Every single medicinal product in transit, in any part of the world, is potentially at risk of falsification. The US based ‘Centre for Medicines in the Public Interest’ (CMPI) estimates the value of the counterfeit drug sales in 2010 in the vicinity of $75 Billion USD.
A falsified medicinal product is any medicinal with a false representation of:
- its identity – includes the packaging and labelling, name or composition with regard to any of the ingredients (including excipients) and the strength of those ingredients
- its source – includes the manufacturer, country of manufacturing, country of origin or the marketing authorisation holder, or
- its history – includes the records and documents relating to the distribution channels used.
The world over, organisations are facing the challenge of maintaining supply chain integrity and implementing appropriate strategies to protect against falsified medicines.
I will cover three key components of falsified medicines in this blog:
- Supply chain challenges
- A risk based approach to Good Distribution Practice (GDP)
- Considerations and legislative updates in the EU
1. Supply chain challenges
Supply chain challenges will vary depending on the geographical region of origin and destination of medicinal products. Medicinal products must be protected from theft, adulteration and breakage, and distribution of medicines should have no impact on the integrity of the product.
Strategies to further protect the supply chain include:
- clarification of the GMP/GDP responsibilities and appropriate, formal technical/supply agreements
- contingency plans that have been tested and are capable of being implemented
- continuous measuring and monitoring of the GDP processes
- consideration of who else may be involved in handling products without prior consent or knowledge.
Imagine a scenario where you need to move pallets of high-value, cold-chain medicinal products from Melbourne to Hong Kong.
Consider the various aspects that need to be assessed, including:
- the safety and integrity of the various modes of transport to be used
- the road transport vehicles – their suitability and who owns them
- whether a single provider own all modes of transport throughout the journey
- whether the product will be moved in dedicated or shared containers and trucks
- whether a GDP/technical agreement is in place
- temperature and humidity on the ground at airports and in loading docks
- weather conditions, such as monsoons, that may impact the delivery time
- contingency plans.
2. Risk based approaches to GDP
In response to the far reaching impact of falsified medicines, the MHRA of the UK has seen a 75% increase in their GDP inspection team in 2012 and the EU has incorporated a risk-based approach to supply chain integrity into its Falsified Medicines Directive (2011/62/EU).
In short, supply chain risks must be systematically assessed, controlled and reviewed.
Risk-based approaches to GDP mean that a complete analysis of distribution processes, providers and contingent systems must be formalised.
3. Considerations and legislative updates in the EU
Falsified Medicines Directive
The EU’s Falsified Medicines Directive has been adopted by the EU parliament with implementation to be staged over 36 months from June, 2011. A working group has been established to develop technical specifications for safety features. A technical report is due for publication in 2014.
The Falsified Medicines Directive includes:
- Safety features for ‘at risk’ products.
- Stricter controls on wholesalers and brokers.
- Strategies for internet supply issues.
- Stricter inspection regimes and penalties for non-compliance.
Discussed safety features to counter falsified medicines include:
- tamper-evident seals on outer packaging
- unique identifiers for ‘at risk’ products
- dedicated recognition devices, for intended recipients to verify the contents of delivered products.
Industry feedback in the EU
Two of the most common sources of feedback from the public included:
- Handling of quarantined products, which remains a sensitive issue. What are the exact roles for responsible persons handling quarantined products?
- Returns – are returned products acceptable under any circumstances and is it appropriate to rely exclusively on the discretion of responsible persons for decisions on handling returned products?
A collective approach
In a clear demonstration that falsified medicines pose a threat to patient safety all over the world, the US FDA has sought a listing under the EU’s Falsified Medicines Directive.
Falsified medicines must be managed in a consistent way through industry and regulatory controls.
- Center for Medicines in the Public Interest (CMPI, 2013)
- World Health Organisation (WHO, 2013)
- MHRA GMP/GDP Symposium, 2012
- Falsified Medicines Directive (2011/62/EU), 2011