Rest of PHARM 120 info Flashcards
1
Q
What is Canada’s life expectancy compared to the US and the average (OECD)?
A
Above average, above US
2
Q
What is the % smoking rates of Canada compared to the US and the average (OECD)?
A
Way below average, below US
3
Q
What is the % Obesity rates of Canada compared to the US and the average (OECD)?
A
Above average, below US
4
Q
Where is Canada in the HC system performance rankings
A
2nd last. US is last
5
Q
Who has the worst mortality rates?
A
US
6
Q
What is the surgical wait times compared to average in Canada
A
way above
7
Q
Where is Canada compared to average with the # of Physicians?
A
Way below average
8
Q
Why does Canada have so little medical graduates?
A
A provincial strategy to decrease billing
9
Q
Who has the most Healthcare spending as a percentage of GDP
A
US pays the most, but is still lowest for health system performance
10
Q
What are seniors covered by in the US? what about low income people?
A
Seniors
Medicare - Federal
Low income
Medicaid - Federal & State
11
Q
What are cost drivers in the US health care compared to Canada (5)
A
- High physician salaries
- Hospital charges
- Heavy Use of technology
- Pharmaceutical costs
- Administration costs
12
Q
How did Obamacare help healthcare?
How did they lower # of uninsured in America?
A
Improve access to care
Improve efficiency and control costs
Increase emphasis on disease prevention
- Children can be covered by parents policy until 26
- Insurance can no longer deny coverage based on pre-existing conditions
- Creation of health insurance exchanges for purchasing coverage
- Tax credits for purchase of health insurance
- Expansion of Medicaid
13
Q
What was the effect of Pandemic on Life expectancy for Canada and US.
Comment on their rates of COVID Mortality
A
Canada above average
US way below average
US has 3 times more mortality rate than Canada
14
Q
What did the Oxford Stringency Index indicate
A
Idea is to keep people out of the healthcare systems.
Prevention methods during the pandemic
- however does not measure adherence
Canada was more strict than US
15
Q
Which country has the highest pharma spending. Why?
A
US higher than Canada
Canada has controlled costs of patented drugs and compare it to other countries
US has no costs control as the drug manufacturers in the US set their own prices and federal law prevents it from giving up its purchasing power to secure lower drug prices
16
Q
How is pharmacy in Canada compared to the US
A
Canada has more pharmacists than US
Scope in the US is not as broad as Canada in Hospital pharmacies
17
Q
What are the US values and beliefs towards healthcare
A
- distrust of government, and health experts
- individual responsibility for health and freedom of choice
- national health insurance = communism
- Americans lead (do what they want despite other countries)
18
Q
What is our original sin for the indigenous people
A
Colonialism (political takeover)
19
Q
How are indigenous people affected now? (5)
A
- boil water advisories
- Food insecurity
- Sub-standard and overcrowded housing
- Poorer and shorter education
- Dramatically higher suicide rates especially in the young
20
Q
What are some common stereotypes that indigenous people endure?
A
- Less worthy of care
- Drinkers
- Drug seekers
- Bad parents
- Less capable
- Unfairly advantaged
21
Q
What are some comparisons of the SDOH of indigenous vs non-indigenous
A
All lower
- Income
- higher Poverty rate
- Education levels
- housing
- Food insecurity
- Life expectancy
22
Q
Define social determinants of health & Health inequities
A
SDOH
- the conditions in which people are born, grow, live, work and age. These circumstances are shaped by distribution of money, power, and resources at global, national and local levels
Health inequities
- the unfair & avoidable differences in health status seen within and between countries
23
Q
What are the 4 dimensions of wellness
A
- Physical
- Mental
- Emotional
- Spiritual
24
Q
What are the 17 Social Determinants of Health
A
- Income and Income Distribution
- Education
- Unemployment and Job Security
- Employment and Working Conditions 5. Early Child Development
- Food Insecurity
- Housing
- Social Exclusion
- Social Safety Net
- Health Services
- Geography
- Disability
- Indigenous Ancestry
- Gender
- Immigration
- Race
- Globalization
25
What is Community Service Learning?
What are the 3 steps
Gives an opportunity to learn about these indigenous people
Preparation
- workshops
Action
- Volunteer
- Service reflections
Application
- Final assignment
26
What are the proximal (downstream), intermediate, and distal (upstream) factors of health?
Distal (upstream)
- Economic systems
- Culture
- Race
- Gender
Proximal (downstream)
- Health behaviours
- Exposure to physical risks
- Access to healthcare
Intermediate
- Social supports and coping skills
- Education and literacy
- Employment
- Income and social status
27
Differentiate between a high risk approach vs a population health approach
High risk approach
- Focus on the right-hand of the tail
- Screening for high risk
- Targeted programs
Ex. Dietary interventions for people with obesity
Population health approach
- Focus on shifting distribution to the left
- Making smaller changes to affect more people
Ex. Promoting more daily activity by increase walking pathways in cities
28
What are advantages and disadvantages of a high risk approach?
Advantages
- motivated clinicians and patients
- potentially high impact for patients
- Clear connection between intervention and desired outcome
Disadvantages
- Usually requires screening (expensive and complicated)
- Can be hard to modify behaviours among high risk people
29
What are advantages and disadvantages of a population health approach?
Which risks does it emphasize on?
Advantages
- Might be easier changes to make, does not require the same motivation
- Might result in greater reduction in the overall burden of disease
Disadvantages
- Can leave those at high risk unaffected
- Might increase health inequities
Has an emphasis on the "upstream" approaches to reduce the distal risks
30
What are the 4 key elements of a population health approach
1. Focus on the health of populations
2. Address the determinants of health
3. Increase upstream investments
4. Collaborate across levels and sectors
31
What are the characteristics of population that effects the population health effectiveness (4)
1. Population size and composition
2. Geographic distribution
3. Changing contexts in which people live
4. Exposure to risk factors
32
What is the demographic transition characterized by?
What is the current state of this transition
Fertility and mortality rates
Low fertility and low mortality rates
33
What does the epidemiologic transition describe?
What are its 3 stages of transition?
What does it conclude?
Describes the causes of mortality
3 stages
1. Pestilence and famine
2. Receding pandemics
3. Man-made and degenerative disease
Concludes that older people will die of chronic disease
34
1. Early improvements in mortality were primarily at older/younger ages
2. More recent improvements have affected those at older/younger ages
1. younger
2. older
35
What does the Ageing transition describe?
Because of the baby boom, Canada is moving very quickly from a young population to an old population
36
What does the Migration transition describe?
28% of Canadians were born outside of Canada
- Immigrants are generally healthier than other Canadians (immigration process is selective)
37
What does the urbanization transition describe?
What are the 3 causes of urbanization
3 causes
1. Rural to urban migration within cities
2. Immigrants going to cities
3. Reclassification of formerly rural to urban areas
Rural areas
- older demographic, few immigrants
- higher unemployment and low income
Urban areas
- ethnically diverse
- becoming more dense
38
What are the 4 implications of transitions and population health overall
- population has never been so large or old
- Canadians have never been healthier
- Canada has never been so diverse
- Canada has never been so urban
39
What is the fastest growing sector in terms of healthcare dollars
Physicians
40
How do Canadians spend on Drugs
Public: 30-50%
Private insurance: 35-40%
Out of pocket: 20%
41
Why was there a large increase in public drug spending in 2018?
OHIP+ was introduced
42
What are some of the drivers of pharmaceutical spending?
1. increase # of Rx's
2. Use of newer and expensive drugs
3. Inflation
4. Ageing population (more % over 65+)
5. Population growth
5. Price changes (expensive brand names)
43
Where does Canada place for most expensive brand name drug? generic name
4th
11th
44
What % of claims for brand and generic in comparison to the % of funds
Generic: 79% of drug claims but 28% of funds
Brand: 20% of claims but 46% of funds
45
What is funding for prescriptions based on?
Age
income
employment status
46
Canada is the ONLY developed country with universal health insurance that EXCLUDES prescription drugs T/F
True
47
According to the FDA, a drug is considered anything that is used in.. (4 things)
Are NHPs considered drugs
- The diagnosis, treatment or prevention of a disease or disorder in humans and animals
- Restoring and correcting organic functions in humans and animals
- Disinfection in premises in which it is manufactured and kept
- Therapeutic claims are made
Yes, some are
48
In the discovery phase, is a new drug always discovered?
No, some can be repositioned or repurposed
(ex. viagara)
49
What are key questions answered in the preclinical studies for animal or in vitro testing? (3)
- Can formulation/dosage form be developed?
- Is the drug bioavailable after oral administration?
- Is the drug toxic to any key organs?
50
What are the 3 applications/submissions in the drug approval process
After drug discovery:
1. Clinical trial application to the health products and Food Branch (HPFB) and Therapeutic Products Directorate
After clinical trials
2. New drug submission
(data on safety, effectiveness, quality)
(if benefits outweigh the risks)
After regulatory review
3. Approval/marketing authourization (DIN) (Notice of Compliance)
51
What occurs in the 3 Phases of clinical trials
Phase 1
- 20-100 volunteers
- Does the drug have the same effects on humans as animals?
- Discover its pharmacokinetic profile (absorption, distribution, metabolism, excretion)
- Dosage form
Phase 2
- 100-500 patients
- Discover safety and efficacy
- select the best dose
Phase 3
- Large scale 1000-5000 patients
- Randomized control trials
- Assess effectiveness by comparing with current drug choice
52
Who is responsible for the Post Market Surveillance?
What activities are involved?
The Marketed Health Products Directorate
They check on possible long-term interactions and variability between patients
53
Who conducts a common drug review? What is the review for?
the Canadian Agency for Drug and technologies
- compares the new drugs to existing alternatives
- compares its therapeutic effects and cost effectiveness
54
When can generic drugs be made?
What are some characteristics of generics?
After 20 years patent protection of brand names
- preclinical and clinical testing does not need to be repeated
- has to be pharmaceutically equivalent
- has to be bioequivalent
- plasma concentrations of generic product are superimposable with the brand name
55
What are the federal roles? Provincial? Shared?
Federal
- National standards for health care system
- safety of pharmaceuticals, medical devices etc
- prices for patented drugs
- Health funding to provinces
- Funding and direct health care services to specific groups
Provincial
- Management, organization and delivery of healthcare to residents
- Determine the extent to which they offer coverage for out-of-hospital Rx's
Shared
- CADTH (drugs & tech), pCPA, CIHI
56
What are the 5 principles of the Canada Health Act
UP PAC
1. Comprehensiveness
2. Portability
3. Public administration
4. Universality
5. Accessibility
57
T/F healthcare moves away from hospitals to home and community
T
58
What were the 3 provincial/territorial conditions from the Liberal Pharmacare promise
- improved access to drugs
- Long-term funding
- Control over design & delivery
59
What is drug spending breakdown % for public, private, out-of-pocket
Public: 43.6%
Private insurance: 37%
Out-of-pocket 20%
60
How many % Canadians have private coverage
70%
61
What are 6 ways to achieve pharmacare
1. Single-payer, public universal coverage
2. Catastrophic drug coverage
3. Closing the gaps
4. Essential Medicines
5. Commonly prescribed drugs
6. Comprehensive approach
62
What is the CPhA's recommendations for pharmacare? (4)
1. Complete the coverage
2. Establish a minimum standard of coverage (ensure all plans have consistent formulary coverage)
3. Protect Canadians from catastrophic drug costs
4. Promote optimal use of medications
63
How is the government planning on accelerating a universal pharmacare program at the moment? (2)
- Through a rare-disease strategy to help Canadian families save money on high-cost drugs
- Establishing a national formulary to keep drug prices low
64
What was the Liberal Pharmacare promise in June 2019? (4)
- Universal, singe-payer public system
- Establishment of Canadian Drug Agency
- Dedicated Funding and pathway for expensive drugs for rare diseases
- Long-term funding
65
What is Health technology assessment HTA?
What is its intention?
A multi-disciplinary field of policy analysis that examines the MEDICAL, ECONOMIC, SOCIAL and ETHICAL implications of the incremental value, diffusion and use of a medical technology.
- intention is to bridge between research and decision-making
66
What are the 3 main disciplines of HTA (health technology assessment) and their primary objectives
1. Evidence based medicine (base decisions on best evidence) (efficacy, effectiveness)
2. Economic evaluation (maximize health benefit given resource constraints) (economic, values)
3. Bioethics/ social science (fair process)
67
What does Pharmacoeconomics consider? (2 things)
How much more EXPENSIVE the new drug is
How much more EFFECTIVE the new drug is
68
What are the 3 options for the consequences of different economic evaluation programs being measured
3 options
1. Physical units
2. Composite measure of overall health
3. Willingness to pay
69
Explain what each economic evaluation compares:
- Cost-effectiveness Analysis
- Cost-Utility Analysis
- Cost-Benefit Analysis
CEA
- Compares different treatments for the same health problem
CUA
- Compares different treatments for different health problems.
Ex. Should more money be spent on treating depression vs arthritis (examine health gains of each by QALY quality adjusted life year)
CBA
- compares different programs, health and non-health related, and benefits of both are measured using willingness to pay
Ex. which offers a larger social surplus: building a new hospital or a new highway?
70
Explain the incremental cost effectiveness ratio ICER equation
ICER = Cost B - Cost A / Health B - Health A (in physical units)
Cost A is usually the standard cure
Cost B is the new treatment being considered
- Looks at the COST of obtaining an additional unit of health by using B instead of A
71
What are 2 approaches to estimate costs & consequences of alternative treatments in pharmacoeconomics
1. Randomized controlled trial (subject's costs and consequences are tracked over time)
2. Decision analytic model (creating a model of how treatment affects disease progression)
72
Which provinces have pharmacare and what is their public and private plan integration
BC, SK, MB
Everyone is covered
Government is first payer. (have a deductible based on income)
- Coverage switches from private to public after deductible is met
73
What is the role of plan sponsors/employers, Insurers, and Plan-Benefit managers
Plan sponsors/employers:
- Chooses WHICH FORMULARY they want
- Chooses drug plan design
Insurers
- decides WHICH DRUGS go on each formulary
Plan-benefit managers
- deals with all the money and deals directly with pharmacies
74
Define what a formulary is and list 3 types
Formulary: List of prescription drugs covered by a health insurance plan
Prescription by law: covers all rx drugs (open plan)
Provincial mimic: covers drugs that the province also covers
Managed formulary: Limited list of eligible drugs determined by a payer drug review committee
75
What are the 3 types of plan and thier characteristics
Drug choice:
- change prescription
- Eliminating claim
Cost Sharing
- Shift cost to patient or provincial plan
Drug cost
- Reduce purchase price
76
What does private drug plan "costs" mean.
Define premiums.
Means the cost of the DRUG PLAN - the premiums they pay for the drug plan
- does not mean drug prices or drug claims
Premiums: set amount payed on a regular basis for coverage
- need to be competitive and profitable
77
What are some factors that influence a plan's health premiums?
* drug cost
* utilization (claims experience)
* plan member demographics
* Insurers’ charges
* plan advisors' commissions
* trend factors (projections)
* pool charges
78
What are risks and benefits of pharmacy compounding?
Benefits
- customized to patient
- Makes it easier for patients to take meds
Risks
- If not properly compounded, risk for med errors
79
What does AIMS stand for? What is the process? Define medication incident and near miss.
AIMS
- Assurance and Improvement in Medication Safety
1. Report
2. Document
3. Analyze
4. Share
Medication incident/error: preventable event that leads to inappropriate med use or prevents harm
Near miss: a med error caught early before it reaches a patient (still needs to be reported)
80
What is the current shift in medication safety that needs to be made? describe it
Define Just culture.
Person shift --> System approach
- not looking at who did but how it happened (focus on prevention)
Just culture: organizations do not punish, but look at errors through questions
- employees speak up about safety issues without fear of punishment
81
Define the following terms:
Adverse Drug Event ADE
Adverse Drug reaction ADR
Serious ADR
Medication incident
Pharmacovigilance, purpose?
Adverse Drug Event ADE
- Any untoward medical occurrence in a patient administered a drug which does not necessarily have to have a casual relationship with this treatment
Adverse Drug reaction ADR
- a negative outcome which occurs at doses normally used or tested for the diagnosis, treatment, or prevention of an organic function
Serious ADR
- Requires hospitalization, is life threatening, or results in death
Medication incident
- Medication error that could have been prevented
Pharmacovigilance
- The science and activities relating to the detection, assessment, understanding and prevention of ADR
- Purpose is for: Safety, Efficacy, Quality
82
Whats the % range of ADRs that are reported
1-10% range
83
Are hospitals required to report ADRs?
Yes
84
What group of people had the highest voluntary ADR reports? why?
Pharmacists
- They are the front line of AR reporting since they are medication experts
- Change in scope of practice - shift from dispensing role
85
Which NAPRA domain does ADR reporting takes place in
Domain 1: Providing care
86
What health products are in scope to report for ADR?
Prescription drugs
Non-prescription drugs
NHP
Biologics
Disinefectants and sanitizers
Radiopharmaceuticals
87
Is proof or consent required for ADR reporting
No
88
When should a HCP report ADRs in special cases of suspected associations (3)
when ADRs are:
- unexpected (not consistent with product info or label regardless of their severity)
- Serious whether expected or not
- if a product has been on the market less than 5 years
89
What are 4 broad ADR Risk factors
1. Patient related factors (age, gender, race)
2. Social factors (diet, smoking, alcohol)
3. Drug related factors (polypharmacy, wrong medication use or prescribing, drug interactions)
4. Disease related factors (multiple conditions)
90
What are the mandatory fields for ADR reporting (4)
Patient age & sex
Reporter’s name & contact
Suspected product name
Side effect
91
What is the goal of Vanessa's Law?
What do new post-market authourities include?
Goal:
- to improve the quality and increase the quanitity of reporting serious ADRs and MDIs to Health Canada to optimize detection of potential health product safety issues
1. Power to require information, tests or studies
2. Power to require a label change/package modification
3. Power to recall unsafe therapeutic products
4. Ability to require and disclose information in certain circumstances
5. Tougher measures for those that do not comply
6. Mandatory reporting of serious adverse drug reactions and medical device incidents by healthcare institutions
92
Where can you search drug information and adverse reports
Drug Health Product Register DHPR
93
What is the goal of the Canadian Medication Incident Reporting and Prevention System? Who is involved and what is involved
How can this goal be done?
Goal:
To reduce and prevent harmful med incidents in Canada
- looks at mistakes with medications
- CIHI, ISMP (institute safe medication practices), CPSI groups
Through: reporting, sharing, and learning
94
What are the steps (4) and key components (3) of Continuous Quality Improvement?
Steps
1. Reporting
2. Analysis
3. Implementation
4. Solution Development
Key components:
1. Proactive: regular performance of a pharmacy safety self-assessment
2. Retrospective: Anonymous reporting of medication incidents
3. Documentation: Regular pharmacy staff CQI meetings
95
Describe the 2 complementary approaches for ISMP and their limitations
Quantitative analysis (broad picture, numbers)
- Summarize medication incident data, descriptive data (frequency tables)
- Role: the "what" questions
- Monitor trends and areas for improvement
Limitations:
- does not address case specific contributing factors
- voluntary reporting does not ensure reliability of results
Qualitative analysis (to understand the contributing factors)
- The stories data
- Role: the "why"
Limitations
- Does not identify incident rates
- Time consuming
96
What are the 3 main themes in the qualitative analysis with medications associated with harm
1. High-risk process in the pharmacy
2. Communication gaps
3. Preventable adverse drug events
97
Describe the Neighbourhood Pharmacies Association.
What is their purpose?
National, non-profit, that delivers insights and solutions as a knowledgeable, experienced stakeholder and sought-after thought leader in public health, primary care, and policy development
- voice of the pharmacy business in Canada
- Represent pharmacy organizations with varied business models (chain, LTM etc)
Purpose:
- to advocate for pharmacy's potential to improve Canadians health and contribute as partners to the shared vision of a robust, resilient health system
98
What are the current advocacy priorities federally
- to have pharmacy services remuneration
- vision and model for funding pharmacy as a community health hub
- to have National Pharmacare that improves our scope, services, and funding
99
What are some HHR challenges through resilient pharmacy work environments that Neighbourhood Pharmacies are trying to advocate more
- Support more resilient workplaces for their teams (optimizing workflow & workload)
- Appropriately mobilize the team resources they do have (optimizing workforce)
- Remove barriers to optimal use of workforce
- Remove barrier to technology adaption and innovation
100
What is the future of pharmacy goals for Neighbourhood Pharmacies
* Value of pharmacy to fill gaps in health care – catalyzed for past three years
* Knowledge, skill, access, relationships
* Medication Management
* Greater focus on Pharmacy Services; diminished focus on traditional dispensing
* Practice to Full Scope
* Greater Role in Public Health
* Greater Role in Primary Care
* Patient/community services and education * Virtual Care
101
What are specialty drugs?
- High cost drugs (10,000)+
- Complex disease-state
- Require special storage, handling or administration (high touchpoint)
- Accounts for less than 1% of all prescriptions but 30-40% of all drug expenses
102
What are patient support programs (PSPs)
- Sponsored by drug manufactures and administered at arms-length by providers to help patients with coverage it initiate and continue their treatment
103
What are some reimbursement navigations for PSPs
- Drug coverage verification
- Preparation/submission of prior authorization forms
- Coordination of benefits between insurance plans
- Coordination of financial assistance
- Pay the difference of drug after insurance (A commercial sale)
- Coordination of compassionate drug product
- It is absolutely free coverage (Free stock, giving it away)
- Expedited access to treatment through coordination of commercial drug bridging
- Giving compassionate drug product until patient finds a mean of paying
104
What are Preferred Provider/Pharmacy Networks
Define an open and closed PPN
Help plan sponsors (employers) reduce dispensing fees and drug markups paid to pharmacy providers for prescriptions for their patients
Open PPN
- Allow any pharmacy to dispense the medication if they follow the same price (dispensing, markup)
Closed PPN
- only has to be 1 pharmacy despite the pharmacy agreeing to the same price conditions
105
Why does a Pharmaceutical manufacturer elect to utilize a PSP provider to administer their specialty drug services vs. providing them directly to prescribers and patients?
- They need to be at arms length by PSP due to ethical obligations
- the drug manufacturers do not want to be bias and pick who receives coverage and not.
- It is also structured to help with adherence
