It is impossible to talk about major identification and labeling events in 2010 from a pharmaceutical, chemical or medical device perspective, without discussing compliance and the battle to combat counterfeits.
Regulations and compliance played a key role in 2010, including:
- FDA 21 CFR Part 11 – the implementation of controls, including audits, validation and documentation for the software and systems involved in printing pharmaceutical and medical device labels
- GMP (Good Manufacturing Practice) – global quality guidelines for pharmaceutical and medical device manufacturers
- MHRA (Medicines and Healthcare Products Regulatory Agency) – to enhance and safeguard the health of the public in the UK by ensuring that medicines and medical devices work, and are acceptably safe.
- CLP (Classification, Labeling and Packaging) – aligns the European Union system of classification, labeling and packaging chemical substances and mixtures to the Globally Harmonized System (GHS)
- GHS Classification and Labeling of Chemicals – addresses the classification of chemicals by types of hazard and proposes harmonized hazard communication elements, including labels and safety data sheets
- HDMA (Healthcare Distribution Management Association) – this American association represents primary healthcare distributors and aims to protect patient safety and access to medicines
But even with all of these regulations (and more!) in place, counterfeiting continued to be a concern. In 2010 we learned that $14.3 Billion worth of counterfeit drugs are sold yearly within Europe. Overall counterfeit drug revenues were estimated to be in the region of $75 Billion in 2010 and are projected to grow at 13% annually. The World Health Organization stated that it is impossible to quantify the size of the problem but that it may be as much as 10% of the global market.
Standards have to be put in place to prevent counterfeits, but agreeing on the best way to manage the problem continues to be easier said than done. Some feel ePedigree, an electronic record surrounding chain of custody and chain of ownership, is the way to go while others favor mass serialization, allocating a unique serial number to products at the item level. Unique Device Identification (UDI) of medical devices offers a standard way of presenting information in a standard format or barcode, but while some like the idea of using barcodes others prefer RFID.
Within bar coding there are different schools of thought as well. HIBC (Health Industry Barcode) is specific to healthcare and tracks data via barcodes while GTIN (Global Trade Item Number), which is used across many industry sectors, ensures every product has a single reference number that is globally unique. Compliance on chemical labeling has also been a hot topic this year for the pharmaceutical market. With the EU having made its first transition across to GHS on December 1st 2010, interest is now developing as to when the USA will follow suit.
These debates will rage on and continue to be important topics as we move through 2011. We will be watching to see which standards are adopted and what insight the new year will bring.
What are your predictions? Where do you stand on the ePedigree vs. Serialization and Barcodes vs. RFID debates?
