Abstract
ObjectiveTo determine the frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in medium-sized municipality of Rio Grande do Sul, Brazil. MethodsCross-sectional study with retrospective data collection, which analyzed prescriptions issued to 326 patients from August to December/2012 in two basic health units in the city of Viamão, state of Rio Grande do Sul. It included all prescriptions of patients whose medical records or service records were available and complete in relation to the date of presence, weight and date of birth. Off-label prescriptions were those which, in relation to the drug leaflet, showed dose different the recommended range, frequency of prescription and/or different form of administration and younger age than the indicated range. Descriptive statistics with absolute frequencies, means and standard deviations were used. ResultsDuring the study period, a total of 731 drug prescriptions were issued and the frequency of off-label medications prescribed was 31.7%, especially antihistamines and antiasthmatics (32.3% and 31.5%, respectively). The main type of off-label prescription was dose (38.8%), followed by age range (31.5%) and frequency of administration (29.3%). Regarding the dose off-label prescription, overdose was more frequent (93.3%) than the underdose (6.7%). Prescriptions of unapproved drugs were not identified. ConclusionsThe study showed that off label prescription is common in both assessed units. The observed percentage of off label prescription was higher than that reported by European studies carried out in primary care. On the other hand, the prescription of drugs not approved for children was not observed.
Highlights
Considering the lack of drugs for use in children, especially those under 2 years of age, the off-label prescription drugs have become a routine practice both in hospitals and ambulatory and brings doubts to prescribers and providers regarding the benefit to the pediatric patient.[1,2]
203 (62.3%) patients were from the Family Health Strategy (FHS) Itapuã and the other 123 (37.7%) from the Reference Unit (RU) Lomba Sabão
There was no prescription of unlicensed drugs for children
Summary
Considering the lack of drugs for use in children, especially those under 2 years of age, the off-label prescription drugs have become a routine practice both in hospitals and ambulatory and brings doubts to prescribers and providers regarding the benefit to the pediatric patient.[1,2]The term ‘‘off-label’’ refers to drugs prescribed in different manner than that directed in the instructions or official compendia in relation to dose, indication, age group, dosing interval, or form of administration.[3]. Considering the lack of drugs for use in children, especially those under 2 years of age, the off-label prescription drugs have become a routine practice both in hospitals and ambulatory and brings doubts to prescribers and providers regarding the benefit to the pediatric patient.[1,2]. There are several clinical, ethical, and safety factors that should be considered and there are no guidelines to assist off-label prescription. The decision on this type of prescription should be assessed according to clinical indication, treatment options, and risk-benefit analysis. It must obtain the patient’s or guardian consent, taking care to avoid exposing children to unnecessary risks.[4]
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