SPONTANEOUS REPORTING SYSTEM & GUIDELINES FOR ADR REPORTING.pptx

Good

1. SPONTANEOUS REPORTING SYSTEM & reporting to regulatory authorities Presented By: MOHD ASHHAR SUHAIL NOMANI M.PHARM 2 ND 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 Data acquisition Data assessment 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 8

9. SPONTSANEOUS REPORTING- UK Authority’s key function : control of medicines by UK Medicines and Healthcare Products Regulatory Agency(MHRA) formed on 1 st 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 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 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 reported. 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. 16

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. 17

18. 18

19. Who can report Healthcare professionals(physicians,dentists,clinicians) Non healthcare professionals(consumers) Pharmacists Nurses Pharmaceutical companies 19

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. 20

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 24 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. 26

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 Emepromium bromide Oesophageal ulceration 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. 30

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. 31