White Paper

Personal Medication Adherence
Ash Patel, Healthcare Segment Manager – Renesas Electronics America Inc.
Ron Rosenbaum, Principal – Ron Rosenbaum Consulting
September, 2016

Abstract
Personal Medication Adherence (PMA), or lack of PMA compliance, is a $300 billion problem in
the U.S. and it bogs down our healthcare system(1). Patients forget to take or may confuse their
medication, which can result in being readmitted to the hospital, a skilled nursing home orassisted-living facility, or with another visit to the doctor’s office. Recent healthcare laws areemphasizing value-based healthcare and use of technology to improve quality of service. The
advent of the Internet of Things (IoT) has brought various technologies to the forefront that,when applied to PMA devices, can help resolve some of the issues we currently face.

The Problem at Hand
Studies show that 20% to 80% of patients make errors in taking medication and that 20% to 60%
stop taking medications before being instructed to do so. With older populations, compliance rates
range roughly from 40% to 60%, with an average rate of less than 45%. Patients forget to take their
medications, creatively alter their medication regimens, engage in unendorsed polypharmacy(taking multiple medications), mix up their medications, and take medications in combinations
that may have dire synergistic interaction effects due to multiple physician prescribers. The percentage drop in medication prescribed to medication continued is alarming, as shown in Figure 1(2).

Prescribed

FilledTaken

Continued

100%

88%

76%

47%

Figure 1. Medication prescribed as compared to actual medication use has dropped substantially.
Note 1: Source: http://worldofdtcmarketing.com/non-adherence-costs-us/cost-of-healthcare-in-the-u-s/
Note 2: Source: http://multiple-sclerosis-research.blogspot.com/2014/02/make-sure-you-take-your-medication-poor.html

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Studies have also shown that 40% to 60% of patients could not correctly report what their
physicians expected of them 10 to 80 minutes after they were provided with the information.
Yet another study reported that over 60% of the patients interviewed immediately after the visit
with their doctors had misunderstood the directions regarding prescribed medications(3).
An Express Scripts report spells out the high price of medication nonadherence, stating that in 2013
alone the cost on the U.S. healthcare system due to this issue was $337 billion. The annual deaths
caused by noncompliance far exceed deaths caused by auto accidents and AIDS combined (4).

Studies report that over 60% of thepatients interviewed immediately
after a visit with their doctors havemisunderstood the directions
regarding prescribed medications.

Industry Statistics
Medication nonadherence is an enormous burden to the U.S. health care system.
Poor medication adherence costs the healthcare systemsome $300 billion annually due to medication-related prob“In the United States, it is estimatedlems, but can be mitigated, the American Heart Associationthat lack of adherence causessays. For every dollar we spend on medication adherence inapproximately 125,000 deaths anddiabetes, for example, the healthcare system saves $7. That’s
at least 10% of hospitalizations.”
a 7:1 savings ratio, and the savings for hypertension andcholesterol (4:1 and 5:1, respectively) aren’t far behind. Poor
– Aja B. Williams, J.D., ONC,
medication adherence is a common problem, according to
Office of Policy and Planning
The American College of Preventive Medicine (ACPM). Some
20%–50% of patients don’t take their medication as prescribed for a variety of reasons, including low health literacy, cost, lack of understanding why theyneed the medication, and inadequate follow-up, among others, according to the organization.
Total U.S. Healthcare spending is estimated at $3 trillion, while spending of retail prescriptions isestimated at around $300 billion according to CMS.
According to a recent publication of the World Health Organization, the proportion of people age
60 and over is growing faster than any other age group, leading to a total population of about
1.2 billion people over the age of 60 in the year 2025.
The use of multiple medicines is considered aleading drug safety issue among this patient
population because of potential drug interactions
or inappropriate prescribing. National Council on
Patient Information and Education (NCPIE) datasuggest four out of five older Americans live with
one or more chronic conditions and two out of fivereport taking five or more prescription medicines.

”Half of the 3.2 billion annual prescriptions
dispensed in the United States are not taken
as prescribed.”– Hayden B. Bosworth, Ph.D.,
Duke University Medical Center

Thus, Hippocrates’ exhortation to the physician to “not only be prepared to do what is righthimself, but also to make the patient…cooperate” has consistently failed for more than 2000 years.
Note 3: Harold Gottlieb, PhD, Article in MedScape Global Medical Publications
Note 4: Source: http://www.2brothersgiftstore.com/pilldispenser.html

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Healthcare Laws & Stakeholders
Ensuring people stay healthy and get the right care is important. However, making sure a
medication regimen is adhered to is an integral part of care delivery and presents itself as an
attractive business opportunity.
Pharmaceutical companies, insurance providers and pharmacies have a vested interest in patientsadhering to their medication regimens. Hospitals can benefit with lower patient readmission,
better medical plan ratings and lower insurance costs. For instance, under the Affordable Care
Act (ACA), Centers for Medicare & Medicaid Services (CMS) are required to impose penalties on
hospitals with patient readmission rates that are higher than the national average. Improved PMA
rates would help lower these charges. Stakeholders are addressing this problem in their own way,
and one can foresee the need for a unified solution with multi-stakeholder participation in thenear future. All the stakeholders should contribute toward the cost of providing PMA solutions topatients for the greater good of healthcare.

Money Spent (on medication)

CH

F

TES
BE
DIA

EN
RT
PE
HY

DY

SLI

PID

EM

SIO

IA

N

Money Saved (in total healthcare costs)

Source: Medication Adherence
Leads to Lower Healthcare Use
and Costs Despite Increased Drug
Spending, Health Affaires, 2011

Figure 2. Preventative healthcare (proper medication) saves substantially in the long run
Recent regulatory changes and technology advancements are also driving the industry toward
better systems for adherence. Service providers will be paid based on the value of the service
provided and not the event, which means hospitals do not want patients to come back for thesame illness (i.e., the ACA). Service providers are incentivized to use technology to lower costs
and reduce readmission rates (HITECH: Health Information Technology for Economic and Clinical
Health Act).
The Physician Quality Reporting System (PQRS) is a voluntary Medicare program that provides a
0.5% incentive payment to practices with eligible professionals that satisfactorily report data on
quality measures for covered physician fee schedule services furnished to Medicare Part B
fee-for-service beneficiaries. Many of the PQRS measures rely heavily on patient adherence.
The widespread adoption of Electronic Health Records (EHRs) has also been successful in driving
medication adherence. EHRs have become the central information source in an integrated medicalcare environment, enabling better checks and balances. A recent study by Kaiser Permanente has
shown an improved number of patients following physician recommendations on medications forchronic illnesses. Only 7% (hypertension), 11% (diabetes), and 13% (cholesterol) of those Kaiser
patients receiving medical care in this “integrated” manner failed to pick up their medication.
Previous studies have shown up to 22% of patients in non-“integrated” health systems neglect tofill new prescriptions.
Pharmaceutical companies will need to determine the value of incorporating EHR and,specifically, ePrescribing into their strategic marketing plans. For example, can ePrescribing beused as a means to increase adherence and brand loyalty through an ePrescribing coupon?
Also, what impact will ePrescribing have on how brands engage with patients?
The ever-improving technology, meaningful use and financial incentives, and the need for
operational efficiencies will continue to drive the adoption and improvement of ePrescribing
and EHR systems. Going forward, EHR will provide an opportunity for pharmacies to partner withWhite Paper – Personal Medication Adherence

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institutions by encouraging them to use EHR data to identify where patients are in theirtreatment and help determine what could be done to help them increase adherence.
Patient education is another key factor. CVS Caremark recently partnered with Dovetail Health, aprovider of transitional care services, to help prevent hospital readmissions, stating that helping
patients better manage and understand their medication regimens after they are discharged froma hospital can play a large part in reducing the likelihood of readmissions. To that end, Dovetail isproviding plan members with in-home medication counseling focused on medication adherence
and drug safety.

Hospital Costs
The ACA requires the Centers for Medicare & Medicaid Services (CMS) to impose penalties on
hospitals whose readmission rates for heart failure, heart attack, and pneumonia are worse than
the national average. CMS has announced that two thirds of the hospitals in the U.S. would
be assessed the penalty in the form of reduced Medicare payments. With nearly one in five
Medicare patients returning to the hospital within 30 days, many institutions could improve theirreadmission rates through improvement in their patients’ adherence to treatments recommended
at discharge(5).

Figure 3. Nonadherence leads to higher readmittance rates and expenses at hospitals
Hospitalization costs also increase dramatically due to nonadherence. In a recent study byHealthentic of over 100,000 patients with either diabetes, high-blood pressure or high cholesterol,
only half of whom were judged adherent, the avoidable cost of hospitalizations was $8.6 million.
In a report funded by the Anthem Foundation and completed in partnership with the Foundation,
Anthem Blue Cross in California, and Anthem Blue Cross Blue Shield in Connecticut, and supported
in part by a grant from the California Health Care Foundation in Oakland, Calif., it was found that
readmissions lead to an estimated $41.3 billion in additional hospital costs each year in the U.S.,
and hospitals and health systems are being held accountable for this financial burden through new
payment models, such as accountable care organizations, and through penalty programs, such as
the CMS’ hospital readmission reduction program (Source: report from the Network for Excellencein Health Innovation (NEHI)).
In 2011, roughly 20% of Medicare patients (nearly 2 million people) were readmitted to a hospital
within 30 days of discharge, though it is estimated that 75% of these readmissions could havebeen prevented with an annual savings to Medicare of $17 billion. As a result, the Medicare
Hospital Readmissions Reduction Program (HRRP) was created within the ACA of 2009.
Medication management and lack of patient engagement in their care constitutes the largest
percentage of readmissions.
Note 5: Source: Michael C. Sokol, MD, MS, Kimberly A. McGuigan, PhD, Robert R. Verbrugge, PhD, and Robert S. Epstein, MD, MS,
Impact of Medication Adherence on Hospitalization Risk and Healthcare Cost, Medical Care • Volume 43, Number 6, June 2005.

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Recommendations from the Network for Excellence in Health Innovation and Anthem include
making real-time, comprehensive and accurate patient medication adherence data available at all
points of care an explicit goal.

Home care Advancement in mobile technology is pushing point of care from hospital tohome. Causes of nonadherence in home care patients include confusion of medications andregimens, cost of prescriptions, forgetfulness, and questions of need. There is also a lack ofskilled oversite and patient engagement. 80%-90% of people requiring care in the U.S. receive itfrom family members or friends. Using home-delivery methods increases medication adherenceby 19%, and by 28.5% when paired with Express Script’s
advanced adherence solutions.

Assisted living The situation here is similar to homecare; however, there may be some patient engagement
interaction, but no skilled oversite or assistance. Medications
are typically ordered through an individual’s retail pharmacy
of choice. Assisted-living facilities are looking for beneficial
medication management systems to enhance their resident
care and extend the time clients can enjoy the freedom of
independent living before transitioning to more restrictive and more expensive skilled nursing
environments. The ability to stay “at home” or move to facilities with more assistance and care ishighly dependent on the individual’s ability to manage their medications as prescribed.

Telehealth Monitoring of vitals and patient engagement is a burgeoning industry, but there
is no medication oversight or reliable adherence information. Telehealth organizations may bewell positioned to provide monitoring and call center services to enhance medication adherence.
URAC© has developed accreditation standards that will ensure not only professional standards, but
uniformity of information and interactions between providers, payer organizations and patients.

Pharmacy Engagement Due to the number and variety of medications taken bypolypharmacy patients, it is necessary for a single pharmacy to manage all prescriptions to protect
patients from potentially over-medicating and adverse drug interactions. Pharmacies can playa critical role by being the middleman between the patient and the doctor or hospital; thus,
improving adherence rates.

PMA and Technology (IoT)
The Internet of Things (IoT) has enabled the various components of the medical ecosystem to beconnected, as shown in Figure 4 (6). Major companies are recognizing the potential market and are
introducing clever PMA devices, such as the med-ic® Electronic Compliance Monitor (ECM©) ande-pill® automatic pill dispenser, which will help patients track medicine usage and alert them

Medication Adherence & Management
PayersClinical
Systems
Healthcare
ProvidersConnectivity

HealthGateway

Patient, Family& Friends
Therapeutic
Devices/Drugs

Figure 4. PMA Solution Components
Note 6: Source: http://www.s3group.com/connected-health/solutions-development/

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when it is time to take their medication. These devices help patients avoid taking the wrong
medication and may also have automatic refill ordering capability. Advances in sensors,
processors, wireless/efficient charging, wireless connectivity, cloud infrastructure and mobile
apps provide a reliable and cost-effective way for product designers to implement PMA devices.
Technology is helping drive patient behavior toward improved adherence in various ways.
For example:• Sensing – Sensors allow for automatic detection of when medicine is taken or not taken.
They can also track the quality of the medicine by measuring environmental exposure.
• Wireless Connectivity – Leveraging Bluetooth® Smart communications, PMA devices canconnect to the cloud without any clumsy wires. Mobile applications allow patients to
self-manage the required interactions, scheduling, and event acknowledgements via
smartphones. For instance, the mobile applications would communicate with the pharmacy
cloud via an Internet connection (cellular or Wi-Fi) to upload adherence data and receive
medicine pack Radio Frequency Identification (RFID) validation information.
• Mobile Devices – Smartphones and tablet devices provide an easy gateway to the cloudand personal alert system. Automated event alerts and notification can be made via text
messaging or phone calls to patients, caregivers, doctors and family members to assist inadherence, engagement and education.
• Mobile Applications – Intuitive mobile apps empower patients to manage their personal
healthcare on mobile devices.
• Cloud Infrastructure – Cloud-based platforms allow physicians to communicate quickly,
efficiently and securely with each other and their patients to provide improved understandingof their conditions and their often complex drug regimens.
Technological advances from the IoT are enabling a new class of PMA devices that are easy touse, affordable and keep the patient involved in monitoring their own health as shown in
Table 1. This is truly a case where technology is helping to solve a real problem, and the statistics
will speak for themselves as we make further progress.
Table 1. Electronic Telehomecare devices
Type of Device

Special Features

Medication Alert Watch

Vibrating alarm signals patient to take pills

Blister pack

Scanned by a reader and data uploaded to a computer; reports when each pill isremovedSmart pill container

Microchip in cap sounds an alert and transmits a notice to a computer that the cap
was opened

Multi-compartment
pillboxes

Alert function and reporting function that uploads data to a computer

Mobile technology App

Visual and audible medication dose reminders; patient reports back to clinic when“medication taken”

Mobile technology App

Electronic health record and e-prescribing tool provides mobile access forclinical medication management

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Renesas Personal Medical Adherence Reference Solutions
Solution 1. Smart Connector Model
The Smart Connector model (Figure 5) was designed while keeping the requirements of a small
form factor and low development cost in mind. The blister pack to be used with this model needs
to have traces printed on the back foil. The user interface and setup is very simple and intuitive.
The blister pack clips on to the smart connector and the device is ready to be powered up.

Figure 5: Smart
Connector with
Printed Foil
Blister Pack

Figure 6:
Mobile App
Screenshots

On the mobile phone side (Figure 6), the user logs into the app and enters the prescription
information (blister pack ID, time table of dosage). Once that is done, the phone has to be paired
via BLE to the smart connector. Every time a new blister pack is inserted, it will be authenticatedagainst the mobile app. When it is time to take a dose, the smart connector will give an audio
alert and the LCD screen will display the blister number from which the dose has to be taken.
The mobile phone can also be set up for visual, audio or vibrate alert(s). Whether the user pops
the blister or not, when it’s time to take the medicine, the action will be logged into the mobile
app data log.
Wireless and USB charging capabilities are provided for flexibility along with fuel-gauge function
for the battery. Temperature and humidity sensors monitor environmental exposure for the
medicine. A summary of all the features is listed in Table 2.
Table 2. Renesas Smart Connector Solution
FeaturesBenefits

Printed traces on blister
pack back foil

Auto detect of which blister was popped to track medicine adherence

Qi Wireless Charging

No-hassle charging to enable quick and repetitive usage

Fuel Gauge

Accurate measure of the battery charge to avoid shutdown

Alert

Audio alert to indicate it is time to take the medicine

USB Charging

Standard micro-USB charging for additional charging method

RFID on Blister Pack

Authenticate blister pack type and serial number to the prescription to avoid error

Bluetooth Smart (BLE)

Secure, reliable and low power method to communicate to the mobile device

Temperature Sensor

Ensures medicine has not been subjected to extreme conditions

Humidity Sensor

Ensures medicine has not been subjected to extreme conditions

LCD Screen

Displays blister number to take meds from for current dose, battery remaining percent,time to next dose, charging status

Touch Buttons

Clear alert, select display options

Mobile App

Enter prescription and patient information, authenticates user and blister pack, alerts
for reminder to take medicine, adherence log to be reviewed by pharmacist or doctor

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Smart Connector Model
12

Smart Sleeve Model

Blister Pack with printed
traces on back foil

1
2

Blister Pack
Optical sensing

RL78/G1D
ModuleResistive sensing

PMOD™ Connector

Blister PackUSB

USB Charger

PMOD Connector

RFID tag
Meds

Meds

Meds

Meds

Meds

Meds

Meds

LCD
2

Touch
Buttons
RFID
ReaderBattery

Audio Alarm
Temp and
Humidity Sensors
Qi Wireless
Charger

LCD Pin Header

Meds

MCU Pin Header

Renesas Synergy™
S3 Target Board

MCU Pin Header

1

MCU Pin Header

Figure 7: Smart Connector and Smart Sleeve configurations.

Solution 2. Smart Sleeve Model
The Smart Sleeve model (Figure 8) was designed for elegance and compatibility with off-the-shelf
blister packs. The user interface and setup is very simple and intuitive. The blister pack slides into
the smart sleeve and the device is ready to be powered up.
On the mobile phone side (Figure 9), the user logs into the app and enters the prescription information (blister pack ID, time table of dosage). Once that is done, the phone has to be paired via
BLE to the smart sleeve. Every time a new blister pack is inserted, it will be authenticated against
the mobile app. When it is time to take a dose, the smart sleeve will give an audio alert and the
LCD screen will display the blister number from which the dose has to be taken. The mobile phone
can also be set up for visual, audio or vibrate alert(s). Whether the user pops the blister or not,when it’s time to take the medicine, the action will be logged in the mobile app data log.

Figure 8: Smart Sleeve with Blister Pack

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Figure 9: Mobile App Screenshots

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Wireless and USB charging capabilities are provided for flexibility along with fuel-gauge function
for the battery. Temperature and humidity sensors monitor environmental exposure for the
medicine. A summary of all the features is listed in Table 3.
Table 3. Renesas Smart Sleeve Solution
FeaturesBenefits

Optical Sensing

Auto detect which blister was popped by finger detection to track medicine adherence

Qi Wireless Charging

No-hassle charging to enable quick and repetitive usage

Fuel Gauge

Accurate measure of the battery charge to avoid shutdown

Alert

Audio alert to indicate it is time to take the medicine

USB Charging

Standard micro-USB charging for additional charging method

RFID on Blister Pack

Authenticate blister pack type and serial number to the prescription to avoid error

Bluetooth Smart (BLE)

Secure, reliable and low power method to communicate to the mobile device

Temperature Sensor

Ensures medicine has not been subjected to extreme conditions

Humidity Sensor

Ensures medicine has not been subjected to extreme conditions

LCD Screen

Displays blister number to take meds from for current dose, battery remaining percent,time to next dose, charging status

Touch Buttons

Clear alert, select display options

Mobile App

Enter prescription and patient information, authenticates user and blister pack, alerts
for reminder to take medicine, adherence log to be reviewed by pharmacist or doctor

Optional Enhancements
Renesas developed these solutions to show proof of concept and give customers a head startfor designing world-class products. This solution showcases the Renesas Synergy™ Platform
featuring the Renesas Synergy S3 MCU, RL787/G1D Intelligent Bluetooth Smart MCU and the
USB Charger IC.
Renesas Synergy is a complete and qualified platform that accelerates embedded development,
inspiring innovation and enabling differentiation. The RL78/G1D is an industry-leading,
low-power Bluetooth Smart v4.1 MCU. Renesas has a portfolio of USB battery charger ICs.
Customers have the option to use wireless or cellular technology for connectivity instead of
the provided BLE function. The mobile app can be further enhanced by providing back-end
connectivity to a cloud platform and building a dashboard in the cloud. These dashboards canbe a single point of interaction between the doctor, pharmacy and patient.

Conclusion
The global medication adherence systems market is increasing significantly due to the growing
awareness of the health and financial aspects to all stakeholders; identified chronic conditions
such as diabetes, CHF and HIV; and a growing geriatric population.
As per the United Nations Department of Economic and Social Affairs (UN-DESA) report on the
global aging population, the population of people aged 60 years or above is expected to reach
21.1% by the end of 2050.
Furthermore, the evolution of mobile health (mHealth) technologies and increasing demand for
personalized healthcare technologies are also driving the growth of the global medication
adherence market.

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The chronic underuse of medications is one of the most common forms of nonadherence.
According to the CDC, the nonadherence of drug therapy causes 30% to 50% of treatment failures
and leads to 125,000 deaths annually.
The HITECH Act has provided more than $35 billion in incentives to healthcare organizations. Morethan 30% of clinical settings now utilize EHRs. It is estimated that HITECH incentives will boost
EHR adoption rates to 90% by 2019. This creates a uniform infrastructure for data acquisition andanalysis, which will enhance and promote technology solutions to the problem of nonadherence.
There are many stakeholders who will rely on the improved outcomes and benefits of adherence
including patients, healthcare providers, payers, pharmacies and pharmaceutical manufacturers.
For example, the U.S. pharmaceutical industry loses an estimated $188 billion annually due to
medication nonadherence. Hospitals face penalties for readmissions when an estimated 38% arecaused by nonadherence to medications after discharge.
Visits to doctors and emergency rooms, admissions to assisted living and skilled nursing facilities
and deaths could all be drastically reduced if medication adherence were improved.
Through new secure technologies for data collection and pervasive smart phone and otherintelligent devices for communications and user-facing applications, a widespread community ofpatients can be assisted, thereby saving lives, improving health, and dramatically reducing thecosts of healthcare.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Renesas is under license.
Other trademarks and trade names are those of their respective owners.

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