Week 11 / Introduction to Medicines Regulations

Question 1

Flashcard 1
Q: What are the two major classes of law?

Flashcard 2
Q: How is Statute Law divided?

Flashcard 3
Q: Which types of law might pharmacy professionals encounter? [3]

Flashcard 4
Q: Do penalties differ for breaches of different types of law?

Answer 1

A: Statute Law and Civil Law.

A: Statute Law is divided into Criminal Law, Administrative Law, and Professional Law.

A: Pharmacy professionals may encounter Criminal Law, Administrative Law, and Professional Law.

A: Yes, penalties vary for breach of each type of law.

Question 2

Q: What is the the HMR 2012 legislation?

Answer 2

A: HMR 2012 is a UK-wide legislation with a single legal framework applicable to all medicinal products for human use at every stage of development, production, licensing, and supply.

Question 3

Q: What is the primary aim of HMR 2012?

Answer 3

A: The primary aim is consumer (patient) protection.

Question 4

Q: Does HMR 2012 apply to substances not used as medicines?

Answer 4

A: No, it only applies to substances used as medicines or as ingredients in medicines.

Question 5

Q: Which organizations enforce and monitor the HMR 2012?

Answer 5

A: The Medicines and Healthcare Products Regulatory Agency (MHRA) monitors and enforces the Act, while some aspects related to pharmacy are monitored by the General Pharmaceutical Council.

Question 5

Q: Does HMR 2012 apply to veterinary medicines?

Answer 5

A: No, veterinary medicines are governed by separate legislation.

Question 5

Q: What did the Commission on Human Medicines (CHM) replace?

Answer 5

A: CHM replaced the former Committee on Safety of Medicines (CSM).

Question 6

Q: What is the role of the CHM in relation to medicines regulation? [2]

Answer 6

A: CHM advises ministers on policy matters relating to medicines regulation

and

provides independent advice to MHRA about the safety, quality, or efficacy of medicinal products.

Question 6

Q: Who comprises the members of CHM?

Answer 6

A: CHM members have a wide range of clinical, scientific, and professional expertise.

Question 6

Q: Who appoints the Chairman and members of the CHM?

Answer 6

A: The Chairman and members are appointed by the Appointments Commission, which is independent of Government Ministers.

Question 7

Q: What does the CHM promote regarding adverse drug reactions?

Answer 7

A: CHM promotes the collection and investigation of information relating to adverse drug reactions.

Question 8

Q: What is the primary responsibility of the Medicines and Healthcare Products Regulatory Agency (MHRA)?

Answer 8

A: MHRA is responsible for ensuring that medicines and medical devices work properly and are acceptably safe, safeguarding public health.

Question 9

Q: What is MHRA’s role in licensing in the UK?

Answer 9

A: MHRA is the licensing authority for medicines in the UK.

Question 9

Q: Why does the MHRA regulate clinical trials?

Answer 9

A: MHRA regulates clinical trials of medicines to ensure they are conducted safely and effectively.

Question 10

Q: What does the MHRA do regarding adverse drug reactions?

Answer 10

A: MHRA collects and investigates information related to adverse reactions for human medicines through post-marketing surveillance.

Question 10

Q: What is the MHRA’s role in monitoring the safety and quality of medicines? [2]

Answer 10

A: MHRA monitors the safety and quality of

imported unlicensed medicines

and

investigates the sale of medicines via the internet.

Question 11

Q: What actions does the MHRA take when it identifies issues with medicines?

Answer 11

A: MHRA issues drug alerts, recalls medicines, and investigates counterfeit medicines.

Question 12

Q: How does MHRA promote good practice?

Answer 12

A: MHRA promotes good practice in the safe use of medicines and medical devices.

Question 13

Q: What is the definition of a medicinal product?

Answer 13

A: A medicinal product is any substance or combination of substances presented as having properties of preventing or treating disease in human beings, or any substance that may be used to restore, correct, or modify a physiological function, or make a medical diagnosis.

Question 14

Q: What are the two main purposes a medicinal product serves according to its definition?

Answer 14

A: (1) Preventing or treating disease, and (2) Restoring, correcting, or modifying physiological function or making a medical diagnosis.

Question 15

Q: How is the term “administer” defined in the context of medicinal products?

Answer 15

A: Administer means to give a substance to a human being, either orally, by injection, or by introduction into the body in any other way, or by external application, whether or not it is mixed with a vehicle substance.

Question 15

Q: Are foods and cosmetics considered medicinal products?

Answer 15

A: No, some products such as foods and cosmetics are exempted from medicines legislation.

Question 16

Q: What is included in the definition of a “hospital”?

Answer 16

A: A hospital includes a clinic, nursing home, or similar institution.

Question 17

Q: What should happen if there is doubt about whether a product is a food or a medicinal product?

Answer 17

A: If there is doubt, the product should be regulated as a medicinal product, which means it will undergo stricter regulation.

Question 18

Q: What are Foods that can be prescribed under the NHS, even though they are not medicinal products?

Answer 18

A: Foods listed in the British National Formulary (BNF), approved by the Advisory Council on Borderline Substances (ACBS) for NHS reimbursement, can be prescribed.

Question 19

Q: What similar regulatory issues exist for medical devices?

Answer 19

A: Similar challenges arise with medical devices, as some products may fall into categories that are not clearly defined as medicinal products.

Question 20

Q: How are medical devices regulated?

Answer 20

A: Medical devices are regulated under separate legislation, the Medical Devices Regulation 2002 (as amended), which is not considered medicinal product legislation.

Question 21

Q: What are the three main types of medical devices?

Answer 21

A: Active implantable medical devices (e.g., cardiac pacemakers, catheters) General medical devices (e.g., bandages, contact lenses) In vitro diagnostic medical devices (IVDs) (e.g., pregnancy testing kits, BP machines, blood glucose monitors)

Question 22

Q: What is the main difference between a medical device and a medicinal product?

Answer 22

A: A medical device does not achieve its principal intended action on the human body by pharmacological, immunological, or metabolic means.

Question 23

Q: What logo should medical devices have to show they meet safety and performance requirements in the UK?

Answer 23

A: The UKCA (UK Conformity Assessed) logo, indicating the device is fit for its stated use.

Question 24

Q: Is the CE logo still valid for medical devices in the UK?

Answer 24

A: Yes, the CE logo is still accepted by the MHRA until 30 June 2030, even though the UK is no longer part of the EU.

Question 25

Q: What is the difference between the UKCA and CE logos?

Answer 25

A: The UKCA logo is used for devices marketed in the UK, while the CE logo is the EU symbol and is not accepted within the UK after 30 June 2030.

Question 26

Q: How can adverse effects from medical devices be reported in the UK?

Answer 26

A: Adverse effects and defective devices can be reported to the MHRA via the yellow card scheme.

Question 27

Q: What kind of alerts does the MHRA issue regarding medical devices?

Answer 27

A: The MHRA can issue alerts about medical devices, similar to the way they issue alerts for medicinal products.

Question 28

Q: When did the Medicines and Medical Devices Act 2021 become law?

Answer 28

A: The Medicines and Medical Devices Act 2021 became law on 11 February 2021.

Question 29

Q: Why was the Medicines and Medical Devices Act 2021 introduced?

Answer 29

A: The Act was introduced after the UK left the EU to amend medicines legislation that had been repealed and to create a legal authority for the Government to make changes to medicines laws.

Question 30

Q: What role does the Patient Safety Commissioner play under the Medicines and Medical Devices Act 2021?

Answer 30

A: The Patient Safety Commissioner’s statutory core duties are to: Promote patient safety regarding the use of medicines and medical devices. Promote the importance of patients’ and the public's views on the safety of medicines and medical devices.

Question 31

Q: What is one significant change related to patient information leaflets under the Medicines and Medical Devices Act 2021?

Answer 31

A: The Act allows medicine manufacturers to signpost patients to up-to-date statutory information about certain medicines on digital platforms, instead of including hard copy patient information leaflets in packaging.

Question 32

Q: What healthcare change does the Medicines and Medical Devices Act 2021 allow regarding the prescribing of medicines?

Answer 32

A: The Act allows the prescribing of 'low risk' medicines by a range of other healthcare professionals, expanding prescribing authority beyond traditional prescribers.

Question 33

1) There is no definition of ‘medicine’ in the Human Medicines Regulations 2012. False The Human Medicines Regulations 2012 define ‘medicinal product’ in detail, as any substance or combination of substances presented as having properties to prevent or treat disease, or to modify physiological functions through pharmacological, immunological, or metabolic action. 2) Cigarettes containing nicotine are medicinal products. False Cigarettes containing nicotine are not considered medicinal products. However, nicotine replacement therapies (like gums or patches) are medicinal products because they are intended to help people stop smoking. 3) Transdermal nicotine patches are medicinal products. True Transdermal nicotine patches are medicinal products as they are intended to help people quit smoking, and they are designed to deliver nicotine in a controlled way to manage withdrawal symptoms. 4) A condom is a medical device. True Condoms are regulated as medical devices because they are intended to prevent pregnancy and sexually transmitted infections (STIs), and they do not achieve their principal action by pharmacological means. 5) All shampoos are cosmetics and are therefore exempt from the HMR 2012. False Not all shampoos are cosmetics. Some shampoos with medicinal claims or ingredients, such as those intended to treat dandruff, might be classified as medicinal products under HMR 2012. 6) A salbutamol MDI inhaler is classified as a medical device. False A salbutamol MDI (Metered Dose Inhaler) is classified as a medicinal product under the Human Medicines Regulations because it contains an active pharmaceutical ingredient (salbutamol) that exerts a pharmacological effect. 7) A 5ml oral syringe is classified as a medical device. True A 5ml oral syringe is considered a medical device because it is intended to be used for medical purposes to administer a measured dose of liquid to a patient. 8) Medical devices cannot be prescribed on an NHS prescription. False Medical devices can be prescribed on an NHS prescription. Certain devices, like blood glucose monitors or insulin pens, are commonly prescribed to patients. 9) A medical device may have the CE and the UKCA logo on the packaging. True A medical device can have both the CE mark (for the EU) and the UKCA mark (for the UK) on the packaging, depending on where the device is being marketed. The UKCA mark is required for the UK market after Brexit. 10) The UKCA logo is not valid in Northern Ireland. True Due to the Northern Ireland Protocol, the UKCA logo is not valid in Northern Ireland for medical devices; instead, the CE mark continues to be accepted in Northern Ireland. 11) A smart phone app can be regulated as a medical device. True A smartphone app can be regulated as a medical device if it is intended for medical purposes, such as monitoring a health condition or providing diagnostic information.

Answer 33

1) There is no definition of ‘medicine’ in the Human Medicines Regulations 2012. False The Human Medicines Regulations 2012 define ‘medicinal product’ in detail, as any substance or combination of substances presented as having properties to prevent or treat disease, or to modify physiological functions through pharmacological, immunological, or metabolic action. 2) Cigarettes containing nicotine are medicinal products. False Cigarettes containing nicotine are not considered medicinal products. However, nicotine replacement therapies (like gums or patches) are medicinal products because they are intended to help people stop smoking. 3) Transdermal nicotine patches are medicinal products. True Transdermal nicotine patches are medicinal products as they are intended to help people quit smoking, and they are designed to deliver nicotine in a controlled way to manage withdrawal symptoms. 4) A condom is a medical device. True Condoms are regulated as medical devices because they are intended to prevent pregnancy and sexually transmitted infections (STIs), and they do not achieve their principal action by pharmacological means. 5) All shampoos are cosmetics and are therefore exempt from the HMR 2012. False Not all shampoos are cosmetics. Some shampoos with medicinal claims or ingredients, such as those intended to treat dandruff, might be classified as medicinal products under HMR 2012. 6) A salbutamol MDI inhaler is classified as a medical device. False A salbutamol MDI (Metered Dose Inhaler) is classified as a medicinal product under the Human Medicines Regulations because it contains an active pharmaceutical ingredient (salbutamol) that exerts a pharmacological effect. 7) A 5ml oral syringe is classified as a medical device. True A 5ml oral syringe is considered a medical device because it is intended to be used for medical purposes to administer a measured dose of liquid to a patient. 8) Medical devices cannot be prescribed on an NHS prescription. False Medical devices can be prescribed on an NHS prescription. Certain devices, like blood glucose monitors or insulin pens, are commonly prescribed to patients. 9) A medical device may have the CE and the UKCA logo on the packaging. True A medical device can have both the CE mark (for the EU) and the UKCA mark (for the UK) on the packaging, depending on where the device is being marketed. The UKCA mark is required for the UK market after Brexit. 10) The UKCA logo is not valid in Northern Ireland. True Due to the Northern Ireland Protocol, the UKCA logo is not valid in Northern Ireland for medical devices; instead, the CE mark continues to be accepted in Northern Ireland. 11) A smart phone app can be regulated as a medical device. True A smartphone app can be regulated as a medical device if it is intended for medical purposes, such as monitoring a health condition or providing diagnostic information.