For decades innovative packaging has been used to aid adherence. Packaging includes: blister packs, smart pills, smart caps, bottles, boxes, pill dispensers, and organizers. But to proceed, we must first discuss adherence measures.

Medication adherence has 3 different measures:

• Primary adherence—was the original prescription filled?
• Secondary adherence—is the prescription being refilled as measured by medication possession ratio (MPR) and percentage of days covered (PDC)? And is the medication being taken as prescribed?
• Persistence—is the medication being taken over time (measured at 30, 90 and 360 days)?

Estimates from large claim studies suggest that “no fulfillment” of first fill can range as high as 1 in 4. Secondary adherence is lower and drops off as the number of doses per day increases.

Persistence drops in an almost linear fashion over time for virtually every drug category and can hit the 20% range at 1 year for some drugs.

Actual medication utilization is likely to be worse than studies suggest as, historically, there was no ability to accurately measure and control daily utilization in an outpatient settings. The secondary adherence measures above were, at best, statistical inferences of behavior based on data from prescription claims over a period of time and provided no control regarding actual adherence to regimens on a daily basis.

Numerous packaging devices, starting with rather low-tech blister packs (ie Medrol Dose Pack and Z-Pak) as well as manual pillbox organizers, have been created in response to the challenges of monitoring and increasing adherence.

Cheap processing power along with wireless technology and the Internet has changed the marketplace and created a whole category of “smart packaging.” The various types of smart packaging vary widely in target audience as well as their underlying technology. For instance, some are designed for clinical trials, others for bed-ridden patients, and others specifically for the masses.

The smart bottles, caps, organizers, and dispensers can remind people to take the dose, dispense the medication, record the event, and more. They can beep, play a song, or flash a light. Some communicate with your phone and in some cases they can transmit the event (or lack thereof) to an accountability agency/partner. There are even large book-sized or “Frisbee”-size dispensers that can be used to dispense multiple drugs, multiple times per day and if the medications are not taken, the devices can alert a call center or caregiver to intervene.

The major brands include:

GlowCap
Adhere Tech
MEMS Cap
eCaps
MedMinder
CleverCap

These devices differ in a number of important ways that are worth considering in light of a proposed use. Differentiating characteristics include:

Data
How are reminders provided and is the reminder system inactive during shipment?
What is collected?
To whom can data be delivered: the patient’s phone, pharmacy, integrated system, etc?

Cost
Can the patient refill the device with by screwing it to a new bottle, or can it only be filled by the pharmacy? This is important for clinical trials.
What are the initial, monthly, and maintenance costs?
Is the battery rechargeable/replaceable?

Authentication
Does it require a fingerprint or other authentication process or can anyone use it? This is not much of an issue for most applications, but for some drugs (ie narcotics and drugs subject to diversion) this may prove to be an important issue.

Pill Dispensing
Can the device prevent accidental overdosing by locking out for periods of time?
Does the device dispense an individual pill or does it just open and allow the patient to take any number of pills? This is important if you are attempting to control dose carefully for drugs such as narcotics or for those patients with cognitive impairment.

Complex Regimens
Can it dispense several different drugs simultaneously as needed, multiple times per day? This is particularly important when considering the increasing Alzheimer’s population.
Is it something that can be fit into a purse or pocket?

Miscellaneous
Is it “child safe”?
Is it “senior friendly”?

Although there is no one device that can meet every need, one of these devices, the CleverCap, seems to meet what I envision to be the most important characteristics for a commercial setting as a component of a comprehensive intelligent solution for overall adherence. (I have no financial or other relationship with any smart packaging device company.)

What strikes me about CleverCap is its modularity and flexibility: it can regulate simple and complex regimens; provide dose-by-dose and pill-by-pill monitoring; and reminders are physical and/or digital. It can control dose if desired and has the capability to incorporate temperature trackers and tamper detection.

The device can be used with hubs, companion apps, and even as a standalone device with fully integrated cellular connectivity. It is a novel delivery system in itself which allows it to monitor at the dose level with high reliability while also giving it the ability to control access. In comparison, some other options track enclosures being open/closed and/or moved around. In my opinion, CleverCap offers great value in the outpatient setting with the greatest balance between reliability, granularity of data capture, passive engagement, and costs.

Although every one of these devices can help with reminders and even notify a caregiver or specialty pharmacy provider, they do not actually enter into a conversation with the patient to actually inquire why he or she is not adhering. Additionally, these systems have little ability to actually solve the problems leading to non-adherence. The typical system does not integrate with other patient engagement systems, (eg, apps) and are typically not able to deal with lifestyle issues.

Since no disease is made better by inactivity and a poor diet, a more comprehensive lifestyle approach is needed that can deal not only with forgotten meds but also root causes of non-adherence to both diet, exercise, and medication.

The ultimate solution will need to draw upon numerous health behavior theories and will need to be able to be personalized. And, the ultimate personalization is conversation.

Author: Thomas Morrow, MD
Article Originally Posted By: AJMC.com