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
|