Category: Supply Chain

diet-pills

Counterfeit Drugs and the Logistics Industry

Earlier this week the BBC reported that diet pills containing the potentially lethal chemical 2,4-Dinitrophenol (DNP) remain available for sale online, despite a major crackdown by the government and regulatory bodies. According to the Food Standards Agency, around 19 websites were shut down last year. However an investigation led by the BBC found multiple sites on the dark web selling products containing the banned drug.

DNP is an industrial chemical licensed for commercial use, but not for human consumption. And the reason for this is clear: DNP has been linked to multiple deaths. An article published by the Journal of Medical Toxicology in 2011 found 62 deaths that could be attributed to DNP since the turn of the twentieth century. Yet despite knowledge of DNP’s potential to cause severe adverse reactions, there have been numerous further fatalities over the past five years.

It is clear that even though DNP is not licensed for medicinal use, diet pills containing it remain attractive to consumers looking to lose weight. Recent casualties have included: a medical student in 2012; a bodybuilder (also in 2012); and a 21 year old (2015) who was believed to have known the risk but thought being slim was worth it. This means that even though diet pills containing DNP remain illegal, as long as supply and demand exists counterfeit drugs will continue to be a problem.

Which is why regulation and compliance within the Logistics Industry is so vital. It is crucial that every single person within the Supply Chain understands the importance of working within strict guidelines to ensure the quality and safety of each product. It may be easy to think that the odd slip won’t matter, but the reality is that the products we ship could prove to be fatal if we don’t validate their source and maintain robust procedures throughout the entire Supply Chain.

And this goes beyond management setting up Quality Assurance and SOPs: training needs to be provided for all workers, so that they understand exactly why the procedures they follow have been developed and what their individual role entails. By equipping all staff with the knowledge and skills to do this, we automatically reduce the risk of counterfeit drugs entering the Supply Chain. And when facing an illegal drug such as DNP, it is clear to see just how important this is.

We offer a range of training options to assist you in providing your staff with the skills and knowledge they need. Please contact us for further information, including to find out more about our online training courses (coming soon). 

Counterfeit Drugs

The Importance of Supply Chain Security: Counterfeit Drugs

A large part of what we do at ASC Associates is supporting key stakeholders throughout the supply chain to maximise efficiency and compliance, in order to maintain product integrity and ensure the safety of the consumers. And a major aspect of this is recognising the threat of counterfeit drugs, and developing ways to secure the supply chain against this threat.

The sheer scale of the counterfeit drugs market was demonstrated recently when police in Poland shut down an illegal factory near the city of Bydgoszcz which was capable of producing millions of counterfeit medications. Within the raid, police found 100,000 counterfeit erectile dysfunction pills, alongside 430,000 vials of steroids, worth around $4.4million. However in a statement issued by the Central Bureau of Investigations in Poland (CBSP) it was recorded that the illegal unit was capable of producing much more than this.

The police managed to seize equipment that would create a whole pharma production line, including: mixers, tablet presses, blister packs, and screen printers, making it almost impossible to distinguish the counterfeit drugs from the real ones. A complex supply chain that included shipment to the UK was uncovered within the raid, and it is understood that the majority of these drugs would have been sold over the internet.

It is important to remember that the problem with counterfeit drugs goes beyond the financial implications of illegal reproductions. There are no regulations governing the production of counterfeit drugs, meaning that some may not contain even a trace of the active ingredient. And even when the medications produced do contain the active ingredient, it is often in an insufficient amount, making them ineffective and potentially dangerous as they can contribute to the development of drug-resistant strains of life-threatening diseases such as malaria and tuberculosis. People die every single day because of counterfeit drugs, and that is unacceptable.

So what can we do? Well, we need to be proactive in ensuring that we are doing everything we possibly can to ensure the integrity of the supply chain. By reducing the risk of counterfeit drugs entering the supply chain, we reduce the risk to the consumer. This can be done through a combination of a thorough audit of the entire supply chain, robust planning and quality managements systems, and adequate and appropriate training for every member of staff.

We also need to be aware of changes to regulations within the industry, such as the new Delegated Regulation (EU2016/161) published recently by the European Parliament and Council to supplement the Falsified Medicines Directive. This will come into effect by 2019 and aims to introduce two new safety features – a unique identifier that can be scanned at various points along the supply chain, and tamper evident features on the packaging.

Such safety features have already been introduced and trialled, thanks to tech start-ups, and these have shown real promise. However, as this article on the BBC shows, the tech start-ups cannot solve the problem alone – for these safety measures to have any real effect they have to be embraced by us all.

We offer Supply Chain Security Audits and can advise you on the best practices for Logistics and Supply Chain Security. If you would like to know more about our services, please contact us to discuss your requirements. 

Importance of Supply Chain Security

ASC Highlights The Importance of Supply Chain Security in PMPS Magazine

Back in June, Henry Moran, our Chief Operating Officer, wrote about his experience of the FlyPharma Conference. Attending the conference had been a great opportunity for ASC Associates to network with others working in the Pharmaceutical Logistics Industry, and Henry came back full of passion for the work that we do to help manufacturers, third party logistics providers, and airlines to achieve excellence throughout the supply chain.

One of the areas that Henry highlighted in his post was the fact that, whilst there is a great focus on Temperature Management within the supply chain, security is often overlooked. We’re pleased to announce that this observation has been shared in the latest edition of the Pharmaceutical Manufacturing and Packing Sourcer Magazine (PMPS), which you can read here. Henry is mentioned on page 50, in the article about the FlyPharma Conference 2016, which you can also see below.

ASC Associates Supply Chain Security PMPS

We’re looking forward to attending the FlyPharma Conference again next year, when it will be held on 6-7th June 2017 in Brussels. Why not head over to their site and register your interest, so that you receive the most up-to-date information straight into your inbox?

And if you’re interested in working with us to review your supply chain security, check out the services we offer or contact us for more information.

The Potential Impact of Brexit to Your Supply Chain

The Potential Impact of Brexit to Your Supply Chain

Following on from the very recent vote for Britain to leave the EU, here are our top tips to consider for your supply chain.

  1. Customs Clearance – The re-introduction of UK Customs Clearance is a possibility. We would recommend that you run a health check over your Tariff Codes, ensuring that they are up to date and reflect the commodity you are importing or exporting.
  2. Customs Regimes – If you are operating under any Customs Regimes, now would be a good time to explore what impact the EU vote might have. Are your regimes still valid or do you need to implement new ones? Make sure you pause to understand the impact before you make any changes.
  3. UK Border Enforcement – The potential enforcement of the UK border may well impact transit times through ports and airports. Stay up-to-date with developments to ensure that you limit any effect this may have on your Supply Chain.
  4. Time and Temperature Shipments – For Time and Temperature Sensitive Products, including pharmaceutical shipments, we would strongly recommend you conduct a robust risk assessment for both the security and potential temperature impacts on your products. Longer transit times could mean heightened risk.
  5. Collaboration – Finally, now is the time to ensure that you are communicating and collaborating with all of your supply chain stakeholders – the more dialogue and knowledge you have, the more robust the chain will be.

Change is never easy and the uncertainty of what the future may look like is an added difficulty. Unification of key stakeholders, and a cohesive project plan to mitigate risk and adapt to new legislative and regulatory compliance is critical to securing a safe and effective supply chain.

ASC Associates provide a range of services which could help you navigate the uncertainty that lies ahead. Why not contact us to find out more.