Final Flashcards
NPS Proposed Actions (9)
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
4 core objectives of. The pharmaceutical policy
Access (universal coverage)
Appropriate prescribing
Value for money
Safety
PCPA - what were their goals and what happened
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)
PMPRB - what do they do
Set the ceiling price for a drug based on 7 countries (Canada is usually at the middle of these prices)
CDR - what do they do?
Set the SOCIAL VALUE of the drug “As high as the price should be”
Drivers of Adaptive licensing (4)
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
Patient expectations in AL - trade-off
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)
Regulatory Roadmap Themes (5)
Transparency International collaboration Sustainability Benefit, harm, uncertainty Remove financial barrier
Which of the NPS Proposed actions have been achieved
1 - catastrophic drug coverage
Government and the Pharm. industry - extensive government involvement due to:
Ensuring drugs are safe for human use
“Life and death products”
Unique features of the health care market
Patent protection creates monopolies
Strategies that provincial governments use to deal with rising drug costs
Formularies Generics Reference-based pricing Professional fees and Mark-up negotiated with professional association Cost shifting - users pay more
What is the 10% R+D Sales Ratio
10% of all Canada sales of brand name companies were supposed to be used for Canada R+D expenditures (pledge to invest)
How are urgency and worse off different and why is this important
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)
Important components of APs
Iterative process (always cycling back)
Goes beyond normal framework - lifecycle of drug
NOT meant for every drug - criteria for fast tracking
CDR - Do not list recommendations are most common for?
First drug for a disease
Drugs for rare or life-threatening diseases
Validated surrogate endpoints to measure in studies
Post-market surveillance is the responsibility of the federal government BUT..
HC does not have the authority to enforce drug companies to conduct post-market studies or make label changes
HC cannot currently impose penalties
What is a type A versus a Type B ADR
Type A - common, predictable, dose-dependent
Type B - allergies, idiosyncratic, rare or hard to predict
What are the limitations of pre-market studies?
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
Traditional areas of Inquire for post-market studies
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
Justification for formal post-marketing studies
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
Pharmacovigilance methods
Spontaneous reports
Data mining
Intensive monitoring
Hypothesis based studies
5 Challenges of pharmacovigilance
Engaging the public Collaboration and partnership Incorporating informatics Adopting a global approach Assessing the impact of efforts
What are important factors in recruitment and retention in rural SK
Recruitment - loan forgiveness programs, rural training programs, practicum experiences, competitive salaries, professional opportunities
Retention - economic incentives, opportunity for promotion, professional development, community appeal
Cannabis Important Themes
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)
