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Healthcare systems > Exam 2 > Flashcards

Exam 2 Flashcards

Decks 1,2,3,4, 5.1 so far

1
Q

Upstream and downstream determinants of population health

A

Bottom -> Top

Individual, pop health
Genetic factors
Individual risk factor
Social relationship
Living conditions
Neighborhoods and communities
Institutions 
Social and Economic policies
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2
Q

“Population health”

A

Health outcomes of a group of individuals

Distribution of outcomes within group

Importance and management of non-clinical factors (social, economic, environmental) in outcomes

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3
Q

Examples of “population”

A

Hospital or pharmacy catchment area
Student population
Employer’s workers
County, state, or country

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4
Q

Disparities

A

inequalities within a population

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5
Q

Distinguish between associating from causality

A

lower income = poorer health
educated people = better health

these are associations or correlations but not necessarily one causing other

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6
Q

SDOH

A

Social Determinants of Health

Many are modifiable factors

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7
Q

Policies and Programs

A

Policies influence health outcomes and/or have influence on determinants/factors

ie. School breakfast program for low-income children

Violent mortality (guns) and transportation mortality (cars)

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8
Q

Theory for increase violence 1990s

A

Lead in gasoline and paint, rose and fell 25 years prior

caused issues in kids like reduced IQ, learning disabilities, hyperactive/antisocial behaviros

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9
Q

Why have transportation mortality rates decreased?

A

increasing focus on safety like seat belts, airbags, antilock breaks, better highway design, Drunk driving is a no no

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10
Q

Effect of Income and Education

A

They matter, strongly associated with poor/fair health status.

More money/ higher ed the overall better health.

Less money/less ed overall worse outcomes

Infant mortality also tied to Ed of mother

Affect life expectancy too

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11
Q

Hispanic Paradox

A

Recent immigrants have less diabetes and other health problems than those who had longer exposure to our “toxic socioeconomic and physical environment”

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12
Q

Expanded Chronic Care Model

A

Incorporating the principles of health promotion and the focus on the determinants of health as directed by a population health approach enables the Chronic Care Model to be used by the entire team in an integrated way.

Community:
Build Health Public Policy
Create Supportive Environments
Strengthen Community Action

Health System:
Self-Management/Develop Personal skills
Delivery system Design/ Reorient Health services
Decision Support
Info systems

Activated community and Prepared Proactive community partners

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13
Q

Chronic Care Model

A 
Healthcare system:
Self-management support
Delivery System support
Decision support
Clinical Info support

Community:
Resources and policy

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14
Q

Health Definition (WHO)

A

Health is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity

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15
Q

Health Promotion

A

Actions affecting one or more determinants of health

Goal to enable people to maintain or improve their physical, mental, or social well-being.

By promoting health, disease may be prevented

Health promotion does not = treatment of disease

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16
Q

Levels of Health Promotions

A

Individual - own education, income
Community - environment, school, accessibility of essential services
State - laws by state legislature
National - grant program improve local service
Global - org that do global response to crises

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17
Q

Community Level interventions

A

Goal and Rationale: an individuals immediate environment can enable or inhibit health behaviors

Target ex: community infrastructure

Intervention ex: improve park, safe neighborhoods

Outcomes and eval ex: Obesity rate, teen violence

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18
Q

State and National Level interventions

A

Goal and Rationale: resource allocations or regulations can improve community infrastructure or services

Target ex: infrastructure or services

Interventions ex: budgets and grant programs improving infrastructure, law restricting pollution

Outcome and Eval ex: quantity and quality of park, bike trail, drinking water and air quality

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19
Q

Global Level interventions

A

Goal and Rationale: prevent illness or injury

Target ex: imported products, including toys, foods and meds

Interventions ex: trade agreements, regulations, quality standards manufacturing

Outcome and eval ex: reduced exposure to contaminated product, fewer reports of defective

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20
Q

Health Promotion and Disease prevention

A

Health promotion = optimize overall health

Disease prevention = reduce occurrence and impact of specific diseases

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21
Q

3 Levels of disease prevention

A

Primary, secondary and Tertiary

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22
Q

Primary Prevention

A

Goal: To reduce number of new cases

Target pop: those most likely to be exposed or can increase their resistance

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23
Q

Secondary Prevention

A

Goal: reduce number of new cases (mostly among those expose) or reduce number of severe cases

Target pop: Those who’ve been exposed or have early symptoms of disease

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24
Q

Tertiary Prevention

A

Goals: Reduce number of complications and death

Target pop: those who have and need treatment

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25
Q

Healthly people

A

US national agenda that communicates a vision for improving health and achieving health equity

Measurable objectives within distinct topic areas

subset of objectives designated as Leading Health Indicators

Every 10 years, Ie 2020 came out in 2010

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26
Q

Healthy people evolution

A

More ambitious over time and more broad going beyond the medical/ clinical

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27
Q

Social Determinants of Health

A 
ED access and quality
Healthcare Access and quality
Neighborhood and Built environment
Social and Community context
Economic Stability
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28
Q

WHO 1998 Health definition

A

a DYNAMIC state of complete physical, mental, SPIRITUAL, and social well-being and not merely the absence of disease or infirmity

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29
Q

Public Health is..

A

what we as a society do collectively to assure the conditions in which people can be healthy

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30
Q

Medicine vs public Health

A

Saves 1 life at a time vs millions at a time

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31
Q

10 Great US Public Health Achievements

A 
Vaccinations
Safer Workplace
Safer and healthier food
Motor Vehicle Safety
Control of infectious diseases
Decline in deaths from coronary heart disease and stroke
Family planning
Recognition of tobacco use as a health hazard
Healthier mothers and babies
Fluoridation of drinking water
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32
Q

10 Essential Services of public Health

A 
monitor health status
diagnose and investigate
inform, educate and empower
mobilize community partnership
develop policies and plans
encore laws and regulations
link people to need services/assure care
Assure a competent workforce
evaluate health services
research
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33
Q

CDC

A

US Centers for Disease Control and Prevention

Mission: to promote health and quality of life by preventing and controlling disease, injury, and disability

Surveillance (active/passive), guidelines, grants to states and non-profits

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34
Q

Code of Ethics Pharmacists VII

A

A pharmacist serves individual, community, and societal needs

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35
Q

Traditional vs Behavioral “nudges” Economics

A

Traditional = Assumes we know what is best for ourselves and act that way….rational decisions

Behavioral = assumes we don’t always know what is best for ourselves. We make automatic decisions, so lets try to maximize pools well-being by structuring choices

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36
Q

“Nudging” to promote health choices

A

Food/menu labels - information plus
Health choice is the easy one - change the default
Financial incentive
Social norms and framing

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37
Q

Traffic Light Labels

A

Green - consume often
Yellow - Consume less often
Red - Theres a better choice in green or yellow

Study found that this works and led to sustained healthier choices

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38
Q

Specialty meds

A

Account for a lot of the spending increases we see

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39
Q

Generics capture…

A

80% of a brands volume within 6 months

Policies aimed at encouraging generic entry have gotten stronger

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40
Q

New Drug Therapy Starts

A

people who are starting therapy are more likely to be started on a generic than a brand now.

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41
Q

Generics make up…

A

90% of prescriptions dispensed, dispensed 97% of the time when available

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42
Q

Hurdles for Generic drugs

A

take time for price to come down after generic released

Patent holders try to block generic entries through different means

Evergreening

Generic makers want to come in lower, but not too low

Some drugs hard to duplicate

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43
Q

Evergreening

A

When brand-drug gets patents on “new inventions” that are merely slight modifications fo their older drugs - with little therapeutic gain, and a lot of economic gain for them

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44
Q

Price Gouging

A

Legal business behavior, widely criticized as unethical

Company find cheap, old drug, make sure they have monopoly on it and jack up price

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45
Q

1983 Orphan Drug Act (ODA)

A

intended to incentivize development of drugs to treat rare and neglected diseases

gave a bunch of financial perks, extended monopoly

drugs that have no expectation of being profitable

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46
Q

Recycling

A

Finding old cheap drug that is already being used off label for an orphan condition, buy that drug production, run a trial, get orphan statues then increase price alot

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47
Q

Unapproved uses

A

Get orphan approval and all incentives that come with it but then actually sell the drug to treat other common conditions

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48
Q

Salami slicing

A

narrowly sub typing a disease or condition as finely as possible, in order to sell the drug to each disease subtype for the seven years of exclusivity

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49
Q

Changes who pays for RX

A

fewer scripts are on commercial or cash plans

Increase in exchange plans, Medicare Part D, Medicaid in expansion states and Medicaid in non-expansion states

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50
Q

Pharma spending

A

Spends considerably more for Sales/ Marketing compared to Research/Development

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51
Q

Big Pharma Changes

A

Alot of outsourcing

Product lines are less exciting

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52
Q

Challenges presented by globalization supply chain

A

more dispersed facilities supplying global market

increase volume of imported products

more outsourcing of manufacturing

Greater complexity in supply chains

Imports from countries with less developed regulatory systems

Greater opportunities for economic fraud

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53
Q

FDA Foreign Offices

A

All over the world

supposed to ensure GMP

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54
Q

Drug Manufacturer

A

Develops and produces med

Sells med to wholesaler

Negotiates with PBM

Markets med to patient and to physicians via free samples, etc

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55
Q

Repackaging

A

Med sold in bulk can be repackaged into smaller containers then sent to pharmacy

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56
Q

Wholesaler = Distributor

A

Purchase med in bulk from manufacturer
Sends med to repackager
Sells meds to pharmacies and healthcare institutions

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57
Q

Pharmacy

A

Buy from wholesaler
dispenses med to patients
stocks med based on variety of info

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58
Q

Drug samples

A

Provided free to doctor

Doctor cant sell or trade samples

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59
Q

Doctors and Dispensing Doctors

A

diagnose and monitor patients

Prescribe med, can give free samples

Decisions can be influenced

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60
Q

Patient (insured)

A

pays premium

Pays cost sharing of drug

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61
Q

Pharmacy Benefit Mangers

A

Develops and maintains formulary based on cost-effectiveness

Essentially hired by insurance company

Works as the middle man

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62
Q

Types of Emergencies

A

Natural disasters, disease outbreaks, man made ( radiation release or terrorist attacks)

Natural disasters costs US more than terrorist attacks

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63
Q

Levels of approaches to Emergency planning

A

National/Federal/US:
FEMA (under Dept of HS)
DHHS (CDC, ASPR, SNS)

State level:
MEMA (Mass emergency Mgmt Agency)
Mass Dept of Public Health

Institutional:
Hospitals, community pharmacies, uni, etc

Individual

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64
Q

SNS

A

Strategic National Stockpile

Under Dept of Health Human Services DHHS

created due to “Y2K”

has meds, vaccines, antidotes, medical and surgical supplies

help is requested by the states

free to areas in need

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65
Q

CHEMPACKs

A

forward placed in locations throughout US, mostly at hospitals and fire stations

done for quick access to nerve agent antidotes in the event of a nerve agent attack or chemical accident that overwhelms local resources

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66
Q

12-Hour push packages

A

rapid delivery to anywhere in US within 12 hrs of federal decision to deploy them

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67
Q

Apportionment

A

Breaking up the materials at RSS into smaller packages for individual deliveries

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68
Q

Managed Inventory

A

these are as-needed and as-requested, especially when threat is known

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69
Q

SNS Request flow

A

Local -> State -> national + help flows back

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70
Q

SNS does not include

A

routine maintenance medications, such as high blood pressure meds

Medication to treat adverse reactions to vaccines or emergency medications

Supplies to support the EDS staff, such as water or sanitation supplies

  • more medical materials can be purchased and supplied by SNS to states for specific situations *
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71
Q

High water mark

A

must consider what their max population is.

ex. school in session, colleges/universities, homeless, seasonal workers, etc

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72
Q

SNS prioritize

A

First responders (Fire, police, EMS)

Strategic personal (Transport, utilities)

Family members of the above

Some special populations

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73
Q

SNS special populations

A

Long-term care facilities, rest homes, nursing homes

Correctional facilites

Organize w/ special populations leadership to pick up medications at designated EDS for assisted living centers and group homes

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74
Q

Emergency Dispensing: Local planning team include

A 
Local public health
Emergency management directors
various reserve teams and committees
Fire/police
Local/Regional hospitals
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75
Q

Role of Pharmacists

A

Public-health-level activities

Pharmacy-level activities

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76
Q

Community-Based Pharmacy Disaster plans

A

make plans before an emergency happens

minimize impact on the pharmacy itself

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77
Q

Managing effects of disaster on supply chain

A

ID in advance the essential supplies required to maintain critical pharmacy operations

Evaluate supply logistics and ID potential alternate sources of supplies

Ensure that institution or community pharmacy is in accordance with state and national priorities

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78
Q

Staffing issues in pharmacy with disaster

A

expect some work force reduction

solutions:

develop policies for flexible work sites, cross-training employees, ID business functions that can be outsourced

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79
Q

Pharmacists preparing their community for disaster

A

ensure patients have adequate supply of medication

work with local physicians; educate MDs on refill policies

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80
Q

Individual Pharmacist Responsibilities for disaster

A

Training for pharmacists such as CPR, basic cardiac life support, vaccination certification

Train other health professionals and volunteer

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81
Q

Emergency Prescription Assistance Program

A

EPAP

US DHHS and FEMA

For uninsured people with proof of prescription, in a disaster

Provides eligible individuals 30-day prescription assistance

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82
Q

Rx open

A

Mapping pharmacy status during disasters

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83
Q

CMS Emergency Preparedness Rule

A

health care providers and supplies must be in compliance with new CMS emergency Preparedness regulations fi they wish to participate in the Medicare or Medicaid program

To ensure adequate planning and coordination for disasters

84
Q

Individual Preparedness

A

6 in 10 Americans have at least one chronic medical condition

majority of Americans with chronic illness use a prescription medication

chronic illness accounts for 50% of all US healthcare expenditures

85
Q

Household prescription drug stockpiles

A

1/3 of persons with chronic medical conditions keep less than a weeks supply of medications

Guidelines on “personal stock” are inconsistent

Extra stocks can be hard for vulnerable persons to keep and maintain

economically and socially vulnerable people are disproportionately affected by both chronic illness and disaster

86
Q

Backpack Emergency Card

A

designed for children

make plan with child to memorize key names and numbers

make a “to go” bag for emergency, include copies of important info and meds

87
Q

Cost

A

An economist would say cost is what a provider has to spend to deliver care, the resources that go into a unit of health care service

88
Q

Charge

A

What a provider attempts to bill a payer

89
Q

Price ( or payment)

A

What a payer actually pays for a unit of care

that is also the payers unit cost

90
Q

Spending

A

Price X Quantity

This is the payers total cost

91
Q

Per capita

A

Per person

Remember, total health care spending will increase due to population growth alone

92
Q

“Cost reduction” vs “Cost control”

A

usually refer, respectively, to drop in level of cost (not easy) vs a slowdown in rate of growth

Usually refer to spending ( bigger/total picture)

93
Q

Key factors affecting spending changes over time

A

Changes in demographics

Changes in quality

94
Q

Regulatory approaches to cost control

A

Price regulation

Medicare’s Hospital DRG rates

Bundled payments

Global budget

Government price-setting for drugs

Growth regulation

95
Q

Rate setting

A

usual language for price regulation when talking about hospitals

96
Q

Softer, more indirect regulatory approaches

A

standardization of care and practice guidelines

System transformations to increase efficiencies

97
Q

Market approaches to cost control

A

Less government top-down decision-making, mandating what you must do

ex. provide good information

98
Q

Internal reference pricing

A

sets the reference price as a function of prices of local/nearby substitutes

99
Q

External reference pricing

A

typically sets the reference price as a function of prices of substitute products in other countries

100
Q

Medicare inpatient prospective payment

A

Regulatory aspect: Gov payment policy

Market aspect: private hospitals responding to per-DRG budget, making new choices based on new government policy

DRGs came in response to trend of increasing inpatient costs

101
Q

DRG payment

A

depends on which DRG bucket the case belongs in

102
Q

Cost control techniques organized by Market characteristic

A

Budgets exist and constrain choices

Buyer has good info

Buyer pays price

Buyer decides

Firms seek profits

Multiple buyers and sellers

103
Q

Market characteristic:

Budget constraints

A

DRG

CMS bundled payment for hip/knee replacement

Accountable Care organizations- read or penalize based on spending targets

104
Q

Market characteristic:

Good info

A

Public quality ratings “stars” for hospitals, physicians, Part D plans, MCOs

Practice guidelines, what experts recommend

Price transparency tools for patients listing charges or avg payments for different providers services

head-to-head comparisons of treatments

105
Q

Market characteristics:

Price

A

Cost-sharing for patient - incentives patients to not overuse care

Value based payments, payment to provider is partly based on how effective treatment is

Medicare payments to providers partly based on the quality of their care

106
Q

Market characteristics:

Patient Autonomy

A

Patient engagement in own care and shared decision making

This should raise quality of care

107
Q

Market characteristics:

Profit seeking

A

penalties cut into profits

penalize healthcare practices that result in high costs and hope is that then you get more cost-effective care

108
Q

Market characteristics:

Multiple buyers and sellers

A

internal reference pricing

telemedicine

antitrust enforcement

retail clinics

109
Q

IOM definition of Quality of Care

A

The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.

110
Q

Joint commission

A

1951

Assesses the quality of hospitals

Hospitals must be TJC-accredited to receive Medicare payments

111
Q

Avedis Donabedia

A

Creater of the Donabedian model

Structure, process, and outcomes

112
Q

Example of structure measure

A

Does an ICU have critical care specialist on staff at all times

113
Q

Example of a process measure

A

Percentage of diabetes patients who receive regular eye exams

114
Q

Example of an outcome measure

A

Percentage of diabetes patients with their blood sugar under control

115
Q

National Committee for quality Assurance (NCQA)

A

1990

Accreditation programs for health plans, MCOs, medical groups, and individual physicians

Health plans seek accreditation and measure own performance with HEDIS and CAHPS

116
Q

National Quality forum

A

1999

Evaluates quality measures

117
Q

6 guiding principles for healthcare quality improvement

A 
Safe
Effective
Patient-centered
Timely
Efficient
Equitable
118
Q

Patient safety

A

initiatives focus on identifying and preventing harm

119
Q

Definition of harm to patients

A

any unintended physical injury resulting from or contributed to by medical care, that require or prolongs hospitalization, and/or results in permanent disability or death

120
Q

preventable harm

A

a medical error

121
Q

Quality improvement

A

initiatives focus on ensuring patients get what they need, when they need it, in an appropriate way

122
Q

Continuous Quality Improvement (CQI)

A

idea that most things can be improved

ID problems and errors

Build systems to prevent errors from happening again

P.D.S.A = Plan, Do, Study, Act

123
Q

Dartmouth Atlas project

A

revealed large, unexpected geographical variations in process of care

Implies differences in the quality of care

Using massive claims dataset from medicare

124
Q

“Hard” endpoints

A

Mortality

Physiologic measurements

125
Q

“Soft”

A

involve more subjective assessments by clinicians or patients

Functioning, quality of life, pain

126
Q

“Never events” or “Sentinel events”

A

Devastating, preventable, unacceptable

TJC mandates performance of a “root cause analysis” after a sentinel event

127
Q

The Checklist Manifesto

A

Designed a checklist, applicable in any kind of surgery, at any hospital, anywhere in the world

128
Q

100,000 Lives Campaign

A

Example of a hospital safety initiative

129
Q

Hospital penalties in the ACA

A

penalties for high rates of hospital-acquired conditions, especially infections following surgery

penalties for high readmission rates

130
Q

HEDIS measures

A

Dozens of measures across several domains

Effectiveness of care, utilization measures, access/availability of care

131
Q

CAHPS

A

Survey of consumer/patient experience with care

Used to star-rate

132
Q

Pharmacy accreditation/quality measures

A

URAC and CPPA

133
Q

URAC

A

runs accreditation programs for health plans, providers, and pharmacies, PBMS, specialty pharmacies and mail service pharmacies

134
Q

CPPA

A

Partnership among pharmacist/pharmacy organizations

135
Q

Health insurance plans accreditation/quality measures

A

NCQA - using HEDIS (including CAHPS)

136
Q

Hospitals accreditation/ quality measures

A

TJC

137
Q

P4P

A

Pay for Performance, “value based purchasing”

Financial incentives to providers for meeting certain performance measures

One provider’s bonus is another’s penalty

138
Q

Medication error defined as

A

any preventable event that may cause or lead to an inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer

139
Q

Focus on 4 erros

A

Prescribing
Transcribing
Dispensing
Administration

140
Q

Error-Prone Notations

A

Examples of notations that should never be used

“Do not use” list required to be present in facilities for accreditation by The Join Commission

141
Q

Computerized Physician Order Entry

A

CPOE

SureScripts - enabling providers to transmit new prescriptions to patients pharmacy of choice and electronically authorize refill requests

142
Q

Potential Benefits of Physician Connectivity for the pharmacy provider

A

Reduces the volume of call-backs to physicians and patients

Provides a computerized record of renewal requests to/from the physician office

Improved patient satisfaction

Improved relationship with physicians

Improved turnaround time

143
Q

Why so many medication errors?

A

We take a lot of medications

increasing numbers of Rx/year

More opportunities for confusion and drug-drug interactions

144
Q

Other potential contributors to medication errors

A

Health info tech can greatly reduce some types of errors but can also contribute to errors

False sense of security

Garbage in, garbage out

can also have too little trust in IT, ignore warnings

145
Q

Medication reconciliation

A

should be done at transitions in care

5 steps:

  1. develop list of current meds
  2. develop lost of med to be prescribed
  3. compare med on the two lists
  4. make clinical decisions based on comparison
  5. communicate new list to appropriate caregivers and to the patient
146
Q

Bar Coding

A

Can reduce med errors by ~ 50 - 90% assuring the “5 rights”

Scanning barcode of patient, caregiver, med itself to track med from pharmacy through caregiver to patient

Very low error rate, 1 in 10 mil

147
Q

Bar coding limitations

A

up-front costs

bulk meds have to by repackaged or cut into smaller ones

cant barcode all drugs

148
Q

Adverse Drug reaction

A

unexpected, unintended, undesired, or excessive response to a medication (think side effects)

Majority of ADEs are preventable

149
Q

Five rights

A

Right….

drug

patient

dose

route

time

150
Q

1 recommendation of IOM report

A

Allow and encourage patients to take a more active role in their own medical care

151
Q

Phase I

A

Researchers test a new drug in people for the first time, usually healthy people, to evaluate its safety/interaction with the human body and determine a safe dosage range and id side effects

152
Q

Phase II

A

Drug given to larger group of people who have target condition, to test efficacy and safety, although the studies still small to confirm if drug will be beneficial

153
Q

Phase III

A

Drug given to large groups (300-3000) to confirm its efficacy, monitor side effects, compare it to commonly used treatments, and collect additional info to allow drug to be used safety

154
Q

Phase IV

A

studies done after the drug or treatment has gone on the market, to gather info on effectiveness in diverse populations and side effects associated with longterm use

155
Q

FDA reviews IND within….

A

30 days and declares

approval to begin clinical trials or clinical hold to delay or stop the investigation (rare)

IND must be submitted before beginning clinical research

156
Q

CDER

A

Center for Drug Evaluation and research

157
Q

CBER

A

Center for biologics evaluation and research

158
Q

FDA approval of and NDA

A

permission to market new drug

FDA approves label

each indication and claim requires separate filing material, approval is for specific indications and claims

159
Q

PDUFA

A

Prescription Drug User Fee Act

NDA’s sponsors pay a “user fee” for each app

That funding goes toward hiring more FDA reviewers

Meant to supplement and not replace existing gov funding

FDA must now adhere to strict timetables for approval, to speed up review process

160
Q

Standrad review

A

90% should be completed within 10 months of filing date, goal now is max 12 months

161
Q

Priority review

A

90% completed within 6 months of filing date

162
Q

PDUFA IV 2007

A

part of user fees paid to FDA go toward post-market surveillance of drug effectiveness and safety

Post-market eval are performed 18 months after approval of drug, or after its use by 10,000 individuals whiter is later

163
Q

Point of Phase IV

A

Examines effectiveness in realworld and safety

164
Q

PDUFA V 2012

A

Added fee for Generic drugs and Biosimilars

More patient engagement in the drug eval and approval process

165
Q

4 special designations to speed of NDA approvals

A

10 month timeline
Fast track, Breakthrough and Accelerated approval

6 month timeline
Priority review

166
Q

Factors in making special designations

A

Improved safety or efficacy over existing therapies

Effects on clinically significant endpoints

Effects on surrogate endpoints

167
Q

only 2 countries that allow DTCA

A

USA and NZ

168
Q

Key points to know about pre-1997 drug marketing in US

A

Drug ads primarily in print, aimed at health professionals

Due to 1938 FDCA….

Drugs proven safe and effective and approved by FDA can be on Markey

AD and promo must include “brief summary” of FDA approved info

Include essentially all benefits and risk

“fair balance” among side effects, contraindications and effectiveness

169
Q

“Brief Summary”

A

includes approved use of drug,
who should not take,
circumstances under which should not be taken,
possible serious side effects and how to lower chances of having them,
frequent side effects

170
Q

“Fair Balance”

A

content and presentation of drugs most important risks must be similar to content and presentation of its benefits

Does not mean have to give equal space to info on ad

171
Q

DTCA 1997

A

New FDA guidance opened up DTCA to broadcast media/TV

TV ads must include “major statements/risk” and “adequate provisions….ie where to get info”

172
Q

“Adequate provision”

A

directing views where to find the more complete brief summary info

173
Q

Research on DTCA suggest that….

A

it increases adherence

Does not have direct effects on particular drugs prices

Increases sales, but not for only advertised drugs

Increases doctor visits

patient drug requests increase chances of appropriate care

174
Q

“Medicalization”

A

When what had been non-medical problems get re-defined as treatable illnesses

“disease mongering” by Pharma? expanding its markets

175
Q

4 types of DTC ads in print

A

Institutional ads: visibility for company and its research

Reminder ads

“see your doctor”/ “Help seeking” ads

Product-claim ads

176
Q

Institutional Ad

A

Includes info such as company name, area of research

Dose not mention any drug names

177
Q

Reminder ads

A

A reminder to ask your doctor about

Calls attention to drugs name, but not intended use or condition

Must identify brand and generic drug

Must not show picture of anything suggesting condition or indication

** No claim is made about the drug **

178
Q

Help Seeking or Disease Awareness Ads

A

Includes medical conditon

Symptoms

Recommend seeking doctor’s help

Pharmaceutical company name

Cannot have drug name or drug image

179
Q

Product Claim Ads

A

Mentions brand/generic and disease/condition/indication

Most informative and regulated type

180
Q

FDA recommendations for Brief Summary

A

Use consumer-friendly language

Text is visually presented in a manner designed for ease of understanding by consumers

Provide clinically significant info on serious and common risks

include statement reminding consumers that the info presented is not comprehensive

181
Q

Most common promotion concerns

A

FDA examines ads and what’s being said at scientific meetings

Problems FDA tends to observe…

  1. Omitting or downplaying risks
  2. Overstating efficacy
  3. Promo of unapproved uses
182
Q

FDA Office of Prescription Drug Promotion

A

Says no to bad ads

regulates promotional materials

usually sees ad after its been published, Ads can be reported to FDA’s bad Ad program

183
Q

FDA’s Bad Ad Program

A

encourages Healthcare providers to call if they see a bad ad

OPDP can issue warning letters, notices of violation, penalties, criminal action

184
Q

Submitting ads for OPDP review

A

requires submission of all promo materials at the time of their initial dissemination or publication

Built-in delay during which public will see the ad

OPDP entourages companies to voluntarily submit ad materials in advance to get OPDP comments

185
Q

MedWatch

A

FDAs safety info and adverse event reporting program

186
Q

FDA Drug definition

A

Substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

187
Q

Dietary ingredient

A

maybe one, or any combo, of the following…

Vitamin, mineral, herb or botanical, amino acid, concentrate/extract/etc

188
Q

Dietary Supplement

A

product intended for ingestion that contains a “dietary ingredient” intended to add further value to the diet and therefore supplement the diet

Always labeled as dietary supplements

189
Q

Regulation of Dietary Supplements

A

Regulated primarily under DSHEA

Relatively loose regulations apply

190
Q

Dietary supplements cannot claim to…

A

diagnose, mitigate, treat, cure or prevent a specific disease

But problems with manufacturing, safety, and health claims are generally addressed only after they reach the market

191
Q

New Dietary Ingredient

A

a dietary ingredient that was not sold in the US in a dietary supplement before 10/15/1994

older ingredients grandfathered in

Companies must notify FDA before marketing product with NDI

192
Q

Manufacturer responsibilities for NDIs

A

minimal

FDA recommends manufacturer conduct search of scientific literature for evidence

explain how they conceded their DS with NDI is expected to be safe

193
Q

FDA responsibilities for NDIs

A

Under DSHEA, FDA has to prove DS supplement is harmful or posses risk

FDA responsible for taking action against unsafe DS after it reaches market

no proactive system, only reactive

194
Q

FDA can prohibit dietary supplements that…

A

present significant or unreasonable risk

contain any poisonous or deleterious substances

are adulterated

make a drug claim

have untruthful labeling

195
Q

Dietary Supplement and Nonprescription Drug Consumer Protection Act

A

2006

requires companies to report serious adverse effects

established industry-wide standards for dietary supplements, in order to encourage manufacturing that is consistent as to their identity, purity, strength, and composition

196
Q

cGMP standards

A

Qualified employees

Manufacturing facility designed to prevent adulteration

Proper manufacturing process

Testing of final product, QC

Proper sotrage

Keep records of product complaints

197
Q

USP-Verified

A

independent 3rd party certification of product quality

  1. That what’s on the label is in the bottle, ingredients in declared amounts
  2. does not contain harmful levels of contaminants
  3. will break down and release ingredients in the body
  4. has been made under good manufacturing practices
198
Q

Health claim

A

Links products to specific disease

Ex “This product may reduce risks of developing varicose veins”

Only risk reduction claims are allowed currently, have to give FDA advance notice

199
Q

Structure and function claim

A

No specific diseases, just structures or functions of body Don’t have to give advance notice

Doesn’t fix or stop a disease, more health promoting

Ex. “Helps support the body in maintaining health circulatory function in leg veins”

200
Q

1990 Nutrition Labeling and Education Act

A

allowed for health claims in food labeling

but these must have a significant scientific agreement

201
Q

1994 DShea

A

allowed structure/function claims in DS labeling

allowed claims of general well-being, and nutrient deficiency claims

202
Q

Functional Foods

A

like normal foods, but provide health benefits beyond basic nutrition

ex “Oats may reduce Cholesterol”

Statements on FFs about extra health benefits mean FFs require extra oversight

203
Q

Health Claim essential components

A

a substance and a disease or health related condition

204
Q

Structure/function claim quick definition

A

address the role of a specific substance in maintaining normal healthy structures or functions of the body

205
Q

FDA regulates…

A

product labeling

206
Q

FTC enforces…

A

consumer protection laws on advertising for both functional foods and dietary supplements

207
Q

USDA regulates…

A

label claims for functional foods containing more than a certain percentage meat or poultry

Healthcare systems (6 decks)

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