Continued Prescribing of Periprocedural Codeine and Tramadol to Children after a Black Box Warning

Area of Science:

• Pediatric Surgery
• Pharmacovigilance
• Pain Management

Background:

• Codeine and tramadol are common postoperative analgesics.
• The Food and Drug Administration (FDA) issued contraindications for codeine (2013) and tramadol (2017) in pediatric populations.
• These warnings targeted specific age groups and procedures, including tonsillectomy and adenoidectomy.

Purpose of the Study:

• To evaluate the prescribing patterns of codeine and tramadol in pediatric surgical patients in Wisconsin.
• To assess changes in prescribing rates after the expanded FDA warning in April 2017.
• To identify specific procedures and specialties with continued prescribing to contraindicated populations.

Main Methods:

• A statewide Wisconsin claims database was utilized.
• Pediatric ambulatory surgical procedures were identified across multiple surgical specialties.
• Perioperative prescription fill rates for codeine and tramadol were analyzed before and after the FDA contraindication.

Main Results:

• Codeine continued to be prescribed to pediatric patients post-contraindication, while tramadol was rarely prescribed.
• High initial rates of codeine fills were observed for strabismus repair, circumcision (>1 year), and laparoscopic appendectomy.
• Codeine fills decreased significantly for circumcision (>1 year), orchiopexy, and inguinal hernia repair after the warning.
• Otolaryngology showed consistently low codeine fill rates (<2.5%).
• Codeine prescribing for strabismus repair did not show a significant decline.

Conclusions:

• Codeine and tramadol remain prescribed to children in contravention of FDA guidelines.
• These findings highlight a target for future interventions aimed at de-implementing inappropriate prescribing.
• Further research and targeted interventions are needed to ensure adherence to pediatric analgesic safety warnings.