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GM-013 Quality management system: Analysis and improvement in an oncology pharmacy unit
  1. L Recuero Galve,
  2. C Martí Gil,
  3. L Martínez Valdivieso,
  4. J Sánchez Gundín,
  5. A Flor García,
  6. D Barreda Hernández
  1. Hospital Virgen de La Luz, Pharmacy Service, Cuenca, Spain


Background One of the leading objectives of healthcare organisations is continuous quality improvement. It is necessary to plan and implement monitoring, measurement, analysis and control for the improvement processes of quality management system (QMS) and demonstrate the ability of processes to achieve the planned results.

Purpose To analyse continuous quality improvement in the oncology pharmacy unit (OPU) of a pharmacy service (PS) certified with a QMS based on ISO 9001:2008 standard.

Material and methods Retrospective observational study in a second level hospital, in which OPU had a workload of 636 preparations/month and 182 patients/month. The main key process involved was sterile compound preparation, but other processes were included, such as pharmacoeconomics, drug safety, dispensation and logistics.

We revised all documents during and after implementation of QMS (December 2013–September 2015), recording data from incidents logbook, FarhosOncology and QMS computer file (Openkm):

  • Number of incidents, medications errors (ME) and non-conformities.

  • Quality indicators (QI): QI1 (% intravenous mixture of chemotherapy returned to PS; standard ≤1%) and QI2 (errors registered in the progress of chemotherapy; standard ≤1%).

  • Corrective actions.

  • Recommendations for improvement.

Results We collected 199 incidents identified by PS staff in the incidents logbook, 6% of which were detected in the OPU. The major processes involved were logistics (58.3%) and dispensation (33.3%). We detected 69 ME (medical prescription (43.5%), preparation/dispensation (21.7%), administration (10.1%), pharmaceutical validation (17.4%) and extravasation/effusion (7.2%)), 14.5% of which produced damage to the patient.

13.3% of all non-conformities (n = 15) were related to the OPU and some corrective actions were carried out: (1) managing appointments in the admission service to avoid work overload in the outpatient pharmacy; (2) increasing the amount of medications dispensed; and (3) PS staff training and meetings.

The monthly averages of QI were 0.35% (QI1) and 0.5% (QI2), reaching standard values.

The recommendations for improvement were: (1) creating a new outpatient pharmacy to dispense oncological and haematological oral drugs, (2) implementation of a new laminar flow cabinet to allow traceability of chemotherapy preparations and (3) implementation of the control automatic system to all refrigerators to improve the logistics of oncology and haematology drugs.

Conclusion QMS are important work tools which help us to improve healthcare quality, pharmacotherapeutics and patient safety.

No conflict of interest.

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