The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) data assessment of individual cases and pooled data, and 3) data interpretation to generate safety signals. Countries have different reporting forms, like the Yellow Card used in the UK since 1964. Factors like educational campaigns and inclusion of reporting options in prescription pads have helped increase reporting rates in the UK. India's Pharmacovigilance Programme similarly encourages voluntary reporting of all suspected adverse reactions via established adverse drug monitoring centers.

1. Jasdeep Singh
(Pharmacology)
Spontaneous
Reporting
System

2. THE SPONTANEOUS REPORTING
SYSTEM
 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 a voluntary basis

3. The spontaneous
reporting system
process
1. Data acquisition
which depends largely on the input
of information derived from reports
submitted by the health professionals
who have encountered what they
suspect is an ADR
The spontaneous reporting
system
1.data acquisition
2.data assessment
3.data interpretation

4. The spontaneous
reporting system
processes:-
2. data assessment
which involves assessment of
the individual case reports and
assessment of pooled data
obtained from various sources
such as the international database
of the WHO
The spontaneous reporting
system
1.data acquisition
2.data assessment
3.data interpretation

5. The spontaneous
reporting system
processes:-
3. data interpretation
based on the available data and
the assessments made, a signal
related to the adverse reaction
may be generated
The spontaneous
reporting system
1.data acquisition
2.data assessment
3.data interpretation

6.  India – ‘Suspected Adverse Drug
Reaction Reporting Form’
 UK – ‘Yellow Card’, since 1964
 Australia – ‘Blue Card’ , since 1964
 US – ‘Med Watch’

7. Spontaneous reporting - UK
Lincencing authority: Ministers, including Sect., of state for
health .
 Authority’s key function: control of medicines by
the 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, quality and efficacy of
medicines and safeguard public health.

8. Introduction of yellow card scheme
• Introduced in 1964 (Sir Derrick Dunlop) after
thalidomide tragedy
• Over 600,000 confidential reports have been
received in UK
• Doctors, dentists, pharmacists, coroners, nurses,
midwifes, health visitors
• Non medical prescribers and
now patients
• MHRA can detect duplicate reports

9. • Survey in 1984: Only 16% of doctors who were
eligible to report suspected ADRs to the Scheme
had actually submitted a Yellow Card between
1972 and 1980.
• Analysis of Yellow Card reports submitted
between 1992 and 1995 showed that around one-
third of practising doctors submitted report.

11. a.Introduction of the CSM(committee on safety of
medicines) drug safety bulletin Current
Problems in Pharmacovigilance
b.The inclusion of a yellow page in
prescription pads used by GPs
Reasons

13. Information to include on a
Yellow Card
 4 critical pieces of information that must be
included on the report :-




Suspected drug(s)
Suspect reaction(s)
Patient details
Reporter details

14. Suspected Drug(s)
• Name of medicine
• including brand and batch number if known
Route of administration
• Daily dose
• Date medicine started
and stopped if applicable
• Reason why the medication was given
• Multiple drugs can be listed if more than one
drug is suspected of causing the reaction

15. Suspect reaction(s)






Describe the reaction
Include a diagnosis if relevant
Include when the reaction occurred
whether the reaction was considered to be serious
and complete tick box for reasons why
Document if any treatment was given for the
reaction
Eventual outcome tick relevant box

16. Patient Details





Sex of the patient
Age at time of reaction
Weight if known
Do not need to know name or DOB as this could
identify patient and break patient confidentiality
Patients initials and local identification number
(hospital or practice number) which will identify
patient to you in the event of future
correspondence

17. Reporter details
 Must be completed in all cases
 Name and full address
Need to acknowledge receipt of report
and follow up further information if
necessary.
 Profession

18. Drug Safety Update
–Published monthly
Registerfor alerts
http://www.mhra.gov.uk/Publication

19. Drug Analysis Prints (DAPs)



Complete list of all suspected ADRs reported via
yellow card scheme for named suspect drug
Inclusion of a particular reaction does not
necessarily mean it has been caused by the drug
Certain reported reactions are conditions which
occur spontaneously
Reporting rates are influenced by seriousness of
ADR, ease of recognition, extent of use
www.mhra.gov.uk/daps


21. Where to find ADR information


Reference texts
British National Formulary (BNF)
Summary of Product Characteristics (SPC)
Martindale
AHFS Drug information
Meyler’s 'The Side effects of drugs
Davies’ textbook Adverse Drug Reactions
Lee’s textbook Adverse Drug Reactions
Journals
Adverse Drug Reaction Bulletin
Drug Safety Update
Medline/Embase/Pharmline search
Electronic sources
Micromedex
www.mhra.gov.uk

22. INDIA
• Indian Pharmacopoeia Commission (IPC), Ghaziabad is
functioning as a National Coordination Centre (NCC)
for Pharmacovigilance Programme 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

23. What to Report
• PvPI encourages all types of suspected ADRs
reporting whether they are known, unknown,
serious, or nonserious, frequent.
• ADRs related with the use of allopathic
medicines, vaccines, traditional medicines, medical
devices, contrast media, etc., can be reported.

24. Where to Report
• All healthcare professionals (clinicians, dentists,
pharmacists, nurses) and patient/consumers can report
ADRs to NCC or AMCs.
• The pharmaceutical companies can also send
individual case safety reports for their product to NCC.

25. How to Report
• Suspected ADR reporting forms for healthcare
professionals and consumers are available on the
website of IPC to report ADR.
• To remove language barrier in ADR reporting, the
consumer reporting form are made available in 10
vernacular languages (Hindi, Tamil, Telugu, Kannada,
Bengali, Gujarati, Assamese, Marathi, Oriya, and
Malayalam)

27. References
1.Kalaiselvan V, Mishra P, Singh GN. Helpline facility to assist reporting
of adverse drug reactions in India. WHO South East Asia J Public
Health. 2014;3:194.
2.Kalaiselvan V, Prasad T, Bisht A, Singh S, Singh GN. Adverse drug
reactions reporting culture in pharmacovigilance programme of
India. Indian J Med Res. 2014;140:563–4. [PMC free article] [PubMed]
3.Vivekanandan K, Rishi K, Prasad T, Arunabh T, Singh GN. Status of
documentation grading and completeness score for Indian individual
case safety reports. Indian J Pharmacol. 2015;47:325–7.[PMC free
article] [PubMed]

28. Thank You.
ਧੰ ਨਵਾਦ।