The quality of medicines for the prevention and management of
hypertensive disorders of pregnancy: a systematic review
Abstract
Background There is evidence to suggest that many medicines
commonly used for pregnant women for the management of hypertensive
disorders of pregnancy are poor quality. Objective To review
the available studies systematically reporting medicine quality,
routinely used in the prevention and management of hypertensive
disorders of pregnancy. Search strategy We searched five
electronic databases- Ovid MEDLINE, EMBASE, CINAHL, ProQuest and
Cochrane Library, without year or language limitations.
Selection criteria Studies reporting on quality parameters of
nine medicines - magnesium sulphate, aspirin, calcium supplements,
amlodipine, nifedipine, methyldopa, enalapril, hydralazine and
labetalol, using any valid laboratory methods. Data collection
and analysis Two reviewers independently screened the studies,
extracted data and assessed the quality. Results were reported
narratively by type of medicine. Main results Of 5669 citations
screened, 33 studies from 27 countries were included. Five quality
studies on 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
antihypertensives quality studies, 12 found substandard medicines and
one study identified counterfeit medicines. Conclusion We
identified multiple findings of poor quality across all types of
medicines used in hypertensive disorders of pregnancy, raising concerns
regarding their safety and effectiveness.