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

Law, Ethics and Professional Practice syllabus — full chapter and topic list

Expand any chapter to see its topics and sub-topics. This is the whole examinable outline for Law, Ethics and Professional Practice in General Pharmaceutical Council Registration Assessment (GPhC Assessment), not a summary of it.

1. 1

   Medicines Legislation and Classification

   4 topics

   • Legal Categories of Medicines
     • GSL, P and POM classification
     • Reclassification and switches
   • Human Medicines Regulations 2012
     • Sale and supply requirements
     • Wholesale dealing and falsified medicines
   • Prescription Requirements
     • Legally valid prescription elements
     • Prescriber types and scope
     • Electronic prescriptions and repeats
   • Record Keeping and Retention
     • Prescription-only medicine registers
2. 2

   Controlled Drugs

   4 topics

   • Misuse of Drugs Act and Schedules
     • Schedules 1 to 5 classification
   • Prescription Requirements for Controlled Drugs
     • Handwriting, quantity in words and figures, validity period
   • Safe Custody, Storage and Destruction
     • CD cabinet and register requirements
     • Witnessed destruction and denaturing
   • Accountable Officer and CD Governance
     • Reporting concerns and CD monitoring
3. 3

   Professional Ethics and Standards

   4 topics

   • GPhC Standards for Pharmacy Professionals
     • The nine standards
     • Person-centred care
   • Consent, Capacity and Confidentiality
     • Mental Capacity Act principles
     • Gillick competence and young people
     • Data protection and information governance
   • Ethical Decision-Making
     • Ethical frameworks and balancing duties
     • Conscientious objection
   • Raising Concerns and Duty of Candour
     • Whistleblowing and safeguarding
4. 4

   Pharmacy Governance and Regulation

   4 topics

   • Registration and Fitness to Practise
     • GPhC registration and revalidation
     • Fitness to practise process
   • Responsible Pharmacist Regulations
     • Duties and absence rules
   • Standard Operating Procedures and Audit
     • Clinical governance pillars
   • Veterinary and Special Categories
     • Veterinary medicine cascade overview
     • Unlicensed medicines and specials

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

18 of 51 cards from the Law, Ethics and Professional Practice deck — real questions with worked answers.

1. What are the three legal categories of medicines in the UK?

   General Sale List (GSL), Pharmacy medicines (P), and Prescription Only Medicines (POM).

2. What distinguishes a Pharmacy (P) medicine from a GSL medicine?

   A P medicine can only be sold from a registered pharmacy under the supervision of a pharmacist, whereas a GSL medicine can be sold from any lawful retail outlet (e.g. supermarket) without pharmacist supervision.

3. What conditions must normally be met for a POM to be supplied lawfully?

   It must be supplied against a valid prescription written by an appropriate practitioner (or under a PGD/exemption), from a registered pharmacy, by or under the supervision of a pharmacist.

4. Which legislation is the primary framework governing the licensing, sale and supply of medicines in the UK?

   The Human Medicines Regulations 2012 (which consolidated and replaced most of the Medicines Act 1968).

5. Under the Human Medicines Regulations 2012, what is a 'wholesale dealer's licence' required for?

   It is required to legally sell or supply medicinal products to anyone other than the end patient/consumer (i.e. business-to-business supply such as to another pharmacy or wholesaler).

6. List the core particulars that must appear on a valid POM prescription under the Human Medicines Regulations 2012.

   Patient's name and address; signature (in ink) of the prescriber; prescriber's address; date; particulars indicating the prescriber's type; and for a child under 12, the age. The medicine, dose and quantity must also be stated.

7. For how long is a standard (non-CD) POM prescription valid from its appropriate date?

   6 months from the appropriate date (the later of the date of signing or any indicated start date).

8. How long is a repeatable prescription for a non-controlled drug valid, and how must the first dispensing occur?

   It is valid for 6 months; the first dispensing must take place within 6 months of the appropriate date (for oral contraceptives the limit is generally treated more flexibly but the same 6-month rule applies).

9. What is the difference between a written prescription and an electronic prescription's legal status under the Human Medicines Regulations 2012?

   Both are valid; an electronic prescription must be created in electronic form, signed with an advanced electronic signature and transmitted as an electronic communication via an approved system (e.g. EPS).

10. What is the minimum legal retention period for POM prescription records (private prescription register/electronic equivalent)?

    2 years from the date of the sale or supply (or from the date of the last entry where it is a record of repeated dispensing).

11. For how long must records relating to wholesale dealing (receipt and supply of medicines) be kept?

    At least 5 years.

12. What is the legal record-keeping requirement for the supply of a Schedule 2 controlled drug?

    Entry in the Controlled Drugs Register (CDR) within 24 hours, and the CDR must be retained for at least 2 years from the date of the last entry.

13. Which Act provides the primary criminal-law framework for controlling dangerous or harmful drugs in the UK?

    The Misuse of Drugs Act 1971, supported by the Misuse of Drugs Regulations 2001.

14. Under the Misuse of Drugs Act 1971, what do the three classes A, B and C represent?

    They classify controlled drugs by harm for the purpose of penalties: Class A (most harmful, e.g. heroin, cocaine, morphine), Class B (e.g. codeine, cannabis), Class C (e.g. benzodiazepines, anabolic steroids).

15. Describe the five Schedules of the Misuse of Drugs Regulations 2001.

    Schedule 1: no medicinal use, Home Office licence needed (e.g. LSD, raw cannabis). Schedule 2: full CD controls (e.g. morphine, diamorphine, methadone). Schedule 3: e.g. buprenorphine, temazepam, midazolam, tramadol. Schedule 4: Part I benzodiazepines/Part II anabolic steroids. Schedule 5: low-strength preparations with minimal controls.

16. Which Schedule of controlled drug requires safe custody, a CD register entry, AND a fully compliant CD prescription?

    Schedule 2 (and certain Schedule 3 drugs such as temazepam are exempt from CD register requirements, while buprenorphine requires safe custody).

17. What specific particulars must a Schedule 2 or 3 controlled drug prescription contain in addition to standard prescription requirements?

    The total quantity of the preparation (or number of dosage units) in both words and figures; the form and strength of the preparation; the dose to be taken; the prescriber's signature and date; and the patient's full name and address.

18. For how long is a Schedule 2, 3 or 4 controlled drug prescription valid from the appropriate date?

    28 days from the appropriate date.

See more Law, Ethics and Professional Practice flashcards →

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

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