Lecture 5 - The use of Unlicensed medication in the UK Flashcards
describe licensing exemption for pharmacists
- Preparing or dispensing medicinal products based on a prescription from a practitioner.
- Preparing or dispensing medicinal products according to a formula provided by the purchaser for self-administration or for someone in their care.
- Dispensing medicinal products as part of counter prescribing, where the pharmacist uses their judgment to treat a patient who is present in the pharmacy.
- Preparing a stock of products for use in the above activities.
- Preparing a stock of medicinal products for sale from the pharmacy without advertising them (known as 6. Chemist Nostrums).
Assembling medicinal products for retail sale without advertising, either from the same pharmacy or another pharmacy within the same retail business. - Engaging in wholesale dealing.
what is a marketing authorisation?
marketing authorisation is the regulatory approval of a specific medicinal product enabling it to be marketed
It is unlawful to sell, supply or offer to sell or supply a medicinal product unless that product has a UK MA
MA are issued for a period of time (usually 5 years or less) and may have certain restrictions attached
After this period the MA holder must re-apply
MHRA has power to withdraw, amend or suspend a MA at any time such a medicinal product for sale impractical
what is SPC
spa is summery of product characteristics for the product that must be submitted as part of the licensing process
it is prepared BY THE HOLDER OF THE AMRKETIGN AUTHORISATION.
only part of the application made public
SPC describes the medical products properties and the conditions attached to its use.
what information does an SPC contain?
- NAME OF THE MEDICINAL PRODUCT
- QUALITATIVE AND QUANTITATIVE COMPOSITION
- PHARMACEUTICAL FORM
- CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose - PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties 5.2 Pharmacokinetic properties
5.3 Preclinical safety data - PHARMACEUTICAL PARTICULARS 6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling - MARKETING AUTHORISATION HOLDER
- MARKETING AUTHORISATION NUMBER(S)
- DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10. DATE OF REVISION OF THE TEXT
describe unlicensed product vs unlicensed use
An unlicensed product is a medicinal product that lacks a (MA) and does not have a (SPC). Additionally, it is not included in the (BNF) monograph.
Unlicensed use of a licensed medicinal product refers to situations where a medicine, although licensed, is used or prescribed in a way that is not covered by its license. This unlicensed use might or might not be mentioned in the BNF monograph for the licensed product, either in the dosage section or under the ‘unlicensed use’ section
describe when unlicensed medicines are used and risks
Unlicensed medicines should only be prescribed or dispensed if no equivalent licensed product exists
Prescribing and dispensing an unlicensed medicine carries an increased risk and the liability rests with the prescriber and dispenser rather than the manufacturer
what are specials?
‘Specials’ are unlicensed products prepared by a Special’s Licence holder that are made on the order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for use by a patient that they are treating
The dispensing pharmacy must keep records for 5 years regarding the patient, name and quantity of product, who manufactured it, batch number and date supplied to patient
the manufacturer must Hold a Manufacturer’s ‘Specials’ Licence
what us the GOHC guidance for registered pharmacies preparing unlicensed medicines?
The one-time preparation of an unlicensed medicine in response to a specific prescription for an individual patient.
The preparation of a stock of unlicensed medicines in anticipation of future prescriptions, which will later be dispensed from the pharmacy by or under the supervision of a pharmacist to individual patients.
The preparation of methadone for supply according to a prescription, either for immediate supply as per the prescription or initially as stock to be dispensed from the pharmacy at a later time, under the supervision of a pharmacist.
The preparation of an unlicensed medicine based on the pharmacist’s professional judgement, also known as Chemist’s Nostrum.
The preparation of an unlicensed medicine by or under the supervision of a pharmacist, according to the specifications of the patient.
what is unlicensed off label use?
This prescribing of a licensed medicinal product which is being used outside of its license (i.e. outside of what the MA/SPC states)
Unlicensed use may be due to * Dose
* Age (especially children) * Route
* Indicatio
what are parallel imported medicines?
Parallel imported medicines (PIs) are imported from another country which are a version of the same medicine which is available in the UK and which has a UK marketing authorisation
he PI must have a MA from the country of manufacture
* The PI must have no different therapeutic effect from the UK product covered by the UK MA
* PIs need a UK MA but, instead of full MA with all data from clinical trials etc. being submitted, an application for a product licence (parallel import) – PL(PI) can be made instead
* PIs must be re-labelled in English and must have a patient information leaflet in English
how to dispense a parallel import medicines
check authenticity before dispensing, beware of counterfeit medicines, consider rebooting if packaging has foreign language, watch out for calendar packs, expiry dates, pack size etc
what is a counterfeit medicine?
A medicine which is deliberately and fraudulently mislabelled
with respect to identity or source
Estimates 10% of global market in meds – up to 30% in Russia/Africa/Asia, 1% in EU
what are types of counterfeit medicines?
Illegally labelled authentic product
* Relabelled expired product
* Generic medicine packaged as branded medicine * Sub-standard ‘copy’
* Product containing no active ingredient
* Product containing toxic ingredient
* Examples in UK: Lipitor (x3), Cialis, Zyprexa, Plavix
steps to prevent is are packaging harder to copy, better internet regulation, supply chain security, increasing public awareness
