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.
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.
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.
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.
To reach consensus on core competency statements for natural health products (NHPs) for Canadian pharmacy students.
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.
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.
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.
natural health products (NHPs); competencies; Delphi method; complementary and alternative medicine; herbal medicine
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.
meeting; natural health products; alternative therapies; ethnobotany; chemical analysis; quality control; drug development
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.
The purpose of this study was to explore pharmacy and stakeholder leaders’ perceptions of pharmacists’ professional NHP roles and responsibilities.
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.
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.
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.
PMID: 20188329 CAMSID: cams1316
natural health products; pharmacists; professional roles and responsibilities
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.
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.
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.
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.
To identify the best method to ascertain information on NHP, and the prevalence of use in a population with acute cardiovascular disease.
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.
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.
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.
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.
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).
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.
This paper demonstrates that consumers' expectations and behaviour significantly impact pharmacists' perceptions of their professional responsibilities with respect to NHPs.
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.
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.
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.
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.
Natural health products; Decision-making; Means ends chain analysis; Osteoarthritis
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.
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.
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.
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.
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.
A survey using the Dillman approach.
Newfoundland and Labrador.
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.
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.
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.
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.
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.
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.
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.
Natural health products; Adverse events; Mood disorders
Registered dietitians (RDs) play a key role in disseminating information about nutrition and intervening in nutrition-related disorders in the Canadian context. Natural health products (NHPs) are increasingly associated with nutrition in patient and health professional discussions. For this study, NHPs were divided into three categories: nutritional supplements (NS); functional foods/nutraceuticals (FF/N); and herbal preparations (HP). The objective was to explore RDs’ perceptions about their professional roles and responsibilities with respect to three categories of natural health products (NHPs).
This research consisted of an on-line survey of registered dietitians (RDs) in Ontario.
Surveys were distributed electronically to all practicing RDs in Ontario by the College of Dietitians of Ontario. There were 558 survey respondents, a response rate of 20%.
The vast majority of RDs reported being consulted by clients about all product categories (98% for NS; 94% for FF/N; 91% for HP), with RDs receiving the most frequent questions about NS and the least frequent about HP. 74% of RDs believed that NS are included within the current scope of practice, compared to 59% for FF/N and 14% for HP. Even higher numbers believed that these products should be included: 97% for NS, 91% for FF/N and 47% for HP. RDs who report personally ingesting FF/N and HP were significantly more likely to report that these products should be in the dietetic scope of practice. In contrast, RDs who provide one-on-one counselling services or group-level counselling/workshops were significantly less likely to believe HP should be in the dietetic scope of practice.
Opinions of RDs indicated that NS and FF/N (and possibly HP) fall within, or should fall within, RDs’ scope of practice. Opportunity exists for RDs to undertake a professional role with respect to NHPs. Policy clarification regarding RD roles is needed.
Dietitians; Professional roles and responsibilities; Natural health products; Dietary supplements; Nutritional supplements; Functional foods; Nutraceuticals; Herbal preparations
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.
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.
Newfoundland and Labrador.
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.
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.
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.
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.
Newfoundland and Labrador.
Parents of children who were using NHPs (N = 20).
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).
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.
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.
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.
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.
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.
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.
Current controlled trials ISRCTN 62853520
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.
CAM; complementary and alternative medicine; cost effectiveness; natural health products; NHPs
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.
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.
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.
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.
PMID: 20218027 CAMSID: cams1317
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.
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.
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.
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.
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.
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.
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.
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?
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.
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.
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.
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.
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.
Ethnopharmacology; integrated approach; Ayurveda; Indian system of medicine
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.