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1.  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
2.  Pharmacists’ knowledge and attitudes about natural health products: a mixed-methods study 
Objectives
To explore knowledge and attitude of pharmacists in Qatar towards natural health products (NHPs).
Methods
The quantitative component of this study consisted of an anonymous, online, self-administered questionnaire to assess knowledge about NHPs among pharmacists in Qatar. Descriptive statistics and inferential analysis were conducted using Statistical Package of Social Sciences (SPSS®). Means and standard deviation were used to analyze descriptive data, and statistical significance was expressed as P-value, where P≤0.05 was considered statistically significant. Associations between variables were measured using Pearson correlation. The qualitative component utilized focus group (FG) meetings with a purposive sample of community pharmacists. Meetings were conducted until a point of saturation was reached. FG discussions were audio-taped and transcribed verbatim. Data were analyzed using a framework approach to sort the data according to emerging themes.
Results
The majority of participants had average to poor knowledge about NHPs while only around 7% had good knowledge. In the FG meetings, participants considered the media, medical representatives, and old systems of natural health as major source of their knowledge. They criticized undergraduate pharmacy courses (for inadequately preparing pharmacists to deal with NHPs) and the pharmacy regulations (for being irrelevant). A perception of NHPs as being “safe” still exists among pharmacists.
Conclusions
Pharmacists’ ability to provide effective services associated with NHPs is limited by poor access to evidence-based information and poor knowledge. A perception of NHPs and CAM as ‘safe’ still exists among pharmacists, and regulations related to NHPs require addressing to follow best practice and ensure patient safety.
doi:10.2147/DHPS.S57756
PMCID: PMC3912048  PMID: 24501547
Qatar; focus group; complimentary alternative medicine
3.  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
4.  Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health Product and Prescription Drug Use in Community Pharmacies 
PLoS ONE  2012;7(9):e45196.
Background
Many consumers use natural health products (NHPs) concurrently with prescription medications. As NHP-related harms are under-reported through passive surveillance, the safety of concurrent NHP-drug use remains unknown. To conduct active surveillance in participating community pharmacies to identify adverse events related to concurrent NHP-prescription drug use.
Methodology/Principal Findings
Participating pharmacists asked individuals collecting prescription medications about (i) concurrent NHP/drug use in the previous three months and (ii) experiences of adverse events. If an adverse event was identified and if the patient provided written consent, a research pharmacist conducted a guided telephone interview to gather additional information after obtaining additional verbal consent and documenting so within the interview form. Over a total of 112 pharmacy weeks, 2615 patients were screened, of which 1037 (39.7%; 95% CI: 37.8% to 41.5%) reported concurrent NHP and prescription medication use. A total of 77 patients reported a possible AE (2.94%; 95% CI: 2.4% to 3.7%), which represents 7.4% of those using NHPs and prescription medications concurrently (95%CI: 6.0% to 9.2%). Of 15 patients available for an interview, 4 (26.7%: 95% CI: 4.3% to 49.0%) reported an AE that was determined to be “probably” due to NHP use.
Conclusions/Significance
Active surveillance markedly improves identification and reporting of adverse events associated with concurrent NHP-drug use. Although not without challenges, active surveillance is feasible and can generate adverse event data of sufficient quality to allow for meaningful adjudication to assess potential harms.
doi:10.1371/journal.pone.0045196
PMCID: PMC3461007  PMID: 23028841
5.  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
6.  Public awareness, patterns of use and attitudes toward natural health products in Kuwait: a cross-sectional survey 
Background
There has been a global rise in the use of natural health products (NHPs). Proper regulation of NHPs is pivotal to ensure good quality control standards, enhance consumers' safety and facilitate their integration into modern healthcare systems. There is scarcity of published data on the prevalence of NHPs usage among the general Kuwaiti population. Hence, this study was designed to determine awareness, patterns of use, general attitude and information requirements about NHPs among the public in Kuwait.
Methods
A descriptive cross-sectional survey was performed using a pretested self-administered questionnaire on a sample of 1300 Kuwaiti individuals, selected from six governorates in Kuwait using a multistage stratified clustered sampling. Descriptive and multivariate logistic regression analysis were used in data analysis.
Results
The response rate was 90.2%. NHPs were thought to be herbal remedies by most of participants (63.5%), followed by vitamins/minerals (40.5%), traditional medicines (21.1%), probiotics (14.9%), amino acids and essential fatty acids (7.2%), and homeopathic medicines (5.6%). NHPs usage was reported by 71.4% (95% CI: 68.8-74.0%) of respondents, and mostly associated with females (OR: 1.90; 95% CI: 1.44-2.51). Herbal remedies were the most commonly used (41.3%; 95% CI: 38.5-44.2%). The most common reasons for using NHPs were to promote and maintain health and to prevent illness and build immune system. Family members and/or friends and mass media were the main sources for providing information about NHPs. About 18% of consumers have experienced a side effect due to using a NHP. Attitudes toward NHPs were generally positive; with more than 75% of participants believing that the Ministry of Health in Kuwait should regulate the claims made by the manufacturers of NHPs and it is important to talk to a medical doctor or a pharmacist prior to using NHPs. Most of the respondents showed increased interest to acquire knowledge about different types of information related to NHPs.
Conclusions
The prevalence of use of NHPs among Kuwaiti population is high. The present findings have major public health policy implications for Kuwait. Therefore, there is an apparent need to establish effective health education programs and implement better and more regulated NHPs use policies in Kuwait.
doi:10.1186/1472-6882-14-105
PMCID: PMC3999934  PMID: 24646341
Natural health products; Herbal remedies; Patterns of use; Kuwait
7.  Community Pharmacists role in obesity treatment in Kuwait: a cross-sectional study 
BMC Public Health  2012;12:863.
Background
Obesity is a growing health concern in Kuwait. Obesity has been identified as a key risk factor for many chronic diseases including hypertension, dyslipidemia and type 2 diabetes mellitus. It has been shown that community pharmacists' involvement is associated with successful weight management in developed countries. This study was conducted to investigate the role of community pharmacists in obesity counseling, and to identify the barriers to counseling in Kuwait.
Methods
A descriptive cross-sectional study involved 220 community pharmacies that were selected via stratified and systematic random sampling. A pretested self-administered questionnaire collected information on frequency and comfort level with obesity counseling, and the perceived effectiveness of four aspects of obesity management (diet and exercise, prescribed antiobesity medications, diet foods, and nonprescription products and dietary supplements). Information on perceived confidence in achieving positive outcomes as a result of counseling and barriers to counseling was also collected. Descriptive and Spearman’ r analysis were conducted using SPSS version 17. Responses with Likert scale rating 1(low score) to 5 (high score) and binary choices (yes/no) were presented as mean (SD) and (95% CI), respectively.
Results
The response rate was 93.6%. The overall mean (SD) responses indicated that pharmacists counseled obese patients sometimes to most of the time, 3.67 (1.19) and were neutral to comfortable with counseling about aspects of obesity management, 3.77 (1.19). Respondents perceived obesity management aspects to be somewhat effective, 3.80 (1.05). Of the four aspects of obesity management, diet and exercise, and diet foods were the highest ranked in terms of frequency of counseling, comfort level and perceived effectiveness. Pharmacists were neutral to confident in achieving positive outcomes as a result of obesity counseling, 3.44 (1.09). Overall mean responses of counseling obese patients by pharmacists were positively correlated with their perceived comfort with counseling and perceived effectiveness of obesity management aspects. The most anticipated barriers to obesity counseling were lack of patient awareness about pharmacists' expertise in counseling 76.2% (95% CI: 69.7-81.7) and pharmacists’ opinions that obese patients lack willpower and are non-adherent to weight reduction interventions 71.8% (95% CI: 65.1-77.8).
Conclusions
Strengths, weaknesses and barriers related to obesity counseling by pharmacists in Kuwait were identified, and suggestions were provided to strengthen that role.
doi:10.1186/1471-2458-12-863
PMCID: PMC3491033  PMID: 23057422
Community pharmacists; Obesity; Obesity counseling; Kuwait
8.  The Prevalence of Natural Health Product Use in Patients with Acute Cardiovascular Disease 
PLoS ONE  2011;6(5):e19623.
Background
Natural health products (NHP) use may have implications with respect to adverse effects, drug interactions and adherence yet the prevalence of NHP use by patients with acute cardiovascular disease and the best method to ascertain this information is unknown.
Objective
To identify the best method to ascertain information on NHP, and the prevalence of use in a population with acute cardiovascular disease.
Methods
Structured interviews were conducted with a convenience sample of consecutive patients admitted with acute cardiovascular disease to the University of Alberta Hospital during January 2009. NHP use was explored using structured and open-ended questions based on Health Canada's definition of NHP. The medical record was reviewed, and documentation of NHP use by physicians, nurses, and pharmacists, compared against the gold-standard structured interview.
Results
88 patients were interviewed (mean age 62 years, standard deviation [SD 14]; 80% male; 41% admitted for acute coronary syndromes). Common co-morbidities included hypertension (59%), diabetes (26%) and renal impairment (19%). NHP use was common (78% of patients) and 75% of NHP users reported daily use. The category of NHP most commonly used was vitamins and minerals (73%) followed by herbal products (20%), traditional medicines including Chinese medicines (9%), homeopathic preparations (1%) and other products including amino acids, essential fatty acids and probiotics (35%). In a multivariable model, only older age was associated with increased NHP use (OR 1.5 per age decile [95%CI 1.03 to 2.2]). When compared to the interview, the highest rate of NHP documentation was the pharmacist history (41%). NHP were documented in 22% of patients by the physician and 19% by the nurse.
Conclusions
NHP use is common in patients admitted with acute cardiovascular disease. However, health professionals do not commonly identify NHP as part of the medication profile despite its potential importance. Structured interview appears to be the best method to accurately identify patient use of NHP.
doi:10.1371/journal.pone.0019623
PMCID: PMC3090400  PMID: 21573067
9.  Use of natural health products in children 
Canadian Family Physician  2013;59(8):e357-e363.
Abstract
Objective
To determine the experiences of family physicians in Newfoundland and Labrador with parents’ use of natural health products (NHPs) for their children and to assess physicians’ attitudes toward use of NHPs in children.
Design
A survey using the Dillman approach.
Setting
Newfoundland and Labrador.
Participants
All family physicians in the province.
Main outcome measures
Physician demographic characteristics; whether physicians inquire about the use of NHPs in children; the degree to which they think patients disclose use of NHPs in children; whether they counsel parents about the potential benefits or harms of NHPs; their own opinions about the usefulness of NHPs; whether they recommend NHPs in children and for what reasons; and the particular NHPs they have seen used in children and for what reasons.
Results
A total of 159 (33.1%) family physicians responded; 65.4% were men, 71.7% were Canadian medical graduates, and 46.5% practised in rural areas. Overall, 18.8% of family physicians said they regularly or frequently asked about NHP use; 24.7% counseled patients about potential harms. Only 1.9% of physicians believed NHPs were usually beneficial, but a similarly small number (8.4%) thought they were usually harmful. Most respondents were somewhat neutral; 59.7% said they never recommend NHPs for children, and a further 37.0% said they would only “sometimes” recommend NHPs.
Conclusion
Most physicians believed that NHPs were probably of little benefit but not likely to be harmful. Most NHPs used were vitamins and minerals. Physicians recognized that NHPs were often used by parents for children, but in general they believed NHPs had little effect on their day-to-day medical practices. Thirty-eight (24.7%) of the 154 physicians had at least once recommended an NHP (including vitamins) for their pediatric patients. Physicians believed that parents did not often disclose use of NHPs for their children, but at the same time physicians generally did not actively inquire.
PMCID: PMC3743712  PMID: 23946042
10.  Pharmacists and Natural Health Products: A systematic analysis of professional responsibilities in Canada 
Pharmacy practice  2008;6(1):33-42.
PURPOSE
Natural health products (natural health products) such as herbs, vitamins and homeopathic medicines are widely available in Canadian pharmacies. The purpose of this paper was 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 CAMSID: cams1356
pharmacist; legal responsibilities; natural health products; dietary supplements
11.  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
12.  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
13.  Nutrient- and non-nutrient-based natural health product (NHP) use in adults with mood disorders: prevalence, characteristics and potential for exposure to adverse events 
Background
To address knowledge gaps regarding natural health product (NHP) usage in mental health populations, we examined their use in adults with mood disorders, and explored the potential for adverse events.
Methods
Food and NHP intake was obtained from 97 adults with mood disorders. NHP data was used to compare prevalence with population norms (British Columbia Nutrition Survey; BCNS). Bivariate and regression analyses examined factors associated with NHP use. Assessment of potential adverse effects of NHP use was based on comparing nutrient intakes from food plus supplements with the Dietary Reference Intakes and by reviewing databases for reported adverse health effects.
Results
Two-thirds (66%; 95% CI 56 to 75) were taking at least one NHP; 58% (95% CI 47 to 68) were taking NHPs in combination with psychiatric medications. The proportion of each type of NHP used was generally higher than the BCNS (range of p’s < 0.05 to 0.0001). When intakes from food and NHP sources were combined, a small proportion exceeded any Lowest-Observed-Adverse-Effect-Levels: only for niacin (n = 17) and magnesium (n = 6), two nutrients for which the potential for adverse effects is minimal. Conversely, about 38% (95% CI 28 to 49) of the sample were taking a non-nutrient based NHP for which previous adverse events had been documented.
Conclusions
The prevalent use of NHPs in this population suggests that health care providers need to be knowledgeable about their characteristics. The efficacy and safety of NHPs in relation to mental health warrants further investigation.
doi:10.1186/1472-6882-13-80
PMCID: PMC3626531  PMID: 23570306
Natural health products; Adverse events; Mood disorders
14.  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
15.  Use of natural health products in children 
Canadian Family Physician  2013;59(8):e372-e378.
Abstract
Objective
To gain a more thorough understanding of why parents choose to give their children natural health products (NHPs), parents’ sources of information about NHPs, and the extent of disclosure and conversation with family doctors about the use of NHPs.
Design
Qualitative study.
Setting
Newfoundland and Labrador.
Participants
Parents of children who were using NHPs (N = 20).
Methods
Individual, semistructured interviews were carried out with parents to obtain a better understanding of the reasoning behind the use of NHPs. Key themes emerging from the qualitative data were identified according to a number of criteria, including relevance to the research objectives, frequency with which a theme was mentioned, relative importance of the themes based on the amount of text taken up to address an issue, and emphasis (eg, emphatic or emotional speech).
Main findings
The types of NHPs used by parents participating in this study varied, except for the use of multivitamins. In addition, use of the products themselves was variable and inconsistent. Parents reported few concerns about the use of NHPs. The most commonly reported source of information about NHPs was family and friends. Most participants had not spoken to their family doctors about the use of NHPs.
Conclusion
Participants considered NHPs to be “natural” and seemed to equate this assessment with safety. This might explain why these parents sought advice and information from family and friends rather than from their family doctors and often failed to disclose the use of NHPs to their children’s family doctors.
PMCID: PMC3743714  PMID: 23946044
16.  Core Competencies in Natural Health Products for Canadian Pharmacy Students 
Objective
To reach consensus on core competency statements for natural health products (NHPs) for Canadian pharmacy students.
Methods
Four rounds of a modified Delphi method were used to achieve consensus on core competency statements for NHPs. Pharmacy educators from Canada and the United States, and representatives from Canadian pharmacy organizations ranked their agreement using a 5-point Likert scale.
Results
Consensus was achieved on 3 NHP-related core competency statements: (1) to incorporate NHP knowledge when providing pharmaceutical care; (2) to access and critically appraise NHP-related information sources; and (3) to provide appropriate education to patients and other health care providers on the effectiveness, potential adverse effects, and drug interactions of NHPs.
Conclusions
Consensus was reached among leaders in NHP education on 3 NHP-related core competency statements. Implementation of these competencies would ensure that graduating Canadian pharmacists would be able to fulfill their professional responsibilities related to NHPs.
PMCID: PMC2865411  PMID: 20498738
natural health products (NHPs); competencies; Delphi method; complementary and alternative medicine; herbal medicine
17.  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
18.  Consumers of natural health products: natural-born pharmacovigilantes? 
Background
Natural health products (NHPs), such as herbal medicines and vitamins, are widely available over-the-counter and are often purchased by consumers without advice from a healthcare provider. This study examined how consumers respond when they believe they have experienced NHP-related adverse drug reactions (ADRs) in order to determine how to improve current safety monitoring strategies.
Methods
Qualitative semi-structured interviews were conducted with twelve consumers who had experienced a self-identified NHP-related ADR. Key emergent themes were identified and coded using content analysis techniques.
Results
Consumers were generally not comfortable enough with their conventional health care providers to discuss their NHP-related ADRs. Consumers reported being more comfortable discussing NHP-related ADRs with personnel from health food stores, friends or family with whom they had developed trusted relationships. No one reported their suspected ADR to Health Canada and most did not know this was possible.
Conclusion
Consumers generally did not report their suspected NHP-related ADRs to healthcare providers or to Health Canada. Passive reporting systems for collecting information on NHP-related ADRs cannot be effective if consumers who experience NHP-related ADRs do not report their experiences. Healthcare providers, health food store personnel, manufacturers and other stakeholders also need to take responsibility for reporting ADRs in order to improve current pharmacovigilance of NHPs.
doi:10.1186/1472-6882-10-8
PMCID: PMC2847952  PMID: 20184759
19.  Availability of Tobacco and Alcohol Products in Los Angeles Community Pharmacies 
Journal of Community Health  2012;37(1):113-118.
The availability of tobacco and alcohol products in community pharmacies contradicts the pharmacists’ Code of Ethics and presents challenges for a profession that is overwhelmingly not in favor of the sale of these products in its practice settings. The primary aim of this study was to estimate the proportion of pharmacies that sell tobacco products and/or alcoholic beverages and to characterize promotion of these products. The proportion of pharmacies that sell non-prescription nicotine replacement therapy (NRT) products as aids to smoking cessation also was estimated. Among 250 randomly-selected community pharmacies in Los Angeles, 32.8% sold cigarettes, and 26.0% sold alcohol products. Cigarettes were more likely to be available in traditional chain pharmacies and grocery stores than in independently-owned pharmacies (100% versus 10.8%; P < 0.001), and traditional chain drug stores and grocery stores were more likely to sell alcoholic beverages than were independently-owned pharmacies (87.5% vs. 5.4%; P < 0.001). Thirty-four (41.5%) of the 82 pharmacies that sold cigarettes and 47 (72.3%) of the 65 pharmacies that sold alcohol also displayed promotional materials for these products. NRT products were merchandised by 58% of pharmacies. Results of this study suggest that when given a choice, pharmacists choose not to sell tobacco or alcohol products.
doi:10.1007/s10900-011-9424-0
PMCID: PMC3394176  PMID: 21644021
Tobacco sales; Alcohol sales; Tobacco control; Pharmacies
20.  Access to Multilingual Medication Instructions at New York City Pharmacies 
An essential component of quality care for limited English proficient (LEP) patients is language access. Linguistically accessible medication instructions are particularly important, given the serious consequences of error and patient responsibility for managing often complex medication regimens on their own. Approximately 21 million people in the U.S. were LEP at the time of the 2000 census, representing a 50% increase since 1990. Little information is available on their access to comprehensible medication instructions. In an effort to address this knowledge gap, we conducted a telephone survey of 200 randomly selected NYC pharmacies. The primary focus of the survey was translation need, capacity, and practice. The majority of pharmacists reported that they had LEP patients daily (88.0%) and had the capacity to translate prescription labels (79.5%). Among pharmacies serving LEP patients on a daily basis, just 38.6% translated labels daily; 22.7% never translated. In multivariate analysis, pharmacy type (OR=4.08, 95%CI=1.55–10.74, independent versus chain pharmacies) and proportion of Spanish-speaking LEP persons in the pharmacy’s census tract (OR=1.09, 95%CI=1.05–1.13 for each 1% increase in Spanish LEP population) were associated with increased label translation. Although 88.5% of the pharmacies had bilingual staff, less than half were pharmacists or pharmacy interns and thus qualified to provide medication counseling. More than 80% of the pharmacies surveyed lacked systematic methods for identifying linguistic needs and for informing patients of translation capabilities. Consistent with efforts to improve language access in other health care settings, the critical gap in language appropriate pharmacy services must be addressed to meet the needs of the nation’s large and ever-growing immigrant communities. Pharmacists may require supplemental training on the need and resources for meeting the verbal and written language requirements of their LEP patients. Dispensing software with accurate translation capability and telephonic interpretation services should be utilized in pharmacies serving LEP patients. Pharmacists should post signs and make other efforts to inform patients about the language resources available to them.
doi:10.1007/s11524-007-9221-3
PMCID: PMC2232041  PMID: 17926130
LEP patients; Medical instructions; Pharmacists; Label translation;  Immigrants; Language access
21.  Use of natural health products in children 
Canadian Family Physician  2013;59(8):e364-e371.
Abstract
Objective
To determine how common it is for parents to give natural health products (NHPs) to their children, which NHPs are being used, why they are being used, and parents’ assessments of the benefits and side effects of NHPs.
Design
Survey.
Setting
Newfoundland and Labrador.
Participants
Parents waiting in their family doctors’ offices.
Main outcome measures
Parent and child demographic characteristics; pediatric chronic medical conditions affecting the children; prescribed medications, over-the-counter medications, and NHPs used by the children; why the medications and NHPs were being used, the dose, and parents’ assessments of the effectiveness and side effects; and where parents had heard about the NHPs, whether they had told their physicians that the children were taking the products, and where they had obtained the products.
Results
A total of 202 (53.4%) of the 378 eligible adults who were approached completed the survey. This represented 333 children. Mean (SD) age of the children was 5.1 (3.3) years. Overall, 28.7% of parents reported using nonvitamin NHPs for their children. A total of 137 children (41.1%) had taken NHPs (including vitamins); 61.1% of the NHPs being used were vitamins. The remainder fell under teas (primarily chamomile and green teas), echinacea, fish or omega-3 oils, and a large category of “other” products. These NHPs were most commonly used to improve general health, improve immunity, and prevent colds and infections. Approximately half of the parents (51.7%) believed their children had benefited from taking NHPs, and 4.4% believed their children had experienced adverse side effects. Slightly less than half of the parents (45.0%) had informed their physicians that their children were taking NHPs.
Conclusion
Overall, 45.5% of parents attending physicians’ offices reported using NHPs in their children. If vitamins are not included in the definition of NHPs, this rate drops to 28.7%. Parents most commonly use NHPs to maintain the general health of their children, to prevent colds, and to boost children’s immune systems. About half of the parents believed the NHPs helped, very few had noticed any side effects, and approximately half had informed their physicians that they were giving their children NHPs.
PMCID: PMC3743713  PMID: 23946043
22.  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
23.  Cost Effectiveness of Natural Health Products: A Systematic Review of Randomized Clinical Trials 
Health care spending in North America is consuming an ever-increasing share of Gross Domestic Product (GDP). A large proportion of alternative health care is consumed in the form of natural health products (NHPs). The question of whether or not NHPs may provide a cost-effective choice in the treatment of disease is important for patients, physicians and policy makers. The objective of this study was to conduct a systematic review of the literature in order to find, appraise and summarize high-quality studies that explore the cost effectiveness of NHPs as compared to conventional medicine. The following databases were searched independently in duplicate from inception to January 1, 2006: EMBASE, MEDLINE, CINAHL, BioethicsLine, Wilson General Science abstracts, EconLit, Cochrane Library, ABI/Inform and SciSearch. To be included in the review, trials had to be randomized, assessed for some measure of cost effectiveness and include the use of NHPs as defined by the Natural Health Products Directorate. Studies dealing with diseases due to malnutrition were excluded from appraisal. The pooled searches unveiled nine articles that fit the inclusion/exclusion criteria. The conditions assessed by the studies included three on postoperative complications, two on cardiovascular disease, two on gastrointestinal disorders, one on critically ill patients and one on urinary tract infections. Heterogeneity between the studies was too great to allow for meta-analysis of the results. The use of NHPs shows evidence of cost effectiveness in relation to postoperative surgery but not with respect to the other conditions assessed. In conclusion, NHPs may be of use in preventing complications associated with surgery. The cost effectiveness of some NHPs is encouraging in certain areas but needs confirmation from further research.
doi:10.1093/ecam/nem167
PMCID: PMC2722206  PMID: 18955290
CAM; complementary and alternative medicine; cost effectiveness; natural health products; NHPs
24.  Transcriptional Regulation of the Nitrile Hydratase Gene Cluster in Pseudomonas chlororaphis B23▿  
Journal of Bacteriology  2008;190(12):4210-4217.
An enormous amount of nitrile hydratase (NHase) is inducibly produced by Pseudomonas chlororaphis B23 after addition of methacrylamide as the sole nitrogen source to a medium. The expression pattern of the P. chlororaphis B23 NHase gene cluster in response to addition of methacrylamide to the medium was investigated. Recently, we reported that the NHase gene cluster comprises seven genes (oxdA, amiA, nhpA, nhpB, nhpC, nhpS, and acsA). Sequence analysis of the 1.5-kb region upstream of the oxdA gene revealed the presence of a 936-bp open reading frame (designated nhpR), which should encode a protein with a molecular mass of 35,098. The deduced amino acid sequence of the nhpR product showed similarity to the sequences of transcriptional regulators belonging to the XylS/AraC family. Although the transcription of the eight genes (nhpR, oxdA, amiA, nhpABC, nhpS, and acsA) in the NHase gene cluster was induced significantly in the P. chlororaphis B23 wild-type strain after addition of methacrylamide to the medium, transcription of these genes in the nhpR disruptant was not induced, demonstrating that nhpR codes for a positive transcriptional regulator in the NHase gene cluster. A reverse transcription-PCR experiment revealed that five genes (oxdA, amiA, nhpA, nhpB, and nhpC) are cotranscribed, as are two other genes (nhpS and acsA). The transcription start sites for nhpR, oxdA, nhpA, and nhpS were mapped by primer extension analysis, and putative −12 and −24 σ54-type promoter binding sites were identified. NhpR was found to be the first transcriptional regulator of NHase belonging to the XylS/AraC family.
doi:10.1128/JB.00061-08
PMCID: PMC2446774  PMID: 18408036
25.  Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality 
BMJ Open  2014;4(3):e003431.
Objectives
To investigate the rates and causality of adverse event(s) (AE) associated with natural health product (NHP) use, prescription drug use and concurrent NHP-drug use through active surveillance in community pharmacies.
Design
Cross-sectional study of screened patients.
Setting
10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011.
Participants
The participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications.
Primary outcome measures
Patients were screened to determine the proportions of them using prescription drugs and/or NHPs, as well as their respective AE rates. All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality.
Results
Over a total of 105 pharmacy weeks and 1118 patients screened, 410 patients reported taking prescription drugs only (36.7%; 95% CI 33.9% to 39.5%), 37 reported taking NHPs only (3.3%; 95% CI 2.4% to 4.5%) and 657 reported taking prescription drugs and NHPs concurrently (58.8%; 95% CI 55.9% to 61.6%). In total, 54 patients reported an AE, representing 1.2% (95% CI 0.51% to 2.9%), 2.7% (95% CI 0.4% to 16.9%) and 7.3% (95% CI 5.6% to 9.6%) of each population, respectively. Compared with patients who reported using prescription drugs, the patients who reported using prescription drugs and NHPs concurrently were 6.4 times more likely to experience an AE (OR; 95% CI 2.52 to 16.17; p<0.001). Combined with data from Ontario, Canada, a national proportion was calculated, which found that 45.4% (95% CI 43.8% to 47.0%) of Canadians who visit community pharmacies take NHPs and prescription drugs concurrently, and of those, 7.4% (95% CI 6.3% to 8.8%) report an AE.
Conclusions
A substantial proportion of community pharmacy patients use prescription drugs and NHPs concurrently; these patients are at a greater risk of experiencing an AE. Active surveillance provides a means of detecting such AEs and collecting high-quality data on which causality assessment can be based.
doi:10.1136/bmjopen-2013-003431
PMCID: PMC3975764  PMID: 24682573
Complementary Medicine; Toxicology

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