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MEDICATION RELATED DECISION EVALUATION SBAR
Codeine products for Pediatrics
Melanie Geer, PharmD, BCPS, Providence Health Plan
June 2015
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Situation:
 The purpose of this review is to assess the utilization of codeine products in pediatric members (< 18 years
old) of Providence Health Plan. This review of utilization is subsequent to action taken by Providence Health
and Services to restrict use of codeine for pediatrics in acute settings.
 Providence Health & Services implemented a pediatric codeine interchange in the Providence Epic system
acute environment included ED in January of 2013, in response to FDA warnings about risk. 1-3 The
interchange offered suggestions of safer agents but still allowed practitioners to continue prescribing
codeine. A medication use evaluation conducted at Sacred Heart Medical Center and further enhanced by
system-wide data revealed continued use of codeine for pediatrics in acute settings, primarily the ED
setting.4
 Effective May 19, 2015, codeine became no longer orderable for patients under 18 in Providence Epic acute
settings, including the ED. Safer alternatives will be displayed when codeine is ordered in this population.
Swedish Epic does not currently have an interchange built and is reviewing to determine inclusion.
Drug Background:
 Codeine is a prodrug which is converted to its active metabolite, morphine, by CYP2D6. There is
interpatient variability in the activity of enzymes responsible for conversion of codeine to morphine.5
 Some individuals are rapid metabolizers of codeine, increasing risk for toxicity; some individuals are poor
metabolizers, risking ineffectiveness of codeine. 5
FDA Safety Alerts:
 An FDA alert released in August 2012 warned about the risk of respiratory depression and death in pediatric
patients receiving codeine for post-tonsillectomy and adenoidectomy pain management.2
 In 2013, the FDA updated recommendations and added a black box warning and contraindication for use of
codeine for post-operative pain management in children undergoing tonsillectomy and/or adenoidectomy.
Per the 2013 FDA alert: The FDA’s Adverse Event Reporting System (AERS) database identified 10 deaths
and three cases of life-threatening respiratory depression associated with codeine, used in typical doses,
between 1969 to May 1, 2012. Ages ranged from 21 months to 9 years and many were recovering from a
surgery to remove tonsils or adenoids.3
Efficacy and Additional Safety Data:
 For acute musculoskeletal pain, more pediatric patients given ibuprofen achieved adequate analgesia
compared to acetaminophen or codeine. There was no significant difference between the codeine and
acetaminophen groups with regard to pain management.6
 For post-tonsillectomy pain and fever, ibuprofen was found to be at least as effective as acetaminophencodeine, without a difference in post-operative bleeding. Fewer patients experienced nausea with
ibuprofen compared to acetaminophen-codeine. (A limitation with the study results is that 22 percent of
the ibuprofen patients received rescue codeine and/or acetaminophen). 7
 A study in patients aged 18 months to 12 years with a nighttime cough for less than 14 days compared
dextromethorphan with guifenesin and codeine with guaifenesin to placebo. Parents rated amount of
coughing, loss of sleep because of coughing, and any post-tussive emesis and there was no difference seen
between placebo and codeine nor dextromethorphan groups.8
 Deaths following administration of codeine as an antittusive for children are reported in the literature.9-10
Guidelines:
 World Health Organization (WHO) guidelines for treatment of persisting pain in children do not recommend
use of codeine, but rather recommend treatment with a strong opioid after failure of NSAIDs and/or
SYSTEM-WIDE MEDICATION RELATED DECISION EVALUATION SBAR: Dimethyl Fumarate (Tecifdera®) in Multiple Sclerosis
Provided by Jane Hoh, PharmD, BCPS, Providence Health Plan
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MEDICATION RELATED DECISION EVALUATION SBAR
Codeine products for Pediatrics
Melanie Geer, PharmD, BCPS, Providence Health Plan

June 2015
acetaminophen.5
An American Academy of Pediatrics article regarding codeine and dextromethorphan-containing cough
products states: “Education of patients and parents about the lack of proven antitussive effects and the
potential risks of these products is needed.”11
Assessment:
 Use of codeine for pediatric patient poses a serious safety concern; clinical trial data to prove efficacy is
lacking.
 Codeine use for pediatrics is not recommended by guidelines for pain management nor as an antitussive. 5,11
 A substantial number of codeine containing prescriptions have been dispensed for pediatric members of
Providence Health Plans:
Prescriptions Containing Codeine
Dispensed 4/01/14– 3/31/2015
A

Age Range
Prescriptions
0-5 years
141
6-12 years
594
13-17 years
856
Total, 0-17 years
1,591
The majority of codeine products dispensed to members aged 0-5 contain guaifenesin, suggesting use as an
antitussive:
Prescriptions Containing Codeine
4/01/14– 3/31/2015
Ages 0-5 Years
R
Tablets
4
Liquid with promethazine
22
Liquid with guaifenesin
115
Recommendation
 We recommend removing coverage of codeine products for members under 6 years old effective
June 1, 2015. There are well documented cases of deaths in children under 6 who were administered
codeine.9-10,12 The FDA contraindication for use of codeine in children is in the setting of
tonsillectomy or adenoidectomy pain management. However, there is a safety concern with use of
codeine for pediatric patients, for any indication. Deaths have been reported in cases of codeine use
for cough for pediatric patients.9-10
 Providence Health Plan Pharmacy and Customer Service staff will be educated about the codeine age
restriction and rationale via email and SharePoint posting.
 Participating pharmacies will be alerted to codeine coverage age restriction and safety concerns with
codeine use in pediatrics, through the RXConsultant Newsletter.
SYSTEM-WIDE MEDICATION RELATED DECISION EVALUATION SBAR: Dimethyl Fumarate (Tecifdera®) in Multiple Sclerosis
Provided by Jane Hoh, PharmD, BCPS, Providence Health Plan
Page 2 of 2
MEDICATION RELATED DECISION EVALUATION SBAR
Codeine products for Pediatrics
Melanie Geer, PharmD, BCPS, Providence Health Plan
June 2015
Providence Health and Services. Opioid Therapeutic Interchange. SFC approved 1/8/2013. Last revised
5/14/2013.
2. 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.
http://www.fda.gov/Drugs/DrugSafety/ucm313631.htm. (Assessed 15 April 2015)
3. FDA Safety Communication (02/20/2013): Codeine Use in Certain Children After Tonsillectomy and/or
Adenoidectomy: Drug Safety Communication - Risk of Rare, But Life-Threatening Adverse Events or Death.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm31
5627.htm. (Assessed 15 April 2015)
4. Miller J, Muncey L, Albertson, B. Medication Utilization Evaluation: Codeine, Ambien, Promethazine and
PTA. Sacred Heart Medical Center, Spokane, WA: Sacred Heart Medical Center, August 2014.
5. World Health Organization. Guidelines on the pharmacological treatment of persisting pain in children with
medical illnesses. 2012. Available at:
http://whqlibdoc.who.int/publications/2012/9789241548120_Guidelines.pdf. (Accessed March 16, 2015)
6. Clark E, Plint AC, Correll R, Gaboury I, Passi B. A randomized, controlled trial of acetaminophen, ibuprofen,
and codeine for acute pain relief in children with musculoskeletal trauma. Pediatrics. 2007;119(6):460-7.
7. St Charles CS, Matt BH, Hamilton MM, Katz BP. A comparison of ibuprofen versus acetaminophen with
codeine in the young tonsillectomy patient. Otolaryng Head Neck Surg. 1997;117(1):76-82.
8. Taylor JA, Novack AH, Almquist JR, Rogers JE. Efficacy of cough suppressants in children. J Pediatr.
1993;122(5 Pt 1):799–802.
9. Magnani B, Evans R. Codeine intoxication in the neonate. Pediatrics. 1999;104(6):75-8.
10. Hermanns-Clausen M, Weinmann W, Auwarter V, et al., Drug dosing error with drops: severe clinical
course of codeine intoxication in twins, Eur J Pediatr. 2009;168 (7):819–24.
11. Berlin et al - Committee on Drugs, American Academy of Pediatrics. Use of codeine and dextromethorphan
containing cough remedies in children. Pediatrics. 1997;99(6);918-20.
12. Kelly LE, Rieder, van den Anker, et al. More codeine fatalities after tonsillectomy in North American
children. Pediatrics. 2012;12(5):e1343-7.
1.
References
SYSTEM-WIDE MEDICATION RELATED DECISION EVALUATION SBAR: Dimethyl Fumarate (Tecifdera®) in Multiple Sclerosis
Provided by Jane Hoh, PharmD, BCPS, Providence Health Plan
Page 3 of 3