FEATURE
A SPECIAL Message
Within Northern Ireland, the use of “specials” has become increasingly more common recently, with pharmacists moving consistently further away from the extemporaneous preparation of medicines from within pharmacy premises.
W
hile this might offer a number of advantages, the use of these medicines is
not without cost, and pharmacists need to be aware when the use of specials is appropriate. These factors and others will allow pharmacists to assist in the effective use of these valuable products, benefiting patient and healthcare system alike.
What is a special? The term “special” encompasses a number of different product forms, but in short, these products can be defined as unlicensed medicines which are formulated due to the absence of an existing suitable licensed product for a particular indication. In today’s pharmacy environment, these products are particularly prevalent, with pharmacists regularly being involved in the often-complicated process of ordering and dispensing these products, and providing advice about their use to patients or carers.
The use of these products can be recommended by prescribers for a number of reasons, which can often revolve around the patient’s current state or pre-existing issues, and the compatibility of existing licensed products with these particular scenarios. A list of some commonly cited examples for the provision of a special product is shown in Box 1.
As a result of this highly varied use of special products, the range of dosage forms available is seemingly endless. However, some of the most commonly dispensed preparations include creams, ointments, oral preparations
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(including liquids (most common), capsules and tablets), ear/eye/ nose drops, suppositories and parenteral products.
From this, we can quickly realise that the world of special formulations is a particularly complex one. Thus, and as with all products which are licensed, pharmacists should endeavour to make sure they know how these special preparations are used and administered, so that they can pass this information onto the patient, or to a caregiver, and ensure that these products are used both safely and effectively.
Common reasons for the prescription of specials(1)
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• Allergy to ingredients within licensed products • Flavour of an oral preparation is unacceptable to the patient • Inability for an oral preparation to be swallowed (e.g. dysphagia) • Patient may have a phobia or dislike for the conventional route of administration (for example, needle-phobia) • A combination of products not available in a licensed product may be required
Special circumstances? While pharmacists are familiar with the use of specials, what might not be so familiar is the extent to which these products are used. For example, it is estimated that specials accounted for 0.95% of total prescription costs in the UK for 2014, a total spend of £89.5 million, a reduction of £10
However, as any pharmacist who has dealt with specials will tell you, the price of these products seems to range from the expensive to the extraordinarily expensive! So why are the prices of these special formulations so high? According to the Association of Pharmaceutical Specials Manufacturers (APSM), the elevated cost of these items stems from the array of factors involved in getting such a product into the hands of the patient.
These factors span from the small- scale, high quality manufacturing processes that need to be adhered to during the manufacture of the product, through to the administration and red tape involved in the specials manufacturer being appropriately licensed by the MHRA. When this is considered in addition to processes such as quality assurance, batch
million on the previous year(2). If we
compare this number to previous figures, we can see that spend on these products has decreased in more recent times (for example, in 2010, the NHS in England alone spent upwards of £160 million).
However, the current spending on specials is not something to be ignored, and has generated its own fair share of controversy. Indeed, the use of specials has placed pharmacists in the firing line, leading to accusations of fraud and unethical behavior arising in some instances, with some professionals allegedly marking up the price of these products with the aim of making a profit (3)
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testing, product labeling, adverse event recording and the manning of customer support lines, it is slightly easier to understand the expense of these products, especially when it is considered that these manufacturers can’t attain the same cost- effectiveness as the big pharma who produce their products on an exponentially larger scale (4).
We can now hopefully empathise with the specials manufacturers, and perhaps even actively try to reduce the disbelief normally experienced when looking at an invoice for a special item. However, despite the justification for these high prices, pharmacists must continue to ensure that the unnecessary prescribing of such products is avoided, in order to assist with reducing costs to the NHS, whilst still offering our patients the best care possible.
Ensuring specials are used correctly Due to the relatively high levels of spending on special products from within the NHS, a number of health boards and trusts across the UK have introduced initiatives and supplied guidance to healthcare professionals in order to make them more fully aware of the cost of these items, and also to suggest ways by which the spend on specials can be reduced.
At present, there appears to be no Northern Ireland-specific guidance on these practices, but as always, healthcare professionals, especially pharmacists, should act to ensure that they are facilitating the best patient treatment possible, whilst preventing >
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