An in-depth cover article was written about counterfeit
consumer products in the February edition of Business Week.1 The
article pointed out that counterfeit consumer products present
a worldwide economic problem, and a competitive threat, plus for
some fake products, there are safety concerns. The article stated
that the counterfeit industry is growing even in the United States.
In fact, the counterfeit threat has stimulated many authentic
product manufacturers to take security measures to protect their
products and intellectual property. It is one thing for US consumers
to purchase counterfeit handbags, jewelry, cell phones, shoes,
clothing and golf clubs; it is another thing for the unknowing
consumer to purchase a counterfeit drug product that contains
no active ingredient, an insufficient quantity of active ingredient
or the wrong active ingredient. The consequences of using fake
pharmaceutical products vary but can be devastating.
As pharmacists, we are trusted to provide high-quality pharmaceutical products to the American public. The American public expects nothing less and, thus, pharmacists must follow due diligence in purchasing high-quality drug products; they must examine and seriously inspect products to ensure that the product is what it is supposed to be.
One problem pharmacists have is differentiating between the counterfeit product and the authentic product. Today, pharmaceutical counterfeiters have access to sophisticated drug manufacturing equipment and the best printing and packaging technologies. Thus, counterfeiters make products that on the surface are indistinguishable from the authentic product. Despite these instances, pharmacists can help protect patients from counterfeit drug products. Here are some tips that may assist you in protecting your patients from substandard fake drug products.
First, purchase from reliable, trusted wholesalers and suppliers. Currently, there are over 6,000 licensed wholesalers in the US. However, three wholesalers control the vast majority of the drug wholesale trade (McKesson, Cardinal Health and AmerisourceBergen). Following these top three, there are approximately 25 regional drug wholesalers. As the name implies, these wholesalers primarily provide products within a regional area or supply specialized products.
The remaining wholesalers are referred to as "secondary" wholesalers. Some of these are legitimate, highly trusted suppliers. They distribute a variety of products, but many concentrate on distributing specialized products. Despite the existence of legitimate secondary wholesalers, there are some secondary wholesalers with questionable trade practices. Some have been found to sell counterfeit products, stolen and diverted products, or counterfeit product labels to either change the expiration dates or the strength of the product. Secondary wholesalers have been implicated in most counterfeit product distribution in the US. Thus, the first tip is to avoid un-trusted, suspicious secondary wholesalers. Be very careful in responding to those early-morning faxes and e-mails from secondary wholesalers offering the "unbelievable deal." If the deal looks too good to be true-stay away from it!
Second, look for signs of a removed or switched product label. One common practice used by drug diverters and counterfeiters is to remove the original label and replace it with a counterfeit label. To do this, they use lighter fluid, acetone or some other solvent. Many times a tacky residue will be left on the container. Also, the label may be faded or discolored along the edges because of the solvent. Finally, look for an altered expiration date; diverters commonly buy "short-dated" products (products that will expire soon) and then alter the label's expiration date.
|The consequences of using fake pharmaceutical products vary but can be devastating.
Third, look for subtle changes in the product's label. When doing this, compare product labels with those on previously purchased products. For example, examine product labels for the following:
- Examine the paper or packaging materials for differences in paper texture, size and thickness of the labels. Also examine the gloss or finish on the paper.
- Examine for different fonts and font size differences, print color and raised printing. In one recent example, the counterfeiters forgot to put the degree mark (º) on the storage temperatures listed on the label. Many makers of the authentic product are using raised printing because it is more difficult to counterfeit. Feel the label to see if raised print is present. Finally, look for differences in distances between the printing and the label edges or printed borders within the label.
- Examine all printing on flaps and surfaces of the box. Compare with previously purchased products. You will be surprised to see the number of identification marks on the box surfaces inside and out.
- Look for overt security features such as holograms or color-shifting inks. Many companies use holograms, and this year some companies started using color shifting inks on labels. The color of the print/image changes by changing the angle at which you look at the label. Color-shifting inks are difficult to counterfeit.
- Look for breaks or tears in the sealing tape and seals. Look for replaced seals that do not match those of previously purchased products. Some products are using holograms on the seals, and when broken, the hologram changes color.
Fourth, look for variations in medication container size. Again, compare with existing containers you have purchased; hopefully, these are not counterfeit. Some things to look for include:
- Examine for variations in bottle or container lengths, diameters and shapes
- Examine for variations in diameters of the bottle openings or lids
- Examine for variations in the thickness of the glass or plastic container materials
- Examine for variations in container color tints
Fifth, listen to patients. Most counterfeit medications are first detected by patients. For example, they notice a difference in taste; for products for injection, they notice a different sensation upon being administered, such as a burning sensation or pain at the injection site. Listen to those patients who tell you that they are having trouble splitting the tablet. Counterfeit tablets may be compressed tightly which makes it difficult to split while others may fall apart when being split. Also, if you see an unexpected change in a patient outcome such as a change in clinical, or laboratory value, especially an unexpected worsening of the patient, this may be due to the lack of effectiveness from the substandard or fake medication.
|Most counterfeit medications are first detected by patients.
Finally, compare the physical characteristics of the product such as color, tablet or capsule markings with those of previously purchased products. Examine the shape, thickness, etc. One can also weigh the product to see if there are wide variations between tablets.
If, indeed, you suspect that a product is substandard or a counterfeit product, please contact the FDA at
http://www.fda.gov/medwatch or call 1-800-FDA-1088. Also, call the manufacturer of the authentic product. I also suggest that you contact your state board of pharmacy.
- Balfour Frederick, "Fakes" Business Week, February 7, 2005, 54-64.