Practice Flashcards
What is medicines reconciliation?
The process of identifying an accurate list of a persons current medications and comparing them with the current list in use, recognising any discrepancies, and documenting any changes.
In an acute setting when should medicines reconciliation take place?
Within 24 hours or sooner if clinically necessary
When should medicines reconciliation take place in primary care?
As soon as practically possible, before a new prescription is issued. Within one week of the GP practice receiving the information.
Aims of the 1971 misuse of drugs act?
Sort out existing fragmentary, inadequate and inflexible legislation
Advisory council on misuse of drugs was established
Imposes a total prohibition on the possession, supply, manufacture, import or export of controlled drugs and except as allowed by misuse of drugs regulations or under a home office license
How are drugs classified by the misuse of drugs act?
According to potential harm
In classes A,B and C
How are drugs classified by the misuse of drugs regulations?
According to their use in medicine and potential abuse
In schedules
What strength of morphine can be schedule 5?
0.2% or less
Another name for class 1 medicines recall?
National patient safety alert
Timeframe to action class 1 medicines recall?
Immediately upon receipt
Timeframe to action class 2 medicines recall?
Within 48 hours
Timeframe to action class 3 medicines recall?
5 days
Definition of asepsis?
Absence of bacteria, viruses, and other microorganisms
What is good manufacturing practice?
Compliance ensures products are produced consistently to the quality standards appropriate to their community intended use
What are the two types of aseptic activities?
Licensed manufacture
Unlicensed preparation
What is aseptic licensed manufacture?
Allows manufacturing of a product that doesn’t have a product licence or marketing authorisation
Potential to sell to external customers
Assign extended expiry dates to products provided they are supported by stability data
What is aseptic unlicensed preparation?
Prepare aseptic products under an exemption from a section 10 of the medicines act 1968
What conditions need to be met to operate under an exemption from section 10?
Preparation done by or under supervision from a pharmacist
Preparation uses closed systems
Licensed sterile products used as ingredients
Allocated a maximum of 7 days expiry
All activities in accordance with defined NHS guidelines
What legislation must licensed aseptic units comply with?
EU guide to good manufacturing practice (orange guide)
What legislation must unlicensed aseptic units comply with?
NHS guidance: quality assurance of aseptic preparation services
Good practice to comply with orange guide
Quality assurance definition?
The sum total of all the organised arrangements made with the objective of ensuring that medicinal products are of the quality for the intended use
What are positive pressure isolators used for?
Parenteral nutrition and civas products
In event of isolator breach air will leave the isolator
Product protection takes priority over operator protection
What are negative pressure isolators used for?
Cytotoxic and monoclonal antibody products
In event of isolator breach air will enter the isolator
Operator protection takes priority over product protection
How are ingredients decontaminated in an aseptic unit?
Four step wipe and spray process
