Journal for Patient Compliance

JOURNAL FOR

Strategies to enhance Health OutcomesPATIENT COMPLIANCE✓

Volume 1 - Issue 3

www.JforPC.com

From formulation to drug delivery to specialty packaging A comprehensive approach to patient adherence

Patients first: Shifts in industry thinking

The introduction of targeted medicines use reviews and the new medicine service in England

Creating a value proposition To adherence enrolment

PEER REVIEWED

FOREWORD

PaTIEnT STORy

Placing the Power of Health Back with the PatientLaura Barnwell discusses the key topics emerging from the 8th annual Patient Adherence, Communication and Engagement (PACE) Summit, where thought leaders from across the pharma space discussed the latest innovations and breakthroughs in patient engagement. Covering the patient voice, patient education, patient-physician relationship, personalised health solutions, empowerment and many other key focal areas in improving adherence, Laura questions the prospect of placing the power of health back with the patient.

WaTCH PagES

adherence Happenings in the USOn September 22, 2011, a new and unique roadmap was unveiled – The Medication Adherence Roadmap: A Path Forward – by NEHI, a not-for-profit, independent health policy institute focused on transforming healthcare for the benefit of patients and their families. Ray Bullman of NCPIE explains how this roadmap lays out multiple over-arching routes for addressing medication adherence improvement -- all intended to lead to better outcomes for patients.

Patient Reported Outcomes: a key to Compliance Success FactorsSubject compliance is a hot topic in the industry right now. Yet some of the discussions out there can be a little misleading since ‘compliance’ means different things to different people / companies. Kai Langel of CRF Health discusses the importance of defining what we mean when we use the term ‘compliance’, because it can mean any one of many definitions, dependent upon the individual. Heather also highlights the necessity that we carefully define the reports and metrics collected in clinical studies.

adherence Happenings in EuropeAt the invitation of HCPC Europe, leading industry opinion-shapers gathered in London on September 22nd for the first round table discussion with the objective of exploring the imminent changes around healthcare funding, and whether intelligent packaging can help translate the billions invested in medication into measurable improvements in compliance and patient outcomes. Tassilo Korab, co-founder of HCPC Europe, outlines the issues discussed and the directions to be explored in improving adherence through packaging.

How ‘Digital’ is the Future of Patient Compliance?Welcome to the future: the rapid development of smartphone technologies and applications, social networking and internet access on the go, interactive video games and smart gadgets has already changed the way the world functions, communicates and conducts business. Lulia Calota, collaborator of BIOAXIS Healthcare, will discuss a few examples of how new technologies are presently used to increase patient compliance, and how these will influence the increase of patient adherence to treatment in the years to come.

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DIRECTORS Martin Wright

PUBLISHERMark A. Barker

ManagIng EDITOR Mark A. Barker

EDITORIaL COORDInaTORJaypreet Dhillon

EDITORIaL aSSISTanTSNick Love, Kevin Cross, Lanny McEnzie

DESIgn DIRECTOR Ricky Elizabeth

RESEaRCH & CIRCULaTIOn ManagERDorothy Brooks

BUSInESS DEVELOPMEnTBryony Whittaker

aDMInISTRaTOR Petya Stefanova

FROnT COVER © iStockphoto

PUBLISHED By Pharma PublicationsUnit 7a, Evelyn CourtGrinstead RoadLondon SE8 5ADTel: +44 0208 6922878 Fax: +0014802475316Email: [email protected]

Journal For Patient Compliance – Strategies to enhance Health Outcomes. ISSN 2045-9823 is published quarterly by PHARMAPUBS.

The opinions and views expressed by the authors in this magazine are not necessarily those of the Editor or the Publisher. Please note that although care is taken in preparation of this publication, the Editor and the Publisher are not responsible for opinions, views and inaccuracies in the articles. Great care is taken with regards to artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright.

2011 PHARMA PUBLICATIONSVolume 1 issue 3

JOURNAL FOR


Contents

Journal For Patient Compliance Strategies to enhance Health Outcomes 1www.JforPC.com

REgULaTORy & MaRkETPLaCE

new Medical Software Design StandardsThere are now regulations that govern the development of software that could be classified as a medical device. It’s likely that many software products out there, which are not currently registered as medical devices, will now need to be. In light of this, Josh Taylor of Partizan International asks ‘Does your patient website need to be registered as a medical device?’

Risk Mitigation Regulation in the USPrior to the implementation of REMS regulations, the FDA removed from the market many drugs that could benefit patients because they had been inappropriately prescribed. Jean Steckler from i-Reminders explores how under the REMS programme, the FDA can now allow continued access to drugs deemed advantageous or necessary, while restricting access to these drugs when they are not.

The Introduction of Targeted Medicines Use Reviews and the new Medicine Service in EnglandStatistics released from the Information Centre have shown a 70 per cent increase in prescription items dispensed in England since 2000. This rise is thought to be due to a number of factors, including our increasing and ageing population, greater access to new and more effective medicines, changes in period of treatment, and an increase in prescribing medicines preventatively. Whatever the reason, prescribed medicine represents the largest non-staff element of the NHS budget, so it is vital to get value for money from this investment. Michael Holden of the National Pharmaceutical Association (NPA) argues that there is no doubt that we can gain much more value for patients and the taxpayer by supporting effective medicine use.

Patients First: Shifts in Industry ThinkingThe patient is receiving more and more attention from the pharmaceutical industry. Although the physician was the centre of their commercial activities in the last few decades, the spotlight is now increasingly being placed on the comprehensive care of patients. However, apart from the knowledge that this also means a change in business models, the industry has not yet offered concrete solutions for how this is to be done. Karsten Sternberg of Pharmexx discusses how patient-centred services can be considered from various standpoints and illustrates several successful approaches.

BEHaVIOUR PROgRaMMES

Creating a Value Proposition to adherence EnrolmentThe recent adherence debate at the European Parliament in Brussels reinforced the fact that poor adherence carries a huge cost, both in terms of patient safety and quality of life. It also presents a serious problem for health systems, leading to inferior health outcomes, and unnecessary treatments and hospitalisations. Carol North of 90TEN Healthcare argues that providing adherence support for your medication has never been more important in these times of austerity. Yet one must consider the biggest problem in delivering patient

adherence programmes - how do you get the patients on board and enrolled?

Either Patients adhere or the Industry May PayThe poor rates of adherence observed in patients taking chronic therapy invalidate many of the results seen in randomised clinical trials. The results of these trials are often used to prove economic benefit and so these analyses must also be questioned. Ian De’Ath of Wizzard suggests either the industry is either going to have to perform economic evaluations in “real world” settings or find a way to make adherence rates match those seen in clinical trials.

CLInICaL TRIaLS

Optimising Patient-Centric Services: a Tailored SolutionAcross the healthcare ecosystem, there is significant focus on medication adherence and patient programmes as a tool that can increase health outcomes, and decrease health system utilisation. For years, multiple healthcare stakeholders have sponsored patient programmes which have collectively sought to drive positive patient behaviours, including improved patient wellness and medication adherence. Davis Walp and Himanshu Jain of Quintiles explore how patient behaviour – the largest single factor in compliance and wellness – can be influenced through a suite of patient-centric services (PCS) allowing the design and implementation of programmes that support better patient outcomes while reducing healthcare costs.

THERaPEUTICS

Detecting Pro-cognitive Effects in Clinical Drug Trials: Case Studies from alzheimer’s Disease.John Harrison of Metis Cognition Ltd and Honorary Senior Lecturer in the Dept. of Medicine at Imperial College in London describes the turmoil in the world of Alzheimer’s disease clinical drug trials over the past couple of years. Unfortunately the promise of new compounds to modify the course of the disease and offer symptomatic relief has not been realised, and we have instead witnessed a succession of failures. These failures have focused attention on not just the disease mechanisms, but also the instruments used to measure drug effects, particularly with respect to the assessment of cognition, the hallmark deficit of Alzheimer’s disease.

MODERn TECHnOLOgy

Compliance Spotlight on Speciality DrugsWhen it comes to compliance, speciality drugs are pretty special. They are often highly complex medications, typically biology-based, that structurally mimic compounds found within the body. Speciality drugs are developed to treat complex chronic diseases, such as multiple sclerosis, hemophilia, arthritis or cancer. Pamela Swingley of MobilePRM explores how whilst speciality drugs have been available for several decades, rapid growth in both the quantity and cost of these drugs over the last few years has put speciality drug therapies in the spotlight.

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Contents

Volume 1 - Issue 32 Journal For Patient Compliance Strategies to enhance Health Outcomes

DRUg DELIVERy, DRUg PaCkagIng, LaBELLIng & DISPEnSIng

From Formulation to Drug Delivery to Speciality Packaging: a Comprehensive approach to Patient adherencePharmaceutical companies have long understood that patient adherence to their prescriptions is an addressable barrier that can help lead to better and more cost-effective treatments for patients. Steven Hamlen and Bill Hartzel from Catalent explore how patient non-adherence to medications is heavily dependent on the individual needs of specific patient demographics. Even though the action and goal is easily identifiable, the solutions are often complex and multilayered.

Stuck Between a Pill and a Hard PlaceMost of us would hope that pills prescribed for loved ones, designed to potentially extend or save their lives, are taken correctly. But who is responsible for ensuring this actually happens? A visit to the doctor every two to three months doesn’t cut it and certainly isn’t working based on long-standing statistics – Michael Clayton from Atlantis Healthcare suggests that this level of support is simply not enough to improve adherence rates.

Close to you, More than Ever …near Field CommunicationNear Field Communication (NFC), is a very short-range radio technology that makes use of two interacting electromagnetic fields, meaning data transmission is limited to interaction of two NFC-enabled devices, based on inductive coupling. Willem Kort and Jos Geboers of Confrérie Clinique describe the role and potential uses of NFC in patient monitoring that could lead to improved health outcomes.

Industry-Suitable Technologies for Protection of Pharma Products against CounterfeitingWith the new European directive 2011/62/EU concerning prevention of the entry of falsified medicinal products into the legal supply chain, it appears that patient safety will be achieved with the combination of three components. This paper from Dr Jordan of Alpvision concentrates on one such component, the authentication features and the way they can be implemented within the manufacturing plants of the pharmaceutical laboratories.

In THE SPOTLIgHT – PROFESSIOnaL PERSPECTIVE The Past, Present and Future of adherenceAn Interview with Professors Weinman and Petrie brought to you by Mark Barker – Editor of Journal for Patient Compliance, in association with Atlantis Healthcare.Two of the most prominent researchers in medication adherence are Prof John Weinman from Kings College London, and Prof Keith Petrie from the University of Auckland. Their research has greatly increased our understanding of the factors affecting patient behaviour and the ways in which adherence to prescribed medication can be improved. We asked them both how our understanding of treatment adherence has developed, where we are at today, and where they see the field going over the next five years.

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Welcome to the latest issue of Journal for Patient Compliance.

As someone whose professional involvement in patient compliance

revolves around packaging and pack design, I sometimes feel

rather remote from the patient. Although I know that the work we

at Brecon Pharmaceuticals do in developing packs is an important

element of an often complex picture, I don’t often have the time or the opportunity to

stand back and admire the big picture.

I was fortunate enough recently to be able to engage more directly by participating in HCPC-

Europe’s round table debate. Along with a number of other participants whose remit is the

theory and technology of patient compliance, I heard patient representatives and medical

practitioners express loudly and clearly that empowering patients to understand their

condition and take control of their treatment is a key factor in increasing compliance levels.

We’re all familiar with the depressing statistics about how compliance rates in treatments

for chronic conditions are depressingly low, and we all know that overall healthcare costs

would be significantly lower if patients adhered to their treatment regimes; but for those

of us blessed with good health, it can be hard to understand why anyone would not take

medication deemed to be required. But perhaps that’s just it – we don’t understand, in the

same way that many patients don’t fully understand their condition or the consequences

of not treating it as prescribed.

Those consequences vary widely depending on the condition involved: a patient with type

I diabetes might be reminded of failure to take his insulin by a very rapid deterioration in

his condition where in other cases, the decline will be more insidious.

So there you have it: we can implement as many pack features to aid compliance as we

like, but at the end of the day, if the patient doesn’t understand his condition, we’re

wasting time and money. While it falls principally to clinicians to educate patients at the

diagnosis stage and at the outset of treatment, packaging has a significant role to play in

the next phase of treatment, that of continuation. Here, according to an EU-funded study

into Barriers to Compliance, the attitude of patients and carers is crucial to adherence.

Brand owners and manufacturers would do well to take this on board in the context of a

recent US study which shows that when patients fully appreciate the need to take their

medication, the right choice of pack and pack features can improve compliance rates from

60% to an astonishing 96%.

All of which is heartening stuff for those of us who are not involved directly at the patient

interface. The packs we design and the compliance-enhancing features we develop are not

just gimmicks: they have a vital role to play in improving and maintaining the health of

patients requiring medication on a long-term basis.

We also look at the growing use of digital technology in prompting compliance. As

smartphones become the norm, the potential to use these coupled with specific apps is

increasingly attractive.

The theme of patient empowerment was also to the fore at the 8th Annual Patient

Adherence, Communication and Engagement Summit. The conference heard how the

patient who plays an active role in the decision-making process and management of his

treatment is likely to have a far better outcome than one who feels like a passive subject.

As the politicians say – education, education, education.

Steve Kemp, Business Development Director at Brecon Pharmaceuticals and Chairman of

HCPC Europe

Editorial advisory Board

Andree Bates, Managing Director, Eularis

Anna Dirksen, Senior Manager, PSI Behavior Change

Chris Penfold, Vice Chairman - East Midlands Packaging

Society, Consultant, Freelance Packaging Specialist

Carole North, Managing Director, 90 TEN Healthcare

Dyan Bryson, Managing Partner/VP Patient Strategy

& Outcomes for Inspired Health Strategies

Edwina Rogers, Executive Director of the Patient

Centered Primary Care Collaborative

Elisabeth Moench, President & CEO of Medici Global

Helen Lawn, Managing Director, Helen Lawn & Associates

a healthcare PR and communications agency

Isabelle Moulon, Head of Medical Information

Sector, European Medicines Agency

Jay H. Bolling, President and CEO,

Roska Healthcare Advertising

Joseph Bedford, Director of Marketing

Almac Clinical Technologies

Laura Bix, Assoc. Prof. School of Packaging

Michigan State University

Louis A. Morris, Ph.D., is President of Louis

A. Morris and Associates, Inc

Mark Duman, Managing Director ,

MD Healthcare Consultants

Michael Wong is Managing Director at hcCatalyst

Peter van Iperen, Experienced Pharmaceutical Professional

Phill Marley, Packaging Account Manager,

Global Quality Operations AstraZeneca

Ronald E. Weishaar, Executive Director, Observational

Research, PharmaNet Development Group

Saurabh Jain, Director of Patient Value

Services and CME Solutions at Indegene.

Steve Kemp, Business Development Director at Brecon

Pharmaceuticals and Chairman of HCPC Europe

Tassilo Korab, Co-founder of HCPC Europe

(Healthcare Packaging Council)

Vassilis Triantopoulos, CEO of BIOAXIS Healthcare

Walter Berghahn, Executive Director, The

Healthcare Compliance Packaging Council

FOREWORD


Patient Story

Last month, Philadelphia played host to eyeforpharma’s 8th annual Patient Adherence, Communication and Engagement (PACE) Summit, where thought leaders from across the pharma space discussed the latest innovations and breakthroughs in patient engagement.

After months of anticipation (and a few sleep-deprived nights) the summit arrived, and as the initial morning caffeine buzz and business card swapping had ended we all took our seats, ready to learn from our peers in patient engagement!

The patient voice was a focal point of discussion, with key patient advocates and patients on hand to share their perspectives. I believe that in every aspect of healthcare it’s vital to have the patient voice represented – which is why I was keen to involve Jeanne Barnett, founder of cycticfibrosis.net, in this project. This online platform has allowed patients with cystic fibrosis (CF) to seek answers where pharma and physicians cannot. It also enables the patient to share stories, gain expert advice and find out about clinical trials for which they’re eligible. Lauren Brenneman, a member of the site, joined the summit to tell her story, and how often the industry has failed to meet her needs

Brenneman began by taking us through her typical day, which took the room by surprise. Some members of the audience awkwardly shifted in their seats in the face of such an open and vivid explanation of a patient’s condition. Getting close with patients was a main theme of the event, but through the voice of a patient we wanted to highlight the importance of being comfortable with them too. This point later became an important area of debate, sparking discussion and conversation throughout the two days.

Through her explanation of how CF affects her family, it became clear that pharma could be missing an opportunity to get closer to patients at the point of diagnosis. “Diagnosis is the point when the life of a person changes dramatically, and when families need hope and support, learning to adapt to a disease,” Brenneman said. Building programmes from the diagnosis phase onwards, through an interactive two-way platform, could be a solution. At the same time one of the common observations from patients

like Brenneman is that the very people providing her medication don’t seem to understand the condition beyond the chemistry and list of symptoms.

“It seems the marketers do not know about the disease they are selling. If you really look at how a patient does something, for example nebulizer cleaning, they could learn how to design their products better,” continued Brenneman. Those in the CF

Placing the Power of Health Back with the Patient – Lessons from eyeforpharma’s 2011 Patient Adherence, Communication and Engagement Summit


community, most of whom are diagnosed at a young age, have remarkably few interactions with pharma, with even a pro-active patient like Brenneman engaging with only two companies on a very transactional basis. Like many others, she does not view pharmaceutical companies as organisations that can help support her daily life or affect how adherent she is to treatment. So even with all of the positive outcomes data and re-filled scripts, the industry still seems to be missing out on a crucial element…engagement and relationship-building. So what’s the next step?

Those at the eyeforpharma summit discussed next steps for realising this opportunity. Society as a whole is more educated than ever when it comes to health. The amount of information available online in a user-friendly format is vast, and online communities like cycticfibrosis.net and PatientsLikeMe enable patients to have more control in their care by interacting with others and sharing experiences. Lauren sends her doctor emails the night before an appointment, a system they developed together to ensure Lauren was getting the answers she deserves. Chris Preti, Vice President Patient Engagement, GSK, gave his insight into this emerging patient-physician relationship: “Patients who are involved in shared decision-making with their providers, and who understand how to manage their health achieve better outcomes,” thereby supporting the movement towards more consultative healthcare decisions and improving health outcomes.

“Patients are looking for simple, personalised health solutions from a trusted, respected source,” continued Preti. Creating effective communication platforms would be invaluable, but they cannot be achieved as part of a marketing campaign or with any kind of commercial agenda. Credible partnerships need to be made across pharma to host these kinds of platforms, allowing open communication between pharma, patients and physicians. This is an opportunity for pharma to take pro-active steps in getting patients to see pharma as a support channel and to respond more positively to adherence communications they receive after they start a certain treatment.

Patient empowerment, another issue raised at the summit, clearly remains a key challenge in the industry. “I accept I’m in control of my own care, and receive support from my physician, family and even my community, but the responsibility is my own,” said Brenneman. Although patient empowerment is the holy grail of adherence, a surprising amount of companies don’t seem to be addressing this effectively. Flashing lights, easy to open pill packets,

nurse calls and text reminders, although effective should be seen as the foundation of adherence, the nuts and bolts that facilitate treatment options. The real future of patient adherence, though, that emerged at the summit is getting patients to accept that their health is in their own hands … literally.

Rebecca Burkholder, who is part of the National Consumers League medication adherence campaign, showed the audience a clip from the “I will” commercials, currently airing across the USA. The commercials encourage patients to realise that if they take their medication as prescribed “they will” be able to do things they would otherwise be unable to. This is the kind of angle that everyday people respond to, and is a step in the right direction in placing the power of health back with the patient.

Laura Barnwell is an eyeforpharma Global Event Director, focusing mainly on projects centred around patients, adherence and communication. She is currently in the process of putting together the Patient Adherence, Communication and Engagement Europe Congress - for more

information visit www.eyeforpharma.com/patient or contact her directly on Email: [email protected]


Watch Pages


Watch Pages

Back to the FutureIn today’s high-tech world of always on – always available communication, there is some comfort to be taken in harkening back to items that connect me to the way things once were. Take for example, the roadmap. I recently came upon a US interstate roadmap – circa 1998 – stashed in a garage drawer. It was crumpled, wrongly folded, and streaked with fading yellow highlighter extending from points A to B and elsewhere – hieroglyphics of past journeys.

On September 22, 2011, a new and unique roadmap was unveiled – The Medication adherence Roadmap: a Path Forward – by NEHI, a not-for-profit, independent health policy institute focused on transforming healthcare for the benefit of patients and their families. This roadmap lays out multiple over-arching routes for addressing medication adherence improvement – all intended to lead to better outcomes for patients.

Like all roadmaps, at first glance, the overall look of The Medication Adherence Roadmap is one of tangle and complexity. Yet, as noted below, closer examination of the seven broad megatrends and six “golden” (high-level) opportunities identified as key to adherence advancement laid out in the NEHI Roadmap reveals form and purpose – providing direction and guidance to key stakeholders committed to improving medication adherence.

NCPIE – a member of the NEHI Conference Advisory Committee – is pleased to have participated in the development of the Adherence Roadmap, which helps point to true north – the ultimate destination of better health outcomes for patients.

Megatrends & golden Opportunities NEHI Broad Megatrends to Advance adherence • Health Information Technology • Care Coordination • Payment Innovation• Quality Improvement • Patient Engagement• Product Innovation• Research

NEHI Golden Opportunities to Advance adherence • Patient-centred medical homes and payment innovations

that support coordinated care• Retail pharmacy transformation and pharmacy quality

measures• Hospital readmissions policy• Medication Therapy Management (MTM), Medicare, and

Value-based Insurance Design (VBID)• Cardiovascular health• E-prescribing and generics Relevant Web Links: 1. NEHI (Home): /www.nehi.net/ 2. NEHI Medication Adherence Roadmap: A Path Forward: www.nehi.net/

events/multimedia/

Research UpdateIn the August 2011 issue, I reported that the National Alliance of State Pharmacy Associations (NASPA) – Alliance for Patient Medication Safety (APMS) was reviewing proposals from state pharmacy associations seeking to identify ways in which pharmacists can assist patients to improve adherence. The goal of what NASPA-APMS refers to as adherence Discovery Projects, is to select projects intended to produce measurable, scalable, replicable and sustainable programmes in community pharmacy to improve adherence or methods to identify non-adherent patients.

Six state pharmacy association proposals have been selected, and each received funding to complete an adherence Discovery Project. Of the six projects, one researched a new adherence toolkit for use by the pharmacist and patient, two used a telephone model, and three used either a health coaching or modified health coaching system. For the final report and details about each project, see the web link below. Relevant Web Link: 1. NASPA-Alliance for Patient Medication Safety Adherence Discovery Projects:

www.naspa.us/documents/grants/NASPAAdherenceDiscoveryProjectProcess.pdf

Ray Bullman joined the National Council on Patient Information and Education (NCPIE) in 1985. He has served as Executive Vice President since January 1995. NCPIE, organised in 1982, is a non-profit coalition of diverse member organisations working together to stimulate and

improve communication of information on safe and appropriate use of medicine to consumers and health care professionals. (www.talkaboutrx.org) Email: [email protected]

adherence Happenings in the US


Watch Pages

Subject compliance is a hot topic in the industry right now. Some of the discussions out there can be a little misleading since ‘compliance’ means different things to different people / companies. Many eDiary vendors focus on a subject’s compliance with data entry, whereas sponsors are more interested in the subject’s compliance with the study procedures, and clinicians are interested in the subject’s compliance with their medication / treatment.

I think it’s important that we define what we mean when we use the term compliance, because it can mean any of the above items. It is also important that we carefully define the reports and metrics that are collected in clinical studies. I see many studies attempting to come up with a single metric for ‘total compliance’, which includes a number of different things, such as compliance with different medications, diary entry, etc. By doing this they are actually hiding some important details. Individual metrics for individual items would most likely be much more useful. If a subject is having issues with their medication compliance, it should be addressed separately from their compliance with the entering of information into their eDiary.

CRF Health has been collecting eDiary compliance metrics for many years now, and our compliance database is getting quite extensive, and becoming more useful as we collect more data. Every single CRF Health eDiary device automatically collects project specific eDiary compliance for every subject. While it is sometimes difficult to define a reliable compliance metric for every study (OAB and other event-driven diaries are difficult, for example), there are some interesting trends that are starting to emerge:

africa is the Leading geographic Region, with 94.5% CompliancePersonally, I find this surprising. However, we only have a limited amount of data for Africa – only 2% of our subjects are from Africa (n=1785). Africa is followed by Eastern Europe (92.8%) and Asia (92.1%).

adult Populations have the Lowest ComplianceThis is another surprise, since most people would expect the ‘tech-savvy’ groups to be high on the list, but the statistics are almost the opposite. Infants (e.g. care-givers) lead with 93.9%, elderly subjects are close behind with 92.3%, and adults are well below the average with 88.5%.

Healthier Populations Perform Better than Sicker PopulationsThis is not surprising at all. Our vaccine studies have 93.8% compliance with a standard deviation of 10.9, compared

to 86.1% / 15.7 in pain, and 86.3% / 18.2 in COPD. What is interesting is that there are studies within some of the ‘difficult’ indications that have very good compliance, and there are studies that are not doing so well. It proves that it is possible to get very good results even within the difficult indications. This actually raises some interesting questions – what are the key success factors in these studies and what can we learn from the studies that are not doing so well?

Compliance Success FactorsThe space allotted for this article is not enough to discuss the details, but here’s my shortlist of what I personally consider to be the key points:• Subject focused eDiary design that will proactively guide

the subject AND study sites through the study• Efficient compliance management tools for sites and CRAs

– online reports, email notifications, etc• Active study team from the sponsor / CRO who will use the

compliance monitoring tools and stay on top of everything

These are all generic concepts that can be adopted in virtually every study. There are obviously many protocol / disease specific best practices that can be utilised. Study sponsors should expect the eDiary vendor to be able to proactively guide them through the design process to ensure best results for each study. This is exactly what the CRF Health teams are used to doing – we actively use our existing experience and best practices and provide these recommendations to our sponsors.

Kai Langel has worked with CRF Health since the company’s inception in 2000 and is one of the pioneers in the ePRO industry. During this time, Kai has been involved in all aspects of ePRO operations from system design to deployment and support. Kai spent 5 years in the United

States where he was responsible for building CRF Health’s technical delivery team. He is currently based in Europe in a consultative role providing advice and guidance to both customers and CRF Health’s internal teams on technical, operational and regulatory issues. Kai is a true global ePRO expert, having worked both in the United States, Europe and more recently in Japan and Asia.Email: [email protected]

Patient Reported Outcomes: a key to Compliance Success Factors


Watch Pages

at the invitation of HCPC-Europe, leading industry opinion-shapers gathered in London on September 22nd for the first round-table discussion with the objective of exploring the imminent changes around healthcare funding, and whether intelligent packaging can help translate the billions invested in medication into measurable improvements in compliance and patient outcomes.

The debate focussed on • barriers to compliance, • how compliance aids can be integrated into the healthcare

supply chain• the future role of intuitive packaging in patient care• the role of medical professionals, insurers, patients,

pharmacists and pharmaceutical manufacturers• the terminology to be used: compliance, adherence or

concordance• the measurement of compliance

The experts on the panel answered questions from the audience and tried to find an answer to the key question:

“How we can work together to bring about change.”

The panel represented the main stakeholders in healthcare: Robert a. Johnstone, patient organisation (IAPO)Sven Stegemann, patient organisation, in a dual role as the chairman of the Geriatric Medicines Society and as representative of the pharma industry (Capsugel)Dr. Mario knight, general practitionerDavid Stevens, health insurance (AXA Assistance)Steve kemp, packaging industry (Brecon Pharmaceuticals)Paul J. goerdt, pharmacy (Medco Celesio)Prof Przemyslaw kardas, research (University of Lodz)Bernard Vrijens, technology industry (Aardex Group)

It was Robert A. Johnstone, who emphasised the importance of empowering patients to understand their condition and to see why they need to take their medication, and why to take it at a particular time. Educated and empowered patients will be better patients; they will be managing their own condition most of the time rather than having to rely on external professionals, and they will also know when to call in a professional. He then set the direction of the debate when he stated that the last point of contact with the healthcare providers was not the dispensing pharmacist, but when you then get home and open the pack, which can represent a huge barrier.

Assessing the size of the problem, Medco, who have a database of 65 million patients, calculate that roughly 45% of the population needed ongoing medication for chronic and/or complex diseases. The figure of patients in the US needing support to stay compliant/adherent/persistent would therefore be some 150 million, and for Europe the relative figure would be in excess of 220 million people, of

whom actually 50% give up their treatment within one year, while they are supposed to stay on. According to Aardex’s database, every day 10% of those who are engaged with their therapy forget to take their medicine. These figures don’t take into account the so-called primary non-compliers, people who get a prescription but never buy it.

Furthermore, the improper use of medicines in short-term therapies, in particular incomplete treatment with antibiotics and the severe consequences of such non-adherence, needs to be addressed.

Referring to the EU-funded ABC (Ascertaining Barriers to Compliance) project, Professor Przemyslaw Kardas stated that the clear understanding of the different terms used in the context of patient compliance was of utmost importance for a constructive debate, and that the experts involved agreed on a taxonomy rather than a definition, and that they needed to look at two processes: “one process, which we have called medication adherence or adherence to medication, a process by which the patient takes his medication. And that is a process which has a beginning, “initiation”; a middle, “execution” of the dosing regimen and an end “discontinuation”. ..”And then you have a second process that is a process by which the healthcare provider, the healthcare system, the patients family helps the patient to adhere. And that is management of adherence. And I think concordance is a major step in management of adherence. Concordance is the base for compliance, adherence and persistence and that patients need to get positive information from their physician about their treatment to achieve the level of understanding of their condition which leads to concordance.”

Peter Williams, pharmacist and General Manager of MTS Europe, who participated in the discussion from the audience, quoted findings in the US: According to a study carried out by the Walter Reed Center in the US in 2006/2007, published in the Journal of the American Medical Association, showed that by using the right form of packaging, adherence increased from 60% to 96%, and that when the service was removed over a period of time it went back to 60%. The re-packaging of the medicines was having an impact on the accurate use of the complex regimen that a specific group of patients was using; it was convenience, but more than anything it was a tangible reminder. The debate led to the formation of a working group who set their goal as galvanising all those with a stake in health to make pro-compliance measures an inextricable part of patient care.

Tassilo Korab holds MSc in healthcare Management. He started his career as an International Sales Manager, and has been in the packaging industry for more than 25 years. Focusing on patient compliance, standards and regulations for child resistant packaging and the war

against counterfeits. Co-founder of HCPC Europe, Tassilo Korab is the MD of TKM HandelsgmbH, Austria. Email: [email protected]

adherence Happenings in Europe


Watch Pages Adherence 360°

Welcome to the future: the rapid development of smartphone technologies and applications, social networking and internet access on the go, interactive video games and smart gadgets have already changed the way the world functions, communicates and conducts business. no wonder pharmaceutical companies decided to tap into the potential of the digital technologies and adjust their strategy in order to increase patient compliance. Below we will discuss a few examples of how new technologies are presently used to increase patient compliance, and how these will influence the increase of patient adherence to treatment in the years to come.

According to the FirstWord Dossier, ‘Digital technologies to boost patient compliance’, published in 2010, 70% of Americans play online computer and video games, already 33% of Americans use social media and online sites to research health issues, and some experts predict that 21% of medicine will be practised online or over smartphones. There have already been mentions of virtual hospitals or virtual care schemes to support this prediction.

As the world goes mobile (in Gambia, for example, mobile phone penetration is as high as 96%) and some health issues such as diabetes, asthma and depression grow in prevalence, more and more compliance is being achieved with the help of the digital technologies. Adherence providers have been using mobile SMS communications in order to interact directly in a personalised and cost-effective manner with the patients. SMS reminders and educational and motivational messages have been used to improve compliance, as well as electronic patient reported outcomes, eDiaries and visit reminders, with a significant compliance rate of success.

With the development of smart mobile phone technologies, it was only a matter of time until phone applications were going to be introduced for compliance-boosting purposes. In September 2011, Drugs.com announced the launch of a new iPhone app, “My Meds” – a personal medication record (PMR) and pill reminder app designed to help manage prescription medications and improve patient compliance. The company also released a comprehensive pill reminder application for the iPhone and iPod Touch.

Smart pills packaging like Vitality’s GlowCap or the Pill Timer, and standalone devices such as digital insulin pens that have already been on the market for a while, are concrete proofs of how the technological development impacts on boosting patient compliance.

New digital technologies also allow for new ways of improving patient compliance in an unobtrusive way that fits around the patients’ lifestyle and gives them a sense of empowerment, such as video games that award points for complying with disease management. Such an example is the game ReMission, created by HopeLab staff in collaboration with video game developers and medical consultants for cancer patients, designed to be fun and challenging, while

helping players stick to their prescribed treatments and giving them a sense of power and control over their disease.

With people spending more and more time online, the use of password-protected websites where users can find out more about their condition but also engage in conversations with people who share their health issues is on its way to almost becoming a traditional method. There are numerous examples of such websites for various drugs and conditions, some of them pioneered by patient and carers associations, but also by adherence programmes providers.

A growing trend for online patient communities has been noted with the spread of access to the internet and its resources. Many patients feel they can comply better with their treatment if they feel they are not alone in dealing with their condition, especially for less known and less common diseases, where information and support are scarce. Online

How ‘Digital’ is the Future of Patient Compliance?


Watch Pages Adherence 360°

communities and forums have been a common sighting on the net and, according to the New York Times, researchers have already tapped into the popularity of online patient communities for innovative medical studies. However, regulatory concerns have been the main reason behind the cautious approach of medical companies and adherence providers towards engaging patients online for treatment compliance purposes. Pharma presence on social networking sites such as Facebook has its own limitations, as no promotion of drugs or specific treatments is allowed.

Judging by the great deal of progress that has been made so far in boosting patient compliance with the use of new digital technologies, it is safe to say that this is only the beginning. New technologies are being created, and people around the world are integrating them in their daily lives. As discussed, evidence is indicating that digital technologies will play a crucial role in improving adherence in the years to come.

Sources: 1. Digital Technologies to Boost Patient Compliance - a

FirstWord Dossier report, Sept 20102. www.healthspotrr.com/weeklydigest/20-the-reason-why-

smart-packaging-can-improve-habits-and-transform-healthcare, [accessed Nov 2011]

3. www.engagementstrategy.tv/articles/the-new-era-of-pCRM, [accessed Nov 2011]

4. www.bonesmart.org/hip/benefits-of-online-communities-for-

hip-replacement-patients/ [accessed Nov 20115. www.ihealthbeat.org/Articles/2009/8/25/Online-Patient-

Forums-Provide-New-Avenues-for-Medical-Research , [accessed Nov 2011]

6. www.blog.nielsen.com/nielsenwire/online_mobile/what-americans-do-online-social-media-and-games-dominate-activity/, [accessed Nov 2011]

7. www.gamerlimit.com/2011/06/games-give-real-health-point/

8. www.capgemini.com/m/en/tl/Patient_Adherence__The_Next_Frontier_in_Patient_Care.pdf, [accessed Nov 2011]

9. www.theappleclan.com/new-iphone-app-by-drugs-com-reminds-patients-to-take-medications-on-time/,[accessed Nov 2011]

Iulia Calota, collaborator of BIOAXIS Healthcare, is a specialist in healthcare communications and a player in the field of adherence providing. Essentially a marketing communications professional with a global approach, and having worked in the global communications

and localisation sector for important pharma clients, Iulia’s view is always integrated. Recently involved in medical nutrition projects, she also has a genuine interest in putting forward new methods and approaches to enhancing patient compliance.Email: [email protected]


Regulatory & Market Place

There are now regulations that govern the development of software that could be classified as a medical device. It’s likely that many software products out there, which are not currently registered as medical devices, will now need to be.

There are a couple of interesting questions to ponder, if we take your simple SMS patient reminder application as an example. Does your application provide a generic, non-treatment-related message to the patient at a specified time of day, much like the way your alarm works on your mobile phone? Or does the content of the reminder relate to treatment and therefore could influence whether a patient takes the drug or not on a particular day? If it’s the former you’re in luck. Your reminder application probably doesn’t classify as a medical device.

Even a standardised SMS reminder message like “don’t forget to take your next pill this evening” is now likely to be considered a medical device by most health authorities.

It is all about the interpretation of definition statements by FDA and EU regulators, and unfortunately, like many aspects of the pharmaceutical industry, the guidelines are not exactly crystal clear.

The thing that potentially makes simple reminder software like this a medical device in light of Directive 93/42/EEC is not the functionality or the complexity of the software, but the “intended use”, and this is probably why everyone is having so much difficulty interpreting the guidelines - it is the context that changes everything.

Up until recently, the regulations governing software used in the medical domain were not very rigorous when compared with the safety requirements for the development of traditional devices like pacemakers and defibrillators.

This is changing rapidly, with software products playing an increasingly significant role in recent times due to the constantly changing digital landscape - all aspects of healthcare including the diagnosis and ongoing management of patients are evolving at a rapid rate.

With the new medical software design standard IEC 62304 in force, we can expect to see potentially massive process and cost implications for the development of any software in the medical domain.

Anticipating some of these challenges brought on by this software environment would seem to be a suitable next step. There are perhaps three suggested processes to act upon.Firstly, pharmaceutical companies should develop their own internal policies and procedures with regard to their software development. These policies should be drafted to assist with early identification of projects that require device registration. If a project does classify as a medical device the company needs processes in place, and partners, suitable for

new Medical Software Design Standards – Does Your Patient Website need to be Registered as a Medical Device?

Figure 1: Decision diagram for qualification of software as a medical device

development in line with IEC 62304. All existing and future software development projects should be reviewed against these standards.

Secondly, organisations will need to look at taking existing products through that process and to develop the necessary documentation trail.

And finally, this may require a potential re-development and re-release of the software.According to the FDA, standalone software is most likely classified as a medical device if: o It is involved in the diagnosis of disease or other

conditions o It is involved in the cure, mitigation, treatment, or prevention

of disease, in man o It is intended to affect the structure or any function of the

body of man (or other animals) According to the EU Medical Device Directive, your software is a medical device if it influences: o Diagnosis, prevention, monitoring, treatment or alleviation

of disease o Diagnosis, monitoring, treatment, alleviation of or

compensation for an injury or handicap o Investigation, replacement or modification of the anatomy

of a physiological process There may also be some issues on your hands if the

software is intended to be used together with an existing, regulated medical device to enable the current device to meet its intended use.

In a practical sense, if a piece of software is classified as a medical device you need to follow IEC62304 for the

development of the software, maintain a technical file and in the EU the software will require a CE Marking, which is a legally binding statement by the manufacturer that the device (software) has met all the requirements of the EU Medical Devices Directive.

The European Coordination Committee of the Radiological, Electromedical and Healthcare IT industry (COCIR) published a useful decision diagram guideline that includes some clear and concise examples, which is what is often missing from guidelines in general.

The FDA recently published additional information that applies to all mobile phone applications as well. At Partizan we are currently using the COCIR Contribution Decision Diagram to review whether our software development programmes qualify as the development of a medical device.

It is important to review and react to these changes now to avoid more expensive time-consuming measures further down the track.

Josh Taylor is the Managing Director of Partizan International, based in Partizan’s European headquarters in London. Josh has worked extensively in the pharmaceutical industry for the last 12 years and has been at the forefront of establishing Partizan’s global position

as a leader of innovative and effective patient support programmes. Email: [email protected]





Risk Mitigation Regulation in the USThe US FDA regulations regarding risk management have been growing since the Kefauver-Harris Amendments of 1962 (Full Disclosure Policy), inspired by the thalidomide tragedy in Europe. The most recent regulation -- the Food and Drug Administration Amendments Act of 2007 (FDAAA) -- mandates enforceable guidelines referred to as Risk Evaluation and Mitigation Strategies (REMS).

The FDA is no longer restricted to an all-or-none approach to drug approval and withdrawal.

Prior to the implementation of REMS regulations, the FDA removed from the market many drugs that could benefit patients because they had been inappropriately prescribed. Under the REMS programme, the FDA can now allow continued access to drugs deemed advantageous or necessary while restricting access to these drugs when they are not.

When designed and implemented properly, a REMS programme can both protect patients from known or potential serious risks, and offer an economic upside to the biopharmaceutical business.

Several REMS components include commonly used communications tools, such as patient package inserts (PPI), medication guides, and “Dear Doctor/Dear Pharmacist” letters. Other elements may also include HCP (health care providers) and pharmacist education, restrictive distribution, dispenser and patient registries, and required patient laboratory testing.

The FDA has legal authority over pharmaceutical companies. It does not, however, maintain any legal authority over healthcare providers, pharmacies, payers or patients. Each pharmaceutical manufacturer of REMS drugs is tasked with designing and paying for their REMS implementations. These multiple programmes have generated a number of workflow interruptions and inefficiencies for US pharmacies and healthcare providers.

As REMS programmes evolve, however, we are seeing trends towards the harmonisation of similar programmes, as well as cooperation and coordination between pharmaceutical manufacturers and the emergence of a few class-wide programmes. For complex REMS systems, greater automation will improve patient, HCP and pharmacy compliance. Examples include:• Automated IVR, email, SMS reminders to patients to remind

them of upcoming laboratory testing and refill dates • Automated alerts to HCPs and pharmacies when patients

report that they will not comply with laboratory testing or refill pick-ups

• Automated distribution and printing of medication guides at the pharmacy and HCP office

• Online access for:• pharmacies to determine certification status of HCPs • prescribers to determine certification status of

pharmacies• wholesalers to determine certification status of

pharmacies• HCP and pharmacy training and certification• Online storage of HCP and patient agreement

documentation

Much of the current record keeping for complex REMS systems is paper-based, providing gross inefficiencies and poor transparency for all stakeholders.

II Background

To better ensure proper drug use and to keep HCPs and patients informed about the safety and efficacy of drugs, the REMS programme was established as one of many post-marketing safety provisions included in the Food and Drug Administration Amendments Act of 2007 (FDAAA). This legislation increased the FDA’s ability to require labelling changes, post-approval studies, and publication of clinical trial results.

Since the programme went into effect in March 2008, the FDA has negotiated nearly 200 REMS programmes as part of the approval of new drugs. Initially, a large number of REMS programmes required only a medication guide. Medication guides are paper handouts that come with many prescription medicines. These guides help patients avoid serious adverse events. In February 2011, however, the FDA published a Draft Guidance relaxing the rules under which drugs are required to have a REMS programme. Every medication guide is no longer necessarily part of a REMS, and 86 drugs have now been released from REMS requirements.

a. Legal RequirementsBefore the FDAAA was enacted, the FDA approved a small number of drug and biological products with risk minimisation action plans (RiskMAPs) to reduce known risks while preserving drug benefits. As a result of the FDAAA, REMS programmes are now required for new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) with sufficient risk profiles. REMS differ from RiskMAPs by two significant aspects:1. Periodic assessments – All programmes must be formally

assessed at 18 months, three years, and seven years post-REMS approval.

2. Legal enforcement through civil penalties and fines.With REMS, HCPs and pharmacies have an additional

set of responsibilities to their patients. REMS programmes provide checklists, akin to those developed by Atul Gawande for surgery1. These FDA-mandated requirements are cross-functional checklists for HCPs, pharmacies, patients, manufacturers and, in some cases, distributors.

The key to the successful implementation of checklists is to make these cross-functional processes as simple and transparent as possible. Automation and data storage should be employed to minimise the burden of REMS programmes on the entire healthcare system.

B. accountabilityAccording to FDA requirements, pharmaceutical manufacturers are responsible for designing REMS programmes. These pharmaceutical manufacturers are thereby exposed to civil penalties for REMS non-compliance. Penalties include



a maximum of $250,000 per violation, not to exceed $1 million. However, if the violation continues after written FDA notice, the manufacturer is fined $250,000 for the first 30 days, doubling with each 30-day period, not to exceed $1 million in a 30-day period and a maximum of $10 million for all violations adjudicated in a single proceeding.

If a generic company then manufactures a REMS-regulated product, the generic company is required to use a single shared system with the product innovator (NDA holder) or to obtain a waiver. In these cases, the innovator company is required by the FDA to negotiate with the generic company. The NDA holder is responsible for the REMS strategy, design, and implementation. This presents a difficult situation in which NDA holders are responsible for the compliance of REMS by generic manufacturers without holding any authority over the generic manufacturers.

Pharmaceutical companies also need to earn the acceptance of the REMS programme from HCPs, pharmacies, and distributors (when required). Since the REMS participation of a customer is optional, the level of customer participation can make or break the success of a brand. Manufacturers cannot force their customers to participate, but they can encourage participation by explaining the REMS’ importance and offering practical solutions. Their task is to understand what is important to HCPs, pharmacies and distributors and offer the solutions to provide it.

III REMS Programmes

a. RequirementsThe requirements of REMS programmes vary by class or by specific drug. They may include medication guides, patient package inserts (PPIs) and communication plans. A REMS programme may also include:• Restricted refills dependent on the results of laboratory

testing• Patient registries• Specialised training, and/or • Certification for prescribers and pharmacists

B. Industry ResponseThe most rigorous REMS requirements to date are for long-acting and extended-release opioid drugs. For 24-hour, long-acting or extended-release opioid products, the FDA has asked manufacturers to develop a single REMS programme for the drug class, instead of separate programmes for each product2. The industry has responded by establishing an industry working group (IWG) comprised of representatives from 22 pharmaceutical companies. This IWG provided a draft of its recommendations for a class-wide opioid REMS programme in December 20093.

On May 16, 2011, the FDA met with members of the IWG and other sponsors of long-acting and extended-release opioid drugs to discuss a single shared REMS system. To support this effort, the National Council for Prescription Drug Programs (NCPDP) published pharmacy data REMS standards: the REMS Reference Guide for Telecommunication Standard version 5.1. The objective of the standard is to support the REMS registration verification, clinical appropriateness, counselling documentation, and/or dispensing activity reporting requirements.

Given these standards, the communications networks between pharmacy management systems and payer systems can provide class-wide REMS programmes that minimise workflow disruptions. During prescription processing, RelayHealth’s REMS process verifies enrolment of the prescriber and pharmacy, as well as supporting patient enrolment and verification.

CephalonWhile the IWG was preparing its response to the FDA, Cephalon sponsored an industry-wide online portal for REMS compliance for drugs treating pain at www.readyforrems.com. It should be noted that Cephalon’s ACTIQ® (oral transmucosal fentanyl citrate) was the first FDA-approved opioid with a risk management plan in 1998. Cephalon has branded their REMS for FENTORA® (fentanyl buccal tablet) as COVERS™.

Cephalon has since replaced the original ACTIQ and



FENTORA REMS programmes with more automated systems, built on the RelayHealth communications network.

ProStrakan groupProStrakan Group plc, a pharmaceutical company based in the UK, also has selected RelayHealth as its connectivity partner for its FDA-approved Abstral opioid REMS programme.

amgenIn February 2010, the FDA announced a second REMS class-wide restriction for all erythropoiesis-stimulating agents (ESAs), such as Procrit, Eopgen and Aranesp – all Amgen products4. To comply, Amgen established an HCP registry called “Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs (APPRISE).” (This programme is described in more detail in Section VIII.)

The FDA continues to increase the number of REMS drug classes. In February 2010, the FDA called for a class-wide REMS for long-acting asthma drugs. A broader REMS for ESAs in renal-disease treatment is currently under development. Additional initiatives may be launched for anti-seizure drugs and anti-depressants, as well as other medicines that carry risk. The industry anticipates that the FDA will require REMS for most new medications.

When class-wide REMS programmes have not yet been developed, manufacturers are left to determine how to comply with REMS requirements on their own. Some REMS components such as medication guides, PPIs and communication plans (such as “Dear Healthcare Provider” letters) are well understood and relatively easy to implement.

Other components, however, such as elements to assure safe use (ETASU), may require the brand to build new communication and feedback mechanisms between the HCP and the pharmacy. In these cases, manufacturers are able to improve their probability of launching a successful REMS programme by adopting off-the-shelf solutions, thereby:• Decreasing development time to implement• Reducing risk for implementation• Benefiting from economies of scale

C. Elements to assure Safe Use (ETaSU)An ETASU may require that a drug be dispensed to patients with evidence of safe-use conditions. For example, certain patient laboratory test results may be required before a drug may be dispensed.

Currently the FDA requires 33 drugs to provide ETASU in their REMS programme. Table 1 lists these drugs, their REMS class (if any), the manufacturer, and the drug’s indications.

gileadBy way of example, we provide a deeper look into the REMS ETASU requirements for LETAIRIS. Gilead’s extensive REMS programme provides the goals, details and implementation plans for this drug.

LETAIRIS’ REMS programme strives to minimise the risk of hepatotoxicity and risk of fetal exposure. To minimise these risks, women who are pregnant cannot be prescribed LETAIRIS, and those who do take LETAIRIS must not become pregnant. Gilead’s ETASU programme provides for

a prescriber certification process, and prescriber attestations regarding patient communications (medication guide and patient educational brochure). Prescribers also must agree to “order and review liver function tests (including aminotransferases and bilirubin) and pregnancy tests (for female patients of childbearing potential) prior to initiation of LETAIRIS treatment and monthly during treatment.” If the patient does not comply with these tests, the prescriber must counsel the patient.

Prescribers face a burdensome series of activities. They must prescribe the monthly tests, determine if the tests were completed satisfactorily, and counsel non-compliant patients – a recurring set of tasks that would be difficult for even the most efficient physician offices without the additional support of automated systems.

Gilead’s ETASU programme also provides a certification process for all pharmacies, hospitals, HCP offices and other healthcare settings (e.g., clinics) that dispense LETAIRIS. Before dispensing this drug, the dispenser has to first receive acknowledgement of prescriber and patient enrolment, and HCP attestation that they have counselled patients on risks and benefits. Refills are restricted to a 30-day schedule. Those who prescribe also are required to “speak with each patient, or their prescriber, every month to obtain confirmation that liver function testing and, for female patients of childbearing age, pregnancy testing was completed.”

As with HCPs, these recurring tasks are challenging for even the most efficient pharmacies, and they would benefit from automation.

References 1. The Checklist Manifesto: How to Get Things Right.2. US Food and Drug Administration. Risk evaluation and

mitigation strategies for certain opioid drugs. Federal Register. 2009;74:17967-17970. Available at: http://edocket.access.gpo.gov/2009/pdf/E9-8992.pdf Accessed May 20, 2010.

3. Food and Drug Administration. December 4, 2009 FDA/Industry Working Group (IWG) Public Meeting on Risk Evaluation and Mitigation Strategies (REMS) for Certain Opioids. 2009. http://www.fda.gov/Drugs/DrugSafety/ InformationbyDrugClass/ucm193499.htm.

4. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm200471.htm

5. www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM164969.pdf

Jean Steckler is the Senior Vice President & Co-Founder of iReminder, LLC, a healthcare technology company. Its products are: Compliance for Life for dosing, appointment reminders and refill reminders; Global e-Trials™ for patient recruitment to and retention in clinical

trials; and MedTrigger™ a REMS program that reminds patients to comply with all events required by their risk management plan. Email: [email protected]




The Introduction of Targeted Medicines Use Reviews and the new Medicine Service in England

Statistics released from the Information Centre have shown a 70 per cent increase in prescription items dispensed in England since 2000.1 This rise is thought to be due to a number of factors, including our increasing and ageing population, greater access to new and more effective medicines, changes in period of treatment, and an increase in prescribing medicines preventatively. Whatever the reason, prescribed medicine represents the largest non-staff element of the nHS budget, so it is vital to get value for money from this investment. There is no doubt that we can gain much more value for patients and the taxpayer by supporting effective medicines use.

Improving adherence should lead to a fall in hospital admissions, helping the NHS in its mission to find new efficiencies while also caring for a larger, ageing population. 5-8% of hospital admissions have been attributed to the preventable adverse effects of medicines, and 11-30% of these involve patients not taking their medicines as they have been prescribed.2

Research shows that non-adherence to medications for long-term conditions develops rapidly, with 30% of patients being non-adherent at 10 days. Studies have also shown that patients who receive support from a pharmacist when starting a new medicine, to complement advice given by the prescriber, are more likely to be taking it as prescribed at 28 days.3,4 The research also demonstrated that the number of patients with medicine-related problems also reduced significantly. Better adherence to medication is associated with better clinical outcomes.

To tackle this medicine waste and to help people to get the maximum benefit from their medicines, it was announced in March 2011 that a fourth community pharmacy ‘advanced service’, the New Medicine Service (NMS), would be commissioned in England. The National Pharmacy Association spent several months working on the implications for our pharmacy members. Since October 1st, pharmacists have been delivering the service which is aimed at patients who have been newly prescribed a medicine for asthma and Chronic Obstructive Pulmonary Disease, type 2 diabetes, antiplatelet and anticoagulant therapy, and hypertension.

The therapy areas and conditions were selected following proof of concept research, and on the basis that long-term conditions are where community pharmacists are best able to demonstrate the value of the service. Pharmacists and their teams have an integral role to play in supporting people with long-term conditions; medication is a mainstay of many treatments and community pharmacists are the experts in medicines.

The NMS itself has three stages, and will typically take

place in the privacy of a pharmacy consultation room, although a telephone consultation can also be used if the patient agrees. The first step is to engage the patient. After identifying a suitable participant, the pharmacist can provide initial advice about a new medicine, covering issues such as storage, missed doses and possible side-effects. A time will then be set for an appointment within 14 days of this first conversation, and the patient also receives any appropriate healthy living advice. Provided the patient consents to their information being shared with their GP and within the NHS for audit purposes, the second stage then involves a semi-structured interview about their medicines, with one of three possible outcomes. The patient will either be taking them effectively, problems are identified and a solution is agreed, or the problems cannot be resolved. In the latter case, the patient is referred to their GP immediately, but otherwise a further consultation will take place within 14-21 days when the service is completed. The pharmacist is required to keep a record of the whole process, including method of entry to the service, relevant demographic details, and the outcomes of interventions or reasons for referrals.

All community pharmacies in England with consultation rooms and pharmacists who have declared that they have the necessary competencies are able to provide the service. GPs can refer into this service or patients can self-refer. The practice will not receive paperwork every time a patient enrols in the New Medicine Service, and pharmacists will only refer patients back to the practice when it is clear to them that a prescriber review is required.

Up to £55m will be made available for the NMS in both 2011/12 and 2012/13. Re-commissioning for the NMS will take place in April 2013, which means that pharmacies need to ensure that it quickly becomes embedded in everyday practice – which is no small task. Pharmacists and their teams need to be fully engaged, inspired and enabled to ensure they are building outcomes-based evidence for the service as well as achieving the numbers that will trigger remuneration.

The New Medicine Service is in addition to – not a replacement for – the NHS Medicines Use Review (MUR) service, which remains available in pharmacies. MUR was the first advanced service introduced within the NHS community pharmacy contractual framework, and consists of accredited pharmacists undertaking structured adherence-centred reviews with patients taking multiple medicines, particularly those taking medicines for long-term conditions. The aims of the MUR are to help review the patient’s understanding of their medicines, identify any problems they are experiencing, and provide solutions.

In October 2011, the service was amended to introduce



national target groups for MURs. The aim is to allow pharmacies to demonstrate to commissioners the benefits of the MUR service, and provide assurance that it is high quality, value for money, and can improve health outcomes for patients who will benefit the most. there are now three national target groups: • Patients taking high-risk medicines • Patients recently discharged from hospital who had changes

made to their medicines while they were in hospital. Ideally patients discharged from hospital will receive an MUR within four weeks of discharge

• Patients with respiratory disease50% of all MURs undertaken by each pharmacy in each year should be on patients within the national target groups. MURs can also be carried out on patients who are not within the target groups, but pharmacists are expected to select patients who will benefit the most from the MUR service. An MUR can be completed on a patient who has benefited from the NMS after six months.

Targeted MURs, and the implementation of the NMS, give pharmacies the opportunity to own the medicines pathway, and work more closely with GPs and other healthcare professionals to deliver: • Improved adherence, which will mean that the NHS will get

more value from its spend on medicines, and could reduce costs associated with acute admissions in line with the NHS QIPP programme

• Improved outcomes for patients by ensuring that they get the maximum benefit from the medicines

• Support for QOF targets - there is no cost to either the practice or a commissioning group for this service, as the NMS is funded from a central ring-fenced budget

• Reduced waste

References1. Prescriptions Dispensed in the Community: England, Statistics for

2000 to 2010. The Health and Social Care Information Centre

2. YHEC/School of Pharmacy, University of London (2010). York

3. Health Economics Consortium and the School of Pharmacy at the University of London Nov

4. Haynes R, McDonald H, Garg A, Montague P (2002). Interventions for helping patients to follow prescriptions for medications. The Cochrane Database of Systemic Reviews, 2. Clifford S, Barber N, Elliott R, Hartley E, Horne R. (2006). Patient-centred advice is effective in improving adherence to medicines. Pharmacy World and Science, Sep; 28(3), p.165-170.

Michael Holden, MRPharmS, Chief Executive, National Pharmacy Association.Michael Holden read pharmacy at Portsmouth School of Pharmacy. He was awarded a BSc Pharm in 1976 and did his pre-registration year in Southport, Lancashire. Following a number of

years in various management positions, Michael established his own community pharmacy group in Hampshire between 1988 and 2002. He then set up a consultancy to support the implementation of change in community pharmacy before working with Pharmacy Alliance between 2003 and 2005. In 2005 he was appointed Chief Officer of the Hampshire and Isle of Wight Local Pharmaceutical Committee and jointly established balance consultancy in 2008. Michael has always been actively involved in the expansion of community pharmacy services including the development of the Healthy Living Pharmacy initiative. He is a member of the recently formed Pharmacy and Public Health Forum, the Public Health England Engagement Group and the Pharmacy Clinical Leadership Network. Michael was appointed Chief Executive of the National Pharmacy Association in January 2011 and became a Fellow of the Royal Pharmaceutical Society in March 2011. Michael is married with three daughters and lives in Hampshire, England. Email: [email protected]



Patients First: Shifts in Industry Thinking

The patient is receiving more and more attention from the pharmaceutical industry. Although the physician was the centre of their commercial activities in the last few decades, the spotlight is now increasingly being placed on the comprehensive care of patients. However, apart from the knowledge that this also means a change in business models, the industry has not yet offered concrete solutions for how this is to be done. In the following article, the topic of patient-centred services will be considered from various standpoints, and various successful approaches illustrated.

Should or must the patient be considered at all in the complex interaction between those prescribing medication, health insurers and dispensing pharmacies? At the end of the day, they are only “consumers”. These thought-provoking questions need several answers.

Firstly: Increased Weakening of the Traditional Marketing and Sales approach The marketing and sales concepts for patent-protected medication have been similar for the majority of manufacturers for decades now. The mix of marketing solutions with all their various facets around opinion-leaders, specialists and general practitioners is virtually repeated during every launch. Added to this are the sales activities applied to the A, B and C segments. For years, large sales teams played a significant role in the amount of turnover generated by a product. However, discount agreements with health insurance companies, the imperative cost-benefit analysis compiled by neutral institutions, statutory limits on visiting doctors, plus the reduced influence of the sales force on doctors, have changed market conditions. A new approach puts the patient in the limelight. Manufacturers practising this already, however, lack the tailor-made and detailed marketing concepts required. With this lack of alternative, they simply turn to sporadic or standardised programmes which often do not have the desired effect, and are certainly not sustainable.

Secondly: Patients have Changed They are, thanks to the internet, more knowledgeable than ever before, and therefore display more confidence. Whilst many of the older generation mostly take prescribed medication without argument and with full faith in their doctor, the younger generation asks critical questions and discusses possible therapies and medication with the doctor. Justifiably, the more severe the illness, the more this happens. From a medical point of view, it is precisely these chronically ill patients that have become more mature and often know exactly what therapy alternatives are on offer. In addition to this, there has been a rise of well-organised information and patient organisations which, above all, provide chronically ill patients with detailed information.

The Industry has also Recognised an additional and Vital Reason for an Orientation towards the PatientThis is the topic of adherence. Numerous studies carried out on a patient level have shown alarming insights into their behaviour when taking medication. In the past it has been assumed that a chronically ill patient takes at least the majority of the medication as prescribed, the doctor prescribes this medication anew if side-effects arise, and not taking the medication is an exception. However, patient-based studies now show a completely different picture1.

Within the first twelve months, each indication in the graphic shows that between 47% and 70% are adherent to their therapy; even approx. 20% of the AIDS patients involved did not take their medication as prescribed. The medication intake behaviour observed has dramatic consequences, mainly for the patient himself, as it is the wrong intake, interruption or even stopping the medication which reduces the success of therapy substantially. Various studies also show, however, that non-adherence behaviour leads to the rise of hospitalisation costs, as is to be expected.These findings have led to two main consequences for the pharmaceutical industry: Firstly, slimmer chances of therapy success for the patient; or in the worst case, increased side-effects due to lack of adherence can endanger product approval for the market.

Secondly, if the marketing approach employed till now aimed to convince physicians to prescribe the best medication for the patient, this is thwarted by the patient with his own wrongdoings, by non-adherence. This is particularly obvious with chronic illnesses where the medication is designed to help the patient long-term and where annual therapy costs are high. All these patients lost in a year have to be won back from an economic viewpoint, so that volume and sales can be upheld.

Both factors lead to more and more pharmaceutical companies wanting to involve their patients in their marketing activities. This is illustrated, for example, by the

following quote found in the 2010 annual report published by Novartis AG:

“Prior to the launch of gilenya, we talked with patients, physicians and payers about possible hurdles to access to treatment. We wanted to design a program that would address their needs.”

What kind of patient approach can be taken by the pharmaceutical industry? A few hurdles and uncertainties need to be overcome here which have, to date, contributed to the industry having a rather reserved approach:- The whole marketing and sales organisation, as well as all

their instruments, are focussed on providing an optimal amount of information to the medical profession. This means that there are no instruments or even culture of working with patients. At most, patient organisations were sporadically involved in the past.

- A degree of uncertainty in all types of patient activity comes from the legal context. Under which conditions can patients be worked with? How about data protection regulations? And of course, there is the sword of Damocles hanging over the Advertising of Medicines Act.

- The relationship between doctor and patient should remain undisturbed.

However, the good news here is that there are sustainable solutions for all these issues.Of course, the cultural shift in an organisation is a major and long-term venture. This is why many pharmaceutical concerns have begun using outsourcing solutions and turning to professional service-providers specialising in patient-centred services. In addition, the service partner offers tailor-made solutions and concepts which are specifically geared towards the product, target group and geographic markets, and what is more, also involve the sales force of the manufacturer and the physician.

This may sound complicated at first, but it isn’t. This is because, as a rule, the sales force takes the patient-centred programme to the doctor and is even provided with a new tool for the interaction with the profession.

The legal stipulations always need to be observed, although they often do not pose hurdles. Basically the patient has to consent to every service that one wants to explain to him. This is patient consent, as the industry knows of from clinical studies. Only when a patient provides active consent can he be cared for by such services. The services the patient can receive vary in detail from country to country within Europe. In principle, the application of medication cannot be undertaken by a nurse at the home of a patient – with the exception of Great Britain. Every form of explanation of an illness, the importance of the regular intake of medication, and reminders of intake or explanation such as, for example, how auto-injectors are used, is possible. Psychosocial support helps chronically ill patients and increases their views on adherence.

This programme further supports the therapy of the physician, who, when convinced of the benefits, also actively offers it to his patient. Such programmes are already being used in several European countries.

In Finland, nurses support the early diagnosis of Alzheimer’s patients in clinics. To this end, these nurses train the staff at the clinic on behalf of the pharmaceutical company. Training includes points such as what needs to be considered during the diagnosis and how patients can be identified at a very early stage. Patient questionnaires complement the programme. With the aid of this approach in 2010 approx. 2500 clinic staff in 40 clinics were trained. Feedback received from the staff was very positive.

In clinics in Scandinavia, programmes were also set up to increase the quality of a TNF-alpha inhibitor and, at the same time, to reduce infusion times. For this, 45 clinics in Sweden took part in a programme financed by the industry. This was designed to increase the quality of processes from which patients benefited.

In Germany there are programmes where nurses care for MS patients. As soon as the patient agrees, personal care begins firstly with the visit of trained personnel. Personal visits are alternated with phone calls from a medical service centre; the patient also has the possibility of phoning the service centre himself. The contents of the calls include questions on the medication, providing answers to questions to do with





the illness, and pointing out the importance of adhering to taking the medication being taken regularly.

A common factor in these examples is the goal of increasing the success of the therapy, which is a benefit to the patient. This is why this programme has been well-received by the healthcare professionals involved.

The increase in the adherence of the programme described is certainly impressive. Those involved describe an increase in adherence from 60% to 90% for patients involved in the programme. The costs involved here, when compared to the rise in turnover, are also manageable, and lead to a significant RoI of the measures.

In addition, the concept of the measures leads to a rather reliable economic management system. In this way, for example, individual care of a patient by a nurse in the case of individual biotech products makes sense compared to products with comparably slim annual therapy costs. In the latter case the measures are not designed so much for care via personal contact, but rather via general channels of communication such as text message reminders, outbound call centres or even remote-rep concepts, thus ensuring economic success.

The Three approaches in Patient-Oriented ServicesThere are essentially three varying approaches in patient-oriented services:1. At the doctor or in the clinic: With the aid of operative help

in diagnosis or process management. 2. At the pharmacy: Information can be provided to patients

via pharmacy training courses – these are designed to offer reminders about the necessity of adherence.

3. The most direct approach is with the patients themselves, assuming they have consented and are accessible by the doctor responsible.

Additionally, the feedback received from the doctors involved clearly shows that a well-thought-out patient programme also has a positive effect on their prescription practice. This is slightly surprising, as the doctor only participates in the programme when he is confident of its goal and the way it is carried out. As long as it fulfils its conditions, the pharmaceutical company differentiates itself from the competition as far as the doctor is concerned.

The health-economic aspect is not to be underestimated: Good adherence reduces hospitalisation costs and, at the same time, increases the success rates of the therapy. Both arguments can contribute to strengthening the negotiating power of a pharmaceutical company with authorities and health insurance companies.

References1. Journal of the European Academy of Dermatology and

Venereology, volume 20, Issue 4, pp. 370-379, April 2006; Kathleen Costello, Patricia Kennedy, Jo Scanzillo: “Recognizing Nonadherence in Patient with Multiple Sclerosis and maintaining treatment adherence in the long term”; The Medscape Journal, September 30 2008; van den Bemt et al.: “Adherence Rates and Associations with Nonadherence in patients with Rheumatoid Arthritis using Disease Modiifying Antirheumatic Drugs”, May 12, 2009; de Achaval, S., Suarez-Almazor, M.: “Understanding has increased, but several issues are yet to be resolved”, October 12, 2010; Elliott, R.: “Poor Adherence to Medication in Adults with Rheumatoid Arthritis: Reasons and Solutions” , 2008

2. Novartis, Annual Report 2010, S. 32.

Karsten Sternberg was born in 1968 in Herne (Germany) where he grew up. He studied at the Ruhr-University of Bochum Business Administration and Economics with international study assignments in Spain and Finland. Besides a Master of Business Administration and

Economics, Karsten Sternberg also holds a Master of Science in Pharmaceutical Medicine. He has many years of professional experiences in the biotech as well as in the pharmaceutical industry where he had various national and international management position in Finance, in Marketing and Sales as well as in General Management. Besides this Karsten Sternberg is appointed lecturer for Pharmaceutical Medicine at the University Duisburg-Essen. Email: [email protected]


Behaviour Programmes

Creating a Value Proposition to adherence EnrolmentThe recent adherence debate at the European Parliament in Brussels reinforced the fact that poor adherence carries a huge cost, both in terms of patient safety and quality of life. It also presents a serious problem for health systems, leading to inferior health outcomes, unnecessary treatments and hospitalisations.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) wants to encourage more data-gathering, evaluation and best-practice sharing, and involve all relevant stakeholders.

Providing adherence support for your medication has never been more important in these times of austerity. It differentiates your product from the competitors and emphasises your commitment to supporting your stakeholders.

Most patient adherence programmes focus on the psychology of the patient and the identification of patients who are least likely to adhere. A patient adherence programme without enrolled patients, however, is a poor investment of time and money. In this article, I’ll be exploring the biggest problem in delivering patient adherence programmes - how do you get the patients on board and enrolled?

getting Patients On BoardThe traditional route of enrolling patients onto a patient adherence programme is a long and convoluted one: brand managers train sales reps, sales reps detail to HCPs, and HCPs outline to patients. The problem here is fundamentally simple – a failure in the information pathway, at any point in the chain, will ultimately result in a misunderstanding of the value and necessity of treatment adherence. While it may be easy to lay blame on specific actions (or omissions) of reps and HCPs, the issues surrounding an information failure are often much more complex.

Despite a surge in the last few years of understanding of the importance of adherence, patient adherence programmes still tend to be secondary to the perceived importance of a product. If the pathway is weak at the beginning, it will inevitably fall apart further down the line.

Inadequate training from the outset, lack of time to effectively detail treatment, let alone the adherence programme, and a weak perceived value may all contribute to a lack of motivation from the sales force. Consider a sales rep who does not know enough about an adherence programme, attempting to detail it to a HCP in the few minutes they are allocated each visit. Then consider an under-engaged, time-stricken HCP attempting to outline all the aspects of a product (efficacy, treatment regimen, potential side-effects) and the adherence programme to a patient, who has little or no understanding of their illness, let alone treatment. With minimal perceived value at every stage, it is little wonder a patient will not receive a take-home message of adherence.

Funding concerns along with scepticism and suspicion of

the pharmaceutical industry can add to the challenges faced by pharma. Considering these underlying issues exist at the end of the information pathway, it is vital that appropriate messages are relayed down the line. Improved understanding and increased perceived value in an adherence programme is key to maximising enrolment and ultimately ensuring continued adherence.

Building a Value PropositionIn order to engage with the patient adherence programme, the healthcare provider has to understand the value proposition it brings - not only in supporting their relationship with the patient, but also in terms of how it supports the patient holistically to manage their condition.

To understand what makes a good value proposition, an examination of the HCP’s needs must be conducted during the planning stage of the programme. It’s all very well, for example, to inform the HCP that your research shows that this adherence programme, using these tactics and this messaging, is what their patients want. But they need to also understand how it will support their dialogue with, and management of, that patient.

Addressing patient adherence early on in a product’s life-cycle will play a key role in improving treatment outcomes, and this will create a compelling value proposition.

An adherence programme that has a clear value proposition should be able to demonstrate:• Outcomes showing that patients on this programme are

x% more adherent to their medication and manage their condition more effectively

• That patients on this programme will be better informed about their condition, how to manage it holistically, and the importance of treatment. This means that they are less likely to have had a relapse or be non-compliant because of side-effects of the medication

• A justification as to why the programme is important, e.g. During the first 30 days of treatment, 36% of patients discontinue [condition] therapy

• Reasons why they should recommend the programme to their patients, e.g. The aim of this programme is to improve patient outcomes. It does so by:o Supporting patients through the initial stages of treatment

when they are most vulnerable to side-effectso Providing information, education and encouragement

to adherence patients to take [treatment] exactly as prescribed

• Details of how programme adherence assists healthcare professionals, by:o Complementing their treatment of the patiento Reinforcing their adviceo Supporting the dialogue between them and their patient


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Patient Reminders partner program allows companies to Build Your Own (BYO) solutions. Specifically designed for easy use by CRO’s, agencies, device companies charities and market place neighbours.

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o Keeping them closely informed about the progress of patients on the programme [in countries where you are able to provide this information]

The Planning StageA nurse recently mentioned to us that her HCV patients who are of Asian descent were least likely to adhere to medication if they had no personal or consistent relationship with their physician. This example shows how patients are influenced by so many different factors, whether it is their background, their history, their understanding of the condition, or just their lifestyle and circumstances.

Before any adherence programme is devised, it is important to gain a comprehensive understanding of the patients who will be engaging with it:1. Their demographics and lifestyles2. The journey they have gone through with their condition

and treatment3. Their perception of their illness4. Their expectations of their medication5. Their perceived barriers and motivators to adherence6. What information they need, at which point, in their

treatment pathway7. The methods of communication they would willingly

engage with

Involving the Healthcare Professionals“I don’t think any of our members keep track of adherence. We just figure if patients don’t come back, they’re doing fine.” This was the comment made by a physician (anon) during a survey we undertook to find out if doctors monitored their patients’ adherence rates. Not one out of the 257 physicians surveyed, did.

We all know that healthcare professionals are busy and under pressure so we need to ensure that an adherence programme adds value by supporting them in their communication with the patient. Providing easily accessible educational tools can help them establish meaningful patient-HCP discussions and close the treatment loop.

When engaging healthcare professionals in the planning phase, we not only ensure that we develop the right tools to support that doctor-patient discussion, but that they can provide input and feedback on content, logistical roll-out and storage of materials, etc. This ensures that, right from the outset, the adherence programme is user-friendly and readily acceptable, not only in content, but also in terms of access and usability.

Multi-disciplinary advisory boards during the planning phase should be used to encourage 360-degree input and feedback. They can be utilised to gain an understanding of the potential routes for delivery of the adherence programme, e.g. pharmacy-to-patient, physician-to-patient, nurse-to-patient. Some of the discussion topics should be:• Which HCPs diagnose and/or provide the first

prescription?• Which HCPs do the patients engage with, and when during

their treatment pathway?• What adherence tools would support the HCP in their

dialogue with the patient?

• Which tools do they already use and how could these be improved?

One key lesson we took away from an international programme implementation was the need for simple registration tools. We have already talked about the lack of time healthcare professionals have when dealing with patients, and simplistic enrolment measures can be paramount to engaging HCPs with the entire programme. No matter what your patient population is, healthcare professionals will most usually be connected to the internet and technology savvy. Consider providing digital options (electronic forms, website registration) where an HCP can save common details and simply update the patient-specific fields for each enrolment. Create an HCP-only section to a patient website, and provide them with, for example, repeat prescription reminders for their patients, to close the treatment loop.

Choosing the Right Touch-Points to Interact with PatientsThe care pathway – The potential routes to delivering your adherence programme to the patient requires thorough research and consideration. A good place to start is to thoroughly understand the care pathway and the healthcare professional involved in treating the patient over the course of their treatment.

This will help identify what healthcare professionals need from the programme, whether it is dialogue enhancers such as diagnostic or treatment questionnaires, educational



information for the patient about their treatment, condition, or dealing with side-effects, or educational tools to help the HCP explain the condition and importance of adhering to their medication.

Cultural and regulatory environments – should also form part of your considerations, particularly if a multi-country approach is required. In the Netherlands, for instance, pharmacists can be incentivised to sign patients onto adherence programmes, thereby relieving the time-pressure that physicians often find themselves under. However, in Greece, women expect others around them to register them onto programmes, making it more difficult for form-filling and necessitating call-centre interaction with the patients. These are only two examples of some of the big differences between countries across Europe, proving that a one-size-fits-all approach is not always the most appropriate solution.

The product life-cycle – For a new product which is just launching, consideration needs to be given to understanding the physicians’ likelihood to engage with a patient adherence programme from the start, or whether a tiered approach would be more suitable. Prescribing a new or different product to a patient comes with a unique set of questions and discussions that are required between the physician/nurse/pharmacist and the patient to instil their future concordance with their medication.

Research shows that an average of 17% of patients on

a newly-launched drug are likely to sign up to an adherence programme within two years of the product launch, however this statistic increases up to 25-30% for patients who are on a more established product.

Sales Force EngagementOur experience of implementing an adherence programme in Slovakia has demonstrated the necessity of engaging a sales force right from the outset. In this instance, sales rep training was conducted in anticipation of the product launch, and crucially the training incorporated an extensive synopsis of the patient adherence programme. Sales reps were also given targets not only for product sales, but also adherence programme enrolments through their HCPs.

The three critical areas which reps need to detail to the HCP are: aims, elements and value. That is, what does the programme aim to do, how is it going to do it, and what will that mean to everyone involved? A small sacrifice in the HCP’s time to enrol a patient onto an adherence programme should, ultimately, save the HCP time in the future. If a patient feels supported and well-informed in terms of their treatment, there will be less need for continual visits to their hospital or clinic. This benefits the patient – better health and wellbeing, the HCP – less time taken up with responsibilities for providing holistic adherence, and the healthcare organisation – cost savings and employer / patient satisfaction. Motivating the sales force to convey these positive messages when detailing the programme will increase the HCPs’ perception of the value to both themselves and their patients.

Centralised training is far more effective than individual sessions contained in specific areas. This will allow a consistent and common message to be passed to the entire sales force, while also providing an opportunity for the reps to express any concerns or queries regarding the programme. Ensuring the reps have a better understanding at the initial stages of product and programme launch will ultimately reap rewards in patient enrolment.

The key to a steadfast information pathway must start with an unshakeable beginning. Training and motivating the sales force should be the very first tactic of all programme implementations.

Focussing your planning on developing an adherence programme that has a clear value-based proposition for HCPs, that is detailed by an educated and motivated sales team, and that provides patients with the holistic support they need to manage their condition, creates a win-win-win solution for everyone. In the words of Richard Bergstrom, EFPIA’s Director-General, “a medicine that is sold but not taken is a waste for everyone.”

Carole North is co-founder of 90TEN Healthcare. She has over 10 years’ experience delivering award-winning patient compliance programmes, concordance tools for healthcare professionals, and social marketing and experiential learning campaigns that

result in behavioural change. 90TEN Healthcare is currently delivering patient adherence programmes in 23 countries.Email: [email protected]

Either Patients adhere or the Industry May Pay

The poor rates of adherence observed in patients taking chronic therapy invalidate many of the results seen in randomised clinical trials. The results of these trials are often used to prove economic benefit, and so these analyses must also be questioned. The industry is either going to have to perform economic evaluations in “real world” settings, or find a way to make adherence rates match those seen in clinical trials.

The industry routinely uses large-scale randomised clinical trials (RCTs) to assess whether a new therapeutic intervention works. However, there is often little attention paid to the fact that people treated in these studies do not accurately represent the population that receives the drug once it is in general use. It is these same studies that are frequently then used to provide an economic evaluation of the treatment or procedure under investigation. More than this, these evaluations are then used to justify the price being charged for newer medicines.

According to independent pharmaceutical physician Dr Sarah Clarke, “The so-called ‘gold standard’ of RCTs can tick all the right boxes in terms of rigour and robustness of design, but simply extrapolating their results to the real world can be a costly mistake.”

Van Staa et al published a study that compared the cost-effectiveness data from RCTs with observed clinical data for a group of COX 2 inhibitors1. The trials suggested that the costs of switching from a standard NSAID to a COX 2 inhibitor to avoid a single serious adverse gastrointestinal event was in the region of £12,500. In reality, when data from the UK General Practice Research Database was analysed, the cost of avoiding one gastrointestinal bleed was actually £65,000.

How do Clinical Trial Conditions Differ from Reality?The reasons for this are obvious. In the clinical trial situation, patients are diagnosed using strict criteria, they have a carefully defined risk profile for the event being evaluated, they do not have other serious illnesses, and with the intensive support of the clinical trials centre they are far more likely to adhere to treatment. Add to this the fact that physicians have to prescribe the drug according to the study protocol and the intervention of other trained staff, and one can begin to understand how far away from the general day-to-day workings of the general practitioner’s working day this becomes.As Dr Clarke goes on to say, “Health economic data based on RCTs and numerous suppositions do not necessarily inform the real effectiveness of a medicine in clinical practice where patients are not hand-picked, [and] have co-morbidities and other issues that are airbrushed from RCTs by stringent inclusion and exclusion criteria.”

So Do We need to Change Study Design?Explanatory trials, that are designed to answer questions

about efficacy and safety, are the bedrock of the licensing process. The generalisability of the economic evaluation will almost certainly be impaired by the stringent inclusion criteria and treatment protocols. Not only that but, for new drugs, these are nearly always conducted against placebo rather than a “usual care” arm.

Pragmatic trials offer economists the opportunity to evaluate the cost-effectiveness of an intervention under “real” conditions, with enrolled patients representative of those typically treated, a comparison of the new intervention with current practice, and follow-up under routine conditions. However, these studies by definition cannot be performed until a drug is on the market, and may take several years. Under normal circumstances, it is difficult imagining the industry rushing to perform them in great numbers.

What are the authorities Doing about the Situation?There still appears to be little appetite from the European Medicines Agency or the US Food and Drug Administration to force companies to provide data against any comparator, bar placebo. This being the case, true cost-effectiveness studies are unlikely to appear until well into a brand’s lifecycle.Rather the tack appears to be for authorities and insurers to try to implement stricter guidance on which patients should be treated and which drugs may be used. The kinds of protocols that are being introduced are far more like those



seen in the clinical trial situation. Diagnostic procedures are required to be more closely followed and stricter treatment algorithms imposed. This attempt to remove much of the clinical judgment from physicians often causes resentment, but such guidelines are here to stay.

What Can the Industry Do?The industry has tended to plough familiar furrows by concentrating their efforts on physicians, payers and authorities. Until recently the problem of patient non-adherence has been largely ignored, even though there is a wealth of evidence showing that it is a major issue costing billions of dollars and unknown morbidity and mortality.There is strong evidence that in all chronic therapy areas the rates of non-adherence are incredibly high. One study shows that at 12 months, the percentage of patients still collecting prescriptions was 11% for overactive bladder medications, 21% for prostaglandins, 28% for bisphosphonates, 29% for statins, 36% for angiotensin receptor blockers and 38% for oral antidiabetics2. One adherence programme that runs in the UK has resulted in 80% of patients being retained on their treatment for overactive bladder over 12 months.There are now programmes in place that can demonstrate that companies are able to significantly increase adherence rates amongst patients receiving a wide range of medications. There are still vast untapped potential revenues to be

mined amongst patients on these treatments and, just as importantly, if patients adhere to their treatments they are more likely to work. The goal for the industry must be to try to maintain as many patients on treatment in the real world as they do in clinical trials. Only then will the cost-effectiveness figures begin to mean anything.

What Will Payers Do?Times being as they are, payers are unlikely to start investing large sums into adherence programmes. Rather they look for cost savings, and will continue to do so.

One possibility is that they will look at cost-effectiveness studies and look to remodel the numbers based on what they believe adherence will be like in the real world, almost trying to pre-empt the type of study performed by van Staa on the COX 2 inhibitors. If this is the case the ultimate result is obvious – much lower prices!

The FutureIt is obvious that results from cost-effectiveness studies based on randomised clinical trials are going to come under greater scrutiny. As Toby Shephard, Associate

Medical Director at Boehringer Ingelheim, points out, “Those companies that look at the value of a medicine and its evaluation from early in its development have the potential to steal a march on their competitors.”

The industry will have to start remodelling so that the figures produced more closely reflect the real world, OR change patient behaviour so that it more closely matches that seen in the trials. If this does not happen, it will only be a matter of time until authorities will more critically assess the prices that are being paid.

References1. van Staa TP, Leufkens HG, Zhang B, Smeeth L. A comparison

of cost effectiveness using data from randomised trials or actual clinical practice: selective COX 2 inhibitors as an example. PLoSMed 2009;6:e 10000194

2. Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes J Manag Care Pharm. 2009;15(9):728-40

Ian De’Ath is a Partner and Director at Wizzard. Having spent over 10 years within the pharmaceutical industry in the UK and Germany Ian helped to establish Wizzard in 2000. Wizzard specialise in communicating healthcare messages to the public for a range of clients in

different industry sectors. Since 2002 they have been running targeted programmes aimed at improving compliance and adherence winning many awards for their effectiveness.Email: [email protected]




Clinical Trials

Optimising Patient-Centric Services: a Tailored Solution The cost of avoidable hospitalisations and disease progression in the United States has reached the unprecedented level of some $290bn per year; in turn these costs translate into suboptimal patient health outcomes and lost revenue. across the healthcare ecosystem, there is significant focus on medication adherence and patient programmes as a tool that can increase health outcomes, and decrease health system utilisation. For years, multiple healthcare stakeholders have sponsored patient programmes which have collectively sought to drive positive patient behaviours including improved patient wellness and medication adherence. Some leading entities, such as the US Centers for Disease Control and Prevention, University of California at San Francisco and Institute for the Future, estimate that the biggest factors influencing patient compliance and wellness are the healthcare system (10%), patient environments (20%), individual genetics (20%), and behaviour (50%).1, 2, 3

Patient behaviour – the largest single factor in compliance and wellness – can be influenced through a suite of patient-centric services (PCS) allowing the design and implementation of programmes that support better patient outcomes while reducing healthcare costs. This approach is based on a solid understanding of factors that influence patient behavior, and then employing technology and predictive analytics to change that behaviour. This paper discusses the need for a more sophisticated approach to PCS that includes the use of predictive analytics for risk modelling, and defines medication adherence, health and wellness programmes, and remote patient monitoring. For present purposes, remote patient monitoring includes technology platforms that serve as the basis for two-way “machine to machine” communications. The technology platforms can transfer electronic information about a patient’s health, or messages that can be used to monitor and/or influence a patient’s behaviour or a physician’s medical judgment. An overview of the currently available PCS is then given, followed by a discussion of the advantages and challenges associated with next generation tailored solutions. Table 1 provides a summary of definitions and acronyms to help explain the PCS concepts outlined in the paper.

Currently available Patient-Centric ServicesThere are numerous PCS solutions currently available, but generally these can be mapped to one of the following examples or to the “one-size-fits-all” strategy outlined in due course. Examples of PCS solutions include:• An adherence programme sponsored by a large

pharmaceutical company deploying mobile phone messaging medication reminders.

• A pharmaceutical company-sponsored, web-based brand loyalty programme that delivers educational content to

patients who have been prescribed a branded therapy.• A health and wellness-based programme sponsored by an

Accountable Care Organisation (ACO) designed to create a community of more informed and engaged patients.

• An adherence programme sponsored by a payer that uses a smart pill bottle to remind patients to take their medication.

• A programme sponsored by an ACO using wearable biosensors that enable physicians to monitor congestive heart failure patients, adjust medications as needed, and help prevent emergency room visits.

Table 1: List of Selected Terms and acronyms Related to Patient-Centric Services

Term or acronymPatient-Centric Services (PCS)

Predictive Analytics

Neural Networks

FDA

HIPAA

PHI

ACO

Adherence

Disease Management

Wellness Programmes

DefinitionThe targeting of various sub-populations of patients with specific messaging designed to influence behaviour to support medication adherence, wellness or even direct healthcare through remote patient monitoring. The key goals are to support better patient outcomes and avoid hospitalisations.

Mathematical tools that include predictive modelling based on patient information, scoring the predictive models based on patient characteristics, and forecasting of interventions targeted for patients.

A programming construct that mimics the biological properties of neurons.

United States Food and Drug Administration

Health Insurance Portability and Accountability Act of 1996

Protected Health Information

Accountable Care Organisation

Medication adherence measures patient compliance as a percentage derived from taking the amount of medication actually taken over a prescribed course divided by the total amount of medication that should have been taken during that period.4

Disease management is defined as “a system of coordinated healthcare interventions and communications for populations with conditions in which patient self-care efforts are significant.” 5, 6, 7

Duke University Medical Center’s Personalized Medicine Program defines wellness services as “those specially designed to help you turn advice such as ‘eat better’ and ‘exercise more’ into a customized plan that works for your lifestyle and unique health concerns—whether you seek to maintain good health or need help adopting the lifestyle changes that can help you manage existing health problems, including chronic diseases such as diabetes, heart disease, pulmonary disease, or arthritis.”8

Although the market competition for patients and their healthcare dollars is intense, many patient-centric programmes currently employ a “one-size-fits-all” strategy. Examples of this type of strategy can be found on large pharmaceutical websites and usually include the same basic information, intended to drive brand loyalty, including links for:• Product information (package insert, adverse event

information, information from clinical trials, mechanism of action).

• Patient support services (FAQs, advice on questions to ask physicians, etc.).

• Disease management information (such as the impact of lifestyle changes).

• Tools and resources (allowing estimation of out-of-pocket costs based on plan coverage).

• Member information (how to create an account, obtain incentives or financial assistance, or receive reminders or product updates).

• Promotion/free sample (such as discounts or product samples).

The US Food and Drug Administration (FDA) has not issued formal guidelines for pharmaceutical companies using social media. However, the industry has typically worked on the assumption that the agency’s requirement to provide comprehensive product safety information in promotional material can be satisfied if this is directly accessible from a link in the original promotional piece (i.e., no more than one click away). This was known as the “one-click” rule. However, this rule was rejected by the FDA when, on April 2, 2009, the agency issued enforcement letters to 14 companies on a single day for their failure to include risk information banner advertisements placed on search engine pages.9

Predictive analytics: The next generation approachA deep understanding of the patient-centric value chain is required to successfully tailor and optimise a PCS solution. The one-size-fits-all strategy is a step in the right direction, with potential to enhance patient compliance and empower patients to change behaviours to positively impact their health. However, rapidly-evolving new technologies – and parallel changes in the regulatory environment – mean that pharmaceutical companies may need to look outside for expertise if they are to provide a tailored, best-in-class PCS solution for each product. To meet this need, service companies are forming alliances and partnerships.

The “next generation approach” – which is arguably the most important factor to consider when providing a tailored solution approach to optimise PCS – involves the creation of predictive analytic tools. These include predictive modelling based on patient information, scoring the predictive models based on patient characteristics, and forecasting of interventions targeted for patients. A successful predictive analytics group may include experts from myriad disciplines, such as: behavioural science, psychiatry, psychology, neurology, clinical science (e.g., PhDs), clinicians (e.g., MDs with board certification), demographics experts, biostatisticians, mathematicians, analytical forecasters, marketing groups, and brand management specialists.

Predictive analytic tools may include methods for

discovering patterns and relationships such as statistics (scoring and segmentation and hypothesis testing) and clustering (segmentation and identifying patient characteristics). Later, classification of patient data can be done through decision trees, and forecasting or scoring of outcomes can be enabled through artificial neural networks (see below). Each predictive analytics engine will enable discovery of relationships between patient clusters and prediction of trends/behaviour of patient clusters to enable targeted patient intervention for increasing medication compliance. Figure 1 provides an illustrative example of how predictive analytics can be used to tailor a PCS programme.

In predictive analytics, artificial neural networks can be used in models that require significant statistical analysis. Such networks attempt to abstract the complexity and interconnections of real biological networks and focus on what may matter most from an information processing viewpoint. An artificial neuron is a mathematical function that accepts multiple weights (a floating point number) and is adjusted in training the network of neurons. For example, as each input enters a neuron, it is multiplied by its weight. The neuron function adds the input values and that, in turn, provides an activation number. If the activation number is greater than the threshold value, the number rises incrementally by a set amount, but if not, then the neural output is zero. This method is a part of artificial intelligence and can be used for forecasting, scoring, and classification. Accurate performance is measured by factors such as good predictive ability and low generalisation error.

a Syndicated approachThe best service companies will either possess the ability to recruit patients, or will partner to obtain this capacity. They will then need to subgroup or segment patients based on myriad factors that include the clinical context, psychosocial factors, demographics, life context, attitudes/practices, health literacy, motivation and consumer behavioural styles, individualised health risk, and an evaluation of the potential to achieve outcomes.

The PCS solution – which takes into account all of these factors – will then tailor messages and interventions to each subgroup. The tailored solution approach adjusts to the needs and financial capabilities of the sponsor, the individual product (or products) and the geographic aspiration of the sponsor (to comply with local regulations). The solution may include mobile phone applications, web portals, clinical educators, social media, text messages, call centres, patient

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Figure 1: Illustrative Predictive analytics Platform for Patient-Centric Solutions

communities or registries, wellness programmes, incentives, and video conferencing.

After the tailored solution approach is provided, a cost/benefit analysis is completed to assess the impact on the patient, all the while remaining compliant with existing legal (e.g., Health Insurance Portability and Accountability Act of 1996 (HIPAA))18 and FDA regulations regarding patient privacy from disparate data sources.

While no single solution is perfect for every company, attractive solutions could involve one or more of the following categories of vendors as shown in Table 2 below.

After the interventions are implemented, feedback must be obtained via metrics to determine the benefits of the tailored PCS approach. These metrics could include an increase in real-world efficacy, patient engagement, adherence, brand loyalty, health outcomes, and reductions in health system utilisation and health risk.

In addition to the commercial market expertise required to employ and evaluate a tailored PCS model, vendors must comply with legal and regulatory requirements. The next section of this paper discusses examples of remote patient monitoring, and key regulations associated with the transmission of messages and patient data, and highlights the challenges associated with each.

Remote Patient MonitoringRemote patient monitoring devices are evolving quickly and include mobile smartphone technology and remote transmitter devices. Some examples are:• Smart pill containers that record when a patient takes or

misses a pill, and then use wireless technology to notify the patient and/or doctor, or send a reminder via a text, e-mail or electronic voice mail message (e.g., Vitality GlowCaps10).

• “Wellbeing Monitor” from Sonomba for home-bound patients. This tablet device, designed with seniors in mind, has e-mail capability, can text message and has audible reminders for medication (as well as a panic button).11

• A blood glucose monitor for a person with diabetes who is at home, which can remotely send information to the doctor’s office (e.g., ACCU-CHEK Smart Pix device reader).12

• A mobile application that monitors vital signs and sends this information to the patient and/or doctor (e.g., Remote Vital Sign Monitoring System from Argonne National Laboratory and Northwestern University, MEMS-Wear Biomonitoring System).13,14

Although remote patient monitoring can employ different modalities, this paper focuses primarily on mobile phone applications, because mobile phones (and their corresponding applications) have particular potential to change human behaviour. For example, in the US, 89% of the population has access to mobile phone technologies, but only 76% has access to desktop computers (PCs).15,16,17

Regulatory Implications and ChallengesRegardless of the technology, all data transfers for covered entities – including healthcare providers that conduct electronic transactions, healthcare clearing-houses or health plans – are governed by HIPAA, which seeks to protect patient privacy. This act specifies, for example, that a secure transmission line is not enough; the line must also be encrypted. The FDA guidelines for mobile medical applications, currently in draft form, should also be consulted, particularly when finalised.19

In addition to HIPAA, the most important regulations impacting PCS include:1. The Health Information Technology for Economic and

Clinical Health Act of 2009 (HITECH),20 which enhances HIPAA’s privacy and security regulations.

2. The 510(k) and PMA Device Classification and its implications on mobile apps.21

3. Social media guidance from FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) when issued. There have been discussions about DDMAC’s providing guidance since 1996; however, no guidelines have been issued.

4. FDA’s Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications, published on 21 July 2011.19

5. Code of Federal Regulations (CFR)21 Code set (consisting of Part 11, Part 50).22

6. FDA’s Risk Evaluation and Mitigation Strategy (REMS).23

It is beyond the scope of this paper to discuss each of these regulations in detail; however, it is important to note that PCS

Clinical Trials


Type of EntityLarge contract research organisation

Large call centre

Pharmacy

Motivational segmentation frameworks and web content

Mobile agencies

Speciality pharmacy distribution company

In silico healthcare modelling firm

Social network portal

Credit risk scoring companies

Large physician networks

Large pharmacy networks

Patient access networks

Firms that have ability to merge risk of non-adherence & source of non-adherence creating predictive models that are used to tailor an intervention

CapabilityDeep understanding of the patient-centric value chain (e.g., recruit, segment, etc.)Knows impact on the patientUnderstands the cost/benefit of different tailored PCS solutionsCompliant with existing legal and FDA regulations regarding patient privacy from disparate data sources

Ability to contact patients rapidly on a global basis (for health and wellness messaging)

Identify pharmacy workflow

Web content based on segmentation

Identify experiences for patients

Can recruit patients into programmes

Can assign each patient a risk score

Can aid physicians who can support patient recruitment efforts

Can do predictive analytics based on consumer/patient profiles

Access to patients

Access to patients/prescribing behaviour

Access to patients

Predictive modelling component consists of segmentation of patients, predicting level of non-adherence risk, predicting source of non-adherence and tailoring intervention based upon above three steps

Table 2: Potential Vendors for Tailored Solutions

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must fully comply with HIPAA and apply the proper HIPAA-mandated measures to prevent the breach of Protected Health Information (PHI). It is also important to note that sponsors are not typically an HIPAA-covered entity and so compliance is not mandatory, but may be voluntary.

Due to the multiplicity of regulations, there is high potential for overlap. For example, if a company wishes to use social media to promote or brand a product, there is the potential for private information about a patient to be shared inadvertently or for efficacy to be exaggerated. As such, pharma is reluctant to use social media at present.24 The inadvertent sharing of information by covered entities would be considered a HIPAA violation, while exaggeration would be a violation of DDMAC regulations. Thus, a thorough understanding of regulations is critical for firms launching patient-centric programmes. Importantly, those offering PCS programmes will have to conduct due diligence not only internally but also on each of the partners in the ecosystem to ensure regulatory compliance.

Finally, firms that launch PCS solutions will need to acquire an architecture platform that is scalable and flexible enough to accommodate frequent change in technology as well as adapt to future modifications in regulations.

Summary• PCS includes the design and implementation of programmes

that support better patient outcomes while reducing

healthcare costs.• PCS will evolve to address the need for changing behaviours

to achieve better health outcomes through various tools that are not yet available from a single source provider.

• A deep understanding of the patient-centric value chain is a key factor that will determine the success of any tailored PCS programme.

• Next generation programmes will leverage outcomes research methodologies to wrap an observational study around each programme – thereby yielding clear and convincing success metrics. There will also be an emphasis on predictive analytics to estimate the impact on health risk as well as health outcomes and cost.

• Patient recruitment will be supported by multiple partners/channels/consortia to recruit patients into patient-centred programmes.

• Patients have differing needs, and PCS programmes will deploy multi-modal approaches to segmenting patients based on clinical context, psychographics, and consumer behaviour.

• Tailored solutions are based on each patient archetype, with an optimal combination of channel and message that will resonate with each patient. There is a significant emphasis on adaptive messaging, and ‘mobile’ content/channels given the increasing prominence of handheld consumer technology and content.

• Adherence and disease management, wellness programmes and remote patient monitoring are three of the largest drivers for any successful PCS tailored solution.

• Sponsors who employ PCS programmes that rely on remote patient monitoring will need to be compliant with FDA regulations. Mobile applications may also be subject to HIPAA regulations. There will therefore be instances where regulations overlap, making an understanding of the regulatory implications more complex.

References1. Center for Disease Control and Prevention at http://www.

cdc.gov/, accessed 15 September 2011.2. University of California at San Francisco at http://www.ucsf.

edu/, accessed 15 September, 2011.3. Institute for the Future at http://www.iftf.org/, accessed 15

September, 2011.4. Defining Adherence, PQA Hyperlipidemia Cluster

Group, Quality Measures at www.pqaalliance.org/files/HyperlipidemiafinalNov20.doc, accessed 13 September, 2011.

5. Care Continuum Alliance (CCA) definition of disease management, http//www.carecontinum.org/dm_definition.sap., accessed 6 September, 2011.

6. Congressional Budget Office. An analysis of the literature on disease management programs. 2004-10-13.

7. IMS National Sales Perspectives, Pharmaceutical Patient Adherence and Disease Management Report by Cutting Edge Information, 2006.

8. Duke Health and Wellness Programs at http://www.dukepersonalizedmedicine.org/patient_care/prevention_wellness/, accessed 1 September, 2011.

9. See:“14 Warning Letters in a Day! What’s That About?” at http://www.eyeonfda.com/eye_on_fda/2009/04/14-warning-

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letters-in-a-day.html, accessed 10 September, 2011.10. Vitality GlowCaps at http://latimesblogs.latimes.com/

technology/2011/01/ces-consumer-electronics-show-att-offers-internet-connection-for-your-pill-bottle.html, accessed 1 September, 2011.

11. Wellbeing Monitor, Sonomba website. http://sonamba.com/sonamba-at-a-glance/well-being-monitor/. Accessed 12 September, 2011.

12. ACCU-CHEK Smart Pix device reader at https://www.accu-chek.com/us/data-management/smart-pix.html, accessed 1 September, 2011.

13. Remote Vital Sign Monitoring System from Argonne National Laboratory and Northwestern University at http://www.ne.anl.gov/std/multimedia/mmw/index.shtml, accessed 1 September, 2011.

14. Tay FEH, Guo DG, Xu L, Nyan MN, Yap KL. MEMSWear-biomonitoring system for remote vital signs monitoring, National University of Singapore, Journal of the Franklin Institute, Volume 346, Issue 6, August 2009, Pages 531-542.

15. Zappe J. More Cell Phones Than Computers Means You Can’t Ignore Mobile. ERE.net website. http://www.ere.net/2010/10/21/more-cel l -phones-than-computers-means-you-cant-ignore-mobile/. Accessed 12 September, 2011.

16. Melanson D. Gartner forecasts phones overtaking PCs as most common web browsing device by 2013. 15 January 2010. Engadget website. http://www.engadget.com/2010/01/15/gartner-forecasts-phones-overtaking-pcs-as-most-common-web-brows/. Accessed 12 September, 2011.

17. Goldman D. Smartphones have conquered PCs. 9 February, 2011. CNN website. http://money.cnn.com/2011/02/09/technology/smartphones_eclipse_pcs/index.htm. Accessed 12 September, 2011.

18. HIPPA Privacy Rule and modifications can be found at http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html, accessed 13 September, 2011.

19. Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications (July 21, 2011) available at www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf, accessed 31 August, 2011.

20. HITECH and Interim Final Rules including enforcement and breach notification at http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/hitechblurb.html, accessed 13 September, 2011.

21. 510(k) regulations, at http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm, accessed 12 September, 2011.

22. FDA’s Code of Federal Regulations (CFR) 21 Code set (consisting of Part 11, Part 50).

23. Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications, Draft Guidance, DHHS, FDA, September 2009.

24. R McBride. J&J, AZ nix Facebook pages on commenting rule change, FiercePharma, 15 August, 2011 (at http://www.fiercepharma.com).

AcknowledgementThe authors would like to thank Jill Dawson, Ph.D., consultant to Quintiles, for her keen editorial insights and comments.

Davis Walp, MBA, Head of Value-Based Solutions, Senior Director, Quintiles Global Commercial Solutions. Mr. Walp has 15 years of progressive experience in commercial strategy/new product planning through roles held at Johnson & Johnson, Pharmacia, Pfizer,

and GlaxoSmithKline and has also authored and lectured on innovative approaches in the area of R&D portfolio optimization. Mr. Walp earned a BA in Psychology from the University of Rochester in Rochester, NY, and an MBA in Finance and Marketing from the William E. Simon School of Business Administration. Email: [email protected]

Himanshu Jain, MS, MBA, Value-Based Solutions, Strategic Planning Intern, Quintiles Global Commercial Solutions. Mr. Jain has experience in strategic planning and product management through roles held in multiple industries such as retail, healthcare, automotive

and consulting. He has worked globally in Sweden, the U.S. and India and conceptualized or executed innovative solutions with companies such as Volvo, Frost and Sullivan, Aditya Birla Group and IBM. Mr. Jain holds an MS in Electrical Engineering from Chalmers University of Technology and a MS in Management from Jenkins College of Management, North Carolina State University. Email: [email protected]

Christian Nimsch, MA MBA, Senior Director of Value Based Solutions, Quintiles Global Commercial Solutions. Mr. Nimsch joined Quintiles to support the creation of patient centric services aimed at improving patient compliance/adherence with medication treatments

via targeted patient interventions. Mr. Nimsch earned a MA in Applied Economics from the University of North Carolina at Greensboro, and an MBA from the Kenan Flagler Business School at UNC-CH. Email: [email protected]

Raymond A. Huml, MS, DVM, RAC, Executive Director of Global Due Diligence, Quintiles Capital Solutions. Dr. Huml identifies risks associated with Quintiles product-based investments, working with specialists on all components of the due diligence process and has worked on all

major investment transactions involving more than $2.7 billion in capital on alliances with biotechnology and pharmaceutical partners. Dr. Huml holds an MS in Biology from East Stroudsburg University and his DVM from North Carolina State University’s College of Veterinary Medicine, and has earned the RAC (U.S.) Certification. Email: [email protected]


Therapeutic


Detecting Pro-cognitive Effects in Clinical Drug Trials: Case Studies from alzheimer’s DiseaseProblems with the Status QuoThere has been turmoil in the world of Alzheimer’s disease (AD) clinical drug trials over the past couple of years. Not too long ago we believed we had a good handle on the pathology that underlies brain cell death in this devastating disease – and better yet, drugs that could remove the pathological hallmarks. As well as compounds intended to modify the course of the disease, we also had a crop of drugs that might offer symptomatic relief. Unfortunately the promise of these new compounds has not been realised and we have instead witnessed a succession of failures, of which Neurochem’s ‘Alzhemed’, Lilly’s ‘Semagacestat’ and Pfizer’s ‘Dimebon’ have been just the most high profile examples. Alzheimer’s disease remains a major area of unmet need, and there is still plenty of enthusiasm amongst drug developers to continue research in this indication. The failures of the past two years have focused attention on not just the disease mechanisms, but also the instruments used to measure drug effects, particularly with respect to the assessment of cognition, the hallmark deficit of AD.

For the past 20 years the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) has been a feature of almost all late-phase development trials, and often included in exploratory studies where the ambition has been to establish Proof of Concept (PoC). However, it has long been recognised that the ADAS-cog, like many of the tests borrowed from clinical psychology, is an imperfect means of measuring cognition in clinical drug trials (1). A key issue in this context is the instrument’s tendency to confounding factors such as practice, familiarity and learning effects. Further, a lack of placebo decline, likely the result of practice, has long confounded our best intentions to test for beneficial drug effects. In spite of this, the drug development community has persevered with the ADAS-cog. In fairness the practice effect is not solely an issue for the ADAS-cog, but also for other measures used in AD trials, and more generally across central nervous system (CNS) drug research. Two reasons are usually proffered to account for continued use of the ADAS-cog. The first is a dogmatic belief that regulators require use of the ADAS-cog. However, recent statements from both the FDA and EMA confirm that it is not a requirement. Second, the ADAS-cog has a reputation of being a ‘gold standard’, largely, it would seem, based on the fact that marketing approval for many of the so far registered AD drugs was gained on the basis of significant differences between treatment and placebo patients on this measure. However, many recent study results have undermined the utility of this measure, and in the following section we will discuss its inadequacy with particular relevance to issues of patient capacity and compliance.

Issues of Patient Capacity and ComplianceA key issue in the cognitive assessment of patients with Alzheimer’s disease is the selection of appropriate measures with which to assess individuals at different stages of disease severity. Trials have routinely been stratified to focus on patients of different severity and the Mini-Mental State Examination (MMSE) is the most commonly employed staging instrument. The 0-30 point MMSE continuum is typically divided to yield mild (20-30), moderate (12-20) and severe (<12) groups and separate trials of i) mild-to-moderate and ii) severe stage patients have been commonplace. Common also is the selection of different cognitive tests, with the Severe Impairment Battery (SIB) being employed for use with severe patients. This is in recognition of the fact that they would find the measures employed in studies of mild-to-moderate patients so challenging that would likely perform at

Therapeutic

‘floor’ levels. Interestingly this concern, and that of ‘ceiling’ effects, is also an issue with the use of the ADAS-cog in mild-to-moderate patients. Figure 1, reproduced from Grundman et al. (2), illustrates both of these phenomena. This figure shows that performance on verbal memory tests from the ADAS-cog is close to floor in the ‘questionable dementia’ (CDR=0.5) and Mild (CDR=1.0) AD groups. Ceiling effects are evident on many of the remaining subtests, typically those measuring praxis and language skills. Floor performance has also been seen on aspects of an alternative mild-to-moderate AD assessment, the Neuropsychological Test Battery (NTB), particularly on the delayed recall memory measures (3). Adoption of the NTB, coupled with the desire to employ all possible means of capturing cognitive effects, has led to AD trial protocols including a number of cognition assessments. The inclination to employ comprehensive cognitive measurement is understandable, but a legacy of this approach is that the time taken to administer the ADAS-cog, NTB and CDR can extend to more than three hours of assessment. This represents a considerable burden of testing. Levels of refusal to continue, and anecdotal accounts of fatigued and frustrated patients, suggest that for a significant number of trial participants such testing regimes are overly taxing. Little empirical evidence exists regarding the tolerance levels for testing of patients with AD. However, it seems likely that tolerance will be idiosyncratic and probably linked to disease severity. Our own inclination is to aim for a maximum total testing time per patient of approximately 30 minutes per visit.

In spite of the traditional scale deficiencies, versions of the ADAS-cog and NTB both routinely feature in studies of patients in the mild-to-moderate stages of AD. However, a recently published study has highlighted the virtues of what can be achieved with what we would view as more appropriate test use. Scheltens et al. (4) recently published the results of a 24-week trial of the medical food ‘Souvenaid’ on mild stage AD patient cognitive function. The sponsor of this trial selected a version of the NTB featuring tests of verbal memory and executive function (EF), but opted to analyse data for these two cognitive domains separately. Combined performance on two verbal memory tests drawn from the NTB was specified as the primary efficacy measure, and four tests of EF were combined to yield a secondary efficacy measure. The results of this study yielded a significant benefit for memory of Souvenaid use after 24 weeks. The decision to analyse treatment effects on memory and EF separately was in part based on previous evidence showing a pharmacological dissociation between these two cognitive domains. A previous study of the active immunotherapy AN1792-201 yielded significant effects on the statistically-derived memory factor, but not on the EF factor (5). In contrast, studies of the compound PBT2 have witnessed significant effects on the EF factor, but only trends on the memory score (6). As the effect of Souvenaid had previously been witnessed only on tests of verbal memory, it was decided to look for primary efficacy solely in this domain of function.

The above approach has in our view much to recommend it. As discussed, the inclination of many sponsors has been to employ the ADAS-cog based solely on a perception that from a regulatory perspective this measure is the preferred

cognition measure. However, representatives of the FDA have stated publicly that they have no particular expectation that trial sponsors will necessarily employ the ADAS-cog (7). The EMA have pointed out that there is no ‘reference technique’ (8) and have added the NTB as a candidate primary efficacy measure in recent revised guidelines for dementia drug development. Furthermore, a section of these guidelines reveals that cognitive domains such as attention and psychomotor speed are specified for investigation. Neither of these functions is indexed by the NTB or by the ADAS-cog, and so new measures will need to be employed to meet these requirements.

Many sponsors are seeking to treat patients as early as the prodromal phase of the disease, with the intention of halting cognitive decline and preventing conversion to a diagnosis of AD. Expert groups such as the European Task Force for Alzheimer’s disease have focused on the need to measure cognitive function in domains such as episodic memory, working memory and executive function (9) in these early stage patients, but have made few specific recommendations concerning how appropriate tests should be selected. Our inclination is to be guided by best practice advice offered by Ferris et al. (10) and Harrison & Maruff (11), both of whom stress the need for tests to be sensitive, valid and reliable.

next StepsNew challenges in dementia drug development will require the use of appropriate cognitive measures. Much can be learned from the extensive neuropsychological research that has been conducted in patients with Alzheimer’s disease. However, in the context of clinical trial work, with the need for repeated patient assessment, the best measures of cognitive change may not necessarily come from the traditional canon of psychological testing. Instead the emphasis should be on the adoption of stable and validated measures of cognitive change, which can ideally also be used to address the issue of clinical relevance.

References1. Wesnes, K. & Harrison, J.E. The evaluation of cognitive

function in the dementias: methodological and regulatory


Figure 1: Performance of Control, MCI and aD patients on aDaS-cog subtests (2) This figure illustrates that compared to control study participants, the performance of individuals with Mild Cognitive Impairment (MCI) and patients with Alzheimer’s disease (AD) on Word List tests and, to some extent, Orientation, is impaired. However, performance on the remaining subtests is at, or close to, ceiling.

considerations. Dial. Clin Neurosci. 5, 77–88 (2003).2. Grundman, M.P.H., Petersen, R.C., Ferris, S.H. and the

Alzheimer’s Disease Cooperative Study. Mild cognitive impairment can be distinguished from Alzheimer’s disease and normal aging for clinical trials. Arch Neurol. 61, 59-66 (2004).

3. Harrison, J. & Caveney, A. 10 years of the Neuropsychological Test Battery (NTB). PRO Newsletter 45, 21-4 (2011).

4. Scheltens, P., Twisk, J., Blesa, R., Scarpini, E., Von Arnim, C., Bongers, A., Harrison, J., Swinkels, S., De Deyn, P., Wieggers, R., Vellas, B., Kamphuis, P. Souvenaid improves memory in drug-naïve patients with mild Alzheimer’s disease: Results from a randomized, controlled, double-blind study (Souvenir II). J Nutr Health Aging, 15(1), S13 (2011).

5. Gilman, S., Koller, M., Black, R.S. and the AN1792(QS-21)-201 Study Team. Clinical effects of A-beta immunization (AN1792) in patients with AD in an interrupted trial. Neurol, 64, 1553-1562 (2005).

6. Lannfelt, L., Blennow, K., Zetterberg, H., Batsman, S., Ames, D., Harrison, J., Master, C.L., Targum, S., Bush, A.I., Murdoch, S., Wilson, J. & Ritchie, C.W. Safety, efficacy, and biomarker findings of PBT2 in targeting A as a modifying therapy for Alzheimer’s disease: a phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol, 7(9), 779-786 (2008).

7. Katz, R. Presentation at Alzheimer’s Association Research Roundtable, Washington, April, 2008.

8. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003562.pdf, visited on 4th November, 2011.

9. Vellas, B., Andrieu, S., Sampaio, C., Coley, N., Wilcock, G. and the European Task Force Group. Endpoints for trials in Alzheimer’s disease. Lancet Neurol. 7, 436-50 (2008).

10. Ferris, S. et al. Objective psychometric tests in clinical trials of dementia drugs. Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines. Alz Dis Assoc Disord.11(S3), 34-8 (1997).

11. Harrison, J. & Maruff, P. Measuring the mind: assessing cognitive change in clinical drug trials. Exp Rev Clin Pharmacol. 1(4), 471-473 (2008).

John Harrison, Scientific Consultant at CRF Health, and an Honorary Senior Lecturer in the Dept. of Medicine at Imperial College in London.. John has for the past 15 years advised pharmaceutical and biotechnology companies with the selection and successful integration of cognition testing

into their drug development programmesEmail: [email protected] and [email protected]

Therapeutic


Modern Technology


Compliance Spotlight on Speciality Drugs: Improved Outcomes through Mobile Patient Relationships

What’s so Special about Speciality Drugs?When it comes to compliance, speciality drugs are pretty special. They are often highly complex medications, typically biology-based, that structurally mimic compounds found within the body. Speciality drugs are developed to treat complex chronic diseases, such as multiple sclerosis, hemophilia, arthritis or cancer.

While speciality drugs have been available for several decades, rapid growth in both the quantity and cost of these drugs over the last few years has put speciality drug therapies in the spotlight.

Speciality pharmaceuticals are the fastest-growing component of today’s pharmaceutical industry. The pipeline is bulging with more than 600 speciality pharmacy products. Medco’s 2011 Drug Trend Report noted that the amount of speciality spending has been increasing steadily. This year it will represent 17 per cent of the total spend, and current projections are that within five years it will grow to represent a full 40 per cent of spend.Speciality drugs come with a special price tag, typically more than $1800 a month. Drug treatment costs for one person on speciality medications can be as much as $250,000 per year.

Compliance, while important in taking all medications, is critically important with speciality drugs. Delivered through speciality pharmacies, these medications often require focused, in-depth patient education, compliance monitoring, side-effect management and even injection technique education. Side-effects can be extreme, and medication schedules confusing for the patient to manage. Drugs that are required by the FDA to have Risk Evaluation and Mitigation Strategy (REMS) programmes require even closer surveillance and reporting. Smartphones and Speciality Drug ComplianceStudies show that increased adherence, early intervention, patient education and treatment monitoring all improve compliance. Traditionally compliance monitoring has been extremely difficult to accomplish. Fortunately, the widespread adoption of smartphones has opened a new, cost-effective channel to address patient compliance. Interactive, real-time, 24x7 patient connections improve patient care and outcomes, reducing costs.

From the patient’s point of view, mobile health services accessed through their smartphone gives them control over their health, and makes it easier to follow their doctor’s orders.

Flexible medication reminders simplify the most complex schedules and improve adherence. Compliance reporting,

goal monitoring, and bio-metric tracking from their smartphone can be done with a single touch. Tracked daily, and reported in easy-to-understand charts, this data gives patients and providers unique insights into how the patient’s behaviours influence their wellness.

Patient relationships are strengthened through ongoing tweets and articles that provide disease and treatment education, encouragement, and access to financial aid resources.

As new mobile health services become available, patients may receive sponsored accounts through their pharmacy, from pharmaceutical manufacturers, or through their employer as part of a pharmacy benefit management programme.

Outcome-Oriented Speciality Pharmacies Shine in Compliance ManagementAs speciality drugs increase in prevalence, the speciality pharmacy may turn out to be at the very centre of the accountable care movement. New reimbursement models tied to improving outcomes are emerging, and these will help to offset the continual decline in pharmacy margins.

While many speciality pharmacies are eager to attract new business that comes from delivering improved patient outcomes, providing services that meet new expectations for patient care is a challenge.

Traditional call centre and mail communications are expensive and often ineffective. Call centres are often used to place regular calls to check on the patient’s status, but these calls frequently go to voicemail. Or, when contact is made, it’s not with the patients who are in the greatest need. In the worst case, call centre staff try to minimise the time they spend with patients to meet call volume incentives.

The first alert the pharmacy may receive that the patient is struggling with compliance is failure to reorder at 30 or 45 days. At this point, intervention is much less effective. The patient may never complete their treatment or has already experienced serious, and expensive, side-effects.

For the speciality pharmacy, new mobile patient relationship solutions provide real-time intelligence and the ability to reach patients with coaching, education, and reminders. These services improve the management of all types of drugs, including those that require REMS programmes.

With the patient’s permission, the pharmacy receives real-time alerts of skipped medications, as well as exception reports for bio-metrics that are outside predetermined thresholds. Healthcare staff can proactively reach out to these patients to provide support, control side-effects, and

prevent serious complications. By focusing professional health services on the most critical patients, the pharmacy optimises resources, and provides high touch care when the patient needs it the most.

In addition, as thousands of speciality drug users monitor their treatment, the database of patient-reported outcomes expands to provide insight into the most effective therapies.

Speciality pharmacies that differentiate themselves through patient services that deliver better outcomes will thrive in the new world of healthcare. Physicians refer more patients. Payers celebrate lower healthcare costs. Pharmaceutical manufacturers reward increased sales. And most importantly, patients live better.

Smartphones Star in Patient Relationships for Speciality Drug Manufacturers Speciality drug manufacturers are also in a position to improve compliance through sponsorship of mobile patient compliance services in conjunction with the introduction of new drugs. These services help patients to take control of their health, while drug companies benefit from direct, long-term patient relationships.

Included in the physician launch kit, and promoted through QR codes in a variety of advertisements, drug manufacturers can build direct patient relationships that not only improve compliance, but facilitate patient education, new product sales and marketing outreach throughout the patient lifecycle.

An added benefit for the manufacturer is real-time access to aggregated data on patient-reported outcomes. This data can support the value of the drug in improving patient health, as well as provide unique insights into marketing opportunities and product development.

Mobile Patient Relationship Services Receive Top Billing across the Healthcare EcosystemWhen it comes to improving compliance through mobile patient services that leverage the power of smartphones to build two-way, 24x7 relationships; everyone wins.

Pharmacies are able to cost-effectively provide a higher level of care that gives them a competitive advantage. Healthcare plans save money. Providers have a more complete picture of the patient’s health, and see better results from prescribed treatments. Pharmaceutical manufacturers experience higher sales.

Most importantly, new mobile patient relationship services help patients achieve the greatest benefit from their speciality drugs, and enjoy a better quality of life.

Pamela Swingley, Enterprise software marketing executive, has spent more than two decades helping businesses of all types adopt technologies that improve their performance. A bit more geek than she’d admit to, Pam’s contributed to the success of several tech companies,

including ADP, Siebel Systems, and OnLink Technologies. Today, as the CEO of Mobile PRM, Pam’s passion is to transform patient relationships through mobile services built on a patient relationship management platform that delivers improved outcomes at a lower cost. Mobile PRM’s suite of mobile services improve medication adherence, provide treatment feedback, reduce patient acquisition costs, disseminate health information, and facilitate market research. Most importantly, Mobile PRM keeps people healthier. Email: [email protected]

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Improved Outcomes through Mobile Patient Relationships

Drug Delivery, Dug Packaging, Labelling & Dispensing


From Formulation to Drug Delivery to Specialty Packaging: a Comprehensive approach to Patient adherencePharmaceutical companies have long understood that patient adherence to their prescriptions is an addressable barrier that can help lead to better and more cost-effective treatments for patients. Patient non-adherence to medications is heavily dependent on the individual needs of specific patient demographics. Even though the action and goal is easily identifiable, the solutions are often complex and multilayered.

Patient non-compliance in America is a major medical problem, with an estimated cost in excess of $290 billion a year, according to a report from the New England Healthcare Institute.1 The increased cost of non-compliance, combined with payor systems implementing “pay-for-performance” reimbursement models, leads to the need for additional approaches to tackle the issue of patient non-compliance.

Understanding the root causes and underlying drivers of patient non-adherence is critical to developing solutions. In a survey of 10,000 patients conducted by Harris Interactive and BCG (Figure 1), they cited a high level of forgetfulness to using or refilling the medication (24%) and also not wanting to experience side-effects (20%) as main reasons for non-compliance.2

Additional studies show dosing regimens have dramatic effects on adherence. In a study conducted by Claxton and Cramer3, the rate of adherence varied inversely with the number of doses needed throughout the day. For example, in the study, once-daily dosing had a higher adherence rate than three-times-daily dosing. Illustrated in Figure 2, these results suggest that a reduction in the number of the dosages can have positive effects on adherence.

While researchers have identified improved patient education about disease management and medications, pharmacist and physician assistance, and simplified drug regimens as means

for improving compliance, many in the pharmaceutical community are recognising that drug delivery and specialty packaging may also be influential factors. Figure 3 illustrates solutions that can be implemented to improve patient adherence at any stage of drug development, launch, and life-cycle management.

The Role of Drug Delivery in non-complianceMultiple factors impact a patient’s compliance to their prescription medication. Among treatment-related factors are: route of administration, pattern of dosing, length of treatment, side-effects, and cost of treatment to patient. Patient-related factors also contribute to non-compliance, such as age, cognitive impairment, and gender. Children also are dependent on adult supervision to follow their medication treatment plan.

Controlled ReleaseControlled release formulations for oral drug delivery can address several of these factors that represent barriers to patient adherence, through modification of drug pK profiles to deliver drug when it is needed, to pill burden reduction through extended release and combination medications, to pulsed release delivery of drug where it is needed in the body. A summary of how Catalent Pharma Solutions helps pharmaceutical companies address compliance factors through controlled release and OSDrC® OptiDoseTM technologies is shown in Figure 4.

According to Harris Interactive, a market research and consulting firm, more than 40% of adults in the US general population reported problems with swallowing pills.4 As a result, 14% delayed taking their medication, 8% missed or skipped their dose, and 4% discontinued their medicine.

Orally Disintegrating Tablets (ODT)Orally disintegrating tablet (ODT) formulations dissolve in the mouth, without the need for water, therefore eliminating the need for patients to swallow pills. ODT applications have continued to expand as dysphagia (i.e., difficulty swallowing), patient compliance, and consumer convenience issues gain prominence.

A recent study of longitudinal patient records at Catalent Pharma Solutions supports the theory that drug delivery can

Figure 1: Reasons for Patient non-compliance

Figure 2: a systematic review of the associations between dose regimens and medication compliance.

Figure 3: Patient Compliance Solution options.

Figure 4: Patient compliance factors addressed by controlled release formulations.

improve patient medication compliance. The one-year study compared the compliance rates of two oral delivery methods for delivery of selegiline, a treatment for Parkinson’s disease: standard pill and an orally disintegrating tablet (ODT) formulation that achieved pre-gastric absorption. Results showed a 98.5% compliance rate with the ODT formulation compared to 81% with the standard oral treatment in US Medicare patients, shown in Figure 5.5

This same patient records study showed an improvement in compliance across all patients studied. Additionally, Zydis® ODT formulations have shown patient preference and improved compliance in other therapeutic applications compared to traditional tablets, shown in Figure 6.

The Role of Specialty Packaging in non-complianceSpecialty packaging is another piece of the patient medication adherence puzzle that appears to have a significant impact on patient persistency and patient outcomes. “The Impact of Innovative Packaging on Adherence and Treatment Outcomes in Elderly Patients with Hypertension”, often referred to as the Ohio State Study,10 and the Federal Study of Adherence to Medications in the Elderly (FAME), which observed the impact of a comprehensive pharmacy care programme on medication adherence and control of blood pressure and low-density lipoprotein cholesterol (LDL-C),11 are two studies that are often cited to highlight the positive correlation between specialty packaging and improved patient medication adherence.

To further support the influence packaging formats have on patient adherence, Catalent conducted a study with SDI in January 2011 to measure patient persistency to a medication by comparing a unit-dose patient adherence package to a conventional 30-count bottle package for the same drug12. The study utilised patient prescription data from SDI, a provider of anonymous patient-based prescription data. The data set are from claims from more than 50% of the retail pharmacies in the United States, and account for one-half of dispensed claims across all pay types. This adherence study looked at patient persistency rates over a 12-month period

by analysing a cohort of ~200,000 qualified patients who filled their prescriptions in either a traditional bottle or a patient adherence package. Persistency rates were defined as the percentage of patients who remained compliant or restarted therapy over the 12-month tracking cycle. The new study strongly correlated improved adherence rates with the packaging format. The patient adherence packaging led to a 17-point increase in patient persistency to a drug over 12 months, as compared to the 30-count bottle.

To most effectively enhance the packaging to drive patient adherence, the package must incorporate multiple adherence drivers customised to the needs of the specific therapeutic area. Many features can be added to the package to address an array of barriers to medication adherence. For example, different features for opening the package can allow for easier use and create a positive initial experience with the medication. Titration packages are a prime example of adherence-prompting packages. These designs simplify the dosing process for the patient through their format and drug layout, while reminder-prompting features such as the printing of dates, numbering, or icons encourages the patient to take the right medication dose at the right time, as illustrated in Figure 7.

SummaryMedication non-adherence is recognised as a major issue that burdens our healthcare system, and in many cases can impact patient outcomes. Developing drugs with optimal safety/efficacy/side-effect profiles; patient, physician, and pharmacy education programmes; and patient payment assistance programmes are a common focus for pharmaceutical companies to address patient adherence.

Additional and proven solutions, such as drug delivery formulation and specialty packaging, exist to improve patient adherence and are sometimes overlooked in the pharmaceutical industry.

Moreover, the root cause for patient non-adherence is multi-factorial, requiring solutions that are both multilayered and multifunctional within the pharmaceutical industry. These solutions bridge across drug development, drug delivery formulation, and specialty packaging, and are enhanced post-launch through patient/physician/pharmacy education programmes and patient access programmes.

This cross-functional solution approach is the foundation of Catalent’s new programme to enhance patient adherence, called Adherence by Design™ (described in Figure 8). This programme is derived from the Quality by Design (QbD) philosophy, which starts with the desired outcome and then works backwards in the process to control the critical parameters.



Figure 5: Zydis® fast-dissolve tablet patient compliance compared to traditional tablet formulations.

Figure 6: Zydis® fast-dissolve tablet patient preference and adherence data summary.

Figure 7: Titration Package.


Key stakeholders in Adherence by Design™ programmes look at multiple parameters early in the drug development cycle and then build in features that will help promote adherence for the specific therapeutic class. This unique approach throughout the product development life-cycle can create a tailored solution designed to drive increased patient medication adherence. Figure 9 describes the potential

adherence benefits and corresponding technologies. The drug delivery and specialty packaging format can be

revisited at multiple points in the product life-cycle, and may ultimately play a key role in enhancing patient medication adherence.

As the cost burden of patient non-adherence continues to increase and payor systems alter their reimbursement models, the healthcare industry will be forced to redefine ways to improve the overall system. The adoption of more comprehensive patient adherence solutions can assist in enhancing patient outcomes and improving adherence results.

References1. New England Healthcare Institute, Thinking Outside the Pillbox,

A System-wide Approach to Improving Patient Medication Adherence for Chronic Disease, August 2009.

2. Harris Interactive and BCG 2002 Survey on reasons for patient non adherence.

3. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23(8):1296–1310.

4. PRNewswire, website: http://www.spraynswallow.com/links&Articles.html, January 15, 2004.

5. 12-month longitudinal patient records analysis conducted by

SDI Health, a division of IMS Health, conducted in January, 2011. Study included 1520 US patients prescribed Zelapar, Eldepryl, or generic Selegiline.

6. Clarke A, Johnson ES, Mallard N, Corn TH, Johnston A, Boyce M, Warrington S, MacMahon DG, A new low-dose formulation of selegiline: clinical efficacy, patient preference and selectivity for MAO-B inhibition, J Neural Transm. 2003 Nov 27;110(11):1257-1271.

7. Giorgio Ciprandi, Clinical Utility and patient adherence with ebastine for allergic rhinitis, Patient preference and adherence, Volume 4, PubMed Central, October 14, 2010.

8. Karagianis J, Grossman L, Landry J, et al., A randomized controlled trial of the effect of sublingual orally disintegrating olanzapine versus oral olanzapine on the body mass index: The PLATYPUS study. Schizophr Res. 2009; 113:41-48.

9. Reig AR, Fernandez JP, Cervera JG, Navarro JH, Ferragud MA, Hortal EG, Acceptance survey of a fast dissolving tablet pharmaceutical formulation in allergic patients. Satisfaction and expectancies. Allergol Immunopathol. 206; 34:107-112.

10. Schneider P, Murphy J & Pedersen C. The Impact of Medication Packaging on Adherence and Treatment Outcomes in Older Ambulatory Patients. Journal of the American Pharmacists Association, 48(1), 58-63.

11. Lee J, Grace K &Taylor A (2006), Federal Study of Adherence to Medications (FAME): Effect of Pharmacy Care Program on Medication Adherence and Persistence, Blood Pressure and Low-Density Lioprotein Cholesterol: A Randomized Controlled Trial. JAMA 296,2563-2571.

12. Catalent/SDI study “Compliance packaging study utilizing claims data” (2011)

Zydis® is a registered trademark of Catalent Pharma Solutions OSDrC® is a registered trademark of Sanwa Kagaku Kenkyusho Co., Ltd.OptiDose is a registered trademark of Catalent Pharma SolutionsZelapar® is a registered trademark of Valeant Pharmaceuticals North America Corp.Eldepryl® is a registered trademark of Somerset Pharmaceuticals, Inc

Steve Hamlen is Group Product Manager for Catalent’s Modified Release Technologies. He has 19 years’ experience in the life sciences industry and prior to joining Catalent, held a number of senior positions within leading pharmaceutical companies developing

life-cycle strategies for new molecules, and those approaching patent expiry. Steve has a BS in Chemical Engineering and an MBA from Lehigh University.Email: [email protected]

Bill Hartzel is a Product Manager for Catalent’s Medication Delivery Solutions division. He specialises in patient adherence solutions and has worked with many of customers’ brand management teams to understand and design adherence solutions for their products’

specific needs. Prior to joining Catalent Bill held roles within the biopharmaceutical industry and specialised in material selection for single-use devices. He also held leadership positions within several industry organisations including ASME BPE and BPSA. Bill has a B.Sc. in Chemical Engineering and an expected MBA from Villanova University. Email: [email protected]

Figure 8: Catalent’s adherence by Design™ programme.

Figure 9: adherence by Design™ programme potential adherence benefits and technologies.


While the recent controversy surrounding pharmacists being paid to enrol patients into support programmes adds to a well-trodden path of bashing the pharmaceutical industry, it does little to address the astonishing fact that according to the World Health Organisation, half of all patients who are prescribed medicine fail to take their prescription as recommended1. This well-entrenched issue is universal across disease states as diverse as cancer, cardiovascular disease, HIV, asthma and many others.

And while failure to take your anti-hypertensive or osteoporosis medication as prescribed may not seem like a big deal, it can lead to hospitalisation for stroke, heart attack or hip fracture, and the costs to the individual patient, society in general and the health system are immense. Non-adherence to medication has been estimated to cost $300 billion per annum in the US in avoidable medical spending. In Europe, non-adherence is a contributing factor in 200,000 deaths per annum, and costs the economy €125 billion each year and is rising2.

The old maxim that a pill doesn’t work unless the patient takes it is quite obvious, yet this has been a source of ongoing frustration and mystery to heathcare practitioners for years – remember the rate of non-adherence is 50%.

Most of us would hope that pills prescribed for loved ones, designed to potentially extend or save their lives, are taken correctly. But who is responsible for ensuring this actually happens? A visit to the doctor every two to three months doesn’t cut it, and certainly isn’t working based on long-standing statistics – this level of support is simply not enough to improve adherence rates.

There is abundant clinical literature and evidence regarding rates of non-adherence, and many proven interventions have been successfully designed to address the issue. Professor Keith Petrie, Head of Health Psychology at Auckland’s School of Psychological Medicine, cites research suggesting that 70 per cent of non-adherence is intentional. The reasons why people deliberately choose not to take their medication are complex and personal, encompassing an individual’s beliefs about their illness and treatment.

However simple examples of ‘reasons’ for not taking pills from patients themselves can include “The internet said...”, “It reminds me I am sick”, and “I don’t have any symptoms”.

This highlights a simple dilemma - many life-threatening conditions are asymptomatic, such as high blood pressure and high cholesterol, which is a de-motivating factor for a patient to adhere correctly to their medication. It’s no wonder patients take it upon themselves to self-manage and intentionally reduce their recommended medication regimen, thereby increasing their risk of a poor (and expensive) outcome.

Other medications are often prescribed to reduce symptoms and must be used long-term in order to achieve the intended results for patients. Asthma preventer treatment is

a good example of this; however, recent data has shown that only 28% of asthma patients correctly take their preventative medication in Australia3.

So what to do? Yes, current support programmes are primarily funded by pharmaceutical companies – who else is ready to fund them? Let’s not forget that support programmes are primarily designed to connect patients with information around their condition that helps them to understand why their medication is important and address any concerns they may have, while assisting them to manage side-effects. These programmes also equip patients with realistic treatment expectations and tips for healthy lifestyle and behavioural change. Many are run by registered nurses with significant involvement from healthcare professionals and health psychologists – the bottom line is that support

Stuck Between a Pill and a Hard Place



programmes play an important role in the health sector.Meanwhile, a requirement of the Therapeutics Goods

Administration (TGA) is to ensure manufacturers’ quality use of medicine (QUM) is upheld, including recommendations for patients to take their medication as prescribed. The TGA itself has a requirement to ensure QUM, yet recent regulatory changes by the TGA have prevented the long-standing practice of including patient enrolment forms within medicine packaging. This has previously proven to be the most successful method for enrolling patients and is the most direct way to ensure that only patients actually prescribed the medication receive support. Furthermore, this required no money to change hands.

Though GPs and specialists are in the best position to provide patients with access to support programmes, it is a

well-known fact that they are over-burdened with paperwork and are desperately pressed for time – which can put patient enrolments onto the back burner. Not surprisingly, a patient support programme cannot work if a patient isn’t on it.

The next best avenue to provide patients’ access to support is at the point of sale, when the medication is dispensed by a pharmacist. On the back of recent negative press coverage which has presented it as a sales and marketing revenue tactic, it looks as if this channel could also potentially dry up.

At Atlantis, we support hundreds of thousands of patients, and receive letters of thanks from the individuals on our programmes on a daily basis. Among many things, our clinical team, comprising health psychologists and registered nurses, coach patients on how to self-inject to manage diabetes and osteoporosis, assist them in coping with diagnoses of cancer and MS, and encourage them to persist with injections into their eyes to save their sight. Support for their families and carers (with patient consent) are also available. We work in partnership with healthcare professionals and complement the role of doctors, while providing additional services such as SMS reminders and smartphone apps.

Giving patients access to the support they need is a concern that the wider healthcare industry must address before better population health outcomes can be realised. And let’s also not forget that improving medicines adherence saves the taxpayer countless millions of dollars.

Disclosure of Interest• Atlantis Healthcare manages more than 80 patient support

programmes worldwide. • Professor Keith Petrie is a global authority on non-adherence

and consults to Atlantis Healthcare.

References1. World Health Organization. Retrieved from http://www.who.

int/chp/knowledge/publications/adherence_report/en/2. Cap Gemini (2011). Patient Adherence, the next frontier in

patient care.3. Cap Gemini (2011). Patient Adherence, the next frontier in

patient care.

As Director of Strategy for Atlantis, Michael leads the new business and strategy function for the Australian market, while tapping into the global network and Atlantis Research Institute to deliver best practice adherence solutions. He has 15 years of experience

in advertising and professional communications; comprising healthcare, consumer and digital agency leadership roles.Email: [email protected]





Close To you, More than Ever… Near Field Communication, or NFCThe Buzz“Carrying a mobile phone has become almost as common as carrying a wallet,” said Scott McElroy, Vice President Technology Realization for Cingular Wireless. “NFC will continue to help us learn more about how customers will want to use their phones as part of their real-world transaction process.”

“NFC offers Citi customers a new payment experience and, in fact, the first step in the convergence of the wallet with the mobile phone,” said Ed Garofalo, Executive Vice President, Citi Cards.

“Most people have their mobile phone with them wherever they go to stay in touch. The simplicity of conducting everyday transactions, such as low cost purchases with their phone, adds high value and convenience for consumers,”said Dieter May, Vice President and Head of Nokia Emerging Business Unit.

“The selected hotel guests receive a mobile phone with NFC and relevant software. They book hotel rooms the usual way and receive booking confirmation on the mobile phone. The guests can check in on the mobile phone already before arrival at the hotel. When check-in is complete, a digital hotel room key is delivered to the mobile phone. On arrival at the hotel the guests skip the check-in line, go directly to their room and open the door by holding the mobile phone close to the door lock. When leaving the room, the doors lock automatically, the guests checkout from their mobile phones and the digital hotel room keys are deactivated.”

The EssenceNFC, short for Near Field Communication, is a very short range radio technology that makes use of interacting two electromagnetic fields, meaning data transmission is limited to interaction of two NFC-enabled devices, based on inductive-coupling. This is unique among radio communication devices because it guarantees a limited, well defined range of data communication enabling applications where a physical touch (or bringing close to each other) of the two devices is required, in order to maintain security.

NFC is the brainchild of the former Royal Philips Semiconductors (at present NXP) and Sony, both founding fathers of the NFC forum established in 2003. In the meantime more than 50 companies have joined this association, so that it is one of the most comprehensive technology-driven organisations in the electronic industry.

NFC devices share the basic technology with proximity (13.56MHz) RFID tags (Radio Frequency IDentification) and contactless smartcards, which we all know from contactless credit cards, smart passports or from the smartcards you get in hotels to enter your room, used on a daily basis by millions of people worldwide. The NFC standards determine not only the “contactless” operating environment, such as the physical requirements of the antennas, but also the format of the data, the protocol to be transferred, and the data rates for that transfer.

NFC is planned for use in mobile phones for, among other things, secure payment, in conjunction with an electronic wallet, ticketing, and for instance for setting up connections between Bluetooth devices (rendering the current manual Bluetooth pairing process obsolete) – but there are hundreds of other conceivable applications which we will explain later in this article.

NFC standards are acknowledged by ISO/IEC (International Organisation for Standardisation / International Electrotechnical Commission), ETSI (European Telecommunications Standards Institute), and ECMA (European Association for Standardising Information and Communication Systems).

The Founding Fathers“Philips is already the global industry leader in contactless smartcards through its Philips MifareTM technology, supplying some of the world’s major transport systems, and the banking sector, with supply to customers such as Visa. Sony has a significant market position in Hong Kong and Shenzhen (China), Singapore and Japan utilising Sony’s FeliCaTM contactless smartcard technology, mainly in the transportation and financial sectors. As nFC is fully operable on both platforms, all consumer devices containing NFC technology will be compatible.“Philips and Sony will promote the NFC technology as an open standard in order to integrate it into consumer devices, including those of other manufacturers in the CE, PC, automotive, and other industries. The companies intend to explore new applications together with relevant content and network service providers.”

The Tech (Tag) StoryNFC data transmission is measured in kilobits per second (kbps). The NFC standard supports varying data rates, to ensure interoperability between pre-existing infrastructures. The current data rates are 106kbps, 212kbps, and 424kbps.

The main difference between an NFC-enabled device and a simple RFID tag is that an NFC device can operate in reader/writer and peer-to-peer mode, and may operate in card emulation mode. An RFID or NFC tag is typically a passive device (for example, integrated in a smart poster) that stores data that can be read by an NFC-enabled device.• In reader/writer mode, the NFC device is capable of reading

NFC forum-mandated tag types, such as in the scenario of reading an NFC smart poster tag. The reader/writer mode on the RF interface is compliant to the ISO 14443 Mifare and FeliCa schemes.

• In peer-to-peer mode, two NFC devices can exchange data. For example, you can share and exchange data such as virtual business cards or digital photos. Peer-to-peer mode is standardised on the ISO/IEC 18092 standard.

• In card emulation mode, the NFC device appears to an external reader much the same as a traditional contactless smart card. This enables contactless payments and

ticketing by NFC devices without changing the existing infrastructure.

NFC technology provides simplicity and ease of use. Users hold NFC-enabled devices together to access services, interact with content, set up connections, make a payment, or present a ticket. Many corporations use contactless ID cards to control access to their facilities and networks. NFC can reduce the cost of card issuance and management just by downloading an authorisation code in the employee’s or visitor’s mobile phone.

From a commercial perspective, NFC technology makes sense for service providers and device manufacturers for many reasons.• Reduced cost of electronic issuance. Multi-issue ticketing

operators, like mass transport operators or event ticketing operators, see phenomenal cost reductions in electronic ticketing. Security-sensitive airlines have already moved to “e-ticketing” in order to reduce costs.

• Increased revenue from interactive services. Mobile network operators and content providers earn revenue when users choose to use value-added services. NFC surrounds the user with advertisements and valuable information within easy reach.

• nFC-enabled devices drive consumption of rich media content. NFC will fuel the market for advanced personal devices that consumers use to purchase, play, store, and share rich media content.

• Consumer preference for nFC-enabled services. Users may have no choice about which ticket they use for a service, but they typically can choose how they pay. Convenience is a strong differentiator, and more convenient payment will drive adoption of contactless and NFC technology.

The good Old Values, and Some Quite new …NFC is based on existing contactless infrastructure around the world that is already in use by millions of people on a daily basis. NFC is not a fashionable nice-to-have technology, but actually a technology that makes peoples’ lives easier – easier to pay for goods and services, easier to use public transport, and easier to share data between devices.

At the heart of NFC’s benefits is its simplicity of use – bringing two objects together is intuitive for everyone, young or old. NFC is building on existing systems and human actions, so it has a very good chance of being valued and used for many years to come. Analysts have provided various market projections. Jupiter Research has projected that up to 700 million NFC-enabled mobile phones will be sold by 2013, representing up to 25 per cent of the market at that time (November 2008). Jupiter Research has also projected (September 2009).that NFC mobile payments will exceed $30bn by 2012. Mifare and FeliCa, which are similar passive mode contactless technologies, have already been implemented with payment as a primary application and are used in many other applications where NFC will take over.

The RFID and nFC Identity: Matchable?Since NFC is based on the same technology, it is easy to

mistake it for RFID. It takes the same type of chip and bumps

it up a notch by adding computing power. That’s why putting it on a phone is so critical; NFC not only needs the proper hardware (an antenna and controller, both shown below) but the right software (OS platform support, apps, etc) as well.Google Wallet is a prime example of blending hardware and software together. The Wallet is an Android APP (available on Nexus S phones at first) that will store virtual versions of your credit cards, gift cards, and coupons. Go into the app, punch your PIN code in, and you’ll be able to tap your phone onto the merchant’s pay-station to checkout and purchase stuff. But this app wouldn’t do a thing if the Nexus S didn’t have an NFC chip already built in.

As highlighted earlier, mobile payments are just the tip of the NFC iceberg. There are virtually limitless applications and uses that could be developed for it, and here are some that are in the works (if not already out and ready to go):

• Monitor your medicine intake and other e-health applications

• Mobile tickets for trains/planes/mass transit • Unlock doors: hotel rooms, cars, etc.• Pair bluetooth devices by tapping on your phone• Log onto WiFi networks• Check-ins: Foursquare, Latitude, etc.• Initiate a video chat or join a conference call• Share files between phones: music, docs, photos• Store mobile “punch cards” for restaurants• Replace grocery store value cards with mobile coupons

Now, it may go without saying that both devices will need to have NFC chips and antennas installed already, but what if your handheld device doesn’t have one? In the US, that means anybody that doesn’t own a Samsung Nexus S or Nokia’s N9, N700 or 601 – at least, those are your only choices at this particular moment of time. However there are a few external methods you can employ:

NFC-enabled SIM cards and MicroSD have been developed that would allow the same kinds of contactless pay on your NFC-less phone. The only negative aspect factored into this method is the idea that these chips are lying underneath

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multiple layers of metal and plastic, which could downgrade the quality of the antenna’s signal.

Over the coming years, a much heavier emphasis will likely be placed on NFC adoption. Several analysts have estimated how many phones will ship with this capability by 2015, all indicating an explosion of growth in NFC use; the chart below takes a look at one such forecast, courtesy of iSuppli.

According to the estimates, over 30 per cent of all phones globally will have NFC built in within the next four years.

The Major LeaguesMajor Players in the NFC world are NXP, the chip manufacturer, and Sony, together setting up the NFC forum, the open association to realise a standard for this technology. The major players in the consumer market are:

nokia – Nokia began incorporating NFC into a few of its phones a few years ago. The only one that hit any sort of stride in Europe and the US was the 6131. However all new smartphone devices brought out over the last few months, and the devices announced, all incorporate the NXP PN544 NFC chip. It’s hard to imagine NFC really picking up steam without Nokia’s involvement.

google – By adding NXP’s NFC hardware to its Nexus S and software into Gingerbread, Google laid the foundation to its new empire of mobile payments and other potential applications. It found traction by signing critical deals with MasterCard, Subway, Macy’s, and several other vendors, and announced Wallet (presumably in anticipation of any possible Apple announcement). The company helped NFC move forward a great deal by giving it plenty of needed exposure.

ISIS – As a joint venture by AT&T, Verizon Wireless and T-Mobile, ISIS aims to integrate contactless pay and interactive coupons into your phone. The company is reportedly working to partner with Visa and MasterCard for now, and the system will be trialled in the summer of 2012 on the Utah Transit Authority in Salt Lake City. ISIS could easily be influential due to the support it has from three out of the four national US carriers.

MasterCard – MasterCard is one of the pioneers of mobile payments, and was instrumental in setting up a thriving

infrastructure with Paypass. Enough time has passed for consumers to become accustomed to the concept of contactless pay, and the costs of setting it up on our phones are a lot lower thanks to existing infrastructure. Certainly having the buy-in from Google and ISIS will be extremely beneficial to continue growing at a faster rate.

Visa – Visa has already been hard at work rolling out its mobile payment system worldwide, but Samsung has partnered up with the company to get London hooked up for the 2012 Olympics. An Olympic and Paralympic Games mobile handset will be available complete with a Visa-enabled SIM card. The idea is so crazy it might just work -- so long as the handset is offered at an affordable price, that is. International travellers will rely mainly on prepaid SIM cards to communicate during their Olympic visit, and we think having an inexpensive phone to go along with that SIM is a no-brainer. So, why not add NFC to the handset and let your new visitors take it for a spin?

These are just a few of the companies working together to make mobile commerce real. As a result of their hard work, millions upon millions of handsets will start shipping with NFC-enabled chipsets over the next year. But just as we see happen with any blossoming technology, there’s bound to be some concerns along the way.

Naturally, most people have a difficult time coming to terms with leaving their wallets at home; it is a huge risk to rely solely on our electronic devices. Glitch hardware or software can cause your phone to crash, and at one time or another we’ve all probably experienced a panic attack as our battery dies. Nobody will leave home without a backup, and no merchant will ditch plastic altogether, either. Most businesses still take cheques and cash, after all. We have difficulty swallowing the mantra of “keep your wallet at home,” since we’re going to need our photo ID, licenses, permits, or other random rubbish we fill them with. And so what if it takes an extra ten seconds to open our wallet, take a card, and swipe through the machine?

Over the years ...

The History of RFID, nFC’s Parent Technology

1940-1950World War II: Secret development of practical RADAR by several nations1940: Term RADAR coined by the US Navy (RAdio Detection And Ranging)1948: Invention of RFID by Harry Stockman in his paper “Communication by Means of Reflected Power”. Stockman’s vision was before its time – before the invention of the transistor (1950s), the integrated circuit (late 1950s) and the microprocessor (1970s).

1950-1960R&D exploration of RFID technology

1960-1970Development of RFID theory. Emergence of RFID applications. Late 1960s: first and most widespread use of


Modern Technology


RFID by the Electronic Article Surveillance (EAS), which was used to prevent shoplifting or book theft from the library.

1970-1980Flurry of interest into RFID from inventors, companies, academia and government labs. Early adopter implementations of RFID: Los Alamos Scientific Laboratory, Northwestern University, the Microwave Institute Foundation in Sweden, Raytheon, RCA, General Electric.

1980-1990Mainstream commercial RFID applications, especially in transportation and tolls, animal tagging, and personal access. 1987: Norway tests RFID toll collection.1989: Dallas North Turnpike and the Lincoln Tunnel (between New York and New Jersey) test RFID toll collection.

1990-2000Standardisation by the International Organization for Standardization (ISO). RFID widely deployed. 1991: first open highway electronic tolling system opens in Oklahoma. ©2011 Omosola Odetunde, Nadja Rhodes, Levert Griffin III, www-cs-faculty.stanford.edu/~eroberts/cs181/projects/2010-11/NFCChips/rfid.html

2005 First ever RFID application in medication blister packaging to objectively measure patient therapy adherence, Diovan160™, Novartis Pharmaceuticals, The Netherlands, based on the invention (patent) of Jos Geboers and Willem Kort.

List of nFC-Enabled Mobile Phones:• Google Nexus S, Android 2.3• Samsung Nexus S 4G, Android 4.0• Samsung Galaxy S II Android 2.3• BlackBerry Bold 9900 and 9930, RIM• Nokia C7 Symbian Belle• Nokia Astound• Nokia N9 MeeG• Nokia 603 Symbian Belle• Nokia 700• Nokia 701• Nokia 600• HTC Ruby ( HTC Amaze 4G) Android• Sonim XP1301 Core NFC• Samsung Wave 578 Bada • LG T530 (LG Ego) Android 2.3• Mobiwire Cosyphone • Samsung S5230 NFC, (GT-5230N)• Samsung S5260 NFC• Huawei Sonic Android• Samsung SHW-A170K• Hedy • Shanghai Simcom • Motorola MC75A HF Coming soon (Q4 - 2011)• Samsung Galaxy Nexus

• Microsoft’s Windows Phone • HTC • LG• Motorola• Sony Ericsson • BlackBerry Curve 9350• BlackBerry Curve 9360• BlackBerry Curve 9370• Samsung Wave M and Wave Y Bada 2.0• Acer E320 Liquid Express Android• LG LU6200 Android• Samsung SHV-E120L • LG LU6200• Nokia Oro• Nokia N5 Symbian• LG Optimus Net Android • Sony Ericsson Xperia Android• ZTE QSC6270• Fonelabs X-Series X1 and X2• Toshiba TG01Source : NFC world 10 November 2011For the article, sources have been

cited i.e. NFC Forum, NFC Times, The Internet, NXP, NFC World

Jos Geboers graduated as an Electronic Engineer in Eindhoven in 1972, after which he took up a position with Philips Research Netherlands, where he worked for a number of years on the research and development of semiconductors. In 1978 he joined the Philips Semiconductors

division (now NXP) where he was involved in the design of integrated circuits for applications in telecommunications, rising to the position of Application Manager for Telecommunication ICs in the Asian Pacific region before his departure in 1994. He then founded ECCT BV in Eindhoven. ECCT is a company which specialises in the development of telecommunication equipment, Near Field Communication (NFC) and medical consumer electronic devices. In his capacity as Chief Technology Officer he leads a team of engineers in the design of innovative products and systems used in the medical application areas. Therefore he co-founded The Compliers Group BV in 2005 which is a company dedicated to the development and marketing of consumer medical devices for use in objective therapy compliance measurements. In 2011 he co-founded Confrérie Clinique S.A./B.V. which is a company specialising in patient vigilance systems such as electronic leaflets and diaries, compliance and temperature monitoring and serialisation of medication, as well as cold chain management systems.Email: [email protected]

Willem Kort is a contributing editor of the “Journal for Patient Compliance”. Willem is Jos Geboers’ co-equipper, and co-founder of both The Compliers Group and Confrérie Clinique. Both Jos and Willem invented and patented OtCM™, and in 2011 the next generation of MEDICCINE™

and MEDICCINET™ technology for patient vigilance, serialisation (authentication) and cold chain management, T-sensoring. Email: [email protected]



Industry-Suitable Technologies for Protection of Pharma Products against CounterfeitingWith the new European directive 2011/62/EU¹ concerning prevention of the entry of falsified medicinal products into the legal supply chain, it appears clear that patient safety will be achieved with the combination of three components:- Verification of the authenticity of the medicinal product,- Identification of individual packs,- Verification of the outer packaging to uncover any

tampering.This series of measures to increase patient safety shall come into force by January 2013 in the member states.There are several estimations as to how much these measures will cost the pharmaceutical industry to comply with this directive. This paper concentrates on the authentication features and the way they can be implemented within the manufacturing plants of the pharmaceutical laboratories.

authentication and IdentificationSome papers and conferences have reported that identification of individual packs can be used to show up counterfeiting. More and more experts, however, have doubts, because a serial number which is visible can be copied by counterfeiters². Banknotes have been an example of serialised items for decades but are still heavily counterfeited. Even if the packaging or dose of a medicine will never be comparable to a banknote from the cost of authentication features point of view, there is some banknote expertise that can be used in authentication of medicine.

Visible (Overt) or Invisible to the naked Eye (Covert) Security FeaturesMany pharmaceutical companies have added visible security features to their packaging to prevent counterfeiting (Fig. 1). These include, for example, holograms, kinegrams, embossing, micro-printing, moiré or special ink such as optical variable ink. However, these visible features provide not only minimal security; they also require training for effective authentication. A side-effect is that if a visible security feature is introduced, it is difficult to later abandon it because consumers may consider the genuine production

to be a fake, through not seeing the overt security feature anymore.

Counterfeiters today have availability of the best printing equipment and components to replicate perfectly the visible aspect of a packaging, including visible authentication features. The use of “covert” features - invisible to the naked eye – will produce a higher level of protection, due to the inability of counterfeiters to identify the presence of such features. In the case of “good” banknote counterfeits, they always show a replication of the visible security features, but not the invisible ones which are difficult to counterfeit. Covert security should never be disclosed; to prevent leaks it should only be known to a limited number of trustworthy persons.

It is generally admitted in anti-counterfeiting literature that covert features need a dedicated scanner or analysis process to show up the presence of these features, making a “genuine-or-fake” verification a quite expensive and time-consuming process. However, as in other industries, the digital or software revolution opens up exciting new possibilities, such as, for example, the Cryptoglyph® on-packaging³ (folding boxes, blister packs, labels) invisible protection achieved with application of normal visible ink or varnish (Fig. 2). This security feature only requires a simple off-the-shelf office flatbed scanner to perform a “genuine-or-fake” verification. In this case, the covert feature scanner can be purchased on the consumer electronics market anywhere, while proprietary hardware is the rule when security substances, taggants or dedicated invisible optical effects are used.

Replacing security consumables with software also has considerable impact on the cost of implementing an anti-counterfeiting programme worldwide for multiple brands and production plants. For example, when using security consumables it is necessary to dispatch these features to the various production plants in proportion to the quantity of packaging elements to be produced, plus an extra percentage for overproduction. This requires careful management of the shipment of these security features in order to prevent theft during transportation and misuse of the overproduction, which otherwise could be used for production of counterfeits

Figure 1: overt security features: examples of holographic marking Figure 2: covert security: example Cryptoglyph® invisible marking on the entire surface of a packaging including in the blank areas

Drug Delivery, Drug Packaging, Labelling & Dispensing


containing genuine security elements. The use of security components can also affect the packaging printing equipment if special ink is used or if extra features such as hologram or taggant are included in the production run. On the contrary, digital security features using normal ink will not alter any printing processes or their production speed; this is an important cost-saving factor.

Human Sensory Perception-based or Machine-based “genuine-or-Fake” VerificationOn selection of a security feature, it is not enough to just evaluate the purchase cost, the robustness against fraudulent replication, the cost of implementation in the production process, the cost of global management or any impact on the production process. An important part of the evaluation is how a “genuine-or-fake” verification is performed.

In this case, the various anti-counterfeiting features can be placed in two main categories:- features which use human sensory perception;- features which are machine-readable.

If human sensory perception is used (visual, tactile, oral), adequate training is required for a person to be able to distinguish a genuine security feature from a fake replication when both are in hand. Meanwhile, in the case of a machine-readable feature, only a step-by-step process is required. When well documented, it can be performed by anyone without any specific knowledge or training.

There are some solutions which combine a human visual decision and a device such as the Raman spectroscopy analyser capable of analysing the chemical components of a tablet and comparing it with the results of analysis of genuine production stored in the device. Such an analyser may cost thousands of Euros, and specific knowledge will be required for its correct operation. Generally only a few analysers are available in the company, requiring shipment of the suspected tablets to a specialised laboratory.

Other visual inspection may be directed to details of the packaging related to its shape or details in the printing that counterfeiters may not have identified. It follows that a discrepancy between a genuine pack and a counterfeit, identified with the help of a detailed description, which might be provided by an online database, can lead to discovery of counterfeits until the counterfeiters find the remedy for such discrepancies.

However, an important question is the cost related to the whole process carried out to perform the machine-readable “genuine-or-fake” verification. Again here the Cryptoglyph® on-packaging digital solution requires only off-the-shelf office scanners to take a picture of part of the packaging component (folding box, blister pack or label). This device could already be in place for other purposes; if not, its purchase would cost about 100 US dollars on the open consumer electronics market anywhere in the world (Fig. 3).

Local or Remote Verification ProcessesIn order to carry out a “genuine-or-fake” verification, we have to consider either a local process with everything available locally, or remote identification via an online server. Local verification could be seen as a plus through not requiring any

data connection. However, for covert security it is important to ensure that the equipment in hand does not contain sensitive security elements which could fall into the hands

of counterfeiters who have been able to acquire or steal such equipment. If the pharmaceutical products manufacturer needs to carry out verification in multiple locations, it will have a need for a corresponding number of pieces of equipment as well as provision of training, maintenance and calibration on site. This cost should not be neglected, taking into account the turnover of employees and possible updates or renewal of the equipment.

Internet and mobile connections are today widely available around the world, developing countries included. A security feature enabling “genuine-or-fake” verifications to be carried out remotely via a central secured server results in an almost instant verdict. This constitutes a major benefit, eliminating the need for sensitive security elements to be in the hands of an operator. Another major benefit of remote verification is the consolidation of all the verifications performed worldwide, thus facilitating the detection of any correlation between various fraudulent sources within the supply chain. As for all criminal acts, the quicker you uncover them the more you are well positioned to identify the criminal source and to stop it.

Security Level and Protection against LeaksA recent report4 shows that organised crime is active in counterfeit medicine, as this represents a very lucrative and a less risky criminal business compared to others. One can therefore estimate that corruption and coercion could be used to benefit from leaks related to security elements or programmes. An important criterion is to see how many people and companies are necessary to be involved in the security chain. It is easy to understand that the fewer people involved in critical security elements and the lower the

Figure 3: genuine-or-Fake” verification using a simple office scanner

Drug Delivery, Drug Packaging, Labelling & Dispensing


number of suppliers, the better the possibility of limiting leaks. When consumable security elements are used, the suppliers of these elements are part of the security chain on a recurrent basis. Delivery of these elements will also expose the recipient company to theft or misuse of the overproduction necessary in the manufacture of the security packaging, as mentioned earlier in this paper.

Web-based Secured Server Solutions There are two fundamental ways in which web servers can be used. The first approach consists of using the server as a data repository system in order to know what different anti-counterfeiting features are deployed for a given packaging or production batch. For example, the IPM system (Interface Public-Members of the World Customs Organization system) contains such information delivered and maintained by the branded product manufacturers. This information is available for use by customs officers to detect counterfeits at customs clearance of imported goods.

The second approach uses the secured server to analyse different parameters of a packaging in order to assess its authenticity automatically. For instance the AlpVision Krypsos5 server is able to process a picture of a packaging component (folding box, blister pack, label, flip-off top, part of a vial, etc.) and detect if it is authentic (Fig. 4).

If the secured server is able to also manage the anti-counterfeiting features deployment, and if these features are digital elements, there is no additional security supplier involved in the security chain. The branded pharmaceutical products manufacturer has full control over the generation of the digital security elements and can allocate individual authorisation via password and profile for online automated “genuine-or-fake” verification worldwide.

Such a centralised secured server could be the best solution

for protection against leaks, especially if very few high-level employees are entitled to access critical security elements such as encryption key or generation of security patterns. The digital security elements are then digitally routed via encrypted and secured data networks to local markets and the corresponding production plants.

The cost of such a solution is related to software licenses and software customisation for the deployment of the application within an existing Information technology environment. Royalties for use of the digital security feature have also to be considered. If the web-based system is well conceived, no software beyond a free internet browser should be necessary at the user level. This also avoids a complex computer validation process in place in every large organisation when new pieces of software are to be implemented on each local PC, and affecting medicinal products.

In RésuméCovert (invisible to the naked eye) security is providing higher security compared to overt (visible) security. Digital solutions based on software are easier to deploy compared to solutions based on security consumables. Machine-readable security features are more reliable for authentication of genuine or fake items compared to human sensory-based features; because no specific knowledge is required beyond the capability to follow a step-by-step process that, if well described, could be performed by anyone. Remote online verification using an internet web application needs only a free internet browser at the user level; it does not require specific coding at the verification side. It will limit the risk of leaks, especially if very few people are involved in managing the sensitive security data elements. Digital solutions for product authentication based on software are less costly compared to security consumable-based solutions, especially when large production volumes are considered.

References1 Directive 2011/62/EU of the European Parliament and of the

Council of 8 June 2011 (54 –o)2 International Pharmaceutical Industry, August 2011,

volume 3 issue 3, “Should we Leave it to Patients to Identify Counterfeit Medicines?”

3 Cryptoglyph digital security solution, www.alpvision.com/cryptoglyph-covert-marking.html

4 FDA Conducts Preliminary Review of Agency’s Diversion and Counterfeit Criminal Case Information September 2011.

5 Krypsos Web Application, www.alpvision.com/krypsos-online-authentication.html

Dr. Jordan is co-founder of AlpVision and has served as CEO since June 2001. He is the author of numerous publications and patents and co-inventor of Cryptoglyph and Fingerprint, the core technologies currently being used by AlpVision. Dr. Jordan has work experience in the USA

and France. In 1999 he obtained his PhD title from the “Ecole Polytechnique Fédérale de Lausanne (EPFL)” Signal Processing Institute (ITS). Email: [email protected]

Figure 4: Web application (example krypsos ) snapshot showing the various functionalities available depending on the password and the profile of each authorised user

Interview


The Past, Present and Future of adherence An Interview with Professors Weinman and Petrie brought to you by Mark Barker – Editor of The Journal For Patient Compliance in association with Atlantis Healthcare

Two of the most prominent researchers in medication adherence are Prof John Weinman from Kings College London, and Prof Keith Petrie from the University of Auckland. Their research has greatly increased our understanding of the factors affecting patient behaviour and the ways in which adherence to prescribed medication can be improved. We asked them both how our understanding of treatment adherence has developed, where we are at today, and where they see the field going over the next five years.

The last few decades have seen great advances in the development of effective treatments for a wide range of medical conditions. Generally, these advancements have arisen from the study of the patient as a biological organism, with physiology and biochemistry providing the main objectives and tools for improving health outcomes.

But increasingly, the behaviour of the patient is being recognised as an important factor influencing health. The way patients take their prescribed medications is an important behavioural consideration that can affect patient health outcomes. The desired benefits of a medication are unlikely to be realised if it isn’t taken in accordance with the prescriber’s recommendations.

Mark Barker: How long have we known that non-adherence is a problem in healthcare?Prof John Weinman: Oh, we’ve known for many, many years. There have been studies that go back forty, fifty years that show that patients don’t take treatment as prescribed. The work really gathered momentum in the 1980s and 1990s. People started to do reviews [of the research], looking at the extent of the problem, realising finally that the problem was huge. And the interesting thing was that the reviews showed that the problem was right across all clinical domains. I think, in the past people had thought it might just be a problem for treatments that didn’t really matter. I think what the emerging evidence over the last twenty or thirty years showed is that the problem goes right across all treatments and all conditions, including really serious conditions, where non-adherence [poses] a huge risk.

Mark Barker: So obviously it is a huge problem. But does it really matter if patients don’t follow treatment recommendations? Does it affect the patient’s health?Prof John Weinman: It matters hugely. Some people have said this, that there is no relation between adherence and outcome. In fact, there are now many really good studies that show that there is a very clear relationship between adherence and medical outcome for the patients.

And there are a number of reasons for this. If the treatment is an evidence-based treatment, it has been shown to be effective in clinical trials. If you [don’t] take it, you’re [not] going to get the clinical benefit. There is a very famous saying, “the treatments don’t work if the patients don’t take them”. The relationship between adherence and outcome is clear but it’s not a one-to-one relationship. Part of this [better outcomes found with adherent patients] is due to taking the medication. But also, without a doubt, part of the improvement is due to the fact that people who are adherent are probably more interested in healthcare and so on. The patient who adheres is probably gaining all sorts of health benefits not just from the treatment but also from their attention to looking after their health in other ways. But overall, looking at [studies of] the relationship [between adherence and treatment outcome], there is always a consistent correlation between whether you take the treatment and the clinical outcome.

Mark Barker: What have been the key developments in research and theory that have led to our present understanding of the adherence problem?Prof John Weinman: I think there are a number, really. One is that the methods for studying adherence have improved. There are still problems in how we actually measure adherence, but there are technological and other developments that allow us to get more precise estimates of the adherence problem.

In terms of changes in our understanding of what is actually going on and in our developments of theory, there has been a move away, very strongly, from the idea that adherence is just a problem for certain sorts of patients or

Interview


in certain sorts of diseases. We now know that more or less every patient, across diseases, will be non-adherent at some point. Non-adherence can occur with anybody.

A third important development is the realisation that non-adherence is not a single thing. It’s actually driven by a number of factors. Usually we make a distinction between what we call intentional non-adherence and unintentional non-adherence. We know that unintentional non-adherence is based very much on the patient’s understanding – or perhaps failure to understand - or the patient’s lack of skill, or problems such as memory or planning ability. That accounts for a certain proportion of adherence.

The perhaps more profound aspect of non-adherence, that I think people have gradually come to realise much more over the years, is the so-called intentional non-adherence. Here the patients know what to do. They have no memory problems or planning problems. But they have made a decision that they don’t want to take this treatment in [the prescribed] way, or not at all, or they are only going to take it partially. We now know that this is very much a motivational factor and [their decision is] based on their own beliefs and understanding of what they think their condition is, or on what they think the treatment is or isn’t doing to them.

Really, that [finding has] been particularly important. Because that’s the more profound aspect to non-adherence and now we know that we need to develop interventions to target both types of non-adherence.

Mark Barker: Professor Petrie, what can we do to improve patients’ adherence?Prof keith Petrie: I think that’s the biggest question in the field at the moment - what are the effective interventions that can make a difference, so we can get people to adhere more? I think that there are a number of things that can be done. [The most basic things] are making sure the person understands the treatment, and making sure the treatment is delivered in the simplest ways so it’s not complicated for the patient to take and to know what to do, and so forth.

Regarding the point that John was making before, about patients deciding not to adhere to treatment; really, to make any inroads into that, you have to change beliefs. Firstly, you have to identify what beliefs a patient has got about the treatment that they’re taking and then target those beliefs and [influence] them in a direction that’s more consistent with adherent behaviour. To do that so you can make a difference to that particular person really involves personalising the interventions around the patient themselves, so the intervention makes sense to the person you’re targeting. And that does take a bit of work because you have to analyse or understand how the patient is seeing their illness and also understand how the patient is seeing their treatment, then identify those beliefs that are not helpful and target those in particular. That, I think, is probably the biggest area that people can focus on in the [adherence] field at the moment.

Mark Barker: And finally, looking to the future, what are some of the new developments to improve adherence? What’s on the horizon?Prof keith Petrie: Well I think the biggest area of change is technology. Technology gives us the opportunity to monitor

how patients are doing with their treatment, to let us know whether they are taking it and so forth. But it also, interestingly enough, gives us the opportunity to reach out and touch the person directly and to change or modify some of those beliefs that they have. Things like smartphones offer us an opportunity to deliver information and messages to patients in a way we couldn’t do before. We can also use technology such as iPads and tablet technology to show people in an interactive and visual way what’s actually happening in their body when they take medication or why a particular disease process works so that people can develop a much more concrete understanding of the treatment itself.

I think there are some other areas that are going to be important in the future, and are already important to some degree, but interventions along these lines haven’t been developed yet. One is dealing with patient side-effects.

Side-effects are a big area in adherence because they are a very big reason for people to stop treatment or to modify their treatment or to go onto other types of treatment. So, making people able to deal more effectively with the side-effects they get. Preparing them for the types of side-effects and building up their confidence about dealing with those side-effects is also a major area.

A lot of the treatments now are not just delivered by a tablet – there are also infusions and all sorts of other modes of treatment that people have to deal with. So we have to be reasonably creative about how we equip patients to deal with those problems, including, of course, changing patient beliefs about them.

Really, the challenge for the [adherence research] field is that it is critical that we develop new ways of doing this that are effective, economic and scalable.

Professor Weinman consults to Atlantis Healthcare as the Head of Health Psychology for Europe and is the HOD for Health Psychology at Kings College, London, UK. He was recently awarded an Honorary Fellowship of the British Psychological Society for his major

role in the development of academic and professional health psychology in the UK. He is recognised as one of the world’s leading academics on the subject and has inspired a generation of health psychologists as well as influencing the thinking and practice of healthcare professionals.

Keith Petrie is a Professor of Health Psychology at the University of Auckland Medical School. Professor Petrie’s work in this area has been published in major international medical and psychology journals. His recent awards include a Fulbright Senior Fellowship to

Harvard Medical School, a Lifetime Achievement Award from the International Association of Applied Psychology and the Gluckman Medal for research excellence.

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