The provision of made-to-order drugs, in primary care is expensive, often unnecessary, and associated with legal pitfalls, warns the latest Drug and Therapeutics Bulletin (DTB).



The recent review calls for a major overhaul of the practice.

Bespoke drugs, known as “specials”, are medicines made specifically to meet the needs of individual patients, so may be prepared in formulations and strengths which differ from those of standard licensed medicines.



Although made by a licensed manufacturer, these drugs are not themselves licensed. Therefore the DTB warn of the lack of assessment for safety, quality, or effectiveness.



Unwanted effects caused by a licensed medicine, used as intended, are the manufacturer’s responsibility. By contrast, prescribers, and potentially, supplying pharmacists, are legally liable for harmful effects caused by a special, unless it can be proved the product is defective.


Specials are also expensive. In 2008 the total spend on specials in primary care in England was £63 million. By 2009, this had risen 68% to £109 million - equivalent to 1.4% of the total prescribing budget in primary care.



The cost of an individual special depends on the ingredients and the complexity of the processes involved in its manufacture, to which can be added levies charged by distributors and/or “out of pocket expenses” claimed by pharmacists.





In August this year, the legislation was changed to permit manufacturers to produce price lists of unlicensed medicines, including specials. But the bespoke nature of the products means that it will be difficult to include all of them on price lists.

DTB said: “This lack of information on pricing means that at the point of prescribing, prescribers are often unable to judge whether a particular product represents value for money.

They added: “On occasion it may be necessary to meet a particular need through the use of an unlicensed special ... However, this should be a matter of last resort once all the options using licensed products have been explored.

“We believe that the use of specials in primary care requires a major overhaul and much closer scrutiny than it has had to date.”


(BMcN/GK)