Pharmaceutical regulation adverse drug reports

The health care professional, pharmaceutical manufacturer and regulator all share a common interest in the development and use of drugs that are effective and have an acceptable level of undesirable effects. Medwatch and similar programs are important tools for detection of adverse events effects. However, they are limited by the reUance on voluntary reporting as an individual health care professional is not required by law to report adverse drug reactions to the FDA [4]. 

As nutraceuticals are not classified as medicinal products, their manufacture is often not legally regulated. Nutraceuticals are widely available for sale, and the many suppliers may formulate their products differently this leads to variations between products of different manufacturers. Products available for purchase are not necessarily of the same quality as those used in reported clinical trials. For effective and safe use, the products must contain the same active ingredient, at the same concentration, have known bioavailability per delivery system, and state detailed and correct information on packaging or patient leaflet. However, possibly due to purchase from non-pharmaceutical sources such as the Internet, there is often little information on efficacy, drug interactions, effect of long-term use, abrupt discontinuation, or potential adverse effects available to patients. 

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