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.
Intermittent preventive treatment (IPT) is used to reduce malaria morbidity and mortality, especially in vulnerable groups such as children and pregnant women. IPT with the fixed dose combination of piperaquine (PQ) and dihydroartemisinin (DHA) is being evaluated as a potential mass treatment to control and eliminate artemisinin-resistant falciparum malaria. This study explored alternative DHA-PQ adult dosing regimens compared to the monthly adult dosing regimen currently being studied in clinical trials. A time-to-event model describing the concentration-effect relationship of preventive DHA-PQ administration was used to explore the potential clinical efficacy of once-weekly adult dosing regimens. Loading dose strategies were evaluated and the advantage of weekly dosing regimen was tested against different degrees of adherence. Assuming perfect adherence, three tablets weekly dosing regimen scenarios maintained malaria incidence of 0.2 to 0.3% per year compared to 2.1 to 2.6% for all monthly dosing regimen scenarios and 52% for the placebo. The three tablets weekly dosing regimen was also more forgiving (i.e., less sensitive to poor adherence), resulting in a predicted ∼4% malaria incidence per year compared to ∼8% for dosing regimen of two tablets weekly and ∼10% for monthly regimens (assuming 60% adherence and 35% interindividual variability). These results suggest that weekly dosing of DHA-PQ for malaria chemoprevention would improve treatment outcomes compared to monthly administration by lowering the incidence of malaria infections, reducing safety concerns about high PQ peak plasma concentrations and being more forgiving. In addition, weekly dosing is expected to reduce the selection pressure for PQ resistance.