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PHARM 129 > Jurisprudence > Flashcards

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
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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
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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
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4
Q

What are the 4 Registration Classes?

A
  • Pharmacist *
  • Registered pharmacy student
  • Intern
  • Pharmacy technician *
    • protected titles
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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16
Q

Models of Regulation - No Regulation

A
  • allows the market to determine which activities or practitioners will be chosen
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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
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18
Q

Models of Regulation - Direct Government Regulation

A
  • provincial gvmt could have the Ministry of Health & Long-term care regulate the pharmacy profession
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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
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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
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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
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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
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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
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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
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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

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26
Q

What are Controlled Acts?

Definition

A
  • tasks w/ the potential to cause harm if not done correctly by a competent person
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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38
Q

OCP - Executive committee

A
  • Coordinates operations of the college
  • Deals w/ any matters requiring immediate attention b/w meetings
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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
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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
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41
Q

OCP - Inquires, Complaints & Reports Committee

A
  • Investigates concerns about members relating to misconduct, incompetence, or incapacity
  • can take various types of action
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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
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43
Q

OCP - Fitness to Practice Committee

A
  • Holds hearings to determine whether a member is incapable or impaired
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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
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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
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46
Q

What are the 4 Regulatory Activities of the College?

Just list them

A
  • Restrictive regulation
  • Reactive regulation
  • Proactive regulation
  • Transparent regulation
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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
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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
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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
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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
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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
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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

PHARM 129 (3 decks)

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