Health care providers have long known that patients are poorly compliant with recommended treatment. The extent of non-compliance has only become apparent during the last two decades. An extensive literature now demonstrates that non-compliance is a problem in every area of health care. Many non-compliance issues are in the area of clinical pharmacy. With rapid advances in the understanding of the biological bases of medical and psychiatric disorders, pharmacotherapy has become by far the predominant therapeutic approach.
It is widely accepted that patients participating in clinical trials are less than perfectly compliant with their medication regimens. The extent to which non-compliance affects the results of clinical trials is unknown. Several factors mitigate against the assessment of this phenomenon, principal of which is the lack of a methodology to monitor patient compliance in a non-invasive (ie: unbiased) way.
The problem of having patients determine their own dosing during clinical trials is widely recognized. If data obtained in clinical trials where patients take medication once or twice a day are known to be inaccurate, it follows that data from patients taking medication intermittently over longer intervals will be even less accurate. Such studies generally rely on the patient recording the date and time of self-medication.
All research, including pharmacotherapy, may be viewed in terms of a signal to noise ratio (S/N). In administering a medication, the aim is to maximize the S/N. The signal is the desired clinical effect; the noise comprises a multitude of factors that interfere with, or obscure, the clinical effect. The clinical effect might be reduction in pain, control of seizures, reduction in white cell count, etc. Most of the myriad noise factors come under the category of 'individual differences' in response to medication. Gastrointestinal differences ranging from malabsorption to eating habits, differences in metabolism, concomitant use of alcohol and street drugs, body mass, level of activity, use of herbal remedies, and many other noise factors conspire to obscure the therapeutic effect (signal).
Clinical trial costs are spiralling out of control. Studies generally estimate the cost of bringing an Investigational new drug (IND) to market at $1B although there is considerable variability in such estimates. Data handling and pickup costs related to patient records account for a staggering 30 percent of drug development costs. This is just the beginning of the cost of non-compliance – for more details, refer to “Medication Non-Compliance”, “How Valid Are Your Clinical Trials Data?” and “Are Patient Reports Accurate?”
"At some point, perhaps not in the far future, it will seem as wrong to run a clinical trial without compliance measurement as without randomization." B. Efron, Statistics in Medicine, 1998 (17), 249-250.
Of course we are all aware of the central role played by randomization in the clinical research process. Virtually all clinical research employs this technique. However clinicians are generally surprised to hear that the physical sciences get along quite nicely without randomization.
The classical approach to decision-making in clinical research is the randomized trial. Patients are assigned to treatment conditions according to sample sizes that are determined a priori by power calculations. The data are not analyzed until the end of the study, at which time assignment codes are typically broken. Most clinical trials employ the Intent to Treat strategy which involves keeping all patients enrolled in the trial to its end. Positive decisions as to drug efficacy generally cannot be made until the study has been completed. Due to the cost and time involved in recruiting and processing subjects, size determination is extremely important. Unfortunately, this relies on two parameters that are rarely available during the study of new drugs – within-subject variability and the estimated magnitude of experimental effect.
A Risk Evaluation and Mitigation Strategy (REMS) is an FDA-mandated approach to ensuring the safety of medications. The baseline for ensuring the safe use of prescribed medication is professional labelling. REMS applies to situations where professional labelling is considered inadequate to ensure the safe use of a drug or class of drugs.
With aging population demographics combined with spiralling health-care costs, cost-reducing measures are the order of the day. Many involve systems that combine existing strategies in novel ways to give cost savings. The key to such systems is wireless interconnectivity – the ability of the various elements to intercommunicate in real-time without physical connections.
Wireless data transmission is the key to an efficient, flexible information system. It is prerequisite to the development of increasingly comprehensive information information and home care systems. Med-ic® and eCAP™ both support wireless data transmission and connectivity.
Patients who don't take their medications as prescribed pay a price in poorer health, more frequent hospitalizations, and a higher risk of death. They also incur up to $290 billion annually in increased medical costs, according to a Boston-based health policy group that urges making the issue part of the national debate on overhauling health care.
It is estimated by industry experts that 30% of perishable food crops are lost in transit, costing billions of dollars in profits and putting additional pressure on already high food costs. With biofuels diverting crops formerly grown for food, such unnecessary losses are now driving the problem into the realm of national security.
It is estimated by industry experts that 30 percent of perishable food crops are lost in transit, costing billions of dollars in profits and putting additional pressure on already high food costs. With biofuels diverting crops formerly grown for food, such unnecessary losses are now driving the problem into the realm of national security.
According to Forbes magazine in 2007, global waste from perishable goods in the supply chain amounts to $35 billion annually. In the US, supermarkets perishables account for more than half of all shrink, while temperature-related shrink per store averages almost $80,000 a year, or $40 million across a 500-store chain, according to a 2003/2004 Supermarket Shrink Survey.
Information Mediary Corporation of Canada describes how RFID monitors compliance with medication instructions, saving lives and improving the integrity of data in drug trials, such as the US National Institutes of Health Azithromycin trial recently. The US Army present on supply chain and shelf life management such as recording temperature time profile.
RFID technology is conceptually easy to understand. So is data warehousing, and we know there's a lot to data warehousing. RFID is a tagging technology that uses electronic transmitters, or backscatters, containing (usually) a standard code representing the item that it is attached to - whether that is a shirt, an automobile, a cow, a bird, a computer, a pallet of goods or a passport. The tags are read by readers, which are usually in a fixed location.
Sistema de Trazabilidad Térmica, ganador del premio a la innovación en la feria RFID World 2007, permite realizar el seguimiento completo a los embarques de frutas, verduras, alimentos y otros productos perecibles.
Evidencia LLP (distributor/integrator) won this award for cold chain management of temperature and delivery of avocados, an application spanning 6,000 miles—from the Rio Blanco farms (end user) in Chile to the end customer in California, a subsidiary of Green Giant. Using RFID-enabled temperature logging technology from Evidencia’s affiliate, Information Mediary, the pilot produced 100 percent read rates despite challenging temperature and humidity conditions.
RFID is still an emerging solution, but it's quickly becoming a realistic answer to the challenges of many businesses, and it must be implemented by each company on its own terms. As I mentioned in my first article on this subject, the RFID industry is rapidly changing. This statement still holds true today. Companies looking to adopt the technology must understand the truth behind the myths.
One of the often-overlooked accessories required for a RFID solution are equipment enclosures. Many never think about this issue until after the initial installation. Not surprisingly, managers are focused on tags, readers, software, and multitudes of other minutiae and neglect to consider how equipment will be physically incorporated into their operations. Depending on the set-up, choosing the right enclosure may be as important as selecting the appropriate tags and readers.
In any rapidly emerging market sector, there are those that make bold initiatives but miss their targets and there are those that quietly create profitable businesses. So it is with RFID, where many companies are reviewing their strategies after disappointment while others are succeeding. However, as far as the press and the analysts are concerned, profit is a taboo subject. Until now.
The current buzz is about item-level tagging, in essence implementing a numbering scheme and fitting a unique serial number onto every imaginable item. Following are some aspects of the technology and its possible applications.
A new market research report covering RFID from 2005 to 2015, researched by IDTechEx, reveals some surprising new disruptions. The bottom line is that this year's global market for RFID including tags, systems and services is $1.94 billion but it will be driven by demand and new laws to $26.90 billion in 2015.
Item level RFID is the Mount Everest of RFID, with by far the largest potential at up to ten trillion tags yearly as most barcodes are replaced. Infrastructure, software and services to make it happen are likely to approach one hundred billion dollars yearly across the world - roughly the sum that will be needed for the tags.
IDTechEx announces that its RFID Knowledgebase now exceeds 1000 case studies of RFID in action, covering activities of over 1250 companies in action. Chairman Dr Peter Harrop said, .RFID is now so ubiquitous that few participants know of all the activities in their chosen application, let alone the reasons behind their success or failure.
A smart label is a flat responsive device that is usually electronic. Most electronic devices are becoming flat because it is easier to lower their cost and fit them in awkward places such as packaging but we are not defining smart labels as generally as this.
Other technologies can be combined with the RFID chip to provide an extraordinary range of silent commerce services. Small microsensors that monitor the environment around them are currently being tested. Want to make sure the fish is fresh, the beer has never been warmed or the equipment has not been exposed to moisture? Scan the chip and the sensors will tell you what the product has been exposed to at any place along the value chain. Or, using new display technologies such as electronic ink, manufacturers can dynamically change the text or writing on the package to provide useful safety and quality information about the product.
Die Verbesserung der Compliance ist für alle Medizinalpersonen und insbesondere für die Patienten eine alltägliche Herausforderung. Es gilt, die Notwendigkeit einer Therapie einzusehen, mit der Therapiewahl sich anfreunden zu können und dann einen Therapieplan in den Alltag integrieren zu können – allenfalls mit einer lebenslangen Dauer. Willentliche und unwillentliche Non Compliance sind häufig; Studien berichten von bis zu 50 %. Die Apotheker, als letztes Glied in der Versorgungskette, sind in bester Position um den Patienten nach Motivation, Kenntnissen und Hindernissen zu befragen und maßgeschneiderte technische und motivationale Hilfe zu leisten. Unverzichtbar ist die eingehende Anwendungsinstruktion bei der Abgabe, damit allfällige eingeschränkte Fertigkeiten (Geschicklichkeit, Sehvermögen, Kognition) erkannt und Hilfe angeboten werden kann. Eine Vielzahl von Hilfsmitteln sowie neue Technologien können gezielt eingesetzt werden um auch die langfristige Befolgung eines Therapieplanes zu gewährleisten.
Every once in a while, a new "RFID Smart Blister" arrives on the scene, and the OtCM package from The Compliers Group in Netherlands is one such latest design. A new research study conducted by University Hospital Mainz in Germany found that, when testing another recently launched smart blister technology, only 82 out of 94 packages survived patient use and from those, just 80% to 95.7% of events accurately, or at all. Furthermore, these packages were tested by just removing 10 doses from the blister, presumably making the situation much worse had packages with 21, or 30 doses been tested in similar fashion.
Med-ic's 7-year experience with self-adhesive smart labels for medication blisters, and real-life, multi-year, multi-center clinical studies which demand an extremely high level of accuracy and reliability, has resulted in many designs yielding real-life package survival over 90 days in patients hands of better than 95%, and dose reporting accuracy of 99.6% or better, even with 14, 21, 30 and up to 42 doses per package. Med-ic smart labels are easy to apply, and are produced with non toxic conductive inks printed directly on paper labels.
Med-ic Blisters are designed to be better than 99.6% accurate in reporting dosing events, even when packages are handled in adverse, moist, or cold conditions. Validation data and references are available to qualified parties by contacting
Adherence to therapies is a primary determinant of treatment success. Poor adherence attenuates optimum clinical benefits and therefore reduces the overall effectiveness of health systems.
“Medicines will not work if you do not take them” — Medicines will not be effective if patients do not follow prescribed treatment, yet in developed countries only 50% of patients who suffer from chronic diseases adhere to treatment recommendations. In developing countries, when taken together with poor access to health care, lack of appropriate diagnosis and limited access to medicines, poor adherence is threatening to render futile any effort to tackle chronic conditions, such as diabetes, depression and HIV/AIDS.
New international standards no longer require directly observed therapy for all tuberculosis (TB) patients, but state that practitioners must be capable of assessing adherence and addressing poor adherence. Massproduced electronic medication monitors, which record removal of medication from a container, could help overcome the problem of assessing treatment adherence accurately even in poor countries. Both health facilities and community workers could dispense drugs for self-administered treatment in medication monitors and retrieve the adherence record with inexpensive built-in displays. These devices could keep the adherence record from the beginning of therapy for managing patients who move. Pharmacists using medication monitors could provide surveillance of self-administered treatment prescribed by private physicians with less adherent patients referred to the health departments. Less adherent patients could be managed with focused counselling, directly observed therapy when necessary, and extensions in treatment duration. Removal of the directly observed therapy burden would encourage patients to seek free high-quality supervised pubic care and help expand effective TB treatment services. If resources saved by giving less directly observed therapy were focused on poorly adherent patients, medication monitor-based programmes could create less acquired drug resistance than overwhelmed treatment programmes that attempt but fail to give uninterrupted directly observed therapy to all patients.
The outcome of this study should help programs determine the most appropriate interventions. If evidence demonstrates, for example, that freezing occurs most commonly during vaccine transport, new procedures for conditioning of ice packs, or ice-free transport can be implemented. If there is a correlation between specific types of refrigerators and freezing, equipment replacement may be required or, alternatively, more attention given to the training of cold chain supervisors.
Sixty years after the introduction of effective chemotherapy, the World Health Organization (WHO) estimates, based on surveillance and survey data, that the number of new tuberculosis (TB) cases has reached 8.9 million in 2004, with an annual rate increase of 0.6%...
To determine the frequency with which direct observation actually occurred within a district-level DOTS programme, and the association of treatment observation with treatment outcome under programme conditions.
Rifabutin was recommended in place of rifampin during treatment of HIV-related tuberculosis (TB) to facilitate concomitant potent antiretroviral therapy, but this approach has not been evaluated in a prospective study....
The purpose of this website is to present the status of development of a wide variety of portable electronic medication monitors that could be used to supervise the self-administered treatment of tuberculosis and perhaps AIDS. The discussion includes both commercially available devices and various designs of potential medication monitors, to allow investigators and funding sources to chose the optimal device for their needs and encourage inventors to develop improvements.
"This is the first study to ask the question, 'Are we gaining ground or losing ground in drug safety and improving patient safety in prescription drugs?' And I think, inescapably, the conclusion is that we're losing ground," said study lead author Thomas Moore, of the Institute for Safe Medication Practices, in Huntingdon Valley, Pa.
"This is a subject the public or health professionals just don't like to think about," Moore added. "Doctors don't like to think that what they're doing could be hurting patients. The pharmaceutical industry wants the public focused on benefits, and many people just want to believe this drug is going to help them. We need to focus on this problem. We can manage the risks of prescription drugs if we start to pay attention."
A slew of new technologies, ranging from RFID and printed electronics, through shape memory alloys to novel battery and display technologies, is enabling a new kind of packaging: smart packaging. Smart packaging relies on the use of chemical, electrical, electronic, or mechanical technology, or any combination of them to add numerous features and functions to packaging.
Smart packaging opens up new opportunities for enhancing inventory tracking, product safety and security, user friendliness and brand enhancement. Its impact is already being felt now in packaging for sectors as diverse as retailing, food and beverage, pharmaceuticals, cosmetics, military and toys. The use of smart packaging is also being pushed forward by changes in demographics and environmental concerns.
The report analyzes the market from all perspectives including materials suppliers, technology providers, printers and converters, product manufacturers and retailer/distributors. Companies mentioned in the report include:
* 3M * Aveso * Campbell * Coca Cola * CSIRO * Cypak * DuPont * DHL * Duracell * Heinz * IBM + Information Mediary * Intel, Konarka * Marks & Spencer * MeadWestvaco * PowerPaper * Proctor and Gamble * pSivida * Wal-Mart
For marketed products in the US, poor compliance with treatment regimens is estimated to cost the health care system around $100 billion each year. More than 100,000 patient deaths and one million hospital admissions each year, in addition to increased antibiotic resistance, are believed to be due to poor patient compliance. The cost of poor compliance in clinical trials is equally serious. Data from non-compliant patients can affect trial results to such an extent that they can make or break a candidate drug. While measures are in place to monitor compliance and avoid this (paper diaries and pill counting, for instance), these are far from perfect.
Accenture White Paper on U-commerce: Using microprocessors and sensors to make ordinary objects both intelligent and interactive, silent commerce opens up business opportunities and the possibility of new business models
Presented at the 2002 International Pharmaceutical Congress New York, April 2002
Introduction Health care costs threaten to overwhelm the economy. New technologies, pharmaceuticals and procedures add enormous costs to health care budgets. With advances in health care people are living longer, shifting the burden of the costs to an increasingly smaller percentage of the population. As population demographics shift to the older end of the spectrum, there is more opportunity for age-related chronic health problems to develop, further exacerbating the problem.
Information Mediary Corporation is dedicated to reducing health care costs by developing leading edge devices, systems, business models and technologies. This White Paper addresses the issue of patient non-compliance and outlines Information Mediary Corporation's solution. The Med-ic ECM (Electronic Compliance Monitor) is an electronic inventory monitoring system designed to address the issue of patient non-compliance with prescribed medication.
Vaccines are sensitive to heat and must be kept cold from the time they are manufactured until they are used. The equipment and people that keep vaccines cold during their journey are together called cold chain.
The new Ecoslide-RX® with integrated Med-ic® technology made its debut April 21 at the 2013 Global Clinical Supplies Conference in New Mexico. The package is senior friendly and child-resistant (F=1). Ideal for clinical trials where dosing data should be precisely recorded, Ecoslide-RX with Med-ic incorporates an electronic module and printed sensor grid inside the package, both of which are invisible to the patient. The hidden technology records the time, date and location when a dose is removed from the blister package.
Traditional clinical trials, in which a protocol is designed according to certain assumptions and strictly followed throughout the study, have numerous inefficiencies. Because there is no opportunity for researchers to adapt a protocol to reflect their increasing understanding of a drug as a trial progresses, the outcome may be inconclusive if the initial assumptions prove incorrect. The concept of reinventing the phases of clinical trials by certain adaptations made to the trial and/or statistical procedures of on-going clinical trials based on accrued data have been in practice for years in clinical research and development, thereby revolutionizing the way clinical research is being conducted.
Clinical studies registered in clinicaltrials.gov between 2007-2010 are dominated by small, single-center trials and contain significant heterogeneity (different in nature, difficult to compare) in methodological approaches, including the use of randomization, blinding, and data monitoring committees, according to a study in the May 2 issue of JAMA.
American Thermal Instruments (ATI) will be featured in a nationally broadcast video on emerging cold chain management technologies. .Today in America,. hosted by Terry Bradshaw, highlights the latest technological trends impacting people and businesses. The five-minute segment featuring ATI will air nationally on the FOX Business Network and in 19 major regional markets on CNN Headline News.
RFID technology to be presented at Free Coldchain Seminar at Thaifex 2008 May 22 & 23
The Log-ic ThermAssure RF and Log-ic ThermProbeRF (on the web: www.log-ic.biz) have been added to the “USDA Treatment Manual, Appendix H, as Portable Temperature Recorder Equipment for Warehouse Applications”, according to USDA’s Center for Plant Health Science and Technology (CPHST). It may take several months for the information to show up in the manual, however, the devices can be used immediately.
Med-ic ECM technology records patient adherence to correlate critical bloodwork
Med-ic RFID smart sensor labels will monitor over 250,000 doses in a large Phase II clinical trial to be conducted in Europe over the next 6 months. IMC has already delivered 6,000 self-adhesive smart labels to Aptuit, the study’s packaging supplier.
Med-ic RFID Blister Package Tracks Medication Use, Warns of Abuse and Diversion
"Fines for Schedule II drug makers are a wake-up call as the industry has turned its back on commercially available technologies designed to avoid abuse and diversion of addictive drugs", states Allan Wilson, MD, PhD, President of Ottawa-based smart packaging experts Information Mediary Corporation (IMC).
A pilot conducted by Evidencia LLP using Information Mediary Corp's Log-ic Temperature Logger received the 2007 "Excellence in RFID Pilot Award" At the 5th Annual RFID World Conference's RFID for Business Excellent Award Event today. This award recognizes the Log-ic team as playing a leading role in an RFID pilot significantly advancing the RFID industry.
Log-ic Thermassure RF Temperaturmarke erzielt hohe Leistung zum kleinen Preis Berlin 7. Februar 2007. Intelligent Devices Inc. (eine Tochter des Kanadischen Smart Packaging Expertunternehmens Information Mediary Corporation) premiert in Zusammenarbeit mit Evidencia LLP ihren revolutionären RFID Temperaturlogger zum Zweck der Kühlkettenüberwachung verderblicher Waren auf der Fruit Logistica 2007 (Halle 24, Stand C1) in Berlin. Unter dem Namen Log-ic Thermassure RF stellt Evidencia (www.evidencia.biz) diese drahtlose elektronische Temperaturmarke zum ersten Mal öffentlich der Lebensmittelindustrie vor.
Low-cost RFID Temperature Loggers Promise to Revolutionise Perishable Shipments Berlin, Germany (Feb 7, 2007). Intelligent Devices Inc. (a subsidiary of smart packaging experts Information Mediary Corp.) in partnership with Evidencia LLP, is pleased to announce the official product launch of their revolutionary RFID temperature logger to perishable cold chain customers. The Log-ic Thermassure RF Temperature Logger (www.evidencia.biz) will be presented at Fruit Logistica 2007 in Berlin, Germany, the largest global forum for packaging, shipping, distribution and storage for fruits and perishables, held from February 7 to 10 at Messe Berlin.
Intelligent Devices Inc., a subsidiary of Canadian smart packaging experts Information Mediary Corp., has been awarded a sweeping anti-tampering Intelligent Active Packaging patent in the US and Europe. In its actual implementation it involves an ECM® (Electronic Content Monitor) RFID sensor tag and printed traces on a packaging box detecting openings and unauthorized openings or penetration.
Intelligent Devices Inc. (a subsidiary of smart packaging experts Information Mediary Corp.) in partnership with American Thermal Instruments Inc. (ATI) is pleased to announce the official product launch of their revolutionary RFID temperature tracker to pharmaceutical cold chain customers. The Log-ic® Temperature Tracker (www.log-ic.com) will be presented at the 4th Annual Cold Chain Distribution for Pharmaceuticals, the only global forum for discussions on temperature controlled packaging, shipping, distribution and storage for pharmaceuticals and biopharmaceuticals, held from September 25 - 28, 2006 at the Pennsylvania Convention Center in Philadelphia.
The market for radiofrequency identification (RFID) tags in healthcare is set to explode from $90m (€70m) in 2006 to $2.1bn in 2016, driven by the item level tagging of drugs and the growing appeal of "smart packaging."
In the span of a few years, we have made major strides in advancing the science of drug development, incorporating sophisticated tools for screening drugs for effectiveness and safety, tools that were unimaginable even a few decades ago -- things such as toxicogenomic assays that mimic the activity of human liver or heart cells or proteomic panels that can measure minute changes in the regulation and activity of genes, to mention just a few advances.
Information Mediary Corporation and its affiliates retain the exclusive rights to use XINK formulations for its award-winning Med-ic Digital Package and pharmaceutical smart label technologies. Information Mediary Corporation will continue to provide pharmaceutical packaging and smart label technologies design, development and prototype services in their Ottawa-based Intelligent and Active Packaging Laboratory facilities.
Information Mediary Corporation has begun to supply over 30,000 of its Med-ic® RFID smart sensor labels for use in a large multi-year COPD macrolide study. The study, sponsored by NIH’s National Heart, Lung, and Blood Institute (NHLBI) will be enrolling over 1100 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), with emphasis on the prevention and management of exacerbations of the disease.
The technology leaders at the OMET Company of Lecco, Italy are following the development of UHF RFID labels with great interest, carrying out research in this strongly developing technology. Research on applications and production of printed paper RFID antennae has begun in earnest with the production and testing of flexographically printed UHF antennas.
The future of inexpensive on-press manufactured RFID transponders has arrived and it will be unveiled for the first time ever to the general public at LabelExpo Europe 2005 held in Brussels from September 21-24, 2005.
Information Mediary Corporation (IMC) is proud to announce the expansion of its revolutionary Med-ic ECM (Electronic Compliance Monitor) lineup to include eCAP, a smart RFID closure for medication bottles and vials (www.eCAP.biz). IMC, a leader in medication compliance technology, has teamed with Remind Cap International Ltd. to provide a dynamic, reliable and cost-effective packaging solution.
In this article, the author examines the growth of the RFID industry,
The Med-ic 21 Dose Multi-Med Pharmacy Seal Pack was initially developed for a study to monitor Hepatitis C. The package provides large blisters for multiple dosages, is easily filled at the Pharmacy level and can be heat or cold sealed, depending upon the pharmacy requirements.
One of the judges was very impressed with the Med-ic Multi-Med Pharmacy Seal Pack and commented, "This package is quite unique-especially with a way to transmit information about adherence to the pharmacist straight from the packaging. The ECM tag is a great feature that does not require a patient report of behavior. The simple act of opening a blister pack becomes both a way to get the patient needed medication, but also gather data on adherence.
and the increasing applications and benefits of this system of monitoring.
DHL Global Forwarding Life Sciences Conference works with global partners and customers to bring tangible solutions to the problems of managing the health products supply chain. Log-ic is proud to be part of the future of supply chain logistics.
The low proportion of people selected from the general population who were capable of sustaining satisfactory compliance to antihypertension medication may correspond to the maximum effectiveness of medication interventions based on a screening and treatment strategy in the general population. The results stress the need for both high-risk and population approaches to improve hypertension control.
Intelligent Devices Inc., a subsidiary of Information Mediary Corp (IMC), in partnership with Evidencia LLP and Prodecom, announce that the entire line of Log-ic ThermAssureRF devices have received EN12830, IP68, and COFRAC certifications from the French Institute Cemafroid, a United Nations- and World Health Organization (WHO)-authorized testing and certification laboratory.
According to a recent informal poll of Healthcare Packaging (HCP) readers, half the respondents agreed that packaging should enter the stream at the beginning of the clinical trial. An encouraging number, considering the metamorphosis the primary package will likely undergo as the drug formulation continues to change during the course of the trial.
IDTechEx staged its annual conference on Active RFID and Real Time Locating Systems RTLS in Dallas USA 5-6 December. Delegates at over 240 and exhibitors at 20 were again sharply up, reflecting this prosperous and innovative industry. Here we look at aspects relevant to printed electronics. Passive RFID is most amenable to being totally printed because, in most cases, the logic consists of just a memory chip. However, although printing the microprocessors commonly used in active RFID is probably ten years off, the opportunity to print the antennas, sensors, interconnects and batteries is much closer. The primary motivation is to make these devices thinner, flexible and lower in cost.
Winners of the first RFID Excellence in Business Awards, announced today at CMP Technology's RFID World 2007 conference and exhibition, highlight the industry's diversity as well as the business benefits organizations are gaining from this innovative technology. Using RFID, honorees achieved 30 to 50 percent reductions in inventory and labor costs, respectively; 100 percent tag read rates despite temperature and humidity challenges and a 100 times reduction in cost compared with a Global Positioning System (GPS) tracking option.
In October 2006, shipments of Fluvirin influenza vaccine by Novartis arrived at Cardinal Health Care “in either a frozen state and/or below the required storage temperature,” according to a statement on FDA’s Web site. The frozen Fluvirin, which was supplied in 5-ml multidose vials bearing the Chiron Vaccines label, apparently didn’t put patients at any particular risk other than having to be revaccinated. Novartis hasn’t named the cause of the temperature excursion.
Global experts in respiratory disease have called for an immediate increase in efforts to improve the treatment and management of COPD exacerbations. The ‘call' follows heightened political interest in the disease in the UK following recent announcements by the Health Secretary[i] and Chief Medical Officer[ii]. The Exacerbations Taskforce, an international multidisciplinary group of respiratory experts, has published its recommendations in the latest issue of the Primary Care Respiratory Journal[iii].
The market for smart pharma packaging will grow to $1.7bn (€1.3bn) in 2013 from the current $21m, driven by the need for new clinical trial compliance-and brand protection measures, according to a new forecast report.
Information Mediary Corporation has a unique device and software solution to one of the most persistent problems in clinical trials: noncompliance. Its Med-ic ECM (Electronic Compliance Monitor) can be used with any blister package to track medication use without active patient input.
New pharmaceutical packaging for prescription-drug and clinical-trial patients uses electronics to monitor and record drug compliance, which is becoming increasingly critical as the U.S. faces nearly $100 billion in annual healthcare costs related to noncompliance.
New InstaCure formulations allow printing of RFID antennas and complex electronic circuitry, including flexible paper sensors (package security), sensor grids (pharmaceutical packaging monitors), keypads (disposable electronic paper diaries) and backplane components (flexible displays).
The Med-ic eCap uses radio-frequency identification (RFID) technology to track the use of medication without any input from the patient, according to IMC. It consists of an RFID sensor that is embedded in the bottle closure and records when the bottle is opened and closed. The usage data is read using a reader; IMC's CertiScan Software allows the physician, researcher or pharmacist to review the data.
The use of electronic compliance packaging continues to grow, with two recently launched products joining the fray. MeadWestvaco Healthcare Packaging (Mebane, NC) has begun initial testing of Cerepak, an electronic update of its award-winning Dosepak package. Information Mediary Corp. (Ottawa, ON, Canada), meanwhile, is currently testing the Med-ic ECM (electronic compliance monitor) blister package.
Dr. Allan Wilson speaks at the 3rd Annual Forum on Patient Compliance and Persistency, Philadelphia
April 19 2004
Topic: Accelerating Clinical Research through ECM and Digital Packaging: Electronic compliance monitoring (ECM) has evolved over the last decade to where it is now a powerful tool for clinical trials research. Seamlessly integrated into standard medication packaging, ECM offers numerous scenarios for high return on investment (ROI). Professor Wilson will review the evolution of ECM and will present Monte Carlo results showing dramatically the advantages of ECM.
The patient could be reminded by an alarm to take the next dosage. However, with the upwelling of interest in anti-counterfeiting and tamper resistance, the ECM might find its niche as a solution for that problem as well.
FDA News: The new initiative includes creating an internal task force to explore the use of modern technologies and other measures such as stronger enforcement that will make it more difficult for counterfeit drugs to get distributed with - or deliberately substituted for -- safe and effective drugs.
Drug Store News, Chain Pharmacy: The Med-ic Electronic Compliance Monitor could help enhance patient care by automatically tracking the day and time that a patient breaks open a blister foil to take prescribed medication.
CPC Healthcare Communications Whitepaper Series: Patient non-compliance is somewhat of a mystery among pharmaceutical manufacturers today, with the majority of them accepting the inevitable fact that a large percentage of their consumers will be non-compliant. These same manufacturers pour millions of dollars into research and development, and into launching a new prescription, but do little to ensure compliance.
Elsevier Patient Education and Counseling:This study examined whether a self-management intervention based on feedback of adherence performance and principles of social cognitive theory improves adherence to antiretroviral dosing schedules. Forty-three individuals with HIV/AIDS who were starting or switching to a new protease inhibitor regimen were randomly assigned to be in a medication self-management program or usual care control group.
Now in its 22nd year, RxAdherence 2014 is the singular educational event which focuses specifically on patient adherence and compliance prompting pharmaceutical packaging. Each year, the latest trends and topics impacting this area of drug delivery are examined and addressed by speakers who have expertise in this packaging niche. Registrants will find no other conference so highly focused on how patient compliance is positively impacted through appropriate packaging.
RFID Journal LIVE! will feature two keynotes and three general sessions. These are open to everyone, including Exhibit Hall Pass holders. We invite speakers who are leading some of the largest and most important RFID deployments around the world, so these sessions are among the most important presentations each year. Check back regularly, as we will be adding new speakers.
The Global Clinical Supplies Group (GCSG) is a forum for likeminded clinical supply professionals to share knowledge, best practices and engage in open discussion.
Our stated vision is for group members to contribute to inspire each other, and in so doing influence, advance and give service to our industry. Becoming a GCSG member grants you entry to a community of likeminded professionals. Before, during, and after the conference your peers are an amazing resource with whom to discuss ideas and challenges. Whether you are interested in the latest trends in the industry, identifying and avoiding common pitfalls, need help with a current challenge or simply want to network and share knowledge, GCSG is the perfect forum.
Held once a year in China, the DIA China Annual Meeting is expected to attract 1400 participants. As the largest annual meeting held in the Asia Pacific region, the DIA China Annual Meeting will provide a neutral platform for information exchange, featuring speakers that include high-level representatives from government, industry and academia in China and abroad.
Welcome to the next generation of trade shows.
When retailers and suppliers cut the ribbon to open the inaugural NACDS Total Store Expo, they ushered in a new era of Teamwork, Synergy and Execution. Make this event a game-changer for your company, too!