Discontinuation of Implanon NXT®

among users at public health facilities in South Africa

Presenter : Shimona Prosad

Contributors : Shimona Prosad, Elizabeth Ojewole, Mukesh Dheda & Boikhutso Tlou

Source: MIMS (n.d)

Overview

1• Background

2• Aim & Objectives

3• Methodology

4• Results/Discussion

5• Conclusion

6• Recommendations

•Single-rod subdermal implant

68mg Etonogestrel

Effect for 3 years

Background

(Concept News Central, 2017) (Merck Sharp & Dohme Australia, 2010, Family Planning NSW Reproductive and sexual health) (Reproductive Health Supplies Coalition, 2013)(United Nations Department of Economic and Social Affairs Population Division, 2018, Tsui et al., 2017) (Law et al., 2018, Apter et al., 2016, Teunissen et al., 2014, Harvey et al., 2009) (Bhatia et al., 2011, Singh et al., 2015) (Guazzelli et al., 2010) Asaye et al. (2018) ( Siyoum et al., 2017) ( Madugu et al., 2015, Ezegwui et al., 2011). (Aziz et al., 2018)

(Lince-Deroche et al., 2016, Pillay et al., 2017b) (Arribas-Mir et al., 2009) (Mrwebi et al., 2018) (Pillay et al., 2017a)

Early User Discontinuation

HIC ± 25%

India & Brazil: 0-29%

Africa : 13,5 %-65%

Increase in reports in SA

Main reason: adverse drug reactions (ADR)

SA Pledge 2012

Updated Contraception policies 2013

Roll out of Implanon

NXT

Early User Discontinuation

Poor monitoring&Lack of PV

Complete range of FP methods

Addition of contraceptive implants

In public health facilities : Feb 2014

• no. of removals• Change in prescription

guidelines

True extent of discontinuation unknown.

Background

(Family Planning 2020, 2012, National Department of Health, 2013b, National Department of Health, 2013a) (Patel, 2014) ( Pillay et al., 2017a, Lince-Deroche et al., 2016, Adeagbo et al., 2017, Mrwebi et al., 2018) (Pillay, 2014) (Department Of Health, 2014) (Pleaner et al., 2017, Pillay et al., 2017b)

To evaluate discontinuation of Implanon NXT® among users at

public health facilities in SA

1• To determine extent of user

discontinuation

2• To determine reasons for

discontinuation

3• To evaluate factors associated with

discontinuation

Aim & Objectives

Secondary data analysis

Gatekeeper & Ethics:National Pharmacovigilance

Centre (NPC)UKZN (BE266/17)

NPC national

data:April 2015-Sep 2017

SampleN=3743

Data Extraction:Demographics & discontinuation

Analysis:• Tests of association• Univariable& Multivariable Analysis• Descriptive

Methodology

Results/Discussion

Provincially Tertiary Hosp n=44

National Central Hosp n=55Regional Hosp n=175

CHC n=438District Hosp n=528

PHC n=1004

Discontinuation Cases per health facility n=2366

1 209

604 578442

251 129 38 80

200

400

600

800

<15 15-19 20-24 25-29 30-34 35-39 40-44 45-49 >49No.

of c

ases

Age group

Age of Discontinuers n=2260

(Tadesse et al., 2017a) Asaye et al. (2018) (Mrwebi et al., 2018b)

No.

of c

ases

Early discontinuation; 1210; 81%

Discontinuation upon expiry; 282; 19%

200

193

534

283

282

0 200 400 600

<6 months

≥6 months to <12 months

≥12 months to <24 months

≥24 months to <36 months

≥36 months

Cases

No.

of m

onth

s

Time period of cases discontinuing n=1492

Results/DiscussionDiscontinuation n=1492

(Weisberg et al., 2014, Obijuru et al., 2016, Arribas-Mir et al., 2009) (Cea Soriano et al., 2015) (Siyoum et al., 2017) Asaye et al. (2018) Mrwebi et al. (2018b)(Adeagbo et al., 2017, Pleaner et al., 2017)

Univariable model Multivariable model

Variable Odds Ratio

CI p-value Adjusted odds ratio

CI p-value

Cases reporting ADR/s

Yes 4.62 3.93-5.45 <0.001 11.98 8.10-17.72

<0.001

No 1 ----- ----- 1 ----- -----

Univariable & Multivariable Analysis

Results/Discussion

(Asaye MM et al., 2018, Birhane et al., 2015, Siyoum et al., 2017)(Aziz et al., 2018).

Reason No. of Cases %

Menorrhagia 728 34,27Expiry 628 29,57Headache 218 10,26

Desire to conceive 1265,93

Dizziness 106 4,99

Irregular menstruation 763,58

Painful arm 72 3,39Weight gain 67 3,15Pregnancy 65 3,06Weight loss 63 2,97

Top 10 Reasons for discontinuation (n=2124) Results/Discussion

(Burusie, 2015, Pillay et al., 2017) (Harvey et al., 2009). (Al-Jefout et al., 2015) (Mrwebi et al., 2018) (Burusie, 2015, Siyoum et al., 2017, Asaye et al., 2018, Pillay et al., 2017a, Tadesse et al., 2017)

Conclusion

Adeagbo et al. (2017) (Pleaner et al., 2017) (Statistics South Africa, 2017)(World Health Organisation, 2017) .

Half of users who reported adverse drug reactions to a health practitioner discontinued on the same day

•Younger women are discontinuing Implanon NXT

•Extent of early discontinuation of Implanon NXT® appeared high

•Adverse drug reactions associated with Implanon NXT®

discontinuation

Recommendations

Rigorous monitoring1

Counselling & management2

Design : Follow-up protocol & treatment algorithm3

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