from drug discovery to patient #3

Question 0

medication therapy accounts for more than ____ % of the reduction on heart attack mortality

Answer 0

50

Question 1

since 1960, age adjusted death rate for diseases of the heart dropped ____ %

Answer 1

54

Question 2

food and drug administration - center for drug evaluation and research (CDER) role (6)

Answer 2

1. evaluation and approval of new medications- drug advisory committees
2. monitors the use of marketed medications (RX and OTC)- appropriate labeling, unexpected health risks
3. monitors manufacturers for quality
4. monitors MedWatch program
5. monitors advertising of prescription medications (not OTC)
6. DTC advertising

Question 3

food and drug administration monitors the MedWatch program which:

Answer 3

• enables HCP and consumers to report ADR
• AERS (adverse event reporting system)
• NME pilot program for adverse events
• FDA administration amendments act of 2007
• Risk evaluation and mitigation strategies REMS

Question 4

FDA administration amendments act of 2007 (FDAAA)

Answer 4

18 months or 10,000 patients requires summary of ADRs

Question 5

implementation system

medication guide, communication plan, elements of safe use

Answer 5

risk evaluation and mitigation strategies REMS

Question 6

_______ billion spent in pharmaceutical research and development in 2011

Answer 6

67.4

Question 7

industry employed _______ in 2011

Answer 7

810,000

Question 8

indirect jobs totaled ____ million people employed

Answer 8

3.4

Question 9

in florida- _____ jobs in 2011

Answer 9

84,000

Question 10

approximately _____ pharmacists employed in the industry

Answer 10

10,000

Question 11

four stages of drug development

Answer 11

discovery
exploratory development
full development
registration and approval

Question 12

new development of drug: discovery period

Answer 12

2-4 years

Question 13

preclinical testing time frame

Answer 13

3-6 years

Question 14

phase one of new product development: clinical pharmacology

Answer 14

healthy volunteers/preliminary safety 20-100
single to multiple dose tolerance studies to determine max tolerated dose
pharmacokinetics

Question 15

phase that focuses on efficacy and safety

Answer 15

phase III

Question 16

large scale phase
obtain both efficacy and safety
comparative studies with placebo and standard therapies
8 years 
25-30%

Answer 16

phase III

Question 17

FDA investigational review occurs in which phase

Answer 17

III

Question 18

5000-10,000 screened
250 enter pre-clinical testing
___ enter clinical testing
___ approved by the FDA

Answer 18

5

1

Question 19

during stage one - discovery, some compound criteria are:

Answer 19

selectivity
stability
potency
safety

Question 20

stage one discovery- compound synthesis and screening process

Answer 20

molecular development
drug design - 3D computer model
high throughput screening- screen for activity on target cell site against know receptors/enzymes

Question 21

stage one- preclinical testing

Answer 21

chemistry test - establish purity, stability, shelf life
assess safety before human testing
3-6 years
IND application filed
if approved clinical trials begin

Question 22

stage 2: phase I studies

Answer 22

pharmacodynamic studies
1/3 compound fail due to poor tolerance and absorption
70% successful test

Question 23

preliminary data on effectiveness
100-500 patients
determine short term side effects and safety
determine optimal dose strength schedule
33% success

Answer 23

phase II

Question 24

who reviews: protocols safety of research subjects conduct continuous review

Answer 24

FDA investigational review board IRB

Question 25

who can stop a trial based on clear superiority or inferiority of the test drug and conducts periodic reviews of accumulated data

Answer 25

data and safety monitoring board

Question 26

stage 4 - registration phase

Answer 26

6-18 months approval not guaranteed 80-90% with successful phase III trials are approved

Question 27

``` in this phase: studies performed after the drug is approved determine incident of adverse reactions determine long term effects study a different patient population ```

Answer 27

post marketing studies- phase 4

Question 28

patent life is ____ years

Answer 28

20

Question 29

______ drugs must demonstrate bioequivalence code "A" | in new drug application, not required to include safety and effectiveness

Answer 29

generic drugs

Question 30

this act offers financial incentives for developing a drug for a rare disease (<200,000 patients)

Answer 30

orphan drug act 1983

Question 31

actual incentives offered by orphan drug act 1983

Answer 31

tax credit 50%- clinical research expense | 7 year period of exclusive marketing

Question 32

between 1997-2010 FDA has approved ____ drugs for rare disease

Answer 32

202

Question 33

Asheville, NC created a program granting _____ free access to prescription drugs and other services if they enrolled in a care management program

Answer 33

diabetics

Question 34

____ out of ____ patients leave with at least one prescription ____ of all american adults take 5 or more medications

Answer 34

4 5 1/3

Question 35

medicare beneficiaries with multiple illnesses: see on average ___ different physicians have ___ different prescriptions filled each year account for ___% of all hospital admissions account for ___% of physician visits are ___ times more likely to have a preventable hospitalization than someone without a chronic condition accounts for ___ % of all prescription

Answer 35

``` 13 50 76 72 100 88 ```

Question 36

________ are the most common medical intervention, and their potential for both help and harm is enormous. ~ everett Koop

Answer 36

pharmaceuticals

Question 37

pfizer provides over ____ patient assistance program more than _____ medications available ____ million have been helped in the past 7 years

Answer 37

475 | 2500

Question 38

career pathways for pharmacists in the industry

Answer 38

``` research and development manufacturing regulatory affairs public-relations training and development sales and marketing service and consulting drug information /medical information ```

Question 39

levels of research and development

Answer 39

applied basic science pharmaceutical formulation clinical research

Question 40

educational need for research and development

Answer 40

Ph. D. preferred | BS, pharm d positions available

Question 41

``` during _____ & ______: clinical investigation of a drug preparation for submission to the FDA phase I-III working with physicians to design, implement and manage clinical studies ```

Answer 41

research and development

Question 42

recommendations for students interested in research and development:

Answer 42

summer internships in pharmaceutical Research/development | work study under professor guidance

Question 43

the following are factors of _______ ______: product development production and quality control regulatory affairs - assuring compliance with FDA increasing technology means increasing opportunities for RPhs

Answer 43

pharmaceutical manufacturing

Question 44

________ _________ have the following function/role: - work with US FDA on regulation of drug development/promotion - coordinate all communication with the FDA - compilation of the FDA submissions - oversight of the production of promotional materials - primary liaisons with FDA throughout product's life span

Answer 44

regulatory affairs

Question 45

``` ________-_______ interacts with: trade representative gov't policy makers trade association professional groups state medicaid board ```

Answer 45

public-relations

Question 46

this position requires the following: provide medical records directly to physicians, pharmacists, and other health professionals require communication and interpersonal skills provide value added service

Answer 46

pharmaceutical sales

Question 47

function/role of professional healthcare representatives PHR

Answer 47

primary care

Question 48

role of therapeutic specialty representatives

Answer 48

specialist

Question 49

account managers and employer account managers are in _______ _______

Answer 49

managed care

Question 50

pharmaceutical marketing function/role

Answer 50

develop internal/external educational and promotional product materials conduct market research involve in product management, promotion, pricing work closely with regulatory affairs department

Question 51

drug/medical information role

Answer 51

``` request clinical trial info non label info patient inquiries communication and computer skills research analysis, clinical literature review ```

Question 52

what is a medical outcome specialist clients?

Answer 52

work with individual clients (medical directors, pharmacy directors, clinical pharmacist, outcomes department, ...) conduct disease therapy evaluations perform pharmacoeconomic analysis using software etc