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Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India.

Tandon VR, Mahajan V, Khajuria V, Gillani Z - Indian J Pharmacol (2015 Jan-Feb)

Bottom Line: The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR.UR is a matter of concern PvPI.Multiple interventions are needed to improve ADR reporting.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology and Therapeutics, Government Medical College, Jammu, J and K, India.

ABSTRACT

Aim: The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India.

Materials and methods: A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance.

Results: At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India. Indian AMC functional rate was 56.45%. The average number of Individual Case Safety Reports reported by our center via VigiFlow per month was 48.038. In a period of the 3 years the total number of ADRs reported was 3024. The average number of reports per month was 80.08. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% of the total ADRs (P < 0.0001). Outpatient Department (OPD) contribution was 76.05% and indoor contribution was 23.94% of total reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%) and chest disease (13.49%) contributed maximally. The contribution of Pharmacology ADR monitoring OPD was 16.20%. Eye, ear, nose and throat and surgery, private Medical Colleges, hospitals in periphery, sub-district and district contributed no ADRs. ADR detection rates by clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57%, and 1.09% respectively (P < 0.0001). Reporting by postgraduate, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19% respectively (P < 0.0001). PG students in Pharmacology contributed an average number of 5.61 ADR reports/month. The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR. Major academic activity, exams, thesis and synopsis submission time influenced reporting of ADRs by postgraduate students.

Conclusion: UR is a matter of concern PvPI. Multiple interventions are needed to improve ADR reporting.

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Related in: MedlinePlus

Number of adverse drug reactions (ADR) reports submitted by ADR monitoring centre, Government Medical College Jammu to National Pharmacovigilance Centre, New Delhi
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Figure 3: Number of adverse drug reactions (ADR) reports submitted by ADR monitoring centre, Government Medical College Jammu to National Pharmacovigilance Centre, New Delhi

Mentions: In a period of the 3 years total number of ADRs reported was 3024. The average number of reports per month reported by the center was 80.08 [Figure 3]. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% (P < 0.0001) of the total ADRs. OPD based reports comprised 76.05% and ADR reported from indoor patients was 23.94% of total ADR reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%), chest disease (13.49%) contributed maximally in the current study. Total number of ADRs contributed by OPD of ADRM of Pharmacology was 490 (16.20%). However, few departments like eye, ENT, surgery did not contribute any ADR. Total number of ADRs contributed by private Medical Colleges in the adjoining region and by hospitals in periphery, sub-district and district hospitals was nil. ADR detection rates based on clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57% and 1.09% respectively, that is detection based on clinical presentation was significantly high as compared to laboratory and diagnostic tools (P < 0.0001). Total reporting by postgraduate students, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19%, respectively (P < 0.0001). The average number of ADR reports contributed per month by Pharmacology postgraduates was 5.61. Pharmacology postgraduate (66.13%) in comparison to other postgraduates (6.61%) contributed most ADRs (P < 0.0001). Number of thesis related to ADR were five during the period; three carried by Department of Pharmacology and one each by Dermatology and HIV medicine. Total four retrospective research analyses related to ADRs were carried out. Various measures to enhance the ADR reporting are depicted in Table 1.


Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India.

Tandon VR, Mahajan V, Khajuria V, Gillani Z - Indian J Pharmacol (2015 Jan-Feb)

Number of adverse drug reactions (ADR) reports submitted by ADR monitoring centre, Government Medical College Jammu to National Pharmacovigilance Centre, New Delhi
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4375822&req=5

Figure 3: Number of adverse drug reactions (ADR) reports submitted by ADR monitoring centre, Government Medical College Jammu to National Pharmacovigilance Centre, New Delhi
Mentions: In a period of the 3 years total number of ADRs reported was 3024. The average number of reports per month reported by the center was 80.08 [Figure 3]. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% (P < 0.0001) of the total ADRs. OPD based reports comprised 76.05% and ADR reported from indoor patients was 23.94% of total ADR reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%), chest disease (13.49%) contributed maximally in the current study. Total number of ADRs contributed by OPD of ADRM of Pharmacology was 490 (16.20%). However, few departments like eye, ENT, surgery did not contribute any ADR. Total number of ADRs contributed by private Medical Colleges in the adjoining region and by hospitals in periphery, sub-district and district hospitals was nil. ADR detection rates based on clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57% and 1.09% respectively, that is detection based on clinical presentation was significantly high as compared to laboratory and diagnostic tools (P < 0.0001). Total reporting by postgraduate students, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19%, respectively (P < 0.0001). The average number of ADR reports contributed per month by Pharmacology postgraduates was 5.61. Pharmacology postgraduate (66.13%) in comparison to other postgraduates (6.61%) contributed most ADRs (P < 0.0001). Number of thesis related to ADR were five during the period; three carried by Department of Pharmacology and one each by Dermatology and HIV medicine. Total four retrospective research analyses related to ADRs were carried out. Various measures to enhance the ADR reporting are depicted in Table 1.

Bottom Line: The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR.UR is a matter of concern PvPI.Multiple interventions are needed to improve ADR reporting.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology and Therapeutics, Government Medical College, Jammu, J and K, India.

ABSTRACT

Aim: The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India.

Materials and methods: A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance.

Results: At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India. Indian AMC functional rate was 56.45%. The average number of Individual Case Safety Reports reported by our center via VigiFlow per month was 48.038. In a period of the 3 years the total number of ADRs reported was 3024. The average number of reports per month was 80.08. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% of the total ADRs (P < 0.0001). Outpatient Department (OPD) contribution was 76.05% and indoor contribution was 23.94% of total reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%) and chest disease (13.49%) contributed maximally. The contribution of Pharmacology ADR monitoring OPD was 16.20%. Eye, ear, nose and throat and surgery, private Medical Colleges, hospitals in periphery, sub-district and district contributed no ADRs. ADR detection rates by clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57%, and 1.09% respectively (P < 0.0001). Reporting by postgraduate, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19% respectively (P < 0.0001). PG students in Pharmacology contributed an average number of 5.61 ADR reports/month. The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR. Major academic activity, exams, thesis and synopsis submission time influenced reporting of ADRs by postgraduate students.

Conclusion: UR is a matter of concern PvPI. Multiple interventions are needed to improve ADR reporting.

Show MeSH
Related in: MedlinePlus