Heraeus Kulzer takes action to protect dentists, patients
SOUTH BEND, Indiana--Your patient arrives at his appointed time for the first appointment in an extensive treatment plan. You’ve chosen an appropriately sized impression tray, and open a new container of Flexitime VPS material to begin the impression process.
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But instead of the easily manipulated, malleable putty you have come to expect, you open the Flexitime container to find an unfamiliar product with a strange odor. The package says Heraeus, and the expiration date is a year away. So what happened?
You soon learn that in an attempt to save money and improve the bottom line, the front office didn’t order the products from Heraeus, but rather ordered them online from an unknown overseas distributor who offered deep discounts.
These discounted materials were likely stored improperly by an unauthorized distributor, or perhaps the expiration dates were altered, resulting in expired or spoiled products reaching the offices of well-meaning U.S. dentists. Welcome to the grey market!
“If a product is not managed through the appropriate channels, it can potentially be sitting in a warehouse somewhere for years, and then sold to a dentist at an extremely deep discount,” explained Chris Holden, president of Heraeus Kulzer. “As a dentist, you really don’t know what you are getting or what you are placing in a patient’s mouth.”
Hardly a new issue, the grey market is a term that describes the distribution of a product through channels that, although legal, are not authorized or intended by the product’s original manufacturer. Often, grey market products are not properly shipped or stored, diminishing the efficacy of the product. They may have altered expiration dates, or worse, may be counterfeit. The use of these tainted products then compromises patient care and becomes a public health issue.
The Federal Drug Administration regulates that dental products used and placed in patients' mouths meet accepted standards--standards that include proper storage, shipping, and shelf life. However, with the recent economic global downturn, distributors and doctors have been forced to find ways to conserve/reduce costs.
These attempts to “cut corners” have placed a brighter light on the grey market problem, have resulted in risky approaches to savings, and have created potential problems with serious repercussions on several fronts.
Drug Expiration Dates - News
The American Regent drug recall affects lot 0362 of Concentrated Sodium Chloride Injection, USP, 23.4% in 30 mL single dose vials. They have an expiration date of May 2012 and NDC # 0517-2930-25. The Bedford Laboratories drug recall affects lot 1948138
coupons may not be accepted locally, they can be used by our military families for up to six months past the expiration date. In a powerful packet of information, Hale included the coupon policies for many of the local grocery and drug stores.
They may have altered expiration dates, or worse, may be counterfeit. The use of these tainted products then compromises patient care and becomes a public health issue. The Federal Drug Administration regulates that dental products used and placed in
For instance, why would anyone keep on hand a container of skin cleaner with an expiration date of 1/20/1999? Well, really tough skin? Something that could have been “2 refills before 3/22/01,” with smudged-over words that looked like “Swamp water
This portfolio includes many patents with expiration dates ranging from 2014 through to 2019," she added. "After the patent was granted in 2009, AstraZeneca has enforced this patent in several countries in Europe. We will continue to decide on a case
Passing the expiration date doesn't always lead to danger | Many Hands
Chicago Tribune
There are telltale signs that a product has gone bad. Moldy bread. Clumpy milk. The layer of fur blanketing the cream cheese. But what about the toothpaste sitting in your pantry for years after a zealous bulk purchase? Or those condoms waiting optimistically in your nightstand for longer than you wish you recall?
Many such products carry expiration dates, but thrifty shoppers often wonder if they really must toss dated items that still "seem" perfectly fine. After all, how can headache medicine stop working from one month to the next? And why should you believe the expiration date on one lotion when another doesn't carry one at all?
The Food and Drug Administration requires that expiration dates be printed on all prescription and over-the-counter drugs, but not on cosmetics -- unless the cosmetics are also considered drugs, such as toothpaste with fluoride, anything with sunscreen, anti-dandruff shampoo and antiperspirant. But even then, over-the-counter drugs without dose limitations don't have to carry expiration dates if tests have proven they're stable for at least three years, which is why one sunscreen may have a date while another won't.
Expiration doesn't necessarily mean the product turns putrid or ineffective once the date passes. Manufacturers set expiration by choosing a date and conducting stability tests to ensure the product will still be good at that time.
Expiration dates tend to be conservative to account for a wide range of storage conditions and consumer handling, said Dr. John Bailey, chief scientist with the Personal Care Products Council, an industry trade group. But for some products there can be a cushion. Here's a guide to products that commonly carry expiration dates.
Condoms: Because the latex in condoms degrades over time, becoming brittle and more prone to breakage, the FDA requires they carry an expiration date, up to five years from the date of packaging, established by testing to ensure their integrity. (Ed. note: an integrity test for condom use? Novel idea.) Storing condoms for prolonged periods in a hot environment, such as a windowsill or glove compartment (a wallet is usually OK), can speed up deterioration, while storing in a cool, dry place could make them usable past the expiration date, said Dr. John Santelli, professor of clinical population and public health at Columbia University's Mailman School of Public Health.
Saline solutions, eyedrops: Sterility is the greatest concern. The preservatives used to prevent microbial overgrowth become less effective over time, putting the solution at risk of contamination, said Dr. Thomas Steinemann, ophthalmology professor at Case Western Reserve University. Patients who have used outdated or contaminated product can get eye infections or worsen a problem they aimed to treat, he said. Also, especially once a bottle has been opened, the water starts to evaporate, leaving behind a greater concentration of salt, said ophthalmologist Elmer Tu.
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