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1.  The Canadian Natural Health Products (NHP) regulations: industry perceptions and compliance factors 
Background
The use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP) Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time); and explore the factors that affect regulatory compliance.
Methods
Twenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes.
Results
The major finding of this study is that most (17 out of 20) companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size.
Conclusion
The Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.
doi:10.1186/1472-6963-6-63
PMCID: PMC1524757  PMID: 16734916
2.  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
3.  Science Across Borders: 5th Annual Natural Health Product Research Conference—March 26–29, 2008, Toronto, Canada 
Canada is experiencing a growing interest in the use of alternative therapies and products particularly natural health products (NHP). In 1997, Canadians spent around C$ 2 billion on NHP. In an attempt to catch with this popularity of NHP use, Canadian researchers and administrators from academia, industry and government jointly established the Natural Health Product Research Society of Canada (NHPRS). Since its formation, NHPRS has been organizing an annual meeting which brings together world renowned researchers and experts in the area of NHP research. For 2008, the annual NHPRS meeting took place in Toronto from the 26th to 29th of March with a focus on ‘Science Across Borders: Global Natural Health Products Research’. The scientific program was spread into three days of plenary lectures and oral presentations. The different sessions containing these talks were on: ethnobotany around the world; chemical analysis of NHP; product standards and quality control; ethnomedicine; novel analytical approaches; systemic research, nutrisciences and molecular medicine; and drug development from NHP. The meeting proved to be a great success in terms of the speakers that were invited and based on the data that was presented which highlighted recent research taking place in the field of NHP not only in Canada but from many parts of the world.
doi:10.1093/ecam/nen059
PMCID: PMC2887334  PMID: 18955362
meeting; natural health products; alternative therapies; ethnobotany; chemical analysis; quality control; drug development
4.  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
5.  Canada's Patented Medicine Notice of Compliance regulations: balancing the scales or tipping them? 
Background
In order to comply with the provisions of the North American Free Trade Agreement, in 1993 the Canadian federal government introduced the Patented Medicine Notice of Compliance Linkage Regulations. These regulations were meant to achieve a balance between the timely entry of generic medicines and the rights of patent holders. The regulations tied the regulatory approval of generic medicines to the patent status of the original brand-name product.
Discussion
Since their introduction the regulations have been a source of contention between the generic and the brand-name industry. While the regulations have generated a considerable amount of work for the Federal Court of Canada both sides dispute the interpretation of the "win rate" in the court cases. Similarly, there is no agreement on whether multiple patents on single drugs represent a legitimate activity by the brand-name industry or an "evergreening" tactic. The generic industry's position is that the regulations are being abused leading to the delay in the introduction of lower cost generic products by as much as 8 years. The brand-name companies counter that the regulations are necessary because injunctions against the introduction of generic products are frequently unavailable to them. The regulations were amended in 2006 and again in 2008 but both sides continue to claim that the regulations favour the other party. The battle around the regulations also has an international dimension with interventions by PhRMA, the trade association representing the United States based multinational companies, arguing that the regulations are not stringent enough and that Canada needs to be placed on the U.S. Priority Watch List of countries. Finally, there are multiple costs to Canadian society as a result of the NOC regulations.
Summary
Despite the rhetoric there has been almost no empiric academic research done into the effect of the regulations. In order to develop rational policy in this area a number of key research questions have been formulated.
doi:10.1186/1472-6963-11-64
PMCID: PMC3073891  PMID: 21435247
6.  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
7.  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
8.  Understanding the role of scientific evidence in consumer evaluation of natural health products for osteoarthritis an application of the means end chain approach 
Background
Over 30% of individuals use natural health products (NHPs) for osteoarthritis-related pain. The Deficit Model for the Public Understanding of Science suggests that if individuals are given more information (especially about scientific evidence) they will make better health-related decisions. In contrast, the Contextual Model argues that scientific evidence is one of many factors that explain how consumers make health-related decisions. The primary objective was to investigate how the level of scientific evidence supporting the efficacy of NHPs impacts consumer decision-making in the self-selection of NHPs by individuals with osteoarthritis.
Methods
The means-end chain approach to product evaluation was used to compare laddering interviews with two groups of community-dwelling Canadian seniors who had used NHPs to treat their osteoarthritis. Group 1 (n=13) had used only NHPs (glucosamine and/or chondroitin) with “high” scientific evidence of efficacy. Group 2 (n=12) had used NHPs (methylsulfonylmethane (MSM) and/or bromelain) with little or no scientific evidence supporting efficacy. Content analysis and generation of hierarchical value maps facilitated the identification of similarities and differences between the two groups.
Results
The dominant decision-making chains for participants in the two scientific evidence categories were similar. Scientific evidence was an important decision-making factor but not as important as the advice from health care providers, friends and family. Most participants learned about scientific evidence via indirect sources from health care providers and the media.
Conclusions
The Contextual Model of the public understanding of science helps to explain why our participants believed scientific evidence is not the most important factor in their decision to use NHPs to help manage their osteoarthritis.
doi:10.1186/1472-6882-12-198
PMCID: PMC3517436  PMID: 23107559
Natural health products; Decision-making; Means ends chain analysis; Osteoarthritis
9.  New Canadian natural health product regulations: a qualitative study of how CAM practitioners perceive they will be impacted 
Background
New Canadian policy to regulate natural health products (NHPs), such as herbs and vitamins were implemented on January 1st, 2004. We explored complementary and alternative medicine (CAM) practitioners' perceptions of how the new regulations may affect their practices and relationships with patients/consumers.
Methods
This was an applied ethnographic study. Data were collected in fall 2004 via qualitative interviews with 37 Canadian leaders of four CAM groups that use natural products as a core part of their practises: naturopathic medicine, traditional Chinese medicine (TCM), homeopathic medicine and Western herbalism. All interviews were transcribed verbatim and coded independently by a minimum of two investigators using content analysis.
Results
Three key findings emerged from the data: 1) all CAM leaders were concerned with issues of their own access to NHPs; 2) all the CAM leaders, except for the homeopathic leaders, specifically indicated a desire to have a restricted schedule of NHPs; and 3) only naturopathic leaders were concerned the NHP regulations could potentially endanger patients if they self-medicate incorrectly.
Conclusion
Naturopaths, TCM practitioners, homeopaths, and Western herbalists were all concerned about how the new NHP regulations will affect their access to the products they need to practice effectively. Additional research will need to focus on what impacts actually occur as the regulations are implemented more fully.
doi:10.1186/1472-6882-6-18
PMCID: PMC1481533  PMID: 16686960
10.  DEChealth: A Comprehensive Occupational Health Information System 
Today, corporations are faced with the responsibility of protecting the health of their employees and the health of the general public through control of the industrial environment. DEChealth, the DEOmed Occupational Health System, developed by an inter-disciplinary team of occupational health professionals and computer engineers, is designed to provide an information management tool in the industrial setting. The DEChealth system enables management to comply with governmental regulations and to meet the increasing demands of employees for information on potential health risks associated with their job.
As a comprehensive occupational health surveillance system, employees, agents, and areas are tracked over time and integrated with industrial hygiene data and medical data. In addressing the complex issues of employee health and safety, the DEChealth product offers unique advantages.
PMCID: PMC2580326
11.  Funding medical and health-related research in the public interest. 
Public funding for medical and health-related research in Canada is declining. At the same time, the pharmaceutical industry is directing increasing amounts of money to publicly funded agencies such as universities and the Medical Research Council of Canada. However, the kinds of research most valuable to commercial firms may not be those most valuable to the Canadian public. There is a danger that research priorities and activities in public institutions may become skewed as a result of increased drug-industry funding. Mechanisms need to be found to ensure an appropriate balance between the research that is most valuable to the public interest and to the long-term advancement of knowledge, and the research that is likely to lead to marketable products. One such mechanism is the direction of a proportion of the money from drug companies to a "no-strings-attached" fund specifically to support types of research that are in the public interest but not likely to lead to marketable products.
PMCID: PMC1487997  PMID: 8705910
12.  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
13.  Promoting mental health in small-medium enterprises: An evaluation of the "Business in Mind" program 
BMC Public Health  2009;9:239.
Background
Workplace mental health promotion (WMHP) aims to prevent and effectively manage the social and economic costs of common mental illnesses such as depression. The mental health of managers and employees within small-medium enterprises (SMEs) is a neglected sector in occupational health research and practice, despite the fact that this sector is the most common work setting in most economies. The availability and propensity of SME staff to attend face-to-face training/therapy or workshop style interventions often seen in corporate or public sector work settings is a widely recognised problem. The 'Business in Mind' program employs a DVD mode of delivery that is convenient for SME managers, particularly those operating in regional and remote areas where internet delivery may not be optimal. The objective of the intervention program is to improve the mental health of SME managers, and examine whether employees of managers' whose mental health improves, report positive change in their psychosocial work environment. The mechanisms via which we aim to improve managers' mental health are through the development of their psychological capital (a higher order construct comprised of hope, self efficacy, resilience and optimism) and their skills and capacities for coping with work stress.
Methods/Design
The effectiveness of two versions of the program (self administered and telephone facilitated) will be assessed using a randomised trial with an active control condition (psychoeducation only). We aim to recruit a minimum of 249 managers and a sample of their employees. This design allows for 83 managers per group, as power analyses showed that this number would allow for attrition of 20% and still enable detection of an effect size of 0.5. The intervention will be implemented over a three month period and postal surveys will assess managers and employees in each group at baseline, intervention completion, and at 6 month follow up. The intervention groups (managers only) will also be assessed at 12 and 24 month follow-up to examine maintenance of effects. Primary outcomes are managers' levels of psychological capital (hope, resilience, self-efficacy and optimism), coping strategies, anxiety and depression symptoms, self-reported health, job satisfaction and job tension. Secondary outcomes are participating managers subordinates' perceptions of manager support, relational justice, emotional climate and job tension. In order to provide an economic evaluation of the intervention, both employees and manager rates of absenteeism and presenteeism will also be assessed.
Discussion
The intervention being trialled is expected to improve both primary and secondary outcomes. If proven efficacious, the intervention could be disseminated to reach a much larger proportion of the business community.
Trial registration
Current controlled trials ISRCTN 62853520
doi:10.1186/1471-2458-9-239
PMCID: PMC2714843  PMID: 19604351
14.  The Ethics of Dietary Supplements and Natural Health Products in Pharmacy Practice: A Systematic Documentary Analysis 
Aims and Objectives
Many natural health products (NHPs) and dietary supplements (DS) are purchased in pharmacies and it has been argued that pharmacists are in the best position to provide patients with evidence-based information about them. This study was designed to identify how the pharmacist’s role with respect to NHPs/DS is portrayed in the literature.
Method
A systematic search was conducted in a variety of health databases to identify all literature that pertained to both pharmacy and NHPs/DS. Of the 786 articles identified, 665 were broad-coded and 259 were subjected to in-depth qualitative content analysis for emergent themes.
Key Findings
Overwhelmingly, support for the sale of NHPs/DS in pharmacies is strong. Additionally, a role for pharmacists in NHP/DS counselling is underscored. But another recurrent theme is that pharmacists are ill-equipped to counsel patients about these products that are available on their shelves. This situation has led some to question the ethics of pharmacists selling NHPs/DS and to highlight the existence of an ethical conflict stemming from the profit-motive associated with NHP/DS sales.
Conclusion
This analysis raises concerns about the ethics of NHPs/DS being sold in pharmacies, and about pharmacists being expected to counsel about products of which they have little knowledge.
PMCID: PMC2918535  PMID: 20218027 CAMSID: cams1317
15.  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
16.  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
17.  Medical fund took off like a rocket, but will budget bring it down to earth? 
In 18 months the Canadian Medical Discoveries Fund (CMDF) has attracted investments worth $180 million to spend on biotechnology and medical research. Although eight initial investments totalled only $9.7 million, Dr. Cal Stiller, chair and CEO of the fund's management corporation, says there are many good Canadian-based technology firms and research projects that merit investment. Examples include a London, Ont., firm that is bringing a 3-D ultrasound-imaging system to market, and world-class genetics research at the University of Ottawa. However, the federal government recently changed tax rules for venture-capital funds, making them less attractive to investors. How will this affect the effort to build a health-research industry in Canada?
Images
PMCID: PMC1488060
18.  Ethnopharmacology and integrative medicine – Let the history tell the future 
Traditional systems of medicines need more evidence-based studies on both crude drugs and purified phytomolecules. Utilization of natural products as pharmacological tools could lead to a number of new major therapeutically active metabolites. Lead molecules are further screened for their potential in terms of quality control, safety assessments, and studies about molecular pharmacology and their related properties. Identification, and quality and safety evaluation of natural products, is a fundamental requirement of industry and other organizations dealing with natural health products (NHPs). Marker analysis, based on chemo-profiling and development of characteristic fingerprints for individual plants, could help to develop uniform standardization tools. Beside such evaluations of clinical parameters, safety profiles as well as drug–herb and herb–herb interactions are the most important parameters for assessment and promotion. With the steady growth of the NHPs, advanced analytical- and mechanism-based screening should be considered for their promotion and value addition in every way for the betterment of healthcare. Thus, there is an urgent need for the development of international co-ordination to promote and develop NHPs, including their assessment, perspectives, pharmacovigilance, and potential harmonization of regulation, quality control and clinical uses.
doi:10.4103/0975-9476.65077
PMCID: PMC3151376  PMID: 21836796
Ethnopharmacology; integrated approach; Ayurveda; Indian system of medicine
19.  Interactions of natural health products with biomedical cancer treatments 
Current Oncology  2008;15(s2):s109.es81-s110.es86.
The use of complementary and alternative medicine (cam), including the ingestion of natural health products (nhps), is common among cancer patients. Of concern to clinicians and patients alike is the possibility that cam, used concurrently with biomedical therapy, may interact poorly with that therapy, especially chemotherapy and radiotherapy. Proponents of nhps argue that taking such products can help to reduce the side effects of conventional therapy and can provide an additional anticancer effect. However, opponents insist that the potential for harm is too great to warrant the risk of concurrent administration. There are promising examples of specific nhps that may provide patient benefit even when given in close proximity both to chemotherapy and to radiotherapy, but unfortunately, in part because of a rather limited evidence base, caution is warranted when considering the issue of therapeutic interactions. Strategic application of nhps before or after conventional therapy may be considered; however, concurrent application should be avoided as a general principle until further evidence is available regarding specific interactions.
PMCID: PMC2528552  PMID: 18769615
Complementary medicine; cam; natural health products; nhps; chemotherapy; radiotherapy; antioxidants; drug–herb interactions; pharmacology
20.  Engaging with economic evaluation methods: insights from small and medium enterprises in the UK medical devices industry after training workshops 
Background
With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers.
Methods
A short questionnaire was completed by participants attending one of five workshops on product development in the medical device sector that took place in England between 2007 and 2011. From all responses obtained, a large proportion of participants were based in SMEs (N = 43), and these responses were used for the analysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval scales. Qualitative data from participant responses were analysed to reveal emerging themes.
Results
The questionnaire results revealed that 60% of SME participants (mostly company directors or managers, including product or project managers) rated themselves as having low or no knowledge of health economics prior to the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or cost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products to purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion, cost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise these factors. There was no significant dependence of the use of decision-making tools in general with respect to professed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of potential value when deciding whether to develop a product. A majority of SMEs stated they would use a health economics tool. Research and development teams or marketing and sales departments would most likely use one.
Conclusion
This study points to the need for further research into the education requirements of SMEs in the area of Health Technology Assessment (HTA) and also for investigation into how SMEs engage with existing HTA processes as required by assessors such as NICE.
doi:10.1186/1478-4505-10-29
PMCID: PMC3507868  PMID: 22943625
21.  Actual and perceived impacts of tobacco regulation on restaurants and firms 
Tobacco Control  2001;10(1):33-37.
OBJECTIVE—To examine the actual and anticipated costs of a law regulating workplace smoking and smoking in restaurants, taking into consideration observed and anticipated infrastructure costs, lost productivity, increased absenteeism, and loss of clientele.
SETTING AND DESIGN—A survey of 401 Québec restaurants and 600 Québec firms conducted by the Québec Ministry of Health before the enactment of the law was used to derive costs incurred by those who had already complied and anticipated by those that did not.
RESULTS—Direct and indirect costs associated with tobacco regulation at work and in restaurants were minimal. Annualised infrastructure costs amounted to less than 0.0002% of firm revenues and 0.15% of restaurant revenues. Anticipated costs were larger and amounted to 0.0004% of firm revenues and 0.41% of restaurant revenues. Impacts on productivity, absenteeism, and restaurant patronage were widely anticipated but not observed in currently compliant establishments.
CONCLUSION—Firms and restaurants expected high costs to result from strict tobacco regulation because of infrastructure costs, decreased productivity, and decreased patronage. That none of these were actually observed suggests that policy makers should discount industry claims that smoking regulations impose undue economic hardship.


Keywords: regulation; firms; restaurants; costs; survey
doi:10.1136/tc.10.1.33
PMCID: PMC1763993  PMID: 11226358
22.  Are intrinsic motivational factors of work associated with functional incapacity similarly regardless of the country? 
Background: Many psychosocial models of wellbeing at work emphasise the role of intrinsic motivational factors such as job autonomy, job complexity, and innovativeness. However, little is known about whether the employees of multinational enterprises differ from country to country with regard to intrinsic motivational factors, and whether these factors are associated with wellbeing similarly in the different countries. The purpose of this study was to examine the level of intrinsic motivational factors and their impact on functional incapacity in different countries in a multinational corporation.
Methods: In 2000, data were collected from a globally operating corporation with a questionnaire survey. The participants were 13 795 employees (response rate 59%; 56% under age 45; 80% men; 61% blue collar employees), who worked in similar industrial occupations in five countries (Canada, China, Finland, France, and Sweden).
Results: The Chinese employees reported higher autonomy and lower complexity at work than the employees from the other countries. After adjustment for age, sex, socioeconomic status, and physical work environment, job autonomy, and job complexity at work were associated with functional incapacity in most countries, whereas in China the impact was significantly stronger. In Finland and in China employees with low innovativeness at work were more prone to functional incapacity than corresponding employees in other countries.
Conclusions: The level of intrinsic motivational factors varied between the Chinese employees and those in other countries. In line with theoretical notions, the relation between intrinsic motivational factors of work and functional incapacity followed a similar pattern in the different countries. However, these country specific results show that a culture specific approach to employee wellbeing should also be applied.
doi:10.1136/jech.2004.030106
PMCID: PMC1732910  PMID: 16166359
23.  Molecular targets of natural health products in arthritis 
Patients with rheumatoid arthritis (RA) and osteoarthritis (OA) consume 'natural health products' (NHPs) whose therapeutic efficacy, toxicity and mechanisms of action are poorly understood. In a previous issue of Arthritis Research and Therapy, Haqqi and colleagues characterized IL-1-activated mitogen-activated protein kinase kinase 3 (MKK3) and p38-mitogen-activated protein kinase (MAPK) isoforms in human OA chondrocytes. The cartilageprotective mechanisms of pomegranate extract involve diminishing MKK3-activated p38α, JNK, NF-κB and Runx2 pathways, which regulate inflammatory proteins and cartilage-destroying proteases. Epigallocatechin- 3-gallate, resveratrol, curcumin and other NHP active ingredients suppress multiple inflammatory and catabolic molecular mediators of arthritis. Non-toxicity, reduced severity and incidence of arthritis in animal models warrant testing NHP active ingredients for preventing human OA and RA.
doi:10.1186/ar3222
PMCID: PMC3157637  PMID: 21345249
24.  A Simple Strategy for Implementing Standard Reference Terminologies in a Distributed Healthcare Delivery System with Minimal Impact to Existing Applications 
The Veterans Administration (VA) has adopted an ambitious program to standardize its clinical terminology to comply with industry-wide standards. The VA is using commercially available tools and in-house software to create a high-quality reference terminology system. The terminology will be used by current and future applications with no planned disruption to operational systems. The first large customer of the group is the national VA Health Data Repository (HDR). Unique enterprise identifiers are assigned to each standard term, and a rich network of semantic relationships makes the resulting data not only recognizable, but highly computable and reusable in a variety of applications, including decision support and data sharing with partners such as the Department of Defense (DoD). This paper describes the specific methods and approaches that the VA has employed to develop and implement this innovative program in existing information system. The goal is to share with others our experience with key issues that face our industry as we move toward an electronic health record for every individual.
PMCID: PMC1839746  PMID: 17238306
25.  The Binding of Triclosan to SmeT, the Repressor of the Multidrug Efflux Pump SmeDEF, Induces Antibiotic Resistance in Stenotrophomonas maltophilia 
PLoS Pathogens  2011;7(6):e1002103.
The wide utilization of biocides poses a concern on the impact of these compounds on natural bacterial populations. Furthermore, it has been demonstrated that biocides can select, at least in laboratory experiments, antibiotic resistant bacteria. This situation has raised concerns, not just on scientists and clinicians, but also on regulatory agencies, which are demanding studies on the impact that the utilization of biocides may have on the development on resistance and consequently on the treatment of infectious diseases and on human health. In the present article, we explored the possibility that the widely used biocide triclosan might induce antibiotic resistance using as a model the opportunistic pathogen Stenotrophomonas maltophilia. Biochemical, functional and structural studies were performed, focusing on SmeDEF, the most relevant antibiotic- and triclosan-removing multidrug efflux pump of S. maltophilia. Expression of smeDEF is regulated by the repressor SmeT. Triclosan released SmeT from its operator and induces the expression of smeDEF, thus reducing the susceptibility of S. maltophilia to antibiotics in the presence of the biocide. The structure of SmeT bound to triclosan is described. Two molecules of triclosan were found to bind to one subunit of the SmeT homodimer. The binding of the biocide stabilizes the N terminal domain of both subunits in a conformation unable to bind DNA. To our knowledge this is the first crystal structure obtained for a transcriptional regulator bound to triclosan. This work provides the molecular basis for understanding the mechanisms allowing the induction of phenotypic resistance to antibiotics by triclosan.
Author Summary
The wide utilization of biocides for different purposes, including toothpastes, soaps, house-hold compounds surfaces' disinfectants and even their use as additives of different materials (from textiles to concrete used in germ-free buildings) to avoid their colonization by microorganisms, poses a concern on the impact of these compounds on natural bacterial populations. Furthermore, it has been demonstrated that such biocides can select, at least in laboratory experiments, bacteria resistant to antibiotics. This situation has raised concerns on the impact that the utilization of biocides may have on the development on resistance and consequently on the treatment of infectious diseases. In the present article we study whether biocides can induce phenotypic resistance to antibiotics, a process that would be barely detectable unless purposely searched out. In the article, we present functional, biochemical and structural data showing that the widely used biocide triclosan induces antibiotic resistance, mediated by the binding of the biocide to SmeT, the transcriptional regulator of the expression of the Stenotrophomonas maltophilia multidrug efflux pump SmeDEF, which can extrude an ample range of antibiotics. Our study provides an unambiguous link between the presence of this biocide and the increased efflux of antibiotics by the opportunistic pathogen S. maltophilia.
doi:10.1371/journal.ppat.1002103
PMCID: PMC3128119  PMID: 21738470

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