Specials Flashcards
What is a marketing authorisation
A license that is required by law for any pharmaceutical product, issued by the regulator for that country
what is the regulator in the UK
medicines and healthcare products regulatory agency (MHRA)
why is licensing necessary
guarantees the medicine is safe and effective for human use, which must be proved by extensive testing before the marketing authorisation will be given
- guarantees product quality
what does the marketing authorisation include
includes details of exactly which patients, conditions and clinical situations the medicine can be used for, including the specific doses
what is a special product
an unlicensed medicine, used for patients with unique clinical requirements or unusual circumstances
describe the manufacture of special products
- made by a company who have a specials manufacturing licence from the MHRA
- normally made according to specific prescription
- must comply with certain standards and keep specific records
- companies can also perform limited batch manufacturing of specials
how common are medication errors
account for 10% of all incidents reported to the national reporting and learning system
- include many look alike/sound alike errors
when can LASA errors occur
can occur during prescribing, dispensing, supply or administration of medicines and can lead to administration of the wroth medication with potentially fatal consequences
what needs to be included in the labelling of unlicensed medicines
- the international non proprietary name
- a statement of the active ingredients
- intended route of administration
- instructions for use, including any special warnings
- the pharmaceutical form
- the contents of the container by weight, volume or number of doses
- excipients of known effect
- keep out of reach and sight of children
- expiry date
- any special storage precautions
- the manufacturers MS number
- manufacturers name and address
- batch number
- statutory warnings
what are unlicensed medicines
medicines with no marketing authorisation at all
what is meant by unlicensed use
using a medicine with a marketing authorisation, in a way that is different to the conditions stipulated on the MA
what is the need in specials
- always situations where patient requirements are unique
- doesn’t merit applying for a full MA (costly and takes years to approve)
- to avoid extemporaneous preparations
who might need specials
- babies and children
- people with swallowing difficulties
- long term or permanent feeding tubes
- allergies and intolerances
- specific treatment required but no licensed products available in the UK
- to avoid extemporaneous preparation in a pharmacy
when should we consider a special
- under MHRA rules we should always use a licensed product where possible
- must consider a licensed product in an unlicensed way, before resorting to a special
list the order of choosing an option for a product
- licensed product, sued within the conditions of the license
- if not suitable, is there an alternative licensed product?
- if not suitable, is there a licensed product that can be used in an unlicensed way?
- consider use of a special
give examples of batch manufacture
- common liquids for children
- ophthalmic preparations (eye drops, ointment)
- many preservative free products
- non routine parenteral products
- epidural infusions
- dermatology preparations that would be made extemporaneously
what does the law say about using special products
- specials have an exemption for the need of an MA
- manufactured and supplied in accordance with prescriber specifications
- patient falls into category of having special needs
- clear reason why licensed alternative is not clinically appropriate
outline the responsibilities as a pharmacist in using special products
- patient care is always primary concern
- ensure all medicines prescribed and supplied are safe, effective and appropriate for condition
- make certain no other licensed alternatives can be used
- should always be an exception, never routine supply
- patient and prescriber made fully aware of unlicensed status and patient must share decision to use a special
- ensure the quality of the special product
- use reputable specials manufacturers
- keep all records in relation to purchase and supply
- you share accountability with the prescriber
what is involved in making a clinical assessment for the use of a special
- need to establish this patients clinical situation is different from normal
- should not be in relation to cost
- should not be in relation to simple convenience, must be justifiable
what are the 5 principles in the professional practice guide
- establish the patients special clinical need
- understand patients experience
- identify a preparation and a supplier
- ensure effective governance is in place
- monitor patient and review need for the special
what are the disadvantages of specials
- no robust testing like a licensed medicine so can’t guarantee safety and efficacy
- short expiry dates and instability are common, especially if preservative free
- very expensive, Gps struggle to fund them in the longer term for chronic diseases