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PHARAMA COVIGILANCE
A BOON OF SAFETY
Dr Nitika Rattan PG Scholar
Desh Bhagat PG School of Ayurveda &
Research.
Contents
 .Introduction,Defination of Pharma covigilance
& Aims of Pharma co vigilance
 .Commonly used terms for drug safety
 Adverse Drug Reaction Reporting
a) The 4 Elements of an AE Case
b) Coding of Adverse Events
c) Seriousness Determination
d) Expedited Reporting
e) Clinical Trial Reporting
f) Spontaneous Reporting
g) Aggregate Reporting
 Risk Management
a) Causality Assessment
b) Risk Management Plans
c) Pharmaco epidemiology
d) Pharamaco genetics and pharmaco genomics
 Authorities Regulating PV
 PV for Herbal Med
 International Collaboration on PV
 References.
INTRODUCTION
a) The term Pharamcovigilance is derived from two words
Pharma+ Vigilance. The etymological roots for the word
“Pharmacovigilance” are Pharmakon (Greek word for drug)
and vigilare (Latin Word for to keep watch)
b) It is also known as Drug Safety.
DEFINITION OF PHARMACO VIGILANCE
It is the science relating to the collection, detection,
assessment, monitoring and Prevention of adverse effect with
Pharmaceutical Products
c) Pharmacovigilance heavily focus on ADR
ADR (Adverse Drug Reaction)ADR (Adverse Drug Reaction)
ADR is defined as any response to a drug which is noxious and
unintended including lack of efficacy.
d) Medication errors such as overdose and misuse and abuse of a drug as in
as drug exposure during pregnancy and breast feeding are also interest,
because they may result in ADR
e) Pharamcovigilance is an important and integral part of clinical research.
Both clinical trail safety and post marketing PV are critical throughout
the product lifecycle.
f) Pharmacovigilance is not new to India and had in fact been going on from
1998.
g) Further, India is becoming a hub for clinical research activities due to its
large population.
h) The office of The Drug Controller General of India(DCGI) has been
making sincere attempts for the implementation of NPP(National
Pharmacovigilance Program)
Aims of PV
 Research the efficacy of drug and monitoring the adverse
effect of drugs right from the lab to the Pharmacy and then
on many years.
 PV keeps track of any drastic effects of drugs.
 It improves patient care and safety in relation to the use of
med and all medical and paramedical intervention
 PV contribute to the assessment of benefit, harm,
effectiveness and risk of medicines, encouraging their safe,
rational and more effective use.
 Commonly terms used for drug safety mainly PV has its own unique
terminology that is important to understand.
* AE(Adverse Event) It is a side effect with a drug.
* ADR is a side effect occurring with a drug where positive casual
relationship between event and the drug has been proved
Causal Relationship: It is said to be exit when a drug is thought to have
caused or contributed to the occurrence of an ADR.
Clinical Trail : It refers to an organized program to determine the safety and
efficacy of a drug in patients.
Control Group :It is a group of individuals patients that is used as standard
of comparison with in a clinical trail.
Effectiveness: It is extent to which a drug works under real world and ideal
circumstances i.e clinical practice.
Efficacy: It is the extent to which a drug works under ideal circumstances in
clinical trails.
Risk: Risk is the probability of harm being caused, usually expressed as a
percent or ratio of the treated population.
Adverse Drug Reaction Reporting
a) The 4 Elements of an AE case. Adverse event reporting is most commonly
associated activity with Pharmacovigilance
“The 4 elements are the main Principle of AE reporting
It includes
a) A identifiable patient
b) And identifiable reporter
c) A suspect drug
d) An Adverse Event
If one or more of these four elements is missing, the case is not valid for AE
report.
b) Coding of Adverse Event
It is the process by which information from an AE reporter called “Verbatin” is
coded using standardized terminology from a medical coding dictionary eg Med
DRA(is medical coding Dictionary)
Main aim of Medical coding is to convert adverse event into terminology that can
be readily identified and analyzed.
Seriousness Determination
An adverse event is considered seriousness it meets one or more of the
following data or criteria.
* AE results in death or is life threatening
* Require inpatient hospitalization
* Results in persistent or significant disability
* Medically significant is it doesn’t meet preceding criteria.
* Results in congenital Anomaly
Life threatening refers to an adverse event that places the patient at an
immediate risk of death such as MI
d) Expedited Reporting: This reporting involves the unlabelled event and
serious event (an event not described in the drugs labeling)
In most of the countries, the time frame for reporting expedited cases
from the time a drug company receives notification of such a case is 15
calendar days.
Clinical Trail Reporting
It is also called SAE(Serious Adverse Event ) reporting from clinical Trails
*SAE reporting occurs as a result of study of patients who experience
serious Adverse Event during conducting clinical Trails.
Then this information from clinical Trails is forwarded to sponsoring
Pharmaceutical company which is responsible and then to drug regulating
Authority
SPONTANEOUS REPORTING
* It is main data generating system of international PV, relying on
healthcare professional to report the AE to national PV Centre.
* Spontaneous reports are submitted voluntarily.
* Main drawback of spontaneous reporting is under reporting
It is the crucial Element in the worldwide enterprise of PV and from the
core of WHO Database.
Aggregate Reporting
*It is also called periodic reporting
*It plays important role in the safety assessment of drugs
*Main advantage of Aggregate reporting is that it provide a
broader view of safety profile of a drug.
* World wide, the most using aggregate report is PSUR
( Periodic Safety update Report)
Risk Management
It is the discipline with PV that is responsible for signal detection
and monitoring of the risk benefit Profile of drugs
a) Pharmacoepidemiology
It is the study of incidence of adverse event or Adverse drug
reaction in patient population using drug agents
b) Pharmacogenetics
It is the study or clinical testing of genetic variation that give rise
to different responses to drugs.
c) Pharmacogenomics: It is the broader application of genomic
technologies to new drug discovery and further characterization of
older drug
International Collaboration on PV
a) WHO conducted an WHO International Drug Monitoring
Program
b) CIOMS(The council for International Organization of
Medical Sciences) It is the part of WHO and is globally
oriented think tank provided guidance on drug safety related
topics through its working groups.
c) The International Society of PV (ISOP)
Authorities Regulating PV
1.US :FDA is largest national drug regulatory Authority
RADAR and Public citizen is the main Authorities in US.
2.EU5: EMA(European Medicine Agency) is the main drug
regulating authority in EU5
PV for Herbal Medicines
*Thousand year back Acharya Charak describes that a useful
drug can be poisonous if not processed properly and
poisonous drug can be helpful if processed properly.
*Proper dosage of herbal medicine is mandatory
* In addition there is an ongoing problem with unexpected
toxicity of herbal products due to quality issues, including
use of poor quality herbal material, misidentified herbs,
incorrect processing method.
*These quality issues can be addressed to some degree by
improves regulation requiring GMP standards for
manufacturing
ReferencesReferences
1.WHO Technical Report No 498(1972)
2. The importance of PV ,WHO(2002)
3.Current Challenges in PV-Pragmatic Approach
4.httpp//www.pv.pharmacovigilence.org
5.www.pv.pharmacoboardkenya.org

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Pharmacovigilance Overview
 

PHARAMA CO VIGILANCE

  • 1. PHARAMA COVIGILANCE A BOON OF SAFETY Dr Nitika Rattan PG Scholar Desh Bhagat PG School of Ayurveda & Research.
  • 2. Contents  .Introduction,Defination of Pharma covigilance & Aims of Pharma co vigilance  .Commonly used terms for drug safety  Adverse Drug Reaction Reporting a) The 4 Elements of an AE Case b) Coding of Adverse Events c) Seriousness Determination d) Expedited Reporting e) Clinical Trial Reporting f) Spontaneous Reporting g) Aggregate Reporting
  • 3.  Risk Management a) Causality Assessment b) Risk Management Plans c) Pharmaco epidemiology d) Pharamaco genetics and pharmaco genomics  Authorities Regulating PV  PV for Herbal Med  International Collaboration on PV  References.
  • 4. INTRODUCTION a) The term Pharamcovigilance is derived from two words Pharma+ Vigilance. The etymological roots for the word “Pharmacovigilance” are Pharmakon (Greek word for drug) and vigilare (Latin Word for to keep watch) b) It is also known as Drug Safety. DEFINITION OF PHARMACO VIGILANCE It is the science relating to the collection, detection, assessment, monitoring and Prevention of adverse effect with Pharmaceutical Products c) Pharmacovigilance heavily focus on ADR
  • 5. ADR (Adverse Drug Reaction)ADR (Adverse Drug Reaction) ADR is defined as any response to a drug which is noxious and unintended including lack of efficacy. d) Medication errors such as overdose and misuse and abuse of a drug as in as drug exposure during pregnancy and breast feeding are also interest, because they may result in ADR e) Pharamcovigilance is an important and integral part of clinical research. Both clinical trail safety and post marketing PV are critical throughout the product lifecycle. f) Pharmacovigilance is not new to India and had in fact been going on from 1998. g) Further, India is becoming a hub for clinical research activities due to its large population. h) The office of The Drug Controller General of India(DCGI) has been making sincere attempts for the implementation of NPP(National Pharmacovigilance Program)
  • 6. Aims of PV  Research the efficacy of drug and monitoring the adverse effect of drugs right from the lab to the Pharmacy and then on many years.  PV keeps track of any drastic effects of drugs.  It improves patient care and safety in relation to the use of med and all medical and paramedical intervention  PV contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective use.
  • 7.  Commonly terms used for drug safety mainly PV has its own unique terminology that is important to understand. * AE(Adverse Event) It is a side effect with a drug. * ADR is a side effect occurring with a drug where positive casual relationship between event and the drug has been proved Causal Relationship: It is said to be exit when a drug is thought to have caused or contributed to the occurrence of an ADR. Clinical Trail : It refers to an organized program to determine the safety and efficacy of a drug in patients. Control Group :It is a group of individuals patients that is used as standard of comparison with in a clinical trail. Effectiveness: It is extent to which a drug works under real world and ideal circumstances i.e clinical practice. Efficacy: It is the extent to which a drug works under ideal circumstances in clinical trails. Risk: Risk is the probability of harm being caused, usually expressed as a percent or ratio of the treated population.
  • 8. Adverse Drug Reaction Reporting a) The 4 Elements of an AE case. Adverse event reporting is most commonly associated activity with Pharmacovigilance “The 4 elements are the main Principle of AE reporting It includes a) A identifiable patient b) And identifiable reporter c) A suspect drug d) An Adverse Event If one or more of these four elements is missing, the case is not valid for AE report. b) Coding of Adverse Event It is the process by which information from an AE reporter called “Verbatin” is coded using standardized terminology from a medical coding dictionary eg Med DRA(is medical coding Dictionary) Main aim of Medical coding is to convert adverse event into terminology that can be readily identified and analyzed.
  • 9. Seriousness Determination An adverse event is considered seriousness it meets one or more of the following data or criteria. * AE results in death or is life threatening * Require inpatient hospitalization * Results in persistent or significant disability * Medically significant is it doesn’t meet preceding criteria. * Results in congenital Anomaly Life threatening refers to an adverse event that places the patient at an immediate risk of death such as MI d) Expedited Reporting: This reporting involves the unlabelled event and serious event (an event not described in the drugs labeling) In most of the countries, the time frame for reporting expedited cases from the time a drug company receives notification of such a case is 15 calendar days.
  • 10. Clinical Trail Reporting It is also called SAE(Serious Adverse Event ) reporting from clinical Trails *SAE reporting occurs as a result of study of patients who experience serious Adverse Event during conducting clinical Trails. Then this information from clinical Trails is forwarded to sponsoring Pharmaceutical company which is responsible and then to drug regulating Authority SPONTANEOUS REPORTING * It is main data generating system of international PV, relying on healthcare professional to report the AE to national PV Centre. * Spontaneous reports are submitted voluntarily. * Main drawback of spontaneous reporting is under reporting It is the crucial Element in the worldwide enterprise of PV and from the core of WHO Database.
  • 11. Aggregate Reporting *It is also called periodic reporting *It plays important role in the safety assessment of drugs *Main advantage of Aggregate reporting is that it provide a broader view of safety profile of a drug. * World wide, the most using aggregate report is PSUR ( Periodic Safety update Report)
  • 12. Risk Management It is the discipline with PV that is responsible for signal detection and monitoring of the risk benefit Profile of drugs a) Pharmacoepidemiology It is the study of incidence of adverse event or Adverse drug reaction in patient population using drug agents b) Pharmacogenetics It is the study or clinical testing of genetic variation that give rise to different responses to drugs. c) Pharmacogenomics: It is the broader application of genomic technologies to new drug discovery and further characterization of older drug
  • 13. International Collaboration on PV a) WHO conducted an WHO International Drug Monitoring Program b) CIOMS(The council for International Organization of Medical Sciences) It is the part of WHO and is globally oriented think tank provided guidance on drug safety related topics through its working groups. c) The International Society of PV (ISOP)
  • 14. Authorities Regulating PV 1.US :FDA is largest national drug regulatory Authority RADAR and Public citizen is the main Authorities in US. 2.EU5: EMA(European Medicine Agency) is the main drug regulating authority in EU5
  • 15. PV for Herbal Medicines *Thousand year back Acharya Charak describes that a useful drug can be poisonous if not processed properly and poisonous drug can be helpful if processed properly. *Proper dosage of herbal medicine is mandatory * In addition there is an ongoing problem with unexpected toxicity of herbal products due to quality issues, including use of poor quality herbal material, misidentified herbs, incorrect processing method. *These quality issues can be addressed to some degree by improves regulation requiring GMP standards for manufacturing
  • 16. ReferencesReferences 1.WHO Technical Report No 498(1972) 2. The importance of PV ,WHO(2002) 3.Current Challenges in PV-Pragmatic Approach 4.httpp//www.pv.pharmacovigilence.org 5.www.pv.pharmacoboardkenya.org