Pharmacovigilance in pediatrics and geriatrics is of paramount importance due to the unique physiological and pharmacokinetic characteristics of these populations. In pediatrics, factors such as rapid growth, organ maturation, and differences in drug metabolism can influence the safety and efficacy of medications. Therefore, monitoring for adverse drug reactions (ADRs), including both known and unexpected effects, is crucial in ensuring the safe use of drugs in children. Additionally, since pediatric patients often receive off-label or unlicensed medications due to limited clinical trials in this population, pharmacovigilance efforts play a critical role in gathering real-world data to inform pediatric drug use.

1. Welcome
NAME:-BOGALA SRAVANTHI
REDDY
BSC AGRICULTURE BSC
STUDENT ID:-016/022024
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PHAMACOVIGILANCE IN PEDIATRICS AND
GERIATRICS

2. INDEX
• DEFINITIONS
• INTRODUCTION
• PEDIATRIC PHARMACOVIGILANCE
• GERIATRIC PHARMACOVIGILANCE
• HISTORY OF GERIATRICS
• CONCLUSION
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3. DEFINITIONS
PHARMACOVIGILANCE:-It is science and activities relating to the
Detection,Assessment,Understanding and Prevention of adverse
effects or any other medicine /vaccine related problem.
PEDIATRIC PATIENT:-A pediatric patient is an individual target of
health care services,who is minor to 15 years.pediatric patients are
neonates,infants,toddlers,preschoolers,school-aged children, and
adolescents.
GERIATRICS PATIENT:-Geriatrics is a specialty that focuses on the
health care of elderly people who is above years of age.
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INTRODUCTION
● Pharmacovigilance is defined by world health organisation.
● It is conducted throughtout the life cycle of medicinal products,strating
with the first administration in humans and usually ending when the
product is no longer marketed in the country.
● Pharmacovigilance is performed on safety data originating from many
sources and countries.
● It includes a continuous evaluation of all available,global data,[i.e.,non
clinical and clinical data,including solicited and spontaneous reports].
● PV monitors case level and population level data to detect and analyse
treatment related risks.
● PV in pediatrics aim to reduce harms,optimise pediatric pharmacotherapy
and provide parents and prescribers with accurate descriptions.

5. PEDIATRIC PHARMACOVIGILANCE:-
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● It is well known that in terms of drug therapy,childern are not small adults.
● In past children were rather often subject to serious harms caused by drugs which
led to specific messures to improve the safety of pediatric drug therapy.
● 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 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,was not taken into account.

6. ● A few decades later, in late 1960s, the use of Thalidomide during
pregnancy led to babies being born with malformed limbs.
● In US this led to the Kefauver Harris Amendment to the
food,Drug,and Cosmetic Act consequently the establishment of
global pharmacovigilance.
● Following this laws were being rigorously tested with regard to
Quality,Efficacy and Saftey before being introduced into the
market.[licensing].
● Although clinical trails became mandatory before marketing
approvals,the unintended consequence of new drug safety
legislations was that pharmaceutical companies generally did not
conduct trails in children even for treatments clearly indicated for
pediatric conditions.
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7. ● In late 1990s first initiatives in the US aimed to improve the availability of medicines for
children .
● In Europe,the European clinical trails directive,which came into force in 2001,included
provisions for vulnerable populations,including children, allowing there inclusion in
clinical trails.
● In 2002 initiative for better medicines for children and best pharamaceuticals for
children Act in US was came into force.
● In 2007 European pediatric regulation came into force comprising various measures of
which the conduct of pediatric clinical trials for newly marketed drugs is the most
important.
● Notably the pediatric regulation applies to all medicinal products including those in
development ,patent protected and off- patent products (i.e.,generics)needed for
treating children.
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8. GERIATRIC
PHARAMACOVIGILANCE:-
• Geriatrics or Geriatric medicine is medical specialty that
focused on providing care for the unique health need of
elderly people.
• The term geriatrics orginates from Greek,geron meaning
“old man”and iatros means “healer”.
• It aims to promote health by preventing,diagnosing and
treating disease in older adults.
• There is no defined age at which patients may under the
care of a geriatrician or geriatric physician.
• This care may benefit those who are managing multiple
chronic conditions or experiencing siginficant age related
problems that threaten quality of life.
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9. • Geriatric care maybe indicated if caregiving
responsibilities become increasingly stressful or medically
complex for family and caregiversto manage
independently.
• Geriatric providers receive specialized training in caring
for elderly patients and promoting healthly aging.
• It is common for elderly adults to be managing multiple
medical conditions,or multi morbidity.
• Geriatrics is highly interdisciplinary consisting of specialty
providers from the fields of medicine,nursing,pharmacy
social work,physical and occupational therapy.
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10. HISTORY
• A number of physicians in the Byzantine Empire studied
geriatrics,with doctors like Aetius of Amida evidently
speciliazing in the field.
• The works of Aetius describe the mental and physical
symptoms of aging.
• It is recommended that elderly patients consume a diet
rich in foods that provide “heat and moisture”.
• In The Canon of Medicine,written by Avicenna in 1025,the
Author was concerned with how “old folk need plenty of
sleep”and how their bodies should be anointed with oil,
and recommended excercises such as walking,or horse
riding.
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11. • The Arab physician Algizar wrote a book on the medicine
and health of elderly patients.
• He also wrote a book on sleep disorders and another one
on forgetfulness and how to strengthen memory and a
treatise on causes of mortality.
• George Day published the Dieases of Advanced life in
1849, one of the first publications on the subject of
geriatric medicine.
• The first modern geriatruc hosptial was founded in
Belgrade, Serbia,in 1881 by doctor Laza Lazarevic.
• The term geriatrics was proposed in 1908 by llyich
Mechnikov laurate of nobel prize for medicine.
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12. CONCLUSION
• Frequency of ADR increased with number of medications
patient was receiving.
• Health care providers involved in in the care of childern
must be aware of this fact and should use additional drugs
when absolutely necessary.
• pediatric pharmacovigilance is the need of the hour and
should be given utmost importance for monitoring the
safety of drugs in childern.
• Motivating HCPs for voluntary reporting of ADRs fir
preventing the morbidity and mortality in this Vulnerable
population should be immense importance.
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13. CONCLUSION
• We observed that monitoring of ADRs in geriatric
population is mandatory due to their polypharmacy.
• Followup studies after discharge is much more needed to
assess the appropriateness of prescribing practice in
geriatrics by the general practitioners.
• Also to improve the report of ADRs that has occurred due
to delayed reactionsin the patients after discharge from
hospital which will be one step ahead to improve the
quality of life.
• This can reduce the hospital readmission which can in turn
reduce the economic burdenof the patients.
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14. Thank You!
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