Objectives: Many hospital-based studies throughout Europe have shown that a substantial number of children receive off-label prescribed drugs that lack marketing authorisation for paediatric use. Since information about the extent and characteristics of this prescribing pattern in paediatric primary health care is limited, we assessed the proportion of off-label drug prescribing for paediatric outpatients in a reference population of 350,000 children using a computerised prescription database. We also determined the adherence to a treatment guideline provided by the Stockholm county council as a quality of prescribing indicator.
Methods: All drugs prescribed for children younger than 16 years of age in the Stockholm county in the year 2000 were ranked by the number of prescription items. The retrospective, descriptive analysis was restricted to those drugs that accounted for 90% of total prescribing. We calculated the proportion of off-label drug prescribing for different age and therapeutic groups with respect to age, formulation and route of administration using the Swedish Physician's Desk Reference. The quality of prescribing was estimated as the proportion of prescription items corresponding to recommended drugs in the local treatment guideline Kloka Listan (The Wise List).
Results: Among the 317 drugs accounting for 90% of total prescribing, 575,526 prescription items were identified with an average proportion of off-label and recommended drug prescribing of 20.7% and 60.5%, respectively. The off-label proportion was similar in various age groups but widely different between therapeutic groups being much higher for topical (70.4%) than for systemic (5.4%) drugs. The extent to which recommended drugs were prescribed also greatly varied between therapeutic groups irrespectively of the off-label proportion.
Conclusions: Off-label drug prescribing for paediatric outpatients is a common phenomenon. However, it mainly applied to topical drugs and was to a substantial extent recommended by the local treatment guideline. Thus, off-label prescribing might represent a more administrative rather than clinical problem in the paediatric outpatient setting.