Challenges of post‐authorization safety studies: Lessons learned and results of a French study of fentanyl buccal tablet

Gavrielov-Yusim, Natalie; Bidollari, Ilda; Kaplan, Sigal; Bartov, Netta

doi:10.1002/pds.4331

Cited by 4 publications

(2 citation statements)

References 22 publications

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“…The low response rate and participation of medical centers in the study are noteworthy, even though the study was intended as a pilot and the recruitment goal for the pilot was met. Observational post-authorization safety studies involving primary data collection may suffer from insufficient recruitment and participation 25 , 26 . In order to increase participation, several recruitment strategies were used, including passive outreach (e.g.…”

Section: Discussionmentioning

confidence: 99%

Prescribing patterns from medical chart abstraction of patients administered lipegfilgrastim: a pilot study in Europe

Kaplan

Lang

Gašparić

et al. 2019

Journal of Drug Assessment

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Purpose: The objective of this pilot study was to explore the feasibility of conducting a drug utilization study of lipegfilgrastim in Europe using medical records and to examine the pattern of lipegfilgrastim on-label and off-label use. Methods: Data on lipegfilgrastim use between September 2014 and April 2017 were abstracted from medical records by two independent medical abstractors. Lipegfilgrastim indication was categorized either as on-label or as one of four types of off-label (I–IV) according to pre-defined criteria. An inter-rater reliability analysis was conducted to measure the degree of abstractor agreement for on-label and off-label use. Results: Information from 46 medical records was abstracted. Lipegfilgrastim use during the first chemotherapy treatment cycle was mostly indicated for prevention of neutropenia (82.6% of patients). On-label use was documented in 42 patients (91.3%), while off-label use was documented in two patients (4.3%); all events of off-label use were attributed to use with non-cytotoxic drugs. The remaining two patients (4.3%) had missing data. Overall agreement between the abstractors was high (91.6%). For three types (Types I–III) of off-label use, the kappa values suggested a perfect agreement ( κ = 1). For Type IV off-label use (use in patients treated with non-cytotoxic drugs), κ = 0, suggesting a poor agreement. Conclusions: While recruitment was challenging, the results of this pilot study confirm the feasibility and availability of medical records and the use of pharmacists as abstractors to assess on- and off-label use of lipegfilgrastim. Lipegfilgrastim was mainly prescribed according to the approved indications. Key points Findings from this pilot study confirm the feasibility and availability of medical records and the use of pharmacists as abstractors to assess on-label and off-label use of lipegfilgrastim in routine clinical practice. Lipegfilgrastim was mainly prescribed according to the approved indications, and the proportion of off-label use was low. The high inter-rater agreement between the two abstractors suggests that one abstractor is sufficient for conducting chart abstraction of on- and off-label use. Additional data abstraction sources other than pharmacists will need to be identified to improve response rate and center recruitment. Findings from this pilot study are important for the successful planning and execution of subsequent drug utilization studies.

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Section: Discussionmentioning

confidence: 99%

Prescribing patterns from medical chart abstraction of patients administered lipegfilgrastim: a pilot study in Europe

Kaplan

Lang

Gašparić

et al. 2019

Journal of Drug Assessment

Self Cite

View full text Add to dashboard Cite

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“…From the perspective of clinical importance, clinical drug effectiveness is tested extensively during clinical evaluations, mostly randomized controlled trials [9,10]. When drugs are introduced into the market, post-authorization safety studies are conducted to detect adverse events, which cannot be noticed in pre-marketing phases, and must be established in epidemiological studies, predominantly in the field of pharmacoepidemiology [11].…”

Section: Introduction: the Complexities Of Pharmaceutical Policymentioning

confidence: 99%

The plague of unexpected drug recalls and the pandemic of falsified medications in cardiovascular medicine as a threat to patient safety and global public health: A brief review

et al. 2022

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Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance

et al. 2019

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Challenges of post‐authorization safety studies: Lessons learned and results of a French study of fentanyl buccal tablet

Cited by 4 publications

References 22 publications

Prescribing patterns from medical chart abstraction of patients administered lipegfilgrastim: a pilot study in Europe

Prescribing patterns from medical chart abstraction of patients administered lipegfilgrastim: a pilot study in Europe

The plague of unexpected drug recalls and the pandemic of falsified medications in cardiovascular medicine as a threat to patient safety and global public health: A brief review

Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance

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