	Supply chain security is of crucial importance in the pharmaceutical industry. Should counterfeit or falsified drug products enter distribution channels and end up with a patient, not only is the reputation of the drug company at stake but also the health, and even in severe cases the life, of the end user.

	To combat counterfeiting within the pharma industry, regulatory authorities have been putting various measures in place. One example is the Falsified Medicines Directive (FMD), which was implemented in Europe on 9 February 2019. 

	Compliance with the new FMD regulation means that pharmaceutical companies must ensure all drug products have safety features placed on the packaging, comprising a unique identifier and an anti-tampering device. These safety features will then be used by medicines suppliers to verify and authenticate the products prior to distribution to the public.

	Radio-frequency identification (RFID) technology has been identified as a potentially useful tool to track items in the pharmaceutical supply chain. “RFID is the transmission of, at minimum, a unique identification (UID) between a transmitter and a reader using radio waves,” explains Gillian Ewers, vice-president of marketing at PragmatIC, a company that specializes in flexible electronics.

	“The transmitter could be a package that includes an RFID tag,” she says. “A tag (which is sometimes referred to as an inlay, as they are inlaid behind labels or inside packages) in this case is usually simply an integrated circuit (IC) mounted on a substrate (paper or film) that also has an antenna either etched or printed on to it. This is the simplest form of a tag, called a passive tag, as it contains no batteries and needs the reader to provide it with the energy to wake up and send the signal to the reader.”

	It has been reported that RFID is a more reliable technology than two-dimensional barcoding and is more difficult to counterfeit. However, uptake of the technology as a tracking and identification solution has been limited in the pharmaceutical industry, despite it becoming more affordable as the technology has matured over time. 

	Ewers details some of the main applications of RFID technology in pharma. “For supply chain management, RFID technology can not only help companies to manage inventory, control stock, and, as such, manage costs effectively, but can also help in grey market prevention-where products are bought in a low-priced country and sold for a higher price in a different country,” she says.

	Through assigning an invisible unique identifier (UID) to each product, it is possible to audit complete stock at the point of sale, or anywhere along the supply chain, Ewers explains. “Key to this is it being invisible, so machine readable barcodes are no good (plus require digital printing to be truly unique), custom solutions that are not readable by commercially available RFID readers would be ideal,” she adds. “The UID can be assigned to a specific end retailer at POS.”

	As mentioned earlier, authentication is an obvious application of RFID. The technology can be used to track and trace various materials and products throughout the supply chain and, hence, reduce the likelihood of counterfeit or falsified products entering distribution channels. “Furthermore, it is possible to use RFID technology to provide consumers with information about the medicine through near-field communication enabled devices and tags,” Ewers continues. 

	The ability to connect the patient to the drug manufacturer through smart packaging has been forecasted as an area of growth in pharma (1). Through smart packaging, companies are offered additional benefits, such as improved patient adherence, which inevitably leads to higher rates of therapeutic success. 

	“Non-adherence is a significant problem across the world,” asserts Ewers. “One estimate puts the cost per year in the United States at $290 billion (2) in ‘otherwise avoidable medical spending’.” Reasons behind non-adherence are numerous, with the simplest being that patients forget to take the dose. There is an easy solution to remedy this issue, which is a reminder on the patient’s smartphone or wearable device, for example, Ewers notes. 

	“Another reason for non-adherence is failure to re-order in time, which again can be automated, either purely by time or by the packaging,” she says. “Other possibilities are regulating dosages, providing better information and reporting to remove the fear of taking a medicine and its potential side effects. There is also talk of using technology to motivate people to take medicine (3), especially in the case of ones given to reduce the probability of an event occurring.”

	“In terms of FMD compliance, RFID can be used to assign a digital UID to each medical product, which means the technology can be used in combination with an appropriate software platform for serialization,” she continues. “When the technology is integrated onto packaging, it needs to be read, and so an appropriate software package is required to ensure that the UID is actually unique and to enable reporting of any exceptions to the appropriate data controllers.”

	“RFID tags require an additional step in the production of labels and packages to insert the tags,” notes Ewers. “There are many packaging suppliers that are already able to perform this step and so pharma companies, without in-house capabilities, should be looking to partner with relevant label manufacturers and packaging converters.” 

	PragmatIC offers a technology platform that features flexible integrated circuits (FlexICs). As the flexible options are thin and low-cost compared with traditional RFID systems, they are ideally suited for pharma applications, reveals Ewers. “The first ConnectIC product family, which is aimed at RFID applications, was announced in February 2019,” she says. “Additionally, there is a range available for closed RFID systems, which when coupled with a low-cost custom reader can provide a cost-effective solution for covert tagging of products to monitor grey market division, for example.”

	The flexible tech is currently manufactured in the United Kingdom on a specific production system, FlexLogIC, which is an automated and scalable manufacturing model for FlexIC production. “As adoption of the technology is happening globally,” Ewers adds, “we envisage FlexLogIC systems being implemented around the world for the manufacture of FlexICs close to where they will be integrated.”

,” Report, March 18, 2016.
	2. HealthPrize Technologies, “

Medication Adherence: Pharma’s $637 Billion Opportunity

, [accessed July 8, 2019].
	3. Harvard Chan School, “

Increasing Cholesterol Medication Adherence with Financial Incentives May be Cost-Effective

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Feature

Radio-frequency identification on packages aid drug supply-chain security.

Safe and Sound with RFID

	As Industry 4.0 takes hold, simulation via virtual reality (VR) or augmented reality (AR) is assuming larger roles in machine design, engineering, construction, operation, and maintenance. VR offers an immersive experience in a fully simulated setting; AR overlays digital elements on a real-world environment. 

	Bausch & Ströbel is already using AR and VR technologies. VR is helping its design teams fix problems in the development phase before pharmaceutical fill/finish machine construction begins. Using VR, the design team can reduce turbulence and areas of low velocities, avoid cross-flows above containers, and show static pressure and upward flow to optimize air-flow and ensure the cleanest possible environment for filling. VR also can help check ergonomic features, such as reachability for machine access by short or tall operators. “VR allows earlier decision making and helps determine if adaptations are needed,” explains Florian Naser, an engineer in the Data Processing Organization, Systems Product Creation, Applications at Bausch & Ströbel. 

	VR can be used to train operators before the machine is installed and whenever new hires come onboard. There are several advantages. VR training doesn’t tie up the machine, and all operators are trained the same way. VR can also support maintenance because it can ensure that the proper spare parts are on hand and help optimize machine modifications.   

	AR also can assist with machine troubleshooting by highlighting the problem area on a tablet computer that is brought to the machine. AR can identify the correct part and part number, zoom in, offer different views, present the virtual view next to the actual machine, and provide visual instructions for the operator or maintenance person, eliminating the need to search through paper-based standard operating procedures. “Nothing is forgotten or out of sequence, and the program is easily edited if changes are needed,” says Naser. 

The Industry 4. 0 tools of augmented and virtual reality aid pharmaceutical fill/finish equipment design, training, and troubleshooting.

Equipment and Processing Report-09-18-2019

Safe and Sound with RFID

Augmented and Virtual Reality in Machine Design