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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.

ABSTRACT: 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.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.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.

SUBMITTER: Vohra S

PROVIDER: S-EPMC3461007 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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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.

Vohra Sunita S Cvijovic Kosta K Boon Heather H Foster Brian C BC Jaeger Walter W LeGatt Don D Cembrowski George G Murty Mano M Tsuyuki Ross T RT Barnes Joanne J Charrois Theresa L TL Arnason John T JT Necyk Candace C Ware Mark M Rosychuk Rhonda J RJ

PloS one 20120928 9

<h4>Background</h4>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.<h4>Methodology/principal findings</h4>Participating pharmacists asked individuals collecting prescription medications ...[more]

PMID: 23028841

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Project description:ObjectivesTo investigate the rates and causality of adverse event(s) (AE) associated with natural health product (NHP) use, prescription drug use and concurrent NHP-drug use through active surveillance in community pharmacies.DesignCross-sectional study of screened patients.Setting10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011.ParticipantsThe participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications.Primary outcome measuresPatients were screened to determine the proportions of them using prescription drugs and/or NHPs, as well as their respective AE rates. All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality.ResultsOver a total of 105 pharmacy weeks and 1118 patients screened, 410 patients reported taking prescription drugs only (36.7%; 95% CI 33.9% to 39.5%), 37 reported taking NHPs only (3.3%; 95% CI 2.4% to 4.5%) and 657 reported taking prescription drugs and NHPs concurrently (58.8%; 95% CI 55.9% to 61.6%). In total, 54 patients reported an AE, representing 1.2% (95% CI 0.51% to 2.9%), 2.7% (95% CI 0.4% to 16.9%) and 7.3% (95% CI 5.6% to 9.6%) of each population, respectively. Compared with patients who reported using prescription drugs, the patients who reported using prescription drugs and NHPs concurrently were 6.4 times more likely to experience an AE (OR; 95% CI 2.52 to 16.17; p<0.001). Combined with data from Ontario, Canada, a national proportion was calculated, which found that 45.4% (95% CI 43.8% to 47.0%) of Canadians who visit community pharmacies take NHPs and prescription drugs concurrently, and of those, 7.4% (95% CI 6.3% to 8.8%) report an AE.ConclusionsA substantial proportion of community pharmacy patients use prescription drugs and NHPs concurrently; these patients are at a greater risk of experiencing an AE. Active surveillance provides a means of detecting such AEs and collecting high-quality data on which causality assessment can be based.

Project description:Studies of neonatal health risks of unconventional natural gas development (UNGD) have not included comprehensive assessments of environmental chemical exposures. We investigated a clustering of dysphagic cases in neonatal foals born between 2014 and 2016 in an area of active UNGD in Pennsylvania (PA),USA. We evaluated equine biological data and environmental exposures on the affected PA farm and an unaffected New York (NY) farm owned by the same proprietor. Dams either spent their entire gestation on one farm or moved to the other farm in late gestation. Over the 21-month study period, physical examinations and blood/tissue samples were obtained from mares and foals on each farm. Grab samples of water, pasture soil and feed were collected; continuous passive sampling of air and water for polycyclic aromatic hydrocarbons was performed. Dysphagia was evaluated as a binary variable; logistic regression was used to identify risk factors. Sixty-five foals were born, 17 (all from PA farm) were dysphagic. Odds of dysphagia increased with the dam residing on the PA farm for each additional month of gestation (OR = 1.4, 95% CI 1.2, 1.7, p = 6.0E-04). Males were more likely to be born dysphagic (OR = 5.5, 95% CI 1.2, 24.5, p = 0.03) than females. Prior to installation of a water filtration/treatment system, PA water concentrations of 3,6-dimethylphenanthrene (p = 6.0E-03), fluoranthene (p = 0.03), pyrene (p = 0.02) and triphenylene (p = 0.01) exceeded those in NY water. Compared to NY farm water, no concentrations of PAHs were higher in PA following installation of the water filtration/treatment system. We provide evidence of an uncommon adverse health outcome (dysphagia) in foals born near UNGD that was eliminated in subsequent years (2017-2019) following environmental management changes. Notably, this study demonstrates that domestic large animals such as horses can serve as important sentinels for human health risks associated with UNGD activities.

Dataset Information

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.

Publications

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.

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