Natural Health Product-Drug Interaction Causality Assessment in Pediatric Adverse Event Reports Associated with Attention-Deficit/Hyperactivity Disorder Medication.

Background: Some pediatric patients with attention-deficit/hyperactivity disorder (ADHD) use natural health products (NHPs) such as herbal remedies. Although herbal remedies are generally considered to be safe when they are used appropriately, they may contain active components that can interact with medications being used concurrently, with potential for NHP-drug interactions leading to adverse events. Objectives: The objectives of this study were (1) to identify adverse event reports (AERs) involving commonly used herbal remedies and ADHD prescription medicines in children and adolescents; (2) to evaluate the quality of collected AERs; and (3) to assess whether NHP-drug interactions can be causally linked to reported adverse events. Methods: We systematically searched the FDAble database (FDAble.com) for herbal remedies commonly used by patients (4-18 years old) also taking ADHD drugs from 1997 to 2015. We assessed the completeness of the AERs and used three causality assessment tools modified for NHPs (Naranjo Adverse Drug Reaction Probability Scale, HORN Drug Interaction Probability Scale, and World Health Organization Uppsala Monitoring Centre Scale). Results: Of the 23 identified AERs involving both an herbal remedy and an ADHD prescription medication, most involved multiple (>3) substances with inadequate detail to assess multiple potential interactions. Following data extraction and evaluation of completeness, five AERs involving only one herbal remedy and one ADHD medication were evaluated for causality. An NHP-drug interaction was assessed to be probable in one case and to be possible in another. Both these reports involved a methylphenidate formulation and St. John's wort. Conclusions: Eighteen of the 23 identified AERs involving both an herbal remedy and an ADHD drug also involved other multiple ingredient products. The reporting quality was poor for the five AERs examined. Further research is needed to study the interaction between St. John's wort and methylphenidate.

Health Disparities in Access to Nonpharmacologic Therapies in an Urban Community.

OBJECTIVE: The overuse of prescription opioids for chronic pain is recognized as a public health crisis. Yet, poor access to nonpharmacologic treatments is the norm in low-income, racially and ethnically diverse patients with chronic pain. The main objective of this study was to understand how chronic pain impacts low-income individuals with chronic pain and their communities from multiple perspectives. DESIGN: This was a qualitative study using a Science Café methodology. SETTING: The Science Café event was held at an urban community center in Boston, MA. SUBJECTS: Inclusion criteria included the following: having the ability to attend the event, being at least 18 years of age or older, and participating in English. METHODS: Data were collected through self-reported questionnaires and audio or video recordings of two focus groups. Quantitative and qualitative data were analyzed with SAS 9.3 and NVivo 10. RESULTS: Thirty participants attended the Science Café event. The average age was 45 years, 77% reported as female, 42% identified as black, and 19% as Hispanic. Participants identified themselves as either patients (46%) or providers (54%) to the chronic pain community. Our forum revealed three major themes: (1) nonpharmacologic options for chronic pain management are warranted, (2) larger sociodemographic and contextual factors influence management of chronic pain, and (3) both patients and providers value the patient-provider relationship and acknowledge the need for better communication for patients with chronic pain. CONCLUSIONS: Future research should consider identifying and addressing disparities in access to nonpharmacologic treatments for chronic pain in relation to underlying social determinants of health, particularly for racially and ethnically diverse patients.

Engaging women with an embodied conversational agent to deliver mindfulness and lifestyle recommendations: A feasibility randomized control trial.

OBJECTIVE: This randomized controlled trial evaluates the feasibility of using an Embodied Conversational Agent (ECA) to teach lifestyle modifications to urban women. METHODS: Women were randomized to either 1) an ECA (content included: mindfulness, stress management, physical activity, and healthy eating) or 2) patient education sheets mirroring same content plus a meditation CD/MP3 once a day for one month. General outcome measures included: number of stress management techniques used, physical activity levels, and eating patterns. RESULTS: Sixty-one women ages 18 to 50 were enrolled. On average, 51% identified as white, 26% as black, 23% as other races; and 20% as Hispanic. The major stress management techniques reported at baseline were: exercise (69%), listening to music (70%), and social support (66%). After one month, women randomized to the ECA significantly decreased alcohol consumption to reduce stress (p=0.03) and increased daily fruit consumption by an average of 2 servings compared to the control (p=0.04). CONCLUSION: It is feasible to use an ECA to promote health behaviors on stress management and healthy eating among diverse urban women. PRACTICE IMPLICATIONS: Compared to patient information sheets, ECAs provide promise as a way to teach healthy lifestyle behaviors to diverse urban women.

The clinical content of preconception care: nutrition and dietary supplements.

Women of child-bearing age should achieve and maintain good nutritional status prior to conception to help minimize health risks to both mothers and infants. Many women may not be aware of the importance of preconception nutrition and supplementation or have access to nutrition information. Health care providers should be knowledgeable about preconception/pregnancy-related nutrition and take the initiative to discuss this information during preconception counseling. Women of reproductive age should be counseled to consume a well-balanced diet including fruits and vegetables, iron and calcium-rich foods, and protein-containing foods as well as 400 microg of folic acid daily. More research is critically needed on the efficacy and safety of dietary supplements and the role of obesity in birth outcomes. Preconception counseling is the perfect opportunity for the health care provider to discuss a healthy eating guideline, dietary supplement intake, and maintaining a healthy weight status.

The clinical content of preconception care: the use of medications and supplements among women of reproductive age.

The use of prescription and over-the-counter medications and dietary supplements are common among women of reproductive age. For medications, little information about the teratogenic risks or safety is available, as pregnant women are traditionally excluded from clinical trials, and premarketing animal studies do not necessarily predict the effects of treatment in human pregnancy. Even less is typically known about the effects of dietary supplements on pregnancy outcomes, as they are not held to the same rigorous safety and efficacy standards as prescription medications. Congenital anomalies associated with medication use are potentially preventable, because they are linked with modifiable maternal exposures during the period of organogenesis. However, as women of reproductive age experience acute and chronic conditions that can result in adverse outcomes for the woman and her offspring, the benefits of use of a particular medication before or early in pregnancy may outweigh the risks. Resources and principles outlined in this article will aid healthcare providers in selecting appropriate medication regimens for women of reproductive age, particularly those with chronic health conditions, those who are planning a pregnancy, and those who may become pregnant.

Herbal and dietary supplement disclosure to health care providers by individuals with chronic conditions.

BACKGROUND: Very little is known about herbal and dietary supplement disclosure in adults with chronic medical conditions, especially on a national level. OBJECTIVE: To examine herbal and dietary supplement disclosure to conventional health care providers by adults with chronic medical conditions. DESIGN: Data on herbal and dietary supplement use (N = 5456 users) in the previous year were used from the 2002 National Health Interview Survey. Bi-variable analyses compared characteristics between herbal and dietary supplement disclosers and nondisclosers. Multivariable logistic regression identified independent correlates of herbal and dietary supplement disclosure. RESULTS: Overall, only 33% of herbal and dietary supplement users reported disclosing use of herbal and dietary supplements to their conventional health care provider. Among herbal and dietary supplement users with chronic conditions, less than 51% disclosed use to their conventional health care provider. Hispanic (adjusted odds ratio and 95% confidence interval = 0.70 [0.52, 0.94]) and Asian American (adjusted odds ratio and 95% confidence interval = 0.54 [0.33, 0.89]) adults were much less likely than non-Hispanic white Americans to disclose herbal and dietary supplement use. Having less than a high school education (adjusted odds ratio and 95% confidence interval = 0.61 [0.45, 0.82]) and not having insurance (adjusted odds ratio and 95% confidence interval = 0.77 [0.59, 1.00]) were associated with being less likely to disclose herbal and dietary supplement use. CONCLUSION: Herbal and dietary supplement disclosure rates are low, even among adults with chronic conditions. These findings raise concerns about the safety of herbal and dietary supplements in combination with allopathic care. Future studies should focus on educating physicians about crosscultural care as well as eliciting information about herbal and dietary supplement use.