Brainscape's Knowledge GenomeTM

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


See full index

Clinical Pharmacy PH2506 > ADR > Flashcards

ADR Flashcards

1
Q

What is an ADR

A
  • ‘A response to a medicinal product which is noxious and unintended’
  • EMA: This may arise form use of the product within or outside the terms of MA or from occupational exposure
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Who can get ADR

A

-Anyone who takes drugs

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

Are they important

A
  • Major cause of hospital admission- 6.5%
  • Affect quality of life
  • Cost to NHS in £hundreds of millions
  • Many are preventable
  • Several hundred deaths per year
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Issues faced

A
  • Not enough information from clinical trials
  • Increased polypharmacy and co-morbidities
  • Number of patients admitted to hospital with ADR increasing
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Type of classification

A
  • Rawlins and Thompson

- DoTS

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

Rawlins and Thompson- TYPE A

A
  • Dose related
  • Common, predictable
  • Related to the pharmacology
  • Low mortality
    e. g. digoxin toxicity, constipation from morphine or sedation from hypnotic
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Rawlins and thompson- TYPE B

A
  • Not dose related
  • Uncommon, unpredictable
  • Not related to pharmacology
  • High mortality
    e. g. penicillin hypersensitivity, malignant hyperthermia, hepatitis
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

ACEI induced angioedema

A
  • Life threatening
  • Rare
  • Unlikely to be picked up on clinical trials
  • Biggest cause of angioedema presenting to A&E
  • 0.2% incidence
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Rawlins and thomspons- TYPE C,D,E and F

A 
Classification became complicated 
-Type C- long term 
-Type D- Delayed 
-Type E- end of use (withdrawal) 
-Type F- Failure of treatment 
NEW and simplified classification DoTS
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

DoTS-DOse, Time, Sususceptibility:

DOSE (response)

A 
The ADR can occur 
-At doses below therapeutic doses 
\+Anaphylaxis with penicillin 
-In the therapeutic dose range 
\+Nausea with morphine 
-At high doses
\+Liver failure with paracetamol
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

DoTS-DOse, Time, Sususceptibility:

TIME (course) can be characteristic

A
  • With the first dose
  • Early, or after a time or with long-term treatment
  • On stopping treatment (withdrawal)
  • Delayed
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

TIME (course)

A
  • Easily observed in the patient
  • Relevant to monitoring and prevention in a patient
  • Relevant to pharmacovigilance and drug development
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Time- Independent

A

-Time-independent
-e.g. increased risk of haemorrhage with change in effective dose fo warfarin
-NSAID- induced GI bleeding
SO
-Close monitoring throughout treatment

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

Time- immediate

A

-Immediate, due to rapid administration
e.g.
-Red man syndrome from vancomycin
-Or cardiac arrest in rapid infusion of K+
SO
-Infuse slowly

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

Time- first dose

A

-After first dose
e.g.
-Hypotension from ACEI
-Anaphylaxis (type I hypersenstiivity)
so
-Take special precautions for first dose

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

Time- Early

A
  • Early risk falls with time
    e. g. Nitrate induced headache
  • MONITOR
17
Q

Time- intermediate

A

Intermediate- risk maximal after a few weeks or days

  • e.g. ampicillin rash, delayed hypersensitivity
  • Quinine and thrombocytopenia (Type II)
  • Penicillin and interstitial nephritis (Type III)
  • Cutaneous reactions to anti-histamine (type IV)
18
Q

Time-Late

A
  • Late (risk increase with time)
  • e.g.
  • Osteoporosis with corticosteroids use
  • Withdrawal reactions
  • SO prevent; monitor those on long term treatments
19
Q

Time- delayed

A

Delayed
-e.g. carcinogenesis (ciclosporin
-Teratogenesis with thalidomide
So avoid

20
Q

Time- After withdrawal

A 
After withdrawal 
e.g. 
-Withdrawal syndromes (opiates, benzodiazepines) 
-MI from Beta blockers 
So withdraw slowly
21
Q

Types of time reactions

A
  • Independent
  • Immediate
  • First dose
  • Early
  • Intermediate
  • Late
  • Delayed
  • After withdrawal
22
Q

DoTS-DOse, Time, Sususceptibility:

SUSCEPTIBILITY

A

Increased risk of ADR can be due to
1)Genetic variation (Porphyria- cant produce enough Haem; Malignant hyperthermia- severe reaction to meds in anesthesia (fever, tachycardia)
2)Age (aspirin in U16- Reyes; Neonates- chloramphenicol Greys syndrome))
3)Sex (Osteoporosis in menopausal women; mefloquine and psychiatric effects in females)
4)Physiological variation
5)Exogenous factors (interacitons with food e.g. grapefruit juice and simvastatin or warfarin)
6)Disease (CKD effects clearance with Li)
NB- more than one factor can be present at any one time

23
Q

Examples of DoTS

Steroids

A

Oseteoporisis due to corticosteroids
DOSE- collateral effect (unintentional effects)
TIME- Late
SUSCEPTIBILITY- older people; women

24
Q

Examples of DoTS

Isoniazid

A

Hepatoxicity
Dose- collateral effect
Time- intermediate
Susceptilibility- Genetics (drug metabolism), Age, Exogenous (Alcohol) disease (malnutrition)

25
Q

Spontaneous reporting systems

A
  • Main system for national and international pharmacovigilance
  • Reports are analysed to detect signals
  • Significant under reporting
26
Q

Why report ADRs

A

-Important for patient safety
-Allow continuous monitoring of old and new drugs
-Provide data on ADRs to new drugs
-Provide data on special patient groups
+Young and old
+Pregnant
+with Co-morbidities or polypharmacy

27
Q

Yellow card scheme

A

-MRHA-run ADR reporting scheme 1964 response to thalidomide disaster
-Secure, spontaneous, suspicions
-Provide early warning of possible ADR
-Provide ‘real world data’
-The scheme collects reports of suspected problems or incidents involving
+side effects (ADR)
+Medical device adverse incidents
+Defective medicines (those that are not of an acceptable quality)
+Counterfeit or fake medicines or medicinal device

28
Q

How to complete yellow card

A
  • https://yellowcard.mhra.gov.uk
  • On back of BNF
  • APP
29
Q

What to report

A
  • Serious reactions to established drugs
  • Even if well recognised
  • Report suspicion, not proven causality
30
Q

What is a serious reaction

A

-Any reaction which results in hospitalisation (42%)
Serious reaction also include those that are
+Fatal (5%)
+Life-threatening (20%)
+Disabling (10%)
+Cause congenital abnormalities (1%)
+Medically significant (22%)

31
Q

Medical significance

A

1) Mild- No antidote or treatment is required
2) Moderate- A change in treatment, but not necessarily discontinuation of the drug, is required; Hospitalisation may be prolonged or specific treatment may be required
3) Severe- An ADR is potentially life threatening and requires discontinuation of drug and specific treatment of the ADR
4) Lethal- ADR directly or indirectly contributes to a patient death

32
Q

Black triangle drugs

A
  • Means intensive monitoring
  • Contains new active substance
  • Is a biological medicine
  • New indications
  • Has conditionsal approval
  • Company been asked for more data
33
Q

Who may report

A

-1964- doctors, dentists, coroners
-1997- Hospital pharmacists
-1999- Community pharmacists
-2002- Nurses, midwives and health visitors (2005 pilot patient scheme)
2008- Patients
Pharmaceutical companies MUST report

34
Q

Areas of Instrest

A 
MRHA particularly keen on reports in 
\+Children 
\+Over 65s 
\+Biological medicines and vaccines 
\+Delayed ADRs and interactions 
\+Complimentary and herbal medicines
35
Q

Future of pharmacovigilance

A
  • Studies are being conducted on social media sites and blogs
  • Smart technology
  • Genomic technology to understand the genetic basis of variable drug responses
  • Spontaneous reports along side new initiatives

Clinical Pharmacy PH2506 (20 decks)

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