The European Agency for the Evaluation of Medicinal Products

Pre-authorisation Evaluation of Medicines for Human Use

London, 4 April 2002

EMEA/H/8227/02

EMEA/CPMP Paediatric Expert Group

Concept paper

GOOD PHARMACEUTICAL PRACTICES FOR EXTEMPORANEOUS DISPENSING

Introduction

Many medicines used for children have not been developed for use in the age-group. Pharmacists may
‘extemporaneously’ prepare suitable paediatric products by modifying an existing authorized
preparation intended for adults or from raw materials. Licensing arrangements for, and the location
(hospital, commercial laboratory, community pharmacy) of, such preparation varies between member
states.
When using products with a Marketing Authorization assurance of the quality of the product is
available. Similar assurances for the quality of raw materials or final product may not be available for
extemporaneous products.

Problem statement

Suitable preparations of medicines with Marketing Authorisations (MA) for adults are not always
available for use in children. These medicines may not have a MA for children but their use is
considered by clinicians to be beneficial and to outweigh the risks. Extemporaneous preparation by
the pharmacist of a suitable paediatric preparation is not optimal but permits use of the drug
considered to be clinically most appropriate. Quality of the original product with MA is not assured
when it is modified. Suitable raw materials of appropriate quality may be difficult to obtain.

Some individual member states are understood to have prepared guidance on extemporaneous
dispensing (Ireland, Germany and Spain) whilst others are in the process of preparation (France, UK).
There are no common European standards or guidance for extemporaneous preparation in contrast to
those for manufactured medicines (GMP reference). There is a need to prepare guidance on good
pharmaceutical practice in hospital and community pharmacy in relation to extemporaneous
dispensing to offer a uniform standard to all member states and to improve the assurance of quality of
medicines administered to children.

Scope of the guidance

Guidance on good pharmaceutical practice in relation to extemporaneous dispensing should include

consideration of the following:

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 - Risk management

Avoiding extemporaneous dispensing: use of authorized products when available;

pharmaceutical and therapeutic alternatives; imported products.
When extemporaneous dispensing is unavoidable: modification of authorized dosage forms;
preparation from raw materials

- Personnel and training

Training, competence and supervision

- Documentation

Master documents; labelling; standard operating procedures

- Raw materials

Sources, testing and quality assurance

- Facilities, equipment and processes

Design; standards; validation

- Cleaning, disinfection and hygiene

Avoidance of chemical and microbial contamination

- Monitoring and audit

Environment; raw materials; process; product

- Formulation and stability

Validation of formula; physical, chemical and microbial stability; assignment of shelf life

- Reference sources

Approved sources of formulae; advice on formulation; contacts and interest groups

Consideration should also be given to:

- providing information on sources and quality of raw materials and the availability of suitable,
authorized medicines for importation

- encouraging pharmaceutical manufacturers to supply to pharmacists information on formulation

and raw materials of suitable quality.

- producing a European formulary of approved preparations whose quality has been determined

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Recommendation

EMEA/CPMP should determine which committees will collaborate to produce detailed guidance.
National medicines agencies should be contacted to determine if guidance is available or in
preparation in member states.

Timeframe

The draft concept paper is to be discussed by the Inspector’s working party in April and at the CPMP
Paediatric Expert Group in April 2002. Draft guidance to be available by December 2002.

Prepared by:
Tony Nunn
Member, CPMP Paediatric Expert Group
March 2002

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