Purav Gandhi, Healthark Insights

Patient safety and medication adherence are some of the major concerns in the pharmaceutical industry. With an increase in medication errors, counterfeit medicines, and supply chain mismanagement, the industry has seen a rising demand for transparency, security, engagement, and digitization.

Smart packaging has emerged as a key solution to address these problems by integrating digital tools such as NFC (near field communication), digital tags readable by smartphones that store product information, certifications, and tracking details; QR codes (quick response codes), scannable codes that verify authenticity and provide instant product details to consumers; RFID (radio-frequency identification), radio tags that give each drug a unique ID for tracking and information sharing; and other similar new technologies into the packaging of pharmaceutical products.

The integration of such technologies offers several benefits like maintaining drug authenticity, allowing user engagement, enhancing patient adherence, enabling real-time tracking, and ensuring overall drug safety.

The cost of medication errors and counterfeits

As per estimates by WHO, the global cost of medication errors can be as high as $42 billion per year.

 Moreover, in 2022, INTERPOL seized over 3 million units of illegal and counterfeit medicines in a global mission focused on cracking down on illegal online pharmacies.

 Such high level of inefficiencies in the industry makes smart packaging solutions much more relevant in today’s environment by helping to tackle these problems through innovations, including AI-driven label management, blockchain-enabled traceability, and digital adherence tools.

This article will dive into such innovations which are supporting the industry in overcoming major challenges.

AI-driven packaging: Reducing errors and accelerating compliance

Pharmaceutical packaging is not just limited to containing the drug—it also requires more complex features like storage safety, regulatory compliance, patient ease, and label clarity. With recent developments in AI and a growing demand for precision and patient-centricity, healthcare companies have started to integrate AI tools into medical packaging which can provide real-time data, maintain consistency, monitor product integrity, and reduce time-to-market.

Unlike smart packaging, traditional packaging involves manual artwork management and labeling, leaving high scope for human errors that can lead to delays and regulatory penalties. However, with the help of AI, these processes are automated, leaving minimal scope for human errors and ensuring regulatory compliance, while also accelerating time-to-market.

AI tools help ensure consistency in pharmaceutical packaging and labeling for regulatory compliance by automating content verification, pattern recognition, and real-time comparison with regulatory standards and product data. These tools use natural language processing (NLP) and computer vision to analyze both text and visual elements of packaging artwork, identifying discrepancies such as missing warnings, incorrect dosage information, or improper symbols.

Automation also streamlines the collection and organization of regulatory data, reducing manual effort and the risk of non-compliance while improving decision-making. By consistently including accurate dosing information, warnings, and proper symbols, AI helps companies meet compliance requirements, protect patient safety, and maintain brand integrity, while reducing operational risks and potential financial losses or product recalls.

An example for this is Almirall, a global pharmaceutical company that uses Esko’s WebCenter platform to streamline its artwork management for over 2,000 packaging designs, and consequently improving efficiency and reducing turnaround time. Another example can be AstraZeneca, which uses Loftware’s Smartflow platform to manage over 10,000 artwork changes annually, which has helped the company to reduce lead times by 60% and ensure compliance across 1,000+ stakeholders.

Smart packaging technologies like AI, IoT, RFID, and blockchain are transforming pharmaceutical supply chains by improving product authenticity, safety, and traceability.

AI-driven artwork and labeling automation reduce errors, ensure regulatory compliance, and accelerate time-to-market for pharmaceutical products.

Blockchain-enabled serialization and IoT sensors provide real-time visibility and cold-chain monitoring, helping to combat counterfeit drugs and enhance patient safety.

Blockchain and IoT: Strengthening supply chain security

As mentioned earlier, counterfeiting of pharmaceutical products has emerged as a major challenge in the pharmaceutical industry in recent times. Apart from this, there are other security threats, such as theft and supply chain mismanagement. Such challenges can be attributed to lack of traceability and transparency in the supply chain, which can be effectively solved with the help of modern AI tools like internet of things (IoT) devices and blockchain technology. 

Integration of IoT devices such as RFID tags, NFC, QR codes, and temperature sensors in medical packaging has emerged as an effective way to track pharmaceutical products in the supply chain, improve security, and enhance management. For example, Merck has started using temperature sensors for packaging of its biologics products to ensure smooth cold chain management. Another example of IoT integration is Roche, which began using RFID tags to enhance traceability of its products throughout the supply chain.

In addition to IoT devices, blockchain has also become a key solution to traceability and security problems in the pharma sector. Specifically, blockchain technology acts as a ledger for pharmaceutical products and adds an extra layer of security. It allows effective and efficient tracking of the products by the manufacturers, wholesalers, and pharmacies. With the help of such visibility, these stakeholders can easily verify the authenticity of the products in real-time, which not only helps to prevent counterfeit drugs from entering the market but also ensures that patients receive safe medicines.

The convergence of blockchain and IoT technologies in pharmaceutical supply chains offers several additional advantages. For instance, IoT-enabled sensors can provide real-time monitoring of environmental conditions such as temperature and humidity during storage and transport, ensuring that sensitive drugs maintain their efficacy and safety throughout the supply chain. Automated alerts generated by these devices can immediately notify stakeholders of any deviations, enabling rapid intervention and minimizing the risk of compromised products reaching patients.

Blockchain technology further enhances data integrity by creating immutable and tamper-proof records of every transaction and movement within the supply chain. This level of transparency not only deters fraudulent activities but also supports regulatory compliance by providing auditable trails for inspections and recalls. The use of smart contracts on blockchain platforms can automate verification and authorization processes, reducing administrative overhead and the risk of human error.

Moreover, the serialization process—where each drug package is assigned a unique identifier-combined with blockchain—enables end-to-end visibility from the manufacturer to the end consumer.

The best example for use of blockchain in smart packaging is the MediLedger Project, which involves many big companies like Pfizer, Genentech, Amgen, Sanofi, and Cardinal Health. The project supports the FDA’s Drug Supply Chain Security Act (DSCSA) by using blockchain to securely track and verify pharmaceutical products throughout the supply chain. This initiative has helped the participating companies in ensuring regulatory compliance, enhancing security of the products and reducing the scope of drug counterfeiting.

Smart packaging has brought in some major improvements in the pharmaceutical industry by making it more patient-centric and secure. While AI solutions are shortening the time-to-market by automating label and artwork management, blockchain and IoT devices are improving product safety by lowering the risk of theft or counterfeiting. Moreover, various digital tools are effectively improving patient adherence leading to patient well-being.

The combination of these technologies has significantly changed the way pharmaceutical companies engage with their customers and handle their products in the supply chain. The application of such technologies in pharmaceutical packaging will not only solve present issues, but also propel the sector towards more effective, patient-centered care as the adoption grows steadily.

Purav Gandhi is the founder and CEO of Healthark Insights.

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https://lbbonline.com/news/smart-packaging-for-pharma-ensuring-safety-compliance

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Articles

These innovations are revolutionizing pharmaceutical packaging by enhancing drug safety, combating counterfeiting, ensuring regulatory compliance, and improving patient adherence across the supply chain.

Smart Packaging in Pharma: Driving Adherence and Safety Through Digital Innovation

Logistics play a very important role in the pharmaceutical industry, as the activities involved are highly sensitive to time and quality control. It involves delivering drugs to the right place, at the right time, in a safe and secure manner, and at a competitive operational cost. Given this crucial nature of activities, drug shipping faces multiple challenges, including the requirement of temperature-controlled transportation, regulatory compliance, difficulties in demand forecasting, and the need for timely deliveries.

In recent years, many companies have introduced software and artificial intelligence (AI)-driven innovations to help the pharmaceutical logistics industry by addressing these gaps and loopholes. With such advancements, AI has emerged as a key tool to overcome the above challenges and, in turn, optimize pharmaceutical shipping and delivery processes.

Pharmaceutical logistics can be complicated due to the multiple challenges discussed above, but any product shortages due to human errors or delays in delivery can lead to compromised patient safety. As a result, many large pharmaceutical companies have started to rely on third-party logistics (3PLs) providers for managing transportation, warehousing, and quality control of their products. Many large 3PLs, such as Maersk, DHL, UPS Healthcare, and FedEx offer specialized services, including temperature-controlled delivery and regulatory compliance, which are vital for safe and efficient distribution of pharmaceutical products.

AI: Streamlining pharma logistics by filling the gaps

In recent times, AI has become the talk of the town for its potential applications in every sector, including logistics. When it comes to pharma logistics, software and AI-driven innovations are transforming operations and helping in overcoming challenges in the following six pivotal ways:

Pharmaceutical shipments often face various on-road hurdles like traffic, weather changes, natural disasters, or geopolitical factors that could potentially lead to delays in deliveries. Such delays not only affect the schedules but also pose a risk to the efficacy of pharmaceuticals. In such a scenario, AI has emerged as a solution to tackle these challenges by optimizing shipping routes that analyze real-time traffic, weather conditions, and historical data.

 This approach helps in ensuring timely delivery of shipments, while minimizing the risks of degradation of pharmaceutical products during transit.

 An example for this can be Maersk, which uses AI to dynamically plan shipping routes by evaluating traffic, weather patterns, ocean currents, and other factors.

 Pharmaceuticals are required in every region of the world; as a result, pharmaceutical deliveries often span thousands of miles. This makes tracking of shipments a very complex task. However, AI technologies have now made real-time tracking of delivery vehicles possible, and are able to provide up-to-date status information to all concerned stakeholders. This approach not only increases transparency but also keeps customers informed about any potential delays, so that they can make required decisions accordingly.

 One example is FedEx, which uses AI for predicting potential delivery delays based on weather conditions and traffic, and keeps customers notified of these factors in real-time.

 Apart from optimizing the operations, AI can also help in reducing delivery management costs for the suppliers. It can decrease fuel costs with the help of dynamic route planning, can reduce labor costs with the help of automation, and can lower vehicle maintenance expenses by optimizing driving patterns and using predictive analytics. All these savings allow businesses to allocate these resources to other important tasks and long-term goals.

As discussed earlier, temperature control during transit is critical for maintaining the efficacy of pharmaceuticals. AI-powered internet of things (IoT) devices can be very helpful in this space. These devices continuously monitor the temperature and humidity levels of the shipment during transit. Such an approach saves time, as the drivers don’t need to frequently stop and inspect the goods. In case of any temperature fluctuations, the team is instantly notified about the deviation.

 For example, DHL SmarTrucking—a service officed in India—uses IoT-enabled sensors to provide real-time temperature tracking of shipments to their customers.

Regulatory compliance and audits are an integral part of pharmaceutical logistics since quality assurance is required at every step. AI can help in maintaining compliance by ensuring that transit regulations are followed at all times. It can continuously monitor the temperature data and compare it with industry standards to make sure that everything is under control. Moreover, it can notify the team in case of any deviations and potential risks to shipment, so that they can take corrective actions on time. One example of this is Kuehne + Nagel, who utilizes its "KN PharmaChain" solution to guarantee compliance with the strict transportation regulations governing pharmaceutical products in order to provide a standardized logistics service.

 By using predictive analytics on historical data, AI can predict future market trends, such as peak demands and seasonal demands. This information can help suppliers prepare for unexpected demand via surges or dips in the market, allowing them to manage number of vehicles and delivery intervals accordingly.

 Additionally, AI can use real-time data from IoT sensors on vehicles to assess vehicle health and identify any potential failures. This approach can reduce unexpected failures and minimize downtime, eventually optimizing the operations.

 For example, UPS uses sensors in its trucks to generate important information such as tire pressure, engine temperature, freight weight, etc. and use it to predict maintenance needs of the vehicles.

We look forward to seeing how innovations in this sector continue to be brought to light in the years to come. Will other forms of technology emerge?

Purav Gandhi is the CEO of Healthark Insights.

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How artificial intelligence tools are helping to optimize the pharmaceutical transport process.