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

The Prevalence of Natural Health Product Use in Patients with Acute Cardiovascular Disease

Background: Natural health products (NHP) use may have implications with respect to adverse effects, drug interactions and adherence yet the prevalence of NHP use by patients with acute cardiovascular disease and the best method to ascertain this information is unknown. Objective: To identify the best method to ascertain information on NHP, and the prevalence of use in a population with acute cardiovascular disease. Methods: Structured interviews were conducted with a convenience sample of consecutive patients admitted with acute cardiovascular disease to the University of Alberta Hospital during January 2009. NHP use was explored using structured and open-ended questions based on Health Canada’s definition of NHP. The medical record was reviewed, and documentation of NHP use by physicians, nurses, and pharmacists, compared against the gold-standard structured interview. Results: 88 patients were interviewed (mean age 62 years, standard deviation [SD 14]; 80 % male; 41 % admitted for acute coronary syndromes). Common co-morbidities included hypertension (59%), diabetes (26%) and renal impairment (19%). NHP use was common (78 % of patients) and 75 % of NHP users reported daily use. The category of NHP most commonly used was vitamins and minerals (73%) followed by herbal products (20%), traditional medicines including Chines

Improving hypertension management through pharmacist prescribing; the rural alberta clinical trial in optimizing hypertension (Rural RxACTION): trial design and methods

<p>Abstract</p> <p>Background</p> <p>Patients with hypertension continue to have less than optimal blood pressure control, with nearly one in five Canadian adults having hypertension. Pharmacist prescribing is gaining favor as a potential clinically efficacious and cost-effective means to improve both access and quality of care. With Alberta being the first province in Canada to have independent prescribing by pharmacists, it offers a unique opportunity to evaluate outcomes in patients who are prescribed antihypertensive therapy by pharmacists.</p> <p>Methods</p> <p>The study is a randomized controlled trial of enhanced pharmacist care, with the unit of randomization being the patient. Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up, and prescribing/titration of antihypertensive medications) or usual care. Participants are patients in rural Alberta with undiagnosed/uncontrolled blood pressure, as defined by the Canadian Hypertension Education Program. The primary outcome is the change in systolic blood pressure between baseline and 24 weeks in the enhanced-care versus usual-care arms. There are also three substudies running in conjunction with the project examining different remuneration models, investigating patient knowledge, and assessing health-resource utilization amongst patients in each group.</p> <p>Discussion</p> <p>To date, one-third of the required sample size has been recruited. There are 15 communities and 17 pharmacists actively screening, recruiting, and following patients. This study will provide high-level evidence regarding pharmacist prescribing.</p> <p>Trial Registration</p> <p>Clinicaltrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT00878566">NCT00878566</a>.</p

Clinical Decision Making by Fourth-Year Pharmacy Students: Understanding Their Uncertainty

Clinical decision making is a critical process underpinning much of a pharmacist’s daily activities. Pharmacists in Alberta have a scope of practice that includes prescribing medications, and prescribing includes clinical decision making. Ensuring pharmacy education actively prepares students for clinical decision making is therefore a priority. While it is known that pharmacists hesitate to make decisions, it remains unclear whether pharmacy students experience similar hesitancy. Clinical decision making is dependent on many factors, such as knowledge and experience, that need to be considered when investigating hesitancy and uncertainty in decision making by pharmacy students. Adult learning theories of experiential education and reflective practice are applicable to the pedagogy of decision making given that experience is considered a critical influencer in clinical decision making. This study was designed from a social constructivist paradigm using case study methodology. The purpose was to investigate issues related to hesitancy in clinical decision making by fourth-year pharmacy students. Data was collected through observation of students engaging in simulations, post-simulation interviews, and written reflections. Data analysis included multiple stages of coding, followed by pattern identification and discovery of interrelationships. The primary themes relating to issues in pharmacy student clinical decision making were relational factors, teaching and learning, degree of certainty, and personal characteristics. These themes represent elements that affected decision making before the final stage where the students were either willing or unwilling to make a decision. Pharmacy students construct their decision making primarily by using the patient care process, through repeated practice, and by observing role models. Students felt facilitated in their decision making when there were positive relationships with patients and physicians, practise in the skills lab, and development of comfort with ambiguity. Students discussed that strategies for responsible decision making were complex and related to many of the previously mentioned themes. Students struggled with responsibility taking for decisions both throughout the curriculum and in experiential education. Future research plans include investigating how Albertan students compare with those in other jurisdictions and investigating the training of preceptors to include building student comfort with ambiguity by creating education underpinned by adult learning theories of experiential learning

Enhancing skills in patient care documentation and transfer of care: An example of intra-professional collaboration across pharmacy schools through video-conferencing

Documentation of care is a challenging skill to teach, especially when assessments are performed by individuals with familiarity with the case being documented. We designed an activity utilizing peer-review of documentation by students unfamiliar with the patient case, to better replicate real-life interprofessional communications. Pharmacy students from the University of Waterloo and the University of Alberta were provided anonymized notes from a group of students at the other institution. Groups met via video-conference to provide feedback and ask questions about the notes they received. Students were surveyed on their confidence and skills in documentation prior to and following the activity, and also submitted reflections on the experience, which were assessed using qualitative content analysis. Improvements in students’ self-perceived documentation skills showed slight improvement after versus before the activity; however, student reflections were highly positive and showed a change in perspective from documentation being considered something to be done for the documenter׳s personal reference, to something that is invaluable to seamless care transitions between professionals and care settings. Students commonly receive feedback from peers and instructors; however, educators should consider the added benefit of offering feedback from the perspective of individuals unfamiliar with the patient case and from different institutions. Keywords: Peer review, Feedback, Documentatio