Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Opioid crisis in US - Describing the historical background and discussing the regulatory strategies to tackle the epidemic ***

Dr. Sapuna Mary Kuriakose (Abschlußjahr: 2019)

Summary
Language: English
Currently, USA is in the midst of a devastating opioid epidemic. According to the Centers for Disease Control and Prevention, over 70.000 drug overdoses cases have been recorded in 2017. Two third of these deaths are attributable to opioids. Overdose related opioids include prescription opioids (hydrocodone, oxycodone, codeine and morphine), illicit opioids like heroin and illicitly manufactured synthetic fentanyl.
This work describes the factors contributing to the development of opioid crisis and discusses the strategies used to combat the crisis.
Multiple factors have been described in the literature which have contributed to the onset of this crisis. In the 1990s, claims about underassessment and inadequate treatment of pain dominated the medical society. In response to this, the American Pain Society suggested the classification of pain as the fifth vital sign. The use of numerical pain scores was suggested for the measurement of pain. In response Joint commission, responsible for the accreditation of health care facilities in the US, integrated pain assessment and pain management standards for accredited hospitals. Likewise, Hospital Consumer Assessment of Healthcare Providers and Systems-Survey (HCAHPS), a standardized and publicly reported patient satisfaction survey, used to determine the quality care of a hospital included questions about pain management. This survey was also used for health care reimbursement issues. Consequently, the adequate assessment and management of pain became increasingly important and thus pressurized physicians to prescribe opioids to satisfy the patients and avoid administrative criticism.
In addition, many misleading publications with studies lacking sound scientific principles claimed opioid analgesics were less addictive and called for opioid treatment for patients with chronic non-cancer pain.
Moreover, the fact that pain was undertreated formed the basis for the “aggressive” marketing strategy of many pharmaceutical companies who overstated the benefits of opioids for chronic pain and induced physicians to issue more and more prescriptions resulting in more addicted people.
To combat the opioid epidemic various approaches have been implemented. The focus of this work has been laid on the strategies used to control the “supply chain” of the prescription opioids. On the state level, the strategies include prescription drug monitoring systems and limits on opioid supply and dosage derived from the CDC Guideline for Prescribing Opioids for Chronic pain. On the federal level, FDA has recently released a draft guidance for the assessment of benefits and risks of opioid analgesics through laying additional focus on evaluating the effect of inappropriate use of opioids on public health. For all newly applied opioid ER/LA medications, FDA requires a Risk Evaluation and Mitigation Strategy. Finally, to avoid abuse of medication opioids, it encourages the development of abuse deterrent formulations.
All these approaches have their benefits and limitations. Although PDMPs help to control misuse and abuse, through state-wide variations there are still challenges to overcome. Setting firm limits on opioid dosage and therapy duration managed to show a decline in prescription rates. However, patients with chronic pain are undertreated. The high cost of abuse deterrent formulation and the fact that insurance companies refuse to provide coverage make them unaffordable for patients. It can be concluded that the strategies help to minimize abuse and misuse, however without considering addicted people and chronic pain patients. Creating a better balance between treating pain and preventing abuse still remains a challenging issue.
Pages: 42