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

Outlines

2Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

Introduction

Aim

Method

Results

Conclusion

Future Recommendations

3

Introduction

Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

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.

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.

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

7

Aim

Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

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

9

Method

Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

Method

10Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

Product Selection Screening Data

Analysis

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

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

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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15

Results

Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

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

Results

17Evaluation of Pediatric Dosing Equipment Project - DUPHAT 2014

Dosing Equipment

were found in 32 products (60.38%)

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

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

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)

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

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

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

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

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%

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.

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

ANY QUESTIONS ?