Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Pharmacology > Pharm 6 > Flashcards

Pharm 6 Flashcards

1
Q

which drugs are poison

A

all - they all have the potential to produce harmful and beneficial effects

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

new drugs are gotten from

A

natural sources or synthesized

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

sequence of drug development

A 
discovery/characterization of drug, 
experimental animal studies, 
IND application, 
Clinical studies (phase I, II, III), 
submission of NDA, 
approval of NDA, 
post marketing surveillance (Phase IV)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

types of studies

A

animal studies and clinical trials

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

experimental animal studies (pre-clinical) ascertain

A

beneficial/harmful effects on vital organs,
elucidate the mechanism of action,
determine the pharmacokinetics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Animal toxicity testing

A

tests for teratogenicity, mutagenicity, carcinogenicity:
acute,
subacute,
chronic

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

acute toxicity

A

single does, to calculate TI (LD50/ED50)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

subacute toxicity

A

3 doses, 4weeks to 3 months

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

chronic toxicity

A

6 months

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

investigational new drug application (IND)

A

an application for investigational new drug (IND) must have been approved by the FDA before the drug can be distrubuted for conducting clinical studies in human subjects

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Clinical trials

A

once IND is approved by FDA, testing on humans canbe divided into 3 phases before approval of general marketing of the new drug for the prescription use

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

4th phase of study follws

A

NDA approval - phase 4 is a surveillance/observation of patients taking these drugs and monitor adverse effects

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

volunteers of clinical trials must give

A

written infomrmed concent (from patients or legal guardians of patients)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

clinical trials should be conducted in conformity with

A

helsinki declaration

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Phase I consists of

A

carful evaluation of safety in a small number of healthy volunteers (25-50)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

phase 1 determines

A

whether humans and animals show significantly different responses to the durgs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

phase 1 establishes

A

the probable limits of the safe clinical dosage range

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Phase 1 can be conducted

A

nonblind or open (both investigator and subjects know what drug is administered)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Phase 1 often measures

A

pharmokinetics - absorption, half-life, and metabolism

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Phase 2 involves

A

evaluation of a drug in a moderate number of patients ( approx. 200) with the target disease

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Phase 2 types of studies

A

single or double blind with an inert substance (placebo) or an older active drug (positive control) in addition to the investigational agent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Phase 2 goal

A

to determine the desired therapeutic effect at the doses that are tolerated by the patients

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Phase 3 consists of

A

large design involving many pateins ( approx. 5000)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Phase 3 study incudes

A

placebo or positive controls in double blind corssover design

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

Phase 3 goal

A

compare efficacy and safety with older drugs, explore spectrum of beneficial effets of new drug and to discover toxicity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

NDA (new drug application) approval occurs

A

when phase 3 meets expectation of the FDA to market the new agent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

NDA contains

A

hundred volumes of reports of all preclinical and clinical data pertaining to the durg under review

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

How long does FDA review

A

may take 3yrs or longer,

may be greatly accelerated if there is an urgent need (cancer, chemotherapy, AIDS)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

Phase 4

A

post marketing surveillance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

Phase 4 is done to

A

monitor safetly in pateint population and represents the phase of evaluation in which the toxicities that occur very infrequently are detected and reported to prevent major disaster

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

Phase 4 and FDA

A

phase 4 is not regulated by the FDA

32
Q

Orphan drug

A

when a drug is not developed into a usable medicine form bc the developer will not recover the costs (disease - orphan disease, sufferer - health orphan)

33
Q

orphan drug is for

A

a rare disease affecting fewer than 1/200,000 people

34
Q

free-market economy is liable to leave

A

untreated rare diseases eg. Some cancers (in all countries), some common diseases eg. Parasitic infections (in poor countries)

35
Q

current legislation provides

A

regulatory incentives encouraging the development of orphan drugs,
eg Digibind for digoxin toxicity

36
Q

prescription

A

written order for compunding, dispensing, and administering drugs to a patent and once signed by a physician it becomes a legal document

37
Q

rational prescribing

A

define the patient’s problem (make a specific diagnosis),
consider the pathophysiology of the diagnosis selected,
select a specific therapeutic objective (what do you want to achieve with the treatment),
select a drug of choice (p-drug/P-treatment),
determine the appropriate dosing regimen,
give information instructions and warnings (very importnat and often neglected),
montior the treatment

38
Q

P-drug (P-treatment) (Pre)

A

select a drug of choice on the bases of a comparison of their efficacy, safety, suitability, and cost

39
Q

Essential medicines

A

drugs that satisfy the health care needs of the majority of the population –they should be available at all times in adequate amounts and in appropriate dosage forms at a price the community can afford

40
Q

WHO list of essential medicines

A

contains a core list and a complementary list

41
Q

core list

A

presents a list of minimum medicine needs for a basic health care system, listing the most efficacious, safe and cost-effective medicines for priority conditions
(priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost-effective treatment)

42
Q

complementary list

A

presents essential medicines for priority diseases, for which specialized diagnostic monitoring facilites are needed

43
Q

since 1977 to 2002 the number of complementary list durgs has

A

doubled form 186 to 320

44
Q

Prescription consists of

A

superscription, inscription (body), subscription, signa

45
Q

superscription

A

it consists of heading and where there is symbol Rx (meaning to take Rx comes before the inscription)

46
Q

Inscription

A

the body of the prescription and provides the name and quantities of the chief ingredients of the prescription. Also the does and dosage form included

47
Q

subscription

A

consists of specific instructions to the pharmacists on how to compound the medication expressed in latin or english (but tyr and avoid latin)

48
Q

all prescriptions should contain

A 
prescribers full name adress telepohone number, 
patients full name address age and sex, 
date of issuance, 
drug name dosage form and dose, 
directions for use, 
refil instructions, 
signature of prescriber
49
Q

compliance

A

the extent to which a person’s behavior in terms of taking medications, following diets, or executing lefestyle changes coincides with medical or health advice - compliant when they do what dr recommends, this view considers the patient as a passive actor abiding by instructions and directions pronounced by prescribers

50
Q

what is the contorvery against compliance

A

the term fails to respect the idea of patient autonomy suggesting that doctor knows best and follow the doctor’s orders

51
Q

adherance

A

the term has been regarded as more respectful of the role the patient can play in his or her own treatment suggesting that the doctor is engaged in reasonable negotiations with the patient rather than in the perfunctory issueing of instructions (RPSGB)

52
Q

concordance

A

shared decision making and arriving at an agreement that respects the wishes and beliefs of the patient,
aim is to optimize health gain from the best use of medicines,
compatible with what patient desire and is capable of chieving

53
Q

concordance is intended to convey

A

respect for the health beliefs of both doctor and patient and specifies that medicine taking should be the result of a mutually arrived agreement between aptient and doctor and not the result of the patient’s more or less reluctant compliance with orders issued by the doctor as per tradition

54
Q

Doctor compliance

A

extent to which the behavior of doctors fulfils their professional duty: not to be ignorant,
adopt new advances when they are sufficiently proved,
prescribe accurately,
tell patients what they need to know,
warn

55
Q

FDA recognized 2 types of durgs

A

over the counter durgs,

prescription durgs/legend drugs

56
Q

comprehensive drug abuse prevention and control act

A

also called controlled substances act - CSA classified drugs into five schedules based on their potential for abuse and clinical usage

57
Q

Schedule I drugs

A

high abuse potential and no legitimate medical use,
distribution and possession prohibited,
lack of accepted safety for use of the drug or other substance under medical supervision

58
Q

Schedule I drugs ex

A

Heronin,

lysergic acid diethylamide (LSD)

59
Q

Schedule II drugs

A

high abuse potential but have a legitimate medical use,
distribution is highly controlled through restrictions on prescriptions,
abuse of the drug may lead to severe psychological or physical dependance

60
Q

Schedule II ex

A

morphine and methadone

61
Q

Schedule III durgs

A

less potential for abuse than the drugs or other substances in schedules I and II,
abuse of the drug may lead to moderate or low physical dependence or phsychological dependence

62
Q

Schedule III drugs ex

A

anabolic steroids,
codeine,
buprenorphine

63
Q

Schedule IV drugs

A

low potential for abuse,

abuse may lead to limited physical dependence or psychological dependence

64
Q

Schedule IV drugs

A

propoxyphene,
pentazocine,
diazepam,
alprazolam

65
Q

Schedule V durgs

A

low potential for abuse relative to the drugs or other substances in Schedule IV,
abuse of the drug or other substances may lead to limited physical dependence or psychological dependence

66
Q

Schedule V ex

A

diphenoxylate,

Pregabalin

67
Q

schedule II can’t be

A

refilled,

prescscription may not be transmitted on phone

68
Q

III-V can be refilled but

A

for max 5 times and no case after 6 months from the date of prescription

69
Q

Teratogenic drug classes

A

A B C D X

70
Q

A

A

Preg animals:No teratogenocity
Preg Humans:No teratogenocity
Ex: Folic acid

71
Q

B

A

Preg animals: May be teratogenic
Preg Humans: No teratogenocity
Ex:Zidovudine

72
Q

C

A

Preg animals: May be teratogenic
Preg Humans:No studies
Ex: Asprin

73
Q

D

A

Preg animals: Teratogenic
Preg Humans: May be Teratogenic
Ex: Phenytoin, Benefit outweigh risk

74
Q

X

A

Preg animals:Teratogenic
Preg Humans: Teratogenic
Ex: Thalidomide, PG , Risk outweigh Benefit

75
Q

Pharmacoepidemiology

A

study of the use of effects of drugs in large number of people proficing further insight into the efficacy, and especially the safety of new drugs once they have passed from limited exposure in controlled therapeutic pre-registration trials to the looser conditions of their use in the community

76
Q

Pharmacoeconomics

A

identifies measures and compares the costs and consequences of durg therapy to healthcare systems and society.

77
Q

healthcare costs can be categorized as

A

direct medical,
direct nonmedical,
indirect nonmedical,
opportunity

Pharmacology (15 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions