Chronic pain is a significant health care problem affecting 53 million Americans. It is also a major social problem that seriously affects the quality of people’s social and working lives. The impact of pain includes difficulties with basic everyday activities such as walking, dressing and sleeping (14 million Americans cannot function without opioids to control their chronic pain) and extends to depression, job loss and family breakdown.
Today there are two epidemics. The most visible is the tragic opioids epidemic. It has resulted in pressure from multiple fronts to preclude opioids prescribing and to hold everyone related to the manufacture, distribution, prescribing, sale, and dispensing of opioids legally accountable for this tragedy. This has precipitated a second epidemic (tragedy), precluding access by chronic pain patients to get the required opioids to control their pain ... and the ability of those patients who cannot function without opioids to manage their pain ... or to receive the appropriate treatment.
Opioids represent a unique challenge. Pain is an individual threshold. What is excruciating for one person may be a minor irritant for another. This requires careful opioid dose titration to balance pain relief versus side effects and the ability to function. Another problem is that patients begin to develop opioid tolerance within the first few days of beginning to take the opioid. This means that as tolerance builds, a higher opioid dose is required to control the same level of pain. Simultaneously, tolerance is developed for certain opioid dose mediated side effect, e.g., opioid induced constipation, nausea, vomiting, respiratory depression, etc. However, side effect tolerance does not develop as fast as pain tolerance. This requires careful patient monitoring to preclude dose-mediated side effects such as overdose and constipation, etc. In addition, over time, the opioid may become ineffective and require the prescriber to switch opioids to manage the patient's pain. Another concern arises when high opioid dose patients stop taking their dose and then decide to start taking the prescribed high dosage opioid again. When they stop taking the opioid, opioid tolerance quickly decreases. If a high dose patient begins to take a high dose of an opioid after taking an opioid holiday, the patient could overdose due to decreased tolerance. Yet another concern has to do with stopping opioid therapy. Sudden withdrawal can result in severe withdrawal symptoms.
While dependence on and/or addiction to opioids is always a concern, for some patients who cannot function without opioids therapy, the bigger concern is managing the patient’s pain - so they are able to function in society and enjoy some resemblance of quality of life.
Various federal, state and local governments, represented by different agencies from the DEA, FDA, NIH, MEDICARE, MEDICAID, law enforcement, foster care services, etc., are interested in controlling access to prescription opioids because their use has precipitated the prescription as well as illegal opioids epidemic. Their general focus is on prescription compliance, the control of opioids misuse, abuse, diversion, and accidental ingestion. They are doing this by establishing prescribing restrictions (prior approval, step therapy, limited prescription size, etc.), requiring prescription education (REMS programs), centralized opioids prescription monitoring/tracking (PDMP programs) to preclude multiple prescriptions, opioids chain of custody tracking, etc.
Opioids are effective medications for certain patients. However, new opioid therapies are needed that address the clinical and societal issues related to opioids. The focus needs to be on safely managing the patient’s pain while precluding dose-mediated adverse events. Ideally, they also need to address the societal issues which have contributed to the opioid epidemic.
ACCOY's singular focus is on doing what is best for the patient. ACCOY is developing "Novel New Pain Therapies" that address both the patient's needs and societal concerns to make effective pain management available with an improved opioid safety profile for those patients who cannot function without their opioids to control their pain.
Sources: PopulationPyramid.net, Population Pyramids of the World from 1950 to 2100, United States of America 2019, https://www.populationpyramid.net/united-states-of-america/2019/, May 1, 2019. Prevalence and Profile of High-Impact Chronic Pain in the United States by Mark H. Pitcher, Michael Von Korff, VM., Catherine Bushnell, and Linda Porterz, The Journal of Pain, Vol 20, No 2 (February), 2019: pp 146−160, Available online at www.jpain.org and www.sciencedirect.com. Trends and Patterns of Geographic Variation in Opioid Prescribing Practices by State, United States, 2006-2017, Lyna Z. Schieber,MD, DPhil (Oxon); Gery P. Guy Jr, PhD, MPH; Puja Seth, PhD; Randall Young, MA; Christine L. Mattson, PhD; Christina A. Mikosz, MD, MPH; Richard A. Schieber,MD, MPH, JAMA Network Open. 2019;2(3):e190665. doi:10.1001/jamanetworkopen.2019.0665, March 15, 2019.