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ADVERSE DRUG
REACTION
REPORTING TOOLS
RIMA SINGH
M. Pharm, 2nd Sem
(DEPARTMENT OF PHARMACOLOGY)
INDO-SOVIET FRIENDSHIP COL...
Contents
2
• Introduction
• History
• Adverse drug reaction
• ADR reporting tools
• Role of Pharmacovigilance in ADR monit...
Introduction
3
Clinical trial study of the drug detects ADR but, the
reactions occurs after long duration in a specific p...
Adverse drug reaction
According to WHO, an adverse drug reaction defined as,
“Any response to a drug which is noxious unwa...
1957- Thalidomide tragedy.
1968- WHO Programme established with 10 member states
for International ADR terminology and dru...
Type Type of
Effect
Characteristics Example
A Augmented Dose dependent, Predicted from the
known pharmacology of the drug
...
Adverse drug reaction reporting tools
7
Adverse drug reactions reporting tools or monitoring
is a process of continuously ...
Healthcare professionals
Peripheral centers
Regional centers
Zonal centers
NPC/CDSCO
WHO/UMC
Fig.1: ADR reporting process 8
Objectives of ADR monitoring
9
1. Todetect the nature and frequency of ADRs
2.To assist the Drug Regulatory Authority, Pub...
Benefits of ADR monitoring
10
and safety of1. It caters information about quality
pharmaceuticals products.
2. It initiate...
Information required for ADR monitoring
1. Patient Information
2. ADRs Description
3. Information Related to Suspected Dru...
ADR monitoring studies for the
identification of adverse events.
12
monitor• Case reports: This is done to
unpredictable A...
• Intensive monitoring
13
studies: In this, selected
population is screened and continuously watched
to record all the eve...
• Case control studies: These are retrospective
study design. Patient have illness or disease due
to the use of drug are i...
Methods of ADR monitoring
15
•Spontaneous reporting: Mostly used ADR for
monitoring, it records the safety of a drug based...
Active surveillance: It
which
16
is pre-designed
is conducted in addition to
process
passive
surveillance to find out more...
Role of pharmacovigilance in ADR monitoring
17
Different study designs are included for proper
pharmacovigilance study:
a....
What to report
1.All ADRs as a result of Prescription and Non-Prescription
medicinal products.
2. All suspected ADRs regar...
Who should report
19
as possible.
inaccurate
1. Health care Professionals and Providers
2. Manufacturers of Product
3. Hea...
How to report
20
1.Report should be on a standardized ADR reporting
form.
2.Dully filled the ADRs in the reporting from wh...
5.Any follow-up information for an ADR case that has
already been reported can be sent on another ADR
form, or communicate...
Why post-marketing surveillance and reporting ADR
is needed
The information collected during the pre-marketing phase of
dr...
ADR reporting form, IPC
23
ADR reporting form, CDSCO
24
Fig.2: Workflow of PV for reporting ADR 25
What happens to submitted information
26
1.The causality assessment is carried out at Adverse Drug
Reaction Monitoring Cen...
Argus oracle method of ADR reporting
27
• It is a software for ADR monitoring, mainly used by
drug manufacturer in USA.
• ...
Capabilities of the software
28
• Single global database
• Case processing updates
• E2B compliance( ICH)
• Periodic submi...
Adverse
event
Literature
review
Data entry of adverse
event information
Coding of event
and drug info
Medical
review
Writi...
Aris g Pharmacovigilance
30
•It is a software for ADR monitoring, and is mainly used
by drug manufacturer in Europe.
•Aris...
Vigiflow, Vigibase
31
• Vigiflow: It is a management system for recording,
processing and sharing reports of adverse effec...
Fig.4: Reporting system in Vigiflow
ICSRs uploaded in Vigiflow at AMC
Received at
NCC for quality
Valid or
complex
ICSR
WH...
Conclusion
33
In India, PV system has increased awareness in people
regarding ADR reporting. The issues of underreporting ...
References
34
1.Safety Monitoring of Medicinal Products. Guidelines for setting
up and running a Pharmacovigilance centre....
35
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Adr reporting ppt

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Adr reporting ppt

  1. 1. ADVERSE DRUG REACTION REPORTING TOOLS RIMA SINGH M. Pharm, 2nd Sem (DEPARTMENT OF PHARMACOLOGY) INDO-SOVIET FRIENDSHIP COLLEGE OF PHARMACY, MOGA 1
  2. 2. Contents 2 • Introduction • History • Adverse drug reaction • ADR reporting tools • Role of Pharmacovigilance in ADR monitoring • Methods of ADR reporting and Process • Software used in ADR reporting • Conclusion • References
  3. 3. Introduction 3 Clinical trial study of the drug detects ADR but, the reactions occurs after long duration in a specific population remains undetected. So, (PV) Pharmacovigilance is a activity which keeps constant watch on the drug throughout its life cycle. In India, IPC and NCC through the CDSCO regulate the PV activity. Then Pharmacovigilance programme in India have been proposed in 2010. Anyone can report ADR by filling the suspected ADR reporting form available online or offline to the nearest centers in suitable languages. Then, the reported ADRs are collected and processed at the centers in vigiflow software. The centers detects signals which are reported to CDSCO and WHO.
  4. 4. Adverse drug reaction According to WHO, an adverse drug reaction defined as, “Any response to a drug which is noxious unwanted effect of drug doses used in human for prophylaxis, diagnosis and therapy”. For example, (when drug metabolism is temporarily inhibited by a disorder or another drug). 4
  5. 5. 1957- Thalidomide tragedy. 1968- WHO Programme established with 10 member states for International ADR terminology and drug dictionary. 1969- Definition of Adverse drug reaction. 1978- Operations transferred to the UMC (Uppsala) from WHO(Geneva); setting-up of relational database management system. grading field was added to Vigibase. 1991- On-line WHO database search programme available to national centre. 2001- Start of Vigibase Online project (now VigiFlow). 2010- 100th country joins the WHO Programme for International Drug Monitoring. 5 History
  6. 6. Type Type of Effect Characteristics Example A Augmented Dose dependent, Predicted from the known pharmacology of the drug Hypoglycemia- insulin B Bizarre Unpredictable, Dose independent, Rare. Anaphylaxis to penicillin C Chronic Prolong treatment. Analgesic - neuropathy D Delayed After years of treatment. Antipsycotic- turdive dyskinesia, 6 Types of ADR
  7. 7. Adverse drug reaction reporting tools 7 Adverse drug reactions reporting tools or monitoring is a process of continuously monitoring of undesirable effect suspected to be associated with use of medical products. ADR reporting covers all pharmaceutical products, biological, herbal drugs, cosmetics and medical devices.
  8. 8. Healthcare professionals Peripheral centers Regional centers Zonal centers NPC/CDSCO WHO/UMC Fig.1: ADR reporting process 8
  9. 9. Objectives of ADR monitoring 9 1. Todetect the nature and frequency of ADRs 2.To assist the Drug Regulatory Authority, Public Health Programs, Scientists and Consumer Society to minimize ADRs. 3.Providing updated Drug Safety Information to Health Care Professionals. 5.Dissemination of information by designing proper education program to consumers 6.To identify risk factors that may predispose, induce or influence the development, severity and incidence of ADRs.
  10. 10. Benefits of ADR monitoring 10 and safety of1. It caters information about quality pharmaceuticals products. 2. It initiates risk management plans. helps in3. It prevent the predictable adverse effects and measuring ADR incidence. 4. It instructs health care team, patients, pharmacists and nurses about adverse drug effects and creates awareness regarding ADRs.
  11. 11. Information required for ADR monitoring 1. Patient Information 2. ADRs Description 3. Information Related to Suspected Drug(s) 4. Information on Management of ADR 5. Information about the reporter 11
  12. 12. ADR monitoring studies for the identification of adverse events. 12 monitor• Case reports: This is done to unpredictable ADRs. • Anecdotal reporting: This monitoring is done for the medicinal product whose ADR are not reported in medical bulletin. • Impulsive reporting system: it is most efficient and spontaneous method of ADR recording.
  13. 13. • Intensive monitoring 13 studies: In this, selected population is screened and continuously watched to record all the events when the drug or different drug is administered. • Contingent studies: These types of studies are conducted on population on a specific conditional bases and comparing a particular drug ADR group or population with another population having similar treatment.
  14. 14. • Case control studies: These are retrospective study design. Patient have illness or disease due to the use of drug are investigated to check if they have taken the drug, these patients are compared with matched control group. • Case cohort studies: Both prospective & retrospective in nature. • Meta analysis: It is performed by applying statistical analysis on two or more independent studies to predict the long term outcomes of a particular drug treatment or a disease situation. 14
  15. 15. Methods of ADR monitoring 15 •Spontaneous reporting: Mostly used ADR for monitoring, it records the safety of a drug based on post marketing surveillance to identify new, rare, serious ADRs of a drug. •Case series reporting: It is used to develop a hypothesis between approved drugs and it outcomes. •Stimulated reporting: It encourages and facilitates health professionals report ADRs under special situation.
  16. 16. Active surveillance: It which 16 is pre-designed is conducted in addition to process passive surveillance to find out more serious adverse drug events. Comparative observation studies: Includes study designs such as cross- sectional, cohort and case study to compare the possible ADR associated with drug use with other group etc.
  17. 17. Role of pharmacovigilance in ADR monitoring 17 Different study designs are included for proper pharmacovigilance study: a. Descriptive studies: It is conducted to obtain the rate of outcome of drug use in specific population. b. Analytical studies: Analytical studies are performed to study related outcomes of the exposure to the drugs. c. Observational based study: Usually help to evaluate the effectiveness of the drug in the patients during treatment.
  18. 18. What to report 1.All ADRs as a result of Prescription and Non-Prescription medicinal products. 2. All suspected ADRs regardless of product information provided by the company. 3. Unexpected reaction with the product regardless of their nature or severity. 4. A serious reaction, whether expected or not. 5.All suspected ADRs associated with drug-drug, drug- food or drug-food supplements interactions. 6. ADRs occurring from overdose or medication error. 7. Unusual lack of efficacy or when pharmaceutical defects are observed. suspected 18
  19. 19. Who should report 19 as possible. inaccurate 1. Health care Professionals and Providers 2. Manufacturers of Product 3. Health care centers When to Report 1. ADR should be reported as soon 2.Delay in reporting make the report and unreliable
  20. 20. How to report 20 1.Report should be on a standardized ADR reporting form. 2.Dully filled the ADRs in the reporting from when an ADR is encountered. 3.Use a separate from for each patient and filled with the complete information. 4.The completed ADR form is then returned to the nearest adverse drug reaction monitoring Centre (AMC) or to National Coordinating Centre.
  21. 21. 5.Any follow-up information for an ADR case that has already been reported can be sent on another ADR form, or communicated by telephone, fax or e-mail. 6.Follow-up reports should be identifiable and the following should be indicated on the report a) Follow-up Information b) Date of Original Report c) Patient Identity 21
  22. 22. Why post-marketing surveillance and reporting ADR is needed The information collected during the pre-marketing phase of drug development is incomplete with regard to possible ADRs. This is mainly because, tests in animals are insufficient to predict human safety, Patients used in clinical trials are selected and limited in number, the conditions of use differ from those in clinical practice and the duration of trials is limited. Information about rare but serious adverse reactions, chronic toxicity, use in special groups (such as children, the elderly or pregnant women) or drug interactions is incomplete or not available. Thus, post-marketing surveillance is important to permit detection of less common, but sometimes very serious ADRs. 22
  23. 23. ADR reporting form, IPC 23
  24. 24. ADR reporting form, CDSCO 24
  25. 25. Fig.2: Workflow of PV for reporting ADR 25
  26. 26. What happens to submitted information 26 1.The causality assessment is carried out at Adverse Drug Reaction Monitoring Centers (AMCs) by using WHO-UMC scale. 2.The analyzed forms are forwarded to the National Coordinating Centre through the ADR database. 3.Finally the data is analyzed and forwarded to the Global Pharmacovigilance Database managed by WHO Uppsala Monitoring Center in Sweden. 4.The reports are periodically reviewed by the National Coordinating Centre (PvPI). 5.The information generated on the basis of these reports helps in continuous assessment of the benefit-risk ratio of medicines.
  27. 27. Argus oracle method of ADR reporting 27 • It is a software for ADR monitoring, mainly used by drug manufacturer in USA. • It is a comprehensive pharmacovigilance platform enabling manufactures to make faster and better safety decision and risk management. • In other words it is necessary for clinical and post marketing surveillance.
  28. 28. Capabilities of the software 28 • Single global database • Case processing updates • E2B compliance( ICH) • Periodic submission • Advance querying and reporting • Data model for single detection • Automated unblinding, etc.
  29. 29. Adverse event Literature review Data entry of adverse event information Coding of event and drug info Medical review Writing case narratives Safety data reconciliation Verificationof case information Aggregate report writing Regulatory reporting Periodic safety update reports 29 Fig.3: Argus work flow
  30. 30. Aris g Pharmacovigilance 30 •It is a software for ADR monitoring, and is mainly used by drug manufacturer in Europe. •Arisg is a leading pharmacovigilance and clinical safety system that helps companies efficiently process all safety cases and generate appropriate global reports for distribution to regulatory authorities and partners.
  31. 31. Vigiflow, Vigibase 31 • Vigiflow: It is a management system for recording, processing and sharing reports of adverse effects. It supports the domestic collection and processing of individual case safety report data. • Vigibase: It is the single largest drug safety data repository in the world. Since 1978, the Uppsala Monitoring Centre on behalf of WHO, have been maintaining Vigibase, used to obtain the information about a safety profile of a medicinal product.
  32. 32. Fig.4: Reporting system in Vigiflow ICSRs uploaded in Vigiflow at AMC Received at NCC for quality Valid or complex ICSR WHO-UMC Sweden CDSCO HQ 32 QuerySafety updates Invalid ICSR Revert to AMC
  33. 33. Conclusion 33 In India, PV system has increased awareness in people regarding ADR reporting. The issues of underreporting are resolving due to available reporting facilities like toll free dial number, message, mail and ADR form in vernacular languages. Various multinational companies have started the outsourcing of PV activity in India which is creating the good PV culture. Various universities have incorporated PV courses in their curriculum as compulsory or elective subject. Still government needs to focus on the awareness and enhancement of pharmacists knowledge and providing them facilities and power to conduct PV activity. Every hospitals should have special PV cell for ADR monitoring.
  34. 34. References 34 1.Safety Monitoring of Medicinal Products. Guidelines for setting up and running a Pharmacovigilance centre. Uppsala Monitoring Centre-WHO Collaborating Centre for International Drug Monitoring, EQUUS, London, 2000. 2.Ghewari P, Salunke S, Bhatiya N, Killedar S (2014) Strategies and current scenario of pharmacovigilance in India. JADD 1: 122-134. 3.Indian Pharmacopoeia Commission Pharmacovigilance Program of India. 4.World Health Organization (2002) World Health Organization Collaborating centre for International Drug Monitoring. The Importance of Pharmacovigilance Safety Monitoring of Medicinal Products, Geneva.
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