The Use of Medicines

Question 1

List aims of medicine regulation

Answer 1

To ensure :

• Medicines have required quality, safety and efficacy
• Medicines are appropriately manufactured, stored, distributes and dispensed
• Promotion and advertising is fair

Question 2

What does medicine regulation allow ?

Answer 2

Detection of illegal manufacturing and trade.

Question 3

What does health regulation provide ?

Answer 3

Health professionals/patients with information to enable the safe use of medicines.

Framework to allow access to new medicines

Question 4

What % of medicines in the world are counterfeit ?

Answer 4

Up to 10% of medicines in the world are counterfeit.

Question 5

State the Medicine Regulator in the UK

Answer 5

MHRA - Medicines and Healthcare products regulatory agency

Question 6

What is the function of the MHRA ?

Answer 6

Approves and Licences meds in the UK - issues clinical trial authorisations and marketing authorisations

Question 7

Describe the role of MHRA

What does MHRA have the power to do ?

Answer 7

Has the power to withdraw meds from the market

Monitors safety

Issues manufacturers and wholesale dealers licenses.

Question 8

What are marketing authorisations ?

Answer 8

Granted for a period of 5 years.

Ensures that the medicine meets the standards of safety, quality and efficacy.

Question 9

What is the Summary of Product Characteristics ?

Answer 9

The terms which specifies what sort of conditions and patients the medicine is licensed for.

Question 10

SmPC

Answer 10

Summary of product characteristics

Question 11

Where can you find the SmPC ?

Answer 11

Electronic Medicines Compendium

Question 12

Describe unlicensed medicines

Answer 12

No marketing authorisation, includes “special/bespoke” formulations, imported drugs, chemicals.

Question 13

“special/bespoke formulations “

Answer 13

Crushing a tablet

(tablet is the licensed form not crushed form)

Question 14

Describe off-label medicines

Answer 14

Has a marketing authorisation but prescribed outwith the terms of licence.

(different dose, age of patient, indication, route, contra-indication)

Question 15

Off-label medications

Answer 15

Using a licensed medicine for an indication thats not on the summary of product characteristics.

Question 16

Understand the significance of prescribing medicines unlicensed or off-label

Answer 16

There is an increased prescriber responsibility.

You must document and justify reasons for prescribing

Benefits outweigh risk ?

Question 17

When prescribing unlicensed or off-label medicines, what are some things you need to ensure ?

Answer 17

Ensure :

• Sufficient evidence for use
• Adequate monitoring and follow-up
• Patient is aware the medicine being used is outwith license (“label”)

Question 18

Describe off-label thalidomide use

Answer 18

Marked as a sedative - became over-the counter

Resulted in tragedy - caused malformation of limbs and other developmental problems

Question 19

Medicine Act 1968

Answer 19

Provided legal framework regarding control of medicines in the UK

Question 20

Misuse of Drugs Act 1971

Answer 20

Prohibits activities around certain drugs

Question 21

Aim of the misuse of drugs act 1971

Answer 21

To prevent misuse of potentially dangerous drugs by applying penalties to their manufacture, supply or possession.

Separated drugs into 3 classes

Question 22

Class A drugs examples

Answer 22

Cocaine, Heroin, Methadone, Magic Mushrooms

Question 23

Consequences for possessing/supplying Class A drugs

Answer 23

Possession : 7 years + fine

Supply : Life + Fine

Question 24

Class B drugs examples

Answer 24

Cannabis, Mephedrone

Question 25

Consequences for possessing/supplying Class B drugs

Answer 25

Possession : 5 Years + fine Supply : 14 years + fine

Question 26

Class C drugs examples

Answer 26

Anabolic steroids, Benzodiazepines

Question 27

Consequences for possessing/supplying Class C drugs

Answer 27

Possession : 2 years + fine Supply : 14 years + fine

Question 28

Misuse of Drugs Regulations 2001

Answer 28

To allow the possession and supply of controlled drugs for legitimate purposes

Question 29

Describe the misuse of drugs regulations | State the schedules of controlled drug

Answer 29

5 Schedules of Controlled Drug : 1. Lysergide 2. Opiates 3. Some benzodiazepines 4. Anabolic steroids 5. Codeine

Question 30

Human Medicines Regulations 2012

Answer 30

Simplified set of rules, introduced pharmacovigilance requirements.

Question 31

Describe human medicines regulations 2012

Answer 31

Information on labelling of medicines and patient group directions.

Question 32

Controversies of drugs

Answer 32

Just because a drug is legal to supply and use doesn't mean it is safe.

Question 33

FRANK

Answer 33

Honest information about drugs

Question 34

State the 3 legal categories of medicines in the UK

Answer 34

GSL P POM

Question 35

GSL

Answer 35

General Sales List

Question 36

P

Answer 36

Pharmacy Only

Question 37

POM

Answer 37

Prescription only medicine

Question 38

Describe General Sale List

Answer 38

Can be sold in registered pharmacies but also in other retail outlets : e.g. paracetamol - over the counter

Question 39

Describe pharmacy only medicines

Answer 39

Not for public self-selection Additional legal/professional considerations Check for contra-indications, and give appropriate advice.

Question 40

Describe prescription only medicine

Answer 40

Written by an "appropriate practitioner" before it can be sold/supplied An increasing number of medicines are reclassified from POM to P - improving access to medicines with safety net of pharmacists.

Question 41

Who are appropriate practitioners ?

Answer 41

Doctor Dentist Supplementary Prescriber Nurse independent practitioner Pharmacist independent prescriber

Question 42

Describe the GMC 2013

Answer 42

Describe what is expected of all registered doctors

Question 43

Summarise general principles of safe and legal prescribing

Answer 43

Prescriber is responsible for prescriptions signed for Must be able to explain and justify your decision to prescribe, including if unlicensed/off-label use.

Question 44

General principles of safe and legal prescribing (in terms of prescriber)

Answer 44

Keep up to date Report adverse events Work within limits of competence Take account of evidence-based, clinical guidelines

Question 45

Legal considerations of prescription writing

Answer 45

Name and Address of patient If patient is under 12, specify age Name of drug, strength, quantity, dose, frequency

Question 46

Describe controlled drugs

Answer 46

Valid for 28 days from the appropriate date Specify formulation and strength Total amount in words and figures

Question 47

State the 5 R's of medicine safety

Answer 47

Right patient Right drug Right dose Right route Right time

Question 48

State some important parts of safe prescribing

Answer 48

Legible writing Unambiguous No abbreviations No latin

Question 49

Summarise the routes available to report adverse events involving medicines

Answer 49

MHRA Yellow Card Scheme MHRA Drug Alerts

Question 50

MHRA yellow card scheme

Answer 50

Report suspected adverse reactions to any therapeutic agent

Question 51

"Black triangle" drugs

Answer 51

Newly licensed drugs that require intensive monitoring

Question 52

MHRA Drug Alerts

Answer 52

To communicate problems to al healthcare professionals

Question 53

Why use incident reporting systems ?

Answer 53

Improves medicine safety TO share the learning, look for trends, target areas of concern.

Question 54

Explain the role of evidence based guidelines

Answer 54

Maximise safety and efficacy Reduce variation in practice Advise on best value Support practitioners

Question 55

What are evidence based guidelines ?

Answer 55

Result of a systematic review of literature by multi-disciplinary teams.

Question 56

What do evidence based clinical guidelines do ?

Answer 56

Recommend management and treatment options for specific conditions

Question 57

UK Guidelines

Answer 57

SIGN - Scottish NICE - English

Question 58

Explain the role of medicine formularies

Answer 58

A list of prescription drugs used by practitioners to identify drugs that offer the greatest overall value in terms of safety, efficacy and cost.

Question 59

Individual country medicine advice (SMC)

Answer 59

Independent, multi-professional Analyses health benefits of meds Compares to other treatment