Shendale:  Medication only works if taken correctly, everyday.  Forgetting to take your pills can steal your health and your life.  Incorrect timing of dosage reduces the efficacy and therapeutic benefit of medications.  Taking doses too soon, accidentally doubling up causes adverse effects including progression of illness and the medical complications associated with pharmaceutical treatment failure. One thing that's important to realize is that removing prescription medication from a USP approved pharmacy vial is extremely dangerous and may expose the chemicals in prescription medications than can reduce the efficacy of the medications.

CT: With those kinds of risks, can you explain your understanding of the reasons behind medication non-adherence? Why don't patients take the mediations they've been prescribed in the way they are instructed to?

Shendale: Patients or their care-givers end up having certain time-keeping responsibility imposed on them by the need to take medications on a schedule specified by the prescriber.  The problem of non-adherence can be aggravated if more than one person cares for the patient. Multiple people must accurately communicate with one another and confusion may result that leads to accidental underdosing or overdosing.  But the most common reason people don't take medication correctly is simple forgetfulness. Approximately 50% of patients are not properly adhering to their medication regimen and of that group 28% are non-adherent because of forgetfulness.

CT: Can you give us a sense of the scope of the issue we're facing here?

Shendale: Medication non-adherence is an epidemic nation wide in the United States and in other developed countries as well. The New York Times called non-adherence America's other drug problem. Now when they reference that, they are referring to the fact that medication non-adherence causes at least 300,000 accidental deaths each year. According to the CDC, medication non-adherence is the fourth leading cause of death in America and the number one cause of accidental death. Non-adherence causes 20,000,000 emergency room visits and 10,000,000 hospitalizations each year. It costs the healthcare system $290 billion each year, according to the Institute of Medicine,

CT: Let's go back to forgetfulness, which you mentioned as the main reason for non-adherence. What are some of the methods that people - patients, caregivers, and pharmacists - use to deal with this?

Shendale: I'll start with the patient, because the patient is always the center of the universe to me.  Patients try every possible way to take medications correctly. The classic ways are taking prescriptions when you wake up or go to bed or with meals. Americans also spend close to $1 billion every year on pill boxes and other products designed to remind them.  But I'll go back to something I said earlier: Removing prescription medication from an USP-approved pharmacy vial is extremely dangerous. You won't necessarily remember which pill is which, and if you miss a dose you have a terrible time trying to figure out which pills are important. For caregivers, there's no perfect way to know if a patient has taken his or her pills.  The problems in the pharmacy is that time is extremely limited. Pharmacists don't even necessarily have time to verbally counsel. In fact, the percentage of patients verbally counseled at the pharmacy and the number of topics covered have both been declining at an alarming rate. The touch point here has been lost because of all the pressure on pharmacists to dispense.

CT: We've talked about some background and coverage in the media, but what are some trusted sources for more information?

Shendale: There are thousands upon thousands of studies from the FDA, the American Pharmacists Association, the National Community Pharmacists Association, Frost and Sullivan, Modern Medicine, the Institute of Medicine, CBS, Medco, and more. A major complication is that most patients and caregivers think that they are good medicine takers. However, a National Community Pharmacists Association survey from October 2006 found that while people answered ‘yes' when asked if they are good medicine takers, 57% also answered ‘yes' to the next question, which asked if they ever forget to take medication. So people believe they're good and want to be good at taking their medicines, but they're not.  Considering that forgetfulness is the major cause of non-adherence, let's then think about the fact that there are currently 5,000,000 people with Alzheimer's disease. Now how many people are turning 65 over the next decade, and how many of them will suffer from Alzheimer's or early dementia?

When we look at healthcare costs in America and we look at the numbers of people who are accidentally underdosing and overdosing and being taken to hospitals or nursing homes, that number is going to grow exponentially. Early onset Alzheimer's in an aging population means that there are going to be so many people who don't know if they've taken their medications or not.

CT: Clearly there's a lot of thought and research being put in to the issue of medication adherence, but even with all this attention, adherence remains a major issue, right?

Shendale: When I look at the campaigns to increase disease screening, adherence programs, efforts by insurers and drug companies, pill boxes, efforts by conscientious individual clinicians, medication regimen manipulation, and patient empowerment efforts, all of which are done in the name of compliance improvement, and when you consider all the money spent in the same pursuit since 1995, and I ask what have we gotten, the answer is we've gotten nothing. No improvement whatsoever. The cost has grown from $77 billion to $290 billion attributed to preventable medication-related problems.

CT: Why is this?

Shendale: Most of the currently used compliance-adherence interventions benefit some of the patients some of the time under some conditions.  Reliably predicting when a specific intervention will benefit a specific patient in a specific situation is an unachievable goal.

CT: Okay. With all this as background, tell me about the Pill Timer vial cap solution that Med Time has come up with.

Shendale: First, we looked at creating a medication management system that would meet USP requirements and was so simple to use, that a six year old could understand.  We were first and foremost concerned with the ability of an individual to actually understand how to set a Pill Timer.  Next, our solution had to be easy to use and had to provide the information patients and caregivers need in order to know that medication is being taken properly. Our solution is as simple as taking the cap off the vial, setting your dosage interval, and replacing the cap. It can't be simpler. We entertained all sorts of other notions, but the simple fact was that we were looking for a cue to remind people to take a medication. The most common question asked of every patient is: When did you take your medication last? And then they often wonder, "Did I take it?"

CT: Tell me how Pill Timer conveys this information.

Shendale: We created an information screen that will tell someone very simply when they last took their medication, what the dosage interval is, and how many times the vial has been opened and closed.  These are the three very simple, basic pieces of information that the Pill Timer offers and that tell you a lot about adherence. For the hearing impaired, we've put in a flashing red light. For sight impaired, we utilize a 73-decibel piezo-buzzer. For procrastinators, we included a snooze feature. We included 24 subsequent reminder alerts so that if someone is not home, simply forgets, or doesn't hear the initial alarm or see the flashing LED light, the Pill Timer will continue to remind them that they haven't take their medication.

CT: And considering that Pill Timer is a vial cap, your partnership with Rexam, a vial producer, is particularly critical, right? Tell me about what Rexam brings to the adherence efforts you are making.

Shendale:  Rexam is the largest provider of medication vials in the world and the support of a world-class company gave us the opportunity to be as good as we can be.  Rexam has worked with us to a greater degree than anyone before in reducing sub-therapeutic dosing intervals  and they are our partners in of our war on medication non-adherence.

They believe along with us that Pill Timer is the most cost-effective, technologically advanced medication management system on this earth.  It costs two pennies per day, 66 cents a month. If a patient uses Pill Timer and improves adherence by a tablet or a tablet and a half a month, then the pharmacy is more than covering their initial cost while providing invaluable support to their most valued pharmacy customers. Consider these amounts in light of the fact that we'll spend at least $100,000 on an organ transplant or $25,000 on a hospitalization, or thousands of dollars for an emergency room visit. Proper medication adherence can substantially reduce or completely eliminate these costs.

But these dollar amounts are less important than the human tariff of non-adherence.  There are the times when someone is readmitted to the hospital because of non-adherence, and there's a real personal and emotional cost to that person and his or her family. Or if someone dies because he or she hasn't taken medication properly, then there are mothers, fathers, brothers, sisters, husbands, and wives who have lost that person. 

CT: What do pharmacists think of Pill Timer, in your experience?

Shendale: Well, there's a whole philosophy that goes along with Pill Timer and that we've come to understand through our living laboratory that we have as a result of our working relationship with Health Mart Pharmacies. One of the things that we've been told by our pharmacists is that when they first see the Pill Timer, they see great opportunities to improve patient adherence and to differentiate themselves from their competitors. But then they find that their pharmacy is transformed. They stop simply giving instructions on how to take medication and move to having real conversations based around taking medication properly each and every day.  A pharmacy's staff has opportunities to really encourage medication adherence with every patient, and it all starts with talking with patients.

CT: Ian, I want to thank you for taking time to talk with me.  Any closing thoughts?

Shendale: Yes. I want to emphasize the effort we've put into developing a simple solution to this major problem. Everyone studies the problem of non-adherence, but believe that we need to come to the table with simple, cost-effective solutions and that's what we've done.

One other very important thing I'd like to mention is our Pediatric Pill Timer Campaign.  We are going to give Pill Timers to every pediatric transplant patient in North America.

CT: That sounds like a very worthwhile cause, Ian.  Where can readers find out more about this campaign?

Shendale: People can contact me directly at 561-245-8897 or ian@pill-timer.com.

CT: Okay, great. Thanks again, Ian.