Experiences of Implanon NXT® users at public health facilities in South Africa.

Abstract

Background and aim: Implanon NXT® was introduced in South Africa (SA) in the public health sector in February 2014. There exist concerns with premature Implanon NXT® user discontinuation in SA however, the true extent remains unknown due to delayed monitoring systems and limited empirical data. This study aimed to evaluate the experiences of Implanon NXT® among users in the public health sector in SA. Methods: A retrospective study was conducted and entailed analysis of secondary data attained from the National Department of Health Pharmacovigilance Centre for Public Health Programmes using reports submitted from 1 April 2015 to 11 September 2017. A total of 3743 cases were extracted and analysed using SPSS®. Tests of association were performed using demographics, adverse drug reactions and discontinuation variables. Chi square test and Mann Whitney U-Test were performed to test differences between Gauteng and KwaZulu-Natal (KZN). Results: The 20-24-year olds were the most frequent Implanon NXT® users (25.70%; 962/3743). Of the 36.57% (1369/3743) cases which reported adverse drug reactions (ADRs), menorrhagia (52.01%;712/1369), headache (20.45%;280/1369) and dizziness (11.18%;153/1369) were the most frequent ADRs. Discontinuation was reported by 63.56% (2379/3743) of case reports and premature discontinuation was reported by 81.1% (1210/1492). The common reasons for discontinuation were menorrhagia (34.27%;728/2124), expiry (29.57%;628/2124) and headache (10.26%;218/2124). Overall, ADRs were found to be the main reason for discontinuation (83.99%; 1784/2124). Pregnancies reported with Implanon NXT® occurred in 4.97% (68/1369) of case reports and efavirenz-based therapy was suspected to be associated with pregnancy in Implanon NXT® users (p<0.001). The common ADRs and reasons for discontinuation of Implanon NXT® reported in Gauteng was consistent with the national data while drug interaction and pregnancy were commonly reported in KZN. Premature discontinuation of Implanon NXT® was higher in Gauteng (82.6%, 252/305) than KZN (76.7%, 23/30). Conclusion: Young women were frequent users of Implanon NXT® . Menorrhagia was the predominantly reported ADR among all the users. A high frequency of discontinuation was identified, and ADRs were mainly responsible for discontinuation. The frequency of failure was small and efavirenz was suspected to be associated. The experiences of Implanon NXT® users differed between KZN and Gauteng which emphasizes tailored strategies need to be considered. Users’ counselling, adverse drug reaction treatment and management, monitoring and evaluation are recommended to address high discontinuation in SA.