Study ID Group* Surveillance period and setting Denominator Surveillance methodology (identifying candidate ADRs) ADR definition Causality assessment Seriousness assessment Preventability assessment
Oshikoya 200736 1,2 36 months ending 2006, paediatric wards of single secondary/tertiary hospital in Nigeria All paediatric patients admitted Prospective and retrospective augmented folder review by multidisciplinary team WHO definition54, with specific inclusion: herbal / traditional medicines Done according to Jones method55. Numerator includes cases rated definite, probable, and possible Implied (study reported serious outcomes) Done. Criteria not reported
Mehta 200837 1,3 3 months in 2005, medical wards of single secondary/tertiary hospital in South Africa Non-random sample of adult patients (>16 years) admitted: 1% excluded for missing records. All deaths of adult patients admitted. Prospective folder review by multidisciplinary team WHO definition54, with specific exclusions: intentional overdose and poor adherence; specific inclusion: accidental overdose Done by multidisciplinary team (different from ADE surveillance team), according to WHO-UMC method56. Numerator includes cases rated definite, probable, and possible Done by multidisciplinary team (different from ADE surveillance team), according to Temple criteria57 Done by multidisciplinary team (different from ADE surveillance team), according to Schumock criteria58
Soukho-Kaya 201038,39 1 12 months ending 2006, medical wards of single secondary/tertiary hospital in Mali Non-random sample of adult patients admitted: 4% excluded for receiving cancer chemotherapy Prospective folder review WHO definition54 Done according to French method59. Numerator includes cases rated definite and probable. Implied (study reported serious outcomes) Not done
Oshikoya 201140 1 18 months ending 2007, paediatric wards of single secondary/tertiary hospital in Nigeria Non-random sample of paediatric patients admitted: unknown number excluded for admission < 24 hours or repeat admission or missing records Prospective augmented folder review by multidisciplinary team Edwards and Aronson8 Done by same investigators who conducted ADE surveillance, according to Jones method55. Not reported which categories were included in numerator. Implied (study reported serious outcomes) Done by same investigators who conducted ADE surveillance, according to Schumock criteria58
Tumwikirize 201141 1 6 months in 2005, medical wards of multiple hospitals (primary and secondary/tertiary) in Uganda Non-random sample of adult patients (>13 years) admitted: 35% excluded for no consent or too ill to cooperate Prospective folder review by multidisciplinary team WHO definition54, with specific exclusion: herbal / traditional medicines Done by multidisciplinary team (different from ADE surveillance team), according to Naranjo method60. Numerator includes cases rated definite, probable, and possible Implied (study reported serious outcomes) Done according to Schumock criteria58
Kauffman 201442 1 6 months in 2012, single secondary/tertiary hospital in Malawi (wards not reported) Non-random sample of adult patients (>18 years) admitted: 84% excluded for missing records Retrospective folder review Not defined Done by multidisciplinary team (different from ADE surveillance team), according to Naranjo method60. Numerator includes cases rated definite, probable, and possible Implied (study reported serious outcomes) Not done
Aderemi-Williams 201543 1 12 months ending 2009, medical wards of single secondary/tertiary hospital in Nigeria Non-random sample of adult patients admitted: 96% excluded for unclear reasons Retrospective folder review WHO definition54, with specific exclusions: intentional overdose, accidental overdose, and poor adherence Not done Implied (study reported serious outcomes) Not done
Ayetoro 201544,45 1 12 months ending 2014, medical wards of single secondary/tertiary hospital in Nigeria Not applicable Spontaneous reporting Not defined Not reported or unclear Implied (study reported serious outcomes) Not reported or unclear
Mouton 201546 3 1 month in 2013, medical wards and intensive care units of multiple secondary/tertiary hospitals in South Africa All deaths of adult patients admitted Retrospective folder review by single investigator Aronson and Ferner61, with specific exclusion: intentional overdose Done by multidisciplinary team (different from ADE surveillance team), according to WHO-UMC method56. Numerator includes cases rated definite, probable, and possible Implied (study reported serious outcomes) Done by multidisciplinary team (different from ADE surveillance team), according to Schumock criteria58
Mouton 201647 1 1 month in 2013, medical wards and intensive care units of multiple secondary/tertiary hospitals in South Africa All admissions of adult patients Prospective folder review by multidisciplinary team Aronson and Ferner61, with specific exclusions: intentional overdose and therapeutic failure Done by multidisciplinary team (different from ADE surveillance team), according to WHO-UMC method56. Numerator includes cases rated definite, probable, and possible Done by multidisciplinary team (different from ADE surveillance team), according to Temple criteria57 Done by multidisciplinary team (different from ADE surveillance team), according to Schumock criteria58
Russom 201748 1 5 months in 2014, all hospitals (primary and secondary/tertiary) in Eritrea (wards not reported) Non-random sample of adult and paediatric patients admitted: unknown number excluded for age < 30 days or no consent or admitted for delivery Prospective surveillance by multidisciplinary team. WHO definition54 Done by investigators different from ADE surveillance team, according to Naranjo method60. Numerator includes cases rated definite, probable, and possible Done according to ICH/CIOMS criteria9 Done according to P-method62
Angamo 201849,50 1,3 16 months ending 2016, medical wards of single secondary/tertiary hospital in Ethiopia Non-random sample of adult patients (>18 years) admitted: 69% excluded for no consent or missing records or no drug exposure or not interviewed due to health or other reasons. All deaths of adult patients admitted. Prospective augmented folder review by single investigator WHO definition54, with specific exclusions: intentional overdose, accidental overdose, drug abuse, and therapeutic failure Done by multidisciplinary team (different from ADE surveillance team), according to Naranjo method60. Numerator includes cases rated definite and probable Done by same investigators who conducted ADE surveillance. Criteria not reported Done. Criteria not reported
Makiwane 201951 1 3 months in 2016, paediatric wards of single secondary/tertiary hospital in South Africa Non-random sample of paediatric patients (<16 years) admitted: unknown number excluded for admission <24 hours or no consent Prospective folder review by single investigator WHO definition54, with specific inclusion: herbal / traditional medicines Done according to Naranjo method60. Numerator includes cases rated definite, probable, and possible Done according to ICH/CIOMS criteria9 Not done
Adedapo 202052 1 12 months ending 2013, medical wards of single secondary/tertiary hospital in Nigeria Non-random sample of adult patients admitted: 57% excluded for no consent or existing admissions or repeat admissions or very ill Prospective augmented folder review WHO definition54, with specific inclusions: herbal / traditional medicines, medication errors Done according to WHO-UMC method56. Numerator includes cases rated definite, probable, and possible Implied (study reported serious outcomes) Done according to Wolfe criteria35
Mouton 202053 1,2 1 month in 2015, paediatric wards and intensive care units of multiple secondary/tertiary hospitals in South Africa Non-random sample of admissions of paediatric patients: unknown number excluded for elective admissions, rehydration therapy, postnatal stays Prospective and retrospective folder review by multidisciplinary team Aronson and Ferner61, with specific exclusions: herbal / traditional medicines, intentional overdose, poor adherence, medication errors without harm, therapeutic failure Done by multidisciplinary team (different from ADE surveillance team), according to WHO-UMC method56. Numerator includes cases rated definite, probable, and possible Done by multidisciplinary team (different from ADE surveillance team), according to Temple criteria57 Done by multidisciplinary team (different from ADE surveillance team), according to Schumock criteria58