legal prescribing, licencing and advertisisng Flashcards
(7 cards)
why do we need drug regulation?
to ensure that medicines are efficious, pure and acceptably safe
what are the current systems for drug regulation?
- minister of Europe
- commission on human medicines
- all supported by MHRA - medicine and healthcare products regulating agency
what is drug licencing?
Drug licencing is required before medicine can be used in the UK. It relates to manufacture, distribution and supply of a drug and it assesses Quality, Safety (adverse reactions) and Efficacy. cost effectiveness is not a licencing issue.
Overseen by the european medicines agency who are responsible for evaluating applications for marketing authorisation in europe
unlicenced and off label drugs may still be used
what are controlled drugs?
They are identified in the BNF with various symbols
they are subject to strict requirements for both the prescriber and the patient
what is good practice in prescribing and managing medications
legal aspects are set out in the misuse of drug regulations (2001) which interprets the misuse of drugs act (1971)
as well as following the law you must follow other regulations
eg. you must not prescribe for your own/ your colleagues convenience and you must not prescribe for yourself or anyone with whom you have a close relationship
who can prescribe
doctors nurses pharmacists optometrists podiatrists radiographers and many more...
the aim of non medical prescribing is to make more effective use of the skills and expertise of groups of professionals, improve patient access to treatment and advice, and improve patient choice and convenience.
medical prescribers must share all relevant infomation with all HCPs involved in the patients care
what do you need to be aware of with drug advertising?
vast amounts of money is spent on the advertising of drugs and it tends to play on psychological needs so it is important not to be influenced as a prescriber.
be aware of ghost writing and ghost talking as well as off licence advertising
always ask
- is the drug safe?
- will it be safe for this particular patient?
- is it effective?
- is it as/more effective than the existing drug?
- is it as / more safe than the existing drug?
- is it cost effective?
