ADRs Flashcards
(41 cards)
What are the preventive roles of pharmacists in ADR prevention?
- Avoid inappropriate use of drugs
- Appropriate drug administration (Rational Therapeutics)
- Dose, dosage form, duration, route, frequency, technique
- Ask for previous history of drug reactions and allergies
- Always suspect ADR when new symptom arises after initiation of treatment
- Ask for laboratory findings like serum creatinine etc.
What kind of adverse events can medication and device errors, and product defects lead to?
Preventable Adverse Events
What are the categories of adverse events in the schematic of preventable and unavoidable ADRs?
- Medication and Device Error
- Known ADRs and Side Effects
- Product Defects
- Remaining Uncertainties
Where does the data in each iDAP come from?
Yellow Card Scheme and pharmaceutical companies
What are Interactive Drug Analysis Profiles (iDAPs)?
ADR reports on the Yellow Card website
What types of reactions or drugs should healthcare professionals report through the Yellow Card Scheme?
All SERIOUS reactions or drugs with black triangle status
- Fatal
- Life-threatening
- Disabling / incapacitating
- Congenital abnormality
- Result in or prolongs hospitalisation
According to the MHRA, what is an adverse event?
Any undesirable event experienced by a patient taking medicine
What are side effects usually documented as?
Therapeutic effect, beyond the desired effect
What is a side effect defined as?
Unintended effect occurring at normal dose
According to the MHRA, what is an adverse drug reaction? According to the WHO, what is an adverse drug reaction?
Harmful reaction suspected to be related to the drug
Noxious and unintended response at normal doses
What does EMA stand for?
European Medicines Agency
What uses are ADR reporting not limited to?
Uses outside Marketing Authorisation terms
What uses outside of the terms of Marketing Authorisation should ADRs be reported for?
- Misuse and abuse
- Medication error
- Overdose
- Occupational exposure
Approximately how many admissions a year in the UK resulted from ADRs?
250,000
What classifications can ADRs be classified based on?
Onset, Severity and Types
How is an ‘acute’ ADR defined based on onset? How is a ‘sub-acute’ ADR defined based on onset? How is a ‘latent’ ADR defined based on onset?
Within 60 mins
1-24 hours
>2 days
What severity of ADR requires no antidote, treatment or prolonged hospitalisation? What severity of ADR requires a change in treatment? What severity of ADR is potentially life threatening? What severity of ADR directly or indirectly contributes to a patient’s death?
Mild
Moderate
Severe
Lethal
What are the types of ADRs?
Type A (Augmented/Exaggerated)
Type B (Bizarre)
Type C (Continuous)
Type D (Delayed)
Type E (Ending Use)
Give 3 examples of Type A ADRs
- Bleeding anticoagulants
- Hypotension from anti-hypertensives
- Hypoglycaemia from anti-diabetics
What basis do Type B ADRs develop on?
Immunological reaction on a drug (Allergy)
Genetic predisposition (Idiosyncratic reactions)
Give an example of type D ADRs
Teratogenesis with anticonvulsants
What are Type C ADRs associated with?
Cumulative long term exposure
What do Type E ADRs involve? And give an example
Drug withdrawal syndromes
Sudden withdrawal of b-blockers induces rebound tachycardia and hypertension
What are ADRs categorised as?
- Side effects
- Secondary effects
- Toxic effects
- Intolerance
- Idiosyncrasy
- Drug allergy
- Photosensitivity
- Drug dependence
- Drug withdrawal reactions
- Teratogenicity
- Mutagenicity and Carcinogenicity
- Drug induced diseases (Iatrogenic disorders or Iatrogenicity)
