Session 4 - Drug Development Flashcards
Name the 5 principles of drug development
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
What is a clinical trial ?
- A research study
- Consisting of human participants
- Includes one or more health care interventions
- To evaluate the effect of health outcomes
Explain the 4 phases of a clinical trial
1- Side effects
2- Adverse Reaction
3-Wider demographics
4-Longer time frame
Name the 3 concepts that make up the whole drug development process
1- The drug development
2- Trials
3 - surveillance
Explain the yellow card scheme
A way of reporting side effects/ adverse actions to drugs .
Important part of post marketing surveillance
What does MHRA stand for ?
Medicines and Healthcare products regulatory agency.
What do MHRA do ?
Responsible for regulating all medicines and medical devices in the UK by ensuring the work and are acceptably safe.
What is meant by poly pharmacy ?
Regular use of at least 5 medications
What was lessons have been learnt from clinical trials ?
1 - Release of data
2- Systematic risk assessment
3 - Sequential dosing
4- Reporting hospitalisation
Name the regulatory agencies and professional bodies involved in drug safety
1 - Medicines and Healthcare products regulatory agency
2 - Royal pharmaceutical society
3 - Care quality commission
What are the 6 policy/legislations involved with medicine safety ?
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
Warfarin + Antibiotics =
Increased bleeding due to altered vitamin k synthesis
Warfarin + Asprin =
Increase risk of bleeding put the patient at risk of a haemorrhage
Warfarin + Paracetamol =
Paracetamol increases the effect of warfarin and therefore increases risk of bleeding.
Only 500mg doses should be taken
St Johns Wort + Citalopram =
Increase risk of serotonin syndrome ( confusion, agitation, muscle twitching)
How does grapefruit interfere with drugs ?
Grapefruit inhibits some p450 enzymes, more drugs become bioavailable which puts the patient at risk of toxicity.
What does CQC stand for ?
Care quality commission
Explain the 4 steps involved in post marketing surveillance
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.
How are nurses involved in drug development ?
Pharmacovigilance, reporting and following the policy/legislation involved.
What does the MHRA do ?
Regulates medicines, medical devices, and blood components for transfusion.
Concentrating on safety, quality, efficacy, supply chain, international standardisation, education, research, and development regulation.
What do the royal pharmaceutical society do ?
Standards for prescribing
What do the CQC do ?
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.
An inverted black triangle against the drug name in the BNF means what ?
It’s under extra surveillance but the MHRA
In the BNF, “POM” is seen next to certain drugs, this means what ?
Prescription only medicine
