Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health product and Prescription Drug Use in Community Pharmacies

Background: Many consumers use natural health products (NHPs) concurrently with prescription medications. As NHP-related harms are under-reported through passive surveillance, the safety of concurrent NHP-drug use remains unknown. To conduct active surveillance in participating community pharmacies...

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Main Authors: Vohra, S., Cvijovic, K., Boon, H., Foster, B., Jaeger, W., LeGatt, D., Cembrowski, G., Murty, M., Tsuyuki, R., Barnes, J., Charrois, Theresa, Arnason, J., Necyk, C., Ware, M., Rosychuk, R.
Format: Journal Article
Published: Public Library of Science 2012
Online Access:http://hdl.handle.net/20.500.11937/34392
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author Vohra, S.
Cvijovic, K.
Boon, H.
Foster, B.
Jaeger, W.
LeGatt, D.
Cembrowski, G.
Murty, M.
Tsuyuki, R.
Barnes, J.
Charrois, Theresa
Arnason, J.
Necyk, C.
Ware, M.
Rosychuk, R.
author_facet Vohra, S.
Cvijovic, K.
Boon, H.
Foster, B.
Jaeger, W.
LeGatt, D.
Cembrowski, G.
Murty, M.
Tsuyuki, R.
Barnes, J.
Charrois, Theresa
Arnason, J.
Necyk, C.
Ware, M.
Rosychuk, R.
author_sort Vohra, S.
building Curtin Institutional Repository
collection Online Access
description Background: Many consumers use natural health products (NHPs) concurrently with prescription medications. As NHP-related harms are under-reported through passive surveillance, the safety of concurrent NHP-drug use remains unknown. To conduct active surveillance in participating community pharmacies to identify adverse events related to concurrent NHP-prescription drug use. Methodology/Principal Findings: Participating pharmacists asked individuals collecting prescription medications about (i) concurrent NHP/drug use in the previous three months and (ii) experiences of adverse events. If an adverse event was identified and if the patient provided written consent, a research pharmacist conducted a guided telephone interview to gather additional information after obtaining additional verbal consent and documenting so within the interview form. Over a total of 112 pharmacy weeks, 2615 patients were screened, of which 1037 (39.7%; 95% CI: 37.8% to 41.5%) reported concurrent NHP and prescription medication use. A total of 77 patients reported a possible AE (2.94%; 95% CI: 2.4% to 3.7%), which represents 7.4% of those using NHPs and prescription medications concurrently (95%CI: 6.0% to 9.2%). Of 15 patients available for an interview, 4 (26.7%: 95% CI: 4.3% to 49.0%) reported an AE that was determined to be “probably” due to NHP use. Conclusions/Significance: Active surveillance markedly improves identification and reporting of adverse events associated with concurrent NHP-drug use. Although not without challenges, active surveillance is feasible and can generate adverse event data of sufficient quality to allow for meaningful adjudication to assess potential harms.
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spelling curtin-20.500.11937-343922017-09-13T15:52:51Z Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health product and Prescription Drug Use in Community Pharmacies Vohra, S. Cvijovic, K. Boon, H. Foster, B. Jaeger, W. LeGatt, D. Cembrowski, G. Murty, M. Tsuyuki, R. Barnes, J. Charrois, Theresa Arnason, J. Necyk, C. Ware, M. Rosychuk, R. Background: Many consumers use natural health products (NHPs) concurrently with prescription medications. As NHP-related harms are under-reported through passive surveillance, the safety of concurrent NHP-drug use remains unknown. To conduct active surveillance in participating community pharmacies to identify adverse events related to concurrent NHP-prescription drug use. Methodology/Principal Findings: Participating pharmacists asked individuals collecting prescription medications about (i) concurrent NHP/drug use in the previous three months and (ii) experiences of adverse events. If an adverse event was identified and if the patient provided written consent, a research pharmacist conducted a guided telephone interview to gather additional information after obtaining additional verbal consent and documenting so within the interview form. Over a total of 112 pharmacy weeks, 2615 patients were screened, of which 1037 (39.7%; 95% CI: 37.8% to 41.5%) reported concurrent NHP and prescription medication use. A total of 77 patients reported a possible AE (2.94%; 95% CI: 2.4% to 3.7%), which represents 7.4% of those using NHPs and prescription medications concurrently (95%CI: 6.0% to 9.2%). Of 15 patients available for an interview, 4 (26.7%: 95% CI: 4.3% to 49.0%) reported an AE that was determined to be “probably” due to NHP use. Conclusions/Significance: Active surveillance markedly improves identification and reporting of adverse events associated with concurrent NHP-drug use. Although not without challenges, active surveillance is feasible and can generate adverse event data of sufficient quality to allow for meaningful adjudication to assess potential harms. 2012 Journal Article http://hdl.handle.net/20.500.11937/34392 10.1371/journal.pone.0045196 Public Library of Science fulltext
spellingShingle Vohra, S.
Cvijovic, K.
Boon, H.
Foster, B.
Jaeger, W.
LeGatt, D.
Cembrowski, G.
Murty, M.
Tsuyuki, R.
Barnes, J.
Charrois, Theresa
Arnason, J.
Necyk, C.
Ware, M.
Rosychuk, R.
Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health product and Prescription Drug Use in Community Pharmacies
title Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health product and Prescription Drug Use in Community Pharmacies
title_full Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health product and Prescription Drug Use in Community Pharmacies
title_fullStr Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health product and Prescription Drug Use in Community Pharmacies
title_full_unstemmed Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health product and Prescription Drug Use in Community Pharmacies
title_short Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health product and Prescription Drug Use in Community Pharmacies
title_sort study of natural health product adverse reactions (sonar): active surveillance of adverse events following concurrent natural health product and prescription drug use in community pharmacies
url http://hdl.handle.net/20.500.11937/34392