Medicine safety & Risk management Flashcards
(20 cards)
What is a Human Medicinal Product?
Any substance or combination of substances used to treat or prevent disease in humans, or to modify physiological functions via pharmacological, immunological or metabolic action, or for medical diagnosis.
Define Medication Safety.
Safe and quality use of medicines to prevent harm. Ensures right patient, medication, indication, dose/form, route, time, instructions, response, monitoring, and documentation.
What is a Medication Error?
Any unintended incident in prescribing, preparing, dispensing, administering, monitoring or advising on medicines, possibly leading to harm.
Differentiate between Errors of Commission and Errors of Omission.
Commission: doing something wrong (e.g., wrong drug/dose). Omission: failing to do something (e.g., missed dose, lack of monitoring).
Define Adverse Drug Reaction (ADR).
A noxious and unintended response to a drug, from normal use or errors/misuse. Includes off-label, abuse, or overdose scenarios.
Name and describe Type A and Type B ADRs.
Type A: Augmented, dose-dependent, predictable (e.g., bleeding with warfarin). Type B: Bizarre, unpredictable (e.g., anaphylaxis with penicillin).
What are Type C, D, and E ADRs?
C: Chronic, long-term (e.g., osteonecrosis with alendronic acid). D: Delayed (e.g., leucopenia post-chemotherapy). E: End-of-use/withdrawal (e.g., withdrawal symptoms from opioids).
What are High Risk Drugs?
Drugs likely to cause serious harm even when used correctly. Examples: opioids, lithium, insulin, warfarin, methotrexate.
Why is Medication Safety important?
Medication errors are a leading cause of avoidable harm, costing globally $42B/year. In England, 237M errors/year cause £98M cost and 1700 deaths.
What is the goal of the WHO’s Medication Without Harm initiative?
To reduce severe avoidable medication-related harm globally.
List the four domains of the WHO Medication Without Harm framework.
Patients and public, Health care professionals, Medicines, Systems and practices of medication.
What are the three key action areas of Medication Without Harm?
Polypharmacy, High-risk situations, Transitions of care.
What is a Marketing Authorisation (MA)?
A license granted to a medicinal product meeting standards of safety, quality, and efficacy.
What does the Yellow Card Scheme do?
Collects reports of suspected ADRs to detect new risks and monitor known effects. Run by MHRA.
What is the role of MHRA in medication safety?
Regulates medicines, operates pharmacovigilance, publishes alerts, and manages recalls.
When should a Yellow Card be submitted?
For any suspected ADR, especially serious reactions or those in vulnerable populations.
What are National Patient Safety Alerts and who issues them?
Alerts on medicine/device risks issued by MHRA to guide safety actions.
What is the role of a Medication Safety Officer (MSO)?
To promote safe medicine use, improve reporting, and bridge initiatives with operations.
List pharmacist responsibilities in medication safety.
Prescribing, reviewing prescriptions, educating, monitoring, reporting errors/ADRs, policy development.
Describe the PINCER intervention.
Pharmacist-led IT system identifying prescribing risks in GPs, now part of NICE guidelines.
