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General and Risk Management, Patient Safety (including: medication errors, quality control)
Review of clinical management process for drugs: a safety audit
  1. S. Mastrangelo,
  2. V. Stelluto,
  3. P. Ragni,
  4. S. Fiori,
  5. R. Benedetti,
  6. A.M. Nasi
  1. 1Azienda USL Reggio Emilia, Pharmacy Department, Reggio Emilia, Italy
  2. 2Azienda USL Reggio Emilia, Clinical Risk Management Unit, Reggio Emilia, Italy
  3. 3Azienda USL Reggio Emilia S. Anna Hospital, Surgical Department, Reggio Emilia, Italy


Background Adverse events (ADEs) connected with drugs management are 10% of incidents for patients. Among the main causes: poor professional integration, poor quality of information, incorrect procedures and poor recording tools.

Purpose (1) Implement good safety practices in clinical management of medication; (2) identify critical points about use of treatment sheet.

Materials and methods The authors made an observation with incident reporting and subsequent analysis with FMECA to highlight critical steps in drug management process. The FMECA analysis highlighted the following critical factors: quality of information concerning the prescription and management of intravenous drugs, exchange of drugs, verification of effects of drugs. Analysis of the data collected on the incident reporting sheet highlighted problems with: Incomplete or no filling in of the therapy sheet, comprehensibility of the prescription, etc. The improvement plan has allowed us to identify a therapy sheet which meets safety requirements, procedure for use, a list of authorised abbreviations/acronyms. After the application, an audit was conducted about use of new therapy sheet. A team composed of doctors, nurses, midwives and pharmacists, driving by nurse risk manager, has defined some indicators (identification data, allergies, start/end date of therapy, prescriber signature, substance/trade name of drug, dosage, acronyms/abbreviations, medications as needed, writing in pencil, erasures, use of ink for correction) and evaluated the quality of 168 therapy sheet (10% of patients hospitalised in 2009 at surgical department in Castelnuovo Monti Hospital), randomly selected and distributed proportionately for three wards (surgery, orthopaedics and obstetrics-gynaecology).

Results The identification patient data set was correctly reported in 97%; allergies in 78%. The drugs were properly prescribed and signed in 91%, there was a correct description of the dose (quantity, dosage form) in 74%. The prescription for medications as needed (present in 107 patients of 168) was complete in 24% of cases. The signing about administering or not, was evident in 65%. From 3% to 5% of the therapy sheet reported writing in pencil, erasures or inadequate correction.

Conclusions Although the audit results demonstrated in general a safe use of new therapy sheet, further improvements seem possible. In fact a strong development about to the safety in prescription of drug and in the entire process of clinical management of drug, will be achievable in the future, with the introduction of computer technology.

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