The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
Assesing cold chain compliance for biotherapy drugs in a university hospital’s medical departments
European Statement
Patient Safety and Quality Assurance
Author(s)
AMINE BAYEN, OUMAIMA KHARKHACH, HICHAM EL HORR, LHOUSSAIN ZARAYBY, SANAE DERFOUFI
Why was it done?
It has been observed that within the gastroenterology, neurology, internal medicine, rheumatology, and dermatology departments, there exist inconsistencies and disparities. These include extended transportation times averaging 8 minutes, a lack of isothermal bags for transportation, and refrigerators not connected to the main hospital generator.
Strict adherence to storage guidelines is crucial, as any breach in the cold chain could compromise the drug’s therapeutic effectiveness, increase the risk of adverse effects, and lead to significant financial losses for healthcare institutions.
What was done?
Ensuring optimal storage and transportation conditions for biotherapy drugs in various medical departments within a university hospital by assessing and improving cold chain compliance.
How was it done?
Implemented corrective actions and recommendations have been primarily directed towards minimizing transportation duration and procuring thermal bags for all departments handling biotherapy products. These initiatives encompass enhancing staff awareness in the cold chain process through sensitization campaigns and regularly evaluating refrigerator temperatures. Moreover, a strategic plan is underway to establish their connectivity to the generator system in the near term.
What has been achieved?
A notable reduction in the transportation time of biotherapeutic drugs has been achieved, decreasing the average duration from 8 minutes to 6 minutes. Additionally, the widespread adoption of thermal bags across audited departments has substantially bolstered the stability of biotherapeutic drugs, mitigating temperature fluctuations and enhancing patient safety. Moreover, our efforts in sensitising medical and pharmaceutical staff within these departments have yielded a significant increase in awareness and adherence to stringent cold chain protocols.
What next?
The inconsistencies and disparities identified during the assessment of the biotherapy drug cold chain within our hospital suggest a potential lack of adherence to procedural standards. This situation poses a considerable risk to patient safety, warranting further investigation and action.
Our focus will extend beyond the cold chain assessment to evaluate other pharmaceutical procedures. Specifically, we will investigate the adherence to autoclave sterility cycles for medical devices and the robustness of the preparation process for oncology medicines.
Acceptance of pharmaceutical interventions in a resuscitation unit
European Statement
Clinical Pharmacy Services
Author(s)
Xabier Larrea Urtaran, Elisabet Nogué Pujadas, Alba Couso Cruz, Guillem Pla Escriva, Carol Batlle Perales, Carla Subirana Batlle, MIreia Bruguera Teixidor, Carmen Ortí Juan, Anna Dordà Benito, Mireia Vila Curris
Why was it done?
The aim of the study is to analyze pharmaceutical interventions (PI) carried out by a hospital pharmacist in a Resuscitation Unit (RU) in terms of number and degree of acceptance.
What was done?
The integration of a pharmacist in the critical care unit allows optimizing pharmacotherapy, prevent s medication errors in critical patients and working in a multidisciplinary methodology .
How was it done?
It is a prospective study carried out from 1 August 23 to 15 September 23 on weekdays, in which patients with a minimum of 48 hours of admission were included, recording the PIs conducted during the daily clinical activity of a pharmacist at the RU. The variables collected were: age, sex, type of PI, medication involved, acceptance of PI and day since admission. The percentage of acceptance of the PIs and activity indices (PI/patient, PI/days and day of PI in respect to admission to the RU were calculated. For the descriptive analysis, the means and standard deviation (SD) were used.
What has been achieved?
80 patients were included during a total of 31 weekdays, mean age ± SD of 59.6 ± 18.4, 46.3% were women (n=37). Patients had 8.9 ± 3.0 drug prescriptions and 3.8 ± 2.0 infusions and on-demand drugs. There were 5.9 patients admitted per day in the RU .107 IPs were carried out, with activity indices of 1.3 IP/patient, 3.45 IP/day and 3.21 IP days compared to admission to the RU.
The groups of drugs with the highest IP were: anti-infective agents for systemic use (n=57), blood and hematopoietic organs (n=17) and nervous system (n=15).
The interventions carried out were: adjustment of anti-infective therapy (n=21); pharmacokinetic adjustment (n=18); administration (n=17); conciliation (n=16); dose adjustment by glomerular filtration rate (n=16); dose adjustment (n=10); duplicity (n=5); no need (n=2); compounding (n=1) and allergy (n=1).
The degree of acceptance of the IP was 92.5% (n=99).
What next?
The acceptance of PIs in the RU is very high , being greater than 90%, with an activity of more than 3 PIs per day, reinforces the integration of a hospital pharmacist in a multidisciplinary team to ensure patient safety and improve the pharmacotherapeutic profile. It is necessary to have a pharmacists integrate in the RU.
Securing the management of experimental product in investigator services in case of non-nominative dispensing: a risk based approach
European Statement
Patient Safety and Quality Assurance
Author(s)
Mélanie Hinterlang, Mona Assefi, Pauline Glasman, Delphine Brugier, Meriem Charfi, Fanny Charbonnier-Beaupel, Marie Antignac, Carole Metz
Why was it done?
Clinical trials in critical care sometimes demand swift inclusion and administration, often occurring at any hour of the day or night. To enhance patient care, the experimental drug may be provided in a non-nominative manner directly from the pharmacy unit to the care unit for storage before any inclusion as a stock. This dispensing pathway is considered less secure than the conventional named dispensing but can be necessary. The objective of this risk analysis for this dispensing process was to identify the risks, determine the number of them with unacceptable criticality, and propose actions to reduce criticality of these risks.
What was done?
A risk analysis of non nominative dispensation of experimental drugs process was conducted to streamline, secure, optimize, and standardize this dispensing process.
How was it done?
Following a preliminary investigation, three pilot services were chosen: surgical intensive care, post-interventional recovery room (SSPI), and cardiology. The Failure Mode, Effects, and Criticality Analysis (FMECA) method was applied to the non-nominal dispensing circuit of experimental drugs from reception at the pharmacy unit to the administration of the drug to patient. Investigators, clinical research associates, nurse, and pharmacists participated.
What has been achieved?
Following the FMECA, 281 risks were identified. The majority were either acceptable (123 or 44%, 110 or 39%, 147 or 52%) or tolerable (139 or 49%, 148 or 53%, and 130 or 46%) for the intensive care, SSPI, and cardiology services, respectively. Unacceptable risks numbered 19 (7%), 23 (8%), and 4 (1%) for intensive care, SSPI, and cardiology services, respectively. The process identified as most critical for all three services was communication. After risk prioritization, a plan comprising 17 actions was implemented.
What next?
This risk analysis demonstrated that control over the non-nominal dispensing circuit is achievable. Once the actions are in place, a reduction in criticality is anticipated due to a decrease in the frequency. Theoretically unacceptable risks are now at 0%. In the long term, this project has the potential to participate to improve the care of patients enrolled in emergency clinical trials and boost research in the concerned units.
Development of a new method for risk assessment related to management of clinical trials in hospital pharmacy: classification of protocols by risk index (ρ) and development of strategies for errors’ minimization
European Statement
Patient Safety and Quality Assurance
Author(s)
Giulia CANCELLIERI, Piera POLIDORI
Why was it done?
Hospital pharmacist provides all management of investigational medical product(IMP), i.e. its conservation, distribution, return and destruction. However, each clinical trial involves different methods of managing the drug: this can mislead the pharmacist who has to manage multiple trials at the same time. With the aim of minimizing errors that may arise from the simultaneous management of different clinical trials, we have developed a method to classify clinical protocols by “risk index”.
What was done?
With the aim of minimizing errors resulting from management of clinical trials in hospital pharmacy, we have developed a method to classify experimental protocols into low-moderate-high risk(risk index). For each of these categories, standard procedures were then outlined in order to minimize the occurrence of any errors.
How was it done?
In order to determine risk index(ρ) we have identified all risks related to IMP’s management: pharmacological risk(φ), dependent on pharmacological characteristics of IMP; technological risk(α), if drug should be compounding; risk related to number of patients enrolled(np); risk inherent to the protocol(π), i.e. whether protocol involves placebo, or randomization, etc. These risks were then related through the formula created by us, ρ=φ+(α*np)+π: protocols are defined low-risk if ρ<50, moderate-risk if 51<ρ151. For each risk index, standard procedures were outlined in order to minimize risks, i.e.(for high-risk) inclusion of at least four pharmacists in “Delegation of Responsibilities Log”; scheduling monthly meetings with trial’s Monitor; dispensing of IMP with supervision by at least two pharmacists; etc.
What has been achieved?
We applied this method to 45 active trials in our hospital. For 3/45(6,7%) protocols, φ>75 because IMPs are carcinogenic; instead, 26/45(57,8%) protocols, involve IMP’s compounding; finally 29/45(64,4%) protocols are randomized and 14/29(48,3%) of these involve use of placebo. By applying aforementioned formula, we found that 3/45(6,7%) protocols are low-risk, 32/45(71,1%) moderate-risk, 10/45(22,2%) high-risk. For these 10, standard procedures were applied, to improve the safety of patients enrolled in a clinical trial.
What next?
We promote use of this method in other clinical centers, because we believe it can be a valid tool for risk minimization. Finally, we hope that we will receive numerous feedback from these centers to further improve the proposed method.
Analysis of quality indicators in the compounding area through a mobile application
European Statement
Patient Safety and Quality Assurance
Why was it done?
To identify improvement opportunities in the Pharmacy Compounding Area through the analysis of indicators obtained from a traceability App.
What was done?
In 2022, a mobile application (App) was designed and implemented to facilitate the traceability of preparations compounded in the Pharmacy (parenteral nutrition, chemotherapy and other individualized sterile preparations). In addition, the analysis of data registered in the App has provided valuable information about the compounding unit performance.
How was it done?
Monthly reports from May to December 2022 were analysed, focusing only on chemotherapy preparations. The indicators selected were: the average number of monthly preparations, weekly workload distribution, daytime distribution of compounded preparations, preparations returned to the Pharmacy, percentage of treatments prepared on the same day of administration, and percentage of preparations compounded after the scheduled administration time.
What has been achieved?
An average of 139 chemotherapy preparations per day was recorded. The daily distribution highlights that Thursdays and Fridays are the busiest days with the 45% of the total weekly preparations. Furthermore, the morning shift carries out most of the compounding work, with 79% of the preparations being compounded before 3 PM. This information might be useful to the management team to better distribute tasks and resources. Data analysis indicates that 62% of the preparations are compounded in advance, while the remaining 38% are prepared on the same day of administration, which is also valuable information to organize the compounding workflow. On average, 59 preparations were returned per month. Finally, we found that 8.1% of the chemotherapy drugs were prepared with a median delay of 47 minutes from the expected time of administration. All these items are currently being monitored as quality indicators in order to find the way to minimize them.
What next?
The analysis of data recorded in the App provides us valuable management indicators for organizing work in the preparation area.
Tracking these indicators serves as a quality tool for the area and helps us identify opportunities for improvement.
Reconciliation of weekly methotrexate for non-oncologic use: results from a prospective cohort
European Statement
Clinical Pharmacy Services
Author(s)
Adrian Viudez-Martinez, Ana Ramirez-Lopez, Javier Lopez-Nieto, Geronima Riera, Eduardo Climent-Grana
Why was it done?
Medication errors harm at least 1.5 million people every year. According to the Institute for Safe Medication Practice (ISMP), ongoing errors with oral methotrexate (MTX) for non-oncologic use suggest that more needs to be done to reduce the risk of patient harm, especially considering its potentially severe side effects.
What was done?
Identification and prevention of MTX-related medication errors for non-oncologic use by medication reconciliation at hospital admission. Analysis of errors’ type prevalence were also performed.
How was it done?
Design: prospective cohort performed in a tertiary hospital from September 2021 to April 2023.
Inclusion criteria: Inpatients with weekly methotrexate for non-oncologic use.
Intervention applied: medication reconciliation comparing inpatient’s e-prescription, clinical record, outpatient medication history and pharmacist-driven interview.
Data analysed: demographic data (age, sex, admission cause) treatment-related data (indication, methotrexate and folic acid posology, administration route, day of the week).
What has been achieved?
Out of 79 admission episodes (53.1 % men, median age: 72 years (range: 18-96 years), 63 (80% )were urgent.
Most patients had been prescribed methotrexate for rheumatoid arthritis (n=56), but also for polyarthritis (n=9), psoriatic arthritis (n=8), pulmonary sarcoidosis (n=2), pemphigus (n=1), spondylarthritis (n=1) and Still syndrome (n=1).
Methotrexate doses’ frequency were: 15 mg (28.9%), 10 mg (27.6%), 20 mg (11.9%), 7.5 mg (9.2%), 25 mg (7.9%), 12.5 mg (6.6%), 17.5 mg (5.3%) and 5 mg (2.6%).
Medication errors were identified and prevented in 38 out of the 77 episodes recorded (49.4%). There were classified as follows: dose (38.5%), day (17.9%), dose and day (17.9%), dose and administration route (10.3%), omission (10.3%), administration route (2.6%) and lack of indication (2.6%).
Folic acid doses’ frequency was: 10 mg the day after MTX (47%), 5 mg the day after MTX (28%), 5 mg daily except the same day as MTX (17%), 15 mg the day after MTX (8%).
Medication errors were identified and prevented in 51 out of the 77 episodes recorded (66.2%). There were classified as follows: omission (38.8%), day (33.3%), day and dose (16.7%), dose (9.3%) and drug (1.9%).
What next?
Performing medication reconciliation in every admission, measuring its potential benefits using validated tools for clinical pharmacists’ intervention assessment, such as the CLEO tool, which can, ultimately, serve as preamble to objectively measure the pharmacists’ impact in healthcare efficiency and patients’ safety.
The pharmaceutical approach to the processing of donor human milk in a human milk bank
European Statement
Production and Compounding
Author(s)
Susana Fraga, Cláudia Cunha, Susana Pissarra , Carla Sampaio, Diana Silva, Pedro Soares, Teresa Soares, Renata Barbosa
Why was it done?
Human milk banks (HMBs) must use rigorous quality assurance practices to protect infants and milk processing, and post-pasteurization procedures are important in maintaining high-quality breast milk and safeguarding its quality.
The compounding pharmacist has all the knowledge and experience needed to implement processing circuits based on good handling practices and sterile technique, combined with quality assurance procedures to ensure their safety.
What was done?
Pharmacy implementation of the Donor Human Milk (DHM) processing circuit (by pasteurization) and conditions.
How was it done?
Bibliographical research and critical analysis of the functioning of HMB worldwide, with multidisciplinary meetings to define the best and most secure quality practices.
Equipment choice, in accordance with recommendations and assessment of their technical requirements.
Adaptation of the informatic medical integrated system to the DHM prescription, processing, quality control and dispensing circuit.
Design of the DHM circuit based on good practices for the safe use of products of human origin and on a robust quality assurance plan.
What has been achieved?
A DHM circuit was put into practice, with pharmacist intervention in DHM processing, quality control, and batch release.
Procedures for aseptic handling, quality control with check points and risk analysis, packaging, and labelling of DHM were outlined.
Work instructions were also established for handling equipment (pasteuriser, bottle sealer, laminar flow chamber) as well as procedures for cleaning facilities and material/equipment, with training sessions for the professionals involved.
The multidisciplinary circuit was adapted to the organisational management of the Neonatal Intensive Care Unit (NICU), HMB, and Pharmaceutical Services, certified on 18 April 2023 according to ISO 9001:2015 recommendations.
Guidelines for the correct use of equipment in accordance with its recommendations and technical requirements were established.
What next?
Opening more HMB worldwide is an inevitability. Prevailing know how at the level of hospital pharmacies represent several advantages to these projects, based on experience and expertise in manipulating biological products and maintaining a controlled circuit based on safety and quality standards.
Development of a hospital pharmacist led re-evaluation of medication errors
European Statement
Patient Safety and Quality Assurance
Why was it done?
All errors, whether involving medication or not, are required to be reported and classified in the hospital reporting system. However, the system is poorly adapted for medication management and lacks the relevant terms. This results in the same type of error being classified in various ways, making systematic quality improvement difficult. A pilot study confirmed the system’s shortcomings, after which a new medication management process was developed and evaluated.
What was done?
The existing process for classifying medication errors was supplemented with a new process in which hospital pharmacists reclassified medication errors detected in the reporting system. The reclassification was based on a predefined medication management process.
How was it done?
A medication management process was developed in collaboration with specialist nurses and in accordance with applicable regulations and policies. The process consisted of the following activities: 1) Prescription, 2) Ordering/Delivery, 3) Storage/Narcotics Control, 4) Preparation, 5) Handover/Administration, 6) Medicines information in transitions of care, 7) Follow-up of treatment, and 8) Miscellaneous. The process was validated by having four hospital pharmacists independently classify 176 medication errors. Consistency in the assessment was evaluated, and the process was corrected as needed. All medication errors classified as medication-related in 2022 or containing the word “medication” in free text were thereafter exported from the reporting tool to Microsoft Excel and then into a data processing and performance monitoring tool for further analysis.
What has been achieved?
A total of 756 medication errors were identified in the reporting tool, distributed across 65 different activities. Hospital pharmacists identified an additional 305 errors through free-text searches that had not been reported as medication-related. A total of 1,061 medication errors (756+305) were reclassified and grouped into eight activities. The highest risk of errors was associated with the preparation (19%), followed by storage/narcotics control (18%), and prescription (17%). The new process, involving hospital pharmacists in classification, creates conditions for a more systematic approach to medication errors. The pilot project was presented at the hospital’s themed day for World Patient Safety Day 2022.
What next?
Discussions have been initiated with system developers to improve the reporting tool. Discussions with hospital management will be initiated with the goal of creating a structure in which hospital pharmacists have an active role in the hospital’s work on patient safety related to medication.
Flashpharma: a training tool to ensure quality medication management
European Statement
Patient Safety and Quality Assurance
Author(s)
Samantha HUYNH, Catarina GONCALVES BARROSO, Sophie PATERNOTTE, Sofia DA SILVA MENDES, Claire JUDEL, Elvire MARTIN-LEMAIRE, Georges NICOLAOS, Chloé DUPONT, Nicolas CORNILLET
Why was it done?
Raising awareness and ongoing training of healthcare professionals is a crucial criterion for High Authority for Health certification. Flashpharma provides reliable information, particularly for night-shift nurses. This becomes critical in a context of reduced physician presence and absence of pharmacists, and the increasing presence of temporary nurses due to staffing shortages.
What was done?
The pharmacy department developed FlashPharma, an innovative training tool to enhance medication management within healthcare units. For instance, it contributes by promoting the proper use of high-risk medications (HRM) and risky medications (RM) by providing information to care teams as close to the patient as possible.
How was it done?
A working group created eleven sheets based on literature and adapted to the practices of adult hospitalization departments. Validated by medical experts and institutional committees, they include points to watch and key figures. They link up with our institutional protocols, our prescribing software and the points addressed by the visiting experts during the mock certification. Accessible by flashing QR codes strategically positioned or on our web platform, they serve as a basis for discussion with caregivers. Trainers included pharmacists, a pharmacy intern, and a hospital quality manager. Anonymous written questionnaires were used to gather feedback.
What has been achieved?
Two QR codes are placed on automated dispensing cabinets and mobile medical carts, linking to sheets on MHR, RM, and guidelines for proper drug crushing and administration via an enteral feeding tube. Another QR code on refrigerators provides information on drug storage and temperature alerts management. A label provides information on drugs prescribed outside the booklet, with six therapeutic equivalence tables validated by doctors.
Three sessions were attended by nurses, healthcare managers, orderlies, and doctors (n=18). Fifteen (83%) participants strongly agreed, and 3 (17%) agreed that they acquired new knowledge. All participants would recommend these sheets; 16 (89%) strongly expressed their willingness to participate in a second session.
What next?
Positive feedback highlighted the need for further education in various hospital units. Feedback on the use of QR codes by day and night teams will be sought during subsequent sessions and quantified using analytical dashboards. Appropriate continuing education initiatives will be implemented in paediatrics, intensive care and operating room departments.
«At the pharmacy, it is not just the cross that is green » Design and distribution of an awareness video on sustainable development related to the hospital pharmacy sector
European Statement
Education and Research
Author(s)
Pascaline Hubot, Anais Lumen , Marion Lefebvre, Audrey Christiaens , Claudia Tavernier , Olivia Dalleur
Why was it done?
With the healthcare sector’s climate footprint accounting for 4.4% (2019) of global greenhouse gas emissions, sustainable development in healthcare is one of today’s challenges. It is important and urgent to highlight the simple actions that can be implemented to reduce these emissions and to promote them. The objectives were: (1) To identify eco-friendly practices related to the pharmacist’s work. (2) To design an animated video and (3) To raise awareness among pharmacy staff about sustainable development.
What was done?
Students in their final year of a complementary master’s degree in hospital pharmacy at the Université Catholique de Louvain (Belgium) decided to take on the challenge of producing an animated video on eco-actions specific to the profession of hospital pharmacist.
How was it done?
Firstly, a literature review (PubMed, Google Scholar) on sustainable development in healthcare followed by a focus group was carried out to identify and select ten eco-actions most relevant to the hospital pharmacist’s job. We provide at least one example for each sector of the pharmacy. Secondly, a brainstorming session was held to select the most appropriate communication tool.
What has been achieved?
An 8-minute animated video was produced using Powtoon software (January 2023 version). This video is available free of charge on Youtube (https://www.youtube.com/watch?v=5eKQVcVlP00). A poster was created for display in all hospital pharmacies in French-speaking Belgium to inform as many staff members as possible about best practices in sustainable development. A QR code was added to the poster to enable a direct access to the video. The project was presented by webinar for French-speaking Belgian hospital pharmacists in April 2023. This video is now included in the programme of a complementary Master’s degree in hospital pharmacy at the Université Catholique de Louvain.
What next?
In the face of climate challenges, raising awareness of sustainable development issues remains the watchword This educational video is a first step in initiating actions to make pharmacy more sustainable. It will be presented at the next annual meeting of French-speaking Belgian hospital pharmacists in 2024 and we hope that pharmacists will implement these concrete eco-friendly practices within their institutions.