Pharmacovigilance Indicators for Monitoring Health Interventions in India

The pharmacovigilance indicators outlined by the Indian Pharmacopoeia Commission focus on evaluating the status of pharmacovigilance systems in India. These indicators help measure the effectiveness of health services and interventions, identify strengths and weaknesses, and determine the impact and return on investments in pharmacovigilance. Key indicators include core structural, process, and outcome/impact indicators, emphasizing the need for simple, reproducible, and sensitive measures applicable to all facilities engaged in pharmacovigilance activities.

• Pharmacovigilance
• Health interventions
• India
• Monitoring
• Health services

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1. Pharmacovigilance Indicators Indian Pharmacopoeia Commission Ministry of Health & Family Welfare Ghaziabad National Coordination Centre Pharmacovigilance program of India

2. Indicators: Objective Measures that allow an evaluation of baseline situation and progress in health services and interventions. National Coordination Centre Pharmacovigilance program of India

3. WHY Pharmacovigilance Indicators ? -Needed to Measure status of Pharmacovigilance System. -Able to identify Strengths, Weakness, Achievements, Growth, Impact -Return on Investments in PV. National Coordination Centre Pharmacovigilance program of India

4. Classification: Background : Demographics, Economics, Healthcare system, Pharmaceutical Scenario . - Structure - Process - Output - Specific Indicators for public health Programmes. National Coordination Centre Pharmacovigilance program of India

5. Requirements: - Simple to understand - Easy to measure and interpret - Reproducible(Independent of investigator) - Sensitive to detect problems - Applicable to any Facility engaged in PV National Coordination Centre Pharmacovigilance program of India

6. Core Structural Indicators: Existance of: A PV centre with Standard Accommodation. - Human Resource to carry out its function properly. - ADR reporting format. - Collection, Recording and analysis of ADRs. - A News letter/ Information Bulletin/ Website for - PV information . - PV advisory committee or Expert committee. National Coordination Centre Pharmacovigilance program of India

7. Core process indicators: No. of ADR report received . - No. of Reports entered in Database. - Percentage of Total Annual Reports Acknowledged. - Percentage of reports submitted to WHO. - Percentage of Reports on therapeutic effectiveness. - Percentage of Reports on Medication errors. National Coordination Centre Pharmacovigilance program of India

8. Core outcome /Impact indicators: - No of regulatory actions taken based on national Data -Label Change -Safety warning -Medicine Suspension/ withdrawl/other Restrictions. - No. of medicine related Hospital Admission . - No. of medicine related Deaths. - Average duration of Extension of medicine related Hospital Stay. National Coordination Centre Pharmacovigilance program of India

9. Core indicators for public health programmes: - All main treatment guidelines /protocols in use within the PHP systematically . - Total no. of ADR report s collected within PHP. -Total no. of Reports submitted to NCC. - Percentage of completed reports submitted to NCC and to WHO. National Coordination Centre Pharmacovigilance program of India

10. Core indicator format: Definition. - Description and USE: -Source and method of data collection. -Calculation of indicators. -Limitations. -Measure -importance -Scope of Indicator -Results be interpreted National Coordination Centre Pharmacovigilance program of India

11. Assessment Checklist: Coordinator contact(s) for AMC audit Name of Coordinator for audit Contact number and e-mail address of Coordinator Date of Audit AMC where pharmacovigilance activities are performed AMC name AMC Address Telephone number(s) Qualified Person(s) for Pharmacovigilance (QPPV) Name of Technical Associate (QPPV) Contact number and e-mail address of Technical Associate National Coordination Centre Pharmacovigilance program of India

12. S.No Parameter Status Yes Remark S.No Parameter Status Yes Remark No No Quality Assurance Personnel s details 12 Does the source document mentions Essential Required Item (ERI) such as patient information/ reaction with date/ suspected drug with date/ outcome and sender information? Determine whether entry by Technical Associate in VigiFlow is should be same with documents. Whether all ADRs were reported in Suspected ADR Reporting Form. Verify the reporting the SAE to NCC and CDSCO. 1 Personnel prior education and GVP experience. 2 Whether provided by the Zone/NCC/ sponsor? Does personnel known Job descriptions/responsibilities? GVP training division/ 3 13 data Administrative Responsibility infrastructure is sufficient for PV? Whether sufficient working place? Whether logistic support provided by NCC such as Computer system, internet connection are work properly? source 4 Whether 14 5 6 15 timeline for Data collection and its security data 16 Use capture or data transcription from Suspected Reporting into an electronic record (VigiFlow). Record retention. of electronic 7 Storage of hard copies as well as soft copies of documents. ADR 8 Whether co-operation by other Dept to PV section? Documents review 17 18 9 Verify version number and effective date of SOPs provided to NCC with AMC s SOPs. Data security in case of disasters, e.g., power failure. Contingency backup files. Determine personnel has methods e.g., ID/password for the security of electronic data. 19 plans and 10 Verify Records/Certificates. Randomly Verify the data of source documents with entreated ICSRs. Training 20 whether Access User 11 National Coordination Centre Pharmacovigilance program of India

13. S.No Parameter Status Remark Yes No Competence of Technical Associate 21 He is conversant with the drug for which he is sending the report? Is he conversant with the rechallenge and dechallenge process? Is this a side effect or ADR? Any SAE reported from the centre? How quickly it was forwarded. 22 23 24 Authenticity of Data 25 Mechanism of identifying the patient from the registration number of the case report random check should be done by the inspecting team 26 27 28 How many times TA visits various wards. How quickly he sends the report to NCC. Is he taking interest in reporting drugs of current interest i.e. from CVS, Psychiatry, Oncology and Diabetes? 29 Interaction with coordinator frequency and documentation for the same. Name of Auditor: Auditor/ Inspector: Date of Audit: Stamp /Seal: National Coordination Centre Pharmacovigilance program of India

14. THANK YOU National Coordination Centre Pharmacovigilance program of India