Hazards of Hindsight - Monitoring the Safety of Nutritional Supplements
Americans spend more than $32 billion a year on dietary supplements, which do not require premarketing approval before they reach store shelves. Under current law, the FDA must identify and remove dangerous supplements only after they have caused harm. Epidemiologists at the Centers for Disease Control and Prevention (CDC) recently confirmed what an astute liver-transplant surgeon in Honolulu already suspected: OxyElite Pro, a popular over-the-counter supplement, was responsible for a cluster of cases of severe hepatitis and liver failure.(1) Although patients began to develop severe hepatitis in May 2013, the Food and Drug Administration (FDA), whose job it is to remove dangerous supplements from store shelves, did not learn of the cases until mid-September, 4 months later. By February 2014, the CDC had linked 97 cases, resulting in 47 hospitalizations, three liver transplantations, and one death, to OxyElite Pro. . . .
Available from: sciencedirect.com
[Show abstract] [Hide abstract]
ABSTRACT: Active pharmaceutical ingredients (APIs) from the purchase and use of medications are recognized as ubiquitous contaminants of the environment. Ecological impacts can range from subtle to overt - resulting from multi-generational chronic exposure to trace levels of multiple APIs (such as in the aquatic environment) or acute exposure to higher levels (such as with wildlife ingestion of improperly discarded waste). Reducing API entry to the environment has relied solely on conventional end-of-pipe pollution control measures such as wastewater treatment and take-back collections of leftover, unwanted drugs (to prevent disposal by flushing to sewers). An exclusive focus on these conventional approaches has ignored the root sources of the problem and may have served to retard progress in minimizing the environmental footprint of the healthcare industry. Potentially more effective and less-costly upstream pollution prevention approaches have long been considered imprudent, as they usually involve the modification of long-established norms in the practice of clinical prescribing. The first pollution prevention measure to be proposed as feasible (reducing the dose or usage of certain select medications) is followed here by an examination of another possible approach - one that would rely on the excretion profiles of APIs. These two approaches combined could be termed eco-directed sustainable prescribing (EDSP) and may hold the potential for achieving the largest reductions in API entry to the environment - largely by guiding prescribers' decisions regarding drug selection. EDSP could reduce API entry to the environment by minimizing the need for disposal (as a consequence of avoiding leftover, unwanted medications) and reducing the excretion of unmetabolized APIs (by preferentially prescribing APIs that are more extensively metabolized). The potential utility of the Biopharmaceutics Drug Disposition Classification System (BDDCS) is examined for the first time as a guide for API prescribing decisions by revealing relative API quantities entering sewage via excretion.
Science of The Total Environment 06/2014; 493C:392-404. DOI:10.1016/j.scitotenv.2014.06.013 · 4.10 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: Introduction: The use of natural health products by pediatric patients is common, yet health care providers often do not provide management guidance. The purpose of this project was to improve management of natural health products by pediatric nurse practitioners. Method: Pediatric nurse practitioners from large metropolitan city were recruited (n = 32). A paired pretest-posttest design was used. Study participants were engaged to improve knowledge of natural health products, and a management toolkit was created and tested. Results: Mean knowledge scores increased from 59.19 to 76.3 (p < .01). Management practices improved with regard to patient guidance (p < .01) and resource utilization (p < .01). Assessments of product use (p = .51) and drug/herb interactions (p = .35) were not significant. Discussion: This investigation is the first known study to improve knowledge and management of natural health products in pediatric clinical practice.
Journal of Pediatric Health Care 09/2014; 29(2). DOI:10.1016/j.pedhc.2014.08.012 · 1.44 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: A synthetic stimulant never before studied in humans, 1,3-dimethylbutylamine (DMBA), was suspected of being present in dietary supplements. DMBA is an analogue of the pharmaceutical stimulant, 1,3-dimethylamylamine (DMAA), which was recently banned by the US Food and Drug Administration. We obtained all dietary supplements sold by US distributors that listed an ingredient on the label, such as AMP Citrate, that might be a marketing name for DMBA. Supplements were analyzed for the presence and quantity of DMBA. Fourteen supplements met our inclusion criteria and were analyzed by two separate laboratories using ultra high performance liquid chromatography (UHPLC) - mass spectrometry and a reference standard. The identity of DMBA was confirmed in 12 supplements in the range of 13 to 120 mg DMBA per serving. Following recommendations on the supplement label for maximum daily intake, customers would consume from 26 to 320 mg of DMBA per day. Supplements containing DMBA were marketed to improve athletic performance, increase weight loss and enhance brain function. DMBA has never before been detected in supplements. The stimulant has never been studied in humans; its efficacy and safety are entirely unknown. Regulatory agencies should act expeditiously to warn consumers and remove DMBA from all dietary supplements. Copyright © 2014 John Wiley & Sons, Ltd.
Drug Testing and Analysis 10/2014; 7(1). DOI:10.1002/dta.1735 · 2.51 Impact Factor
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.