Drug Topics - February 11, 2008 - (Page HSE4) 4 HSE DRUG TOPICS FEBRUARY 11, 2008 www.drugtopics.com Guest Spot Fekadu Fullas, R.Ph., Ph.D. Do dietary supplements have a place in health systems? o dietary supplements have a place in health systems? That has been the question when patients are admitted for acute care. There have been various published surveys conducted to answer this question. The answers, however, have varied from total prohibition of supplements being used in some hospitals to allowing them under certain conditions. So the approaches taken have varied from one hospital to another. Allowing these supplements has required at times only a written physician order, or in some cases as much as a patient’s consent. Some hospital policies are somewhat fuzzy in that they invoke what seems to be a long process of Institutional Review Board interventions for inpatient use of these products. In general, hospitals that have barred supplements have cited concern over patient risk and possible alternative medicine-conventional medication interactions. In almost all cases, dietary supplements are not part of hospital formularies. Instead, patients are requested to bring in their own supplies of supplements that they had been taking prior to admission. D Until now, alternative medicine has not been regulated with the same level of rigorous requirements as conventional medications. Confounding the problem of regulation in the past had been lack of standardization, purity problems, and controversial therapeutic attributes (implied or stated) claimed for dietary supplements. The FDA itself has been grappling with these problems for some time. GMP regulations Although they do not address efficacy and toxicity concerns, the recent release of Good Manufacturing Practices (GMP) regulations for dietary supplements is a welcome and long-overdue step. These regulations require that manufacturers of alternative substances provide evidence of the identity, quantity, and purity of their product’s ingredients. In a different vein, the United States Pharmacopeia has initiated a voluntary program, by which manufacturers can obtain a USP seal on their products after submitting their products and meeting the USP independent laboratory testing specifications for content and ingredient quantity. These two major developments in regards to dietary supplements represent a major step toward streamlining the regulation of what hitherto has been a chaotic industry. They raise to a certain degree the confidence level of consumers in the quality of supplements that they take. Similarly, health-system pharmacists will be in a better position to ascertain the ingredients of alternative substances, once the FDA regulations take full effect. At least for now, it appears that there is no clear-cut answer to the question: “Should patients be allowed to take dietary supplements while hospitalized?” The general answer may depend on the kind of dietary supplements at issue, the intended medical benefits, other concurrent conventional medications being taken, patient population types (pregnant, nursing, or geriatric patients), morbidities and co-morbidities, medical procedures involved, etc. In the meantime, oversight agencies, such as the Joint Commission, state boards of pharmacy, and ASHP , have given hospitals broad latitude to handle the problem. Indeed, clearly health systems should have practical policies in place to address the issue. is an inpatient hospital pharmacist at St. Luke’s Regional Medical Center in Sioux City, Iowa. He also holds a Ph.D. degree in pharmacognosy (natural products chemistry) from the University of Illinois at Chicago. THE AUTHOR What’s covered? The term “dietary supplements” has been used in the literature interchangeably with terms such as “alternative medicines [substances],” “complementary medicines,” and “nutraceuticals.” According to the Dietary Supplement Health and Education Act (DSHEA), dietary supplements are defined as products intended to supplement the diet, and include vitamins, minerals, herbs, amino acids, metabolites, etc. The Joint Commission gives some latitude to hospitals for managing “orders for herbal products” in a comprehensive way. Further, it classifies dietary supplements and herbal products under a broader category of nutraceuticals, which are used with the intention of deriving medical or health benefits. ASHP is of the opinion that all efforts should be made to closely monitor the use of alternative substances in the inpatient setting, including but not limited to, obtaining the patient’s consent with appropriate documentation should such use become necessary. It also advocates adoption of clear policies on the subject. In addition, ASHP is against the inclusion of supplements in hospital formularies, owing to lack of sufficient safety and efficacy data on a par with the evidence involved in Food & Drug Administration-approved conventional prescription and/or over-the-counter medications. http://www.drugtopics.com
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.