Medication adherence is ultimately a human behavior. As such it is complex, but many complex human behaviors can become simplified, routine and based on habit rather than on cognitive level executive functioning, if they can be broken down to the component actions.

It seems to me that the opportunity for connected care technologies would be to move what is normally considered a cognitive level activity, such as "deciding" to take my medication, to a behavior that is rote or habitual and daily. We know for example that simply moving medications to first thing in the day helps improve compliance. We know that moving from twice a day to once a day improves compliance. On the flip-side, we know that human behaviors can change when motivation is applied (extrensic and/or intrensic), when personal "value" is created by the new behavior, when it becomes a part of a daily routine that requires a minimum level of time and effort to achieve the value.

Engaging patients in their self-care using connected care technologies will require the following attributes: 1) break down complex human actions into simple component steps; 2) demonstrate personal value to the patient, both for using the technologies and for adopting the desired behavior, in this case taking medications; 3) leverage or enhance motivation through appropriate positive and negative feedback loops; and 4) be designed for use DAILY with minimal time and effort. The keys to success, though, are around the human-technology interface and workflows. Technology alone will not solve this complex human behavioral challenge.

Unfortunately, I cannot agree with the premise that patient self-reported data are intrinsically flawed. To the contrary, patient self-reported medication adherence questionnaires are well-validated in the peer-reviewed literature. Our own experience with connected health technologies in chronic care populations demonstrates clear differences between self-reports using diaries filled out for drug trials, which are often done just before they are due, and the use of daily self-reporting through computerized surrogate technology. The latter approach has proven to be both RELIABLE and ACCURATE, and benefits from the human behavior of engraining habit.

One question that might be added to the list proposed, is whether medication adherence technology and solutions should be "stand alone" offerings, or might have the best impact when part of a more comprehensive self-care support system.

My first reaction to Randall's opinion is that adherence is indeed more complex. The assumption that patients will do their best to take their medications and report their behaviour accurately is massive. The reality is that patients often choose not to adhere - peer advice, fear of side-effects, belief in life-style changes, herbal remedies, magnetism, whatever. When challenged, many patients tell the doctor or pharmacist or concerned relation what they think that person wants to hear - not necessarily what they are doing.

What amazed me most when I entered this field is that even patients with life threatening conditions do not adhere to medication.

Providing reminder systems only addresses a small part of the problem. Having an alarm clock next to your bed is no guarantee that you are actually going to get up.

The new technologies promise a much closer relationship between the individual and his/her physician. The health care provider and carer actually see if and when a pill is popped from a blister pack. This is a big change from the current situation in which the provider only becomes aware of an adherence problem when a prescription is not renewed, the patient admits non-adherence during the next surgery or out-patient visit, or even worse, the patient is taken into hospital or care home.

Having an early indication of non-adherence provides an opportunity for intervention. At the very least the health care provider can discuss the situation with a patient and give appropriate advice. Studies show that many patients do not even understand why they have been given a prescription and why it is important to take the medication. Early intervention can help educate the patient and prevent many problems.

Shanta raises two challenging questions:
- how will patients react to being monitored? Will it be perceived as a welcome extra attention - having the doctor around 24/7 - or as an unwelcome intrusion into personal privacy.
- how will doctors cope with all this extra information? Where are the systems and processes to filter out all the noise? Will they get paid for making an intervention call, even if it prevents a hospital or care home admission.

I do not see a "one size fits all" solution. Patients are individuals, and even if you segment them into groups such as "the worried well" and "the ostrich". you still have several categories. We need to start thinking about "Connected Health" in the same way as any other consumer marketing challenge. Start with the early adopters, people who will show the way to the others.

Payers need to rethink their strategies and, as Aneurin Bevan said when he started the NHS, stuff the appropriate mouths with gold (as well as investing in systems and processes). The return for the payers should make this easily affordable - currently with non-adherence, 50% of the pharmaceutical bill is wasted and adherence related hospital admission are said to be approaching 20%, while care home admissions are much higher.

Nearly one year ago I was fortunate to sit in on a Center for Connected Healthcare session where Alice Watson M.D. presented several systems addressing the challenge of tracking meds for the elderly. This session was very interesting and inspired me to keep informed in this field as much as possible.
The technologies deployed at that time centered on automated dispensers, and turning a ball different colors to signify if a med was dispensed or not. None of the approaches seemed to provide a high level of certainty that a med was in fact consumed by the patient. For instance, a med could be dispensed, dropped on the floor, stepped on, and forgotten.
I believe this problem can be solved by architecting systems based on existing technologies. However, it may be cost prohibitive at this point but certainly not in the future (I will go out on a limb to say “near future”). Technologies exist today for tracking the whereabouts of people and things by utilizing low power transmitters and receivers. I believe these technologies can be put to the challenge of making medicine intelligent enough to announce itself. Thus an intelligent dispenser could be loaded with intelligent meds and automatically record the meds while building a database within the dispenser (learning). The intelligent dispenser could communicate with the patient’s healthcare provider or primary care physician informing them that the dispenser is loaded with the proper meds of a particular type(s). The conventions deployed in the field of RFID (Radio Frequency Identification) technology allow for affixing labels to objects. The labels contain information about the object and can be detected by sensors strategically placed throughout an area. The unknown piece of this vision was whether this intelligence can be incorporated into meds and consumed by people. I ran this thought by Dr Julian Goldman who provided me with information about a camera pill that can be ingested for transmitting images of a patient’s digestive tract as it travels through their body (FDA approved). Thanks, Julian! If it weren’t for that information I might not have pursued this idea any further. Thus a med can be consumed which is capable of sending information to a receiver. This can help prove my hypothesis that intelligent medication dispensers can be developed to learn what meds are placed within them and detect when any of those meds are within you (not on the floor). The intelligent dispenser could know what meds are in storage and detect when any of those meds are in you. In addition, it could notify the proper parties automatically of any abnormalities with the consumption of your meds.

Thinking out of the box!

The second part of the challenge (to develop strategies to improve adherence) is indeed complex and needs to consider the mental and emotional state of the individuals. For a great many people, the very idea of being asked to adhere to specific requirements can create a host of thoughts and feelings that will sabotage their ability to succeed. They may believe they aren't good at creating consistent routines, have a bad memory for things like this, it isn't really that important to finish the treatment, that they know better than their doctor, or that have failed at adhering in the past and aren't sure if they can be good now. They may also feel anxiety about taking medications, simply hate the whole idea of taking pills, experience feelings of being bad when they do miss a time that reinforces they are incapable and unworthy, or not feel good enough about themselves to put in the effort. Few people are aware of their beliefs, thoughts or feelings. All they know is whether they took their meds or not.

My point is that people are dealing with issues of readiness, self-efficacy and self-esteem at an unconscious or partially conscious level. It isn't just about adherence. The emphasis on adherence or compliance without addressing the underlying unconscious drivers of behavior won't solve the problem. Solving the problem, I believe, includes the use of social cognitive theory, positive psychology and behavioral psychology through the use of a healthy lifestyle or wellness coaching model. This is not the same as the health coaching approach that is now widely used to support disease management, which is primarily focused on adherence and monitoring.

A healthy lifestyle or wellness coaching approach helps individuals
~ recognize why taking their medication will assist them in living the life they really want,
~ recall aspects of themselves that can help them succeed with the current behavior,
~ achieve a positive, affirming perspective of themselves and abilities,
~ identify the mental or emotional obstacles to being consistent,
~ create realistic strategies in their daily life to take the medication regularly, and
~ feel successful and good about themselves as they meet their weekly goals using these strategies.

By assisting people to achieving greater self-awareness, self-motivation, self-confidence, self-esteem and self-responsibility, you are more likely to achieve adherence. I am a healthy lifestyle coach and use these techniques successfully to guide people in making healthier choices that feels so good physically, emotionally and mentally that they stick with them. I presume they would also work with medication management, although that is not my specific area of focus with my clients.

There is a saying that I have found true in my practice, which is: people don't resist change; they resist being changed. And as I once mentioned in a conversation with Alice, the emphasis on compliance may in fact be creating the problem you are trying to solve. Few people like to be told what to do or how to do it, and when they are corrected or monitored, many of them further resist the feelings it creates and the intrusion - which by the way is not just external. The intrusion is also coming from the inner self-critic, which is demeaning, negative and self-sabotaging. It may even bring up experiences from their childhood of someone trying to exert force over them, which very often creates a rebellious overreaction and refusal to do what they are being told. Again this is subconscious and seldom evident to the individual. In addition, when people fail to do what is asked of them, they lose confidence in themselves and prove their inner-critic right and harbor more bad feelings. This only adds to the mental and emotional baggage they have about their health, body and selves.

Now this is really thinking out of the box, and it gets to the heart of the issue!

Medication compliance in the US is a national healthcare tragedy. With costs estimated at $100 B annually widely reported in the press one has to question why more solutions have not been developed.

Clearly one issue is complexity. I agree with many of the comments of the authors and comments posted here regarding the scope and the behavioral aspects of medication compliance. There are no simple solutions that fit all situations. Each individual needs to be assessed and managed appropriately for their circumstances. There does need to be a continuum of solutions to make compliance and persistence work. This may include counseling and or the use of a medication monitoring device to insure progress towards goals.

These solutions will need to operate within fragmented delivery systems. In addition to the issues raised by the authors we have a significant challenge to manage the daily medication organization and delivery to the patient. Currently this is typically handled by the patients themselves, family members, or caregivers for patients living at home, which, presents a very challenging situation. Pharmacists, primary care physicians, and other health care professionals rarely get involved in managing compliance. This needs to change.

I think the overriding issue here is the lack of investment in scalable commercial solutions along with incentives for healthcare professionals in the delivery of care. We have a tremendous capability to develop innovative healthcare technologies when there is an economic incentive. Currently that incentive in the form of reimbursement by both federal and private payors is non existent. Without a reimbursement model it is difficult for the small entrepreneurial companies, which have been the back-bone of medical device innovation, to create viable business plan’s that can be successfully financed. In addition we need to provide the proper financial incentives to our healthcare professionals to deliver this care.

Medication monitoring solutions have an important role to play in this continuum of care, but without necessary changes to our current payment models it may be difficult for these solutions to come out of the US healthcare system.

Mike Gavin

There seems to be many approaches to solving the puzzle of poor adherence as evident by the unique and varying solutions offered by our responders. I think we all agree that there is not one right answer or best approach that will end this challenge for all of our patients, but the discussion proved to be insightful and creative on many levels.

The discussion included a comment about engaging responsible parties in taking a more significant role in helping patients manage their medications. We believe that offering incentives to health care providers to become more involved in medication management in the form of “payment for performance” may help reach this goal. For example, rather than only being paid for completed visits, payment would also be based on the quality of the services rendered (e.g. taking time to fully educate the patient on medication benefits) and outcomes (improvement in patient health).

But even with the full investment of health care providers, some patients would still struggle with medication adherence. Technology has a role in medication management by offering an objective, although not perfect, measure of medication taking behavior. A medication adherence device is a tool that can be used to inform the patient, family members, and health care providers about the level of mismanagement or non-adherence that is experienced by the patient. This information can facilitate a conversation around issues that affect adherence (e.g. readiness to change, self-efficacy and self esteem) between interested parties. Therefore, technology can supplement interventions geared towards reducing medication non-adherence.

Technology as a supplemental intervention may be best introduced to early adopters who are often eager and open to new solutions. However, we have to be careful not to stop at the early adopters and understand that our target population is people who have fewer resources, lower education, and more hospitalizations related to medication non-adherence. We believe it is important to find creative ways to reach this population and demonstrate that advances in science and technology are not only for the well informed but for everyone who needs it.

Creativity is also needed to continue to advance the science and learn ways to gather more accurate adherence information. The intelligent dispenser is truly innovative, and represents “thinking outside the box” to address this issue. As we consider new technology, we also have to consider people’s response to that technology. Will this system be perceived as helpful or intrusive? Will people be open to this technology or fear it? People feel more comfortable with things that are familiar to them, so how could we create this new technology and have it appear to be natural?

Lastly, it was expressed that our goal should be making medication taking behavior second nature. Interestingly, our routine behavior is an action that we have to decide to do. We become “used” to going to work, but we decide each day to take this action. There are some behaviors that are automatic such as breathing; we don’t have to consciously think about it. But everything else in life is a conscious decision which allows us to more freely alter our behavior by deciding if and when we are ready to change.

Thank you all for your wonderful comments, and for those who have yet to comment, please don’t hesitate to join in.

Shanta and Alice

You are right that there is no "one size fits all" solution. However, it seems that we accept that compliancy is a problem that needs a solution.

I think there are a number of standard processes that could be adopted.
- The prescriber needs to make an assessment whether a patient will comply and make it a discussion in the surgery. There is no point giving drugs to people who have no intention of taking them, and often objections may be overcome with a discussion and with a serious interaction about side-effects. This is a difficult skill and probably doctors would benefit from training, guidelines, and support.
- An objective measurement system should be integrated with pharmaceutical packaging so that the issue of compliancy becomes a measured and and objective reality that patient and healthcare provider can discuss dispassionately.
- Where needed, patients could be supported with reminder systems and encouraged to report any unusual side-effects.
- I particularly like the system that is piloting successfully in UK for medication usage reviews. In this system the pharmacist takes an active role to monitor compliancy and coach their customers.
- Compliancy history should form part of a patient's medical record, helping the professional assess whether a particular person needs special support.
- The payers should move further toward independent assessment of drug therapies - both before and after regulatory approval. Accurate in-life data about compliancy, linked to outcomes, would provide a solid base for determining the cost effectiveness of different therapies. With 50% of patients not adhering and nobody knowing which 50%, it is virtually impossible to establish an evidence base. With such a system in place we could start to think about paying pharma companies for results.

Measuring compliancy is the starting point for improvement. As has been proved in many other situations, what gets measured gets done.

I would also like to draw readers' attention to the current draft policy on Medication Concordance being prepared by NICE. No doubt many of you have either read it already or have access. They have conducted an extensive review of the trials done to date and have much good advice, especially regarding the importance of making compliancy assessment part of the prescribing process. I recommend a long read (it is altogether over 400 pages) and will be published later this year.