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.

1. Name: Shaikh Awais Shaikh Abbas
Roll no: 55
M.Pharm Pharmacology I yr II Sem
Department: Pharmacology
Subject Incharge: Dr. Khan Dureshahwar
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MAULANA AZAD EDUCATIONAL TRUST’S, Y. B. CHAVAN COLLEGE OF
PHARMACY, AURANGABAD.

2. Introduction
• Passive surveillance system
• 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.
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3. Spontaneous ADR Reporting process:
Data acquisition
Data assessment
Data interpretation
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4. Data Acquisition
 Which depends largely on input of information derived from reports submitted by health
professionals who have encountered what they suspects in an ADR.
 Which involves assessment of the individual case reports and assessment of pooled data
obtained from various sources such as international database of the WHO.
 Data interpretation based on available data and assessment made, a signal related to the
adverse reaction may be generated.
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Data Assessment
Data Interpretation

5.  A spontaneous report is an unsolicited communication by healthcare
professionals or consumers, pharmaceutical companies to National
Pharmacovigilance Centre (NPC) or other organisations (CDSCOs, AMCs)
that describes one or more suspected ADR in a patient given a medicinal
product that does not drive from study or any organised data collection
scheme.
 Presently Pharmacovigilance program of India (PvPI) is following
spontaneous reporting system to collect data on drug safety.
 Doctors are provided with forms, upon which, if they detect any suspected
ADRs, they can notify it to “ central authority”.
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6. Different countries ADR reporting system
India- suspected ADR reporting form
UK- Yellow card since 1964
Australia- Blue card since 1964
United States- Med watch
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7. Spontaneous Reporting- UK
• Authority’s key function: control of medicines by UK, Medicines and
Healthcare Products Regulatory Agency (MHRA) formed on 1st April 2003
from merger of Medicines Control Agency (MCA) and Medical Devices
Agency (MDA).
• Key functions: safety, efficacy and quality of medicines and safeguard public
health.
• Yellow card scheme introduced in 1964: after thalidomide tragedy.
• Over 600,000 confidential reports received in UK by:
• Doctors, dentists, pharmacists, nurses, health visitors, non medical prescribers
and now patients.
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8. India
• Indian Pharmacopoeia Commission (IPC), Ghaziabad is functioning as
National Coordination Centre (NCC) for
• Pharmacovigilance Program of India (PvPI),
• 150 ADR Monitoring Centres (AMCs) were established in various medical
institutions/hospitals across India to monitor and collect ADR reports under
NCC-PvPI.
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9. Suspected ADR Reporting form
• The NCC has designed a ‘Suspected Adverse Drug Reaction reporting form’
to record adverse reactions related to drugs.
• Seprate forms are available to record adverse reactions associated with
transfusion of blood and blood related products and Adverse Event following
Immunization (AEFI).
• Following are the information to be filled in an ADR form:
1. Patient Details
• Patient name or initials: A reporter should mention the name of patient or
initials of patient.
• Age at the time of event or date of birth: Write either the date of birth or
age of patient at the time of event occurred.
• Weight: Mention the weight of patient in kg.
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A. Patient Information

10. B. Suspected Drugs
• It may be one drug or more than one drug.
• The details of suspected medications such as:
 Drug name (brand or generic)
 Manufacturer
 Batch no. and expiry date
 Dose and route used
 Date of therapy started and stopped
 Indication of use must be provided by reporter.
 Concomitant drugs including self medication, OTC medication, herbal
remedies with therapy dates should be included by reporter.
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11. Suspected Adverse Drug Reaction
1. Describe reaction or any treatment given:
• A reporter must briefly describe the event in terms of nature, localization etc.
For eg: Patient developed rash over upper and lower limbs
• The reporter must also indicate is any treatment is given against the suspected adverse
drug reaction
• Also mention if the suspected drugs was withdrawn or continued.
• Date of reaction started: Reporter must mention the date on which the reaction was
first occurred.
• Date of reaction stopped: If the reaction recovered, the date on which reaction stopped
should be reported.
• Outcomes: The reporter must tick the outcomes of event as
Recovered- if the patient has recovered from event
Recovering- if the patient is recovering from existing adverse event.
Continuing- if the patient is continuing to have symptoms of adverse event which
occurred.
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12. 2. Seriousness of the reaction:
If any event is serious in nature, a reporter must select the appropriate reason for
seriousness eg:
Death- if patient died due to adverse event
Hospitalized/prolonged- if the adverse event led to hospitalization or increased the
hospital stay of patient.
Life-threatning- if patient was at substantial risk of dying because of adverse event.
Significant Disability- if the adverse event resulted in substantial disruption of
person’s ability to conduct normal life functions.
Congential anamoly- if exposure of drug prior to conception or during pregnancy
may have resulted in adverse outcomes in the child.
Other medically significant- when the event does not fit the other outcomes but the
event may put up the patient at risk and may require medical or surgical intervention
to prevent one of the other outcomes.
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Reporter
•Name and professional address: A reporter must mention his/her name and
professional address on the form. The identity of reporter will be confidential if
necessary.
•Date of report: Mention the date on which he/she reported the adverse event.

14. Who can Report
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•Healthcare
professionals
(Physicians, dentists,
clinicians)
•Non healthcare
professionals
(consumers)
•Nurses
Pharmacists
•Pharmaceutical
companies

15. • All serious reactions, whether expected or not.
• ADR which are not clearly stated in package insert.
• Poisoning due to traditional or herbal, medicines, medical devices, contrast
media etc can be reported.
• ADR of new drug
• All suspected ADRs associated with drug-drug, drug-food interactions.
• ADRs occurring from overdose or medication error
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What to report

16. • Suspected ADR reporting forms for healthcare professionals and
consumers are available on website of IPC (www.ipc.gov.in) to report
ADR.
• NCC-PvPI created a helpline no. 1800-180-3024 to report ADR associated
with medical products.
• To remove language barrier in ADR reporting, the consumer reporting
form are made available in 10 languages (Hindi, Tamil, Telegu, Kannada,
Oriya, Bengali, Gujarati, Assamese, Marathi and Malayalam)
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How to report

17. • Various Peripheral, Regional and Zonal centers have been proposed and established
in India.
• Peripheral PV center: It is primary ADR information gathering center. It includes
small medical centers, private hospitals, dispensaries, nursing homes and
pharmacies.
• Regional PV center: It is regarded as secondary PV center, It is located in medical
college having relatively large facilities. They are identified and coordinated by
zonal centers.
• Zonal PV center: It’s regarded as tertiary PV center. Generally located in metro
city’s medical college having attachment of sufficient facility. It is identified by
CDSCO and act as first ADR data collection center. Zonal center for North and East
zone is AIIMS.
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Where to report

18. Health care professionals
Peripheral centers
Regional centers
Zonal centers
NPC/CDSCO
WHO/UMH
ADR reporting process
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Flow of ADR Reporting

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Work Flow
DATA
COLLECTION
DATA ENTRY
IN DATABASE
CESE
PROCESSING
REVIEW
PANEL
CASUALITY
ASSESSMENT
SIGNAL
DETECTION
AGGREGATE
REPORTING
REGULATORY
AUTHORITIES
ACTIONS

20. • All the ADR reports from various sources are collected at ADR Monitoring Center (AMC).
• PV staff at AMC study, validate and prioritize the report and perform provisional casuality
assessment.
• The assessed ADR forms are then directed towards authorized co-ordinating centers for further
proceedings.
• The AMCs staff maintains a record of all activities of center and carries out ADR monitoring of
drugs.
• The coordinating centers then conduct final casuality evaluation and feed the reports in PV database.
• These centers also prepare an aggregate report of ADRs collected at said time and send it to WHO-
UMC.
• The findings of PV analysis is then implemented and integrated into general population health
program.
• Finally, the integrated ADR data is transferred through Vigi-Flow database to UMC database.
• UMC team analyses the submitted data and detects drug- ADR relationship called as signal is very
important aspect and communicate with NCC-PvPI via CDSCO to stop marketing or use of drug in
India.
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Flow of ADR Reporting

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Examples
Drug ADR identified
Amisulpride Torsades de pointers
Cisapride Palpitations, tachyarrhythmias
Rosiglitazone Fluid retention and CHF
Clozapine Agranulocystosis
Amiodorane Hepatotoxicity, pulmonary fibrosis
Zimeldine Guillian-Barre syndrome
Fansidar Multi-system toxicity
Zomepirac Anaphylactoid reactions

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Pros & Cons of Spontaneous Reporting
PROS CONS
• Covers the whole population. . Inherent under reporting.
• Includes all medicine . Capture only suspected ADR.
• Continual monitoring through . Reporting Bias.
out life cycle of medicine.
• Detect signal of new, rare or serious ADR . Difficult to detect delayed ADR and ADR
with high background incidence.
• Most commonly used method. . Missing data.
• Easiest method to establish.
• Relatively inexpensive.
• Least labour intensive.

23. • Fear of litigation: fear of taking legal action in court of law.
• Lethargy or indifference about contributing to the general
advancement of knowledge.
• Guilt at having caused an adverse effect.
• Ignorance of the need for reporting.
• Diffidence: about reporting a mere suspicion
• Complacency: the mistaken belief that only safe drugs are
licensed.
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Why under Reporting

24. • Not aware of correct reporting centers.
• Did not have ADR reporting form
• Feeling that ADR was well known
• Was not sure about the drug causing ADR
• Did not have set procedure of ADR reporting in their organization.
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Reasons for Not Reporting ADR (India)

25. Thank you
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