SPECIALS
So why are specials prices so high? According to the Association of Pharmaceutical Specials Manufacturers, the price of special products takes into account factors such as the high-quality manufacturing processes that must be adhered to by manufacturers who wish to supply products listed on the Specials Tariff. In addition, these manufacturers must be appropriately licensed by the MHRA, and incorporate processes such as quality assurance, batch testing, product labelling, adverse event reporting and customer support lines, with the cost of these processes being proportionately more expensive in comparison to large scale pharmaceutical manufacturers5
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However, even in the event that the high cost of specials is unavoidable, pharmacists must play a role in the prevention of unnecessary or inappropriate prescribing of specials, liaising with other appropriate healthcare professionals where appropriate.
ENSURING SPECIALS ARE USED CORRECTLY As a result of the high level of spending on specials, health boards and trusts across the UK have introduced initiatives which are aimed at making healthcare professionals aware of the cost of these medications, and also suggesting ways in which the cost of prescribing and dispensing of these medications can be reduced, with Scotland being no different. Pharmacy plays a critical role in the appropriate use of these medications, and there are a number
In addition to these points, pharmacists are urged to ensure that they obtain their specials from the most cost effective source in order to reduce costs where there is no option but to supply a special, and also to ensure that they regularly communicate with their suppliers to ensure they are aware of new licensed products which may replace more expensive special versions. Of course, pharmacists are not the only professionals involved in the provision of these special medications, and as such, these NHS initiatives also provide some advice to prescribers, suggesting ways in which the volume of specials prescribed can be reduced. These suggestions include direct substitution with an alternative formulation which contains the same drug, the use of an alternative drug from the same therapeutic class which exists in a more appropriate formulation, and
of steps which we pharmacists can take in order to reach the goals set out by the NHS. Simply speaking, pharmacists can help reduce specials spending by liaising with prescribers in the following ways:
• Making the prescriber aware that the prescribed item is a special this is not always apparent from the prescriber’s computer system
• Informing the prescriber of the cost of the requested special medicine
• If appropriate, suggesting an alternative which is currently licensed and has an associated cost reduction in comparison to the special product
also the use of licensed medications in an unlicensed way i.e. off-label. Examples of the latter may include the crushing and dispersal of tablets and capsules into a liquid form, forgoing the need to order a bespoke special product. In all of these cases, pharmacists must be aware of the nature of the medicinal product, and be able to counsel patient or carer on the nature of the medication, and how it is to be taken in order to ensure the effective treatment of the patient’s condition4,6
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It has also been reported that some pharmacists have been using other means to reduce the cost of special medications, which should be addressed with caution. For example, The Pharmaceutical Journal has reported that pharmacists are making use of manufacturers who assemble products under the Section 10 exemption of the Medicines Act 1968, permitting the manufacture of these products without the need for a manufacturer’s license7
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Pharmacists should be aware that this exemption is designed to be used only in emergencies, and they should consider the implications associated with providing a medication of this nature in a non-emergency situation.
SPECIAL CONSIDERATIONS As always, pharmacists have specific responsibilities which must be adhered to with relation to specials. These
16 - SCOTTISH PHARMACIST
responsibilities have been detailed by the Royal Pharmaceutical Society RPS, and include:
• Ensuring that the patient receives a medication that is appropriate for their condition and clinical circumstances, with an associated minimal clinical risk
• Supplying a special only when there is no available licensed medicine which fully meets the patient’s requirements
• Checking that continued prescription of a special is regularly reviewed and continually justified
• Full understanding of other professional responsibilities when ordering a special product, i.e. provision of a medication of assured quality
In addition to these responsibilities, which may seem obvious, the RPS also recommend that records are kept for specials which are ordered and dispensed to patients. It is recommended that these records are kept for a minimum of five years, and should detail the following:
• A record of the purchase and supply of the special, and the specification of the product as agreed with the supplier
• Documentation which verifies the specifications of the product, i.e. a certificate of analysis or
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