1
Q
What is a regulatory body?
A
- Mandate of public protection established in legislation
- Membership - mandatory
-> Authority to restrict entry or revoke - Accountable to the public
2
Q
What is an Association?
A
- “union”
- Advocacy body - mandate to further the interests of its membership
- Membership - voluntary
-> No authority over practice - Accountable to governing board & membership of association
3
Q
What is the Section 3(2) Duty of the College?
A
- The college has a duty to serve and protect the public interest
4
Q
What is Section 2.1 Health Professions Procedural Code?
A
Work in consultation w/ the Minister to ensure, as a matter of public interest, that the people of Ontario have access to adequate numbers of qualified, skilled & competent regulated health professionals
5
Q
What is Section 3(1) Objects of the College?
A
- To develop, establish & maintain programs and standards of practice to assure the quality of the practice of the profession
- To develop, establish & maintain standards of knowledge and skill and programs to promote continuing evaluation, competency and improvement among the members
- To develop… standards of professional ethics
6
Q
Beneficence
A
- To benefit
- Pts seek our care & services b/c they trust we will apply our knowledge, skills & abilities to help make them better
7
Q
Non Maleficence
A
- Do no harm
- Diligent in our efforts to do no harm and whenever possible, prevent harm from occurring
- Proactive in identifying red flags
8
Q
Respect for Persons/justice
A
- autonomy
- Must treat all pts fairly and equitably and respect their vulnerability autonomy and right to be decision makers in their own health
9
Q
Accountability
A
- Fidelity
- Keep our promise to our pts & society and inevitably act in their best interests and not our own
10
Q
Explain Boundary Violations
A
- Boundary violation - is the point at which a relationship changes from professional & clinical to unprofessional and inappropriate
- Boundary violations exploit the power imbalance inherent in the registrant-patient relationship
11
Q
What does it mean to be a Professional?
A
- Duty to prioritize pt benefit above all else
- Accountable to society
- Holding each other accountable to meet the standards of ethics and care
12
Q
What is the Mandate of the College?
A
- to serve & protect the public
13
Q
Code of ethics vs. Standards of practice
A
- Code of ethics - set of aspirational goals based around the values of integrity, respect & responsibility
- Standards of practice - the minimum standards of practice a pharmacist must meet & against which their performance will be measured
- These work together, and have some overlap
14
Q
What are MSOPs?
A
- Model standards of practice that all licensed Canadian Pharmacists must meet
- Not applicable ONLY to Ph at entry to practice
- NAPRA acknowledges Ph fulfill a number of professional roles
- When performing specific role, the Ph must meet ALL of MSOP associated w/ this role
15
Q
List the 4 MSOP Domains
A
- Expertise in medications & medication use (central domain)
- Collaboration (central domain)
- Safety & Quality (critical attribute)
- Professionalism & Ethics (critical attribute)
16
Q
MSOP - Expertise and medication use
A
- 61 general standards
- Phs maintain their competence
- Phs apply their medication & medication-use expertise while performing daily activities
- Phs provide evidence of application of their medication & medication-use expertise through documentation
17
Q
MSOP - Collaboration
A
- 21 general standards
- Phs work constructively w/ students, peers & members of inter-professional team
- Phs communicate effectively
18
Q
MSOP - Safety & Quality
A
- 16 general standards
- Phs undertake continuing professional development, quality assurance & quality improvement
- Phs respond to safety risks
19
Q
MSOP - Professionalism and Ethics
A
- 11 general standards
- Phs demonstrate professionalism & apply ethical principles in their daily work
- ** this is where we see overlap w/ CoE
20
Q
Why do we have MSOPS?
A
- Creates the foundation of our profession
- Sets levels of accountability for all
- Reflects the progress of the profession
- To support workplace initiatives
- For advancement of the profession
- Basis for other College programs such as Registration, QA, complaints & discipline
21
Q
Main themes in new NAPRA MSOPs
A
- Giving pharmacists & pharmacy techs a broader, more holistic framework to guide their practice
- Emphasizing the importance of health system collaboration, where pharmacy professionals are integral parts of a pt’s circle of care
- Reinforcing the importance of being a parnter in a pt’s health decison-making
- Using professional judgement in decision making
22
Q
List the 5 new MSOP Domains
A
- providing care
- knowledge & expertise
- communication & collaboration
- leadership & stewardship
- professionalism
23
Q
What is Bill 179?
A
- The Regulated Health Professionals Statute Law Amendment Act 2009
- Significantly amended the Pharmacy Act creating a greater role for RPh’s in the delivery of primary health care
- Allowed pharmacists to inject, test blood, help w/ inhalation products
24
Q
US vs. Canada Self care market
A
- US - 2 class of regulated products (prescription & OTC), unregulated misc product
- Can - 3 schedules, 4 catgories of regulated drugs (I, II, III, U), regulated misc products
25
Current regulatory structure (fed & prov)
* Fed (health canada) - decided whether it should be rx or non-rx
* Prov (pharm regulatory authorities) - we use NAPRA
- decide on scheduling
26
Principles for requiring prescription
* supervision by HCP is necessary
* level of uncertainty or it's effects justify HCP supervision
* use can cause harm or risk to the public that can be mitigated by HCP supervision
27
Non-RX Drug regulation
* scientific evidence required
* facts table labelling
* mandatory recall
* fines & penalties up to $5M
28
Natural Health Product (NHP) regulation
* broad standard of evidence, recognize traditional forms of evidence
* no standard format for labelling
* no inspections
* voluntary recall
* fines & penalties up to $5000
29
Self-care Framework Proposal
- oversight proportional to risk
- similar evidence for similar claims
- informed consumer choice
- Risk-based post-market overnight
30
3 category risk-based approach
* Moving away from a system based on claim, source of ingredients, and uncertainty
* Category 1 - least we are concerned w/
* Category 2 - all routes (oral, rectal), relieve your symptoms
* Category 3 - most stringent, use too much of ingredient cause a problem, ALL NSAIDs
31
Risk-based Approach - Category 1
Must meet all of the following:
* topical/dental only
* attests to pre-cleared info
* self-limiting conditions
* not sterile
32
Risk-based Approach - Category 2
* all routes of admin
* relief symptoms
33
Risk-based Approach - Category 3
If ONLY 1 met:
* safety concern w/ ingredient
* no pre-cleared info
* serious risk that requires review
* condition could worsen
* indicated for HCP use only
34
How are Herbal Products typically Prepared?
- typically an extract
- fresh or dried plant material is soaked in solvent followed by filtering, then concentrated and prepared as dry form or liquid form
35
Issues w/ Herbal Products
* Complex mixtures of compounds
* Active ingredient(s) may be unknown
* Plant misidentification
* Adulteration/contamination w/ "drugs", other species etc.
* Microbial or heavy metal contamination
* Exaggerated claims, misleading advertising
* Products w/ multiple herbs
* Quantity of active ingredient different than label
36
Standardization of Herbal Products
| What and how?
* created by identifying a suspected active ingredient & altering manufacturing process to obtain a consistent amount
* Methods of analysis include chemical fingerprinting (using HPLC), microscopy of plant material etc.
37
Vitamins & minerals
* Vitamin D, Calcium, Multivitamins
* Can be used to correct deficiency (ex. Iron for anemia) or for pharmacological purposes (ex. Niacin for dyslipidemia)
* Can be natural-source or synthetic
38
What is Homepathy?
* System of alternative medicine
* Homeopathic remedies can use plant, animal or mineral substances as starting material
* Principle 1 - law of similars
* Principle 2 - use very small doses
Take extract & dilute it
39
What are Traditional Medicines?
* Traditional Chinese medicine
- Herbal medicines are used (along w/ other modalities such as acupuncture) to restore balance of yin and yang
- Typically use combination of herbs
Common examples - ginseng, licorice, Ma huang
* Ayurveda
- A system of traditional medicine native to India
- Incorporates herbal therapies
40
What are Probiotics?
* Live microorganisms which when administered in adequate amounts confer a health benefit on the host
* Usually bacteria but can be yeast as well
* Common probiotics: Lactobacillus sp., Bifidobacterium sp., Saccharomyces boulardii
* Common use - treatment of antibiotic-associated diarrhea, IBS, infantile colic, bacterial vaginosis
41
How are NHPs regulated?
* NHPs are regulated by Natural Health Product Regulations, which came into effect 2004
* Regulated as a subset of drugs
* Pre-market review required for NHP to obtain a product license
* Approved products are given either a Natural Product Number (NPN) or DIN-HM (homeopathic medicines)
* Product license application must contain info on safety, efficacy, quality & proposed label text
42
Compendial Applications
* only need to refer to single ingredient or product monographs, available from Health Canada
* Applications do not require additional data supporting safety or efficacy
43
Traditional Health Claims
* Non-compendial applications
* Evidence must demonstrate use of medicine ingredient(s) as part of a recognized system of traditional medicine
* Efficacy is based theories/belief systems of the healing paradigm
* Must show >2 generations of traditional use
44
Modern Claims
* Non-compendial applications
* More stringent requirements for scientific evidence
* Sources of evidence - clinical studies, pharmacopeias, textbooks, peer-reviewed published articles, pre-clinical studies, reputable regulatory authority reports, expert opinion reports
45
When are Randomized Controled Trials required for NHPs?
* Randomized controlled trials - only needed for "high risk" claims
* Compendial applications do not require independently conducted RCTs
* Traditional use claims do not require RCTs
46
Homeopathic Medicine Licensed
* Require a product license application (given DIN-HM)
* Ingredients must be based on those found in a pharmacopeia
* Evidence for efficacy is typically pharmacopeias, homeopathy encyclopedias
* Must be labeled as homeopathic medicine/remedy/preparation
47
What info is listed in the Licensed National Health Database?
* Product name
* Product license holder
* NPN/DIN-HM
* Medicinal and non-medicinal ingredients
* Dosage form
* Recommended use/purpose (ie health claim or indication)
* Risk info (cautions, warnings, contra-indications)
48
What is the safety of NHPs
* usually safe
* Potential for drug-NHP interactions
* Adverse effects
* Safety in pregnancy, lactation, children, specific conditions - Often not established
49
What are the COE principles?
* beneficence
* non-maleficence
* respect for persons/justice (autonomy)
* accountability (fidelity)
50
What is circle of care?
* ability of certain health info custodians to assume and individual's implied consent to collect, use or disclose personal health info for the purpose of providing health care in circumstances defined in PHIPA
51
PHIPA vs PIPEDA
* PHIPA - prov legislation, to do with collection, use & disclosing personal health info by Health info custodians
* PIPEDA - fed legislation, to do with collection, use, disclosing personal health info by organizations in commercial activites
52
CRT - Husband of one of your long-time female pts (rose) requests prescription receipts for his wife for income tax purposes. Known family for years, he states wife is busy (night shift at hosp), and she misplaced receipts you previously issued. Do you print the receipts for him?
* NO - violates autonomy (respect for persons)
* Can only disclose med info: if they are an imminent harm to themselves or others, or by law
53
CRT- Long time pt who you know to be nonadherent from his history has just had a heart attack. Discharge orders include a new drug to help prevent another heart attack. He tells you he is not going to take this med either. Do you call his physician & relay this info?
* YES - beneficence
* Call physician & relay info, since you are in the circle of care
* But 1st try to discuss to pt why they are not taking the med
54
CRT - Long time pt brings your prescription renewal for HTCZ 25mg QID. She has always taken this dose QD. You call the Dr to question the dose & he tells you to "just fill it the way I wrote it." do you fill this prescription as is?
* NO - non maleficence
* In Ontario we can renew and ADAPT prescriptions
55
CRT - A patient presents to your pharmacy requesting Plan B the use of which goes against your beliefs. Do you have a right to refuse to dispense this medication?
* YES - falls under non-maleficence - 2.13 refusal to fill for moral or religious reasons
* ONLY IF you provide a viable alternative
56
CRT - a 26 year old pt presents requesting Plan B, the use of which does NOT go against your beliefs. You note she is overweight and there have been recent studies suggesting decreased efficacy of this drug in obese women. Do you have the right to refuse to dispense this medication?
* NO - Non-maleficence?? Beneficence?
* Ask: is decreased efficacy providing harm to pt - No it should still work
57
CRT - A teenager comes into your pharmacy and requests an OTC cough syrup containing Dextromethorphan. He declines having any symptoms that would indicate a need for this medication. Do you have the right to restrict the sale of such item?
* YES - non-maleficence
* You have right to restrict sale if you believe it is going to be abused
58
CRT - A patient comes into your pharmacy and requests isopropyl (rubbing) alcohol. Do you have the right to restrict the sale of such item?
* YES - non-maleficence & Beneficence
* IF you feel that is is going to be abused
59
CRT - parents bring in round, yello tabs marked w/ number 40 that they found in their 16-year old son's room. You don't have their son in your pharmacy computer system & don't know anything about him. You identify the pills as Oxycontin (prescription narcotics) that have a high potential for misuse. Do you tell the parents?
* YES - Non-maleficence
* They're telling you they found it in their son's room - you don't know for sure
* You are allowed and should help identify pills
60
CRT - a pt is being put on new chemo regimen & the physician fears that she will not want to take it b/c of side effects. He requests that you do NOT provide the medication info sheet w/ the prescription since he feels he has already reviewed the risks and benefits of treatment w/ the pt and she doesn't need to see those really rare adverse effects. Do you give the pt the info sheet?
* NO/YES - non-maleficence
* You MUST offer counselling, however not required by law to provide med info sheet
* A physician cannot tell you NOT to counsel pt
* If pt refuses counseling can document it and not be liable
61
CRT - A pt in her late teens comes into pharmacy to tell you she suspects she might be pregnant, and is taking Isotretinoin, a highly teratogenic drug. You are very concerned, and she is unaware that you know her parents personally. You believe she needs help and support of her family, and if you were her parent you would want to know. Do you call her mom and tell her?
* NO - Respect for persons
* Breach of confidentiality
62
CRT - You are working in pharmacy when you notice a child running up and down the aisles, knocking products down. You observe his intoxicated father reprimanding him by throwing him on the ground & hitting him multiple times. You hear him yell, "wait until you see what's going to happen to you when we get home." Do you report this?
* YES!
* Under jurisprudence I - mandatory reporting incidents
* You have an obligation to report
63
CRT - you are working in your pharmacy when a pt asks to purchase insulin syringes. You know this pt does not have diabetes and confides in you about his long history of injection drug use. Do you sell the pt the syringes?
* YES - Non-maleficence
* It is in best interest for the pt to use clean, safe syringes
* The risk of harm of not giving clean syringes outweighs
64
CRT - Pt received a prescription for amoxicillin 500mg TID for 7 days. Dr informed pt that they could discontinue the AB after 5 days if symptoms resolved. On day 6, the pt presents to the pharmacy to return the remaining caps for disposal. Pt tells you they are feeling 100% better. When you empty vial into drug disposal bin, you realize the pt received 250mg caps instead of 500 mg caps. Do you disclose the error to the pt?
* YES - Accountability
* You must disclose the error & document it, if they go complain to college you will be in better stance than if you hadn't disclosed it
65
CRT - you are DM of a pharmacy. You have discovered that a pharmacist working at your pharmacy is struggling to show up on time for her shift. Upon discussion, the Ph admits that she is struggling w/ an addiction to alcohol that has affected her work. You agree to place Ph on leave until she has sought appropriate help and support. Should you report this info to the College?
* YES - non-maleficence
* You have a responsibility to report
66
CRT - you are pharm tech. while out in community you witnessed a pharmacist co-worker engaged in a public display of affection w/ an individual who you know is a pt of pharmacy. Upon preparing the pt's next prescription for pick up later that week, you review the pt's file and note the pharmacist has recently signed off on pt's prescription, including that the pt counselling was provided. Your suspect that the Ph and Pt may be engaged in a sexual relationship. Should you report this info to the OCP?
* YES - Accountability? Sexual Abuse
* You have a responsibility to report
67
CRT - You are a pharmacist in a community pharmacy. You have reason to believe DM is engaged in unethical behaviour including offering monetary incentives for pts to stay at the pharmacy. Should you report this info to the college?
* YES - accountability
* You hold each other to uphold the COE
68
What is the definition of self-care?
* the ability of individuals, families & communities to promote health, prevent disease and maintain health and to cope with illness & disability with or without the support of a health-care provider
69
What are the 7 pillars of self-care
* Knowledge & health literacy
* Mental wellbeing
* Physical activity
* Healthy eating
* Risk avoidance
* Good hygiene
* Rational use of products and services
70
More than __% of healthcare is selfcare
* 80%
71
Self-care can be used for...
* Symptomatic relief of mild or self-limiting conditions
* Control of signs and/or symptoms of chronic conditions
* Prevention of problems & complications
72
Self-care Options
| types of products used for self-care
* Nonprescription meds (ex sched I, II, U)
* Natural health products
* Nonpharmacologic therapy
* Diagnostic tests & monitoring devices
* Devices
* Other - insulin
73
Self-care vs. Minor ailment
* minor ailment - health conditions that can be managed w/ minimal treatment and/or self-care strategies
* self-care - the broad approach taken for target illness (could be minor or chronic conditions)
74
Self-medication
| what is it?
* One element of self-care
* Selection & use of medicines by individuals to treat self-recognized illness or symptoms
* Facilitated self-medication - when consumers seek help at the point of purchase
75
Benefits of Self-care
* Increased coverage & access
* Increased quality of services
* Improved health, human rights and social outcomes
* Reduced health disparities and increased equity
* Reduced cost and more efficient use of healthcare resources & services
76
Key takeaways from Self-care in Covid-19
* Increased interest in caring for one's own health
* Critical role of health literacy
* Missed "self-care as public health" opportunity
* The link b/w self-care behaviour and demand for health services sharply underscored
77
Benefits of self-treatment
* Financial advantages
* Lightened workload for tired health care system
* Convenience
* Wide variety of OTC products available
78
Risks of self-treatment
* Potential for drug-drug and drug-disease interactions
* Overuse or misuse of OTC products
* Incorrect diagnosis of the self-care condition
* Misinterpretation of the drug fact label
* Pt confusion caused by combination products & brand line extensions
79
What is a Minor Ailment?
* Can be reliably be self-diagnosed by a patient
* Can be managed w/ self-care/ minimal treatment
Criteria:
* **Usually a short-term condition**
* **Lab results are usually not required**
* Treatment has a low risk of masking underlying condition
* Meds and medical histories can reliably differentiate more serious conditions
* Only minimal or short-term follow-up is required
80
OTC consult
| as compared to prescribing consult
* quick assessment
* semi-private
* plan results in - Referral to other HCP, Using a wait-and-see approach, Recommending a non-rx nonpharmacologic therapy
* No (minimal) follow-up
* No (minimal) documentation
* No (minimal) notification of PCP
81
Prescribing Consult
| as compared to OTC consult
* Semi-detailed Assessment
* Private
* Plan results in - Referral to HCP, Using a wait-and-see approach, Recommending non-rx, non-pharmacologic therapy, **Prescribing I, II, II drug**
* Follow-up
* Documentation
* Notification of PCP
82
T or F: I can only prescribe NAPRA level I prescription drugs for ON minor ailment services
* false
* can give schedule I, II, III
* you are limited to the actual active ingredient
83
True or False: I am required to follow up with the pt after I have prescribed for their minor ailment
* False
* you are NOT required BY LAW
* but if you prescribe a med and bill it through ODB, you must or they will claw back the money
84
TRUE or FALSE: I am required to notify the PCP if I prescribe for their patient's MA
* True
* excpet if they are non-OHIP or do NOT have a PCP
85
RPhs are required to make a referral to another HCP (during MA assessment) when...
* A condition is not of a minor issue
* A condition that is not authorized for RPh prescribing
* Medication not included in Schedule 4 of the Regulation
86
T or F: I can conduct/bill ODB for an annual Medscheck on the same day as MA service for a pt
* True
* what you can't do, is a medscheck follow up
87
T or F: I can add refills on prescriptions I wrote for minor ailment service candidates
* True
88
T or F: I can only provide a MA service to those with a valid OHIP card
* False
* can provide to anyone, but can only bill govmt with OHIP
89
T or F: I can bill for more than 1 MA for the same pt in the same day, as long as ailment is different
* True
* exception - can't bill tick bites and bug bits same day and can't bill influenza and covid on same day
90
Examples of Knowledge & health literacy
* ability to acquire and understanda health info and services
91
Examples of Self-awareness of physical & mental condition
* awareness of current health (BMI, cholesterol, BP etc.) and engaging in health screening
92
Examples of Physical activity
* practicing moderate levels of exercise regularly
93
Examples of Healthy eating
* having a nutritious balanced diet with appropriate caloric intake
94
Examples of Risk avoidance or mitigation
* smoking cessation, limiting alcohol use, practicing safe sex, recieving vaccinations, using sunscreen
95
Examples of good hygiene
* regular hand-washing, proper dental care, washing food
96
Examples of Rational & responsible use of products & services
* awareness of dangers, using responsibly when necessary
97
Physical activity can reduce the risk of...
| which physical diseases
* Premature death
* Heart disease
* Stroke
* High blood pressure
* Certain types of cancer
* Type 2 diabetes
* Osteoporosis
* Obesity
98
Physical activity does improves what for mental health?
* boost the function of our neurotransmitters
○ Increases serotonin (mood regulator)
○ Increases dopamine (pleasure & reward center)
* Improves confidence
* Improves connectedness
* Improves sleep
* Improves mood
* Improves energy
* Improved mental alertness
* Improved resiliency through effective stress management
99
What is the talk test
* If you can carry on conversation but feel a little out of breath -> moderate intensity
* If you cannot say more than a few words or a sentence -> vigorous intensity
100
What are the Physical Activity recommendations
* 150 mins of moderate to vigorus aerobic exercise per week
* 2 days of strength training per week
101
what are the 5 stages of change?
* pre-contemplation
* contemplation
* preparation
* action
* maintenance
102
What are the 3 essential elements to a professional patient care practice?
* A philosophy of practice
* A patient care process
* A practice management system
103
What is PPCP?
* pharmacist patient care process
104
What is patient-centered care?
* providing care that is respectful of and responsive to, individual patient preferences, needs and values, and ensuring that pt values guide all clinical decision
105
What is Practice Management system?
* includes the infrastructure to deliver care, including physical space, documentation systems, payment for services, and qualified support personnel
106
Patients need their meds to be
| IESA
* Indicated
* Effective
* Safe
* Something they can adhere to
107
What are the 5 main steps in patient care process?
* Collect - subjective and objective info from the pt
* Assess - collected data to identify problems and set priorities
* Plan - create individualized care plan that is evidence-based and cost-effective
* Implement - the care plan
* Follow-up - monitoring pt over time, evaluate the effectiveness of plan and modify it if needed
108
What do you do for collect step?
* HAMS
* SCHOLAR
* demographics
* prime Q's
109
What info do you collect for a self-care encounter?
* Demographic
* SCHOLAR
* HAMS
110
What info do you collect for a new rx encounter?
* demographics
* prime Q's
* HAMS
111
What info do you collect for a refill rx encounter?
* demographics
* prime q's
* hams
112
What info do you collect for a holistic assessment encounter?
* demographics
* HAMS
113
What should always be your first question when asked for a recommendation?
* "Who is this recommendation for?"
114
What does SCHOLAR stand for?
* Symptoms
* Characteristics
* History
* Onset
* Location
* Aggravating Factors
* Remitting Factors
115
What does HAMS stand for?
* Health status
* Allergies/intolerances
* medication history
* social history
116
HAMS vs. SCHOLAR
| what are they used for?
* HAMS - health status about the pt
* SCHOLAR - presenting illness, self-care or MA assessment
117
What do you do for Assess step?
| IESA
* ask is it Indicated, effective, safe and something they can adhere to
117
What are the 6 drug therapy problems?
1. Medication unnecessary
2. **Medication needed**
3. Medication ineffective
4. Medication dose incorrect
5. Medication unsafe
6. Medication not being/unlikely to be adhered to
118
What makes a pt not appropriate for self-care
* Has any severe symptoms
* Has any symptoms that persist or return repeatedly
* Is self-treating to avoid medical care
119
What are the steps in the Plan stage?
* goals of therapy
* intervention
* follow-up
120
What are the 5 different goals of therapy?
1. Cure disease
2. Reduce or eliminate signs and/or symptoms
3. Slow or halt progression of a disease
4. Prevent a disease
5. Normalize laboratory values
121
What are the 5 steps to Implementation?
1. address meds and other health-related problems
2. initiate, modify, discontinue or administer therapy
3. provide education & self-management training
4. contribute to coordination of care
5. schedule follow-up care as needed to achieve goals of therapy
122
What are the 3 A's when providing drug education?
* Action
* Administration
* Adverse effects
123
In the follow up, you should monitor and evaluate...
* effectiveness
* safety (no adverse effects)
* outcomes of care (goals of therapy)
124
PHARM 129
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