Our medicines article provides you with information on:
- how medicines are licensed
- how it is decided if licensed medicines will be used by the NHS in Scotland
- ways in which you can access medicines once they are available for use
- why some medicines have more than one name
- how to report adverse side effects.
Licensing of medicines
Before any medicine can be used to treat people in the UK, it first must be licensed. This can take several years and cost a lot of money.
It is an important stage in the process though, making sure high standards of safety and quality are met and that the product works for the purpose intended.
Find out more in our section on the licensing of medicines.
Use of new medicines within the NHS in Scotland
After being granted a license, a new medicine will go through some more stages in the process of review before it can be used by the NHS in Scotland.
This is to make sure it is both clinically and cost effective as it is important that funding for medicines is spent in a way that best benefits everyone in Scotland.
An overview of the decision-making process for new medicines is provided below:
Stage 0 – a new medicine is granted a license
Stage 1 – The Scottish Medicines Consortium (SMC) make a decision on the use of the new medicine and this is issued to all Health Boards in Scotland.
Find out more about stage 1 in our SMC section.
Stage 2 – A group of health care professionals within each Health Board considers whether the new medicine should be made available for routine prescribing within their Health Board area.
If they decide that it will be made available, then it is added to the Health Board list of medicines for prescribing. This is called the Board Formulary.
If they decide that it will not be made available, then the Health Board will await any further evidence or recommendation from the SMC before reviewing any decision again.
Find out more about stage 2 in our Health Board Committee section.
Flowchart of stages
This flowchart summarises the above stages a medicine goes through before it can be used by the NHS in Scotland.
More information can be found in the factsheet, New medicines in Scotland – who decides what the NHS can provide? PDF (303 KB)
How can you access medicines?
The accessibility of a medicine depends on the legal status of the medicine as well as the level of supervision experts believe is needed before use.
Under laws governing the supply of medicines, there are three main categories:
Prescription-only medicines (POMs)
These need a prescription issued by a GP or other suitably qualified healthcare professional. You then take the prescription to a pharmacy or a dispensing GP surgery to collect your medicine.
Pharmacy medicines (P)
These are available from a registered pharmacy and don’t need a prescription. The pharmacist, or trained member of staff, will check that any ‘P’ medicine is appropriate for you and your health problem by asking you some questions. Pharmacy ‘P’ medicines are kept ‘behind the counter’ and are not available for self-selection on the pharmacy shelves.
General sales list medicines (GSL)
These can be bought from pharmacies, supermarkets and other retail outlets without the supervision of a pharmacist.
Pharmacy (P) and GSL medicines are often referred to as ‘over-the-counter’ (OTC) medicines. OTC medicines include those that treat minor, self-limiting complaints, which people may feel are not serious enough to see their GP about.
Can the legal category of a medicine change?
Many medicines are licensed in the POM category and you will continue to need a prescription to access them. This is the case with new medicines so that healthcare professionals can supervise their use during the first few years that they are available, making sure they are safe and effective in practice.
If a POM medicine proves safe in large numbers of patients over several years, the regulatory agency might consider allowing its legal status to switch from POM to P in specified conditions and circumstances regarding it’s use.
If the medicine continues to be safe for another few years as a P medicine, a switch to GSL status may be considered so it can be sold from any retail outlet.
If a medicine switches from POM to P or from P to GSL, the active ingredient remains exactly the same. This means the medicine is just as effective as when it had to be prescribed by a qualified prescriber. It also means there is the same risk of side effects if you take too high a dose or do not follow instructions on the label. Therefore, it is important you follow the instructions of any OTC medicine carefully.
Naming of medicines
Medicines can sometimes have more than one name, which may seem confusing.
Find out more about the difference between brand names and scientific or generic names in our section on why the same medicines can have different names.
Reporting an adverse effect
You can help regulate the safety of medicines by reporting symptoms you experience to the Yellow Card scheme.
Find out more in our section on reporting an adverse side effect.
Last updated: 12 March 2014
Continue to next section: Licensing of medicines