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1.  Clinical Utility of Vitamin D Testing 
Executive Summary
This report from the Medical Advisory Secretariat (MAS) was intended to evaluate the clinical utility of vitamin D testing in average risk Canadians and in those with kidney disease. As a separate analysis, this report also includes a systematic literature review of the prevalence of vitamin D deficiency in these two subgroups.
This evaluation did not set out to determine the serum vitamin D thresholds that might apply to non-bone health outcomes. For bone health outcomes, no high or moderate quality evidence could be found to support a target serum level above 50 nmol/L. Similarly, no high or moderate quality evidence could be found to support vitamin D’s effects in non-bone health outcomes, other than falls.
Vitamin D
Vitamin D is a lipid soluble vitamin that acts as a hormone. It stimulates intestinal calcium absorption and is important in maintaining adequate phosphate levels for bone mineralization, bone growth, and remodelling. It’s also believed to be involved in the regulation of cell growth proliferation and apoptosis (programmed cell death), as well as modulation of the immune system and other functions. Alone or in combination with calcium, Vitamin D has also been shown to reduce the risk of fractures in elderly men (≥ 65 years), postmenopausal women, and the risk of falls in community-dwelling seniors. However, in a comprehensive systematic review, inconsistent results were found concerning the effects of vitamin D in conditions such as cancer, all-cause mortality, and cardiovascular disease. In fact, no high or moderate quality evidence could be found concerning the effects of vitamin D in such non-bone health outcomes. Given the uncertainties surrounding the effects of vitamin D in non-bone health related outcomes, it was decided that this evaluation should focus on falls and the effects of vitamin D in bone health and exclusively within average-risk individuals and patients with kidney disease.
Synthesis of vitamin D occurs naturally in the skin through exposure to ultraviolet B (UVB) radiation from sunlight, but it can also be obtained from dietary sources including fortified foods, and supplements. Foods rich in vitamin D include fatty fish, egg yolks, fish liver oil, and some types of mushrooms. Since it is usually difficult to obtain sufficient vitamin D from non-fortified foods, either due to low content or infrequent use, most vitamin D is obtained from fortified foods, exposure to sunlight, and supplements.
Clinical Need: Condition and Target Population
Vitamin D deficiency may lead to rickets in infants and osteomalacia in adults. Factors believed to be associated with vitamin D deficiency include:
darker skin pigmentation,
winter season,
living at higher latitudes,
skin coverage,
kidney disease,
malabsorption syndromes such as Crohn’s disease, cystic fibrosis, and
genetic factors.
Patients with chronic kidney disease (CKD) are at a higher risk of vitamin D deficiency due to either renal losses or decreased synthesis of 1,25-dihydroxyvitamin D.
Health Canada currently recommends that, until the daily recommended intakes (DRI) for vitamin D are updated, Canada’s Food Guide (Eating Well with Canada’s Food Guide) should be followed with respect to vitamin D intake. Issued in 2007, the Guide recommends that Canadians consume two cups (500 ml) of fortified milk or fortified soy beverages daily in order to obtain a daily intake of 200 IU. In addition, men and women over the age of 50 should take 400 IU of vitamin D supplements daily. Additional recommendations were made for breastfed infants.
A Canadian survey evaluated the median vitamin D intake derived from diet alone (excluding supplements) among 35,000 Canadians, 10,900 of which were from Ontario. Among Ontarian males ages 9 and up, the median daily dietary vitamin D intake ranged between 196 IU and 272 IU per day. Among females, it varied from 152 IU to 196 IU per day. In boys and girls ages 1 to 3, the median daily dietary vitamin D intake was 248 IU, while among those 4 to 8 years it was 224 IU.
Vitamin D Testing
Two laboratory tests for vitamin D are available, 25-hydroxy vitamin D, referred to as 25(OH)D, and 1,25-dihydroxyvitamin D. Vitamin D status is assessed by measuring the serum 25(OH)D levels, which can be assayed using radioimmunoassays, competitive protein-binding assays (CPBA), high pressure liquid chromatography (HPLC), and liquid chromatography-tandem mass spectrometry (LC-MS/MS). These may yield different results with inter-assay variation reaching up to 25% (at lower serum levels) and intra-assay variation reaching 10%.
The optimal serum concentration of vitamin D has not been established and it may change across different stages of life. Similarly, there is currently no consensus on target serum vitamin D levels. There does, however, appear to be a consensus on the definition of vitamin D deficiency at 25(OH)D < 25 nmol/l, which is based on the risk of diseases such as rickets and osteomalacia. Higher target serum levels have also been proposed based on subclinical endpoints such as parathyroid hormone (PTH). Therefore, in this report, two conservative target serum levels have been adopted, 25 nmol/L (based on the risk of rickets and osteomalacia), and 40 to 50 nmol/L (based on vitamin D’s interaction with PTH).
Ontario Context
Volume & Cost
The volume of vitamin D tests done in Ontario has been increasing over the past 5 years with a steep increase of 169,000 tests in 2007 to more than 393,400 tests in 2008. The number of tests continues to rise with the projected number of tests for 2009 exceeding 731,000. According to the Ontario Schedule of Benefits, the billing cost of each test is $51.7 for 25(OH)D (L606, 100 LMS units, $0.517/unit) and $77.6 for 1,25-dihydroxyvitamin D (L605, 150 LMS units, $0.517/unit). Province wide, the total annual cost of vitamin D testing has increased from approximately $1.7M in 2004 to over $21.0M in 2008. The projected annual cost for 2009 is approximately $38.8M.
Evidence-Based Analysis
The objective of this report is to evaluate the clinical utility of vitamin D testing in the average risk population and in those with kidney disease. As a separate analysis, the report also sought to evaluate the prevalence of vitamin D deficiency in Canada. The specific research questions addressed were thus:
What is the clinical utility of vitamin D testing in the average risk population and in subjects with kidney disease?
What is the prevalence of vitamin D deficiency in the average risk population in Canada?
What is the prevalence of vitamin D deficiency in patients with kidney disease in Canada?
Clinical utility was defined as the ability to improve bone health outcomes with the focus on the average risk population (excluding those with osteoporosis) and patients with kidney disease.
Literature Search
A literature search was performed on July 17th, 2009 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 1998 until July 17th, 2009. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
Observational studies that evaluated the prevalence of vitamin D deficiency in Canada in the population of interest were included based on the inclusion and exclusion criteria listed below. The baseline values were used in this report in the case of interventional studies that evaluated the effect of vitamin D intake on serum levels. Studies published in grey literature were included if no studies published in the peer-reviewed literature were identified for specific outcomes or subgroups.
Considering that vitamin D status may be affected by factors such as latitude, sun exposure, food fortification, among others, the search focused on prevalence studies published in Canada. In cases where no Canadian prevalence studies were identified, the decision was made to include studies from the United States, given the similar policies in vitamin D food fortification and recommended daily intake.
Inclusion Criteria
Studies published in English
Publications that reported the prevalence of vitamin D deficiency in Canada
Studies that included subjects from the general population or with kidney disease
Studies in children or adults
Studies published between January 1998 and July 17th 2009
Exclusion Criteria
Studies that included subjects defined according to a specific disease other than kidney disease
Letters, comments, and editorials
Studies that measured the serum vitamin D levels but did not report the percentage of subjects with serum levels below a given threshold
Outcomes of Interest
Prevalence of serum vitamin D less than 25 nmol/L
Prevalence of serum vitamin D less than 40 to 50 nmol/L
Serum 25-hydroxyvitamin D was the metabolite used to assess vitamin D status. Results from adult and children studies were reported separately. Subgroup analyses according to factors that affect serum vitamin D levels (e.g., seasonal effects, skin pigmentation, and vitamin D intake) were reported if enough information was provided in the studies
Quality of Evidence
The quality of the prevalence studies was based on the method of subject recruitment and sampling, possibility of selection bias, and generalizability to the source population. The overall quality of the trials was examined according to the GRADE Working Group criteria.
Summary of Findings
Fourteen prevalence studies examining Canadian adults and children met the eligibility criteria. With the exception of one longitudinal study, the studies had a cross-sectional design. Two studies were conducted among Canadian adults with renal disease but none studied Canadian children with renal disease (though three such US studies were included). No systematic reviews or health technology assessments that evaluated the prevalence of vitamin D deficiency in Canada were identified. Two studies were published in grey literature, consisting of a Canadian survey designed to measure serum vitamin D levels and a study in infants presented as an abstract at a conference. Also included were the results of vitamin D tests performed in community laboratories in Ontario between October 2008 and September 2009 (provided by the Ontario Association of Medical Laboratories).
Different threshold levels were used in the studies, thus we reported the percentage of subjects with serum levels of between 25 and 30 nmol/L and between 37.5 and 50 nmol/L. Some studies stratified the results according to factors affecting vitamin D status and two used multivariate models to investigate the effects of these characteristics (including age, season, BMI, vitamin D intake, skin pigmentation, and season) on serum 25(OH)D levels. It’s unclear, however, if these studies were adequately powered for these subgroup analyses.
Study participants generally consisted of healthy, community-dwelling subjects and most excluded individuals with conditions or medications that alter vitamin D or bone metabolism, such as kidney or liver disease. Although the studies were conducted in different parts of Canada, fewer were performed in Northern latitudes, i.e. above 53°N, which is equivalent to the city of Edmonton.
Adults
Serum vitamin D levels of < 25 to 30 nmol/L were observed in 0% to 25.5% of the subjects included in five studies; the weighted average was 3.8% (95% CI: 3.0, 4.6). The preliminary results of the Canadian survey showed that approximately 5% of the subjects had serum levels below 29.5 nmol/L. The results of over 600,000 vitamin D tests performed in Ontarian community laboratories between October 2008 and September 2009 showed that 2.6% of adults (> 18 years) had serum levels < 25 nmol/L.
The prevalence of serum vitamin D levels below 37.5-50 nmol/L reported among studies varied widely, ranging from 8% to 73.6% with a weighted average of 22.5%. The preliminary results of the CHMS survey showed that between 10% and 25% of subjects had serum levels below 37 to 48 nmol/L. The results of the vitamin D tests performed in community laboratories showed that 10% to 25% of the individuals had serum levels between 39 and 50 nmol/L.
In an attempt to explain this inter-study variation, the study results were stratified according to factors affecting serum vitamin D levels, as summarized below. These results should be interpreted with caution as none were adjusted for other potential confounders. Adequately powered multivariate analyses would be necessary to determine the contribution of risk factors to lower serum 25(OH)D levels.
Seasonal variation
Three adult studies evaluating serum vitamin D levels in different seasons observed a trend towards a higher prevalence of serum levels < 37.5 to 50 nmol/L during the winter and spring months, specifically 21% to 39%, compared to 8% to 14% in the summer. The weighted average was 23.6% over the winter/spring months and 9.6% over summer. The difference between the seasons was not statistically significant in one study and not reported in the other two studies.
Skin Pigmentation
Four studies observed a trend toward a higher prevalence of serum vitamin D levels < 37.5 to 50 nmol/L in subjects with darker skin pigmentation compared to those with lighter skin pigmentation, with weighted averages of 46.8% among adults with darker skin colour and 15.9% among those with fairer skin.
Vitamin D intake and serum levels
Four adult studies evaluated serum vitamin D levels according to vitamin D intake and showed an overall trend toward a lower prevalence of serum levels < 37.5 to 50 nmol/L with higher levels of vitamin D intake. One study observed a dose-response relationship between higher vitamin D intake from supplements, diet (milk), and sun exposure (results not adjusted for other variables). It was observed that subjects taking 50 to 400 IU or > 400 IU of vitamin D per day had a 6% and 3% prevalence of serum vitamin D level < 40 nmol/L, respectively, versus 29% in subjects not on vitamin D supplementation. Similarly, among subjects drinking one or two glasses of milk per day, the prevalence of serum vitamin D levels < 40 nmol/L was found to be 15%, versus 6% in those who drink more than two glasses of milk per day and 21% among those who do not drink milk. On the other hand, one study observed little variation in serum vitamin D levels during winter according to milk intake, with the proportion of subjects exhibiting vitamin D levels of < 40 nmol/L being 21% among those drinking 0-2 glasses per day, 26% among those drinking > 2 glasses, and 20% among non-milk drinkers.
The overall quality of evidence for the studies conducted among adults was deemed to be low, although it was considered moderate for the subgroups of skin pigmentation and seasonal variation.
Newborn, Children and Adolescents
Five Canadian studies evaluated serum vitamin D levels in newborns, children, and adolescents. In four of these, it was found that between 0 and 36% of children exhibited deficiency across age groups with a weighted average of 6.4%. The results of over 28,000 vitamin D tests performed in children 0 to 18 years old in Ontario laboratories (Oct. 2008 to Sept. 2009) showed that 4.4% had serum levels of < 25 nmol/L.
According to two studies, 32% of infants 24 to 30 months old and 35.3% of newborns had serum vitamin D levels of < 50 nmol/L. Two studies of children 2 to 16 years old reported that 24.5% and 34% had serum vitamin D levels below 37.5 to 40 nmol/L. In both studies, older children exhibited a higher prevalence than younger children, with weighted averages 34.4% and 10.3%, respectively. The overall weighted average of the prevalence of serum vitamin D levels < 37.5 to 50 nmol/L among pediatric studies was 25.8%. The preliminary results of the Canadian survey showed that between 10% and 25% of subjects between 6 and 11 years (N= 435) had serum levels below 50 nmol/L, while for those 12 to 19 years, 25% to 50% exhibited serum vitamin D levels below 50 nmol/L.
The effects of season, skin pigmentation, and vitamin D intake were not explored in Canadian pediatric studies. A Canadian surveillance study did, however, report 104 confirmed cases1 (2.9 cases per 100,000 children) of vitamin D-deficient rickets among Canadian children age 1 to 18 between 2002 and 2004, 57 (55%) of which from Ontario. The highest incidence occurred among children living in the North, i.e., the Yukon, Northwest Territories, and Nunavut. In 92 (89%) cases, skin pigmentation was categorized as intermediate to dark, 98 (94%) had been breastfed, and 25 (24%) were offspring of immigrants to Canada. There were no cases of rickets in children receiving ≥ 400 IU VD supplementation/day.
Overall, the quality of evidence of the studies of children was considered very low.
Kidney Disease
Adults
Two studies evaluated serum vitamin D levels in Canadian adults with kidney disease. The first included 128 patients with chronic kidney disease stages 3 to 5, 38% of which had serum vitamin D levels of < 37.5 nmol/L (measured between April and July). This is higher than what was reported in Canadian studies of the general population during the summer months (i.e. between 8% and 14%). In the second, which examined 419 subjects who had received a renal transplantation (mean time since transplantation: 7.2 ± 6.4 years), the prevalence of serum vitamin D levels < 40 nmol/L was 27.3%. The authors concluded that the prevalence observed in the study population was similar to what is expected in the general population.
Children
No studies evaluating serum vitamin D levels in Canadian pediatric patients with kidney disease could be identified, although three such US studies among children with chronic kidney disease stages 1 to 5 were. The mean age varied between 10.7 and 12.5 years in two studies but was not reported in the third. Across all three studies, the prevalence of serum vitamin D levels below the range of 37.5 to 50 nmol/L varied between 21% and 39%, which is not considerably different from what was observed in studies of healthy Canadian children (24% to 35%).
Overall, the quality of evidence in adults and children with kidney disease was considered very low.
Clinical Utility of Vitamin D Testing
A high quality comprehensive systematic review published in August 2007 evaluated the association between serum vitamin D levels and different bone health outcomes in different age groups. A total of 72 studies were included. The authors observed that there was a trend towards improvement in some bone health outcomes with higher serum vitamin D levels. Nevertheless, precise thresholds for improved bone health outcomes could not be defined across age groups. Further, no new studies on the association were identified during an updated systematic review on vitamin D published in July 2009.
With regards to non-bone health outcomes, there is no high or even moderate quality evidence that supports the effectiveness of vitamin D in outcomes such as cancer, cardiovascular outcomes, and all-cause mortality. Even if there is any residual uncertainty, there is no evidence that testing vitamin D levels encourages adherence to Health Canada’s guidelines for vitamin D intake. A normal serum vitamin D threshold required to prevent non-bone health related conditions cannot be resolved until a causal effect or correlation has been demonstrated between vitamin D levels and these conditions. This is as an ongoing research issue around which there is currently too much uncertainty to base any conclusions that would support routine vitamin D testing.
For patients with chronic kidney disease (CKD), there is again no high or moderate quality evidence supporting improved outcomes through the use of calcitriol or vitamin D analogs. In the absence of such data, the authors of the guidelines for CKD patients consider it best practice to maintain serum calcium and phosphate at normal levels, while supplementation with active vitamin D should be considered if serum PTH levels are elevated. As previously stated, the authors of guidelines for CKD patients believe that there is not enough evidence to support routine vitamin D [25(OH)D] testing. According to what is stated in the guidelines, decisions regarding the commencement or discontinuation of treatment with calcitriol or vitamin D analogs should be based on serum PTH, calcium, and phosphate levels.
Limitations associated with the evidence of vitamin D testing include ambiguities in the definition of an ‘adequate threshold level’ and both inter- and intra- assay variability. The MAS considers both the lack of a consensus on the target serum vitamin D levels and assay limitations directly affect and undermine the clinical utility of testing. The evidence supporting the clinical utility of vitamin D testing is thus considered to be of very low quality.
Daily vitamin D intake, either through diet or supplementation, should follow Health Canada’s recommendations for healthy individuals of different age groups. For those with medical conditions such as renal disease, liver disease, and malabsorption syndromes, and for those taking medications that may affect vitamin D absorption/metabolism, physician guidance should be followed with respect to both vitamin D testing and supplementation.
Conclusions
Studies indicate that vitamin D, alone or in combination with calcium, may decrease the risk of fractures and falls among older adults.
There is no high or moderate quality evidence to support the effectiveness of vitamin D in other outcomes such as cancer, cardiovascular outcomes, and all-cause mortality.
Studies suggest that the prevalence of vitamin D deficiency in Canadian adults and children is relatively low (approximately 5%), and between 10% and 25% have serum levels below 40 to 50 nmol/L (based on very low to low grade evidence).
Given the limitations associated with serum vitamin D measurement, ambiguities in the definition of a ‘target serum level’, and the availability of clear guidelines on vitamin D supplementation from Health Canada, vitamin D testing is not warranted for the average risk population.
Health Canada has issued recommendations regarding the adequate daily intake of vitamin D, but current studies suggest that the mean dietary intake is below these recommendations. Accordingly, Health Canada’s guidelines and recommendations should be promoted.
Based on a moderate level of evidence, individuals with darker skin pigmentation appear to have a higher risk of low serum vitamin D levels than those with lighter skin pigmentation and therefore may need to be specially targeted with respect to optimum vitamin D intake. The cause-effect of this association is currently unclear.
Individuals with medical conditions such as renal and liver disease, osteoporosis, and malabsorption syndromes, as well as those taking medications that may affect vitamin D absorption/metabolism, should follow their physician’s guidance concerning both vitamin D testing and supplementation.
PMCID: PMC3377517  PMID: 23074397
2.  Community Pharmacists’ Views and Practices Regarding Natural Health Products Sold in Community Pharmacies 
PLoS ONE  2016;11(9):e0163450.
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.
doi:10.1371/journal.pone.0163450
PMCID: PMC5035072  PMID: 27661618
3.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
Objective
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
Technology
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT Trial
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
Conclusions
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
4.  Pharmacists’ Perceptions of Their Professional Role: Insights into Hospital Pharmacy Culture 
Background:
Numerous studies have demonstrated the positive impacts of pharmacists on patient outcomes. To capitalize on these positive impacts, hospital pharmacy organizations around the world are now calling on pharmacists to shift their focus from distribution of medications to patient outcomes. This new emphasis is consistent with the vision statement for the profession of pharmacy in Canada, as set out in the Blueprint for Pharmacy: “Optimal drug therapy outcomes for Canadians through patient-centred care”. Given the ambitious nature of this statement and these goals, it is essential to understand what pharmacists currently think of their practice.
Objective:
To conduct a qualitative and semiquantitative analysis of hospital pharmacists’ perceptions of their role in patient care.
Methods:
A researcher posing as a University of Alberta student who was studying how health professionals use language to describe what they do contacted the pharmacy departments of all hospitals in Alberta. The “top-of-mind” approach was used in asking hospital pharmacists 2 questions: (1) How many years have you been practising pharmacy? (2) In 3 or 4 words (or phrases), from your perspective could you please tell me, “What does a pharmacist do”? These techniques were used to minimize the impact of social desirability bias. Content analysis was used to categorize hospital pharmacists’ responses into 4 broad categories: patient-centred, drug-focused, drug distribution, and ambiguous.
Results:
A total of 103 phone calls were made to hospital pharmacies, and 85 pharmacists contacted in this way were willing to participate in the survey. Hospital pharmacists provided 333 individual responses to the question about their activities. Of these, 79 (23.7%) were patient-centred, 98 (29.4%) were drug-focused, and 82 (24.6%) were in the drug-distribution category. Ambiguous responses accounted for the remaining 74 (22.2%).
Conclusion:
Aspects of care categorized as other than patient-centred should not be construed as unimportant. However, the fact that they were reported in this survey more frequently than patient-centred aspects suggests that hospital pharmacists in Alberta may have not fully embraced the concept of patient-centred care as outlined in the Blueprint for Pharmacy.
PMCID: PMC3053190  PMID: 22479026
patient-centred; drug-focused; drug distribution; top-of-mind approach; hospital pharmacist; pharmacy culture; pratique axée sur le patient; pratique axée sur les médicaments; distribution des médicaments; analyse des réponses spontanées; pharmacien d’hôpital; culture de la pharmacie
5.  Medication Reconciliation Practices in Canadian Emergency Departments: A National Survey 
Background:
As of 2015, Accreditation Canada’s Qmentum program expects emergency departments (EDs) to initiate medication reconciliation for 2 groups of patients: (1) those with a decision to admit and (2) those without a decision to admit who meet the criteria of a risk-based, health care organization–defined selection process. Pharmacist-led best possible medication histories (BPMHs) obtained in the ED are considered more complete and accurate than BPMHs obtained by other ED providers, with pharmacy technicians obtaining BPMHs as effectively as do pharmacists. A current assessment of the role of pharmacy in BPMH processes in Canadian EDs is lacking.
Objectives:
To identify and describe BPMH and medication reconciliation practices in Canadian EDs, including those performed by members of the ED pharmacy team.
Methods:
All Canadian hospitals with an ED and at least 50 acute care beds were contacted to identify the presence of dedicated ED pharmacy services (defined as at least a 0.5 full-time equivalent position). Different electronic surveys were then distributed to ED pharmacy team members (where available) and ED managers (all hospitals).
Results:
Survey responses were obtained from 60 (63%) of 95 ED pharmacy teams and 128 (53%) of 243 ED managers. Only 38 (30%) of the 128 ED managers believed that their current BPMH processes were adequate to obtain a BPMH for all admissions. Fifty-nine (98%) of the ED pharmacy personnel reported obtaining BPMHs (most commonly 6–10 per day), with priority given to admitted patients. Only 14 (23%) of the 60 ED pharmacy teams reported that their EDs had adequate staffing to comply with Accreditation Canada’s requirements for obtaining BPMHs. This result is supported by the 104 (81%) out of 128 ED managers who reported that additional ED staffing would be needed to comply with the requirements. Numerous ED managers identified the need to expand ED pharmacy services and improve information technology support.
Conclusions:
BPMH processes in Canadian EDs were variable and inadequately supported. Survey responses suggested that additional staff and significant improvements in structured processes would be required to meet Accreditation Canada standards.
PMCID: PMC4485507  PMID: 26157181
emergency department; medication reconciliation; pharmacist; pharmacy; survey; service des urgences; bilan comparatif des médicaments; pharmacien; pharmacie; sondage
6.  Factors Influencing Fourth-Year Pharmacy Students’ Decisions to Pursue a Hospital Pharmacy Residency 
Background:
The Canadian Society of Hospital Pharmacists promotes the recruitment of residency-trained pharmacists for work in hospitals and related health care settings. However, Quebec hospitals are still hiring non–residency trained pharmacists, in part because of a severe shortage of hospital pharmacists. To date, no studies have examined the factors influencing the career choices of fourth-year pharmacy students in Canada.
Objectives:
To identify motivating factors and barriers influencing students’ decision to pursue a hospital pharmacy residency.
Methods:
All 186 fourth-year students in the Faculty of Pharmacy, Université de Montréal, were invited by e-mail to participate in a validated and institutionally approved survey that was available online between March and May 2014.
Results:
Of the 138 respondents who returned a completed survey (74% response rate), 36 (26%) planned to apply for a hospital pharmacy residency. Those planning to apply for a residency were older (p = 0.037) and had more hospital work experience (36% versus 3%, p < 0.001) than those not planning to apply. The most important motivators for pursuing a residency were potential gains in knowledge (reported by 88% of respondents, whether or not they were planning to pursue a residency), experience (80%), and self-confidence (62%). The most frequently reported barriers were recognition that a hospital pharmacy residency is a highly demanding program (65%), having work available upon graduation from the undergraduate program (43%), and financial obligations (34%). Hospital experiential rotations influenced, either positively or negatively, 23 (72%) of the 32 students who changed their decision to pursue or not pursue residency training over the course of their studies.
Conclusions:
The potential gain in knowledge and experience acquired through residency, the fact that it is considered a highly demanding program, and having work available upon graduation from undergraduate studies were the most influential factors in fourth-year pharmacy students’ decision of whether to pursue a hospital pharmacy residency.
PMCID: PMC4924941  PMID: 27403000
pharmacy education; residency training; pharmacy student; career choice; enseignement de la pharmacie; résidence; étudiant en pharmacie; choix de carrière
7.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
8.  Clinical Pharmacy Services in Canadian Emergency Departments: A National Survey 
Background:
Providing clinical pharmacy services in emergency departments (EDs) is important because adverse drug events commonly occur before, during, and after ED encounters. Survey studies in the United States have indicated a relatively low presence of clinical pharmacy services in the ED setting, but a descriptive survey specific to Canada has not yet been performed.
Objectives:
To describe the current status of pharmacy services in Canadian EDs and potential barriers to implementing pharmacy services in this setting.
Methods:
All Canadian hospitals with an ED and at least 50 acute care beds were contacted to identify the presence of dedicated ED pharmacy services (defined as at least 0.5 full-time equivalent [FTE] position). Three different electronic surveys were then distributed by e-mail to ED pharmacy team members (if available), pharmacy managers (at hospitals without an ED pharmacy team), and ED managers (all hospitals). The surveys were completed between July and September 2013.
Results:
Of the 243 hospitals identified, 95 (39%) had at least 0.5 FTE clinical pharmacy services in the ED (based on initial telephone screening). Of the 60 ED pharmacy teams that responded to the survey, 56 had pharmacists (27 of which also had ED pharmacy technicians) and 4 had pharmacy technicians (without pharmacists). Forty-four (79%) of the 56 ED pharmacist services had been established within the preceding 10 years. Order clarification, troubleshooting, medication reconciliation, and assessment of renal dosing were the services most commonly provided. The large majority of pharmacy managers and ED managers identified the need for ED pharmacy services where such services do not yet exist. Inadequate funding, competing priorities, and lack of training were the most commonly reported barriers to providing this service.
Conclusions:
Although the establishment of ward-based pharmacy services in Canadian EDs has increased over the past 10 years, lack of funding and a lack of ED training for pharmacists were reported as significant barriers to the expansion of this role in most hospitals.
PMCID: PMC4485506  PMID: 26157180
emergency department; pharmacist; Canada; survey; pharmacy; technician; service des urgences; pharmacien; Canada; sondage; pharmacie; technicien
9.  Personality Traits of Hospital Pharmacists: Toward a Better Understanding of Factors Influencing Pharmacy Practice Change 
Background
The profession of pharmacy has adopted a mandate to become more patient-centred; however, significant change in this direction has not been achieved.
Objective:
To characterize the personality traits of hospital pharmacists in one Canadian province, to provide insights into potential barriers to practice change.
Methods:
A cross-sectional survey of hospital pharmacists was conducted in Alberta, Canada. An invitation to participate was sent to all 766 hospital pharmacists practising in the province’s 2 health service organizations. The survey was based on the Big Five Inventory, a validated, reliable instrument that uses a 5-point Likert scale to measure the traits of extraversion, agreeableness, conscientiousness, neuroticism, and openness.
Results:
Of the 347 pharmacists who completed the survey (45% response rate), the majority (297 [86%]) were staff pharmacists working full time in an urban setting. The average age of respondents was 41 years (standard deviation [SD] 11 years), and the average period in practice was 17 years (SD 11 years). Respondents’ mean scores were 3.2 (SD 0.7) on extraversion, 3.8 (SD 0.4) on agreeableness, 4.0 (SD 0.4) on conscientiousness, 2.5 (SD 0.7) on neuroticism, and 3.5 (SD 0.6) on openness. Total frequency counts revealed that respondents tended toward stronger expression of extraversion, agreeableness, conscientiousness, and openness and low levels of neuroticism (with the latter indicating stability).
Conclusion:
The Big Five Inventory represents a novel approach to examining pharmacists’ change-related behaviours. Improving understanding of hospital pharmacists’ personality traits will provide insights for the development of training and support programs tailored specifically to this group.
PMCID: PMC3806417  PMID: 24159231
pharmacy practice change; personality traits; Big Five Inventory; hospital pharmacy practice; changement de la pratique de la pharmacie; traits de personnalité; Inventaire des cinq grands facteurs de personnalité; pratique de la pharmacie hospitalière
10.  Public’s attitudes towards community pharmacy in Qatar: a pilot study 
Objectives
To assess the public’s attitudes towards the community pharmacist’s role in Qatar, to investigate the public’s use of community pharmacy, and to determine the public’s views of and satisfaction with community pharmacy services currently provided in Qatar.
Materials and methods
Three community pharmacies in Qatar were randomly selected as study sites. Patients 16 years of age and over who were able to communicate in English or Arabic were randomly approached and anonymously interviewed using a multipart pretested survey.
Results
Over 5 weeks, 58 patients were interviewed (60% response rate). A total of 45% of respondents perceived community pharmacists as having a good balance between health and business matters. The physician was considered the first person to contact to answer drug- related questions by 50% of respondents. Most patients agreed that the community pharmacist should provide them with the medication directions of use (93%) and advise them about the treatment of minor ailments (79%); however, more than 70% didn’t expect the community pharmacist to monitor their health progress or to perform any health screening. Half of the participants (52%) reported visiting the pharmacy at least monthly. The top factor that affected a patient’s choice of any pharmacy was pharmacy location (90%). When asked about their views about community pharmacy services in Qatar, only 37% agreed that the pharmacist gave them sufficient time to discuss their problem and was knowledgeable enough to answer their questions.
Conclusion
This pilot study suggested that the public has a poor understanding of the community pharmacist’s role in monitoring drug therapy, performing health screening, and providing drug information. Several issues of concern were raised including insufficient pharmacist– patient contact time and unsatisfactory pharmacist knowledge. To advance pharmacy practice in Qatar, efforts may be warranted to address identified issues and to promote the community pharmacist’s role in drug therapy monitoring, drug information provision, and health screening.
doi:10.2147/PPA.S22117
PMCID: PMC3176180  PMID: 21949604
pharmacist; public; attitudes; Qatar
11.  Canadian community pharmacists’ use of digital health technologies in practice 
Background:
In 2010, a pan-Canadian study on the current state and benefits of provincial drug information systems (DIS) found that substantial benefits were being realized and that pharmacists perceived DIS to be a valuable tool in the evolving models of pharmacy practice. To understand changes in digital health and the impact on practice since that time, a survey of community pharmacists in Canada was conducted.
Methods:
In 2014, Canada Health Infoway (Infoway) and the Canadian Pharmacists Association (CPhA) invited community pharmacists to participate in a Web-based survey to understand their use and perceived benefits of digital health in practice. The survey was open from April 15 to May 12, 2014.
Results:
Of the 447 survey responses, almost all used some form of digital health in practice. Those with access to DIS and provincial laboratory information systems (LIS) reported increased productivity and better quality of care. Those without access to these systems would overwhelmingly like access.
Discussion:
There have been significant advances in digital health and community pharmacy practice over the past several years. In addition to digital health benefits in the areas of productivity and quality of care, pharmacists are also experiencing substantial benefits in areas related to recently expanded scope of practice activities such as ordering lab tests.
Conclusion:
Community pharmacists frequently use digital health in practice and recognize the benefits of these technologies. Digital health is, and will continue to be, a key enabler for practice transformation and improved quality of care. Can Pharm J (Ott) 2016;149:xx-xx.
doi:10.1177/1715163515618679
PMCID: PMC4713894  PMID: 26798376
12.  Opinions of Hospital Pharmacists in Canada Regarding Marijuana for Medical Purposes 
Background:
Canada’s most recent Marihuana for Medical Purposes Regulations have changed the way in which patients access marijuana. Furthermore, if authorized by the person in charge of the hospital, a pharmacist practising in a hospital may now place orders with licensed producers for dried marijuana for in-hospital use by patients. As use of this product increases, hospital pharmacists may have an increased role in the care of patients who are using marijuana for medical purposes.
Objectives:
The primary objective of this study was to determine the opinions of hospital pharmacists in Canada regarding marijuana for medical purposes. The secondary objective was to assess the factors influencing these opinions.
Methods:
An online survey was made available in early 2015 to licensed hospital pharmacists in Canada through individual provincial and territorial pharmacy regulatory bodies, pharmacist associations, hospital pharmacy directors, the Canadian Society of Hospital Pharmacists, and the Association des pharmaciens des établissements de santé du Québec. Responses were based on a 5-point Likert style scale, ranging from “completely agree” to “completely disagree”.
Results:
A total of 769 valid survey responses were received. Among the respondents, 44.6% (333/747) agreed that marijuana is safe, whereas 55.2% (411/745) agreed that it is effective. Only 17.2% (129/748) agreed that they were knowledgeable about marijuana for medical purposes, and about 65% of respondents reported no formal training in this area. Factors that influenced respondents’ opinions were age, education, area of clinical practice, province of work, and personal experience.
Conclusion:
Many Canadian hospital pharmacists agreed that marijuana for medical purposes is safe and effective, yet few considered themselves knowledgeable about this substance, with more than half reporting no formal training on the topic.
PMCID: PMC4853179  PMID: 27168633
medical marijuana; Marihuana for Medical Purposes Regulations; hospital pharmacists; safety; efficacy; knowledge; marihuana à des fins médicales; Règlement sur la marihuana à des fins médicales; pharmaciens d’hôpitaux; sécurité; efficacité; connaissance
13.  Impact of Graphic and Text Warnings on Cigarette Packs: Findings from Four Countries over Five Years 
Tobacco control  2009;18(5):358-364.
Objectives
To examine the impact of health warnings on smokers by comparing the short-term impact of new graphic (2006) Australian warnings with: (i) earlier (2003) United Kingdom (UK) larger text-based warnings; (ii) and Canadian graphic warnings (late 2000); and secondarily, to extend our understanding of warning wear-out.
Methods
The International Tobacco Control Policy Evaluation Survey (ITC Project) follows prospective cohorts (with replenishment) of adult smokers annually (5 waves: 2002–2006), in Canada, United States, UK, and Australia (around 2000 per country per wave; total n=17,773). Measures were of pack warning salience (reading and noticing); cognitive responses (thoughts of harm and quitting); and two behavioural responses: forgoing cigarettes and avoiding the warnings.
Results
All four indicators of impact increased markedly among Australian smokers following the introduction of graphic warnings. Controlling for date of introduction, they stimulated more cognitive responses than the UK (text-only) changes, and were avoided more, did not significantly increase forgoing cigarettes, but were read and noticed less. The findings also extend previous work showing partial wear-out of both graphic and text-only warnings, but the Canadian warnings have more sustained effects than UK ones.
Conclusions
Australia’s new health warnings increased reactions that are prospectively predictive of cessation activity. Warning size increases warning effectiveness and graphic warnings may be superior to text-based warnings. While there is partial wear-out in the initial impact associated with all warnings, stronger warnings tend to sustain their effects for longer. These findings support arguments for governments to exceed minimum FCTC requirements on warnings.
doi:10.1136/tc.2008.028043
PMCID: PMC4527864  PMID: 19561362
Health warnings; graphic warnings; tobacco product labelling; consumer information; tobacco health information
14.  Learning and Networking: Utilization of a Primary Care Listserv by Pharmacists 
Background
Expanding into new types of practice, such as family health teams, presents challenges for practising pharmacists. The Primary Care Pharmacy Specialty Network (PC-PSN) was established in 2007 to support collaboration among pharmacists working in primary care. The PC-PSN offers to its members a listserv (also referred to as an electronic mailing list) jointly hosted by the Canadian Society of Hospital Pharmacists and the Canadian Pharmacists Association.
Objectives:
To characterize PC-PSN membership and participation in the listserv and to examine how the listserv is used by analyzing questions posted, concerns raised, and issues discussed.
Methods:
Qualitative content analysis was used to examine 1 year of archived PC-PSN listserv posts from the year 2010. Two coders used NVivo software to classify the content of posts. Research team members reviewed and discussed the coding reports to confirm themes emerging from the data.
Results:
Overall, 129 people (52.9% of the 244 listserv members registered at the end of the calendar year) posted to the listserv during the study period. These participants worked in various practice settings, with over half residing in Ontario (68/129 [52.7%]). A total of 623 posts were coded. Agreement between coders, for a sample of posts from 10 users, was acceptable (kappa = 0.78). The listserv was used to share information on a diverse set of topics, to support decision-making and acquire solutions for complex problems, and as a forum for mentorship.
Conclusions:
The qualitative content analysis of the PC-PSN listserv posts for the year 2010 showed that the listserv was a medium for information-sharing and for providing and receiving support, through mentorship from colleagues. Apparent learning needs included effective question-posing skills and application of evidence to individual patients.
PMCID: PMC4214576  PMID: 25364016
pharmacy; listserv; social media; social networking; primary care; pharmacie; gestionnaire de liste de diffusion; médias sociaux; réseautage social; soins de santé primaires
15.  A Guide for Health Professionals Working with Aboriginal Peoples: Executive Summary 
Objective
to provide Canadian health professionals with a network of information and recommendations regarding Aboriginal health.
Options
health professionals working with Aboriginal individuals and communities in the area of women’s health care.
Outcomes
improved health status of Aboriginal peoples in Canada.
Appropriateness and accessibility of women’s health services for Aboriginal peoples.
Improved communication and clinical skills of health professionals in the area of Aboriginal health.
Improved quality of relationship between health professionals and Aboriginal individuals and communities.
Improved quality of relationship between health care professionals and Aboriginal individuals and communities.
Evidence
recommendations are based on expert opinion and a review of the literature. Published references were identified by a Medline search of all review articles, randomized clinical control trials, meta-analyses, and practice guidelines from 1966 to February 1999, using the MeSH headings “Indians, North American or Eskimos” and “Health.”* Subsequently published articles were brought to the attention of the authors in the process of writing and reviewing the document. Ancillary and unpublished references were recommended by members of the SOGC Aboriginal Health Issues Committee and the panel of expert reviewers.
Values
information collected was reviewed by the principal author. The social, cultural, political, and historic context of Aboriginal peoples in Canada, systemic barriers regarding the publication of information by Aboriginal authors, the diversity of Aboriginal peoples in Canada, and the need for a culturally appropriate and balanced presentation were carefully considered in addition to more traditional scientific evaluation. The majority of information collected consisted of descriptive health and social information and such evaluation tools as the evidence guidelines of the Canadian Task Force on the Periodic Health exam were not appropriate.
Benefits, costs, and harms
utilization of the information and recommendations by Canadian health professionals will enhance understanding, communication, and clinical skills in the area of Aboriginal health. The resulting enhancement of collaborative relationships between Aboriginal peoples and their women’s health providers may contribute to health services that are more appropriate, effective, efficient, and accessible for Aboriginal peoples in Canada. The educational process may require an initial investment of time from the health professional.
Recommendations
Recommendations were grouped according to four themes: sociocultural context, health concerns, cross-cultural understanding, and Aboriginal health resources. Health professionals are encouraged to learn the appropriate names, demographics, and traditional geographic territories and language groups of the various Aboriginal groups in Canada. In addition, sensitivity to the impact of colonization and current socioeconomic challenges to the health status of Aboriginal peoples is warranted. Health services for Aboriginal peoples should take place as close to home as possible. Governmental obligations and policies regarding determination are recognized. With respect to health concerns, holistic definitions of health, based on Aboriginal perspectives, are put forward. Aboriginal peoples continue to experience a disproportionate burden of health problems. Health professionals are encouraged to become familiar with several key areas of morbidity and mortality. Relationships between Aboriginal peoples and their care providers need to be based on a foundation of mutual respect. Gaps and barriers in the current health care system for Aboriginal peoples are identified. Health professionals are encouraged to work with Aboriginal individuals and communities to address these gaps and barriers. Aboriginal peoples require culturally appropriate health care, including treatment in their own languages when possible. This may require interpreters or Aboriginal health advocates. Health professionals are encouraged to recognize the importance of family and community roles, and to respect traditional medicines and healers. Health professionals can develop their sensitivities towards Aboriginal peoples by participating in workshops, making use of educational resources, and by spending time with Aboriginal peoples in their communities. Aboriginal communities and health professionals are encouraged to support community-based, community-directed health services and health research for Aboriginal peoples. In addition, the education of more Aboriginal health professionals is essential. The need for a preventative approach to health programming in Aboriginal communities is stressed.
Validation
recommendations were reviewed and revised by the SOGC Aboriginal Health Issues Committee, a panel of expert reviewers, and the SOGC Council. In addition, this document was also reviewed and supported by the Assembly of First Nations, Canadian Institute of Child Health, Canadian Paediatric Society, College of Family Physicians of Canada, Congress of Aboriginal Peoples, Federation of Medical Women of Canada, Inuit Tapirisat of Canada, Metis National Council, National Indian and Inuit Community Health Representatives Organization, and Pauktuutit Inuit Women’s Association.
Sponsor
Society of Obstetricians and Gynaecologists of Canada.
PMCID: PMC3653835  PMID: 23682204 CAMSID: cams2752
16.  Effects of prescription adaptation by pharmacists 
Background
Granting dispensing pharmacists the authority to prescribe has significant implications for pharmaceutical and health human resources policy, and quality of care. Despite the growing number of jurisdictions that have given pharmacists such privileges, there are few rigorous evaluations of these policy changes. This study will examine a January 2009 policy change in British Columbia (BC), Canada that allowed pharmacists to independently adapt and renew prescriptions. We hypothesize this policy increased drug utilization and drug costs, increased patient adherence to medication, and reduced total healthcare resource use.
Methods/Design
We will study a population-based cohort of approximately 4 million BC residents from 2004 through 2010. We will use data from BC PharmaNet on all of the prescriptions obtained by this cohort during the study period, and link it to administrative billings from physicians and hospital discharges. Using interrupted time series analysis, we will study longitudinal changes in drug utilization and costs, medication adherence, and short-term health care use. Further, using hierarchical modelling, we will examine the factors at the regional, pharmacy, patient, and prescription levels that are associated with prescription adaptations and renewals.
Discussion
In a recent survey of Canadian policymakers, many respondents ranked the issue of prescribing privileges as one of their most pressing policy questions. No matter the results of our study, they will be important for policymakers, as our data will make policy decisions surrounding pharmacist prescribing more evidence-based.
doi:10.1186/1472-6963-10-313
PMCID: PMC2994856  PMID: 21083922
17.  Societal perspectives on community pharmacy services in West Bank - Palestine 
Pharmacy Practice  2012;10(1):17-24.
Background
Understanding the public's view of professional competency is extremely important; however little has been reported on the public's perception of community pharmacists in Palestine
Objective
To determine the perception of Palestinian consumers of the community pharmacist and the services they offer.
Methods
This project used the survey methodology administered by structured interviews to consumers who attended the 39 randomly selected pharmacies, in six main cities in Palestine. The questionnaire had range of structured questions covering: Consumers' patronage patterns, consumers’ interaction with community pharmacists, consumers’ views on how the pharmacist dealt with personal health issues, procedure with regard to handling private consultations.
Results
Of 1,017 consumers approached, 790 consumers completed the questionnaire (77.7 %). Proximity to home and presence of knowledgeable pharmacist were the main reasons for patients to visit the same pharmacy. Physicians were identified as the preferred source of advice by 57.2% and pharmacists by 23.8%. Only 17% of respondents considered pharmacists as health professionals who know a lot about drugs and are concerned about and committed to caring for the public. In addition, 49% indicated that pharmacists spoke more quietly cross the counter during counseling and almost one third reported that the pharmacist used a private area within the pharmacy. The majority of respondents would be happy to receive different extended services in the community pharmacy like blood pressure monitoring.
Conclusions
Palestinian consumers have a positive overall perception of community pharmacists and the services they offer. Awareness should be created amongst the public about the role of pharmacist and the added value they can provide as health care professional. There is a need to consider privacy when giving patient counseling to increase user satisfaction.
PMCID: PMC3798164  PMID: 24155812
Patient Satisfaction; Pharmacists; Professional Role; Middle East
18.  What Patients Want: Preferences Regarding Hospital Pharmacy Services 
Background
The role of hospital pharmacists has evolved over the past couple of decades from preparation and distribution of medications to active involvement in health care teams, through identification and resolution of patients’ medication-related issues in an effort to improve patient outcomes. However, patients’ preferences about pharmacy services are not well known.
Objective:
To use content analysis of open-ended survey responses from recently discharged patients to determine desired pharmacy services.
Methods:
Former inpatients were randomly selected for participation in a telephone survey following discharge from acute care hospitals in the Horizon Health Network in New Brunswick. The survey included the question, “What service or information would you like a pharmacist to provide in the hospital that would most help you in managing your medications?” For responses to this question, 2 raters established response categories, obtained acceptable inter-rater agreement, and independently scored the responses.
Results:
Four global categories of responses were obtained, each having multiple subcategories. Of the 703 responses (from 325 respondents), 445 (63.3%) were related to the category “information about medications”, including purpose, adherence, and side effects. The second most common response category was “self-disclosure” (167 [23.8%]), including experiences with pharmacies, medications, or hospitals. Less frequently, responses pertained to “pharmacy services” (54 [7.7%]), such as medication costs and continuity of care, and to “information source for medications” (37 [5.3%]).
Conclusions:
Most respondents to this survey wanted hospital pharmacists to provide a general medication overview, including information about side effects and interactions, during their admission. The results suggest that many patients are unaware of other potential clinical services that pharmacists can provide. A future study could assess patients’ willingness to select from a guiding list of potential clinical services.
PMCID: PMC3694939  PMID: 23814285
clinical pharmacy services; expanded pharmacy services; patient expectations; services de pharmacie clinique; services de pharmacie élargis; attentes des patients
19.  Hospital pharmacists' participation in audit in the United Kingdom. 
Quality in Health Care  1993;2(4):228-231.
OBJECTIVE--To investigate systematically participation in audit of NHS hospital pharmacists in the United Kingdom. DESIGN--Questionnaire census survey. SETTING--All NHS hospital pharmacies in the UK providing clinical pharmacy services. SUBJECTS--462 hospital pharmacies. MAIN MEASURES--Extent and nature of participation in medical, clinical, and pharmacy audits according to hospital management and teaching status, educational level and specialisation of pharmacists, and perceived availability of resources. RESULTS--416 questionnaires were returned (response rate 90%). Pharmacists contributed to medical audit in 50% (204/410) of hospitals, pharmacy audit in 27% (108/404), and clinical audit in only 7% (29/404). Many pharmacies (59% (235/399)) were involved in one or more types of audit but few (4%, (15/399)) in all three. Participation increased in medical and pharmacy audits with trust status (medical audit: 57% (65/115) trust hospital v 47% (132/281) non-trust hospital; pharmacy audit: 34% (39/114) v 24% (65/276)) and teaching status (medical audit: 58% (60/104) teaching hospital v 47% (130/279) non-teaching hospital; pharmacy audit 30% (31/104) v 25% (68/273)) and similarly for highly qualified pharmacists (MPhil or PhD, MSc, diplomas) (medical audit: 54% (163/302) with these qualifications v 38% (39/103) without; pharmacy audit: 32% (95/298) v 13% (13/102)) and specialists pharmacists (medical audit: 61% (112/184) specialist v 41% (90/221) non-specialist; pharmacy audit: 37% (67/182) v 19% (41/218)). Pharmacies contributing to medical audit commonly provided financial information on drug use (86% 169/197). Pharmacy audits often concentrated on audit of clinical pharmacy services. CONCLUSION--Pharmacists are beginning to participate in the critical evaluation of health care, mainly in medical audit.
PMCID: PMC1055151  PMID: 10132456
20.  Improving pharmacy practice through public health programs: experience from Global HIV/AIDS initiative Nigeria project 
SpringerPlus  2013;2:525.
Background
The use of medicines is an essential component of many public health programs (PHPs). Medicines are important not only for their capacity to treat and prevent diseases. The public confidence in healthcare system is inevitably linked to their confidence in the availability of safe and effective medicines and the measures for ensuring their rational use. However, pharmacy services component receives little or no attention in most public health programs in developing countries. This article describes the strategies, lessons learnt, and some accomplishments of Howard University Pharmacists and Continuing Education (HU-PACE) Centre towards improving hospital pharmacy practice through PHP in Nigeria.
Method
In a cross-sectional survey, 60 hospital pharmacies were randomly selected from 184 GHAIN-supported health facilities. The assessment was conducted at baseline and repeated after at least 12 months post-intervention using a study-specific instrument. Interventions included engagement of stakeholders; provision of standards for infrastructural upgrade; development of curricula and modules for training of pharmacy personnel; provision of job aids and tools amongst others. A follow-up hands-on skill enhancement based on identified gaps was conducted. Chi-square was used for inferential statistics. All reported p-values were 2-tailed at 95% confidence interval.
Results
The mean duration of service provision at post-intervention assessment was 24.39 (95% CI, 21.70–27.08) months. About 16.7% of pharmacies reported been trained in HIV care at pre-intervention compared to 83.3% at post-intervention. The proportion of pharmacies with audio-visual privacy for patient counseling increased significantly from 30.9% at pre-intervention to 81.4% at post-intervention. Filled prescriptions were cross-checked by pharmacist (61.9%) and pharmacy technician (23.8%) before dispensing at pre-intervention compared to pharmacist (93.1%) and pharmacy technician (6.9%) at post intervention. 40.0% of pharmacies reported tracking consumption of drugs at pre-intervention compared to 98.3% at post-intervention; while 81.7% of pharmacies reported performing periodic stock reconciliation at pre-intervention compared to 100.0% at post-intervention. 36.5% of pharmacies were observed providing individual counseling on medication use to patients at pre-intervention compared to 73.2% at post-intervention; and 11.7% of pharmacies had evidence of monitoring and reporting of suspected adverse drug reaction at pre-intervention compared to 73.3% at post-intervention. The institution of access to patients’ clinical information by pharmacists in all pharmacies at post-intervention was a paradigm shift.
Conclusion
Through public health program, HU-PACE created an enabling environment and improved capacity of pharmacy personnel for quality HIV/AIDS and TB services. This has contributed in diverse ways to better monitoring of patients on pharmacotherapy by pharmacists through access of pharmacists to patients’ clinical information.
doi:10.1186/2193-1801-2-525
PMCID: PMC3824707  PMID: 24255831
Pharmaceutical care; HIV/AIDS; Public health programs; Patients; Nigeria
21.  Does a transition in education equate to a transition in practice? Thai stakeholder’s perceptions of the introduction of the Doctor of Pharmacy programme 
BMC Medical Education  2015;15:205.
Background
Pharmacy education and pharmacy practice are facing remarkable changes following new scientific discoveries, evolving patient needs and the requirements of advanced pharmacy competency for practices. Many countries are introducing or undertaking major transformations in pharmacy education. The Thai pharmacy curriculum has been changed from a 5-year BPharm and a 6-year PharmD to only a 6-year PharmD programme. Curriculum change processes usually involve stakeholders, including both internal and external educational institutions, at all levels. This study aims to understand the experiences and perceptions of stakeholders regarding the transition to an all-PharmD programme in Thailand.
Methods
Semi-structured interviews were conducted in Thailand with 130 stakeholders (e.g., policy makers, pharmacy experts, educators, health care providers, patients, students and parents) from August-October 2013. The interviews were audio recorded, transcribed verbatim and analysed using an inductive thematic analysis.
Results
Three main themes were derived from the findings: 1. influences on curriculum change (e.g., the needs of pharmacists to provide better patient care, the US-Thai consortium for the development of pharmacy education); 2. perceived benefits (e.g., improve pharmacy competencies from generalists to specialists, ready to work after graduation, providing a high quality of patient care); and 3. concerns (e.g., the higher costs of study for a longer period of time, the mismatch between the pharmacy graduates’ competency and the job market’s needs, insufficient preceptors and training sites, lack of practical experience of the faculty members and issues related to the separate licenses that are necessary due to the difference in the graduates’ specialties).
Conclusions
This is the first study to highlight the issues surrounding the transition to the 6-year PharmD programme in Thailand, which was initiated due to the need for higher levels of competency among the nation’s pharmacists. The transition was influenced by many factors. Many participants perceived benefits from the new pharmacy curriculum. However, some participants were concerned about this transition. Although most of the respondents accepted the need to go forward to the 6-year PharmD programme, designing an effective curriculum, providing a sufficient number of qualified PharmD preceptors, determining certain competencies of pharmacists in different practices and monitoring the quality of pharmacy education still need to be addressed during this transitional stage of pharmacy education in Thailand.
doi:10.1186/s12909-015-0473-4
PMCID: PMC4653906  PMID: 26585968
Stakeholders; Perceptions; Transition; PharmD programme; Preceptors; Workforce; Thailand; A qualitative study
22.  A demonstration study comparing “role-emergent” versus “role-established” pharmacy clinical placement experiences in long-term care facilities 
BMC Medical Education  2013;13:104.
Background
Increasing challenges to recruit hospital sites with full-time on-site pharmacy preceptors for institutional-based Advanced Pharmacy Practice Experiences (APPE) has made it necessary to consider alternate experiential models. Sites with on-site discipline specific preceptors to supervise students have typically been referred to in the literature as “role-established” sites. In British Columbia, long-term care (LTC) facilities offered a unique opportunity to address placement capacity issues. However, since the majority of these facilities are serviced by off-site community pharmacists, this study was undertaken to explore the viability of supervising pharmacy students remotely – a model referred to in the literature as “role-emergent” placements. This paper’s objectives are to discuss pharmacy preceptors’ and LTC non-pharmacist staff experiences with this model.
Methods
The study consisted of three phases: (1) the development phase which included delivery of a training program to create a pool of potential LTC preceptors, (2) an evaluation phase to test the viability of the LTC role-emergent model with seven pharmacists (two role-established and five role-emergent) together with their LTC staff, and (3) expansion of LTC role-emergent sites to build capacity. Both qualitative and quantitative methods were used to obtain feedback from pharmacists and staff and t-tests and Mann–Whitney U tests were used to examine equivalency of survey outcomes from staff representing both models.
Results
The 76 pharmacists who completed the training program survey rated the modules as “largely” meeting their learning needs. All five role-emergent pharmacists and 29 LTC participating staff reported positive experiences with the pharmacy preceptor-student-staff collaboration. Preceptors reported that having students work side-by-side with facility staff promoted inter-professional collaboration. The staff viewed students’ presence as a mutually beneficial experience, suggesting that the students’ presence had enabled them to deliver better care to the residents. As a direct result of the study findings, the annual role-emergent placement capacity was increased to over 45 by the end of the study.
Conclusions
This study demonstrated that role-emergent LTC facilities were not only viable for quality institutional APPEs but also provided more available sites, greater student placement capacity, and more trained pharmacy preceptors than could be achieved in role-established facilities.
doi:10.1186/1472-6920-13-104
PMCID: PMC3737056  PMID: 23915080
Residential care; Long-term care; Pharmacy; Clerkship; Clinical education; Clinical practice; Non-traditional clinical placements; Role-emergent; Role-emerging; Institutional; Experiential
23.  Roles and Responsibilities of Pharmacists with Respect to Natural Health Products: Key Informant Interviews 
Background
Although many pharmacies sell natural health products (NHPs), there is no clear definition as to the roles and responsibilities (if any) of pharmacists with respect to these products.
Objective
The purpose of this study was to explore pharmacy and stakeholder leaders’ perceptions of pharmacists’ professional NHP roles and responsibilities.
Methods
Semi-structured key informant interviews were conducted with pharmacy leaders (n= 17) and stakeholder (n=18) leaders representing consumers, complementary and alternative medicine practitioners, conventional healthcare practitioners, and industry across Canada.
Results
Overwhelmingly all participants believed a main NHP responsibility for pharmacists was safety monitoring. One challenge identified in the interviews was pharmacists’ general lack of NHP knowledge. Stakeholder leaders did not expect pharmacists to be experts on NHPs, rather that pharmacists should have a basic level of knowledge about NHPs. Many pharmacy leaders appeared to be unfamiliar with current pharmacy policies and guidelines concerning NHPs.
Conclusion
Participants described pharmacists’ professional roles and responsibilities for NHPs as similar to those for over-the-counter drugs. More awareness of existing NHP-related pharmacy policies is needed. Pharmacy owners/managers should provide additional training to ensure front-line pharmacists have appropriate knowledge of NHPs sold in the pharmacy.
doi:10.1016/j.sapharm.2009.02.004
PMCID: PMC2923149  PMID: 20188329 CAMSID: cams1316
natural health products; pharmacists; professional roles and responsibilities
24.  How reaction to cigarette packet health warnings influence quitting: Findings from the ITC Four Country survey 
Addiction (Abingdon, England)  2009;104(4):669-675.
Objectives
To examine prospectively the impact of health warnings on quitting activity.
Design
Five waves (2002–2006) of a cohort survey where reactions to health warnings at one survey wave are used to predict cessation activity at the next wave, controlling for country (proxy for warning differences) and other factors. These analyses were replicated on four wave-to-wave transitions.
Setting and participants
Smokers from Australia, Canada, the UK and USA. Samples were Waves 1–2: n=6525; Waves 2–3: n=5257; Waves 3–4:n=4439; and Waves 4–5: n=3993.
Measures
Warning salience, cognitive responses (thoughts of harm and of quitting), forgoing of cigarettes and avoidance of warnings were examined as predictors of quit attempts, and of quitting success among those who tried (1 month sustained abstinence), replicated across four wave-to-wave transitions.
Results
All four responses to warnings were independently predictive of quitting activity in bivariate analyses. In multivariate analyses, forgoing cigarettes and cognitive responses to the warnings both prospectively predicted making quit attempts in all replications. However, avoiding warnings did not consistently add predictive value, and there was no consistent pattern for warning salience. There were no interactions by country. Some, but not all, of the effects were mediated by quitting intentions. There were no consistent effects on quit success.
Conclusions
This study adds to the evidence that forgoing cigarettes as a result of noticing warnings and quit-related cognitive reactions to warnings are consistent prospective predictors of making quit attempts. This work strengthens the evidence base for governments to go beyond the FCTC to mandate health warnings on tobacco products that stimulate the highest possible levels of these reactions.
doi:10.1111/j.1360-0443.2009.02508.x
PMCID: PMC4394051  PMID: 19215595
Health warnings; graphic warnings; tobacco product labelling; consumer information; tobacco health information
25.  Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters 
Background: For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers.
Methods: The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed.
Results: Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling.
Conclusion: Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of prescription drugs.
doi:10.15171/ijhpm.2015.157
PMCID: PMC4663084  PMID: 26673465
Pharmaceutical; Direct-to-Consumer Advertising (DTCA); Food and Drug Administration (FDA); Fair Balance of Information; Online Promotion of Prescription Drugs

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