Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, is of critical importance in pediatric populations. However, pharmacovigilance in this population presents unique challenges and requires specific considerations. Here are some key challenges and considerations in pharmacovigilance pertaining to pediatric populations

1. Welcome
Pharmacovigilance in Pediatric Populations:
Challenges and Considerations
Renuka Muppana
Pharm. D
094/052023
10/18/2022
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2. INDEX
• Pharmacovigilance definition
• Historical background of pediatric pharmacovigilance
• Challenges and considerations for pediatric pharmacovigilance
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3. Pharmacovigilance
• Pharmacovigilance has been defined by the WHO(2002) as the 'Science and activities related to the
detection, assessment, understanding and prevention of adverse effects or any other drug related
problems'.
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• The information generated by pharmacovigilance is useful in educating doctors about ADRs and in
the official regulation of drug use.
• Its main purpose is to reduce the risk of drug- related harm to the patients.

4. Pharmacovigilance in Pediatric Populations:
Historical Background of Pediatric Pharmacovigilance
• The first instance of safety related problem that led to a pharmacovigilance reflection was published in
British medical journal in 1877 by chloroform issues. In 1898, with the commercialization of diacetyl
morphine, heroine which people got addicted to it.
• In 1938, the Food, Drug, and Cosmetic Act was signed in the United States (US) following the death of
107 patients, mainly children who had taken a new liquid form of the oral antibiotic sulphanilamide. The
pharmaceutical company had intended to manufacture a special liquid formulation and used diethylene
glycol as excipient to obtain an acceptable taste. However, its toxicity, which led to metabolic acidosis.
• Later in the beginning of the 1950’s di iodo diethyl of tin was added to stalinon for topical application on
skin which resulted in the 102 deaths associated with the encephalopathy and hundred patients developed
severe, irreversible, neurological after effects
• A few decades later, in the late 1960s, the use of thalidomide during pregnancy led to babies being born
with malformed limbs
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5. • A few decades later, in the late 1960s, the use of thalidomide during pregnancy led to babies being
born with malformed limbs..
• In 1957, thalidomide which was OTC hypnotic / sedative used to treat the morning sickness in the
pregnancy women showed the teratogenic effects in the newborns. Considering this thalidomide
disaster, the WHO formerly established a programme for International Drug Monitoring in 1968 and
founded Uppsala monitoring centre (UMC).
• Along with the Paediatric Regulation, the European Medicines Agency (EMA) published a
paediatric pharmacovigilance guidance, initially in 2006, which now is included in the Good
Pharmacovigilance guidance of the EMA in the section for special populations.
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Three databases include paediatric ADR reports
1. US Food and Drug Administration (FDA)
2. The FDA Adverse Event Reporting System (FAERS)
3. The WHO (VigiBase).

7. Challenges in Pediatric Pharmacovigilance
• Likely extensive underreporting of suspected adverse reaction reports in children.
• Concern that risk of ADRs greater in off-label use in children.
• Medication errors more frequent and more serious in pediatric population.
• As new medicines become available for pediatric population, must shift from reactive to proactive,
demonstrate effectiveness of risk minimization.
• Adapting pharmacovigilance communications to pediatric population’s needs
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8. • Getting messages across about importance of ADR reporting – additional monitoring and patient
reporting.
• Adapting signal detection to pediatric population, especially in area of vaccines.
• Incorporating patient and public views in referrals.
• Focus on better science – supporting research in pediatric population - involving ENCePP pediatric
network and Enpr-EMA
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Current opportunities to strengthen
Pharmacovigilance in Pediatric Population

9. Methodological and Practical Considerations
for Pediatric Pharmacovigilance
 Pediatric Safety Specification
 Pediatric risk management and risk minimisation.
 Pediatric Pharmacovigilance.
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12. Clinical Studies in Pediatrics: considerations for
Pharmacovigilance and Risk management
Protocol development:
• Background information
• Objectives
Exclusion Criteria
Stopping rules
Discontinuation/ withdrawal criteria
• Treatments not permitted
• Safety monitoring and Follow up
• Safety data analysis plan
• Safety criteria for trial termination
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13. Safety Data Collection and safety monitoring in pediatric
studies:
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• Age
• Weight and Height and Percentile or Z score
• Alert values for laboratory and vital signs
• Adverse events
• Co- medications
• Medical history
• Developmental Assessment
General aspects of Paediatric Spontaneous reports:
• Age, Growth (Weight, Height and head circumference)
• Suspected drugs and comedications
• Dose, Route of administration, Medication errors, Laboratory tests and vital signs
• Medical history,
• ADR, Lack of efficacy

14. Pediatric Investigation Plan:
• Benefit- Risk assessment in pediatric
• Formulation development and drug safety
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Advanced Paediatric Pharmacovigilance methods:
1. Signal Detection
2. Signal Evaluation

15. Thank You!
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