Medication safety overview Flashcards
What is the definition of a Human Medicinal Product?
Any substance or combination of substances presented as having properties for treating or preventing disease in humans, or used to restore, correct, or modify physiological functions, or for medical diagnosis.
What does Medication Safety involve?
Ensuring safe and quality use of medicines to prevent harm. Includes correct patient, drug, dose, form, route, time, instructions, monitoring, documentation; spans prescribing, dispensing, administration, and monitoring stages.
Define a Medication Error.
Any unintended incident that could lead to harm, occurring during prescribing, preparing, dispensing, administering, monitoring, or advising on medicines.
What are the two categories of Medication Errors?
Errors of Commission (e.g., wrong drug/dose) and Errors of Omission (e.g., omitted dose or failure to monitor).
What is an Adverse Drug Reaction (ADR)?
An unintended and harmful response to a medicinal product, even at normal doses. Includes reactions from misuse or errors.
List and define the five types of ADRs.
Type A: Predictable, dose-dependent (e.g., warfarin bleeding); Type B: Unpredictable (e.g., penicillin anaphylaxis); Type C: Long-lasting (e.g., osteonecrosis); Type D: Delayed (e.g., leucopenia); Type E: Withdrawal effects (e.g., muscle ache from opioids).
What are High Risk Drugs?
Drugs with high potential for harm even when used correctly, e.g., opioids, lithium, methotrexate, insulin, anticoagulants, amiodarone.
Why is Medication Safety important?
Medication errors cause injury and cost healthcare systems globally. In the UK, 5-8% of unplanned admissions and 237 million errors/year occur, costing the NHS £98 million and 1700 lives.
What is the WHO’s ‘Medication Without Harm’ initiative?
A global campaign to reduce medication-related harm. Domains: patients/public, professionals, medicines, systems. Focus: polypharmacy, high-risk situations, transitions of care.
What does the MHRA require before marketing medicines?
Marketing Authorisation (MA) demonstrating safety, quality, and efficacy. Herbal/homeopathic products need to meet safety standards.
What system is used to report Medication Errors in the UK?
The National Reporting and Learning System (NRLS), managed by NHS England and MHRA, promotes a culture of reporting and learning.
What structures exist for Risk Management in large healthcare providers?
Medication Safety Officers, Safety Committees, and Board oversight. Committees analyse data, coordinate training, and promote best practices.
How should small providers manage medication safety?
Report to NRLS, seek support from safety officers or local professional committees.
What should be done if an ADR is suspected?
Assess severity, take full history, review drug and allergy history, check known effects, and consider further tests.
What is the Yellow Card Scheme?
MHRA scheme collecting ADR reports. Focus on unrecognised ADRs, serious cases (e.g., children, elderly, biologicals). Reporting doesn’t require proof.
What are the classes of medicine recalls?
Class 1: Critical defect (immediate); Class 2: Major (within 48h); Class 3: Minor (within 5 days); Class 4: Caution (within 5 days).
What is the pharmacist’s role in medication safety?
Manage risk, prescribe safely, audit, educate, monitor high-risk drugs, respond to MHRA alerts, lead safety projects.
What is the PINCER intervention?
A pharmacist-led IT tool used in general practice to reduce prescribing errors by identifying at-risk patients and guiding corrective action.
What are pharmacists encouraged to do to improve medication safety?
Stay updated on regulations, embrace technology, understand safety principles, and commit to lifelong learning.
