Continued Prescribing of Periprocedural Codeine and Tramadol to Children after a Black Box Warning
Codeine and tramadol are commonly used analgesics in surgery. In 2013, the Food and Drug Administration (FDA) issued a contraindication to the use of codeine in tonsillectomy and adenoidectomy patients aged below 18 y. This warning was expanded in April 2017 to include tramadol and all children aged...
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Published in | The Journal of surgical research Vol. 256; pp. 131 - 135 |
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Main Authors | , , , |
Format | Journal Article |
Language | English |
Published |
United States
Elsevier Inc
01.12.2020
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ISSN | 0022-4804 1095-8673 1095-8673 |
DOI | 10.1016/j.jss.2020.06.023 |
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Abstract | Codeine and tramadol are commonly used analgesics in surgery. In 2013, the Food and Drug Administration (FDA) issued a contraindication to the use of codeine in tonsillectomy and adenoidectomy patients aged below 18 y. This warning was expanded in April 2017 to include tramadol and all children aged below 12 y. We sought to describe the prescribing of codeine and tramadol to contraindicated populations in Wisconsin before and after the release of the expanded FDA warning.
Using a statewide Wisconsin claims database, we identified common pediatric ambulatory surgical procedures across the specialties of otolaryngology, urology, general surgery, orthopedics, and ophthalmology. For these procedures, we examined the rates of perioperative codeine and tramadol prescription fills and change in prescribing after the FDA contraindication.
Surgeons in all of the specialties studied continued to prescribe codeine to pediatric patients after the contraindication, but tramadol was rarely prescribed. Procedures with relatively high rates of codeine fills were strabismus repair (65% of opioid fills), circumcision >1 yo (22%), and laparoscopic appendectomy (15%). Codeine fills significantly declined after the contraindication to 6% for circumcision >1 yo and 5% for orchiopexy and inguinal hernia repair. Otolaryngology, which was subject to the 2013 codeine contraindication, has low rates of codeine fills (under 2.5%) for the whole period studied. Codeine prescribing for strabismus repair showed no significant decline.
Codeine, and to a lesser extent tramadol, continue to be prescribed to contraindicated populations of children. This represents a target for future de-implementation interventions. |
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AbstractList | Codeine and tramadol are commonly used analgesics in surgery. In 2013, the Food and Drug Administration (FDA) issued a contraindication to the use of codeine in tonsillectomy and adenoidectomy patients aged below 18 y. This warning was expanded in April 2017 to include tramadol and all children aged below 12 y. We sought to describe the prescribing of codeine and tramadol to contraindicated populations in Wisconsin before and after the release of the expanded FDA warning.BACKGROUNDCodeine and tramadol are commonly used analgesics in surgery. In 2013, the Food and Drug Administration (FDA) issued a contraindication to the use of codeine in tonsillectomy and adenoidectomy patients aged below 18 y. This warning was expanded in April 2017 to include tramadol and all children aged below 12 y. We sought to describe the prescribing of codeine and tramadol to contraindicated populations in Wisconsin before and after the release of the expanded FDA warning.Using a statewide Wisconsin claims database, we identified common pediatric ambulatory surgical procedures across the specialties of otolaryngology, urology, general surgery, orthopedics, and ophthalmology. For these procedures, we examined the rates of perioperative codeine and tramadol prescription fills and change in prescribing after the FDA contraindication.MATERIALS AND METHODSUsing a statewide Wisconsin claims database, we identified common pediatric ambulatory surgical procedures across the specialties of otolaryngology, urology, general surgery, orthopedics, and ophthalmology. For these procedures, we examined the rates of perioperative codeine and tramadol prescription fills and change in prescribing after the FDA contraindication.Surgeons in all of the specialties studied continued to prescribe codeine to pediatric patients after the contraindication, but tramadol was rarely prescribed. Procedures with relatively high rates of codeine fills were strabismus repair (65% of opioid fills), circumcision >1 yo (22%), and laparoscopic appendectomy (15%). Codeine fills significantly declined after the contraindication to 6% for circumcision >1 yo and 5% for orchiopexy and inguinal hernia repair. Otolaryngology, which was subject to the 2013 codeine contraindication, has low rates of codeine fills (under 2.5%) for the whole period studied. Codeine prescribing for strabismus repair showed no significant decline.RESULTSSurgeons in all of the specialties studied continued to prescribe codeine to pediatric patients after the contraindication, but tramadol was rarely prescribed. Procedures with relatively high rates of codeine fills were strabismus repair (65% of opioid fills), circumcision >1 yo (22%), and laparoscopic appendectomy (15%). Codeine fills significantly declined after the contraindication to 6% for circumcision >1 yo and 5% for orchiopexy and inguinal hernia repair. Otolaryngology, which was subject to the 2013 codeine contraindication, has low rates of codeine fills (under 2.5%) for the whole period studied. Codeine prescribing for strabismus repair showed no significant decline.Codeine, and to a lesser extent tramadol, continue to be prescribed to contraindicated populations of children. This represents a target for future de-implementation interventions.CONCLUSIONSCodeine, and to a lesser extent tramadol, continue to be prescribed to contraindicated populations of children. This represents a target for future de-implementation interventions. Codeine and tramadol are commonly used analgesics in surgery. In 2013, the Food and Drug Administration (FDA) issued a contraindication to the use of codeine in tonsillectomy and adenoidectomy patients aged below 18 y. This warning was expanded in April 2017 to include tramadol and all children aged below 12 y. We sought to describe the prescribing of codeine and tramadol to contraindicated populations in Wisconsin before and after the release of the expanded FDA warning. Using a statewide Wisconsin claims database, we identified common pediatric ambulatory surgical procedures across the specialties of otolaryngology, urology, general surgery, orthopedics, and ophthalmology. For these procedures, we examined the rates of perioperative codeine and tramadol prescription fills and change in prescribing after the FDA contraindication. Surgeons in all of the specialties studied continued to prescribe codeine to pediatric patients after the contraindication, but tramadol was rarely prescribed. Procedures with relatively high rates of codeine fills were strabismus repair (65% of opioid fills), circumcision >1 yo (22%), and laparoscopic appendectomy (15%). Codeine fills significantly declined after the contraindication to 6% for circumcision >1 yo and 5% for orchiopexy and inguinal hernia repair. Otolaryngology, which was subject to the 2013 codeine contraindication, has low rates of codeine fills (under 2.5%) for the whole period studied. Codeine prescribing for strabismus repair showed no significant decline. Codeine, and to a lesser extent tramadol, continue to be prescribed to contraindicated populations of children. This represents a target for future de-implementation interventions. |
Author | Kohler, Jonathan E. Cartmill, Randi S. Schumacher, Jessica Kalbfell, Elle |
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Cites_doi | 10.1056/NEJMoa041888 10.1542/peds.2017-1765 10.1002/lary.26719 10.3389/fphar.2018.00148 10.1001/jamaoto.2017.1089 10.1016/j.surg.2018.10.029 |
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Keywords | Postoperative pain Pediatric surgery Tramadol Drug contraindications Codeine |
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References_xml | – year: 2012 ident: bib5 article-title: FDA Drug Safety Communication: codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death – start-page: e20171765 year: 2017 ident: bib7 article-title: Effect of FDA investigation on opioid prescribing to children after tonsillectomy/adenoidectomy publication-title: Pediatrics – volume: 143 start-page: 1052 year: 2017 end-page: 1054 ident: bib9 article-title: Pediatric Posttonsillectomy analgesia before and after the black box warning against codeine use publication-title: JAMA Otolaryngol Head Neck Surg – year: 2017 ident: bib4 article-title: FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women – volume: 128 start-page: 264 year: 2018 end-page: 268 ident: bib8 article-title: Otolaryngology practice patterns in pediatric tonsillectomy: the impact of the codeine boxed warning publication-title: Laryngoscope – year: 2014 ident: bib10 article-title: Impact intelligence datamart guide, version 3.0 – year: 2013 ident: bib6 article-title: Safety review update of codeine use in children; new boxed warning and contraindication on use after tonsillectomy and/or adenoidectomy – volume: 9 start-page: 148 year: 2018 ident: bib3 article-title: When the safe alternative is not that safe: tramadol prescribing in children publication-title: Front Pharmacol – year: 2015 ident: bib2 article-title: Tramadol therapy and CYP2D6 genotype - medical genetics summaries - NCBI bookshelf – volume: 165 start-page: 838 year: 2018 end-page: 842 ident: bib11 article-title: National variation in opioid prescribing after pediatric umbilical hernia repair publication-title: Surgery – volume: 351 start-page: 2827 year: 2004 end-page: 2831 ident: bib1 article-title: Codeine intoxication associated with ultrarapid CYP2D6 metabolism publication-title: N Engl J Med – volume: 351 start-page: 2827 year: 2004 ident: 10.1016/j.jss.2020.06.023_bib1 article-title: Codeine intoxication associated with ultrarapid CYP2D6 metabolism publication-title: N Engl J Med doi: 10.1056/NEJMoa041888 – start-page: e20171765 year: 2017 ident: 10.1016/j.jss.2020.06.023_bib7 article-title: Effect of FDA investigation on opioid prescribing to children after tonsillectomy/adenoidectomy publication-title: Pediatrics doi: 10.1542/peds.2017-1765 – volume: 128 start-page: 264 year: 2018 ident: 10.1016/j.jss.2020.06.023_bib8 article-title: Otolaryngology practice patterns in pediatric tonsillectomy: the impact of the codeine boxed warning publication-title: Laryngoscope doi: 10.1002/lary.26719 – volume: 9 start-page: 148 year: 2018 ident: 10.1016/j.jss.2020.06.023_bib3 article-title: When the safe alternative is not that safe: tramadol prescribing in children publication-title: Front Pharmacol doi: 10.3389/fphar.2018.00148 – volume: 143 start-page: 1052 year: 2017 ident: 10.1016/j.jss.2020.06.023_bib9 article-title: Pediatric Posttonsillectomy analgesia before and after the black box warning against codeine use publication-title: JAMA Otolaryngol Head Neck Surg doi: 10.1001/jamaoto.2017.1089 – ident: 10.1016/j.jss.2020.06.023_bib2 – volume: 165 start-page: 838 year: 2018 ident: 10.1016/j.jss.2020.06.023_bib11 article-title: National variation in opioid prescribing after pediatric umbilical hernia repair publication-title: Surgery doi: 10.1016/j.surg.2018.10.029 – year: 2014 ident: 10.1016/j.jss.2020.06.023_bib10 – year: 2013 ident: 10.1016/j.jss.2020.06.023_bib6 |
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SubjectTerms | Administrative Claims, Healthcare - statistics & numerical data Adolescent Ambulatory Surgical Procedures - adverse effects Child Child, Preschool Codeine Codeine - therapeutic use Drug contraindications Drug Labeling Drug Prescriptions - standards Drug Prescriptions - statistics & numerical data Female Humans Inappropriate Prescribing - prevention & control Inappropriate Prescribing - statistics & numerical data Infant Male Pain, Postoperative - drug therapy Pain, Postoperative - etiology Pediatric surgery Perioperative Care - standards Perioperative Care - statistics & numerical data Postoperative pain Practice Patterns, Physicians' - standards Practice Patterns, Physicians' - statistics & numerical data Retrospective Studies Tramadol Tramadol - therapeutic use Wisconsin |
Title | Continued Prescribing of Periprocedural Codeine and Tramadol to Children after a Black Box Warning |
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