Adverse drug reactions Flashcards by Emily Newland

Definition of an ADR

?dose, given for what?

Toxic, unintended response of body to drug when given at a normal dose for treatment/prophylaxis

How well did you know this?

Not at all

Perfectly

4 features of ADRs

always … and …, detrimental to … cause complications to …

Always harmful
Always impact pts recovery/wellbeing
Detrimental to patients trust in prescriber and drug
Cause complications to care/finances

How well did you know this?

Not at all

Perfectly

ADRs can be useful true or false?

True

How well did you know this?

Not at all

Perfectly

Is an overdose an ADR?

How well did you know this?

Not at all

Perfectly

Definition of an adverse drug event

Group term for the errors made when prescribing or dispensing a drug

How well did you know this?

Not at all

Perfectly

What are the 3 types of ADR classification?

ABCDE
Severity
Incidence

How well did you know this?

Not at all

Perfectly

What does the ABCDE of ADR classification stand for?

Augmented 
Bizzare 
Chronic 
Delayed 
End of dose

How well did you know this?

Not at all

Perfectly

Definition of a augmented ADR?

Excessive reaction to a drug

How well did you know this?

Not at all

Perfectly

What are 3 features of an augmented ADR?

Frequency, ?morbidity ?mortality, related to …, can they be predicted?

Common- high morbidity, low mortality
Dose related
Predictable yes

How well did you know this?

Not at all

Perfectly

Definition of a bizzare ADR?

unpredictable reaction to a drug

How well did you know this?

Not at all

Perfectly

What are 3 features of a bizzare ADR?

severity, are they dose related, effect which group why

Serious
Not related to dose
Likely to effect minority groups as they are not included in clinical trials

How well did you know this?

Not at all

Perfectly

Definition of chronic ADR

Induced over a long time, body adapting to drug

How well did you know this?

Not at all

Perfectly

Definition of a delayed ADR

Develops after a period of time having had the drug

How well did you know this?

Not at all

Perfectly

Definition of end of dose ADR

Withdrawl reaction when drug is stopped

How well did you know this?

Not at all

Perfectly

Where can the incidence of ADRs for a drug be found?

Under summary of produce characteristics

How well did you know this?

Not at all

Perfectly

What unit are incidence ADRs given in and what for patients are they better being given as?

Better given as frequency

How well did you know this?

Not at all

Perfectly

5 classifications of incidence ADRs

Very common 
Common 
Uncommon 
Rare 
Very rare

How well did you know this?

Not at all

Perfectly

What is the % and frequency (fraction) of a very common ADR?

> 10%

>1/10

How well did you know this?

Not at all

Perfectly

What is the range of % and frequency (fractions) of a common ADR?

1-10%

1/100 - 1/10

How well did you know this?

Not at all

Perfectly

What is the range of % and frequency (fractions) of a uncommon ADR?

01-1%

1/1000 - 1/100

How well did you know this?

Not at all

Perfectly

What is the range of % and frequency (fractions) of a rare ADR?

0.01-0.1%

1/10000 - 1/1000

How well did you know this?

Not at all

Perfectly

What is the % and frequency (fraction) of a very rare ADR?

<0.01

1/10000

How well did you know this?

Not at all

Perfectly

4 categories of ADR severity

Mild
Moderate
Severe
Life threatening

How well did you know this?

Not at all

Perfectly

Definition of a mild ADR

May not be noticed by pt

How well did you know this?

Not at all

Perfectly

Definition of a moderate ADR

Requires correcting but doesnt require admission to hospital

Definition of a severe ADR

Damage to patients organs, requires hospital admission

7 factors that contribute to pts risk of ADR

``` Age Sex Ethnicity Comorbidities Allergies Polypharmacy Narrow therapeutic index ```

7 high risk pt groups for ADRs

``` Elderly Children Female Heart arrythmia HIV Abnormal metabolism Allergies ```

6 reasons why elderly are at increased risk of ADR

``` Organ deterioration Low homeostatic reserve, less ability to compensate Cardiac/CNS drugs effect at lower dose New drug may cause AKI Multiple comorbidities Polypharmacy ```

4 reasons why children are at increased risk of ADRs

Different metabolism/excretion of drugs to adults Different pharmodynamics Children excluded from clinical trials Water and fat distribution changes quickly altering drug distribution

2 reasons why ADRs more common in females than males

?better reporting | Difference in hormonal/immune systems

What area of the body is more likely to have a reaction to drugs in HIV patients?

Skin

If patient experiences suspected ADR should another drug be added, or ?

Drug causing ADR should be changed

Acronym for identifying ADRs, what does each letter stand for and mean?

TRIP Time - of ADR after drug administered Recovery - ADR stop after not taking drug Independent - test to objectively monitor ADR e.g. BP Predictable - ADR understandable from drug's method of action

5 common drug interactions and their resulting ADRs

``` NSAIDs + corticosteroids = dyspepsia Laxatives + abx + cytoxics = diarrhoea ACE inhibitors = dry cough Opioids + tricyclic antidepressants + iron = constipation Opioids + cytotoxics + SSRIs = Nausea ```

5 common food/drink interactions with drug/their effect

``` Grapefruit juice - enzyme inhibitor Cranberry juice + warfarin Milk/dairy products = chelation Alcohol + antidepressants = additive St Johns Wort + oral contraceptives = enzyme inducer ```

What does chelation mean?

Formation of insoluble compounds by agents converting metal ions into inert versions of drug

6 ways to reduce ADRs

Take pt history - predisposing factors, high risk group Current/past drug history Medication reviews Regular monitoring of known ADRs - drugs with narrow therapeutic index Pt aware of what to do when ADR occurs Prescription of lower risk drug

Definition of pharmacovigillance

Monitoring of a drugs effect after on population being introduced to see its effect

Definition of a drug interaction | presence of what on what, changes what

Occur when effect of a drug or food changes with presence of another drug, chemical or food

How can you identify a drug interaction in the BNF?

Will have a black dot next to it | Or be in bold text with a pink background

3 outcomes of drug interaction | work any more?, effect

Ineffective Increase in effect Beneficial harmful effect

Definition of a drug with a narrow therapeutic window

Difference between therapeutic and toxic dose of drug is very small

What should be done when a patient is on a drug with a narrow therapeutic window and to ensure what?

Monitor plasma concentration of drug to ensure concentration remains within therapeutic range

Name 2 types of drug interaction effect

Additive | Antagonistic

Define a additive interaction effect

Drug interaction increases or adds to drugs effect

Define a antagonistic drug interaction effect

Drug counteracts the action of the other, meaning desired therapeutic effect doesnt occur

Name 2 mechanisms of drug interaction

Pharmodynamically | Pharmokinetically

What feature of a drug to the one being given may result in a pharmodynamic interaction?

Drug with similar antagonist effect

What 3 things might cause one drug interact to effect the absorption of another drug?

Dose of drug Alteration of GIT motility/pH Chelation

How might a drug interact with another to effect its distribution? (displace where, why cause ADR)

Displacement of protein bound drug- leaving unbound drug bioactive causing ADR/toxicity Lower albumin concentration - same reason as above

How in general terms might a drug interact with another to effect metabolism?

Increase or decrease the rate of drug break down

What would a drug do to increase the metabolism of another?

Induce enzymes

What is the effect of a drug enzyme inducer on drug concentration?

Decrease plasma concentration of drug

What would a drug do to decrease the metabolism of another?

Inhibit enzymes

What is the effect of a drug enzyme inhibitor on drug concentration?

Increase in plasma concentration of drug

Would drug dose need to be increased or decreased when taken with a enzyme inducer to have same therapeutic effect?

Increased

Would drug dose need to be increased or decreased when taken with an enzyme inhibitor to have same therapeutic effect?

Decreased

How might one drug interact to effect the excretion of another when they are both excreted renally? Ad what effect on drug plasma conc would this have?

Compete to be removed | Increase drug plasma concentration

Clinical trials only identify common ADRs true or false?

True

What is the usual sample size involved in a clinical trial?

1500

What 2 incidences of ADRs wont have occurred in a clinical trial?

Uncommon and rare

Is the duration of a clinical trial short or long?

Short

True or false, clinical trials involve minority populations?

False

What system and organisation is in place to report ADRs?

Yellow card scheme to MHRA

In well established drugs which ADRs should be reported?

Serious, medically significant ADRs with harmful reactions

What should be reported as an ADR? | which drugs, just drugs?, smoking

Ineffective drugs Medical devices Conterfeit drugs Nicotine devices

What group term should all ADRs be reported for?

Minority groups e.g. elderly, children etc

What symbol shows that a drug is new and under increased monitoring?

Upside down black triangle

Where can you find out if a drug is new and under increased monitoring? (2 places_

On summary of medical product characteristics | On patient information leaflet

In a new drug identified with a upside down triangle should all ADRs be reported, Yes or no?

Yes