By Renard P. JacksonFollowing a daily regimen of prescriptions is a time-consuming effort on the part of the consumer. But the impact of not taking medication correctly or skipping doses can lead to big problems. With more and more branded and generic pharmaceuticals on the market, and an aging population, the issue of compliance has emerged as one of the health industry’s biggest challenges.
Whether the issue is designing packaging that meets both strict child-resistant and senior-friendly regulations, or simply the struggle to aid patients and consumers in their efforts to comply with their dosing instructions, manufacturers and packagers face a dilemma – producing compliant solutions that are efficient, effective and low cost.
Just how serious is the issue of non-compliance? Non-compliance results in:
* Increased healthcare costs, stemming from $8.5 billion in hospitalizations with direct and indirect costs reaching $100 billion, including $50 billion in lost productivity, according to the Healthcare Compliance Packaging Council.
* Increased adverse outcomes, as 320 deaths a day are attributed to non-compliance according to the Healthcare Compliance Packaging Council.
* Increased hospitalizations, as 10 per cent of hospitalized patients are admitted because of incorrect medication usage, reports the American Health Care Association.
In fact, M.H. Becker, author of Medical Care, noted that patient compliance, specifically related to medication safety, has become the best documented, but least understood, health-related behavior. A 2003 World Health Organization study notes that increasing the effectiveness of adherence interventions may have a far greater impact on the health of the world population than any improvement in medical treatment. The compliance issue is heightened and must be addressed because as more sophisticated medications emerge, it will be increasingly important for patients to strictly adhere to dose requirements.
The health-care community has explored many ways to improve patient adherence from physician prodding to patient education – and, increasingly, innovative technologies. The Internet allows physicians and health insurers to remind their patients to take their medicine. For instance, some health insurers are reviewing computer records regarding prescription refills and sending reminders or even calling their clients to alert them to get a refill. Educating patients about compliance and the dire consequences that can occur if they don’t comply also has become a priority among medical professionals, pharmaceutical companies and others. The Patient Education Institute, for example, offers a myriad of services, including online training, patient education stations and kiosks, custom patient-education content, custom multimedia software, and integrated patient-education systems.
While the above offer great strides in educating the patient, advances in packaging technology still represent one of the biggest opportunities to improve compliance. One of the newest breakthroughs, often referred to as “smart” packaging, promises to revolutionize compliance packaging. It is packaging-identification technology called Radio Frequency Identification (RFID). These “smart tags” provide a viable means of medical-packaging traceability. This new generation of packaging technology – blending the access capabilities and the data storage of a smart silicon computer chip with the power of a radio-frequency signal – can provide a real time picture of medication inventory and helps manufacturers, suppliers and health providers track medications through the supply chain. In years to come, it may provide individual solutions at the unit of use level by replacing or complementing bar code technology. RFID may, through additional product regimen tracking, help ensure patient safety and compliance.
Another new packaging technology concept includes the smart medicine cabinet that has the ability to prompt patients to adhere to medication regimens. While technology is promising, packaging operations have a long way to go to embrace many of these innovative solutions. This reflects several factors, including differences in global customs, difficulties with regulatory-oversight requirements, significant capital outlays and even over-engineering of new, sophisticated packaging — they’re often too simple and too difficult at the same time. Consider that in Europe, only 20 percent of drug products are packaged in bottles compared to 80 per cent in the U.S. On the regulatory front, it is often challenging to launch new compliance-packaging forms, like blister pack unit-dose products, because of the CPSC’s (Consumer Protection Safety Commission) strict requirements on child-resistant technologies. For manufacturers, switching to new packaging can cost an individual company millions of dollars in capital expenditures.
Cardinal Health’s packaging roleCardinal Health’s vertically integrated medication packaging includes cartons, inserts, outserts, labels, patient information and promotional print materials. Contract packaging services include blister packaging, cold-formed foil blisters and blister cards, bottle-filling, pouch and strip packaging, flow packs, and break-off bottles.
Specialized packaging offerings range child resistant and senior friendly solutions to hospital unit dose offerings. These include tamper-evident packaging, child resistant packaging, medical-device packaging and unit dose packaging. Cardinal Health can assist pharmaceutical manufacturers solve packaging problems. Take child-resistant packaging, for example. For a manufacturer, developing such packaging is difficult, and the protocol for testing child-resistant packaging is complex. The tamper-proof containers must restrict access by children but still be accessible by the elderly.
Cardinal Health’s child-resistant packaging solutions comply with the Consumer Product Safety Commission’s rules. These packages include patented blister cards that contain medication, and multiple variations of the child-resistant cards are being developed continually to satisfy the unique needs of the company’s pharmaceutical clients.
Packaging solutions from Cardinal Health vary. To open the Slide Pack, for instance, a patient must insert the index finger through an opening, pull the plastic trigger to expose the foil, hold and press the blister to push the medication through the foil and release the trigger, thus preventing access again. With the E-Z Tear package, the patient must remove a single dose at the perforation, which will tear at the bubble blister only. The child-resistant foil will not puncture. And in RxBarrier package, blisters are protected by a barrier – a PVC cover – that prevents a child from biting individual cavities.
The Future for Compliance PackagingThe future promises more significant forms of innovative compliance packaging that act as “smart” systems. For instance, as conventionally bottled tablet taking medication is replaced by other dosage forms, more opportunities exist to build compliance packaging into the development of the product. Anti-counterfeiting and tamper-proof packaging will also become more widespread, including packaging technologies that can’t be replicated easily, e.g., covert and overt optical variable inks and devices, security papers, sequential bar codes and RFID tags.
But while technology will continue to help improve medication compliance, it alone shouldn’t be considered a panacea. The human impact of technology requires consideration of factors such as patient education, execution and ongoing monitoring. The near and long-term goals, however, are clear. Through enhanced packaging technology, a patient should be able to follow a drug dosing regimen as prescribed by their physician – with as little hassle as possible.
About the author: Renard P. Jackson is Cardinal Health’s executive vice president, sales and business development, packaging services.