|Year : 2015 | Volume
| Issue : 3 | Page : 325-327
Status of documentation grading and completeness score for Indian individual case safety reports
Kalaiselvan Vivekanandan, Kumar Rishi, Thota Prasad, Tripathi Arunabh, GN Singh
Pharmacovigilance Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghazibad, Uttar Pradesh, India
|Date of Submission||06-Feb-2015|
|Date of Decision||13-Mar-2015|
|Date of Acceptance||10-Apr-2015|
|Date of Web Publication||18-May-2015|
Dr. Kalaiselvan Vivekanandan
Pharmacovigilance Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghazibad, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour.
Keywords: Completeness score, individual case safety reports, Pharmacovigilance Programme of India, Uppsala Monitoring Centre
|How to cite this article:|
Vivekanandan K, Rishi K, Prasad T, Arunabh T, Singh G N. Status of documentation grading and completeness score for Indian individual case safety reports. Indian J Pharmacol 2015;47:325-7
|How to cite this URL:|
Vivekanandan K, Rishi K, Prasad T, Arunabh T, Singh G N. Status of documentation grading and completeness score for Indian individual case safety reports. Indian J Pharmacol [serial online] 2015 [cited 2022 Jul 4];47:325-7. Available from: https://www.ijp-online.com/text.asp?2015/47/3/325/157133
| » Introduction|| |
Pharmacovigilance Programme of India (PvPI) launched in the country in the year 2010 to ensure the safety of medicine. Indian Pharmacopoeia Commission functions as National Coordination Centre (NCC) for PvPI under the aegis of Ministry of Health and Family Welfare, Government of India. ,,, Currently 150 Adverse Drug Reaction Monitoring Centres are recognized to monitor and report adverse drug reactions (ADRs)  in VigiFlow, World Health Organization-Uppsala Monitoring Centre (WHO-UMC) web-based system to report ADRs and participating in international drug monitoring program. The Generated individual case safety reports (ICSRs) are evaluated by NCC and submitted to UMC. Documentation grading and completeness of ICSRs plays a vital role in quality of ICSRs also quality ICSRs facilitate the process of signal detection  NCC plays a very important role in generating quality ICSRs before submitted to UMC. UMC grades the ICSRs of every individual member of countries on quarterly basis. The Present article describes about the documentation grading and completeness score of Indian ICSRs for the period of July 2011 to December 2014.
| » Material and Methods|| |
The ICSRs received by NCC-PvPI for the period of July 2011 to September 2014, were evaluated for their completeness by applying the factors such as age at onset, free text, gender, indication, outcome, primary source, report type, time to onset. After this preliminary screening at the NCC level, the reports were further assessed for documentation grading and completeness score of data by WHO-UMC. WHO-UMC uses the following formula [Equation 1] for calculating completeness score for ICSRs.
Where, C = Completeness score, j = Drug-ADR combination, i = is the Field included in the score, wi = is the Field weight and fi = is the Field score, N = is total number of Drug-ADR combination.
The factors (fields) were taken into consideration for documentation grading and completeness score with their weights is given in [Table 1].
|Table 1: The number of factor considered for completeness scoring by WHO - UMC with their weight in equation 1 |
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The documentation grading-completeness score for Indian ICSRs as per WHO-UMC for the period of July 2011 to September 2014 is analyzed in this article.
| » Results|| |
The progress of completeness scoring pattern of Indian ICSRs reported during the period of July 2011 to Dec. 2015 is given in [Table 2]. The score ranges from 0.07 to 1. The full score was given if the all the mandatory fields [Table 1] are addressed. In [Figure 1] the completeness score for each quarter starting from 3 rd quarter of 2011 to the 3 rd Quarter of 2014 is depicted and the trend line of completeness score for each year given separately. It shows the growth of completeness score from 0.66 in September 2012 to 0.94 in September 2014.
|Table 2: Completeness scoring by WHO - UMC for Indian ICSRs.(year, quarter wise) |
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| » Discussion|| |
Indian Pharmacopoeia Commission started function as National Centre for PvPI since 15 April 2011 at that time major challenge was to initiate the culture of reporting rather than looking at the quality of reports. Health care professionals were sensitized to report the ADRs though less information available. The health care professionals were not trained on pharmacovigilance concept. Therefore the documentation grading and completeness score was around 0.6 during the period of year 2011 to 2012. After 2012 NCC organized several awareness training programs on pharmacovigilance and subsequently the quantity and quality of reports were increased in 2012-2013. During the year 2012-2013 the average completeness score increased to 0.8. In the year 2013-2014 NCC appointed technical associates to assist in the process of ADR monitoring and assessing of ADRs. These technical associates were trained on the concept of pharmacovigilance and to generate quality ICSRs. Therefore, the quality of reports was increased up to 0.94 out of 1. Since, to identify the signal from Indian Drug safety database, quality ICSRs by addressing all required fields is essential. This could be achieved only by organizing regular training to health care professional.
| » Acknowledgment|| |
Authors are sincerely thankful to UMC, Sweden, for providing useful tools and technical support to conduct this research.
| » References|| |
Kalaiselvan V, Sharma S, Singh GN. Adverse reactions to contrast media: An analysis of spontaneous reports in the database of the pharmacovigilance programme of India. Drug Saf 2014;37:703-10.
Kalaiselvan V, Prakash J, Singh GN. Pharmacovigilance programme of India. Arch Pharm Pract 2012;3:229-32.
Kalaiselvan V, Thota P, Singh A. Current status of adverse drug reactions monitoring centres under pharmacovigilance programme of India. Indian J Pharm Pract 2014;7:19-22.
Thota P, Vivekanandan K, Prakash J, Singh S, Singh GN. Weight gain in association with insulin use-An analysis of individual case safety reports an Indian database. J Pharmacovigil 2014;2:119.
Bergvall T, Norén GN, Lindquist M. vigiGrade: A tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf 2014;37:65-77.
Edwards IR, Aronson JK. Adverse drug reactions: Definitions, diagnosis, and management. Lancet 2000;356:1255-9.
[Table 1], [Table 2]
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