Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis

Table 4 ADR reporting rates in 2017^{a, b}

Country	Numberof reportsreceivedat the PVcentre	Millioninhabitants	Reportsper millioninhabitants	Number ofTB reportsreceived bythe NTP	Numberofpatientswith TB	Reports per1000 TBpatients	Number ofreports frompatientsincluded inaDSM	Numberofpatientson NDR	aDSM reportsper 1000patientson NDR
Eswatini	224^c	1.2	187	NA (9 MDR-TB)	1374(318 MDR-TB)	NA (28.3 MDR-TB)	19^d	276^d	69
Ethiopia	706	105	6.7	67	117,705	0.6	28^e	218^e	128
Nigeria	2173	186	11.7	1210 (156)^f	109,637	11.0 (1.4)^f	5	33	152
Tanzania	287	60	4.8	49	69,818	0.7	114^g	129^g	884

^a Unless otherwise indicated
^bAbbreviations used in this table: ADR adverse drug reaction, aDSM active drug safety monitoring and management, NDR new drugs and regimens (i.e. bedaquiline, delamanid, and a shorter treatment regimen), PV pharmacovigilance, TB tuberculosis
^cJune 2016 – May 2017
^dJanuary 2016 – December 2018
^eJuly 2016 – June 2018
^fOf the 1210 reports received by the NTP, only 156 were forwarded to NAFDAC. The number of reports per 1000 TB patients was calculated both for all reports received by the NTP, and for the reports that reached the NMRA (in brackets)
^gNovember 2017 – July 2018

ISSN: 1472-6963