Patient Care to Drug Tracking

Expanding Value Proposition of RFID in Healthcare and Pharmaceutical Sectors

A WHITEPAPER FROM

2011 Frost & Sullivan. All rights reserved. This document contains highly confidential information and is the sole property of Frost & Sullivan. No part of it may be circulated, quoted, copied or otherwise reproduced without the prior written approval and consent of Frost & Sullivan

Ever felt the requirement for An intelligent track and trace and anti-counterfeiting pharmaceutical packaging solution reducing the risk of diversion and adulteration A prominent tool to facilitate data collection in clinical trials, which would record every dosage event and deliver the information to your analysis database A technology that boosts your competitive advantage by a remarkable streamlining of your supply chain, enabling an improved and effective Inventory Management and stocktaking In brief, a magic bullet towards an Efficient Pharmaceutical Operation and an Intelligent Healthcare industry And the answer is Radio Frequency Identification (RFID); a technology that uses radio frequency for identification and data capture. RFID has proven to be the most effective technology for supply chain and asset management applications. Advent of global standards in electronic product codes and implementation standards has driven the usage of RFID. High efficiency, effective durability, desirable form factors, application orientation, and enhanced security have helped RFID penetration in various applications. Healthcare in recent years is evolving to be an application holding huge promise for RFID. This whitepaper discusses the role of RFID, its benefits, and potential in the Healthcare and Pharmaceutical industries. RFID Demystified From US $22.6 million in 2009, the market for RFID in India is estimated to have grown to almost US $50 million in 2010. The market is expected further grow at a Compound Annual Growth Rate (CAGR) of 54.3 percent until 2014, driven by increasing usage and growing awareness of its high ROI yields. In India, the supply chain and asset management applications contribute more than 40 percent to the total RFID market revenues. RFID has at its core a simple process for detection and identification. The basic principle is the usage of Radio Frequency (RF) for transmission and reception to identify locations and track objects. The RFID

system is a network of readers and tags that base their function on the ability to trap and connect radio waves. Typically, an RFID system consists of three components - tag, reader, and software. The tag and reader are the most important components of the RFID system. The tag carries vital information about the item intended for tracking, the reader detects the information carried in the tag, and the software in the backend server is used for the data analytics. The data thus captured is organized and integrated further in the context of the larger supply chain through relevant software packages. These software packages organize the information captured and relay it to relevant destinations for decision making. The ability to identify objects without the line-of-sight and hard-resistant nature, and relatively large read ranges, render RFID advantageous over other Auto ID technologies. RFID tags are the central component of the RFID platform. For the most part, tags determine the efficiency of the RFID system. Integration of a specific RFID system to an environment is determined by the kind of tag that is built in the RFID system. RFID tags are classified into active or passive based on the power supply. An active tag is powered using internal battery, where a passive tag gets energized using the power from a tag reader. Healthcare Industry in India An Introduction Frost & Sullivan estimates that the Indias Healthcare industry was estimated to be worth US $35 billion in 2010 and is expected to triple in size by 2025. Majority of the growth is seen in the Pharmaceutical (estimated to be around US $12.6 billion in 2010) and Healthcare delivery side (estimated to be around US $12 billion), which will be the major thrust in coming years. Key factors that would push the market upwards is the growing influence of the Indian middle class population, increased investments in healthcare infrastructure and technologies, and the phenomenal rise in chronic and lifestyle diseases in coming years, to name a few. Indias population, which is the engine of the consumer economy, is expected to surpass that of China by 2030, implying that a growing population presents both challenges and opportunities for the healthcare industry in particular.

Challenges would include higher capital costs, limited human resources, and a largely undefined unorganised sector all of which add to the complexity of managing a large populace. Opportunities on the other hand would be a large populace leading to an increased demand for good quality healthcare at a premium, health insurance, medical tourism, budgetary support and public private partnership initiatives.

Tier II and Tier III cities have increasingly become attractive to the healthcare players, especially because of the tax sops, increasing disposable incomes among Indian families across the country, and dearth of quality healthcare infrastructure in these locations.

Business Pain points Some of the Business Pain Points are summarized below. These are namely: Patient safety Counterfeit drugs Asset tracking Optimal utilization of assets

Technology and Healthcare Technology will play a major role in bringing quality in healthcare, be it better nursing communication systems, patient monitoring devices, or telemedicine to provide low-cost diagnosis to remote patients, etc. Telemedicine and remote diagnosis is seen as a rising trend, as part of the outsourcing model.

Business Case for RFID Healthcare in recent years is evolving to be an application that holds huge promise for RFID. RFID implementation in healthcare can help improve patient care, inventory, and workflow processes, resulting in increased patient throughput, reduced paper forms, and greater visibility of supplies and assets. Contribution from the healthcare industry to the Indian RFID market has been minimal at 1.5 percent in 2010, but this is expected to grow as the industry evolves with qualified system integration network and growth in indigenous manufacturing.

As traditional business models make way for more out-of-the-box unconventional thinking, healthcare players, decision makers, and strategy thinkers are working towards ensuring better operations and improving the manner in which healthcare is delivered. The ability to outsource non-core activities such as imaging department, kitchen, and housekeeping is a starting point towards this direction. The entry of foreign healthcare service providers in the Indian market shall result in the need of Operational efficiencies which can be achieved through emerging technologies such as RFID.

The business case for RFID-enabled medication administration relates to the well-known five rights of medication administration. Chart 1.1 illustrates the five rights of medical administration.
Chart 1.1: Five Rights of Medical Administration Chart 1.1: Five Rights of Medical Administration

Source: Frost & Sullivan

Like bar codes, RFID can help ensure these five rights are upheld and hence contribute toward reduced medical error rates. Some of the key industry trends observed in the RFID industry for healthcare applications can be defined as follows: The biggest use of RFID in healthcare in the next ten years will come from labeling of drugs at the item level and development of infrastructure and services needed to support this throughout the supply chain and hospitals The challenge is to prevent counterfeiting of drugs by establishing a complete history of each package at all times, known as pedigree A key application for RFID in healthcare is the use of Real time Locating System (RTLS) for staff, patients, visitors, and assets Error prevention is one application that cuts across both item level drug tagging and RTLS, and is one of the biggest uses of RFID. These solutions use an electronic handshake to prevent any

wrong procedure that might occur with an RFID system, and recording the actual event for future references The efficacy and advantages of RFID being established, its usage in the healthcare industry at large is yet to gain great momentum. The restraints surrounding RFID and indecisiveness in terms of implementation of RFID in healthcare pose further challenges. Uncertainty on the need and exact usage of RFID in healthcare applications is a primary cause for this. The key challenges plaguing RFID adoption in healthcare applications are: Lack of Plug-and-Play Capabilities vis--vis Cost: A key weakness from a technology perspective for RFID is the lack of a plug-and-play scenario, as is seen with the universal serial bus (USB) drive system or presentday laptops. The plug-and-play capability is in the case of a hospital environment. The hospital setting and revolution in healthcare requires significant implementation of plug-and-play capabilities. Interference Issues from RF Instruments: An additional challenge when applying RFID technology to healthcare is the possibility of RF interference. Electromagnetic interference (EMI) from certain frequencies of RFID technology has the potential to interfere with medical devices. This happens if the device and the EMI source are transmitting and receiving on the same frequency and if there is sufficient power and proximity for the transmissions or emissions to reach and affect the medical device. Safety Concerns of RFID Application: A final, but nevertheless important challenge, is patient security and privacy concerns, which must be considered when dealing with RFID in healthcare settings. RFID tags emit signals omni-directionally, and their radio transmissions can carry a relatively long distance. This makes it possible for the tags to be read remotely, without Line of Sight and without the knowledge or consent of the individual bearer. The challenge remains in terms of developing proper safeguard, and to that end there is currently little in place that can allow to meet the challenge. At the end of the day, there have to be sufficient stringent systems in place to ensure efficient use of RFID applications in healthcare. Chart 1.2 shows the current scenario of the RFID healthcare industry.

Chart 1.2: Current Scenario of RFID in Healthcare Industry

Source: Frost & Sullivan

While these challenges remain to be addressed, there are some applications in healthcare where RFID adoption is expected to be beneficial. These include: Enhancing the Healthcare Supply Chain Activity: The application of RFID tags would have a significant impact in ensuring the efficient management of the healthcare supply chain. Essentially, by means of tagging the pharmaceutical products with RFID tags and other medical supplies such as surgical instruments, the manufacturer has total control in terms of ensuring smooth transfer of goods from the manufacturer to the end user, and further to adopt appropriate checks if any discrepancies are observed in the supply chain. Automation of Workflow in Healthcare: With increasing patient numbers and diagnostic activity mushrooming lately, there is a strong need to ensure effective process utilization and movement. Essentially, there is a need for automation of the middle processes that are critical. The implementation of RFID in the healthcare setting is bound to bring about significant changes in the workflow. Limitation of Barcode Technology in Terms of Tracking: RFID technologies eliminate the limitations of barcode. RFID allows for detection of goods and transmission of information across short, medium, and

long ranges at convenient speeds without the necessity for line-of-sight. There is no requirement for a proximal scanner or reader, and this is a unique advantage in a healthcare setting. This serves ultimately as an important driver that thereby offers a suitable opportunity for RFID to oust the bar code technology as the next-generation tracker. Patient Safety and Tracking: RFID in the healthcare setting enables enhancement of patient safety and information tracking. For a hospital setting as also for remotely-located patients, it is of utmost importance that patients are given a sense of security during their treatment process. Recent developments have made RFID applications more compelling. Several companies have started using this technology as an important tool to increase efficiency. The healthcare industry is facing tremendous challenges in order to reduce costs and manage efficient ways to save lives. Overall, healthcare companies need the types of solutions that RFID can provide. RFID offers hospitals and medical facilities the technology for access control of doctors, nurses, and technical staff in the assigned territory. It also can be applied to monitor key assets (equipment, emergency medicines, etc.), patient tracking, patient-care systems, for newborn and baby tracking, and for asset and medical staff and emergency vehicle-tracking. This would enable the hospital personnel to better understand the patient flow, allowing staff to make better and timely decisions for patients. It is believed that it can bring tremendous benefits to companies in the Indian healthcare sector and aid them in their quest for global competitiveness. RFIDs Benefits in Healthcare RFID can bring lots of benefits in healthcare in managing various resources like blood samples, assets, and patients. A recent survey of healthcare executives by the National Alliance for Health Information Technology, reported the following business benefits that could be realized through RFID. Table 1.1: Business benefits realised by RFID Business task Achieve compliance with policy Anti-theft/anti-counterfeit/antitampering Improve asset visibility Improve business processes Realised by RFID

Improve patient flow management Improve patient safety Improve productivity Improve security Precision location Reduce inventory Reduce labour costs RFID in Pharmaceutical Applications The proven identification and tracking abilities of RFID technology in supply chain management make it ideal for combating drug counterfeiting and improving public safety. The U.S. Food and Drug Administration (FDA) stated in its February 2004 Anti-Counterfeiting Report that RFID represents one of the most important tools to help improve the safety of the drug supply chain. Following are some of the key considerations and opportunities for RFID solutions in the pharmaceutical supply chain: Drug Counterfeiting and Packaging Problems Drug counterfeiting has reached a level that threatens to damage the entire medical system and pharmaceutical industry. The condition is more severe in developing countries like India, where networks of distributors and laboratories making counterfeit drugs are strong. In the past few months, the Food and Drug Administration (FDA) of India conducted several raids and apprehended numerous people involved in fake drug trafficking. Even in cities like Delhi, Mumbai, Bangalore, and Chennai, pharmacists are selling fraudulently mislabelled and substandard drugs without any fear. The drugs were often found to be contaminated with paints, chalk powder, and other impurities. Some drugs were degraded because of poor storage, or they were repackaged after expiry. Several supposedly life-saving drugs and antibiotics were discovered without the essential active ingredients. The Indian pharmaceutical industry in 2010 estimates to be about $10 billion and some sources reckon that 10 percent of it is producing sub-standard drugs. Thousands of people die every year after consuming counterfeit or substandard drugs. Packaging of medicines and their seals can be easily

duplicated. Hence, efforts to take action against those who indulge in such counterfeit processes and malpractices are often rendered ineffective. Clinical Trials The pharmaceutical drug approval process is rigorous and dependent on meticulous documentation. The progress with drugs and the entire development of new methods of treatment is dependent on clinical trials. No new pharmaceutical can be approved without such trials. As new drugs go through the clinical trial phase, accurately tracking patient usage is crucial. Inventory Management and Stock-taking Inventory management is essential and mostly crucial, as manufacturers and distributors need improved visibility throughout the supply chain to gain accurate information and optimize their volume transactions. Is RFID the Right Prescription? RFID can be a single-stop solution to address these serious concerns of the pharma sector. Some of the RFID/EPC-based solutions can be implemented at case level, which will be a cost-effective solution towards preventing interspersing of undesirable and substandard drugs. To counter drug counterfeiting, information regarding the seal time, packaging date, etc. can be stored in tags memory that can be built into the package, which is easily accessible for cross references. RFID technology can reduce the inefficiencies of the clinical trials and increase visibility, which will improve the quality of information obtained during these trials. Improved tracking and quality of information will speed the FDA drug approval process. Inventory management and supply chain monitoring for manufacturers and distributors can be made easier manifold with RFID. Increased inventory visibility could reduce buffer stocks, reduce total inventory costs, and avoid total stock depletion. RFID will save time and also improve the efficiency of suppliers and distributors.

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Chart 1.3 shows a simplified yet typical pharmaceutical supply chain (including repackaging), where RFID technology can be used to manage data.Chart 1.3: Pharmaceutical Supply Chain

Chart 1.3: Pharmaceutical Supply Chain

Source: Frost & Sullivan

RFID Benefits in Pharmaceuticals: Chart 1.4 illustrates the benefits of RFID for pharmaceutical companies. Chart 1.4: RFID Benefits Pharmaceutical Companies Chart 1.4: RFID Benefits for for Pharmaceutical Companies

RFID
Benefits

Low

Medium

High
Source: Frost & Sullivan

Implementation in India Healthcare and Pharmaceutical Sector

*CRO-Contract Research Organisation

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Mr. Prashant Agarwal, Chief Executive Officer, Orizin Technologies Pvt. Ltd, India, via an interview, has shared that although the adoption of RFID in India has been slow (due to lack of awareness), most CIOs of top Indian hospitals have approached Orizin with queries to know more about RFID solutions and how it would benefit the Indian healthcare industry, mainly for patient tracking and asset tracking. Some hospitals have already implemented RFID-based Dynamic Queue Management solution for regular patients, to reduce the wait time for lab testing. He further added that with respect to the Indian healthcare industry, RFID can bring lots of benefits in managing various resources like blood samples, assets, and patients. It will be considered as a key technology in eliminating some of the major bottlenecks in hospital management and improving process efficiencies. He summed that the top four business benefits expected by using RFID are: improved patient safety, patient flow management, productivity, and business processes. The recent adoption of RFID in the Indian healthcare space is ASHWINI and MEMIS proposed by officials of the Andhra Pradesh Medical Services and Infrastructure Development Corporation (APMSIDC). ASHWINI the supply, installation, and maintenance of equipment required for RFID-based tracking of medicines in central warehouses of the corporation, along with CCTV surveillance system implementation, and MEMIS Medicine and Equipment Management Information System. This reflects the gradual penetration of RFID in the government sector of the Indian healthcare segment as well. In the pharmaceutical industry, Ranbaxy, a wholly-owned subsidiary of Ranbaxy Laboratories Limited, Indias largest pharmaceutical company, has chosen Acsis Inc. to implement RFID tracking system to meet Wal-Marts RFID mandate for its Class 2 pharmaceutical suppliers. Another recent adoption of RFID has been at SevenHills Hospital, Mumbai, which has chosen Ruckus Wireless, Inc automated real-time data collection system to reduce errors and instantly capture patient information. The hospital will use wireless handheld devices and patient wrist bands employing RFID technology to make it possible to track the location and status of patients throughout the hospitals 17acre campus. Also, Apollo Hospitals has implemented RFID to accelerate patient checkups. Table 1.2 below lists some of these RFID implementations in the healthcare and pharma sectors in India.

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Table 1.2: RFID Implementations in Healthcare and Pharmaceutical Sector in India:

1. With the Union Commerce Ministry firm on the implementation of ID and bar codes for pharma exports, the Drugs Controller General of India (DCGI) has recommended the adoption of radio frequency identification (RFID) technology to trace and track the products in circulation. The DCGI has identified 96 products to come under the trace and track umbrella beginning from July 1, 2011. This effort would help to control the entry of counterfeit medicines in the market and help the enforcement teams to carry out faster checks.

2. Indian pharma major Ranbaxy has employed RFID technology to Class 2 prescription drugs, defined as addictive painkillers and other prescriptive narcotics.

3. Indias leading hospital chain, Apollo Group, Chennai, has deployed a real-time locating system (RTLS) that enables patients to move through a series of 26 diagnostic procedures within a day.

4. Indias Armed Forces Medical Depot has deployed at its warehouse a RFID-enabled asset tracking system, which ensures asset identification and monitoring mechanism.

5. Andhra Pradesh Medical Services and Infrastructure Development Corporation (APMSIDC) has implemented ASHWINI supply, installation and maintenance of equipment required for RFIDbased tracking of medicines in Central Warehouses of the Corporation, along with CCTV surveillance system implementation, monitoring and the activity in the premises; and MEMIS Medicine & Equipment Management Information System.

6. Bhagwan Mahaveer Jain (BMJ) Heart Centre at Bengaluru is using Ultra-High Frequency-based RFID passive tags to help maintain patient records, monitor patient flow and care, and track assets throughout the hospitals outpatient department.

RFID Return on Investment (ROI) in Healthcare and Pharma Sectors The business case for quantifying ROI for applications such as tracking mobile assets like oxygen cylinders and infusion pumps can be established through time saving, which can be realised via Real time Locating System (RTLS). These time savings can be realized by both clinical engineering staff and nursing staff, and can often amount to a couple of days per week per person. ROI can thus be justified and quantified by looking at all of these factors and comparing them with the initial and ongoing costs involved in implementation.

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The justification for better patient-flow management is related to the ability of the emergency department to process more patients per year. It can also be used for Six Sigma purposes and continuous improvement. Better flow management may also help to increase revenue by more accurately capturing services rendered, enabling full billing for those services and supplies.

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Conclusion The new generation of low-cost RFID tags and readers, combined with emerging software solutions, has the potential to deliver unprecedented value for Supply Chain Management. Healthcare and other allied life sciences sectors are expected to follow the trends observed in the pharmaceutical industry. The reason is that these industries are driven by the need for anti-counterfeiting measures and patient safety enhancements, and not just economics. This is good for the Healthcare industry as it will drive scale, which in turn will drive down costs for all Healthcare constituents.

The need of the hour is affordable technology solutions aided to improve overall process efficiencies in Healthcare Industry which in turn shall enable a reduction in delivery costs to the end user, which in this case is the patient

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Annexure RFID in Healthcare and Pharmaceutical Applications Globally North America The pharmaceutical and healthcare industry in North America is deploying RFID for asset tracking, such as for surgical instruments, medical equipment, syringes, and other equipment, in order to prevent shrinkage and reduce the time required to find an item in case of an emergency situation. The RFID tags and readers not only help to track medical equipment, but also help to validate the drugs authenticity, patient identification, and blood samples. A steady increase in demand is anticipated throughout the forecast period, due to the benefits achieved by deploying this technology.

The use of RFID for patient identification has helped to provide the right treatment, thereby reducing the treatment error rate. In addition, tracking and tracing assets, drugs, blood, and equipment have had a positive impact on the analysis and treatment of a patient. Blood bank supplies are equipped with RFID chips, in order to prevent any confusion or mix-ups with respect to blood transfusion and blood treatments. Moreover, RFID is being used because of its convenience and user-friendliness. For example, active tags are being used because it has the ability to alert and indicate when a drug has to be given to a patient. However, in order to gain maximum benefits and quick ROI from RFID deployment, the infrastructure should be compatible with the technology.

Some key deployments in the healthcare vertical are as follows: In March 2009, St. John's Children's Hospital, located in Springfield, Illinois, employed an RFIDenabled security system to protect newborns and children up to 18 years of age. The center is using 100 RFID-enabled bracelets and a network of readers to secure three floors of its sixstoreyed facility St. Elizabeth Medical Center, located in Utica, New York, has deployed the RFID-enabled inventory management solution to track and manage implantable devices. This eliminated the need to manually track the inventories, thereby reducing chances of thefts and losses Virginia Hospitals, operated by Bon Secours Richmond Health System in the United States, has deployed an RFID network to track mobile medical equipment at its three centers. The three facilities are St. Mary's Hospital, Richmond Community Hospital, and the Memorial Regional Medical Center

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Integris Health, located in Oklahoma City, recently completed a project on tagging hernia meshes to reduce shrinkage and ensure that expensive items do not lapse their expiry date. It estimated a significant ROI with the deployment of this technology.

The California State Board of Pharmacy has delayed the implementation of its e-pedigree requirement until 2015. However, some of the other pharmaceutical companies in the United States that have deployed this technology include CVS Pharmacy, Johnson & Johnson, Purdue Pharma, Cardinal Health, and West Pharmaceutical Services, among others. Hospitals that have deployed RFID for the management of blood, supplies, and equipment are Massachusetts General Hospital, Portsmouth General Hospital, Georgetown University Hospital, and Medline Industries. Revenues for the healthcare vertical are expected to grow from $78.8 million in 2008 to $279.8 million in 2015, at a CAGR of 19.8 percent between 2008 and 2015. Asia Pacific The Asia Pacific RFID market in the healthcare vertical is expected to amass revenues of $205.3 million by 2016, growing at a CAGR of 22.2 percent from $50.0 million in 2009. For the Asia Pacific region, the healthcare vertical currently accounts for ~10 percent of total RFID revenues. Some of the major hospitals in Singapore, such as Alexandra Hospital, Tan Tock Seng Hospital, and Singapore General Hospitals have implemented RFID technologies to track patients, staff, and assets. Recently, Singapores National University Hospital (NUH) has been automating the counting of gauze to ensure that none is left behind in the patients bodies in midst of an ongoing surgery, apart from plans to tag assets and patients. Hospitals in Bangkok, Taiwan, South Korea, India, and Japan are working toward implementing RFID systems for pharmaceutical tagging, as well as asset and patient tracking. To avoid counterfeit drugs, the South Korean Government plans to tag 50 percent of all its drugs by 2015. This initiative is expected to improve inventory control and reduce prescription errors. The project involves the Ministry of Health and Welfare, The Korea Food and Drug Administration, and the Ministries of Knowledge Economy and Education, as well as Science and Technology.

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A passive far-field UHF tag has proved to be a beneficial solution. This ensures high performance in an itemlevel tracing system in the whole supply chain. Item-level tagging of drugs and RTLS for the staff, patients, and assets to improve efficiency, safety, and availability, and to reduce losses are some of the key factors driving RFID in the healthcare vertical. In some parts of Asia Pacific, blood banks also use RFID. Trials were done in Malaysia with the ultimate aim of rolling out RFID to 300 government and private hospitals and clinics.

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