scholarly journals Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance

2021 ◽  
Vol 41 ◽  
pp. 101135
Author(s):  
Liang Zhao ◽  
Zhichuan Li ◽  
Lanyan Fang ◽  
Myong-Jin Kim ◽  
Srikanth C. Nallani ◽  
...  
Pharmaceutics ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 284
Author(s):  
Maksim Khotimchenko ◽  
Victor Antontsev ◽  
Kaushik Chakravarty ◽  
Hypatia Hou ◽  
Jyotika Varshney

The use of opioid analgesics in treating severe pain is frequently associated with putative adverse effects in humans. Topical agents that are shown to have high efficacy with a favorable safety profile in clinical settings are great alternatives for pain management of multimodal analgesia. However, the risk of side effects induced by transdermal absorption and systemic exposure is of great concern as they are challenging to predict. The present study aimed to use “BIOiSIM” an artificial intelligence-integrated biosimulation platform to predict the transdermal disposition of opioid analgesics. The model successfully predicted their exposure following the topical application of central opioid agonist buprenorphine and peripheral agonist oxycodone in healthy human subjects with simulation of intra-skin exposure in subjects with burns and pressure wounds. The predicted plasma levels of analgesics were used to evaluate the safety of the therapeutic pain control in patients with the dermal structural impairments caused by acute (burns) or chronic cutaneous lesions (pressure wounds) with topical opioid analgesics.


2014 ◽  
Vol 14 (4) ◽  
pp. 219-234 ◽  
Author(s):  
Marie Claire Van Hout

Purpose – The misuse of pharmaceutical opioid analgesics is identified as a global public health concern. Codeine represents an interesting quandary in terms of its regulated status, with individuals varying in their metabolism of codeine, estimation of safe dosages, risk of adverse health consequences and abuse potential. Efforts to quantify and address hidden non-compliant medical codeine use, overuse and intentional misuse is compromised by availability to the public in prescribed and over the counter forms. The paper aims to discuss these issues. Design/methodology/approach – A review of literature on codeine use, misuse and dependence, and associated innovative medical and pharmacy interventions is presented, and was conducted as part of a larger scoping review on codeine. Findings – The review highlights the complexities associated with monitoring public health awareness of codeine's abuse potential, and customer/patients trends in non-compliant codeine use for therapeutic and recreational purposes. Aberrant codeine behaviours centre on visiting multiple doctors for prescriptions, repeated lost or stolen prescriptions, forging prescriptions and use of multiple pharmacies. Innovations to monitor misuse of codeine include national prescription databases and recent developments in real-time monitoring of dispensing activity. Practical implications – Further development of real-time monitoring processes with process evaluation is advised. Originality/value – This viewpoint is intended to demonstrate how efforts to quantify and address codeine use are compromised by its availability. It intends to encourage further policy and practitioner dialogue on how to monitor, support and intervene with consumers misusing codeine.


Author(s):  
Dirk K. Wolter

Zusammenfassung. Zielsetzung: Übersicht über Suchtpotenzial und andere Risiken von Opioidanalgetika im höheren Lebensalter. Methodik: Narrativ review. Literaturrecherche in PubMed (Suchbegriffe: opioid analgesics UND abuse; opioid analgesics UND dependence; opioid analgesics UND addiction; opioid analgesics UND adverse effects; jeweils UND elderly) sowie aktuellen einschlägigen Standardwerken; Auswahl nach altersmedizinischer Relevanz und Aktualität. Ergebnisse: Die Verordnung von Opioidanalgetika (OA) hat in den letzten 25 Jahren massiv zugenommen, die weitaus meisten Verordnungen entfallen auf alte Menschen und Menschen mit chronischen Nicht-Tumorschmerzen (CNTS). Die diagnostischen Kriterien für die Opiatabhängigkeit in ICD-10 und DSM-5 sind für die OA-Behandlung von CNTS ungeeignet. Bei langfristiger OA-Behandlung bei CNTS kann eine spezifische Form von Abhängigkeit entstehen, die nicht mit der illegalen Opiat-(Heroin-)Sucht gleichzusetzen ist. Vorbestehende Suchterkrankungen und andere psychische Störungen sind die wesentlichsten Risikofaktoren. Weitere Nebenwirkungen sind zu beachten. Schmerztherapie bei Suchtkranken stellt eine besondere Herausforderung dar. Schlussfolgerungen: Die Anwendung von OA bei CNTS verlangt eine sorgfältige Indikationsstellung. Die besondere Form der Abhängigkeit von OA ist nicht ausreichend erforscht und wird zu wenig beachtet.


2009 ◽  
Author(s):  
Petra L. Rovers ◽  
John J. Van Epps ◽  
Esra B. Akturk ◽  
Elizabeth A. Skowron

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