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Central  South  Dakota  Medical News
The Clinical View
by P.E. Hoffsten, M.D.
3 APRIL 2003

MORE ON PATIENT SAFETY

     There was a time when hucksters sold snake oil at the back of a covered wagon making all kinds of claims about what the product was and what it would do.  Watching some of the television advertisements one sees today could lead a person to believe that we are not far past that with all the dietary supplements, liniments, and health enhancing devices offered for sale.

     But through the years, the healthcare industry has endeavored to standardize drug preparations. Today, all prescriptions medications must meet strict criteria regarding patient safety, the purity of the medication and appropriate demonstrated effectiveness.

     In a column published in October of 2002, I pointed out that manufacturers and sellers of dietary supplements were not required to certify the purity or composition of the product.  By the same token, if a product was used and an adverse reaction occurred, there was no requirement that it be reported to any given government agency.  When the National Institute of Health attempted to do a scientific study to determine the effectiveness of the drug, they were unable to find a product on the store shelves that was pure enough to use.  I ended that column emphasizing the adage “buyers beware”.  The nutritional supplement market really had no controls.

     Fortunately, due to the United States Pharmacopeia (USP), a program has been launched to safeguard consumers of dietary supplements.  This program is called the “dietary supplement verification program (DSVP)”.  It is a voluntary program whereby manufacturers can submit their products to USP for testing to ensure the following: 1.  That the product contains the ingredients stated on the label.  2.  That the concentration of the ingredients is correct.  3.  That the product will dissolve effectively to release the contents for absorption into the body.  4.  That the product has been screened for harmful contaminants.  5.  That the product has been manufactured using safe sanitary and well-controlled procedures.

     Once the product has been evaluated by the above five standards, it will receive a designation on the label stating “DSVP” which is the United States Pharmacopeia mark ensuring the above five standards.

     While the above DSVP mark ensures the purity and integrity of the product, the program makes no claim regarding the product safety or effectiveness.  To answer this problem, the Federal Drug Administration has started a new program called “The Consumer Health Information for Better Nutrition”.  By this program, dietary supplement manufacturers will not be allowed to make false or misleading calms about their dietary product.  Efforts are made by the FDA to help consumers obtain scientific information regarding the effectiveness and safety of dietary supplements.

     These two programs are examples of the continued efforts by the healthcare industry to ensure the safety and effectiveness of health related products.  Now, not only will prescription medications be required to adhere to accuracy of dose but also dietary supplements obtainable without a prescription are being made safer.

     There are going to be mistakes and misadventures in the arena of pharmaceutical drug use or dietary supplements.  There are too many products and too much diversity in the human population to ever completely stop drug side effects but the healthcare professionals at your local clinics strive in their every step to maintain patient safety and avoid adverse drug reactions.