Category Archives: News

Facebook.com/RxIntegrativeSolutions -> Upcoming Events

For a complete list of Dr. Rosenbaum’s upcoming events related to natural healing, integrative health practices, dietary supplement usage, medicinal herbal teas, and much more, please visit Facebook.com/RxIntegrativeSolutions and click ‘like’. Visit www.rxintegrativesolutions.com for information on personalized wellness consultations.

Grapefruit Interactions with Medication

Certain prescription and/or OTC medications and dietary supplements may negatively interact with grapefruit juice, grapefruit, Seville oranges, pomelos, and tangelos due to chemicals in the fruits.

Fruit chemicals are thought to block enzymes in the body that metabolize medication in the small intestine, thereby causing the medication to hang around longer than expected. Interestingly, these fruits may also interfere with transporters in the body, causing medication to be less well absorbed into the bloodstream, and may reduce medication or supplement effects. Sound confusing? It’s complicated.

Product classes involved in unwanted interactions include, but are not limited to:

-Antihistamines (e.g., Allegra)
-Antianxiety
-Antihypertensives
-Cholesterol-lowering ‘statins’
-Corticosteroids for Crohn’s disease and ulcerative colitis
Dietary supplements

Only some of the medications and supplements in each of the categories can be affected by the fruit/juices. Every person may react differently based on the amount of fruit they consume, the medication or supplement type/dose taken, and the individual’s natural ‘enzyme levels.’

Don’t worry, but do get educated about how and when to properly take your medications and supplements to be safe. Enjoy healthy nutrition. Talk with your pharmacist about what’s best for you!

Beyond Use Dates on Prescription/OTC Medications & Dietary Supplements

Expiration dates on OTC & prescription medications and dietary supplements typically fall between 12 – 60 months after product production. Pharmaceutical manufacturers are required by law to establish these dates but do not have to study product stability and potency beyond those dates.

A recent study published in JAMA Internal Medicine using eight medications containing 15 active ingredients demonstrated product potency for decades beyond the original expiration dates. Another study in the military concluded the same results for 100 medications after 15 years.

The U. S. government has a Shelf Life Extension Program to extend dates on federal stockpiles for the military. But this is the exception to the rule in a special population to save the government money in repurchasing.

The bottom line for consumers is this – > follow the product manufacturer’s established expiration date stamped on the OTC bottle or prescription vial. Follow these same guidelines for your dietary supplements as well.

Keep all of these products in a cool, dry, dark place in your home.

Frogsicles – Dr. Cathy’s Children’s Book Now Available

On June 29, 2017, Frogsicles about the Parks’ family adventure to Alaska finally arrived!

Please cut and paste the link below into your internet browser for more details and share with others.

https://www.amazon.com/s/ref=nb_sb_noss_1?url=search-alias%3Daps&field-keywords=frogsicles

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. Explore other natural healing practices to help with this challenging time of life. 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)