Quiz #3 Study Guide PDF

Quiz #3 – Study Guide There will be approximately 30 - 35 multiple-choice, true/false, and matching questions. Chronic Disease and Disability Goffman and the concept of stigma o How do those with disability handle normals? - Assume normals are ignorant;not malicio...

Quiz #3 – Study Guide There will be approximately 30 - 35 multiple-choice, true/false, and matching questions. Chronic Disease and Disability Goffman and the concept of stigma o How do those with disability handle normals? - Assume normals are ignorant;not malicious - Ignore snubs or patiently refute the offense - Reduce tension by breaking the ice with humor - Treat normals as wise - Follow disclosure etiquette by using disability as a topic for serious discussion - Use tactful pauses during conversations to allow recovery from shock over something said - Allow intrusive questions and agree to be helped - See oneself as normal to put normals at ease o Who determines who gets stigmatized - An attribute that is deeply discredited by society results in rejection of an individual with that attribute - The stigmatized are those who bear the stigma - The normal are those who do not bear the stigma - The wise are normals who are accepted by the stigmatized as “wise” to their condition Nagi’s Disablement Process Effort to define and conceptualize disability Framework of disability and a process of change Concept describes a pathway with several domains from pathology to disability ○ Know the pathway and what falls under each construct (1) Origin: pathway (chronic health conditions) (2) Organ level: impairment (disability- related symptoms) (3) Person level: functional limitation ( functional limitations) (4) Society level: disability (activity limitations) The ranking of chronic diseases for the most direct and indirect costs o Where are most of the chronic diseases found – where do they fall in terms of States? - Southern states o Risk factors for chronic diseases - Tobacco use - Poor nutrition - Physical inactivity - Excessive alcohol use o Which factors explain health and disease differences with respect to race? - Socioeconomic status - Environmental factors - Access to healthcare  - Exposure to discrimination - Education level o Which area of the country carries the greatest disease burden? - The south Nutrition/Obesity/Diabetes Who is at risk for obesity and diabetes? - Non hispanic blacks have a higher risk of obesity - Higher BMI - Older people - Increase central fat - Smoking - Low fitness level - Hispanics, african americans, and asians have a higher risk of diabetes - Prevalence of obesity - 42% are obese - 1 in 3 are overweight What are people with obesity and diabetes at risk for? - Cardiovascular risks (obesity) - Hypertension - CHD - Heart failure - Myocardial steatosis - ECG findings - Atrial fibrillation - Stroke - Cancer - Complications (diabetes) - Cardiovascular - Neuropathy - Retinopathy - Nephropathy - Foot damage - Skin conditions - Alzheimer's disease - Depression How can diabetes be mitigated? - Exercise - Health diet - Smoke less How is obesity medicalized? - Surgery, diet pills, weight loss plans Mental Health What are the trends for the type of mental health expenditures/treatment from 1986 –  2014? - Impatient has gone down - Outpatient care has gone up - Retail prescription drugs have gone up - Residential care has gone down Suicide rates…who has the highest; who has the lowest (racial groups)? - Men have the highest rate - Biracial people have the heist rates of major depression - Asian is the lowest What are the social determinants of mental health? - All SDoH apply - Environment - Race - Neighborhood - Healthcare Stages of schizophrenia (1) Prodromal: 12-18, built slowly, become socially withdrawn (2) Acute (psychosis): 18-24, become socially withdrawn but added anxiety, fear and hallucinations (3) Residual (chronic disability): > 24, functioning Mental Health Illnesses and Disability-adjusted life years - Differences in mental illness diagnoses between men, women, and teens and between race - African american women and white women have the most diagnoses - Hispanic women have the least Pharma & Medical Devices Drug trial phases (1) Pre-clinical (2) Clinical (a) Phase 1 ○ approve of the clinical trials protocol by an institutional review board ○ between 20-100 human subjects (b) Phase 2: ○ Hones in on specific disorders 100-500 subjects Goal is to determine the maximum safe dose of the drug To compare the response achieved to that of the current standard treatment Number of subjects used on ranges from a few dozen to about 300 Successful drugs are those that can be given safely  with minimal or acceptable side effects, while demonstrating beneficial effects on the symptoms, staging or diagnosis of the chosen disease (c) Phase 3: ○ Holy grail of drug development ○ Many promising drugs crash and burn at this stage ○ Randomized controlled trial (RCT) 1000-5000 subjects Double blinded and randomly assigned to treatment or placebo group Results are stratified into a) Different patient populations b) Different drug dosages c) In combination with other drugs to determine the drug and patient combinations that are most likely to ensure benefit d) Success in this phase almost always results in being on the market within a year (3) New drug application (NDA) review (4) post-marketing How pharmaceuticals spend their money - Most money is spent on marketing and typical very little is spent on research and development Know the classes of medical devices (definition and examples) - Class 1 devices: - Subject only to general controls - Basic authorities (power) of medical devices amendments that allow the FDA to regulate - Apply to all three classes, but are only level of controls for class 1 - Present in lowest potential for harm - Simpler in design than class 2 or class 3 - Examples: - Elastic bandages - Disposable examination gloves - Hand-held surgical instruments - Tongue depressors - Medical thermometers - Class 2 devices: - General controls alone are insufficient to provide a reasonable assurance of safety and effectiveness - Subject to special controls identified by the FDA - Special labeling requirements - Performance standards - Postmarket surveillance - Examples: - Power wheelchairs - Infusion pumps  - Surgical drapes - Computers that assist in medical testing - Prostheses - Class 3 Devices: - Insufficient information exists to determine that general or special controls are sufficient to provide a reasonable assurance of safety and effectiveness - Examples: - Replacement heart valves - Silicone gel-filled breast implants - Implanted cerebellar implants - Cochlear implants - Pacemakers - Vascular grafts - Intraocular lenses - Orthopedic pins - Surgical lasers Differences between U.S. and EU approval process for medical devices - FDA: two regulatory pathway - Pre-market approval - class 3 devices - Large randomized, multicentered trails - 510(k) - class 1, 2, 3 - Manufacturer only needs to demonstrate that device is ‘substantially equivalent’ to predicate device - EU: Class 3 approval very different - EU medical Device Directive - Approval based on ‘CE mark’ (certification mark) of conformity - ‘Notified bodies’: third parties implement regulatory control - Independent, commercial organizations - ‘Competent authorities’: monitor ‘notified bodies’ - Devices need to only demonstrate safety and performance, not effectiveness History of pharma regulation - Regulation is the pharmaceutical industry is relatively recent - Assumption that patient safety was in the commercial interests of the industry - Late 1920’s to med 1970s, government regulation was instituted - 1928 in norway - 1962 in US  - 1976 in Germany - Pharmaceutical companies are now responsible for paying the majority of the FDAs operating costs Differences in the regulatory process between pharmaceuticals and medical devices - Medical devices are mechanical rather than chemical - Medical devices have different efficacy dynamics to pharmaceuticals - Effectiveness of a medical device depends upon many more variables - Research and development models are different - Generally cannot evaluate using randomized clinical trials due to ethical and practical issues - Medical devices have regulatory systems based on shorted product life cycles - Sales and marketing models differ - Many more stakeholders influencing the adoption and use of a device - Greater emphasis on training, education, service and maintenance - Distribution differs How medical devices affect women - Women are most at risk - Not only for devices strictly for women, but sex-neutral instruments - Higher rate of hip implant failures - Stronger immunological reactions to metal in devices - Similar to drug studies (women not included) until legislation passed Social Construction, Medicalization & Pharmaceuticalization - Pharmaceuticalization: the process by which social, behavioral or bodily conditions are treated or deemed to be in need of treatment, with medical drugs by doctors or patients - Driven by political economy of pharma (any government policy that have an economic impact), Deregulatory state ideology (approval is based on quality, safety and efficacy, not demonstrating therapeutic advancement) and consumerism - Medicalization does not include the consumption of pharmaceuticals as their main feature - Ex: pregnancy (midwives out), beauty, and celiac (no pharmaceutical solutions) - Choice not to take alternate routes for a problem, but to treat w/Rx for pre-existing, established conditions - Ex: pharmaceuticalization eg. ADHD - no therapy, but only drugs - Occurs when medical profession is by passed - lifestyle drugs (baldness, wrinkles, acne) Social constructionist approach: opioid addiction - Asks more than just, “is this a problem” - Who id defining the issue as a problem - Who is associated with the issue - When did the issue start getting attention Environment, Exposure, and Health Environmental Justice - Fair treatment and meaningful involvement of all people regardless of race, color national origin, or income, with respect to the development, implementation and enforcement of environmental regulations and policies. - Goals achieved when - The same degree of protection from environmental and health hazards - Equal access to the decision making process to have a healthy environment in which to live learn and work. Environmental Racism - Where people of color are situated- concentrated near un safe areas - Associated with policy and regulation enforcement - Racial discrimination in environmental policy making. EDCs - Personal Care products - Industrial chemicals - Pesticides, herbicides, fungicides - Heavy metals - Synthetic and naturally occurring hormones - Pharmaceutical drugs - Personal care products What are Superfund sites? - contaminated sites How many Superfund sites there are in U.S. and NJ - 1340 in the US - 115 sites in NJ, more than any other states Major environmental events Brownfields Initiative - Redevelop prior contaminated sites - Clarck, NJ golf course on former G.M. Industrial site (Hyatt hills) - Project cost between 50-70 million (all but 10 million was cleanup) - G.M. paid for it Different meanings of risk - External risks and manufactured risks - Risk provide a mechanism to probabilistically codify how hazards and insecurities are governed How risk is stratified? - Classes/radicalized risk - Gendered risks - geographical/occupational risks Regulatory principles - Precautionary principles (EU) - An approach to risk management that states new products and policies must be proven safe for the public  - When no scientific consensus, those taking action must prove that products or policies are not harmful - Permissive principles (US) - Explains the shifting nature of (de)regulation as a tendency to permit product distribution to open markets even if they do not meet standards of efficacy or safety - Ex: The dose makes the toxin “The dose makes the toxin” - Basic principle of toxicology - “All things are poison and nothing is without poison, the dosage alone makes it so a thing is not poison.” - Paracelsus- swiss scientists and philosopher Manufactured doubt - Products can continue to circulate, generating profit - Can be packaged into neoliberal ideology to make you pay more - ex: organic, non GMO - Organic and non- (fill-in-the-blank) labels raise the cost of food Health consequences - Of waste management - Land filling: congenital abnormalities - Incineration: Non-hodgkin's lymphoma, sarcomas - Sewage contaminated water: gastroenteritis - Radiation: increase in almost all cancers - Of living in E-waste recycling towers - Change in thyroid function, cellular expression/function - Spontaneous abortions, stillbirth, premature births and reduced birth weights and lengths - Some elements carcinogenic, cytotoxic, obesogenic, or contribute to various kinds of heart disease Colonialism