Brainscape's Knowledge GenomeTM


Top Flashcards (Certified)
All Flashcards

CPTP 4.1-4.4 > CPTP 4.1-4.4 > Flashcards

CPTP 4.1-4.4 Flashcards

1
Q

What is required before a drug can be tested for the first time in man studies

A

In preclinical development phase. pharmaceutical and analytical studies. Safety pharmacology, toxicology studies in at least 2 preclinical species. drug metabolism and distribution.

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

What is phase 1 clinical development

A

First use in humans - healthy volunteers (or patient volunteers in high risk drugs). Confirm pharmacokinetics established from animal studies. find dose limiting toxicity level.
effects of single/multiple dosing. effects of food. potential drug interactions

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

What is phase 2 clinical development

A

wider use in patient groups. establish potential therapeutic value, determine effective dose range, adverse effects

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

What is phase 3 clinical development

A

Large scale trials in patient groups, often international. compare with placebo and other tx already established. establish clinical benefit. common adverse effects at therapeutic doses

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

What happens after phase 3 clinical development

A

approval and launch - licencing process

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

criteria used to make licencing decisions

A

quality (contains active ingredients at stated dose, bioavailability acceptable), efficacy (positive effect in affected patients, beneficial), safety (relative absence of harm, no such thing as absolute safety). cost is not taken into account.

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

is cost taken into account when licencing decisions are made

A

no

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

For which medicines is a central procedure (e.g. considered by European Medicines Agency) compulsory?

A

HIV, cancer, diabetes, neurodegenerative disease, AI, viral disease tx
tx derived from biotech processes (genetic engineering)
gene therapy etc

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

what does licencing mean for the doctor

A

they are protected from litigation if the medicine is used in accordance with SPC (summary of product characteristics - part of product licence)

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

how long is a standard patent

A

20 years

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

market lifespan of drugs

A

5-15 years as takes 10-15y to develop drug and patent only lasts 20 years before generics can be marketed

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

What is ABPI

A

Association of British Pharmaceutical Industry

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

What is an ADR

A

Any response to a drug which is noxious, unintended and occurs at doses used for prophylaxis, diagnosis or therapy

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

What is a medication error

A

any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of health professional, patient or consumer

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

benzodiazepine antagonist

A

flumezenil

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

NICE definition of compliance

A

the extent to which patient’s behaviour matches the prescribers recommendation. term being used less as implies lack of patient involvement

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

NICE definition of adherence

A

the extent to which the patient’s action or behaviour matches the agreed recommendations from the prescriber

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

NICE definition of concordance

A

relationship between the patient and the prescriber and the degree to which they agree about the treatment

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

E.g.s of drugs where monitoring plasma drug conc is appropriate as there is a good relation between plasma conc and pharmacological or toxic effect

A

lithium, carbamazepine

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

e.g. of a drug where dose and plasma conc relation is unpredictable

A

phenytoin

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

what is considered to be the steady state concentration in general

A

5 half lives unless loading dose used

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

drugs with a narrow TI

A

digoxin, lithium, methotrexate, carbamazepine, ciclosporin, phenytoin, sulphonylureas, theophylline, warfarin

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

why is free phenytoin sometimes useful

A

it is highly albumin bound, and can be displaced by other drugs

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

ABCDE classification of ADRs - explanation of each

A

Augmented - predictable, dose-related
Bizarre - not dose-related, not predictable
Chronic - variable, occur with prolonged duration tx but not with short-duration
Delayed - variable, occur some time after discontinuation of tx
End of tx - effects occur on withdrawal

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
e.g. of an augmented ADR
nitrates causing headaches
26
e.g. of a bizarre ADR
penicillin anaphylaxis, halothane hepatitis, agranulocytosis with chloramphenicol (BM failure)
27
e.g. of a chronic ADR
osteoporosis with steroids, tardive dyskinesia with antipsychotics
28
e.g. of a delayed ADR
drug induced cancers, drug induced foetal anomalies
29
e.g. of end-of-tx ADR
adrenocortical insufficiency after steroid tx, drug withdrawal seizures
30
drugs causing galactorrhoea and gynaecomastia as an ADR?
spironolactone can cause gynaecomastia, as can: oestrogens, methyldopa, digoxin antipsychotics can cause galactorrhoea, as can: metoclopramide, oestrogens, methyldopa
31
what are skin target lesions associated with
erythema multiforme, lymes disease, steven Johnson syndrome
32
e.g. of drugs that have syngergistic effects when taken together
alcohol and benzos (at GABA - sedative). rifampicin and isoniazid against TB can give lower doses if give together
33
Are acidic drugs better or worse absorbed in the stomach
better - as no ionisation occurs
34
why shouldn't you take antacids with some drugs
if you take with acidic drugs will reduce the absorption of
35
effect of alcohol on acid drug
increase speed of absorption. alcohol causes more acidic contents in stomach, less ionisation, faster absorption. taking a basic drug with alcohol also contraindicated as will slow down absorption
36
high protein binding drugs
phenytoin, warfarin, statins, NSAIDs, heparin, diazepam
37
consequence of drug displacement from plasma binding protein?
increase in free drug concentration
38
what happens if you administer a drug which is a cytochrome CYP 450 inducer
may interact with other drugs causing a reduced effect of these drugs - as inducers accelerate metabolism
39
time difference between enzyme induction and inhibition
induction takes days/weeks - liver grows larger and drug metabolising enzymes increase. inhibition has immediate onset
40
e.g. drugs that are hepatic enzyme inducers
alcohol (CHRONIC), st john's wort, rifampicin, phenytoin, carbamazepine
41
e.g. drugs that are hepatic enzyme inhibitors
Erythromycin/clarithromycin, SSRIs, omeprazole, grapefruit juice, amiodarone, alcohol (ACUTE)
42
possible adverse consequence of grapefruit juice and statins
rhabdomyolysis and kidney failure
43
why are the progesterone only pill and COCP interactions with ABx different?
POP - no interaction as undergoes total phase I inactivation. OCP - proportion undergoes phase II conjugation without phase I and relies on enterohepatic circulation regenerating active oestrogen. (accounted for in dose). when abx administered they disrupt gut flora and can cause a break in enterohepatic circulation (loss of effect - conjugates not reabsorbed).
44
probenecid interactions
inhibits active tubular secretion of acidic drugs. increases conc and effect of penicillin. increases conc and toxicity of methotrexate
45
lithium and dehydration effect? and effect of thiazides
When patients on lithium become dehydrated their kidneys will retain sodium and also lithium (as both closely related). thiazides cause initial sodium loss, therefore get compensatory sodium retention in proximal tubules, lithium also retain (PTs cannot distinguish well between lithium and sodium)
46
methotrexate and trimethoprim interaction
folate deficiency, bone marrow suppression (must give folic acid replacement)
47
ESSENTIAL DRUG INTERACTION: | warfarin and erythromycin or metronidazole
increased warfarin effect, select alternative ABx
48
ESSENTIAL DRUG INTERACTION: | warfarin and aspirin/NSAID
increased bleeding risk, PPI cover
49
ESSENTIAL DRUG INTERACTION: | carbamazepine and erythromycin/clarithromycin
increased CBZ effect, so monitor levels
50
ESSENTIAL DRUG INTERACTION: | lithium and NSAID/diuretic
increased lithium levels, so decrease dose by 50%
51
OCP and ABx
effect - pregnancy, use alternative contraception
52
OCP and rifampicin/carbamazepine
pregnancy, use a higher oestrogen containing pill
53
SSRIs and st john's wort/MAOI/triptans
serotonin syndrome hypertensive crisis. avoid or monitor for signs of
54
At what stage of drug development are ADR and drug interactions usually detected?
Phase 4
55
what are phase 4 studies
post marketing studies
56
what is the yellow card scheme
Means by which suspicions that an ADR has occurred may be collated Voluntary - relies on co-operation of healthcare professionals
57
three categories medicinal substances placed in
POMs (prescription only medicines), pharmacy medicines, general sales list (GSL)
58
E.g. of class A drugs
diamorphine, morphine, LSD, mescaline, ecstacy
59
e.g. class B drugs
cannabis, amphetamines, barbituates
60
e.g. class C drugs
benzodiazepines
61
schedule 1 vs schedule 2 vs schedule 3
1 - LSD, cannabis. not for use without home secretarys permission. no recognised medical use. 2 - diamorphine, morphine, ketamine - controlled drug prescriptions, special arrangements for storage. medicinal use, subject to special prescription 3 - subject to special prescription, barbiturates, temazepam, tramadol
62
how are controlled drugs prescribed
extra things included - dosage form, quantity in words and figures, signed and dated
63
definition of tolerence
a higher dose of the drug is needed to achieve the same level of response achieved initially
64
describe physical dependence
develops when neurons adapt to repeated drug exposure and only function normally in the presence of the drug. Withdrawal precipitates unpleasant physiological effects
65
5 classes of depressant drugs and e.g.s
Opioids (heroin, methadone, morphine), benzos (diazepam, temazepam), benzo-like (zopiclone), barbiturates, GHB
66
clinical adverse effects of depressants
hypothermia, hypotension, sedation, ataxia, resp failure
67
benzodiazepine antidote
flumazenil
68
name some stimulants
cocaine, amphetamines, 2C-B,
69
name some hallucinogens
cannabinoids, LSD, ketamine, tryptamines
70
clinical effects of hallucinogens
hyperthermia, hypertension, nausea. behaviour not clinical effects that cause deaths
71
features of serotonin syndrome
agitation, coma, hyperreflexia, myoclonus, autonomic dysfunction - tachycardia, fever, flushing, vomiting, seizures, rhabdomyolysis. life threatening unless get temperature down, aggressive cooling measures
72
risks of long term noz
neurological effects - B12 inactivation, demyelination

CPTP 4.1-4.4 (1 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions