Clinical pharmacology Flashcards
Who regulates the licensing of medications?
MHRA - Medicines and Healthcare products Regulatory Agency
What does the MHRA do?
Ensures medicines meet standards on safety, quality, efficacy, effectiveness
What is the yellow card scheme?
Main method for post-marketing surveillance of ADRs in the UK
Collects info on side effects, medical device adverse incidents, defective meds, fake meds, safety concerns
What info is included on a yellow card report?
The side effects
Info about the patient
Name of medicine
Physician’s name and full address
Should you report neutropenia in use of a drug which is well established and has this as a listed side effect in BNF?
Yes
Should you report sleep disturbance in use of a well established drug which already has this listed in BNF as a side effect?
No
What does unlicensed mean?
No marketing authorisation
What does off label mean?
Licensed but prescribed out with the terms of marketing authorisation
What does Specials mean?
Special formulations of medicines made for clinical reasons when an existing formulation of an available licensed product is not suitable for patient = unlicensed
What are the 2 main classifications of medicines?
Prescription only (POM) OTC
What are some requirements for a prescription?
Name and address of patient
Age of patient
Drug name, formulation, dose, frequency and quantity dispensed
Signed in indelible ink by appropriate practitioner
Date signed
Type of prescriber and address
What are CD’s?
Controlled drugs
E.g. opiates, temazepam, tramadol
How do you write doses?
If less than 1g write mg
If less than 1mg write microgram
Do not abbreviate micrograms or nanograms!
What does o.d. mean?
Omni die
Every day
What does prn mean?
Pro re nata
When required