Extemporaneous dispensing

More and more clinical trials in children are taking place and are improving the availability of ready-made specific paediatric drug delivery systems. Moreover, from the perspective of the new European Union regulations on medicines for children (European Commission, 2006), the number of trials will increase in the future. Meanwhile, extemporaneous dispensing, even though it should remain the last resort, is still an important activity for paediatric pharmacists and carers (Yeung et al., 2004). 

Ideally, extemporaneous products are prepared from pure drugs (or less suitably from chemicals) but, more frequently, commercial dosage forms intended for adults are manipulated into a suitable form for administration to children. They should be prepared in registered premises (pharmacy, hospital, health centre) under the supervision of a pharmacist and in accordance with a prescription for administration to a particular patient or in anticipation of such a prescription. These manipulations come under the heading of magistral (extemporaneous) preparations. Specials have a similar status but are made in larger volumes by licensed manufacturers (licence issued by the MHRA in the UK), which include suitably licensed hospital units. However, these products are not always subjected to full quality assurance. 

In practice, many extemporaneous preparations are made by nurses/carers at home or at the bedside. This non- special extemporaneous dispensing carries a greater risk as very little risk assessment 

If no alternative is available, fractional doses can be prepared by diluting powdered tablets or capsules with suitable common excipients, such as lactose or starch, and repacking them into sachets or empty capsules using a hand-filling machine. It is important that uniformity of dose distribution and incompatibility or stability of new single units can be compromised and should be checked with appropriate pharmacopoeia monographs. 

If no adequate dosage form is available, it is possible to use oral liquids rectally, eye drops in the ear or a sometimes costly injectable solution orally (e.g. clonidine) and, less frequently, by respiratory routes (e.g. gentamicin, vancomycin). Doses may need to be adapted due to differing 

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Farley CA, Lund W. Suspending agents for extemporaneous dispensing evaluation of alternatives to tragacanth. Pharm 1976 216 562-566. 

Smith G, McIntosh IFF. Suspending agents for extemporaneous dispensing [letter]. Pharm J 1976 217 42. 

Category E - Extemporaneously prepared items for which the fee listed for extemporaneous dispensing in Part IIIA will be claimed. No endorsement is required. Broken bulk is not allowed, but may be paid on the ingredients. 

Extemporaneously dispensed items can require additional information on the label. For further... 

This chapter will discuss drug handling in paediatric practice, general considerations in extemporaneous dispensing for children, the suitability of excipients, and the potential of the main administration routes and corresponding dosage forms in paediatrics. 

In an attempt to provide some guidance, a few publications describing extemporaneous dispensing have been compiled (Nahata and Hippie, 2003 Woods, 2001) and should be referred to as well as peer-reviewed journals. 

This handbook has a part on standards for extemporaneous dispensing and a part containing stability summaries for the 50 most frequent extemporaneously prepared medicines in UK NHS hospitals. It also includes sections relating to clinical risk assessment and advice for procuring tmlicensed medicines from manufacturers. 

If this Kern needs to be added to catalogue refer to the Catalogue Request Pack (found in dispensary Extemporaneous Dispensing File) Also refer to the Extemporaneous Dispensing Policy. 

Farley, C.A., 1976, Suspending Agents for Extemporaneous Dispensing Evaluation of Alternatives to Tragacanth , The Pharmaceutical Journal, June 26, pp 562-566. 

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