This document provides an introduction to pharmacoepidemiology. It defines pharmacovigilance and pharmacoepidemiology, and discusses key epidemiological principles. It describes how epidemiological methods are applied in pharmacovigilance, including signal detection, creating a pharmacovigilance plan with a safety specification and PV plan, and using technical solutions like AERS and Q-Scan for pharmacoepidemiology.
pharmacoepidemiology is the study of use and effect of drugs in large number of population.
pharmacoepidemiology enhances or supplements the information from the preclinical studies.
Guidelines of ADR reporting are mentioned. Where to report? How to report? Whom to report? These are the major part of the ppt. Normal people can understand about the drug safety process.
pharmacoepidemiology is the study of use and effect of drugs in large number of population.
pharmacoepidemiology enhances or supplements the information from the preclinical studies.
Guidelines of ADR reporting are mentioned. Where to report? How to report? Whom to report? These are the major part of the ppt. Normal people can understand about the drug safety process.
Pharmacoepidemiology is the study of effects of drugs in large numbers of people.
Epidemiologic Study Designs, Reasons to perform Pharmacoepidemiology studies, Users of pharmacoepidemiology and Role of Pharmacists & other Public Health Practitioners in Pharmacoepidemiology are discussed in this presentation.
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
Definition and scope of Pharmacoepidemiology ABUBAKRANSARI2
In these slides I shared the information of definition and scope of pharmacoepidemiology. Types of studies - cohort studies, cross-sectional studies etc.
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
With MiFID II just round the corner, the need to consider how to meet regulatory demands on the recording of telephone conversations and electronic communications is imminent. Here are our top 6 compliance-driven solutions to consider.
Pharmacoepidemiology is the study of effects of drugs in large numbers of people.
Epidemiologic Study Designs, Reasons to perform Pharmacoepidemiology studies, Users of pharmacoepidemiology and Role of Pharmacists & other Public Health Practitioners in Pharmacoepidemiology are discussed in this presentation.
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
Definition and scope of Pharmacoepidemiology ABUBAKRANSARI2
In these slides I shared the information of definition and scope of pharmacoepidemiology. Types of studies - cohort studies, cross-sectional studies etc.
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
With MiFID II just round the corner, the need to consider how to meet regulatory demands on the recording of telephone conversations and electronic communications is imminent. Here are our top 6 compliance-driven solutions to consider.
Journal of Advances in Pharmacoepidemiology and Drug SafetyOMICS International
OMICS Publishing Group journal, Advances in Pharmacoepidemiology and Drug Safety is a peer-reviewed, open access journal that publishes original research articles dealing with all aspects of research on the use and effects of drugs in large numbers of people and drug safety. The emphasis is on publishing quality papers quickly and making them easily accessible to researchers all over the world.
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
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Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
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SAFETY
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PARAXEL
SRISTEK
ACCENTURE
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Pharmacovigilance planning refers to the systematic and proactive approach taken by pharmaceutical companies, regulatory agencies, and other stakeholders to establish strategies and procedures for monitoring the safety of drugs throughout their lifecycle. It involves creating a comprehensive framework to detect, assess, understand, and prevent adverse effects or any other drug-related problems. Here are some key aspects to consider in pharmacovigilance planning
Safety reports rmp risk management plan pharmacovigilanceAzierta
A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
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ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE INTERVIEWS & Its PREPARATIONSJonaid Ali
FREQUENTLY asked questions about pharmacovigilance in an interview. Pharmacovigilance is fastest growing career in these days in the healthcare sector specially for pharmacy students although some corporates allow non pharm candidates also
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
2. Topics
• Definitions
– Pharmacoepidemiology
– Pharmacovigilance
• Overview of Epidemiologic Principles
• Application of Epidemiologic Principles in Drug Monitoring
– Signal Detection
– Pharmacovigilance Plan
– Safety Specification
– PV Plan
• Technical Solutions for Pharmacoepidemiology
– AERS
– Q-scan
• Exercise
• References
2
Introduction to Pharmacoepidemiology
3. Definition
• Pharmacovigilance – Two pervasive definitions
(Abenhaim, Moore, & Begaud, 1999)
– Watchfulness in guarding against danger from products or
providing for safety of the product
– Expansive beyond just regulations and frames the construct for
use in academia and the sciences
– The collection and scientific evaluation of adverse drug
reactions (ADR), under normal conditions of use for
regulatory purpose.
– Restricts the concept to regulatory compliance only
• Pharmacoepidemiology – The application of
epidemiologic techniques used to study the effects of
drugs in populations
– First mentioned in the early 1980’s (Abenhaim, Moore, &
Begaud, 1999)
3
Introduction to Pharmacoepidemiology
4. Epidemiology Overview
• The study of determinants of health and
illness in populations serving as the
science behind public health and
preventative medicine
– Concerned with relationships between
disease and exposures
–While these correlations do provide insight into
causal plausibility, correlation between disease
and exposure does NOT constitute causation
4
Introduction to Pharmacoepidemiology
6. Epidemiology Methods
• Epidemiology Methods are segregated into two
broad categories
– Experimental
– Study designs used to describe (report) the distribution of
exposure and effect
– Observational
– Study designs used to analyze and understand the degree
of association between exposure and effect
6
Introduction to Pharmacoepidemiology
7. Epidemiology Measures
Occurrence Association
Incidence Relative (calculated by division)
1. Incidence Proportions 1. Risk Ratio
2. Incidence Rates or Relative Risk
3. Cumulative Incidence or Rate Ratio (RR)
2. Odds Ratio (OR)
Prevalence:
1. Lifetime Prevalence Absolute (calculated by subtraction)
2. Point Prevalence 1. Attributable Risk
3. Period Prevalence 2. Rate Differences
7
Introduction to Pharmacoepidemiology
8. Pharmacoepidemiology Overview
• Application of epidemiologic principles
described above to the bio-
pharmaceutical industry
–Starts with Signal Detection
–Results in Creation of
Pharmacovigilance Plan (or PV Risk
Management Plan)
–Safety Specification
–PV Plan (PVP)
8
Introduction to Pharmacoepidemiology
9. Signal Detection
• When determining if a particular safety issue
warrants inclusion in a PVP, a company must
weigh its risk to benefit ratio for further research
of an issue
– The use of signal detection methods aids in the
process of clarifying the presence of a true signal
• The term signal in PV is often used as a
synonym to signal of disproportionate reporting
(SDR)
– Technically, a true signal includes a more
thorough evaluation (including clinical plausibility,
pharmacologic method of action etc.) compared
to the simple statistical measurement used to
identify an SDR 9
Introduction to Pharmacoepidemiology
10. Measures of Signal Detection
• All measures calculated from a 2X2 Table
– Proportional Rate Ratio (PRR)
– Reporting Odds Ratio (ROR)
– Relative Reporting Ratio (RRR)
– Information Component (IC; Bayesian)
Event All Other TOTAL
(R) Events
Medicinal Product (P) A B A+B
All other medicinal C D C+D
products
TOTAL A+C B+D N=A+B+C+D
10
Introduction to Pharmacoepidemiology
11. Signal Detection
• All measures of SDR are basically calculations of
OBSERVED/EXPECTED event/drug reports
– Since the EXPECTED data is actually originating from
the same pool as the OBSERVED data, we CANNOT
use a PRR as an RR nor a ROR as an OR
– EXPECTED data in epidemiology comes from sources
other than the OBSERVED
• In PV, the EXPECTED data is also referred to as
the “background”
• What you include in the “background” is a point
of contention in the industry and no real rules
are present (Gogolak, 2003)
11
Introduction to Pharmacoepidemiology
12. Signal Detection
• Since the simple calculation is O/E, the
relationship between background and the
statistic of interest is inversely related:
– As the background increases the resulting
statistic decreases
– Large E results in small PRR
– As the background decreases the resulting
statistic increases
– Small E results in large PRR
12
Introduction to Pharmacoepidemiology
13. PV Planning and Documentation
• Whatever statistic used, they are wrought
with assumptions and limitations that
must be clearly addressed before
expending company time and money on
further evaluation
• The EMEA has established a guidance
document interpreting the ICH guidance
E2E on the documentation of a PV Plan
(European Medicines Agency (EMEA),
2006a)
– The PV Plan can be seen as your company’s
tool justifying and focusing your PV activities
13
Introduction to Pharmacoepidemiology
14. Safety Specification
• This section of (or individual document) is intended
to summarize the existing knowledge and limitations
of that knowledge concerning the product
• Included Elements should include
– Non-Clinical Drug information
– Toxicity
– Drug interactions
– General Pharmacology
– Clinical
– Limitations of Human Safety Data
– Populations not studied in the pre-approval stage
– Adverse Events/Adverse Drug Reactions
– Potential Interactions
– Epidemiology
– Pharmacologic Class Effects
14
Introduction to Pharmacoepidemiology
15. Pharmacovigilance Plan
• PV Plan documentation
– Designed to explain the company’s approach to addressing the
limitations and findings in the safety specifications documentation
• Should contain the following information
– Summary of ongoing safety issues
– Description of Routine PV Initiatives
– Action plan for safety issues
– Specific protocols may be added as references to this document
– Summary of actions to be completed
• A PV Plan is a living document and is revised as needed
based on regulatory submissions (such as PSUR and NDA
Periodic) and the changing landscape of the safety data
and knowledge
15
Introduction to Pharmacoepidemiology
16. Technical Solutions
• To aid in PV methods, safety
systems are created like AERS
–These systems store the data,
prepare reports for submission
and provide information for case
and case series analysis
16
Introduction to Pharmacoepidemiology
17. Technical Solutions
• Data mining tools provide a tremendous
assistance in the evaluation of a signal
– Right now, several tools provide a method
to data-mine the world-wide reporting of
spontaneous event data with a out of the
box user interface
– FDA – AERS Database
– WHO – Vigibase Database (~3.7 million reports)
– Tools such as Q-Scan, Lincoln Technologies
among others
17
Introduction to Pharmacoepidemiology
18. Technical Solutions
• Use of these databases requires that certain
assumptions be made
– Drugs used in the marketplace are used by a
representative sample of the greater population
• Any information derived from these databases
should be interpreted using the limitations of the
data contained therein (Edwards, 1999)
– Limited clinical quality of data
– USA allows reporting into the AERS system from anyone
(Health care provider {HCP} or not)
– EMEA only allows reporting by HCP thus typically more
complete clinical information
18
Introduction to Pharmacoepidemiology
19. Technical Solutions
• Underreporting of serious events
– Changes the number of expected events
– “Weber Effect”: The peak reporting for events in
a drug on market occurs within the first 2 years of
approval (Hartnell, & Wilson, 2004) during the
initial 5 year marketing period
• Over reporting of events of non-interest
(expected non-serious)
• False Causality attribution
– Signals ARE NOT CAUSAL INDICATIONS
– They are disproportionate reporting indicators
19
Introduction to Pharmacoepidemiology
20. Summary
• PV is a fascinating relatively new field of product
development
• Signals are detected using ratios of Observed number of
event/drug occurrences divided by some Expected count
(O/E)
– ROR
– RR
– PRR
– IC
• Signals are not estimates of incidence, prevalence nor
are they descriptors of causality
• Caution should ALWAYS be exercised when evaluating
data originating from spontaneous reports
• The ICH PV Plan helps organizations focus their
information and aids in only spending money on true
events of interest
20
Introduction to Pharmacoepidemiology
21. References
• Abenhaim, L., Moore, N., and Begaud, B.. (1998). The Role of Pharmacoepidemiology in Pharmacovigilance: A
Conference at the 6th ESOP Meeting, Budapest, 28 September 1998. Pharmacoepidemiology and Drug Safety, 8(S1-S7)
• Bortnichak, E. A., and Dai, W. S. (1999). Epidemiologists and Adverse Event Data: A Challenge to the Field
Pharmacoepidemiology and Drug Safety, 8, 457-461
• Brown, E. G.. (2004). Using MedDRA Implications for Risk Management. Drug Safety, 27(8), 591-602
• Checkoway, H., Pearce, N., and Kriebel D.. (2004). Research methods in Occupational Epidemiology. Oxford University
Press. New York.
• Edwards, R.. (1999). Spontaneous reporting-of what? Clinical concerns about drugs. British Journal of Clinical
Pharmacology, 48, pp. 138-141
• European Medicines Agency (EMEA). (2006a). ICH Topic E2E Pharmacovigilance Planning (PVP). Retrieved on May 23,
2007 from http://www.emea.europa.eu/pdfs/human/ich/571603en.pdf
• European Medicines Agency (EMEA). (2006b). Guideline on the use of statistical signal detection methods in the
Eudravigilance Data Analysis System. Retrieved on May 23, 2007 from
http://eudravigilance.emea.europa.eu/human/docs/10646406en.pdf
• Gogolak, V. V. (2003). The effect of backgrounds in safety analysis: the impact of comparison cases on what you see.
Pharmacoepidemiology and Drug Safety, 12, 249-252
• Hartnell, N. R., Wilson, J. P.. Replication of the Weber effect using post marketing adverse event reports voluntarily
submitted to the United States Food and Drug Administration. Pharmacotherapy, 2004; 24(6): 743–749
• Hartzema, A. G., Porta, M. S., and Tilson, H. H. (2006). Introduction to Pharmacoepidemiology. The Annals of
Pharmacotherapy, 40, 1651-1652
• Hauben, M., Madigan, D., Gerrits, C. M., Walsh, L., and Van Puijenbroek, E. P. (2005). The role of data mining in
Pharmacovigilance. Expert Opinion in Drug Safety, 4(5), 929-948
• Hoffmann, K., Heidemann, C., Weikert, C., Schulze, M. B., and Boeing, H. (2006). Estimating the Proportion of Disease
due to Classes of Sufficient Causes American Journal of Epidemiology, 163(1), p. 76-83
• Moore, N., Hall, G., Sturkenboom, M., Mann, R., Lagnaoui, R., and Begaud, B. (2003). Biases affecting the proportional
reporting ratio (PRR) in spontaneous reports Pharmacovigilance databases: the example of sertindole.
Pharmacoepidemiology and Drug Safety, 12, 271–281
• Rothman, K. J., Lanes, S., Sacks, S. T. (2004). The reporting odds ratio and its advantages over the proportional reporting
ratio. Pharmacoepidemiology and Drug Safety, 13, 519-523
• Stephenson, W. P., and Hauben, M.. (2006). Data mining for signals in spontaneous reporting databases: proceed with
caution. Pharmacoepidemiology and Drug Safety, 16 (4), 359-365
• The Center for Education and Research on Therapeutics (CERTs) Risk Assessment Workshop Participants. (2003). Risk
assessment of drugs, biologics and therapeutic devices: present and future issues. Pharmacoepidemiology and Drug 21
Safety, 12, 653-662 Introduction to Pharmacoepidemiology
22. Contact Information
Rodney has over 12 years experience in clinical research
including raw laboratory experimentation, clinical data
management, clinical trial design, dictionary coding and
pharmacovigilance.
Rodney has worked for BioPharm Systems for nine years
now serving in a variety of roles all related to the
technical and/or clinical implementations of software
systems used in the clinical trial process.
Prior to coming to BioPharm Systems Rodney worked at
pharmaceutical and technology companies in the
Dictionary Coding, Statistical Programming and Data
Management areas.
In addition to his current work at BioPharm Systems,
Rodney holds an Associate faculty position at Walden
University teaching a variety of classes in their Masters
of Clinical Research program.
Rodney holds a Bachelor of Science in Genetic
Engineering, a Masters of Public Health in International
Epidemiology and a Ph.D. in Epidemiology focusing on
Social Epidemiology
22
Introduction to Pharmacoepidemiology