A Special is an unlicensed medicine prescribed to meet the individual clinical need of a patient when a suitable licensed medicine is not available. ‘Specials’ account for approximately 1% of all prescriptions in the UK, but account for more than 75,000 different formulations.
Medicines for specific patient needs
There are many different reasons why a licensed medicine might not be available. Often the formulation that would best meet the patient’s needs has not been commercially manufactured by any drug company in a licensed version. Sometimes the licensed product that may suit the patient’s needs has been discontinued temporarily. In these circumstances a Special will be prescribed. These Special prescriptions are dealt with in exactly the same way as any other prescription, except that the pharmacist dispensing the drug will have to take steps to fulfil the prescription in a different way. This can be either by formulating it themselves or, as most often happens, by contacting a pharmaceutical Specials manufacturer to make up the prescription.
How are Specials made?
Most Specials are produced by pharmaceutical companies who dedicate their resource and expertise to this very specialist area of medicines manufacture. In the UK, these companies are represented by the APSM – Association of Pharmaceutical Specials Manufacturers.
Specials manufacturing is a unique and important part of the pharmaceuticals industry. Traditionally, pharmacists used to mix their own medicines, but these days most Specials are manufactured by pharmaceutical companies in dedicated manufacturing facilities
Currently, to manufacture Specials in the UK, a company must hold a ’Specials Manufacturer's Licence’ which is granted by the MHRA.
This type of Specials manufacture has largely replaced the traditional method of ’in pharmacy’, or ’extemporaneous’ preparation and although pharmacists still possess the necessary skills to prepare medicines, in most cases it is a costly, time consuming process. See Supplying a Special - A decision guide for Pharmacists - RPS.pdf For this reason the majority of pharmacists now choose to order from a recognised Specials manufacture so they can be assured of reliability, safety and consistency.
Most Specials are made individually or in very small batches and dispatched within hours of the order being received from a pharmacist. The patient will usually be able to collect their prescription the following day.
Types of Specials
There are more than 75,000 different formulations of Specials prescribed every year and very many reasons why a Special is needed.
Although Specials represent approximately 1% of prescriptions, this volume is made up of a huge array of different formulations, from creams and liquids to intravenous and injectables. Very few Specials prescriptions are exactly the same or are required at the same time, and so although some can be made up in small batches, a large number are made up individually to meet the needs of the patient.
Who needs Specials and why
The patients who are most often prescribed an unlicensed medicine are the most vulnerable groups in society.
A premature baby that can't tolerate a standard dose; a stroke patient or older patient who has lost the swallow reflex and needs liquid medicine, a child with learning difficulties who won't take a tablet and needs a liquid format, a patient in intensive care who has specific intravenous nutritional needs, a cancer patient undergoing complex oncology or someone with skin problems who has an allergic reaction to common drug excipients and needs a preservative-free formulation.
Many licensed medicines are not developed in the correct dosage or formulation for these patients and so would be too costly for it to be commercially viable for pharmaceutical companies. This is why prescribers are given the freedom to prescribe any drug in any formulation for these patients. In some cases and for patients in hospital, these Specials are made up by the hospital pharmacy. In others, the patient can take their prescription to any pharmacist and their Special will be individually made to order for them and delivered usually the following day.
Because of MHRA regulations, companies can't provide information about an unlicensed medicine. However, please see the case studies page in this section for examples of how unlicensed medicine has benefited patients.
A child where the adult dose was not appropriate
A GP prescribed an anti-inflammatory drug in a dispersible tablet formulation for a child with arthritis. A week later the mother returned to the GP because the child was still in pain despite giving the medicine as directed. The GP found out that the child had been given 50mg dispersible tablets and told to dissolve these in 5ml of water then give the child 1ml to provide a dose of 10mg. Dispersible tablets are designed to provide the full 50mg dose. When dispersed in water a lot of the product falls to the bottom of the glass, so taking 1ml out of the total volume resulted in a variable dose. On testing this ranged from between 2mg and 8mg and the 10mg required was rarely achieved. Had the child been given a properly formulated Special, their pain could have been more adequately controlled. (adapted from Tomlin S, et al. Making medicines safe for children – guidance for the use of unlicensed medicine in paediatric patients. Berkhamsted: MGP Ltd, February 2009.)
An allergy to an ingredient in the licensed product
A Special was required when a patient developed an allergy to benzalkonium chloride, which was used as a preservative in a licensed eye drop. The eye drops were used to treat bacterial infections of the eyelid and eyeball and without treatment the patient could suffer severe loss of sight or, in the worst case, blindness. One of the members of the APSM was able to produce the eye drops without the benzalkonium chloride so that the patient was able to have the treatment they needed.
Our quality process
Many of our APSM members are Specials Manufacturers who are licensed, regulated and inspected by the Medicines and Health Regulatory Authority (MHRA) and must also comply with the principles of Good Manufacturing Practice (GMP) adopted by the EU Commission.
Frequently asked questions
Medicines and licenses
What is a licensed medicine and how do they gain their licence?
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.
Why do medicines need to be licensed?
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.
Who licenses medicines?
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.
Why are some medicines unlicensed?
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.
How do I know if a medicine is unlicensed?
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 less than 1% 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)
What does using a licensed medicine ’off-label’ mean?
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).
When should Specials be prescribed?
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.
Is it safe to take Specials?
Specials manufacturers in the UK must hold a 'Specials Manufacturing 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. Specials are manufactured to a very high standard in premises regulated to pharmaceutical standard and regularly checked by MHRA inspectors. Read more about our Quality Processes.
Who is responsible for the safety of patients taking a Special?
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.
Why can’t licensed alternatives be given?
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.
Once a Special is made, why doesn’t the manufacturer apply for a licence for that Special?
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.
How do I find out what Specials cost?
The reimbursement prices of Specials in England, Wales and Scotland is regulated by Tariff. The England & Wales Specials Tariff was introduced by The Department of Health in 2011 to provide sustainability of supply and a mechanism to ensure that safe and effective Specials are available to the NHS via a resilient supply chain that provides a fair return, ensuring the long term sustainability of the Specials market. Tariff changes are made every 3 months based on volume and pricing data submitted to the MHRA by organisations involved in Specials supply and manufacture, including APSM member companies. Some Specials are not included in the Tariff, if for example, only a very small number of prescriptions are required each year and so the cost is too small to warrant inclusion. Prescriptions are reimbursed by the DH at Tariff price. For non-Tariff items reimbursement is at net price i.e. invoice price less any discount given The Scottish Tariff covers a smaller number of products (50) and uses a different mechanism for setting prices, although commercial and NHS prices are also taken into account. Overall, the price of the majority products on the Specials Tariff in Scotland is similar to the England Tariff with some fluctuations as the sizes and volumes are not always comparable.
What does the term ‘Extemporaneous Preparation’ mean?
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.
SAFETY. If you are unsure about a medicine, or experience any side effects, you should contact your doctor or pharmacist immediately for advice. More information about medicines safety and reporting can be found here
Next day Specials – The one medicine you don’t have to wait for
Specials manufacturers are continuing to meet patient need on a daily basis – 365 days a year. Continuity of supply is a priority in spite of the fact that Specials are unusual and account for less than 1% of all prescriptions annually.
All APSM members sign up to a commitment of timely delivery to patients and that now means next day delivery as standard. Members report that between 95-99% of orders are despatched the same day of receipt for delivery the following. Patients who are prescribed Specials often have a specific and urgent clinical need and should not have to wait for this medicine just because it isn’t a licensed or off the shelf preparation.
Although Specials manufacturers are geared towards bespoke manufacture, with more than 20,000 potential preparations it’s not possible to predict demand. An order is received, it is manufactured, goes through QA and is despatched all within 24 hours. For a typical Specials manufacturer this can mean 500 different orders a day – and of course the inherent costs associated with express delivery costs and maintaining a high level of manufacturing capacity so that orders can always be fulfilled.