[Measurement of continuous improvement in the safety of oncologic patients].

Objective: To analyze continuous improvement in the safety of oncologic patients through the change of quality indicators established with the implementation of a quality management system (QMS) according to the ISO 9001-2008 regulation at a oncologic pharmacy unit (OPU).

Method: Prospective and observational study carried out between January of 2008 and December of 2011. The ISO 9001-2008 certification of the OPU included the proceedings of electronic prescription,validation, preparation, delivery, and administration of the antineoplastic therapy. The following quality indicators were established: medication errors (ME), preparation and delivery errors not reaching the patient, and ME reaching the patient. The indicators were calculated quarterly through the Farmis-Oncofarm® software; the adherence standard was defined at ≤ 1 ME per one thousand and the follow-up was done through control graphs. One « post-implementation » period (2008-2011) and one « pre-implementation » period (2007) were established and the U Mann Whitney test was used to compare the median of the indicator for both periods.The differences between the two periods were considered to be statistically significant when the p value was p ≤ 0.05.

Results: 140,440 preparations were made at the OPU, for 4,770 patients, corresponding to 52,906 patients-day. The adherence to the standard during the first one-year period allowed reducing the three indicators to ≤ 0,5 ME per one thousand. For preparation ME an abnormal value was identified; the causes were analyzed and improvement measures were proposed. In the post-implementation period, ME were reduced during the post-implementation period as compared to the pre-implementation period (p<0.05).

Conclusions: The follow-up of the quality indicators allows measuring and assessing the pharmaco-therapy safety in the oncologic patient. After the implementation of the QMS at the OPU, the number of ME has been reduced.