FAQ’s
Medicines and licenses
Q. What is a licensed medicine and how do they gain their licence?
A. A licensed medicine is a medical product prescribed by doctors to patients, which holds an MHRA (Medicines and Healthcare products Regulatory Agency) approved marketing authorisation.
In order to get a licence, the medicine that has been discovered, must be successfully tested via clinical trials. These trials will be carried out on people with the aim of ensuring that the medicine is safe, effective and to discover what side effects the medicine may cause. About one fifth of medicines that are tested on clinical trials are successful.
Once the clinical trials have proved successful, then the MHRA can issue a marketing authorisation for that medicine and it can go on the market. The effects of the medicine will be continuously monitored for safety.
Q. Why do medicines need to be licensed?
A. Having a marketing authorisation means that the medicine has passed all the safety checks, which will have included a clinical trial on humans. In order for a marketing authorisation to be issued, the trials must have concluded that the product is of a high standard, will effectively treat the ailment it was designed for and also that the risks and side effects are at a minimum. In short, licensing medication helps to protect patients from adverse side effects.
Q. Who licenses medicines?
A. The Medicines and Healthcare products Regulatory Agency (MHRA) are in control of the issue of a marketing authorisation. The MHRA are a government controlled organisation founded in 2003 and are responsible for making sure that medicine and medical devices work effectively and are safe to all users.
Q. Why are some medicines unlicensed?
A. Unlicensed medicine is only available by prescription and is known in the industry as a ‘Special’. They are specially formulated for a patient’s specific needs and this is why they remain unlicensed; there is no commercial interest for the medicine to be mass produced. A fairly common occurrence in the Specials industry is when a medicine is available in the form of a tablet, but needs to be formulated into a liquid for a patient who has difficulty swallowing.
Q. How do I know if a medicine is unlicensed?
A. The patient will be informed if a medicine that has been prescribed is an unlicensed medicine. It isn’t common for a Special to be prescribed, as can be seen by the NHS expenditure figures in 2009, where unlicensed medicines only accounted for 1.4% of primary care expenditure.
(Reference: David Lloyd, Personal Communication, The information Centre & Putting QUIPP into action: Reinvesting at least £100 million through quality and effective prescribing. Views of an expert panel online)
Q. What does using a licensed medicine ’off-label’ mean?
A. This term refers to a prescription for medication that will be used to treat an ailment that the particular medication does not have the marketing authorisation for. The licence for a medicine will usually specify it is a treatment for a particular illness, but in practise, healthcare experts may notice that the drug also helps treat other conditions too. In order for the medicine to be an official treatment for the secondary condition, it would have to be re-licensed. The manufacturer would have to perform new clinical trials in order to seek approval from the Medicines and Healthcare products Regulatory Agency (MHRA).
Specials
Q. When should Specials be prescribed?
A. Specials need to be prescribed when a patient needs treatment for an illness that no licensed medicine can treat, or if a Special formulation of an existing licensed medicine needs to be made. For example, if someone has suffered a stroke and has lost the ability to swallow, then they may need a medicine that is only licensed in the form of a tablet. In this case, a Special will be made changing this tablet into a liquid.
Q. Is it safe to take a 'Special'?
A. Special manufacturers in the UK must hold a 'Specials Manufacturering Licence' which is issued by the MHRA. Risks to patients are minimal, as in most cases, the prescribers are experts in the use of Specials. Risks can be reduced further by selecting a reliable manufacturer and supplier, ensuring that the quality and safety of specials does not differ from a licensed medicine.
Q. Who is responsible for the safety of patients taking a Special?
A. The prescriber would take responsibility for any adverse side effect caused by the Special. It is also possible that the pharmacist that supplied the medicine can be held accountable alongside the prescriber. This differs from licensed medicines, where the manufacturer would take responsibility for any adverse side effects outside of its marketing authorisation.
Q. Why can’t licensed alternatives be given?
A. Unlicensed medicine, or ’Specials’, will only be prescribed if a licensed alternative is unavailable. If a licensed medicine is available to treat the patient then that medicine will be prescribed. It is only if there are no suitable licensed medicines to treat the patient that the healthcare professional will prescribe a Special.
Q. Once a special is made, why doesn’t the manufacturer apply for a licence for that Special?
A. If there is little demand for a Special that has been individually tailored, then it would not be cost effective for the manufacturer to complete all the clinical trials necessary to be able to obtain a licence.
Q. How do I find out what Specials cost?
A. In August 2010, legislation was amended so that price lists for unlicensed medicine could be published. This could help ensure that wholesalers who have purchased ready-made Specials cannot unethically mark up the price. However, because of the ‘made-to-order’ nature of the Specials industry, it would be unlikely that all products would be included in this price list.
Press release - ACSM Welcomes price list for Specials
Q. What does the term ’Extemporaneous Preparation’ mean?
A. Extemporaneous preparation refers to the process of preparing unlicensed medicines to fulfil a prescription in a registered pharmacy by a pharmacist, rather than by a Specials manufacturer. This practise has been in steady decline because of the growth of Specials manufacturers. MHRA licensed Specials manufacturers offer a clean environment for experts to prepare Specials, which has all the latest equipment and facilities.