Extemporaneous (magistral) preparation of oral medicines for children in European hospitals.
OBJECTIVE
To evaluate methods of preparation of oral medicines in European children's hospitals when drugs prescribed are unlicensed or off-label, and to determine whether such extemporaneously prepared medicines are available as suitable, authorized products in other countries.


METHODS
A questionnaire was distributed to 41 hospital pharmacists in 18 European countries, requesting information on the most frequent extemporaneously prepared oral liquid, powder and capsule medicines, and on their formulation and stability. Information was gathered on the availability of suitable authorized forms of these medicines in other European countries, the USA and Australia.


RESULTS
21 questionnaires from 16 countries returned showed that the methods of extemporaneous preparation vary in different European countries with, for example, liquid preparations predominating in England and Sweden, capsules in France and Spain, and powders in Finland and Italy. The top 20 preparations are made in many different strengths and formulations. The same drug may be prepared in liquid, capsule or powder form, depending on the country. Many of the extemporaneous preparations were available as suitable authorized paediatric medicines in other countries. The quality of information available on formulation and stability was limited, and there was concern about the availability and quality of chemical ingredients.


CONCLUSIONS
Preparation of children's oral medicines is subject to much variation in hospitals throughout Europe and there is little harmonization of formulations or information on stability of products. The European Union could be the focus for improving the availability of appropriate authorized medicines for children and ensuring that when extemporaneous preparation is necessary it is of a common high standard.
Brion
F
F
Hôpital Robert Debré, Paris, France.
Nunn
A J
AJ
Rieutord
A
A
D000284:Administration, Oral; D000367:Age Factors; D002648:Child; D003132:Commerce / Q000331:legislation & jurisprudence / Q000592:standards; D004304:Dosage Forms / Q000592:standards; D004339:Drug Compounding / Q000592:standards*; D004348:Drug Labeling / Q000331:legislation & jurisprudence / Q000592:standards; D005060:Europe; D019538:Health Care Surveys; D006761:Hospitals / Q000592:standards* / Q000600:supply & distribution*; D006801:Humans; D007223:Infant; D008004:Licensure / Q000331:legislation & jurisprudence* / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards* / Q000600:supply & distribution*; D010818:Practice Patterns, Physicians' / Q000331:legislation & jurisprudence / Q000592:standards
D004304:Dosage Forms; D004364:Pharmaceutical Preparations