Bayer Biological Products has unveiled a number of new product developments as part of its major campaign to combat product tampering and counterfeiting.
These include the addition of shrink-bands to a number of products, changes to the distribution process for a plasma product that eliminates third-party handlers, and a new security seal for use in transportation.
The initiatives are the latest in a multiphase programme that began in September 2002, when Bayer became the first company in the biological products industry to introduce enhanced tamper-evident packaging (TEP). The new TEP innovations now cover every liquid-filled product made by the firm, it said.
According to World Health Organisation estimates, counterfeit medicines comprise 6 per cent of the world market, higher in some areas, and developed countries are not immune to the problem. In the US, the number of cases of counterfeiting investigated by the FDA has gone up from a level of around five a year in the 1990s to more than 20 a year at present, spurring the agency to look at ways to combat the rapid increase.
A report issued by the agency earlier this year identified radiofrequency identification (RFID) as a primary means of tackling the problem. It also concluded that unit dose packaging (such as blister packs) is not enough of a cost deterrent to counterfeiters, even when combined with tamper-evident technologies. This means that some other form of authentication technology will likely be required, particularly for products at high risk of being copied.
Joseph Akers, president of Bayer Biological Products, said the company has created an 'anti-counterfeit mindset'.
"We have sought to identify enhanced tamper-evident packaging and other innovations that can be implemented in the near-term," said Akers. "We will, however, continue to look for new tools to further ensure the safety of our products."
Bayer's shrink-bands, now added to Plasbumin and Albumin, as well as Bayer BP's hyperimmunes in vials, cover the neck and lid of the bottle in a clear plastic wrap with the company's imprinted logo. If tampered with, the shrink-band will be broken or loosened and the disruption will be obvious to the average consumer. Bayer says the innovation is difficult to duplicate.
For Prolastin Alpha-1 Proteinase Inhibitor (Human), a plasma product for the treatment of alpha-1 antitrypsin deficiency, also known as hereditary emphysema, Bayer BP is focusing on distribution process innovations to protect product safety along the supply chain.
A new service called Bayer Direct provides Prolastin to patients through a central pharmacy, eliminating unnecessary third-party handlers.
The company has also created Tug-Tight Banding, a security seal specialized for use in transportation. It is located on the temperature-controlled Envirotainer shipping solution to help ensure verification once a shipment arrives at a Bayer BP affiliate or third-party destination.
There will also be ongoing education for treaters and patients through Bayer BP's sales force, said the German company.
Bayer BP began with the introduction of seal tabs (also known as tamper tape) on boxes of its IGIV product, Gamimune N, Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated.
Since then, it has replaced seal tabs with shrink-bands on all Gamimune; Gamunex, Immune Globulin Intravenous (Human) 10%, Caprylate/Chromatography Purified; and Polyglobin®, Immune Globulin Intravenous (Human) 5% Solvent /Detergent Treated.