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:

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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


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


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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

Documents

Quality of medicines for life-threatening pregnancy