In Clinical

Follow this topic

Bookmark

Record learning outcomes

Trainee dispensing assistant Georgia is talking to pharmacy technician Vicky.

“I was wondering,why aren’t specials used more?” Georgia replies.

“What do you mean?” asks Vicky. “You always complain about having to order them!”

“Well, yes, it’s a pain from our point of view,” agrees Georgia. “But from the patient’s side of things, they are ideal, aren’t they? It’s like my boyfriend getting a suit from a tailor instead of going into a shop to buy one – it’ll fit so much better because it’s made specifically for him. It’s the same for specials surely? With so many medicines not taken and wasted, wouldn’t it be better for people to get something that is exactly right for them in terms of liquid versus tablet, flavourings and other ingredients for allergies – all of that kind of thing?”

Answer

Georgia’s argument is persuasive, but there are a few counter-arguments to her points, including the fact that specials – bespoke medicines – are unlicensed. This means that although manufacturers have to adhere to Good Manufacturing Practice (GMP) standards, they don’t have to provide evidence of quality, safety and efficacy in the same way that they would have to when obtaining a license for a particular product from the Medicines and Healthcare products Regulatory Agency (MHRA).

Furthermore, specials are usually considerably more expensive than their licensed equivalents and, because they are made to order, they can take some time to reach the patient compared to medicines that can be picked off the shelf, or even ordered from a wholesaler for the same- or next-day delivery. In many cases, this delay to treatment – particularly for a new or urgent medicine – is unacceptable.

The bigger picture

The MHRA has published a hierarchy for the use of unlicensed medicines:

• First choice should be a product that is licensed in the UK for the patient’s particular clinical needs, if it is available.
• Second choice should be product that is licensed in the UK, albeit not for the indication the patient requires it. This is because many aspects of the license will hold good, for example, it will be clear that the product meets certain standards of quality and the side effect and interaction profiles will be well known. This is referred to as using a medicine “off label”, and increases the responsibility and potential liability of the prescriber.
• Third choice – assuming a UK-licensed product cannot meet the patient’s need, either within or outside its license – is that a medicinal product licensed outside the UK may be imported for use by the patient. 
• Fourth choice, and assuming nothing can be found that meets the patient’s needs and fits into any of the above criteria, is a UK-manufactured special.
• The last option, and one that should be avoided if at all possible, is an imported product that is unlicensed and not considered a medicine in the country of origin, for example, a food supplement from abroad with an ingredient that is regarded as a medicinal in the UK.

The MHRA states that the above hierarchy is for guidance only, and stresses the importance of considering every case on an individual basis.

Extend your learning

• Look through your dispensary records and see how many specials your patients have had over the last few weeks or months. How do they compare price-wise to their off-the-shelf equivalents?
• What are the reasons for these patients having been prescribed a special? Can you think of any more?
• Look at the website of the Association of Pharmaceutical Specials Manufacturers, and specifically the sections titled “Types of specials” and “Who needs specials and why”
• Correct reimbursement for specials is a priority so read the information on this topic, particularly on endorsing prescriptions before submitting them for payment, from PSNC 
• Did you know that splitting or crushing a tablet, or emptying the contents of a capsule, effectively makes that product into a special? Read more about this, and the issues this practice presents, via the Royal Pharmaceutical Society.