Problems When Patients Hide Supplements – Part 7

Part 7 of 7 parts.

The clinician should use the clinical encounter to inquire about supplement use and take the opportunity to discuss the benefits and risks of supplements, when/whether they should be taken, and how they compare with prescription and over-the-counter medications. On the basis of the medical history, the clinician should determine whether supplement use is an important issue for a certain patient's health. For example, appropriate supplement use should be discussed with patients for whom the following situations apply:

1. Consuming fewer than 1600 calories per day;
2. Vegans, vegetarians, and anyone eliminating an entire food group from their diet;
3. Pregnant and breast-feeding women;
4. Postmenopausal women and those with heavy menstruation;
5. Chronic diarrhea;
6. Food allergies and food intolerances; and
7. Surgical removal of portions of the digestive tract or bariatric bypass surgery.

Additionally, oncology patients should be warned about the possibility that antioxidative supplements, such as vitamins C and E, can interfere with anticancer medications.

One way to become aware of potential issues with supplement use is through health information technology. Not only can numerous educational programs on supplements be found online, but many search engines also can cross reference different types of medicines, and many of them can easily check for interactions between supplements and other medications. Most office electronic medical record (EMR) systems have software that flags interactions between active ingredients in drugs and supplements. However, given the variability of dietary supplements in the marketplace, EMRs are not foolproof.

For more information about dietary supplements, and herbal medications, look to this for vitamins and minerals under articles. Then look to this for Complementary and Alternative Medicine Guide. Both are good resources for reading about natural medicines that conflict with prescription drugs. Most of the time, these are found near the bottom of the article.

For the first one above I have selected the mineral magnesium and you will need to be down about two thirds of the article under drug interactions to see the problems that it can cause.

For the second one above I have selected the herb Cranberry and about two fifths of the way down at Possible Interactions you will discover problems with Warfarin, Aspirin, and other medications.

This is the reason for the seven parts of this blog series and why we need to be aware of them and not ignore them just because they are natural. Your doctor does need to be aware of these natural drugs.

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.

Problems When Patients Hide Supplements – Part 3

Part 3 of 7 parts.

When you read the label of dietary supplements, there is not much to tell you if the quality is good, if there is small amounts of prescription drugs included, or even if the ingredients are correct. The amount of quality control depends on the manufacturer, the supplier of the ingredients, and the workers on the production line.

It is important to know that in 2007, the Food and Drug Administration (FDA) issued the Good Manufacturing Practices (GMPs) for dietary supplements. The GMP is a set of requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality. All manufacturers are expected to guarantee the identity, purity, strength, and composition of their dietary supplements.

The goal of the GMP is to prevent the inclusion of the wrong ingredients, the addition of too much or too little of a dietary ingredient, the possibility of contamination (by pesticides, bacteria, heavy metals such as lead, etc.), and the improper packaging and labeling of a product.

The widely inclusive definition of dietary supplements makes assessment of user prevalence difficult. Whereas some authors limit their description of supplement use to multivitamins and minerals, others include herbals and botanicals as well. It is recommended that providers consider all dietary supplements, minerals, vitamins, and herbals that patients might be taking.

The most often quoted rates of supplement use in the United States are from the National Health and Nutrition Examination Survey (NHANES) data. Estimates of supplement use by adults range from 50%-80%. Supplement use is higher in white and Asian populations, in those with high household incomes, and in college-educated persons. Women and older individuals tend to use supplements more often. Other factors related to supplement use include lean or normal body mass index, moderate to vigorous recreational physical activity, no use of tobacco products, and moderate ingestion of distilled spirits and wine.

More than 40% of the population report taking multivitamins, the most common vitamin product used. More than 20% of the population also report use of vitamins C and E, and 10% report use of vitamin B. Vitamin D use has increased in recent years because evidence suggests that it may be essential to health beyond calcium homeostasis.

Calcium is the most commonly used mineral, with up to 50% of the population reporting use when antacid/calcium combinations are considered. The next most commonly used mineral is iron. Herbals used by more than 5% of the population include echinacea, garlic, ginkgo, ginseng, glucosamine, fish oil, flax seed oil, and St. John's wort. Use of all food supplements is increasing in most age groups in the United States.

Drug-Drug Interactions Put Elderly at Risk

Barry called me when he read thisarticle in MedPage Today. Why don't people understand the problems polypharmacy cause and especially when they don't talk to their doctors about all the dietary supplements and complementary and alternative medicines (CAM) they are taking? Barry said he talks about all medications he is taking and if the doctor ignores him, he asks the doctor why.

I commented that many people do not because in the past many doctors would tell their patients not to take non-prescription medications and were none too polite about telling them this. Other doctors would belittle them for taking CAM.

Barry agreed and said that these people are putting their lives in jeopardy. He said his friend that ignored the pharmacist and died a few days later was a huge wake-up call for him. I added that many people today are not concerned and feel that the doctors don't care or they would be asking the proper questions. Some people have been told by the homeopathic practitioners that the medications they order are natural and not to talk to medical doctors about them. This is because of medical doctors in the past talked against homeopathic medications and CAM.

I found this very much on point and a warning to our doctors!

Action Points

• One in six U.S. seniors might be potentially at risk for a major drug-drug interaction, and 25% of adults did not disclose herb or supplement use to primary care physicians.
• Note that one study found that one-third of the population used complementary and alternative medicine.

Based on the 20 most commonly used medications and the 20 most commonly used supplements, the researchers identified 93 potential drug-drug interactions. And among the 20 common medications, 15 interactions were classified as "potentially of major or life-threatening severity."

Much of the article was about the following and I find this interesting and conflicting at the same time as many doctors do ask for a complete list or bringing in all medications to their appointment. The most common reason for nondisclosure was lack of inquiry by physicians (57%), while 47% of patients said they didn't believe their physician needed to know about their use of CAM.

"Contrary to earlier findings, our results attribute most nondisclosure to physicians not asking about CAM use or to concerns about physician knowledge regarding CAM rather than to physician discouragement or negativity about the use of CAM," Jou and Johnson wrote.

Only 2% of patients said their physician had discouraged them from CAM use in the past, and 3% said they had received discouragement in the present.

"Physicians should consider more actively inquiring about patients' use of CAM, especially for modalities likely to be medically relevant," they wrote.

Many Recalled Dietary Supplements Remain Unchanged

From recent studies, it appears that many dietary supplement manufacturers that have recalls made because of contaminated products, thumb their nose at the FDA and continue to sell the product. How bad is it? A study published in the October 22/29 issue of JAMA found that about two-thirds of FDA recalled dietary supplements analyzed, still contained banned drugs 6 months after being recalled. It is sad that this study has to be behind a pay wall.

The U.S. Food and Drug Administration (FDA) initiates class I drug recalls when products have the possibility of causing serious adverse health consequences or death. The FDA has used class I drug recalls in an effort to remove dietary supplements adulterated with pharmaceutical ingredients from U.S. markets. Research has found that even after FDA recalls, dietary supplements remain available on store shelves. However, it has not been known if the supplements on sale after FDA recalls are free of the adulterants, according to background information in the article.

Pieter A. Cohen, M.D., of Harvard Medical School, Boston, and colleagues conducted a study to determine if banned drugs were still present in dietary supplements purchased at least six months after a recall. Twenty-seven of the 274 FDA recalled supplements (9.9 percent) met inclusion criteria for the study. These supplements were analyzed using the same methods at the FDA’s laboratories (e.g., gas chromatography/mass spectrometry). Supplements were purchased an average of 34.3 months (range 8-52 months) after the FDA recall. Seventy-four percent of supplements (20 of the 27) were produced by U.S. manufacturers.

The researchers found that one or more pharmaceutical adulterant was identified in 66.7 percent of recalled supplements still available for purchase (18 of the 27). Supplements remained adulterated in 85 percent (11 of 13) of those for sports enhancement, 67 percent (6 of 9) for weight loss, and 20 percent (1 of 5) for sexual enhancement. Of the subset of supplements produced by U.S. manufacturers, 65 percent (13 of the 20) remained adulterated with banned ingredients.

Sixty-three percent of analyzed supplements contained the same adulterant identified by the FDA. Six (22.2 percent) supplements contained 1 or more additional banned ingredients not identified by the FDA. Some supplements contained both the previously identified adulterant as well as additional pharmaceutical ingredients.

“To our knowledge, this is the first study to determine if adulterants remain in supplements sold after FDA recalls,” the authors write. “Action by the FDA has not been completely effective in eliminating all potentially dangerous adulterated supplements from the U.S. marketplace. More aggressive enforcement of the law, changes to the law to increase the FDA's enforcement powers, or both will be required if sales of these products are to be prevented in the future.”