As medicines are a crucial part of medical treatment, it is important to have a good understanding of them.
How can you get medicines?
Some medicines are available from pharmacists or supermarkets, while others require a prescription from your GP or another healthcare professional.
The availability of medicines depends on the level of supervision experts believe is necessary before you use a particular medicine.
Under laws governing the supply of medicines, you can obtain medicine under three categories:
general sales list medicines
These are explained in more detail below.
Prescription-only medicines need a prescription issued by a GP or another suitably qualified healthcare professional.
You then take the prescription to a pharmacy or a dispensing GP surgery to collect your medicine.
Pharmacy medicines are available from a pharmacy without a prescription, but under the supervision of a pharmacist.
You will need to ask staff at the pharmacy for this type of medicine because it is kept behind the counter and is not available on the pharmacy shelves.
The pharmacist will check the medicine is appropriate for you and your health problem. They will ask you questions to ensure there is no reason why you should not use the medicine.
General sales list medicines
General sales list medicines can be bought from pharmacies, supermarkets and other retail outlets without the supervision of a pharmacist. These are sometimes referred to as over-the-counter medicines.
Over-the-counter medicines include those that treat minor self-limiting complaints people may feel are not serious enough to see their GP or pharmacist about.
Who can prescribe medicine?
The main prescribers are called independent prescribers, which include:
nurse, pharmacist and optometrist independent prescribers
Independent prescribers can assess someone and prescribe a medicine as part of that person's care.
There are also supplementary prescribers, who can prescribe any medicine for any condition within their competence, with the agreement of an independent prescriber and the patient.
Can medicines change their status?
New medicines tend to be licensed in the prescription-only medicines category so that healthcare professionals can supervise their use during the first few years they are available.
If a medicine proves safe in large numbers of patients over several years, the regulatory agency may consider changing its status from prescription-only to pharmacy.
If it continues to be safe for another few years, a switch to general sales list status may be considered so it can be sold directly from retail outlets.
If a medicine switches from prescription only to pharmacy, or from pharmacy to the general sales list, 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 the instructions on the label. It is therefore important you follow the instructions carefully.
How are medicines developed?
In the UK, before any medicine can be used to treat people, it has to be licensed. Licences are only granted if high standards of safety and quality are met throughout the development process and the product works for the purpose intended.
In the UK, licenses can only be granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
Potential medicines are first thoroughly researched using tissue culture, computer analysis techniques and animal testing.
If strict standards of safety and effectiveness are met, clinical trialsinvolving humans can then be used. If a medicine passes all the phases of clinical trials, it can be licensed for wider use.
The whole process from discovery to licensing can take around 10 to 15 years.
How are medicines regulated?
No medicine is completely risk free, but attempts are made by the MHRA and EMA to ensure any medicine approved for widespread use is as safe as possible.
As well as a strictly monitored development process, medicines continue to be carefully regulated after they have been granted a license. This involves checking for problems, such as reports of previously unknown side effects.
In rare cases, medicines may be withdrawn if there are significant safety concerns or if the risks of the medicines outweigh the potential benefits.
You can help the MHRA monitor the safety of medicines by reporting any suspected side effects to the Yellow Card Scheme. Reports can also be made on behalf of someone you're caring for.
The MHRA is the UK medicines watchdog. Its Yellow Card Scheme collects reports of side effects for all medicines (including complementary medicines) and vaccines.
If a new side effect is found, the MHRA will review the way the medicine can be used and alert the public to the potential risks.
Why do the same medicines sometimes have different names?
Many medicines have at least two different names – a brand name and a generic name.
The brand name is usually what the medicine is called by the company that first discovered and developed it. The generic name is the name of the active ingredient in the medicine that makes it work.
Initially, for a few years the company that developed the medicine is the only one that can sell it, which means they can choose the price.
To make a profit from the very costly development process, this usually means the medicine is very expensive at this point.
Generic copies are allowed to be made once this period ends. Generic medicines are usually as effective as the brand-name medicine because they contain the same active ingredients.
Generic medicines are used more often for treatment because they are as effective as the original medicine, but cost far less.
Licensing of medicines
Before a medicine can be widely used in the UK, it must first be granted a licence.
While no medicine is completely risk free, a licence indicates all the proper checks have been carried out and the benefits of a medicine are believed to outweigh the risks.
This licence is also known as a marketing authorisation.
UK medicine licences
Licences are only granted if high standards of safety and quality are met during the whole development and manufacture of a medicine.
The product must also work for the purpose it is intended for if it is to be licensed.
In the UK, licences can be granted by:
the Medicines and Healthcare Products Regulatory Agency (MHRA) – which can grant licences for medicines only in the UK
the European Medicines Agency (EMA) – which can grant licences for medicines in the European Union (EU)
Before a licence can be granted, the medicine needs to be developed and tested.
Developing a medicine
Potential medicines are thoroughly researched using tissue culture, computer analysis techniques and animal testing.
All new medicines are required by law to be tested for safety, quality and effectiveness.
Data is needed from two separate species of animal before a medicine can be used in clinical trials involving humans.
Clinical trials are research studies carried out in human volunteers and patients. They carefully test the safety and effectiveness of medicines using strict criteria.
If clinical trials are going to be carried out in the UK, the manufacturer of the medicine must first apply to the MHRA for permission to test its medicine.
In the UK, clinical trials are sponsored by:
the, through the National Institute for Health Research
the Medical Research Council
the Department of Health and other government departments
medical research charities
pharmaceutical and other healthcare companies
Finding and developing new medicines takes around 10 to 15 years. It is a very expensive process. Estimates vary, but it can cost more than £1 billion to develop a new medicine, from its discovery to gaining a licence.
Stages of research
Four stages of clinical trials are used to investigate a new medicine:
phase 1 – the medicine is tested in small numbers of healthy volunteers (up to 100 people) to find out how it works in the body and whether side effects increase at higher doses
phase 2 – the medicine is tested in moderate numbers of people (several hundred) with a particular condition or disease to see how effective it is and identify common short-term side effects
phase 3 – information about the medicine is gathered from a larger number of people (often several thousand) to see how well it works and how safe it is
phase 4 – this happens after a licence has been granted, and involves studies to monitor the medicine on an ongoing basis to see if there are any unexpected side effects, or if it causes problems in certain categories of people
What information does a licence include?
The licence for a medicine includes information such as:
what health condition it should be used to treat
what dose should be used
what form it takes – such as a tablet or liquid
who can use the medicine – for example, only people above a certain age
how long treatment with that medicine should last
warnings about known safety issues – such as side effects and interactions with other medicines
how the medicine should be stored
when the medicine expires
This information is usually included in the summary of product characteristics. This is a leaflet that comes with the medicine to inform healthcare professionals about how it should be used.
As well as a summary of product characteristics, medicines should come with a patient information leaflet. This leaflet provides patients with certain facts about the medicine. However, a patient information leaflet is not necessary if all of the information fits on the medicine label.
Copies of summary of product characteristics and patient information leaflets are available from the MHRA and EMA websites.
Sometimes a healthcare professional may recommend an unlicensed medication or an off-label use for a medicine.
Off-label use means that the manufacturer of the medicine has not applied for a license for it to be used to treat your condition. In other words, the medicine has not undergone clinical trials to see if it is effective and safe in treating your condition.
However, the medicine will have a licence to treat another condition and will have undergone clinical trials for this.
Many experts will use an unlicensed medication if they think the medication is likely to be effective and the benefits of treatment outweigh any associated risk.
If your specialist is considering prescribing an unlicensed medication, they should inform you it is unlicensed, and discuss possible risks and benefits with you.
How is the safety of medicines regulated?
All medicines licensed for use in the UK are strictly regulated to ensure they are as safe as possible.
The entire process of medicine development is controlled, and monitoring continues after medicines become widely available.
In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is the organisation that looks after the safety of prescribed medicines and other health devices and equipment.
Its main job is to make sure that medicines and medical devices, from painkillers to pacemakers, work properly and are acceptably safe.
The MHRA works closely with the European regulator, the European Medicines Agency (EMA), which oversees the safety of medicines across Europe. In some cases, the EMA takes the lead in licensing medicines used in the UK.
No product is completely risk free, so the MHRA uses as much information as it can to ensure the benefits of medicines for patients justify any possible risks.
Both the MHRA and EMA routinely carry out inspections to check all parts of the medicine development process, from testing to manufacturing, are carried out in line with strict regulations.
The MHRA assesses the results of clinical trials to decide whether or not new medicines should be licensed for use. Clinical trials are research studies that carefully test the safety and effectiveness of medicines, using strict criteria.
No medicine or medical device can be used in the UK until the MHRA or EMA has given it a licence that sets out how it should be used and which health condition it should be used to treat.
However, no medicine is completely risk free and medicines can affect different people in different ways. For example, depending on your age, sex and what other medicines you are taking, a medicine might cause you to have a side effect that someone else who is also taking it wouldn't have.
Ultimately, you and your healthcare professional have to weigh up the pros and cons of each medicine when deciding on the most appropriate treatment.
The MHRA continues to monitor the safety of medicines once they are in wider use by checking reports about any problems or defects, and reviewing new scientific evidence on different medicines.
If any problems arise, the MHRA can take action to deal with it. This may mean alerting healthcare professionals about a potential issue with a medicine, and withdrawing a medicine from the market if it becomes apparent that side effects outweigh the benefits.
Reporting an adverse effect
The Yellow Card Scheme is a special reporting system for possible adverse effects of medicines.
If the healthcare professional treating you thinks a medicine may have caused a potentially concerning effect, they will fill in a report and send it to the MHRA.
You can also use the Yellow Card Scheme yourself, or on behalf of a child or adult in your care, by:
calling 0808 100 3352 to report an adverse effect over the phone
asking your pharmacist for a Yellow Card form you can send in the post
logging on to the Yellow Card Scheme website to report an adverse effect online
Why the same medicines can have different names
The names of medicines can often be confusing, as the same medicine can sometimes be called different things.
Many medicines have two names:
the brand name – this is given to a medicine by the pharmaceutical company it is developed by
the scientific or generic name – named for the active ingredient of the medicine, which is decided by an expert committee
For example, sildenafil is the generic name of a medicine used to treat erectile dysfunction. However, the company that makes sildenafil, Pfizer, sells it under the brand name Viagra.
Both medicines have the same clinical effect, but each separate manufacturer can give it a different name.
It is similar to buying branded goods or a supermarket's own label – both products do the same job, but the supermarket's own version is usually cheaper.
During the first few years a new medicine becomes available, it is usually marketed as a brand under a name given by the pharmaceutical company that developed it.
Companies take out patents (exclusive rights) on each new drug they discover to ensure they regain the money they spent on its development – which can be as much as £1 billion – and make a profit.
Having a patent means only that company can produce the medicine for a certain length of time. In the UK, the standard patent lasts 20 years, although this can sometimes be extended by up to another five years.
On average, it takes the first 10 to 15 years of this period to develop the medicine and obtain a licence.
During the remaining years, only that company can produce and sell the medicine to recover their costs and make a profit. They give the medicine a brand name for marketing purposes to make it more memorable, such as Viagra.
Once the patent protection expires, other companies can produce their own version of the medicine. For example, ibuprofen is the generic name of a medicine commonly used to treat pain and inflammation.
There are many branded versions of ibuprofen, such as Nurofen and Hedex. However, it is also sold under the generic name ibuprofen, but made by different manufacturers, such as Boots or Tesco.
Generic medicines are usually cheaper because there are fewer research and development costs, but they contain the same active ingredient as the branded products.
Generic medicines go through the same detailed safety and quality requirements as the original branded product.
Prescribing generic medicines
Prescribers (people who prescribe medicines, such as GPs) are encouraged to prescribe medicines by their generic name. This is because generic medicines are usually as effective as the branded versions, but can cost up to 80% less.
This frees up resources to pay for other treatments. It also gives the pharmacist the widest choice of products to dispense. This can be important, particularly if there is a shortage of a particular product.
Switching to a generic medicine
If your prescriber changes your regular prescription from a branded medicine to a generic version, they should tell you about the change before you collect your prescription.
This is to ensure you understand that although your medicine may have a different name, it will still contain the same active ingredient. Your pharmacist can also be a helpful source of information and advice when this happens.
When you pick up your prescription, the medicine may look different and there will be a different name on the label. However, it will contain the same active ingredient as the medicine you used before.
Generic medicines with different activity
In rare cases, it is important for a patient to stay on the branded medicine previously prescribed for them, rather than changing to a generic medicine. In such cases, the branded medicine is the most suitable product.
Some examples of when you should keep taking your brand of prescribed medicine include:
medicines – these should be treated with care because different versions may have slight differences in the way they are absorbed, which can cause big differences in their effect; for example, prescribers may decide the branded version of lamotrigine (Lamictal) is more suitable than the generic version
modified-release preparations of medicines – such as modified-release versions of theophylline, nifedipine, diltiazem and verapamil; a branded version may sometimes be a better option than the generic equivalent as they can be absorbed differently
ciclosporin – a medicine that suppresses the immune system (the body's natural defence system); different branded versions may cause different levels of ciclosporin in your blood
mesalazine – which is used to treat ulcerative colitis (a long-term condition that affects the colon); the way that mesalazine is absorbed varies between different brands
lithium – this treats a number of mental health conditions; different brands vary widely in terms of how much of the medicine is absorbed and becomes active
beclometasone dipropionate CFC-free inhalers to treat asthma– there are two inhalers that contain the same active substance (beclometasone dipropionate), but one is much stronger