Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
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
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
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 science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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.
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 science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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.
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 (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.
a presentation in CME activities by Saad Specialist Hospital, KSA
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.
by: Dr. Vishal Pawar, MD Pharmacology
All the recent updates regarding antiepileptics, composed into a single ppt presentation to make researching and learning easier
By Dr. Vishal Pawar, MD pharmacology
considering the complex nature of this topic, i am hereby providing a comprehensive review of prostaglandins and its various effects in the body, which after a through go through should be enough for simplifying the understanding of prostaglandins
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
2. • Pharmacovigilance (PV) Etymological roots : pharmakon (Greek) means
drug and vigilare (Latin) means to keep awake or alert, to keep watch
WHO Definition
Science, activities relating to detection, assessment, understanding and
prevention of adverse effects or any other drug related problems
Side Effect
Any unintended effect of a pharmaceutical product occurring at doses
normally used in man which is related to the pharmacological properties
of the drug e.g. sedation with anti histaminics
Adverse Event / Adverse Experience
Any untoward medical occurrence that may present during treatment
with a pharmaceutical product at the same time, does not necessarily
have a causal relationship with this treatment 2
3. Adverse Reaction (ADR)
A response to a drug which is noxious and unintended, and which occurs
at doses normally used in man for the prophylaxis, diagnosis, or therapy
of disease, or for the modification of physiological function
Active surveillance system
Collection of case safety information as continuous pre-organized
process
Spontaneous reporting
System whereby case reports of adverse drug events are voluntarily
submitted from health professionals and pharmaceutical manufacturers
to the national regulatory authority
Signal
Reported information on a possible causal relationship between an
adverse event and a drug, the relationship being unknown or
incompletely documented previously 3
5. 5
Poor knowledge of Pharmacology, adverse effects of drugs
Irrational use of drugs, poor prescribing patterns
Promotional activities by pharmaceutical company detailers
Lack of authentic sources of information
Liberal drug outlets and unhealthy pharmaceutical practices
Liberal OTC and self medication practices
Ignorant, illiterate public
6. Pharmacological classification by Rawling and Thompson:
6
Type A (Augmented)
Type B (Bizarre)
Type C (Chronic)
Type D (Delayed)
Type E (End of use)
Type F (Failure)
7. Type A (Augmented) (dose related)
• Related to exaggerated pharmacological effects of drug
• Eg. Hypoglycemia with Insulin, hypotension by beta blockers, NSAID’s
induced gastric ulcers
Type B (Bizzarre)
• Unexpected, unpredictable, related to patient factors like genetic
predisposition
• Eg. Penicillin hypersensitivity, malignant hyperthermia
Type C (Chronic)
• Uncommon, irreversible, unexpected, unpredictable
• Due to long term use of drugs
• Eg. Hypothalamic pituitary adrenal axis suppression by corticosteroids
Type D ( Delayed)
• Time related
• Eg. Teratogenesis, Carcinogenesis like clear cell cancer of female
reproductive tract 7
8. Type E (End of use/ withdrawal)
• Occurs due to sudden discontinuation of the drug after long term therapy
• Eg. Adrenocortical insufficiency due to sudden withdrawal of
corticosteroids, MI due to beta blocker withdrawal
Type F (Failure of therapy)
• Common, Dose related
• Often caused by drug interactions
• Eg. Inadequate dosage of an oral contraceptive particularly when used
with specific enzyme inducers
• FDA monitors safety of human and veterinary drugs, biologics, medical
devices, foods, cosmetics, & other products
• Centre for Drug Evaluation and Research (CDER) regulates
prescription drugs
8
9. • Encourage active surveillance
• Consider special activities and expertise required for the detection of
safety concerns related to vaccines, biologicals, herbal medicines,
biotechnology products and investigational drugs
• Improve signal detection systems by facilitating availability of ADR data
• Revisit definitions of terms used within field of PV including definitions of
specific ADRs to ensure reliability and universal understanding of data
obtained through ADR reporting systems
• Develop and implement ADR detection systems
9
10. PREVENTION
• Improve access to reliable, unbiased drug information at all levels of
healthcare
• Improve access to safer and more effective medicines for neglected
diseases prevalent in developing communities
• Encourage awareness of drug safety and rational drug use among health
professionals and the public
• Integrate PV activities into national drug policies e.g. standard treatment
guidelines, essential drugs lists and clinical practice
• Improve regulation and PV of traditional and herbal medicines
• Develop systems which assess the impact of preventive actions taken in
response to drug safety problems 10
11. COMMUNICATION
• Improve communication, collaboration between key partners in PV
• Principles of good communications practice in PV and drug regulation
should be encouraged
• Different solutions are likely to be developed in different countries and
• regions, and the experience should be shared
• Develop better understanding of patients, their expectations of
medicines and their perception of risk, in order to facilitate programmes
that will inform public on benefit and harm associated with medicine
• Develop sustained, active relationships with media
11
12. Post-marketing monitoring or PV or Phase IV clinical studies
• Provides information about long-term safety of drug
• Safety in extremes of age, special population like pregnant and nursing
women
• Information about Type B ADR’s, rare ADR’s
• In India, mandatory to submit Post Marketing Surveillance (PMS)
Report within 2 years of marketing drug
12
13. • Limited value of animal experiments, Clinical trials
• ADRs constituting enormous burden on society
• Cost of drug related morbidity, mortality exceeding that of drug itself
• 30-50% of ADRs are preventable
• Early detection and prevention can help make drug therapy lot safer
• Rare or delayed serious reactions are likely to remain unnoticed
13
14. • 1881 systemic recording of illnesses associated with pharmacotherapy
started much later and a book in this regard was published by L. Lewin.
• 1937 Unexplained death of hundreds of children. Elixir of
sulfanilamide dissolved in diethylene glycol killing 107 children
• 1938 Stimulus for food and drug Act (drug safety) for stringent action
regarding safety requirement and testing of a new drug before
marketing.
• Thalidomide disaster in 1962
• 1968 WHO established a system for collecting reports of ADR
14
15. NEWER CHALLENGES FACED TODAY
• Illegal sale of medicines and drugs of abuse over Internet
• Increasing self-medication practices
• Widespread manufacture and sale of counterfeit and sub standard
medicines
• Increasing use of traditional medicines outside confines of traditional
culture
Recently, PV concerns have been widened to include:
• Herbals
• Traditional and complementary medicines
• Blood products
• Biologicals
• Medical devices
• Vaccines
15
16. 16
Rational and safe use of medical drugs
Encourage their safe, rational, more effective, cost effective use
Educating and informing patients
Assessment and communication of risks and benefits of drug
Promote understanding, education and clinical training in PV and its
effective communication to the public
Improve patient and public healthcare and safety in relation to use
of medicines
Contribute to regulatory assessment of benefit, harm, effectiveness
and risk of medicines
17. • Established in 1968
• As of October 2008, 89 countries had joined
• It consists of a network of the
i. National Centres
ii. WHO Headquarters
iii. Uppsala Monitoring Centre
17
18. 18
Identification and analysis of new adverse reaction signal
Provision of the WHO database
Information exchange between WHO and National Centres
mainly through Vigiflow
Publication of periodical newsletters, guidelines, books
Provision of training and consultancy support to National Centres
19. • Located in Uppsala, Sweden, World Health Organisation Collaborating
Centre for International Drug Monitoring
• Principal function manage international database of ADR reports
received from National Centres
• Works by collecting, assessing and communicating information from
member countries' national PV programs in regards to benefits, harm,
effectiveness and risks of drugs
• Annual meetings for representatives of National Centres
• Producing WHO Drug Dictionary and WHO Adverse Reaction
Terminology
19
21. Pre Clinical Studies
• Toxicity tests
• General pharmacology
• Effect of hepatic and renal dysfunction,
• Drug interactions, and
• Other toxicity-related information or data
Animal Tests
- Acute toxicity - Kinetics
- Carcinogenicity - Organ damage
- Mutagenicity - Species specificity
- Teratogenicity - Dose dependence
21
22. Clinical Studies
• Adverse events (AEs) / Adverse drug reactions
• Identified and potential interactions, including food-drug and drug-
drug interactions
• Epidemiology of indication(s) and important adverse events
• Pharmacological class effects
• Limitations of the human safety database
22
23. 23
Monitoring center
Investigator
Global HQ
Sponsor’s Safety Officer
Death and
life-threatening,
Associated (by
Investigator)
Cases
Immediately or
within 24 hours
to entry site
immediately or
within 24 hours
immediately or
within 24 hours
immediately or
within 24 hours
25. • Relationship between the drug treatment and occurrence of an
adverse event
• Defined: structured and standardised assessment of individual
patients/case reports of the likelihood of involvement of suspected
drug in causing particular event in a given patientWHO assessment
scale
• Methods
25
Naranjo's scale European ABO system
Karch and Lasagna's scale Kramer scale
Bayesian Neural network Yale algorithm
26. • Data collection & Data management
• Signal detection
• Risk assessment and quantification
• Benefit/ Risk assessment
• Actions to reduce risk or increase benefit
• Communication of risks or interventions
• Audit
26
27. • Passive surveillance
a) Spontaneous reporting
b) Case series
c) Large linked administrative database
d) Electronic medical records
• Intensified reporting
• Active Surveillance
• Comparative Observational Studies
• Targeted Clinical Investigations
• Descriptive studies
27
28. Spontaneous reporting
• Identification of safety signals once a drug is marketed
• Is voluntary for health professionals
• Most useful where reaction is unusual and unexpected
• And where ADRs occur in close temporal relation with start of
treatment or increase in dose
• Provide important information on at-risk groups, risk factors, and
clinical features of known serious ADRs
28
29. Reports for regulatory authorities are in form of
• Expedited adverse drug reaction (ADR) reports
• Periodic Safety Update Reports (PSURs)
• Underreporting is an important limitation
• Causes being lack of awareness of time, ill filled report forms,
misconception that the medicine caused the event
• Reporting rates cannot be used to reliably estimate incidence rates
29
30. Case series
• Provide evidence of association between drug and adverse event
• More useful for generating hypotheses than for verifying an association
between drug exposure and outcome
• Reports of events like SJS, Anaphylaxis should undergo detail and rapid
follow up
Large linked administrative database
• Eg. Medicaid in USA and Ontario provincial database
• Contain data on millions of subjects
• Completeness of details, such as diagnoses, are questionable in many
circumstances
• May not be representative of the whole population
Electronic medical record
• Large number and detail of variables are available like use of tobacco
products and nonprescription drugs, symptoms and signs,
• Can be combined to generate new diagnoses or adverse events,
• Hypotheses which are not restricted to existing diagnoses, can be
explored 30
31. • To encourage and facilitate reporting for new products, methods
used are
• Onine reporting of adverse events
• Systematic stimulation of reporting of adverse events based on a
pre-designed method
ACTIVE MONITORING
• Patients might be identified from electronic prescription data or
automated health insurance claims
• A follow-up questionnaire can then be sent to each prescribing
physician or patient to obtain outcome information
• More detailed information can be collected
• Limitation - poor response rates
31
32. • A registry is a list of patients presenting with the same characteristics
• Used as information gathering and hypothesis generating tool
• Particularly on drug exposure during pregnancy and for orphan drugs
• Can act as population basis for linkage studies
COMPARATIVE OBSERVATIONAL STUDIES
• Are key component in evaluation of adverse events
• Cross- sectional studies - primarily used to gather data for surveys or
for ecological analyses
• Case-control studies - used to investigate whether there is an
association between a drug (or drugs) and one specific rare adverse
event, as well as to identify risk factors for adverse events
• Cohort studies - incidence rates of adverse events in addition to the
relative risks of adverse events are calculated
32
33. • Evaluate MOA for adverse reaction
• Pharmacodynamic and pharmacokinetic studies
• Investigate potential drug-drug interactions and food-drug interactions
DESCRIPTIVE STUDIES
• These are primarily used to obtain background rate of outcome events
• Establish prevalence of use of drugs in specified populations
33
34. • Reported information on a possible causal relationship between an
adverse event and a drug
• Relationship being unknown or incompletely documented previously
• Usually more than a single report is required to generate a signal
• Depending upon seriousness of event and quality of the information
• Describes the first alert of a problem with a drug
• Cannot be regarded as definitive
• Indicates the need for further enquiry or action
• The automated systems used to generate signal is called as data
mining 34
35. DATA MINING
Application of statistical techniques, e.g. predictive modeling,
clustering, link analysis, deviation detection and disproportionality
measures, to databases to generate signal
35
Formulation of
hypothesis of
association
Method of
highlighting
potential ADR and
safety issues of a
drug needing
further
investigations
Signal
Generation
Assessment of
available data
Improved
knowledge
about suspected
ADR and
indicates need
for early
warning or
intervention
Signal
strengthening
36. SNIP criteria
Strong signals that are judged to be New, clinically Important, and
have potential for Prevention, be given priority for further evaluation
Methods of signal detection
• Spontaneous reporting system
• Hospital based surveillance system
• Prescription- event monitoring
• Case reports in literature
• Epidemiological studies
Aim of statistical aids
• To provide means of comparing the frequency of a medicine - event
combination
• With all other such combinations in the database under consideration
• With potential for early detection of signals of possible medicine -
event association
36
37. Evaluation of drug safety issue
• Causality assessment
• Identifying other possible cause
• Assessing the risk to individual and public
• Benefit/ Risk assessment is continued throughout life of a drug
• Guidelines to assess risk/ benefit differ from country to country
Key elements
• Description of target disease, populations being treated, purpose of
intervention
• Degree of efficacy, presence of alternative therapy
• Type of risk and identification of risk factors
• Consideration of all benefits and risks by indication and population
37
38. Actions to reduce risk or increase benefit and Communication
• Contraindicate use of drug in specific group
• Reducing maximum authorized dose
• Contraindicating concomitant use of interacting drug
• Monitoring early warning signs
• Educating practitioners and consumers
• Withdrawal of drug
AUDIT
• To evaluate outcomes of the interventions
• To plan future activities
38
39. Other issues relevant include
• Substandard medicines
• Medication errors
• Lack of efficacy reports
• Use of medicines for indications that are not approved and for which
there is inadequate scientific basis
39
40. • 1986: ADR monitoring system consisting of 12 regional centres each
covering population of 50 million, was proposed for India
• 1989: 6 regional centers : Delhi, Mumbai, Calcutta, Pondicherry,
Lucknow, Chandigarh
• 1997: India joined WHO Monitoring Programme based in Uppsala,
Sweden
• 2004: The WHO sponsored and World Bank funded National
Pharmacovigilance Program (NPP) for India was made operational
• NPP was to be overseen by National Pharmacovigilance Advisory
Committee
40
41. • 2009: World bank funding ended and programme was temporarily
suspended
• Late 2009: workshop org by AIIMS, Dept. of Pharmacology and
CDCSO when a framework of new programme was formulated
• July, 2010: Recognizing the need for improved ADR monitoring in the
country, under the aegis of Health Ministry, a nation-wide revised
ADR monitoring programme was launched and named as
Pharmacovigilance Programme of India (PvPI)
41
42. • Provides a system to collect the data and use the inferences
• To recommended regulatory interventions, besides communicating
risks to healthcare professionals and public
• Indian Pharmacopoeia Commission (IPC) under the Ministry of Health
and Family Welfare has been functioning as the National Coordination
Centre (NCC) for PvPI since April 2011
• Medical colleges and hospitals are cornerstone of PvPI
• Under PvPI, ADRs are being identified and spontaneously reported by
the healthcare professionals of Adverse Drug Reaction Monitoring
Centres (AMC)
42
43. • Currently, 179 Medical Council of India approved teaching hospitals
and corporate hospitals have been identified as AMCs across the
country
• These AMCs are responsible for collecting adverse event as per
Standard Operating Procedure (SOP)
• Performing follow up if require for the completeness of ADR reports
• Uploading these reports in net- based software used for ADR
reporting called as Vigiflow
• These drug safety information/Individual Case Safety Reports
(ICSRs) are collected in predesigned suspected ADR reporting forms
• Broadly consisting of 4 sections i.e., patient’s information, suspected
adverse reaction, suspected medication(s), and reporter’s
information
43
44. • Under PvPI, AMC plays a vital role in collection and follow-up of ADR
reports from healthcare professionals
• At present there are 400 AMCs under this programme and
categorized into four zones i.e., North, South, East and West
• Making this one of the largest Pharmacovigilance Programme in the
world
• PvPI have also extended its reach to other National Health
Programmes within country
• Integrating with Revised National Tuberculosis Control Program,
National AIDS Control Organization
• Has collaborations with Central Drugs Standard Control Organization
(CDSCO)
44
45. • Education and Training on PV at Regional Training Centres
• India, with a current population of 1.27 billion, is the fourth largest
producer of pharmaceuticals in the world
• With more than 6000 licensed manufacturers and over 60,000 branded
formulations in the market
• Over 5 years, has played a significant role in creating awareness among
healthcare professionals about reporting ADRs
• Having more than 1,49,000 ADRs reported till December 2015
• Currently, the contribution of India to the WHO global Individual Case
Safety Reports (ICSRs) database is 3%
• Its trying to create sufficient database on ADRs, awareness among
healthcare providers of government, corporate hospitals
45
46. Communications
• Website : websites of CDSCO (www.cdsco.nic.in) and NCC (www.
ipc.gov.in) are important tools for communication to the stakeholders
and public seeking specific information
• Media : communicate the findings in national newspapers, electronic
media, etc., on regular basis
• Newsletter: unique among healthcare professionals because it focuses
on the ADRs related information
• Scientific Journals
• Helpline Facility to Provide Assistance in ADR Reporting
• Android Mobile Application for Adverse Drug Reaction Reporting
46
47. • Co-ordination among clinician, pharmacist, and nurse appears vital in
contributing each of their respective expertise and experience to
promote the rational use of medicines
• The reason for poor reporting may also include financial incentives,
ignorance (only serious ADRs are to be reported), apprehension of
reporting serious ADRs, and lack of time or over load
• In year 2013, India’s contribution to WHO–UMC’s global drug safety
database was 2%
• India was 7th in position among top 10 counties contributing to
global drug safety database
• Awareness about the ADR reporting among the healthcare providers
can improve the rate of reporting across the country
47
48. • Wide misconception that ‘natural’ means ‘safe’
• There are examples of traditional and herbal medicines being
adulterated or contaminated
• With allopathic medicines, chemicals such as corticosteroids, non-
steroidal anti-inflammatory agents and heavy metals
• Self-medication further aggravates the risk to patients
• When used in conjunction with other medicines there is potential of
serious adverse drug interactions
• These products should be governed by standards of safety, quality and
efficacy that are equivalent to those required for other pharmaceutical
products
48
49. • New vaccines for pandemic diseases such as HIV/AIDS and malaria are
in the later phases of development
• Vaccines and biologicals require modified systems of safety monitoring
often administered to healthy children, particularly used within a
national immunization programme
• The skills and infrastructure to deal with genuine adverse events are
essential in preventing or managing misplaced fear
• Caused by false or unproven signals from patients and health workers
that might adversely affect immunization cover
49
50. • Eg. concerns about safety of whole-cell Pertussis resulted in dramatic
reductions in vaccines coverage and a resurgence of Pertussis in
many countries
• Contamination of blood and blood products by infectious organisms
such as HIV and hepatitis B
• Quality of screening and sterilization procedures and appropriate
selection of donors are linked to the risks of contamination
• Such safety issues related to the use of plasma-derived medicinal
products fall under PV programmes
50
51. • Drug safety monitoring is an essential element for the effective use of
medicines and for high quality medical care
• PV is a clinical discipline in its own right - one that contributes to an ethos
of safety and serves as an indicator of standards of clinical care practised
within a country
• 3 approaches that might serve to increase awareness and interest in drug
safety among clinicians, and to address research issues are
• Education, training and access to reliable information
• Health professionals are more likely to identify and report important ADRs
if they have confidence in their ability to diagnose, manage and prevent
such reactions
• National PV centres and training institutions play a central role in this by
encouraging inclusion of the principles and methods of PV
• And the study of iatrogenic disease at UG and PG levels in schools of
medicine, pharmacy and nursing
51
52. • For all medicines there is a trade-off between benefits and the potential for harm
• To minimize the harm, it is necessary that medicines of good quality, safety and
efficacy are used rationally, and that the expectations and concerns of the patient
are taken into account when therapeutic decisions are made
• The discipline of PV has developed considerably since the 1972 WHO technical
report, and it remains a dynamic clinical and scientific discipline
• It has been essential to meet the challenges of the increasing range and potency of
medicines (including vaccines), which carry with them an inevitable and sometimes
unpredictable potential for harm
• When adverse effects and toxicity appear - particularly when previously unknown
in association with the medicine - it is essential that they should be analysed and
communicated effectively to an audience that has the knowledge to interpret the
information 52
53. • This is the role of PV. Much has already been achieved
• PV activities are expanding around the world
• This is reflected in the increasing number of national PV centres that
have been established in recent years
• There are still many countries where no formal systems for PV are in
place
• To ensure that the existing centres are effective, their impact on
public health and health costs should be measurable and the benefits
demonstrable
• Only then will widespread support and long term sustainability of PV
centres be assured
53
54. The following is a summary of some of the serious challenges facing PV
programmes in the next ten years
• Globalization
• Web-based sales and information
• Broader safety concerns
• Public health versus pharmaceutical industry economic growth
• Attitudes and perceptions to benefit and harm
54
55. • Very concept of detection of an ADR can jeopardize their economics
• Should realize that ADR monitoring can be a source of revenue
generation if a new indication is found for the drug
• Can be tackled by giving conditional clearance for marketing of a new
drug
• Enforcing strict drug regulations
• So that Fraudulent and counterfeit drugs do not find a way into the
market
55
56. • Handbook of resolutions and decisions of the World Health Assembly
and Executive Board, Clinical and pharmacological Evaluation of Drugs,
Vol 11948-1972. Geneva: World Health Organization, 1973. WHA16.36.
• WHO Medicines Strategy: Framework for Action in Essential Drugs and
Medicines Policy 2000-2003. WHO/EDM/2000.1.
• Meyboom RHB, Egberts ACG, Gribnau FWJ, Hekster YA.
Pharmacovigilance in perspective. Drug Safety 1999; 21(6): 429-447.
• The importance of pharmacovigilance, safety monitoring of medicinal
products, WHO.
• Lihite R, Lahkar M. An update on the Pharmacovigilance Programme of
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57. • Portnoff J, Lewis D. The Enigma of Pharmacovigilance of Patient
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• Khosla P, Bhati N, Kannan S. Good pharmacovigilance practice: Need
of the hour from pharmaceutical companies. Perspectives in Clinical
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58. • Preda A. Pharmacovigilance and Beyond. Journal of Pharmacovigilance.
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• Pharmacovigilance guidance document, Indian Pharmacopoeia
commission and CDSCO.
• Gagnon S, Schueler P. Pharmacovigilance and Risk Management, global
clinical trials playbook, chapter 15:142.
• Sloane R, Osanlou O, Lewis D, Bollegala D, Maskell S, Pirmohamed M.
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challenges. British Journal of Clinical Pharmacology. 2015;80(4):910-920.
• Harugeri A, Shastri V, Patel C. Deriving meaningful insights from clinical
trial and postmarketing safety data: Perspectives from India.
Perspectives in Clinical Research. 2017;8(2):68.
• Casadevall N, Edwards I, Felix T, Graze P, Litten J, Strober B et al.
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Encourage active surveillance of specific drug safety concerns through epidemiological methods such as case control studies
Consider special activities and expertise required for the detection of safety concerns related to vaccines, biologicals, herbal medicines, biotechnology products and investigational drugs
Improve signal detection systems by facilitating availability of ADR data
Revisit definitions of terms used within field of PV including definitions of specific ADRs to ensure reliability and universal understanding of data obtained through ADR reporting systems
Develop and implement ADR detection systems that could benefit populations with restricted access to health care