Evidence Based Medicine

Topics: Dietary supplements, Dietary supplement, Food and Drug Administration Pages: 9 (2279 words) Published: June 27, 2009

Evidenced Based Medicine

The evidence, does not make a decision for you, but it can help support the patient care process. Constructing a well-built clinical question can lead directly to a well-built search
strategy. Every time we see a patient, we need new information about some element of the diagnosis, prognosis or management. Because our time to try to find this information is often
limited, we need to be very efficient in our searching. To
achieve this efficiency, we need to become skilled at
formulating clinical questions, so our research is accurate, efficient and appropriate.

Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. (David L. Sackett, 1996).

Evidenced based practice enables nurses to address healthcare questions with an evaluative and qualitative approach. It allows the nurse to assess current and pass research clinical
guidelines in order to identify relevant literature while
differentiating between high quality and low quality
information. Evidenced based practice integrates the best
evidence and clinical expertise.
What is a dietary supplement?
Congress defined the term "dietary supplement" in the
Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is 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. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every

supplement be labeled a dietary supplement, (Administration, 2001).
What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them? In October 1994, the Dietary Supplement Health and
Education Act(DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements. The FDA does not approve dietary supplements.

Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are
substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products. Also, manufacturers do not need to register

themselves nor their dietary supplement products with FDA before producing or selling them. Currently, there are no FDA
regulations that are specific to dietary supplements that
establish a minimum standard of practice for manufacturing
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