharmacy where such drugs are kept is the most relevant controlled act affecting the pharmacy profession
- other controlled acts including prescribing & administering, by injection or inhalation, certain drugs
25
Q
Controlled Acts in Pharmacy
A
- Dispensing, selling or compounding a drug, or supervising the part of a pharmacy where drugs are kept
- Administering, by injection or inhalation, a substance specified in the regulations
- drugs as listed & only for education & demonstration purposes
- Prescribing a drug specified in the regulations
- renewing & adapting prescriptions
- Prescribing a drug, other than a drug mentioned in paragraph 3 in accordance to regulations
- Performing a procedure on tissue below the dermis
NOTE: NOT all members of the pharmacy profession can perform ALL of these authorized acts
26
Q
What are Controlled Acts?
Definition
A
- tasks w/ the potential to cause harm if not done correctly by a competent person
27
Q
Exceptions to Controlled Acts
When can individuals w/out specific authorization complete controlled ac
A
- In the case of emergency
- Family members can perform some
- Ex. Administering an injection to a child - May be delegated by a member in accordance w/ profession-specific regulations
28
Q
What is the Fiduciary Duty?
A
- Members are said to have a fiduciary duty to their pts
- It is an obligation of undivided loyalty & utmost good faith to the person being served
- Member of pharmacy has to put the interests of the pt above their own
29
Q
What is Mandatory Reporting?
A
- A legal obligation to disclose important info to the appropriate authority even if info is protected by a duty of confidentiality or one would prefer not to make the report
- The benefit to society in making the mandatory report outweighs the usual considerations to privacy
30
Q
Mandatory Reporting - Sexual Abuse
A
- When there are reasonable grounds to believe that a member of the pharmacy profession has engaged in sexual abuse
- Must be reported in writing to the OCP
- Does not have to be directly observed
- Apply to other health practitioners as well
31
Q
Mandatory Reporting - Facility Operators & Employers
A
- Required when a member of pharmacy terminates the employment of, or association with another member for professional misconduct, incompetence or incapacity
- includes if someone quits before you fire them
- Operators of facilities which are not necessarily members, must also report practitioners who are incompetent or incapacitated
32
Q
Mandatory Reporting - Self-reports
A
- If a member is found guilty of an offence, he or she must report that to the Registrar
- Made for findings of professional negligence (malpractice)
- Must be made by the member in writing to the College Registrar right after the finding has been made
33
Q
Mandatory Reporting - Child Abuse
A
- Report a child in need of protection to the local children’s aid society under the Child & Family Services Act
34
Q
Mandatory Reporting - Long Term Care
A
- Long-term care & retirement home statutes require the reporting of abuse or neglect of residents to the appropriate gvmt office
35
Q
Mandatory Reporting - Risk of Harm
A
- Case law requires members to intervene when they become aware of a risk of serious bodily harm or death of a person
36
Q
What is the OCP?
A
- Ontario College of Pharmacists
- created by statute to regulate the pharmacy profession in the public interest
- College holds members accountable to meet their professional responsibilities under the RHPA, the Pharmacy Act and the DPRA
- College is independent of the gvmt - can make its own regulatory decisions but is still accountable to the gvmt
37
Q
OCP Council
Who makes it up?
A
- Council serves as a board of directors
- Under the Pharmacy Act, Council (board) is composed of:
- 9 elected directors (pharmacy professionals, 2 must be techs)
- 9-16 public directors appointed by gvmt
- The deans of the Ontario Pharmacy programs
- Council is supported by Committees & Registrar
38
Q
OCP - Executive committee
A
- Coordinates operations of the college
- Deals w/ any matters requiring immediate attention b/w meetings
39
Q
OCP - Registration Committee
A
- Determines whether an applicant meets the requirements for registration
- A panel can decide if exceptions can be made, or if further education/training is required
40
Q
OCP - Quality Assurance Committee
A
- Develops & maintains QA program which includes: 2-part register, continuing education, min practice requirements etc.
- Encourages members to engage in continuous professional development
41
Q
OCP - Inquires, Complaints & Reports Committee
A
- Investigates concerns about members relating to misconduct, incompetence, or incapacity
- can take various types of action
42
Q
OCP - Discipline Committee
A
- Holds hearings to determine whether a member has engaged in professional misconduct or is incompetent
- The panel has authority to revoke, suspend or limit a member’s registration, impose a fine or reprimand the member
43
Q
OCP - Fitness to Practice Committee
A
- Holds hearings to determine whether a member is incapable or impaired
44
Q
OCP - Patient Relations Committee
A
- Develops programs to encourage healthy interactions b/w pts & members
- Handles matters of funding for therapy & counselling of pts who have been sexually abused by members
45
Q
OCP - Accreditation Committee
A
- Established under pharmacy act
- Reviews concerns about operation of pharmacies
- Can direct further inspections or refer them to the Discipline committee
46
Q
What are the 4 Regulatory Activities of the College?
Just list them
A
- Restrictive regulation
- Reactive regulation
- Proactive regulation
- Transparent regulation
47
Q
What is Restrictive Regulation?
A
- Limiting those who can perform pharmacy activities or use pharmacy titles
- College sets out requirement for registration in its regulations
- College has requirements for good character whereby the individual will practise pharmacy w/ decency, honesty & integrity and in accordance w/ the law
- If unclear if applicant meets requirements, Registrar refers application to Registration Committee (through panel) to make decision
- If unregistered person uses a protect pharmacy title or performs controlled act, the college can prosecute them in court
48
Q
What is Reactive Regulation?
A
- responding to complaints & concerns about the conduct, competence & capacity of members of the profession
- Complaint brought to ICRC, complaint is brought to member, have chance to respond in writing
- Member could be reminded to follow certain standards, could be cautioned verbally, could be asked to complete continuing education
49
Q
What is Proactive Regulation?
A
- designed to enhance the knowledge, skill & judgement of members
- Quality assurance program, Inspection/pharmacy assessment, Patient relations program, Practice tools on OCP
50
Q
What is the Quality Assurance Program? What are the parts?
A
- Help members enhance their knowledge, skill & judgement
- All members are expected to engage in continuing professional development & maintain a learning portfolio
- Pharmacy techs are selected once in every 5 year cycle to complete a self-assessment, self assessments for Pharmacists (A) is voluntary
- ALL pharmacists & techs are required to undergo a practice assessment w/ a college practice advisor when selected (4-6 years)
- Pharmacists (A) are required to undergo a knowledge assessment when selected every 5 years, tech will come in the future
51
Q
What is the Patient Relations Program?
A
- Program has a detailed plan to prevent sexual abuse of patients from occurring
- includes education in pharmacy schools, providing resources for members & their employers, & through public education
- Training college staff on recognizing & responding appropriately to concerns
- Maintaining professional boundaries is always the responsibility of the member, consent is never an excuse
52
Q
What is Transparent Regulation?
A
- providing info to the public about members of the profession so that the public can make informed choices
- Public expects to know about background & any significant concerns of regulate entities
- Public register - Includes name, location, registration status, regulation history
- Open Public Hearings
53
Q
OCP regulates the Registrant and the Practice site?
True or False
A
- True
- Registrant is regulated under PA & RHPA
- Practice site is regulated under the DPRA
54
Q
What is the DPRA?
A
- Drug and Pharmacies Regulation Act
- provincial legislation that serves to protect the public by ensuring safe, ethical, and competent pharmacy practice at accredited locations
55
Q
The DPRA regulates…
A
- Licensing & ownership of pharmacies
- Standards for accreditation
- Dispensing of drugs
- Record keeping
- Accountability & responsibility
56
Q
What other legislation (fed & prov) does the DPRA work with?
A
- Food & Drugs Act
- Controlled Drugs & Substances Act
- Privacy Legislation: PIPEDA, PHIPA
- Drug interchangeability & dispensing fee act
- Ontario Drug benefit act
57
Q
What is a Drug (DPRA definition)?
A
- The term “drug” means any substance or preparation containing any substance,
- (a) manufactured, sold or represented for use in
- (i) diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state or the symptoms thereof in humans animals or fowl
- (ii) restoring, correcting, or modifying functions in humans, animals or fowl - (b) referred to in Schedule I, II, or III
- (c ) listed in a publication named by the regulations
- (d) named in the regulations
58
Q
What is NOT considered a drug (in DPRA)?
A
- Anything approved for sale of food, drink or cosmetic
- Natural health products (NHP) are not considered a drug
- Any substance found in the unscheduled category (Schedule U)
59
Q
Compounding, dispensing & selling drugs is restricted to…
A
- Pharmacist
- Intern or pharmacy student under supervision of Ph
- For RDL, Pharm tech, under supervision (visual link) of Ph
60
Q
College adopted what MSOPs from NAPRA
A
- Model Standards for Pharmacy Compounding of Non-sterile Preparations
- Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations
- Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations
61
Q
What are the NAPRA drug schedules?
A
- I - rx
- II - no rx, BTC
- III - no rx, OTC
- U - any retail outlet
62
Q
What factors affect Drug Schedule changes?
A
- (1) clinical experience with the use of the product
- (2) it’s dose
- (3) package sizes
- (4) patient population
63
Q
Schedule I Drugs
A
- Require a prescription
- Includes all the drugs listed in the Prescription Drug List (PDL) - established under the Food & Drugs Act
- Includes all of the drugs in the Schedule of Controlled drugs & Substances Act
64
Q
Schedule II Drugs
A
- Do NOT require a prescription
- Only available through professional intervention by a pharmacist
- Kept in a restricted area of a pharmacy not accessible to the public
65
Q
Schedule III Drugs
A
- Available without a prescription
- Can only be sold in a pharmacy or from an area of a pharmacy (as required by the College) that allows for patient self-selection
- A registrant must be available if needed
66
Q
Unscheduled Drugs
A
- Sold without professional intervention
- Sold from any retail outlet
- Information on product label is sufficient
67
Q
Conditions for selling schedule I drugs
A
-
The pharmacist must be physically present
○ For RDL the pharmacist must be physically present at the RDL or the accredited pharmacy that operates the RDL
○ Drugs must only be sold from the automated pharmacy system or the dispensary at the RDL - There must be a prescription
- The pharmacist must approve the sale
- The drugs can only be sold from the dispensary
68
Q
Conditions for selling schedule II drugs
A
- Pharmacist must be physically present in the pharmacy
- Pharmacist must approve and intervene in the sale
- Confirm appropriate self assessment by the pt or to ensure safe & appropriate use of the drugs
- Drugs can only be sold from the dispensary
- For RDL, pharmacist must be physically present either at the RDL or at the accredited pharmacy that runs the RDL
- Drugs must only be sold from the automated pharmacy system or the dispensary at the RDL
69
Q
Conditions for selling Schedule III drugs
A
-
The pharmacist must be physically present
- For RDL the pharmacist must be physically present at the RDL or the accredited pharmacy that operates the RDL
- Drugs must only be sold from the automated pharmacy system or the dispensary at the RDL
- Drugs must only be available for sale in the pharmacy from the dispensary or from an area of the pharmacy that allows for patient self selection
- A pharmacist (or pharmacy student/intern under their supervision) must be available for consultation if the patient needs assistance in making a clinically appropriate self-medication selection
70
Q
What is a prescription?
A
- An order for a specific individual ordered by a prescriber after a diagnosis
- For a medical device (ex. Hearing aids) or medication
- Drugs will not be dispensed in a pharmacy unless the prescription has been authorized by a prescriber
- Authorization may be given verbally or by signature
71
Q
Out of Province Prescriptions
Do we accept these?
A
- DPRA permits Pharmacists to accept prescriptions from out of the province but within Canada, provided they are from a prescriber licensed in a jurisdiction of Canada
- A prescriber is anyone that has the authority to prescribe a drug from the Canadian jurisdiction
72
Q
Verbal Prescriptions
When is it allowed, exceptions, what must be recorded?
A
- Acceptable if the drug is not a narcotic
- The order must be received by a registrant (pharmacist or inter, pharm student or pharm tech under direct supervision)
- NOTE: a pharmacy tech may not accept verbal prescriptions for controlled substances (i.e verbal narcotics, controlled drugs or targeted substances)
- must record the date, number of authorized refills and the name of registrant receiving the prescription
73
Q
What info for a prescription must be recorded on dispensing record?
A
- The name and address of the person for whom the drug is prescribed
- The name, strength (where applicable) and quantity of the prescribed drug
- The directions for use as prescribed
- The name and address of the prescriber
- The identity of the manufacturer of the drug dispensed
- An identification number or other designation (ex. RX number)
- The signature of the person dispensing the drug and, where different, the signature of the person receiving a verbal; prescription
- The date on which the drug is dispenses
- The price charged
74
Q
What info must be on the dispensed drug container?
A
- The identification number (ex. Prescription # or transaction # that is generated by the pharmacy where the prescription is dispensed
- The name, address, and telephone number of the pharmacy in which the prescription is dispensed
- Drug name, strength and its manufacturer (unless otherwise specified by the prescriber)
- Quantity of the drug dispensed
- Name of the owner of the pharmacy
- Date the prescription is dispensed
- Name of the prescriber
- Name of the person for whom it is prescribed
- Directions for use as prescribed
- NOTE: Available as child-resistant due to safety concerns over accidental poisonings and overdoses in children (this is legislated & mandated)
75
Q
College policies on prescription labelling (in addition to NAPRA)
A
- single entity drugs - must be labeled with the chemical name of the drug and the manufacturer
- Ex. atorvastatin, Pfizer
- multi-medication compliance packs - description of each tablet must be added to label
76
Q
What schedule of drugs can be delivered?
A
- schedule I including narcotic & controlled
- Any drug can be mailed or delivered within Canada
77
Q
Delivering Drugs by registered Mail
A
- Person addressed on the package signs & receives the prescription
- Other delivery methods (ex. Courier) must meet same principles
- Delivery must be traceable & auditable including the signature of the patient
- Any drug can be mailed or delivered within Canada
78
Q
Shipping Drugs outside of Canada
A
- Shipping drugs to other countries has its own restrictions
- pharmacy should contact delivery service for requirements
- Should check with that countries customs or embassy
- Ex. Narcotics, controlled drugs, benzodiazepines/targeted substances and precursor drugs cannot be shipped to the U.S. by international agreements
79
Q
Accountability for transfering Prescriptions?
A
- A prescription shall be transferred upon the patient’s request
- Patient’s choice of pharmacy must be respected & the pharmacy must transfer in a professional and timely manner
- Registrants, including pharmacy techs may transfer prescriptions
- Must be between 2 licensed or accredited pharmacies
80
Q
What Prescriptions can’t be transferred?
A
- The transfer of narcotic or a controlled substance in not allowed
- A prescription cannot be transferred if there are no refills
- If the prescription was transferred back to the originating pharmacy, and refills remained, it could once again be transferred
- EXCEPTION: benzodiazepines & targeted substances – can only be transferred ONCE, and only valid for 1 year from the date prescribed
81
Q
Requirements (info) when transferring a prescription?
A
- Name & address of pt
- Name & strength of drug prescribed
- Directions for use
- Name & address of prescriber
- Name of manufacturer of the drug most recently dispensed
- Identification number of prescription
- Total quantity of drug remaining
- The quantity most recently dispensed if different from quantity prescribed (ex. Drug plan rules)
- The name of registrant transferring the prescription; can be given verbally or under the signature of the registrant making the transfer
- The date the drug was first dispensed and last dispensed date
- Exception: for benzodiazepines also need date prescription was issued
82
Q
Transferring Benzodiazepines
A
- Need date prescription was issued
- Prescriptions are only valid for 1 year from the date it was written or authorized
- Benzodiazepines are targeted substances can only be transferred ONCE
83
Q
What info does the Pharmacy providing a transfer need to record?
A
- The date of the transfer
- The identity of the pharmacy where the prescription was transferred
- The name of the registrant responsible for the transfer by the pharmacy
- The name of the registrant accepting the transfer if transferred verbally
84
Q
What info does the Pharmacy receiving the transfer need to record?
A
- The name of the pharmacy where the prescription originated
- The information regarding the prescription from that pharmacy is complete
- The name and signature of the registrant receiving & recording the info
85
Q
How long does a Pt record need to be kept for?
A
- 10 years from the last recorded professional pharmacy service provided to the patient
- Until 10 years after the day on which the patient reached or would have reached the age of 18 years
86
Q
Certificates of Accreditation
Why do you need to be accredited? what about if you move? Who decides?
A
- Only pharmacies w/ a certificate of accreditation issued by the Registrar of the College may operate a pharmacy in Ontario
- Pharmacy is inspected (I.e assessed by an operations advisor) before it opens to make sure the physical requirements comply and the pharmacy is safe to operate
- Every acquisition and/or relocation of a pharmacy will need an application for a new certificate of accreditation
- Accreditation Committee can direct the Registrar to:
- Refuse the certificate
- Place terms, conditions & limitations
- Issue the certificate of accreditation
87
Q
Expiry of Certificated of Accreditation
A
- expire yearly on May 10th
- certificated must be renewed
- registrar has authority to refuse renewal under certain conditions (ex. non-payment of fees)
88
Q
College inspections (pharmacy assessments)
A
- help ensure a pharmacy is maintaining or meeting all the standards set out in the regulations
- promote and understanding & awareness of any relevant and current pharmacy practice issues
- Most inspections will conclude w/out any action, or upon receipt of an acceptable Action Plan
- In some cases, a re-inspection at a future date is required
- The outcome and/or status of a pharmacy inspection is posted on the College’s public Register
89
Q
Accreditation Committee can…
A
- direct registrar to renew certificate
- direct registrar to renew w/ TCLs
- direct registrar NOT to renew certificate
90
Q
What is Proprietary Misconduct?
A
- Act or omission that is in breach of the accepted ethical and professional standards of conduft for pharmacy professionals
- All owners or operators of a pharmacy are accountable for its operations whether they are registrants of OCP or not
- Proprietary misconduct regulations are modeled after the professional misconduct regulations for registrants
91
Q
Conflict of Interest Regulations
A
- a situation where a person’s private interests might benefit from their professional actions or influence
- Conflicts of interest are a matter of proprietary misconduct
- Persons held accountable for proprietary misconduct include owners, directors, and designated managers
92
Q
Ownership of Pharmacies
A
- Ontario requires a pharmacy to be owned & operated by a pharmacist
- Majority of directors must be pharmacists & the majority of each class of shares must be owned/registered in the name of a pharmacist
93
Q
What if a shareholder dies
A
- These shares are considered to be registered in the name of a pharmacist for up to 4 years
- Gives the company time to find another pharmacist to buy those shares
- When sole owner of a pharmacy dies, the shares are also considered to be registered in the name of a pharmacist for up to 4 years
94
Q
2 exemptions to Ownership of Pharmacy requirements
A
- Pharmacies that were operating on May 14, 1954
- Non-profit, multi-disciplinary health facilities (ex. hospitals)
95
Q
Impact of revocation
impact on the community pharmacy
A
- No longer a registrant of the College
- Cannot be employed as a pharmacist in a pharmacy
- Cannot act as a director or shareholder of a corporation owning a pharmacy
- Corp can use the name of the revoked pharmacist as a director/shareholder for up to 6 months
- During this time, the revoked pharmacist cannot act in the capacity of director/shareholder
96
Q
Impact of Suspension
impact on the community pharmacy
A
- they are not considered a registrant of the College
- a suspension of a pharmacist’s licence does not affect the corp’s ability to continue naming that person as a director or shareholder during the suspension
- This allows the pharmacy to remain open
97
Q
Impact of Bankcrupcy
Impact on the community pharmacy
A
- When a pharmacy, or corp owning the pharmacy, goes bankrupt, the person owning the pharmacy must notify the college
- The trustee in bankruptcy may operate the pharmacy during this time
98
Q
Impact of death of owner
impact on the community pharmacy
A
- For the death of sole owner of a pharmacy, a personal representative may own & operate the pharmacy for 4 years
- This gives time to either sell or form a corporation w/ a pharmacist who would own the majority of shares & be the director of the company
99
Q
The Standards for Accreditation are…
A
- Safe, clean & properly maintained envmt
- Secure & safeguarded pharmacy
- Pt confidential info protected
- Equipment & technology as needed for site
- Appropriate staffing & resources
- Info management systems
- Audit trail for drugs
100
Q
Required Resources & References to have in a phamracy
A
Online access to reliable websites such as:
* OCP
* CPSO
* NAPRA
* Health Canada & the Ministry of Health
Required reference guides:
* Canadian Drug Reference/Compendium of Pharmaceutical Specialties
* Drug Interaction Publication
* Drug Therapy/Pharmacotherapeutics Publication
* Patient counselling publication
101
Q
OCP symbol
who can use it?
A
- College’s trademarked symbol can only be used in Ontario by an accredited community pharmacy
- Helps public identify that the pharmacy is registered & licenced in OCP
- Must be displayed to public
102
Q
What are RDLs?
A
- DPRA permits the operation of a “remote dispensing location” or RDL, provided a certificate of accreditation has been granted and the operation meets the requirements of the regulations
- where drugs are dispensed or sold by retail to the public & operated at a different location from the accredited pharmacy
103
Q
RDL requirements
A
- Meet the qualifications & requirements to operate a pharmacy in Ontario, and be granted a certificate of accreditation
- Apply for an amended certificate of accreditation that will allow the operation of one or more RDLs
104
Q
Standards of Accreditation for RDLS
A
- can only exist if there is an accredited pharmacy operating it
- DM is accountable & responsible for the proper operation of the remote location
- restricted to the opening hours of the pharmacy operating it where a pharmacist is physically present to provide services
- accredited pharmacy is responsible for all the record-keeping
- must be equipped w/ live, 2 way audio-visual links
- meet the same standards as a regular pharmacy, except under certain circumstances as specified by the regulations
105
Q
RDL restrictions
A
- cannot carry any narcotics, controlled drugs, or targeted substances unless safeguards are in place to prevent diversion
- All RDLs must display the 2 yellow notification signs (Notice to patients, Usual and Customary Fee)
- The DM, or a delegate, should complete an onsite inspection of the RDL at least once every 30 days to check the equipment and drugs
- cannot be a Ph or Ph tech that regularly works there
106
Q
Pharmacy Advertising
A
- should be clear & easily underdtood
- should be professional & ethical and not make claims that are not true
Generally 2 parts of advertising:
* Commercial over-the-counter products
* Professional services offered by a pharmacy
107
Q
What is not allowed in Pharmacy Advertising?
think testimonials & ednorsements
A
- Pharmacies are NOT allowed to use testimonials, endorsements or comparative statements
- makes a claim about a specific area of practice being offered, the advertisement must mention the registrant’s area of expertise
- cannot advertise or promote the safety or effectiveness of any prescription drug
108
Q
Prescription pricing advertising
A
- Any advertising of prescription prices, must include at least 15 different drugs from 10 different therapeutic categories
- also include the quantity, total cost (including the dispensing dee), brand name, strength, and dosage form of the drug as well as the period of time it will be advertised
- only price that can be advertised w/out all these requirements is the Ontario Drug Benefit (ODB) co-payment or dispensing fee
109
Q
A
109
Q
What is the FDA
A
- Food and Drugs Act
- to ensure safety, quality & distribution of food, cosmetics, and medical devices
110
Q
The FDA lets the Minister…
A
- Regulate
- Inspect
- Seize
- Impose penalties
- On all activities involving: drugs, food, cosmetics, medical devices
111
Q
What are the FDA Schedules?
A
- A - treatment may not be promoted to public
- B - official or internal standards
- C - radiopharmaceuticals
- D - allergenic substances, blood derivatives, and immunizing agents
- G - controlled drugs
- Prescription Drug list - excludes controlled drugs
112
Q
What are the subsections of the Food & Drugs Regulations
what are most important to pharmacists
A
- A - administration
- B - food & food production safety
- C - drugs
- D - vitamins, minerals, amino acids
- E - cyclomate & saccharine sweeteners
- G - controlled drugs
- J - restricted drugs
Most important are C & G
113
Q
Child resistant package
A
- package that meets the child test protocol requirements of the Canadian Standards Association (CSA) or other standards as specified in the Food and Drug Regulations
114
Q
What is the Pr symbol?
A
- refers to product requiring a prescription for sale
115
Q
What is the N symbol?
A
- refers to narcotic products
116
Q
What is the TC symbol?
A
- refers to benzodiazepines and other targeted substances
116
Q
What is the C symbol?
A
- refers to controlled products
117
Q
Manufacturing of drugs is enforced by?
fed or prov
A
- federally (health canada)
118
Q
Compounding of drugs is enforced by?
fed or prov
A
- Provincially (OCP)
119
Q
Process of approving drug for sale
A
- HC reviews safety, quality & efficacy of a drug
- FDA describe regulatory requirements for manufacturers of drug products (Good manufacturing practices)
- once approved by HC, given market authorization & a DIN
- DIN means its been approved for sale!
120
Q
True or False. Only drug products that have recieved Health Canada authorization are approved for sale in Canada?
A
- True
121
Q
Type I recall
A
- most serious
- Reasonable probability that the use of, or exposure to a product will cause serious adverse health consequences or death
122
Q
Type II recall
A
- Use of or exposure to may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote
123
Q
Type III recall
A
- Use of or exposure to is not likely to cause any adverse health consequences
124
Q
Reporting Adverse reactions
A
- Manufacturers must report any adverse reactions to HC within 15 days
- Reporting by public or health professionals is voluntary although encourages (canada vigilence program)
125
Q
What is the Canada Vigilence Program?
A
- Post-market surveillance program that collects and asses reports of suspected adverse reactions to health products marketed in Canada
- HC may order a review of a product & take action where there is potential risk to the public
126
Q
Criteria for Drugs in the PDL
A
- PDL = prescription drug list
- requires supervision of a practitioner for the diagnosis, treatment or prevention of a disease or disorder for which the drug is recommended and for monitoring the drug’s use
- level of uncertainty with the drug’s use or its effects
- Potential harm that a drug could cause that would require a supervision by a practitioner
127
Q
A
