Renewal in pharmaceutical compounding sterile preparations circuit in Pharmacy Service
European Statement
Production and Compounding
Author(s)
PILAR RANZ ORTEGA, MARÍA ARRIETA LOITEGUI, DANIEL GONZALEZ ANDRES, ANA MARÍA AGUI CALLEJAS, MARIA TERESA POZAS DEL RIO
Why was it done?
– Optimize the workflow:Nursing staff are independent in final product quality control.Dissapear the manual register of compounding sterile preparations.Fewer mixtures are discarded.Also in Pharmacy Service only elaborate the sterile preparations with an economic and safety impact.
– Improve the safety of drug administration in pediatric patients: there are ready-to-use commercial parenteral presentations, which can lead to errors when dosing per kilo,fe: enoxaparin…
– Optimize economic savings:all excess vials are reused
What was done?
Previously,some parenteral drugs were compounded at Pharmacy Service.The rest of the vials were discarded daily,so the pharmacist had to anticipated some elaborations not to throw,so then some were suspended.
Also, the pharmacists done the final product quality control,it could be delayed the dispensing and specially when it´s necessary to repeat the mixture.
The changes were:
– Re-selection of the parenteral drugs compounded at Pharmacy Service by:
• Economic criterio:the cost of drug has to be >20 euros/vial
• Safety for the pediatric patient:redose individually parenteral drugs “readytouse”
– Review the storage conditions:physicochemical (technical data sheet drug,Stabilis web) and microbiological stability (Good practices for preparation drugs in hospital pharmacy services publised by Spain Goverment) of all parenteral drugs previously selected.Although the physicochemical stability is higher,the final stability will be limited by the microbiological stability and the risk level microbial contamination(USP 2004).
– Standard Operating Procedures with structured and updated information
– Reuse of partially used multi dose vials:we reviewed the physicochemical and microbiological stability of open vial
– Final product quality control by nursing staff
– Save time to pharmacist:daily scheduling instead of anticipated elaboration of sterile preparations
How was it done?
– A nurse involved in the circuit change giving her feedback on the changes
– Traceability of the rests of the vials:stickers are affixed to the opened vials indicating the reconstitution data and the expiration date
– Final product quality control should be done by a diferente nurse to elaborated to detect potencial errors
What has been achieved?
The total cost savings for this year is 295.778€. After the circuit´s change, the savings have increased by 55% for liposomal amphotericin b, 51% defibrotide, 24% micafungin.
What next?
Compounding sterile preparations individualized in Pharmacy Service to patients hospitalized at home, transplanted of hematopoietic progenitors and immunocompromised
INTEGRATION OF A ROBOT INTO THE EXISTING WORKFLOW OF THE CYTOSTATIC DRUGS DEPARTMENT IN A HOSPITAL PHARMACY (submitted in 2019)
Pdf
European Statement
Production and Compounding
Author(s)
Swantje Eisend, Herwig Heindl, Karen Tiede, Sven Jirschitzka
Why was it done?
Definition of an organisational structure for the best implementation of APOTECAchemo technology in the UKSH hospital pharmacy workflow
What was done?
The implementation of robotic systems for aseptic compounding cytotoxic drugs requires a specific workflow organisation in the hospital pharmacy to ensure an optimal combination of manual and automated production as well as the effective use of the technology. Since 2017, the APOTECAchemo robot has been installed in the hospital pharmacy and one of the first objectives was to create an organisational structure that would allow successful integration of the system into the existing workflow of the cytostatic department.
How was it done?
The pharmacy has carried out an analysis to identify the active substances that can best be transferred into automated production based on 4 main points: • Pharmaceutical form of the active ingredients: liquid or powder; • Average of vials needed for the compounding of one preparation for each active ingredient; • Average of ml of medication required for the compounding of a preparation associated with each specific active ingredient; • Robot compounding speed. In addition, the pharmacy has also tried to identify the optimal organisation of personnel and daily workflow for the automated compounding. The effectiveness of these measures and the work organisation defined have been evaluated through an intensive compounding week in April 2018.
What has been achieved?
The analysis of the active substances and the data collected during the “Robotic Intensive Week” showed the following results: • 42% of the total production was operated by APOTECAchemo; • 87% of active ingredients was handled by APOTECAchemo; • average of 60 preparations per day (with an actual working time of 5 hours); – average of 12 preparations per hour.
What next?
The study shows that the planning and organisation of the workflow plays a central role in the implementation of a robot solution in a hospital pharmacy. Through the work carried out, the hospital pharmacy has successfully integrated automated and manual production.
IMPLEMENTATION OF INDIVIDUAL, HOSPITAL PHARMACY-COMPOUNDED NEONATAL TPN
Pdf
European Statement
Production and Compounding
Why was it done?
Individual total parenteral nutrition (TPN) for neonates was originally compounded by nursing staff on the respective wards. This process of TPN compounding was error-prone. Documentation and traceability was inadequate. Clean room conditions were absent. By transferring the compounding of TPN from the ward to the pharmacy level, several aims were accomplished. Time of nursing staff was released and the highest quality standards for compounding were implemented. By doing so, several types of errors (e.g. overdosing, wrong additives) were eliminated.
What was done?
Development and implementation of nutrition support protocols by using an electronic prescribing and compounding software (catoPAN™) to address the special needs of neonates and ensure a high level of individualized care.
How was it done?
In cooperation with neonatologists, nutrition protocols were developed. Furthermore, a TPN compounding process was implemented and validated, including the validation of catoPAN™ software and compounding pumps. An integrated risk analysis was performed, stability data to allow TPN supply for weekends were generated and fail-safe procedures were determined. To finally succeed, various process and organizational changes concerning the wards, the production and the QC department of the hospital pharmacy were required.
What has been achieved?
Compounding of individualized nutrition solutions within defined standards, predetermined specifications and quality attributes is implemented. The production process is continuously monitored, including complete traceability. A strong interprofessional collaboration between physicians, nurses and pharmacists was established, ultimately leading to a high level of confidence among all members. Workload of nurses in terms of compounding medicines was dramatically reduced.
Currently, we provide nutrition bags for four wards (24 ICU- and 30 intermediate care beds), equaling an average production of 50 bags per day. In 2016, a total of 11.126 bags were supplied, implying an increase of 75% compared to 2015. We expect an increase of around 30% in 2017 due to rising demand.
What next?
With the expansion of TPN compounding to further pediatric wards, new nutrition protocols addressing other requirements have to be developed. Process changes are likely to follow. Further support can be provided by pharmacy-based IV admixture service. Additionally, due to current software updates, the prescribing and compounding software catoPAN™ must continually be revalidated.
COMPUTERIZED QUALITY CONTROL OF THE TABLET SPLITTING PROCESS
Pdf
European Statement
Production and Compounding
Author(s)
María Lourdes Recio Blázquez, Alberto Pérez Morales
Why was it done?
It was necessary to establish a quality control of this pharmaceutical process.
What was done?
A computer method of gravimetric quality control of the tablet splitting process was designed.
How was it done?
The procedure consists on a precision scale connected to a computer in which, according to the uniformity of mass assay of the European Pharmacopoeia, the weights of 20% of a batch of whole tablets destined to be split are automatically recorded in a spreadsheet, carrying out the following formulas:
=AVERAGE: provides the average weight of the sample of whole tablets.
=MAX and =MIN: selects respectively the largest and the smallest of the weights.
=STDEV: calculates the standard deviation of the sample weights.
With the average weight of the whole tablets, the theoretical weight of the half-tablets is calculated, establishing a maximum and a minimum admissible limit with the following formulas:
=AVERAGE(whole tablets)/2: determines the theoretical average weight of each half-tablet.
=AVERAGE(whole tablets)/2 ± 7.5%: establishes upper and lower gravimetric limits that cannot be exceeded by any half-tablet.
All the half-tablets need to be weighted, as the tablet-splitting process is carried out tablet-by-tablet and this modus operandi is not reproducible enough. In case of non-compliance with maximum and minimum weight criteria, the half-tablet must be discarded.
Conditional functions were established such that the spreadsheet itself reflects the half-tablet acceptance/rejection decision.
Basic technical computer skills, training in the technique of tablet splitting, appropriate clothing and environmental measures to avoid risks to the operator and the medications are required.
What has been achieved?
Since 2015, two different medicinal products were subjected to the tablet splitting technique. A total of 10,536 halves of suitable tablets were obtained, which permitted safe dosing at lower doses than commercialized, and also generated a financial asset of 101,724 Euros. 566 halves were discarded. The splitting efficiency was of 94.9%.
What next?
This quality control procedure is applicable to all divisible solid oral dosage forms. The standardization of the technique and the quality controls will allow to extend it to other medicinal products with dosing and economic purposes.