Clinical Pharmacology

Question 1

What is the difference in remit between EMEA and MHRA?

Answer 1

EMEA is an EU wide central regulatory authority, authorisation from them is valid throughout Europe.
MHRA is UK specific, authorisation from them is required to run a trial or license a product in the UK

Question 2

What is a clinical trial authorisation?

Answer 2

it’s an authorisation given by a regulatory authority to run a clinical trial on a drug

Question 3

What is a marketing authorisation?

Answer 3

it’s an authorisation given by a regulatory authority that confirms that a drug is effective and safe to use

Question 4

What is a manufacturer’s licence?

Answer 4

it’s an authorisation given by a regulatory authority that confirms that a drug’s production, distribution and supply have been carried out according to the required safety and quality standards

Question 5

What is pharmacovigilance?

Answer 5

it’s the continued monitoring by a regulatory authority of a drug’s efficacy and safety after it has been licensed for use

Question 6

What is the system used in the UK to report adverse drug reactions as part of pharmacovigilance?

Answer 6

Yellow Card Scheme

Question 7

What are the three main types of reactions which should be reported through the Yellow Card Scheme?

Answer 7

1. reactions to new drugs
2. reactions in children
3. severe reactions to established drugs

Question 8

What four pieces of information should be included in a Yellow Card report?

Answer 8

1. name of drug
2. initials, age and gender of patient
3. description of adverse reaction
4. your name and contact details

Question 9

What five types of incidents can be reported in a Yellow Card report?

Answer 9

• drug reaction
• faulty device
• defective drug
• fake/counterfeit drug
• e-cigarette malfunction

Question 10

What is the difference between an off-label and an unlicensed drug?

Answer 10

• off-label is a drug used for a different condition than it’s licensed for
• unlicensed is a drug that does not have a license from a regulatory authority

Question 11

Are “special” drugs licensed?

Answer 11

no

Question 12

Explain what “special” drugs are

Answer 12

they are specific, unlicensed formulations of existing drugs, tailored to patients who cannot tolerate the licensed formulation

Question 13

What is the difference between off-label and special drugs?

Answer 13

• off-label drugs are used for a different condition than what they are licensed for
• special drugs are used for the condition they are licensed for, but in a formulation that is unlicensed

Question 14

give an example of a special drug prescription

Answer 14

• adult only drug used for a child

- oral medication administered as injection in someone with parenteral feeding

Question 15

what are the three categories of drugs outlined by the Human Medicines Act 2012?

Answer 15

• POM (prescription only medicines)
• P (pharmacy only drugs)
• GSL (general sales list)

Question 16

which act categorises medicines as GSL, POM and P?

Answer 16

Human Medicines Act 2012

Question 17

What two types of medicines make up the “over the counter” drugs?

Answer 17

GSL and P drugs

Question 18

What does a pharmacist need to do before being able to dispense a P medicine?

Answer 18

they need to check for contraindications or any other potential problems with the medication

Question 19

When writing out prescriptions, which doses should not be abbreviated?

Answer 19

micrograms

nanograms

Question 20

When writing out prescriptions, which doses can be abbreviated?

Answer 20

milligram to mg
milliliter to ml
gram to g

Question 21

What is “PAR” and what are the different formats it can be found in?

Answer 21

Prescription and Administration record (ie Kardex)

can be standard, two-page or long stay

Question 22

When can a PAR be reused and when should a new one be used?

Answer 22

• it can be reused if the patient is transferred in the same admission period
• a new one should be used with every new admission

Question 23

What 5 pieces of information about a prescribed drug should always be added on the form?

Answer 23

• generic name of drug
• dose of drug
• formulation of drug
• quantity of drug
• frequency of drug

Question 24

Name a drug that should always be prescribed under its specific brand name

Answer 24

insulin

Question 25

When prescribing liquids, how are liquid prescriptions quantified?

Answer 25

liquid prescriptions are quantified in “milligrams of active ingredient” per liquid quantity of solution (eg 5mg/20ml)

Question 26

When prescribing combination inhalers, what does the number at the end of the name refer to?

Answer 26

it refers to the amount of steroid contained in the formulation