Transcript Prescribing in Practice Part 1 (b)

Prescribing in Practice
Part 1 (b)
Legal Issues (1)
The Law
• The Medicines Act 1968 assures the
quality safety and efficacy of medicines as
well as maintain the safety of the public by
controlling routes of access
• The Misuse of Drugs Act 1971 adds an
additional layer of tougher supply controls
for drugs with a high potential of abuse
Licensing
Why is this important?
• Greater control and safety needed
• Marketing Authorisation (MA) (formerly
Product Licence) granted by MHRA once
they are satisfied of the safety, quality and
efficacy of a drug.
• This process may take many years
• The drug is then licensed
• The MA states the indications and contra
indications & age range for the drugs use
Off Label / Off Licence
• You as a prescriber must be very aware of
the licence situation of all that you
prescribe, because you are liable (or your
employer is) if harm is proven following an
off label prescription
• Such prescribing is common in
paediatrics, palliative care
• Is there anything in your practice that you
will be prescribing off label?
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