The document discusses spontaneous reporting systems and reporting adverse drug reactions (ADRs) to regulatory authorities. It describes the spontaneous reporting process which involves data acquisition from health professionals, data assessment of individual case reports and pooled data, and data interpretation to generate signals related to ADRs. Health professionals voluntarily report suspected ADRs directly to regulatory authorities or pharmaceutical companies. Various countries have different reporting systems, like the yellow card system in the UK. Underreporting remains a limitation of spontaneous reporting systems.

1. SPONTANEOUS REPORTING
SYSTEM & REPORTING TO
REGULATORY AUTHORITIES
Presented By:
MOHD ASHHAR SUHAIL NOMANI
M.PHARM 2ND SEM
DEPARTMENT OF PHARMACOLOGY
JAMIA HAMDARD, NEW DELHI 1

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.
2

3. SPNTANEOUS ADR REPORTING
PROCESS
1. Data acquisition
2. Data assessment
3. Data interpretation
3

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.
4

5. DATA ASSESSMENT
• Which involves assessment of the individual
case reports and assessment of pooled data
obtained from various sources such as
international database of the WHO.
5

6. DATA INTERPRETATION
• Data interpretation based on available data
and assessment made, a signal related to the
adverse reaction may be generated.
6

7. • A Spontaneous report is an unsolicited
communication by healthcare professionals or
consumers, pharmaceutical companies to National
Pharmacovigilsnce Centre(NPC) or other
organisations(CDSCOs, AMC) 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”. 7

8. 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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9. SPONTSANEOUS 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
sageguard public health.
• Yellow card scheme introduced in 1964 after
thalidomide tragedy.
• Over 600,000 confidential reports received in UK by:
• Doctors, denstists, pharmacists, nurses, midwifes, health
visitors, non medical prescribers and now patients. 9

10. INDIA
• Indian Pharmacopoeia Commission(IPC),
Ghaziabad is functioning as National
Coordination Centre(NCC) for
Pharmacovigilance Program of India(PvPI).
• 150 ADR Monitering Centres (AMCs) were
established in various medical
institutions/hospitals across India to moniter
and collect ADR reports under NCC-PvPI.
10

11. 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:
11

12. A. PATIENT INFORMATION
1) Patient Details
• Patient name or initials: A reporter should mention
the name of patient or initials of patient.
For eg: Mohit Gupta or MD(whichever is convenient)
• 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 occured
• Sex: Mention the gender of patient.
• Weight : Mention the weight of patient in kg.
• Other relevant history: must also mention other
relevant history pertaining to patients including pre
existing medical conditions. For eg: Allergies,
Pregnancy, Alcohol use, Renal dysfunction. 12

13. 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.
13

14. 3. 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 if 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 occured,.
• Date of reaction stopped: If the reactions recovered,
the date on which reaction stopped should be
14

15. CONTD…
• 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.
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.
15

16. CONTD…
• 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.
• Congenital anamoly- if exposure of drug prior to
conception or during pregnancy may have resulted in
adverse outcome 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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17. 4. 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.
• Qualifications
• Date of report: Mention the date on which
he/she reported the adverse event.
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18. 18

19. WHO CAN REPORT
• Healthcare
professionals(physicians,dentists,clinicians)
• Non healthcare professionals(consumers)
• Pharmacists
• Nurses
• Pharmaceutical companies
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20. WHAT TO REPORT
• 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 in case of drug abuse and drug use in
pregnancy and during lactation.
• ADRs occurring from overdose or medication error.
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21. HOW TO REPORT
• 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).
21

22. WHERE TO REPORT
• Various Peripheral, Regional and Zonal centres have been
proposed and established in India.
• Peripheral PV centre: It is primary ADR information
gathering centre. It includes small medical centres, private
hospitals, dispensaries, nursing homes and pharmacies.
• Regional PV centre: It’s regarded as secondary PV centre.
It is located in medical college having relatively large
facilities. They are identified and coordinated by zonal
centres.
• Zonal PV centre: it’s regarded as tertiary PV centre.
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 centre. Zonal centre for
North and East zone is AIIMS. 22

23. FLOW OF ADR REPORTING
23

24. WORK FLOW
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DATA
COLLECTION
DATA ENTRY
IN DATABASE
CESE
PROCESSING
REVIEW
PANEL
CASUALITY
ASSESSMENT
SIGNAL
DETECTION
AGGREGATE
REPORTING
REGULATORY
AUTHORITIES
ACTIONS

25. PROCESSING OF ADR
• All the ADR reports from various sources are collected
at ADR Monitering Centre(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 centres for further
proceedings.
• The AMCs staff maintains a record of all activities of
centre and carries out ADR monitering of drugs.
• The coordinating centres then conduct final casuality
evaluation and feed the reports in PV database. 25

26. CONTD…
• These centres also prepare an aggregate report of
ADRs collected at said time and send it to WHO-
UMC.
• The finding of PV analysis is then implemented and
integrated into general population health program.
• Fianally, the integrated ADR data is transfered
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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27. EXAMPLES
DRUG ADR identified
Amisulpride Torsades de pointes
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 27

28. PROS
• Covers the whole population
• Includes all medicine
• Continual monitering throgh
out life cycle of medicine
• Detect signal of new, rare or
serious ADR
• Most commonly used method
• Easiest method to establish
• Relatively inexpensive
• Least labour intensive
• Inherent under reporting
• Capture only suspected ADR
• Reporting Bias
• Difficult to detect delayed ADR
and ADR with high
background incidence
• Missing data
CONS
28
PROS & CONS OF SPONTANEOUS
REPORTING

29. WHY UNDER REPORTING
• 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.
29

30. REASONS FOR NOT REPOTING ADR
(INDIA)
• Not aware of correct reporting centres.
• 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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31. REFERENCES
• “Guidanace Document for Spontnaeous Adverse Drug
Reaction Reporting”, Spontaneous Reporting,
Published by Indian Pharmacopoeia Commission,
NCC-PvPI, 2014, Page no: 10-17
• ‘Post marketing surveillance of suspected adverse
drug reactions through spontaneous reporting :
current status, challenges and future’ by Muaed
Alomar, Ali M Tawfiq, Nageeb Hassan and Subish
Palaian, Therapeutic Advances in Drug Safety,2020
[journals.sagepub.com]
• https://www.slideshare.net/ Spontaneous Reporting
by Sonal Pande.
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