The biggest danger of counterfeit medicine is not the dollar loss for the industry, but the threat to patient health. Pierre Pienaar* FAIP outlines how packaging plays a role in ensuring product safety in the pharmaceutical sector.
The danger of counterfeiting is one of the greatest battles the pharmaceutical industry has to fight. Over recent decades, the industry has been investing millions of dollars into R&D for new tracking and anti-counterfeiting systems.
Non prescription, over-the-counter (OTC) medicines are among the most safely packaged consumer products in the world. The majority (by law) are sealed in tamper-evident packaging for our protection.
Tamper evidence
In designing closures, one needs to strike a balance between convenience and accessibility. Closures need to be child-resistant, yet easy to open by an ageing adult. This same philosophy is applied to tamper-evident closures.
There have been major developments in the design and technology of closures over recent years that have brought change to other packaging components such as the removal of undercap seals. There is also a definite move towards linerless components.
Demand for medication closures will likely lose momentum due to the increasing penetration of blister packs and other closureless containers. Among all medication closures, combined senior-friendly, child-resistant types will fare best in the marketplace.
The radio frequency identification (RFID) tags consist of a tamper-evident technology to ensure that the RFID tag has not been interfered with after initial positioning on an article. These tags, if tampered with, become disabled, thereby preventing use of the tags on counterfeit or substitute products. Fears of bioterrorism, tampering concerns and the huge growth in counterfeiting, all present serious security issues in today’s society.
Drug companies have been battling tamperers and counterfeiters for decades and looking at tamper-evident and anti-counterfeiting devices to help deter and prevent illegal copying and diversion. Drug companies are game to try RFID, but the technology still needs to prove itself. I believe that we will see rapid introductions of anti-counterfeit technology and materials over the next few years; there will be a proliferation of tamper-evident packaging and anti-diversion concepts.
The pharmaceutical industry is unique in its demands on radio frequency identification. Pharmaceutical manufacturers are as interested in RFID as makers of consumer packaged goods. But the needs and goals of the pharmaceutical industry are different from those of other goods manufacturers. These differences in goals lead to differences in equipment, overall system set-up, data encryption and utilisation, and many other aspects of a RFID system. They also lead to different timetables for RFID implementation.
For food and other mass goods, RFID has evolved, and continues to evolve, primarily as a way to track goods through the supply chain. But as far as pharmaceutical manufacturers are concerned, RFID’s reason to be is security.
The time has come for us to commence placing tamper evidence onto any product that touches the body and is ingested, inhaled or absorbed into the blood stream. Apart from pharmaceuticals, this would include the likes of hand lotion, perfume, sunscreen, baby powder, soap, deodorant, toothpaste and lipstick.
* Pierre Pienaar is the immediate past president of the Australian Institute of Packaging. He has a Master of Science Degree (Packaging Engineering/Technology) from Brunel University, UK, and a Master of Manufacturing and Production Degree from University of Hertfordshire, UK. He has been National President of the South African Institute of Packaging, a director of the Packaging Council of Southern Africa and a representative on the board of the World Packaging Organisation. He has his own business, PackTech Solutions.
