PMK final

drug discovery

Understand molecular basis of disease, select and validate therapeutic target, link target to mechanism, discover a ”druggable” chemical lead that is novel and works in vitro, 5,000-10,000 compounds

preclinical

establish initial safety and efficacy parameters prior to human trials, define mechanism of action, absorption, distribution, metabolism, and excretion in vitro, 250 compounds

high throughput screening

customized biochemical and cell based assays to evaluate and model interaction of molecule and target

phase 1

examines drug on healthy normal volunteers, establish drug safety profile and safe dosage range, 20+ volunteers, future trials limited until phase 1 shows drug is safe, 5 compounds

phase 2

confirms safety and determines clinical efficacy profile in humans, clinical trials with 100+ people who have disease, placebo and double blind, analyze data for correct dose with safety

phase 3

clinical trials with up to 10,000 patients to confirm phase 2 findings, 2 pivotal placebo and double blind trials, large trials needed to investigate unforeseen adverse effects and subpopulations, validate safety and efficacy, provide data for regulatory filing, approval and launch

second opinion

1/5 seek second opinion, 1/3 get new diagnosis

alternative medecine

cheaper, complementary to conventional medicine, substitute conventional medicine, haven’t been shown scientifically, can be sold by anyone

supplements

classified as food products not medicines, lack standards, herbal products sold as food products, what is in the bottle may not match label, use USP verified product

nutrition facts contain

serving size, calories, nutrient information

mandatory nutrients

total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugar, protein, vit A,vit C, calcium, iron

the following statements are true about serving size except

no standards exist for serving size

true or false: one serving (8 oz of skim milk) has a 1% DV for cholesterol. This means that 1 cup of skim milk is low in cholesterol.

true

ingredient statement

required for food with more than 1 ingredient, listed from ingredient weighing most to least, ingredients with less than 2% should be listed, include food coloring/preservatives

where is the ingredient statement located?

on the information panel

in what order must the ingredients be listed?

in descending order of predominance by weight

place of business

food label must include name and address of manufacturer, packer, or distributor, located on lower portion of information panel, phone number isn’t required

all of the following are required on food labels except?

phone number

what part of the food label most often contains the place of business information?

information panel

basic format

packages with 40 or more square inches of label space

smaller packet format

less than 40 square inches, packages smaller than 12 square inches don’t need label, need phone number or address

health claim

meet criteria preapproved by FDA, confirm relationship between food and disease, ex: Three grams of soluble fiber daily from oatmeal, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.

nutrient content claim

characterize level of nutrient, must contain FDA designated amount of nutrient, ex: reduced fat

structure functions claim

role of nutrient that affects or maintains normal structure or function of body, ex: antioxidants maintains cell integrity

dietary guidelines

describe the health benefits of broad category of food, ex: diets rich in fruits and veg may reduce risk in types of cancer and disease

probiotics

manufacturers don’t have to disclose which strain and how much they use

cost

dollar amount it costs for a provider to deliver a health care service

charges

financial amount a health care provider asks for a service, often much higher than cost and reimbursement, only uninsured patients are billed charges

reimbursement

amount a third party payer (insurance), negotiates as payment to the provider, may drive charge inflation

price

the amount a patient pays out of pocket for a service, hardest number to estimate, matters most to patients

individual private insurance

individual polices involve an individual paying a premium directly to a health plan or insurance company which reimburses providers, 11% of US pop

employer-based private insurance

employers usually pay all or part of premium that purchases health insurance for their employees, tax deductible business expense and gov doesn’t treat the health insurance fringe benefit as taxable income to employee, gov is subsidizing employer-sponsored health insurance

government-financed insurance

medicare and medicaid

medicare part a

hospital insurance plan for elderly, financed through SS taxes, at age 65, ppl who have paid > 10 years into SSI automatically enrolled, those <65 totally and permanently disabled may enroll after 2 years of disability, those with ESRD on HD usually enroll without wait period

medicare part b

insures elderly for physicians services, financed by fed taxes and monthly premiums from beneficiaries, avalible to those eligible for medicare part a who elect to pay medicare part b premium of $104,90/mo

medicare part D

voluntary prescription coverage that is added to original medicare, plans to have monthly premiums in addition to that paid for Part B, deductibles vary but may not exceed $360 per year, beneficiaries may owe a late enrollment penalty if they are without drug coverage for >63 days

medicare advantage plan

beneficiaries can enroll in a private health plan to receive medicare covered benefits, plans cover parts A,B, and D, one must have parts A and B to sign up

Medicaid

federal program administered by states, paying between 50-76% of total medicaid costs, broad set of services be covered, a low income persons and disabled covered

affordable care act

decrease number of uninsured Americans and reduce health care costs, medicaid expansion: minimum income eligibility across the US to <138% federal poverty level, health insurance exchanges: competitive markets to assist people in purchasing insurance; subsidized for families, 400% poverty limit

diagnosis-related groups

physician or hospital is paid one sum for all services delivered during one illness, diff set case-price for each 750 DRGs (medicare)

Per Diem

hospital is paid for all services delivered to patient during 1 day (private insurance, PPOs, HMOs)

Fee-For-Service

physician or hospital is paid a fee for each service provided, ex: medication, IV fluids, ECG, surgical procedure (uninsured, some private insurance)

capitation

one payment is made for each patient’s treatment during a month or year (has disappeared, before HMOs)

accountable care organizations (ACOs)

doctors, hospitals, other health care providers who come together to coordinate high quality care for medicare patients, ensure that patients get the right care at right time without duplication of services or errors, ACOs who provide high-quality care with lower costs will share the savings with medicare