|In 2013, the Children’s Hospital of Philadelphia (CHOP) revised its policy on dietary supplements to become the first hospital in the nation to officially discourage their use. CHOP is questioning and regulating dietary supplement use because the FDA does not routinely review the manufacturing of dietary supplements, and therefore cannot guarantee their safety and effectiveness. There are a number of arguments for and against CHOP’s decision, including lack of regulation, insufficient research, patient-provider communication, lack of provider education, unknown interactions with prescription medications, and recognition of other cultural healing systems. As the popularity of CAM in the U.S. continues to increase, dollars invested in the dietary supplement industry reach into the billions, and few health care institutions have formal stated policies regarding dietary supplement use, CHOP’s new regulation is an important and far-reaching medical ethics issue. By using an abundance of caution, CHOP is creating an environment in which patients and health care providers are more aware of the state of dietary supplement regulation and safety and will make more educated decisions about their use.|
In October 2013, the Children’s Hospital of Philadelphia (CHOP) became the first hospital in the nation to essentially disallow the use of dietary supplements in what was widely reported as a “ban” on their use (Kabat, 2013; Abrams, 2013). CHOP is known as the first hospital in the country dedicated to the care of children and is consistently ranked as one of the best children’s hospitals in the United States (“Rankings & Ratings”). But the institution had generally not included many forms of complementary and integrative medicine (CIM) or complementary and alternative medicine (CAM), of which dietary supplements are included, in the care of its young patients. As the popularity of CAM in the U.S. continues to increase and dollars invested in the dietary supplement industry reaches into the billions (Sax, 2015, 375), CHOP’s new regulation is an important medical ethics issue.
The role hospitals and health care providers should play in the regulation of patients’ dietary supplement usage is complex because it brings together questions of patient autonomy and patient safety with a largely unregulated multi-billion dollar industry frequently marketed as an essential part of a healthy lifestyle. Dietary supplements are defined as “vitamins, minerals, herbs, botanicals, amino acids, enzymes, and animal extracts meant to ‘supplement’ the diet and…not intended to replace a healthy diet or to treat, diagnose, prevent, or cure diseases” (“Research Communications”). While it may seem that CHOP was being overly restrictive in its decision to discourage the use of dietary supplements, there are many arguments that support this decision. Although the solution may not be an ideal one, considering the huge patient safety questions that remain unanswered for both children and adults, not enough is known about the content and interactions of the vast majority of products considered to be dietary supplements to safely allow their use. This concern is amplified in an inpatient setting at an institution like CHOP in which many of the patients are children who are often quite ill with complex and rare health conditions.
The role hospitals and health care providers should play in the regulation of patients’ dietary supplement usage is complex because it brings together questions of patient autonomy and patient safety with a largely unregulated multi-billion dollar industry frequently marketed as an essential part of a healthy lifestyle.
Dietary Supplements and CAM
Complementary and alternative medicine (CAM) is a group of medical, health care and healing systems other than those included in mainstream (allopathic) health care in the United States (“Chapter 2: Overview”). CAM includes mind and body practices such as acupuncture, meditation, yoga, massage therapy, tai chi, and hypnotherapy (“CAM Basics”) and ancient healing systems including Ayurveda, from India, and Traditional Chinese Medicine (“Chapter 2: Overview,” “Complementary and Alternative Medicine”). Dietary supplements, including natural products, like herbs, probiotics and vitamins and minerals, are a part of CAM. The use of many forms of CAM in conjunction with allopathic medicine is on the rise (Tovey, 2004, 51) and herbal medicine and use of dietary supplements may be one of the fastest growing areas (Cohen, 2000, 107). The NIH’s National Center for Complementary and Alternative Medicine (NCCAM) reports that results from its 2007 Complementary and Alternative Medicine National Health Interview Survey (NHIS) indicate that 38% of adults (approximately 83 million people) and 12% of children use some form of CAM (Nahin, 2009, 1). The survey also found that adults spent nearly $34 billion on out-of-pocket visits to CAM practitioners and on purchases of CAM products, classes, and materials (Nahin 2009, 3). Non-vitamin, non-mineral natural products made up nearly 44% of spending (“The Use of Complementary”).
CHOP’s definition of a dietary supplement is in line with the definition put forth by the Food and Drug Administration (FDA), which Congress defined in 1994 in the passage of the Dietary Supplement Health and Education Act (DSHEA) as, “a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet. The ‘dietary ingredients’ in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet” (“Research Communications”). Dietary supplements are considered to be foods, not drugs (“Strength Knowledge”). Because individual dietary supplements can be classified in different ways, causing confusion as to the category in which they belong, many are sold as combination products containing numerous ingredients (Glisson, 2010, 577). CHOP provides the following as examples of some of the most commonly used supplements: melatonin, Echinacea, chondroitin sulfate, glucosamine, CoEnzyme Q10, milk thistle and probiotics (“Research Communications”).
Dietary Supplement Use
Since the passage of the DSHEA in 1994, use of dietary supplements in the U.S. has soared. The DSHEA defines dietary supplements, but leaves them largely unregulated, with consumers spending some $23 billion annually on “natural products marketed to maintain or enhance health” (Ashar, 2008, 91). In fact, the DSHEA is estimated to have resulted in average annual growth rates of 15-20% for the dietary supplement industry in the 1990s (Gershwin, 2010, 107). A 2006 national survey of dietary supplement use found that 48% of the U.S. adult population reported using some type of dietary supplement, with one survey of 2,000 adults indicating that 85% had used one or more type of supplement in the past year (Timbo, 2006, 1966). More recently, a 2010 study states that 40-60% of Americans report using some type of dietary supplement (Gershwin, 2010, 107). However, Americans are not replacing allopathic medicines with dietary supplements. Reports indicate that between 16% and 45% of adult Americans are taking herbal products along with their prescription medications (Sparber, 2004, 133; Ashar, 2008, 91).
When it comes to dietary supplements use by children, a study by Wu et al. showed that fewer children in the U.S. use herbs or dietary supplements than adults and reported a pattern of, “moderate and appropriate herb and supplement use in the pediatric population” (Wu, 2013, 358). However, a significant number of children still use these products. According to the 2007 National Health Interview Survey, 37% of U.S. children use some type of dietary supplement (Dwyer, 2013, 1333).
Dietary supplements and CAM in general are particularly popular with children and adolescents, especially those with chronic illnesses or disabilities requiring frequent medical care and those with a poor prognosis and limited medical treatments available (Ball, 2005, 81; Gardiner, 2008, e775; Harris, 2005, 34). Parents of hospitalized children, especially those in neonatal and pediatric intensive care units, have a strong interest in providing CAM to their children during hospitalization (Kemper, 2001, 449). The 2007 National Health Interview Child Complementary and Alternative Medicine Supplement showed that children with activity limitations due to chronic health conditions, long-term prescription use, or relatively heavy use of physician services were more likely to use herbal and dietary supplements (Wu, 2013, 361). Ball et al. reported that in a sample of 505 parents of chronically ill children and adolescents, 62% of the population used dietary supplements and 30% used non-prescribed supplements (Ball, 2005, 78). However, parents rarely discuss this use with their children’s health care provider; one study reported that only 20% of those using non-prescribed supplements had discussed their use with a health care provider (Kemper, 2001, 449; Ball, 2005, 81). These products are also used preventatively, with up to 70% of parents giving their children herbs and dietary supplements to preserve good health and treat minor illnesses (Woolf, 2010, 155).
Regulation of Dietary Supplements
When it comes to regulation, dietary supplements can be divided into two categories: those marketed before 1994 and those marketed after the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. The DSHEA has several aims, including defining dietary supplements and holding manufacturers responsible for safety. It also identifies how literature may be used in connection with sales, specifies types of statements of nutritional support that may be made on labels as well as certain labeling requirements, and provides for the establishment of good manufacturing practices to help ensure product quality and consistency (“Executive Summary”; Frankos, 2010, 239). In addition, its passage also led to the creation of the Office of Dietary Supplements (ODS) in the National Institutes of Health (NIH), which was charged with coordinating scientific research relating to dietary supplements within NIH and with advising federal agencies on issues relating to dietary supplements (“Executive Summary”).
In the United States, the FDA is responsible for regulating dietary supplements, but it does so under a different set of regulations than those covering “conventional” foods and drug products (prescription and over-the-counter). Under the DSHEA, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Manufacturers must make sure that product label information is truthful and not misleading. The FDA’s post-marketing responsibilities include monitoring safety, such as creating the Safety Reporting Portal, a secure online method for consumers and those in the supplement industry to voluntarily submit a report if they experience an adverse event or suspect defects in quality or safety, and product information, such as labeling, claims, package inserts and accompanying literature (“Strength Knowledge”). Furthermore, the DSHEA specifies that supplement ingredients marketed before the DSHEA do not need approval from the FDA as long as the manufacturer ensures that they are safe (Glisson 2010, 577; Frankos, 2010, 239-40; Cohen, 2012, 458). The failure to require FDA approval and instead simply trust the judgment of these manufacturers leaves the consumer open to potential harm.
Advertising of dietary supplements in newspapers, magazines, direct mail, radio, television, or the Internet is regulated by the Federal Trade Commission (FTC), which requires that all information about supplements be truthful and not misleading. The FDA is responsible for acting against marketed dietary supplements that are unsafe (Glisson, 2010, 578). It must offer evidence that a product is unsafe, contains a controlled substance or does not have ingredients it claims to have before the product may be removed from the market (Denham, 2011, 428). The FDA monitors dietary supplement safety by following adverse event reports and reviewing labeling and labeling requirements (Glisson, 2010, 578).
Because the DSHEA classifies dietary supplements as foods rather than drugs, they are not regulated by the FDA’s Center for Drug Evaluation and Research, but instead by the Center for Food Safety and Applied Nutrition. Therefore, dietary supplement manufacturers are forbidden from making any drug-like claims, which means they may not market their products to treat, cure, diagnose or prevent disease (Glisson, 2010, 578). They are allowed to make “structure” or “function” claims; for example, they may market a product to “improve joint health” but they cannot claim to treat arthritis or joint pain (Glisson, 2010, 578). The FDA therefore requires that any dietary supplements making structure or function claims state on the label: “This claim has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease(s)” (Glisson, 2010, 578; Frankos, 2010, 239). To further ensure the quality and safety of dietary supplements the FDA implemented the Current Good Manufacturing Practices guidelines in 2007 (Glisson, 2010, 578). These practices include quarantining herbs, proper identification of herbs based on chemical composition and pharmaceutical grade production practices (Ashar, 2008, 93). The Dietary Supplements Final Rule requires manufacturers to evaluate the identity, purity, strength and composition of dietary supplements (Gershwin, 2010, 111). Despite these safety attempts, not advertising dietary supplements as drugs that serve to cure or treat an illness may lead consumers to view these supplements as harmless. This could lead to a dangerous lack of concern for the potential of these supplements to cause adverse events, alone or in combination with prescription medications consumers may be taking.
Consumer Spending on Dietary Supplements
The implementation of the DSHEA led to a dramatic rise in the sale of dietary supplements (Ashar, 2008, 91). In 2007, dietary supplement sales reached $27 billion, with almost 50% of Americans reporting that they use these products (Woolf, 2010, 155). However, along with these dramatic sales, many consumers of dietary supplements have assumed that because these products are “natural,” they are automatically both safe and effective (Woolf, 2010, 155). As Julie Stone writes in An Ethical Framework for Complementary and Alternative Therapists, “Much reliance in the marketing of herbal remedies is placed on the idea that these remedies are natural and, by implication, free from side effects” (Stone, 2002, 234). In fact, a 2009 U.S. Government Accountability Office report found that consumers are often not well informed about the safety and efficacy of dietary supplements (Denham, 2011, 428). Patients often assume that the FDA regulates dietary supplements in the same way as prescription medications (Woolf, 2010, 155). Nearly 60% of respondents in a national survey reported believing that dietary supplements, “must be approved by a government agency like the FDA…before they can be sold to the public” (Gershwin, 2010, 112). Furthermore, Dodge et al. reported that consumers do not understand how the FDA regulates dietary supplements, and that information about FDA approval did not have a statistically significant effect on their beliefs about the safety or efficacy of dietary supplements (Dodge, 2011, 230). This is a troubling finding because it suggests that consumers of dietary supplements do not seek to educate themselves about the substances they are ingesting, often in large quantities.
Despite these safety attempts, not advertising dietary supplements as drugs that serve to cure or treat an illness may lead consumers to view these supplements as harmless. This could lead to a dangerous lack of concern for the potential of these supplements to cause adverse events, alone or in combination with prescription medications consumers may be taking.
Research on Dietary Supplements
In fact, there is little data on the efficacy and safety of many of the dietary supplements currently available, though some systematic reviews and small, nonrandomized or unblinded clinical trials have recently been published (Ashar, 2008, 93). As of May 31, 2014, there were 29,483 active studies on dietary supplements according to clinicaltrials.gov. By far, the majority of these studies are categorized as “Vitamins” (22,696 or 77%), followed by “Other dietary supplements” (3,565 or 12.1%), “Amino Acids” (2,080 or 7%), “Herbal and Botanical” (677 or 2.3%), “Flavonoid” (254 or 0.9%) and “Mineral” (211 or 0.7%)(“See Studies by Topic”). This suggests that many scientists are conducting rigorous research in the field of dietary supplements. Considering the amount of money consumers spend on dietary supplements each year, it seems likely that research will continue to be conducted and that the rigor of the studies funded will continue to rise. However, when it comes to pediatric populations, few clinical studies support the use of herbs and dietary supplements for treating common childhood conditions and there are a number of research and ethical barriers to building this type of evidence base (Woolf, 2010, 155). The National Center for Complementary and Integrative Health (NCCIH) has spent more than $1 billion in research on CAM, but “laments the continuing lack of rigorous scientific studies investigating the use and safety of dietary supplements in children” (Woolf, 2010, 156).
Questioning Dietary Supplement Use by Healthcare Institutions
Dietary supplement use is being questioned and regulated by CHOP because the FDA does not routinely review the manufacturing of dietary supplements, and therefore cannot guarantee their safety and effectiveness (“Research Communications”). Because of this lack of regulation, there are a number of concerns about supplement use, including adverse events and drug interactions, patient non-disclosure of use, unclear contents and a lack of clinical trials. Additional concerns about children’s use of dietary supplements are related to differences between children and adult dosages.
Adverse Events, Drug Interactions, and Patient Non-Disclosure of Use
In general the use of herbal and dietary supplements is an issue because of adverse reactions and drug interactions (Wu, 2013, 358-59). The 1994 DSHEA did not stipulate that dietary supplement manufacturers report adverse events related to their products, meaning that the FDA was reliant on voluntary reporting. Concern about this system led to Congress passing the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act, which established a definition of serious adverse events and set requirements for labeling and mandatory reporting for the dietary supplement industry (Frankos, 2010, 240). While this was an important step toward improving the safety of dietary supplements, much is left to learn about the safety and efficacy of dietary supplements — including the adverse effects of these supplements and their interactions with medications — in the inpatient pediatric setting.
Despite this lack of knowledge, many patients, or parents of pediatric patients, wish to continue using them (Gardiner, 2008, e775). Further complicating the issue is the fact that not only do patients or their parents often fail to disclose their use of dietary supplements to their health care providers (Ashar, 2008, 91; Gilmour 2011, Harris, 2005, 36), but that inpatient supplement use often goes unnoticed because physicians do not ask about its use (Boyer, 2005, 32). This makes identifying possible adverse events difficult.
Few Clinical Trials
Specific concerns about pediatric use of dietary supplements have been raised due to physiological differences between children and adults and their subsequent dosage issues as well as the presence of potentially dangerous additives or adulterants (Wu, 2013, 359). Although this type of CAM is one of the most commonly used, few studies have focused on dietary supplement use in pediatric populations and few have been found to support the use of herbs and supplements for treatment of common childhood conditions (Woolf, 2010, 156; Ball, 2005, 78). Furthermore, because the FDA does not require clinical trials for supplements before they enter the market, there is little scientific data or consensus about the benefits of these supplements for any population (Sax, 2015, 379).
Dietary supplements may also contain undeclared or simply unclear contents (Woolf 2010, 156). The uncertainty of a product’s contents means that it may not contain the substances as claimed on the label and that it may contain other substances that are unaccounted for, with potentially catastrophic results. A pediatric patient was inadvertently poisoned and nearly died, because his mother had been giving him an Asian patent remedy that, when analyzed, was found to contain a number of adulterants (Boyer, 2002, e49). Further complicating matters, some supplements have been intentionally “spiked” (for example, including prescription stimulant drugs in weight loss supplements or prednisone to “natural” supplements for arthritis) by unethical manufacturers looking to turn a quick profit (Glisson, 2010, 580).
CHOP’s New Policy
CHOP’s formulary (list of medications approved for use) will no longer include most dietary supplements. This regulation is being called a landmark case because it makes CHOP the first hospital in the United States to “discourage patients from using [dietary supplements] without a doctor’s provision as a matter of policy” (“Research Communications”). In its press release, the hospital states that it is taking this action because the FDA cannot guarantee safety or effectiveness of dietary supplements since it does not regularly review their manufacturing (“Research Communications”).
As a result of these findings, CHOP created a new policy that states that when a child is admitted, his or her parent or guardian will be asked if the child is taking any medications or supplements. If the child is taking a supplement, the attending nurse or physician will “review the hospital’s policy discouraging the use of supplements and inform parents or guardians of the potential risks associated with the supplement.” They list these potential risks to include contamination, mislabeling, interactions with medications, or unforeseen adverse effects (“Research Communications”). Some dietary supplements will be allowed, as long as they are on CHOP’s formulary. They include some key vitamins, minerals and amino acids (Imus, 2013). In order to be on this list, supplements must follow guidelines similar to those for FDA-approved medications. CHOP has stated that if a supplement is able to meet these criteria, its pharmacy will stock and dispense it as a formulary medication, avoiding the need for a waiver. The parent or guardian must sign a hospital waiver stating that they agree to be responsible for providing products that are not part of CHOP’s formulary if they insist that their child continue to take them while at CHOP. The hospital’s previous formulary included most dietary supplements as approved for use (“Research Communications”).
Arguments On Both Sides of CHOP’s Policy
There are a number of arguments for and against CHOP’s decision to discourage dietary supplement use.
Lack of Regulation of Dietary Supplements
Perhaps the most obvious argument in favor of the regulation is that dietary supplements are not regulated. Since the FDA does not review manufacturing of dietary supplements, it cannot guarantee that they are safe or effective. Paul Offit has stated that lack of good manufacturing practices is a major concern, with what he estimates to be fewer than 0.001 percent meeting the U.S. Pharmacopeial Convention standards of strength, quality, and product purity (Wanjek, 2013). However, some might respond that simply “because the FDA or another regulating body puts their stamp of approval on something does not necessarily guarantee its quality” (Imus, 2013). As a case in point, Merck removed its painkiller, Vioxx, from the market in 2004 after it was not only shown to increase the risk of heart attacks and strokes, but was linked to thousands of deaths (Imus, 2013).
Insufficient Research on Dietary Supplements
The lack of clinical trials measuring the benefits or risks associated with taking dietary supplements is a major concern for those in favor of the regulation. “FDA-approved medications also certainly have side effects,” Offit said, but at least doctors understand what the dangers are because they have been documented in studies (Wanjek, 2013). Although it is true that more research is needed on dietary supplements in order to determine their safety, one counterargument is that hospitals in the U.S. administer medications or therapies with known side effects to patients on a daily basis because the benefits outweigh the potential risks (Imus, 2013). Those against the regulation might contend that it limits potentially beneficial treatments. However, those in favor of the regulation would respond that without proper research to back up the potential benefits, the risks weigh more heavily.
Communication Between Patient and Provider
As previously stated, communication between patients and providers is already tenuous when it comes to discussing complementary and alternative medicine, with many providers wary of patients coming to them with their homeopathic remedies or professing the wonders of Reiki. Patients may not feel that they can trust their provider to support use of or to provide feedback about certain CAM modalities. This type of regulation could lead to families withholding or hiding supplement usage from doctors and other healthcare providers because they fear having the dietary supplements taken away from them or being shamed for their decision to use them. In a study examining patient-provider communication about CAM, a subject stated, “When my little boy was born, I used to give him herbs for his stomach aches. And…I wouldn’t tell [the doctor] because… ‘she’ll get madder.’ So I don’t tell them that I use herbs on the kids” (Shelley, 2009, 143). However, the policy could also improve health care providers’ dialogues with families, leading to an improvement in tracking everything that patients are taking and how these things are affecting them. Patients may feel that because they are being asked about their use of dietary supplements, their providers are open and possess some level of knowledge about the products they are taking.
Lack of Provider Education About Dietary Supplements
Another argument in favor of the regulation is based on the fact that western healthcare providers are simply not educated about dietary supplements like herbs and often do not know what they are for or how they will interact with allopathic medicine and/or treatments. This lack of knowledge could be especially dangerous in cases where experimental drugs are being administered to children. Sarah Erush, a member of CHOP’s Therapeutic Standards Committee, states, “Administering these medications — particularly to children with serious health complications — is unethical when the risks are unknown, and when there are alternative treatments that have been proven in clinical trials to be safe and effective,” (“Research Communications”). However, in a letter to CHOP, Michael McGuffin of the American Herbal Products Association counters that, “simply removing these popular vitamins and supplements from the CHOP Formulary is unlikely to eliminate unintended drug interactions with dietary supplements.” He adds: “A more effective approach would be to educate staff and patients about the benefits and risks of drugs and supplements so patients have informed and safe access to the broadest selection of health care options” (McGuffin, 2013).
Unknown Interactions with Standard Medications
The issue of medicinal and unknown interactions is an important argument in favor of the regulation. Because we do not know how allopathic medications might interact with dietary supplements, health care providers and patients cannot be certain what risks they are taking in mixing these different products. For example, St. John’s wort is an herb that is metabolized through the liver and can cause life-threatening side effects when taken with certain medications (Wanjek, 2013). Other herbal medicines are blood thinners, may be contraindicated for pregnant women, or may impact health negatively in some other way. A health care provider with little or no knowledge of herbal interactions with allopathic medications could unintentionally endanger patients. However, this is the case with allopathic medications as well.
While many common side effects of allopathic medications are known, as well as a number of common interactions, patients are commonly taking a number of medications that have not been combined in that particular manner before, which poses a number of potential risks. However, health care providers frequently prescribe medications in unknown groupings regardless of this because there are far too many possible combinations to be reasonably tested.
Culturally Limiting and Insensitive
The regulation is culturally limiting and insensitive to large populations of patients whose primary approach to medicine may not be allopathic. Cultural influence may play a strong role in patients’ and parents’ decisions to use dietary supplements such as herbs (Gardiner, 2007, 862). These patients may have different views on health and choose to utilize various other healing practices. While allopathic health care professionals approach therapy from a knowledge base, patients may have strong beliefs about a product’s efficacy that could stem from effectiveness in a friend/family member, or a religious, ethnic or historical view (Harris, 2000, 1299). Restricting a patient’s culturally significant medical philosophy and treatment is a significant argument against the regulation, which makes it all the more essential for hospitals to recognize the ways in which their treatment methodology may differ from that of their patients. While allopathic medicine relies on scientific evaluations of data from clinical trials, patients may not understand the importance of this type of data or simply choose to prioritize anecdotal reports, testimonials, and non-controlled studies (Harris, 2000, 1299). Futhermore, clinicians must be attuned to and educated about the potential for cultural misunderstandings regarding the use of certain herbal medicines or other supplements. For example, Traditional Chinese Medicine has included the use of the herb known as ephedra (Ma huang) for more than 5,000 years as a bronchodilating and stimulatory agent (Sadovsky 2008). However, a patient who admitted to taking ephedra would cause alarm in the US, where it is considered to be a dangerous workout and weight loss enhancing supplement and was banned in 2004 due to hundreds of reports of toxicity and 22 deaths (“Drugs and Supplements”). Such disparities in approaches to and understandings of treatment could create difficulties in communication and bring about issues of trust between patients and health care providers. It is essential for both parties to find effective ways to communicate about their beliefs and relay their knowledge about health care and healing practices so that patients receive the best possible care.
It is essential for both parties to find effective ways to communicate about their beliefs and relay their knowledge about health care and healing practices so that patients receive the best possible care.
Other Health Care Institution Policies
Health care institutions often have ambiguous policies about herbs and dietary supplements (Woolf, 2010, 155) or lack them entirely. In a recent survey of 109 U.S. children’s hospitals, Woolf et al. found that while only 2% of hospital formularies include herbs and 38% include other dietary supplements, 84% of these hospitals would allow a hospitalized child to use a home supply of dietary supplements (Woolf, 2010, 155). Little is known about how many children’s hospitals have created their own policies regarding dietary supplements on hospital formularies or the patient’s home supply, and in cases where they do exist, little is known about both the content of these policies and their implementation in the inpatient setting (Gardiner, 2008, e776). Gardiner et al. reported that there was currently no universal guideline for managing a patient’s dietary supplements in the pediatric hospital setting (Gardiner, 2008, e776). Boyer et al. found that hospitals are managing inpatient use of herbal and dietary supplements from patients’ home supplies in a number of ways, including banning them entirely; developing a policy that allows their use, but does not require that they are identified; and permitting restricted use of dietary supplements because of a lack of policy regulating this field (Boyer, 2005, 31).
In a study researching policies governing use of CAM therapies in 19 U.S. hospitals, Cohen et al. found that less than one third of the hospitals had a formal stated policy regarding dietary supplement use (Cohen, 2005, 289). This lack of policy was echoed in the results from a national survey of more than 300 pharmacy directors to determine policies and practices related to dietary supplement use, which concluded that many acute care facilities had neither a formal policy for dietary supplements nor had they implemented planning for such a policy (Bazzie, 2006, 65). The study results showed that institutions with such policies commonly required a written order by an authorized prescriber, documentation of use in the medication record, and a mechanism for the provider to identify the supplement prior to patient use (Bazzie 2006, 67). Consistent with CHOP’s stated reasons for its policy, pharmacists in this study expressed concerns about the consistency of dietary supplement formulations, the lack of FDA regulation, and the difficulty of identifying supplements and distinguishing reputable manufacturers (Bazzie, 2006, 68).
Calls to Action
While several calls to action have been made by regulatory and oversight organizations, there is still a lack of consensus about the use of dietary supplements. In 2001, the National Institutes of Health Clinical Center implemented a policy titled “Use of patient’s own dietary supplements and alternative consumable products brought into the Clinical Center,” which stated that patients may only use these types of products upon authorizing orders by their Clinical Center physician (Sparber, 2004, 135). The Institute of Medicine also recommended that the FDA set up a panel of experts to review the safety of certain supplements and to require more vigorous reporting of adverse events (Sparber, 2004, 133).
As a result of the lack of institutionalized regulation of CAM therapies, the Joint Commission Accreditation of Healthcare Organizations (JCAHO) and the American Health System Pharmacists created standards and guidelines for the use of dietary supplements in hospitals (Gardiner, 2008, e776). JCAHO asks hospitals seeking accreditation specific questions about how patients who bring herbal supplements from home are being managed, whether herbs are on the hospital formulary, and whether physicians are required to assess the use of herbals during the hospital stay (Sparber, 2004, 133; Gardiner, 2008, e776). On the other side of the process, there has been an increase in voluntary verification programs, in which manufacturers of dietary supplements can receive recognition from the United States Pharmacopeia for complying with audits, product and ingredient testing and manufacturing document review (Williams, 2011, 1657).
As steps are taken to determine the best ways to manage dietary supplements and to improve the DSHEA, scientists have begun proposing possible pathways. In 2008, Ashar et al. presented a 6-step approach to advising patients who are considering dietary supplement use that includes a discussion of regulatory issues, efficacy and safety, potential interactions between dietary supplements and prescription drugs and monitoring for both adverse and therapeutic effects (Ashar, 2008, 91). In 2010, Woolf et al. used the American Society for Clinical Pharmacology and Therapeutics’ 2005 position statement to improve the oversight and safety of herbs and dietary supplements as a framework to propose six recommendations for specifically safeguarding children’s interests (Woolf, 2010, 156; Morrow, 2005, 114). These recommendations included giving the FDA expanded regulatory oversight and funding for supplements, heath care provider education about theses products prior to discussing them with patients, higher priority of researching the safety and efficacy of these supplements by government agencies as well as more clinical trials, the adoption of best-practice guidelines by hospitals and the support of new research and public policy initiatives to address poisoning prevention and abuse of certain supplements (Woolf, 2010, 157).
CHOP’s Policy: The Next Natural Step
These calls to action all speak to the major issues in dietary supplement use, including the general lack of regulation, research data, and health provider education, as well as unknown contents and interactions with prescriptions medications. CHOP’s policy speaks to these issues and provides a framework for its healthcare providers to provide consistent care for their pediatric patients. While the policy received a great deal of press as a “ban” on dietary supplements, in announcing the change, CHOP’s own media used the word “disallows” in the title of its press release, and went on to state that the institution was the first in the nation to “discourage patients from using these products without a doctor’s provision as a matter of policy” (“Research Communications”). To discourage use is quite different from implementing a ban. In fact, in discouraging use, CHOP is leaving a sense of autonomy in the hands of its patients and their families; the patient’s ability to choose is left intact. By giving its patients a waiver to sign in the event that they choose to continue to take their dietary supplement while an inpatient at the hospital, CHOP is creating a moment in time for contemplation, a cautious pause. Such a gate-keeping mechanism provides the opportunity for CHOP to remind its patients and health care providers that hospitals must be vigilant when it comes to dispensing — and therefore taking responsibility for the consequences of — dietary supplements for those under their care.
Rather than focusing on the policy change as a moratorium, perhaps the greater insight to be had is in understanding the motivations and implications of safety and caution, rather than in the act of blocking dietary supplements. CHOP is not, in fact, “banning,” dietary supplement use by inpatients, but rather, by using an abundance of caution, the institution is creating an environment in which not only patients but pharmacists, nurses, doctors and other health care providers are more aware of the state of dietary supplement regulation and safety. When prompted to develop this awareness, patients will, hopefully ask more questions and make more educated decisions about their use of dietary supplements. As we become more aware of dietary supplement regulation in the U.S., it is likely that more research will be conducted that will provide safety data about specific dietary and herbal products so that consumers will be able to make wise choices if they decide to complement their diets with these types of supplements.
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