Background Paclitaxel is commonly associated with infusion reactions (IR) with no clear influence of different paclitaxel formulations.
Purpose To analyse the number and severity of IR related to administration of different generic formulations of paclitaxel registered by means of an adverse drug reactions reporting programme (ADRRP).
Material and methods Observational, retrospective study from January 2010 to March 2015. Identification of IR was carried out by an active collaboration of day hospital nursing staff based on voluntary reporting of adverse drug reactions (ADRs) documented centrally at the pharmacy department (chemotherapy unit) using the application Farmis-Oncofarm within the framework of ADRRP. Variables collected: sex, age, generic brand name, cycle, IR severity (CTCAE v4.03), ADRs medication management and re-administration tolerance.
5 different generic formulations (A-E) were used during the study period, with no significant differences in type and concentration of the excipients. All patients received premedication with corticosteroids, antihistamines and H2 antagonists, as recommended by the summary of product characteristics.
Relative frequencies and severity were calculated, and χ2 and Fisher exact tests were used for statistical comparison (SPSS v.19).
Results During the study period, 648 patients (401 women (61.9%)), median age 59.5 years (range 23–86) received a total of 4845 paclitaxel intravenous infusions: 61.3% (paclitaxel A), 28.4% (B), 6.7% (C), 3.3% (D) and 0.4% (E).
61 IR were recorded. Paclitaxel A: 36 (1.21%), B: 14 (1.02%), C: 6 (1.86%), D: 1 (0.62%) and E: 4 (23.53%). No statistically significant differences (SSD) were observed in IR number or severity except with E paclitaxel (p < 0.001). 41% of IR occurred during the first administration. 46/61 grade 2; 14/61 grade 3; and 1 grade 4 (ICU admission after the second cycle). All IR were managed by temporarily stopping the current infusion and symptomatic treatment with corticosteroid+antihistamine±paracetamol as per protocol. 18/61 did not tolerate re-administration.
Conclusion SSD were only observed with E paclitaxel without finding out the cause. Sample imbalance among formulations was due to the regional health department centralised purchasing system through public tenders and several shortage supplies over the study period. The ADRRP based on the active voluntary collaboration of nurses was effective in detecting drug related problems and implementing interventions accordingly (notification to national surveillance programme, laboratory involved and changing the available presentation at the hospital) to enhance drug safety.
No conflict of interest.
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