The document discusses pharmacovigilance and adverse drug reaction (ADR) reporting in India. It provides information on the national pharmacovigilance program, including who can report ADRs, how to report them, and the benefits of reporting. It describes the ADR reporting process and forms for healthcare professionals and consumers. It also discusses other vigilance programs in India related to medical devices, vaccines, blood products, and several research projects conducted with these programs.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
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.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
complete description of causality assessment with the definition of basic terminologies.& relation with an adverse event and adverse drug reaction, causality terms & assessment criteria.
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.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Slides includes ADR monitoring process, Safety reporting, what is pharmacovigilance, types of ADR, basic terms in ADR monitoring, what is PvPI in India, role. stakeholders, ADR reporting form, Apps, Role of community Pharmacist in ADR monitoring, Importance of ADR monitoring, etc.
Best Practice Document on Handling of Market Complaints.pdfTom Aspinall
Market complaints in the pharmaceutical industry refer to issues raised by consumers or regulatory bodies regarding product quality, safety, or marketing practices. These complaints are crucial for maintaining industry standards, ensuring patient safety, and regulatory compliance.
ADR reporting (Clinical Research & Pharmacovigilance).pptxDureshahwar khan
The content here, include passive surveillance system, ADR reporting, ADR reporting process, different countries ADR reporting systems, what to report?, how to report?, where to report?, Health professionals are encouraged to report adverse reactions which they believe to be drug related directly to The regulatory authority or The company marketing the suspected product on voluntary basis.
Similar to Pharmacovigilance and Method of ADR reporting (20)
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
Follow us on: Pinterest
Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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
1. Pharmacovigilance and methods of
Adverse Drug Reactions
reporting
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Dr. Lokendra Sharma
Professor,
Department of Pharmacology &
Coordinator, ADR Monitoring Centre,
SMS, Medical College,
Jaipur.
4. Adverse Drug Reaction (ADR)
A response to a drug which is
Noxious and Unintended
occurs at doses normally used in man for the prophylaxis, diagnosis, or
therapy of disease, or for the modifications of physiological function.
(WHO, 1972)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
5. WHY ADR Reporting ?
ADRs are among the leading causes of death in many countries (World Health
Organization, 2008)
Account for 5% of all hospital admissions in India.
Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3795320/
Constitutes a significant economic burden on the patient and government
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
6. Benefits of ADR Reporting
Assess the safety of drug therapies, especially recently approved
drugs.
Provides updated drug safety information to health care professionals
and other stakeholders
Measuring the economic impact of ADR prevention as manifested
through reduced hospitalization, optimal and economical drug use,
and minimized organizational liability
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
7. Benefits of ADR Reporting Cont.....
Regulatory action on the basis of ADR reports to ensure
patient’s safety
Upgrading package insert
Marketing Authorization Recall (withdrawal)
Batch recall based on clustering of ADR
Changes in classification, e.g.
o From over the counter to prescription only medicines.
o Special prescription
o Restricted prescription
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
8. ADR Reporting Procedure
Who can report
What to report
How to report
Whom to report
Where to report
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
9. Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
Who can report?
• All healthcare professionals
(Clinicians, Dentist, Pharmacist, Nurses, Physician, Physiotherapist etc)
• All non- healthcare professionals including consumers/ patients etc can report ADRs.
10. What to Report ?
All types of suspected adverse reactions
Known or unknown,
Serious or non-serious and
Frequent or rare
Reactions from all types of pharmaceutical products
Allopathy,
Ayurvedic,
Vaccines,
Medical devices etc.
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
11. Indian Pharmacopoeia Commission , Pharmacovigilance Programme of India
How & Whom to Report ?
• Use the ‘Suspected Adverse Drug Reaction Reporting Form/ Medicine side effect
Reporting form which are available on the official website of IPC (www.ipc.gov.in)
to report any ADR
Link for ADR form http://ipc.nic.in/showfmkl;ile.asp?lid=416&EncHid=
Filled ADR form submitted to nearest ADR Monitoring Centres (AMCs ) or directly
to the NCC-PvPI.
A reporter can also email the Suspected ADR form at
pvpi@ipcindia.net or pvpi.ipcindia@gmail.com.
13. A reporter can also report ADR Via Helpline number launched in
October 2013
1800 -180- 3024
(Monday to Friday 9:00AM to 5:30 PM)
Toll free-Helpline Number
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
14. Android Application
ADR Reporting App. can be downloaded from Google play store (free to download)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
ADR-PvPI is the
indigenously developed
Mobile App for all
healthcare professionals
and consumers to report
adverse drug reactions
16. ADR Reporting form for Healthacare
Professionals
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
17. Suspected Adverse Drug Reaction Reporting Form For
Health Care Professionals
This form is divided into four sections:
A. Patient Information
B. Suspected Adverse Reaction
C. Suspected Medication(s)
D. Reporter Details
Indian Pharmacopoeia Commission,
Pharmacovigilance Programme of India
18. A. Patient Information
Indian Pharmacopoeia Commission,Pharmacovigilance Programme of India
A. Patient Information
1. Patient
Initials
_____________
2. Age at time of event
or date of birth
__________________
3. M □ F □ Other □
_________________________________
4. Weight __________ Kgs
19. B. Suspected Adverse Reaction
B. Suspected Adverse Reaction
5. Date of reaction started (dd/mm/yyyy)
6. Date of recovery (dd/mm/yyyy)
7. Describe reaction or problem
Indian Pharmacopoeia Commission,Pharmacovigilance Programme of India
20. C. Suspected Medications
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
C. Suspected medication(s)
S.N
o
8. Name
(Brand
/Generic)
Manufact
urer
(If
known)
Batc
h
No./
Lot
no.
Exp. Date
(if known)
Dose
used
Route
used
Frequency
(OD,BD,
etc.)
Therapy dates Indica
tion
Causalit
y
assessm
ent
Date
starte
d
Date
stopped
i
ii.
21. C. Suspected Medications Cont...
Action taken- Mark the appropriate option for the action taken with respect to
Suspected drug.
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
S.No.
as per
C
9. Action Taken ( Please Tick)
Drug
withdrawn
Dose
increased
Dose
reduced
Dose not
changed
Not
applicable
Unknown
i
ii
22. C. Suspected Medications Cont..
• Rechallenge/ Reintroduction - The point at which a drug is again given to a
patient after its previous withdrawal.
• Mark the appropriate option whether the suspected drug reintroduced & reaction
occurred or not or effect unknown.
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
10. Reaction reappeared after reintroduction ( Please Tick)
S.No. Yes No Effect Unknown Dose
(If reintroduced)
i
ii
23. Concomitant medications Cont..
Concomitant medical product (s) information given in the following tabs.
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
11. Concomitant medical product including self medication
and herbal remedies with therapy dates (exclude those
used to treat reaction)
S.No. Name
(Brand
/Generic)
Dose
used
Route
used
Frequency
(OD, BD, etc.)
Therapy dates Indication
Date
started
Date
stopped
i
ii
24. D. Reporter Details
Indian Pharmacopoeia Commission,Pharmacovigilance Programme of India
D. Reporter Details
16. Name and professional address ____________________________
Pin ___________________ E - mail___________________________
Tel. No. (With STD code)____________________________________
Occupation__________________________ Signature ___________
17. Date of this Report (dd/mm/yyyy) ___________________________
25. Other important sections of ADR Reporting form
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
12. Relevant test and laboratory data with dates
13. Relevant medical / medication history ( Allergies, race, pregnancy,
smoking , alcohol use, renal and hepatic dysfunction etc.)
14. Seriousness of the reaction: No □ If Yes □ (please tick anyone)
□ Death (dd/mm/yyyy) □ Congenital anomaly
□ Life threatening □ Required intervention to prevent
permanent impairment/ damage
□ Hospitalization/ prolonged □ Disability
□ Other (specify)
26. Other important sections of ADR Reporting form
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
15. Outcome (please tick anyone)
□ Recovered □ Recovering
□ Not Recovered □ Fatal
□ Recovered with Sequelae □ Unknown
27. Other important sections of ADR Reporting form
Additional Information:
More information on the ADR report that are not fit in the respective column given
in ADR form can be entered in the filed of additional information (i.e. More
information about suspected drug, indication etc.)
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
28. Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
Consumers can provide detailed first-
hand information about their experiences
with medicines and how these medicines
have affected their life.
NCC-PvPI launched its first ADR
reporting form for consumers in August
2014.
Medicine Side Effect Reporting Form for
Consumers and Journal Release
29. ADR reporting form for consumers
(in Hindi)
Indian Pharmacopoeia Commission,
Pharmacovigilance Programme of India
30. Consumer Reporting Form launched in different
languages by NCC-PvPI.
Available in English, Hindi & Nine other regional languages
Gujarati, Kannada, Bengali
Malayalam, Oriya, Tamil
Marathi, Telugu, Assamese
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
31. Materiovigilance Programme of India (MvPI)
• To monitor and report the adverse events due to the medical
devices,
• The MvPI was launched by the DCGI, Dr. G.N. Singh at Indian
Pharmacopoeia Commission, Ghaziabad, on July 6, 2015.
• The MoHFW, Government of India, nominated Sree Chitra
Tirunal Institute of Medical Science & Technology,
Thiruvanthapuram,
• As a National Collaboration Centre and National Health
System Resource Centre for providing technical support.
33. Adverse event following Immunization (AEFI)
• AEFI is defined as a medical event that takes place after
immunization , cause concern and is believed to be caused by
immunization programme .
• AEFI surveillance system in India has come a long way since its
inception in 1986.
• In India, the safety of vaccines is monitored by the division of
AEFI , Ministry of Health and Family Welfare, Government of
India and PvPI.
34. AEFI reporting form (in case of serious event)
Indian Pharmacopoeia Commission,
Pharmacovigilance Programme of India
35. Haemovigilance Programme of India
• Heamovigilance Programme of India was launched on
10/12/2012 as an integral part of PvPI.
• National Institute of Biological, Noida is functioning as a
National Coordination Centre for this Programme.
It is responsible for
1. Collate & analyze adverse drug reaction data for blood and
blood products
2. Help in identifying trends, recommend best practices and
interventions required to improve patient care and safety, while
reducing overall cost of the healthcare system.
36. Adverse Blood Donor Reaction Reporting Form
Indian Pharmacopoeia Commission,
Pharmacovigilance Programme of India
37. Transfusion Reaction Reporting Form (TRRF) For Blood & Blood
Components & Plasma Products
Indian Pharmacopoeia Commission,
Pharmacovigilance Programme of India
40. Journey of S.M.S. Medical College as ADR Monitoring Centre in Jaipur
• Establishment: In year 2011 by IPC Ghaziabad
• CME & Presentations:
-3 CME
- More than 40 presentation on PVI & ADR Reporting for the health care professional
& consumer
41. Academics working in India with UK academics in
Bangor, Manchester and Oxford Universities. The
purpose of the GMHAT and GCRF-SASHI project is to
help to find effective responses to deliberate PvPI,self-
harm and suicide in South Asia by building research
infrastructure and expertise in India
.
42. Sensitization of PVI
Training:
• 20 training for Doctors
• 4 training for Nurses
• 3 training for BDS student
• 4 training for Pharmacists & pharmacy students
45. Details of Poster Presentations
• 1st July, 2017 : Poster on “Awareness on
Pharmacovigilance and ADR reporting” in Hindi
was launched by the Principal, SMS Medical
College, Jaipur.
• 16th December, 2017 :Poster on“ Materiovigilance-
an Approach for monitoring and evaluation of
medical device associated adverse events"
presented at ICMR Institute , Jodhpur.
46. Details of Poster Presentations
• Poster presentation on "Pharmacists as
Pharmacovigilance Practitioner" in the 12th
Indo-African International Conference on on
“Trends,
• Challenges and Future Scenario of
Pharmaceutical Science” held on 6th March,
2018 at Arya College of Pharmacy, Jaipur.
47. ADR Reporting From SMS Medical
College
• Targeted Reporting:
• In Year 2017:Total 327 ADR reports have been sent
to PVI Ghaziabad
• Monthly Average ADR reporting in 2017: 27 /
month
• From Jan to March 2018: 91 ADR reports have
been collected.
48. ADR Reporting From SMS Medical
College
• Targeted Reporting:
• In Year 2017:Total 327 ADR reports have been sent
to PVI Ghaziabad
• Monthly Average ADR reporting in 2017: 27 /
month
• From Jan to March 2018: 91 ADR reports have
been collected.
49. ADR Monitoring in SMS Medical
College
ADR
monitoring
& reporting
for the drugs
used in
national
health
programmer
s as
NACO ,T.B.,
Deworming
50. Preface
• Medical students play an important
role for screening the health status of
public.
• So this study was undertaken to screen
the hidden cases of ADR present among
MBBS students Clinical Training .
51. Research Projects of Digital
Training
1. Mental health assessment by medical students of Batch 2016
using GMHAT.
2. Mental health assessment by medical undergraduate of Batch 2017
students using GMHAT.
3.Assessment of Mental health of participants by MBBS Batch 2018 by
using
GMHAT.
4. To assess and compare the effect of traditional teaching with Integrated
teaching in MBBS students with the help of GMHAT this also
included in teaching timetable.
5. Use GMHAT By Postgraduate students in there training & thesis work
on Cancer,
HIV, TB, Diabetes and Osteoarthritis patients.
52. Projects with National and
international university
Indian Pharmacopoeia Commission,
Pharmacovigilance Programme of India
53. Approach
• Integrated teaching on PvPI was
implemented by the active
involvement of the departments of
Physiology, Medicine and Psychiatry
etc.
• At the end of their training, both
groups were again assessed with a
post-test questionnaire.
54. Present Pharmacovigilance Committee
• Dr. Lokendra Sharma : Co-ordinator
• Dr. Rupa Kapadia : Member Secretary
• Dr. Monica Jain : Assistant Co-ordinator
• Dr. Monika Mishra : Member
• Chaitanya Prakash : Pharmacovigilance Associate
• There are also co-opting Pharmacovigilance members from the various
Departments of SMS Medical College, Jaipur.
55. ADR Monitoring Centers
• Total number of Adverse Drug Reaction Monitoring Centres in India : 250
(till Dec-2018)
• Total number of Adverse Drug Reaction Monitoring Centres in Rajasthan : 11
(till Jan-2019)
• S.M.S. Medical College, Jaipur
• S. P. Medical College, Bikaner
• R.N.T. Medical College, Udaipur
• Dr. S. N. Medical College, Jodhpur
• Government Medical College, Kota
• J.L.N. Medical College, Ajmer
• Institute of Respiratory Diseases, Sashtri Nagar, Jaipur
• AIIMS, Jodhpur
• Geetanjali Medical College, Udaipur
• NIMS Medical College, Jaipur
• JNU Medical College, Jaipur
56. ADR reporting status
• In the Year-2017 : 327 ADR reports were sent
• From January to December-2018 : 463 ADR reports have been
sent to NCC-PVPI.
• From January-2011 to June-2018 : More than 2000 ADR
reports have been sent to the National coordination Centre-
Pharmacovigilance Programme of India.
57. CMEs and Seminar organized at AMC
• One day CME on “Pharmacovigilance it’s relevance in current
Medical Practice” was organized on 23rd September, 2011 at
Rajasthan University of Health Sciences, Jaipur.
• A half day Seminar on “Pharmacovigilance” funded by Indian
Pharmacological Society was held on 17th September, 2012 in the
Library Seminar Hall, SMS Medical College, Jaipur.
• One day CME on “Pharmacovigilance” funded by Indian
Pharmacopoeia Commission, Ghaziabad with the technical support
of PGIMER, Chandigarh, was organized on 08th May, 2015 in the
Library Seminar Hall, SMS Medical College, Jaipur.
59. Awareness programmes and PV trainings
• Total 41 Awareness
programmes and PV
trainings on
Pharmacovigilance have
been conducted at ADR
Monitoring Centre, and other
hospitals as well as Medical,
Nursing and Pharmacy
Colleges.
• More than 2800 healthcare
professionals and students
have been sensitized through
these programs and
trainings.
60.
61. Poster publications
• A poster regarding “Awareness on Pharmacovigilance and ADR
reporting” in hindi was launched on 1st July, 2017 by Dr. U. S.
Agrawal, Principal & Controller, SMS Medical College, Jaipur.
• The Addl. Principal, Coordinator, Members of Pharmacovigilance
Committee and the Faculty, Department of Pharmacology, SMS
Medical College, Jaipur were present in the launching ceremony.
• The poster was placed in various clinical Departments of SMS
Medical College & attached hospitals.
71. Workshop-cum-Training Programme on Pharmacovigilance for
NABH-Accredited Hospitals in Rajasthan State
• Indian Pharmacopoeia Commission,
National Coordination Centre (NCC)
for Pharmacovigilance Programme of
India (PvPI), has signed a
Memorandum of Understanding with
National Accreditation Board for
Hospitals and Healthcare Providers
(NABH) for effective implementation
of ADR-reporting.
• To train NABH-Accredited Hospitals
staff on Pharmacovigilance, one day
Workshop-cum-Training programme
was organized on 20th June 2018 at
Santokba Durlabhji Memorial
Hospital, Jaipur.
• 62 healthcare professionals
participated in the Workshop.
74. ADR Data entry through Vigiflow
• VigiFlow is a web-based Individual Case Safety Report (ICSR)
management system that is available for use by national
pharmacovigilance centres of the WHO Programme for
International Drug Monitoring.
• VigiFlow supports the collection, processing and sharing of
data of ICSRs to facilitate effective data analysis.
75. ADR Data entry through Vigiflow
• ADRs reports (Individual Case Safety Report) are
processed through VigiFlow to NCC, Ghaziabad.
• At NCC, the Signal Review Panel, Quality Review Panel
evaluate the ICSR and send the regulatory
recommendations to the CDSCO, New Delhi.
76. Please Report
Adverse Drug Reactions
(Known, Unknown, Serious and Non-Serious)
Due to Medicines, Medical Devices, Blood products, Vaccines and Herbal products
To
Adverse Drug Reaction Monitoring Centre, SMS Medical College, Jaipur.
Dr. Lokendra Sharma
Prof. Pharmacology & Coordinator,
Phone No. 9414048334, 0141-2518682
Email ID: drlokendra29@gmail.com
Mr. Chaitanya Prakash
Patient Safety-Pharmacovigilance Associate
Mob. No. 7727017839
Email ID: pchaitanya84@gmail.com
ADR Reporting Toll free number: 1800-180-3024
ADR reporting Android App ‘ADR PvPI’ available on Google play Store
For more information please visit at www.ipc.gov.in
Council for International Organizations of Medical Sciences
The Global Mental Health Assessment Tool (GMHAT) is a computerized clinical assessment tool which is used to evaluate and screen mental health problems in primary care.
We have conducted four studies to assess the mental health status by MBBS students of different year’s on patients by using GMHAT . Before conducting the studies , we have trained the students for assessment of mental health by GMHAT and in every years we were also planned integrated medical teaching for mental health assessment of students by themselves.
1. Mental health assessment by medical students of batch 2016 using Global Mental Health Assessment Tool ( GMHAT).
2. Mental health assessment by medical undergraduate of batch 2017 students using Global Mental Health Assessment Tool ( GMHAT).
3.Assessment of mental health of patients by MBBS batch 2018 by using GMHAT.
4. To assess and compare the effect of traditional teaching with Integrated TL modular teaching in MBBS students with the help of GMHAT this also included in teaching timetable.