September 14, 2016
Problems When Patients Hide Supplements – Part 6
Part 6 of 7 parts.
Doctors and patients can report adverse events, product use errors, and product quality problems associated with dietary supplements through an FDA voluntary online reporting system known as MedWatch. MedWatch is the FDA Safety Information and Adverse Event Reporting Program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
If a doctor has a patient that suffered a serious harmful effect or illness after taking a dietary supplement, a healthcare provider can report this by calling FDA's MedWatch hotline at 1-800-FDA-1088 or online at the Medwatch Website. The identity of the patient is kept confidential.
Consumers also can report an adverse event or illness they believe to be related to the use of a dietary supplement. Health professionals and consumers also can check for dietary supplement alerts and safety information at http://www.fda.gov/Food/DietarySupplements/Alerts/default.htm or by contacting the FDA Center for Food Safety and Applied Nutrition Outreach and Information Center at 1-888-SAFEFOOD. Clinician resources can be found online or in software packages for computers and mobile devices, usually as part of an electronic health records package.
With an estimated 50% of the US population using dietary supplements, it is imperative that the clinician always ask about dietary supplements during the clinical encounter. This is particularly important during early encounters when the patient care dyad is being established. The clinician should clearly ask about vitamins, minerals, and botanicals and encourage patients to bring their dietary supplements to clinic visits. The US Preventive Services Task Force recommends including questions about supplement use in the patient education and counseling for prevention section of the clinical encounter.
Clinicians who have regular interaction with patients need to be up to date on current dietary supplement usage patterns in the clinician's patient pool and in the United States in general. NHANES collects the most comprehensive data on supplement use, and studies using NHANES data are likely to provide the most accurate, representative information. A search on PubMed or Google will produce several articles and journals on dietary supplement use patterns among various populations and subgroups in the United States and elsewhere.
The FDA regulates dietary supplements far less stringently than it regulates pharmaceutical drugs. Because of this disparity in regulation, patients could be taking supplements that have unreliable amounts of the active ingredient or those that are adulterated with impurities. Certain geographic areas of the world may be associated with specific patterns of contamination. It is essential, therefore, to understand not only the epidemiology of supplement use patterns but also the sources of the supplements used by the population in order to identify possible side effects or contaminants.