Non-compliance with drug regimes is a perennial and extremely costly issue for governments, healthcare bodies and pharma producers. Stora Enso and Swedish “intelligent electronics” specialist Cypak have jointly developed a pack they believe should maximise the chances of patients taking their medicines and completing their course of treatment. Jonathan Baillie reports
November 7 month saw Stora Enso introduce, in conjunction with Cypak, a pharmaceutical carton packaging system which the companies say is both “child-resistant and “senior-friendly” to the highest industry standards but should also substantially improve patient compliance and enable doctors to better monitor the effectiveness, and effects, of drugs on individual patients.
Launched in Copenhagen, the Stora Enso Pharma DDS (Discreet Dose Slider) carton is reportedly “compact, discreet and easy to use”, even by those with reduced manual dexterity. However, thanks to its child-resistant features, it is also “extremely difficult for children to open”. Only by pushing on a circular button on one end and simultaneously sliding out the inlay from the other can medicines within the inner blister inlay be accessed. In tests the DDS pack has reached the highest F=1 testing result for child-resistance (F=1 is a US child-resistant packaging standard under which a random sampling of subject packages may not be compromised by an age-specific test pool of children at a failure rate of over 10%.). It is suitable both for high volume branded drugs or generics, and medication requiring high compliance and child-resistance.
Ismo Saarinen, director, Stora Enso Pharmaceutical Solutions, who introduced the Pharma DDS carton and an even “smarter” Pharma DDSi derivative to customers and journalists, said both can be made in a range of sizes at high speed on existing cartoning equipment “with only minor” tooling modifications.
Both packs incorporate a “smart” inner design to enable incorporation of effective unit dose packaging such as fold-over blisters or perforated push-through applications. The inlays shown at the launch incorporate clear, simple “night” and “day” symbols to remind patients when to take their medication, together with numbering below each blister “pocket’ to help ensure doses are taken in sequence.
Speaking at the launch, Tassilo Korab, executive director of HCPC Europe, the Healthcare Compliance Packaging Council Europe, (an organisation established to help the healthcare sector improve patient compliance via “packaging solutions”) said research showed GPs typically take just 60 seconds explaining the benefits and side-effects of prescribed drugs and discussing the need for compliance with patients.
Consequently many are left confused about why they are taking a drug, unsure about when and how it should best be taken and, in some instances, excessively worried about side-effects.
While patient information leaflets could provide important information not always provided by doctors, Korab said such leaflets were “often inaccessible” and, studies had shown, “were not really what patients want to see”.
The DDS and DDSi packs are designed, conversely, to incorporate simple graphics indicating when to take the medication, but also offer substantial printable areas for key textual and other information/graphics, in place (in Korab’s words), of “lengthy, unwieldy patient information leaflets with text often too small and difficult to read”.
To further enhance the cartons’ child-resistance, the inlays can be made from Stora’s tear-resistant CKB Pharma TR board. While the DDS is designed to enhance the chances of patients taking medication, the DDSi takes the compliance theme on step further. The pack incorporates sensors, printed one per pocket in the inlay using conductive inks, in which an electronic circuit is broken every time the patient removes the tablet, pill or capsule. Breaking the circuit can be made to sound a beeper, which continues sounding until the patient presses a separate button within a questionnaire panel to indicate how they are feeling at the time and any reaction to the individual dose.
Once a course of medication is finished the pack, including its smart inlay, can be taken to the doctor’s surgery and linked to a PC or laptop. The data that has been recorded on an smart ASIC chip build into the inlay over, say, the preceding month, can then be downloaded to give the GP a complete record of the time and date each tablet has been taken and any patient reaction. Alongside enabling detailed monitoring of individuals’ treatment regimes, Stora and Cypak believe the technology could be invaluable in clinical trials.
The ASIC NFC (near field communication) chip, which is being used for the first time in an intelligent packaging solution, can hold up to 32kb of data, while 128 bit AES encryption prevents downloaded data falling into the wrong hands. The DDSi packs can incorporate up to 32 sensors per pack, allowing a drug manufacturer, for instance, to incorporate 20 sensor-equipped daily pill pockets plus a further 12 sensors to monitor drug reaction in one inlay. Whether inlays are supplied with the conductive sensors already incorporated and the electronics pre-mounted is up to the customer.
Cypak, which is supplying the key electronic components, can also supply a portable GSM/GPRS reader, obviating the need to connect the pack to a PC. This can configured to e-mail or SMS data on dosage /time taken/ drug reaction etc to the doctor wirelessly at specified intervals.
Stora Enso stresses that, being compatible with the latest mobile technology, the DDSi technology allows packs to also include an alarm to remind patients it is time to take the dose, further increasing the likelihood of adherence to drug regimes. Saarinen predicts the system will “probably be used first in a clinical trial or packaging revamp for a drug requiring high compliance and compliance monitoring”.
While Cypak supplies basic software with the DDSi carton to enable downloading of data to a doctor’s PC, Stora Enso offers as an alternative its own recently introduced PackAgent software, which also includes modules for product authentication and tracking and tracing and to enable companies to comply with e-pedigree regulations.
Addressing representatives from many of Europe’s top pharmaceutical manufacturers, speakers from Stora Enso, Cypak and HCPC Europe all endorsed the urgent need for packaging such as the DDS and DDSi to combat a non-compliance problem which the HCPC’s Korab said “costs or endangers many, many thousands of human lives and costs government, pharma companies and the healthcare industry billons of dollars annually”. He concluded: “Packs like the DDS and DDSi can play a critical part in improving compliance and thus preventing many medical conditions from worsening unnecessarily and indeed causing deaths which, with correct adherence to drug regimes, could be easily preventable.”
Stora Enso Consumer Board
T: +358 400 654 928
The Pharma DDSi carton incorporates printed electronic sensors to enable in-pack data storage on the patient’s reaction to a particular medicine throughout a course of treatment The dedicated DDSi reader, in which the inlay from completed packs is placed, can be linked to a PC or laptop