Pharmacovigilance and Method of ADR reporting

CME on Pharmacovigilance at NIA

1. Pharmacovigilance and methods of Adverse Drug Reactions reporting Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India Dr. Lokendra Sharma Professor, Department of Pharmacology & Coordinator, ADR Monitoring Centre, SMS, Medical College, Jaipur.

2. Pharmacovigilance in India Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

3. National Pharmacovigilance Programme 02-Jan-2018 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

4. Adverse Drug Reaction (ADR) A response to a drug which is Noxious and Unintended occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. (WHO, 1972) Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

5. WHY ADR Reporting ? ADRs are among the leading causes of death in many countries (World Health Organization, 2008)   Account for 5% of all hospital admissions in India. Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3795320/ Constitutes a significant economic burden on the patient and government Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

6. Benefits of ADR Reporting Assess the safety of drug therapies, especially recently approved drugs . Provides updated drug safety information to health care professionals and other stakeholders Measuring the economic impact of ADR prevention as manifested through reduced hospitalization, optimal and economical drug use, and minimized organizational liability Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

7. Benefits of ADR Reporting Cont..... Regulatory action on the basis of ADR reports to ensure patient’s safety Upgrading package insert Marketing Authorization Recall (withdrawal) Batch recall based on clustering of ADR Changes in classification, e.g. From over the counter to prescription only medicines. Special prescription Restricted prescription Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

8. ADR Reporting Procedure Who can report What to report How to report Whom to report Where to report Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

9. Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India Who can report ? All healthcare professionals (Clinicians, Dentist, Pharmacist, Nurses, Physician, Physiotherapist etc) All non- healthcare professionals including consumers/ patients etc can report ADRs.

10. What to Report ? All types of suspected adverse reactions Known or unknown, Serious or non-serious and Frequent or rare Reactions from all types of pharmaceutical products Allopathy , Ayurvedic , Vaccines, Medical devices etc . Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

11. Indian Pharmacopoeia Commission , Pharmacovigilance Programme of India How & Whom to Report ? Use the ‘Suspected Adverse Drug Reaction Reporting Form/ Medicine side effect Reporting form which are available on the official website of IPC ( www.ipc.gov.in ) to report any ADR Link for ADR form http://ipc.nic.in/showfmkl;ile.asp?lid=416&EncHid= Filled ADR form submitted to nearest ADR Monitoring Centres (AMCs ) or directly to the NCC- PvPI . A reporter can also email the Suspected ADR form at [email protected] or [email protected] .

12. Health Care Professionals Consumer NCC-PvPI Ghaziabad AMCs Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India Industry Who can report? How to report ?and whom to report?

13. A reporter can also report ADR Via Helpline number launched in October 2013 1800 -180- 3024 ( Monday to Friday 9:00AM to 5:30 PM) Toll free-Helpline Number Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

14. Android Application ADR Reporting App. can be downloaded from Google play store (free to download) Indian Pharmacopoeia Commission , Pharmacovigilance Programme of India ADR-PvPI is the indigenously developed Mobile App for all healthcare professionals and consumers to report adverse drug reactions

15. Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India Worldwide Reporting Forms CIOMS for US MED-WATCH FOR UK

16. ADR Reporting form for Healthacare Professionals Indian Pharmacopoeia Commission , Pharmacovigilance Programme of India

17. Suspected Adverse Drug Reaction Reporting Form For Health Care Professionals This form is divided into four sections: Patient Information Suspected Adverse Reaction Suspected Medication(s) Reporter Details Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

18. A. Patient Information Indian Pharmacopoeia Commission,Pharmacovigilance Programme of India Patient Information Patient Initials _____________ 2. Age at time of event or date of birth __________________ 3. M □ F □ Other □ _________________________________ 4. Weight __________ Kgs

19. B. Suspected Adverse Reaction Suspected Adverse Reaction 5. Date of reaction started ( dd /mm/ yyyy ) 6. Date of recovery ( dd /mm/ yyyy ) 7. Describe reaction or problem Indian Pharmacopoeia Commission,Pharmacovigilance Programme of India

20. C. Suspected Medications Indian Pharmacopoeia Commission , Pharmacovigilance Programme of India Suspected medication(s) S.No 8. Name (Brand /Generic) Manufacturer (If known) Batch No./ Lot no. Exp. Date (if known) Dose used Route used Frequency (OD,BD, etc.) Therapy dates Indication Causality assessment Date started Date stopped i ii.

21. C. Suspected Medications Cont... Action taken- Mark the appropriate option for the action taken with respect to Suspected drug. Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India S.No. as per C 9. Action Taken ( Please Tick) Drug withdrawn Dose increased Dose reduced Dose not changed Not applicable Unknown i ii

22. C. Suspected Medications Cont.. Rechallenge/ Reintroduction - The point at which a drug is again given to a patient after its previous withdrawal. Mark the appropriate option whether the suspected drug reintroduced & reaction occurred or not or effect unknown. Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India 10. Reaction reappeared after reintroduction ( Please Tick) S.No. Yes No Effect Unknown Dose (If reintroduced) i ii

23. Concomitant medications Cont.. Concomitant medical product (s) information given in the following tabs. Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India 11. Concomitant medical product including self medication and herbal remedies with therapy dates (exclude those used to treat reaction) S.No. Name (Brand /Generic) Dose used Route used Frequency (OD, BD, etc.) Therapy dates Indication Date started Date stopped i ii

24. D. Reporter Details Indian Pharmacopoeia Commission,Pharmacovigilance Programme of India D. Reporter Details 16. Name and professional address ____________________________ Pin ___________________ E - mail___________________________ Tel. No. (With STD code)____________________________________ Occupation__________________________ Signature ___________ 17. Date of this Report ( dd /mm/ yyyy ) ___________________________

25. Other important sections of ADR Reporting form Indian Pharmacopoeia Commission , Pharmacovigilance Programme of India 12. Relevant test and laboratory data with dates 13. Relevant medical / medication history ( Allergies, race, pregnancy, smoking , alcohol use, renal and hepatic dysfunction etc.) 14. Seriousness of the reaction: No □ If Yes □ (please tick anyone) □ Death ( dd /mm/ yyyy ) □ Congenital anomaly □ Life threatening □ Required intervention to prevent permanent impairment/ damage □ Hospitalization/ prolonged □ Disability □ Other (specify)

26. Other important sections of ADR Reporting form Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India 15. Outcome (please tick anyone) □ Recovered □ Recovering □ Not Recovered □ Fatal □ Recovered with Sequelae □ Unknown

27. Other important sections of ADR Reporting form Additional Information: More information on the ADR report that are not fit in the respective column given in ADR form can be entered in the filed of additional information (i.e. More information about suspected drug, indication etc.) Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

28. Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India Consumers can provide detailed first-hand information about their experiences with medicines and how these medicines have affected their life. NCC-PvPI launched its first ADR reporting form for consumers in August 2014 . Medicine Side Effect Reporting Form for Consumers and Journal Release

29. ADR reporting form for consumers (in Hindi) Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

30. Consumer Reporting Form launched in different languages by NCC- PvPI . Available in English, Hindi & Nine other regional language s Gujarati, Kannada, Bengali Malayalam, Oriya, Tamil Marathi, Telugu, Assamese Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India

31. Materiovigilance Programme of India ( MvPI ) To monitor and report the adverse events due to the medical devices , The MvPI was launched by the DCGI, Dr. G.N. Singh at Indian Pharmacopoeia C ommission, Ghaziabad, on July 6, 2015. The MoHFW , Government of India, nominated Sree Chitra Tirunal Institute of Medical Science & Technology , Thiruvanthapuram , As a National C ollaboration C entre and National H ealth S ystem R esource C entre for providing technical support.

32. Medical Devices Adverse Event Reporting Form

33. Adverse event following Immunization (AEFI) AEFI is defined as a medical event that takes place after immunization , cause concern and is believed to be caused by immunization programme . AEFI surveillance system in I ndia has come a long way since its inception in 1986. In I ndia, the safety of vaccines is monitored by the division of AEFI , Ministry of Health and Family W elfare, Government of India and PvPI .

34. AEFI reporting form ( in case of serious event ) Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

35. Haemovigilance Programme of I ndia Heamovigilance Programme of I ndia was launched on 10/12/2012 as an integral part of PvPI. National Institute of Biological, Noida is functioning as a National C oordination C entre for this P rogramme . It is responsible for 1. Collate & analyze adverse drug reaction data for blood and blood products 2. Help in identifying trends, recommend best practices and interventions required to improve patient care and safety, while reducing overall cost of the healthcare system.

36. Adverse Blood Donor Reaction Reporting Form Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

37. Transfusion Reaction Reporting Form (TRRF) For Blood & Blood Components & Plasma Products Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

38. VIGI Flow Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

39. VIGI FLOW Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

40. Journey of S.M.S. Medical College as ADR Monitoring Centre in Jaipur Establishment : In year 2011 by IPC Ghaziabad CME & Presentations : -3 CME - More than 40 presentation on PVI & ADR Reporting for the health care professional & consumer

41. Academics working in India with UK academics in Bangor, Manchester and Oxford Universities. The purpose of the GMHAT and GCRF-SASHI project is to help to find effective responses to deliberate PvPI,self -harm and suicide in South Asia by building research infrastructure and expertise in India .

42. Sensitization of PVI Training: 20 training for Doctors 4 training for Nurses 3 training for BDS student 4 training for Pharmacists & pharmacy students

43. Training of Digital technique of Students in Safe Medication

44. Poster on Pharmacovigilance

45. Details of Poster Presentations 1 st July, 2017 : Poster on “ Awareness on Pharmacovigilance and ADR reporting ” in Hindi was launched by the Principal, SMS Medical College, Jaipur . 16th December, 2017 :Poster on “ Materiovigilance - an Approach for monitoring and evaluation of medical device associated adverse events " presented at ICMR Institute , Jodhpur.

46. Details of Poster Presentations Poster presentation on " Pharmacists as Pharmacovigilance Practitioner " in the 12th Indo-African International Conference on on “Trends, Challenges and Future Scenario of Pharmaceutical Science” held on 6th March, 2018 at Arya College of Pharmacy, Jaipur .

47. ADR Reporting From SMS Medical College Targeted Reporting : In Year 2017 :Total 327 ADR reports have been sent to PVI Ghaziabad Monthly Average ADR reporting in 2017 : 27 / month From Jan to March 2018 : 91 ADR reports have been collected.

48. ADR Reporting From SMS Medical College Targeted Reporting : In Year 2017 :Total 327 ADR reports have been sent to PVI Ghaziabad Monthly Average ADR reporting in 2017 : 27 / month From Jan to March 2018 : 91 ADR reports have been collected.

49. ADR Monitoring in SMS Medical College ADR monitoring & reporting for the drugs used in national health programmers as NACO ,T.B., Deworming

50. Preface Medical students play an important role for screening the health status of public. So this study was undertaken to screen the hidden cases of ADR present among MBBS students Clinical Training .

51. Research Projects of Digital Training 1. Mental health assessment by medical students of Batch 2016 using GMHAT. 2. Mental health assessment by medical undergraduate of Batch 2017 students using GMHAT. 3.Assessment of Mental health of participants by MBBS Batch 2018 by using GMHAT. 4. To assess and compare the effect of traditional teaching with Integrated teaching in MBBS students with the help of GMHAT this also included in teaching timetable. 5. Use GMHAT By Postgraduate students in there training & thesis work on Cancer, HIV, TB, Diabetes and Osteoarthritis patients.

52. Projects with National and international university Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

53. Approach Integrated teaching on PvPI was implemented by the active involvement of the departments of Physiology, Medicine and Psychiatry etc. At the end of their training, both groups were again assessed with a post-test questionnaire.

54. Present Pharmacovigilance Committee Dr. Lokendra Sharma : Co-ordinator Dr. Rupa Kapadia : Member Secretary Dr. Monica Jain : Assistant Co-ordinator Dr. Monika Mishra : Member Chaitanya Prakash : Pharmacovigilance Associate There are also co-opting Pharmacovigilance members from the various Departments of SMS Medical College, Jaipur.

55. ADR Monitoring Centers Total number of Adverse Drug Reaction Monitoring Centres in India : 250 ( till Dec-2018 ) Total number of Adverse Drug Reaction Monitoring Centres in Rajasthan : 11 (till Jan-2019) S.M.S. Medical College, Jaipur S. P. Medical College, Bikaner R.N.T. Medical College, Udaipur Dr. S. N. Medical College, Jodhpur Government Medical College, Kota J.L.N. Medical College, Ajmer Institute of Respiratory Diseases, Sashtri Nagar, Jaipur AIIMS, Jodhpur Geetanjali Medical College, Udaipur NIMS Medical College, Jaipur JNU Medical College, Jaipur

56. Adverse drug reactions (ADRs) are reported from all over the country to National Co-ordination Centre, W hich also work in collaboration with the Global ADR Monitoring Centre ( WHO-Uppsala Monitoring Centre, Sweden) to contribute in the Global ADRs data base. NCC-PvPI monitors the ADRs among Indian population and helps the drug regulatory authority of India in taking decisions for safe use of medicines in the country.

57. Government is running four programmes for patient safety in India Pharmacovigilance programme in India: Monitoring of ADRs due to medicine Materiovigilance programme of India : Monitoring of ADRs due to medical device Haemovigilance Programme of India: Monitoring of ADRs due to blood product Adverse Event Following Immunization: Monitoring of ADRs due to vaccine *

58. ADR reporting status In the Year-2017 : 327 ADR reports were sent From January to December-2018 : 463 ADR reports have been sent to NCC-PVPI. From January-2011 to June-2018 : More than 2000 ADR reports have been sent to the National coordination Centre-Pharmacovigilance Programme of India.

59. CMEs and Seminar organized at AMC One day CME on “ Pharmacovigilance it’s relevance in current Medical Practice ” was organized on 23 rd September, 2011 at Rajasthan University of Health Sciences, Jaipur. A half day Seminar on “ Pharmacovigilance ” funded by Indian Pharmacological Society was held on 17 th September, 2012 in the Library Seminar Hall, SMS Medical College, Jaipur. One day CME on “ Pharmacovigilance ” funded by Indian Pharmacopoeia Commission, Ghaziabad with the technical support of PGIMER, Chandigarh, was organized on 08 th May, 2015 in the Library Seminar Hall, SMS Medical College, Jaipur.

60. CME organized on 8 th May 2015

61. Awareness programmes and PV trainings Total 41 Awareness programmes and PV trainings on Pharmacovigilance have been conducted at ADR Monitoring Centre, and other hospitals as well as Medical, Nursing and Pharmacy Colleges. More than 2800 healthcare professionals and students have been sensitized through these programs and trainings.

62. Poster publications A poster regarding “Awareness on Pharmacovigilance and ADR reporting” in hindi was launched on 1 st July, 2017 by Dr. U. S. Agrawal , Principal & Controller , SMS Medical College, Jaipur. The Addl. Principal, Coordinator, Members of Pharmacovigilance Committee and the Faculty, Department of Pharmacology, SMS Medical College, Jaipur were present in the launching ceremony. The poster was placed in various clinical Departments of SMS Medical College & attached hospitals.

63. Launching of Pharmacovigilance Poster on 01 st July, 2017

64. Pharmacovigilance poster in Hindi

65. Activities in the Science of life exhibition held from 15 th Feb, 2018 to 25 th Feb, 2018 at SMS Medical College, Jaipur.

66. Appreciation by Principal Sir for Good Pharmacovigilance Stall

67. PV-Sensitization during Exhibition

68. Sensitizing nursing students

69. Sensitizing medical students

70. Sensitizing Pharmacy students

71. Workshop-cum-Training Programme on Pharmacovigilance for NABH-Accredited Hospitals in Rajasthan State   Indian Pharmacopoeia Commission, National Coordination Centre (NCC) for Pharmacovigilance Programme of India ( PvPI ), has signed a Memorandum of Understanding with National Accreditation Board for Hospitals and Healthcare Providers (NABH) for effective implementation of ADR-reporting. To train NABH-Accredited Hospitals staff on Pharmacovigilance, one day Workshop-cum-Training programme was organized on 20 th June 2018 at Santokba   Durlabhji Memorial Hospital, Jaipur. 62 healthcare professionals participated in the Workshop.

72. Filled ADR reporting form

73. ADR Data entry through Vigiflow VigiFlow is a web-based Individual Case Safety Report (ICSR) management system that is available for use by national pharmacovigilance centres of the WHO Programme for International Drug Monitoring. VigiFlow supports the collection, processing and sharing  of data of ICSRs to facilitate effective data analysis.

74. ADR Data entry through Vigiflow ADRs reports ( Individual Case Safety Report) are processed through VigiFlow to NCC, Ghaziabad. At NCC, the Signal Review Panel, Quality Review Panel evaluate the ICSR and send the regulatory recommendations to the CDSCO, New Delhi.

75. Please Report Adverse Drug Reactions (Known, Unknown, Serious and Non-Serious) Due to Medicines, Medical Devices, Blood products, Vaccines and Herbal products To Adverse Drug Reaction Monitoring Centre, SMS Medical College, Jaipur. Dr. Lokendra Sharma Prof. Pharmacology & Coordinator, Phone No. 9414048334, 0141-2518682 Email ID: [email protected] Mr. Chaitanya Prakash Patient Safety-Pharmacovigilance Associate Mob. No . 7727017839 Email ID: [email protected] ADR Reporting Toll free number: 1800-180-3024 ADR reporting Android App ‘ADR PvPI’ available on Google play Store For more information please visit at www.ipc.gov.in

76. Pharmacovigilance sensitization with EC of NIA Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

77. THANK YOU . Lets join hands to promote patient safety