WHO TRS (Technical Report Series) 996, 2016 Annex 2

WHO TRS (Technical Report Series) 996, 2016 Annex 2

FIP–WHO technical guidelines: Points to consider in the provision by health-care professionals of children specific preparations that are not available as authorized products

1. Introduction and scope

1.1 Background:

Paediatric patients should have access to authorized, age-appropriate preparations of medicines that can be administered safely and effectively. Nothing in this document should detract from this objective. However, it is recognized that such preparations are not always available and in such cases a safe and effective alternative must be sought.

In the context of paediatric pharmacy practice, and for the purpose of this document, compounding is the technique applied by pharmacists to produce medicines from active pharmaceutical ingredients (APIs) or using authorized medicines when no commercially available, authorized, age-appropriate or adequate dosage form exists. Unless stated explicitly in this document, the compounded medicine is assumed to be dispensed immediately after preparation and not kept in stock. Compounding does not apply to reconstitution of authorized medicines prior to dispensing. A clarification of the terminology of preparation of medicines for children has been proposed by Ernest et al. 2012 (1).

The risks and benefits of compounding and of the alternatives should be fully understood by practitioners. Practitioners who do not have appropriate knowledge should seek advice.

Compared to the use of authorized medicines there are significant risks associated with compounding; quality, safety and efficacy can rarely all be assured, and many errors have been reported in the preparation of such medicines. In some situations compounding of a medicine for a child may be the only option, which may be supported by evidence of quality and occasionally evidence of bioavailability by industry or other parties, such as academia. There may be alternatives to compounding, which should also be considered, for example, use of a commercially available therapeutic alternative or manipulation of authorized dosage forms.

This points-to-consider document is supported by a literature review of the evidence available (2). An annex to the report contains an update on the abstracts and papers published in 2010–2015.

This document is to be considered as a time-limited document that addresses current needs for advice in the search for an alternative to an authorized, age-appropriate dosage form. Wherever possible the guidance is informed by the relevant evidence. However, the evidence base is weak or non-existent in most situations. Consequently, the guidance is predominantly informed by best practice, based on sound scientific and therapeutic principles and expert consensus. Although the guidance takes the form of a working practical document it is important to invite comment and input from interested practitioners so that the guidance can be developed further in response to feedback. The document addresses mainly paediatric medicines for oral administration; comments and proposals concerning other routes of administration are invited as well.

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WHO TRS (Technical Report Series) 996, 2016 Annex 2:

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