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Tuesday, June 22, 2010

Ire and Fire: Progressive Pharmacy Draws Attention

The Most Progressive Pharmacy in Canada 


History


Marigold Compounding and Natural Pharmacy in Courtenay, BC is the first of its kind. It is one of the most progressive pharmacies in North America as far as the scope and the mode of its operation. It is the true integration of pharmacy, homeopathy, Chinese medicine, Ayurvedic medicine and other modalities at a professional level.

It has been recently caught in the controversy that is affecting the delivery of natural health care and natural products in Canada. As one of the most innovative pharmacies in Canada, it has drawn attention to its role in promoting the legitimacy of complementary alternative medicine alongside conventional pharmacy services. This is a unique environment where you will find products and services from different modalities. 

On June 14, 2010 four inspectors from Health Canada, accompanied by two RCMP officers, and inspectors from the College of Pharmacists of BC raided the pharmacy and seized products   without NPN's (Natural Product Number) and ordered the closure of the store.

The total value of the products taken away by Health Canada was $146,290.85 (valued at cost) 

How is Marigold different?


Marigold is no ordinary pharmacy. First of all, the philosophy is based on Vis Curatio Intentio (to heal as nature intended). They do not carry regular drugstore items such as Tylenol, Nyquil, not even Band-aids. Instead, you will find a wide selection of the best quality vitamins and supplements, including professional lines such as Thorne, Seroyal, Metagenics, AOR, and Waiora. They carry functional foods, medicinal mushrooms, Ayurvedic medicine, Traditional Chinese Medicine, homeopathy, tissue salts and chemical free dermatological preparations. They also have their own line of products which are prepared in the compounding pharmacy.

What is the Natural Health Products Directorate (NHPD)? 


The NHPR (Natural Health Products Regulations) came into full effect in January 2010. It is federal legislation through which Health Canada would legislate the sale of natural health products as it does drugs through the Food and Drug Act and the Food and Drugs Regulation. With the classification as drugs, the intent is to have all natural products develop a body of evidence based on science. The fact that natural ingredients can not be patented poses a dilemma for manufacturers. Natural ingredients can be isolated and purified and even chemically altered, but does this change the properties? Are they still natural?

For the quarterly reporting periods (2008/2009 and the first three quarters of 2009/2010) which represents 37.9% of the product licensing applications received since the start of the NHPR in 2004, a total of 19,402 applications have been processed of which 11,195 were licensed, 2,493 were withdrawn and 5,714 were refused. (Source: Clash of the Regulatory Bodies by Andrew Waldie, Integrated Health Practitioner, Special Report, Vol 10-2) This represents just a small fraction of natural products on the market. These are products already currently on the shelves, and does not count products in development. Already, many suppliers have stopped shipping to Canada and many small companies who cannot afford to comply are waiting in anticipation of what will happen. Larger companies are caught in the application process for NPN's and there are many products somewhere along the process.

Since 2004, there has been a growing backlog of applications and the CHFA (Canadian Health Food Association) has described the backlog as alarming.

In January 2010, NAPRA, the National Association of Pharmacy Regulatory Authorities, of which the College of Pharmacists of BC is a member, issued a position statement advising pharmacies to stop selling any products that do not have a DIN ( Drug Identification Number), an NPN ( Natural Product Number) or a DIN-HM (Homeopathic Medicine DIN). This has been adopted by some provincial College of Pharmacists and is now being implemented through the removal of products at the retail level.

Where does Marigold fit in? 


Marigold does not fit in neatly into any category. Although we are a full service pharmacy with prescription services, we are very different from a traditional drugstore. Our expertise is in natural medicine, but we also understand the language and complexity of pharmaceutical drugs.

Marigold Compounding and Natural Pharmacy creates its own line of chemical- free products. In our formulations, we consciously and carefully select natural ingredients and avoid toxic chemicals. As much as possible, we try to stay close to the natural state of the medicine. We avoid using parabens, petroleum distillates, artificial colours, triethanolamine, magnesium stearate, butylated hydroxyanisole, butylated hydroxytoluene, PABA, sodium lauryl sulfate, artificial flavours and clay fillers. We formulate our capsules using alfalfa as the filler, rather than lactose or magnesium stearate.

Authorities from Health Canada have advised us in the past that as a compounding pharmacy, we have the ability to prepare products without an NPN registration as long as it fulfills the following criteria: 

1. It is prepared in a proper laboratory with good manufacturing processes. 
2. It is delivered directly to the end-user, the patient. 
3. There exists a professional relationship between a health practitioner and the patient.

Our ability to deliver professional advice is unparalleled in the industry. We have the following ten accredited practitioners on our staff:

Janette Cormier, AA, RH, R.Ac. Registered Herbalist, Registered Acupuncturist

Michel Duhaime, R.Ac,, DTCM Registered Acupuncturist, Transformation Acupuncture, EFT 

Raje Harwood Registered Reflexologist, Auricular Therapy

Dr. Erika Kneeland, B.Sc., ND Naturopathic Physician with a specialty in obstetrics, pediatrics and women’s health

Dr. Lise Maltais, FCAH, ND Naturopathic Physician, Registered Homeopathic Physician, Bowen Practitioner 

Charlese Nan, RMT Registered Massage Therapist, Injury Specialist

Kira Neumann, RNCP Registered Holistic Nutritionist, Nutrition Consultant

Sharon Niscak, M.Sc., RH Registered Herbalist 

Carol Smith, BA Reiki Master 

Rudy Sanchez, B.Sc. Pharm. Consulting Pharmacist, Formulator

Seizure by Health Canada and the College of Pharmacists:



The store was closed and has been closed since, as we comply with the requirements set out by the College and Health Canada. 

Here are some of the products that were removed from the shelves:

All Natural Sunscreens containing zinc oxide in various concentrations
Buttspackle containing calendula, peru balsam and zinc oxide
Arthrotopik Cream for inflammation, containing devil’s claw, calendula and arnica
Jocamu Ointment containing arnica and Rhus tox
Wild Oregano Oil, pure oil
Arnica Ointment 10% 
Shatavari Ayurvedic Powder 
Oil of Lavender pure essential oil
Grapefruit Seed Extract, pure
Colloidal Silver 
Goldenseal Powder in Manuka 16+ Medicinal Honey

Health Canada has seized inventory which does not bear NPN’s. Part of this inventory are products that we make based on our own formulas. Part of this inventory is from suppliers who have not complied with NPN regulations. The store is closed by the College of Pharmacists of BC pending compliance with regulations. 

These are the steps that are being done at this time: 
1. Institution of individualized professional practitioner consultations prior to sale of products without NPN. This will require that we record patient name, date of purchase and practitioner information, This will allow us to sell these products and continue preparing them if needed.
2. Installation of a service counter to remove public access to Marigold Products.
3. Initiation of the procedure to register a site license for Marigold and allow us eventually to file for NPN’s for our products.
4. Meeting the compliance issues set out by the College of Pharmacists of BC
regarding labeling, compounding registers, etc.

We are using this opportunity to input our inventory into a POS system and make these improvements to allow us to continue serving your health needs.

Marigold is a very unique and progressive pharmacy that happens to be right here in Courtenay. We appreciate your support during this period and ask you to participate as much as you can in the protection of natural health not just for this store, but for all natural health retailers and practitioners. 

1. For more information about Health Canada regulations regarding the requirement of NPN’s, please go to the website for NHPPA (Natural Health Products Protection Association) and watch some of the videos of Shawn Buckley, constitutional lawyer and advocate for protection of natural health products.
website: nhppa.org
 
2. Visit the site of CHFA (Canadian Health Food Association)
website: chfa.ca 

3. If you want to write a letter of support for Marigold, (especially if you have had a chance to use our services and have a story you want to share about outcomes), please send emails to:
marigoldgrassroots@gmail.com

4. All media enquiries are directed to :
250 338 9623