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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-Salam4th Year Student, Faculty of Pharmacy
Alexandria University, Egypt
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Outlines
2Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Introduction
Aim
Method
Results
Conclusion
Future Recommendations
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3
Introduction
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
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Introduction
4Evaluation 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.
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Introduction
5Evaluation 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.
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Introduction
6Evaluation 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
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Aim
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
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Aim
8Evaluation 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
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9
Method
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
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Method
10Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Product Selection Screening Data
Analysis
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Method
11Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Product Selection
2365
846
340
54
506
1519
• Cough & Cold• Analgesics2365• Allergy• Gastrointestinal Products• Antibiotics
ExcludedNon Oral Liquid Medications
23651519Assessed using additional
eligibility criteria
846Excluded
• No dosing Instructions for children < 12 years
• Couldn’t be obtained
506Eligible for Analysis
340Included in analysis
(Top selling products based on a market survey)
54
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Method
12Evaluation 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
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Method
13Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Data Analysis
Data were collected and analyzed using pre-formulated
G-Doc and Microsoft Excel spreadsheets
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Results
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
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Results
16Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
39.62%
43.40%
16.98%SuspensionsSyrups/SolutionsOral Drops
9.43%9.43%
37.74%
22.64%
20.76% Infants onlyChildren onlyInfants & ChildrenChildren & AdultsInfants, Children, and Adults
Product Characteristics
52.83% manufactured by national companies 47.17% manufactured by international companies
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Results
17Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Dosing Equipment
were found in 32 products (60.38%)
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Results
18Evaluation 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
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Results
19Evaluation 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
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Results
20Evaluation 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)
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Results
21Evaluation 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
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Results
22Evaluation 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
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Results
23Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
On package only
On pamphlet only
On both0.00%
20.00%40.00%60.00%80.00%
100.00%
3.77%
84.91%
11.32%
By age only By body weight only
By Both0.00%
10.00%20.00%30.00%40.00%50.00%60.00%70.00%
58.49%
13.21%
28.30%
Dosing Instructions
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Results
24Evaluation 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
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Conclusion
25Evaluation 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%
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Future Recommendations
26Evaluation 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.
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ACKNOWLEDGMENTSSupervisor
Dr. Dalia A. Hamdy
Research TeamSamar A. Rizk
Taghreed T. Moubark
Special thanks to
Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014
Funding
Nourhan Farouk, PharmD
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ANY QUESTIONS ?