title: Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform.
abstract: BACKGROUND
  There is limited safety information on most drugs used during pregnancy. This is especially true for medication against tropical diseases because pharmacovigilance systems are not much developed in these settings. The aim of the present study was to demonstrate feasibility of using Health and Demographic Surveillance System (HDSS) as a platform to monitor drug safety in pregnancy.
  
  
  METHODS
  Pregnant women with gestational age below 20 weeks were recruited from Reproductive and Child Health (RCH) clinics or from monthly house visits carried out for the HDSS. A structured questionnaire was used to interview pregnant women. Participants were followed on monthly basis to record any new drug used as well as pregnancy outcome.
  
  
  RESULTS
  1089 pregnant women were recruited; 994 (91.3%) completed the follow-up until delivery. 98% women reported to have taken at least one medication during pregnancy, mainly those used in antenatal programmes. Other most reported drugs were analgesics (24%), antibiotics (17%), and antimalarial (15%), excluding IPTp. Artemether-lumefantrine (AL) was the most used antimalarial for treating illness by nearly 3/4 compared to other groups of malaria drugs. Overall, antimalarial and antibiotic exposures in pregnancy were not significantly associated with adverse pregnancy outcome. Iron and folic acid supplementation were associated with decreased risk of miscarriage/stillbirth (OR 0.1; 0.08-0.3).
  
  
  CONCLUSIONS
  Almost all women were exposed to medication during pregnancy. Exposure to iron and folic acid had a beneficial effect on pregnancy outcome. HDSS proved to be a useful platform to establish a reliable pharmacovigilance system in resource-limited countries. Widening drug safety information is essential to facilitate evidence based risk-benefit decision for treatment during pregnancy, a major challenge with newly marketed medicines.
authors.affiliation: Ifakara Health Institute, Rufiji, HDSS, P,O Box 40, Rufiji, Tanzania. dfmosha@hotmail.com.
authors.forename: Dominic
authors.initials: D
authors.lastname: Mosha
authors.forename: Festo
authors.initials: F
authors.lastname: Mazuguni
authors.forename: Sigilbert
authors.initials: S
authors.lastname: Mrema
authors.forename: Salim
authors.initials: S
authors.lastname: Abdulla
authors.forename: Blaise
authors.initials: B
authors.lastname: Genton
mesh_terms: D000022:Abortion, Spontaneous / Q000453:epidemiology*; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000996:Antitussive Agents / Q000627:therapeutic use; D000013:Congenital Abnormalities / Q000453:epidemiology; D019587:Dietary Supplements; D005240:Feasibility Studies; D005260:Female; D005296:Ferrous Compounds / Q000627:therapeutic use; D005492:Folic Acid / Q000627:therapeutic use; D005865:Gestational Age; D006801:Humans; D007230:Infant, Low Birth Weight; D050498:Live Birth; D008875:Middle Aged; D008903:Minerals / Q000627:therapeutic use; D060735:Pharmacovigilance; D011159:Population Surveillance / Q000379:methods*; D011247:Pregnancy; D011446:Prospective Studies; D050497:Stillbirth / Q000453:epidemiology*; D013636:Tanzania / Q000453:epidemiology; D014815:Vitamins / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D000996:Antitussive Agents; D005296:Ferrous Compounds; D008903:Minerals; D014815:Vitamins; C020748:ferrous sulfate; D005492:Folic Acid