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Percent of tax dollars going to MOHLTC
Circle of LHIN function
Comunity engagement -> Local health planning -> funding and alocation -> accountability and performance management
Levels of care (based on this hospital guy)?hospitals provide which ones?
- Primary- population health
- secondary- referred services
- tertiary- specialized for diagnosis and treatment
- quarternary- highly specialized, regional services
What is the "Health-Links Model"
Patient centred approach to encourage integration between various levels of care, with an especially strong focus on hospitals (voluntary partnership by HCP to target high usage patients)
What are some stats on high medical care usage patients?
- -5% of health system users account for 60% of spending
- -270,000 ER visits could have been treated in another setting
- -140,000 patients readmitted to hispital within 30 days of discharge
What is the Excellent Care for All Act?
Quality improvement plan that serves to establish metrics that assess performance of public hospitals(safety, effectiveness, access, patient-centred care)
- Guidelines also state that:
- -performance based compensation must be in place
- -quality improvement plans must contain manner in which executive pay is linked to Targets
What are the various types of hospitals?
- Acute Care (inpatient care/usually academic)
- Chronic Care - no emergency or elective procedures, mostly for rehab
What is the trend for hospital beds over the past couple of years?
Decreasing, with a dramatic decrease in acute care beds.
What is the Health System Funding Reform?
Based on "funding follows the patient"-> Quality based funding
QBF makes up 70% of your budget (30% is global)
Of the 70%, 40% is health based allocation method (How much money is required to meet your patient's needs)
30% is Clinical quality groupings: x dollars/service; up to organizations to be more effecient
Explain how quality based funding is broken down?
- Health based allocation method (40%)
- Clinical quality groupings (30%)
Patient flow in hospitals?
What is the most common type of first step of patient flow?
Points of entry -> Acute inpatient -> Discharge/LTC
Emergency (70,000 a year)
Explain the nurse's triage
Canadian triage and acuity scale:
- 1: immediately
- 2: 15 minutes
- 3: 30 minutes
- 4: an hour
- 5: 2 hours
only 1-3 require ER visits
Explain the order of emergency care when admitted to an ER
- primary nurse assessment
- emergency physician assessment
Units in acute care, and which is the most expensive?
- Intensive care unit
- Specialty units (cardiology, respirology)
- General internal medicine
- general surgery
Define alternate level of care.
What is the name of people who are in ALC
Acute care complete; waiting for next level of care (acute care is not the best setting for their current health needs)
People known as "bed blockers"
Problems will patient flow will manifest as____?
How can this be measured?
- backup in to the emergency department
- measured by emergency department length of stay
What are 5 clinical activities where a pharmacist's presence had a positive patient outcome
- attendance on patient care rounds
- patient interviews and assessments
- medication reconciliation
- discharge counselling
- follow-up after discharge
Name 6 types of tox studies
Pre-clinical testing consists of
What phases make up clinical testing? What does each phase do?
- 1) First in man- tolerability, PD, PK (usually in healthy volunteers)
- 2) Dose finding
- 3a) Efficacy+safety
- 3b/4)post-marketing surveillance
What are the four steps of drug regulation framework? (i.e. what organization is at each step?)
- 1) Health Canada
- 2) PMPRB- pricing agency
- 3)CADTH + CDR/pCODR (agencies assessing value)
- 4)a) Reimbursement agencies/formularies (ex. ODB)
- 4)b) regional agencies governed by provincial legislations
- 5) PAAB- advertising review
- 6. R and D code of Ethical practices- interaction between induestries and stakeholders
What do you need to be able to sell your drug in Canada? From whom do you get this? What are alternative forms of this that say you can't sell your product? Which one is better?
Notice of Compliance from Health Canada (based on benefit/risk analysis)
- Notice of Deficiency - inadequate data (this is worse, requires more trials)
- Notice of Noncompliance -questions that need to be addressed
- Notice of compliance with conditions- requires some supplementary data, but can sell
What is the governing legislature for Health's Canada's authority?
Which bodies actually review the drug?
- Food and Drugs Act and regulations
- Therapeutic products directorate- synthetic drugs
- Biologics and genetic therapeutic division- biologics
What does Food and Drugs Act and regulation govern?
When submitting drug for approval, health canada looks at which aspects?
- risk/benefit ratio
- efficacy/safety ratio
- quality of product
- (data on comparison drugs is not necessarily needed)
What are 3 ways in which to distribute drugs in Canada
- Special Access programs or emergency drug release (requires physician request for specific patient)
- Clinical study under an approved protocol (requires clinical trial application
- After approval of a drug (requires approval of new drug submission)
What is the PMPRB? What is the legislation that gives it authority? What are its two major roles? What do they not consider?
- Patented medicine prices review board
- exerts authority through the patent act
2 roles are Regulation(ensuring prices aren't excessive) and reporting (report industry trends and monitor R&D spending-> 10% ofincome to R&D)
The PMPRB do not consider cost-effectiveness
How often must manufacturers submit information to the PMPRB? which info?
- Price and sales information for each strength and form of drug twice a year
- R&D expenditure once a year
What is the Voluntary Compliance Undertaking?
Written commitment by patentee to comply with board's guidelines by adjusting prices or offsetting excessive revenue
What are the levels of therapeutic improvement according to the PMPRB? Most drugs fall into which category?
What are the primary factors when deciding which classification is given?
- Slight or no improvement
- Moderate improvement
- Substantial improvement
Most drugs classified as slight or no improvement or moderate improvement (hard to get substantial improvement or breakthrough classification)
Increased efficacy, and increased safety are the primary factors
As a general rule, how are most drug prices vs breakthrough drugs?
Most drug prices are limited to the cost of therapy of existing drugs
Most breakthrough drugs set as the median price of the 7 countries (Italy, UK, Swiss, France, U.S., Sweden, Germany)
Name 4 PMPRB Price tests
- Reasonable relationship test: compares association between strength and price of same medicine in same or comparable dosage forms
- Therapeutic Class Comparison: price of new drug compared to price of clinically equivalent drugs
- International price comparison: Price of new drug in Canada to median price in the 7 countries (used for breakthroughs)
- Highest International Price comparison test: can't have price higher than highest price of drug in 7 countries
Specifically, how is each type of drug priced (i.e. according to which tests)
- Breakthrough- international price comparison
- Substantial: higher of TCC and International price comparison
- Moderate: midpoint of TCC and IPC
- Little improvement: RRT or TCC
What are the bodies that review therapeutic and economic value? What is their formal legislative authority?
- Canadian agency for drugs and technologies in Health (Common drug review) and
- Pan Canadian Oncology Drug Review
How are positive and negative recommendations different between CDR and pCODR?
- CDR= 50/50 positive to negative
- pCODR= 85/15 positive to negative
What are listing agreements, and how were they implemented?
- Set of agreements between company and payers
- Allows government to negotiate and implement agreements with manufacturers
- Bill 102- Transparent Drug System for Patients Act
what is the pCPA
- pan canadian purchasing alliance (august 2010)
- allows provincial collaboration in purchasing bulk medicines
What is the FDAR definition of advertising?
Any representation, by any means what so ever, for the purpose of promoting, directly or indirectly, the sale or disposal of a drug
Advertising to the general public is limited to: ?
This leads to 3 kinds of ads:
name, price, quantity
help-seeking, brand recognition, objective/balanced ads
Prior to market authorization, who oversees advertising?
After market authorization?
- If ads to HCPs: PAAB
- if ads to consumers: Health Canada, PAAB, ASC
Compare and contrast PAAB with ASC
- Pharmaceutical advertising advisory board
- Advertising standards Canada
PAAB: primary purpose to ensure ads for HCP are evidence-based, accurate ,balanced; ads for HCPs must comply with PAAB standards
ASC: reviews advertising intended for consumer (not just for drugs); must comply with Canadian code of advertising acceptance
Both don't have very strong legislative authority
How much of Canada's GDP is health care expenditure?
About how much per capita?
% of Health care expenditure that's: drugs, physicians, hospitals
- drugs: 17
- physicians: 15
- hospitals: 30
How is money for Health care raised?
Public funds: income tax, consumption tax, mandatory health premiums, business tax, resource extraction royalties
private funds: payments directly by housholds, private insurance (including employer benefits )
What percentage of drugs are publically funded?
33% (45 if you take out toothpaste and stuff)
5 principles of the Canada Health Act
- Public administration(run on non-profit basis by a public authority responsible to provincial government)
- Comprehensiveness (must provide all medically necessary procedures)
- Universality (cover residents for all insured health services provided on uniform terms and conditions)
- Portability: portable across provinces
- Accessibility: provide reasonable access to insured services on uniform terms and conditions
What is the total drug expenditure? How much of this is prescription drugs?
% of GDP that is TDE? Increasing or decreasing?
- 31 Billion (17% of THE); prescription drugs are 83%
- 2% of GDP (increasing)
How is payment for prescription drugs split up?
- 45% public
- 35% prviate
- 18% out-of-product
What kind of drugs are the most dispensed? What is the single dispensed drug? How many prescriptions / year in Canada? most patient visits to a doctor are for what?
CV + psychotherapeutics
Avg price of brand name vs generic drugs
- Brand name = 70$
- Generic = 26$
Nine key elements of the national pharmaceutical strategy
- Catastrophic drug coverage
- Common national drug formulary
- accelerated access to breakthrough drugs
- Evaluation of drug safety+ effectiveness
- Purchasing strategies for best prices
- influence prescribing behaviour
- access to non-patented drugs and prices
- best practices in drug plan policies
What were the five focus areas of the national pharmaceutical strategy?
- Real world safety and effectiveness of drugs
- expensive drugs for rae disease
- drug pricing and purchasing
- catastrophic drug coverage
- common drug formulary
Advantages of a national formulary?
Barriers to a national formulary?
- improving purchasing power
- standardizing drug coverage
- elimination of duplication
- disadv (mostly stem from variations between provinces):
- unequal fiscal resources between provinces
- different populations with different needs
- current provincial formularies were a significant investment
- different political outlook
Define public health
effort of society to keep people healthy and prevent injury, illness and premature death. Combination of programs and services and policies that protect and promote health of canadians with legislative authority
What are the functions of public health?
- Population health assessment
- health,disease and injury surveillance
- health promotion
- disease and injury prevention
- health protection
- emergency response
What did the constitution contribute to public health?
What is the medicine chest clause?
- Creation of marine hospitals
- all indian agents had to have access to meds
What is the chief public health officer
- National figurehead for public health
- Produces an annual report on state of public health
- currently David Butler-Jones
What are the 12 great achievements of public health
- safer/healthier foods
- control of infectious disease
- healthier environments
- recognition of tobacco as a hazard
- motor vehicle safety
- decline in deaths from CHD+stroke
- healthier mothers+babies
- family planning
- universal policies
- acting on social determinants of health
Who is the minister of health and long-term care?
What is the provincial role of public health?
Requires government to appoint a chief medical officer of health (Ontario), and undertake public health initiatives (Health protection and promotion act 2010)
- Ministry of health promotion and sport
- ministry of children and youth services
- ontario agencies for health protection and promotion (AKA Public health ontario- created after SARS)
What is the role of public health Ontario? what was it created as a response to?
Advises the chief medical officer of health and HCPs; created after SARS
What was the Health Protection and Promotion Act (what was it derived from, and what does it seek to establish?)
- derived from the Public Health Act (1884)
- requires appointment of medical officers of health
- requires municipalities to establish Boards of Health
What are the "Ontario Public Health Standards"?
- Set minimum requirements of each board of health (from the health protection and promotion act)
- Based on 4 principles of: Need, Impact, Capacity, Partnership and Collaboration
Who is the head of toronto public health? What is the municipal role of public health
Medical Officer of Health- David McKeown
municipal roles are governance, revenue, and by-laws
What are some roles of pharmacists in public health?
- Chronic disease prevention (cancer, smoking)
- Prevention of injury and substance abuse (opioid, narcotic addiction)
- Family health and planning
- Infectious disease control
Duty to report which infections? and to who?
Sexual health, STD/Is, Blood-borne infections, TB
to the medical officer of health of the local health unit
Foundational standards for pharmacists in public health
- Population Health Assessment
- knowledge exchange (professional development)
- program evaluation
- patient safety
What does ISMP stand for? what is its purpose?
- Institute for Safe Medication Practices
- Independent, non-profit, to reduce preventable harm from medications by creating safe and reliable systems for managing medications
Patient Safety competencies
- Contribute to a culture of patient safety
- communicate with other HCP to ensure patient safety
- Work in teams for patient safety
- Manage safety risks
- Optimize human and environmental factors
- Recognize, respond and disclose adverse events
What is an adverse event?
Undesired, unplanned occurrence, directly associated with care or services; includes preventable and non-preventable injuries
injury from a medicine, or lack of an intended medicine
freedom from accidental injuries
Temporary or permanent impairment in body function/structures
results in serious harm or a significant risk thereof (thus event has gotten to the patient)
event that could have resulted in unwanted consequences but did not due to chance or intervention before event reached the patient
drugs that bear high risk of causing patient harm if used in error
% of all errors in drug dispensing process
% of all harmful errors in drug dispensing process
- Prescribing 40 (30)
- Transcribing 10 (10)
- Dispensing 10 (10)
- Administering 40 (50) (due to lack of checks once the drug is dispensed)
___% of ADE are considered preventable in LTC? Errors that are preventable are mostly in ___ stage? What kind of drugs increasethe risk of adverse events?
- ordering and monitoring stage
- antipsychotics, diuretics, and anti-epileptic agents
What is the systems approach?
Focus on improving processes, systems and environments in which people work rather than attempting only to improve individual skill and performance
What is the Swiss Cheese Model?
Holes in the protective barriers, when alligned, will elucidate an unwanted event.
What is human factors engineering?
Design of systems that account for human capabilities and limitations
What are some major themes of Human factors engineering?
- 1) working memory
- 2) workflow/information flow/handoffs
- 3) repition, fatigue, sleep, inattentional blindness
- 4) information overload
- 5) work area design
What is the hierarchy of effectiveness?
- 1. Forcing functions and constraints
- 2. automation
- 3. simplification/standarization
- 4. reminders, checklists, double checks
- 5. rules and policies
- 6. education and information
What are some hallmarks of high reliability organizations?
- collective preoccupation with possibility of failure
- expect to make errors; train workforce to recognize and recover from them
- continual rehearsal of failure scenarios
What does TRUST stand for? and what are they?
5 rights of the second victim
- Treatment that is just
- Understanding and comparison
- Supportive Care
- Transparency and opportunity to contribute
What is CAM?
any healing resource other than those intrinsic to the dominant health system of a society in time
What are the different NIH classifications?
- Alternative medical systems (Naturopathy, homeopathy)
- Mind-Body interactions (meditation)
- Biological based therapies (herbs, supplements)
- Manipulative and Body-based methods (chiropractors, massage)
- energy therapies (therapeutic touch, Reiki)
% percentage of people visited a CAM in 2003? % of Canadians who have used a NHP? % of Canadians who use a NHP daily? % of canadians who don't disclose to physician about CAM medicine
Pushes and pulls for CAM?
- Push: poor patient/physician interaction
- adverse effects of conventional therapy
- ineffectiveness of conventional therapy
- natural is better
- CAM is safer
- convergence with belief about the nature of health and illness
Why don't patients disclose CAM use?
- Nobody asked
- didnt consider it medicine
- dont think it was important
- fear of rejection
- MD dont know anything about it anyway
What characteristics make something a NHP?
- Must exist in nature (unaltered)
- Must have a medicinal indication
- cant be biologics, tobacco, marijuana, injectables
- must be self-medicatable
What are the two types of health claims you can make for getting a NHP approved?
- modern health claim: requires scientific evidence
- traditional health claim: requires treatment to have been used traditionally for 50 consecutive years in any culture
____% of people use drugs and NHP concurrently
Professional NHP related competencies for pharmacists?
- 1) Practice pharmaceutical care and incorporate NHP knowledge
- 2) Provide NHP information
- 3) Educate patients