An analysis of completeness and quality of adverse drug reaction reports at an adverse drug reaction monitoring centre in Western India

Abstract

Purpose/Aim:The Adverse Drug Reaction [ADR] form is the source document for the Pharmacovigilance Programme of India [PvPI] and captures information first hand from the patient. The raw data from it then gets converted into an individual case safety report [ICSR] after entry into Vigiflow. The National Coordinating Centre [NCC] uses an instrument to assess quality of these ICSRs. We carried out the present study to assess whether the same instrument with minor modifications could be used to check the quality of ADR forms at our centre.Materials and Methods:ADR reports of three months from three consecutive years were selected randomly. The ADR form [18 fields] was matched with the NCC instrument [14 fields] as the latter is made from the former. A perfect ICSR would score 1. Three fields in the NCC instrument - case narrative, compliance with standard operating procedures [SOPs] and free text [5 components] were modified, while the rest were retained. Zero was given to the first two fields. In the third field, we retained only 3/5 components and changed the last two components [sender and reporter comments] to dechallenge and rechallenge while keeping the total score the same.Results:A total of 1008 ADR reports were analyzed. We found an overall completeness score of approximately 80% with the lowest completeness score being for the year 2015. The mandatory fields had close to 100% scores.Conclusion:The NCC instrument was found well suited to evaluate quality and completeness of ADR forms.

Analysis of voluntary reported adverse drug reactions in a tertiary care hospital

“…We completeness score was similar to study conducted by Manali et al except that they have also analysed quality along with completeness of ADR forms using NCC instrument. 15 Mandatory fields (patient initials, age at onset reaction, reaction, date of onset of reaction, suspected medication & reporter information) completely filled for 106 forms (32%) out of 330.…”

Adverse drug reactions reporting: Five years analysis from a teaching hospital

“…Each of these large sections were given 10 points. [ 12 13 ] Total score out of 40 was calculated by adding available information from the four mandatory sections [ Table 1 ]. The total completeness score was calculated as average out of ten.…”

Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework

“…Patient and public reporting of adverse drug reactions (ADRs) offers numerous advantages to health care systems, namely promotion of patient rights, earlier detection of important ADRs, and benefits to healthcare organizations from patient involvement [ 1 , 2 ]. Similarly, there is growing evidence of their value in establishing stronger causality of ADRs [ 1 - 6 ]. Initially established to address substantial under-reporting rates of healthcare professionals, in recent years, systems to receive ADR reports from patients and public have become increasingly common globally [ 3 , 5 , 7 ].…”

“…Patient and public reporting of ADRs has also been investigated, although a large part of this research has focussed on the value of patient and public reporting to health systems [ 1 , 6 , 27 , 28 ]. Such studies have included a 2017 systematic review [ 1 ], and numerous retrospective analyses evaluating the quality and characteristics of ADR reports by patients and public compared against those submitted by healthcare professionals [ 6 , 27 , 28 ].…”