Dosing information in a standard drug reference: are pediatrics still therapeutically neglected?

BACKGROUND: In many countries, the most readily accessible drug information resources, such as the Monthly Index of Medical Specialties (MIMS), lack information concerning use in children. We reviewed the product information (PI) of medications in the most widely used drug information reference in Malaysia in an effort to determine the extent and the nature of available information related to pediatric dosing.
METHODS: The products listed in the 2007 Malaysian MIMS Annual were reviewed for PI on pediatric use as per inclusion and exclusion criteria. The dosing information for each PI was extracted according to age groups. Product information that claimed suitability for use in pediatrics was further evaluated for information on pediatric dosage formulations.
RESULTS: A total of 421 PI items from seven categories of therapeutic classes were reviewed. Of these, 69% gave inadequate pediatric dosing information. The proportions, for each age group of PI items that gave adequate pediatric dosing information were: neonates (13.1%), infants (23.3%), and children (32.2%). Therapeutic classes of drugs differed significantly in terms of dosing information adequacy for all pediatric age groups (P < 0.05). Most PI reviewed under all legal categories provided inadequate pediatric dosing information, but suitable pediatric formulations were commonly (70.1-85.5%) available where the dosing information existed. Overall, category B (prescription only) products did not differ significantly from category C (pharmacy only medicine) products in terms of pediatric dosing information adequacy, except for children.
CONCLUSION: This study has managed to contribute substantial additional information regarding the extent of pediatric dosing information and dosage formulations available in the MIMS Annual, stressing that the majority of PI for the products reviewed did not provide adequate dosing information for pediatric patients, subjecting this population to a therapeutically disadvantaged status.