Candace Necyk

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 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.

Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality.

Objectives To 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. Design Cross-sectional study of screened patients. Setting 10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011. Participants The participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications. Primary outcome measures Patients 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. Results Over 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. Conclusions A 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.

Natural Health Products and Diabetes: A Practical Review

The prevalence of natural health product (NHP) use in Canada is extensive. Patients with chronic diseases, including diabetes, use NHPs at a higher rate than the general population. Many NHPs exert hypoglycemic effects, among other effects relevant to diabetes management. To provide a practical, clinical review of NHPs with such effects targeted to pharmacists, a literature search was performed to collect data on the efficacy and safety profiles of 10 commonly used NHPs that exert antidiabetic properties. The following NHPs are included in this clinical review: alpha-lipoic acid, chromium, magnesium, bitter melon, cinnamon, fenugreek, gymnema, milk thistle, Reishi mushroom and white mulberry. Given the potential of NHPs to additively cause hypoglycemia when used concurrently with conventional medications, pharmacists should be up to date with current evidence around NHPs that may affect diabetes care to prevent adverse reactions and interactions. In addition, effective and respectful communication with patients around NHP use and collaboration with various health-care providers are essential in the patient care process.

Natural health product–drug interaction tool: A scoping review

Natural health products (NHPs), such as herbal medicines, probiotics, vitamins and minerals, are used regularly by 73% of Canadians.1 Many consumers believe that NHPs derived from plants (such as herbal medicines) are safe because they are “natural.”1 However, some plant-derived NHPs can interact with pharmaceutical medications, potentially resulting in serious harm for patients.2 A recent active surveillance study found that approximately 45% of consumers presenting to a Canadian pharmacy report using NHPs and prescription drugs concomitantly, with 7.4% describing an adverse event.3 It is important for clinicians to initiate patient communication about NHP use and be knowledgeable about the potential risks to ensure patient safety. Unless clinicians ask, they may be unaware of patient NHP use. Most NHPs can be purchased from many sources without involvement of a health professional, and many patients do not disclose NHP use to clinicians.4 However, education about NHP interactions is not always included within medical and pharmacy curricula,5 and new evidence on NHP–drug interactions is constantly emerging. In addition, a quick search of the medical literature might identify contradictory information or poor-quality reports that are challenging to interpret. Clinicians could benefit from effective knowledge translation tools to identify and prevent potential NHP–drug interactions in their patients. As pharmacists have confirmed the utility of a NHP–drug interaction grid6 as an effective knowledge translation tool,7 we undertook a scoping review to identify and incorporate new NHP–drug interactions.

P02.148. Assessing interactions between herbal medicines and drugs: updated review

Purpose Natural health products (NHPs) are commonly used, both alone and in conjunction with prescription drugs. This concurrent use has been shown to be a concern due to the potential for harmful interactions. A tool to increase awareness of potential interactions between commonly used NHPs and pharmaceuticals was released in 2009. Given the rapid pace of research, it is likely that new interactions have been published since then. The purpose of this project is to review the recent primary and secondary literature for information to update the 2009 tool.

How well do pharmacists know their patients? A case report highlighting natural health product disclosure.

Natural health products (NHPs), a broad category that includes vitamins, minerals, herbs, homeopathic remedies, traditional medicines, probiotics, amino acids and fatty acids, are used to maintain and promote health, as well as to prevent or treat illness.1 Many consumers report using NHPs because they are perceived to be healthier or safer than conventional drugs.2 A Health Canada survey found that 73% of Canadians have reported using at least 1 NHP, and 20% believe NHPs are without adverse effects.2 As NHPs are available without a prescription, patients often use them to treat their medical conditions, based on advice obtained from the Internet, media sources and/or friends/family.3 Patients also do not consistently disclose NHP use to health care providers, nor are they routinely asked about such use.4-6 This lack of communication may have serious implications; for example, some NHPs, such as kava, have been associated with hepatotoxicity,7 and St. John’s wort may interact with a number of prescription medicines that may lead to failed therapeutic outcomes or increased risk of toxicity.8 Use of these products without health professional input could be inappropriate or lead to delayed recognition of adverse reactions if they occur. Community Pharmacy SONAR (Study Of Natural health product Adverse Reactions) is a multicentre study investigating adverse events (AEs) associated with the use of prescription drugs, NHPs and their concurrent use through the implementation of active surveillance. Consenting patients who reported an AE while also taking an NHP (both alone or concurrently with prescription drugs) were contacted by a research pharmacist (CN) to collect a detailed medical history. Detailed methods are available elsewhere.9 This study was approved by the Human Research Ethics Board at the University of Alberta. Here, we present a detailed case history of a SONAR study participant. The patient’s medication history is presented in a stepwise fashion to illustrate what can be learned when a pharmacist further questions a patient about NHP use—the initial information available is typical of routine pharmacy practice; the subsequent additive information can be learned when additional details are sought by the pharmacist.

A review of ketamine’s role in ECT and non-ECT settings

Up to 20% of depressed patients demonstrate treatment resistance to one or more adequate antidepressant trials, resulting in a disproportionately high burden of illness. Ketamine is a non-barbiturate, rapid-acting general anesthetic that has been increasingly studied in treatment resistant depression (TRD), typically at sub-anesthetic doses (0.5 mg/kg over 40 min by intravenous infusion). More recent data suggest that ketamine may improve response rates to electroconvulsive therapy (ECT) when used as an adjunct, but also as a sole agent. In the ECT setting, a dose of 0.8 mg/kg or greater of ketamine demonstrates improved reduction in depressive symptoms than lower doses; however, inconsistency and significant heterogeneity among studies exists. Clinical predictors of responses to ketamine have been suggested in terms of non-ECT settings. Ketamine does increase seizure duration in ECT, which is attenuated when concomitant barbiturate anesthetics are used. However, most studies are small, with considerable heterogeneity of the sample population and variance in dosing strategies of ketamine, ECT, and concomitant medications, and lack a placebo control, which limits interpretation. Psychotomimetic and cardiovascular adverse effects are reported with ketamine. Cardiovascular adverse effects are particularly relevant when ketamine is used in an ECT setting. Adverse effects may be mitigated with concurrent propofol; however, this adds complexity and cost compared to standard anesthesia. Long-term adverse effects are still unknown, but relevant, given recent class concerns for anesthetic and sedative agents.

Community Pharmacists' Views and Practices Regarding Natural Health Products Sold in Community Pharmacies.

Background Reports of regulatory and evidentiary gaps have raised concerns about the marketing and use of natural health products (NHPs). The majority of NHPs offered for sale are purchased at a community pharmacy and pharmacists are “front-line” health professionals involved in the marketing and provision of NHPs. To date, the involvement of pharmacists in pharmacy care involving NHPs and the degree to which concerns over the safety, efficacy, marketing and regulation of NHPs are addressed in pharmacy care in Canada have not been studied. Methods Using Qualtrics, a web-based data collection and analysis software, and a study instrument made up of fifteen (15) open-ended, closed and rating scale questions, we surveyed the attitudes and practices of 403 community pharmacists in the Canadian province of Alberta regarding NHPs offered for sale in community pharmacies. Results The majority of pharmacists surveyed (276; 68%) recommend NHPs to clients sometimes to very often. Vitamin D, calcium, multivitamins, prenatal vitamins, probiotics and fish oil and omega-3 fatty acids were the most frequently recommended NHPs. The most common indications for which NHPs are recommended include bone and musculoskeletal disorders, maintenance of general health, gastrointestinal disorders and pregnancy. Review articles published in the Pharmacist’s Letter and Canadian Pharmacists Journal were the primary basis for recommending NHPs. The majority of pharmacists surveyed (339; 84%) recommend the use of NHPs concurrently with conventional drugs, while a significant number and proportion (125; 31%) recommend alternative use. Pharmacists in the study overwhelmingly reported providing counselling on NHPs to clients based on information obtained mainly from the Natural Medicines Comprehensive Database. Conclusions The study findings indicate a high prevalence of pharmacy care relating to NHPs among study participants. Although pharmacists’ practices around NHPs are consistent with the existing licensing framework, we found some involvement in problematic practices that necessitate further research and potential policy scrutiny. The study also uncovered patterns of recommendations, including sources relied on in recommending NHPs and in providing counselling to patients, that raise concerns about the quality and credibility of NHP-related care provided to pharmacy patrons.

Study of natural health product–drug adverse reactions (S.O.N.A.R.) in patients seeking mental health services

Abstract Background: Natural health products (N.H.P.s) are frequently used by mental health patients, who are also more likely to be given prescription medications. Few patients report use of N.H.P.s to their health care providers, increasing the challenges of safe N.H.P. use. Objective: To determine: (1) the proportion of patients seeking mental health services taking prescription drugs only, N.H.P.s only, prescription drug–N.H.P.s concurrently and neither, (2) which prescription drugs and N.H.P.s are most commonly used by these patients, either alone or in combination, (3) what proportion of patients in each of the above groups report an adverse event (A.E.) using active surveillance, and (4) what type of A.E.s are reported in these patient groups. Method: Employing active surveillance, participating clinicians from six mental health clinics in Edmonton, Alberta asked individuals seeking mental health services about (i) prescription drug use, ii) N.H.P. use, and iii) experiences of A.E.s. Results: Of 1466 patients with complete screening data available, 672 (45.8%) patients took prescription drugs only, 79 (5.4%) took N.H.P.s only, 279 (19.0%) took N.H.P.s and drugs concurrently and 436 (29.7%) took neither. In total, 147 patients reported an A.E., representing 10.7%, 2.5%, 25.5% and 0.5% of each population, respectively. Compared with prescription drug use, patients reporting concurrent N.H.P.–drug use were 2.8 times more likely to experience an A.E. (95% C.I.: 2.0–4.1; p < 0.001). A key limitation of the study is the lack of causality assessment of A.E.s reported; additionally, the patient population reflects a population that phones a provincial mental health phone line with or without referral from a mental health professional. Conclusion: Nearly one-fifth of patients seeking mental health services take N.H.P.s and prescription drugs concurrently; these patients are also at a greater risk of experiencing an A.E. Active surveillance provides a valuable means of detecting such A.E.s and can be incorporated into the medical histories obtained by clinicians.

Increased bruising with the combination of long-chain omega-3 fatty acids, flaxseed oil and clopidogrel.

A recent national survey shows that 73% of Canadians are taking at least one natural health product (NHP), while more than one-third report taking 3 or more NHPs simultaneously.1-3 Of particular concern, patients with chronic medical conditions are more likely to take NHPs.4-6 These patients are also most likely to be prescribed conventional medications, and therefore the risk of interactions and patient harm is even greater.4-6 For example, 58% of patients taking narrow therapeutic index cardiovascular medications reported concurrent NHP use.6 The Study Of Natural health product Adverse Reactions (SONAR) is a multicentre study assessing a community pharmacy‒based active surveillance system to identify adverse events following NHP use, with a particular focus on NHP–prescription drug interactions. The study was developed in partnership with Health Canada to train participating pharmacists to ask individuals collecting prescription medications about 1) concurrent NHP/drug use in the previous month and 2) experiences of adverse events. If an adverse event was identified and if the patient provided written consent, a research pharmacist (CN) followed up with a detailed phone interview. This study was approved by the Human Research Ethics Board at the University of Alberta. A patient identified in our study presented with increased bruising following the concurrent intake of clopidogrel, flaxseed oil and an additional long-chain omega-3 fatty acid supplement.