LAW

Question 1

What does the Pharmacy Act 1852 establish?

Answer 1

Framework of the pharmaceutical society

Established the power to hold examinations and issue certificates, making ‘pharmaceutical chemist’ a protected title.

Question 2

What are the three legal classes of medicines as per the Medicines Act 1968?

Answer 2

• POM – Prescription Only Medication
• P – Pharmacy Only Medication
• GSL – General Sales List

Question 3

What is required for all products to be legally sold?

Answer 3

A ‘Marketing Authorisation’ issued by the MHRA

Ensures quality and safety of medicines.

Question 4

What does legal classification of medicines relate to?

Answer 4

The PRODUCT and not the active substance

The same drug substance may be classified differently based on the product.

Question 5

Fill in the blank: Paracetamol can be classified as GSL, P, or POM depending on _______.

Answer 5

[pack size]

Question 6

What tighter controls were introduced for Codeine and Dihydrocodeine in September 2009?

Answer 6

Aim to minimize overuse and addiction

These medications are POM for products with over 32 dose units.

Question 7

What is unlawful under the Human Medicines Regulations 2012 regarding Pseudoephedrine and Ephedrine?

Answer 7

Supply of more than 720mg of Pseudoephedrine or 180mg of Ephedrine at one time without a prescription.

Question 8

True or False: The Responsible Pharmacist (RP) can be absent from the pharmacy for a maximum of 2 hours in a 24-hour period.

Answer 8

True

Question 9

What is the statutory duty of the Responsible Pharmacist (RP)?

Answer 9

Ensure safe and effective running of the pharmacy.

Question 10

What major change did the Human Medicines Regulations 2012 introduce regarding pharmacy practice?

Answer 10

Enabled the use of professional judgement when labelling medicines.

Question 11

What is the implication of the Health Act 1999?

Answer 11

Modernised and strengthened regulation of healthcare professionals.

Question 12

What must be displayed by the Responsible Pharmacist in the pharmacy?

Answer 12

A notice with their name, registration number, and a statement confirming they are in charge.

Question 13

What are the potential changes that can be made to medication labels under the Human Medicines Regulations 2012?

Answer 13

• Change directions
• Change name or common name of medicine
• Change precautions on label

Question 14

Fill in the blank: Generic substitution for a branded product would be considered _______.

Answer 14

[NHS fraud]

Question 15

What are the legal requirements for a prescription to be valid?

Answer 15

Specific information must be present as summarized in the MEP section 3.3.

Question 16

What does the term ‘PO’ refer to in pharmacy law?

Answer 16

Pharmacy Only, not a separate legal classification but indicates some GSL ingredients licensed for sale through pharmacies.

Question 17

What is the purpose of formularies in prescribing?

Answer 17

Lists of preparations that can be prescribed by specific types of prescribers.

Question 18

What is the consequence of prescribing restrictions for independent and supplementary prescribers?

Answer 18

Prescribing is restricted to areas of clinical competence and included within an agreed clinical management plan.

Question 19

What does the ‘FP10’ prescription form signify?

Answer 19

Used by GP/Hospital Doctors, Independent Prescribers, and Supplementary Prescribers.

Question 20

What is the main responsibility of a pharmacist regarding Emergency Hormonal Contraception?

Answer 20

Assess clinical suitability and approve sales.

Question 21

What healthcare professionals can sell, supply, and/or administer certain medicines under specific exemptions made under the HMR?

Answer 21

• Midwives
• Orthoptists
• Optometrists
• Paramedics
• Podiatrists/Chiropodists

Question 22

What is the maximum number of dose units for Codeine before it is classified as POM?

Answer 22

32 dose units.

Question 23

What is the legal classification of Levonorgestrel 1500 microgram tablets?

Answer 23

Licensed as a P medicine.

Question 24

What distinguishes between the two preparations of Levonelle?

Answer 24

Different dosages and their implications in terms of supply.

Question 25

What is the majority method of prescribing in practice?

Answer 25

Electronic tokens sent via EPS ## Footnote EPS stands for Electronic Prescription Service, which streamlines the prescribing process.

Question 26

What are the key legal requirements for a prescription to be valid?

Answer 26

Must include the following information: * Signed in ink (if handwritten) * Dated * Written/generated in indelible ink * Address of practitioner * Particulars indicating type of prescriber * Name and address of patient * Age (if under 12 years) * Additional requirements for CDs in schedule 2 and 3 ## Footnote CDs refer to Controlled Drugs.

Question 27

What information is legally required on a medicine label?

Answer 27

Must include: * Name of the patient * Name and address of the supplying pharmacy * Date of dispensing * Name of the medicine * Directions for use * Precautions related to the use of the medicine ## Footnote C&A labels refer to caution and advisory labels.

Question 28

What additional label recommendations does the Royal Pharmaceutical Society suggest?

Answer 28

Should include: * 'Keep out of the sight and reach of children' * 'Use this medicine only on your skin' ## Footnote These recommendations enhance safety for patients.

Question 29

What changes did the amendments to the Poisons Act 1972 introduce?

Answer 29

Changes include: * Classification and regulation of poisons and chemicals * Requirement to report suspicious transactions, significant stock loss, and theft to the police * Valid licence requirement for public to purchase dangerous poisons or chemicals ## Footnote Licences must be checked for validity and matching requests.

Question 30

What must pharmacists do when a licence is required for purchasing poisons?

Answer 30

Pharmacy teams must: * Check the licence is valid * Ensure it is unaltered * Confirm it matches the request ## Footnote This ensures compliance with legal requirements.

Question 31

What are the three key regulations related to chemicals mentioned?

Answer 31

* REACH (Registration, Evaluation, Authorisation and restriction of chemicals) * CLP (Classification, Labelling and packaging of chemicals) * COSHH (Control of Substances Hazardous to Health) ## Footnote These regulations help ensure safety and compliance in handling chemicals.

Question 32

What are Controlled Drugs (CDs)?

Answer 32

Substances controlled by the Misuse of Drugs Act 1971 and Misuse of Drugs Regulations 2001 ## Footnote CDs are scheduled based on the risk and potential harm from abuse.

Question 33

What do drug schedules determine?

Answer 33

Schedules determine: * Degree of control * Storage requirements * Record keeping requirements ## Footnote These vary depending on the substance's classification.

Question 34

What is the significance of the MEP section 3.3.1?

Answer 34

Summarizes the legal prescription requirements ## Footnote MEP stands for Medicines, Ethics, and Practice.

Question 35

What are the two parts of the Pharmacy guide from RPS regarding poisons?

Answer 35

* Part 1 – Regulated explosive pre-cursors * Part 2 – Regulated non-medicinal poisons ## Footnote These guides provide essential information on regulated substances.

Question 36

Fill in the blank: Controlled drugs are scheduled according to their _______.

Answer 36

[risk and potential harm from abuse]

Question 37

True or False: The schedules of controlled drugs are the same as the classes used to classify substances in law.

Answer 37

False ## Footnote Schedules and classes are different classifications.