MHRA Flashcards
(27 cards)
Functions of MHRA
- regulation of medicines, devices and equipment, blood and blood products
- investigating harmful incidents
- with the principle aim to safeguard the public health by making sure medicines and medical devices work properly and are acceptably safe
what does MHRA do
- jhas the power to withdraw a product from the market or suspend production
- can prosecute manufacturers and distributors if they break the law
- work closely with the European medicines authority
- investigates counterfeit medicines or devices
what are the roles of MHRA
- licensing of medicines
- managing clinical practice research database
- yellow card scheme
- issuing safety alerts
before a medicine receives marketing authorisation, what 3 standards must be demonstrated
- licenses only granted when a product meets high standards of safety, quality and efficacy for the purpose intended
- rigorous standards for medicines manufacturers and wholesale dealers who trade in them
- licensing system guarantees accountability for all those involved and ensures that processes, supplies and quality can be monitored
licensing process
- companies apply to MHRA for permission to test rugs through clinical trials
- all results from trials on how well the medicine works, side effects and details of what it contains, how it works, and who it is meant to treat are sent to MHRA for detailed assessment
- once MHRA is satisfied that the medicine works as it should and that its acceoptably safe, its given a marketing authorisation
- black triangle monitoring for 2 years or until MHRA satisfied it works safely in large numbers o fpeople
what is phase 1 clinical trials
- small numbers of healthy people
- designed to find out how the medicine works in the body and what the side effects are
what is phase 2 clinical trials
- whether medicine works in pts with the condition or disease for which its intended
- is it safe, does it work and what dose may be needed
- several hundred people often involved
what is phase 3 clinical trials
- gather more info on how well the medicine works and how safe it is, in larger groups of people
- compare it to placebo or existing
- results inform the labelling and pt info for the medicine when its marketed
what is phase 4 clinical trials
- trials after licensing
- continue to gather info on effects inn various populations, rare or long-term side effects
- post marketing surveillance through CRPD and yellow card reporting scheme
what is the yellow card scheme
- system for recording adverse incidents with medicines and medical devices in the UK
- new medicines and vaccines that are under additional monitoring have an inverted black triangle symbol displayed in package leaflets and SPC
- should report all suspected ADRs
- all HCPs and the public can report
- MHRA will review product and if necessary take action to minimise risk and maximise benefit to pts
what are the benefits of using licensed medicines
MA tells us that the medicine:
- has been assessed for safety, efficacy and quality
- manufactured to the appropriate quality standards
- when placed on the market, is accompanied by appropriate product information and labelling
- manufacturers produces a summary of product characteristics, outlining the indication, dose, side effects, contraindications and warnings
- its in line with such use that the benefits of the medicine have been judged to outweigh potential risks
what is a licensed medicine
- meets acceptable standards of efficacy, safety and quality and should be used wherever possible
what is an off label medicine
a medicine with an existing MA that is used outside of the terms of its MA- eg for a different indication, dose
what is an unlicensed medicine
a medicine that does not have a UK MA
When are unlicensed and off label medicines supplied
- unusual formulation or strength
- preservative or additive free product
- for some diseases there are no licensed medicines
- prescribed for a disease or a type of pt outside of the drugs MA
- pt can’t swallow tablets and non licensed liquid formulation available
what are the types of unlicensed medicines
- imports- products with a license, usually in another country which are imported into the UK
- specials- medicines made under a specials license by a manufacturer to fulfil a prescription ordered for individual pts without the need for a MA
- extemporaneous products- formulations for an individual pt made by a pharmacist compounding ingredients
- eg. tablet manipulation by crushing tablets or susopending - manipulated products- medicines in which the formulation has been altered- crushing tablets
outline the prescribing hierarchy
- licensed product
- off label product
- an imported medicinal product which is licensed in the country of origin
- a completely unlicensed product
- products that are unlicensed in the country of origin, and are not classed as medicines in the country of origin
steps in dealing with a prescription for an unlicensed medicine
- is there a licensed alternative
2.make sure prescriber is aware - make sure pt is aware
- order from specials company
record keeping for unlicensed medicines
- specials manufacturers provide an invoice and a sheet with product details including batch number
- certificate of conformity or certificate of analysis - keep CoC/CoA for 5 years
- prescription will need extra endorsements to inform the prescription pricing authority what they need to reimburse the pharmacy
what are safety alerts
- manufacturers must report to MHRA any important defects in both medicines and medical devices
- warnings can be issued about defective medicines, problems with devices and side effects associated with medicines
- sent out to HCPs and organisations and publicised widely in print and online
what is a national patient safety alert
immediate recalll- serious or life threatening risk to health
what is a class 2 medicines recall
potential harm but not life threatening
what is a class 3 medicines recall
unlikely to harm pts, usually for reasons other than safety
