Use of Medicine

Question 1

What are the medicine regulation aims (6)

Answer 1

• to ensure medicines have required quality, safety, efficacy
• to ensure medicines are appropriately manufactured, stored, distributed and dispensed
• allows detection of illegal manufacturing and trade
• provides health professionals/patients with information to enable safe use of medicines
• ensures promotion and adverting is fair
• provides framework to allow access to new medicines

Question 2

Who is the main medicine regulator in the UK

Answer 2

MHRA

Question 3

what is the MHRA’s tasks (4)

Answer 3

• approves and licenses meds in the UK - issues clinical trial authorisations and marketing authorisations
• has power to withdraw meds from the market
• monitors safety
• issues manufacturers and wholesale dealers licences

Question 4

what is the MHRAS main role

Answer 4

ensure medicine meets the standards of safety, quality and efficacy.

Question 5

what is meant by an unlicensed drug

Answer 5

no UK marketing authorisation

imported drugs, chemicals and bespoke formulations

Question 6

what is meant by off-label or off-licence

Answer 6

has a marketing authorisation but is prescribed outwit the terms of the licence:

• dosage
• age of patient
• indication
• route
• contra-indication

Question 7

What do you have to be aware of as a prescriber in regards to off-licence drugs

Answer 7

ensure sufficient evidence for use
benefits will outweigh the risk
ensure adequate monitoring and follow up

Question 8

what’s a key example of off-licence drug use

Answer 8

thalidomide:
morning sickness but was intended as a sedative
caused malformations of the limbs however is used now to treat skin conditions such as leprosy

Question 9

Medicine Act 1968

Answer 9

Provided legal framework regarding control of medicines in the uk

Question 10

Medicine of Drugs Act 1971

Answer 10

Prohibits activities around certain drugs
to prevent misuse of potencially dangerous drugs by applying penalties to their manufacture, supply or possession
also separates the drugs into three classes
A cocaine
B cannabis
c anabolic steroids

Question 11

Misuse of drugs regulations 2001

Answer 11

to allow for possession and supply of “controlled drugs” for legitimate purposes
import, export, production, supply, possession and record keeping activities for controlled drugs
there are five different schedules

Question 12

Human Medicines Regulations 2012

Answer 12

simplified set of rules, introduced pharmacovigilance requirements
modernised rules in line with EU guidelines
reduced regulatory burden
clearer pharmacovigilance routes

Question 13

what are the three categories of medicines

Answer 13

GSL = general sales list 
P = Pharmacy only 
POM = Prescription Only Medicine

Question 14

GSL = general sales list

Answer 14

can be sold in registered pharmacies but also in other retail outlets
OTC - over the counter like PARACETAMOL

Question 15

Pharmacy only

Answer 15

sold from registered pharmacy premises by a pharmacist

can also be over the counter

Question 16

POM = Prescription Only Medicine

Answer 16

has to be written by an appropriate before it can be sold or supplied

Question 17

Good medical Practise 2013

Answer 17

describes what is expected of all doctors
good practise in prescribing and managing medicines and devices
says prescriber should report adverse drug reactions, medical advice incidents and other patient safety incidents

Question 18

what are the general principles of legal, safe and effective prescribing

Answer 18

prescriber is responsible for prescriptions signed for
work within limits of competence
keep up date
report adverse events

Question 19

what are the legal considerations when writing a prescription

Answer 19

signed in ink
name and address of patient 
dated 
if patient is under 12 you must state 
name of drug, strength, quantity, dose, frequency 
controlled drugs

Question 20

what are the 5 R’s of medicine safety

Answer 20

RIGHT PATIENT 
RIGHT DRUG 
RIGHT DOSE 
RIGHT ROUTE 
RIGHT TIME

Question 21

MHRA yellow card scheme

Answer 21

report suspected adverse reactions to any therapeutic

Question 22

why report medicine incidents

Answer 22

improves medicine safety
to share the learning
identify trends and areas of concern

Question 23

Local report system

Answer 23

DATIX

Question 24

National report system

Answer 24

National Reporting and Learning System

Question 25

Scottish guidelines

Answer 25

SIGN

Question 26

English guidelines

Answer 26

NICE

Question 27

Northern island guidelines

Answer 27

Dept for health, social services and public safety

Question 28

Wales guidelines

Answer 28

All-wales medicine strategy group

Question 29

What is the role of medicine formalities

Answer 29

this is 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 30

SMC

Answer 30

Scottish Medicines Consortium offers individual country medicine adice by analysing the health benefits of meds