med safety Flashcards
(25 cards)
Type A ADR:
Augmented/pharmacological – exaggerated drug action at normal dose; dose-dependent and reversible. Example: bleeding with warfarin.
Type B ADR:
Bizarre/idiosyncratic – not predictable from known pharmacology. Example: anaphylaxis with penicillin.
Type C ADR:
Continuing – persists long-term. Example: osteonecrosis of the jaw with alendronic acid.
Type D ADR:
Delayed – appears sometime after use. Example: leucopenia post-chemotherapy (up to 6 weeks later).
Type E ADR:
End-of-use – occurs on drug withdrawal. Example: opioid withdrawal symptoms
Patient Safety Incident (PSI):
Any unintended/unexpected event that could or did lead to harm to an NHS patient.
Medication error:
A PSI involving mistakes in prescribing
Error of commission:
Mistake such as wrong drug or wrong dose.
Error of omission:
Missing a dose or failure to monitor treatment.
High-risk drugs Include
Medications with potential of abuse (e.g., opioids)
Narrow therapeutic index drugs - small difference between minimum effective and toxic plasma concentrations (e.g., lithium, phenytoin, theophylline & gentamicin)
Disease-modifying anti-rheumatic drugs (DMARDs)-e.g., Methotrexate
Insulin
Anticoagulants (e.g., warfarin, apixaban & rivaroxaban)
Amiodarone
Medication Without Harm:
A WHO strategy to reduce medication-related harm through 4 domains and 3 key action areas.
Four domains of Medication Without Harm:
Four domains of the challenge are Patients and the public, Health care professionals, Medicines and Systems, and practices of medication.
Three action areas of Medication Without Harm:
The three key action areas are Polypharmacy, High-risk situations and Transitions of care
NRLS (National Reporting and Learning System):
NHS England/MHRA database to collect and analyze patient safety incidents and improve care.
Yellow Card Scheme:
especially those with a ▼ symbol (additional monitoring). System to report suspected ADRs -Causality does not have to be proved in order to report a suspected ADR, a suspicion is enough.
ADR reports of interest to MHRA:
In children
In patients that are over 65
To biological medicines;
Associated with delayed drug effects and interactions;
Complementary therapies such as homeopathic and herbal remedies
Is proof of causality needed to report an ADR?: No – only suspicion is required to submit a Yellow Card.
Class 1 drug recall:
Life-threatening or serious risk. Requires immediate action.
Class 2 drug recall:
The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. Requires action to be taken within 48 hours of the recall being issued.
Class 3 drug recall:
Class 3: The defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non-compliance with the marketing authorisation or specification. Action is required within 5 days of the recall being issued.
Class 4 drug recall:
Class 4: There is no threat to patients or no serious defect likely to impair product use or efficacy. These are generally used for minor defects in packaging or other printed materials. Requires caution to be exercised when issuing or using the product
Pharmacist recall step 1:
Check that no stock has been sold – inspect invoices
Pharmacist recall step 2:
Follow alert cascade and communicate with relevant clinical staff.
Pharmacist recall step 3:
Sign the recall notice, add the date checked and scan file it
