Analysis of notified adverse events: a tool for improving risk mapping related to the automatic repackaging and preparation of individual doses
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Mathilde Cadart
Goals
The pharmacy of the CESAME, a psychiatric hospital in France, bought an automatic dispensing machine (ADM) to implement drug safety management. A risk mapping was set up prior to its launching to secure the new process.
This study aims to update this mapping based on notified adverse events (NAE) during the first ten months of production.
Method
Retroactive analysis of NAE: events classification, computation of observed frequencies.
Risk defined prior to the study: risk rating update based on frequency.
Undefined risk: risk introduction with its scoring.
The risk-rate is computed with the combination of two parameters: frequency and severity. It results in a criticality indexed on a scale from 1 to 16.
Results
1 new stage of risk identified and scored in the field of software parameterization,
Rise in criticality of 4 risks: 2 concerning the production, 1 concerning the unpackaging and 1 the visual control of production,
Pharmacy is responsible for 54 % of NAE, 87 % of those are linked to a failure at the stage of visual control of production by the pharmacy technician.
Discussion & Conclusion
This study has allowed us to deepen our understanding of the process’ weaknesses thus helping to identify the needs of corrective measures.
For example, controlling stage is ranked 16. We set up urgent measures aiming to mimize distractions in the production area (new space organization by partitioning locals and the removal of the phone) and a review of the procedure “Implementation of automatic individual dose preparation” with the team. Furthermore, a flowchart called “new drug automatisation” has been created and a monthly description-drug verification has been established.
As 46 % of NAE are not imputed to automation, this work also showed the necessity of emphasizing our communication to nurses on the scope of action and limits of automated individual dose dispensing
Risk-mapping update concerning the stage of visual control of production by the pharmacy technician.
© 2017 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- graphical-abstract
- Editorial
- A special issue dedicated to the GERPAC 2016 meeting
- Conference Reports
- Quality Management Workshop: Feedback on ISO Certification in a Pharmaceutical Technology Unit
- Subcontracting Workshop – GERPAC 2016
- Short Communications
- Stability of 25 mg/mL Azacitidine Suspensions Kept in Fridge after Freezing
- Permeability and Release of Decontaminating Agent Used in Cytotoxic Reconstitution Units: Diffusion of Hydrogen Peroxide in IV Bags
- Innovation in the Transport of Cytotoxic Drugs by a Pneumatic Transport System
- Opinion Paper
- Centrally Prepared Cytotoxic Drugs: What Is the Purpose of Their Quality Control?
- Conference Abstracts
- Stability of midazolam and noradrenaline stored in cyclic olefin copolymer AT-Closed Vials® and polypropylene syringes during 365 days
- Implementation of a remote oncology-monitoring program for cancer patients in outpatient care unit
- Analysis of notified adverse events: a tool for improving risk mapping related to the automatic repackaging and preparation of individual doses
