Ethical responsibilities of pharmacists when selling complementary medicines: a systematic review.

OBJECTIVE: The widespread sale of complementary medicines in community pharmacy raises important questions regarding the responsibilities of pharmacists when selling complementary medicines. This study reviews the academic literature that explores a pharmacist's responsibilities when selling complementary medicines. METHODS: International Pharmaceutical Abstracts, Embase, PubMed, Cinahl, PsycINFO and Philosopher's index databases were searched for articles written in English and published between 1995 and 2017. Empirical studies discussing pharmacists' practices or perceptions, consumers' expectations and normative studies discussing ethical perspectives or proposing ethical frameworks related to pharmacists' responsibilities in selling complementary medicines were included in the review. KEY FINDINGS: Fifty-eight studies met the inclusion criteria. The majority of the studies discussing the responsibilities of pharmacists selling complementary medicines had an empirical focus. Pharmacists and consumers identified counselling and ensuring safe use of complementary medicines as the primary responsibilities of pharmacists. No formal ethical framework is explicitly employed to describe the responsibilities of pharmacists selling complementary medicines. To the degree any ethical framework is employed, a number of papers implicitly rely on principlism. The studies discussing the ethical perspectives of selling complementary medicines mainly describe the ethical conflict between a pharmacist's business and health professional role. No attempt is made to provide guidance on appropriate ways to resolve the conflict. CONCLUSION: There is a lack of explicit normative advice in the existing literature regarding the responsibilities of pharmacists selling complementary medicines. This review identifies the need to develop a detailed practice-specific ethical framework to guide pharmacists regarding their responsibilities when selling complementary medicines.

Non-conventional practice versus evidence-based medicine. A scientific and ethical analysis of the Italian regulation.

BACKGROUND: The current lack of scientific validation of non-conventional treatments in medicine, whose epistemological foundations lie in scientific evidence and experimentation, raises significant questions regarding the costs and benefits of alternative-treatment forms. Nonetheless, in the last few decades non-conventional treatments have been increasingly recognised by the Italian medical profession, with one regional healthcare administration adopting some non-conventional practices as part of its conventional healthcare services. AIMS: The Authors aim to analyse non-conventional treatments in medicine from an epistemological, cultural, ethical, political and economic point of view, in order to highlight criticalities and incongruities, especially when these treatments are approved by a public healthcare system, which should be grounded on the "evidence-based medicine" principle. CONCLUSIONS: Non-conventional treatments in medicine are constituted by meta-theories, i.e. philosophical, religious and ideological concepts that conflict with contemporary rational, empirical medicine. In the interest of patients and society, the paper stresses the incongruity of a healthcare system which, despite being grounded on the "evidence-based medicine" principle, allows the development of non conventional treatments. Having said that, medical science should address not only the biological domain of illness but also its existential implications. Awareness and respect for the individual experience can undoubtedly lead to a new medical model that allows for a more effective therapeutic intervention.

Pediatric Integrative Medicine.

The American Academy of Pediatrics is dedicated to optimizing the well-being of children and advancing family-centered health care. Related to this mission, the American Academy of Pediatrics recognizes the increasing use of complementary and integrative therapies for children and the subsequent need to provide reliable information and high-quality clinical resources to support pediatricians. This Clinical Report serves as an update to the original 2008 statement on complementary medicine. The range of complementary therapies is both extensive and diverse. Therefore, in-depth discussion of each therapy or product is beyond the scope of this report. Instead, our intentions are to define terms; describe epidemiology of use; outline common types of complementary therapies; review medicolegal, ethical, and research implications; review education and training for select providers of complementary therapies; provide educational resources; and suggest communication strategies for discussing complementary therapies with patients and families.

Alternative Medicine and the Ethics Of Commerce.

Is it ethical to market complementary and alternative medicines? Complementary and alternative medicines (CAM) are medical products and services outside the mainstream of medical practice. But they are not just medicines (or supposed medicines) offered and provided for the prevention and treatment of illness. They are also products and services - things offered for sale in the marketplace. Most discussion of the ethics of CAM has focused on bioethical issues - issues having to do with therapeutic value, and the relationship between patients and those purveyors of CAM. This article aims instead to consider CAM from the perspective of commercial ethics. That is, we consider the ethics not of prescribing or administering CAM (activities most closely associated with health professionals) but the ethics of selling CAM.

Moral Legitimacy: The Struggle Of Homeopathy in the NHS.

This article deploys a well-established theoretical model from the accountability literature to the domain of bioethics. Specifically, homeopathy is identified as a controversial industry and the strategic action of advocates to secure moral legitimacy and attract public funding is explored. The Glasgow Homeopathic Hospital (GHH) is used as the location to examine legitimizing strategies, from gaining legitimacy as a National Health Service (NHS) hospital in 1948, followed by maintaining and repairing legitimacy in response to government enquires in 2000 and 2010. An analysis of legitimizing strategies leads to the conclusion that advocates have been unsuccessful in maintaining and repairing moral legitimacy for homeopathy, thus threatening continued public funding for this unscientific medical modality. This is an encouraging development towards open and transparent NHS accountability for targeting limited public resources in pursuit of maximizing society's health and well-being. Policy implications and areas for future research are suggested.

Complementary and alternative drug therapy versus science-oriented medicine.

This opinion deals critically with the so-called complementary and alternative medical (CAM) therapy on the basis of current data. From the authors' perspective, CAM prescriptions and most notably the extensive current endeavours to the "integration" of CAM into conventional patient care is problematic in several respects. Thus, several CAM measures are used, although no specific effects of medicines can be proved in clinical studies. It is extensively explained that the methods used in this regard are those of evidence-based medicine, which is one of the indispensable pillars of science-oriented medicine. This standard of proof of efficacy is fundamentally independent of the requirement of being able to explain efficacy of a therapy in a manner compatible with the insights of the natural sciences, which is also essential for medical progress. Numerous CAM treatments can however never conceivably satisfy this requirement; rather they are justified with pre-scientific or unscientific paradigms. The high attractiveness of CAM measures evidenced in patients and many doctors is based on a combination of positive expectations and experiences, among other things, which are at times unjustified, at times thoroughly justified, from a science-oriented view, but which are non-specific (context effects). With a view to the latter phenomenon, the authors consider the conscious use of CAM as unrevealed therapeutic placebos to be problematic. In addition, they advocate that academic medicine should again systematically endeavour to pay more attention to medical empathy and use context effects in the service of patients to the utmost. The subsequent opinion discusses the following after an introduction to medical history: the definition of CAM; the efficacy of most common CAM procedures; CAM utilisation and costs in Germany; characteristics of science-oriented medicine; awareness of placebo research; pro and contra arguments about the use of CAM, not least of all in terms of aspects related to medical ethics.

Mandatory disclaimers on dietary supplements do not reliably communicate the intended issues.

Some efforts by the government to regulate the promotional statements of pharmaceutical manufacturers have recently been found unconstitutional under the First Amendment, which has been interpreted to protect commercial as well as personal speech. As an alternative means of protecting patients from unreliable marketing claims, courts have proposed that the Food and Drug Administration could add disclaimers to promotional messages that discuss off-label, or unapproved, uses. We conducted a systematic review of studies of the disclaimers currently required for dietary supplements, to assess how well disclaimers inform consumers' health choices. A few small studies reported a modest impact of disclaimers on consumers' attitudes about dietary supplements, but larger and more rigorous studies generally revealed that many consumers were unaware of a disclaimer or reported that it did not affect their perceptions of a product. The available evidence indicates that replacing government restrictions on pharmaceutical marketing with potentially ineffective disclaimers will be an inadequate way of informing patients about the efficacy and safety of drugs, and it risks returning the United States to a previous era when inappropriate marketing claims about prescription drugs proliferated and contributed to the inappropriate use of those products.

Less equal than others? Experiences of AYUSH medical officers in primary health centres in Andhra Pradesh.

The National Rural Health Mission (NRHM) includes, inter alia, the establishment of an AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) component (practitioner, trained assistants, drugs and equipment) in every primary health centre (PHC). However, five years following the launch of the NRHM, the AYUSH mainstreaming scenario is below expectations, riddled with ethical and governance issues. Accounts from AYUSH practitioners at PHCs in various regions of the state of Andhra Pradesh reveal enormous lacunae in implementation: unfilled positions, inequitable emoluments, inadequate or absent infrastructure, assistance and supplies, unethical interpersonal arrangements, and limited support from non-AYUSH personnel. The widespread negative impact of these conditions undermines the value of AYUSH, demotivating both practitioners and patients, and failing to provide the intended support to the public health system.

Ethical implications of the increasing use of complementary and alternative medicine.

BACKGROUND: The increasing demand for complementary and alternative medicine (CAM) raises ethical questions about specific aspects of both CAM and conventional medicine (COM). METHODS: The present article provides a critical survey of the most important ethical aspects in the current debate about CAM. RESULTS: The relevant ethical issues arise mainly in 4 main areas: 1) patient information, 2) research ethics, 3) cost, and 4) education. Most of the contributions used for our purpose are based upon the implicit assumption that, in principle, the ethics of CAM and COM have to be identical because of the same underlying doctor-patient relationship. This premise is shared by the author. CONCLUSIONS: Substantial efforts on various levels will have to be made in order to create the conditions necessary for CAM to be ethically justified. But the ethical implications for COM also have to be considered.

Pediatric use of complementary and alternative medicine: legal, ethical, and clinical issues in decision-making.

In this article we introduce a series of 8 case scenarios and commentaries and explore the complex legal, ethical, and clinical concerns that arise when pediatric patients and their parents or health care providers use or are interested in using complementary and alternative medicine (CAM). People around the world rely on CAM, so similar issues face clinicians in many countries. In law, few cases have dealt with CAM use. The few that have apply the same general legal principles used in cases that involved conventional care while taking into account considerations unique to CAM. In ethics, as with conventional care, the issues surrounding pediatric CAM use usually involve questions about who the appropriate decision-makers are, on what ethical principles should clinical decision-making rely, and what obligations arise on the part of physicians and other health care providers. Clinical decision-making is made more complex by the relatively limited research on the efficacy and safety of CAM compared with conventional medicine, especially in children, which requires clinicians to make decisions under conditions of uncertainty. The clinical scenarios presented focus on patients who represent a range of ages, clinical conditions, and settings. They act as anchors to explore particular CAM policy issues and illustrate the application of and shortcomings in existing guidance and intervention principles. Although the focus on a pediatric population adds another layer of complexity to the analysis, many of the concepts, issues, principles, and recommendations also apply to adults.

Hospitals and complementary and alternative medicine: managing responsibilities, risk, and potential liability.

Patients and families increasingly press hospitals to facilitate provision of complementary and alternative medicine (CAM) therapies and products. At the same time, a growing number of hospitals and health care facilities have taken steps to integrate CAM and conventional care. In this article we consider institutional responsibilities when patients/parents use or are considering CAM. We (1) review hospitals' responsibilities to patients and parents, (2) explain how these principles apply in the case of CAM practitioners and products, (3) address institutional responsibilities for different models of service delivery, and (4) highlight issues that should be addressed when developing institutional policies to govern CAM use and propose ways to do so.

Concluding comments: maximizing good patient care and minimizing potential liability when considering complementary and alternative medicine.

Our goal for this supplemental issue of Pediatrics was to consider what practitioners, parents, patients, institutions, and policy-makers need to take into account to make good decisions about using complementary and alternative medicine (CAM) to treat children and to develop guidelines for appropriate use. We began by explaining underlying concepts and principles in ethical, legal, and clinical reasoning and then used case scenarios to explore how they apply and identify gaps that remain in practice and policy. In this concluding article, we review our major findings, summarize our recommendations, and suggest further research. We focus on several key areas: practitioner and patient/parent relationships; decision-making; dispute resolution; standards of practice; hospital/health facility policies; patient safety; education; and research. Ethical principles, standards, and rules applicable when making decisions about conventional care for children apply to decision-making about CAM as well. The same is true of legal reasoning. Although CAM use has seldom led to litigation, general legal principles relied on in cases involving conventional medical care provide the starting point for analysis. Similarly, with respect to clinical decision-making, clinicians are guided by clinical judgment and the best interests of their patient. Whether a therapy is CAM or conventional, clinicians must weigh the relative risks and benefits of therapeutic options and take into account their patient's values, beliefs, and preferences. Consequently, many of our observations apply to conventional and CAM care and to both adult and pediatric patients.

The unregulated commercialization of stem cell treatments: a global perspective.

Research into the biological properties and clinical potential of stem cells has spurred strong public investment, industry development, media coverage, and patient interest in recent years. To date, however, few clinical applications of demonstrated safety and efficacy have been developed with the exception of uses of hematopoietic stem cells in the treatment of diseases of the blood and immune systems. This lack of an evidence basis notwithstanding, hundreds of companies and private clinics around the world now sell putative stem cell treatments for an enormously broad range of medical and quality-of-life conditions. This represents a major challenge for legitimate scientists working in the field, for authorities seeking to protect their constituencies, and for patients and consumers targeted by such companies' marketing strategies. In this review, I provide an overview of the global industry in pseudomedical stem cell treatments, with an investigation of claims in a single disease area (amyotrophic lateral sclerosis), and make recommendations for the introduction and enforcement of appropriate regulatory responses to this problem.

Touching ethics: assessing the applicability of ethical rules for safe touch in CAM--outcomes of a CAM (complementary and alternative medicine) practitioner survey in Israel.

INTRODUCTION: Recently, ethical guidelines regarding safe touch in CAM were developed in Israel. Publishing ethical codes does not imply that they will actually help practitioners to meet ethical care standards. The effectiveness of ethical rules depends on familiarity with the code and its content. In addition, critical self-examination of the code by individual members of the profession is required to reflect on the moral commitments encompassed in the code. METHODS: For the purpose of dynamic self-appraisal, we devised a survey to assess how CAM practitioners view the suggested ethical guidelines for safe touch. We surveyed 781 CAM practitioners regarding their perspectives on the safe-touch code. RESULTS: There was a high level of agreement with general statements regarding ethics pertaining to safe touch with a mean rate of agreement of 4.61 out of a maximum of 5. Practitioners concurred substantially with practice guidelines for appropriate touch with a mean rate of agreement of 4.16 out of a maximum of 5. Attitudes toward the necessity to touch intimate areas for treatment purposes varied with 78.6% of respondents strongly disagreeing with any notion of need to touch intimate areas during treatment. 7.9% neither disagreed nor agreed, 7.9% slightly agreed, and 7.6% strongly agreed with the need for touching intimate areas during treatment. There was a direct correlation between disagreement with touching intimate areas for therapeutic purposes and agreement with general statements regarding ethics of safe touch (Spearman r=0.177, p<0.0001), and practice guidelines for appropriate touch (r=0.092, p=0.012). CONCLUSION: A substantial number of practitioners agreed with the code, although some findings regarding the need to touch intimate area during treatments were disturbing. Our findings can serve as a basis for ethical code development and implementation, as well as for educating CAM practitioners on the ethics of touch.

The proper role of evidence in complementary/alternative medicine.

In this article we explore the role evidence ought to play in complementary and alternative medicine (CAM). First, we consider the claim that evidence in the form of randomized controlled trials (RCTs) cannot be obtained for CAMs. Second, we consider various claims to the effect that there are ways of obtaining evidence that do not make use of RCTs. We argue that there is no good reason why CAM should be exempted from the general requirement that treatments undergo evaluation by RCT. Third, we consider two implications for health care policy. First, many activities in conventional medicine have never been rigorously evaluated and are widely in use nonetheless. We argue that this fails to provide a reason for exempting CAM from a demand for evidence. Second, CAM use may be compared to a choice of lifestyle, and this has a significant impact on which requirements of evidence can reasonably be imposed.

Unethical prescriptions: alternative therapies for children with cerebral palsy.

The US National Center for Complementary and Alternative Medicine (CAM) defines CAM as "a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine." The problem with said therapies is that, for the most part, their effectiveness is questionable and their side effect profile is essentially unknown. Furthermore, as stated by Rosenbaum, many CAM treatments are based on "at best, anecdotal evidence and at times rather unusual ideas about the biology of the conditions to which they are being applied." In spite of the data shortage,Americans are forecasted to spend more than $42 billion on CAM during 2009. Using a patient for illustration purposes, the author presents 3 CAM treatments that have been advocated for children with cerebral palsy. The current scientific literature on these remedies and their purported benefit is reviewed. The article ends with a discussion on the reasons why prescribing said therapies is contrary to the concept of evidence-based medicine and the tenets of medical ethics.

Advice offered by practitioners of complementary/ alternative medicine: an important ethical issue.

The current popularity of complementary/alternative medicine (CAM) generates many challenges to medical ethics. The one discussed here is the advice offered by CAM practitioners. Using selected examples, the author tries to demonstrate that some of the advice issued through the popular media or provided by acupuncturists, chiropractors, herbalists, homeopaths, pharmacists, and doctors is misleading or dangerous. This, the author argues, can impinge on the main principle of medical ethics: beneficence, nonmaleficence, and autonomy. We should work toward correcting this deplorable situation.

Complementary and alternative medicine for the allergist-immunologist: where do I start?

Complementary and alternative medicine (CAM) therapies present a growing information management challenge for physicians because nearly 40% of their patients may be using and another 50% may be considering use of CAM as part of their healthcare regimen. The National Health Statistics Reports for 2007 described the most commonly used nonvitamin, nonmineral therapy as natural products (eg, herbals at 17.7%). More than 5% of children under the age of 18 years used CAM for allergic conditions including asthma. The amount and quality of information available and concerns about liability risk represent a challenge for most physicians. This review focuses on considerations for approaching a CAM-related consultation, incorporating legal and logistic factors affecting how such an encounter should be approached. A 10-step process is presented that addresses different components of CAM consultations and what should be documented. Access to timely, high-quality information regarding product specific efficacy and safety data, as found in the Natural Medicines Comprehensive Database, is needed to support CAM consultation efficiently. Understanding of serious adverse events associated with CAM is limited; an international need exists for improved safety surveillance and information sharing. Allergy-immunology, as a specialty with expertise in adverse drug reaction evaluation and management, has a unique opportunity to support enhanced CAM-related adverse events evaluations, reporting, and research.