SPECIALS


FROM TIME TO TIME IN HEALTHCARE, SITUATIONS CAN ARISE WHEN THE ONLY APPROPRIATE OPTION IS THE PRESCRIBING OF A ‘SPECIAL’ MEDICINE. BUT WHAT ARE SPECIALS? AND HOW AND WHEN SHOULD THEY BE PRESCRIBED?


Pharma Nord (UK) Ltd Telford Court Morpeth NE61 2DB England Tel: +44 (0)1670 534 901 Fax: +44 (0)1670 534 903 Email: specials@pharmanord.co.uk www.pharmanordspecials.com


THE CASE FOR SPECIALS A


Special is an unlicensed medicine that is prescribed to meet the clinical need of a patient when a suitable licensed medicine is not available. Naturally, if a licensed medicine is available to treat the patient, then that medicine will be prescribed.


The term ‘Special’ can be applied to any medicine product that does not hold a full Marketing Authorisation (MA) or Product Licence (PL), or European Medicines Evaluation Authority Licence (EMEA). The MHRA refers to Specials as ‘unlicensed relevant medicinal products placed on the market in order to meet the special needs of an individual patient’.


At present, Specials account for approximately one per cent of all prescriptions in the UK, but this figure covers more than 75,000 different formulations – from creams and liquids, to intravenous and injectables. Very few Specials prescriptions are either exactly the same, or are required at the same time, and so a large number is usually made up individually to meet the needs of an individual patient.


WHY ARE SPECIALS REQUIRED?


Well, in some cases the formulation that would best suit a patient’s needs may not have been commercially manufactured by a drug company in a licensed version. In other cases, the licensed product that meets the patient’s needs may have been discontinued. In such circumstances a Special will be prescribed and the pharmacist, who is dispensing the drug will have to take the necessary steps to fulfil the prescription in a different way to the ‘norm’. Traditionally, pharmacists would mix their own medicines, but while most


pharmacists still possess the necessary skills to prepare medicines, the process is a costly, time-consuming process. For that reason most will order a Special from a recognised Special manufacturer, who will hold a Specials Manufacturer’s Licence which is granted by the Medicines and Healthcare products Regulatory Authority (MHRA).


Although Specials manufacturers are focused on bespoke manufacture, it’s naturally difficult to predict demand. The process is simple. An order is received, it is manufactured, goes through Quality Assurance and is despatched within 24 hours. For a typical Specials manufacturer this can mean 500 different orders a day!


SO WHEN EXACTLY IS A SPECIAL REQUIRED?


Unfortunately, the Specials market is often most utilised by the weakest and most vulnerable in society.


For children, for example, a Special may be the only option in circumstances such as when a liquid Special carries a lower dose of a prescribed medication, or if a premature baby can’t tolerate a standard dose, or if a child with learning difficulties won’t take a tablet and requires a liquid format


Equally, 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 such a case, a Special will be made to change the tablet into a liquid.


In such cases, many licensed medicines are not developed in the correct formulation and so prescribers are given the freedom to prescribe any drug in the required formulation. If


the patient is in hospital, then the prescription will be made up by the hospital pharmacy. If the patient is at home or in a care home, then the prescription will be taken to the pharmacy and the Special will be individually made to order for them.


WHAT DO SPECIALS COST?


The reimbursement prices of Specials are regulated by the Drug Tariff. Tariff changes are made every three months based on volume and pricing data submitted to the MHRA by organisations involved in Specials supply and manufacture. Some Specials are not included in the Tariff if, for example, only a very small


WHO IS RESPONSIBLE FOR THE SAFETY OF PATIENTS TAKING SPECIALS?


In most cases the prescriber will take responsibility for any adverse side effects caused by the Special medicine, although the pharmacist may also be held accountable. In this instance, the case for Specials differs from that of licensed medicines, where the manufacturer would take responsibility for any adverse side effects outside of its marketing authorisation.•


WHAT PHARMA NORD SPECIALS CAN DO FOR YOU!


Pharma Nord Specials, a division of Pharma Nord (UK) Ltd, has been supplying community pharmacies, dispensing doctors and hospitals in Scotland with unlicensed medicines for many years.


With a combination of own branded unlicensed medicines and strong relationships with other Specials manufacturers, suppliers and wholesalers, Pharma Nord Specials is able to fulfil the vast majority of Drug Tariff and Non-Tariff unlicensed medicines.


Access to thousands of bespoke and imported medicines means that Pharma Nord Specials is able to provide you and your customers with high quality unlicensed medicines, at a fair cost to the NHS.


Natalie Fawcett, Unlicensed Medicines Manager, said, ‘The Pharma Nord Specials team are dedicated to providing an efficient and cost effective service. As well as processing orders, dealing with enquiries and sourcing hard to find special obtain items, the team also work alongside other suppliers to help improve service levels and product range, with competitive pricing.


‘With extensive experience within the industry, the Pharma Nord Specials team are on hand to assist with orders, enquiries and quotations.’


The Specials team are available Monday to Friday, to support you with your unlicensed medicine requirements. Next working day delivery is standard, deliveries to the Highlands/Islands may take longer.


Contact Details:


Telephone: 01670 534 901 Fax:


Email: 01670 534 903 specials@pharmanord.co.uk SCOTTISH PHARMACIST - 27


number of prescriptions are required each year and so the cost is too small to warrant inclusion.


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