Personalised medicines

Question 1

What are personalised medicine?

Answer 1

Using the genetic profile to inform decisions made about an individual’s treatment plan

Question 2

What is the aim of personalised medicine?

Answer 2

Maximum efficacy of treatment and significant reduction in the risk of undesirable side effects

Question 3

What is the US definition of personalised medicine?

Answer 3

The application of genomic and molecular data to better target the delivery of health care, facilitate the discovery and clinical testing of new products, help determine a person’s predisposition to a particular disease or condition, and identify any targeted prevention strategies for that predisposition

Question 4

Where are the highest concentrations of P450s found?

Answer 4

The liver and small intestine

Question 5

How do P450s make molecules more soluble in water?

Answer 5

Add oxygen atoms to them

Question 6

How many genes for human P450 enzymes have been found?

Answer 6

57

Question 7

Which P450 is responsible for codeine metabolism?

Answer 7

CYP2D6

Question 8

Which P450 is responsible for paracetamol toxicity?

Answer 8

CYP3A4

Question 9

Which P450 metabolises warfarin?

Answer 9

CYP2C9

Question 10

HER2 is overproduced in 25% of what?

Answer 10

Breast cancers

Question 11

What is a ‘special’?

Answer 11

A non-licensed medicine manufactured to fulfil the prescriber’s requirements manufactured under a Special Manufacturing Licence (MS)

Question 12

What conditions need to be met for a special?

Answer 12

Bona fide unsolicited order
In accordance with spec of prescriber
For use by prescribers individual patients on his direct responsibility

Question 13

GMC rules allow prescribing of unlicensed medicines as long as what?

Answer 13

the licensed form is inappropriate for the patient

there is evidence the medication is safe and effective

Question 14

Who is liable if an unlicensed medicine causes harm?

Answer 14

the prescriber/ pharmacist

Question 15

Whos consent needs to be gained before a special is prescribed?

Answer 15

the patient

Question 16

Why are pharmacists increasingly buying in specials rather than preparing them extemporaneously?

Answer 16

To ensure quality in the manufacturing process and to enhance patient safety

Question 17

Which act is extemporaneous dispensing carried out under?

Answer 17

Section 10 exemption to Medicines Act 1968

Question 18

Is product testing required for extemporaneous dispensing?

Answer 18

No as its made as a one-off

Question 19

What are five important factors when making unlicsned medicines?

Answer 19

Risk assessment
Record keeping and accountability
Staff training
Patient informaiton
Equipment and facilities

Question 20

Who is liable when using a licensed product within its license?

Answer 20

the manufacturer

Question 21

Who is liable when using an unlicensed product ?

Answer 21

Prescriber and pharmacist