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.

Natural health product-drug interactions: evolving responsibilities to take complementary and alternative medicine into account.

Natural health products (NHPs) (known as dietary supplements in the United States) are a popular form of self-care, yet many patients do not disclose their use to clinicians. NHP-drug interactions are known to occur and can harm patients and affect the efficacy of conventional treatment. Using the example of an HIV-positive adolescent who had been responding well to antiretroviral therapy but then experienced a sudden unexplained deterioration in her condition, we review (1) clinicians' obligation to inquire about complementary and alternative medicine (CAM) use when assessing, treating, and monitoring patients, (2) how clinicians' duty to warn about risks associated with treatment has evolved and expanded, and (3) patients' and parents' responsibility to disclose CAM use. It also addresses the responsibility of hospitals and health facilities to ensure that the reality of widespread CAM/NHP use is taken into account in patient care to effectively protect patients from harm.

Treating teens: considerations when adolescents want to use complementary and alternative medicine.

In this article we examine decision-making about complementary and alternative medicine use when the patient is an adolescent. A case scenario describes patient-parent conflict when a 14-year-old boy who was diagnosed with ulcerative colitis that has continued to progress even with medication refuses recommended surgery despite his physician's and parents' support for that option; he prefers homeopathy instead. We address (1) who has decision-making authority about treatment for young people, (2) how to determine if a young person can consent to or refuse treatment, (3) special considerations when counseling and treating adolescents (whether they can decide about treatment for themselves), and (4) parent-child conflicts about treatment. In addition, we suggest ways that health care providers can foster a trusting relationship with patients and parents.

Childhood immunization: when physicians and parents disagree.

Persistent fears about the safety and efficacy of vaccines, and whether immunization programs are still needed, have led a significant minority of parents to refuse vaccination. Are parents within their rights when refusing to consent to vaccination? How ought physicians respond? Focusing on routine childhood immunization, we consider the ethical, legal, and clinical issues raised by 3 aspects of parental vaccine refusal: (1) physician counseling; (2) parental decision-making; and (3) continuing the physician-patient relationship despite disagreement. We also suggest initiatives that could increase confidence in immunization programs.

Considering complementary and alternative medicine alternatives in cases of life-threatening illness: applying the best-interests test.

In this article we explore decision-making about treatment when a child faces a life-threatening illness but conventional treatment presents substantial risk and uncertain benefit. When is it acceptable for parents to decide to use complementary and alternative medicine as an alternative, rather than a complement, to conventional care? We use the example of a young child suffering from progressive glycogen storage disease, for whom liver transplant offers the only prospect of a cure. Without a liver transplant, the disease usually results in death within a few years. However, experience using transplant to treat this illness has been limited, success is far from ensured, and the risks (including death and continued progression of the disease) are substantial. The child's parents, who are first-generation immigrants, consider the risks of the transplant unjustified because it still does not offer good prospects for a healthy future. They believe that traditional Chinese medicine could help remediate their daughter's disease. In the article we (1) review parents' obligation to make treatment decisions in the best interests of their child, (2) explain limits on parents' decision-making authority, (3) explore how "best interests" are determined, focusing on cases of serious illness for which conventional treatment is risky and benefit is possible but uncertain, (4) explain the standard of care that physicians must meet in advising about treatment, and (5) outline factors that clinicians and parents should take into account when making decisions.

Referrals and shared or collaborative care: managing relationships with complementary and alternative medicine practitioners.

In this article we discuss steps that clinicians should take after deciding to include a complementary and alternative medicine (CAM) treatment that is beyond the clinician's expertise in a patient's treatment plan. We use the example of an adolescent patient with chronic recurrent headaches that have not been relieved by medication or other therapies and whose physician refers her to an acupuncturist for treatment. We focus on (1) circumstances under which referral is appropriate, (2) the nature of the relationship between the referring clinician and the practitioner to whom the referral is made (considering conventional health care and CAM, regulated and unregulated practitioners), and (3) considerations when undertaking shared or collaborative care with other health care practitioners (conventional health care or CAM). We also suggest best practices in managing such relationships.

Informed consent: advising patients and parents about complementary and alternative medicine therapies.

Although research on complementary and alternative medicine (CAM) therapies is still limited, systematic reviews have revealed sufficient evidence to conclude that CAM can be effective for certain conditions. In this article we discuss clinicians' responsibilities to inform parents/patients about CAM alternatives and use the example of acupuncture for chemotherapy-induced nausea and vomiting. Chemotherapy-induced nausea and vomiting remain significant adverse effects of cancer therapy, and some patients cannot find relief with standard therapies. When making decisions for a child with a life-threatening illness, parents must consider all reasonable options and decide what is in the child's best interests. A physician's failure to provide parents with relevant information regarding therapies with the prospect of therapeutic benefit impedes their ability to make an informed decision. Physicians have the ethical duty of beneficence; they must be aware of current research in pain and symptom management and other aspects of care. A physician's duty of care does not necessarily include the obligation to provide information about therapies outside the range of conventional treatment or those not yet supported in the medical literature. However, as CAM therapies such as acupuncture become better studied and their safety and efficacy are established, the scope of disclosure required may expand to include them. The legal and ethical obligation to obtain informed consent to treatment requires disclosure and discussion of therapies when there is reliable evidence of potential therapeutic benefit. At the same time, the more limited state of knowledge regarding effects of a particular therapy in the pediatric population must be factored into decision-making when treating a child.

Complementary and alternative medicine practitioners' standard of care: responsibilities to patients and parents.

In this article we explain (1) the standard of care that health care providers must meet and (2) how these principles apply to complementary and alternative medicine practitioners. The scenario describes a 14-year-old boy who is experiencing back pain and whose chiropractor performed spinal manipulation but did not recognize or take steps to rule out serious underlying disease-in this case, testicular cancer--either initially or when the patient's condition continued to deteriorate despite treatment. We use chiropractic care for a patient with a sore back as an example, because back pain is such a common problem and chiropracty is a common treatment chosen by both adult and pediatric patients. The scenario illustrates the responsibilities that complementary and alternative medicine practitioners owe patients/parents, the potential for liability when deficient care harms patients, and the importance of ample formal pediatric training for practitioners who treat pediatric patients.

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.

Pediatric use of complementary therapies: ethical and policy choices.

OBJECTIVE: Many pediatricians and parents are beginning to integrate use of complementary and alternative medical (CAM) therapies with conventional care. This article addresses ethical and policy issues involving parental choices of CAM therapies for their children. METHODS: We conducted a literature search to assess existing law involving parental choice of CAM therapies for their children. We also selected a convenience sample of 18 states of varying sizes and geographic locations. In each state, we inquired within the Department of Health and Human Services whether staff were aware of (1) any internal policies concerning these issues or (2) any cases in the previous 5 years in which either (a) the state initiated proceedings against parents for using CAM therapies for their children or (b) the department received telephone calls or other information reporting abuse and neglect in this domain. We asked the American Academy of Pediatrics and the leading CAM professional organizations concerning any relevant, reported cases. RESULTS: Of the 18 state Departments of Health and Human Services departments surveyed, 6 reported being aware of cases in the previous 5 years. Of 9 reported cases in these 6 states, 3 involved restrictive dietary practices (eg, limiting children variously to a watermelon or raw foods diet), 1 involved dietary supplements, 3 involved children with terminal cancer, and 2 involved religious practices rather than CAM per se. None of the professional organizations surveyed had initiated proceedings or received telephone calls regarding abuse or neglect concerning parental use of CAM therapies. CONCLUSIONS: Pediatric use of CAM therapies raises complex issues. Clinicians, hospitals, state agencies, courts, and professional organizations may benefit from a policy framework to help guide decision making.