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Equipment and Processing Report
A staggering percentage of people do not take their medication correctly, but pharmaceutical packaging aims to improve patient compliance using new technology to address reasons for non-adherence.
Despite decades of effort to design packaging that helps people take the right dose of the right prescription at the right time, the number of prescriptions that are not taken as directed has been stuck around 50% since at least 1993 (1, 2). Sometimes the reason for lack of compliance, or what increasingly is referred to as “adherence,” is financial. The patient can’t afford the medication, so the prescription goes unfilled. But more often, lack of compliance is due to difficulty accessing and dispensing the proper dose and remembering dosing times.
“The severity of medication non-adherence has been so well documented that the healthcare industry is taking a much more serious look at how to improve patient behavior,” reports Ward Smith, director of Marketing at Keystone Folding Box Co. “People are starting to recognize compliance is a really important factor in determining the outcome for the patient,” agrees Graham Reynolds, vice-president and general manager of Global Biologics at West. Reynolds explains: “Non-adherence has significant financial consequences. The patient ends up in the hospital or back in the hospital and puts additional strain on the healthcare system. From a pharmaceutical company perspective, non-adherence is widely recognized as a cause for a significant loss of revenue; a number recently estimated at $600 billion.”
To improve adherence, many compliance packaging designs have been introduced. The Pharma Compliance Pack from August Faller Group features an integrated sliding mechanism (see Figure 1). As doses are taken, perforated tabs are removed to provide access to the next dose(s) on the blister card. “The patient can directly see which tablets he/she already took,” says Tanja Feldmüller, head of Marketing and Innovation at August Faller.
Keystone’s child-resistant Key-Pak and Ecoslide-RX packaging also calendarize medication dosing. “This type of packaging has been documented to improve medication adherence,” says Smith. He notes, however, that it appears to be less effective for patients on multiple medications. “…if a patient takes more than five medications; all of the packages (blisters and bottles) can become overwhelming,” he explains.
Some patients on multiple medications resort to pill minders with compartments for each day and/or various times of day. However, this solution can be problematic. Filling errors can result in missed doses or overdoses. Sensitive medications can be exposed to detrimental environmental conditions, and product information is separated from the dose.
“No one solution seems to exist to solve non-adherence,” says Smith. As a result, there’s growing interest in more holistic approaches that integrate packaging with interactive devices, software, rewards programs, and personalized support.
An example of a more holistic approach is a smart, wireless pill bottle from AdhereTech. Used primarily for specialty medications like cancer drugs, each bottle contains a wireless cellular chip and numerous sensors. It collects adherence data in real-time, analyzes the information, and populates a secure dashboard. If a dose is missed, the system sends an automated alert via phone call or text message to the patient, caregiver, or pharmacist. The bottle itself offers alerts via blinking lights or audible chimes.
The smart bottles are child-resistant and supplied free to patients and pharmacies through programs sponsored by pharmaceutical companies. When the prescription is dispensed, the pharmacist inputs the necessary information into the system, and the bottle is ready for use. Sensors detect when the bottle is opened and reclosed and can monitor other attributes such as the contents of the bottle, battery level, and signal strength. “If the bottle is in an area with no cellular coverage, the bottle holds data on up to 180 doses for later transmission,” says Josh Stein, CEO and cofounder of AdhereTech. The pharmacist can access the compliance dashboard and intervene if the patient needs help. Results to date show the wireless pill bottle boosts adherence up to 20%, while persistence (the time on therapy) jumps to 30%.
Another smart packaging option, the iCap closure from TimerCap, is Bluetooth-enabled with red, yellow, and green lights to visually indicate medication status. Each time the cap is opened, the onboard timer stops and returns to zero. The cap also collects data for real-time or email transmission. Compatible with Android, iPhone, and Apple Watch devices, the child-resistant, push-and-turn closure is sold as a kit with two caps, two bottles, two batteries, and the MediSafe iConnect app. Various colors make it possible to differentiate medications. The Medi-Safe iConnect app moves setup of the iCap closure to a Smartphone or other device, minimizing energy consumption and maximizing battery life. In addition to tracking adherence, the MediSafe iConnect app can monitor almost two dozen measurements including glucose levels and weight. The iCap not only helps patients take their medication as prescribed, but also can track and detect opioid abuse and diversion.
With the iCap, the pharmaceutical company sees firsthand when a patient takes a medication. “That knowledge helps fix side effects and other issues and determine why a drug works for some and not others,” says Larry Twersky, CEO of TimerCap. As a result, healthcare providers have a better chance of knowing how a particular drug will work for a patient.
Smart labels equipped with a near-field communication (NFC) chip and/or QR code also can support adherence (see Figure 2). “NFC has multiple advantages compared to a QR code, such as a very high security level for authentication purposes, the possibility to individually change or protect specific information or the enhanced convenience to read the tag with your Smartphone,” says Gene Dul, president of Schreiner MediPharm US. “However, the advantage of including both [code and chip] is that online information is also available to those users that do not have an NFC-enabled Smartphone available.” Labels also can be equipped with other features such as anti-slip varnish, hologram for authentication, or a temperature indicator that changes color when a certain ambient temperature is reached.
Medication management tools from Compliance Meds Technologies (CMT) can be tailored to the needs of various settings such as senior care, addiction treatment, and clinical trials. Tools include the CleverCap LITE; the CleverCap PRO; an optional mobile app called Companion App CMT; and secure, cloud-based reporting/analytics portals. The devices are distributed through the pharmacy, incorporated into existing medication vials/bottles, shipped directly to enrolled patients, or given out by a participating doctor.
Moses Zonana, founder and CEO of CMT, described how the integrated technology works. “The CleverCap PRO … detects when a pill is dispensed and can control the dose, ensuring the patient receives the right dose at the right time. The information is automatically transmitted through cellular 3G networks into the CMT Reporting, Analytics, and Engagement System. Devices can generate visual and sound alerts at predefined timeframes or operate under silent mode. The CleverCap LITE does everything the CleverCap PRO does except it doesn’t actually track at the individual pill level of granularity or control dosage. It tracks when the vial/bottle is accessed or is not properly reclosed to provide an extra layer of security.
“We have observed regimen adherence levels of 95% using CleverCap PRO and regimen adherence levels of 96% using CleverCap LITE. In the majority of our programs, there is an intervention layer in addition to the technology layer, which allows us to obtain those types of successful results. These interventions may incorporate nurse support groups and incentives for better medication habits.”
About the author
Hallie Forcinio has reported on packaging as Pharmaceutical Technology’s Packaging editor for more than 20 years. Her first article for the publication, in March 1993, looked at patient compliance, which continues to be a concern today. Tel 216.351.5824, firstname.lastname@example.org.
This article is excerpted from H. Forcinio, “Packaging Improves Medication Adherence," Pharmaceutical Technology 41 (7) 2017.