This document discusses pharmacovigilance and adverse drug reactions (ADRs). It begins by defining pharmacovigilance as the monitoring of drug safety, and describes how the thalidomide disaster in the 1960s prompted significant changes to drug safety systems worldwide. It then discusses various reasons for the need of pharmacovigilance like limited preclinical safety data and changing drug use patterns. The aims and methods of pharmacovigilance including spontaneous reporting, case studies, and periodic safety reports are summarized. It also provides an overview of the Pharmacovigilance Program of India and its goals of monitoring ADRs and ensuring drug benefits outweigh risks. Finally, it defines different types of ADRs and their
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Pharmacovigilance AND ADVERSE DRUG REACTIONS.
MONITORING REPORTING ROLE OF PHARMACIST.
CLASSIFICATION OF ADR. MECHANISM OF ADR
ROLE OF PHARMACIST IN MANAGING ADR. AUGMENTED, BIZZARE, CONTINOUS, DELAYED, END OF TREATMENT, ABCD, ABCDE.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringVenugopal N
Pharmacovigilance is the pharmacological science that aims at the detection, assessment, monitoring, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines to ensure drug safety.
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This ppt is about pharmacovigilance in India & spontaneous reporting of adverse drug effect and there regulation by WHO or uppsala. It also include drug interaction in herbal medicine.
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3. Thalidomide Disaster
• This has brought significant changes in
pharmacovigilance system world over.
• Dr. McBride published letter in The Lancet (1961)
noting large no. of birth defects in children of pt.
prescribed Thalidomide.
• Dr. Lenz from Germany discussed the association
of congenital malformation with maternal use of
thalidomide.
• 6000-12000 children had congenital anomalies
d/t maternal use of Thalidomide.
4. NEED OF PHARMACOVIGILANCE
1.Unavailability of preclinical safety data
-Animal studies are often not a good predictor
for human effects .
-Evidence of safety from clinical trials is
insufficient due to 1) limited size , 2) narrow
population (age &sex specific), 3) narrow
indications (only specific disease), 4) short
duration
5. 2)Changing Pharmaceutical Marketing Strategy
• Direct to consumer advertising
• Launch in many countries at a same time.
3)Changing Physicians and patients preferences
• Increasing use of newer drugs
• Shift of supervised to self administered therapy
4)Easy accessibility
• Easy access by internet
• Increasing conversion of prescription drugs to OTC
Drugs
• Easily available substandard drugs
6. AIMS
• To improve patient care and safety
• To contribute to the assessment of benefit,
harm ,effectiveness and risk of medicines
• To promote education and clinical training
• To promote rational and safe use of medicines
7. Short Term Goals
• To develop and implement pharmacovigilance
system in India
• To enroll all MCI approved medical colleges in the
program covering north, south, east and west of
India
• To encourage healthcare professionals in
reporting of adverse reaction to drugs, vaccines,
medical devices and biological products
• Collection of case reports and data
8. Long Term Goal
• To expand the pharmacovigilance program.
• To develop and implement electronic
reporting system (e-reporting)
• To develop reporting culture amongst
healthcare professionals
• To make ADR reporting mandatory for
healthcare professionals
9. METHODS 0F PHARMACOVIGILANCE
1. Spontaneous Case Reporting
2. Case Series
3. Active Surveillance
4. Comparative Observational Studies
5. Periodic Safety Update Reports (PSUR)
10. Spontaneous Case Reporting
• Unsolicited communication by Health care
professionals/ Consumers to Company ,
Regulatory Authority or other organisation
• It is Voluntary Reporting
• In India form used for reporting is known as”
Suspected Adverse Drug Reaction Reporting
Form”.
• In UK “Yellow Cards” and in USA “Med Watch
forms” are used
11.
12. Case Series
• Useful for generating hypothesis about effects
of drug
• Can provide association between drug and
adverse event.
• Adverse events associated more frequently
with drug therapy such as Anaphylaxis,
Aplastic anaemia, Toxic epidermal necrolysis
and Steven-Johnson syndrome can be
assessed with case series.
14. Comparative Observational Studies
• Traditional methods are key component in evaluation
of adverse events. Major types
1)Cross Sectional Study(Survey)
• Data collected on patients population at a single point
in a time
• Used to gather data for Survey
• Major Drawback is that temporal relation between
exposure and outcome can not be directly addressed.
• Best used to examine prevalence of a Disease at one
point.
17. PERIODIC SAFETY UPDATE
REPORTS(PSUR):
• Medically advanced countries impose the “post
marketing drug safety monitoring period ” on
new drugs
• license holders collect post marketing safety
data, prepare PSUR and submit them to the
health authority.
• If pharmaceutical companies fail to submit PSUR
as required , then the health authority may
reassess the safety of the concerned product.
• The last PSUR should be submitted before the
expiration of the drug safety monitoring period.
18. Causality assessment
• Major component of evaluation of ADR is how much
adverse event is causally related to suspected drug.
• Factors to be considered
1) Temporal relationship between drug administration
and onset of adverse reaction
2) Clinical and pathological characteristics of the event
3) Response to Dechallenge and Rechallenge
4) Patients characterastics and previous medical history.
5) Drug Interaction
21. Pharmacovigilance Program of India
(PVPI) Introduction –
-officially started on 23 November 2004 at new
Delhi
-India is now being recognized as the “global
pharmacy of generic drugs”
-India is also emerging rapidly as a hub of global
clinical trials & destination for drug discovery
and development
22. Background
• 1989 -ADR monitoring system for India
proposed (12 regional centers)
• 1997 - India joined WHO-ADR monitoring
program (3 centers: AIIMS, KEM, JLN)
• 2004 – 2008 - National Pharmacovigilance
Program.
• 2010 – Pharmacovigilance Program of India
23. PVPI is under control of
1.CDSCO(Central Drugs Standard Control
Organization)
2.Directorate General of Health Services
3.Indian Pharmacopeia Commission (Ghaziabad)
-The programme is conducted by NCC (National
Coordinating Centre)
26. Goals & objectives
• Goal- to ensure that the benefits of use of medicine
outweighs the risks
• Objectives
1. To monitor ADR
2. To create awareness among health care professionals
about ADR
3. To monitor benefit –risk profile of medicines
4. Generate independent ,evidence based recommendations
5. Support the CDSCO
6. Communicate findings with all stake holders
7. Create a national center
27. WHO PHARMACOVIGILANCE
PROGRAM
• Introduction :
-started in 1978 known as WHO Program for international
drug monitoring, which is located in Uppsala, Sweden.
-Till now there are 127 full members and 29 associate
members of UMC
Functions –
1. Identification and analysis of new ADR signals from national
centers & sent to the WHO ICSR database
2. Provision of the WHO database as a reference source.
3. Information exchange between WHO UMC , national
centers.
28. 4. Publications, news letters, guidelines and
books in the pharmacovigilance
5. Supplying tools like WHO drug dictionary and
WHO adverse reaction terminology
6. Training to national centers
7. Maintaining of computer software
8. Annual meetings
9. Research on pharmacovigilance
29. Summary
• The world has witnessed horrific disasters following
use of drugs
• Currently WHO collaborating center for international
drug monitoring Uppasala is playing central role in
collecting, compiling, and disseminating information
relating to drug safety monitoring
• National center at CDSCO ,New Delhi monitors ADR
and create awareness among people
• Today there is need of efficient and more integrated
pharmacovigilance system to ensure safe use of drugs
31. • Adverse Event (AE): Any untoward medical
occurrence that may present during treatment
with a pharmaceutical product but which does
not necessarily have a causal relationship with
this treatment.
• Adverse Drug Reaction (ADR): Any noxious
change which is suspected to be due to a drug,
occurs at doses normally used in man, requires
treatment or decrease in dose or indicates
caution in future use of the same drug.
32. Classification of ADRs
1)Onset Of Event: Acute (<60 Minutes), Sub-acute (1-24 Hrs)
And Latent (>2 Days)
2)Frequency: Very common, common, uncommon, rare, very
rare.
3)Severity: Mild, Moderate, severe.
4)Mechanism: Intolerance, Idiosyncrasy, Drug Allergy, Drug
interaction
5)Severity: Minor, Moderate, Severe, Lethal Adrs
6)Pharmacological Classification.
7)Others: Side Effects, Secondary Effects ,toxic effects,
Photosensitivity, Drug Dependence, Drug Withdrawal
Reactions, Teratogenicity, Mutagenicity, Carcinogenicity,
Drug Induced Disease (Iatrogenic)
33. Pharmacological Classification
• Type A (Augmented)
• Type B (Bizarre)
• Type C (Continuous Drug Use)
• Type D (Delayed)
• Type E (End Of Dose)
• Type F (Familial)
• Type G (Genotoxicity)
• Type H (Hypersensitivity)
• Type U (Unclassified)
34. Type A (Augmented) reactions
• Reactions which can be predicted from the
known pharmacology of the drug
• Dose dependent,
• Can be alleviated by a dose reduction
• E.g.
1. Anticoagulants - Bleeding,
2. Beta blockers - Bradycardia,
3. Nitrates - Headache,
4. Prazosin - Postural hypotension.
35. Type B (Bizarre) reactions
• Cannot be predicted from the pharmacology
of the drug
• Not dose dependent,
• Host dependent factors important in
predisposition
• E.g.
1. Penicillin -Anaphylaxis,
2. Anticonvulsant - Hypersensitivity
36. Type C(Continuous Drug Use)
-May be irreversible, unexpected or
unpredictable.
• E.G.
1)Tardive Dyskinesias by Antipsychotics
2)Dementia by Anticholinergics.
37. Type D (Delayed) reactions
• Occur after many years of treatment.
• Can be due to accumulation.
• E.g.
1. Chemotherapy - Secondary tumours
2. Analgesics - Nephropathy
3. Corneal opacities after thioridazine
38. Type E (End of Dose) reactions
• Occur on withdrawal especially when drug is
stopped abruptly
• E.g.
1. Phenytoin withdrawal - Seizures,
2. Steroid withdrawal -Adrenocortical
insufficiency.
39. Side effects
• Unwanted but often Unavoidable,
pharmacodynamic effects that occur at
therapeutic doses
• e.g.
1) Atropine (Pre-anaesthetic) :dryness of mouth
2) Acetazolamide (diuretic-bicarbonate excretion)
:acidosis
3) Promethazine (anti-allergic) :sedation
4) Estrogen (anti ovulatory) :nausea.
40. Secondary effects
• Indirect consequences of a primary action of
the drug
• e.g. Tetracyclines__suppression of bacterial
flora__superinfections
• Corticosteroids__weaken host
defense__activation of latent tuberculosis
41. Toxic Effects
• Excessive pharmacological action of the drug
due to over dosage or prolonged use
• e.g.
1. Barbiturates - Coma,
2. Digoxin - Complete A-V Block,
3. Heparin - Bleeding
4. Atropine -Delirium
5. Paracetamol - Hepatic Necrosis
42. Intolerance
• Appearance of characteristic toxic effects of a
drug in an individual at therapeutic dose.
• e.g.
1)Carbamazepine -ataxia in some individuals
2)Chloroquine - vomiting and abdominal pain in
some individuals
43. Idiosyncrasy
• Genetically determined abnormal reactivity to a
chemical
• Restricted to individuals with particular genotype.
• e.g.
1. Barbiturates -excitement and mental confusion
in some individuals
2. Quinine - cramps, diarrhea, asthma, vascular
collapse in some individuals
3. Chloramphenicol - Rarely causes aplastic anemia
in some individuals
44. Drug Reaction
-Immunologically mediated reaction producing
stereotype symptoms, unrelated to the
pharmacodynamic profile of the drug.
-occur even with much smaller doses
•Type I: Immediate, Anaphylactic e.g: penicillins -
anaphylaxis
•Type II: Cytolytic Reaction e.g: methyldopa - hemolytic
anemia
•Type III: Arthus Reaction e.g: serum sickness
•Type IV: Delayed Hypersensitivity e.g: contact dermatitis
45. Photosensitivity
• Cutaneous reaction resulting from drug induced
sensitization of the skin to UV radiation. the
reactions are of two types
1)Phototoxic: sunburn-like, i.e., erythema, edema,
blistering, hyperpigmentation
e.g. demeclocycline, and tar products, nalidixic acid,
fluoroquinolones, sulfones etc
2)Photo allergic:
e.g. sulfonamides, sulfonylureas, griseofulvin,
chloroquine, chlorpromazine
47. Teratogenicity
• Capacity of a drug to cause foetal
abnormalities when administered to the
pregnant mother.
• E.g:
• Thalidomide__Phocomelia, multiple defects
• Anticancer drugs__Cleft palate,
hydrocephalus, multiple defects
• ACE inhibitors__Hypoplasia of organs (lungs,
kidney)
48. Mutagenicity and Carcinogenicity
-Capacity of a drug to cause genetic defects and
cancer respectively.
-Chemical carcinogenesis generally takes several
(10-40) years to develop.
• e.g. anticancer drugs,
• radio-isotypes,
• estrogens,
• tobacco.
49. Drug induced disease
• Also known as iatrogenic(physician induced)
diseases.
• e.g.
1. Salicylates, Corticosteroids -peptic ulcer
2. Phenothiazines, other antipsychotics -
Parkinsonism
3. Isoniazid -Hepatitis
4. Hydralazine - DLE
50. Summary
• Adverse drug reactions are major clinical
problem.
• ADR also responsible for longer stay in
hospital leading to increased cost
• ADR may mimic diseases and result in
unnecessary investigation or delay in
treatment
• ADR may lead to Disability, Congenital
anomalies and even death.