Quality Improvement Project of Clozapine Prescribing Process in a Mental Health Unit
European Statement
Clinical Pharmacy Services
Author(s)
Charlotte Stafford, Aoife Delaney, Virginia Silvari, Thomas Cronin, Deirdre Lynch
Why was it done?
The Pharmacy Department dispenses clozapine to 142 patients. A new prescription was issued each time a patient was dispensed clozapine (approximately 40 new prescriptions per week). From January 2019 to June 2020 there were 42 clozapine incidents (incidents/month= 2) reported by the Pharmacy Department to the MHU. A four week review also showed that prescription queries (dose changes and transcription errors) consumed 6 hours of pharmacy staff time. The new 6-monthly, electronically stored prescription and the dedicated email address should address these issues.
What was done?
A newly devised proforma clozapine prescription has been developed by the Pharmacy Department and has become valid for 6 months for patients on 4-weekly blood monitoring. A copy of each patient’s prescription is stored electronically in the Mental Health Unit (MHU) share drive. A new dedicated pharmacy clozapine email address has been generated for all clozapine dose changes to be communicated to.
How was it done?
Four new clozapine prescriptions were developed by the Pharmacy Department:
– a maintenance dose prescription
– standard titration days 1 to 8
– standard titration days 8 to 15
– blank titration prescription.
The new prescriptions for patients on 4-weekly blood monitoring, valid for 6 months, are now stored in the MHU share drive to reduce the risk of transcribing errors.
What has been achieved?
Once the new system had been established, a further 4 week review showed that only 10 minutes over 4 weeks was spent by pharmacy staff dealing with a prescription query. All dose changes were now communicated by email. Incident reporting has decreased, with 5 clozapine incidents being reported by the Pharmacy Department between January to June 2021 (incident/month <1).
What next?
A business case highlighting the importance of a dedicated Clozapine Pharmacist has been submitted to further develop the clinic and ensure safety of this vulnerable cohort of patients.
Good Manufacturing Practice and chemotherapy preparation: A case study on implementation of a robotic system in a Danish hospital pharmacy.
Pdf
European Statement
Production and Compounding
Why was it done?
In 2017, the hospital pharmacy has started a project for automated chemotherapy preparation aimed at managing the increasing workload, while ensuring highest level of quality and healthcare workers safety. In Denmark, the authorities expect hospital pharmacy preparation to be GMP compliant. To achieve the best implementation of APOTECAchemo, go-live was preceded by thorough qualification process and followed by robot performance evaluation in a GMP-pharmacy.
What was done?
A robotic system for aseptic preparation of cytotoxic drugs was implemented in the pharmacy-based, Grade C cleanroom compliant with Good Manufacturing Practice (GMP). Specific work organisation allowed the integration of APOTECAchemo into the pharmacy workflow, thereby steadily improving the robot productivity.
How was it done?
A multidisciplinary team defined 228 User Requirements Specification (URS) addressed in the tender and associated to GMP regulations to assess that the technology complied with the intended purpose. APOTECAchemo passed through all qualification stages: design qualification (DQ), factory-acceptance testing (FAT), installation qualification (IQ), site-acceptance testing (SAT), operational qualification (OQ), performance qualification (PQ). The implementation of robot was evaluated in terms of doses prepared, active ingredients processed, and % of the total production compounded. Data were taken from the management software and examined from June 2019 to September 2020.
What has been achieved?
The qualification process was completed in 13 months (from April 2018 to May 2019). APOTECAchemo fulfilled the requirements set in accordance with GMP regulations and went live in May 2019. In the first 15 months of operation, 20,968 doses were prepared with the robot, of which 18,242 infusion bags (87%) and 2,726 elastomeric pumps (13%). The number of active ingredients processed were 21, of which five (5-fluorouracil, calciumfolinate, irinotecan, gemcitabine, carboplatin) covered 58% of the total production. Average production of the robot increased by 39%, from 963 doses/month in 2019 to 1,582 doses/month in 2020. The % of the total production operated by APOTECAchemo rose from 20.9% (2019) to 46.4% (2020).
What next?
APOTECAchemo robot was successfully implemented in a fully GMP-compliant hospital pharmacy, thereby enabling the automation of the preparation process and the reduction of the manual operations. Through the evaluation performed, the hospital pharmacy decided to install a second robotic system to further enhance the automated production.
IMPLEMENTING NEW CHEMOTHERAPY COMPOUNDING WORKFLOW USING SEQUENTIAL PDSA CYCLES TO INCREASE PRODUCTION CAPACITY, REDUCE WAITING TIME, IMPROVE RESOURCES UTILIZATION, AND MINIMIZE THE RISK OF ERRORS
Pdf
European Statement
Production and Compounding
Author(s)
A Elsheashaey, A Elshishiny, A Orabi, A Almutairi, A Aboulwafa, H Alobaid, F Dashti, D Saeed, R Yassin, M Salama
Why was it done?
Kuwait Cancer Control Center (KCCC) is the only oncology hospital in Kuwait. Chemotherapy Preparation Unit (CTPU) was unable to meet the increased orders; causing delivery delay and more patients’ waiting time. Moreover; rework and more waste due to defective and faulty processes of current workflow resulting in frequent incident reports of wrong final products dispatched.
What was done?
Shifting to a systematic multi-step production workflow to increase compounding capacity, minimize risk of errors, reduce processing time, and maximize utilization of integrated technological resources.
How was it done?
Using multiple PDSA cycles, a comprehensive educational and practical training was conducted, proceeded by staff rotation with newly trained team. Every three weeks a new pharmacist trained and assigned to CTPU. Raw materials stores were rearranged for better accessibility and diminishing unnecessary staff movement. A staging step as the first independent double-check before the start of compounding, and for assembly of raw materials and supplies required for compounding. A verification Step as the second independent double-check upon compounding, using bar-code scanners, touchscreens and cross-checking with the chemotherapy order to assure the quality and integrity of the finished product. Production workload were restructured over three parallel line of manual stations and one automated preparation unit. Pharmacy Information System (PIS) screens were customized to give a first and second audio-visual alarms after 30 and 45 minutes of transcription time respectively. Chemotherapy sessions appointment system were established to assess the daily chemotherapy compounding needs from CTPU in advance with an incremental increase of production capacity to reach 100~120 patients/day or 180~200 preparations/day.
What has been achieved?
Number of preparation compounded by CTPU was increase by 8%, where more than 43% of preparations were validated to release in less than 30 minutes and approximately 88% of preparations were delivered in less than 45 minutes. Number of preparation by automation was increased by 82%, Furthermore, all production incidences has been completely eliminated after full implementation of final verification and validation step.
What next?
The new workflow has increase the workload capacity with less production errors and zero incident reports. Patient experience was improved by comparable preparation time to other international Pharmacy Workload Unit and average time required per patient visit.
COMPLETING SELF INSPECTION AUDITS IN THE PHARMACY ASEPTIC UNIT
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
H/PICs are guidelines of professional practice developed by pharmacists working in aseptic compounding units In Ireland in 2013. Chapter 9 advises that ‘a self -audit programme should be established and conducted in an independent and detailed way by designated trained competent people’. In order to adhere to these guidelines a self-audit of one section of the H/PICs was completed.
What was done?
A self-audit against one chapter of the H/PICs guideline was completed.
Changes were implemented where possible.
Issues were escalated to senior managers where required.
How was it done?
Obtain audit skills.
An audit checklist was prepared and an audit, for the premises and equipment section of the H/PICs guidelines was completed.
Non-conformances were identified and graded.
Corrective and preventative action (CAPA) was put in place where possible.
Major/critical non-conformances were escalated to higher management where necessary.
What has been achieved?
An audit training day was completed in November 2014. Skilled auditors in the laboratory were observed completing self-audits.
A checklist for the premises and equipment section of the H/PICs was prepared and an audit of that chapter was completed in March 2015. There were 32 statements in this chapter and non-conformances of various grades were identified. CAPA was put in place where possible. 9 non-conformances were rectified with internal changes. 10 major/critical non-conformances requiring capital/HR funding were presented to higher management, these were summarised into 4 main risks. Business cases were prepared to support the correction of these risks and a summary was added to the risk register. The remaining non-conformances were classified as minor deficiencies and will be corrected at a later date.
What next?
Self-audit is a useful tool and aids compliance with H/PICs guidelines. It allows the identification of high risk activities and grading non-conformances assists in the prioritisation of process improvement projects. It supports the feedback of performance against recognised guidelines to management. An annual self audit plan will be put in place and a peer audit group within a number of other hospitals has been established.
Home Parenteral Nutrition (HPN) Safety and Quality Assurance Project
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Pietka Magdalena, Brniak Witold, Rozkocha Agata
What has been achieved?
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