General Pharmaceutical Council Registration Assessment (GPhC Assessment) Law, Ethics and Professional Practice Syllabus

Which controlled drugs are subject to Safe Custody Regulations requirements?

All Schedule 1 and Schedule 2 drugs (with a few exceptions), and Schedule 3 drugs such as buprenorphine, temazepam (temazepam itself is exempt), diethylpropion, and flunitrazepam must be kept in a locked cabinet meeting BS legal specifications.

What are the legal specifications for a controlled drugs cabinet under the Safe Custody Regulations?

It must be a locked safe, cabinet or room constructed and maintained to prevent unauthorised access (the Misuse of Drugs (Safe Custody) Regulations 1973 specify minimum construction standards).

How must out-of-date or unwanted Schedule 2 controlled drug stock be destroyed in a pharmacy?

It must be denatured/rendered irretrievable and witnessed by an authorised person (e.g. an Accountable Officer or authorised witness such as a GPhC inspector or police), with the destruction recorded in the CD register.

Do patient-returned controlled drugs require an authorised witness for destruction?

No; patient-returned CDs can be destroyed by a pharmacist (denatured) and a record made in a separate patient-returned CD record, but this entry is not made in the running CD register and an authorised witness is not legally required (though good practice recommends a second signature).

What is the role of the Accountable Officer (AO) in controlled drug governance?

The AO is a senior person responsible for the safe, appropriate and effective management and use of controlled drugs within their organisation, including monitoring, auditing, and reporting concerns to the Local Intelligence Network.

Which regulations introduced the role of the CD Accountable Officer?

The Controlled Drugs (Supervision of Management and Use) Regulations 2013 (in England/Scotland; equivalent arrangements elsewhere).

What is a Local Intelligence Network (LIN) in the context of CD governance?

A network coordinated by Accountable Officers that shares information and concerns about the management and use of controlled drugs to identify and act on risks or malpractice.

Name the GPhC's standards document that all pharmacists and pharmacy technicians must meet.

The Standards for Pharmacy Professionals (2017), comprising nine standards.

State the nine GPhC Standards for Pharmacy Professionals.

1) Provide person-centred care; 2) Work in partnership with others; 3) Communicate effectively; 4) Maintain, develop and use professional knowledge and skills; 5) Use professional judgement; 6) Behave professionally; 7) Respect and maintain confidentiality and privacy; 8) Speak up when there are concerns; 9) Demonstrate leadership.

What does 'person-centred care' (Standard 1) require of a pharmacy professional?

Adapting care to the individual's needs, values and preferences, obtaining consent, considering the whole person, and empowering them to make decisions about their own health.

What three elements are required for consent to be legally valid?

It must be given voluntarily, by a person with capacity, who is appropriately informed about the nature and purpose of the intervention.

Under the Mental Capacity Act 2005, what are the two stages of the test for capacity?

Stage 1: Is there an impairment of, or disturbance in, the functioning of the mind or brain? Stage 2 (functional test): Is the person unable to understand, retain, weigh/use the information, or communicate the decision?

What are the five statutory principles of the Mental Capacity Act 2005?

1) Presumption of capacity; 2) Support people to make their own decisions; 3) Unwise decisions do not mean lack of capacity; 4) Acts for those lacking capacity must be in their best interests; 5) Choose the least restrictive option.

What is Gillick competence / Fraser guidelines used for?

To assess whether a child under 16 has sufficient maturity and understanding to consent to their own treatment (Gillick competence); Fraser guidelines specifically apply to contraceptive/sexual health advice for under-16s.

When may a pharmacist lawfully disclose confidential patient information without consent?

When required by law (e.g. court order, notifiable disease), when there is an overriding public interest (e.g. risk of serious harm to the patient or others), or to safeguard a child or vulnerable adult.

What four common steps underpin an ethical decision-making framework in pharmacy?

Identify the ethical dilemma/relevant facts; consider the options and relevant standards/law; weigh the benefits, risks and duties (the patient's best interests); make and document a justifiable decision, then review the outcome.

What are the four key biomedical ethics principles (Beauchamp and Childress)?

Autonomy, Beneficence, Non-maleficence, and Justice.

What is the difference between beneficence and non-maleficence?

Beneficence is the duty to act in the patient's best interest and do good; non-maleficence is the duty to avoid causing harm ('first, do no harm').

What does GPhC Standard 8 ('speak up') require when you have concerns about safety?

You must raise concerns promptly if patients or the public are, or may be, at risk, even if it is not easy, and escalate them appropriately until they are addressed.

What is the professional 'duty of candour'?

The duty to be open and honest with patients (and colleagues/organisations) when something goes wrong with their care that has caused, or could cause, harm or distress, including offering an apology and explanation.

Distinguish the professional duty of candour from the statutory duty of candour.

The professional duty applies to individual registrants under GPhC/regulatory standards for all errors/near-misses; the statutory duty (Health and Social Care Act 2008 regulations) applies to organisations and is triggered only by a defined notifiable safety incident causing moderate/severe harm or death.

What legislation protects employees who 'blow the whistle' on wrongdoing?

The Public Interest Disclosure Act 1998 (PIDA), which protects workers who make qualifying disclosures in the public interest from detriment or dismissal.

What are the GPhC's requirements for registration as a pharmacist in Great Britain?

Completion of an accredited MPharm degree and foundation training year, passing the GPhC registration assessment, meeting fitness-to-practise/health and character requirements, and paying the registration fee.

What is 'fitness to practise' and what can trigger a GPhC investigation?

Fitness to practise means having the skills, knowledge, character and health to practise safely and effectively. Triggers include misconduct, deficient professional performance, criminal convictions, ill health, or a determination by another regulator.

What sanctions can the GPhC's Fitness to Practise Committee impose?

No action, advice/warning, conditions on practice, suspension from the register, or removal (erasure) from the register; interim measures (interim suspension/conditions) can also be applied during investigation.

Under the Responsible Pharmacist Regulations 2008, what must each registered pharmacy have?

A Responsible Pharmacist (RP) in charge of the pharmacy, who must secure the safe and effective running of the pharmacy in relation to the retail sale/supply of medicines.

What three things must a Responsible Pharmacist establish, maintain and operate?

A record (the RP record showing who the RP is and the times in charge), the pharmacy procedures (SOPs), and a notice displaying the RP's name and registration number.

For how long may a Responsible Pharmacist be absent from the pharmacy, and under what conditions?

Up to a maximum of 2 hours during the pharmacy's operating hours; during absence the RP remains contactable and able to return, arrangements are in place, and no POM/P sale or supply requiring a pharmacist may take place.

What is the purpose of Standard Operating Procedures (SOPs) in a pharmacy?

To document the agreed, safe and consistent method for carrying out tasks (e.g. dispensing), define responsibilities, support training and audit, and reduce errors. They must be reviewed regularly and accessible to staff.

What is the purpose of a clinical audit cycle in pharmacy practice?

To systematically review practice against defined standards, identify gaps, implement change, and re-audit to confirm improvement — a continuous quality-improvement loop (set standards, observe practice, compare, change, re-audit).

How may veterinary medicines be supplied, and what classification system applies?

Under the Veterinary Medicines Regulations; categories are POM-V (vet prescription only), POM-VPS (prescribed by vet/pharmacist/SQP), NFA-VPS (non-food animal, by vet/pharmacist/SQP), and AVM-GSL (general sale). Records of POM-V/POM-VPS supplies must be kept for 5 years.