Off-label and unlicensed drug prescriptions for children living with HIV/AIDS

Abstract

Background: The extent and pattern of off-label and unlicensed drug prescriptions have been documented in developed countries leading to development and adoption of guidelines on the use of different classes of drugs in different disease settings. Paucity of data on this subject in developing countries such as Nigeria exposes children to dangers of drug over dosages and overall consequences of poor healthcare delivery.

Objectives: To assess the pattern of off-label and unlicensed prescriptions and prevalent opportunistic infections among children on antiretroviral therapy in a tertiary health facility in Nigeria.

Method: The Pharmacy order forms and treatment files of sixty-nine children who started their anti-retroviral therapy (ART) programme between March 2009 and March 2012 were examined. All prescriptions received by these patients within this period were evaluated and categorised as unlicensed or off-label depending on registration status of the drug or conditions of use compared with what is specified from product information in standard references such as the BNF, EMDEX and Martindale. (Turner et al 1997; Conroy et al., 1999).

Results: There were 47.1% off-label and 1.8% unlicensed drug prescriptions. 94.2% of children on antiretroviral therapy received off-label prescriptions while 23.2% received unlicensed prescriptions. Malaria and respiratory tract infections were the prevalent opportunistic infections presented by children on ART

Conclusion: Nearly half of the drugs prescribed for the children in this study were off-label prescriptions while an insignificant proportion were unlicensed prescriptions. Malaria and respiratory tract infections are the major opportunistic infections that affect children with HIV infection in Federal Medical Center Keffi, north-central part of Nigeria.

Keywords: HIV/AIDS children, Off-label prescriptions, antiretroviral therapy, adverse drug reactions