General Pharmaceutical Council Registration Assessment (GPhC Assessment) Dispensing, Medicines Optimisation and Safety Syllabus

What is the purpose of error reporting in a 'no-blame'/just culture?

To learn from incidents and near misses, identify system weaknesses and implement improvements, rather than to assign individual blame — encouraging open reporting.

Define a 'near miss' in dispensing.

An error that is detected and corrected before the medicine reaches or is taken by the patient, so no harm occurs; recording near misses helps identify error-prone steps.

What is Root Cause Analysis (RCA) used for after a significant incident?

A structured investigation method to identify the underlying system and contributory causes of an incident (not just the immediate human action) so that preventative actions can be taken.

What is the difference between a reactive and a proactive approach to medication safety?

Reactive approaches learn from incidents after they happen (e.g. incident reports, RCA); proactive approaches identify and reduce risk before harm occurs (e.g. risk assessment, FMEA, safety alerts).

What are National Patient Safety Alerts and who must act on them?

Nationally coordinated warnings (issued via the National Patient Safety Alerting Committee) requiring NHS organisations to take specific actions to reduce risk of death or severe harm by a stated deadline.

Through which scheme are suspected adverse drug reactions reported to the MHRA in the UK?

The Yellow Card Scheme, which collects reports of suspected ADRs, defective medicines, and safety concerns from healthcare professionals and patients.

What does the black triangle symbol on a medicine denote?

That the medicine is under additional monitoring and all suspected ADRs should be reported via the Yellow Card Scheme; it is typically applied to newer medicines.

Define 'medicines reconciliation'.

The process of accurately listing a patient's current medicines and comparing them against new prescriptions to identify and resolve discrepancies, particularly at transitions of care (admission, transfer, discharge).

What are the three core steps of medicines reconciliation?

Collecting an accurate, up-to-date medication history; checking/verifying it against the prescribed medicines; and communicating/documenting any changes and resolving discrepancies.

Why are transitions of care high-risk points for medication errors?

Information about medicines is frequently lost or miscommunicated when patients move between settings, leading to unintentional omissions, duplications, or dosing discrepancies.

What is a Structured Medication Review (SMR)?

A comprehensive, patient-centred clinical review of a patient's medicines that uses shared decision-making to optimise therapy, reduce inappropriate polypharmacy, and address problematic medicines.

Which patient groups are prioritised for a Structured Medication Review?

Patients on multiple medicines (polypharmacy), those on high-risk medicines, frail or elderly patients, people in care homes, those with multiple long-term conditions, and patients with addiction/dependence-forming medicines.

Distinguish 'adherence', 'compliance' and 'concordance'.

Compliance is the patient following the prescriber's instructions; adherence is the extent to which the patient's behaviour matches agreed recommendations; concordance is a shared, agreed therapeutic decision based on partnership between patient and prescriber.

What is the difference between intentional and unintentional non-adherence?

Intentional non-adherence is a deliberate decision not to take medicine (e.g. beliefs, side effects); unintentional non-adherence results from practical barriers such as forgetfulness, poor dexterity, or not understanding instructions.

Name common interventions to support medication adherence.

Simplifying regimens, patient education and counselling, reminder charts/alarms, multi-compartment compliance aids, addressing beliefs and side effects, and involving carers.

What is antimicrobial stewardship?

A coordinated programme to promote the appropriate use of antimicrobials — right drug, dose, route and duration — to improve outcomes, reduce resistance, and minimise toxicity and Clostridioides difficile infection.

What does the 'Start Smart then Focus' antimicrobial principle mean?

Start Smart: only prescribe antibiotics when there is evidence of infection, take cultures, and document indication/dose/duration. Then Focus: review at 48-72 hours and decide to stop, switch IV to oral, change, or continue with a documented plan.

What is antithrombotic stewardship concerned with?

Ensuring safe and appropriate use of anticoagulants and antiplatelets — correct indication, dosing, monitoring (e.g. INR, renal function), duration, and managing bleeding risk and interactions.

Which monitoring is required for a patient stabilised on warfarin, and what is the typical target?

Regular INR monitoring; a typical target INR is $2.5$ (range $2.0$–$3.0$) for many indications such as atrial fibrillation and DVT/PE, with a higher range (e.g. $3.5$) for some mechanical heart valves.

What is an advantage of DOACs (direct oral anticoagulants) over warfarin?

DOACs have predictable pharmacokinetics, fewer food/drug interactions, and do not require routine INR monitoring; however dosing must still account for renal function, weight and indication.

What is the New Medicine Service (NMS) in community pharmacy?

An NHS England service providing support to patients newly prescribed a medicine for certain long-term conditions (e.g. asthma/COPD, type 2 diabetes, hypertension, antiplatelet/anticoagulant therapy) to improve adherence in the early weeks of treatment.

What does the Discharge Medicines Service (DMS) involve?

An NHS service where hospitals refer patients to their community pharmacy after discharge so the pharmacy can reconcile and review the discharge medicines and support safe ongoing use.

Define a Patient Group Direction (PGD).

A written instruction allowing named, registered, authorised healthcare professionals to supply and/or administer a specified medicine to a defined group of patients without an individual prescription.

List the legally required content of a valid PGD.

Name of the business/organisation; start and expiry dates; the medicine and its indication; inclusion and exclusion criteria; dose, route and frequency; cautions, contraindications and side effects; signatures of a doctor and pharmacist plus organisational authorisation; and records to be kept.

How does a Patient Specific Direction (PSD) differ from a PGD?

A PSD is a written instruction from a prescriber to administer/supply a medicine to a named individual patient, whereas a PGD applies to a defined group of patients meeting set criteria rather than a named individual.

Under the emergency supply provisions, what quantity may a pharmacist supply at the request of a patient?

Up to 30 days' treatment for most prescription-only medicines, except limited exceptions (e.g. insulin, ointments/creams, and inhalers supplied in the smallest pack), provided the legal conditions are met. Phenobarbital for epilepsy may be supplied (max 5 days) under specific provisions.

What conditions must be satisfied for an emergency supply at the request of a patient?

The pharmacist must interview the patient and be satisfied there is an immediate need, that the medicine has previously been prescribed, the dose is identifiable and appropriate, it is not a restricted Controlled Drug, and the supply is recorded with a label stating 'Emergency Supply'.

Define an 'unlicensed medicine' (special).

A medicine that does not hold a UK marketing authorisation for the intended use — including 'specials' manufactured or imported to meet an individual patient's needs when no licensed product is suitable.

What is 'off-label' use, and how does it differ from an unlicensed medicine?

Off-label use is using a licensed medicine outside its authorised terms (e.g. different age, dose, route or indication). An unlicensed medicine has no UK marketing authorisation at all for the use; off-label uses a licensed product beyond its licence.

Describe the prescribing 'hierarchy' for choosing a medicine when a licensed option may not exist.

First use a licensed medicine within its terms; if unsuitable, use a licensed medicine off-label; only if neither is suitable use an unlicensed 'special' or import — with the prescriber accepting greater responsibility as you move down the hierarchy.

What key information must be recorded when supplying an unlicensed special?

Details to ensure traceability and accountability: product name and supplier, batch number, quantity, the patient, the prescriber, the date of supply, and a certificate of conformity/analysis retained for the required period.