Clinical Pharmacology- Use of medicine

Question 1

What does MHRA stand for?

Answer 1

Medicines & Healthcare products Regulatory Agency

Question 2

What is the function of the MHRA?

Answer 2

Regulates which medications can be used in the UK

Question 3

What licences can the MHRA give out?

Answer 3

• Clinical Trial Authorisation
• Marketing Authorisation
• Manufacturers or Wholesale dealer’s license

Question 4

What is marketing authorisation?

Answer 4

License given by the MHRA to a product once it meets their safety, quality and efficacy standards.

Question 5

When is marketing authorisation given by the MHRA?

Answer 5

Licence given when it meets their safety, quality and efficacy standards.

Question 6

How long does marketing authorisation last?

Answer 6

5 years

Question 7

What is the Manufacturer’s and wholesale dealer’s authorisation?

Answer 7

Licenses given by the MHRA to a company qualifying that their manufacture, distribution and supply of a product meets their safety & quality standards

Question 8

What do the Scottish Medicines Consortium (SMC) do?

Answer 8

Regulates what meds are used in Scotland

Question 9

What’s different about the SMC process to the MHRA process?

Answer 9

• MHRA just review whether the med is safe for use.

* SMC- Essentially dictating which meds should be used in scotland rather than just what’s available

Question 10

What is off-label prescribing?

Answer 10

Prescribing a med with marketing authorisation but for something it’s not authorised for

Question 11

What is unlicensed prescribing?

Answer 11

Prescribing a medication with no marketing authorisation

Question 12

What are the groups of medications based on?

Answer 12

Who can provide them

Question 13

What are the 2 groups of medications?

Answer 13

POM-Pharmacy Only Medication

OTC-Over The Counter medication

Question 14

What are the 2 forms of over the counter medication?

Answer 14

• General Sale List

* Pharmacy only

Question 15

Where can general sales list drugs be sold?

Answer 15

Can be sold outside pharmacies e.g. paracetamol in shops

Question 16

What is the problem with pharmacy only drugs?

Answer 16

Require a pharmacist i.e. not suitable for public selection

Question 17

What formularies can be referred to when prescribing?

Answer 17

• BNF

* NHS Grampian Joint Formulary

Question 18

What is the formal name for a patients Kardex?

Answer 18

Prescription & Administration Record (PAR)

Question 19

What is pharmacovigilance?

Answer 19

Detection, assessment, understanding and prevention of adverse drug reactions (ADRs)

Question 20

What is the yellow card scheme?

Answer 20

Main method for post-marketing surveillance of ADRs

Question 21

Who can file a yellow card report?

Answer 21

The public and healthcare professionals

Question 22

What do yellow cards collection information of?

Answer 22

• Side effects
• Medical device adverse incidents.
• Defective medicines
• Counterfeit or fake medicines or medical devices.
• Safety concerns

Question 23

What type of incidences should be reported via yellow card scheme?

Answer 23

• Vomiting following administration of new vaccine

* Neutropenia following administration of well-established drug

Question 24

What type of incidences should not be reported via yellow card scheme?

Answer 24

Sleep disturbance following administration of new drug

Question 25

What is the GMC guidance on administration of an unlicensed drug?

Answer 25

You may prescribe unlicensed medicines where, based on an assessment of the individual patient, you conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient.