Session 4 - Drug Development

Question 1

Name the 5 principles of drug development

Answer 1

1 - understand the disease
2- Identify a target - eg blocking a receptor
3 - What acts on the target - a molecule or compound that acts on this target
4- Check safety and efficiency - using computerised models, cells and animals.
5- Clinical trial application - by the MHRA before any testing on animals

Question 2

What is a clinical trial ?

Answer 2

• A research study
• Consisting of human participants
• Includes one or more health care interventions
• To evaluate the effect of health outcomes

Question 3

Explain the 4 phases of a clinical trial

Answer 3

1- Side effects
2- Adverse Reaction
3-Wider demographics
4-Longer time frame

Question 4

Name the 3 concepts that make up the whole drug development process

Answer 4

1- The drug development
2- Trials
3 - surveillance

Question 5

Explain the yellow card scheme

Answer 5

A way of reporting side effects/ adverse actions to drugs .

Important part of post marketing surveillance

Question 6

What does MHRA stand for ?

Answer 6

Medicines and Healthcare products regulatory agency.

Question 7

What do MHRA do ?

Answer 7

Responsible for regulating all medicines and medical devices in the UK by ensuring the work and are acceptably safe.

Question 8

What is meant by poly pharmacy ?

Answer 8

Regular use of at least 5 medications

Question 9

What was lessons have been learnt from clinical trials ?

Answer 9

1 - Release of data
2- Systematic risk assessment
3 - Sequential dosing
4- Reporting hospitalisation

Question 10

Name the regulatory agencies and professional bodies involved in drug safety

Answer 10

1 - Medicines and Healthcare products regulatory agency
2 - Royal pharmaceutical society
3 - Care quality commission

Question 11

What are the 6 policy/legislations involved with medicine safety ?

Answer 11

1 - NMC standard 
2- RPS prescribing competency framework 
3- Medicine act (1968)
4- MHRA guidance 
5- Health and social care act 2008/2012
6- NICE guidance

Question 12

Warfarin + Antibiotics =

Answer 12

Increased bleeding due to altered vitamin k synthesis

Question 13

Warfarin + Asprin =

Answer 13

Increase risk of bleeding put the patient at risk of a haemorrhage

Question 14

Warfarin + Paracetamol =

Answer 14

Paracetamol increases the effect of warfarin and therefore increases risk of bleeding.

Only 500mg doses should be taken

Question 15

St Johns Wort + Citalopram =

Answer 15

Increase risk of serotonin syndrome ( confusion, agitation, muscle twitching)

Question 16

How does grapefruit interfere with drugs ?

Answer 16

Grapefruit inhibits some p450 enzymes, more drugs become bioavailable which puts the patient at risk of toxicity.

Question 17

What does CQC stand for ?

Answer 17

Care quality commission

Question 18

Explain the 4 steps involved in post marketing surveillance

Answer 18

1 - Distribution and supply - Distributors wholesalers and retailers have the responsibility to comply with good practices. Regular inspections from the MHRA.
2- Pharmacovigilance - Detection, assessment, understanding and prevention of adverse effects.
3- Reporting via yellow card scheme
4- Market surveys - Regular marketing and surveying of both regulated and unregulated supply chains.

Question 19

How are nurses involved in drug development ?

Answer 19

Pharmacovigilance, reporting and following the policy/legislation involved.

Question 20

What does the MHRA do ?

Answer 20

Regulates medicines, medical devices, and blood components for transfusion.

Concentrating on safety, quality, efficacy, supply chain, international standardisation, education, research, and development regulation.

Question 21

What do the royal pharmaceutical society do ?

Answer 21

Standards for prescribing

Question 22

What do the CQC do ?

Answer 22

Regulate availability of staff training, number of trained staff, local
policies for safe drug administration.

The CQC would never investigate an individual just the providers.

Question 23

An inverted black triangle against the drug name in the BNF means what ?

Answer 23

It’s under extra surveillance but the MHRA

Question 24

In the BNF, “POM” is seen next to certain drugs, this means what ?

Answer 24

Prescription only medicine