11073-10472 a Global Standard for Medication Adherence
04/03/10 17:25
This article is published in IPI (International Pharmaceutical Industry) and reproduced with permission of Chris Johnson, the author. IPI includes several articles relevant for medication compliance and can be accessed by clicking the link (pages 74-76).
The world spends more every year on pharmaceuticals than the USA has spent in total on the war in Iraq. And whatever we think individually about the war in Iraq, most of us agree that much of the pharmaceutical spend is wasted.
We are increasingly convinced that many prescribed medicines are not taken properly. The National Institute of Clinical Excellence (NICE) published a thorough review in 2009; the Cochrane Collaboration presents similar evidence regularly; the World Health Organization supports the broad conclusions. People differ on the exact extent of the problem – we have not been measuring systematically – but most are now convinced that the opportunity to improve patient compliance for prescribed medication is massive. Healthcare costs are rising above 10% of GDP, and a significant amount is directly attributable to the raw pharmaceutical spend. Incidental costs caused by non-compliance are even higher. According to recent back-of-the-envelope calculations done by the New England Health Institute (NEHI), the cost of non-compliance in the USA alone approaches 300 BILLION dollars annually, with two thirds due to avoidable hospitalization. Payers will take action.
Pharmaceutical companies are also convinced. Apart from the pressure to provide an evidence base to support their pricing, they know that over 90% of their marketing spend goes to acquire new clients. When said clients, many with long-term chronic therapies, stop taking their medicines within three months, pharma knows that improving adherence is a vital marketing necessity.
Patients too look for change. The majority trust that medicines work but many forget to take them on schedule, worry about side-effects and efficacy, and want help. Patients are the big winners from improved adherence - they can manage their conditions better with a bigger chance to live outside hospitals and care homes for longer. Monitoring medicine intake and communicating more closely with their support network are the first steps. The technology now exists to support patients manage their own medication, and to build a record of adherence that is of value to themselves, their care professionals, and concerned family. A complete picture of many patients will provide data to analysts, insurers, and pharmaceutical companies – data that has been sadly lacking up to now and which will build a more reliable picture of efficacy in future.
Today adherence data is not captured. The professional rarely has a scientific way to determine whether a patient is compliant. The anecdotal evidence provided by the patient is notoriously imprecise. Memory is fickle and the “white-coat syndrome” well documented.
Standards are needed because over 40% of patients take multiple medications – often from several different sources. Adherence support should work in the same way for all medication, just as we can step into any car and drive it. Doctors and pharmacists have one computer system on their desk and need the data from all their patients to be presented in a similar way. Communication depends on standards and there are potentially many people to communicate with - family members, care visitors, pharmacists, family doctors, and clinical specialists. Many different systems will read adherence data, either a special device in the home, a normal mobile phone or customized pda, or a computer screen linked to a specific clinical network. Standards for adherence data enable integration with the care network. International standards are needed when people travel and to enable manufacturers to develop affordable systems in which innovations can be integrated quickly and easily.
The drive for standards for medication adherence monitoring began in the Continua Health Alliance. Continua was founded in June 2006. It is a unique combination of healthcare organizations, information and health service companies, device manufacturers and health technology providers. Today Continua has over 200 members and many established global leaders. It organizes its activities around three focus areas, fitness and wellness, chronic disease management, and ageing independently.
The Continua mission is: “To establish an eco-system of interoperable personal health systems that empower people & organizations to better manage their health and wellness.” The 22 founding members stated: “We can enable a personal health eco-system where many diverse vendors can combine their products into new value propositions with significant health benefits for people worldwide.”
The Continua Use Case for medication monitoring was developed under the chairmanship of Cypak (www.cypak.com) with input from healthcare providers such as Kaiser Permanente, Partners, and the National Health Service. Pharmaceutical companies such as Pfizer contributed, as did service providers like Tunstall, Philips, and technology companies like Cypak and Panasonic.
After approval of the Use Case by Continua the technical work passed to IEEE. IEEE draws on the expertise of a global membership of over 375000 engineers and is the leading international body responsible for developing and maintaining over 1300 international standards, including Wifi, Bluetooth, and most of the interoperable norms at the heart of today’s information technology. The IEEE 11073 working group is chartered to develop standards for Personal Health Devices, including medication monitoring which is titled 10472. A major benefit of working with IEEE for medication monitoring is to utilize the same common basis – called 11073-20601 – for all monitoring devices. This means the same common core is used for blood pressure monitoring, ecg, glucose monitoring, fitness devices, oxymeters, and many other device specializations. Systems can be built easily on a single platform to measure both medication adherence and efficacy.
IEEE standards are open standards that can be used by any member company to build compliant devices. In the case of 11073-10472 several companies are already offering technology platforms to deliver the basic level of interoperability. Cypak (www.cypak.com) has already made a public announcement.
IEEE made an agreement with ISO, the International Standards Organization, to take the 11073 specifications to full international status. This process started for medication monitoring in 2009 and should result in a fast track acceptance globally. The final vote on content was passed in October 2009 with a 97% approval and substantial changes are not expected before ratification. Ratification will confirm conformance with IEEE and ISO editorial standards and processes, and prepare for publication in 2010.
The active participating organizations – around 50 in total – built a simple patient-centric system. The main actors in improving compliance are the patients themselves, while the other actors, both family and professionals, are enabled to support when given patient permission. 10472 may also be used in future situations where high adherence might be considered mandatory, for example when public health concerns are critical (tuberculosis, hiv, anti-virals) or when the costs of non-compliance are very high (transplant surgery and cancer treatments). However, in many cases patient cooperation is vital to manage long-term use of medication whether for contraception, psychiatric illness, or management of chronic conditions such as hypertension and diabetes.
Patients prefer to be mobile, continuing their normal work and social lives while managing their condition. The standard assumes that many medication monitors will be integrated electronically into a variety of packaging that travels with the patient. Low power, local storage, and low cost are high on the list of priorities.
Typically a 10472 device will be powered for its lifetime by a small battery, have a memory to record dosage events, and a clock for accurate time-stamping and reminders. Dosage events can either be fixed quantities or variable. Optionally the patient is able to record a personal diary as a series of events, a time-stamped indication of subjective feelings such as level of pain or moments of faintness. The data captured is customized to fit the therapy – and the patient. The result is an accurate record of patient compliance and subjective reactions that can be used for an objective discussion around side-effects and adherence with healthcare professionals and other carers.
The 10472 standard is designed for automatic use with a wide variety of packages, including carded blister packs, plain blisters, bottles, syringes, inhalers, and the personalized pharmacy-packed multi-dose containers that are making a big impact in chronic care. The standard is flexible and does not place limitations on the chosen packaging. A report card may also be constructed for use alongside standard packaging. Instead of dosage events being captured automatically, the patient indicates a dosage event or symptoms on the report card. The emphasis is to capture relevant data in a standard format – a shared language that is understood worldwide.
Extensive discussions decided which elements should be included in the core standard, which elements should be optional but in a standard format, and which should be left to manufacturers’ own invention. Technological companies argued long and hard to include pharmaceutical nomenclature in the core standard, before accepting the medical advice that currently there is no universal and appropriate nomenclature. Each 10472 device will, however, have a unique identifier even when a device is refilled. The unique identifier can be used in a local healthcare system to tie an adherence device to a unique context such a patient identifier and individual patient prescription according to local nomenclature standards.
A similar discussion took place around reminder systems, and again it was decided to leave the exact user implementation to the creativity of individual manufacturers while ensuring that basic standards for recording time and adherence intervals are established. Adherence is not an automatic problem for every patient when a dose is missed. Many therapies are designed to accommodate non-compliance, while others are dependent for their success on a rigid adherence. 10472 specifies optional parameters that can be programmed by the pharmacist or manufacturer to define when a patient or professional should be alarmed by an actual level of non-compliance. The exact implementation of a reminder scheme is also flexible. In extreme cases the 10472 can be online to a monitoring centre and trigger intervention 24/7. In other cases a periodic review of adherence is sufficient. Some trials report good results with an sms reminder scheme, others with patients programming their own alarm. 10472 is a solid basis for a wide variety of implementations.
Some healthcare providers expressed a desire to have absolute certainty that a “dosage event” means that a patient actually swallowed the pill after taking it out of the package. The group resisted this on two grounds. Firstly, patient cooperation is essential to improving adherence and outcomes and patients are more likely to cooperate when not compelled. With up to 70% of patients not complying in some studies, it did not seem productive to drive the standard in a direction that would perhaps result in a rejection of the whole concept of adherence monitoring. Secondly, the technology for detecting that a substance is ingested is in a very early stage – RF tagging of pills, for example – and consumer reaction often not tested at all. Instead of striving for absolute certainty, the groups chose to adopt the Continua model of providing vital sign monitors alongside medication monitors to highlight problems in 99% of cases with patient choice paramount.
Some optional features of the 10472 standard are added because they are easy to add reliably to an electronic system. Tampering, for example, is easy to detect and record with an electronic system. Storage of drugs beyond licensed temperatures and humidity ranges are equally easy to detect. The expiry date is easy to detect when you have a real time clock. All these optional features have value for adherence – patients should take medicine that is effective.
Products conforming to IEEE 11073-10472 and Continua Health Alliance will have a major impact on the way pharmaceuticals are packaged and delivered in future. For the first time patients will be provided with a standard system to manage their medications and record data for objective discussions with their carers. As adherence rates rise, hospital and care home admissions will fall and more chronic patients will use medications properly for the long term. All involved should benefit by adopting the international global standards.
The world spends more every year on pharmaceuticals than the USA has spent in total on the war in Iraq. And whatever we think individually about the war in Iraq, most of us agree that much of the pharmaceutical spend is wasted.
We are increasingly convinced that many prescribed medicines are not taken properly. The National Institute of Clinical Excellence (NICE) published a thorough review in 2009; the Cochrane Collaboration presents similar evidence regularly; the World Health Organization supports the broad conclusions. People differ on the exact extent of the problem – we have not been measuring systematically – but most are now convinced that the opportunity to improve patient compliance for prescribed medication is massive. Healthcare costs are rising above 10% of GDP, and a significant amount is directly attributable to the raw pharmaceutical spend. Incidental costs caused by non-compliance are even higher. According to recent back-of-the-envelope calculations done by the New England Health Institute (NEHI), the cost of non-compliance in the USA alone approaches 300 BILLION dollars annually, with two thirds due to avoidable hospitalization. Payers will take action.
Pharmaceutical companies are also convinced. Apart from the pressure to provide an evidence base to support their pricing, they know that over 90% of their marketing spend goes to acquire new clients. When said clients, many with long-term chronic therapies, stop taking their medicines within three months, pharma knows that improving adherence is a vital marketing necessity.
Patients too look for change. The majority trust that medicines work but many forget to take them on schedule, worry about side-effects and efficacy, and want help. Patients are the big winners from improved adherence - they can manage their conditions better with a bigger chance to live outside hospitals and care homes for longer. Monitoring medicine intake and communicating more closely with their support network are the first steps. The technology now exists to support patients manage their own medication, and to build a record of adherence that is of value to themselves, their care professionals, and concerned family. A complete picture of many patients will provide data to analysts, insurers, and pharmaceutical companies – data that has been sadly lacking up to now and which will build a more reliable picture of efficacy in future.
Today adherence data is not captured. The professional rarely has a scientific way to determine whether a patient is compliant. The anecdotal evidence provided by the patient is notoriously imprecise. Memory is fickle and the “white-coat syndrome” well documented.
Standards are needed because over 40% of patients take multiple medications – often from several different sources. Adherence support should work in the same way for all medication, just as we can step into any car and drive it. Doctors and pharmacists have one computer system on their desk and need the data from all their patients to be presented in a similar way. Communication depends on standards and there are potentially many people to communicate with - family members, care visitors, pharmacists, family doctors, and clinical specialists. Many different systems will read adherence data, either a special device in the home, a normal mobile phone or customized pda, or a computer screen linked to a specific clinical network. Standards for adherence data enable integration with the care network. International standards are needed when people travel and to enable manufacturers to develop affordable systems in which innovations can be integrated quickly and easily.
The drive for standards for medication adherence monitoring began in the Continua Health Alliance. Continua was founded in June 2006. It is a unique combination of healthcare organizations, information and health service companies, device manufacturers and health technology providers. Today Continua has over 200 members and many established global leaders. It organizes its activities around three focus areas, fitness and wellness, chronic disease management, and ageing independently.
The Continua mission is: “To establish an eco-system of interoperable personal health systems that empower people & organizations to better manage their health and wellness.” The 22 founding members stated: “We can enable a personal health eco-system where many diverse vendors can combine their products into new value propositions with significant health benefits for people worldwide.”
The Continua Use Case for medication monitoring was developed under the chairmanship of Cypak (www.cypak.com) with input from healthcare providers such as Kaiser Permanente, Partners, and the National Health Service. Pharmaceutical companies such as Pfizer contributed, as did service providers like Tunstall, Philips, and technology companies like Cypak and Panasonic.
After approval of the Use Case by Continua the technical work passed to IEEE. IEEE draws on the expertise of a global membership of over 375000 engineers and is the leading international body responsible for developing and maintaining over 1300 international standards, including Wifi, Bluetooth, and most of the interoperable norms at the heart of today’s information technology. The IEEE 11073 working group is chartered to develop standards for Personal Health Devices, including medication monitoring which is titled 10472. A major benefit of working with IEEE for medication monitoring is to utilize the same common basis – called 11073-20601 – for all monitoring devices. This means the same common core is used for blood pressure monitoring, ecg, glucose monitoring, fitness devices, oxymeters, and many other device specializations. Systems can be built easily on a single platform to measure both medication adherence and efficacy.
IEEE standards are open standards that can be used by any member company to build compliant devices. In the case of 11073-10472 several companies are already offering technology platforms to deliver the basic level of interoperability. Cypak (www.cypak.com) has already made a public announcement.
IEEE made an agreement with ISO, the International Standards Organization, to take the 11073 specifications to full international status. This process started for medication monitoring in 2009 and should result in a fast track acceptance globally. The final vote on content was passed in October 2009 with a 97% approval and substantial changes are not expected before ratification. Ratification will confirm conformance with IEEE and ISO editorial standards and processes, and prepare for publication in 2010.
The active participating organizations – around 50 in total – built a simple patient-centric system. The main actors in improving compliance are the patients themselves, while the other actors, both family and professionals, are enabled to support when given patient permission. 10472 may also be used in future situations where high adherence might be considered mandatory, for example when public health concerns are critical (tuberculosis, hiv, anti-virals) or when the costs of non-compliance are very high (transplant surgery and cancer treatments). However, in many cases patient cooperation is vital to manage long-term use of medication whether for contraception, psychiatric illness, or management of chronic conditions such as hypertension and diabetes.
Patients prefer to be mobile, continuing their normal work and social lives while managing their condition. The standard assumes that many medication monitors will be integrated electronically into a variety of packaging that travels with the patient. Low power, local storage, and low cost are high on the list of priorities.
Typically a 10472 device will be powered for its lifetime by a small battery, have a memory to record dosage events, and a clock for accurate time-stamping and reminders. Dosage events can either be fixed quantities or variable. Optionally the patient is able to record a personal diary as a series of events, a time-stamped indication of subjective feelings such as level of pain or moments of faintness. The data captured is customized to fit the therapy – and the patient. The result is an accurate record of patient compliance and subjective reactions that can be used for an objective discussion around side-effects and adherence with healthcare professionals and other carers.
The 10472 standard is designed for automatic use with a wide variety of packages, including carded blister packs, plain blisters, bottles, syringes, inhalers, and the personalized pharmacy-packed multi-dose containers that are making a big impact in chronic care. The standard is flexible and does not place limitations on the chosen packaging. A report card may also be constructed for use alongside standard packaging. Instead of dosage events being captured automatically, the patient indicates a dosage event or symptoms on the report card. The emphasis is to capture relevant data in a standard format – a shared language that is understood worldwide.
Extensive discussions decided which elements should be included in the core standard, which elements should be optional but in a standard format, and which should be left to manufacturers’ own invention. Technological companies argued long and hard to include pharmaceutical nomenclature in the core standard, before accepting the medical advice that currently there is no universal and appropriate nomenclature. Each 10472 device will, however, have a unique identifier even when a device is refilled. The unique identifier can be used in a local healthcare system to tie an adherence device to a unique context such a patient identifier and individual patient prescription according to local nomenclature standards.
A similar discussion took place around reminder systems, and again it was decided to leave the exact user implementation to the creativity of individual manufacturers while ensuring that basic standards for recording time and adherence intervals are established. Adherence is not an automatic problem for every patient when a dose is missed. Many therapies are designed to accommodate non-compliance, while others are dependent for their success on a rigid adherence. 10472 specifies optional parameters that can be programmed by the pharmacist or manufacturer to define when a patient or professional should be alarmed by an actual level of non-compliance. The exact implementation of a reminder scheme is also flexible. In extreme cases the 10472 can be online to a monitoring centre and trigger intervention 24/7. In other cases a periodic review of adherence is sufficient. Some trials report good results with an sms reminder scheme, others with patients programming their own alarm. 10472 is a solid basis for a wide variety of implementations.
Some healthcare providers expressed a desire to have absolute certainty that a “dosage event” means that a patient actually swallowed the pill after taking it out of the package. The group resisted this on two grounds. Firstly, patient cooperation is essential to improving adherence and outcomes and patients are more likely to cooperate when not compelled. With up to 70% of patients not complying in some studies, it did not seem productive to drive the standard in a direction that would perhaps result in a rejection of the whole concept of adherence monitoring. Secondly, the technology for detecting that a substance is ingested is in a very early stage – RF tagging of pills, for example – and consumer reaction often not tested at all. Instead of striving for absolute certainty, the groups chose to adopt the Continua model of providing vital sign monitors alongside medication monitors to highlight problems in 99% of cases with patient choice paramount.
Some optional features of the 10472 standard are added because they are easy to add reliably to an electronic system. Tampering, for example, is easy to detect and record with an electronic system. Storage of drugs beyond licensed temperatures and humidity ranges are equally easy to detect. The expiry date is easy to detect when you have a real time clock. All these optional features have value for adherence – patients should take medicine that is effective.
Products conforming to IEEE 11073-10472 and Continua Health Alliance will have a major impact on the way pharmaceuticals are packaged and delivered in future. For the first time patients will be provided with a standard system to manage their medications and record data for objective discussions with their carers. As adherence rates rise, hospital and care home admissions will fall and more chronic patients will use medications properly for the long term. All involved should benefit by adopting the international global standards.