Category Archives: News

Menopausal Hot Flashes & Soy-Based Dietary Supplements?

Studies examining the efficacy of soy-based dietary supplements for menopausal hot flashes and night sweats have shown mixed results (e.g., modest to no benefit). Here’s an interesting fact that might explain why! Some women convert the soy-based constituent, daidzein (an isoflavone), to equol (a metabolite with estrogen-like activity). Typically women of Asian or Hispanic background make the conversion and are more likely to experience positive results from a soy-based supplement for their flashes. However, many women do not make this conversion. For the latter group, it would not matter what soy-based dietary supplement they consumed as none would be expected to work.

If you are peri-menopausal and experiencing hot flashes, instead of taking a soy-based dietary supplement, consider adding a 1-2 servings each day of tofu, soy milk, edamame, or a soy-based protein powder for a few months to see if any of these foods/products make a difference.

If you have a history of hormone-dependent cancer (especially estrogen receptor-positive breast cancer) please refrain from consuming soy-based foods, products, or dietary supplements for any reason unless your physician has first given you permission to do so. If you are in the cancer risk category and are suffering from hot flashes that impair your lifestyle, please talk with your physician about the appropriateness of one of several other prescription options including venlafaxine, paroxetine, of clonidine. Hang in there and keep a positive attitude as best you can. This too shall pass – typically within 6 months to 2 years for most women!

Vitamins, Are They Safe?

A recent review of multiple studies indicates that mega-dosing of fat soluble vitamins (A, E, D) and some water soluble vitamins (C, folic acid) may not help prevent disease and can potentially cause harm. Please talk with your doctor or pharmacist about the right combination and dosage of multiple vitamins and other dietary supplements for your health needs. Everyone is unique and different!

– Hamishehkar, Ranjdoost, et al. Vitamins, Are They Safe? Adv Pharm Bull 2016:6(4):467-477.

Turmeric (Curcuma Longa) & Osteoarthritis Pain

This yellow spice/dietary supplement from the ginger family has become popular in recent months. Its active ingredient is curcumin, one of the spices found in curry powder frequently used in Indian cuisine, and in yellow mustard. Curcumin is a potent anti-inflammatory and antioxidant.

Research studies have been conducted with turmeric for osteoarthritis pain management. Turmeric side effects include heartburn, as it is truly ‘spicy.’ So, if you already experience GERD (acid reflux disease) you will not be a candidate for this product.

A typical turmeric extract dose is 1 gram/day or less. One gram is ~ equal to 3 – 15 teaspoonsful of the ground spice, so there is wide variability between products and food. Some of the turmeric dietary supplement manufacturers add black pepper to their formulations to increase turmeric’s absorption and inhibit turmeric’s metabolism. I’m not sure that has been scientifically proven to work.

If you suffer from osteoarthritis pain and have been taking NSAIDs for years (e.g., Naproxen, Motrin, Celebrex, Feldene, Diclofenac), you may wish to consider talking with your physician about the appropriateness of taking the supplement turmeric in place of them to avoid significant long-term NSAID side effects on the stomach, heart, kidneys, and liver.

Please do not start taking turmeric without the advice and consent of your physician. Schedule an appointment for a prescription medication/dietary supplement/integrative health consultation with Dr. Cathy Rosenbaum today!

Happy New Year….Be healthy….Be Wise….Stay Safe

The Long and Short About Drug Shortages

Managing prescription drug shortages has become quite complex and requires a multidisciplinary team of creative healthcare professionals to keep up with the changing supply chain. Shortages include, but are not limited to, generic sterile injectables, anti-cancer drugs, anesthetics, pain medications, and nutritionals, creating an estimated annual impact on U.S. hospitals of $216 million from purchase of therapeutic substitutions.

Pharmacists are frequently asked, “Why does this happen?” There are multiple contributing factors in the supply chain that affect drug shortages.

• Raw Material Shortages. Nearly 80% of pharmaceutical grade raw materials are sourced outside of the USA. Drug availability is impacted when political instability interrupts U.S. trade in foreign countries, animal diseases contaminate tissue from which raw materials are harvested, or environmental issues affect plant growth from which raw materials are sourced. Remember the heparin recall a few years ago due to adulteration with oversulfated chondroitin in China?

• Quality Issues. Nearly 42% of sterile injectable drug shortages in 2010 were caused by product quality issues (e.g., particulates, microbial contamination, stability changes). Recently, Bedford Labs recalled injectable medroxyprogestrone due to silicone particles found in the product. A few years ago, Benvenue announced it was closing a plant that produced injectable methotrexate and Doxil, two chemotherapeutic agents, due to quality control issues. Only three other companies in the USA manufacture either methotrexate or Doxil, causing a supply issue for children with leukemia, as well as women with ovarian cancer, respectively.

• Manufacturing Difficulties or Production Decisions. Business decisions regarding branded drugs are made every day based on availability of generic drugs, the product’s market size, patent expirations, drug approval status, and anticipated clinical demand for the product. Manufacturers are not required to report product discontinuations to the FDA unless they are the sole source of a life supporting medication or a medication used to prevent a debilitating disease. Mature brand enthusiasm decays over time and there is a diminishing financial return to the manufacturer followed by a decision to sunset the brand. J&J stopped manufacturing branded IV Levaquin when it went generic.

• Change in Product Formulation. In 2006 there was a transition from albuterol and other metered dose inhalers with chlorofluorocarbons to metered dose inhalers containing hydrofluoroalkanes. Line extensions and formulation changes can evolve for marketing reasons or safety reasons or both.

• Regulatory Issues. FDA enforces standards like current Good Manufacturing Practice (cGMP). Yet, the FDA will help manufacturers out of cGMP compliance return to compliance when a significant corrective action involves a medically necessary product. FDA does not have the authority to require a manufacturer to produce any drug, even if the drug is a medical necessity. Bedford Labs’ oncology line was shut down by the FDA within the past year (i.e., carboplatin, cisplatin, leukovorin, Taxol). Bedford was told by the Feds that Bedford can not ship out any oncology product on hold in their warehouse until further FDA notice.

• Industry Consolidation and Company Mergers. Mergers frequently involve closing a manufacturing facility and result in a narrowed drug product portfolio for the post merger corporation. Baxter recently sold their entire generic injectable line to Westward resulting in a shortage of lidocaine, fentanyl, ketorolac, and midazolam. There are fewer generic drug manufacturers today than in the past even though there is a long line of applicants for new generic drug manufacturing processes at the FDA.

• Restricted Drug Distribution and Allocation. A drug manufacturer can place restrictions on limited drug supplies by requiring its drug is sourced through a specialty distributor. Clozapine and Tikosyn can only be supplied to a pharmacy registered in the manufacturers’ programs. Other prescription drugs are only supplied specific to each patient at the time the physician prescribes them.

• Just in Time Inventory (JIT). JIT is a strategy to minimize costs at various points along the supply chain. Some drug shortages may be wholesaler dependent, as drug shortages can occur when contracts with suppliers are delayed. Drug wholesalers oftentimes charge the drug manufacturers for stocking their drugs, and the drug manufacturers restrict the wholesalers from overstocking.

Wholesaler purchase differs from direct manufacturer purchase, or purchasing from med/surg suppliers.

• Changes in Product Demand and Shifts in Clinical Practice. When a new indication for a marketed drug is FDA approved, when new hospital programs start, or when a drug representative promotes new products and unanticipated demand increases for those products, it may be more difficult for the hospital or physician office based practice to keep up with supply. Direct-to-consumer advertising on television and in print ads also contributes to fluctuating product demand.

• Gray Market. The number of licensed non-traditional distributors who buy direct from the drug manufacturers to stockpile scarce drugs and resell at much higher prices are increasing as drug shortages go on. Purchasing from the gray market does not ensure drug pedigree, especially if sourced outside of the USA. Drug pedigree is a law in Florida and other states where most of the gray market wholesalers are located, but not law in Ohio. Gray market Epogen was available several years ago.

• Natural Disasters. About seven months ago a fire at a Hospira manufacturing plant in New York reduced inventory for emergency syringes (e.g., dextrose, sodium bicarbonate, epinephrine). This forced the manufacturer to decrease production of another medication in another facility to continue making the drug for a life threatening indication.

Managing Drug Shortages.

Government Interventions.
Participants of the Drug Shortage Summit on November 5, 2010, including the American Society of Health Systems Pharmacists, the Institute for Safe Medication Practices, the American Society of Anesthesiologists, and the American Society of Clinical Oncology, agreed that:

Congress should
• expand FDA authority to require manufacturers to notify FDA of supply interruptions/product discontinuations;
• allow FDA to require manufacturers to develop continuity of supply plans;
• require development of expedited approval pathways for pre-1938 drugs.

FDA should
• encourage confidential notification to FDA when there is a single source active pharmaceutical ingredient.
• explore incentives that encourage manufacturers to enter the market or stay in the market to minimize potential for shortages.
• collaborate with the DEA to alter quotas for controlled substances in short supply.

Senator Amy Klobuchar’s Bill 296 (H.R. 2245) requires drug manufacturers to notify the FDA at least six months in advance when experiencing a planned interruption in the production of a drug potentially resulting in a shortage situation or as soon as possible if an unexpected interruption or adjustment in supply transpires. The bill supports development of contingency plans for drugs vulnerable to shortage.

On October 31, 2011, President Obama issued an executive order directing the FDA to expand its reporting of prescription drugs and speed up regulatory reviews to respond to shortages.

Healthcare professionals around the country are actively working together in multidisciplinary teams to come up with alternate therapeutic options for these drug shortages which are not going away any time soon.

For more information, please visit the ASHP drug shortages web resource center @ www.ashp.org/drugshortages.

Sweet Dreams, Melatonin

Having trouble falling asleep? Most prescription and OTC sleep medications are considered high risk for seniors as they can cause falls or impaired driving skills. Melatonin is a naturally produced chemical in the brain that helps regulate the sleep cycle. Our body produces around 0.1 mg melatonin per night, a very small amount indeed.

Melatonin as a dietary supplement might be an option to consider with the advice of your physician if other lifestyle changes don’t do the trick (e.g., cool bedroom, decluttering your mind, use of relaxing herbal teas like lavender, chamomile, or decaffeinated green tea before bedtime).

Melatonin may reduce the time it takes to fall asleep by only 10 minutes. Starting doses are 1 mg – 3 mg between 30 minutes to 60 minutes before bedtime, maximum 5 mg nightly only as needed. Melatonin does not work for everyone and if it does not, it’s best to stop taking it within a few weeks of trying. Finally, please don’t combine melatonin with other prescription or OTC sleep medications or you may experience drowsiness.

Stay safe and sweet dreams!

List of Excellent CAM Websites

Ask Dr. Weil (http://cgi.pathfinder.com/drweil/)
Alternative Health News Online (http://www.altmedicine.com/)
Colorado Health Site (http://www.coloradohealthnet.org/)
Dogwood Institute (http://www.people.virginia.edu/~pjb3s/Complementary_Practices.html)
NIH NCCAM (http://nccam.nih.gov/nccam/)
NOAH (http://ww.noah.cuny.edu/alternative/alternative.html)
UPitt (http://www.pitt/edu/~cbw/altm.html)

Polypharmacy Is Not Jolly!

Polypharmacy Is Not Jolly! By Cathy Rosenbaum PharmD MBA RPh CHC

Hallelujah. The healing paradigm is finally shifting in the U.S. The time is ripe for doctors to rethink how they prescribe medications. Less is more. As a fellow health care professional, I believe medical students should be taught to utilize drugs sparingly, as only one of many, customizable tools in their future healing quivers.

Envision a country where you as the patient could be asked by your doctor to select from a menu of non-invasive, evidence-based holistic healing regimens when needed. That’s right, you would choose! Aromatherapy, guided imagery, spiritual retreats, Yoga, Tai Chi, personality testing, and acupuncture would be covered by insurance or included as part of your total office visit fee. Doctors would collaborate with evidence-based non-traditional medicine practitioners for your good.

Seniors over age 65 years represent 12% of the U.S. population and consume 32% of prescription medications. Many take five or more prescription medications, intentionally combining them with other over-the-counter medications and multi-ingredient dietary supplements. Boomers, we need to collectively push back against that machine.

Everything changes. Our body’s physiologic clock resets as we mature in the life journey. We become more sensitive to the effects of medications. Talk with your doctor about this list of possible options the next time you go to the office.

• Sleep Restoration – drink a cup of chamomile tea, lavender tea, or decaffeinated green tea before bedtime; try a few minutes of slow, deep breathing as you retire to inhale life-giving oxygen and calm you down from the day’s challenges
• Stress/Anxiety – repeat affirming statements about your life blessings (we all have them); read up on the benefits of acupressure
• Weight Loss – eat apples and drink water for snacks; walk around the dining room table and up/down home stairs for ½ hour a day (yes, and let your neighbors see you through the window)
• Arthritis Pain/Inflammation – talk with your doctor about the appropriateness of glucosamine HCL or turmeric dietary supplements instead of a years worth of NSAIDs like Naprosyn and Motrin that can damage the kidney, heart, and stomach
• Viral Colds – eat chicken noodle soap; try zinc lozenges, as directed on the package label, at the first sign of symptoms
• General Health – exude a positive attitude; teach your family to grow, cook, and eat from the Mediterranean diet (e.g., olive oil, colorful fruits and vegetables, moderate wine consumption, nuts); prefer whole (not processed) foods for your nutrition regimen, locally grown in your own organic garden or community supported agriculture farm

New Year’s Resolutions

Consumers:

• Let your feet do the shopping. Choose a primary care physician that thinks out of the box and is open to integrative health principles & practices (see the Academy for Integrative Health and Medicine @ www.aihm.org )
• Don’t expect to get a prescription medication every time you leave the doctor’s office
• Incorporate medicinal herbal spices and teas into your nutritional regimen for health and taste
• Take charge of holistic you in your body mind and spirit
• Get educated on the exciting integrative health and healing paradigm (visit www.NIHseniorhealth.gov, www.babyboomers.com, www.lifereimagined.com)

Physicians:

• Be aware of all medications and dietary supplements your patients are taking; supplements act like drugs and have interactions and side effects that you must acknowledge and manage
• Treat your patient as an equal partner in the decision-making process and consider his/her point of view before prescribing any medication
• Try prescription drug reduction strategies (one medication as opposed to several, lowest dose possible)
• Try drug holidays (e.g., FLEX study with Fosamax for osteoporosis)
• Try evidence-based, alternate drug regimens (e.g., every other day Zocor for high cholesterol)
• Promote healthy nutrition to your patients at every office visit; discuss connection to eating whole foods and a healthy immune system

Pharmacists:

• Explain to your patients the importance of shopping at one pharmacy for all prescription medications
• Get educated on nutrition and dietary supplements,
• Recommend medicinal herbal teas instead of OTC medications whenever appropriate
• Talk consumers out of taking antibiotics for viral infections

Summary
Integrative health and medicine is here to stay. Take a lifelong learning class in your local community. Teach your grandchildren about it as your contribution to the family legacy. Be a part of the health evolution revolution. Happy New Year!

Dr. Rosenbaum has authored and just published, Don’t Sweep It Under the Drug! Integrating Evidence-Based Body Mind & Spiritual Practices into Your Health & Wellness Tool Kit, available on www.Amazon.com. Her book is the Xulon Press Fall 2015 Second Place Winner of the Christian Authors Award, Category: Health.

The Sunshine Vitamin for Bone Health

By Cathy Rosenbaum PharmD MBA RPh
www.rxintegrativesolutions.com
July 12, 2014

Vitamin D’s Purpose

Vitamin D is found naturally in our body. It maintains normal blood concentrations of calcium and phosphorus, and helps our bones stay strong. Interestingly, the body manufactures vitamin D from cholesterol, through a process triggered in the skin by UVB rays from sunlight. Vitamin D is called ‘the sunshine vitamin.’ 

Per the Institute of Medicine, “despite the many claims of benefit surrounding vitamin D, the evidence does not support a basis for a causal relationship between vitamin D and many of the health outcomes purported to be affected by vitamin D intake.” Some of these claims yet to be proven in well designed human clinical studies include antioxidant, anti-inflammatory, and anti-cancer indications.

Reasons for Low 25-(OH)-Vitamin D Blood Levels

We require a certain level of 25-(OH)-vitamin D in the blood for health. That level can be measured by a simple blood test you can request from your doctor. If you have not yet had your blood tested or it has been awhile since your last blood level drawn, you may wish to ask your doctor to order a 25-(OH)-vitamin D level. The test will determine if you might benefit from supplementation or nutritional changes in your diet to increase vitamin D if your blood level is low (visit http://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional for more information).

Since we’re talking about bone health, it is important to monitor for osteopenia or osteoporosis by way of a DEXA scan. Talk with your doctor about ordering a DEXA scan to measure bone density if you have not had one for several years (visit the National Bone Health Alliance @ www.nbha.org for more information).

25-(OH)-vitamin D blood levels may be low due to reduced exposure to sunlight (e.g., less than 20 minutes of exposure a few times a week), reduced gastrointestinal absorption or nutritional intake, Crohn’s Disease, reduced kidney conversion to the active vitamin form, or from medication interactions such as statins for cholesterol lowering (visit http://www.livestrong.com/article/282052-vitamin-d-deficiency-caused-by-prescription-medication ).

Don’t just start taking vitamin D because you think you need it. You might already be getting enough from sunlight exposure as well as your diet. The Institute of Medicine recommends 600 IU – 800 IU vitamin D3 daily from food or supplements unless otherwise directed by your doctor.

Sources of Vitamin D

Vitamin D can be found in sardines, wild salmon, herring, mushrooms exposed to UV light, fortified milk, yogurt, and breakfast cereals, egg yolks, beef liver, canned tuna, cod liver oil, and cheese.

Vitamin D2, or ergocalciferol, is the form found in prescription strength capsules.
Vitamin D3, or cholecalciferol, is the form found in most over-the-counter vitamin D products.

Vitamin D3 is also available in a variety of dietary supplements. Since there are so many different supplement doses on the market, you may wonder why some people are taking larger doses. Talk to your doctor about your individual needs. Mega doses of vitamin D can cause hypervitaminosis long term if blood levels are found to be excessive.

Side Effects

Fat soluble vitamins like vitamin D can accumulate in the body over time. Symptoms of vitamin D toxicity include headache, diarrhea, nausea, increased blood pressure, anorexia, weight loss, increased thirst, weakness, nervousness, and with long term extreme doses, abnormal heart rhythms. Many of these might not be attributed to vitamin overuse, but confused with other medical conditions. For more information on long term vitamin D safety, visit www.healthlettermayoclinic.com (Sept 2009).

Importance of Exercise for Bone Health

Finally, because bone density decreases after the age of 30 years, bone stressing exercise is important at any age and helps to preserve bone strength. The areas of risk for bone density loss include the wrists, hips, and spine. Talk with your doctor about an exercise program that is right for your individual needs.

“The light of the eyes rejoices the heart, and good news refreshes the bones.” Proverbs 15:30

The Alpha and Omega of Omega 3 Fatty Acids

Growth in the dietary supplement category over the past few years has skyrocketed with over 60,000 products available to consumers worldwide. A dietary supplement is a product that contains an ingredient intended to add further nutritional value to (i.e., to supplement) the diet, and may be one or more of the following:
• a vitamin
• a mineral
• an herb or other botanical
• an amino acid
• a concentrate, tincture, or extract

In the U.S.A., the major regulatory driver within this product category has been the Dietary Supplement Health Education Act (DSHEA) of 1994. Under this Act, supplements are presumed to be safe and do not need FDA approval before they are marketed. Supplements are regulated by the FDA as food under the Center for Safe Food and Nutrition (CSFAN), and bear a nutrition label. However, supplements are used by many like medications to treat medical conditions, and as such may have side effects and interactions that need to be managed. With regard to prevention, supplements are not a replacement for good nutrition or a healthy lifestyle including restorative sleep, exercise, emotional, social, and spiritual wisdom (Proverbs 3:1-8).

According to a survey by Bailey, et al. (JAMA Intern Med 2013;173:355), polls showed people used supplements to improve their health, to improve bone density, to lower total cholesterol levels, boost immunity, or manage joint pain from osteoarthritis. Respondents reported they took multiple vitamins, calcium, and fish oil most often, without the recommendation of a health care professional. That practice may be unsafe!

Anti-Inflammatory Fish Oil Supplements
The USDA’s 2013 Dietary Guidelines for Americans recommend that adults keep daily fat intake to a maximum of 20%-35% of total calories. Most of this fat should come from mono- and polyunsaturated fats (i.e., fish, nuts, vegetable oils).

Omega 6 and omega 3 are two essential (polyunsaturated) fatty acids (EFAs) that we must obtain from our diet. At this time, clinical studies supporting any omega 3 health benefits are inconclusive, with the exception of prescription strength Lovaza (omega 3) which is FDA approved for lowering very high triglyceride levels.

The typical American diet is rich in omega 6 essential fatty acids and lacking in omega 3 essential fatty acids. However, many foods contain both. There are three main omega 3 constituents in nature, namely eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha linolenic acid (ALA). ALA is a precursor to EPA and DHA. Our body does not metabolize ALA into EPA and DHA very well.

Foods rich in omega 6 essential fatty acids in order of decreasing content include sunflower oil, corn oil, wheat germ oil, safflower margarine, sesame oil, walnuts, avocado oil, almond oil, peanuts, peanut butter, and palm oil.

Foods rich in various types of omega 3 essential fatty acids in order of decreasing content include salmon oil, sardine oil, cod liver oil, canola oil, herring, shrimp, krill oil, flaxseed oil, and walnuts (ALA).

When purchasing fish oil-based products, make sure you check with the manufacturer to ensure they have been tested for mercury, polychlorinated biphenyls (PCBs), and other unwanted contaminants. This kind of information rarely appears on the label.

Check to see how much EPA and DHA are in that 1,000 mg dose of fish oil to assess product value before purchase. You should look for EPA and DHA as your active ingredients! If the amount of EPA plus DHA combined is 30% or less of the total dose (i.e. 300 mg in a 1,000 mg capsule) you are not getting the quality you desire for your money. Most of the rest of that dose is typically composed of omega 6 fatty acids or omega 3’s we cannot metabolize (i.e. ALA).

There are no established dietary reference intake (DRI) standards for DHA or EPA daily consumption. The Institute of Medicine suggests an intake of 160 milligrams of DHA and EPA combined each day. The American Heart Association recommends eating fatty fish at least two times each week, which is equal to about 1,250 mg DHA and EPA each day.

The European Food Safety Agency recommends 250 mg/day EPA and DHA combined for adults or 1-2 servings/week of oily fish. The World Health Organization recommends 1-2 servings of oily fish/week providing 200 mg – 500 mg/serving of EPA and DHA for the general population to prevent ischemic stroke and coronary heart disease.

Pregnant women require 200 mg of DHA daily to support fetal development. The Environmental Protection Agency advises women of childbearing age, nursing moms, and young children to consume only 2 servings per week of sardines or salmon and avoid tuna due to the methyl mercury content.

There are three grades of fish oil on the market, namely cod liver oil, health food grade fish oil, and pharmaceutical grade fish oil. Look for pharmaceutical grade omega 3 fatty acids as the highest quality of these three.

In general, please know that the dose of omega 3 that’s right for you may not be appropriate for others and could differ for diabetics and people with heart disease due to potential side effects. Talk with your physician and pharmacist about what’s best for your health needs before you purchase any dietary supplements.

By Cathy Rosenbaum PharmD MBA RPh, Rx Integrative Solutions