Adverse consequences of low-dose methotrexate medication errors: data from French poison control and pharmacovigilance centers

Vial, Thierry; Patat, Anne Marie; Boels, D.; Castellan, Delphine; Villa, Antoine; Torrents, Romain; Kassai, Behrouz

doi:10.1016/j.jbspin.2018.09.006

Cited by 17 publications

(25 citation statements)

References 16 publications

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“…Variables associated (P < .05) with seeking information from a greater number of sources were younger age, tertiary education, higher BMQ-specific MTX concerns and higher BMQ general medicine harms scores ( Figure 2B). Age, y, mean (SD) 59 (11) Age at diagnosis, y, mean (SD) 41 (14) Disease duration, y, mean (SD) 19 (11) ARAD duration, y, mean (SD) 7 (4) Arthritis condition, VAS 0-100, mean (SD) 7 In our study, as has been previously reported, 9 patients may commonly utilize the internet as a source of information about MTX.…”

Section: Mtx Information Sourcessupporting

confidence: 58%

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Selection and perception of methotrexate treatment information in people with rheumatoid arthritis

et al. 2020

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Objective: To determine beliefs about methotrexate (MTX) in patients with rheumatoid arthritis (RA) in relation to utilized information sources. Methods: RA patients, who were current participants in the Australian national biologic registry, completed an online questionnaire regarding their use and views about MTX (N = 1010). Participants who used MTX were asked about which MTX information sources they consulted, and whether positive or negative views were obtained. The Beliefs about Medicine Questionnaire (BMQ), was used to measure patient beliefs about MTX. Results: The survey response rate was 804/1010 (80%). MTX survey data were analyzed for 742 RA participants (mean age 59 years, 76% female, mean disease duration 19 years) who had used MTX, with 494/742 (67%) reporting current use.

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Section: Mtx Information Sourcessupporting

confidence: 58%

“…[8][9][10] The use of MTX for treatment of inflammatory disorders has generated negative publicity. 11,12 These misconceptions relate to documentation of misuse 13,14 or myths 15 obtained from other sources. Deaths due to MTX in Australia were commonly a result of dosing errors despite implementation of safety initiatives.…”

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confidence: 99%

Selection and perception of methotrexate treatment information in people with rheumatoid arthritis

et al. 2020

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“…Despite the fact that the proportion of patients treated with MTX in our cohort was higher than that in the Study of Belimumab in Subjects with SLE (BLISS) trials (7–21.2%) , only 50% of the potentially eligible patients with articular disease and 41% of those with mucocutaneous disease in the present study had previously received MTX. This may reflect a more limited experience with this drug of the nephrologists involved in this study as well as safety concerns related to MTX use . Moreover, according to the timing of reimbursement approval from the Italian and UK Health Systems, 5% of the patients in our cohort would have been eligible for belimumab but were treated with RTX, which may have been the consequence of a greater experience with RTX of the investigators involved in this study.…”

Section: Discussionmentioning

confidence: 99%

Rituximab as Maintenance Treatment for Systemic Lupus Erythematosus: A Multicenter Observational Study of 147 Patients

Cassia

Alberici

Jones

et al. 2019

Arthritis & Rheumatology

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Objective. The efficacy of rituximab (RTX) in systemic lupus erythematosus (SLE) is a subject of debate. This study was undertaken to investigate the outcomes of RTX treatment in a European SLE cohort, with an emphasis on the role of RTX as a maintenance agent.Methods. All patients with SLE who were receiving RTX as induction therapy in 4 centers were included. Patients who received a single course of RTX and those who received RTX maintenance treatment (RMT) were followed up after treatment. Disease flares during the follow-up period were defined as an increase in disease activity and the number or dose of immunosuppressive drugs.Results. Of 147 patients, 27% experienced treatment failure at 6 months. In a multivariate analysis, a low number of previous immunosuppressive therapies (P = 0.034) and low C4 levels (P = 0.008) reduced the risk of treatment failure. Eighty patients received RMT over a median of 24.5 months during which 85 relapses, mainly musculoskeletal, were recorded (1.06 per patient). At the time of the last RTX course, 84% of the patients were in remission. Twentyeight (35%) of 80 patients never experienced a flare during RMT and had low damage accrual. Active articular disease at the time of the first RTX administration was associated with a risk of flare during RMT (P = 0.011). After RMT, relapse-free survival was similar to that in patients receiving a single RTX course (P = 0.72).Conclusion. RMT is a potential treatment option for patients with difficult-to-treat disease. Relapses occur during RMT and are more likely in those with active articular disease at the time of the first RTX administration. Relapse risk after RMT remains high and apparently comparable to that seen after a single RTX course.

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“…National organisations in France, Canada, and Australia have also issued advice to prescribers, similar to the NHS; also similar to the findings presented here, deaths and other errors associated with methotrexate prescribing continue to occur in these countries. [22][23][24] Implications for research and practice Previous work across several countries has resulted in a variety of suggested approaches to minimising the risks involved with methotrexate prescribing, 22,23,25 and the EMA has recently issued further guidance. 4,5 NHS Improvement has classed overdoses associated with methotrexate as a Never Event; 6 however, the authors found no evidence of any action taken by any national NHS body when anomalous prescribing has been detected in a region or practice; this is concerning but may, in part, be explained by the fact that the responsibility for enacting change is unclear.…”

Section: Comparison With Existing Literaturementioning

confidence: 99%

Trends and variation in unsafe prescribing of methotrexate: a cohort study in English NHS primary care

et al. 2020

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BackgroundPrescribing high doses of methotrexate increases the potentially fatal risk of toxicity. To minimise risk, it is recommended that only 2.5 mg tablets are used.AimTo describe trends in GP prescribing of methotrexate over time; the harm associated with methotrexate errors at a national level; ascertain variation between practices and clinical commissioning groups (CCGs) in their implementation of the safety guidance; and map current variations at CCG and practice level.Design and settingA retrospective cohort study of English GP prescribing data (August 2010–April 2018), and data acquired via freedom of information (FOI) requests.MethodThe main outcome measures were: variation in ratio of non-adherent/adherent prescribing, geographically and over time, between practices and CCGs; and description of responses to FOI requests.ResultsOf 7349 practices in England, 1689 prescribed both 2.5 mg and 10 mg tablets to individual patients in 2017, breaching national guidance. In April 2018, 697 practices (≥90th percentile) prescribed >14.3% of all methotrexate as 10 mg tablets, likewise breaching national guidance. The 66 practices at ≥99th percentile gave >52.4% of all prescribed methotrexate in the form of 10 mg tablets. The prescribing of 10 mg tablets fell during the study period, with 10 mg tablets as a proportion of all prescribed methotrexate tablets falling from 9.1% to 3.4%. Twenty-one deaths caused by methotrexate poisoning were reported from 1993–2017 in England and Wales.ConclusionThe prevalence of unsafe methotrexate prescribing has reduced but remains common, with substantial variation between practices and CCGs. The authors recommend investment in better strategies around implementation. As 21 deaths that occurred from 1993–2017 in England and Wales were attributed to methotrexate poisoning, the coroners’ reports for these deaths should be reviewed to identify recurring themes.

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Adverse consequences of low-dose methotrexate medication errors: data from French poison control and pharmacovigilance centers

Abstract: This study confirms that dosing errors with methotrexate can be lethal and persisted despite several warnings from drug agencies. Further measures are awaited from the European Medicine Agency.

Cited by 17 publications

References 16 publications

Selection and perception of methotrexate treatment information in people with rheumatoid arthritis

Selection and perception of methotrexate treatment information in people with rheumatoid arthritis

Rituximab as Maintenance Treatment for Systemic Lupus Erythematosus: A Multicenter Observational Study of 147 Patients

Trends and variation in unsafe prescribing of methotrexate: a cohort study in English NHS primary care

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