This document provides an introduction to post-marketing drug safety surveillance conducted by the FDA's Center for Drug Evaluation and Research (CDER). It defines pharmacovigilance and describes the Division of Pharmacovigilance's key roles in postmarketing safety monitoring, including collecting and analyzing adverse event reports from healthcare providers and patients. Spontaneous reporting systems like FDA Adverse Event Reporting System (FAERS) are useful for detecting rare or long-term safety issues not seen in clinical trials. The division evaluates safety signals and can recommend actions such as label changes or risk management plans based on its analyses.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
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
Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilis...Dr.Amreen Saba Attariya
detailed information about Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilisation, DU90%, WHO Collaborting Centre for drug statistic methodology, DDD/1000inhabitants/day, DDD/100beddays, DDD/1000inhabitants/year, Pediatric DDD, ATC & DDD in drug utilisation research, Electronic Prescribing, Guidelines for ATC classification & DDD assignment 2016
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
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
Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilis...Dr.Amreen Saba Attariya
detailed information about Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilisation, DU90%, WHO Collaborting Centre for drug statistic methodology, DDD/1000inhabitants/day, DDD/100beddays, DDD/1000inhabitants/year, Pediatric DDD, ATC & DDD in drug utilisation research, Electronic Prescribing, Guidelines for ATC classification & DDD assignment 2016
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
TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
PMS are the studies done after the drug is marketed to ensure the safety and efficacy of drugs. Here detailed about the need for PMS, sources of informations and methods of PMS
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Visit : www.acriindia.com
ACRI is a leading pharmacovigilance training Institute in Bangalore.
ACRI creates a value add for every degree. Our PG course is diploma in clinical research and PG diploma in pharmavigilance are approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
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
TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
PMS are the studies done after the drug is marketed to ensure the safety and efficacy of drugs. Here detailed about the need for PMS, sources of informations and methods of PMS
Pharmacovigilance Process Work Flow - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Visit : www.acriindia.com
ACRI is a leading pharmacovigilance training Institute in Bangalore.
ACRI creates a value add for every degree. Our PG course is diploma in clinical research and PG diploma in pharmavigilance are approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
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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
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.
FDA guidance for post marketing study commitments - Pharmaceuticals
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Similar to Introduction to post marketing drug safety surveillance fda 2-11-14 (20)
This presentation highlights the reasons which lead to the withdrawal of the 2002 Guidance of the FDA and the current issue with Blend Uniformity and Content Uniformity Determinations.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
This presentation is compiled from freely available resources like the websites of FDA, EMA ,WHO and research papers published by experts in this field like Sandle, T Reinmüller, B , Hyde, W,, Costello, E.K., Lauber, C. L., Hamady, M., Fierer, N., Gordon, J.I., Knight, R.
Paper published by T. Sandle on clean room contamination was referred extensively for this presentation. “Drug Regulations” is a non profit organization which provides free online resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest information from the world of Pharmaceuticals.
This presentation gives an overview of : Validation of microbiological methods , Considering some of the limitations and
Key criteria that may be applicable for assessment.
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Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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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
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Introduction to post marketing drug safety surveillance fda 2-11-14
1. Introduction to Post-marketing
Drug Safety Surveillance:
Pharmacovigilance in FDA/CDER
CDR Selena Ready, PharmD, CGP
Safety Evaluator
Division of Pharmacovigilance
Office of Surveillance and Epidemiology
Center of Drug Evaluation and Research
February 11, 2014
1
2. Objectives
• Define Pharmacovigilance
• Describe the Division of Pharmacovigilance’s (DPV’s) key
safety roles in FDA’s Center for Drug Evaluation and
Research (CDER).
• Understand components of postmarketing drug safety
surveillance.
• Understand regulatory requirements and the role of
MedWatch for reporting postmarketing safety information.
• Describe how adverse event reports are collected and
analyzed by FDA/CDER/DPV
2
3. Outline
• Pharmacovigilance Background
• Postmarketing Surveillance
• Spontaneous Adverse Event Reports and the FDA Adverse
Event Reporting System (FAERS)
• Signal Detection
• Components of a Good Case Report
• Case Series Development and Evaluation
3
4. Center for
Food
Safety &
Applied
Nutrition
(CFSAN)
Center for
Veterinary
Medicine
(CVM)
Center for
Devices &
Radiological
Health (CDRH)
Center for
Biologics
Evaluation
& Research
(CBER)
Center for
Drug
Evaluation
& Research
(CDER)
Center for
Tobacco
Products (CTP)
Office of
Regulatory
Affairs (ORA)
4
5. Office of Surveillance &
Epidemiology
Office of
Surveillance
&
Epidemiology
Office of
Pharmacovigilance
& Epidemiology
Division of
Pharmacovigilance
I and II
(DPV I and II)
Division of
Epidemiology
I and II
(DEPI I and II)
Office of
Medication Error
Prevention & Risk
Management
Division of
Medication Error
Prevention &
Analysis
(DMEPA)
Division of Risk
Management
(DRISK)
5
6. The science and activities relating to the detection,
assessment, understanding, and prevention of
adverse effects or any other drug-related
problems.
Pharmacovigilance
*
The Importance of Pharmacovigilance, World Health Organization 2002
6
7. Divisions of Pharmacovigilance
• Evaluate the safety of drug and therapeutic biologic
products
• Advance public health by detecting and analyzing safety
signals from all available data sources, utilizing evidencebased methods
• Recommend appropriate regulatory actions, including
labeling changes, Risk Evaluation and Mitigation Strategies
(REMS), etc.
• Communicate relevant safety information
7
8. Safety Evaluators (SEs)
• 10 teams of SEs
– Majority clinical pharmacists
– Provide critical analysis of sources of postmarketing data to
identify and evaluate safety signals
• Team coverage aligned with the Office of New Drugs (OND)
review divisions’ therapeutic areas
– ~ 4-7 SEs per team (including Team Leader)
– Each SE covers assigned product group(s) aligned with therapeutic
area
8
9. Medical Officers (MOs)
• Provide clinical expertise in various therapeutic areas such
as dermatology, oncology, rheumatology, etc.
• Collaborate with DPV teams on safety evaluation
• Collaborate with Office of New Drugs (OND) on safety
evaluation
9
11. Challenge Question #1
True or False
Safety data is only collected during the later phases of
the clinical development program for a medical product.
11
12. Safety in the Lifecycle
of FDA-regulated Products
Preclinical
Phase 1
Phase 2
Phase 3
Safety
&
Biological
Activity
Safety
&
Dosage
Safety
&
Efficacy
Safety
&
Efficacy
A
P
P
R
O
V
A
L
PostMarketing
Safety
Surveillance
Safety Concerns
Strategies and Actions to Minimize Risk
12
13. Limitations of Premarketing
Clinical Trials
• Size of the patient population studied
• Narrow population - often not providing sufficient data on
special groups
• Narrow indications studied
• Short duration
13
14. Benefits of Postmarketing Monitoring
The ability to study the following:
•
•
•
•
•
Low frequency reactions (not identified in clinical trials)
High risk groups
Long-term effects
Drug-drug/food interactions
Increased severity and / or reporting frequency of known
reactions
14
15. Types of Postmarketing Surveillance
• Spontaneous/voluntary reporting of cases
– National (FDA MedWatch)
– Local or Regional (Joint Commission Requirement)
– Scientific literature publications
• Postmarketing studies (voluntary or required)
– Observational studies (including automated healthcare databases)
– Randomized clinical trials
• Active surveillance
– Drug-Induced Liver Injury Network (DILIN)
– Sentinel initiative
15
17. Challenge Question #2
Which of the following countries does not require
practitioners to report adverse events to a national
registry?
A. France
B. Norway
C. Sweden
D. US
17
18. How Postmarketing
Reports Get to FDA
Patients, consumer, and healthcare professionals
Voluntary
Voluntary
Manufacturer
FDA MedWatch
Regulatory
Requirements
FDA
FAERS
Database
5% of all reports
95% of all reports
18
20. Challenge Question #3
True or False?
The incidence of adverse drug events can be
determined through spontaneous reporting
systems.
20
21. Spontaneous Reports
• A communication from an individual (e.g. health care
professional, consumer) to a company or regulatory
authority
• Describes a suspected adverse event(s)
• Passive and voluntary reports
21
22. Factors Affecting Reporting
•
•
•
•
•
•
•
•
Media attention
Litigation (class action lawsuits)
Nature of the adverse event
Type of drug product and indication
Length of time on market
Extent and quality of manufacturer’s surveillance system
Rx or OTC product status
Reporting regulations
22
23. FDA Adverse Event Reporting System
•
•
•
•
•
Computerized database
Spontaneous reports
Contains human drug and therapeutic biologic reports
> 7 million reports since 1969
Nearly 1 million new reports in 2012
23
25. FAERS Strengths
• Includes all U.S. marketed
products
• Includes all uses
• Includes broad patient
populations:
– elderly, children, pregnant
women, co-morbidities
• Simple, relatively
inexpensive reporting system
• Especially good for events
with a rare background rate
• Useful for events that occur
shortly after exposure
• Detection of events not seen in
clinical trials (“signal
generation”)
• Identification of trends, possible
risk factors, populations, and
other clinically significant
emerging safety concerns
25
26. FAERS is less useful for:
•
•
•
•
•
•
•
•
Events with high background rates
Worsening of pre-existing disease
Issue is beyond the name of the drug
Comparative incidence rates
Comparing drugs in the same class
Disease is reflected in the adverse event
Looking for drug interactions
Reporting Biases
26
29. Challenge Question #4
A safety signal could be:
A. New, previously unknown, adverse event
B. New drug interaction
C. An observed change in quantity, severity or the affected
populations of a known adverse event
D. All of the above
29
30. What is a Safety Signal?
• Reported information on a
possible causal relationship
between an adverse event and a
drug
• The relationship being
previously unknown or
incompletely documented
• Supported by multiple case
reports
• New unlabeled adverse events
• An observed increase in a
labeled event OR a greater
severity or specificity
• New interactions
• Newly identified at-risk
population
30
31. Sources of Possible Safety Signals
• Routine pharmacovigilance
•
•
•
•
– FAERS
– Data mining
– Periodic Safety Update Reports from drug manufacturers
Study results
Medical literature
Media
New Drug Application (NDA)
safety database
• Outside inquiry
• Foreign Regulatory Agencies
• Others
31
32. Use of Data Mining
• Mathematical tool identifies higherthan-expected frequency of
product-event combinations
• Tool for hypothesis generation
• Supplements FAERS data review
• Does not replace expert clinical case
review
32
35. Consumer MedWatch Form
• MedWatch Form 3500B
• Includes 4 primary components
• Patient
• Product
• Event
• Reporter
• User-friendly format for non-health
care professionals
35
36. • How to Report:
– Online
(www.fda.gov/medwatch)
– Download the form
• Mail
• Fax 1–800–332–0178
• For questions about the form:
– 1–800–332–1088
36
38. Case #1
A health care worker reported a male patient
started Drug X at 5 mg daily for type 2 diabetes on
February 11, 2011. On an unknown date, the patient
developed liver failure; additional information was
not provided.
38
39. Case #2: Best Case Representative
• 59-year-old male with type 2
diabetes, hyperlipidemia, and
hypertension. No history of liver
disease.
• Started Drug X on February 11,
2011.
• Other medications: simvastatin
and lisinopril.
• Labs drawn on Feb 11 revealed
Liver enzymes, INR, creatinine,
and bilirubin all within normal
limits.
• No alcohol use.
• 8 weeks after starting Drug X
patient presented to ER with 5
day history of jaundice, dark
urine, and nausea/vomiting.
• He was admitted to ICU and
subsequently diagnosed with
acute liver failure.
• Drug X stopped upon admission.
• Viral hepatitis was ruled out.
• 7 days after stopping the
medication, all lab values
returned to normal.
39
40. Components of a
Good Postmarketing Report
• Description of adverse event
• Suspected and concomitant product therapy details (e.g. dose, dates of
therapy)
• Patient characteristics (e.g., age, sex), baseline medical condition, comorbid condition, family history, other risk factors
• Documentation of the diagnosis
• Clinical course and outcomes
• Relevant therapeutic measures and laboratory data
• Dechallenge and rechallenge information
• Reporter contact information
• Any other relevant information
Guidance for Industry - Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, March 2005
40
42. Developing a Case Series
• Identify a well-documented case in FAERS, published
literature, data mining, or other sources to identify a safety
signal.
• Using our knowledge of the clinical course of the disease,
formulate a case definition which may include both clinical
features and laboratory findings, sometimes even
demographic information if we believe the safety signal is
for a specific population.
• Complete a thorough database search for additional cases.
42
43. Principles of Case Evaluation
• Temporal relationship
• Causality assessment- World Health Organization, the Uppsala
Monitoring Centre (WHO-UMC):
–
–
–
–
–
Certain
Probable/Likely
Possible
Unlikely
Conditional/Unclassified
• Key factors in causality assessment including, but not limited to
–
–
–
–
Dechallenge/rechallenge
Comorbidities
Concomitant medications
Consistent with pharmacological effects ( biologic plausibility)
43
44. Regulatory Actions
• Labeling changes – i.e. Warnings, Precautions, Adverse
Reactions
• Pharmacovigilance activities - enhanced surveillance (e.g.,
expedited reporting), registry, epidemiology studies
• Risk Evaluation and Mitigation Strategy (REMS)
– Communication plan, restricted use
• Drug Safety Communication (DSC)
• Market withdrawal
44
46. Communicating Safety Issues
to the Public and Internationally
• MedWatch Safety Alerts
• Drug Safety Newsletter
• Postmarket Drug and Biologic Safety Evaluations (FDAAA
915)
• Potential Signals of Serious Risks/New Safety Information
Identified from FAERS (FDAAA 921)
• Published literature and scientific meetings
• Video and teleconferences with foreign regulatory
agencies:
– European Medicines Agency, Canada, Australia, New Zealand
46
50. References
•
•
•
•
•
•
•
•
•
•
•
•
Arthur N et al. The Importance of Pharmacovigilance – Safety Monitoring of Medicinal Products. WHO
2002.
Drug Safety Communications: http://www.fda.gov/Drugs/DrugSafety/ucm199082.htm
FDA Patient Safety News: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
Guidance for Industry- Postmarketing Safety Reporting for Human Drug and Biological Products including
Vaccines, March 2001:
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Va
ccines/ucm074850.htm
Guidance for Industry- Good Pharmacovigilance Practices and Pharmacoepiemiologic Assessment, March
2005: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf
MedWatch: The FDA Safety Information and Adverse Event Reporting Program:
http://www.fda.gov/Safety/MedWatch/default.htm
MedWatch Medical Product Safety Information:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
MedWatch Safety Alerts: http://www.fda.gov/Safety/MedWatch/ucm287881.htm
MedWatch Safety Alert RSS Feed:
http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xml
Postmarket Drug Safety Information for Patients and Providers (FDAAA 915):
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/defa
ult.htm
Postmarketing Drug and Biologic Safety Evaluations: (FDAAA 915):
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm204091.htm
Potential Signals of Serious Risks/New Safety Information Identified from AERS (FDAAA 921):
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffec
ts/ucm082196.htm#QuarterlyReports
50