1. Over-the-Counter Cough and Cold Product Medication Errors (in children under six years of age) Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee Silver Spring, Maryland October 18, 2007 Richard Abate, RPh, MS Division of Medication Errors and Technical Support Office of Surveillance and Epidemiology Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee Silver Spring, Maryland October 18, 2007 Richard Abate, RPh, MS Division of Medication Errors and Technical Support Office of Surveillance and Epidemiology Center for Drug Evaluation and Research

2. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 2 Objective Describe how medication errors are impacting the safe use of OTC cough and cold products in children under 6 years of age

3. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 3 OutlineOutline Review AERS cases of OTC cough and cold medication errors in children under six years of age Discuss the factors contributing to the medication errors Points to consider Review AERS cases of OTC cough and cold medication errors in children under six years of age Discuss the factors contributing to the medication errors Points to consider

4. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 4 Consumers’ Perspective

5. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 5 Medication Error Cases Case 1 –Product Selection Error within Brand Case 2 –Duplicate Therapy Case 3 –Confusing Nomenclature Case 4 –Improper Dosing Case 1 –Product Selection Error within Brand Case 2 –Duplicate Therapy Case 3 –Confusing Nomenclature Case 4 –Improper Dosing

6. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 Product Selection within a Brand *This presentation is not intended to single out a particular brand, since our analysis did not find any one brand to be more problematic than another.

7. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 7

8. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 8 Contains phenylephrine bromepheniramine, and dextromethorphan Contains chlorpheniramine, and dextromethorphan

9. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 9 Case 1 Pseudoephedrine15 mg/5 mL (3 mg/mL) 7.5 mg/0.8 mL (9.375 mg/mL) Brompheniramine1 mg/5 mLnone

10. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 10 Factors Contributing to Error Similar nomenclature within brand Similar trade dress –layout & color Knowledge deficit –Drug Facts label overlooked; not read; or the consumer couldn’t understand Image of an infant on the principal display Similar nomenclature within brand Similar trade dress –layout & color Knowledge deficit –Drug Facts label overlooked; not read; or the consumer couldn’t understand Image of an infant on the principal display

11. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 11

12. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 12 Case 2: Duplicate Therapy 6 month old diagnosed with pneumonia Prescribed –Amoxicillin – Carbaxefed RF pseudoephedrine/carbinoxamine –Tylenol or Motrin Purchased instead of Tylenol – Infant’s Tylenol Cold pseudoephedrine and acetaminophen 6 month old diagnosed with pneumonia Prescribed –Amoxicillin – Carbaxefed RF pseudoephedrine/carbinoxamine –Tylenol or Motrin Purchased instead of Tylenol – Infant’s Tylenol Cold pseudoephedrine and acetaminophen

13. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 13 Case 2 Infant’s Tylenol Cold administered “according to the instructions on the box.” –source of dose extrapolation unclear Carbaxefed given every 4 hours instead of QID The child received 200 mg of pseudoephedrine over 36 hours Infant’s Tylenol Cold administered “according to the instructions on the box.” –source of dose extrapolation unclear Carbaxefed given every 4 hours instead of QID The child received 200 mg of pseudoephedrine over 36 hours

14. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 14 Factors Contributing to Error Incorrect product selection –similar product nomenclature –packages are similar colors Tylenol Cold not labeled for this age group Prescription label –knowledge deficit –same ingredient - Rx and OTC Mother misunderstood the instructions for frequency of use Incorrect product selection –similar product nomenclature –packages are similar colors Tylenol Cold not labeled for this age group Prescription label –knowledge deficit –same ingredient - Rx and OTC Mother misunderstood the instructions for frequency of use

15. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 15 Emphasis of symptoms on the principal display panel

16. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 16 Confusing Nomenclature Triaminic ® Day Time Cold & Cough PediaCare ® Children's Multi-Symptom Cold Children's SUDAFED PE ® Cold & Cough Liquid Triaminic ® Day Time Cold & Cough PediaCare ® Children's Multi-Symptom Cold Children's SUDAFED PE ® Cold & Cough Liquid PediaCare ® Children's NightTime Cough Children's Tylenol ® Plus Cough & Runny Nose Children’s Tylenol Plus Multi-Symptom Cold Robitussin ® Pediatric Cough & Cold Long-Acting Children’s Benadryl ® Allergy and Cold Fastmelts Triaminic ® Flu, Cough & Fever Robitussin ® Cough & Cold Pediatric Drops Children’s Dimetapp ® Cold and Cough DM Elixir Children’s Motrin ® Cold

17. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 17 Case 3 Confusing Nomenclature A 4 year old developed a fever. Triaminic Severe Cold and Fever –Acetaminophen, pseudoephedrine, dextromethorphan and chlorpheniramine 1 teaspoon every 2.5 to 3 hours –labeled frequency every 4 hours Taken to ER for seizure and tachycardia. A 4 year old developed a fever. Triaminic Severe Cold and Fever –Acetaminophen, pseudoephedrine, dextromethorphan and chlorpheniramine 1 teaspoon every 2.5 to 3 hours –labeled frequency every 4 hours Taken to ER for seizure and tachycardia.

18. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 18 Contributing Factors Nomenclature –Focused attention on symptom (i.e. “Fever”), not product ingredients Knowledge Deficit –Drug Facts label overlooked; deliberately ignored; or the consumer couldn’t understand –Inadequate risk perception Nomenclature –Focused attention on symptom (i.e. “Fever”), not product ingredients Knowledge Deficit –Drug Facts label overlooked; deliberately ignored; or the consumer couldn’t understand –Inadequate risk perception

19. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 Improper Dosing

20. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 20 Dosage Devices Devices include cups, droppers, and oral syringes. Devices deliver an accurate amount of medication. Measurements should agree with doses in the labeling of the product and be presented in a manner that minimizes confusion. Devices include cups, droppers, and oral syringes. Devices deliver an accurate amount of medication. Measurements should agree with doses in the labeling of the product and be presented in a manner that minimizes confusion.

21. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 21 Multiple Units of Measure Dosing cup measures CC, mL, TBS, DSSP, TSP, drams and fluid ounces

22. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 22 Tablespoons vs Teaspoons Measurement marks for tablespoons (15 mL) and teaspoons (5 mL) Labeled doses are only in teaspoons

23. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 23 Inadequate Calibrations Measures 1 and 2 Teaspoons (only) …but instructions for ½ teaspoon dosing in younger children

24. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 24 Case 4 Improper Dosing

25. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 25 Contributing Factors Nomenclature: –Called “drops” but not dosed by dropper Knowledge deficit –prescriber –parent Conflicting dosing recommendation –prescriber vs. label Nomenclature: –Called “drops” but not dosed by dropper Knowledge deficit –prescriber –parent Conflicting dosing recommendation –prescriber vs. label

26. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 26 SummarySummary Medication errors impact the safe use of cough and cold products in children under six years of age particularly when selecting and dosing these products

27. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 27 Points to Consider Only having single ingredient cough and cold product formulations for children under six years of age Requiring that well-designed and product-specific dosage devices be provided for all liquid OTC cough and cold medications Only having single ingredient cough and cold product formulations for children under six years of age Requiring that well-designed and product-specific dosage devices be provided for all liquid OTC cough and cold medications

28. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 28 Points to Consider Requesting further studies to provide more complete dosing instructions in the Drug Facts labeling –< 2 years –2-5 years Revising the “consult/ask your physician” statement Educate healthcare practitioners and consumers on the safe use of these products Requesting further studies to provide more complete dosing instructions in the Drug Facts labeling –< 2 years –2-5 years Revising the “consult/ask your physician” statement Educate healthcare practitioners and consumers on the safe use of these products

29. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee October 18 and 19, 2007 29 AcknowledgementsAcknowledgements Gerald Dal Pan, MD, MHS Carol Holquist, RPh Kimberly Pedersen-Culley, RPh Kellie Taylor, PharmD, MPH Office of Compliance –Kevin Budich –Jason Woo, MD, MPH Gerald Dal Pan, MD, MHS Carol Holquist, RPh Kimberly Pedersen-Culley, RPh Kellie Taylor, PharmD, MPH Office of Compliance –Kevin Budich –Jason Woo, MD, MPH