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1.  Pharmacists and Natural Health Products: A systematic analysis of professional responsibilities in Canada 
Pharmacy Practice  2008;6(1):33-42.
Natural health products such as herbs, vitamins and homeopathic medicines are widely available in Canadian pharmacies.
Purpose
to conduct a systematic analysis of Canadian pharmacy policies and guidelines to explore pharmacists’ professional responsibilities with respect to natural health products.
Methods
Legislation, codes of ethics, standards of practice and guidance documents that apply to the practice of pharmacy in each Canadian jurisdiction were systematically collected and examined to identify if, and how, these instruments establish professional duties in regard to natural health products.
Results
The majority of Canadian jurisdictions now include some explicit reference to natural health products in standards of practice policy or guideline documents. Often natural health products are simply assumed to be included in the over-the-counter (OTC) product category and thus professional responsibilities for OTCs are relevant for natural health products. A minority of provinces have specific policies on natural health products, herbals or homeopathy. In addition, the National Association of Pharmacy Regulatory Authorities’ Model Standards of Practice specifically refers to natural health products. Most policy documents indicate that pharmacists should inquire about natural health product use when counselling patients and, when asked, should provide accurate information regarding the efficacy, toxicity, side effects or interactions of natural health products. Public messaging also indicates that pharmacists are knowledgeable professionals who can provide evidence-based information about natural health products.
Conclusions
Explicit policies or guidelines regarding pharmacists’ professional responsibilities with respect to natural health products currently exist in the majority of Canadian jurisdictions.
PMCID: PMC3265537  PMID: 22282720
Natural health products; Practice Guidelines as Topic; Pharmacists; Canada
2.  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
3.  U.S. and Canadian pharmacists' attitudes, knowledge, and professional practice behaviors toward dietary supplements: a systematic review 
Background
Although dietary supplements (DS) are widely sold in pharmacies, the legal, ethical, and practice responsibilities of pharmacists with respect to these products have not been well defined. This systematic review of pharmacists' attitudes, knowledge, and professional practice behaviours toward DS is intended to inform pharmacy regulators' and educators' decision making around this topic.
Methods
Eligible studies were identified through a systematic database search for all available years through to March 2006. Articles were analyzed for this review if they included survey data on U.S. or Canadian pharmacists' attitudes, knowledge, or professional practice behaviors toward DS published in 1990 or later.
Results
Due to the heterogeneity of the data, it was not possible to draw a conclusion with respect to pharmacists' general attitudes toward DS. Approximately equal numbers of pharmacists report positive as well as negative attitudes about the safety and efficacy of DS. There is strong agreement among pharmacists for the need to have additional training on DS, increased regulation of DS, and quality information on DS. In addition, survey data indicate that pharmacists do not perceive their knowledge of DS to be adequate and that pharmacists do not routinely document, monitor, or inquire about patients' use of DS. Despite this, a large proportion of pharmacists reported receiving questions about DS from patients and other health care practitioners.
Conclusion
Further research is needed to explore the factors that influence pharmacists' beliefs and attitudes about DS, to accurately evaluate pharmacists' knowledge of DS, and to uncover the reasons why pharmacists do not routinely document, monitor, or inquire about patients' use of DS.
doi:10.1186/1472-6882-6-31
PMCID: PMC1586212  PMID: 16984649
4.  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
5.  Exploring consumer and pharmacist views on the professional role of the pharmacist with respect to natural health products: a study of focus groups 
Background
Natural health products (NHPs) such as herbs, vitamins and homeopathic medicines, are currently available for sale in most Canadian pharmacies. However, most pharmacists report that they have limited knowledge about these products which have been regulated in Canada as a specific sub-category of drugs. In this paper, consumers' and practicing pharmacists' perceptions of pharmacists' professional responsibilities with respect to NHPs are examined.
Methods
A total of 16 focus groups were conducted with consumers (n = 50) and pharmacists (n = 47) from four different cities across Canada (Vancouver, Edmonton, Toronto, and Halifax).
Results
In this paper, we illustrate the ways in which pharmacists' professional responsibilities are impacted by changing consumer needs. Many consumers in the study utilized a wide range of information resources that may or may not have included pharmacists. Nevertheless, the majority of consumers and pharmacists agreed that pharmacists should be knowledgeable about NHPs and felt that pharmacists should be able to manage drug-NHPs interactions as well as identify and evaluate the variety of information available to help consumers make informed decisions.
Conclusion
This paper demonstrates that consumers' expectations and behaviour significantly impact pharmacists' perceptions of their professional responsibilities with respect to NHPs.
doi:10.1186/1472-6882-8-40
PMCID: PMC2483265  PMID: 18625059
6.  The practice of OTC counseling by community pharmacists in Parana, Brazil 
Pharmacy Practice  2015;13(4):597.
Background:
In order to provide appropriate advice to the patient at the time of dispensing and over-the-counter (OTC) medication counseling, community pharmacists need access to current and reliable information about medicines. Brazilian pharmacists have assumed new functions such as prescribing medication, in a dependent model, based in protocols.
Objective:
To examine the practice of community pharmacists in a Brazilian State, focusing on OTC recommendation.
Method:
A cross-sectional survey of community pharmacists in a state of Brazil was conducted from October 2013 to January 2014, with data collection through a pre-piloted self-administered anonymous survey via Survey Monkey® platform. Following ethical approval, the online instrument was sent to 8,885 pharmacists registered in Parana State, Brazil, focusing on professionals working in community pharmacies. The questionnaire assessed the community pharmacy setting, the search for information, the knowledge of the evidence-based practice, the important factors to consider when recommending an OTC medicine, and the pharmacist prescribing. Responses were imported into SPSS® (version 22.0) for analysis. Nonparametric tests were used to assess the association between responses and demographic information with a significance level less than 5% (p<0.05).
Results:
Of the pharmacists, 97.4% dispensed medications and counseled patients for a median of six hours per day. Product’s efficacy (97%) and adverse effects (62.3%) were the most important factors taken into account when counseling a nonprescription medicine. Few pharmacists knew the meaning of terms related to evidence-based health. Most respondents agreed that pharmacists have the necessary training to prescribe.
Conclusion:
Over-the-counter medication counseling is a daily practice among Brazilian pharmacists. Learning needs exist for community pharmacists in relation to evidence-based practice. Thus, sources of information with good evidence could be used daily by community pharmacists, especially as regards nonprescription medication counseling.
doi:10.18549/PharmPract.2015.04.597
PMCID: PMC4696117  PMID: 26759614
Nonprescription Drugs; Professional Practice; Pharmacies; Evidence-Based Practice; Brazil
7.  Survey of Sterile Admixture Practices in Canadian Hospital Pharmacies: Part 1. Methods and Results 
Background:
The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its “General Chapter <797> Pharmaceutical Compounding—Sterile Preparations”, which set a more rigorous and enforceable standard for sterile compounding in the United States.
Objectives:
To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards.
Methods:
An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies.
Results:
A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. Part 1 of this series reports the survey methods and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments. Part 2 will report results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It will also highlight some of the key areas where there is considerable opportunity for improvement.
Conclusion:
This survey identified numerous deficiences in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice.
PMCID: PMC2826929  PMID: 22478875
chapter <797>; sterile compounding; aseptic technique; chapitre <797>; préparation de produits stériles; techniques aseptiques
8.  Survey of Sterile Admixture Practices in Canadian Hospital Pharmacies: Part 2. More Results and Discussion 
Background:
The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its “General Chapter <797> Pharmaceutical Compounding—Sterile Preparations”, which set a more rigorous and enforceable standard for sterile compounding in the United States.
Objectives:
To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards.
Methods:
An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies.
Results:
A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. The survey methods for this study and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments were reported in Part 1. Part 2 reports results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It also highlights some of the key areas where there is considerable opportunity for improvement.
Conclusion:
This survey identified numerous deficiencies in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice.
PMCID: PMC2826950  PMID: 22478890
chapter <797>; sterile compounding; aseptic technique; expiry dating; process validation; disposal of hazardous pharmaceuticals; chapitre <797>; préparation de produits stériles; techniques aseptiques; attribution de la date de péremption; validation de la procédure; élimination des produits pharmaceutiques dangereux
9.  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
10.  Survey of Canadian Pharmacists’ Responses to Warnings of Potential Interactions Between Ceftriaxone and Calcium in IV Solutions 
Background:
In 2007, because of a potential interaction between ceftriaxone and calcium-containing IV solutions, Roche Laboratories (manufacturer of Rocephin [ceftriaxone] in the United States) issued letters to health care professionals advising them of changes to the product monograph. Subsequently, warning letters were also issued by the US Food and Drug Administration (FDA) and Health Canada. The Health Canada recommendations and their implications for clinical practice generated debate in the Canadian hospital pharmacy community.
Objective:
To evaluate the response to the warnings among hospital pharmacists and their respective institutions.
Methods:
An anonymous, voluntary 10-question survey was distributed to members of the Pharmacy Specialty Networks of the Canadian Society of Hospital Pharmacists. Requests to participate were solicited via 2 e-mail messages. Responses were analyzed descriptively.
Results:
A total of 152 pharmacists participated in the survey. Forty-three respondents (28.3%) reported being very concerned and 86 (56.6%) reported being somewhat concerned about the Health Canada Notice to Hospitals. About half (77/152 [50.7%]) of the respondents felt that the Health Canada notice did not need to be strictly heeded. Two-thirds (98/145 [67.6%]) reported that their institutions had addressed the risk of an interaction through a change in policy regarding the administration of ceftriaxone. Eighty-eight (61.5%) of 143 participants indicated that their institution’s official position on the notice was that it represented a “relative contraindication” (i.e., the benefit may outweigh the risk).
Conclusions:
Warning letters issued by the manufacturer, the FDA, and Health Canada generated concern within the Canadian hospital pharmacy community. However, a large proportion of hospital pharmacy practitioners did not agree with strict adherence to the Health Canada notice.
PMCID: PMC2827021  PMID: 22478936
ceftriaxone; calcium; administration; precipitation; ceftriaxone; calcium; administration; précipitation
11.  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
12.  Community pharmacists’ perceptions about pharmaceutical service of over-the-counter traditional Chinese medicine: a survey study in Harbin of China 
Background
This study aims to investigate community pharmacist’s perception on the provision of over-the-counter (OTC) traditional Chinese medicine (TCM) pharmaceutical services; focusing on the areas of their attitude, general practice, perceived barriers and suggested improvements.
Methods
Questionnaire survey targeting community pharmacists in Harbin of China was applied in this study. Questionnaires were distributed and collected at community pharmacies. Data was analyzed by combining descriptive analysis and Chi-test.
Results
280 valid questionnaires were collected, giving a response rate of 78%. Respondents generally showed positive attitude towards OTC TCM pharmaceutical services. However, they were uncertain about whether such pharmaceutical services should be considered as their primary responsibility. Respondents indicated that they acted proactively to find out all the medicines taken by their patients and to remind consumers of possible OTC TCM adverse reactions. However, they were less keen on recommending or re-directing consumers to suitable OTC TCM. The three main barriers hindering the provision of OTC TCM pharmaceutical service identified in this study were “insufficient professional knowledge” (54.6%), “ambiguity of the professional role of pharmacists” (54.6%) and “lack of scientific evidence of OTC TCM” (45.4%). The three main actions considered most relevant to improving pharmaceutical service of OTC TCM were “formulating or refining legislation to clarify the legal and professional role of pharmacists with respect to TCM” (60.7%), “strengthening training of pharmacists with respect to TCM” (57.9%), and “promoting public awareness of the pharmacist’s role” (53.6%). According to the results of Chi-test, respondents’ perceptions about the attitude, practice, perceived barriers, and improvement suggestions were significantly different depending on the education levels, certificate types and workloads of western medicine.
Conclusions
The community pharmacists in Harbin, China were positive about the provision of OTC TCM pharmaceutical services. However, they were less certain about taking this duty as their primary responsibility. Insufficient knowledge and lack of role definition in the area of OTC TCM were found to be the major factors discouraging the provision of pharmaceutical service on OTC TCM by community pharmacists.
Electronic supplementary material
The online version of this article (doi:10.1186/s12906-016-1532-z) contains supplementary material, which is available to authorized users.
doi:10.1186/s12906-016-1532-z
PMCID: PMC5217429  PMID: 28056935
Community pharmacist; Community pharmacy; Over-the-counter; Pharmaceutical service; Traditional Chinese medicine; TCM; China
13.  Tobacco sales in pharmacies: a survey of attitudes, knowledge and beliefs of pharmacists employed in student experiential and other worksites in Western New York 
BMC Research Notes  2012;5:413.
Background
Pharmacies are venues in which patients seek out products and professional advice in order to improve overall health. However, many pharmacies in the United States continue to sell tobacco products, which are widely known to cause detrimental health effects. This conflict presents a challenge to pharmacists, who are becoming increasingly more involved in patient health promotion activities. This study sought to assess Western New York (WNY) area pharmacists’ opinions about the sale of tobacco products in pharmacies, and pharmacists’ opinions on their role in patient smoking cessation.
Methods
Participants responded to two parallel surveys; a web-based survey was completed by 148 university-affiliated pharmacist preceptors via a list based sample, and a mail-based survey was completed by the supervising pharmacist in 120 area pharmacies via a list-based sample. The combined response rate for both surveys was 31%. Univariate and bivariate analyses were performed to determine any significant differences between the preceptor and supervising pharmacist survey groups.
Results
Over 75% of respondents support legislation banning the sale of tobacco products in pharmacies. Over 86% of respondents would prefer to work in a pharmacy that does not sell tobacco products. Differences between preceptor and supervising pharmacist groups were observed. Action regarding counseling patients was uncommon among both groups.
Conclusions
Pharmacists support initiatives that increase their role in cessation counseling and initiatives that restrict the sale of tobacco products in pharmacies. These data could have important implications for communities and pharmacy practice.
doi:10.1186/1756-0500-5-413
PMCID: PMC3492148  PMID: 22867129
Tobacco sales; Pharmacists; Preceptors; Public health policy; Survey research; Pharmacies
14.  Utilization of DXA Bone Mineral Densitometry in Ontario 
Executive Summary
Issue
Systematic reviews and analyses of administrative data were performed to determine the appropriate use of bone mineral density (BMD) assessments using dual energy x-ray absorptiometry (DXA), and the associated trends in wrist and hip fractures in Ontario.
Background
Dual Energy X-ray Absorptiometry Bone Mineral Density Assessment
Dual energy x-ray absorptiometry bone densitometers measure bone density based on differential absorption of 2 x-ray beams by bone and soft tissues. It is the gold standard for detecting and diagnosing osteoporosis, a systemic disease characterized by low bone density and altered bone structure, resulting in low bone strength and increased risk of fractures. The test is fast (approximately 10 minutes) and accurate (exceeds 90% at the hip), with low radiation (1/3 to 1/5 of that from a chest x-ray). DXA densitometers are licensed as Class 3 medical devices in Canada. The World Health Organization has established criteria for osteoporosis and osteopenia based on DXA BMD measurements: osteoporosis is defined as a BMD that is >2.5 standard deviations below the mean BMD for normal young adults (i.e. T-score <–2.5), while osteopenia is defined as BMD that is more than 1 standard deviation but less than 2.5 standard deviation below the mean for normal young adults (i.e. T-score< –1 & ≥–2.5). DXA densitometry is presently an insured health service in Ontario.
Clinical Need
 
Burden of Disease
The Canadian Multicenter Osteoporosis Study (CaMos) found that 16% of Canadian women and 6.6% of Canadian men have osteoporosis based on the WHO criteria, with prevalence increasing with age. Osteopenia was found in 49.6% of Canadian women and 39% of Canadian men. In Ontario, it is estimated that nearly 530,000 Ontarians have some degrees of osteoporosis. Osteoporosis-related fragility fractures occur most often in the wrist, femur and pelvis. These fractures, particularly those in the hip, are associated with increased mortality, and decreased functional capacity and quality of life. A Canadian study showed that at 1 year after a hip fracture, the mortality rate was 20%. Another 20% required institutional care, 40% were unable to walk independently, and there was lower health-related quality of life due to attributes such as pain, decreased mobility and decreased ability to self-care. The cost of osteoporosis and osteoporotic fractures in Canada was estimated to be $1.3 billion in 1993.
Guidelines for Bone Mineral Density Testing
With 2 exceptions, almost all guidelines address only women. None of the guidelines recommend blanket population-based BMD testing. Instead, all guidelines recommend BMD testing in people at risk of osteoporosis, predominantly women aged 65 years or older. For women under 65 years of age, BMD testing is recommended only if one major or two minor risk factors for osteoporosis exist. Osteoporosis Canada did not restrict its recommendations to women, and thus their guidelines apply to both sexes. Major risk factors are age greater than or equal to 65 years, a history of previous fractures, family history (especially parental history) of fracture, and medication or disease conditions that affect bone metabolism (such as long-term glucocorticoid therapy). Minor risk factors include low body mass index, low calcium intake, alcohol consumption, and smoking.
Current Funding for Bone Mineral Density Testing
The Ontario Health Insurance Program (OHIP) Schedule presently reimburses DXA BMD at the hip and spine. Measurements at both sites are required if feasible. Patients at low risk of accelerated bone loss are limited to one BMD test within any 24-month period, but there are no restrictions on people at high risk. The total fee including the professional and technical components for a test involving 2 or more sites is $106.00 (Cdn).
Method of Review
This review consisted of 2 parts. The first part was an analysis of Ontario administrative data relating to DXA BMD, wrist and hip fractures, and use of antiresorptive drugs in people aged 65 years and older. The Institute for Clinical Evaluative Sciences extracted data from the OHIP claims database, the Canadian Institute for Health Information hospital discharge abstract database, the National Ambulatory Care Reporting System, and the Ontario Drug Benefit database using OHIP and ICD-10 codes. The data was analyzed to examine the trends in DXA BMD use from 1992 to 2005, and to identify areas requiring improvement.
The second part included systematic reviews and analyses of evidence relating to issues identified in the analyses of utilization data. Altogether, 8 reviews and qualitative syntheses were performed, consisting of 28 published systematic reviews and/or meta-analyses, 34 randomized controlled trials, and 63 observational studies.
Findings of Utilization Analysis
Analysis of administrative data showed a 10-fold increase in the number of BMD tests in Ontario between 1993 and 2005.
OHIP claims for BMD tests are presently increasing at a rate of 6 to 7% per year. Approximately 500,000 tests were performed in 2005/06 with an age-adjusted rate of 8,600 tests per 100,000 population.
Women accounted for 90 % of all BMD tests performed in the province.
In 2005/06, there was a 2-fold variation in the rate of DXA BMD tests across local integrated health networks, but a 10-fold variation between the county with the highest rate (Toronto) and that with the lowest rate (Kenora). The analysis also showed that:
With the increased use of BMD, there was a concomitant increase in the use of antiresorptive drugs (as shown in people 65 years and older) and a decrease in the rate of hip fractures in people age 50 years and older.
Repeat BMD made up approximately 41% of all tests. Most of the people (>90%) who had annual BMD tests in a 2-year or 3-year period were coded as being at high risk for osteoporosis.
18% (20,865) of the people who had a repeat BMD within a 24-month period and 34% (98,058) of the people who had one BMD test in a 3-year period were under 65 years, had no fracture in the year, and coded as low-risk.
Only 19% of people age greater than 65 years underwent BMD testing and 41% received osteoporosis treatment during the year following a fracture.
Men accounted for 24% of all hip fractures and 21 % of all wrist fractures, but only 10% of BMD tests. The rates of BMD tests and treatment in men after a fracture were only half of those in women.
In both men and women, the rate of hip and wrist fractures mainly increased after age 65 with the sharpest increase occurring after age 80 years.
Findings of Systematic Review and Analysis
Serial Bone Mineral Density Testing for People Not Receiving Osteoporosis Treatment
A systematic review showed that the mean rate of bone loss in people not receiving osteoporosis treatment (including postmenopausal women) is generally less than 1% per year. Higher rates of bone loss were reported for people with disease conditions or on medications that affect bone metabolism. In order to be considered a genuine biological change, the change in BMD between serial measurements must exceed the least significant change (variability) of the testing, ranging from 2.77% to 8% for precisions ranging from 1% to 3% respectively. Progression in BMD was analyzed, using different rates of baseline BMD values, rates of bone loss, precision, and BMD value for initiating treatment. The analyses showed that serial BMD measurements every 24 months (as per OHIP policy for low-risk individuals) is not necessary for people with no major risk factors for osteoporosis, provided that the baseline BMD is normal (T-score ≥ –1), and the rate of bone loss is less than or equal to 1% per year. The analyses showed that for someone with a normal baseline BMD and a rate of bone loss of less than 1% per year, the change in BMD is not likely to exceed least significant change (even for a 1% precision) in less than 3 years after the baseline test, and is not likely to drop to a BMD level that requires initiation of treatment in less than 16 years after the baseline test.
Serial Bone Mineral Density Testing in People Receiving Osteoporosis Therapy
Seven published meta-analysis of randomized controlled trials (RCTs) and 2 recent RCTs on BMD monitoring during osteoporosis therapy showed that although higher increases in BMD were generally associated with reduced risk of fracture, the change in BMD only explained a small percentage of the fracture risk reduction.
Studies showed that some people with small or no increase in BMD during treatment experienced significant fracture risk reduction, indicating that other factors such as improved bone microarchitecture might have contributed to fracture risk reduction.
There is conflicting evidence relating to the role of BMD testing in improving patient compliance with osteoporosis therapy.
Even though BMD may not be a perfect surrogate for reduction in fracture risk when monitoring responses to osteoporosis therapy, experts advised that it is still the only reliable test available for this purpose.
A systematic review conducted by the Medical Advisory Secretariat showed that the magnitude of increases in BMD during osteoporosis drug therapy varied among medications. Although most of the studies yielded mean percentage increases in BMD from baseline that did not exceed the least significant change for a 2% precision after 1 year of treatment, there were some exceptions.
Bone Mineral Density Testing and Treatment After a Fragility Fracture
A review of 3 published pooled analyses of observational studies and 12 prospective population-based observational studies showed that the presence of any prevalent fracture increases the relative risk for future fractures by approximately 2-fold or more. A review of 10 systematic reviews of RCTs and 3 additional RCTs showed that therapy with antiresorptive drugs significantly reduced the risk of vertebral fractures by 40 to 50% in postmenopausal osteoporotic women and osteoporotic men, and 2 antiresorptive drugs also reduced the risk of nonvertebral fractures by 30 to 50%. Evidence from observational studies in Canada and other jurisdictions suggests that patients who had undergone BMD measurements, particularly if a diagnosis of osteoporosis is made, were more likely to be given pharmacologic bone-sparing therapy. Despite these findings, the rate of BMD investigation and osteoporosis treatment after a fracture remained low (<20%) in Ontario as well as in other jurisdictions.
Bone Mineral Density Testing in Men
There are presently no specific Canadian guidelines for BMD screening in men. A review of the literature suggests that risk factors for fracture and the rate of vertebral deformity are similar for men and women, but the mortality rate after a hip fracture is higher in men compared with women. Two bisphosphonates had been shown to reduce the risk of vertebral and hip fractures in men. However, BMD testing and osteoporosis treatment were proportionately low in Ontario men in general, and particularly after a fracture, even though men accounted for 25% of the hip and wrist fractures. The Ontario data also showed that the rates of wrist fracture and hip fracture in men rose sharply in the 75- to 80-year age group.
Ontario-Based Economic Analysis
The economic analysis focused on analyzing the economic impact of decreasing future hip fractures by increasing the rate of BMD testing in men and women age greater than or equal to 65 years following a hip or wrist fracture. A decision analysis showed the above strategy, especially when enhanced by improved reporting of BMD tests, to be cost-effective, resulting in a cost-effectiveness ratio ranging from $2,285 (Cdn) per fracture avoided (worst-case scenario) to $1,981 (Cdn) per fracture avoided (best-case scenario). A budget impact analysis estimated that shifting utilization of BMD testing from the low risk population to high risk populations within Ontario would result in a saving of $0.85 million to $1.5 million (Cdn) to the health system. The potential net saving was estimated at $1.2 million to $5 million (Cdn) when the downstream cost-avoidance due to prevention of future hip fractures was factored into the analysis.
Other Factors for Consideration
There is a lack of standardization for BMD testing in Ontario. Two different standards are presently being used and experts suggest that variability in results from different facilities may lead to unnecessary testing. There is also no requirement for standardized equipment, procedure or reporting format. The current reimbursement policy for BMD testing encourages serial testing in people at low risk of accelerated bone loss. This review showed that biannual testing is not necessary for all cases. The lack of a database to collect clinical data on BMD testing makes it difficult to evaluate the clinical profiles of patients tested and outcomes of the BMD tests. There are ministry initiatives in progress under the Osteoporosis Program to address the development of a mandatory standardized requisition form for BMD tests to facilitate data collection and clinical decision-making. Work is also underway for developing guidelines for BMD testing in men and in perimenopausal women.
Conclusion
Increased use of BMD in Ontario since 1996 appears to be associated with increased use of antiresorptive medication and a decrease in hip and wrist fractures.
Data suggest that as many as 20% (98,000) of the DXA BMD tests in Ontario in 2005/06 were performed in people aged less than 65 years, with no fracture in the current year, and coded as being at low risk for accelerated bone loss; this is not consistent with current guidelines. Even though some of these people might have been incorrectly coded as low-risk, the number of tests in people truly at low risk could still be substantial.
Approximately 4% (21,000) of the DXA BMD tests in 2005/06 were repeat BMDs in low-risk individuals within a 24-month period. Even though this is in compliance with current OHIP reimbursement policies, evidence showed that biannual serial BMD testing is not necessary in individuals without major risk factors for fractures, provided that the baseline BMD is normal (T-score < –1). In this population, BMD measurements may be repeated in 3 to 5 years after the baseline test to establish the rate of bone loss, and further serial BMD tests may not be necessary for another 7 to 10 years if the rate of bone loss is no more than 1% per year. Precision of the test needs to be considered when interpreting serial BMD results.
Although changes in BMD may not be the perfect surrogate for reduction in fracture risk as a measure of response to osteoporosis treatment, experts advised that it is presently the only reliable test for monitoring response to treatment and to help motivate patients to continue treatment. Patients should not discontinue treatment if there is no increase in BMD after the first year of treatment. Lack of response or bone loss during treatment should prompt the physician to examine whether the patient is taking the medication appropriately.
Men and women who have had a fragility fracture at the hip, spine, wrist or shoulder are at increased risk of having a future fracture, but this population is presently under investigated and under treated. Additional efforts have to be made to communicate to physicians (particularly orthopaedic surgeons and family physicians) and the public about the need for a BMD test after fracture, and for initiating treatment if low BMD is found.
Men had a disproportionately low rate of BMD tests and osteoporosis treatment, especially after a fracture. Evidence and fracture data showed that the risk of hip and wrist fractures in men rises sharply at age 70 years.
Some counties had BMD utilization rates that were only 10% of that of the county with the highest utilization. The reasons for low utilization need to be explored and addressed.
Initiatives such as aligning reimbursement policy with current guidelines, developing specific guidelines for BMD testing in men and perimenopausal women, improving BMD reports to assist in clinical decision making, developing a registry to track BMD tests, improving access to BMD tests in remote/rural counties, establishing mechanisms to alert family physicians of fractures, and educating physicians and the public, will improve the appropriate utilization of BMD tests, and further decrease the rate of fractures in Ontario. Some of these initiatives such as developing guidelines for perimenopausal women and men, and developing a standardized requisition form for BMD testing, are currently in progress under the Ontario Osteoporosis Strategy.
PMCID: PMC3379167  PMID: 23074491
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.  Factors influencing pharmacists’ adoption of prescribing: qualitative application of the diffusion of innovations theory 
Background
In 2007, Alberta became the first Canadian jurisdiction to grant pharmacists a wide range of prescribing privileges. Our objective was to understand what factors influence pharmacists’ adoption of prescribing using a model for the Diffusion of Innovations in healthcare services.
Methods
Pharmacists participated in semi-structured telephone interviews to discuss their prescribing practices and explore the facilitators and barriers to implementation. Pharmacists working in community, hospital, PCN, or other settings were selected using a mix of random and purposive sampling. Two investigators independently analyzed each transcript using an Interpretive Description approach to identify themes. Analyses were informed by a model explaining the Diffusion of Innovations in health service organizations.
Results
Thirty-eight participants were interviewed. Prescribing behaviours varied from non-adoption through to product, disease, and patient focused use of prescribing. Pharmacists’ adoption of prescribing was dependent on the innovation itself, adopter, system readiness, and communication and influence. Adopting pharmacists viewed prescribing as a legitimization of previous practice and advantageous to instrumental daily tasks. The complexity of knowledge required for prescribing increased respectively in product, disease and patient focused prescribing scenarios. Individual adopters had higher levels of self-efficacy toward prescribing skills. At a system level, pharmacists who were in practice settings that were patient focused were more likely to adopt advanced prescribing practices, over those in product-focused settings. All pharmacists stated that physician relationships impacted their prescribing behaviours and individual pharmacists’ decisions to apply for independent prescribing privileges.
Conclusions
Diffusion of Innovations theory was helpful in understanding the multifaceted nature of pharmacists’ adoption of prescribing. The characteristics of the prescribing model itself which legitimized prior practices, the model of practice in a pharmacy setting, and relationships with physicians were prominent influences on pharmacists’ prescribing behaviours.
doi:10.1186/1748-5908-8-109
PMCID: PMC3847669  PMID: 24034176
17.  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
18.  Challenges in the management of chronic noncommunicable diseases by Indonesian community pharmacists 
Pharmacy Practice  2015;13(3):578.
Objectives:
We explored factors influencing Indonesian primary care pharmacists’ practice in chronic noncommunicable disease management and proposed a model illustrating relationships among factors.
Methods:
We conducted in-depth, semistructured interviews with pharmacists working in community health centers (Puskesmas, n=5) and community pharmacies (apotek, n=15) in East Java Province. We interviewed participating pharmacists using Bahasa Indonesia to explore facilitators and barriers to their practice in chronic disease management. We audiorecorded all interviews, transcribed ad verbatim, translated into English and analyzed the data using an approach informed by “grounded-theory”.
Results:
We extracted five emergent themes/factors: pharmacists’ attitudes, Puskesmas/apotek environment, pharmacy education, pharmacy professional associations, and the government. Respondents believed that primary care pharmacists have limited roles in chronic disease management. An unfavourable working environment and perceptions of pharmacists’ inadequate knowledge and skills were reported by many as barriers to pharmacy practice. Limited professional standards, guidelines, leadership and government regulations coupled with low expectations of pharmacists among patients and doctors also contributed to their lack of involvement in chronic disease management. We present the interplay of these factors in our model.
Conclusion:
Pharmacists’ attitudes, knowledge, skills and their working environment appeared to influence pharmacists’ contribution in chronic disease management. To develop pharmacists’ involvement in chronic disease management, support from pharmacy educators, pharmacy owners, professional associations, the government and other stakeholders is required. Our findings highlight a need for systematic coordination between pharmacists and stakeholders to improve primary care pharmacists’ practice in Indonesia to achieve continuity of care.
doi:10.18549/PharmPract.2015.03.578
PMCID: PMC4582742  PMID: 26445618
Community Pharmacy Services; Professional Practice; Attitude of Health Personnel; Qualitative Research; Indonesia
19.  A multiple case history and systematic review of adoption, diffusion, implementation and impact of provincial daily physical activity policies in Canadian schools 
BMC Public Health  2015;15:385.
Background
Few children meet physical activity (PA) recommendations, and are therefore at increased risk for overweight/obesity and adverse health outcomes. To increase children’s opportunities for PA, several Canadian provinces have adopted school-based daily PA (DPA) policies. It is not clear why some jurisdictions have adopted DPA policies, and others have not, nor whether these policies have been implemented and have achieved their intended outcomes. The purpose of this study was to understand the processes underlying adoption and diffusion of Canadian DPA policies, and to review evidence regarding their implementation and impact.
Methods
We adopted a multiple case history methodology in which we traced the chronological trajectory of DPA policies among Canadian provinces by compiling timelines detailing key historical events that preceded policy adoption. Publicly available documents posted on the internet were reviewed to characterize adopter innovativeness, describe the content of their DPA policies, and explore the context surrounding policy adoption. Diffusion of Innovations theory provided a conceptual framework for the analyses. A systematic literature search identified studies that had investigated adoption, diffusion, implementation or impact of Canadian DPA policies.
Results
Five of Canada’s 13 provinces and territories (38.5%) have DPA policies. Although the underlying objectives of the policies are similar, there are clear differences among them and in their various policy trajectories. Adoption and diffusion of DPA policies were structured by the characteristics and capacities of adopters, the nature of their policies, and contextual factors. Limited data suggests implementation of DPA policies was moderate but inconsistent and that Canadian DPA policies have had little to no impact on school-aged children’s PA levels or BMI.
Conclusions
This study detailed the history and current status of Canadian DPA policies, highlighting the conditional nature of policy adoption and diffusion, and describing policy and adopter characteristics and political contexts that shaped policy trajectories. An understanding of the conditions associated with successful policy adoption and diffusion can help identify receptive contexts in which to pioneer novel legislative initiatives to increase PA among children. By reviewing evidence regarding policy implementation and impact, this study can also inform amendments to existing, and development of future PA policies.
Electronic supplementary material
The online version of this article (doi:10.1186/s12889-015-1669-6) contains supplementary material, which is available to authorized users.
doi:10.1186/s12889-015-1669-6
PMCID: PMC4436021  PMID: 25885026
Physical activity; Policy; Diffusion; Adoption; Implementation; Impact; Systematic review; Children; School
20.  The Role of the Pediatric Pharmacist in Personalized Medicine and Clinical Pharmacogenomics for Children 
With the initiatives by the National Institutes of Health and the Food and Drug Administration, pharmacogenomics has now moved from the laboratory to the patient bedside. Over 100 drug-products now contain pharmacogenomic information as part of their labeling. Many of these are commonly used in the pediatric population. Direct-to-consumer genetic test kits also require intervention and guidance from healthcare professionals. This increased trend towards personalized medicine mandates that healthcare professionals develop a working knowledge about pharmacogenomics and its application towards patient care. Because pharmacogenomic testing can provide patient-specific predictors for response to and safety of medications, pharmacists are positioned to play an active role in pharmacogenomic testing, clinical interpretation of results, and recommendations for individualization of drug therapy. Opportunities for pharmacists exist in both inpatient and outpatient settings, such as pharmacist-managed clinical pharmacogenomics consultation services and educating patients and families about pharmacogenomic testing. In addition to clinical roles, pharmacists may also be involved in genetically-influenced drug discovery and development. Given the potential for genetic and age-dependent factors to influence drug selection and dosing, pediatric pharmacists should be involved in the development of dosing recommendations and interprofessional practice guidelines regarding pharmacogenomic testing in pediatric patients. Opportunities to become knowledgeable and competent in pharmacogenomics span from coursework as part of the pharmacy curriculum to postgraduate education (e.g., residencies, fellowships, continuing education). However, there exists a need for additional postgraduate learning opportunities for practicing pharmacists. As a result, the Pediatric Pharmacy Advocacy Group (PPAG) acknowledges a need for increased education of both student and practicing pharmacists, with consideration of special patient populations, such as infants and children. PPAG endorses and advocates for the involvement of pediatric pharmacists in pharmacogenomic testing and in using those results to provide safe and effective medication use in pediatric patients of all ages. Additionally, PPAG strongly encourages pediatric pharmacists to take responsibility for educating patients and their families about the importance of pharmacogenomic testing and its role in the safe and effective use of medications.
doi:10.5863/1551-6776-16.2.118
PMCID: PMC3208440  PMID: 22477836
pediatrics; personalized medicine; pharmacist; pharmacogenomics; testing
21.  Pharmacy practice and its challenges in Yemen 
Background
Pharmacy practice in Yemen was established in 1875 in Aden.
Objectives
To describe pharmacy practice as it currently exists in Yemen, the challenges the profession faces, and to recommend changes that will improve pharmaceutical care services.
Methods
This study has two parts. Part 1 comprised a literature search performed between May and July 2011 to identify published studies on pharmacy practice in Yemen. Full text papers, abstracts, and reports in Arabic or English between 1970 and 2011 were reviewed. Part 2 consisted of a qualitative study with face-to-face interviews with a representative sample of pharmacists, staff from the Ministry of Public Health and Population (MoPHP), and patients.
Results
The analysis revealed several issues that plague pharmacy practice in Yemen:
Fewer than 10 per cent of pharmacists working in pharmacies and drug stores are graduates of governmentrecognised colleges.
Most Yemeni pharmacists are dissatisfied with their work conditions and opportunities.
Medicines are expensive and hard to access in Yemen, and counterfeit medicines are a serious problem.
Few regulations and standards exist for pharmacists and pharmaceutical care.
Pharmaceutical marketing plays an important role in marketing and selling products in Yemen.
A dearth of standards, regulations, and laws are hurting pharmacy practice in the country and potentially endangering peoples’ lives.
Conclusion
In order to improve pharmacy practice in Yemen, many changes are needed, including updating the pharmacy curriculum taught, implementing industry standards for pharmacy practice, implementing and reinforcing laws, and integrating pharmacists more fully in the healthcare industry. Additionally, the quality of the pharmacy workforce needs to be improved, and there needs to be increased awareness by the public, physicians, other healthcare professionals, and policy makers about the value of pharmacists.
doi:10.4066/AMJ.2014.1890
PMCID: PMC3920470  PMID: 24567762
Pharmacy practice; workforce; satisfaction; challenges; recommendations and Yemen
22.  Self-medication with nutritional supplements and herbal over-thecounter products 
In recent years, the popularity increased for nutritional supplements and herbal products. Prescription drugs, but not herbal therapies are paid by health insurances. They are sold over-the-counter (OTC) on the patients’ own expense. However, there are potential risks of self-medication, e.g. incorrect self-diagnosis, severe adverse reactions, dangerous drug interactions, risk of addiction etc. They are often used by patients at their own discretion without knowledge of and control by their physicians. Certain users are at risk of intoxication. Multiple medications taken by older patients increase the risk for adverse drug reactions, drug-drug interactions, and compliance problems for this age group (polypharmacy). Herbals should be discontinued prior to operations to avoid interactions with anesthetics or anticoagulants. Herbal preparations may also be carcinogenic or interfere with cancer treatments. Pregnant women use various OTC preparations. However, in many cases, it is unclear whether their use is safe for mother or baby. Self-medication with herbals is also largely distributed among anxious and depressive patients, and patients with other conditions and symptoms. The popularity of herbal products has also brought concerns on quality, efficacy and safety. Cases of botanical misidentification, contaminations with heavy metals, pesticides, radioactivity, organic solvents, microbials as well as adulteration with chemical drugs necessitate the establishment of international quality control standards. Hepatotoxic effects have been reported for more than 300 plant species, and some commonly used herbs have been demonstrated to interact with Western medication. Health care professionals have a critical responsibility assessing the self-care ability of their patients. Databases are available for pharmacists with information on action, side effects and toxicities as well as herb-drug interactions. There is a need for established guidelines regarding the correct use of nutritional supplements and herbal OTC preparations (phytovigilance). Physicians, pharmacists, and other health care professionals have to counsel patients and the general public on the benefits and risks associated with herbal drugs. Information centers for consumers and general practitioners are needed, and convincing evidence on safety and efficacy of herbal products has to be demonstrated in placebo-controlled, double blind and randomized clinical trials.
doi:10.1007/s13659-011-0029-1
PMCID: PMC4131654
botanicals; contamination; complementary and alternative medicine; drug interactions; geriatric; gynecology; insomnia; hepatotoxicity; menopause; nephrotoxicity; over-the-counter; pain; phase I/II enzymes; pharmacognosy; pharmacovigilance; phytochemicals; phytotherapy; phytovigilance; quality control
23.  Independent pharmacist prescribing in Canada 
Canadian Pharmacists Journal : CPJ  2012;145(1):17-23.e1.
Background: While pharmacists are trained in the selection and management of prescription medicines, traditionally their role in prescribing has been limited. In the past 5 years, many provinces have expanded the pharmacy scope of practice. However, there has been no previous systematic investigation and comparison of these policies.
Methods: We performed a comprehensive policy review and comparison of pharmacist prescribing policies in Canadian provinces in August 2010. Our review focused on documents, regulations and interviews with officials from the relevant government and professional bodies. We focused on policies that allowed community pharmacists to independently continue, adapt (modify) and initiate prescriptions.
Results: Pharmacists could independently prescribe in 7 of 10 provinces, including continuing existing prescriptions (7 provinces), adapting existing prescriptions (4 provinces) and initiating new prescriptions (3 provinces). However, there was significant heterogeneity between provinces in the rules governing each function.
Conclusions: The legislated ability of pharmacists to independently prescribe in a community setting has substantially increased in Canada over the past 5 years and looks poised to expand further in the near future. Moving forward, these programs must be evaluated and compared on issues such as patient outcomes and safety, professional development, human resources and reimbursement.
doi:10.3821/1913-701X-145.1.17
PMCID: PMC3567533  PMID: 23509483
24.  Pharmaceutical Consultation in UAE Community Pharmacies 
In recent years, the focus of pharmacists as traditional drug dispensers has shifted to more active and participative role in risk assessment, risk management, and other medication related consultation activities. Pharmacy profession is evolving steadily in the United Arab Emirates (UAE). Pharmacists in UAE are so much occupied in their administrative and managerial duties that dispensing is mostly attended to by pharmacy technicians. Pharmacist-led patient counseling is limited to the dosage and frequency of medications and rarely adverse reactions and drug interactions with other medications. Therefore we decided to perform quantitative questionnaires study to explore the role of pharmacist in patient counseling in UAE, the evaluation of pharmacist's opinion on patient counseling and the potential determinants of personal consultation. Results show the frequency and nature of inquiries received by pharmacist. Five to twenty inquires per month are received from patient, most of them related to drug prescription and dose recommendation. Thirty nine percent of pharmacists received inquiries from doctors, most of them related to the dose and mode of action. Ninty two percent of the pharmacists agreed that patient counseling is their professional responsibility. About 82% of pharmacists agreed that counseling will increase their sales and enhance the reputation of their pharmacies. Seventy percent of pharmacists mentioned that they need to undergo training for effective counseling while 46% of pharmacists felt that more staff in the pharmacies would have a positive influence on patient compliance to medication therapies and patient safety. The potential determinants of personal consultation show that 52% of participants trusted pharmacist and 55% considered the pharmacist as a friend. Forty eight percent of participants visited the pharmacy for medical recommendation while 30% for drug compounding, 72% agreed that pharmacist conducts full instruction while 31% agreed about full investigation. In conclusion, reorganization of the pharmacist's activities may improve pharmaceutical consultations. Pharmacists must be exposed to recent trends in drug therapy, dosage forms, dosage, adverse effects and interaction. This will go a long way in providing rational use of drugs to the patients and improve their quality of life.
doi:10.4103/0250-474X.95621
PMCID: PMC3374556  PMID: 22707824
Attitudes and behaviors; community pharmacists; patient counseling; patient information leaflets; personal consultation
25.  Patient attitudes regarding the role of the pharmacist and interest in expanded pharmacist services 
Canadian Pharmacists Journal : CPJ  2014;147(4):239-247.
Background:
Pharmacists are consistently ranked among the most trusted professionals, and research shows high levels of satisfaction with pharmacist services. Studies have also shown that the public is generally unaware of the full range of roles and responsibilities of a pharmacist. The purpose of this study was to explore the public’s knowledge and attitudes regarding the role of the community pharmacist and to determine their likelihood of using expanded pharmacist services.
Methods:
Adults across Newfoundland and Labrador were surveyed by telephone. Survey questions addressed how frequently participants visited the pharmacy, understanding of duties undertaken by pharmacists, perceptions and attitudes regarding pharmacists as health care professionals, likelihood of using expanded pharmacist services and participant demographics. Comparisons were made between responses from urban and rural participants and frequent versus nonfrequent pharmacy users, to determine if there were any differences.
Results:
The majority of participants were generally aware of what pharmacists do when filling prescriptions; those who visited the pharmacy more frequently appeared to be more informed. Participants indicated they would take advantage of the expanded services suggested, with greatest interest in receiving advice for minor ailment management and prescription refills from pharmacists. Results support the prevailing view that pharmacists are trusted health professionals who should have access to patients’ health information to provide best care.
Conclusion:
The public is aware of aspects of the pharmacist’s role, but opportunities exist to better educate the public on the knowledge, skills and unique professional abilities of pharmacists to support uptake of expanded pharmacist services.
doi:10.1177/1715163514535731
PMCID: PMC4212442  PMID: 25360150

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