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The ongoing increase in the misuse and mortality amid the opioid epidemic has been contributing to its rising cost. The worsening health and economic impact of opioid use disorder in the US warrants further attention. Comparing the ratio of the percentage of adverse drug events as reported by the FAERS relative to the percentage of distribution as reported by the ARCOS database is a novel approach to evaluate post-marketing safety surveillance and may inform healthcare policies and providers to better regulate the use of these opioids. Methods: We analyzed the adverse events for 11 prescription opioids, when correcting for distribution, and their ratios for three periods, —, —, and —, in the US. The opioids include buprenorphine, codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Oral morphine milligram equivalents MMEs were calculated by conversions relative to morphine. The relative ADEs of the selected opioids, opioid distributions, and ADEs relative to distribution ratios were analyzed for the 11 opioids. Opioid distributions were relatively constant over time, with methadone repeatedly accounting for the largest proportions. Many ADE-to-opioid distribution ratios increased over time, with meperidine There is further need to monitor and address the ADEs of these drugs. Opioids have been commonly prescribed to treat moderate to severe pain for various conditions, including cancer and trauma. Fentanyl, methadone, and oxycodone are examples of commonly prescribed opioids. Overuse of these drugs can lead to adverse drug events ADEs , tolerance, dependence, addiction, overdose, and death. Drug overdose deaths increased four-fold from to , with opioid-related deaths accounting for about two-thirds of the deaths Singh et al. Although the volume of opioids prescribed in the US decreased from to after peaking in , the amount is still significantly higher relative to Guy, ; Mack et al. Furthermore, the US ranked third for the highest opioid consumption per capita Richards et al. The detrimental health and economic impact of both pain and opioid use disorder treatments in the US warrants further attention. A recent report examining the national patterns in opioid exposure reported to the US poison control centers indicated that the proportion of exposure with adverse drug events ADEs increased despite the overall decrease in the frequency and rate of opioid exposure from to Rege et al. Drug Enforcement Administration, This analysis identifies the opioids that were over- or under-represented for ADEs relative to their use. These opioids were selected based on previous studies and their status as being FDA-approved and commonly prescribed. Nine of them are used primarily for pain, namely, codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone, and tapentadol, and two of them are mainly used for opioid use disorders OUD , buprenorphine and methadone Modarai et al. We separated the analysis into three time periods based on pre- — , intra- — , and post-peak — opioid distribution time intervals. Specifically, was the peak year of opioid count by morphine milligram equivalents MMEs Piper et al. Food and Drug Administration, Supplementary Table S1 indicates the search terms used for these opioids. It includes controlled substances for medical use and is, therefore, a very inclusive and valid database Bokhari et al. The total oral MME was calculated based on the weight of all 11 opioids and expressed in three periods —; —; — for the US, excluding the US territories. Hereafter, these periods are referred to as the first, second, and third, respectively. The first period showed increases in prescription opioid distribution, was the peak year, and the third period showed a further decline in the opioids used for pain and an escalation in OUD treatment Piper et al. The top three reaction groups and reactions were reported for each opioid from — with percentages indicating the amount relative to the total number of adverse events within that period. The oral MME was calculated to correct for the relative potency of each opioid relative to morphine. The conversions were as follows: buprenorphine 10 , codeine 0. For buprenorphine, the CDC MME conversion charts ceased to include the opioid in , while at a low dose, buprenorphine can produce significantly greater opioid responses than morphine. We decided to conduct an average of narcotic treatment programs 12 and other sources 8 for an MME of Additionally, there is a range of the equianalgesic dose ratio of methadone established from previous studies with a median dose ratio ranging 5. As for fentanyl, 75 was selected as it is 50— times more potent than morphine Higashikawa and Suzuki, ; Volpe et al. We extracted the top three reaction groups and reactions to outline the common adverse drug effects associated with the selected opioids, indicating which adverse effects may have been contributing to the reports. It is important to note that the death report percentages are overestimated as large public databases involve individuals who can submit more than one report Stephenson and Hauben, ; United States Drug Enforcement Administration, Data analysis and figure preparation were completed with GraphPad Prism, version 9. Almost one-third Codeine Oxycodone, fentanyl, and morphine were responsible for over half The top three most common reaction groups included injury, poisoning, and procedural complications; general disorders and administration site conditions; and psychiatric disorders. The common specific reactions consisted of abnormal drug effects e. TABLE 1. The three most common reaction groups and reactions are shown. Figure 1 shows the percentage of ADEs for each opioid. Oxycodone was consistently high across all periods: — Fentanyl accounted for the largest portion of ADEs in the first two periods — Figure 2 shows the percentage of the total MMEs due to each opioid over time. The opioids were classified into three groups, which were generally stable over time, namely, high: methadone and oxycodone; intermediate: buprenorphine, hydrocodone, morphine, and fentanyl; and low: hydromorphone, codeine, oxymorphone, tapentadol, and meperidine. Methadone accounted for over two-fifths of the total distribution: — Figure 3 shows the ADE-to-distribution ratio for each opioid for each period. The general pattern was of increases over time, with the most over-represented opioid in the third period being meperidine Values greater than 1. Our study identified the varied ADEs for 11 commonly used opioids. Oxycodone, fentanyl, and morphine accounted for over half Oxycodone shows high potential for misuse due to its high reinforcing characteristics and its administration methods, including pill crushing for immediate release and through IV injections, leading to high dependence Kibaly et al. Fentanyl with its high potency and abuse potential, as well as the tendency to be mixed with other drugs, may contribute to high ADEs across all three periods United States Drug Enforcement Administration, ; Comer and Cahill, ; National Institute on Drug Abuse, Like other opioids, morphine tolerance can develop secondary to its continuous usage due to the changes in the receptor density and G-protein-coupled receptors and its signal transduction pathway Listos et al. The distribution of this ubiquitous agent has continued to decline Harrison et al. Methadone and buprenorphine both showed increases in distribution in the past decade mostly due to their use for OUD, with buprenorphine also showing a These opioids have been commonly used to treat opioid dependence, and with an expanded Medicaid coverage, their prevalence has been rising Mattick et al. The high distribution of oxycodone may be attributed to its common use and effectiveness for treating moderate-to-severe acute pain Moradi et al. Given that meperidine demonstrated the lowest frequency of ADEs, it was surprising to find that its adverse effects were the most overly represented compared to its distribution In contrast to Veronin et al. The decline in oxycodone overdoses might be attributed to the reduction in abuse since the development of its extended release in late Johnson et al. Oxymorphone as a schedule II drug has a high potency and misuse potential related to its euphoric effects explaining the huge increase in proportion, which might also explain its high proportion of deaths from ADEs United States Drug Enforcement Administration, It was, therefore, unexpected to see its over-representation There has been some prior confusion regarding the safety of methadone relative to its role as the most distributed opioid by MMEs in the US Piper et al. The Drug Abuse Warning Network DAWN , a nationwide public health surveillance system administered by the Substance Abuse and Mental Health Services Administration to monitor drug-related visits to hospital emergency departments, reported in its preliminary findings from its drug-related ED visits in that opioids were one of the top five substances for ED visits, with most reports being heroin-related, other opioids oxycodone, buprenorphine, codeine, etc. Combined with the reduced distribution based on the ARCOS reports regarding fentanyl counts in recent periods relative to other opioids, the adverse event-to-distribution ratio has decreased throughout the three periods. The main strengths of our novel study include the analysis of 11 commonly prescribed opioids, separated into uses for pain and OUD, with a new approach using both the FAERS and ARCOS database to quantify adverse events relative to the distribution of the opioids. There are no available data that break down the formulations of buprenorphine i. The FAERS database might have over-represented the selected opioids because of duplicates, incomplete results, non-verifiable data, and uncertainty in adverse effect causalities Veronin et al. In this case, most of the opioid ADE reports were from patients, with one-third being from medical professionals, which may contribute to the heterogenous quality of reports because of differing report behaviors between healthcare professionals and customers Toki and Ono, The FAERS database is specifically populated by both mandatory manufacturers of drugs and voluntary healthcare professionals, consumers, family members, etc. However, the FAERS database is a unique resource and has been used extensively by researchers for exploratory analyses and to identify hypotheses for further investigation Sakaeda et al. The database has also been the primary surveillance database used to identify safety issues and adverse events or post-marketed drugs for decades as there is no other database that provides data on the relation of the drugs and ADEs Wykowski and Swartz, We assume that it is justified that individual opioids are equally likely to be reported to the FAERS and that it is the best database to date to analyze adverse events of prescription drugs, although future studies are needed to evaluate these hypotheses. However, as over three-quarters of FAERS submissions were completed by non-healthcare providers for oxycodone, hydrocodone, oxymorphone, and tapentadol, it is also possible that the US public is increasingly aware of the adverse effects of opioids Macy, and is increasingly willing to utilize the FAERS to play their role in combatting the opioid epidemic. Further investigations with the FAERS and other similar databases will be necessary to determine if Figures 1 , 3 are more informative. Although the FAERS database has known limitations US Food and Drug Administration, , our exploratory analysis of the individual opioids provides novel findings that may guide further research in databases like the DAWN as the system only reports fentanyl-related and heroin-related products as separate groups while grouping other known opioids Substance Abuse and Mental Health Services Administration, Another key limitation is that to date, there is no known database that consistently and accurately reports adverse events, abuse, and deaths. The CDC reporting of overdoses, for instance, has and continues to lack transparency with errors in counting overdose deaths Peppin and Coleman, Another study reports that the death determination process is not uniform across the states Kaufman et al. Our analysis on FAERS and ARCOS databases demonstrated general increases in adverse events relative to opioid counts for the selected opioids, with varied relative individual adverse events when accounting for their distribution. It also provides a novel finding on individual opioids using both databases, further promoting research with other public databases like the Drug Abuse Warning Network. Emergency room visits in involving fentanyl presumably predominantly illicit were only one-fourth as common as other opioids i. Overall, the distribution pattern informs us of the need for continuous efforts to address the ADEs of specific opioids to inform healthcare policies and change the perspectives of healthcare providers on these drugs and their prescription practices. EL was responsible for the data collection, analysis, and writing of the first version of the manuscript. Iris Johnston provided technical support to the authors. BP was part of an osteoarthritis research team supported by Pfizer and Eli Lilly. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors, and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. American Society of Addiction Medicine The ASAM national practice guideline for the treatment of opioid use disorder: focused update. Azar, P. Rise and regional disparities in buprenorphine utilization in the United States. Drug Saf. Bishop-Freeman, S. Buprenorphine-related deaths in North Carolina from to Bokhari, F. An analysis of the significant variation in psychostimulant use across the U. Boyle, J. Declines and pronounced regional disparities in meperidine use in the United States. Burns, R. Policies related to opioid agonist therapy for Opioid Use Disorders: The evolution of state policies from to Cabrera, F. Opioid distribution trends — in the US Territories. PeerJ 7, e Centers for Disease Control and Prevention Calculating total daily dose of opioids for safer dosage. Google Scholar. Understanding the epidemic. Cicero, T. Factors contributing to the rise of buprenorphine misuse: — Drug Alcohol Depend. Collins, L. Trends in the medical supply of fentanyl and fentanyl analogues: United States, to Comer, S. Fentanyl: Receptor pharmacology, abuse potential, and implications for treatment. Davis, C. Laws limiting prescribing and dispensing of opioids in the United States, Addiction 7 , — Eidbo, S. Declines and regional variation in opioid distribution by U. Pain 6 , — Fang, H. Exploring the FDA adverse event reporting system to generate hypotheses for monitoring of disease characteristics. Florence, C. The economic burden of opioid use disorder and fatal opioid overdose in the United States, Furst, J. Pronounced regional disparities in United States methadone distribution. Guy, G. Vital signs: Changes in opioid prescribing in the United States, — Harrison, L. Pronounced declines in meperidine in the US: Is the end imminent? Higashikawa, Y. Studies on 1- 2-phenethyl N-propionylanilino piperidine fentanyl and its related compounds. Structure-analgesic activity relationship for fentanyl, methyl-substituted fentanyls and other analogues. Forensic Toxicol. Johnson, H. Decline in drug overdose deaths after state policy changes — Florida. MMWR Morb. PubMed Abstract Google Scholar. Kaufman, D. Forensic Sci. Opioid mortality following implementation of medical cannabis programs in the United States. Pharmacopsychiatry 54 2 , 91— Kibaly, C. Cell Mol. Lawlor, P. Dose ratio between morphine and methadone in patients with cancer pain: A retrospective study. Cancer , — Listos, J. The mechanisms involved in morphine addiction: An overview. Lowe, A. Fatal overdoses involving hydromorphone and morphine among inpatients: A case series. Mack, K. Physician dispensing of oxycodone and other commonly used opioids, —, United States. Pain Med. Macy, B. Dopesick: Dealers, doctors, and the drug company that addicted America. New York: Little Brown and Company. Mattick, R. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst. Modarai, F. Relationship of opioid prescription sales and overdoses, North Carolina. Moradi, M. Use of oxycodone in pain management. Fentanyl DrugFacts. Pashmineh Azar, A. Peppin, J. CDC's efforts to quantify prescription opioid overdose deaths fall short. Pain Ther. Piper, B. Assessment of controlled substance distribution to U. Trends in medical use of opioids in the U. Rege, S. Opioid exposures reported to U. Poison Centers. Use Misuse 56 8 , — Richards, G. Global, regional, and national consumption of controlled opioids: A cross-sectional study of countries and non-metropolitan territories. Ripamonti, C. Romualdi, P. Pharmacological rationale for tapentadol therapy: A review of new evidence. Pain Res. Sakaeda, T. Data mining of the public version of the FDA adverse event reporting system. Singh, G. Opioid epidemic in the United States: Empirical trends, and a literature review of social determinants and epidemiological, pain management, and treatment patterns. Stephenson, W. Data mining for signals in spontaneous reporting databases: Proceed with caution. Preliminary findings from drug-related emergency department visits, ; Drug Abuse Warning Network. HHS Publication No. Toki, T. Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: A comparison between consumer reports and healthcare professional reports. United States Drug Enforcement Administration Counterfeit prescriptions pills containing fentanyls: A global threat. Diversion control division drug and chemical evaluation section. Drug scheduling. Veronin, M. Opioids and frequency counts in the us Food and drug administration adverse event reporting system FAERS database: A quantitative view of the epidemic. Drug Healthc. Patient Saf. Volpe, D. Uniform assessment and ranking of opioid mu receptor binding constants for selected opioid drugs. Webster, L. An analysis of the root causes for opioid-related overdose deaths in the United States. Wykowski, S. Adverse drug event surveillance and drug withdrawals in the United States, The importance of reporting suspected reactions. Zhou, Z. Complementing the US Food and drug administration adverse event reporting system with adverse drug reaction reporting from social media: Comparative analysis. The use, distribution or reproduction in other forums is permitted, provided the original author s and the copyright owner s are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Liu, eliu som. Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher. Top bar navigation. About us About us. Sections Sections. About journal About journal. Article types Author guidelines Editor guidelines Publishing fees Submission checklist Contact editorial office. Variation in adverse drug events of opioids in the United States. Edward Y. Introduction Opioids have been commonly prescribed to treat moderate to severe pain for various conditions, including cancer and trauma. Statistical analyses The total oral MME was calculated based on the weight of all 11 opioids and expressed in three periods —; —; — for the US, excluding the US territories.

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