Models of pharmacy practice are currently the focus of considerable attention within the North American pharmacy profession. In Canada, through the “Blueprint for Pharmacy” initiative, a vision and implementation plan for pharmacy practice in Canada have been established and endorsed by all pharmacy organizations. Three key objectives of the Blueprint are to incorporate technology, to enhance training and utilization of pharmacists and technicians, and to enhance accountability to patients. If pharmacists are to assume greater responsibility and accountability for management of medication therapy, they will need to spend more time performing direct patient care and less time performing technical drug distribution activities. These plans for the profession of pharmacy, when viewed in aggregate, call for transformative change (whereby the culture of pharmacy is changed), rather than transitional change (whereby only a process is changed). However, there is debate in the literature regarding the best approach for initiating and sustaining transformational change initiatives within organizations. This article describes the process followed and lessons learned during a Blueprint-associated transformative change initiative: organizational restructuring and implementation of a new pharmacy practice model within a large health authority.
Background: A prior learning assessment (PLA) is a summative statement of an individual's learning acquired through education and experience. We developed PLA surveys for 3 groups of pharmacy staff: experienced pharmacists with supervisory or clinical roles; pharmacists entering a pharmacy practice residency program; and experienced pharmacy technicians. Methods: Each PLA survey was developed based on a literature review and desirable learning outcomes for a regional pharmacy program. PLAs consisted of numerous potential learning needs, including possible job roles, competencies, essential skills and areas of practice expertise in 11 domains. Pharmacy staff scored past exposure, perceived ability (prior experience) and interest for each potential learning need. Learning needs were calculated as interest score minus ability score. Results: 23 of 38 (61%) experienced pharmacists, all 24 (100%) pharmacy residents and all 17 (100%) pharmacy technicians invited to complete the PLA responded. For each of the 11 domains, Cronbachs alpha scores were greater than 0.69. For experienced pharmacists, the highest learning needs occurred in technical domains (drug distribution and computer/informatics), with low needs in practice management and patient care. For pharmacy residents, the highest learning needs occurred in patient care domains. Pharmacy technician learning needs were greatest in human resources and drug distribution. Conclusion: We developed PLA surveys for experienced pharmacists, pharmacy residents and pharmacy technicians that demonstrate internal consistency reliability. Regulatory bodies, education providers, employers, managers and individual pharmacy personnel can use PLA to identify learning needs either prior to a practice change or as part of continuing professional development planning.
Ondansetron is frequently used to treat nausea and vomiting during pregnancy. Although some studies reported important safety signals, few studies have been sufficiently large to assess rare pregnancy outcomes.
Objective
To study the association between ondansetron exposure during pregnancy and the risks of spontaneous abortion, stillbirth, and major congenital malformations.
Design, Setting, and Participants
This is a cohort study conducted in 3 countries, with a meta-analysis. Participants included women and girls aged 12 to 55 years who experienced spontaneous abortion, induced abortion, stillbirth, or live birth between April 2002 and March 2016, as recorded in administrative data from 5 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba, and Ontario), the US IBM MarketScan Research Databases, and the UK Clinical Practice Research Datalink. The statistical analysis was completed in October 2020.
Exposures
Exposure to ondansetron during pregnancy was compared with exposure to other commonly used antiemetics to minimize confounding by indication.
Main Outcomes and Measures
The primary outcome was fetal death, defined as either spontaneous abortion or stillbirth. Secondary outcomes were the 2 components of the primary outcome and major congenital malformations identified during the year after a live birth. Adjusted hazard ratios were estimated using Cox proportional hazards models with time-dependent drug exposures and were adjusted using high-dimensional propensity scores. For major congenital malformations, adjusted odds ratios were estimated from logistic models. Site-level results were pooled using random-effects meta-analysis. Sensitivity analyses considered second-line antiemetic exposure and exposure specifically during 4 to 10 weeks of gestation.
Results
Data from 456 963 pregnancies were included in this study of fetal death (249 787 [54.7%] in Canada, 197 913 [43.3%] in the US, and 9263 [2.0%] in the UK; maternal age, ≤24 years, 93 201 patients [20.4%]; 25-29 years, 149 117 patients [32.6%]; 30-34 years, 142 442 patients [31.2%]; and ≥35 years, 72 203 patients [15.8%]). Fetal death occurred in 12 907 (7.9%) of 163 810 pregnancies exposed to ondansetron, and 17 476 (5.7%) of 306 766 pregnancies exposed to other antiemetics. The adjusted hazard ratios were 0.91 (95% CI, 0.67-1.23) for fetal death with time-dependent ondansetron exposure during pregnancy, 0.82 (95% CI, 0.64-1.04) for spontaneous abortion, and 0.97 (95% CI, 0.79-1.20) for stillbirth. For major congenital malformations, the estimated odds ratio was 1.06 (95% CI, 0.91-1.22). Results of sensitivity analyses were generally consistent with those of the primary analyses.
Conclusions and Relevance
In this large, multicenter cohort study, there was no association between ondansetron exposure during pregnancy and increased risk of fetal death, spontaneous abortion, stillbirth, or major congenital malformations compared with exposure to other antiemetic drugs.
Background: There has been limited research about preceptor training programs that include coaching, experiential practice or development of preceptor coaching capacity. We describe the development and evaluation of a workplace preceptor training course for pharmacists and pharmacy technicians within a large regional health authority. Methods: The instructional format was self-study readings and interactive seminars followed by structured practical experience plus feedback from a preceptor coach. During the structured practical experience, each participant served as a preceptor for a student or new staff member. Course evaluations and qualitative interviews were used to evaluate utility and perceived value among participants. Interview transcripts were analyzed using qualitative description and themes were aggregated; illustrative quotes are presented. Results: Since 2006, a total of 40 pharmacists and technicians have participated in the course and interviews were conducted with 14 of these participants. Aspects of the course that interview participants found to be particularly useful included receiving feedback from a coach, implementing a lesson plan and identifying and using different learning and teaching styles. Some participants described changes in attitudes or behaviours toward new employees or students, the use of new learning styles and changes in focus and approach to being a preceptor. Discussion: This unique course could be applied in other workplaces where pharmacy staff members help to deliver experiential education programs. The delivery format was appropriate for a mixed group of pharmacist and technician participants. Conclusion: A preceptor training course of readings, seminars and structured practical experience with feedback from a coach resulted in satisfaction with learning experiences and evidence of attitudinal and behavioural change up to 3 years after the course. Can Pharm J 2012;145:231–236.
It is well documented that clinical pharmacists who provide pharmaceutical care reduce the frequency of drug-related problems (DRPs) and that optimization of drug therapy in this way may influence health expenses, patients’ quality of life, and mortality rates.1,2 It is common for patients admitted for surgical procedures to be taking multiple long-term medications, most of which are unrelated to their surgery.3,4 Previous work has demonstrated that patients undergoing total joint arthroplasty (TJA) of the knee and hip have many DRPs.4 Preadmission clinics (PACs) allow health care practitioners to schedule and perform diagnostic tests, conduct preoperative assessments, provide patient education, and identify discharge requirements on an outpatient basis before surgery.5 By contrast, “prehabilitation” clinics focus on patient care several months before the care received in a PAC, with the goal of optimizing surgical and other health-related outcomes for the patient. Although the role of pharmacists in PACs is well established,4 the literature describing their role in a prehabilitation clinic is limited.6
The calcium, phosphorus, and parathyroid hormone targets recommended by the Canadian Society of Nephrology (CSN) encompass a wider range of values as compared to the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) guidelines. We sought to compare mineral metabolism parameters within the Manitoba Renal Program (MRP) to the CSN and NKF-K/DOQI guidelines. Medication use was also examined.All hemodialysis patients in Manitoba were evaluated. Values for serum albumin, phosphorus, calcium, intact parathyroid hormone (PTH) and pertinent medications were collected.Five hundred and forty-six patients were included in the analysis. Fifty-three per cent to 81% of MRP patients met individual CSN targets. However, only 26% of patients achieved all targets, despite high usage of phosphate (85.5% calcium carbonate, 16.1% sevelamer, 1.3% aluminum) and PTH-lowering drug therapies (30.2% calcitriol, 2.7% cinacalcet).Only a small proportion of patients were able to achieve all three CSN mineral metabolism targets simultaneously. The majority of outliers presented with hyperphosphatemia or hypoparathyroidism.
The use of sodium thiosulfate, bisphosphonates, and cinacalcet for the treatment of calciphylaxis in adults with chronic kidney disease (CKD) is discussed.Calciphylaxis, generally characterized by extraosseous calcification of soft tissues, typically occurs in patients with stage 4 or 5 CKD. Very little data are available regarding the treatment of calciphylaxis. The role of elevated calcium and phosphate concentrations and hyperparathyroidism as risk factors for calciphylaxis has led clinicians to explore therapies that modify these factors, including sodium thiosulfate, bisphosphonates, and cinacalcet. Sodium thiosulfate has been shown to produce clinical improvement of calciphylaxis lesions. Bisphosphonates have been shown to be effective in animal models of calciphylaxis, and the mechanism of action is believed to be due to inhibition of macrophages and local proinflammatory cytokines and binding to calcified vascular smooth muscle cells to inhibit further arterial calcification. Cinacalcet, a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor on the parathyroid gland to calcium, is believed to decrease serum parathyroid hormone levels and stabilize calcium and phosphate concentrations. Cinacalcet has been associated with improved pain control and ulcer healing. Cases describing the use of combination therapy with cinacalcet and sodium thiosulfate for the treatment of calciphylaxis have been published, but the positive effect on wound healing is difficult to attribute to a single drug.Evidence for the treatment of calciphylaxis with pharmacotherapeutic interventions is limited to case reports. Further research is necessary to fully describe the optimal use of sodium thiosulfate, bisphosphonates, and cinacalcet for the treatment of calciphylaxis, including their pharmacokinetics in adults with CKD, optimal dosing strategies, and duration of therapy.
Many Canadian hospital pharmacies are experiencing difficulties recruiting supervisory personnel. It was expected that, through a "learning-by-doing" course, pharmacy staff would learn to apply basic skills in the day-to-day supervision of pharmacy operations and human resources and to apply the principles of supervisory documentation.A supervisory skills course targeted to pharmacy staff members was developed and implemented by the pharmacy department of a large urban health region. The course was initially offered to practising pharmacy technicians. The course design emphasized a constructivist framework incorporating authentic learning and reflective practice during seminars, with experiential and self-directed learning in the workplace. Preceptors assisted learners to achieve the course goals. Learners and preceptors provided feedback about hours spent (as the course progressed) and about their satisfaction with the course itself (at the end of the course). Learners and preceptors completed a post-program evaluation 2 months after completing the course to help in the assessment of the transfer of learning (lasting impact) associated with the course. Overall performance in the course was assessed on a pass/fail basis.Eighteen pharmacy technicians were admitted to the program, but one withdrew because of a job change. All learners successfully completed the course. Two months after the course, learners and preceptors described enhanced organization, time management, leadership, communication, and conflict-resolution skills on the part of learners, as well as their increased confidence, maturity, and ability to supervise staff. Learners' evaluations revealed a broadened perspective of pharmacy. The preceptors valued the enhancement of learners' skills and their increased enthusiasm. At the time of writing, 6 of the participants had secured supervisory positions.Creating formal instruction that engages pharmacy staff to pursue management positions is challenging. Instructional design grounded in constructivist theory and incorporating authentic learning experiences and reflection resulted in high learner satisfaction with learning outcomes.
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