Compliance packaging – packs that aid patient adherence to prescription medications doses – not only supports patient health, but also helps maintain the healthy finances of the brands and retailers that take its principles to heart. Keystone Folding Box explains how compliance packaging is taking hold of the pharmaceutical market, particularly in oral solid dose medication.

When considering how to package oral solid dose medication, manufacturers and marketers should evaluate the benefits of compliance-prompting packaging, which can be defined as a package that incorporates printed day-of-the-week dosing information on each blister cavity.

Over the past two decades, multiple studies have concluded that compliance packs improve medication adherence, helping patients to prevent missed doses. This not only aids patient well-being, but also ultimately helps sell more product; one study revealed that the use of compliance packs increased prescription-refill rates at an average rate of two additional refills a year per patient.

Blistering form

Following a patient’s interaction with doctors and pharmacy staff, the pharmaceutical package is their last interaction with the medical system before taking medication. It is the final opportunity the pharmaceutical industry has to communicate with the patient – and communicate repeatedly with him, each time the patient looks at the prescription. By incorporating ‘calendarisation’ into the package, the patient can easily determine whether he has taken the current day’s dose of medication. This aids in preventing accidental double-dosing as well as preventing unintentional missed doses.

The dispensing of prescription medication in blister packaging has been an ongoing trend in Europe for decades, but in the US, blister packs have rarely been used for packaging prescription medication other than oral contraceptives and some antibiotics.

Maintenance medication, prescribed to treat chronic conditions such as hypertension, cholesterol and diabetes, used to be exclusively distributed by manufacturers in bulk bottles and dispensed by pharmacies in amber vials. Only in recent years have US consumers seen wider use of blisters in compliance-packaging formats.

In 2008, Walmart became the first of several retail pharmacies to dispense generic maintenance medication repackaged in a compliance pack. Since then, studies have shown that packaging formats that incorporate calendarisation demonstrate greater adherence and improved patient outcomes.

The use of compliance packaging has not been limited to generic drugs; brand pharmaceutical companies have also launched products in similar formats. A study on Novartis’s brand drug Diovan, for example, exceeded expectations when adherence improvements were identified and attributed to the use of compliance packaging. And, with retailers and brands beginning to use compliance packs in the US market, consumers have become more accepting of blister packaging.

Compliance and legislation

Recent healthcare reform in the US has created demand to promote medication adherence. Legislation has created financial incentives for insurance companies and pharmacy benefit managers to pursue programmes that help improve patient adherence. A five-star rating system is now in use in the US that ‘rates’ payers, published and reviewed by Medicare. Higher ratings allow increased revenue via higher reimbursements, and attract more members to health plans.

One of several ways to improve ratings is the implementation of a programme that focuses on patient education and self-management of health conditions. This is effectively what compliance packaging is doing in the market today, by improving adherence.

Design for demand

Compliance pack designs have evolved since the concept was first introduced. In the past, some compliance packs used plastic resin in their structure, but following increased demand for sustainability, most new pack designs are manufactured with recyclable and compostable paperboard.

As well as appealing to the sustainability trend, the shift away from plastics also means cost reductions in manufacturing. Design improvements and high-speed automation equipment have reduced the cost of packaging prescription medication in compliance packs. Packages have also become more patient-friendly as child-resistant locking features are redesigned to be easier for adults to open.

Historically, regulatory agencies in Europe are less likely to demand the use of child-resistant packaging to the degree that the US market requires, but as each new generation of design becomes more consumer-friendly, all markets are likely to see greater adoption.