Spontaneous Reporting System
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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.
![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]](https://image.slidesharecdn.com/spontaneousreporting-121217113959-phpapp01-180417192837/85/Spontaneous-Reporting-System-27-320.jpg)
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]