Drug therapy during pregnancy and breastfeeding needs attention that can be solved by clinical decision support
Drug therapy during pregnancy or breastfeeding can be challenging for doctors, pharmacists, and patients due to uncertainties regarding drug dosing and safety. Clinical problem2-3% of all congenital disabilities result from drugs taken to treat a disorder or symptom.
More than 50% of pregnant women take prescription or over-the-counter drugs, use social drugs (tobacco and alcohol), or use illicit drugs during pregnancy.
Integrate drug warnings on the safety of different drugs during pregnancy and lactation into your clinical workflow with Synbase
The Synbase platform enables the integration of drug warnings on pregnancy and lactation into your electronic health record or pharmacy information system and the use of a complimentary web portal. #1 clinical decision support platform
The Synbase platform features for drugs in pregnancy database and drugs in lactation database:
- Includes recommendations in the local language
- Maps drugs with local drug compendium
- Takes drug administration route into account
- Is integrated with other drug databases (e.g., drug interactions or drug dosing in renal or hepatic failure)
- Supports search with local trade name, active substance, and Anatomical Therapeutic Chemical Classification (ATC) code
- Considers both prescription and OTC drugs
- Can be used on a desktop, tablet, or mobile application.
Databases on the use of drugs in pregnancy and lactation include prescription drugs, OTC drugs, and other substances
Clinical databaseDatabase on the safety of drugs during pregnancy and lactation
Gravbase and Lactbase contain information on the safety of drugs during pregnancy and lactation. Databases consist of over 1 300 drugs (prescription and OTC drugs) and other substances, such as vitamin supplements, illicit drugs, caffeine, and nicotine during pregnancy and lactation.
All drug information has been produced according to standard operating procedures (SOPs), including published medical knowledge and the manufacturer-provided information approved by the European Medicines Agency (EMA) and/or The United States Food and Drug Administration (FDA) and data from national drug registers. All references are, whenever possible, linked to their source evidence.
Methodology of pregnancy and lactation database
High clinical usability – all warnings are classified according to clinical significance (A-D) supported by color codes.
Classification of the safety of drugs in pregnancy
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A |
Controlled studies or large patient materials fail to demonstrate an increased risk for malformations or direct or indirect fetal adverse effects after exposure during the first trimester. There is also no evidence of risk after exposure during the second or third trimester. |
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B |
There is only a limited amount of information on the use during pregnancy, and there are no controlled studies in pregnant women. Animal teratology or limited human data indicate no evidence of increased risk of malformations or direct or indirect fetal adverse effects. |
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C1 |
There is only a limited amount of information on the use during pregnancy, and there are no controlled studies in pregnant women, or the information is conflicting. Animal teratology data indicate an increased risk of malformations or direct or indirect fetal adverse effects, or animal teratology data is missing. |
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C2 |
Animal teratology or limited human data indicate no evidence of increased risk of malformations. However, late pregnancy use may pose a risk of adverse effects during the neonatal period or childhood.
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D |
There is a strong suspicion or direct evidence of malformations or direct or indirect human fetal adverse effects. The drug is usually contraindicated during pregnancy, but the benefits may outweigh the risk in some cases. |
Classification of the safety of drugs in lactation
| A |
The drug is not excreted into breast milk in significant amounts, or there is evidence that indicates no adverse effects in the infant when the mother uses the drug in recommended therapeutic doses. |
| B |
There are no studies on the excretion of the drug into breast milk. There is only a limited amount or no data on the safety during breastfeeding. |
| C |
The evidence suggests that a clinically relevant amount of the maternal drug dose is excreted into breast milk. Therapeutic maternal drug doses during breastfeeding pose an increased risk for infant adverse effects. The decision on breastfeeding must be made individually, considering the potential benefits in relation to the potential risk. |
| D |
Breast-feeding is contraindicated while using the drug. The use of the drug during breastfeeding may cause severe adverse effects on the suckling infant. |
Drugs during pregnancy database for patients
Besides pregnancy and lactation tools for professional users, we also provide a patient version, where the safety warnings about drug use in pregnancy and breastfeeding are tailored for patients. The patient tool can be a part of a personal health record (PHR), pharmacy information system, or mobile application.
Regular updates for drugs during pregnancy and lactation database
Up-to-date information to provide medical advice – Gravbase and Lactbase are developed and updated quarterly by Medbase Ltd (Finland).
