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Thursday, September 8, 2016

NON-PRESCRIPTION DRUGS & SUPPLEMENTS


NON-PRESCRIPTION DRUGS & SUPPLEMENTS

Are They Being Inactivated by Sloppy Shipping and Storage?

by Hannah F. Elson, Ph.D.

I remember reaching for a bottle of vitamin capsules on the supermarket shelf, and noticing how warm the bottle felt. The spot light in the ceiling was shining right on that part of the shelf, warming all the illuminated bottles. The store manager was grateful to be informed about this. Several B vitamins (thiamine, pantothenic acid, folic acid) as well as vitamin C break down at high temperatures. Another time, I opened a bottle of capsules containing glucosamine and chondroitin sulfate, and noticed a very unpleasant odor. The capsules were hard to swallow because of this mildly putrid smell. The manufacturer’s customer service representative said this could happen if the bottle was inadvertently heated. Clearly the drug had degraded. He sent me some coupons for new bottles, but I was lost as a customer for that brand. This got me thinking, how often are the non-prescription over-the-counter drugs we buy subjected to unexpected heating during their storage in hot warehouses, on hot loading docks, or shipment in hot trucks?

It is so convenient to order on-line and have our parcels waiting at the door. Prescription drugs can be ordered this way, as well as non-prescription drugs and supplements. No chasing down our favorite product brands from store to store. But there is a down side. If the temperature outside is very hot and the shipment is not refrigerated, many drugs will degrade. It can get very hot inside a non-air-conditioned delivery truck, or sitting on a sunny loading dock, or outside our front door in the summer!

Many drugs are unstable at high temperatures. Heat may break down their chemical structures into inactive forms. Higher temperatures may also encourage reaction with oxygen or water in the air, and result in inactive products, if not actually dangerous ones. Examples of temperature-labile supplements include isoflavones, fats and oils, most vitamins, and some ingredients in herbs. Manufacturers of prescription drugs do temperature stability tests, and if they find the drug is unstable at high temperatures, they use cold chain shipping to keep the drug from degrading, since the FDA requires that the drug be fit for its purpose. There are no such requirements for all the vitamins and herbal supplements that people are taking. Some drugs’ labels advise storing in a cool place, but the distributors don’t ship on ice. The stores that sell these items don’t necessarily keep them refrigerated.

Anecdotally, I found that if I buy soy isoflavones in a store, sometimes they work and sometimes they don’t at reducing hot flashes. Certainly there are quality variations in manufacturing to explain this, and over the years, I have found a reliable brand. However, if I buy these soy isoflavones from a drugstore on the web in the summer time, they don’t ever work, no doubt due to the high heat during shipment. I phoned the site’s Customer Service and offered to pay for refrigerated shipping, but they don’t offer it. All they will do is refund or replace the item that doesn’t work. When shipping in the summer time, the inside of a delivery truck can get extremely hot. Cartons of these supplements can sit on a hot loading dock awaiting transport. Then they get to a store, and they are inactive in the summer, active in the winter. Customers trying out a product will find that it sometimes works, and sometimes doesn’t. Anyone who gets a product that has no activity will not buy it again, and is lost as a long-term customer.

The NIH has been testing the efficacy of nonprescription herbals and supplements. A clinical trial testing the drug may get some shipments that are active and some that are inactive due to heating during the shipment, and this can confound their results. It may explain why different trial results are so conflicting. It may explain why some drugs show so little activity above the placebo. The NIH is funding five research centers, receiving a combined total of $35 million, for a five year study to study to test natural supplements such as black cohosh (used to relieve menopause-related hot flashes), fenugreek (for diabetes and several other ailments), resveratrol (for cardiac health), and milk thistle (for Hepatitis C). Attention to cold chain shipping would make these studies more reliable.

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