Study of natural product adverse events in adult HIV-infected patients in Canada.

INTRODUCTION: Many individuals living with HIV use natural health products (NHPs) in an effort to decrease medication side effects and to enhance overall well-being. METHODS: An active surveillance study of adult patients (≥ 18 years) with HIV was conducted between 2012 and 2014 to detect prescription drug and NHP use and associated adverse events (AEs) in the last month. RESULTS: Of the 167 participants, 85 (50.9%) took prescription medications only, three (1.8%) took NHPs only, 75 (44.9%) took NHPs and prescription medications concurrently, and four (2.4%) took neither. Patients who used both prescription drugs and NHPs concurrently were more than three times more likely to experience an AE compared with those who used prescription drugs only (OR, P = 0.003, 95% CI: 1.47-6.91). CONCLUSIONS: Increased AEs are reported in patients with HIV who combine NHPs and prescription medications, and no serious AEs were reported. Active surveillance was found to be feasible in this clinical setting.

Depression and antecedent medication adherence in a cohort of new metformin users.

AIMS: The association between depression and poor medication adherence is based on cross-sectional studies and cohort studies that measure adherence rates after depression status is determined. However, depressive symptoms occur well before diagnosis. This study examined adherence patterns in the year before a depressive episode. METHODS: This retrospective cohort study followed new metformin users identified in Alberta Health's administrative data between 2008 and 2018. Depressive episodes starting ≥1 year after metformin initiation were identified using a validated case definition. Controls were randomly assigned a pseudo depression date. Adherence to oral antihyperglycemic medications was estimated using proportion of days covered (PDC) and group-based trajectory models to explore the association between depression and poor adherence (PDC<0.8). RESULTS: A depressive episode occurred in 17,418 (10.6%) of 165,056 new metformin users. Individuals with depression were more likely to have poor adherence compared to controls (adjusted odds ratio 1.21; 95% CI 1.17, 1.26). Five trajectories were identified: nearly perfect adherence (PDC >0.95 [34.8% of cohort]), discontinued (PDC=0 [18.3% of cohort], poor initial adherence (PDC 0.75) that declined either rapidly (9.2% of cohort) or gradually (30.1% of cohort), and poor initial adherence (PDC 0.26) that increased gradually (7.6% of cohort). Individuals with depression were more likely to be in one of the four trajectories of poor adherence compared to controls (adjusted odds ratio 1.24; 95% CI 1.19-1.29). CONCLUSIONS: Poor medication adherence occurs in the year before a depressive episode; therefore, poor medication use patterns could be used as an early warning sign for depression.

Exploring the impact of pharmacist comprehensive annual care plans on perceived quality of chronic illness care by patients in Alberta, Canada.

BACKGROUND: In 2012, the Government of Alberta introduced a funding program to remunerate pharmacists to develop a comprehensive annual care plan (CACP) for patients with complex needs. The objective of this study is to explore patients' perceptions of the care they received through the pharmacist CACP program in Alberta. METHODS: We invited 3442 patients who received a pharmacist-billed CACP within the previous 3 months and 6888 matched controls across Alberta to complete an online questionnaire. The questionnaire consisted of the short version Patient Assessment of Chronic Illness Care (PACIC-11), with 3 additional pharmacy-specific assessment questions added. Additional questions related to health status and demographics were also included. RESULTS: Overall, most patients indicated a low level of chronic illness care by pharmacists, with few differences noted between CACP patients and non-CACP controls. Of note, controls reported higher quality of care for 5 domains within the adapted PACIC-like tool compared with CACP patients (p < 0.05 for all). Interestingly, only 79 (44%) of CACP patients reported that they had received a CACP, whereas only 192 (66%) of control patients reported that they did not receive a care plan. In a sensitivity analysis including only these respondents, individuals who received a CACP perceived a significantly higher quality of chronic illness care across all PACIC domains. CONCLUSION: Overall, chronic illness care incentivized by the pharmacist CACP program in Alberta is perceived to be moderate to low. When limited to respondents who explicitly recognized receiving the service or not, the perceptions of quality of care were more positive. This suggests that better implementation of CACP by pharmacists may be associated with improved quality of care and that some redesign is needed to engage patients more. Can Pharm J (Ott) 2021;154:xx-xx.

Evaluation of comprehensive annual care plans by pharmacists in Alberta for patients with complex conditions.

OBJECTIVES: To characterize the population of patients who received a pharmacist-billed comprehensive annual care plan (CACP) in Alberta and to evaluate any changes in health care use for such patients, including physician visits, hospitalizations, and emergency department (ED) visits. METHODS: We used administrative data from Alberta Health to identify all individuals in Alberta who received a pharmacist CACP between July 1, 2012, and March 31, 2015. Two control patients were identified for each CACP patient, matched on age, sex, provider, date of service, and qualifying conditions. Controlled interrupted time series analyses were used to evaluate changes in physician visits, all-cause and ambulatory care-sensitive condition (ACSC)-related hospitalizations, and ED visits in the 12 months before and after the CACP index date. RESULTS: Between July 1, 2012, and March 31, 2015, 188,640 pharmacy CACPs were billed in Alberta. Of these, 137,178 CACP patients were matched to 241,658 control patients. Those who received a CACP were associated with an overall decrease in all-cause hospitalizations, ACSC-related ED visits, and physician visits (181, 144, and 1206 events per 10,000 people, respectively, P < 0.05) compared with controls. However, among those who received a CACP, all-cause ED visits and ACSC-related hospitalizations increased by 40.1 and 8 visits per 10,000, respectively (P < 0.05), compared with controls. CONCLUSION: The uptake of the pharmacy CACP remuneration model has been substantial since 2012. Overall, the CACP philosophy of a single yearly assessment has demonstrated limited impact on major health care use.

An evaluation of Alberta pharmacists' practices, views and confidence regarding prescription drug abuse and addiction within their practice setting.

BACKGROUND: Pharmacists play an important role in managing patients with prescription drug abuse and addiction (PDAA). The objective of this study was to explore Alberta pharmacists' practices, views and confidence in the management of patients at risk of or living with PDAA in their practice setting. METHODS: A 26-question online questionnaire was distributed to 4261 pharmacists across Alberta, of whom 656 (15%) participated. The questionnaire consisted of 17 multiple-choice, 6 multipart and 3 free-response questions. Questionnaire responses were collected and analyzed in Qualtrics. RESULTS: Sixty-six percent (n = 408) of pharmacists indicated that PDAA was prevalent in their practice setting, with 55% (n = 340) of respondents encountering more than 6 patients with suspected or known PDAA a month. Thirty-five percent (n = 198) of pharmacists indicated they were moderately confident at identifying patients with potential PDAA. However, 41% (n = 235) of the pharmacists indicated that they only discuss PDAA with identified patients less than half of the time. Pharmacists lacked confidence in their ability to discuss PDAA treatment options with their patients as well as collaborate with addiction treatment facilities. Lack of training or knowledge in PDAA (48%) and uncertainty of how to initiate discussion or effectively communicate with patients about PDAA (39%) were identified as barriers that significantly or very significantly hindered respondents from managing PDAA in their practice. CONCLUSIONS: Although many pharmacists are moderately confident in identifying patients with potential PDAA, several barriers hinder intervention. Providing pharmacists with additional training and resources may better equip them to manage PDAA within their practice settings. Can Pharm J (Ott) 2019;152:xx-xx.

Between what is and what could be: a survey of pharmacists' practices, attitudes, and beliefs in the provision of mental health care.

BACKGROUND: Pharmacists can have an essential role in providing care for patients with mental illness. There are gaps in the understanding of the current extent of pharmacists' involvement in caring for patients with mental illness and their readiness to effectively provide this care. AIM: To describe the current practices, attitudes, and beliefs of pharmacists in providing care to individuals with mental illness, and to assess factors that may impact these practices. METHOD: An electronic questionnaire was emailed to pharmacists in Saskatchewan, Canada. Likert scale questions were utilized, and data were analyzed using descriptive statistics and content analysis for free-text responses. RESULTS: The response rate was 9.1% (n = 146/1596). Fewer than 20% of respondents reported they were providing the clinical services listed to most or all patients with mental illness, except for providing basic medication education (61%). Almost all agreed it is a pharmacist's role to provide all the services (61-98% for different services) and many were motivated to provide them (47-91%). The factors most frequently selected as having the greatest impact on service provision were insufficient knowledge (27%, n = 34) and competing priorities (19%, n = 24). CONCLUSION: Consistent with international trends, Saskatchewan pharmacists reported low provision of clinical services for individuals with mental illness, despite a readiness to provide these services. There is an opportunity and a need to better utilize pharmacists internationally in the provision of mental health care.

Pharmacists' chronic disease management in chronic obstructive pulmonary disease: Effect on health services utilization.

BACKGROUND: There is limited real-world evidence on evaluation of chronic disease management initiatives provided by pharmacists to patients with chronic obstructive pulmonary disease (COPD). OBJECTIVE: To evaluate changes in COPD-related health care resource utilization between patients with COPD who had pharmacist-provided chronic disease management (comprehensive annual care plan [CACP]) vs those who did not have CACP. METHODS: Patients with COPD who received a CACP in Alberta between 2012 and 2015 were identified within the Alberta Health administrative data. Each of these patients were matched with 2 control patients with COPD based on age, sex, provider, date of service, and qualifying comorbidities. Controlled interrupted time series analysis was used to evaluate changes in COPD-specific hospitalizations, emergency department (ED) visits, physician visits, and claims for pulmonary function test. Immediate and temporal changes were calculated for the difference in outcomes 1 year before and 1 year after receiving the CACP for the intervention group and matched controls. RESULTS: Eligible patients (N = 74,365), of whom 28,795 (38.7%) had received CACPs, were matched to a total of 45,570 controls. In 1 year after the CACPs implementation, the number of COPD-related hospitalization visits decreased by 174 (95% CI = -270.8 to -76.5) per 10,000 patients per month, COPD-related ED visits decreased by 123 (95% CI = -294.9 to 49.6) per 10,000 per month, general practitioner visits decreased by 153.9 per 10,000 per month (95% CI = -293.3 to -14.5), and pulmonary function test claims decreased by 19.5 per 10,000 per month (95% CI = -70.1 to 31.2) when compared with the matched controls. However, significant difference between the 2 groups was found for COPD-related hospitalizations only, which was not confirmed by the sensitivity analysis. CONCLUSIONS: In patients with COPD who were provided with care plans by their community pharmacists, there was no significant decrease in COPD-related hospitalizations or ED visits over 1 year compared with the matched controls who did not have a pharmacist-provided care plan. Physician visits and pulmonary function tests did not change significantly for those who had CACP compared with those who did not. There is a need to further understand how care plans can better impact other outcomes that are important in COPD management. DISCLOSURES: This study was supported by a grant from the M.S.I. Foundation (Grant#895) based in Alberta, Canada. Dr Bhutani has consulted for Astra Zeneca, GlaxoSmithKline, Boehringer Ingelheim, Valeo, Covis, and Sanofi. The authors declare no other relevant conflicts of interest or financial relationships. This study is based on data provided by Alberta Health. The interpretation and conclusions of the results are those of the researchers and do not necessarily represent the views of the government of Alberta nor the funder (M.S.I. Foundation). All authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors.

Case report: Improvement in refractory functional seizures, depression, and quality of life with ketamine-assisted therapy.

Functional seizures, a primary subtype of functional neurological disorder (FND), are a known cause of serious neurological disability with an increasing awareness of their impact amongst the neuroscience community. Situated at the intersection of neurology and psychiatry, FND is characterized by a range of alterations in motor, sensory or cognitive performance, such as abnormal movements, limb weakness, and dissociative, seizure-like episodes. Functional seizures are known, in part, to have psychological underpinnings; however, the lack of effective and consistent treatment options requires research and novel approaches to better understand the etiology, diagnosis and what constitutes a successful intervention. Ketamine, a selective blocker of the N-methyl-D-aspartate receptor, has a well-established safety and efficacy profile. In recent years, ketamine-assisted therapy has shown increasing potential for treating a broad range of psychiatric conditions, building on its demonstrated rapid-acting antidepressant effects. Here we present a 51-year-old female with refractory daily functional seizures leading to significant disability and a medical history significant for major depressive disorder (MDD) and posttraumatic stress disorder (PTSD). After unsuccessful treatment attempts, the patient underwent a novel protocol with ketamine-assisted therapy. After 3 weeks of ketamine-assisted therapy followed by 20 weeks of intermittent ketamine treatment and ongoing integrative psychotherapy, the patient's seizures were significantly reduced in frequency and severity. She experienced significant improvements in depressive symptoms and functional ability scores. To our knowledge, this is the first reported case describing improvement in functional seizures following ketamine-assisted therapy. While rigorous studies are needed, this case report encourages further investigation of ketamine-assisted therapy for functional seizures and other functional neurological symptoms.

Association Between Antidepressant Use and Adherence to Anti-hyperglycemic Medications in Adults With Type 2 Diabetes and Depression: A Retrospective Cohort Study.

OBJECTIVES: Depression is a known risk factor for poor medication adherence, but it is unclear whether depression treatment affects adherence rates. In this study, we examined the association between pharmacologic treatment of a new depressive episode and subsequent adherence to oral anti-hyperglycemic medications. METHODS: In this retrospective cohort study we used administrative health data to follow adult new metformin users in Alberta, Canada, between 2008 and 2018. Depressive episodes starting ≥1 year after metformin initiation were identified and individuals starting antidepressant treatment within the first 90 days were compared with those who did not. The proportion of days covered (PDC) with oral anti-hyperglycemic medications in the subsequent year (days 91 to 455) was used to estimate adherence. The association between antidepressant treatment and poor adherence (PDC<0.8) was examined using multivariate logistic regression models. RESULTS: A new depressive episode occurred in 6,201 people, with a mean age of 56.0 (standard deviation [SD], 15.4) years. Of this cohort, 3,303 (53.2%) were women. Mean PDC was 0.55 (SD, 0.41); 924 (57.0%) of 1,621 people who started antidepressant treatment and 2,709 (59.2%) of 4,580 controls had poor adherence (p=0.13). After adjusting for baseline comorbidities and other characteristics, antidepressant treatment was associated with a lower likelihood of poor adherence (adjusted odds ratio, 0.85; 95% confidence interval, 0.75 to 0.96; p=0.007). CONCLUSIONS: Although overall adherence to anti-hyperglycemic medications was low after onset of a depressive episode, antidepressant treatment was associated with a lower likelihood of poor adherence.

Study of Natural Products Adverse Reactions (SONAR) in Adults with Mental Health Conditions: A Cross-Sectional Study.

INTRODUCTION: Mental illness is a leading cause of non-fatal disease burden worldwide. Natural health products (NHPs) are sought by patients with mental health conditions as a safer and more 'natural' option than conventional pharmacotherapy; however, the possible adverse events (AE) and interactions between NHPs and prescription medicines are not fully known. OBJECTIVES: The aim of this study was to determine (i) the prevalence of adult patients with mental health conditions taking prescription medications only, NHPs only, NHPs and prescription medications concurrently, or neither, (ii) which prescription medications and NHPs are most commonly used, (iii) AEs (serious and non-serious) experienced in the last 30 days for each product use group. METHODS: Mental health clinics in Alberta and Ontario, Canada, were included in an active surveillance study investigating NHP-drug interactions. On their first clinic visit, adult mental health patients were provided with a form inquiring about prescription drug use, NHP use, and any undesirable health events experienced in the last month. Healthcare professionals were also asked to report AEs. RESULTS: A total of 3079 patients were screened at 11 mental health clinics in Alberta and Ontario. In total, 620 AEs were reported in 447 patients (14.9%). The majority of adverse events were seen in patients using both NHPs and prescription medicines (58.8%), followed by patients taking only prescription medicines (37.1%), NHPs only (3.4%) and neither (0.67%). Combining NHPs and prescription medications increases the likelihood of experiencing AEs (OR 2.1; p < 0.001; 95% CI 1.7-2.6). CONCLUSIONS: Adult patients with mental health conditions who are taking both prescription medications and NHPs are more likely to report an adverse event than patients taking prescription drugs or NHPs alone. Polypharmacy increases the likelihood of an adverse event. Active surveillance is feasible and could contribute to enhanced pharmacovigilance.

Study of Natural products Adverse Reactions (SONAR) in children seen in mental health clinics: a cross-sectional study.

BACKGROUND: Paediatric mental health patients frequently use natural health products (NHP) in addition to prescription medications, but very little is known about adverse events and possible NHP-drug interactions. OBJECTIVE: To determine: (1) the prevalence of paediatric mental health patients taking prescription medications only, NHP only, both NHP and prescription medications concurrently or neither; (2) which prescription medications and NHP are most commonly used in paediatric mental health populations and (3) adverse events experienced in the last 30 days (serious and non-serious). DESIGN: Cross-sectional surveillance study. SETTING: Paediatric mental health clinics. POPULATION/INTERVENTION: On their first clinic visit, paediatric mental health patients were provided with a form inquiring about prescription drug use, NHP use and any undesirable event experienced in the last month. RESULTS: Of the 536 patients included in this study, 23% (n=120) reported taking only prescription medication(s), 21% (n=109) reported only NHP use, 21% (n=112) reported using both NHP and prescription drugs concurrently, and 36% (n=191) reported using neither. Overall, there were 23 adverse events reported; this represents 6.3%, 2.8%, 10.8% and 0.6% of each population, respectively. The majority of patients who experienced an adverse event reported taking more than one NHP or prescription drug. No serious adverse events were reported. CONCLUSION: Nearly half of the paediatric mental health patients in this study were taking NHPs alone or in addition to prescription medications. Active surveillance identified multiple adverse events associated with NHP and prescription drug use; none were serious. Healthcare professionals were encouraged to initiate conversations regarding NHP use.

Natural Health Product-Drug Interaction Causality Assessment in Pediatric Adverse Event Reports Associated with Attention-Deficit/Hyperactivity Disorder Medication.

Background: Some pediatric patients with attention-deficit/hyperactivity disorder (ADHD) use natural health products (NHPs) such as herbal remedies. Although herbal remedies are generally considered to be safe when they are used appropriately, they may contain active components that can interact with medications being used concurrently, with potential for NHP-drug interactions leading to adverse events. Objectives: The objectives of this study were (1) to identify adverse event reports (AERs) involving commonly used herbal remedies and ADHD prescription medicines in children and adolescents; (2) to evaluate the quality of collected AERs; and (3) to assess whether NHP-drug interactions can be causally linked to reported adverse events. Methods: We systematically searched the FDAble database (FDAble.com) for herbal remedies commonly used by patients (4-18 years old) also taking ADHD drugs from 1997 to 2015. We assessed the completeness of the AERs and used three causality assessment tools modified for NHPs (Naranjo Adverse Drug Reaction Probability Scale, HORN Drug Interaction Probability Scale, and World Health Organization Uppsala Monitoring Centre Scale). Results: Of the 23 identified AERs involving both an herbal remedy and an ADHD prescription medication, most involved multiple (>3) substances with inadequate detail to assess multiple potential interactions. Following data extraction and evaluation of completeness, five AERs involving only one herbal remedy and one ADHD medication were evaluated for causality. An NHP-drug interaction was assessed to be probable in one case and to be possible in another. Both these reports involved a methylphenidate formulation and St. John's wort. Conclusions: Eighteen of the 23 identified AERs involving both an herbal remedy and an ADHD drug also involved other multiple ingredient products. The reporting quality was poor for the five AERs examined. Further research is needed to study the interaction between St. John's wort and methylphenidate.

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.

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.

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.

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.

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.