Principles of drug use and management in pregnancy
The principles of prescribing in pregnancy involve complex decision-making, including the management of COVID-19 infection and understanding medications contraindicated in pregnancy. Clinicians and patients were often confused by the meaning of the pregnancy risk categories because, according to the FDA, it was overly simplistic, led to misinformation, and did not adequately address the available information.
The Challenges of Pregnancy Risk Categories
Category C is the confusing category. A medication gets this classification if there is insufficient data on its use during pregnancy. It could be safe or probably safe, or it could be potentially harmful. While the new labeling improves the old format, it still does not provide a definitive “yes” or “no” answer in most cases. Therefore, clinical interpretation is still required on a case-by-case basis.
New Labeling System and Implementation
The new labeling system allows better patient-specific counseling and informed decision making for pregnant women seeking medication therapies. The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic products submitted after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually. However, labeling for over-the-counter (OTC) medicines will not change; OTC drug products are not affected by the final rule.
Key Implementation Timeline and Scope
- June 30, 2015: Labeling changes go into effect.
- New Submissions: Prescription drugs and biologic products submitted after June 30, 2015, use the new format immediately.
- Existing Approvals: Labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.
- OTC Products: Labeling for over-the-counter medicines will not change.