Medicines information
Introduction
Some medicines are available from pharmacists or supermarkets. Others require a prescription from your GP or another healthcare professional. The availability of medicines depends on the level of supervision that experts believe is necessary before you use a particular medicine.
Under laws that govern the supply of medicines, you can obtain medicine under three categories:
- prescription-only medicines (POMs)
- pharmacy (P) medicines
- general sales list (GSL) medicines
These are explained in more detail below.
Prescription-only medicines (POMs)
Prescription-only medicines (POMs) are only available with a prescription that is issued by a GP or another suitably qualified healthcare professional (see below). You need to see the healthcare professional before they give you a prescription.
You then take the prescription to a pharmacy or a dispensing GP surgery for your prescription to be dispensed. Examples of POMs are inhalers to treat asthma or medicines to lower high blood pressure (hypertension).
Pharmacy (P) medicines
Pharmacy (P) 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 or another member of staff will check that the medicine is appropriate for you and for your health problem. They will ask you some questions to ensure that there is no reason why you should not use the medicine. An example of a medicine that you can buy from a pharmacy without a prescription is chloramphenicol eye drops to treat conjunctivitis (an eye infection).
General sales list (GSL) medicines
General sales list (GSL) 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’ (OTC) medicines.
OTC medicines include those that treat minor, self-limiting complaints, which people may feel are not serious enough to see their GP or pharmacist about. For example, paracetamol for the common cold or a headache, or antiseptic gel to treat minor cuts or grazes.
Can medicines change their status?
New medicines tend to be licensed in the POM category so that healthcare professionals can supervise their use during the first few years that 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 POM to P.
European Union (EU) regulations encourage switching medicines from POM to P as long as there is no danger to health if the medicine is used without a prescriber’s supervision and the medicine is unlikely to be used incorrectly.
If there have been no problems with a P medicine after several years of use, a switch to GSL status may be considered so that it can be sold directly from retail outlets.
Over the past 20 years in the UK, a wide range of medicines have been switched from POM to P and P to GSL. They include:
The government encourages increasing the availability of medicines where it is safe to do so.
Are P and GSL medicines as effective and safe as POM medicines?
If a medicine switches from POM to P or from P to GSL, the active ingredient remains exactly the same. This means that the medicine is just as effective as when it had to be prescribed by a qualified prescriber.
It also means that there is the same risk of side effects if you take too high a dose or if you do not follow the instructions on the label. Therefore, it is important that you follow the instructions carefully. Your pharmacist will be able to advise you about any possible side effects.
Who can prescribe medicine?
A person who is able to prescribe medicine is called a prescriber. A prescriber is an ‘appropriate practitioner’. This includes:
- doctors
- dentists
- nurse independent prescribers – can prescribe any medicines for any medical condition within their competence, including some controlled medicines (those that are controlled under the Misuse of Drugs legislation) for specified medical conditions
- pharmacist independent prescribers – can prescribe any medicine for any medical condition within their competence, except for controlled medicines
- optometrist independent prescribers – can prescribe any licensed medicine for conditions that affect the eye and surrounding tissue, but they cannot prescribe any controlled drug independently
The above are all ‘independent prescribers’. This means they can assess someone and prescribe a medicine as part of that person’s care. There are also ‘supplementary prescribers’. They work with the independent prescriber and include:
- nurses
- pharmacists
- podiatrists – foot care specialists
- physiotherapists – healthcare professionals who use physical techniques, such as massage and manipulation, to promote healing
- diagnostic and therapeutic radiographers – specialists in using medical imaging techniques, such as X-rays
- optometrists – healthcare professionals who examine eyes, test sight and prescribe and dispense glasses and contact lenses
A supplementary prescriber can prescribe any medicine, including controlled drugs, for any condition within their competence under the clinical management plan agreed with the independent prescriber and the patient.
^^ Back to top
Licensing
When you use a medicine, you expect it to be as safe as possible. No medicine is completely free from risk, but there are many checks in place to ensure that medicines are as safe as possible before becoming available for GPs and other healthcare professionals to prescribe, or before you can buy them over the counter.
UK medicine licences
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 and the product works for the purpose intended. There are also rigorous standards for medicine manufacturers and wholesalers.
Licences can be granted by:
- the Medicines and Healthcare products Regulatory Agency (MHRA) – an executive agency of the Department of Health that ensures that medicines and medical devices work and are safe, including granting licences for their use in the UK
- the European Medicines Agency (EMA) – a health regulatory agency that can grant licences to cover the use of medicines in the European Union (EU); it ensures that medicines are available and used in the same way across all EU member states
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 and computer analysis techniques.
After this, they may be tested in animals. 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 humans.
Clinical trials
Clinical trials are research studies carried out in human volunteers and patients that 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 pharmaceutical industry (companies who make medicines)
- research charities
- research councils
- the NHS
A quarter of the world’s top 100 medicines were developed in this country, which is a leader in clinical research.
See the topic about Clinical trials and medical research for more information.
Finding and developing new medicines takes around 10 to 12 years. It is also a very expensive process. Estimates vary, but it may cost around £550 million to develop a new medicine, from its discovery to gaining a licence.
Stages of research
Four levels 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 to 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 – after it has been licensed, post-marketing studies are used to monitor the medicine on an ongoing basis in real world conditions (possibly in several thousands of people) to see if there are any unexpected side effects or if the medicine causes problems in certain categories of people
See the topic about Clinical trials and medical research - phases of trials for more information.
Unlicensed medicines
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. For example, amitriptyline is licensed to treat depression, but it is sometimes used to treat certain types of pain even though it does not have a licence for this purpose.
Many experts will use an unlicensed medication if they think that 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 that it is unlicensed and discuss the possible risks and benefits with you.
What information does a licence include?
The licence for a medicine tells healthcare professionals information such as:
- what health condition the medicine should be used to treat
- what dose of the medicine should be used
- what form the medicine takes – such as a tablet or liquid
- who can use the medicine, e.g. 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
This information is usually included in the summary of product characteristics (SPC). This is a leaflet that comes with the medicine to inform healthcare professionals about how it should be used.
As well as a SPC, medicines should come with a patient information leaflet (PIL). This is a leaflet that gives the patient information about the medicine. However, a PIL is not necessary if all of the information fits on the label of the medicine.
^^ Back to top
Safety
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 that are used in the UK.
Ensuring safety
No product is completely risk free, so the MHRA uses as much information as it can to ensure that the benefits of medicines to patients justify any possible risks.
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 what health condition it should be used to treat. See Medicines information - licensing for more information.
However, no medicine is completely risk free and medicines can affect different people in different ways. For example, depending on your age and sex and what other medicines you may be taking, a medicine might cause you to have a side effect that someone else who is taking the same medicine does not 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.
Monitoring safety
The MHRA also monitors the safety of medicines once they are in clinical use, and it takes action if a problem arises. 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 the side effects outweigh the benefits.
For example, in January 2010, the EMA recommended that the weight-loss medication sibutramine should be withdrawn across the European Union due to a safety concern. New evidence suggested that the increased risk of having a heart attack or stroke outweighed the benefit of using the medication. As a result, sibutramine is no longer prescribed in the UK.
Reporting an adverse effect
The Yellow Card Scheme is a special reporting system for possible adverse effects of medicines. If the healthcare professional who is treating you thinks that 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
- logging onto the Yellow Card Scheme website to report an adverse effect online
^^ Back to top
Brand names and generics
Why the same medicines can have different names
Many medicines have two names:
- the brand name given to a medicine by the pharmaceutical company that makes the medicine
- the scientific or generic name for the active ingredient of the medicine that is decided by an expert committee
For example, sildenafil is the generic name of a medicine that is used to treat erectile dysfunction (the inability to get and maintain an erection). However, the company that makes sildenafil, Pfizer, sells it under the brand name Viagra.
Another example is simvastatin, which is the generic name for a statin (cholesterol-lowering medicine), which is used to reduce the risk of heart disease. A company called Merck Sharp & Dohme Ltd (MSD) make a version of simvastatin under the brand name Zocor.
The branded version (Zocor) and the generic version (simvastatin) contain the same active ingredient, simvastatin. Both of them have the same clinical effect, but they can be made by different manufacturers and so have different names.
It is similar to buying branded washing powder or a supermarket’s equivalent; both products do the same job but the supermarket’s own version is much cheaper.
Brand names
During the first few years that 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 that they regain the money they spend on its development, usually around £550 million, and make a profit. Having a patent means that only that company can produce the medicine for a certain length time (usually up to 20 years in the UK). In exchange for this, the company must share information about the medicine and how it is produced.
On average, it takes the first 10 to 12 years of this period with a patent to develop a medicine and obtain a licence (see Medicines information - licensing). The company has the remaining years during which only they can produce and sell the medicine. They give the medicine a brand name for marketing purposes to make it more memorable, such as Viagra.
Generic names
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 that is 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 as effective as the branded versions, but can cost up to 80% less. This frees up NHS resources to pay for other treatments. It also gives the pharmacist the widest choice of products to dispense. This is important, particularly if there is a shortage of a particular product.
Generic prescribing is becoming particularly common for statins. This is because generic versions of some of these medicines are now available much more cheaply than their branded equivalent. For example, in October 2010, generic simvastatin (20mg) cost £1.12 for a pack of 28, compared with approximately £30 for a pack of 28 of the branded version.
Generic medicines with different activity
In rare cases, it is important for a patient to stay on the branded medicine that was 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:
- epilepsy 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 that 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 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
- any product where the generic name could cause confusion, such as hormone replacement therapy (HRT) and insulins (used to treat diabetes)
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 that 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, if you look carefully, you will see that it contains the same active ingredient as the medicine you used before.
^^ Back to top