Natural Pharmacy

Introduction

In an ideal world, a natural pharmacy would not be necessary. Instead, we would rely on eating an optimal diet, consuming untainted water and air, exercising appropriately, and having unlimited time to address life challenges in creative ways. Since we do not live in an ideal world or have unlimited time, natural medicines provide an alternative that can augment the other interventions we offer. That is, supplements, botanicals, homeopathic remedies, and other products we offer do not take the place of appropriate diet, exercise, sleep, and lifestyle habits. But they can assist in more rapidly addressing a problem or provide a cost-effective way to engage in prevention practices.

Not all natural medicine clinics have a dispensary, in part because it is a substantial responsibility. There are four main reasons we decided to create one for our center. The first is for the convenience of our patients. The second is because it helps to underwrite various medical and wellness activities that we feel are important for the care of our patients, but for which we do not receive reimbursement. Thirdly, by limiting ourselves to a select number of high-quality supplements that we study intently (out of the thousands in the marketplace), we can provide more effective products to our patients. Finally, having a dispensary allows us a voice in the continuing campaign to improve the quality of natural products.

Challenges of Supplementation

There are a number of challenges anyone faces when they make the decision to use a supplement. We will touch on a few of them to illustrate the benefits of expert clinical guidance.

Bioavailability

A supplement may be perfectly constructed in the laboratory or manufacturing facility, but if your body cannot use it, the supplement is useless. Your body’s ability to absorb and utilize a nutrient can broadly be called bioavailability. While this sounds pretty simple, it is actually quite complex. For example, bioavailability is impacted by what are called host factors, such as your age, gender, any current pathology you may have, and your current physiologic state. One very important host factor is being pregnant, since many of your nutrient requirements and the way your body processes things change dramatically.

A very basic challenge for the bioavailability of any nutrient or medicine is getting past the digestive system. Often times the digestive system will break down a substance in a way that inactives it. This is why certain medicines, such as bio-identical hormones, are often given in topical form.

Bioavailability is also affected by the way the nutrient is delivered to the body, the chemical form of the nutrient, and whether it is taken with food, fluids, other supplements, or other medications. It is often said that vitamins and minerals should be taken with food, for example. While this is generally true, there can be problems for people who are deficient in certain specific nutrients. Phytic acid, which is found in unprocessed whole grains, can bind with iron, cooper, zinc, and calcium in a way that significantly reduces their bioavailability. Thiamine absorption is inhibited by alcohol. Oxalic acid in vegetables and tannins (found in certain botanicals, tea, and coffee) can inhibit the absorption of iron. On the other hand, taking iron with vitamin C can increase iron’s bioavailability.

Another obstacle to being able to effectively absorb the benefits of a supplement is current manufacturing methods. Many supplement products are produced by “jobbers” who manufacturer supplements in large batches. Often they will add compounds to the supplements, such as lubricants, in order to run their machines at very high speeds to maximize profit margins. These lubricants, such as stearic/palmitic acid, can interfere with absorption. To make the product easier to swallow, they may coat tablets with something called “pharmaceutical glaze,” which is basically shellac, the same product used to varnish furniture. Finally, these products are often compressed under hundreds of pounds of pressure in order to stuff everything into a tablet that the customer can take once a day. As you can imagine, this kind of product will be very difficult to absorb and may pass right through the body basically unchanged. Despite being basically useless, it does have one great attraction, however: it is cheap.

As with many industries, the dietary supplement industry is organized around cost and price. It is important to factor this information into your buying decisions, since with supplements you generally get what you pay for. The supplements we carry are professional-grade products from reputable companies, which could be considered the first or prime tier. The focus among these companies is on quality, purity, bioavailability, and effectiveness. On the second tier could be reputable health food store products and products at high-end specialty stores. At the bottom would be big box stores and large, national chains.

One expects that a Ferrari will perform at a higher level than a Yugo and this observation is also true with supplements. Poor raw materials, addition of unnecessary ingredients (i.e. lubricants, fillers, binders, flowing agents, etc.), and poor manufacturing practices can interfere with the quality and effectiveness of natural products. This is particularly problematic for older populations, since the functional capacity of our digestive system and thus our ability to absorb nutrients declines as our body’s age.

Working with a natural medicine expert can be helpful not only in terms of providing you with top quality supplements but in saving you money. For example, the most common form of calcium – calcium carbonate – may be sufficient for most people on an adequate diet without gastrointestinal issues. They may not need a more bioavailable, and more expensive, form of calcium. People with gastrointestinal challenges such as hypochlorhydria, however, may benefit from a more absorbable form of calcium, such as calcium citrate/malate.

Likewise, it is not uncommon for people to acquire a cabinet full of supplements over time because of something they read, suggestions made by family and friends, or perhaps something they saw on sale at a local grocery store. However, no real thought has been given as to whether these products work together, duplicate each other, or turn out to be really necessary. After a thorough assessment, a naturopathic physician can streamline and adjust your supplementation program in a way that is often more affordable, more effective, and more individualized to your needs.

Purity and Safety

Ensuring the purity of the any medicine – natural or pharmacological – is a constant challenge. To examine a single aspect of a complex situation, consider the issue of adulteration. There are several ways a drug or supplement can be adulterated including:

  • Adding synthetic ingredients to bolster inferior products.
  • Using a part of a plant other than the part with active ingredients. Technically, the label is accurate but clinically the product is useless.
  • Substitution of similar but cheaper natural substances. This again results in a clinically inferior product.
  • Substitution of exhausted materials or materials that have passed their expiration date.
  • Addition of large amounts of inert materials
  • Using a product that sounds like the actual clinically useful material. One example is to substitute American ginseng for the much more expensive Korean Red Ginseng, which can cost up to $3000 for one 14 root box.

In the United States, supplements are regulated by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). According to the FDA, CFSAN (one of six product-oriented centers) is, “responsible for promoting and protecting the public’s health by ensuring that the nation’s food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.” The Dietary Supplement Health and Education Act (DSHEA), which established a regulatory framework for supplement safety and labeling in 1994, also established the Office of Dietary Supplements (ODS) within the National Institutes of Health. Independent organizations, such as the National Center for Natural Products Research, which is a unit of the University of Mississippi School of Pharmacy, can also work with the FDA in terms of testing, analyzing, and authenticating dietary supplements.

On June 22, 2007, the FDA issued a final rule establishing regulations for what are called “current good manufacturing practices” (cGMP) for dietary supplements, which is available at http://www.cfsan.fda.gov/~dms/dscgmps6.html. These regulations are aimed at manufacturers and include requirements for establishing quality control procedures, designing and constructing of manufacturing plants, and testing both individual ingredients and the finished product. In their news release, the FDA noted that, “The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.”

For many people, a great deal of confusion exists about what all this regulatory machinery actually does. A 2002 Harris poll showed that 59% of respondents believed supplements had to be approved by a government agency before they could be marketed; 68% believed that supplements had to list potential side effects on their labels; and 55% believed that supplement labels could not make claims of safety without scientific evidence. None of this is true.

When you purchase a supplement, you expect that what you have purchased will do what you expect it to do. But will it? A product review by ConsumerLab.com of 25 probiotic products (i.e. “healthy” bacteria) found that eight of the products had less than 1% of the claimed number of live bacteria. Of these eight, six had less than one-ten thousandth of the amount claimed. Tod Cooperman, MD, ConsumerLab.com’s president and founder, notes, “About 25 percent of the supplements we test have some type of problem, and with herbal supplements it’s closer to 40 percent.”

Similarly, ConsumerLab’s review of multivitamins found that, “Fifty-two percent of multivitamins recently selected for testing by ConsumerLab.com were found to be contaminated with lead, unable to properly break apart, or to contain significantly more or less ingredient than claimed.” The twenty-one products tested included several mainstream multivitamins, including Centrum, Kirkland (Costco), Nature’s Plus, WEIL, and One-A-Day. The review can be found here: http://www.consumerlab.com/news/news_011907_multivitamin.asp

We use three primary methods to ensure the purity and safety of our products, which we discuss in the Quality Assurance section below.

Effectiveness

Once a product is affirmed to be safe, pure, and appropriately manufactured, there is still the issue of whether or not it will be effective. There are several parameters that impact how effective a supplement will be. These include:

  • When the supplement is taken (AM or PM? With meals or away from meals? etc.)
  • For herbs, what part of the plant is used (roots, stems, leaves, etc.)?
  • Age or physiologic parameters (pregnancy, childhood, etc.)
  • Interactions with other medications or other supplements
  • Storage issues (exposure to light, rancidity, exposure to moisture, etc.)
  • The length of time the supplement needs to be used to be effective
  • Contraindications (other medications, allergies, other medical conditions, etc.)
  • Toxicity or lifestyle concerns (beta-carotene use by smokers, etc.)

Manufacturers often make claims about the effectiveness of their products. For example, they will claim that a product is more effective simply because of the delivery form or complexing of the supplement, as in the case of “colloidal minerals,” “nanoencapsulation,” or “food-grown” supplements. Based on this claim of greater effectiveness, the supplier charges more money for the product. Evaluating these claims takes a fair amount of research and reasoning.

In the case of “food-grown,” “yeast-grown,” or “biointeracive”
supplements, it is claimed that the product is safe because it is like food, and like food it has compounds in them that binds to the other constituents in their products. These compounds allegedly increase the activity or enhance the absorption of the constituents in their product. In fact, because of the presence of these compounds, a person can take smaller amounts of their product because their product is therapeutically superior.

It is certainly reasonable that constituents like vitamins and minerals form complexes with other compounds in food and these complexes could also be found in “food-grown” supplements. However, at present there is little research to substantiate these associations, never mind explain any therapeutic effect they may have.

Likewise, while it seems reasonable that compounds found in food may increase activity or absorption of things like vitamins and minerals, vendors of “food-grown” supplements have yet to provide evidence of this. In fact, there is evidence to suggest that some nutrients, like vitamin B12, are best supplemented alone or away from food. In the same way, without head-to-head comparisons between “food-grown” and non-food-grown supplements, it is impossible to say which is superior.

Establishing effectiveness in natural products is a very challenging endeavor, particularly with herbs. Unlike a drug, botanical products can be made up of thousands of constituents that can be affected by the amount of sunlight, cultivation methods, quantity of rain, timing of harvest, storage methods, and so on. Since these constituents work together synergistically to produce a result, a single active ingredient that can be regulated and monitored does not exist for most herbs.

One way companies have tried to solve this problem is with “standardized extracts.” Briefly, a particular chemical constituent within the herb is chosen as a “marker” and then this constituent is standardized to a particular percent. For example, hypericin is the marker used to standardize St. John’s Wort.

As it turns out, there is no legal or regulatory definition for standardization of botanical agents in the United States. Therefore, what constitutes “standardization” can differ from manufacturer to manufacturer. The presence of the word “standardized” is not necessarily an indication of product quality, although standardization is important for research because it helps scientists set reproducible parameters and establish efficacy.

What is often not understood is that a constituent chosen as a marker – that is, the basis of standardization – may not be the herb’s active ingredient. In fact, it may have nothing at all to do with the herb’s therapeutic effect. For example, two products can both be standardized to 0.3% hypericin, but this does not mean that both products are equally effective.

How then can we provide effective supplementation? Experience, research, and education. Simply put, we constantly update our knowledge base through continuing education and reading the medical literature. While a single randomized, placebo-controlled clinical study may not tell us much, several such studies provide a basis of clinical guidance. In addition, our experience with hundreds of patients and our discussions with other clinicians also provide a basis of clinical guidance. Coupling these together provides a very substantial foundation for effective supplementation.

Because researching and studying natural products takes a substantial amount of time, we are only able to give a professional opinion on the supplements we actually dispense from our clinic. However, if you are using or choose to use other products, we are always interested in learning from your experiences and insights.

The “Magic Bullet”

When confronted with a significant medical problem that does not have an easy solution, it is human nature for people to search for a “quick fix” or what has been called a “magic bullet.” Given the hype and exaggerated promotion within the natural products industry, some individuals think that supplements alone could be the answer. This form of therapy, often called “green allopathy,” has little to do with authentic natural medicine. As founding member and president emeritus of Bastyr University, Joseph E. Pizzorno, Jr., ND, notes in speaking about naturopathic medicine: “The fundamental precepts of our medicine [are] the promotion of wellness through healthful living and supporting the body’s own natural healing processes.” Supplementation is a useful modality, but it is only a part of a larger system.

On the other hand, once a protocol that includes supplementation has been created, some patients wonder why something less intricate, like diet alone, cannot be the “magic bullet.” Often they will eschew well-indicated supplementation in favor of “just using diet approaches I have read about.” According to current research, however, many of the protective effects that come from nutrition require healthy diet choices early in life. Trying to make up for several decades of suboptimal health choices by diet changes alone later in life is often less than successful.

The bottom line is that there is rarely a “magic bullet” in medicine. If they did exist, approaches like natural medicine, which require time and commitment, would probably be much less popular.

Quality Assurance

Ensuring the purity, quality, reliability, and effectiveness of our supplements is an evolving effort. There are three primary components to our quality control effort. The first is a Quality Assurance audit. Once a supplement manufacturer is selected, we send them a product quality questionnaire. The questionnaire asks about various aspects of manufacturer operations such as current good manufacturing practices (cGMP), quality control, independent certification of products, and specifications of finished products. The information sent back is reviewed, discussed, and becomes the basis for an ongoing dialogue about quality assurance. To see a copy of our audit, please go here.

The second way we ensure the quality of our products is through the careful selection and long-standing relationships we have with our vendors. During the selection process, we educate ourselves about the company and their products. After we have established a business relationship, the continuation of the relationship is based on the company’s expertise, consistency of excellence, responsive to our questions, and handling of any problems that might arise. We have several companies we have been working with successfully for over a decade.

The final piece of our quality control program is the experiences our patients have with our products. While it is important that our supplements are of high-quality, manufacturer according to cGMPs, and safe, if they are not effective then there is no place for them in our dispensary. Our own observation of the products combined with feedback from our patients has proven to be a critical part of our quality control effort.

Compounding Pharmacies

A compounding pharmacy is a facility that specializes in making customized prescription medications. We do occasionally utilize the services of such a pharmacy for the benefit of our patients. To give one example, for the customization of bio-identical hormone products, we will often use Women’s International Pharmacy. If you have a compounding pharmacy that you have had a good experience with in the past, please feel free to let us know about it.

Dispensary Policies

General Information

All dispensary items are “cash and carry.” That is, payment is due at the time they are picked up from the clinic. If you do not have the funds available at the time, we will be happy to hold them for you.

It is best to call ahead before picking up dispensary items to ensure they are available. Because the particular item may need to be ordered, try to plan to order the needed item before you run out.

Nutritional supplements are not typically covered by insurance plans. However, supplements are not subject to sales tax if a doctor prescribes them. Health savings accounts can be used to pay for the supplements prescribed at our clinic.

Special order items need to be pre-paid at time of order or ordered through our online dispensary. 

Refunds

All sales on dispensary items are final except for the rare instances that they have expired within three weeks of purchase, they are the wrong supplement, or a refund is approved by Dr. Thomas.

Please be aware that we can no longer offer refunds on dispensary items that have been opened or that are special orders; the only exception is that a partial refund may be given if it is determined by our clinical staff that there is a medical reason you cannot take a particular supplement.

Refills

Prescriptions, refills for tinctures, or other dispensary items that require our attention during the business day typically require 24 to 48 hours to be filled. If you are refilling a tincture, we encourage you to bring your old bottle to refill. Not only will you avoid being charged the cost of a new bottle (first one is free), but you will also help us with our recycling efforts.

Mailing Supplements

We do have the ability to mail supplements to you. In addition to the retail price and shipping costs, there is a handling fee of $5.00 if the price is under $100 and $7.50 if the price is over $100. This covers staff processing time and our costs for possible lost shipments. Unfortunately, we cannot be responsible for your reception of these items. No refund can be made, or unpaid replacement sent, if the items fail to reach you. We do everything possible to avoid this, since this represents a loss for both of us.

Supplements that have been opened may be returned only if it is determined there is a medical reason you cannot take them. Unopened supplements may be returned for a refund within four (4) weeks of purchase.