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.
Environmental and humanisation impact after 3 years of a hospital-community pharmacy collaboration delivery programme
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Andrés Sánchez Ruiz, Rocío Contreras Collado, Lucía Gutiérrez Lucena, Juan Jerez Rojas
Why was it done?
The programme began to be developed in March 2020 as an emergency solution to the COVID-19 pandemic, but over time it was refined due to the benefits seen in different areas, especially for pharmacy patients.
What was done?
A hospital drug dispensing programme was created with the collaboration of a community pharmacy and its pharmaceutical distributor. A daily delivery was conducted from the hospital pharmacy, covering the entire province, with a population area of 622,000 inhabitants and an area of 13,500 km2 that includes widely dispersed population centres with complicated communication.
How was it done?
Interlevel collaboration between hospital pharmacy, official college of pharmacists, pharmaceutical distributor and community pharmacy. After the first year, in which the process was more manual and marked by the pace of the pandemic, the programme began to develop. A web application with two-way communication hospital-community pharmacy was created. Hospital Pharmacy reviews and dispenses these requests, with daily shipments to all community pharmacies in the province through the distributor, which ensures safe transportation of the medication with adequate conditions of humidity and temperature.
What has been achieved?
A total of 57,130 dispensations have been made since 2020 (8,089 in 2020, 14,996 in 2021, 16,629 in 2022 and 17,416 in the first half of 2023). Pharmacy Service has dispensed at least once to 5,091 patients. Thanks to the reduction of individual trips (a total of 3,529,022 kms, 52,669 hours travel time, since 2020), it is estimated that the discharge into the atmosphere of 500 tonnes of CO2 in total has been avoided, which is equivalent to the emission of 500 round-trip Spain to Denmark flights (1,000 medium-sized trees are needed for 50 years to absorb that amount of CO2). Eighty-seven percent of private car use was estimated. We did not take into account movements of patients residing in the urban centre of the hospital. The development of ICTs will allow a more clinical approach and an improvement in patient care. We also expect the improvement of the process with the creation of Patient Reported Outcomes (PROs) protocols, already underway for migraine and psoriasis, and Patient Reported Experience Measures (PREMs) protocols.
What next?
The development of ICTs will allow a more clinical approach and an improvement in patient care. We also expect the improvement of the process with the creation of Patient Reportes Outcomes (PROs) protocols, already underway for migraine and psoriasis, and Patient Reported Experience Measures (PREMs) protocols.
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.
THE ROLE OF DNA SEQUENCING AND MOLECULAR TUMOR BOARD COUNSELLING IN THE SELECTION OF THE MOST APPROPRIATED THERAPY IN ONCOLOGY
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Marta Anghilieri, Francesco Guidoni, Vito Ladisa
Why was it done?
The new DNA sequencing techniques, globally defined “Next Generation Sequencing (NGS)”, allow the parallel sequencing of many samples producing in short times a big amount of data. To enable comprehensive analysis of the data and develop new specific and clinically useful therapies, we have introduced the approach of evaluating the data by the MTB, which includes pharmacists as experts in drugs and their use.
What was done?
Hospital Pharmacists (HPs) are integrated into the Molecular Tumour Board (MTB), a multidisciplinary group, to select the most appropriated therapy for oncology patients, ensure and facilitate patient access, and demonstrate therapeutic appropriateness found by MTB analisys.
How was it done?
MTB members, including HPs, perform DNA sequencing on each patient using NGS to identify known/unknown alterations. These data are entered into a database available to all MTB members and are the basic tool for selecting potential target therapy. The MTB meets once a week to discuss and integrate the observed DNA alterations with the patient’s clinical history. In this way, the most appropriate target therapy for the patient can ultimately be selected. The HPs then provide the patient with access to medications.
What has been achieved?
In this study, 208 patients affected by Non-Small Cell Lung Cancer were evaluated. DNA sequencing of patients identify 117 altered genes. After an extensive literature search, 15 genes were highlighted as potential targets for available drugs. They marked 116 patients potentially tractable with target therapy, of which 47 patients were candidates to a target therapy already in clinical practice and 69 to a target therapy not in clinical practice. Comparing the two groups, among candidates for drugs in clinical practice, treatment was started in 65% and continued in 53%; among those treated with drugs not in clinical practice, treatment was started in 23% and continued in 69%.
What next?
The inclusion of HPs in MTB allows for more deliberate use and better selection of drugs. HPs provide valid support to select drugs and facilitate access to them: HPs individualise the applicable therapy for a larger number of patients through MTB, they analyse the therapeutic outcome (MTB-selected therapy has a bigger chance to last longer) and the cost impact on the NHS.
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.
Opioids room of horrors – an interactive learning to improve safety of drug administration
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Sophia Hannou, Cristina Nicorici, Patricia Spitz, Samuel Cotte, Wanda Bosshard, Nancy Perrottet, Pierre Voirol, Farshid Sadeghipour
Why was it done?
Medication use process is at high risk especially for opioids. In our geriatric rehabilitation unit, self-reporting incidents are submitted regularly to our quality system. Among the 44 drugs incidents reported in 2021, 11 included opioids. Prevention with training is a way to reduce these errors. However, theoretical teaching covering the “5 rights” rule remains insufficient. Therefore, an interactive learning with a room of horrors focused on opioids was selected by our unit to prevent these errors. The objective was to cartography and identify the most risky steps and to introduce specific actions to reduce these risks.
What was done?
A room of horrors with a specific focus on opioids has been developed and implemented to reduce errors in medication circuit.
How was it done?
An interprofessional group created the room of horrors based on real incidents. Fictional patient, clinical situation and opioid prescription were created in the medical software. Several drugs and medical devices were available. A model wore an identification bracelet. Ten errors, covering the five rights, were hidden in the room. A pair of healthcare givers had 20 minutes to realise the simulation (5 for the briefing, 10 for the exercise and 5 for debriefing).
What has been achieved?
During the World Patient Safety Day 2022, 38 healthcare professionals (19 nurses, 10 assistant nurses, 9 geriatricians) participated to this training. Errors were detected in variable proportions. For example, 58% of the participants uncover the patient identification error, 53% the pharmaceutical form, 53% the expired date, 47% the allergy contraindication and 47 % used the oral syringe.
What next?
Results and theoretical notions will be presented to all professionals of the unit. This room of horrors is transposable and can be used in other units of the hospital. A video of this simulation was created as an e-learning. It will be implemented as a continuous training or for new collaborators in our unit and can be shared to other units of the institution. Incidents will be continuously monitored and the training will be adjusted in the future. Based on the success of the room of horrors, this interactive learning will be used in other areas with other clinical or technical dimension.
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.
Objective observation of pharmacist-physician collaboration to improve clinical pharmacist services
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Trine R. H. Andersen
Why was it done?
In Region Zealand, 1 of 5 regions in Denmark, clinical pharmacist services have been developed and implemented for the past decade. Especially in the acute wards, clinical pharmacists are an integrated part of the team when receiving, assessing and admitting patients to the hospital. As stated by the EAHP, “Clinical pharmacy services should continuously evolve to optimise patients’ outcomes” (EAHP statement 4.8), and a new approach was taken to further optimise the existing collaboration between the physicians and pharmacists on patients’ medication.
What was done?
The clinical pharmacy department of Region Zealand Hospital Pharmacy engaged a project with a senior year anthropology student. The anthropology student observed clinical pharmacists working with clinical pharmacist services in three acute wards. The observations on the collaboration of patients’ medication processes were disseminated to the pharmacists and physicians at the wards. This will aid in further strengthening of the collaboration and utilisation the healthcare professionals’ individual competencies in the hospital wards.
How was it done?
A senior year anthropology student was engaged to do objective observations of the pharmacists and physicians when collaborating in the acute wards. An anthropologist is trained to suppress subjective opinions and has no previous inception of the healthcare professionals’ work in the acute ward, and hence can do low biased observations. For 4 months the anthropologist made objective observations several times a week at each ward, and towards the end of the studies also supplemented the observations with individual interviews to further understand observed situations.
What has been achieved?
After the field observations and interviews, recurrent observation points were extracted from data and presented to the pharmacist and physicians in plenum. Discussions on the presented observations was found enlightening and strengthened the teamwork by better understanding the differences in the pharmacists’ and physicians’ responsibilities in the medication process respectively. Take home messages were visibility as well as accessibility of the pharmacist, and respect of each other’s contributions to the team.
What next?
The data will further be analysed and processed during the anthropology student’s final year and master’s thesis. The take home messages will be combined in a short introduction leaflet aimed for newly employed clinical pharmacists.