PHARMACEUTICAL SPECIALS

For individual patient clinical needs

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WHAT ARE SPECIALS?

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.

FOR SPECIFIC PATIENT NEED

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.

TYPES OF SPECIAL

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 manufactured in small batches, a large number are made individually to meet the needs of the patient.

WHO NEEDS A SPECIAL AND WHY?

The patients who are most often prescribed an unlicensed medicine are amongst the most vulnerable groups in society.

For example, a 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 able 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.

HOW SPECIALS ARE 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.pdfFor 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.

NEXT DAY DELIVERY

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.

FOR SPECIFIC PATIENT NEED

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.

QUALITY OF MANUFACTURE

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.

CASE STUDY: ALLERGY TO INGREDIENT

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.

CASE STUDY. A CHILD WHERE ADULT DOSE 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.)​