The directives and regulations for the mass-serialisation of drug packaging to fight counterfeits and reimbursment fraud – including the now increasingly populated combination products market – which are either already in place or are in the process of being introduced, are a challenge to medical device manufacturers; however, they also represent an opportunity. Some of the new technologies used to verify the authenticity of a product can also serve consumers/patients in a way that just a few years ago nobody would have dreamed of.

Both the primary and secondary packaging of pharmaceutical and combination products are subject to detailed and tight rules and regulations, including those about direct-to-patient advertising.

The design of packaging is, therefore, more a matter of knowing and understanding the many requirements that regulators have imposed on medical device and pharma companies, rather than just meeting consumer expectations, which traditionally rank low since manufacturers used to consider the prescribing physicians as their customers rather than the patients, who were simply supposed to comply with their doctors’ instructions. As a result, public opinion about packaging reflects a rather negative image of pharma and its related industries.

"The overall picture is clear: pharma spends as little as possible to help the patient (that is the consumer)," wrote Paul Earnshaw, principal consultant at PA Consulting Group, in an article published in PMPS magazine in 2005. "Other industries recognise the significance of helping the consumer (that is the patient) and make the packaging improve function, interest, accessibility and add value, which lead to added revenues, so everyone benefits."

Patient compliance

"Manufacturers used to consider the prescribing physicians as their customers rather than the patients, who were simply supposed to comply with their doctors’ instructions."

People tend to request information about their health condition and the device they are to use or drug they’re told to take before they decide to follow the advice. Yet consultations usually end with a prescription, and most patients are left alone with their questions and concerns regarding treatments, the benefits and risks of the medication, its interaction with other drugs and its side effects. Compliance/adherence depends largely on information about the health condition and the trust between the patient and the healthcare provider; however, practitioners spend an average of less than 60 seconds per prescription for conveying compliance-related information to their patients.

Hence, the term ‘patient compliance’ is widely replaced by ‘concordance’ or ‘adherence’. The lack of proper adherence is a major concern for pharma companies and their partners such as device manufacturers, healthcare systems and society. Patient compliance is an issue as old as medicinal therapy itself, but it has been argued that it has now become the best-documented, but least-understood, health-related behaviour. It has also been suggested that increasing the effectiveness of adherence interventions might have a far greater impact on the health of a population than any improvement in specific medical treatment.

Packaging that improves adherence

While the pharma industry, including manufacturers of combination products, acknowledges the importance of proper pack designs and reminder features in clinical trials, this knowledge seems to be forgotten the moment the decision is made to launch a new product. Then, time-to-market and the lowest possible cost of packaging are the only drivers for pack design.

"Compliance/adherence depends largely on information about the health condition and the trust between the patient and the healthcare provider."

There has been some improvement in recent years. A study conducted by Philip J Schneider et al at the Ohio State University and published in the Journal of the American Pharmacists Association in 2008 concluded that providing medications in a package that identifies the day each dose is intended to be taken and that provides information about proper self-administration, can improve adherence to a treatment regimen and outcomes in elderly patients with hypertension.

It added that incorporation of this durable strategy could also lead to improvements in medication-related outcomes in elderly patients with other chronic diseases.

Technology to help with drug intake

In addition to these visual prompts, technological advances have produced packs that include devices to help patients where treatments may require complex or flexible medication intake. Clyk, the intelligent tablet dispenser, developed by Bayer in cooperation with Balda Medical, was specifically designed to help women comply with a new oral contraceptive and a unique, extended flexible intake regimen.

"When it comes to serious conditions, many patients gladly rely on intake support, even if it means that they are being supervised."

Inserting the first cartridge activates the dispenser without the need for user programming. The device reminds women by a visible and audible alarm to take their pill, guides them through the regimen and informs about what to do when one or more doses are missed. The device can be applied for any other medicinal treatment that may require flexible intake.

For some chronic conditions, the use of smart packaging, such as Merck Serono’s RebiSmart device, which allows people suffering from multiple sclerosis to self-administer and keep control of their injectable remedy, and to inform the physician about the correct application, can be extremely beneficial.

The frequently used argument that such supervision would infringe a patient’s personality and dignity is misleading as it would depend on their explicit prior consent. Besides, when it comes to controlling serious or even life-threatening conditions such as may occur after organ transplants, many patients gladly rely on support, even if it means that they are being supervised. In the end, however, it’s the patient’s decision that must be respected.

Modern technology, which will be used to authenticate drug packs, will also be able to provide services to patients at low cost, assisting them in their medication regime, keeping them on their therapy and improving or stabilising their condition. It will be the brand owners’ decision whether they will implement these novel technologies for the patients’ and their own benefit.