Off-label prescribing for children with chronic diseases in Nigeria; findings and implications

ABSTRACT

Background: Prescribing medicines in an off-label manner for children with chronic conditions is sparsely documented, even more so among developing countries. This needs addressing. The objective of this research was to investigate the extent of off-label prescribing among children with epilepsy, asthma, and sickle cell anaemia in Nigeria.

Methods: Prescriptions for children ≤16 years documented in their case files that attended paediatric clinics in Lagos, Nigeria, for these three conditions between January and October 2015, were reviewed retrospectively to extract data on the medicines prescribed. British National Formulary for children and American Hospital Formulary Service Drug information were used as references.

Results: 477 patients received 1746 prescriptions. Off-label prescriptions were seen in 7.7% of prescriptions, related to dose (93; 68.9%), indication (22; 16.3%), and age (20; 14.8%). Nervous system (525; 30.1%) and anti-infective (441; 25.2%) medicines were the most prescribed but only 9.5% and 8.2% of the respective prescriptions were off-label. Children with epilepsy received the most number (94; 69.6%) of off-label prescriptions. The three chronic conditions did not associate significantly with the category of off-label medicine prescribed (p = 0.925).

Conclusion: Off-label prescribing for children with epilepsy, asthma and sickle cell anaemia occurs. Encouragingly, the overall rate appears low in Nigeria.

KEYWORDS:

• Asthma
• sickle cell anaemia
• epilepsy
• children
• Nigeria
• off-label
• prescribing

Article highlights

• Numerous medicines are used to treat concomitant and chronic illnesses in children. These medicines are often prescribed off-label. Previous studies evaluating off-label prescribing for children with chronic illnesses have typically been performed in developed countries and excluded medicines used for concomitant illnesses

• Epilepsy, asthma and sickle cell anemia are among the chronic conditions posing a significant economic burden on parents in Nigeria; consequently, important to study the off-label use of medicines to treat these conditions in Nigeria

• Overall, these three conditions were associated with a low level of off-label prescriptions, which is encouraging

• Central nervous system and anti-infective agents were the two classes of medicines prescribed for children with epilepsy, asthma and sickle cell anemia. Their off-label prescribing was mostly related to dose, indication, and age.

• There appears to be no significant association between different categories of off-label prescribing and the three chronic conditions evaluated in this study

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Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper was not funded