Smart Packaging for Drug Tracking and Anti-Counterfeiting

I. Introduction

According to Interpol, the problem of counterfeit pharmaceuticals is growing, with more than a million people dying from them annually. [Southwick, 2017] For example, according to estimates, between 72,000 and 169,000 children may suffer pneumonia each year as a result of obtaining false medications, and an additional 116,000 deaths may result from phony anti-malarial drugs. [OECD, 2020] Between April 2020 and April 2021, the US seized 9.5 million counterfeit pills, even though counterfeit drugs are thought to be less than 0.2% of the market in the US. [Bale, 2005] [White, 2023] The prevalence of counterfeit drugs is thought to be much higher in developing and “non-western” countries (Russia 10%, India 15-20%, South East Asia 5-10%, Latin America 10-20%, Africa up to 60%). [Bale, 2005]

Counterfeit drugs pose a significant threat to public health, leading to adverse reactions, treatment failure, and even fatalities. According to the World Health Organization (WHO), counterfeit medicines represent a multi-billion dollar industry. To address this issue, smart packaging offers innovative solutions to verify the authenticity of drugs throughout the supply chain.

Smart packaging refers to the integration of advanced technologies into traditional packaging materials to provide additional functionalities beyond containment and protection. In recent years, the pharmaceutical industry has witnessed a growing trend towards the incorporation of smart packaging technologies to enhance drug tracking and combat the menace of counterfeiting. The smart packaging global market value is expected to reach approximately US$ 52.1 billion by 2032. [Market.Us, 2023] Assuming pharmaceuticals represent a quarter of the smart packaging market, the segment will represent US$ 13 billion.

Smart packaging technologies enable real-time monitoring, tracking, and authentication of drugs, ensuring patient safety and regulatory compliance. In this article, we will explore the various applications and benefits of smart packaging for drug tracking and anti-counterfeiting.

II. Quick Response (QR) Codes

A QR code, or quick response code, is a type of two-dimensional barcode that is used to store and transmit information. It consists of dark squares arranged on a white background, typically in a square shape. QR codes can store various types of data, including text, uniform resource locators (URLs), contact information, and more. [DENSO WAVE, 2013]

QR codes are mainly used for quickly accessing online information. When scanned using a smartphone or tablet's camera, the QR code is decoded and the information it contains is displayed on the device. This allows users to easily access websites, download apps, view product information, make payments, and perform various other actions.

QR codes are commonly used in marketing and advertising to provide a quick and convenient way for users to access websites, promotional offers, or additional product details. They can also be found on business cards, event tickets, product packaging, and other physical objects to provide a digital link or enhance user engagement.

QR codes are also widely used in smart packaging for drug tracking and anti-counterfeiting purposes. These QR codes can store unique product identification codes, the name of the Active Pharmaceutical Ingredients (APIs), the brand name, the name and address of the manufacturer, the batch number, the batch size, the date of manufacture, and the date of expiry or retesting. By scanning the QR code, patients and healthcare professionals can access a wealth of information about the drug, including its authenticity and supply chain history.

QR codes were invented in Japan and have been popular in the country for the past decade. [DENSO WAVE, 2013] In Japan, the package insert bundled with pharmaceutical products has been abolished and replaced by a barcode. The GS1 standard barcode, which may take the form of a QR code, is printed on the outer box of the product and is used to access the electronic version of the package insert, which is published on the website of the Pharmaceuticals and Medical Devices Agency (PMDA) . [Nagaoka, 2022] The barcode system allows for the provision of up-to-date information on the proper use and safety of pharmaceutical products, and it also reduces paper waste and the cost of printing and distributing package inserts.

The Central government of India has mandated the use of QR codes on the packaging of 300 life-saving drugs from August 1, 2023. The QR codes must contain a unique product identification code, the proper and generic name of the drug, the brand name, the name and address of the manufacturer, the batch number, the date of manufacturing, the date of expiry, and the manufacturing license number. [Yadav, 2022] [Moneycontrol, 2022]

The inclusion of QR codes on pharmaceutical packaging is considered favorably by EU regulators, while not specifically mandated, as it facilitates digital communication between manufacturers and patients. Paper package inerts are still required. [eLeaflet, 2018]

In the USA barcoding of drug packaging is a clear requirement mandated in the Drug Supply Chain Security Act (DSCSA). Each packaged drug must have a "product identifier" attached to it or imprinted on it, according to the DSCSA. The term "product identifier" refers to a graphic containing the standardized numerical identifier [SNI], lot number and expiration date of the product. [Cardinal, 2017] This graphic could be a QR code.

In Canada, the Roadmap to the Implementation of GS1 DataMatrix Barcodes on Pharmaceuticals guides a community-led deadline of 2025 for system-wide capabilities in Canada to scan, store and process a GS1 DataMatrix barcode that contains the Global Trade Item Number (GTIN - the number below the old 1D barcode), lot number and expiry date of the drug. The GS1 DataMatrix may take the form of a QR code. [GS1, 2022]

III. Radio Frequency Identification (RFID)

Another key technology used in smart packaging is RFID (Radio Frequency Identification). RFID tags are embedded in packaging materials or labels to provide a unique electronic identity to each drug unit. [Forcinio, 2020] These tags can be scanned at various checkpoints in the supply chain, such as manufacturing facilities, distribution centers, and pharmacies. The data collected through RFID technology allows for real-time tracking and tracing of drugs, ensuring their integrity and authenticity.

Near Field Communication (NFC)

Another important technology employed in smart packaging is NFC (Near Field Communication). NFC is a specific subset of RFID technology that operates in the HF (high-frequency) range, typically around 13.56 MHz. It allows the transfer of data between different devices without any Internet connection. [impacX, 2021] NFC is commonly used for contactless payment systems (e.g., Apple Pay and Google Pay), access control cards, and transit cards. NFC has also been incorporated into select food and drink packaging such as olive oil, wine, and certain limited edition Oreos, to guarantee authenticity, facilitate re-order, and provide an enhanced experience. [Blue Bite, 2022] It has also been adopted by certain players in the cannabinoid industry, which overlaps with the pharma industry, for the same reasons.

For pharmaceuticals, NFC can also enable communication between smart drug packaging and a cellphone or other NFC-enabled device. By simply hovering the smartphone near the package, patients could access detailed information about the drug, including its origin, expiration date, and dosage instructions. This could not only help patients make informed decisions but also enable healthcare professionals to verify the authenticity of drugs before administration. [ST.Com, 2023] The full potential of NFC in pharmaceutical packaging has yet to be realized.

IV. The Benefits of Smart Packaging

The benefits of smart packaging for drug tracking and anti-counterfeiting are numerous. Firstly, it enhances patient safety by ensuring that genuine and safe drugs reach the end-users. Patients can verify the authenticity of drugs before consumption, reducing the risk of adverse reactions or treatment failure. Additionally, smart packaging technologies enable the recall of specific drug batches in case of safety concerns, as the entire supply chain can be easily tracked and traced.

Moreover, smart packaging improves supply chain efficiency and reduces operational costs. Real-time monitoring of drug shipments enables better inventory management, reduces wastage, and prevents stockouts. Pharmaceutical companies can also detect and address supply chain bottlenecks promptly, ensuring timely delivery of drugs to patients.

Furthermore, smart packaging could contribute to regulatory compliance. Regulatory authorities could potentially take advantage of RFID technology to monitor the movement of drugs in real-time, which may enhance adherence to quality standards and prevent the circulation of counterfeit drugs. By implementing smart packaging, pharmaceutical companies can demonstrate their commitment to patient safety and regulatory requirements.

In the future RFID technology may enable the context of the packaging to be used to communicate with the consumer. For example, if they tap the box with their smartphone and the "factory-sealed" ID is recognized. In this instance, the consumer may receive messages on the components of the product or an advertisement aimed at persuading them to purchase it. [Lindsay, 2016]

Once the factory seal has been broken and the 'opened' ID is detected the messaging could assume that the consumer is in consumption mode, and may focus more on usage instructions or repurchase information.

V. Conclusion

In conclusion, smart packaging technologies could revolutionize drug tracking and anti-counterfeiting efforts in the pharmaceutical industry. QR code, RFID, and NFC technologies enable real-time tracking, tracing, and authentication of drugs, ensuring patient safety and regulatory compliance. The adoption of smart packaging not only improves patient safety but also enhances supply chain efficiency and reduces operational costs. As the pharmaceutical industry continues to evolve, smart packaging will play a crucial role in combating the menace of counterfeiting and ensuring the delivery of safe and authentic drugs to patients worldwide.

VI. Sources

■“11 Great Examples of Smart Packaging.” Blue Bite, Blue Bite, 30 Aug. 2022, www.bluebite.com/brand-strategy/smart-packaging-examples.

■ Bale, Harvey. “Pharmaceutical Counterfeiting: Issues, Trends, Measurement.” WIPO/OECD Workshop. ~2005, https://www.oecd.org/sti/ind/35650404.pdf.

■ DENSO WAVE. “History of QR Code | How Was the QR Code Created? | How Has It Come to Be Used so Widely? | And What Is Its Future?” History of QR Code | QRcode.Com |  2013, www.qrcode.com/en/history/.

■ Forcinio, Hallie. “Pharma Packaging Employs RFID Technology in Labels and Caps.” PharmTech, PharmTech, 21 Sept. 2020, www.pharmtech.com/view/pharma-packaging-employs-rfid-technology-in-labels-and-caps.

■ “GS1 DataMatrix Barcodes on Pharmaceuticals in Canada.” GS1 Canada, July 2022, gs1ca.org/pharmacy/roadmap/.

■ “Guidelines for Bar Coding in the Pharmaceutical Supply Chain.” Cardinal Health, Nov. 2017, www.cardinalhealth.com/content/dam/corp/web/documents/data-sheet/Cardinal-Health-barcode-quick-start-guidelines.pdf. 

■ “How NFC Can Help Pharmaceutical Brands Ensure Patient Safety.” ST.Com, Aug. 2023, www.st.com/resource/en/brochure/how-nfc-can-help-pharmaceutical-brands-ensure-patient-safety.pdf.

■ impacX team. “Interesting Facts about NFC Based Packaging Technology.” impacX, impacX, the Internet of Packaging company, 18 May 2021, impacx.io/blog/nfc-based-packaging/.

■ Lindsay. “Scaling up the Pharma Sector’s Smart Packaging Revolution.” Pharmaceutical Technology, 8 June 2016, www.pharmaceutical-technology.com/features/featurescaling-up-the-pharma-sectors-smart-packaging-revolution-4872817/?cf-view. 

■ Market.Us. “Smart Packaging Market Size Is Valued at USD 52.1 Bn by 2032: Cagr of 6.3%.” GlobeNewswire News Room, 5 Apr. 2023, www.globenewswire.com/en/news-release/2023/04/05/2642135/0/en/Smart-Packaging-Market-Size-Is-Valued-At-USD-52-1-Bn-by-2032-CAGR-of-6-3.html.

■ Moneycontrol. “From August 2023, QR Codes Will Be Affixed on Packaging Label of Top 300 Drug Formulations.” Moneycontrol News, 18 Nov. 2022, www.moneycontrol.com/news/trends/health-trends/from-august-2023-qr-codes-will-be-affixed-on-packaging-label-of-top-300-drug-formulations-9559871.html.

■ Nagaoka, Makoto, et al. "E-labeling system in prescription medicines in Japan: measures and perspectives in pharmaceutical industry." Translational and Regulatory Sciences, vol. 4, no. 1, 2022, pp. 12-19. https://doi.org/10.33611/trs.2022-001. 

■ OECD/EUIPO. “Trade in counterfeit pharmaceutical products.” Illicit Trade, 23 Mar. 2020, pp. 1–92, https://doi.org/10.1787/a7c7e054-en.

■ Southwick, Natalie. “Counterfeit Drugs Kill 1 MN People Annually: Interpol.” InSight Crime, 6 Oct. 2017, insightcrime.org/news/brief/counterfeit-drugs-kill-1-million-annually-interpol/.

■ “The QR Code on Medicinal Products Packaging.” The eLeaflet Blog, 26 Aug. 2018, blog.eleaflet.eu/en/use-of-qr-code-on-medicinal-products-packaging.

■ White, C. Michael. “Dangerous Counterfeit Drugs Are Putting Millions of US Consumers at Risk, According to a New Study.” The Conversation, University of Connecticut, 30 June 2023, https://theconversation.com/dangerous-counterfeit-drugs-are-putting-millions-of-us-consumers-at-risk-according-to-a-new-study-183585.

■ Yadav, Laxmi. Drug Manufacturers Hail Draft Rule Mandating QR Code on Packaging of Top 300 Brands of Drugs, Pharmabiz.com, 24 June 2022, www.pharmabiz.com/NewsDetails.aspx?aid=151588&sid=1. 

VII. About The Author

David  Orchard-Webb, Ph.D., is a technical writer with broad interests including  health & technology writing, plus extensive training and knowledge of  biomedicine and microbiology. My Ph.D. and postdoc were in oncology and  developing cancer medicines. I provide technical medical and other writing  services for projects ranging from “knowledge automation” to pure pharma, to  food safety, to the history of science, and everything in between. I also  provide white papers, ebooks, meta-analysis reviews, editing, consulting,  business, and market research-related activities in biomedicine, technology,  and health. In addition to its well-known role in the development of  medicines, I am a big believer in biotechnology’s ability to revolutionize  industries such as food-tech, agtech, textiles & fashion.