Final

Question 1

NPS Proposed Actions (9)

Answer 1

Provide catastrophic drug coverage
Establish common national drug formulary
Accelerate access to breakthrough drugs
Strengthen evaluation of real-world drug safety and effectiveness
Pursue purchasing strategies to obtain best prices for drugs
Accelerate access to non-patented drugs
Influence the prescribing behaviour of HCPs
Develop and deployment of the e-Health record
Enhance analysis of cost drivers and cost effectiveness

Question 2

4 core objectives of. The pharmaceutical policy

Answer 2

Access (universal coverage)
Appropriate prescribing
Value for money
Safety

Question 3

PCPA - what were their goals and what happened

Answer 3

Were suppose to help provide monopsony, increase equal access
But not everyone joined and nobody could agree
NOTE: too low of prices can also have negative consequences (drug companies need incentives to be innovative and take risks)

Question 4

PMPRB - what do they do

Answer 4

Set the ceiling price for a drug based on 7 countries (Canada is usually at the middle of these prices)

Question 5

CDR - what do they do?

Answer 5

Set the SOCIAL VALUE of the drug “As high as the price should be”

Question 6

Drivers of Adaptive licensing (4)

Answer 6

Patient expectations - timely access demanded
Emerging science - fragmenting treatment population and early disease interventions
HC system under pressure - rise of payer influence
Pharma/investors under pressure - to develop drugs

Question 7

Patient expectations in AL - trade-off

Answer 7

Future patients take the level of uncertainty for the benefit of the current patients getting the medications faster (help to mitigate the risk through monitoring post-market)

Question 8

Regulatory Roadmap Themes (5)

Answer 8

Transparency
International collaboration
Sustainability
Benefit, harm, uncertainty
Remove financial barrier

Question 9

Which of the NPS Proposed actions have been achieved

Answer 9

1 - catastrophic drug coverage

Question 10

Government and the Pharm. industry - extensive government involvement due to:

Answer 10

Ensuring drugs are safe for human use
“Life and death products”
Unique features of the health care market
Patent protection creates monopolies

Question 11

Strategies that provincial governments use to deal with rising drug costs

Answer 11

Formularies
Generics
Reference-based pricing
Professional fees and Mark-up negotiated with professional association
Cost shifting - users pay more

Question 12

What is the 10% R+D Sales Ratio

Answer 12

10% of all Canada sales of brand name companies were supposed to be used for Canada R+D expenditures (pledge to invest)

Question 13

How are urgency and worse off different and why is this important

Answer 13

Urgency - these patients will die very soon without treatment
Worse off - those who have had the least of good life (young people compared to 80 years old) with life threatening illness
We should focus on those worse off rather than those with urgency (organ example)

Question 14

Important components of APs

Answer 14

Iterative process (always cycling back)
Goes beyond normal framework - lifecycle of drug
NOT meant for every drug - criteria for fast tracking

Question 15

CDR - Do not list recommendations are most common for?

Answer 15

First drug for a disease
Drugs for rare or life-threatening diseases
Validated surrogate endpoints to measure in studies

Question 16

Post-market surveillance is the responsibility of the federal government BUT..

Answer 16

HC does not have the authority to enforce drug companies to conduct post-market studies or make label changes
HC cannot currently impose penalties

Question 17

What is a type A versus a Type B ADR

Answer 17

Type A - common, predictable, dose-dependent

Type B - allergies, idiosyncratic, rare or hard to predict

Question 18

What are the limitations of pre-market studies?

Answer 18

Only designed to ID common unintended dose-related drug effects
Sample size is a direct determinant of subject to be followed
Too few people, too simple, too median aged, too narrow indications, too brief timeline

Question 19

Traditional areas of Inquire for post-market studies

Answer 19

Long term effects
Low frequency effects
Effectiveness in customary practice
Efficacy of new indications
Efficacy in providing long term secondary effects
Modifiers of efficacy - other drugs, condition severity, lifestyle

Question 20

Justification for formal post-marketing studies

Answer 20

Clinical - to test and generate hypotheses
Regulatory - efficacy, toxicity, earlier approval, in response to case reports
Marketing - for new and existing drugs to increase/maintain market share
Legal - prophylaxis to show non-negligence

Question 21

Pharmacovigilance methods

Answer 21

Spontaneous reports
Data mining
Intensive monitoring
Hypothesis based studies

Question 22

5 Challenges of pharmacovigilance

Answer 22

Engaging the public
Collaboration and partnership
Incorporating informatics
Adopting a global approach
Assessing the impact of efforts

Question 23

What are important factors in recruitment and retention in rural SK

Answer 23

Recruitment - loan forgiveness programs, rural training programs, practicum experiences, competitive salaries, professional opportunities
Retention - economic incentives, opportunity for promotion, professional development, community appeal

Question 24

Cannabis Important Themes

Answer 24

Recreational versus medical differentiation
Public education and awareness
Issues with legal age and cognitive function
Patient focused pricing
Avoid smoking for lung health
Consistency is important (like any medication)