Clinical Pharmacology Flashcards
What is the difference in remit between EMEA and MHRA?
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
What is a clinical trial authorisation?
it’s an authorisation given by a regulatory authority to run a clinical trial on a drug
What is a marketing authorisation?
it’s an authorisation given by a regulatory authority that confirms that a drug is effective and safe to use
What is a manufacturer’s licence?
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
What is pharmacovigilance?
it’s the continued monitoring by a regulatory authority of a drug’s efficacy and safety after it has been licensed for use
What is the system used in the UK to report adverse drug reactions as part of pharmacovigilance?
Yellow Card Scheme
What are the three main types of reactions which should be reported through the Yellow Card Scheme?
- reactions to new drugs
- reactions in children
- severe reactions to established drugs
What four pieces of information should be included in a Yellow Card report?
- name of drug
- initials, age and gender of patient
- description of adverse reaction
- your name and contact details
What five types of incidents can be reported in a Yellow Card report?
- drug reaction
- faulty device
- defective drug
- fake/counterfeit drug
- e-cigarette malfunction
What is the difference between an off-label and an unlicensed drug?
- 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
Are “special” drugs licensed?
no
Explain what “special” drugs are
they are specific, unlicensed formulations of existing drugs, tailored to patients who cannot tolerate the licensed formulation
What is the difference between off-label and special drugs?
- 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
give an example of a special drug prescription
- adult only drug used for a child
- oral medication administered as injection in someone with parenteral feeding
what are the three categories of drugs outlined by the Human Medicines Act 2012?
- POM (prescription only medicines)
- P (pharmacy only drugs)
- GSL (general sales list)
which act categorises medicines as GSL, POM and P?
Human Medicines Act 2012
What two types of medicines make up the “over the counter” drugs?
GSL and P drugs
What does a pharmacist need to do before being able to dispense a P medicine?
they need to check for contraindications or any other potential problems with the medication
When writing out prescriptions, which doses should not be abbreviated?
micrograms
nanograms
When writing out prescriptions, which doses can be abbreviated?
milligram to mg
milliliter to ml
gram to g
What is “PAR” and what are the different formats it can be found in?
Prescription and Administration record (ie Kardex)
can be standard, two-page or long stay
When can a PAR be reused and when should a new one be used?
- it can be reused if the patient is transferred in the same admission period
- a new one should be used with every new admission
What 5 pieces of information about a prescribed drug should always be added on the form?
- generic name of drug
- dose of drug
- formulation of drug
- quantity of drug
- frequency of drug
Name a drug that should always be prescribed under its specific brand name
insulin
