1. Prescribing in Practice Part 1 (b)
Legal Issues (1)
The following lead lectures within this OER are referred to it this presentation and may be useful to review
Prescribing Triangle, Accountability, Concordance and Team Working

2. 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
There are two laws that relate to prescribing

3. 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
MHRA Responsible for enforcing ADR reporting by the ma holders under yellow card scheme MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AUTHORITY (MHRA) all about gathering data and evaluating risk, especially important in children as no clinical trials allowed
If a medicine is licensed then providing it is prescribed for the patients, purposes and conditions it holds its licence then whoever holds the MA is responsible for it…it is in fact a guarantee from them to cover patients for compensation if harm is proven from their product if taken as per the conditions stipulated. This guarantee only applies when is used within the licence
A great deal of prescribing in pall care & paeds is done this way it doesn’t mean that its bad practice its just that there is a lack of licensed meds for kids as clinical research I this area is unethical, refer to childrens BNF or other reliable sources like medicines information
The SPC summary of product characteristics of all licensed drugs is available at this will have a lot of important information for your monologues

4. 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?
Consent…lidocaine patches is it common practice in this field of specialism
When using unlicensed drugs great care should be taken as there is little information on their use

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