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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.

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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

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3
Q

What is phase 2 clinical development

A

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

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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

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5
Q

What happens after phase 3 clinical development

A

approval and launch - licencing process

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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.

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7
Q

is cost taken into account when licencing decisions are made

A

no

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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

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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)

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10
Q

how long is a standard patent

A

20 years

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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

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12
Q

What is ABPI

A

Association of British Pharmaceutical Industry

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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

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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

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15
Q

benzodiazepine antagonist

A

flumezenil

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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

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17
Q

NICE definition of adherence

A

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

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18
Q

NICE definition of concordance

A

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

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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

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20
Q

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

A

phenytoin

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21
Q

what is considered to be the steady state concentration in general

A

5 half lives unless loading dose used

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22
Q

drugs with a narrow TI

A

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

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23
Q

why is free phenytoin sometimes useful

A

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

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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

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25
Q

e.g. of an augmented ADR

A

nitrates causing headaches

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26
Q

e.g. of a bizarre ADR

A

penicillin anaphylaxis, halothane hepatitis, agranulocytosis with chloramphenicol (BM failure)

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27
Q

e.g. of a chronic ADR

A

osteoporosis with steroids, tardive dyskinesia with antipsychotics

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28
Q

e.g. of a delayed ADR

A

drug induced cancers, drug induced foetal anomalies

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29
Q

e.g. of end-of-tx ADR

A

adrenocortical insufficiency after steroid tx, drug withdrawal seizures

30
Q

drugs causing galactorrhoea and gynaecomastia as an ADR?

A

spironolactone can cause gynaecomastia, as can: oestrogens, methyldopa, digoxin
antipsychotics can cause galactorrhoea, as can: metoclopramide, oestrogens, methyldopa

31
Q

what are skin target lesions associated with

A

erythema multiforme, lymes disease, steven Johnson syndrome

32
Q

e.g. of drugs that have syngergistic effects when taken together

A

alcohol and benzos (at GABA - sedative). rifampicin and isoniazid against TB can give lower doses if give together

33
Q

Are acidic drugs better or worse absorbed in the stomach

A

better - as no ionisation occurs

34
Q

why shouldn’t you take antacids with some drugs

A

if you take with acidic drugs will reduce the absorption of

35
Q

effect of alcohol on acid drug

A

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
Q

high protein binding drugs

A

phenytoin, warfarin, statins, NSAIDs, heparin, diazepam

37
Q

consequence of drug displacement from plasma binding protein?

A

increase in free drug concentration

38
Q

what happens if you administer a drug which is a cytochrome CYP 450 inducer

A

may interact with other drugs causing a reduced effect of these drugs - as inducers accelerate metabolism

39
Q

time difference between enzyme induction and inhibition

A

induction takes days/weeks - liver grows larger and drug metabolising enzymes increase. inhibition has immediate onset

40
Q

e.g. drugs that are hepatic enzyme inducers

A

alcohol (CHRONIC), st john’s wort, rifampicin, phenytoin, carbamazepine

41
Q

e.g. drugs that are hepatic enzyme inhibitors

A

Erythromycin/clarithromycin, SSRIs, omeprazole, grapefruit juice, amiodarone, alcohol (ACUTE)

42
Q

possible adverse consequence of grapefruit juice and statins

A

rhabdomyolysis and kidney failure

43
Q

why are the progesterone only pill and COCP interactions with ABx different?

A

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
Q

probenecid interactions

A

inhibits active tubular secretion of acidic drugs. increases conc and effect of penicillin. increases conc and toxicity of methotrexate

45
Q

lithium and dehydration effect? and effect of thiazides

A

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
Q

methotrexate and trimethoprim interaction

A

folate deficiency, bone marrow suppression (must give folic acid replacement)

47
Q

ESSENTIAL DRUG INTERACTION:

warfarin and erythromycin or metronidazole

A

increased warfarin effect, select alternative ABx

48
Q

ESSENTIAL DRUG INTERACTION:

warfarin and aspirin/NSAID

A

increased bleeding risk, PPI cover

49
Q

ESSENTIAL DRUG INTERACTION:

carbamazepine and erythromycin/clarithromycin

A

increased CBZ effect, so monitor levels

50
Q

ESSENTIAL DRUG INTERACTION:

lithium and NSAID/diuretic

A

increased lithium levels, so decrease dose by 50%

51
Q

OCP and ABx

A

effect - pregnancy, use alternative contraception

52
Q

OCP and rifampicin/carbamazepine

A

pregnancy, use a higher oestrogen containing pill

53
Q

SSRIs and st john’s wort/MAOI/triptans

A

serotonin syndrome hypertensive crisis. avoid or monitor for signs of

54
Q

At what stage of drug development are ADR and drug interactions usually detected?

A

Phase 4

55
Q

what are phase 4 studies

A

post marketing studies

56
Q

what is the yellow card scheme

A

Means by which suspicions that an ADR has occurred may be collated
Voluntary - relies on co-operation of healthcare professionals

57
Q

three categories medicinal substances placed in

A

POMs (prescription only medicines), pharmacy medicines, general sales list (GSL)

58
Q

E.g. of class A drugs

A

diamorphine, morphine, LSD, mescaline, ecstacy

59
Q

e.g. class B drugs

A

cannabis, amphetamines, barbituates

60
Q

e.g. class C drugs

A

benzodiazepines

61
Q

schedule 1 vs schedule 2 vs schedule 3

A

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
Q

how are controlled drugs prescribed

A

extra things included - dosage form, quantity in words and figures, signed and dated

63
Q

definition of tolerence

A

a higher dose of the drug is needed to achieve the same level of response achieved initially

64
Q

describe physical dependence

A

develops when neurons adapt to repeated drug exposure and only function normally in the presence of the drug. Withdrawal precipitates unpleasant physiological effects

65
Q

5 classes of depressant drugs and e.g.s

A

Opioids (heroin, methadone, morphine), benzos (diazepam, temazepam), benzo-like (zopiclone), barbiturates, GHB

66
Q

clinical adverse effects of depressants

A

hypothermia, hypotension, sedation, ataxia, resp failure

67
Q

benzodiazepine antidote

A

flumazenil

68
Q

name some stimulants

A

cocaine, amphetamines, 2C-B,

69
Q

name some hallucinogens

A

cannabinoids, LSD, ketamine, tryptamines

70
Q

clinical effects of hallucinogens

A

hyperthermia, hypertension, nausea. behaviour not clinical effects that cause deaths

71
Q

features of serotonin syndrome

A

agitation, coma, hyperreflexia, myoclonus, autonomic dysfunction - tachycardia, fever, flushing, vomiting, seizures, rhabdomyolysis. life threatening unless get temperature down, aggressive cooling measures

72
Q

risks of long term noz

A

neurological effects - B12 inactivation, demyelination

CPTP 4.1-4.4 (1 decks)

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