unlisenced Flashcards
(13 cards)
5 things products need to do to get a license
the safety of medicinal products of each description to which the application relates
the efficacy of medicinal products of each such description for the purposes for which the products are proposes to be administered
the quality of medicinal products of each such description, according to the specification and the method or proposed method of manufacture of the products, and the provisions proposed for securing that the products as sold or supplied will be of that quality.
The Human Medicines Regulations 2012 definition for medicine 3
having properties for treating or preventing disease
➢ used for restoring, correcting or modifying a physiological, metabolic or immunological function
➢ administered to make a medical diagnosis
3 exemptions of lisence
➢ In response to an unsolicited order
➢ Manufactured and assembled in accordance with the specification of a person who is a doctor, dentist, nurse IP, pharmacist IP or SP
➢ For use by a patient whose treatment that person is directly responsible for in order to fulfil the special needs of that patient; and meets the conditions specified in the regulation
The section 10 exemption form the Medicines Act 1968 3 things it allows
The section 10 exemption form the Medicines Act 1968 Prepared or dispensed in a hospital or health centre by or under the supervision of a pharmacist in response to an appropriate practitioners prescription
Assembling a medicinal product in a hospital or health centre by or under the supervision of a pharmacist
Preparing medicinal products in a hospital or health centre by or under the supervision of a pharmacist in anticipation of a prescription.
6 reasons for unlicensed
Licence withdrawn
Required formulation not available
Medicines supply disruption
Clinical trials
EAMS products (early access to medicines scheme)
Products made under Section 10 exemption.
5 requirments of aspetics
➢Preparation carried out under the supervision of a pharmacist
➢Use closed systems
➢Only licensed starting materials
➢Shelf life of no more than 8 days and supported by validated stability data
Carried out in accordance with Assurance of aseptic preparation of medicines
who responsible 3
Employers responsibility to ensure governance systems are in place for unlicensed medicines
Ultimate responsibility for use of an unlicensed medicine lies with the prescriber
Pharmacist must make sure the prescriber is aware of the licensed status of the medicine
6 steps to a quality assesment
Define product specification
Identify potential suppliers
Obtain information about supplier
evaluate supplier suitability
Obtain quality information about the product
Potential problems/ongoing actions
5 potential issues
Time to supply
Continuity of supply
Supply post discharge
Formulation change
Continually monitor suitability for patient
8 things to do with specials
Listed as MS number on licence and labels
Regulated and inspected by the MHRA every 18 months to 2 years
MS licenced manufacturers listed on MHRA website, including type of product they are authorised to prepare.
Product type on licence
Good Manufacturing Practice (GMP) is assessed.
Products are not assessed for efficacy, bioavailability or elimination
Products are assessed for stability/safety/shelf life
Must have special clinical need
10 requirments of quality assesment
Purchasers responsibility to ensure Specials are purchased from reputable licensed units.?
Confirm licence status on MHRA website?
Confirm licence covers medicine to be purchased
If sterile, sterilisation method?
If aseptic, transfer sanitisation process?
Stability data? Shelf life? Shelf life when opened?
Packaging details?
Label details?
Storage conditions?
CD distruction register 6
- drug name
- form
- strength and quantity
- destroyed date
- signature of the authorized witness
- signature of the professional destroying it
CD entry 7
date supplied
name and address of patient
details of authority to posses - prescriber or license holders details
quantity and form supplied
details of person collecting (schedule 2)
whether proof of identity was requested
whether proof of identity was provided
