Following a highly successful Phase I award, this Phase II SBIR application proposes development of MedicaSafe Opioids - a risk management system for the treatment of chronic pain patients prescribed opioid therapies. The need for this system arises from the dramatic increase in the use of opiod painkillers. Although this form of medication can be highly effective in the treatment of pain, it can also be misused, abused, and involve serious risks. Prescription opioids are now the second most abused drugs in the US, and a primary reason prescription drug poisoning has recently become the second-leading cause of unintentional death. To address this issue, leaders in the field have increasingly called for the adoption of a "balanced" approach to opioid risk management that simultaneously reduces the misuse and abuse of these drugs without limiting their availability to patients with legitimate medical needs. MedicaSafe Opioids is intended to achieve this objective. The solution consists of generic opioid painkillers re-branded via "smart" packaging in a specialized low-cost, tamper-resistant drug dispensing device (DDD) that controls access to prescribed medications via limited-use pass codes, a web/phone portal patients use to obtain these pass codes and report on treatment status, and a web-based administrative portal providers use to setup treatment parameters and monitor patient progress. The combined capacities of the system makes it possible for providers to remotely monitor and control patient access to opioid pain killers, while assessing their real-time clinical status and providing education about effective "safe use" practices. In Phase I, a high fidelity "looks like, works like" physical prototype of te core components of the proposed system was developed and tested. As long as the system performs reliably, results suggest that pain patients view the approach as an acceptable and valuable means of managing the risks associated with the use of opioids, and that pain providers view the system as embodying the principles of an ideal opioid risk management solution. In Phase II, continued efforts will focus on the production of a full version of the MedicaSafe system that takes into account Phase I findings;completion of a situational study that assesses performance of the Beta version of the MedicaSafe system in a naturalistic clinical environment;completion of a randomized controlled clinical trial that compares the efficacy of MedicaSafe vs. the latest electronic adherence monitoring (EAM) alternative in the delivery of opioid therapies for chronic pain patients over the course of a year;and, finally, completion of an acceptance study that comprehensively evaluates acceptance of the MedicaSafe system from both the patient and provider point of view.
Chronic pain is a serious and undertreated public health problem. However, the increased use of prescription opioids for pain management has been associated with escalating abuse that healthcare providers are ill- equipped to address. This research will develop a risk management approach that involves re-branding generic opioids through the use of smart packaging intended to reduce prescription opioid abuse while simultaneously promoting effective pain management.