Vitamins and Dietary Supplements: Why Pharmacists' Recommendations Matter
Webb, Jennifer A, Drug Topics
As Americans increasingly turn to vitamins and herbal supplements to prevent, augment, or replace their prescription drug use, medical professionals and government leaders worry that few realize the implications of taking what they perceive as innocuous, over-the-counter dietary aids.
Unbeknownst to many consumers, vitamins and dietary supplements can have toxic and life -threatening side effects when used in megadoses or combined incorrectly with prescription drugs. They also can contain significant levels of heavy metals or be spiked with prescription drugs. And manufacturers may make illegal claims about their drugs' effectiveness in treating, curing, or preventing disease.
A report released in May by the Government Accountability Office (GAO) and covered by The New York Times found pesticide residues that appeared above the allowable limit in 16 of 40 supplements tested as part of a Congressional investigation. This is a matter for concern, in light of the fact that the number of Americans taking vitamins and herbal supplements seems to be growing. Approximately 50% of adults regularly take vitamin supplements, and approximately 25% take herbal supplements at least occasionally - a figure that has gone up 8% since a 2007 national survey - with annual sales reaching approximately $25 billion, the report said. The dietary supplement industry is expected to continue to grow, along with the aging of the population and an increasing popular interest in personal health and wellness, according to a 2009 GAO report.
Although dietary supplements can have widespread harmful effects, the U.S. government has almost no control over supplement manufacturers. That could change soon, as Congress prepares to embark on what is being called a 'landmark" food safety bill that is likely to require supplement manufacturers to register annually with FDA and allow the agency to recall supplements it deems dangerous.
The loophole gives pharmacists, as frontline healthcare professionals, a unique opportunity to counsel patients on the correct use of vitamins and herbal supplements.
"People pick up [a magazine] and read about Gingko biloba, so they go out and buy Gingko, but they don't realize these kinds of herbal medications can be contraindicated with their own [prescription] medications," said Christine R. Jacobson, RPh, of Wasatch Health Mart, Wasatch, Utah. "Because of the economy, they're not going to the doctor. They read it and say, 'I've got that, I'm going to try it' The public thinks it's smarter; they think they know their bodies more. They don't trust their doctors. But they trust their pharmacists."
Federal regulations governing dietary supplements don't go much beyond requiring manufacturers to follow "current good manufacturing practices" (CGMP) - guidelines ensuring that dietary supplements be processed consistently and meet quality standards. CGMP requirements, published in the Federal Register in 2007, took effect in 2008 for large manufacturers, while those with fewer than 20 employees were expected to begin compliance by last month (June 2010). Also in 2007, dietary supplement companies were required to submit to FDA any report received about a serious adverse event; reporting of moderate and mild adverse event reports was considered voluntary. According to the GAO, FDA has seen a threefold increase in comparison with the previous year's statistics on the number of all adverse event reports it has received since the reporting requirement went into effect in 2007.
While in explanations of its final rule FDA takes great care to say that it does not block consumer access to dietary supplements, it has the authority to enforce compliance with CGMP requirements and truth-in -advertising restrictions. FDA spokeswoman Siobhan Delancey said that the agency may conduct routine and for- cause inspections to ensure that manufacturers are complying with CGMP requirements. Once the rule was published in the Federal Register, manufacturers were expected to comply according to the size of their businesses, she said.
'The regulations apply to all finished-product dietary supplement manufacturers, both domestic and foreign," she said. "However, the regulation does not apply to manufacturers of the bulk raw ingrethents used in dietary supplements."
Legislators hoped the rule would prevent dietary supplements from including contaminants, wrong ingrethents, or ingrethents in amounts different from what is listed on the label, as well as prevent the use of improper packaging. However, several Congressmen say the rule doesn't go far enough, and they are working on bills that would give FDA more oversight.
A food safety bill being proposed in the Senate could require supplement manufacturers to register annually with FDA. It also would allow FDA to recall supplements it deems dangerous. Sens. John McCain (R- Ariz.) and Byron L. Dorgan (DN.D.) wanted to go even further with another bill and require companies to disclose a full list of ingrethents used although their proposal apparently will not be included in another bill that is receiving broader support.
"Had this provision been in place earlier, FDA might not have taken 10 years to ban ephedra, a dietary ingrethent that accounted for 64% of all adverse reactions in 2001, despite accounting for 1% of all total dietary supplement sales," McCain said when he introduced the bill on the Senate floor.
While the government wrestles with the question of how much oversight is necessary, some manufacturers of dietary supplements seek outside approval to gain legitimacy and separate themselves from the pads. For example, 10 companies have sought verification by U.S. Pharmacopeia (USP), a Maryland-based, nongovernmental company that sets standards for prescription and over-the-counter medications and other healthcare products manufactured or sold in the United States.
USP thoroughly reviews the manufacturing processes of companies seeking the right to use the USP verification mark on their products, ensuring that they meet standards for quality, purity, strength, and consistency, according to John Atwater, PhD, USP's director of verification programs.
When searching for products they can recommend to patients, pharmacists can visit the USP website, http://www.usp.org/USPVerified/dietarySupplements/ 'companies .html.
"There are a lot of supplements out there of poor quality that might contain ingrethents that might not be listed on the label," Dr. Atwater said. "We certainly feel that our program holds companies to the highest standards."
While vitamins and dietary supplements such as fish oil have been found to be very beneficial, even proponents have concerns about elevated levels of contaminants and environmental toxins such as mercury.
Fish oil is a major source of omega- 3 fatty acids, which have been associated with reducing the risk of heart attack and coronary heart disease, combating depression, reducing inflammation associated with arthritis, lowering cholesterol, and staving off age-related macular degeneration. 'It's essential for life," said Benson Toy, PharmD, CCN, owner of Marin Medical Pharmacy in San Rafael, Calif. "We don't eat enough of them in our diet, so we need to take a supplement."
But fish oil dietary supplements can contain dioxin, furan, pesticides, and mercury, as well as unsafe and illegal levels of PCBs, which have been banned in the United States since 1979 and are linked to cancer, reproductive problems, and impaired fetal brain development.
The challenge is to find a brand of fish oil supplement that is safe. Toy recommends asking manufacturers what their certificate of analysis said about their product's levels of PCB, heavy metals, and mercury. Tolerance levels allowed in the United States are much higher than those approved in Europe, Toy said.
Jacobson, who is Utah's only board- certified anti-aging and functional medicine pharmacist, said that pharmacists must find a brand they can rely on. She recommended that they call manufacturers to inquire about mercury levels. "Call and [ask] what is your potency and your position on being mercury-free," she said. "What I have found to be successful is nutriceuticals."
Toy recommends that his patients take one fish oil capsule twice a day, and patients with cardiovascular risks or arthritis might need even more. However, fish oil can have devastating effects on patients taking blood- thinning drugs, because fish oil is a natural blood thinner.
"Here we're saying it's good for Alzheimer's, dementia, [and] cardiovascular disease, but it can be contraindicated for people taking blood thinners," Jacobson said. 'That's huge. They can bleed out."
Patients must be counseled to stop taking fish oil supplements prior to surgery, she said.
Pharmacists should always consult the "supplement facts" on the side of the bottle, said Jacobson, to determine the type and amount of the active ingrethents in each supplement. For example, many physicians are not specific enough when they tell patients to take fish oil to lower their cholesterol, she said. The supplement facts will list the amount of active ingrethent and the number of doses needed to meet the recommended amount. 'That's where a lot of errors occur, because [patients are] taking the wrong dose," she said.
Pharmacists should familiarize themselves with the advantages of the various forms of each supplement.
See the side bar below for more information about four popular supplements.
The dietary supplement industry is expected to continue to grow, along with the aging of the population and an increasing popular interest in personal health and wellness.
A case of false claims and RC enforcement
With no FDA pre-market approval process required, almost anyone can go into business selling an herbal supplement, but they can't make outlandish claims about the supplement's ability to diagnose, mitigate, prevent, treat, or cure disease without some ramifications from the Federal Trade Commission's Bureau of Consumer Protection (FTC).
In 2008, the FTC charged Airborne with falsely advertising it could cure or prevent the common cold, and the company agreed to pay up to $30 million to settle the charts. The FTC lodgsd similar chargss against Wa I greens, Rite Aid, and CVS, which offered generic store-brand versions of Airborne for a slightly lower price. To settle the claims, Wa lgreens agreed to pay $6 million; CVS, $3 million; and Rite Aid, $500,000. The three companies did not return phone calls and e-mails seeking comment. 'They were making claims they didn't have any medical or reliable scientific basis to make," said Gregory Fortsch, senior attorney in the FTC's division of advertising practices.
While some wild claims have been associated with herbal medicines and unconventional medicinal treatments since the days of the traveling salesmen, the FTC said retailers have a responsibility to their customers. "If they put their name on something, it ought to work;' Fortsch said. "I think the messags has now been sent."
Understanding the influence pharmacists can have, CVS went so far as to tell pharmacists to try the Airborne-type supplement In one exhibit CVS told pharmacists that customers are more likely to try a CVS/ pharmacy-brand item when a friend or pharmacist recommends it According to one line of reasoning, pharmacists can feel as if they are helping customers g3t a great value and product and they can feel confident in recommending any CVS/pharmacy-brand product to the customers.
The FTC's fear, of course, is that in their quesito heal themselves, patents will rely on herbal remedies with unsupported claims to avoid investing time and money in professional medical advice.
It is a matter of concern that consumers may be forgoing proven treatments for - and spending their money on - products that do not work. There is a need for competent and reliable scientific evidence to back up what is being said about a product. So far, there is no competent and reliable scientific evidence available when it comes to finding a cure for the common cold.
Benefits of supplements
* Gingko biloba facilitates blood flow to improve memory and mental function and is used as a treatment for depression. The supplement can be derived from the leaves, stems, or flower of the plant, but the leaves, its most expensive form, will have the best absorption rate.
* Calcium is available in carbonate or citrate forms. Calcium carbonate is less expensive, but individuals with reduced levels of stomach acid can absorb calcium citrate more easily. The carbonate form is absorbed more easily when taken with food. Both forms are absorbed more effectively when no more than 500 mg are taken at a time, according to the National Institutes of Health Office of Dietary Supplements, which recommends that a 1,000-mg dose be divided into 500-mg doses taken twice a day. The most easily absorbed form, according to Christine R. Jacobson, RPh, is calcium hydroxya patite, but that form is contraindicated if patients have gallstones or kidney stones.
* Vitamin D is a fat-soluble vitamin found naturally in very few foods; however, many foods, such as milk, are fortified with it. It helps to strengthen bones, decrease risk of cardiovascular disease and breast cancer, and increase brain function. A daily dose of about 200 IUs to 400 IUs is recommended, but information is available indicating that people who consume a Western diet need more than 400 units daily.
* Selenium is a mineral found naturally in oysters and plant foods such as corn, wheat, and soybeans that works as an antioxidant to prevent cellular damage from free radicals. Selenoproteins help regulate thyroid function and can play a role in the immune system. Studies have linked a daily 200-gg dose of selenium with significant reduction in prostate, colorectal, and lung cancers as well as deaths from these conditions, according to the NIH. Too much selenium has been associated with hair loss.
Jennifer A. Webb is a healthcare writer in Medina, Ohio.…
Questia, a part of Gale, Cengage Learning. www.questia.com
Publication information: Article title: Vitamins and Dietary Supplements: Why Pharmacists' Recommendations Matter. Contributors: Webb, Jennifer A - Author. Magazine title: Drug Topics. Volume: 154. Issue: 7 Publication date: July 2010. Page number: 14+. © Advanstar Communications, Inc. Jan 2009. Provided by ProQuest LLC. All Rights Reserved.