Explosive Increase in Tramadol Use in Korea 2003–2013: Analysis of Patient Trends Based on the Korea National Health Insurance Database

Kim, Kyu-Beom; Lee, Hyesung; Shin, Ju‐Young

doi:10.1080/02791072.2019.1612125

Cited by 13 publications

(14 citation statements)

References 18 publications

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“…In a previous study based on data for 2003–2013, Kim et al 6 reported a marked increase in tramadol consumption (relative change: +67.3%). In contrast, our results based on relatively recent data (2012–2018) showed an increase of only 1.1-fold over 7 years in the number of tramadol users, which implies that the increasing trend has almost reached its peak.…”

Section: Discussionmentioning

confidence: 94%

“…Opioid use in Korea is known to be lower than that in other countries; 5 however, the trend in Korea is also increasing. 6 , 7 A recently published study found a significant rise in the opioid prescribing rate (347.5/1000 persons in 2009 to 531.3/1000 persons in 2019) by investigating the 11-year trend of outpatient opioid prescription nationally, in total and then sorted by potency and formulation. 7 Previous studies on opioid analgesics in Korea have mostly focused on chronic opioid use, adverse events, and the evaluation of the outcomes associated with specific opioid ingredients or specific diseases.…”

Section: Introductionmentioning

confidence: 99%

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Trends in potentially inappropriate opioid prescribing and associated risk factors among Korean noncancer patients prescribed non-injectable opioid analgesics

Noh

Heo

et al. 2022

Therapeutic Advances in Drug Safety

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Introduction: The aim of this study was to investigate trends in the prevalence of potentially inappropriate opioid prescribing (PIOP) and identify potential risk factors among Korean noncancer patients. Methods: We conducted a cross-sectional study of annual national patient sample data from the Korean Health Insurance Review and Assessment Service (HIRA-NPS) for the period 2012–2018. Noncancer patients who were prescribed non-injectable opioid analgesics (NIOAs) at least once were included. The proportion of patients with at least one PIOP in terms of concurrent use of benzodiazepines or gabapentinoids, substance use disorder, treatment duration, and dosage was evaluated. Multivariable logistic regression was performed to identify the risk factors associated with PIOP. Results: Of the 9,772,503 noncancer patients, 1,583,444 (16.2%) were prescribed NIOAs at least once. Among them, 15.7% were exposed to PIOP, and the prevalence was much higher (31.6%) in the elderly group (age: ⩾65 years). The prevalence of PIOP increased 1.1-fold over 7 years (14.8–16.8%) among the total NIOA users and was more pronounced in non-tramadol NIOA users (a 1.5-fold increase, from 13.2% to 19.4%). Multivariable logistic regression indicated that older age, beneficiaries of medical aid or national meritorious service, exposure to polypharmacy, psychological disorder, chronic pain indication, and concomitant sedative use were independently associated with higher odds of PIOP. Discussion and Conclusion: We found that the prevalence of PIOP was 15.7% among Korean noncancer patients, and it increased over the 7-year study period. This increasing trend is alarming because it was more drastic with non-tramadol NIOAs compared with that with tramadol. Several patient-level risk factors associated with PIOP would be useful in targeted management strategies for the safe use of opioids. Plain Language Summary Potentially inappropriate opioid prescribing and related risk factors among noncancer patients prescribed non-injectable opioids in Korea In Korea, the prevalence of non-injectable opioid analgesic (NIOA) use in noncancer patients steadily increased from 15.3% in 2012 to 17.1% in 2018. Also, the prevalence of potentially inappropriate opioid prescribing (PIOP) increased from 14.8% in 2012 to 16.8% in 2018. The following factors were associated with a markedly increased risk of PIOP: age, beneficiaries of medical aid or national meritorious service, polypharmacy, psychological disorder, chronic pain, and concomitant medications.

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Trends in potentially inappropriate opioid prescribing and associated risk factors among Korean noncancer patients prescribed non-injectable opioid analgesics

Noh

Heo

et al. 2022

Therapeutic Advances in Drug Safety

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“…12,14 There was a timetrend in exposure in our study in which the number of tramadol prescriptions gradually increased throughout the study period (Figure S1). 10 To provide reasonable exposure time-trends, we selected control from the future cases only if the index date of the current case was within 120-365 days prior to actual events (Figure 1). 14 Each case was age (±1 year) and sex matched (1:1) to the control selected from eligible future cases on.…”

Section: Methodsmentioning

confidence: 99%

“…Moreover, these results could also be distorted by confounding by indication due to comparison with nonusers. Given the potential bias in previous studies and the necessity for continued drug use to manage acute and chronic pain, further studies are needed to determine the association between tramadol use and incidence of seizures 10,11 …”

Section: Introductionmentioning

confidence: 99%

Association between tramadol use and seizures: A nationwide case–case‐time‐control study

Park

Lee

Kim

et al. 2022

Pharmacoepidemiology and Drug

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Purpose: Tramadol may lower the seizure threshold; however, there is no conclusive evidence to confirm this. This study aimed to determine whether the use of tramadol is associated with the occurrence of seizures. Methods:We conducted a case-case-time-control (CCTC) study by identifying patients who had received tramadol and seizure diagnosis in a nationwide healthcare database in South Korea between 2003 and 2015. Each case was matched for age and sex to one future case to adjust for time trends in exposure without selection bias from the use of an external control group. The use of tramadol was assessed during a risk period of 1-30 days, and two reference periods, 61-90 days and 91-120 days, preceding the first diagnosis of seizures. We calculated the adjusted odds ratio (aOR) by dividing the OR in cases (case-crossover) by the OR in future cases (control-crossover).We performed a dose-response analysis using the average daily dose. Results:We identified 2523 incident cases with matched future cases (mean age, 45.4 years; 50% men). The aOR for seizure with tramadol use was 0.94 (95% confidence interval [CI], 0.98-1.43) in the CCTC analysis, with a case-crossover OR of 1.19 (0.98-1.43) and control-crossover OR of 1.27 (1.03-1.56). The dose-response analysis showed a similar trend in the main analysis: a low-dose aOR of 0.80 (0.50-1.28) and a high-dose aOR of 0.92 (0.41-2.11). Conclusion:We could not identify a significant association between transient use of tramadol and incidence of seizures in clinical practice. Key Points• The effect of tramadol use on seizures remains unclear.• Reports have linked tramadol use to seizures with a potential mechanism, though the results between studies are inconsistent.• We conducted a nationwide case-based analysis that considered control-selection bias and minimized confounding by time-invariant factors.• We used the case-case-time-control design among case-crossover variants to adjust for bias from time trends of exposure in the case-crossover approach by using future-case control group.

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“…Tramadol has earned a reputation for fewer side effects and lower rates of respiratory depression, overdose, and addiction due to its lower affinity with μ-opioid receptors than other opioids [ 3 , 4 ]. As a result, tramadol prescriptions have rapidly increased over the years [ 5 - 7 ] and it is extensively prescribed for many types of pain [ 6 - 8 ]. However, there is insufficient empirical evidence that tramadol is safer than other opioids.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Online Patient Reviews and National Pharmacovigilance Data for Tramadol-Related Adverse Events: Comparative Observational Study

Park¹,

Choi²,

Song³

et al. 2022

JMIR Public Health Surveill

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Background Tramadol is known to cause fewer adverse events (AEs) than other opioids. However, recent research has raised concerns about various safety issues. Objective We aimed to explore these new AEs related to tramadol using social media and conventional pharmacovigilance data. Methods This study used 2 data sets, 1 from patients’ drug reviews on WebMD (January 2007 to January 2021) and 1 from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS; January 2016 to December 2020). We analyzed 2062 and 29,350 patient reports from WebMD and FAERS, respectively. Patient posts on WebMD were manually assigned the preferred terms of the Medical Dictionary for Regulatory Activities. To analyze AEs from FAERS, a disproportionality analysis was performed with 3 measures: proportional reporting ratio, reporting odds ratio, and information component. Results From the 869 AEs reported, we identified 125 new signals related to tramadol use not listed on the drug label that satisﬁed all 3 signal detection criteria. In addition, 20 serious AEs were selected from new signals. Among new serious AEs, vascular disorders had the largest signal detection criteria value. Based on the disproportionality analysis and patients’ symptom descriptions, tramadol-induced pain might also be an unexpected AE. Conclusions This study detected several novel signals related to tramadol use, suggesting newly identified possible AEs. Additionally, this study indicates that unexpected AEs can be detected using social media analysis alongside traditional pharmacovigilance data.

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Explosive Increase in Tramadol Use in Korea 2003–2013: Analysis of Patient Trends Based on the Korea National Health Insurance Database

Cited by 13 publications

References 18 publications

Trends in potentially inappropriate opioid prescribing and associated risk factors among Korean noncancer patients prescribed non-injectable opioid analgesics

Trends in potentially inappropriate opioid prescribing and associated risk factors among Korean noncancer patients prescribed non-injectable opioid analgesics

Association between tramadol use and seizures: A nationwide case–case‐time‐control study

Comparison of Online Patient Reviews and National Pharmacovigilance Data for Tramadol-Related Adverse Events: Comparative Observational Study

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