Ex) Article Title, Author, Keywords
Ex) Article Title, Author, Keywords
R Clin Pharm 2023; 1(1): 84-87
Published online June 30, 2023 https://doi.org/10.59931/rcp.23.002
Copyright © Asian Conference On Clinical Pharmacy.
Hazel Faye R. Docuyanan , Cristina P. Solomon , Mary Jeane S. Robles , Arthur Kevin V. Castor
Correspondence to:Hazel Faye R. Docuyanan
E-mail Hazel.Docuyanan@makatimed.net.ph
ORCID
https://orcid.org/0009-0004-5866-9150
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/bync/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
In this study, presents an approach to enhance compliance with the Joint Commission International Accreditation Standards for Hospitals, 7th edition, regarding medication recall, particularly vaccines. It highlights the hospital’s initiative to develop a standardized streamlined process and implement a computerized centralized vaccine tracking system (VTS) to improve the traceability of administered vaccines up to the patient-specific batch/lot level. When needed, in the case of medication recall, this system allows the extraction of patient data and the batch and lot numbers of vaccines. Compliance to the use of the VTS was monitored, and further improvement initiatives such as training and feedback were implemented to further enhance and sustain the project. After the implementation of the project and monitoring for 11 months, the compliance on the documentation of vaccine batch and lot numbers significantly increased from 21% to 75% in the period from February 2021 to December 2021. In conclusion, the use of the centralized VTS application program, which can track all vaccines administered up to the patient-specific batch/lot level, improved compliance and provided a clean database of documentation that can be readily generated to track patients in the case of vaccine recall.
KeywordsVaccine; Batch and lot number; Medication recall; Traceability; Vaccine tracking
The Joint Commission International Accreditation Standards for Hospitals, 7th Edition requires that the hospital has a medication recall system and has the capability to trace the batch and lot number of the medications administered to patients and be able to track at the patient level in cases of any recall [1].
This study was conducted in a 600-bed capacity, tertiary, private, JCI-accredited hospital in the Philippines. Since vaccines stay in the body generally for longer period compared with most of the medications administered to patients, this study specifically focused the implementation of the project to vaccines.
In January 2021, it was noted that there was no standard process and poor compliance on documenting the batch and lot number of vaccines administered to patients specifically in Inpatient Care Areas.
The objective of the study is to improve the compliance on the medication recall standard of being able to track patients and trace the batch and lot number of the vaccines administered to them by implementing a standardized, computerized, and streamlined process of documentation in the system with centralized data extraction feature for the purpose of vaccine safety monitoring in case of medication recall [2].
The process includes the documentation of the vaccine batch and lot number in the electronic medication administration record on the patient’s medical records by the administering healthcare provider. Compliance is monitored by the Pharmacy comparing the quantity of vaccines administered against the quantity of vaccines administered with proper batch and lot number documentation.
Baseline compliance data on complete documentation of batch and lot number of the vaccines administered to patients were collected retrospectively in October 2020 to January 2021 which is at a low rate of 21% (12 with documented batch and lot number out of 57 total vaccines administered in 4 months).
Prior to the project, there was no standard process and monitoring system in place to ensure that all batch and lot number of vaccines administered were properly documented and can be easily extracted at the patient level for purposes of tracking during medication recall. There was no available field in the medication administration record where the batch and lot number of the vaccine administered can be documented. There are units where the batch and lot number are documented manually in a separate excel file outside the electronic medical record and there are units who document the batch and lot number in the nurse’s notes. Because of the lack of standard process, tracking the patient who received a specific batch and lot number of a vaccine was very tedious and difficult. Hence, a streamlined process and centralized data extraction application was conceptualized as seen in Fig. 1.
The following were done in the implementation of the project:
1. Development of the system program application in collaboration with Information and Communications Technology Division (ICTD) with the following features.
a. standardized process across all nursing units on the documentation of the batch and lot number of vaccines administered by providing a field in the electronic medication administration record on the patient chart where this can be encoded.
b. generation of report extracting the names of patients who were given a specific vaccine.
2. User Acceptance Testing of the centralized Vaccine Tracking System (VTS) to check for completeness of the required information being extracted and the desired functionality.
3. Training of nurses on the standard process and how to use the VTS.
4. Implementation of the standard process and utilization of the VTS.
5. Monitoring of compliance to vaccine batch and lot number documentation.
6. Get feedback from Nursing team to further enhance the process and improve the implementation of the project.
7. Sharing of compliance reports to units involved and to the Medication Safety Subcommittee.
Fig. 1 shows in highlighted green boxes the steps that were improved and streamlined, and highlighted brown boxes are the steps which were removed and computerized in the process. Encoding of the batch and lot number was incorporated in the step of documenting the administration in the system and is implemented in all units. Likewise, instead of tracking and tracing manually, the system now allows a centralized generation of report to know the patients who received a specific batch/lot number.
To measure the success of the project, Pharmacy was designated to monitor the compliance to proper documentation of vaccine batch and lot number within the specified Turn-Around-Time (TAT) of 24 hours after administration [3]. Monitoring compliance to vaccine tracking system documentation was made part of the daily compliance rounds by the clinical pharmacist. Pharmacy extracts in the system the total vaccine administration, computes for the compliance, and reports accordingly.
The following formula was used to monitor compliance:
The project allowed ease in encoding of the batch and lot number which encouraged compliance in documentation by the nurses who administered the vaccines. There was a significant increase in documentation compliance from 21% (12 with documented batch and lot number out of 57 total vaccines administered in 4 months) to 75% (217 compliance out of 291 vaccines administered in February 2021 to December 2021) (Fig. 2).
Inconsistencies in the documentation compliance were initially observed during the first months of implementation. It was noted that these were the months with high attrition rates in nursing. Improvement strategies were implemented including strengthening of the orientation and training on the use of the VTS emphasizing the importance of documentation to track patients and trace the vaccine batch and lot number administered in case of medication recall promoting patient safety. A video training material was also provided as reference for the nurses to remind them on the proper procedure and importance of compliance. Regular feedback on the unit’s compliance to the use of VTS was reported.
This project facilitated generation of report when needed at the patient and vaccines level to enhance the track and trace standard for vaccines in preparation for possible medication recall and safety monitoring.
The Vaccine Tracking System implementation improved the compliance to the vaccine batch/lot number documentation per patient. By streamlining and standardizing the process, it allows ease in encoding and facilitated generating a centralized report to know who the affected patients are in case of medication recall. It also supported and helped the health team realize the importance of batch and lot number documentation for patient safety monitoring. Overall, this project would improve pharmacovigilance and allow immediate and appropriate attention to affected patients of a medication recall.
Currently the VTS and the monitoring process is limited to Patient Care areas that utilize the Integrated Hospital Information Management System (iHIMS) and Electronic Medical Records (EMR) to document vaccine batch and lot number. In the future, this may open new doors in providing solutions not only for traceability of vaccines across all units but other medical devices such as implants of patients. It is recommended that a similar framework and program application be developed to track and trace other medications given to patients as a safety monitoring initiative.
None.
None.
No potential conflict of interest relevant to this article was reported.
R Clin Pharm 2023; 1(1): 84-87
Published online June 30, 2023 https://doi.org/10.59931/rcp.23.002
Copyright © Asian Conference On Clinical Pharmacy.
Hazel Faye R. Docuyanan , Cristina P. Solomon , Mary Jeane S. Robles , Arthur Kevin V. Castor
Department of Pharmacy, Makati Medical Center, Makati, Philippines
Correspondence to:Hazel Faye R. Docuyanan
E-mail Hazel.Docuyanan@makatimed.net.ph
ORCID
https://orcid.org/0009-0004-5866-9150
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/bync/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
In this study, presents an approach to enhance compliance with the Joint Commission International Accreditation Standards for Hospitals, 7th edition, regarding medication recall, particularly vaccines. It highlights the hospital’s initiative to develop a standardized streamlined process and implement a computerized centralized vaccine tracking system (VTS) to improve the traceability of administered vaccines up to the patient-specific batch/lot level. When needed, in the case of medication recall, this system allows the extraction of patient data and the batch and lot numbers of vaccines. Compliance to the use of the VTS was monitored, and further improvement initiatives such as training and feedback were implemented to further enhance and sustain the project. After the implementation of the project and monitoring for 11 months, the compliance on the documentation of vaccine batch and lot numbers significantly increased from 21% to 75% in the period from February 2021 to December 2021. In conclusion, the use of the centralized VTS application program, which can track all vaccines administered up to the patient-specific batch/lot level, improved compliance and provided a clean database of documentation that can be readily generated to track patients in the case of vaccine recall.
Keywords: Vaccine, Batch and lot number, Medication recall, Traceability, Vaccine tracking
The Joint Commission International Accreditation Standards for Hospitals, 7th Edition requires that the hospital has a medication recall system and has the capability to trace the batch and lot number of the medications administered to patients and be able to track at the patient level in cases of any recall [1].
This study was conducted in a 600-bed capacity, tertiary, private, JCI-accredited hospital in the Philippines. Since vaccines stay in the body generally for longer period compared with most of the medications administered to patients, this study specifically focused the implementation of the project to vaccines.
In January 2021, it was noted that there was no standard process and poor compliance on documenting the batch and lot number of vaccines administered to patients specifically in Inpatient Care Areas.
The objective of the study is to improve the compliance on the medication recall standard of being able to track patients and trace the batch and lot number of the vaccines administered to them by implementing a standardized, computerized, and streamlined process of documentation in the system with centralized data extraction feature for the purpose of vaccine safety monitoring in case of medication recall [2].
The process includes the documentation of the vaccine batch and lot number in the electronic medication administration record on the patient’s medical records by the administering healthcare provider. Compliance is monitored by the Pharmacy comparing the quantity of vaccines administered against the quantity of vaccines administered with proper batch and lot number documentation.
Baseline compliance data on complete documentation of batch and lot number of the vaccines administered to patients were collected retrospectively in October 2020 to January 2021 which is at a low rate of 21% (12 with documented batch and lot number out of 57 total vaccines administered in 4 months).
Prior to the project, there was no standard process and monitoring system in place to ensure that all batch and lot number of vaccines administered were properly documented and can be easily extracted at the patient level for purposes of tracking during medication recall. There was no available field in the medication administration record where the batch and lot number of the vaccine administered can be documented. There are units where the batch and lot number are documented manually in a separate excel file outside the electronic medical record and there are units who document the batch and lot number in the nurse’s notes. Because of the lack of standard process, tracking the patient who received a specific batch and lot number of a vaccine was very tedious and difficult. Hence, a streamlined process and centralized data extraction application was conceptualized as seen in Fig. 1.
The following were done in the implementation of the project:
1. Development of the system program application in collaboration with Information and Communications Technology Division (ICTD) with the following features.
a. standardized process across all nursing units on the documentation of the batch and lot number of vaccines administered by providing a field in the electronic medication administration record on the patient chart where this can be encoded.
b. generation of report extracting the names of patients who were given a specific vaccine.
2. User Acceptance Testing of the centralized Vaccine Tracking System (VTS) to check for completeness of the required information being extracted and the desired functionality.
3. Training of nurses on the standard process and how to use the VTS.
4. Implementation of the standard process and utilization of the VTS.
5. Monitoring of compliance to vaccine batch and lot number documentation.
6. Get feedback from Nursing team to further enhance the process and improve the implementation of the project.
7. Sharing of compliance reports to units involved and to the Medication Safety Subcommittee.
Fig. 1 shows in highlighted green boxes the steps that were improved and streamlined, and highlighted brown boxes are the steps which were removed and computerized in the process. Encoding of the batch and lot number was incorporated in the step of documenting the administration in the system and is implemented in all units. Likewise, instead of tracking and tracing manually, the system now allows a centralized generation of report to know the patients who received a specific batch/lot number.
To measure the success of the project, Pharmacy was designated to monitor the compliance to proper documentation of vaccine batch and lot number within the specified Turn-Around-Time (TAT) of 24 hours after administration [3]. Monitoring compliance to vaccine tracking system documentation was made part of the daily compliance rounds by the clinical pharmacist. Pharmacy extracts in the system the total vaccine administration, computes for the compliance, and reports accordingly.
The following formula was used to monitor compliance:
The project allowed ease in encoding of the batch and lot number which encouraged compliance in documentation by the nurses who administered the vaccines. There was a significant increase in documentation compliance from 21% (12 with documented batch and lot number out of 57 total vaccines administered in 4 months) to 75% (217 compliance out of 291 vaccines administered in February 2021 to December 2021) (Fig. 2).
Inconsistencies in the documentation compliance were initially observed during the first months of implementation. It was noted that these were the months with high attrition rates in nursing. Improvement strategies were implemented including strengthening of the orientation and training on the use of the VTS emphasizing the importance of documentation to track patients and trace the vaccine batch and lot number administered in case of medication recall promoting patient safety. A video training material was also provided as reference for the nurses to remind them on the proper procedure and importance of compliance. Regular feedback on the unit’s compliance to the use of VTS was reported.
This project facilitated generation of report when needed at the patient and vaccines level to enhance the track and trace standard for vaccines in preparation for possible medication recall and safety monitoring.
The Vaccine Tracking System implementation improved the compliance to the vaccine batch/lot number documentation per patient. By streamlining and standardizing the process, it allows ease in encoding and facilitated generating a centralized report to know who the affected patients are in case of medication recall. It also supported and helped the health team realize the importance of batch and lot number documentation for patient safety monitoring. Overall, this project would improve pharmacovigilance and allow immediate and appropriate attention to affected patients of a medication recall.
Currently the VTS and the monitoring process is limited to Patient Care areas that utilize the Integrated Hospital Information Management System (iHIMS) and Electronic Medical Records (EMR) to document vaccine batch and lot number. In the future, this may open new doors in providing solutions not only for traceability of vaccines across all units but other medical devices such as implants of patients. It is recommended that a similar framework and program application be developed to track and trace other medications given to patients as a safety monitoring initiative.
None.
None.
No potential conflict of interest relevant to this article was reported.