Raffaella’s Literature Update

The following message is courtesy of Dr Raffaella Ravinetto, Public Health Department, Institute of Tropical Medicine Antwerp, Belgium.

Ref. Maharjan P, Ponganam MP, Lambert P, Vogel JP, McIntosh M, McDougall A (2024) The quality of medicines for the prevention and management of hypertensive disorders of pregnancy: A systematic review. PLOS Glob Public Health 4(2): e0002962.

Dear Friends,

Today I would like to share a new systematic review, that raises concerns about the quality (and thus, the safety and efficacy) of some medicines commonly used to prevent or treat hypertensive disorders during pregnancy. It is of potential interest for those who teach on issues related to quality of medicines, or conduct advocacy in this field, but also for colleagues working in related clinical/ or medical programs. 

For those who do not have time for full reading, I copy-paste here below the abstract.

Very best,

Raffaella

ABSTRACT:

The quality of medicines for the prevention and management of hypertensive disorders of pregnancy globally is a critical challenge in the reduction of maternal mortality rate. We aimed to conduct a systematic review of available studies on the quality of the eight medicines recommended globally for the prevention and management of hypertensive disorders of pregnancy. We searched five electronic databases- Ovid MEDLINE, EMBASE, CINAHL, ProQuest and Cochrane Library, and also grey literature, without year or language limitations. Any study assessing the quality parameters (Active Pharmaceutical Ingredients, pH, sterility, solubility, impurities) of medicines by using any valid laboratory methods was eligible. Two reviewers independently screened the studies, extracted data and applied the Medicine Quality Assessment Reporting Guidelines tool for quality assessment.

Results were narratively reported and stratified by the drug types. Of 5669 citations screened, 33 studies from 27 countries were included. Five studies reported on the quality of magnesium sulphate—two (Nigeria and USA) found substandard medicine due to failing API specification and contaminants, respectively. Another study from Nigeria and a multi-country study (10 lower-middle- and low-income countries) found poor quality due to failing the pH criteria. Seven of eight studies evaluating aspirin found quality issues, including degraded medicines in five studies (Brazil, USA, Yugoslavia and Pakistan). Five studies of calcium supplements found quality issues, particularly heavy metal contamination. Of 15 antihypertensive quality studies, 12 found substandard medicines and one study identified counterfeit medicines.

This systematic review identified pervasive issues of poor-quality medicines across all recommended medicines used to prevent or treat hypertensive disorders of pregnancy, raising concerns regarding their safety and effectiveness.

Have a nice reading.

Raffaella

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