Last month our CEO, Amy had a chat with James Strachan from The Medicine Maker on the popular topic of modal shift. Amy expressed her thoughts and opinions why both modes are very relevant, however their future success is dependant upon embracing current demands in innovation and compliance. Please click here to read the complete article.
On the 20th January 2018 our CEO, Amy Shortman was interviewed by Cordelia Chanton from Letzebuerger Journal on Amy’s journey into Pharmaceutical Logistics, how ASC provides support and business solutions to the industry, as well as opinions on modes and compliance . Please read the full article ‘in German’ here, Letzebuerger Journal .
Just before Christmas we sent out a copy of our Autumn/Winter newsletter to all our subscribers. In it we shared updates on what we had been up, as well as industry news that we felt was particularly interesting.
This is something we like to do twice a year, to capture news and updates that might impact our clients throughout the entire supply chain. Our latest edition includes information about the European Medicines Agency’s (EMA) move to Amsterdam in light of Brexit, as well as research into the value of Air Freight.
You can download a copy of our Autumn/Winter newsletter here. You can also subscribe to our mailing list, to ensure that you receive a copy of our newsletters as soon as they are published.
After several busy months, and following numerous requests from various people, we have decided to launch the ASC Newsletter. Our first copy was published yesterday, and you can get a copy by subscribing to our mailing list.
The Spring/Summer 2017 edition of our newsletter covers the conferences we have attended, the training we have completed with clients, and the journey we took towards launching our new brand.
It also includes a selection of news from within the Pharmaceutical Logistics Industry, as well as security updates which highlight the importance of Supply Chain Security.
We hope that you will find this latest addition to our brand both useful and insightful, and we look forward to bringing you further updates later in the year. In the meantime, don’t forget you can also follow us on both LinkedIn and Twitter where we share regular updates from within the Logistics Industry.
Earlier this week, Bath University announced the results of research into ensilication, a process which involves encasing a protein in silica, which could have far-reaching effects on the transport of vaccines.
The research, which was carried out by teams at both Bath University and Newcastle University, found that vaccines treated in this way could be heated to 100°C or stored at 22°C for at least six months without loss of function.
Currently, vaccines have to be transported using cool-chain logistics, because a small change in temperature can render them useless. Despite advances in both technology and regulation aimed at making cool chain management more reliable, millions of doses are still lost each year.
The researchers trialled ensilication with three different proteins – one from a tetanus vaccine, horse haemoglobin, and an enzyme from egg white, all with great success. It is hoped that this technology could be expanded to other biopharmaceuticals, such as antibodies, anti-virals, and anti-venom drugs.
Such advances in technology are changing the shape of logistics at an increasing rate, and it fascinating to watch how the numerous challenges faced by the healthcare and life-science logistics industry are gradually being reduced. However it is important to remember that the challenges we face are both numerous and varied – temperature regulation is only one part of the puzzle.
Pharmaceutical cargo is often the target of both thieves and those who deal in counterfeit drugs, and so Supply Chain Security must remain a high priority. For instance, in 2009, a truck carrying vaccines in Wisconsin, US, was reportedly left unattended with the engine running at a delivery point. The truck was stolen and later abandoned, with the cargo seemingly untouched, however the vaccines had to be returned to the manufacturer as a precautionary measure.
Technology cannot prevent user error, and so we must always remain aware of best practice at every stage of the supply chain. However it is exciting to see such promising technological advances being made, and we shall be watching for further news on this research to see how it develops.
ASC were delighted to be part of this year’s IQPC Temperature Controlled Logistics Conference 2017. Hosted for the first time in London, the stage was set within the historic London dockland at ExCel. Our CEO Amy Shortman was honoured to be Chairwoman for the conference, saying, “IQPC believe that this is the first time this conference has been Chaired by a woman and I am thrilled to take part”.
Amy’s opening remarks as Chairwoman drew parallels between the Historic Docklands and the challenges we find ourselves dealing with today. The Docklands, which were once a major part of the supply chain, are no longer used since containerized sea freight needs larger vessels and in turn deep sea docks. Similar changes in the way we handle freight can be seen today, with greater regulatory pressure creating more complex supply chains and sensitive products increasing the need for greater emphasis on temperature controlled logistics and supply chain security.
As the conference progressed, a key theme began to emerge, that of the need for greater collaboration combined with outsourcing of key activities to those with the best skills and expertise. Pharmaceutical companies are slowly realising the cost and strategic benefits of doing so whilst focusing on their own strengths.
The modal shift from air to ocean was another trend highlighted at the conference, with more companies altering their stock and inventory management to accommodate the longer supply chains involved with sea freight. Technology was abundant and the continuing development of cloud based temperature monitoring systems demonstrated how the data can be utilised for continual improvements.
ASC’s Henry Moran and Amy Shortman jointly presented on Key Considerations for Supply Chain Security for Temperature Sensitive Medicinal Products, API’s and Excipients. Their message was that whilst adhering to Good Distribution Practice (GDP) is imperative, there should be equal importance placed upon the Falsified Medicines Directive. This helps ensure that counterfeit materials don’t enter the legal supply chain, that products are not tampered with, and that supply chains protect products from theft for sale on the black market.
Henry Moran, COO stated “The sharing of case studies and best practice was exemplary and it is testament to the industry as a whole and IQPC specifically that an educational approach was taken in development of the two days”.
For a more in depth report please read the official IQPC report.
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).
The news today that Amazon has been fined £65,000 for shipping dangerous goods highlights just how critical it is that companies remain aware of the relevant regulations associated with any shipments they organise or undertake, and that all cargo is compliant to those regulations.
The case against Amazon was made by the Civil Aviation Authority (CAA) in relation to the Air Navigation (Dangerous Goods) Regulations 2002 and relates specifically to Amazon’s attempts to ship both lithium-ion batteries and flammable aerosols on flights in and outside of the UK between November 2013 and June 2015. These items are included in international and domestic restrictions due to their potential to become a flight safety risk.
It is important to remain aware of changes to all regulations relevant to your cargo, to ensure that shipments remain compliant at all times. A change relevant to this case happened as recently as February 2016, when the International Civil Aviation Organisation (ICAO) banned shipments of Lithium-ion batteries as cargo on passenger planes.
The barrister acting on behalf of Amazon, Stephen Spence, told the court that the issue was caused by “misclassification” of items due to “individual human error”. This only highlights how crucial it is that every single member of a company’s team is aware of the regulations and how to ensure all shipments remain compliant.
Compliance to regulations is absolutely critical in our industry, especially when noncompliance can have potentially catastrophic consequences, such as in the case of lithium-ion batteries which could overheat, causing burns, fire, and even explosions. Ensuring that products are classified, packaged, and labelled with the correct documentation is paramount. If in doubt, check, check and double check.
If you want to know more about the Amazon case, this article in the Financial Times provides a lot of detail. And if you want to know more about regulations specific to shipments of lithium-ion batteries, the International Air Transport Association (IATA) have produced a range of resources covering everything you need to know.
Finally, if you need help assessing your own supply chain for compliance, please get in touch with us to discuss your needs.