Pharmacovigilanc: The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems
The Thalidomide Tragedy (Lessons for Drug Safety and Regulation)
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION)
Why PV is Necessary?
Objective of PV
Outcomes of Drugs
Causal Relationship
Adverse drug reaction and causality assessment scales
Classification of AE
Serious Adverse Event (SAE)
Sources of Adverse Events (AE) reports
Sources of AE Reports(Solicited Reports)
What to Report?
Who to Report?
When to Report?
Individual case data flow
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.
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
Introduction to ICSR Narrative Writing in 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
Pharmacovigilanc: The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems
The Thalidomide Tragedy (Lessons for Drug Safety and Regulation)
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION)
Why PV is Necessary?
Objective of PV
Outcomes of Drugs
Causal Relationship
Adverse drug reaction and causality assessment scales
Classification of AE
Serious Adverse Event (SAE)
Sources of Adverse Events (AE) reports
Sources of AE Reports(Solicited Reports)
What to Report?
Who to Report?
When to Report?
Individual case data flow
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.
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
Introduction to ICSR Narrative Writing in 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
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 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.
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 - Defination, Aim, Need ,Importance ,history, workflow, co...MADHAV JAJNURE
pharmacovigilance(PV)
Defination of pharmacovigilance
Aims of pharmacovigilance
Origin of pharmacovigilance
History of pharmacovigilance
Importance of pharmacovigilance
Work flow of Pharmacovigilance
Conclusion
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.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem.
All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
The clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time.
Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period.
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
Madeline Smith, The Glasgow School of Art
Acorn Recovery: Restore IT infra within minutesIP ServerOne
Introducing Acorn Recovery as a Service, a simple, fast, and secure managed disaster recovery (DRaaS) by IP ServerOne. A DR solution that helps restore your IT infra within minutes.
2. 1.Introduction
2. Historical Perspective
3.Need of pharmacovigilance
4.Aims
5.Methods of pharmacovigilance
6.Causality Assessment
7. Pharmacovigilance program of India
8.WHO Pharmacovigilance Program
9.Summary
4. Historical Perspective
English Physician William Withering publish his work on
Foxglove in 1785.
In 1789, Wouter van Doeveren, in his lecture named
Remedio Morbi discussed ocurance of ailments d/t
administration of remedies for therapeutic purposes
Sulfanilamide Disaster(1938).
5. 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.
6.
7. 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
8. 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
9. 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
10. 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
11. 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
12. METHODS 0F PHARMACOVIGILANCE
1. Spontaneous Case Reporting
2. Case Series
3. Active Surveillance
4. Comparative Observational Studies
5. Periodic Safety Update Reports (PSUR)
13. 1. 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
14.
15. 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.
17. 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.
20. 6.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.
21. 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
24. 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
25. 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
26. 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)
27. 90 PVPI AMCs
National Coordinating Center,
IPC, Ghaziabad
Ghaziabad Mumbai Kolkata Chennai
PVPI Headquarters, CDSCO
Pharmacovigilance Program of India (PVPI)
28. PERFORMANCE & EFFECTIVENESS OF THE
PHARMACOVIGILANCE SYSTEM
Who can Report What to Report Whom to Report
Healthcare professionals
(clinician, dentist
pharmacist ,nurses and
others) can report
suspected adverse drug
reaction. Pharmaceutical
companies can also send
ADR specific for their
product to NCC.
All types of suspected ADRs-
irrespective of whether they are
known or unknown, serious
and non-serious, frequent or
rare. Although
pharmacovigilance is primarily
concerned with pharmaceutical
medicines, adverse reactions
associated with drugs used in
traditional medicine (e.g.
herbal remedies) should also be
considered.
Use the ‘Suspected Adverse
Drug Reaction Reporting
Form’ which is available on
the official website of IPC
(www.ipc.gov.in) as well as
CDSCO (www.cdsco.nic.in)
to report any ADR.
29. 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
30. 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.
31. 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
32. 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
34. • 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.
35. 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)
36. 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)
Pharmacological Classification-
37. • Reactions which can be predicted from the known
pharmacology of the drug
• Dose dependent,
• Can be alleviated by a dose reduction
E.g.
• Anticoagulants - Bleeding,
• Beta blockers - Bradycardia,
• Nitrates - Headache,
• Prazosin - Postural hypotension.
Type A (Augmented) reactions
38. • Cannot be predicted from the pharmacology of the drug
• Not dose dependent,
• Host dependent factors important in predisposition
E.g.
• Penicillin - Anaphylaxis,
• Anticonvulsant - Hypersensitivity
Type B (Bizarre) reactions
39. Type C(Continuous Drug Use)-
-May be irreversible, unexpected or unpredictable.
E.G. 1)Tardive Dyskinesias by Antipsychotics
2)Dementia by Anticholinergics.
40. • Occur after many years of treatment.
• Can be due to accumulation.
E.g.
• Chemotherapy - Secondary tumours
• Analgesics - Nephropathy
• Corneal opacities after thioridazine
Type D (Delayed) reactions
41. • Occur on withdrawal especially when drug is stopped abruptly
E.g.
• Phenytoin withdrawal - Seizures,
• Steroid withdrawal - Adrenocortical insufficiency.
Type E (End of Dose) reactions
42. 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.
Side effects
43. 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
Secondary effects
44. Excessive pharmacological action of the drug due to over dosage or
prolonged use
e.g. Barbiturates - Coma,
Digoxin - Complete A-V Block,
Heparin - Bleeding
Atropine -Delirium
Paracetamol - Hepatic Necrosis
Toxic Effects
45. 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
Intolerance
46. • Genetically determined abnormal reactivity to a chemical
• Restricted to individuals with particular genotype.
e.g.
Barbiturates -excitement and mental confusion in some individuals
Quinine - cramps, diarrhea, asthma, vascular collapse in some individuals
Chloramphenicol - Rarely causes aplastic anemia in some individuals
Idiosyncrasy
47. -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
Drug Reaction-
48. 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
50. 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)
Teratogenicity
51. -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.
Mutagenicity and Carcinogenicity-
52. Also known as iatrogenic(physician induced) diseases.
e.g.
Salicylates, Corticosteroids -peptic ulcer
Phenothiazines, other antipsychotics - Parkinsonism
Isoniazid -Hepatitis
Hydralazine - DLE
Drug induced disease
53. 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.