Radio Frequency Identification (RFID) is one of the leading technologies under Automatic Identification (Auto ID). Auto ID technologies like bar codes, magnetic links, smart cards and RFID etc, in a way are used for tracking things for purposes, controlling information, and material flow, especially for large production networks. RFID technology has originally triggered a revolution in the automated identification technologies by increasing efficiencies, reliability and improving profitability. The use of this technology exploded into mainstream only during the past couple of years, although it has been around since World War II.
RFID vs. the traditional bar codes, especially in the area of healthcare and pharmaceuticals, made a simple process with RFID that can store vast amounts of information with the necessary details of the drug.
Unlike bar codes, RFID doesn’t require contact or line of sight connection with the object, which closes the gap between the physical object and information system.
The introduction of RFID technology is integrated into various applications ranging from inventory control to human tracking.
RFID market in Pharmaceuticals:
The major problems increasing with the present pharmaceutical industries are “counterfeiting”, “gray market”, and “out of stock”. These issues can be nearly eradicated by Radio frequency identification (RFID).
Pharmaceutical companies spend approximately $802 million to develop a new drug. These drug development cost pressure are due to clinical trials. The clinical trials are based on development of the protocol and it takes twelve years for a drug on average to travel through the clinical testing phases to reach the patients. According to information published by FDA in 2004, a new drug has just an 8% chance of achieving final approval and being brought to the market.
According to Dr Peter Harrop, Raghu Das and Glyn Holland, “the market for RFID tags and systems will rise rapidly from $94.6 million in 2009 to $1.43 billion in 2019. This will be because of item level tagging of drugs, other medical disposables and Real Time Locating Systems (RTLS) for staff, patients and assets to improve efficiency, safety and availability and to reduce losses. This phenomenon was primarily driven by US for the need of improved anticounterfeiting, improved stock control and recalls”.
According to IDTechEx group of RFID analysts, “2006 was a pivotal year for RFID in healthcare and pharmaceutical applications. There was widespread adoption of tagging of the packs of blisterpacks and the plastic bottles used by patients, which improved the quality of data gathered in drug trials by recording the tablet that was taken. The US National Institutes of Health are using 30,000 such packs to trial their new antibiotic Azithromycin and Novartis using the packs in drug trials”.
Pharmaceutical organizations have been using this technology for years; because of high value of products cost barriers for tagging these products within supply chain is relatively low. However, the ‘electronic pedigree’ benefits have been acknowledged by US Food and Drug Administration (FDA), which can identify and track pharmaceutical products individually throughout the supply chain. According to IDTechEx group, “Pharmaceutical industry set to explode from $90 million in 2006 to a staggering $2.1 billion by 2016 with the RFID market, making RFID one of the fastest growing industries in packaging”.
Pain Points for Pharmaceutical Manufacturers:
More than 100,000 pharmaceutical dispensing sites are available alone in US. The drug might be handled by different people, between each time the pill rolls off and encased into the bottle to the moment the drug is ingested by the patient. Each transaction in the supply chain between different people represents a vulnerable point, which might result in counterfeit products.
According to Centre for Medicine in the Public Interest, counterfeit drugs sales are estimated to become a $75 billion business by 2010. Along with counterfeiting, drug recalls and out of stock have also became implications with present pharmaceutical industries, which are striving to find ways in order to ensure the drug authenticity, improve its supply chain and manufacturing operations.
Apart from the implications with the chain of custody of a drug, a lot of errors can happen within the boundary of drug development, which often results in loss of revenue. Clinical trials, which are one of the most important processes for drug discovery and development, are conducted by the pharmaceutical industries by investing huge amounts. In addition to this, clinical trials are outsourced to Contract Research Organizations (CROs), who conduct trials in multiple centers at once on an international scale.
This process involves various activities with participation of different parties such as sponsor, investigator and CROs. A lot can go wrong in a clinical trial process which is often regarded as complex and elongated, especially for an industry that still rely on paperwork where the documents or information could be easily copied or altered. The reasons for these errors could be the lot of movement of investigational product (IP) within different parties, mismanagement of samples, and manual interventions of data etc. Benefits are to be derived from the RFID technologies at all of these levels.
Securing Chain of Custody:
The major concern for the pharmaceutical industries and government agencies is about protecting the chain of custody. In response to this, there is need to track and trace the drugs chain of custody from the time it leaves the factory till the medication is administered to the patient. This track and trace system is said to be the product’s pedigree.
With the use of RFID technologies, ePedigree can be established. With this ePedigree method, it will be easy to track and trace the authenticity of the drugs by monitoring where and when the drugs are manufactured along with where they are shipped. This finally results in reducing the chances of unregistered counterfeiting drugs in the supply chain.
It was concluded in a report issued by the FDA in 2004 on, “Combating Counterfeit Drugs” that the use of RFID technology to establish an electronic pedigree was the “single most powerful tool available to secure the U.S. drug supply.”
Pharmaceutical companies are required to affix the serial numbers to products as with the ePedigree mandates, during the packaging process to track the serialized products electronically. With this unique electronic serial number, the pedigree information for each product can be tracked, which provides detailed information such as source of drug, its name, manufacturer name and its registration number etc. To accomplish this authentication process, techniques such as 2-D Data matrix, High frequency (HF) RFID, and Ultra High Frequency (UHF) RFID are the options available. Currently, RFID is in use which might be replaced with UHF RFID in near future.
RFID is a tool for business process improvements for many industries especially pharmaceutical and healthcare industries, which investments huge amounts. RFID provides tremendous benefits to pharmaceutical companies, which can save millions in securing the supply chain. With the capability of tracking and visibility, RFID can reduce product diversion greatly making counterfeit difficult. With the implementation of RFID track-and-trace technology, the identification of counterfeit drugs can be facilitated and also can eliminate the counterfeit pharmaceutical market at one go. Hundreds of drug recalls which occur every year for the pharmaceutical industries can be done swiftly without any ambiguity. According to a market study from Kalorama Information, one quarter of the pharmaceutical companies by 2012, are expected to implement RFID to reduce compliance costs, improve inventory control, track clinical trials and manage samples.
Moreover, inefficiencies in clinical trials can be removed by tagging test tubes with RFID tags, where the RFID readers can track the test tubes that move between different locations. For the temperature sensitive samples, RFID temperature sensors are enabled that lead to real time tracking of the tubes. Cancellation of the test schedule where the crucial data does not get collected by the CROs can be made easier with the RFID system; resulting in reduction of delays.
Meta Group predicts that, RFID implementation will prove beneficial to pharmaceutical industry offering ROI in five main key areas:
- Inventory management: RFID based on the environment effects on the active ingredients can identify the information like out of stock or product expiry date.
- Recalls: Pharmaceuticals could response and identify recalled product quickly, whenever the event is initiated.
- Patient safety: Most of the 1.25 million adverse drug reactions and 7000 annual deaths estimated by FDA could be prevented with RFID-tagged products along with other identification (patient identification etc.).
- Product diversion: Drug shipments cost millions of dollars every year. With the use of RFID, could significantly reduce the size of grey market, by tracking them.
- Counterfeits: Anti counterfeiting measures – one visible (such as a hologram) and one invisible (such as an RFID tag) are the current possible recommendations to reduce the real obstacles of counterfeits.
People have started to take notice of RFID’s place in this world. However, effective use of RFID technology is based on recognition of benefits that RFID offers and the limitations that cannot be overcome by RFID. The pharmaceutical industry which requires identification system needs to implement the RFID as soon as possible.