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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...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3461007/ https://www.ncbi.nlm.nih.gov/pubmed/23028841 http://dx.doi.org/10.1371/journal.pone.0045196 |
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author | Vohra, Sunita Cvijovic, Kosta Boon, Heather Foster, Brian C. Jaeger, Walter LeGatt, Don Cembrowski, George Murty, Mano Tsuyuki, Ross T. Barnes, Joanne Charrois, Theresa L. Arnason, John T. Necyk, Candace Ware, Mark Rosychuk, Rhonda J. |
author_facet | Vohra, Sunita Cvijovic, Kosta Boon, Heather Foster, Brian C. Jaeger, Walter LeGatt, Don Cembrowski, George Murty, Mano Tsuyuki, Ross T. Barnes, Joanne Charrois, Theresa L. Arnason, John T. Necyk, Candace Ware, Mark Rosychuk, Rhonda J. |
author_sort | Vohra, Sunita |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-3461007 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-34610072012-10-01 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, Sunita Cvijovic, Kosta Boon, Heather Foster, Brian C. Jaeger, Walter LeGatt, Don Cembrowski, George Murty, Mano Tsuyuki, Ross T. Barnes, Joanne Charrois, Theresa L. Arnason, John T. Necyk, Candace Ware, Mark Rosychuk, Rhonda J. PLoS One Research Article 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. Public Library of Science 2012-09-28 /pmc/articles/PMC3461007/ /pubmed/23028841 http://dx.doi.org/10.1371/journal.pone.0045196 Text en © 2012 Vohra et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. |
spellingShingle | Research Article Vohra, Sunita Cvijovic, Kosta Boon, Heather Foster, Brian C. Jaeger, Walter LeGatt, Don Cembrowski, George Murty, Mano Tsuyuki, Ross T. Barnes, Joanne Charrois, Theresa L. Arnason, John T. Necyk, Candace Ware, Mark Rosychuk, Rhonda J. 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 |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3461007/ https://www.ncbi.nlm.nih.gov/pubmed/23028841 http://dx.doi.org/10.1371/journal.pone.0045196 |
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