Assessing the Reality of Loss from Interoperable Data on the Pharma Supply Chain

The reality is, that the loss of interoperable data on the pharmaceutical supply chain costs more than dollars and cents. Lately, we hear the phrase “data interoperability” thrown around like an epidemic outbreak from the digital age. For one second, have we considered the true cost of “data interoperability on the pharmaceutical supply chain?” It’s not the economics, but rather the deficit on patient care.

Recently, I read an op-ed on Becker’s Hospital Review, Interoperability is an Ethical Issue, by the chairmen of the Center for Medical Interoperability. It made me think about the real cost of interoperable patient data across the entire healthcare system (from bench to bedside). We often don’t think or talk about the ethics of interoperable data, but rather we focus on the economics of it all. However, it is socially incumbent upon us, as technologists, industry executives, and advocates, to be conscious of the detriment to patient care as a result of interoperable data.

Let’s take a small sample of real-world losses arising from interoperable data on the pharmaceutical supply chain.

Loss Sample 1: Counterfeit, fake, illicit medicine 

  • Interpol claims pharmaceutical crime is a major threat to public health. The World Health Organization (WHO) estimates that up to 1% of medicines available in the developed world are likely to be counterfeit. This figure rises to 10% globally, but in some areas of Asia, Africa and Latin America counterfeit goods can form up to 30% of the market.
  • According to the NCBI, It has been estimated that fake anti-malarials contribute to nearly 450,000 preventable deaths every year.

Loss Sample 2: Drug shortage

A report from The Pew Charitable Trusts and the International Society for Pharmaceutical Engineering finds: 

  • Drug shortages result in nearly $230 million in additional costs annually for hospitals because of the higher costs of substitute drugs.
  • For the period 2011–14, FDA announced that there were 456 instances of drugs in shortage, a circumstance that can cause adverse outcomes for patients, including substitutions (alternate drugs) or modifications to treatment.
  • The U.S. Government Accountability Office (GAO) reports that 6 out of 10 health care associations say the situation is static or worsening.

A quick checklist where a technology such as blockchain, could potentially offset these economic and social losses from interoperable supply chain data:

  • Restores integrity through security, trust and transparency on the supply chain
  • Optimizes the process of delivering drugs to patients faster and more efficiently
  • Provides true visibility into inventory management to anticipate drug shortages
  • Better manage drug recalls and reduce patient exposure
  • Increase patient prescription adherence rates
  • Evolve into a patient-centric supply chain in line with the progression towards personalized medicine

We live in an era of rapidly emerging technologies that are explosive (in a good way) and beginning to converge. Just imagine a pharma supply chain where AI (artificial intelligence), the suite of IoTs (IHoT, IIot, IMoT, etc) and machine learning converge on the blockchain to “rev” up the pharmaceutical supply chain. What could be the outcome? Better medicine, better patient care. At the end of the day, not every emerging technology can solve every problem. We are going to start with the one that has shown the potential to make an impact at every stage of the pharmaceutical supply chain from production to patient.

If you are asking yourself “can blockchain deliver?” Perhaps, the real question should be “how will we know if blockchain can deliver if we don’t put it to the task?” That may put some balance in the evaluation process.

With this in mind, the IEEE Blockchain Group is presenting the Pharma Supply Blockchain Forum on 6 June 2017 in Rockville, MD. We are going to exclusively present blockchain in terms that best resonates with pharmaceutical executives in order to fully assess the barriers and opportunities to adoption, the necessity of data governance and technical standards, the regulatory agencies’ perspective on the technology, and the untapped benefits of the data trapped within the pharmaceutical supply chain.

If you are a professional who embraces and advocates innovation within the pharmaceutical framework, we invite you to participate. For full details visit http://blockchain.ieee.org/psc-forum-2017/.

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The First Blockchain Conference Exclusively for the Bio/Pharma Industry

Today, DisruptiveRx™ and MAD Event Management announced the first blockchain conference series exclusively for the bio/pharmaceutical industry. The first in the series will take place on November 16, 2016 in Edison, NJ – www.RXBlockchainBootcamp.com.

“Blockchain applications will disrupt pharma’s approach to data management making it more secure, accessible, and utile for competitive advantage.”

Tweet this: DisruptiveRx presents the first blockchain conference for the bio/pharma industry on Nov 16 in NJ!

Applications of blockchain technology have been stealing news headlines for more than a year with the expectation of redefining how businesses operate similarly to what the internet did more than 30 years ago. The pharmaceutical industry is ripe to take advantage of the benefits of blockchain applications to redesign its data strategy so that it can be better protected, leveraged and managed for optimal operational efficiency and competitive advantage.

DisruptiveRx Pharma Blockchain Bootcamp
Blockchain offers pharma the potential of leveraging data for competitive advantage – efficiently and securely.

Although pharmaceutical organizations have many assets in their repertoire, none may be as least leveraged as its data. Blockchain technologies not only offer a decentralized approach to securing, managing and utilizing data but also enables unprecedented access to owned data and that of trusted partners within a secure transfer gateway.

The Pharmaceutical Blockchain Bootcamp is a critical entry point for bio/pharmaceutical and life science executives, who are in the business of securing, managing and leveraging data from R&D to clinical to commercialization. They will get introduced to the explosive potential of this technology, the strategic business and regulatory considerations to support its implementation, and where in the enterprise it could have immediate impact. The speakers will be experts with a unique mix of knowledge of pharmaceutical operations and blockchain technologies and where it will make the most significant contribution to the data strategy.

Due to the interactive nature of the educational sessions, seating is limited to only 75 professionals. For full details on registration and who should attend, visit www.RXBlockchainBootcamp.com.

Tweet this: Save $200 before Oct 15 on early Pharma Blockchain Bootcamp registration!

 

In their own way, the British have just disrupted! They wanted change and now it’s time for the the EU and the rest of the world to embrace it. As many may wonder, have they REALLY realized how much will have to change?

Just this morning, I was in discussion with one of the speakers for the 2016 DisruptiveRx Summit, an experienced global serialization expert. He mentioned to me, “I wonder if the pharma industry realizes the impact of Brexit on serialization regulation in Britain? Their current standards are that of the EU.” So, as of today, Britain is no longer with the EU, what are their regulations surrounding serialization?  The answer right now is TBD!

Before the breaking news of Brexit, global serialization was already a challenge. Serialization is supposed to ensure the integrity of the drug supply chain so that manufacturers, packaging and logistics providers, patients and regulators know the drug supply chain is safe and secure.

If one considers the theory behind serialization at the unit level; the concept and outcome are rather simple: assign a unique code to each unit, track its journey through the supply chain and ensure it gets delivered to the patient without any issues along the way.

Of course in theory, everything looks perfect! Achieving true visibility through the entire drug chain continues to be a challenge. Part of the reasoning for this challenge is the madness around serialization standards.

Each pharmaceutical company come with a complex web of packaging, logistics, track and trace providers, and if you have CMOs integrated into your process, that adds another layer of difficulty. Each of these providers has their own technology, system and method of serialization making harmonization and collaboration within the organization a rather daunting task leading to inefficiency and doubt in the supply chain. Making it more complicated, if you are a multinational company, you need to take all these existing variables and multiply them by the number of international regulatory bodies resulting in an unsolved puzzle of multiple entities that all need to align together.

Now back to Brexit. Their new-found “freedom” means that their standards can no longer be part of the EU. So, what is the UK’s regulatory guidance on serialization? The answer is unknown. At what does that mean for Pharma? Another serialization standard that will require more investment to secure consultants and technology firms to ensure they are compliant with British standards.

Despite all this compliance, there is no guarantee that the drug supply chain is secure and safe! Welcome to the simplicity of serialization…

The 2016 DisruptiveRx Summit will discuss global trends and issues such as the impact of Brexit while presenting forward-looking technologies and ideas to help pharma executives better connect their business strategy with innovation through disruptive thinking.  Executives in manufacturing, enterprise IT and supply chain management at bio/pharmaceutical companies are invited to join us on November 1-2, 2016 in Raleigh, NC. Together with industry innovators, experts, tech gurus, and regulators, we will explore explosive technologies and breakthrough ideas on innovations in supply chain management and advancements in manufacturing technology to create a more agile, efficient and secure drug supply chain. Learn more at www.DisruptiveRxSummit.com.

If you have any thoughts on this topic, share it on the DisruptiveRx blog.