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Clinical pharmacy and clinical trials (including case series)
Improving the quality of data in the Onco-AIFA register as a prerequisite for outcome research studies
  1. L. Esposito,
  2. F. Paganelli
  1. 1Istituto Oncologico Veneto IRCCS Pharmacy Padova, Italy

Abstract

Background The Ministry of Health promoted in 2010 a project to improve the management of cancer drug treatments in five Italian oncology hospitals. A pharmacist was assigned to assist physicians in prescribing, one of the main aims being improving the quality of the data recorded in the Italian web-based Register on oncology drugs. The register onco AIFA was set up in 2006 to evaluate new and costly drugs introduced in the market. For each drug, it ensures both patient eligibility and periodic evaluation of treatment toxicity and patient follow-up.

Purpose One of the outstanding critical issues in the management of the onco-AIFA register was the delay in the data entry of toxicity/patient revaluation. The objective of this project was to verify how the pharmacist's activity could improve the data quality in the tumour registry, which represents a potentially powerful tool in outcome research.

Materials and methods A daily monitoring of the recorded data allowed to identify the pending requests. A reminder e-mail was daily sent to each physician to highlight the incomplete records. Number of patients entry data / overall patients treated, number of treatment completed forms / overall treatments, risk sharing reimbursement obtained / overall treatment cost were evaluated as indicators of the process efficiency.

Results Owing the centralised drug distribution in the IOV Pharmacy department, all the treated patients were eligible and inserted in onco-AIFA. Improving margins have been focused, rather than as of ‘number of entries’, as number of closed and reimbursed treatments. Both doubled compared to the period before the project. In addition, data suggest the investigation and the evaluation of others indicators, which could better demonstrate the efficiency of pharmacist's role in the department. Although daily data entry was not achieved, a significant improvement (81, 42% vs 51.80%) in records within a week was obtained. A predefined report has been developed and suggested as standard format for monitoring oncological data.

Conclusions Results obtained confirm the value of the pharmacist in a multidisciplinary team as part of the process of patient care as warranty of prescriptive appropriateness and as an ‘added value’ in different areas of health intervention, including administrative implications.

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