efficacy

evidence of safety

patient reported outcomes

real-world effectiveness

cost and effectiveness

1 is clinical effectiveness

2 is cost effectiveness

costs of the new treatment-costs of old treatment divided by effects of new treatment- effects of old treamtent

NW is new treatment dominated

NE is a tradeoff

SE is the old treamtent dominates

Sw is a trade off

direct medical costs

direct non medical costs like transportation

indirect (loss of productivity)

are the benefits worth the cost

distributive justice (utilitarianism, egalitarianism)

under 20000lbs it will accept

over 30000 lbs will reject 

1 is there a difference in efficacy

2 is there a difference in clinical significance

patient

provider

community (access to care, environment)

health system (payers, health care organizations)

government

1. patients- demographics, behaviors and cultural issues, education
2. providers- subjective biases, responses to patient information
3. health care systems- access, payment, institutional biases

survellance

translation/application of research results to reduce or eliminate disparities

intervention research

explanatory research on disparity cause and etiology

direct relationships with individual patients

acheievement of medication related outcomes

part A inpatient

part B outpatient

part D drugs

part C managed care

the initial deductable $310

the coverage phase patient pays 25% up to $2830

the gap phase patient pays 100% up to 4550

catastrophic phase patient pays 5%

2/3 of all physician visits get 1 or more scripts

1/3 of all hospital admissions due to adverse drug events

less the 1/2 of all patients on chronic meds adhere

1/ Comprehensive review of current prescribed and self-care medications for use and patterns of use (i.e., adherence)

2/ Systematic assessment of each medication for:

3/ Development of personal medication care plan

4/ documentation and communication of the plan to the patient and the rest of the health care provider team

payment issues

education issues

health technology issues

the core is individual

relationship- social network, famil peers, religions

community- work placeneigborhoods

societal- health economic and educational policies

health outcomes

quality

access

efficiency

equity

1. large variation between top and bottom performing health plans across regions and states
2. us payment system undervalues primary care
3. health professionals are not trained to work in teams despite evidence that health care teams are good
4. little investment in spreadin best practices

problem behavior

bad social skills

bad living skills

bad depression

1. many complex mental illness and little med history
2. prescribinf may reflect lack os access to other treatments
3. non-pharmacological treatments take longer and cost more
4. limited number of children psychiatrists accept medicaid foster care children
5. physician services are influence by regulatory incentives that impact payment

1. costs since they dont get help at preventable stages
2. quality of care- these people will typically clof the ER
3. equity and justice- vast majority of health disparities in vulnerable individuals are avoidable

behavioral model of health 

social determinants of health

predisposing

enabling

need

health behavior

outcomes

make money

make a product that will benefit health of consumer

NIH

universities

choose a target in a disease state

design various compounds

test compounds in vitro

test drug candidates in animal models

start with thousands

narrow down to 100 after in vitro

5-6 will move on to animal toxicolgy studies

abbreviated new drug application

this is used for a change in formulation (generics typically)

1. animal toxicology in two species (rodent and non rodent, reproductive tox, and oncogenecity as well as an LD 10 or TD50)
2. ADME 
3. manufacturing info
4. clinical protocol
5. investigational brochure

1. manufacturing info
2. demonstrate drug is safe and effective- preclinical data, clinical data, human ADME
3. labeling (package insert)

manufacturing

demonstrate equivalence

10-15 years to get approved

1.2-1.3 billion

5000 at preclinical, 5 at trials and 1 approved

at the end of preclinical trials

right before phase 3 trials

when you apply for the NDA

and then they review the drug

risk evaluation and mitigation strategy

Limited to products with unique benefits and significant risks

and

Risks can be avoided or minimized if a  particular protocol is followed

and

Less intrusive programs are not adequate to minimize risks

1. requires patient, prescriber, pharmacist to be enrolled
2. DR faxes script to FOCUS program for verifacation
3. DR sends original hard copy to pharmacy using a courier
4. the FOCUS program will approve then the pharmacy can fill script when they recieve hard copy

Consequences: any effect related to the alternatives modeled

Clinical intermediary: Measurements of a patient’s physical or biomedical status used as a surrogate for or to infer the degree of disease (BP, FEV)

 Humanistic intermediary: Factors that affect the formation of patients’ opinions about the effects of disease or treatment on their lives and wellbeing (perceptions)

Humanistic outcomes: Patient self-assessment of the impact of disease or treatment on their lives and well-being (HRQoL, PROs) surveys

Costs: Direct medical, direct nonmedical, and indirect costs related to treatments

Economic outcomes: Direct and indirect costs compared to consequences of medical treatment alternatives (CBA, CEA, CMA)

Treatment modifiers: Factors that may alter intermediaries or outcomes associated with treatment alternatives (side effects, compliance)

cost containment efforts (HMO)

rapid evolution of drugs

data showing inappropriate care

need for evidence based practice

increas-ed- financial pressure

its a loop evaluation/research> structure (review criteria guidlines etc...)> process (real worl implementation)> outcomes

with feedback education for patients, policy makers, payers

in clinical trials the measure of outcomes is relative risk 

in retrospective outcomes is odds ratio

50 +

adolescents 12-17

young adults (18-25)

POT

Coke, Pain relievers

heavy use was 38%

moderate use was 42.5

compare drug use between men and womenfor

opiate use

stimulant use

illicit drug use

more likely to progress to abuse or dependence

women are more likely to use opiates

men and women are equally likely to use stimulants

men more likely to use illicits or multiple drugs

women are more likely to progress to  dependence

slips attention failure

lapses memory failure

mistake- you do something wrong since you don't have any other choice

violations-your takeing a short cut

system failure (blame free)

culture of blame (punitive)

just culture

whole person

patient DR relationship (therapeutic alliance)

common ground(share power and responsibility)

Disease and illness experience (patient as a person)

design changes in

processes

systems

environment

1st order iis to just fix and move on

2nd order is to help prevent a future mistake

a collection of 34 companies (brand names)

Pharmaceutical Research and Manufacturers of America

journal ads

detailing (sending out drug reps)

direct mailing

direct to consumer ads

1. help seeking ads (wont mention drug so doesn't have to tell side effects
2. reminder ads (just the name of the drugs and wont need product summary)
3. product specefic ads

major statement of side effects

adequate provision for obtaining more info

this is minimizing the overall transactions typically using a whilesaler

wholesaler goes to each manufacturer so you dont have to

                                                              i.      Cardinal Health

                                                            ii.      Bergen Amerisource

                                                          iii.      McKesson

                                                              i.      Allowing pharmacy to purchase small amounts of a manufacturer’s product

                                                            ii.      Delivery to the pharmacy

                                                          iii.      Accepting and processing returns

                                                          iv.      Extending credit to pharmacies

                                                            v.      Allowing for electronic ordering

                                                          vi.      Handling controlled dangerous substance orders for the pharmacy

                                                        vii.      Allowing pharmacies to obtain discounts based on volume

                                                              i.      17,000 (as of 2008)  Source: NCPA

                                                            ii.      Rx Sales: $43.77 Billion  (as of 2008)  Source: NACDS

                                                          iii.      No. Rx:  732 Million (as of 2008)  Source:  NACDS

  i.      39,000 (as of 2008) Source: NACDS

  ii.      Rx Sales: $154.68 Billion (as of 2008)  Source: NACDS

ii.      No. Rx:  2.57 Billion (as of 2008)  Source: NACDS

1.      41.1%  traditional chain pharmacies (e.g., CVS, Walgreen’s)

2.      9.8%  mass merchandiser stores with pharmacies (e.g. Wal-Mart, Target, Costco)

3.      10.2% supermarkets with pharmacies (e.g. Safeway, Giant)

                                                              i.      Medco Health

                                                            ii.      Express Scripts

                                                          iii.      Caremark