In today’s global marketplace, the free flow of goods has opened up a glorious opportunity for “Grey Marketers” to take advantage of unsuspecting dentists and their patients, by selling them products that are not licensed for sale in Canada; or products that are not in their original packaging; or products whose expiry date or efficacy have been compromised by shipping, storage and handling conditions; or in some cases, products that may be counterfeit. The global market creates myriads of opportunity for unscrupulous dealers who want your business.
And, unless you set up your own controls, you may never find out.
Why?
Dental products are designated as Medical Devices or Drugs under the Food and Drug Act. As such, their manufacturers are required to obtain Health Canada Medical Device Licenses or Drug Identification Numbers “as packaged”. Their dealers and distributors are required to obtain Health Canada Establishment Licenses, and among other things, maintain records that allow them to trace the products back to the manufacturer.
But dentists are exempt from Medical Device Regulations as health care facilities. Nobody from Health Canada is going to come into your operatory to let you know that a product was sold to you illegally, or that you bought it from somebody who doesn’t have a license, or that it has been repackaged, or that it is counterfeit. You are supposed to know.
Furthermore, not a single regulatory college for dentists has a standard of practice or even a “best management practice” for sourcing dental supplies. Choosing them is part of your training. Sourcing them is not. Still, you are supposed to know.
So, you are on your own. The first time you find out that you have a problem, you are facing a remake, or a recall or a disciplinary complaint. How does this happen?
Material sciences courses, CRA reports, peer reports, manufacturer representations, conventions — these are some of the many resources dentists use to determine which products they are going to use in their operatories.
Once that decision is made, purchasing (reordering) is generally handled by somebody else in the dental office. Somebody else places the order, somebody else receives the shipment, somebody else opens the box, and somebody else places the contents into the storage cabinet.
In many practices, the dental assistant replenishes the operatory supplies by going into the cabinet, removing the contents from its packaging and bringing it into the operatory. Quite often, the first time a dentist sees a product, it is already “on the mixing pad”.
The person doing your purchasing is a good person, looking after the welfare of your dental practice. When they see multiple flyers coming into your office offering your favourite products at 10%, 20% or 50% less than you normally pay, they can’t help but suggest that you order from these bargain houses.
But where did these goods come from? Did the dealer get it from the manufacturer, or did they get it from the Third World grey market where they can’t account for the shipping, storage and handling of the product? Is the packaging the same or has it been repackaged? Do the lot numbers and expiry dates on the package match the same information on the contents? Are the lot numbers and bar codes tampered with or blacked out?
Some dentists avoid these problems by purchasing only licensed goods, from licensed dealers authorized by the manufacturer.
This information is readily available to you.
Check with the manufacturers that you use for their authorized dealers. Use their web site or call their toll free numbers.
Check the products that you use for a valid Product License at the Health Canada web site
—http://205.193.93.51/mdall/ prepareSearch. do?type=search. active for consummables, or at http://205.193.93.51/dpdonline/startup. do?applanguage=en_CA for drugs.
Check your dealers for a valid Establishment License at the Health Canada web site — http://205.193.93.51/delsonline/ prepareSearchMdel. do. If you have a problem with the product, don’t throw it out. Call the manufacturer, who will be pleased to check if the product is their own, or if it has been circulated through the grey market.
Protect your patients and protect your practice. Buy your products from somebody you know to be reputable, not somebody you want to be reputable.
Seeing is believing.
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Viewpoint Courtesy DIAC The Dental Industry Association Of Canada.
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The global market creates myriads of opportunity for unscrupulous dealers who want your business
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Quite often, the first time a dentist sees a product, it is already “on the mixing pad”
