Exam 2 Flashcards
Decks 1,2,3,4, 5.1 so far
Upstream and downstream determinants of population health
Bottom -> Top
Individual, pop health Genetic factors Individual risk factor Social relationship Living conditions Neighborhoods and communities Institutions Social and Economic policies
“Population health”
Health outcomes of a group of individuals
Distribution of outcomes within group
Importance and management of non-clinical factors (social, economic, environmental) in outcomes
Examples of “population”
Hospital or pharmacy catchment area
Student population
Employer’s workers
County, state, or country
Disparities
inequalities within a population
Distinguish between associating from causality
lower income = poorer health
educated people = better health
these are associations or correlations but not necessarily one causing other
SDOH
Social Determinants of Health
Many are modifiable factors
Policies and Programs
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)
Theory for increase violence 1990s
Lead in gasoline and paint, rose and fell 25 years prior
caused issues in kids like reduced IQ, learning disabilities, hyperactive/antisocial behaviros
Why have transportation mortality rates decreased?
increasing focus on safety like seat belts, airbags, antilock breaks, better highway design, Drunk driving is a no no
Effect of Income and Education
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
Hispanic Paradox
Recent immigrants have less diabetes and other health problems than those who had longer exposure to our “toxic socioeconomic and physical environment”
Expanded Chronic Care Model
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
Chronic Care Model
Healthcare system: Self-management support Delivery System support Decision support Clinical Info support
Community:
Resources and policy
Health Definition (WHO)
Health is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity
Health Promotion
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
Levels of Health Promotions
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
Community Level interventions
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
State and National Level interventions
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
Global Level interventions
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
Health Promotion and Disease prevention
Health promotion = optimize overall health
Disease prevention = reduce occurrence and impact of specific diseases
3 Levels of disease prevention
Primary, secondary and Tertiary
Primary Prevention
Goal: To reduce number of new cases
Target pop: those most likely to be exposed or can increase their resistance
Secondary Prevention
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
Tertiary Prevention
Goals: Reduce number of complications and death
Target pop: those who have and need treatment
Healthly people
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
Healthy people evolution
More ambitious over time and more broad going beyond the medical/ clinical
Social Determinants of Health
ED access and quality Healthcare Access and quality Neighborhood and Built environment Social and Community context Economic Stability
WHO 1998 Health definition
a DYNAMIC state of complete physical, mental, SPIRITUAL, and social well-being and not merely the absence of disease or infirmity
Public Health is..
what we as a society do collectively to assure the conditions in which people can be healthy
Medicine vs public Health
Saves 1 life at a time vs millions at a time
10 Great US Public Health Achievements
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
10 Essential Services of public Health
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
CDC
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
Code of Ethics Pharmacists VII
A pharmacist serves individual, community, and societal needs
Traditional vs Behavioral “nudges” Economics
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
“Nudging” to promote health choices
Food/menu labels - information plus
Health choice is the easy one - change the default
Financial incentive
Social norms and framing
Traffic Light Labels
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
Specialty meds
Account for a lot of the spending increases we see
Generics capture…
80% of a brands volume within 6 months
Policies aimed at encouraging generic entry have gotten stronger
New Drug Therapy Starts
people who are starting therapy are more likely to be started on a generic than a brand now.
Generics make up…
90% of prescriptions dispensed, dispensed 97% of the time when available
Hurdles for Generic drugs
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
Evergreening
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
Price Gouging
Legal business behavior, widely criticized as unethical
Company find cheap, old drug, make sure they have monopoly on it and jack up price
1983 Orphan Drug Act (ODA)
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
Recycling
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
Unapproved uses
Get orphan approval and all incentives that come with it but then actually sell the drug to treat other common conditions
Salami slicing
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
Changes who pays for RX
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
Pharma spending
Spends considerably more for Sales/ Marketing compared to Research/Development
Big Pharma Changes
Alot of outsourcing
Product lines are less exciting
Challenges presented by globalization supply chain
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
FDA Foreign Offices
All over the world
supposed to ensure GMP
Drug Manufacturer
Develops and produces med
Sells med to wholesaler
Negotiates with PBM
Markets med to patient and to physicians via free samples, etc
Repackaging
Med sold in bulk can be repackaged into smaller containers then sent to pharmacy
Wholesaler = Distributor
Purchase med in bulk from manufacturer
Sends med to repackager
Sells meds to pharmacies and healthcare institutions
Pharmacy
Buy from wholesaler
dispenses med to patients
stocks med based on variety of info
Drug samples
Provided free to doctor
Doctor cant sell or trade samples
Doctors and Dispensing Doctors
diagnose and monitor patients
Prescribe med, can give free samples
Decisions can be influenced
Patient (insured)
pays premium
Pays cost sharing of drug
Pharmacy Benefit Mangers
Develops and maintains formulary based on cost-effectiveness
Essentially hired by insurance company
Works as the middle man
Types of Emergencies
Natural disasters, disease outbreaks, man made ( radiation release or terrorist attacks)
Natural disasters costs US more than terrorist attacks
Levels of approaches to Emergency planning
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
SNS
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
CHEMPACKs
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
12-Hour push packages
rapid delivery to anywhere in US within 12 hrs of federal decision to deploy them
Apportionment
Breaking up the materials at RSS into smaller packages for individual deliveries
Managed Inventory
these are as-needed and as-requested, especially when threat is known
SNS Request flow
Local -> State -> national + help flows back
SNS does not include
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 *
High water mark
must consider what their max population is.
ex. school in session, colleges/universities, homeless, seasonal workers, etc
SNS prioritize
First responders (Fire, police, EMS)
Strategic personal (Transport, utilities)
Family members of the above
Some special populations
SNS special populations
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
Emergency Dispensing: Local planning team include
Local public health Emergency management directors various reserve teams and committees Fire/police Local/Regional hospitals
Role of Pharmacists
Public-health-level activities
Pharmacy-level activities
Community-Based Pharmacy Disaster plans
make plans before an emergency happens
minimize impact on the pharmacy itself
Managing effects of disaster on supply chain
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
Staffing issues in pharmacy with disaster
expect some work force reduction
solutions:
develop policies for flexible work sites, cross-training employees, ID business functions that can be outsourced
Pharmacists preparing their community for disaster
ensure patients have adequate supply of medication
work with local physicians; educate MDs on refill policies
Individual Pharmacist Responsibilities for disaster
Training for pharmacists such as CPR, basic cardiac life support, vaccination certification
Train other health professionals and volunteer
Emergency Prescription Assistance Program
EPAP
US DHHS and FEMA
For uninsured people with proof of prescription, in a disaster
Provides eligible individuals 30-day prescription assistance
Rx open
Mapping pharmacy status during disasters
CMS Emergency Preparedness Rule
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
Individual Preparedness
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
Household prescription drug stockpiles
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
Backpack Emergency Card
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
Cost
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
Charge
What a provider attempts to bill a payer
Price ( or payment)
What a payer actually pays for a unit of care
that is also the payers unit cost
Spending
Price X Quantity
This is the payers total cost
Per capita
Per person
Remember, total health care spending will increase due to population growth alone
“Cost reduction” vs “Cost control”
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)
Key factors affecting spending changes over time
Changes in demographics
Changes in quality
Regulatory approaches to cost control
Price regulation
Medicare’s Hospital DRG rates
Bundled payments
Global budget
Government price-setting for drugs
Growth regulation
Rate setting
usual language for price regulation when talking about hospitals
Softer, more indirect regulatory approaches
standardization of care and practice guidelines
System transformations to increase efficiencies
Market approaches to cost control
Less government top-down decision-making, mandating what you must do
ex. provide good information
Internal reference pricing
sets the reference price as a function of prices of local/nearby substitutes
External reference pricing
typically sets the reference price as a function of prices of substitute products in other countries
Medicare inpatient prospective payment
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
DRG payment
depends on which DRG bucket the case belongs in
Cost control techniques organized by Market characteristic
Budgets exist and constrain choices
Buyer has good info
Buyer pays price
Buyer decides
Firms seek profits
Multiple buyers and sellers
Market characteristic:
Budget constraints
DRG
CMS bundled payment for hip/knee replacement
Accountable Care organizations- read or penalize based on spending targets
Market characteristic:
Good info
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
Market characteristics:
Price
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
Market characteristics:
Patient Autonomy
Patient engagement in own care and shared decision making
This should raise quality of care
Market characteristics:
Profit seeking
penalties cut into profits
penalize healthcare practices that result in high costs and hope is that then you get more cost-effective care
Market characteristics:
Multiple buyers and sellers
internal reference pricing
telemedicine
antitrust enforcement
retail clinics
IOM definition of Quality of Care
The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.
Joint commission
1951
Assesses the quality of hospitals
Hospitals must be TJC-accredited to receive Medicare payments
Avedis Donabedia
Creater of the Donabedian model
Structure, process, and outcomes
Example of structure measure
Does an ICU have critical care specialist on staff at all times
Example of a process measure
Percentage of diabetes patients who receive regular eye exams
Example of an outcome measure
Percentage of diabetes patients with their blood sugar under control
National Committee for quality Assurance (NCQA)
1990
Accreditation programs for health plans, MCOs, medical groups, and individual physicians
Health plans seek accreditation and measure own performance with HEDIS and CAHPS
National Quality forum
1999
Evaluates quality measures
6 guiding principles for healthcare quality improvement
Safe Effective Patient-centered Timely Efficient Equitable
Patient safety
initiatives focus on identifying and preventing harm
Definition of harm to patients
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
preventable harm
a medical error
Quality improvement
initiatives focus on ensuring patients get what they need, when they need it, in an appropriate way
Continuous Quality Improvement (CQI)
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
Dartmouth Atlas project
revealed large, unexpected geographical variations in process of care
Implies differences in the quality of care
Using massive claims dataset from medicare
“Hard” endpoints
Mortality
Physiologic measurements
“Soft”
involve more subjective assessments by clinicians or patients
Functioning, quality of life, pain
“Never events” or “Sentinel events”
Devastating, preventable, unacceptable
TJC mandates performance of a “root cause analysis” after a sentinel event
The Checklist Manifesto
Designed a checklist, applicable in any kind of surgery, at any hospital, anywhere in the world
100,000 Lives Campaign
Example of a hospital safety initiative
Hospital penalties in the ACA
penalties for high rates of hospital-acquired conditions, especially infections following surgery
penalties for high readmission rates
HEDIS measures
Dozens of measures across several domains
Effectiveness of care, utilization measures, access/availability of care
CAHPS
Survey of consumer/patient experience with care
Used to star-rate
Pharmacy accreditation/quality measures
URAC and CPPA
URAC
runs accreditation programs for health plans, providers, and pharmacies, PBMS, specialty pharmacies and mail service pharmacies
CPPA
Partnership among pharmacist/pharmacy organizations
Health insurance plans accreditation/quality measures
NCQA - using HEDIS (including CAHPS)
Hospitals accreditation/ quality measures
TJC
P4P
Pay for Performance, “value based purchasing”
Financial incentives to providers for meeting certain performance measures
One provider’s bonus is another’s penalty
Medication error defined as
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
Focus on 4 erros
Prescribing
Transcribing
Dispensing
Administration
Error-Prone Notations
Examples of notations that should never be used
“Do not use” list required to be present in facilities for accreditation by The Join Commission
Computerized Physician Order Entry
CPOE
SureScripts - enabling providers to transmit new prescriptions to patients pharmacy of choice and electronically authorize refill requests
Potential Benefits of Physician Connectivity for the pharmacy provider
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
Why so many medication errors?
We take a lot of medications
increasing numbers of Rx/year
More opportunities for confusion and drug-drug interactions
Other potential contributors to medication errors
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
Medication reconciliation
should be done at transitions in care
5 steps:
- develop list of current meds
- develop lost of med to be prescribed
- compare med on the two lists
- make clinical decisions based on comparison
- communicate new list to appropriate caregivers and to the patient
Bar Coding
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
Bar coding limitations
up-front costs
bulk meds have to by repackaged or cut into smaller ones
cant barcode all drugs
Adverse Drug reaction
unexpected, unintended, undesired, or excessive response to a medication (think side effects)
Majority of ADEs are preventable
Five rights
Right….
drug
patient
dose
route
time
1 recommendation of IOM report
Allow and encourage patients to take a more active role in their own medical care
Phase I
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
Phase II
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
Phase III
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
Phase IV
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
FDA reviews IND within….
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
CDER
Center for Drug Evaluation and research
CBER
Center for biologics evaluation and research
FDA approval of and NDA
permission to market new drug
FDA approves label
each indication and claim requires separate filing material, approval is for specific indications and claims
PDUFA
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
Standrad review
90% should be completed within 10 months of filing date, goal now is max 12 months
Priority review
90% completed within 6 months of filing date
PDUFA IV 2007
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
Point of Phase IV
Examines effectiveness in realworld and safety
PDUFA V 2012
Added fee for Generic drugs and Biosimilars
More patient engagement in the drug eval and approval process
4 special designations to speed of NDA approvals
10 month timeline
Fast track, Breakthrough and Accelerated approval
6 month timeline
Priority review
Factors in making special designations
Improved safety or efficacy over existing therapies
Effects on clinically significant endpoints
Effects on surrogate endpoints
only 2 countries that allow DTCA
USA and NZ
Key points to know about pre-1997 drug marketing in US
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
“Brief Summary”
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
“Fair Balance”
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
DTCA 1997
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”
“Adequate provision”
directing views where to find the more complete brief summary info
Research on DTCA suggest that….
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
“Medicalization”
When what had been non-medical problems get re-defined as treatable illnesses
“disease mongering” by Pharma? expanding its markets
4 types of DTC ads in print
Institutional ads: visibility for company and its research
Reminder ads
“see your doctor”/ “Help seeking” ads
Product-claim ads
Institutional Ad
Includes info such as company name, area of research
Dose not mention any drug names
Reminder ads
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 **
Help Seeking or Disease Awareness Ads
Includes medical conditon
Symptoms
Recommend seeking doctor’s help
Pharmaceutical company name
Cannot have drug name or drug image
Product Claim Ads
Mentions brand/generic and disease/condition/indication
Most informative and regulated type
FDA recommendations for Brief Summary
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
Most common promotion concerns
FDA examines ads and what’s being said at scientific meetings
Problems FDA tends to observe…
- Omitting or downplaying risks
- Overstating efficacy
- Promo of unapproved uses
FDA Office of Prescription Drug Promotion
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
FDA’s Bad Ad Program
encourages Healthcare providers to call if they see a bad ad
OPDP can issue warning letters, notices of violation, penalties, criminal action
Submitting ads for OPDP review
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
MedWatch
FDAs safety info and adverse event reporting program
FDA Drug definition
Substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
Dietary ingredient
maybe one, or any combo, of the following…
Vitamin, mineral, herb or botanical, amino acid, concentrate/extract/etc
Dietary Supplement
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
Regulation of Dietary Supplements
Regulated primarily under DSHEA
Relatively loose regulations apply
Dietary supplements cannot claim to…
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
New Dietary Ingredient
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
Manufacturer responsibilities for NDIs
minimal
FDA recommends manufacturer conduct search of scientific literature for evidence
explain how they conceded their DS with NDI is expected to be safe
FDA responsibilities for NDIs
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
FDA can prohibit dietary supplements that…
present significant or unreasonable risk
contain any poisonous or deleterious substances
are adulterated
make a drug claim
have untruthful labeling
Dietary Supplement and Nonprescription Drug Consumer Protection Act
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
cGMP standards
Qualified employees
Manufacturing facility designed to prevent adulteration
Proper manufacturing process
Testing of final product, QC
Proper sotrage
Keep records of product complaints
USP-Verified
independent 3rd party certification of product quality
- That what’s on the label is in the bottle, ingredients in declared amounts
- does not contain harmful levels of contaminants
- will break down and release ingredients in the body
- has been made under good manufacturing practices
Health claim
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
Structure and function claim
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”
1990 Nutrition Labeling and Education Act
allowed for health claims in food labeling
but these must have a significant scientific agreement
1994 DShea
allowed structure/function claims in DS labeling
allowed claims of general well-being, and nutrient deficiency claims
Functional Foods
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
Health Claim essential components
a substance and a disease or health related condition
Structure/function claim quick definition
address the role of a specific substance in maintaining normal healthy structures or functions of the body
FDA regulates…
product labeling
FTC enforces…
consumer protection laws on advertising for both functional foods and dietary supplements
USDA regulates…
label claims for functional foods containing more than a certain percentage meat or poultry
