PEDIATRICS Vol. 121 No. 4 April 2008, pp. e775-e781 (doi:10.1542/peds.2007-1898)
ARTICLE |
Dietary Supplements: Inpatient Policies in US Children's Hospitals
a Osher Institute, Harvard Medical School, Boston, Massachusetts
c Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Massachusetts
d Department of Pediatrics, School of Medicine, Wake Forest University, Winston-Salem, North Carolina
f Children's Hospital, Boston, Massachusetts
b Department of Family Medicine, Boston Medical Center, Boston, Massachusetts
e Post-Baccalaureate Premedical Certificate Program, University of Massachusetts, Boston, Massachusetts
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ABSTRACT |
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BACKGROUND. Variations in hospital policies and practices regarding the use of vitamins, minerals, herbs, and other dietary supplements could compromise patient safety and quality of care. We undertook this study to describe pediatric hospital policies regarding dietary supplements.
METHODS. We administered a cross-sectional survey of a sample of National Association of Children Hospitals and Related Institutions members. Pharmacy personnel were asked about the following: written policies addressing dietary supplements; how such policies are made; and responsibilities for storage, administration, documentation, and checking for potential interactions. We created a 10-point hospital policy and practices quality score to assess the quality of each policy.
RESULTS. Of the 186 eligible National Association of Children Hospitals and Related Institutions hospitals, 109 responded (59%). Forty-four percent reported having written policies on vitamins and minerals, herbs, and other dietary supplements. Few hospitals had herbs (2%) or other dietary supplements (38%) on formulary. However, most (81%) allowed patients to use their home supply of dietary supplements under defined circumstances, and 64% allowed staff to make recommendations about dietary supplement use. In 70% of hospitals, nurses stored and administered the home supply of dietary supplements. Less than half (46%) required documentation of a check for drug or dietary supplements interactions. One third (32%) had surgical preoperative recommendations regarding dietary supplements. Only 11% of 109 hospitals satisfied the 10 criteria necessary for a perfect hospital policy and practices quality score indicative of quality practices regarding patient use of dietary supplements.
CONCLUSION. Even among those hospitals that have written policies about dietary supplements, there is a wide range in policy quality, which may compromise the safety of patients.
Key Words: dietary supplements • pediatrics • hospitals • policy
Abbreviations: DS—dietary supplement • JCAHO—Joint Commission Accreditation of Healthcare Organizations • HPPQS—hospital policy and practices quality score • FDA—Food and Drug Administration
According to the National Institutes of Health Office of Dietary Supplements, a dietary supplement (DS) is intended to supplement the diet and contains 
1 dietary ingredient (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or ingredient constituents.1 The use of DSs is common in children and adolescents, especially those with chronic conditions who need frequent medical care and hospitalizations.2–5
Little is known about the safety and efficacy of DSs in the inpatient pediatric setting. Although many DSs are safe, some may cause adverse effects or interactions with medications. Many parents of pediatric patients want to continue using their own DSs during hospitalization.5,6 Adolescents may also want to continue the same DSs that they routinely take at home. This practice of using a "home supply" makes identification of DS use among patients admitted to a health care facility important, particularly because of the risks of DS-drug interactions or special risks encountered during surgery (eg, interference with hemostasis or interactions with sedatives or anesthetic agents).7
Currently, there is no universally accepted guideline for managing a patient's DSs in the pediatric hospital setting.5 However, both the Joint Commission Accreditation of Healthcare Organizations (JCAHO) and American Health System Pharmacists offer standards and guidelines on the use of DSs in hospitals.8,9 JCAHO requires that DSs conform to the same hospital standards as prescription medications.8 It is unknown how many pediatric hospitals have created their own guidelines on the use of DSs on hospital formulary or the patient's home supply. Where they do exist, little is known about the content and quality of such policies or how they are implemented in the inpatient setting.
The goal of the current investigation was to gather information on the existence and content of inpatient policies about DSs in children's hospitals in the United States. We were interested in the extent to which DSs are included in hospital formularies, whether and under what condition a patient's use of home supply of DSs is allowed. Furthermore, if they are allowed, questions remain regarding who stores them; who administers them; who checks for and reports adverse effects and interactions; what documentation is required; and what resources are available to answer clinicians' questions about these products. We also asked about presurgical recommendations regarding DSs. We hypothesized that hospitals with poison control, drug information centers, and specialty services would be more likely to have inpatient DS policies.
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METHODS |
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Hospital Documentation
We conducted a cross-sectional survey of the 204 members of the National Association of Children's Hospitals and Related Institutions. Institutions were eligible if they were members of National Association of Children's Hospitals and Related Institutions and had an inpatient pharmacy (n = 186). Institutions were excluded if they did not provide inpatient care to children or did not speak English (n = 18). Hospitals were categorized by size and type (<300 or >300 beds, tertiary hospital, community hospital or rural hospital), region (classified by location in the state: northeast, south, west, or midwest), teaching status, and type of inpatient services.
A total of 186 surveys were mailed to the pharmacy directors. This was followed 2 weeks later by a reminder postcard and 1 month later by a reminder fax.
A 16-item questionnaire with yes-or-no format was based on a previously validated survey on DSs.10 In our survey, a DS was defined as "vitamins, minerals, herbs, or other DS that are neither approved nor classified by the federal Food and Drug Administration as a ‘drug.’" The questions were pilot tested and revised to assess the following: (1) types of DS written policies; (2) formulary decisions about DSs; (3) hospital policies regarding the patient's home supply of DSs; (4) hospital staff responsibilities for DSs; (5) hospital documentation of DSs; (6) surgical and preoperative recommendations of DSs; and (7) DS resources available in the hospital. We asked institution representatives who indicated that they had written policies to send us copies of those policies (n = 26).
To provide guidance for hospitals to assess the quality of their DS policies, we created a hospital policy and practices quality score (HPPQS). We used several resources of expertise to create the HPPQS, including existing guidelines, standards, and other resources on DS use in clinical settings.8,9,11–14 Drs Joseph Betz, Robert Bonakdar, and David Eisenberg provided their expertise in the construction of the HPPQS scale. The HPPQS unweighted final version of the scale contained 10 criteria; each element was worth 1 point. We calculated a score for all of the respondents to our survey.
We entered data into Microsoft's Access (Redmond, WA) database software and analyzed the data by using SAS software 9.1 (SAS Institute, Cary, NC). To analyze the data we used descriptive statistics and the Fisher's exact test to assess whether independent factors (poison control center, drug information center, and specialty services) were associated with the presence of a DS policy. An institutional review board exemption for this study was obtained from Harvard Medical School.
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RESULTS |
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Hospital Characteristics
Of the 186 surveys mailed, 114 surveys were returned, 109 (59%) were complete, and 26 sent copies of their policies. Surveys were completed by 70 pharmacy directors, 7 associate pharmacy directors, 16 pharmacists, 2 pharmacy supervisors, 7 pharmacy managers, 1 dietitian, 2 drug information specialists, 1 clinical coordinator, and 3 undetermined. The responding institutions are described in Table 1. The majority of the hospitals were tertiary (66%), had teaching programs (61%), and represented wide regional distribution.
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Overall, 79% of respondents had some written policy regarding the inpatient use of herbs, 47% had a policy on vitamins and minerals, and 68% had a policy on other DSs. Eighteen respondents (17%) based their policies on national guidance. Most (64%) allowed staff to make recommendations to hospitalized patients about using DSs.
Hospital Formularies
Most hospital formularies included vitamins and minerals (99%). However, only 2% of formularies included herbs, and 38% included other DSs (eg, probiotics or melatonin). The most frequently cited reasons for whether DSs were carried on the inpatient formulary included the following: review by the pharmacy and therapeutics committee, safety data, clinical evidence, availability of standardized products, physician demand, cost, and proof of quality of product (Table 2).
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Hospital Policies Regarding the Patients' Use of a Home Supply of DSs
Eighty-four percent of institutions allowed hospitalized children to use a home supply of DSs, at least under some circumstances (Table 3). Of these who noted restrictions about the use of home supply, 95% reported that there must be an order from a physician, and 66% said they must consult with a pharmacist.
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Hospital Staff Responsibilities for DSs
Most respondents (70%) reported that the nursing staff had responsibility for storage and administration of the home supply of DSs; 26% reported that families stored and administered DSs; and 17% allowed the family to stored DSs at the bedside but a nurse administered them. Eight hospitals identified a role for the pharmacy in both verifying the content of and storing a home supply of DSs (Table 3). Responsibility for checking for drug-DS interactions generally (86%) lay with pharmacists, but 9% reported that they had had no formal checking system for interactions. Potential adverse events because of DSs were reported to the hospital pharmacy (88%), risk management (64%), the Food and Drug Administration (FDA) Medwatch Program (58%), and poison control centers (4%; Table 4).
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Hospital Documentation of DSs
Documentation about previous or current DS use varied, and details are provided in Table 4. Documentation of current and previous use of DSs included the following: admission note (79%), medication administration record (71%), nurse's notes (47%), computer order form or database (38%), medical reconciliation form (13%), or no documentation required (5%). Most hospitals required documentation of type, frequency, and dose and route of DS administration. Only 46% required documentation of a check for interactions with medications.
Surgical and Preoperative Recommendations of DSs
Only 32% of respondents reported that surgical or anesthesia staff made preoperative recommendations about using or stopping DSs before surgery; only 10% provided patient handouts about DSs before surgery (see Table 4).
DS Resources Available in the Hospital
Information resources on DSs available to health care professionals on DSs included the following: internet Web sites or intranet (95%); pharmacy staff (93%); textbooks (90%); online databases (82%); Micromedex-Altmedex (74%); hospital formulary (68%); drug information center (48%); Natural Medicine Comprehensive Database (48%); poison center staff or toxicology personnel (38%); other resources such as dietician, drug information facts, or facts and comparisons (5%); and no response (2%). Respondents could check >1 resource.
Hospital Policy and Practices Quality Score Results
Figure 1 shows the 10 elements in the HPPQS scores and the range of scores among the respondent hospitals (Fig 1). The mean HPPQS was 8 (SD: 1.7), with a median of 8. Figure 1 shows the distribution of the HPPQS scores on a 0 to 10 scale (Fig 1). Eleven (10%) hospitals had a perfect score. The 3 items on the HPPQS least cited by respondents included the following: (1) choosing DSs for formulary based on quality, (2) having a policy for all types of DSs, and (3) complete documentation in the chart.
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Independent Factors Associated With the Presence of Hospital Policies
There was no statistically significant difference in the presence of a hospital DS policy between hospitals with and without poison control centers (P = .11), drug information centers (P = .56), oncology services (P = .80), dialysis services (P = .62), and teaching programs (P = .56).
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Creating policies for the inpatient use of DSs should be an important hospital function to ensure patient safety. Because, under the 1994 Dietary Supplement Health and Education Act, DSs are not held to the same regulatory standards as prescription medications, DS hospital policy and practice is wrought with confusion. Presently, the concern over the quality, safety, and lack of pediatric clinical trials for the efficacy of DSs undermines the confidence of health care professionals in these products. In creating their policies, many hospitals have struggled with balancing patient-centered care with legal and ethical concerns over DS use.7,15,16
In the JCHAO Comprehensive Accreditation Manual for Hospitals, a medication is defined as "any prescription medication, sample medication, herbal remedies, vitamins, nutraceuticals, over the counter drugs, vaccines, diagnostic and contrast agents, used on or administered to person to diagnosis, treat, or prevent disease or other abnormal conditions ..."8 Therefore, JCAHO medication management standards equate many types of DSs, such as herbal remedies, vitamins, nutraceuticals, and over-the-counter drugs containing DSs on the same level as prescription and nonprescription drugs.9 JCAHO expects health systems to manage DS products with the same diligence and care given to any prescription medication brought into the hospital by patients and their families.
Although this study confirmed that many hospitals have policies of herbal products (79%), only 68% had policies about vitamins and minerals, and fewer than half had policies on other DSs. The HPPQS score demonstrated wide variations in the quality of hospitals' policies about DSs. The items most often missing within hospital policies were as follows: choosing DSs for the hospital formulary based on quality, requiring complete documentation in the chart, and having a policy for all types of DSs.
In terms of products available on formulary, most hospitals included vitamins and minerals, yet only 2% had herbs and 38% had other DSs. Hospitals invoked many factors affecting their decision-making as to whether DSs were carried on the inpatient formulary. The most common were as follows: review by the pharmacy and therapeutics committee, safety data, clinical efficacy, and availability of standardized products. Pharmacy directors have reported concerns about the lack of active ingredient consistency, difficulty in identifying reputable manufacturers, difficulties in identifying DSs, and lack of premarketing safety and efficacy reviews.17
Similar to previous studies of adult institutions, only 58% of our respondents reported including proof of a DS's quality before adding it the formulary.17,18 The lack of standards for quality (free of adulterants or contaminants) and variation in the quantity of active ingredients in DSs are major concerns in the United States.19–30 However, the FDA has just released the final rule on good manufacturing practices for DSs made in the United States that will go into affect in 2008. Until then, looking for third-party documentation of testing for quality of a product, such as a US Pharmacopeia seal and buying from pharmaceutical-grade manufacturers are 2 approaches to supplying high-quality DSs.
Like surveys of adult hospitals, pediatric institutions in this survey reported a wide of approaches to patients' use of a home supply of DSs. For example, some hospitals confiscate patients' DSs, and others expressly prohibit their use.17,31 Most (84%) of the pediatric institutions in this current study allowed inpatients to use their home supply of DSs.
Similar to adult institutions, 95% of the pediatric institutions in our survey required a physician order to allow patients to use their home supply.17,32 The requirement for a physician order for patients to use a home supply seems to have emerged as a national standard, provoking the question of physicians' training and confidence in making evidence-based decisions about such use.17,33 Previous research suggests that few health care professionals routinely ask about their patient's use of DSs or feel knowledgeable about DSs.33,34
Ideally, hospitals have standards requiring safe storage and administration of DSs in the inpatient setting. In this study, 77% noted that the nurses had the responsibility of storing and administering the home supply of DSs. Other hospital-based surveys have shown that nurses commonly administer products.17,18 However, there is little information provided in nursing school or continuing medical education that addresses DS administration, knowledge, and interactions.16
Most pediatric institutions require documentation of current and previous use of DSs in the medical chart. There is variability with respect to where this documentation is required, who documents, and how this information gets communicated throughout the hospital. Although we did not directly ask about medical reconciliation forms, 13% of our sample noted the forms as a source of DS documentation. JCAHO's National Patient Safety Goal No. 8-Medical Reconciliation Act, requires documentation of any patient use of herbal remedies, vitamins, nutraceuticals, and over the counter drugs, just like any other medication.35
The American Academy of Pediatrics policy statement on the prevention of medication errors in the inpatient setting cited reasons for medical errors including: "failure to recognize drug-drug or drug herbal/medicinal/dietary product interactions."13,14 The majority of checking for drug-DS interactions generally lay with pharmacists; yet, 9% reported that they had no formal checking system for interactions. This is higher than seen in other surveys.32 Only 46% of children's hospitals in the present survey required written documentation of a query about interactions of DSs with medications. In this study, potential adverse event because of DSs were most often reported to the hospital pharmacy and risk management. FDA Medwatch and poison control centers were used less often.
Although it is common for children or adolescents to use DSs before surgery, little is known about the benefits or risks to surgical patients using DSs.36–41 There are no national guidelines for the use or disuse of DSs before surgery. The American Society of Anesthesiologists makes no formal statement or official policy on the preoperative use of DSs.42 As with similar findings in adult hospitals, only 32% of respondents in the current survey noted that surgical or anesthesia staff made preoperative recommendations about using or stopping DSs, and only 10% routinely provided informational handouts to patients and their families.31,32,43
This survey has several limitations. Only 59% of institutions returned completed surveys, and their responses may not reflect those of all US pediatric hospitals, although we could not detect a systematic bias in who did and did not furnish completed surveys. The self-reported data were filled out by different kinds of respondents at different institutions. We only received a limited number of actual policies to confirm the accuracy of the reporter and the extent of agreement between self-report and actual policies. Even for the hospitals that had policies, it is still unclear how policies are enforced or the extent to which they are followed in actual practice.
The HPPQS score was developed based on the opinions of experts in the field, as well as existing standards, guidelines, and other resources in the literature. HPPQS is intended only as a "benchmarking" tool to gauge the adequacy of a hospital's practices regarding patient use of DSs. This quality score has not been validated in the clinical setting to see whether it truly captures the complexity of a high-quality policy in an inpatient hospital setting, and additional studies investigating the usefulness of the quality score for hospital administrators and health policy-makers are warranted.
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CONCLUSIONS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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There is substantial variation in pediatric hospital policies about DSs. Policy development is complicated by the lack of assurance of quality and standardization of DS products, the lack of safety and efficacy data for pediatric patients, and the difficulty of standardized pharmacy practices. Priorities for improvement include creating a comprehensive policy on all types of DSs, documentation of use, guidelines for preoperative use, and checking for potential adverse effects and interactions. Additional research is needed to discern more precisely the relationship among policies, quality care, and patient outcomes. National guidelines for DS policies and procedures need to be developed to ensure the safe use of DSs in children's hospitals.
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ACKNOWLEDGMENTS |
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We thank Drs Joseph Betz, Robert Bonakdar, and David Eisenberg for construction of the HPPQS scale and Drs Paul Schyve and Angela Bader for commenting on the article before its submission.
Dr Gardiner is supported by National Institutes of Health Institutional National Research Service Award grant T32-AT0051-03 from the National Center for Complementary and Alternative Medicine. Dr Phillips is supported by a National Institutes of Health Mid-Career Investigator Award K24-AT000589 from the National Center for Complementary and Alternative Medicine, National Institutes of Health. Dr Kemper is supported by National Institutes of Health grant K24-AT002207. Dr Woolf is supported by National Institutes of Health grant R25 AT00538-05 from the National Center for Complementary and Alternative Medicine.
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FOOTNOTES |
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Accepted Aug 24, 2007.
Address correspondence to Paula Gardiner, MD, MPH, Boston University Family Medicine, 771 Albany St, Dowling 5, South Boston, MA 02118. E-mail: paula_gardiner{at}hms.harvard.edu
This article was presented, in part, at the annual meeting of the Pediatric Academic Societies; May 7, 2007; Toronto, Ontario, Canada.
The authors have indicated they have no financial relationships relevant to this article to disclose.
| What's Known on This Subject Little is known about the safety and efficacy of dietary supplements in the inpatient pediatric setting. Although many dietary supplements are safe, some may cause adverse effects. Variations in hospital policies and practices regarding use of dietary supplements could compromise patient safety.
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| What This Study Adds Substantial variation in pediatric hospital policies about dietary supplements exist. Policy development is complicated by the lack of safety and efficacy data and the difficulty of standardizing pharmacy practices. Priorities for improvement include creating a comprehensive policy, documentation of use, and checking for potential interactions.
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PEDIATRICS (ISSN 1098-4275). ©2008 by the American Academy of Pediatrics
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