Status of documentation grading and completeness score for Indian individual case safety reports.

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.

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.[1234] Currently 150 Adverse Drug Reaction Monitoring Centres are recognized to monitor and report adverse drug reactions (ADRs)[5] 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[6] 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

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 3rd quarter of 2011 to the 3rd 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)

Figure 1

Completeness score progress in each quarter of year 2011–2014

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.