Quality of medicines for life-threatening pregnancy ...
Transcript of Quality of medicines for life-threatening pregnancy ...
Quality of medicines for life-threatening pregnancy complicationsin low- and middle-income countries: A systematic review
14% Pre-eclampsia/eclampsia (PE/E)27% Postpartum
haemorrhage (PPH) 11% Sepsis due to direct maternal infections cause
The main causes of maternal death are
Ensure healthy lives and promote well-being for all at all ages
GOOD HEALTH AND WELL-BEING
Adequate and timely use of good quality, safe, effective, and affordable medicines is essential to ...
...reduce maternal mortality and to achieve universal health coverage
Sustainable development goals
295,000 womenAn estimated
die every year due to complications of pregnancy and childbirth
Most of these deaths occur in low- and middle-income countries (LMIC)
1 in 10It is estimated that medicines in LMIC are substandard and falsified medicines
to identify, critically appraise and synthesize findings of studies on quality of selected medicines (uterotonics, tranexamic acid, magnesium sulfate, and injectable antibiotics) available in LMIC.
Objective:
1/4
Quality of medicines for life-threatening pregnancy complicationsin low- and middle-income countries: A systematic review
2/4
9,918Records identified through database
searching
9,699Total unique
records screened
122Selected for
full-text reading
234Full-text
articles assessed for elegibility
112Potentiallyrelevant records fromother sources
34studies
Study country income category
Low
Lower-middle
Upper-middle
>1 income level
6
18
4
6
Quality of study
Low
High 12
22
Flow chart of the process of study selection
7 12 15... 2000
Publication date of studies
2001-2011 2012-20
Nearly half of the studies assessed samples collected since 2011, indicating that the quality of these medicines is a current global concern
3,159samples
9 of 129 of 12 review’s
targeted medicines
4Latin America
studies
studies
studies
studies
study
3conducted in more than one region
12Asia
1Oceania
14Africa
34conducted in
40 countries
studies
CENTRAL LEVEL PERIPHERAL LEVEL
International providers
WholesalerCentral /Regional
Medical Store,District Health Office
Clinic
Public sector
Private sector
Health Center
CommunityHealth Worker
Drug Shop/ Pharmacy
National providers
Women
Included studies looked at the quality of medicines at different points in the health supply chain
Clinics, hospitals, local medical stores, pharmacies, or markets that sell directly to costumers
Warehouses, major distributorsor central medical stores
Quality of medicines for life-threatening pregnancy complicationsin low- and middle-income countries: A systematic review
3/4
Level of sample collection
Central level only
Central and Peripheral
Peripheral level only
No information
2
14
15
3
National
National and Imported
Imported
No information
4
8
34 34 10
12
Place of manufacture
Type of medicines
Public only
Private and Public
Private only
No information
5
1434
5
10
Prevalence of samples that failed quality tests
Uterotonics
Anticonvulsant
Injectable Antibiotics
Oxytocin
Ergometrine
MisoprostolMagnesium sulphate
Ampicillin
Cefazolin
Gentamycin
Metronidazole
Penicillin G
14
8
3
19*
2
18*
2
72
9
3
9
34 studies
34 studies
Uterotonics
Anticonvulsant
InjectableAntibiotics
1,890
179
1,090
Oxytocin
Ergometrine
Misoprostol
Magnesium sulphateAmpicillin
Cefazolin
GentamycinMetronidazolePenicillin G
979
500
411
179266
449
22334118
3,159 samples
*Several studies assessed >1 uterotonic or >1 antibioticThere were no studies on carbetocin, TXA and clindamycin
Sector of sample collection
% Fail
% Fail
Samples
Oxytocin 979
39,7%
Ergometrine 500
75,4%
Cefazolin 449
16%
Ampicillin 266
13,5%
Gentamycin 223
9,4%
Penicillin G 118
13,6%
Misoprostol 411
38,7%
Magnesium sulphate 179
3,4%
Metronidazole 34
2,9%
Uterotonics
Anticonvulsant
Injectable Antibiotics
Conclusion:There is a widespread problem with the quality of medicines used in LMIC to manage postpartum haemorrhage, pre-eclampsia/eclampsia and infections. This could be a contributing factor to the persistence of severe maternal morbidity and mortality in these settings despite affordable and effective treatments.
Oxytocin was the drug with the largest number of studies and samples
Ergometrine was the uterotonic with the highest prevalence of failed samples
Misoprostol is a drug stable at room tempe-rature. Nevertheless, a high number of sam-ples were found to be of low quality
Anticonvulsants had one of the lowest prevalence of failed samples
All antibiotics showed similar prevalence of failed samples, except for metronidazole
Torloni MR, Bonet M, Betrán AP, Ribeiro-do-Valle CC, Widmer M (2020) Quality of medicines for life-threatening pregnancy complications in low- and middle-income countries: A systematic review. PLoS ONE 15(7):e0236060. https://doi.org/10.1371/journal.pone.0236060
Quality of medicines for life-threatening pregnancy complicationsin low- and middle-income countries: A systematic review
4/4
Public vs. private sector Central vs. peripheral level
Uterotonics
Private
Public
54.3%45%
Private
Public48.7%
34.3%
Oxytocin
Private
Public73.6%
70.9%
Ergometrine
Private
Public 38.2%31.5%
Misoprostol
Peripheral
Central
Uterotonics
52.7%33.9%
Peripheral
Central
43.8%21.9%
Oxytocin
Peripheral
Central
76.1%64.7%
Ergometrine
Peripheral
Central 18.2%33%
Misoprostol
Private
Public
0.8%8.3%
Magnesium sulphate
Peripheral
Central
2.7%6.7%
Anticonvulsant*
Private
Public
0.8%8.3%
Anticonvulsant*
Peripheral
Central
2.7%6.7%
Magnesium sulphate
Private
Public21.5%
8.8%
Ampicillin
Private
Public
17.9%14.3%
Gentamycin
Private
Public
20%2.3%
Penicillin G
Peripheral
Central
20.6%0%
Penicillin G
Peripheral
Central
17.7%16.7%
Ampicillin
Peripheral
Central
5.6%19.4%
Gentamycin
Peripheral
Central
Injectable antibiotics
14.7%11.9%
Injectable antibiotics
Private
Public
20.3%8.1%
* the only anticonvulsant included was MgSo4
Prevalence of samples that failed quality tests