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By law, a drug company must have a product license to advertise and sell a medicine by a medicines regulator- MHRA

Specially trained panel of assessors who reviews all available evidence from the pre clinical research and trials.

The license will state which illness or condition the medicine can be used for; the age of patients it can be given to; how much to give and how to give it.

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Drug must be first tested in a series of clinical trials, usually in adults aged 18-65

Trials helps drug company prove that the drug works for the specific illness/condition and it is safe

Results from these trials are then forwarded to the MHRA when the drug company applies for the license

All the adverts and branding based on this product can only be based around what is in the license

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The role of the Medicines and Healthcare Products Regulatory Agency

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Finding and developing a new medicine can take up to 10-15 years

EXPENSIVE- estimation can be around £1 billion from discovery to gaining a license

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Every medicine has side effects, ranging from minor to severe

Some side effects become apparent straight away, some appear over time

If the regulators waited for every side effect to be identified before carrying out the licensing, this could potentially deny patients useful and valuable treatments

Before licences are approved, the MHRA needs to know whether the medicine:

- Works well with minimum harm for most of the population who will be taking it

- Is acceptably safe

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High level of side effect in medicines maybe acceptable to help treat a life threatening condition such as cancer but not a minor aliment like hay fever

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A licensed medicine meets acceptable standards of efficacy, safety, and quality

A marketing authorisation or product licence defines a medicine’s terms of use in its summary of product characteristics which outlines, among other things:

- the indication(s),

- recommended dose(s),

- contraindications,

- special warnings and precautions for use on which the licence is based

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Medication is being used in a way that is different to what is described in the licensing of the medication.

For example:

- Using the medication for a different illness to what is stated in the license. This may be supported by expert groups and may work well but the drug manufacturer has not extended the licensing to this specific condition

- Using the medication in a different age group than what is specified in the MA

-Using the medication at a higher dosage than what is stated

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- Doctors can sometimes prescribe a medication ‘off label’

-Typically happens when there is no other alternative or where the access to effective alternatives is restricted

-Doctors can ask the MHRA to import a medicine that has been licensed outside Europe if something suitable is not available in the UK- ‘Unlicensed’

-Common in paediatrics and neonates

-Range of professionals can prescribe unlicensed/off label medications- doctors, dentists, independent nurse and pharmacist prescribers and also supplementary prescribers in some circumstances.

-Subject to individual clinical competence, professional code and ethics of their statutory bodies and the prescribing policies of their employers

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Good Off-Label Use Practice of Medicines

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This typically implies the medication could be one of the following:

- A medicine has a licence in other countries, but not the UK. It has to be imported because it is not available in the UK.

- A medicine has a licence but needs to be made up to be taken as an unlicensed formulation. This is usually as a specially-prepared liquid for someone who has difficulty swallowing the licensed tablets

-A medicine that has no licence at all. These are often medicines used for treating rare illness. The manufacture may have decided that it was too expensive to carry out the clinical trials or it would be difficult to find enough patients for the clinical trials needed to get a license.

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Prescribing an unlicensed or off label medication is ultimately the responsibility of the prescriber

A prescriber should pay attention to the risks associated with using unlicensed or off label medicines

Risks include:

- Adverse drug reactions

-Product quality

-PILs not being consistent with medicines off-label usage as this can lead to confusion to the patient/carer/parents

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Satisfied that there is no alternative available that would meet the patient’s needs before prescribing an unlicensed medication

Satisfied that the use of this medication would serve the patient’s needs than an licensed alternative

Satisfied that there is sufficient evidence/experience of using the medicine to show its safety and efficacy

Competent to take over the monitoring and follow up of the patient as well as taking responsibility for prescribing the medication

Record keeping- ensure it is documented that an unlicensed/off label medication has been prescribed, the reasons and as well as any discussions with the patient/carer/parents that have taken place

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Finally, the importance of communication

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Finally, the importance of communication

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When prescribing, patients/carers/parents should be given sufficient information about the proposed treatment

It is vital to relay to the patient/carer/parents if a medication is unlicensed or off label and provide the reasons of prescribing this medication to the party

Important to monitor safety of medicines in clinical use through submission of suspected adverse drug reactions (ADRs) to the MHRA via the Yellow card scheme.

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Yellow card reporting of New drugs and vaccines

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Yellow card reporting of New drugs and vaccines

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https://bnf.nice.org.uk/medicines-guidance/adverse-reactions-to-drugs/

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Yellow card reporting of established drugs

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Yellow card reporting of established drugs

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https://bnf.nice.org.uk/medicines-guidance/adverse-reactions-to-drugs/