Finding information about a medicine Flashcards
Name an example of a place where you can find out information about medicines.
MHRA.
Name the 3 places where you can find out general information.
Summary of product characteristics.
British National Formulary.
British National Formulary for Children.
What is the summary of product characteristics?
A document used to be approved as part of the marketing authorisation.
‘How to use a medication // what the medication should be used to treat?’
Name the place where you can find patient information.
Patient Information Leaflet.
Name the 2 places where you can find out specialised information.
UK Teratology Information Service
UK Drugs in Lactation Advisory Service
What does licensing a medicine entail?
Researching the medicine in the lab and testing it in clinical trials.
Proves the drug works for the illness.
What is the Medicines Act (1968)?
Regulates the licensing // supply // administration of medicines.
What country does EMA originate from?
Europe
What country does FDA originate from?
America
What is marketing authorisation?
Processing // Receiving // Assessing evidence in order to support a medicinal product.
What is a dossier?
This is a collection of papers containing information about safety // manufacturing // toxicity.
What are the 3 stages for EU marketing authorisation?
Pre - Submission
Dossier Submission
Assessment
What does the pre - submission stage involve?
Requesting for eligibility
What does the dossier submission stage involve?
Product name // product information
Quality of drug
Risk management plan
What does the assessment stage involve?
Of dossier
Inspection of manufacturing site
What does pharmacovigilance mean?
Drug safety
Why is a drug monitored once it has been put on the market?
The main aim is to identify unreported adverse effects.
What can an assessment report entail?
Chemical structure Pharmacology Pharmacokinetics Clinical Efficacy Details of main studies
What is a summary of product characteristics?
A document approved as part of the marketing authorisation of each medicine.
Has key details about the medicine.
What is a patient information leaflet?
A technical document with the written information on the medication = written in the patient’s language.
What are the two main types of patient information leaflets?
Legal PIL
NHS Specific PIL
What is a legal PIL?
Based on information from the summary of product characteristics.
Included in EVERY medicine pack.
What is a NHS specific PIL?
Written by UKMi pharmacists = Has to be published and accepted by them.
What does BNF stand for?
British National Formulary
