L29, 35 Workplace regulations, Advertising

Question 1

29

What are the four types of care in the NHS ecosystem?

Answer 1

Primary care: First contact services like GPs, pharmacists, dentists.

Secondary care: Specialist services, usually via hospital referrals (planned or emergency).

Tertiary care: Highly specialised care like transplants and neurosurgery.

Community health: District nursing, health visiting, and outpatient care at home.

Question 2

29

What is the difference between primary and secondary care?

Answer 2

Primary care is patient’s first point of contact and handles general health needs.

Secondary care involves specialist care, usually in hospitals, and often requires a referral from primary care.

Question 3

29

How are general practices funded under the NHS?

Answer 3

GPs are funded through contracts with NHS England. The Quality and Outcomes Framework (QOF) is used to incentivise quality care. Most GPs are also part of Primary Care Networks (PCNs), which serve local populations within Integrated Care System areas.

Question 4

29

How do community pharmacies fit into the NHS?

Answer 4

Community pharmacies are usually independent businesses contracted to provide NHS services. Their funding is governed by the Community Pharmacy Contractual Framework (CPCF), which is nationally negotiated.

Question 5

29

What are the main types of NHS Trusts involved in secondary care?

Answer 5

Acute Trusts: Provide hospital and emergency services.

Ambulance Trusts: Handle emergencies and transport, including NHS 111 services.

Community Trusts: Provide home-based and outpatient services.

Mental Health Trusts: Offer inpatient and outpatient psychological and psychiatric care.

Question 6

29

What is NHS England and what does it do?

Answer 6

NHS England is the statutory body that oversees healthcare delivery in England. It is independent of the government and is responsible for commissioning services and ensuring their effectiveness.

Question 7

29

What are Integrated Care Systems (ICSs)?

Answer 7

ICSs are partnerships between NHS bodies, local authorities, and third-sector organisations that manage resources and services across regions. Introduced under the Health and Care Act 2022, ICSs replaced Clinical Commissioning Groups (CCGs).

Question 8

29

What are the two statutory bodies within an ICS?

Integrated Care System

Answer 8

Integrated Care Board (ICB): Handles NHS funding, workforce planning, and commissioning.

Integrated Care Partnership (ICP): Sets broad strategies including public health and social care.

Question 9

29

What is a Special Health Authority and who controls it?

Answer 9

A SpHA is an arm’s length body supporting the Department of Health and Social Care’s goals. It operates under the direction of the Secretary of State.

Question 10

29

Name key Special Health Authorities and their functions.

Answer 10

NHS Blood and Transplant (NHSBT): Manages supply of blood, organs, tissues, and stem cells.

NHS Business Services Authority (NHSBSA): Handles payments, drug tariff, and contractor services.

Health Research Authority (HRA): Ensures ethical conduct in health and social care research.

NICE (originally a SpHA): Now a non-departmental public body that produces national guidelines.

Question 11

29

What does NICE do and why is it important?

Answer 11

NICE provides independent, evidence-based guidance on best practice and value for money in healthcare. It develops clinical guidelines, health technology appraisals, and promotes uptake of innovations.

Question 12

29

What is the purpose of the Health and Safety at Work Act 1974?

Answer 12

This Act ensures workplace safety and wellbeing, enforced by the Health and Safety Executive (HSE). It covers slips, sharps, lone working, stress, radiation, expectant mothers, and more.

Question 13

29

What does the Data Protection Act 2018 regulate?

Answer 13

It governs how personal data is collected, stored, and used. Data must be used fairly, lawfully, and only for specific purposes. It provides extra protection for sensitive data (e.g., health, religion, ethnicity, sexual orientation).

Question 14

29

What are the individual rights under the Data Protection Act?

Answer 14

To access personal data.

To have data updated or erased.

To restrict or object to processing.

To reuse data via data portability.

To be informed of data usage.

Question 15

29

When can data access requests be denied under the Act?

Answer 15

Requests can be denied if disclosure would affect crime prevention, national security, tax collection, or judicial appointments.

Question 16

29

What is the Freedom of Information Act 2000?

Answer 16

It gives public access to information held by public bodies. Authorities must publish certain data and respond to public information requests. It does not apply to personal medical or credit records.

Question 17

29

Who handles patient complaints in the NHS?

Answer 17

Each NHS organisation has a complaint process and designated staff. Complaints can also be made to the Care Quality Commission (CQC), which ensures national standards are met.

Question 18

29

Who handles complaints about pharmacists or pharmacies?

Answer 18

The MHRA and GPhC deal with general issues. Serious concerns go to the GPhC’s Fitness to Practise Committee, which can warn, suspend, or remove professionals from the register.

Question 19

29

Which of the following statements about Integrated Care Systems (ICSs) is correct?
A. ICSs are departments within NHS hospitals responsible for training healthcare professionals
B. ICSs were introduced by the Health and Social Care Act 2012 to replace Primary Care Trusts
C. ICSs are statutory partnerships that replaced CCGs and manage commissioning and system-wide strategy
D. ICSs are independent regulatory bodies responsible for assessing clinical research

Answer 19

C. ICSs are statutory partnerships that replaced CCGs and manage commissioning and system-wide strategy

Question 20

29

Which two statutory bodies form part of each Integrated Care System under the Health and Care Act 2022?
A. NHS England and Public Health England
B. Primary Care Network and Mental Health Trust
C. Integrated Care Board and Integrated Care Partnership
D. Care Quality Commission and NICE

Answer 20

C. Integrated Care Board and Integrated Care Partnership

Question 21

29

Which organisation produces the NHS drug tariff and manages pharmacy remuneration?
A. Care Quality Commission (CQC)
B. National Institute for Health and Care Excellence (NICE)
C. NHS Business Services Authority (NHSBSA)
D. Medicines and Healthcare products Regulatory Agency (MHRA)

Answer 21

C. NHS Business Services Authority (NHSBSA)

Question 22

29

What is the primary function of the Care Quality Commission (CQC)?
A. To regulate only private health services
B. To inspect and regulate all health and social care services in England
C. To determine NHS funding allocations to Integrated Care Boards
D. To develop professional guidelines for pharmacists

Answer 22

B. To inspect and regulate all health and social care services in England

Question 23

29

What makes community pharmacies a unique part of NHS primary care?
A. They are all government-owned and directly managed by NHS England
B. They are independent businesses contracted nationally to provide NHS services
C. They are part of secondary care and mainly provide outpatient prescriptions
D. They are regulated by the Department for Work and Pensions

Answer 23

They are independent businesses contracted nationally to provide NHS services

Question 24

29

Under the Data Protection Act 2018, which of the following is classified as sensitive personal information?
A. National Insurance number
B. Date of birth
C. Religion
D. Postcode

Answer 24

C. Religion

Question 25

# 29 Which scenario would justify an organisation withholding personal data under the Data Protection Act 2018? A. The data includes minor personal opinions B. The data involves medical treatment carried out 10 years ago C. The data is linked to an ongoing criminal investigation D. The data was stored digitally rather than in paper records

Answer 25

C. The data is linked to an ongoing criminal investigation

Question 26

# 29 A member of the public submits a Freedom of Information request about medicine use within a hospital. Which of the following is true? A. The request must include a reason to be valid B. The hospital can deny the request because it’s a private matter C. The FOIA applies and the hospital must respond within 20 working days D. The FOIA allows access to personal medical records

Answer 26

C. The FOIA applies and the hospital must respond within 20 working days

Question 27

# 29 Which of the following best describes the function of NICE? A. It determines legal penalties for medicine misuse B. It audits NHS Trusts for safety and infection control C. It provides evidence-based guidance to improve care and ensure cost-effectiveness D. It investigates malpractice in pharmaceutical trials

Answer 27

C. It provides evidence-based guidance to improve care and ensure cost-effectiveness

Question 28

# 29 A pharmacist receives a complaint from a patient regarding the conduct of a pharmacy technician. Who is responsible for investigating serious misconduct? A. Health and Safety Executive B. NHS England C. Fitness to Practise Committee of the GPhC D. National Institute for Health and Care Excellence

Answer 28

C. Fitness to Practise Committee of the GPhC

Question 29

# 35 Why is the advertising of medicines regulated?Why is it necessary to regulate the advertising and promotion of medicines in the UK?

Answer 29

To protect public health and patient safety, ensure advertisements are truthful and not misleading, build public confidence, promote ethical competition with substantiated claims, and comply with additional legislation for herbal and homeopathic medicine

Question 30

# 35 What is considered advertising of medicines?

Answer 30

Any activity promoting prescription, supply, sale, or use of a medicine, including: paid adverts (TV, radio, online), company websites, social media, sales rep visits, emails, supplying samples, gifts, inducements, and sponsorships of relevant meetings.

Question 31

# 35 What materials are not considered advertising for medicines?

Answer 31

Reference materials, factual statements, trade catalogues and price lists without product claims, patient information leaflets, and independent reference sources like the BNF.

Question 32

# 35 Which organisations regulate medicine advertising in the UK?

Answer 32

Medicines and Healthcare products Regulatory Agency (MHRA), Advertising Standards Authority (ASA), and self-regulatory bodies like the ABPI and PAGB.

Question 33

# 35 Which categories of medicines can be advertised to the public in the UK?

Answer 33

General Sales List (GSL) and Pharmacy (P) medicines can be advertised. Prescription Only Medicines (POM) cannot be advertised to the public, except in government-approved campaigns (e.g., vaccinations).

Question 34

# 35 What information must all medicine adverts include?

Answer 34

Product name, active ingredient, intended use, and the statement “Always read the label” or “Always read the leaflet”.

Question 35

# 35 List key restrictions on the advertising of medicines.

Answer 35

No misleading claims, no implication of guaranteed efficacy or safety, no endorsements from healthcare professionals, no claims of being "essential", no free samples to patients, no advertising to children under 16, and no claims based on the product being “natural”.

Question 36

# 35 What is meant by POM to P or GSL switching?

Answer 36

It’s when manufacturers apply to reclassify a Prescription Only Medicine (POM) to Pharmacy (P) or General Sales List (GSL) status, allowing OTC sale with restricted usage, improving accessibility and reducing GP visits.

Question 37

# 35 What is ‘prescription direction’ and is it permitted?

Answer 37

Prescription direction is when a prescriber directs a patient to a specific pharmacy. It is not permitted as it undermines patient choice and breaches NHS regulations. EPS nomination by patient choice is allowed.

Question 38

# 35 What sanctions apply for breaches of medicine advertising regulations?

Answer 38

Sanctions include corrective statements, fines, material audits, pre-vetting of adverts, public reprimands, suspension or expulsion from industry bodies, and prosecution in serious cases.

Question 39

# 35 What key rules does the Human Medicines Regulations 2012 establish regarding advertising?

Answer 39

POMs can only be advertised to the public in government-approved campaigns. Unlicensed medicines cannot be advertised. All adverts must comply with the Summary of Product Characteristics (SPC), promote rational use, and be objective and non-misleading.

Question 40

# 35 What role does the Advertising Standards Authority (ASA) play in medicine advertising regulation?

Answer 40

ASA enforces the Consumer Protection from Unfair Trading Regulations 2008, regulates all UK adverts (broadcast & non-broadcast), and ensures compliance with advertising codes of practice. They cover additional rules for sectors like medicines, food, alcohol, and tobacco.

Question 41

# 35 How does the pharmaceutical industry self-regulate advertising practices?

Answer 41

Through codes of practice by the ABPI (for prescription medicines) and PAGB (for OTC medicines). Self-regulation includes ethical guidelines, reporting mechanisms for concerns, and sanctions such as suspensions or public reprimands for breaches.

Question 42

# 35 What are the advertising requirements when promoting medicines to healthcare professionals?

Answer 42

Adverts must state: product name, active ingredient, licensed indications, SPC summary (adverse reactions, dosage, precautions), licence number, supplier, and cost. Sales reps must be trained (e.g., by ABPI) and scientifically knowledgeable.

Question 43

# 35 What are the rules regarding gifts, sponsorship, and hospitality in medicine promotion?

Answer 43

Gifts/incentives are prohibited unless inexpensive (<£6) and relevant to medical practice. Reasonable hospitality for educational events is allowed. Breaches may result in prosecution for both companies and healthcare professionals.

Question 44

# 35 What rules apply to advertising traditional herbal and homeopathic medicines?

Answer 44

Such medicines must be registered under the Traditional Herbal Medicines Registration Scheme. Advertising must not imply clinical evidence of efficacy, avoiding terms like “clinically proven” or “effective for”.

Question 45

# 35 Which of the following is NOT a primary reason for regulating the advertising of medicines in the UK? A) To ensure medicines are promoted with substantiated claims B) To allow manufacturers to increase brand visibility C) To maintain public confidence in advertised information D) To protect consumers from misleading or exaggerated claims

Answer 45

B – Increasing brand visibility is a commercial interest, not a regulatory aim. Regulation focuses on patient safety, truthful advertising, and ethical standards.

Question 46

# 35 Which of the following activities would NOT be considered advertising under UK medicines legislation? A) A pharmacy chain distributing leaflets about their seasonal flu jab service B) A pharmaceutical company’s website listing product prices without claims C) A company giving branded pens to prescribers as a promotional gift D) A sales representative verbally promoting a new medicine to a GP

Answer 46

B – A price list without product claims is considered informational, not advertising. The other options involve promotional intent.

Question 47

# 35 Which statement regarding the advertising of POMs in the UK is FALSE? A) POMs can be advertised to healthcare professionals under specific regulations B) POMs cannot be advertised to the public except via approved public health campaigns C) Unlicensed “specials” can be advertised to the public with cautionary statements D) Advertising of POMs must comply with their Summary of Product Characteristics (SPC)

Answer 47

C – Unlicensed medicines (“specials”) must not be advertised to the public or professionals under any circumstance.

Question 48

# 35 Which of the following is MANDATORY in all UK medicine adverts directed at the public? A) A celebrity endorsement B) A visual comparison with competitor brands C) The name of the active ingredient D) A claim of having no side effects

Answer 48

C – The active ingredient must be included. Celebrity endorsements and comparisons with named products are restricted, and suggesting no side effects is prohibited.

Question 49

# 35 In the event of an advertising breach, which of the following is NOT an available sanction by the Prescription Medicines Code of Practice Authority (PMCPA)? A) Suspension from the Association of the British Pharmaceutical Industry (ABPI) B) Mandatory re-training of sales representatives C) Requirement to issue a corrective statement D) Pre-vetting of promotional materials for a specified period

Answer 49

B – While companies may choose to retrain staff, mandatory re-training by PMCPA is not a formal sanction. The other options are official sanctions.

Question 50

# 35 Which statement about advertising traditional herbal and homeopathic medicines is INCORRECT? A) Registration is based on traditional use, not clinical evidence B) Claims like “clinically proven” are allowed if supported by anecdotal evidence C) Advertising must not imply scientific proof of effectiveness D) Products must be registered with the Traditional Herbal Medicines Registration Scheme

Answer 50

B – Claims like “clinically proven” are prohibited, even if anecdotal evidence exists. Advertising must not suggest clinical efficacy.

Question 51

# 35 Which of the following scenarios would be considered acceptable practice regarding gifts and incentives? A) Providing free medicine samples to patients as part of a promotional campaign B) Offering a prescriber £50 vouchers for every 10 prescriptions written C) Giving prescribers low-cost educational booklets relevant to their practice D) Sponsoring an all-expenses-paid luxury trip for pharmacists to promote a new OTC product

Answer 51

C – Small, inexpensive items relevant to practice (e.g., educational materials) are allowed. The other options involve prohibited inducements or inappropriate hospitality.

Question 52

# 35 Which of the following is the most accurate reason why POM to P switching is beneficial in healthcare systems? A) It allows pharmaceutical companies to freely advertise prescription medicines B) It reduces the need for Summary of Product Characteristics (SPC) compliance C) It increases patient access to medicines for suitable conditions D) It eliminates the need for MHRA regulation for those medicines

Answer 52

C – Switching increases accessibility by allowing OTC sales for certain indications. SPC compliance and MHRA regulation still apply post-switching.

Question 53

# 35 Why is ‘prescription direction’ by prescribers considered a breach of ethical and legal standards in the UK? A) It contravenes the Human Medicines Regulations 2012 B) It infringes on patients’ right to choose their dispensing pharmacy C) It breaches advertising codes set by the Advertising Standards Authority D) It is considered acceptable as long as no financial inducements are given

Answer 53

B – Prescription direction limits patient choice, violating NHS regulations. Human Medicines Regulations focus on advertising, not prescription direction directly.

Question 54

# 35 Which of the following accurately differentiates the roles of the ASA and MHRA in regulating medicine advertising? A) ASA enforces the Human Medicines Regulations 2012, while MHRA handles general consumer protection B) ASA regulates non-broadcast adverts for medicines; MHRA regulates product licences but not adverts C) ASA oversees advertising standards for all sectors; MHRA specifically regulates medicine advertising and compliance D) ASA provides codes of practice for prescription medicines; MHRA focuses solely on herbal products

Answer 54

C – ASA oversees general advertising standards across sectors, while MHRA specifically regulates medicine advertising compliance, product licensing, and breaches.

Question 55

# 35 Which of the following scenarios is most likely to be considered a subtle breach of UK advertising regulations? A) A pharmacy offers a ‘buy one get one free’ on paracetamol tablets B) An advert claims a herbal cough syrup is “clinically proven” to work C) A social media influencer posts about their experience with a POM D) A pharmacy promotes ibuprofen with a discount for NHS staff

Answer 55

B – Claiming “clinically proven” for a herbal product misleads consumers, as traditional use does not equate to clinical evidence. Influencers discussing POMs (if unpaid & personal) may be grey but less clear-cut than false claims.