PHARM 120 Midterm

Lecture 2
WHO definition of health: state of complete physical, mental and social well
being, not just the absence of disease or infirmity
Global indicators of health: life expectancy, quality of life, infant mortality,
prevalence of common conditions (diabetes, cancer, heart disease, asthma)
Canada and US have highest infant mortality rates
High infant mortality rate in aboriginal communities
Infant mortality rate in Canada influenced by low survival rate of low birth-
weight babes in high risk pregnancies
3 factors that affect health: social/physical determinants of health, health
behaviors, and healthcare system
Social determinants include: income, employment status, education level,
social isolation/support, race (aboriginal health), and gender
Canada on mid-lower end of scale for cost-related access problems in the
past year by income
Physical determinants include: air quality, drinking water, food security
(access to sufficient safe and nutritious food, single parent households), safe
housing (mould, asbestos, lead), transportation (rural communities)
Health Behavior model influences patient behavior within the health care
system as well as smoking, diet/nutrition/obesity, physical activity, and
alcohol/drug use
Health behavior model states that individuals will act to prevent illness and
enhance health if they believe that
o They are susceptible (family history, exposure)
o The condition has serious consequences
o Changing behavior would reduce susceptibility or severity of the
condition
o The benefits associated with changing behavior outweigh the costs
Canada on lower end of spectrum for number of smokers
Canada second last when it comes to same or next day appointment with
doctor
Canada is last for after-hours care and emergency room use
Health care spending is increasing because of increased use of health
services, more healthcare providers, higher wages for healthcare workers,
and new and expensive drugs, diagnostic tests and surgical procedures
Around 40% of budget spent on health care
Health care 70% (65 is govt and 5 is other public sectors) publicly funded
and 30% privately funded
o US is 52% public 48% private
Total spending on health care per person higher in Canada than for OECD
US spends large amount on health care per person
Turkey and Spain on lower ends
30% of budget spent on hospitals, 16% on drugs, 15% on physicians
Older Seniors consume more than 3x more health resources than the
youngest seniors
Average infant (<1) consumes 2.5x more of health resources than average
Canadian
Japan has largest predicted population >80 by 2020 (7.5%)
o Canada predicted increase to 4.4%
Medication spending: public funding 35-40%, private insurance 35-40%, out-
of-pocket (co-pays and payments) 20%
Current spending on annual pharmaceuticals: $30-35 billion
There has been a decrease in pharmaceutical expenditures in Canada from
2000 to 2010
US first in pharmaceutical spending per capita, Canada 2
nd

Reasons for increased spending on pharmaceutics:
1. Volume of use: changes in treatment guidelines, increased disease
prevalence, new drugs
2. Mix of drugs: use of newer and more expensive drugs within a class,
1/3 growth in spending due to cholesterol-lowering drugs, new
biologics for cancer and immunosuppresants
3. Inflation
4. Population aging
5. Population growth
6. Price changes: price of pharmaceuticals dropped 2.7% from 1998-
2007 because of increased use of generics
Canada the only developed country with universal health insurance that
excludes prescription drugs
Govt funding for prescription drugs based on age, income and employment
status
Deductible Co-Pay
Age >65, low income $0 $2
Age >65 $100 $6.11
Age <65, low income ~4% net income $2
~6% of Canadian households spend more than $1,000 annually for Rx drugs
(UK 2%, US 13%)
10% Canadians report non-adherance due to high cost of drugs (highest in
BC)
Compare to UK 2%, US 21%
Cost related access problems to drugs: did not fill rx or skipped dose, had a
medical problem but did not visit doctor, skipped test, treatment, or follow
up
Pharmacare provides universal access to medications of proven value
Additional costs of expanded pharmacare could be offset by savings
associated with
o Improved health outcomes
o Lower pricing of pharmaceuticals
o More cost-effective prescribing
Lecture 3 Diversity 101
Primary aspects of diversity include physical/visible features i.e. gender,
race, ethnicity, age, physical and mental abilities
Secondary aspects not as visible and may change over time i.e. education,
income, marital & parental status, sexual orientation, religion, political
affiliation, work experience
Cultural competence as defined by the American Medical Student
Association (AMSA): A set of academic and personal skills that allow us to
increase our understanding and appreciation of cultural difference between
groups
Steps to cultural competence: denial, defense, minimization, acceptance,
adaptation, and integration
Hofstedes definition of culture: culture is the collective programming of the
mind distinguishing the members of one group or category of people from
others
Hofstedes five dimensions of culture: power distance, long-term orientation,
uncertainty avoidance, masculinity vs femininity, and individualism vs
collectivism (PLUMI)
o Power distance:
Tolerance for distance in wealth and power
Universal health care expected in Canada
o Individualism vs collectivism
Size of group to which you belong ranges from self through
family unit to society as a whole
How prized is the individual?
Insurance campaigns emphasize protection for family
o Masculinity vs femininity
Strong/weak adherence to male/female roles
When providing care for someone from a high MAS country,
husband may speak for the wife
o Uncertainity avoidance
Degree of anxiety when faced with uncertainty
Often manifested in degree of formality in environment
High uncertainty avoidance countries more comfortable with
paternalistic model of care
o Long-term orientation
Value placed on long-term traditions, perseverance, loyalty,
work ethic
China scored a very high 118
Chinese patients may say yes to physician but adhere to
traditional healers
Canada-born patients more likely to accept experimental
treatments
Slide 15-17
Immigrants will account for all labor force growth by 2011 and all population
growth by 2031
By 2031, 1/3 of Canadas population will be visible minorities
Top two countries of greatest immigrants China and Philippines
ASKED model for assessing cultural competence:
o Am I Aware of my own biases
o Do I have skill dealing with patients in a sensitive manner?
o Am I knowledgable?
o Do I seek out encounters?
o Do I have desire to be culturally competent?


Lecture 4 Aboriginal Peoples in Ontario: Policies and Issues in Health
Aboriginal peoples in Canada include Indians (aka First Nations), Metis
(mixed European and Indian), and Inuit (from Northern Canada)
Social determinants of health: poor infrastructure (i.e. access to clean water),
crowded living conditions, inadequate housing, high prices and remoteness
of healthy food, overrepresentation in the justice system, low high school
graduation rates, higher rates of infant mortality, teen pregnancies, obesity,
diabetes, tuberculosis, and disabilities, and alcohol, drugs, and solvent abuse
Life expectancy for first nations people are 7 years lower
From 2001-2011, the Aboriginal Population in Ontario grew by over 100,000
people or 41%
First Nations largest group in need of major repair of homes
Cultural competency: the translation of knowledge about individuals and
groups of people into specific standards, policies, practices, and attitudes
used in appropriate cultural settings to produce better health outcomes
Historical factors affecting Aboriginal well-being include military alliances,
protection, control and civilization (assimilation), integration and
reconciliation
Roles of the federal government: federal government has jurisdiction over
Aboriginal peoples and lands
Roles of provincial government: ensure all citizens have access to provincial
programs and services
o Done by cost-sharing delivery of programs and services with the
federal government (e.g delivery of policing in First Nations
community)
o Ontario can develop policies and programs specific for Aboriginal
peoples, as long as they do not infringe on Aboriginal and treaty rights
The federal government does not recognize a legal obligation to provide
health care services to First Nations, but it has done so based on social policy
or moral obligation
Key priorities for First Nations: diabetes, mental health and addictions, and
public health
First Nations people identified the loss of land and culture as significant
contributors to poor health
Initiatives to improve health for First Nations include the revival of
Aboriginal culture and traditions, increased use of Aboriginal languages,
return to traditional healing practices, and Aboriginal control of health
services
The National Chief of the Assembly of First Nations (AFN) announced the
Getting Results Strategy that established the following key determinants to
First Nations well-being:
o First nations
o Governance
o Education
o Jobs for youth
o Land claims
o Building institutions
o Housing
o Economic partnerships
o Language and cultures
o Revenue sharing
o Environment
Federal government provides limited health services (mostly on-reserve)
including:
o Community health workers, nursing stations, addiction treatment
centres, mental health programming services, health
promotion/prevention, home care services, support for hospitals in Sioux
Lookout and in Moose Factory
Ontario spends about $120m annually for Aboriginal-specific health services

Lecture 5 Developing Interprofessional Competence
Interprofessional Education: occasions when two or more professions learn
from and about each other to improve collaboration and the quality of care
Desired interprofessional practice outcomes:
o Improved patient care
o Improved access to health care
o Improved recruitment and retention of health care providers
o Improved patient safety and communication among health care
providers
o More efficient and effective employment of health human resources
o Improved satisfaction among patients and health care providers
Generally more women enrolled in medical school than men
Saskatchewan only school where women enrolled is less than 50%
Scope of NP-led clinics: physicals, counseling, health promotion,
immunization, short-term acute illnesses, monitoring stable chronic illnesses,
referrals
o Prescribing drugs not covered under Controlled Substance Act
Physician assistant: unregulated profession; must work under direction of a
regulated profession (physican)
Chiropractors not covered by government as of 2004

Lecture 6 Drug Development and Approval
A drug includes any substance or mixture of substances manufactured, sold
or respresented for use in:
o The diagnosis, treatment, mitigation or prevention of a disease,
disorder, abnormal physical state, or its symptoms, in human beings
or animals
o Restoring, correcting or modifying organic functions in human beings
or animals
o Disinfection in premises in which is manufactured, prepared, or kept
Natural health products (herbals, vitamins and minerals) are also regulated
as drugs
Most drugs act by modifying the activity of one or more proteins (enzymes,
transporters)
Roughly 300 drug targets identified to date in human genome or from
pathogenic organisms
Synthetic chemistry for drug discovery: in silico design followed by in vitro
screening
Drugs are often repositioned or repurposed (product already in the market
but discovered for a different use)
o i.e. Minoxidil and sildenafil originally developed for htn, repositioned
for treating baldness and ED respectively
Key question for pre-clinical drug development
o Can the drug be synthesized at a resasonable cost?
o Can a formulation/dosage form be developed?
o How is the drug metabolized and are metabolites active?
o What enzymes are involved in metabolism and is this likely to result
in drug interactions?
o Does the drug reach the site of action?
o Is the drug bioavailable after oral administration?
Biavailability #1 reason why drugs fail in clinical testing
Drug might work in cell culture but not necessarily reach site of action
Want as large of a therapeutic index as possible (ratio of the toxic dosage to
the therapeutic dosage)
Phase 1 of Clinical Testing: 20-100 human test volunteers
o Observe halfives; want to maximize 1/2life so you can use longer
dosing intervals
o Compare pharmacological effects in animals and humans
o Observe absorption, distribution, metabolism, excretion
o Evaluate proper dosage regimen
Phase 2 of Clinical Testing: uses 100-500 patients
o Are the expected therapeutic effects of the drug observed at the dose
being tested?
o Does this appear to be the best dose?
o Is the drug well-tolerated and what are the common adverse effects?
Phase 3 of Clinical Testing: Large scale trial in 1000-5000 patients
o Typically RCTs in target population
o Assess effectiveness including comparisons with current drug(s) of
choice
o Assess safety in a broad range of patients
o At least two Phase III RCTs are required by regulatory agencies
o Highly selective populations
o Companies make me too drugs drugs that are the same as existing
drugs and not any better just for the sake of making money
#1 reason for attrition is efficacy
#2 reason is commercial reasons; drug is okay but does not seem like it will
have commercial success
Average cost of drug development now exceeds $1 billion
Drugs may not work as well as expected because
o Clinical trials have a very selective group of people
o Drug might be being used for treatment that it wasnt approved for
o Patient adherence people in trials obviously have optimal adherence
Some adverse effects may only be apparent after long-term use
o Rofecoxib found to increase risk of MI after 18 months or longer

High number of drug approvals in 1990s led by anti-infectives, CNS drugs
(antidepressants, antipsychotics)
o Production has decreased since then except for new cancer drugs and
immunomodulators
Only 10% of new chemicals classified as breakthrough from 2001 to 2009
Breakthrough: first-in-kind therapies or offering significant improvement
over older substances
Companies dont like to develop antibiotics because they are short-term use
Approved drugs receive a Notice of Compliance and Drug Identification
Number (DIN)
Average length of time for drug review is 18 months
Promising drugs for life-threatening or debilitating diseases (i.e. Alzhimers,
cancer) may be fast-tracked
Common Drug Review must be conducted after drug approval
o Compares new drug to alternatives with respect to clinical effects and
cost-effectiveness
Recommendations made to add to publicly funded drug plans as: list, list
with specific criteria, do not list at suggested price, and do not list
Febuxostat (Uloric): listed for pts with symptomatic gout who have
documented sensitivity to allopurinol
o b/c 2/3 pts show no difference btwn the two drugs
o Febuxostat more expensive than allopurinol
New drugs receive 20 years patent protection
Pharmaceutically equivalent: same active ingredient in the same purity,
strength, dosage form and route of administration
Safety and efficacy assumed if generic is found to be bioequivalent
Generics less expensive b/c pre-clicnical and clinical testing unnecessary
o No cost related to attrition in drug development
o Lower marketing costs
Bioequivalent: plasma concentration-time profile for the generic is
superimposable with brand
Biologics for small market diseases may cost more than $100,000 annually
Biosimilars/follow-on biologics are generic versions of biologics
Prices of new drugs reflect:
o Cost of development (and attrition)
o Profit margin
o Patent life (typically 20 years in Canada)
o Anticipated volume of use (due to competition from follow-on drugs)
o Production costs
Drug prices are established by Medicine Prices Review Board (MPRB)
Rx drugs more expensive in the US than any other country
o Canada on lower end of spectrum
6 common generic drugs set at 18% of brand name price: atorvastastin,
ramapril, venlafaxine, amlodipine, omeprazole, rabeprazole
Loweriing drug spending in Canada can be accomplished by lower brand
name pricing, lower generic drug pricing, increase use of generic drugs,
education of prescribers to improve cost-effective prescribing within drug
class (i.e allopurinol vs febuxostat)