Jurisprudence Flashcards

Question

Controlled Acts in Pharmacy

Answer 1

* 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

Answer 2

* tasks w/ the potential to cause harm if not done correctly by a competent person

Answer 3

* 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

Answer 4

* 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

Answer 5

* 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

Answer 6

* 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

Answer 7

* 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

Answer 8

* 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

Answer 9

* Report a child in need of protection to the local children's aid society under the Child & Family Services Act

Answer 10

* Long-term care & retirement home statutes require the reporting of abuse or neglect of residents to the appropriate gvmt office

Answer 11

* Case law requires members to intervene when they become aware of a risk of serious bodily harm or death of a person

Answer 12

* 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

Answer 13

* 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

Answer 14

* Coordinates operations of the college * Deals w/ any matters requiring immediate attention b/w meetings

Answer 15

* 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

Answer 16

* Develops & maintains QA program which includes: 2-part register, continuing education, min practice requirements etc. * Encourages members to engage in continuous professional development

Answer 17

* Investigates concerns about members relating to misconduct, incompetence, or incapacity * can take various types of action

Answer 18

* 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

Answer 19

* Holds hearings to determine whether a member is incapable or impaired

Answer 20

* 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

Answer 21

* Established under pharmacy act * Reviews concerns about operation of pharmacies * Can direct further inspections or refer them to the Discipline committee

Answer 22

* Restrictive regulation * Reactive regulation * Proactive regulation * Transparent regulation

Answer 23

* **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

Answer 24

* **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

Answer 25

* **designed to enhance the knowledge, skill & judgement of members** * Quality assurance program, Inspection/pharmacy assessment, Patient relations program, Practice tools on OCP

Answer 26

* 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

Answer 27

* 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

Answer 28

* **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

Answer 29

* True * Registrant is regulated under PA & RHPA * Practice site is regulated under the DPRA

Answer 30

* Drug and Pharmacies Regulation Act * provincial legislation that serves to protect the public by ensuring safe, ethical, and competent pharmacy practice at accredited locations

Answer 31

* Licensing & ownership of pharmacies * Standards for accreditation * Dispensing of drugs * Record keeping * Accountability & responsibility

Answer 32

* Food & Drugs Act * Controlled Drugs & Substances Act * Privacy Legislation: PIPEDA, PHIPA * Drug interchangeability & dispensing fee act * Ontario Drug benefit act

Answer 33

* 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

Answer 34

* 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)

Answer 35

* Pharmacist * Intern or pharmacy student under supervision of Ph * For RDL, Pharm tech, under supervision (visual link) of Ph

Answer 36

* 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

Answer 37

* I - rx * II - no rx, BTC * III - no rx, OTC * U - any retail outlet

Answer 38

* (1) clinical experience with the use of the product * (2) it's dose * (3) package sizes * (4) patient population

Answer 39

* **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

Answer 40

* **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

Answer 41

* **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

Answer 42

* Sold without professional intervention * Sold from any retail outlet * Information on product label is sufficient

Answer 43

* **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

Answer 44

* **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

Answer 45

* **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

Answer 46

* 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

Answer 47

* 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

Answer 48

* **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**

Answer 49

* 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

Answer 50

* 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)

Answer 51

* 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

Answer 52

* schedule I including narcotic & controlled * Any drug can be mailed or delivered within Canada

Answer 53

* 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

Answer 54

* 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

Answer 55

* 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

Answer 56

* 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

Answer 57

* 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

Answer 58

* 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

Answer 59

* 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

Answer 60

* 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

Answer 61

* 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

Answer 62

* 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

Answer 63

* expire yearly on May 10th * certificated must be renewed * registrar has authority to refuse renewal under certain conditions (ex. non-payment of fees)

Answer 64

* 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

Answer 65

* direct registrar to renew certificate * direct registrar to renew w/ TCLs * direct registrar NOT to renew certificate

Answer 66

* 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

Answer 67

* **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

Answer 68

* 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

Answer 69

* 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

Answer 70

* Pharmacies that were operating on May 14, 1954 * Non-profit, multi-disciplinary health facilities (ex. hospitals)

Answer 71

* 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

Answer 72

* 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

Answer 73

* 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

Answer 74

* 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

Answer 75

* 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

Answer 76

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

Answer 77

* 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

Answer 78

* 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

Answer 79

* 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

Answer 80

* 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

Answer 81

* 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

Answer 82

* 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

Answer 83

* 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

Answer 84

* 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

Answer 85

* Food and Drugs Act * to ensure safety, quality & distribution of food, cosmetics, and medical devices

Answer 86

* Regulate * Inspect * Seize * Impose penalties * On all activities involving: drugs, food, cosmetics, medical devices

Answer 87

* 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

Answer 88

* 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

Answer 89

* 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

Answer 90

* refers to product requiring a prescription for sale

Answer 91

* refers to narcotic products

Answer 92

* refers to benzodiazepines and other targeted substances

Answer 93

* refers to controlled products

Answer 94

* federally (health canada)

Answer 95

* Provincially (OCP)

Answer 96

* 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!

Answer 97

* most serious * Reasonable probability that the use of, or exposure to a product will cause serious adverse health consequences or death

Answer 98

* Use of or exposure to may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote

Answer 99

* Use of or exposure to is not likely to cause any adverse health consequences

Answer 100

* Manufacturers must report any adverse reactions to HC within 15 days * Reporting by public or health professionals is voluntary although encourages (canada vigilence program)

Answer 101

* 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

Answer 102

* 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

Jurisprudence Flashcards

(129 cards)