Undergraduate Research Work performed summer 2013 in Alexandria University. Presented as oral presentation in DUPHAT conference, Dubai, UAE

1. Evaluation of Consistency between Dosing Directions,
Labeling and Measuring Devices among Pediatric Oral
Liquid Pharmaceutical Dosage Forms in the Egyptian
Market
1
Salma H. Abd El-Salam
4th Year Student, Faculty of Pharmacy
Alexandria University, Egypt

2. Outlines
2
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Introduction
Aim
Method
Results
Conclusion
Future Recommendations

3. 3
Introduction
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

4. Introduction
4
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
• Reports of unintentional drug toxicity are
prevalent in pediatric population.
• The American Academy of Pediatrics
recommends:
Basing pediatric dose on child’s weight.
Employment of accurate measuring devices.

5. Introduction
5
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
• The US Food and Drug Administration
recommends consistency and clarity in OTC
dosing directions and their accompanying
measuring devices.

6. Introduction
6
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
2008-2009
Similar
Study
Aim Determine discrepancies among
popular pediatric OTC medications
in the US market
Top-selling pediatric OTC products
showed high variability and
inconsistency between dosing
directions and measuring devices
Results

7. 7
Aim
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

8. Aim
8
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Evaluation of consistency among:
• Dosing directions
• Labeling
• Measuring devices
in pediatric oral liquid dosage forms in Egyptian
market

9. 9
Method
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

10. Method
10
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Product
Selection
Screening
Data
Analysis

11. Method
11
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Product
Selection
2365
846
340
54
506
1519
• Cough & Cold
• Analgesics2365
• Allergy
• Gastrointestinal Products
• Antibiotics
Excluded
Non Oral Liquid Medications
23651519
Assessed using additional
eligibility criteria
846Excluded
• No dosing Instructions for
children < 12 years
• Couldn’t be obtained
506
Eligible for Analysis
340
Included in analysis
(Top selling products based
on a market survey)
54

12. Method
12
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
• Dosing instructions
• Inclusion of measuring devices
• Reconstitution instructions
• reconstitution vehicle
• Active and inactive constituents
• Storage conditions
• Discrepancies between dosing directions,
labeling and measuring devices
Screening

13. Method
13
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Data
Analysis
Data were collected and
analyzed using pre-formulated
G-Doc and Microsoft Excel
spreadsheets

14. 14

15. 15
Results
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

16. Results
16
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
39.62%
43.40%
16.98%
Suspensions
Syrups/Solutions
Oral Drops
9.43% 9.43%
37.74%22.64%
20.76% Infants only
Children only
Infants & Children
Children & Adults
Infants, Children, and Adults
Product
Characteristics
52.83% manufactured by national companies
47.17% manufactured by international companies

17. Results
17
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Dosing Equipment
were found in 32 products (60.38%)

18. Results
18
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Dosing equipment:
• 63% showed consistency between dosing
instructions and equipment while 37% were
inconsistent.
Adults and Children 6 years
of age and over
The recommended dose is 2 teaspoonful
of syrup once daily
Children 2 to 5 years of age The recommended dose is 1 teaspoonful
once daily
Inconsistency between the
product’s pamphlet and dosing
equipment
Pros

19. Results
19
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Dosing equipment:
• 47% showed Extra unnecessary
markings.
Children less than 6 years 5 ml three times daily
Children more than 6 years 10 ml three times daily
Extra markings not listed in dosing directions
Discrepancies

20. Results
20
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Dosing equipment:
• 34% were missing necessary markings
Adults and
children of 6 years
or above
The recommended dose is
1 ml daily as a single dose
Children between
3 and 6 years
The recommended dose is
 0.5 ml daily as a single
intake
 Or 0.25 ml in the
morning and the
evening
Discrepancies
Missing marking (absent from dosing equipment)

21. Results
21
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Dosing equipment:
• 28% were usage-inconvenient.
Discrepancies
Children over 5 years 50 drops 2-3 times daily
Children 2-5 years 25 drops 3 times daily
Children under 2 years 25 drops twice daily

22. Results
22
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
• 15 products were powders to be reconstituted,
13% of which included reconstitution vehicle.
• Despite storage conditions were mentioned in all
products, there were no specific instructions on
post-reconstitution storage.
Products to be reconstituted

23. Results
23
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
3.77%
84.91%
11.32%
0.00%
20.00%
40.00%
60.00%
80.00%
100.00%
On package
only
On pamphlet
only
On both
58.49%
13.21%
28.30%
0.00%
20.00%
40.00%
60.00%
80.00%
By age only By body
weight only
By Both
Dosing Instructions

24. Results
24
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
50% (n=3) of the herbal-based pharmaceuticals clearly
mentioned the main active ingredients and their exact
percentage.
Herbal-based Pharmaceuticals

25. Conclusion
25
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
The consistency of pharmaceutical products in
Egyptian market is acceptable compared to a
similar study in USA market.
Egyptian Market US Market
Dosing Equipment 60.38% 74%
Inconsistency 37% 98.6%
Extra Markings 47% 81.1%
Missing Markings 34% 24.3%

26. Future Recommendations
26
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
a. Adjusting the dosing labels to include age and weight.
b. Increasing the compliance of OTC labeling with the FDA
guidelines.
c. Adding dosing equipment in all products.
d. Confirming the exact name and percentage of active
ingredients in herbal-based pharmaceuticals.

27. ACKNOWLEDGMENTS
Supervisor
Dr. Dalia A. Hamdy
Research Team
Samar A. Rizk
Taghreed T. Moubark
Special thanks to
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Funding
Nourhan Farouk, PharmD

28. ANY QUESTIONS ?