Implementation of a multidisciplinary circuit for the management of haematologic patients under treatment with bispecific antibodies
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European Statement
Patient Safety and Quality Assurance
Author(s)
Carla Noguera-Jurado, Alba Manzaneque, Gloria Molas, Genis Castells, Sandra Jara, Bernat Tenas, Jordi Nicolas
Why was it done?
Bispecific antibodies (BA) have the ability to specifically bind two different antigens, thereby presenting specificity for two different cells. Among the toxicities associated with these drugs are cytokine release syndrome (CRS) and immunoeffector cell-associated neurotoxicity syndrome (ICANS), the management of which requires multidisciplinary action. The purpose of this circuit is to ensure adequate management of these toxicities to guarantee patient safety.
What was done?
Creation of an action plan for haematological patients treated with bispecific antibodies for the detection and proper management of their toxicities.
How was it done?
A multidisciplinary team formed by Pharmacy, Haematology, Nursing, Intensive Care Medicine and Neurology was created and the healthcare professionals involved were specifically instructed. Moreover, an action circuit was implemented for the detection and management of these toxicities, and a specific protocol was created for the preparation and dispensing of tocilizumab. The protocol contemplated: centralisation of the preparation in the pharmacy department (within the pharmacy hours) or preparation in the hospitalisation ward by trained professionals using a kit previously prepared by the pharmacist (containing drug, serum and closed system dispositive for the preparation and administration of tocilizumab outside pharmacy hours).
What has been achieved?
From July 2022 to August 2023, a total of five patients have been treated with BA in our institution (elranatamab (4/5), and teclistamab (1/5)), including clinical trials and compassionate use, for Multiple Myeloma.
Three patients presented grade 1 CRS in the first cycle of treatment, which was resolved with symptomatic therapy, with no need for tocilizumab administration in any case. In addition, one also presented grade 1 ICANS, which only required monitoring without treatment.
The availability of the toxicity management circuit, in addition to staff training, allowed toxicities to be detected and resolved early and, if tocilizumab had been needed, the circuit would have ensured its immediate availability.
What next?
The implementation of a multidisciplinary care circuit led by pharmacy and haematology guarantees the adequate management of toxicities associated with the treatment, ensuring the best quality of care for the patients and their safety.
Enhancing of patient-centric care and employee satisfaction: the “all activities in alignment” programme
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Afke van de Plas, Judith Baars-Timmermans, Hanneke Goossens, Ellen Frankfort
Why was it done?
This initiative aimed to improve:
1. Personalized Healthcare and Patient Satisfaction: In the pursuit of strict regulatory compliance, pharmacy employees sometimes overlooked the pharmacy’s fundamental mission. With limited direct patient interactions, staff were often unaware of patients’ unique needs and preferences.
2. Employee Satisfaction: The program aimed to empower employees by reducing excessive regulations and allowing them to make decisions that aligned with the overarching mission, with the expectation that this would enhance their job satisfaction.
3. Enhancing Awareness of the Pharmacy’s Mission: By connecting all activities to the pharmacy’s core mission, the program attempts to improve personalized healthcare and patient and employee satisfaction.
What was done?
Maastricht University Medical Centre’s hospital pharmacy introduced the “All Activities in Alignment with Underlying Aim” program.
How was it done?
The program’s implementation involved several key steps:
1. Defining the Underlying Aim and Key Principles: The program team identified the overarching aim as “Happy Patients and Employees” and established four key principles: “See the Person Behind the Patient,” “Focus on What Is Possible,” “Take the Lead Yourself,” and “From Rules to Self-Regulation.”
2. Employee Engagement: The new policy was presented and discussed in detail during a meeting with all employees.
3. Communication: Periodic newsletters and monthly team meetings were used to share illustrative examples and foster discussions about initiatives.
4. Evaluation: Customer and employee satisfaction were measured through surveys before and after program implementation.
What has been achieved?
The outcomes of the program were highly encouraging:
• The adoption of “Happy Patients and Employees” as the guiding aim resulted in numerous instances of personalized healthcare and enhanced collegiality.
• The four key principles empowered employees to align their actions with the program’s aim. The empowerment to decide in the patient’s interest increased from 58% to 73%.
• Surveys indicated improved customer and employee satisfaction.
• Enhanced awareness of the pharmacy’s mission (from 47% to 66%) led to stronger connections between activities and the overarching aim (from 73% to 85%).
What next?
The “All Activities in Alignment” program serves as a successful model for other hospital pharmacies seeking to elevate personalized healthcare, patient and employee satisfaction. Its simplicity and effectiveness make it a valuable initiative worth considering for broader implementation.
Pallet box implementation: a combination of improved working conditions, storage and waste optimisation?
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Elisabeth CESAR, Ludivine LECHEVRETEL, Adrien NIERENBERGER, Laurent DIETRICH, Anne FEGER-FALK
Why was it done?
We decided to experiment this new solution on coronarography-packs, which presents the biggest rotation among surgery-packs (5,392 units estimated for 2,023), in order to improve working conditions of logistic workers, decrease musculoskeletal disorders (MSD) and optimise storage.
What was done?
Pallet box have been implemented as a new logistic solution for surgery-packs in our hospital pharmacy on a proposal from one of our biggest suppliers. The aim of this comparative study between 52-pack pallet boxes and the previous storage solution by 4-pack boxes was to assess the potential benefit on handling work, storage, waste and its economic impact.
How was it done?
In order to compare these two solutions, we clocked the time and evaluated the cost of transport from delivery gate to storage room and healthcare-unit order-picking step (from picking up the first pack to cardboard flattening). We also estimated the amount of waste associated.
What has been achieved?
Pallet-boxes enable a 24% room saving (52 pallet-spots yearly (2 pallet-boxes piled on one spot) instead of 68) and a 31% global time saving (22 hours yearly (13h transport + 9h order picking) instead of 32 hours (17h transport + 15h order picking)). Time saving on order picking was 40%: picking step of one pack from a pallet box requires on average 6 seconds whereas 10 seconds were needed from 4-packs-boxes. Yearly 104 pallet-boxes (603 kg of empty cardboards) will be manipulated whereas 1,348 4-pack-boxes (1,213 kg) used to be handled resulting in a 2-fold decrease. Even though pallet-boxes halve cardboard-waste, they represent 1.5 times more wooden-pallets’ waste (104 versus 68). Furthermore the price of coronarography-packs are impacted by a 2% increase representing around 4,100€ yearly which is not balanced by savings on transport or order picking (10h ≈ 150€).
What next?
Logistic workers are unanimously satisfied in implementing pallet-boxes as it facilitates their work on many aspects: pallet transport, order picking, waste disposal. Despite being costlier, a decision has been made to implement pallet-boxes in the long-term in order to improve waste management and working conditions of logistic workers. Our hospital pharmacy is already thinking about extending pallet-boxes to other references in order to assess more precisely their impact on MSD in logistic workers.
Interdisciplinary management of acute acetaminophen poisoning guided by therapeutic drug monitoring
European Statement
Patient Safety and Quality Assurance
Author(s)
Irene Centeno López, Eva M Legido Perdices, Maria José Cano Cano, Salvador Benlloch Pérez, Federico Peydró Tomás, José Manuel Ventura Cerdá
Why was it done?
Acetaminophen is the most used antipyretic and analgesic drug around the world. Intentional and non-intentional acetaminophen overdose is related to acute liver failure and it is important to start the treatment during the first hours after the intake to reduce liver injury. The main treatment to prevent liver failure is n-acetilcysteine (NAC) and it is administered depending on acetaminophen plasmatic concentrations using Rumack-Matthew nomogram during the first 24 hours. Variability in sampling time and duration of NAC administration was detected when acetaminophen intake was unknown or above the first 24h. Moreover, different NAC administration protocols were used in our institution.
What was done?
An interdisciplinary team involving Hospital Pharmacy, Emergency, Gastroenterology Department and Critical Care Unit was created to establish an agreed protocol for the management of acute acetaminophen poisoning.
How was it done?
The interdisciplinary team agreed the following procedures:
– To change the traditional NAC protocol of three intravenous infusions (150 mg/kg over 1 h, 50 mg/kg over 4h and 100 mg/kg over 16h) to the SNAP protocol of two bags (100 mg/kg over 2h and 200 mg/kg over 10h) reducing duration of administrations from 21 to 12 h.
– To establish the sampling times for the determination of acetaminophen serum concentrations: the extraction will be 4h after the ingestion during the first 24h of the intake. When time is unknown or greater than 24h, two samples separated by at least 2h will be extracted to calculate acetaminophen half-life to assess the probability of liver damage (high probability when half-life (t1/2)>4h).
– Define NAC discontinuation when INR<1.3, transaminases are in normal range and acetaminophen concentration<10 mcg/ml. If one of these parameters remains altered, the last NAC perfusion must be repeated.
What has been achieved?
– Reduce the duration of NAC treatment in the Emergency and hospitalization rooms if all analytical parameters are normalised.
– Reduce the variability in the management of acetaminophen poisoning and sampling time.
– To perform a closer clinical follow up of intoxicated/over-medicated patients.
What next?
Measure the reduction of hospital admissions and safety improvement by modifying NAC administration protocol and therapeutic drug monitoring of acetaminophen.
Improving efficiency in the infusion unit through a critical review of medication protocols
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Jesper van Breeschoten, Chang Chui, Bert Storm, Grootswagers-Sobels Annemieke
Why was it done?
After the introduction of new medications in a hospital, it is uncommon for local treatment and administration protocols to be reevaluated in light of the latest scientific evidence. Infusion units are facing numerous challenges today, including staffing shortages and a growing number of patients receiving intravenous treatments. It may prove beneficial to periodically conduct a comprehensive review of the current protocols, with the objective of minimizing the time patients spend in the infusion unit and to prevent unnecessary use of medication while upholding the delivery of high-quality care.
What was done?
We performed an extensive review of treatment protocols for all medications administered at our infusion unit.
How was it done?
We performed an extensive review of treatment protocols for all medications administered at our infusion unit, drawing insights from the most recent literature. Our evaluation covered a range of factors, including premedication, infusion rates, observation periods, line flushing, administration routes, hydration strategies, and anti-emetic regimens. To provide additional data supporting protocol refinements, we utilized an electronic health record text mining tool known as CTcue, which facilitated the collection of retrospective patient information. Subsequently, these protocol modifications received unanimous approval from both pharmacist and attending specialist.
What has been achieved?
Treatment and administration protocols of 17 medications were optimized. We decreased infusion times for atezolizumab, bevacizumab, carboplatin, doxorubicine, durvalumab, folinic acid, irinotecan, panitimumab, vinblastine and vincristine. Vital sign assessment during infusion were omitted from protocols. Premedication and anti-emetic medication were converted to oral administration. Intravenous administration was converted to subcutaneous administration for abatacept, daratumumab, infliximab, tocilizumab, trastuzumab + pertuzumab and vedolizumab. Observation time after infusion was omitted for daratumumab, infliximab and vedolizumab. Based on the current literature, hydration schemes of cisplatin were shortened from 20 hours to 4 hours. The implementation of all optimization measures resulted in a reduction of ± 6000 hours of bed occupancy by patients annually. Based on our estimation, this has resulted in a reduction of approximately 16% in total time that beds were occupied.
What next?
We aim to periodically review our treatment and administration protocols and share our experiences with other hospital pharmacists. Other infusion units that also face challenges in shortness of staff may copy this blueprint to mitigate these problems.
Green Team clinical pharmacy and pharmacology of a university hospital in the Netherlands: towards sustainable clinical pharmacy
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Patricia Van den Bemt, Thijs Oude Munnink
Why was it done?
Healthcare is responsible for an important part of the carbon footprint and medication production and use contribute substantially to this footprint. In line with Green Teams being established in all layers of society at the moment, the UMCG departments were also starting to implement such teams. The CPP was among the first departments establishing such a Green Team in order to reduce the footprint of medication use.
What was done?
The department of Clinical Pharmacy and Pharmacology (CPP) is responsible for providing pharmaceutical patient care to all hospitalised and ambulatory patients of the University Medical Centre Groningen (UMCG) in tThe Netherlands. Two years ago, the department has established a Green Team, dedicated to making this pharmaceutical care as sustainable as possible.
How was it done?
The Green Team CPP started in June 2021 with a brainstorm on potential subjects. As the main focus we chose to ‘contribute to sustainable medication use and to reduce disposal’. The team consists of representatives of all CPP sub-departments. Proactive measures and projects were defined, but increasingly the Green Team is being consulted by doctors and nurses regarding issues on sustainable medication use. Department-wide awareness is fuelled by a periodic newsletter.
What has been achieved?
Three projects were conducted: 1) Switching from paracetamol intravenous therapy to oral/rectal therapy (based on doctor’s question); 2) Patient’s own medicine use combined with self-administration of medication (POM/SAM project; based on nurse question); 3) Exploring oral anticancer drug waste by patient interviews (in preparation of improvement measures; proactive Green Team project). The results of these projects are of interest to all European hospital pharmacists and can inspire others to establish Green Teams to contribute to sustainable pharmaceutical care.
What next?
Given the success of the paracetamol project, we will expand this to other intravenous medications. The pilot project on POM/SAM has inspired us to implement POM/SAM within all nursing departments of the UMCG. And the results of the interviews on oral anticancer waste form a solid justification of the necessity of implementation of re-use of medication. In addition, we will continue to perform new proactive projects, aimed at deprescribing (by performing medication reviews), improving medication adherence, optimising the logistics of medication (reducing the amount of medication being dispensed, implementing of ready to administer medication, implementing of pharmacy IV service), reducing medication and financial waste using vial rounding, and proper disposal of medication. We will also continue to be the expert group to which doctors and nurses can direct their questions on sustainable medication use.
Implementation in a pharmacy service of a big data analysis programme for successful treatment
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
LUCIA SOPENA, ALBERTO FRUTOS, VICENTE GIMENO, OLGA PEREIRA, RAQUEL FRESQUET, ARITZ MERCHAN, REYES GARCIA, PAULA GOMEZ, ALBERTO APESTEGUIA, MARIA ANGELES ALLENDE, TRANSITO SALVADOR
Why was it done?
The growing technological development of pharmacy services involves the coexistence of traditional warehouses with automated medicine dispensing systems controlled by different computer programs. The information is split into different systems and databases giving rise to possible errors due to the greater complexity. This is a threat but also an opportunity for the hospital pharmacist to lead the development, review, and improvement of medicine use processes and the use of health technologies to improve quality of care, patients’ safety and reduce costs. KNIME data analysis covered the need of our Pharmacy Service to blend data from any source in a single file simplifying the process.
What was done?
The Pharmacy Service of a university hospital has implemented Konstanz Information Miner (KNIME) data analysis and develop successful treatment project to optimise the stock management of several medicines.
How was it done?
An initial algorithm was designed by the union of seven files and can be executed at any time to obtain the updated data.
What has been achieved?
This file provides up-to-date information about the stocks, stock-outs, consumptions, orders and purchasing data of all medicines (average price, laboratory, date and number of orders, units to be received).
In addition, KNIME calculated the coverage time in days and months from weekly and monthly consumption, and the current stock in the warehouses, obtaining a global vision of highest turnaround pharmaceuticals drugs.
The program also allows to link and merge data of the list for shortages of medicines, supply disruptions and restocking time, and to improve the storing, delivering and administering of COVID-19 vaccines.
KNIME program has been especially important in our Pharmacy Service to get better care outcomes and more precise medication ordering, which allows significantly higher patient safety.
What next?
KNIME is a tool that could be successfully implemented and appropriately generalised as recommended to all Pharmacy Services that use different data sources and want to have a generalised view of the information. KNIME represents an advance in the stock and purchase management of medicines specialties to work more efficiently, which improve patient care and safety. Digital medication management also contributes to greener pharmacies by preventing unnecessary overstocking and thus excessive disposal arising from expired medications.
Operational interventions to improve the performance of cytotoxic medicines compounding
Pdf
European Statement
Production and Compounding
Author(s)
Leila Costa, Rui Marques, Ana Castro, João Paulo Cruz
Why was it done?
Cytotoxic medicines are drugs used mainly in the treatment of neoplasms. Their preparation is a key activity of Hospital Pharmacy, carried out in a Class II Type B2 Vertical Flow Chamber (VFC). With the emergence of new cytotoxic drugs, the increase in the number of patients (2100 in 2010 to 3168 in 2021), and preparations (from 30000 in 2010 to 40000 in 2021), the time spent by Pharmacists in routine work and in the organisation and research of information also increased, and innovative approaches in terms of resources optimisation are deemed.
What was done?
Evaluate the performance of cytotoxic compounding after the implementation of relevant operational interventions designed to optimise drug preparation and delivery, between 2018 and 2021 in a University Hospital Centre.
Retrospective analysis of the average waiting times of patients for treatment delivery in some day hospitals (DH), after implementation of the operational interventions.
How was it done?
We began with the computerisation of the chemotherapy protocols, in order to standardise the prescribed treatments, which allows to reduce transcription and prescription time and associated errors. A comprehensive database was also created with the main characteristics of cytotoxic drugs and their physicochemical stability, in order to support pharmaceutical validation. In partnership with DH nursing team, every patient’s treatment schedule was determined beforehand, which allowed an enhanced organisational workflow, and the grouping of more complex drugs to prepare at the same time, and the preparation of drugs with adequate stability in the day before. This resulted in a reduction of average waiting times from 2 hours to only 30 minutes. The DH that benefited the most from these changes was Haematology, which adopted all proposed changes from the start after a multidisciplinary team meeting. Currently, about 45% of treatments are prepared the day before. Since the compounding unit is structured in rotating shifts, this practice allows to minimise drug wastage and to reduce preparation time, which improves the organisational capacity and agility in response to patient needs. When available, preference was given to ready-to-use drug solutions instead of powder formulations, e.g. pemetrexed and bortezomib, reducing preparation time and increasing operator safety. Also, in Gastroenterology DH, we promoted switch from original infliximab to its biosimilar by centrally preparing the biosimilar. We used two pharmacy technicians in the same cabinet instead of one, increasing the preparation yield. The last intervention was in the transportation of the compounded preparations, through the implementation of the delivery of treatments via a pneumatic tube system. This system ensures the integrity of the material and the conformity of the transport, thus allowing the safety and stability of the material transported, without bumps and avoiding changes in physical properties. It was possible to obtain a higher frequency of transportation and better workflow at peak times.
What has been achieved?
With the same human resources and the operational changes described, it was possible to improve the compounding unit performance, and to reduce patient waiting times in 75%, saving time and money.
What next?
With the increasing number of patients and cytotoxic preparations, it was necessary to reorganise the compounding unit in several key features.
A 3-Year transformation of a Belgian clinical trial pharmacy team
Pdf
European Statement
Education and Research
Author(s)
Marie Coenen, Stefanie Goris, Thomas De Rijdt, Isabel Spriet
Why was it done?
These changes were necessitated by the increasing number of (complex) clinical trials conducted at UHL. This Belgian 1995-bed, tertiary care hospital constitutes an attractive setting for clinical trials and a coveted partner for sponsors, due to its specialisation in a wide range of medical fields to treat complex pathologies. Adopting the changing research field whilst ensuring the highest regulatory compliance was challenging.
What was done?
Since 3 years, the clinical trial team of the University Hospitals Leuven (UHL) pharmacy has gone through several metamorphoses. These were realised by introducing an activity based costing (ABC) model enabling financing of staff expansion, extension of the infrastructure, and extensive digitalisation.
How was it done?
In 2016, an ABC-analysis was conducted by the Belgian Association of Hospital Pharmacists to determine the cost of various pharmacy activities within a clinical trial. In 2019, the outcome of the analysis was revised to concur the fast-growing clinical research field.
To affirm the need to apply these updated prices, a retrospective evaluation was performed in 2020 documenting the number of clinical trial protocols, pharmacy staffing and applied prices over the past 4 years.
What has been achieved?
Rapid growth of pharmacy research activities was shown by an increase in the total number of active clinical trial protocols from 964 in 2017 to 1256 in 2020. Until then, quantitative expansion was not followed by qualitative growth since staffing remained steady at 13 full-time equivalents (FTE) and the applied costs were outdated and not cost-effective. To enable this transition, an up-to-date pharmacy budget table was developed based on the latest ABC-analysis and, along with an estimate of future income, approved by the hospital board in 2020. This allowed the pharmacy research staff to be reinforced to 19 FTE and the infrastructure to be extended to integrate extra storage capacity and research dedicated clean rooms. Starting from 2021, the budget table was implemented into practice using computerised support enabling automated billing.
What next?
Future directions include further digitalisation by automating accountability and compounding and focusing on qualitative growth by advancing the role of clinical trial pharmacists into a specialised member of the hospital research development team and of the clinical pharmacy team.
DEVELOPMENT OF A PROTOCOL TO STANDARDISE CELL-BASED MEDICINAL PRODUCTS HANDLING IN AN ONCO-HAEMATOLOGY CLINICAL TRIALS UNIT
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
JOSE MANUEL DEL RIO GUTIERREZ, EUGENIA SERRAMONTMANY MORANTE, SARA GIMENEZ GINER, PILAR ROVIRA TORRES, PATRICIA GARCIA ORTEGA, CARLOTA VARON GALCERA, ISABEL CIDONCHA MUÑOZ, MARIA QUERALT GORGAS TORNER
Why was it done?
One of the most important challenges we currently face is the increase of clinical trials (CTs) including CBMPs. These drugs require special storage, preparation, delivery and administration; so developing standard operating procedures (SOPs) and ensuring proper coordination between all professionals involved, including pharmacists, is essential.
What was done?
Management of cell-based medicinal products (CBMPs) was protocolised in an onco-haematology clinical trials unit.
How was it done?
Pharmacists, doctors and nurses participate in a multidisciplinary team to standardise CBMPs handling. The following protocol was agreed:
1.The entire multidisciplinary team is notified when a CBMP prescription is planned to ensure proper coordination.
2.The CBMP is manufactured by the CT sponsor. Then, it is transferred to the blood bank for cryopreservation. CBMPs usually require a temperature between -80ºC and -200ºC and expire in some weeks.
3.Before CBMP administration, patients undergo lymphodepletion. The lymphodepletion regimen is performed according to the CT protocol or arranged between medical and pharmacy teams. Chemotherapy, serum therapy and antiemetic regimen are discussed and specified.
4.Once the treatment is prescribed, it is verified by a pharmacist who ensures its suitability.
5.On the infusion day, the blood bank delivers the CBMP. Then, a pharmacist checks if it arrives in proper condition and it is defrosted. The pharmacy department reconditions the CBMP in another infusion bag or syringe if required. This is the most critical point because CBMP expires after some minutes of defrosting, requiring extensive coordination.
6.CBMP is administered according to the CT protocol.
What has been achieved?
72 patients were recruited in 15 CT. 8 of them use as CBMP Chimeric Antigen Receptor T-Cells (CAR-T-CELLS), 4 Specific Peptide-Enhanced Affinity Receptor T-Cells (SPEAR-T-CELLS), 2 Tumour-Infiltrating Lymphocytes (TILs) and one cytokine-stimulated Natural-Killer-Cells (CS-NK-CELLS). Seven assays are intended for haematological neoplasms and eight for solid malignant neoplasms. One assay requires CBMP syringe reconditioning in the pharmacy department.
The described process optimises CBMPs handling, avoids delays in administration and reduces the risk of misuse.
What next?
CBMPs represent a novel therapy, and pharmacists have an essential role in developing new procedures to incorporate them into clinical practice. This protocol may be helpful for other centres to implement guidelines to work with CBMPs.