TEXTBOOK Chapter 5 -- Drug use, access, pharmaceutical industry

Question 1

give the definition of drugs

Answer 1

substances that produce a change in cellular or physiological functioning of humans

Question 2

manufacturers focus on a drug’s ______ with what 3 goals?

Answer 2

manufacturers focus on a drug’s THERAPEUTIC EFFECT with the goals of:

-optimizing biochemical activity
-increasing specificity
-limiting negative effects

Question 3

true or false

non-prescription drugs do not have restrictions

Answer 3

false – some do

Question 4

what is the “approved use” of a medication

Answer 4

an indication for a medication officially recognized by the FDA for marketing

Question 5

what is an “unapproved use” of a medication

Answer 5

an indication for a medication WITHOUT FDA permission for marketing

Question 6

what is the definition of medicalization

Answer 6

redefining or relabeling a personal or social problem as a medical condition, thus needing treatment in the HC system
(ie: depression, eating disorders, anxiety, ADD/ADHD)

–conditions with physical pathologies that also have complex mental, emotional, and social processes

Question 7

true or false

consumer beliefs are often very different from the beliefs held by healthcare professionals

Answer 7

true

Question 8

to a consumer, what 2 things may suggest whether or not a health problem exists?

Answer 8

their own perception of current or potential symptoms, and their social knowledge of health

Question 9

what are the 2 possible actions of a consumer when they perceive a health problem

Answer 9

-do nothing
-take action (self care, seek help from physician)

Question 10

_____ are the source of most drug products for consumers

Answer 10

pharmacies

Question 11

breakdown the consumer purchasing of non prescription (OTC) drugs in 2008

Answer 11

35% from pharmacies
29% from mass merchandisers
21% from food stores
15% other

Question 12

name 2 reasons that consumers often use for choosing a particular pharmacy

Answer 12

1. convenience
2. price

Question 13

_______ is a mainstay (chief part) of prescribed treatments by physicians

Answer 13

drug therapy

Question 14

whether right or wrong, prescribing has a ritualistic component between ___ and ____.

explain

Answer 14

between physicians and patients

a symbolic component of healing in the patient’s eyes. provides a sense of satisfaction to the patient. reduces uncertainty and frustration of the disease by reinforcing the physicians power to cure.
fulfills an ingrained need to take ACTION against illness

Question 15

name 5 factors influencing prescriber behavior

Answer 15

1. education (pharmotherapy training, prescribing habits)
2. colleagues or other HC providers
3. control and regulatory mechanisms (drug laws, formularies)
4. demands by consumers and society
5. promotional activities by drug manufacturers

Question 16

as ____ and ___ pressures have mounted, pharmacists have had less time to perform ___________ other than ______

Answer 16

as VOLUME and REGULATORY PRESSURES have mounted, pharmacists have had less time to perform PATIENT CENTERED SERVICES other than DISPENSING

Question 17

In response to pharmacist dissatisfaction for lack of time to perform patient-centered services, what has changed?

Answer 17

• increase in the role of pharmacy techs (certified too)

-robotics to fill prescriptions

-increased clinical activities – pt counseling and computerized monitoring of therapies

Question 18

regulation of PHARMACY PRACTICE and PROFESSIONALS is mainly at the ____ level, but regulation of DRUG PRODUCTS and MEDICAL DEVICES occurs at the ___ level

Answer 18

state - pharmacy practice and professionals
federal (FDA) - drug products and medical devices

Question 19

___ main acts are used by the FDA to control pharmaceuticals:

Answer 19

2:

-FDCA (food, drug, and cosmetic act)
-public service health act

FDCA – small molecules and hormones

public service health act – biologics

Question 20

name 6 functions of the FDA

Answer 20

-premarketing clearance of all new products based on PURITY, SAFETY, AND EFFICACY

-regulation of LABELING and ADVERTISING

-regulation of good manufacturing practices and RECALLS, if necessary

-regulation of bioequivalence standards

-postmarketing surveillance for unanticipated problems after approval

-monitoring of the blood supply

Question 21

true or false

once a drug is approved for the market, the FDA has a lot of power to determine how it is ultimately used

Answer 21

FALSE — FDA has few powers.

–off label uses

Question 22

non-FDA approved indications are also called….

Answer 22

off label

Question 23

explain what off label indications are

Answer 23

uses of a product that were NOT approved by the FDA, but have shown value after approval based on postmarketing research

Question 24

can non-FDA approved indications be promoted by the manufacturer?

Answer 24

NO

Question 25

name 4 stages of the drug development process

Answer 25

1. preclinical research
2. preclinical testing
3. clinical testing
4. NDA submitted for approval

Question 26

in which phase of drug development is animal testing conducted?

Answer 26

pre clinical testing

Question 27

in which phase of drug development is bench research done, and potentially useful compounds are identified?

Answer 27

preclinical research

Question 28

how many phases of clinical testing are there

Answer 28

4 (3 pre market)

Question 29

explain phase 1 of clinical testing.
include length and number of pts

Answer 29

phase 1 – determines safe dosage range, preferred route of administration, mechanisms of ADME, possible toxicities

length: ~1 year
patients: <100 HEALTHY volunteers

Question 30

explain phase 2 of clinical testing.
include number of pts and length

Answer 30

phase 2 — SAFETY and EFFICACY in treating a DISEASE or symptom

length — ~2 years
patients: volunteers with that disease or symptom. <300

Question 31

explain phase 3 of clinical testing.
include length and # of pts

Answer 31

determines safety, efficacy, and dosage range under market conditions
length: ~3 years
patients: WITH THAT DISEASE OR SYMPTOM. <3000

Question 32

what happens after the 3 phases of clinical trials?

Answer 32

sponsor submits an NDA (new drug application)

FDA has 60 days to review or refuse for completeness

Question 33

if approved to review, what part of the FDA reviews the drug? how long does it take?

Answer 33

CDER — centers for drug evaluation and research

takes 10 months for routine reviews and 6 months for priority

Question 34

true or false

the CDER (sector of FDA) inspects the manufacturing facility of the drug which an NDA was submitted for

Answer 34

true

Question 35

if an NDA is approved for the market, what happens next?

Answer 35

the manufacturer continues to submit postmarketing info (phase 4) – including trials on subgroups

Question 36

when are supplemental NDAs submitted?

Answer 36

if there’s a new indication, labeling change, or new manufacture procedure

Question 37

SUGGESTED drug pricing is determined by…..

Answer 37

the manufacturer.
usually a much lower price than what is actually paid out of pocket by most consumers (based on insurance)

Question 38

the price of a drug is ultimately determined by….

Answer 38

costs and profits of supply chain + any discounts and economic factors

-manufacturer’s cost and profit (research and development incentivized)
-wholesaler’s cost and profit
-retailer’s cost and profit
-discounts
-supply and demand

Question 39

when did the FDA allow DTC advertising for drugs?
what were the requirements?

Answer 39

1997
FDA allowed DTC provided that they give “adequate provision” of info requiring fairly balancing the risks and benefits of the medication

Question 40

true or false

research regarding DTC for drugs shows negative results

Answer 40

false – mixed results

Question 41

the Berndt Study of 2005 showed what about the attitude of physicians towards DTC drug commercials?

Answer 41

mixed
40% positive
30% negative
30% no effect

Question 42

list the pros and cons of DTC drug advertising

Answer 42

pros — educate consumers about conditions and symptoms, enhanced communication between physicians and patients

cons – increased promo expenses increase the price of the drug, increased demand also increases price and consumer expenditure

Question 43

what countries permit DTC drug advertising?

Answer 43

US and new zealand

Question 44

what are some reimportation concerns regarding drugs?

Answer 44

safety and efficacy, fraud, counterfeiting, patient infringement

Question 45

true or false

the FDA requires inspection of supply chain for approval for the legal importation of drugs, REGARDLESS of the country of origin

Answer 45

true

Question 46

true or false

the FDA does not ban parallel trading for drugs from unapproved sources

Answer 46

FALSE - the FDA does ban it.

parallel trading means buying drugs in other countries because they are cheaper there, and then reselling them in the US

Question 47

what is the exception to the “parallel trading” rule?

Answer 47

personal importation of a 3 month supply is allowed, only if:

-the person can show a valid prescription from an authorized US healthcare provider

-the intended use of the drug is unapproved and for a serious condition where effective treatment is not available

-the product does not represent an unreasonable risk

Question 48

counterfeits account for ___% of the global drug market in the developing world

Answer 48

30%

Question 49

name 3 consumer risks of counterfeit drugs

Answer 49

1. pt receives no benefit when there is no active ingredient
2. adverse events, including death, from drugs with harmful or toxic chemicals
3. delays the access to actual effective treatment

Question 50

approximately _______% of clinical trials occur outside of the United States

Answer 50

40-60%

Question 51

name 3 concerns with the rise of foreign clinical trials

Answer 51

1. FDA is not equipped to inspect a large number of foreign trials
2. difficulty in attributing differences in patient outcomes among the various sites
3. different sites can have different standards, limiting ability to interpret the data

Question 52

what are IPRs?

Answer 52

intellectual property rights.
laws and regulations to protect the ideas and products of innovators

Question 53

the IPRS for small-molecule drugs are regulated by what?

Answer 53

the Hatch-Waxman act

gives patent protection.
copies of the drug are considered generics

Question 54

what regulates the IPRs for biologics?

Answer 54

regulated by the patent protection and affordable care act.

-data exclusivity
-copies are considered biosimilars