Packaging & Bottling - Stick with it
Designs on you: Effective package design is proven to deliver tangible results and adherence gains, translating into improved health outcomes for patients
With recent governmental reforms in healthcare across the US, Europe, and extending into other developed countries there is more accountability for stakeholders to demonstrate the effectiveness of treatments in driving improved health outcomes. Staggering statistics demonstrate that adherence to some medication regiments can fall as low as 30% for some grave disease states. As such, across the pharmaceutical and healthcare spectrum, industry professionals are working diligently and investing significant resources to solve the enduring challenge of patient compliance and positively affect patient behaviors.
Patient compliance and adherence is drawing significant attention in the clinical healthcare community because of its impact on the ultimate success of demonstrating investigational drug effectiveness in clinical studies. Sponsors simply cannot afford to waste the time, cost and associated resources when studies are undermined by non-adherence.
Techniques designed to monitor patient adherence can provide widely differing results in patient behaviors and realised patient health outcomes for the study medication. The traditional method of studying adherence is to pill count returned study medications however, published studies have proved that patients ‘pill dump’ rather than reporting their inconsistencies in dosing. This creates unreliable data for monitoring true compliance and adherence. These inconsistencies may occur over the course of several days masking lengthier drug holidays where the patient is off therapy. This variable cycle reduces the medication’s therapeutic effect for the patient and hampers the sponsor’s expected study outcomes.
To ensure a more accurate view of patient behaviours sponsors are utilising innovative electronic compliance monitoring technologies, allowing study administrators to identify non-adherent study subjects. As such analysis is based on the true impact of their medication on patient health.
Monitoring patient behavior in clinical studies is less complicated; patients have opted into study participation and are typically receiving therapy free of cost. This patient population is motivated to try a new therapy that may provide hope in addressing their disease state. By contrast, analysing patient behaviour for commercially available medications ushers in many other considerations and environmental influences, most notably cost.
Patient non-compliance in the general population is a multifaceted issue and rarely does a single remedy fully address the cause or significantly affect the health outcome. Non-compliance is driven by conscious and unconscious behaviours, and those behaviors and factors may vary significantly from one disease state to the next.
Stakeholders look to address patient behaviors and their causes at various patient touch points. This may include doctor/nurse interventions, pharmacist counseling or third party clinical counseling, gadgets such as electronic reminders, text messaging, phone or email prompts may also be considered. Other adherence strategies include predictive modeling to identify at-risk patients, goal setting programs and incentivizing patients for positive behaviors.
Experts agree finding synergies and addressing the root cause for the specific patient population and disease state delivers the most effective results.
Published studies demonstrate that the most effective singular strategy is providing medication in unit dose calendarised formats. This is proven to increase patient compliance and adherence, i.e. taking product as prescribed, as well as medication persistence. In 2011 the Clinical Therapeutics journal published a study of 3 million users of generic medicines. The study highlighted the use of calenderised packaging demonstrated a 17 day increase in persistence compared to using traditional vials whilst patients receiving a calendarised blister design also realized up to 37% increase in proportion of days covered (PDC).
A second study in the journal Dove Press analyzed the effect of calendarized packaging for the drug Diovan HCT. This study affirmed the findings in the generic study, demonstrating up to 44 days increased length of therapy for users of calendarized unit dose formats.
These results demonstrate that simple packaging interventions realize modest gains in addressing patient health outcomes. Even more encouraging is the use of compliance prompting packaging in conjunction with other adherence methods. Increasingly calendarized formats in concert with other adherence tools are being used to address conscious and unconscious patient behaviors at the point of administration. These tools may include co-pay cards or instructions for medication reimbursement, education tools about the drug or disease state, enrollment tools for integrated health programs, lifestyle tips and guides, specific dosing guides for complicated drug regimens, patient diaries and goal setting tools. Integrated directly in the packaging, these tools can yield tremendous results.
Utilizing packaging as part of a broader adherence strategy is best achieved with collaborative goal setting and specific measures for Return on Investment. Effective package design is proven to deliver tangible results and adherence gains, translating into improved health outcomes for patients. The rise in prominence of compliance prompting packaging in the competitive landscape underscores its role in the new healthcare paradigm – proven effectiveness in better patient health as a competitive necessity.