Adverse Drug Reactions Flashcards
What patient details should be included when filling out the yellow card?
*at least one section should be filled
*weight is only important if suspected drug is dosed according to weight or if the ADR is weight-related
*include ethnicity if known
What information must be included in the suspected drug section?
*list ALL suspected drugs/vaccines
*dates are important
*if you have the additional information please include in the additional information section
What information must be included in the suspected reactions?
*indicate whether you think it is a serious reaction
*if you have the additional information please include
What should you include in the additional drugs section?
*medicines purchased OTC
*herbal medicines
*recent courses of antibiotics
What should be included in the additional relevant information section?
*register (if using online form):
*to save filing this section for each report
*to have a record for cpd
What does a black triangle mean on drugs?
*drug is being intensively monitored and is assigned to:
- new drugs
- new combination of drugs
- novel routes or delivery systems for drugs
- significant new indication for drugs
What have been the changes to CAPs medicines have to been added to the black triangle drug list?
The following CAPs have been added to the list:
* Omjjara – New active substance
* Skyclarys – New active substance
* Casgevy - New active substance, new biological and conditional marketing authorisation, PASS
* Velsipity – New active substance
What CAPs medicines have been removed from the black triangle list?
The following CAPs have been removed from the list:
* Truvelog Mix - Withdrawal of marketing authorisation
* Rubraca - Five years following its authorisation (June 2018)
what are the details of a Type A (‘Augmented’) ADR?
Common ADRs – Approx. 80% of ADRs
-predictable, dose related
-usually not severe
what are the details of type B (Bizarre) ADRs?
Uncommon but often well recognised ADRs
- unpredictable, not related to dose
-may be severe, fatal
-with new drugs ADRs not recognised
What are the other classifications of ADRs?
Type C (Chronic treatment effects)
* Osteoporosis with steroids
Type D (Delayed effects)
* Drug induced cancers
Type E (End of treatment effects)
* Withdrawal syndromes with opiates
Type F (Failure of therapy)
* Unexpected failure of therapy due to drug interaction
* e.g. Combined Oral Contraceptive and rifampicin
Type G (Genetic or Genomic)
* Irreversible genetic damage (carcinogens, teratogens)
What can ADRs do to impact other aspects e.g healthcare + life?
*Adversely affect patient compliance
*Reduce available choice of drug treatment
*Reduce potential efficacy of drug treatment
*Reduce quality of life
*Cause diagnostic confusion
*Reduce a patient’s confidence in their healthcare
professional
What is an important factor in ADRs (DoTs)?
3 factors: Dose, Time, Susceptibility
What are some example of ADRs occurring in terms of DoTs?
- At doses below therapeutic doses
- Anaphylaxis with penicillin
- In the therapeutic dose range
- Nausea with morphine
- At high doses
- Liver failure with paracetamol
What are some examples of onset problems + how they differ with time took for them to occur?
- With the first or second dose
- Anaphylaxis with penicillin
- Early, or after a time, or with long-term treatment
- First few days: nitrate induced headache
- 10 days – 10 weeks: peptic ulcer with NSAIDs
- Several weeks: drug-induced Cushing’s syndrome
- On stopping treatment (withdrawal)
- Opiate withdrawal syndrome
- Delayed
- Drug induced cancer
Time of onset can be characteristic
What factors affect the susceptibility of the patients?
- Genetics – Greek and African origin are more likely
to experience breathing problems with codeine - Age – parkinsonism with metoclopramide in
adolescents - Sex – ACE-inhibitor induced cough more likely in
women - Physiological state – phenytoin in pregnancy
- Exogenous drugs or foods – warfarin, cranberry
juice, and increased INR - Disease – gentamicin & deafness in renal failure
Are ADRs avoidable? + how?
70% ADRs are potentially avoidable
* Avoid unnecessary drug use
* Avoid/reduce drug interactions
check the patient’s drug history before prescribing
* Consider risk factors for ADRs e.g. age extremes, reduced
hepatic and renal function
* Avoid new (black triangle) drugs
* Patient counselling
* Monitor treatment & optimise dose
* Consider prophylactic therapy where appropriate
