Public Health and FDA

Public Health

science and art of preventing disease, prolonging life, and promoting health of people and their communities

Before 1960s

• focus on infectious diseases

• public health infrastructure

• epidemiology

After 1960s

early treatment and prevention

public health infrastructure and expansion of health departments

epidemiology 9identify pandemics)

social determinants of health

public health policy and advocacy

US Public Health System

Focus on prevention of diseases, injuries, and disability.

Population health rather than at the individual level.

Assessment

Core function of public health.

identifying health problems and causative factors

Policy development

Core function of public health.

developing strategies to address problems

Assurance

core function of public health

making sure that strategies are implemented and goals are achieved

Epidemiology

study of the distribution and determinants of health related states or events in specified population application of this study to the control of health problems

(basic science of public health)

Healthy People 2030 Initiative

Health disparities, health equity, health literacy, social determinants of health, well being

Health People 2030: Health Equity

• one size does not fit all, equality is different from equity

• address avoidable inequalities

• eliminate health and healthcare injustice

• in order to reach highest level of health for people

Healthy People 2030: Health Literacy

• very concerning number of people who don’t understand how to read label

• population more likely to experience health illiteracy: elderly, minority groups, low socioeconomic status

Healthy People 2030: Social Determinants of Health

• economic stability

• education access and quality

• healthcare access and quality

• neighborhood and built environment

• social and community context

Public Infrastructure

Made of people, services, and systems needed to promote and protect health in every US community

HHS: Federal

• two largest employers: NIH and IHS

• employees work in clinical research and services

HHS: State

vary greatly in structure, size, programs, and services

HHS: Local

• frontline agencies in all states

• adopt own constitution and impose taxes

HHS

• secretary who is appointed by president leads this section

• 11 divisions

• assistant secretary heads 8 PHS services

AHRQ

• improve quality, safety, efficacy, and effectiveness of healthcare

• manages CER (evaluation of different options available for treating a certain condition)

• funding usually depends on if program aligns with Healthy People 2030

HRSA

• goal is to improve access to healthcare services to those where it is difficult to find for themselves

AIMM

provide high quality and cost effective clinical pharmacy for patients who deal with high risk, high cost who suffer from multiple chronic conditions

IHS

main federal agency that provides health services to American Indians and Alaska natives

NIH

largest sources of medical research funding. 80% of budget goes to 400,000 research personnel

CMS

federal to prevent fraud and abuse among healthcare providers, evaluate health care financing policies and programs, reimburses the insurance companies

FDA

regulates 20% of US GDP. job to protect public health by ensuring safety and security of drugs, medical devices, food supply, and products that emit radiation

• review research and approve new product

• ensure food and drug safety and proper labeling

• collaborate with other countries to reduce regulatory burden

• work with scientific experts and consumers to fulfill responsibilities

1961 Kefauver-Harris Drug Amendments

after thalidomide tragedy. products need proof of safety and efficacy before released into market and informed consent from test subjectsFDA Product App

FDA Product Approval Process: Pre-Clinical

test for toxicity profile of drugs, lab and animal testing

FDA Product Approval Process: Clinical (Phase I)

after filing IND. test for safety and dosage in humans

FDA Product Approval Process: Phase II

test for efficacy. include # of test subjects (100-300). use of patients with target illness/disease

FDA Product Approval Process: Phase 3

still testing for safety and efficacy but increase # of test subjects (1000-3000)

FDA Product Approval Process: Phase 4

survellience for side effects that may lead to drug recallReca

Recall Process

1. first alert

2. alert public

3. effective checks

4. class

   1. class 1: dangerous or defective products that predictably could cause serious health problems or DEATH

   2. class 2: products might cause temporary health problem, only slight threat

   3. class 3: products unlikely to cause any adverse health reaction, but violate FDA labeling or manufacturing laws

Pharmacists at FDA

• drug evaluation

• research and development

• safet surveillance

• regulatory and advisory roles