Nationwide German standardised concentration list for continuous infusions in intensive care patients
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
In intensive care patients, numerous drugs are continuously administered. Standardised concentrations and dose adjustment by infusion rate are recommended to minimise medication errors, e.g., by the EAHP Special Interest Group for investigating Medication Errors in Intensive Care Units. This principle is also followed more and more in German hospitals. However, there is a lack of a national standardised concentration list.
What was done?
The joint working group aimed to develop and implement a nationwide standardised concentration list for continuously administered infusions in intensive care patients in German hospitals.
How was it done?
A joint working group of the German Society of Hospital Pharmacists (ADKA e.V.) and the German Interdisciplinary Association of Intensive and Emergency Care (DIVI e. V.) compiled a nationwide continuous infusion standard for intensive care patients. Based on a national survey conducted in 2021, a list of plausible, commonly used drugs and concentrations was compiled. Drugs and concentrations to be listed were further evaluated in a multi-stage process based on predefined criteria (e.g. volume sparing concentration, one concentration per drug [where applicable], preferring ready-to-use medication, operational considerations).
What has been achieved?
A joint working group of the German Society of Hospital Pharmacists (ADKA e.V.) and the German Interdisciplinary Association of Intensive and Emergency Care (DIVI e. V.) compiled a nationwide continuous infusion standard for intensive care patients. The national continuous infusion standard encompasses 41 drugs and 49 standard concentrations, recommended vehicle solutions and data on the physicochemical stability of the infusions during administration. Thirty-seven active substances are listed with one concentration, heparin with two concentrations, epinephrine and sufentanil with three concentrations, and norepinephrine with four.
What next?
Healthcare professionals in German intensive care units are encouraged to adopt this standardised concentration list to improve medication safety. Flowcharts provided by the working group will facilitate the implementation of the defined standard concentrations.
Routine generation of real-world evidence: an integrated system for the systematic recording of clinical data on innovative outpatient hospital medicines
European Statement
Patient Safety and Quality Assurance
Author(s)
Manuel Mazarío-García, Amparo Molina Lázaro, Gemma Garrido Alejos, Ferran Sala-Piñol, Núria Juvanet Ribot, Lluís de Haro i Martin
Why was it done?
In 2011, the Catalan Health Service (CatSalut) introduced the Registry of Patients and Treatments of Outpatient Hospital Medicines (RPT-OHM) within their Standard Health Record Platform (SHRP) for the comprehensive evaluation, effectiveness and safety of OHM. CatSalut requires fulfilling RPT-OHM before medicines billing. However, SHRP lacked integration with ICS’ clinical and billing information systems.
What was done?
The Catalan Health Institute (ICS) is the largest healthcare provider in Catalonia and is made up of eight hospitals. The ICS developed and implemented a structured data collection tool named the Hospital-Information-System-integrated Registry of Patients and Treatments (RPT-HIS). This tool systematically collects a range of critical information, spanning from prescription inception to treatment cessation, such as:
• Administrative patient, prescriber, and treatment particulars.
• Active ingredients or combinations, initiation and termination dates, therapeutic indications, and ICD-10 diagnoses.
• Baseline clinical variables recorded upon treatment commencement.
• Dynamic clinical data captured or typed from medical records throughout follow-up according to predefined intervals.
• Cessation variables detailing reasons for treatment discontinuation.
How was it done?
At ICS’ headquarters, a dedicated team of internal business analysts and functional support officers, along with contracted developers, collaborated to design, implement, and maintain RPT-HIS. Monthly coordination meetings ensure efficient integration of new OHM and monitor the registry’s progress. Simultaneously, a network of local reference pharmacists emerged in all eight ICS hospitals, fostering continuous knowledge exchange and driving innovative enhancements.
What has been achieved?
In the first half of 2023, 52,907 initiation, follow-up, or discontinuation forms were completed. Among these, 93.7% met all preset treatment-specific validation rules, underscoring the initiative’s effectiveness. Subsequently, utilization and budgetary impact reports across ICS hospitals have been elaborated, covering general and special patient populations, indicating a positive impact on operational efficiency and patient care.
What next?
In the near future, the real-world data amassed and stored in RPT-HIS could help to underpin refined drug therapy, optimize health outcomes, and strategically position medicines for specific conditions, also aiding in selection and purchase. This initiative serves as a model of good practice, demonstrating the potential of integrated data collection systems, aligned with the routine process of OHM utilization, to improve patient care. The successful implementation of RPT-HIS suggests its viability for adoption in other healthcare settings.
A strategy to prevent weekly methotrexate medication mistakes in a regional health service
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Vanesa Alonso Castro, Pablo Jimenez Moreno, Marta Alcaraz Borrajo, Angel Luis Mataix Sanjuan, Beatriz Casamayor Lázaro, Maria Dolores García Cerezuela , Cristian Rosas Espinoza, Beatriz Santos Mena, Estrella Maroto García, Beatriz López Centeno, Daniele Alioto, María Jose Calvo Alcántara
Why was it done?
MTX is an immunosuppressor drug utilised in certain types of cancer and inflammatory diseases. Its dosage and frequency of administration varies depending on indication.
Throughout the years, medication errors (ME) have been reported at national and supranational levels where patients have received excessive doses (the most common being daily administration of the drug rather than weekly) with severe consequences for the patients, including death.
In our RHS, 222 ME related to MTX have been reported in the last 5 years,seven of them resulted in harm to the patient.
What was done?
An integral strategy to ensure the correct prescribing of weekly Methotrexate (MTX) was developed in a Regional Health Service (RHS).
How was it done?
1st PHASE (May 2021):
a. Monthly reporting to prescribers of their patients affected by duplicated prescriptions or incorrect dosing instructions for review and amending. These reports are available on the IT platform that collates prescribing indicators.
b. Development and dissemination of training materials to correctly prescribe medications with non-daily dosing instructions in the RHS electronic prescription tool.
2nd PHASE (After two years of follow-up):
a. Request to implement ME prevention plans (MEPP) to the hospitals of the RHS.
b. Creation and dissemination of informative material for patients and/or caregivers, where the weekly dosing instructions is emphasized.
What has been achieved?
Incidence of MTX prescribing mistakes: When this strategy was implemented, prescriptions for 2388 patients had been identified as potential mistakes. 1 year later, the incidence had diminished by 78.1% (2146 cases were resolved, 242 were still active and 310 were new). 2 years later, the incidence remained stable with a reduction of 78.5% thoroughout the whole period and 514 patients affected (150 new MTX prescribing mistakes in the last year).
• MEPP implantation (2nd PHASE): In two months, six hospitals (17.6% of all) implemented a MEPP. The key strategies that should be included in the MEPPs were disseminated to all hospitals by our team.
What next?
Thanks to this strategy, MTX prescribing mistakes have fallen by 78.5% in two years. However, prescribing mistakes continue to be made, which demonstrates the need for continuous training and awareness raising among prescribers to prevent ME related to MTX.
Computerised registration of drug prescriptions in the operating room during cardiac surgery: simplicity and traceability
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Elisabetta Volpi, Giuseppa Lo Surdo, Mattia Lorenzini, Anna Carmignani, Debora Luccetti, Stefania Baratta, Mario Cossu, Maurizio Mangione, Pierantonio Furfori, Monica Baroni, Paolo Del Sarto, Stefania Biagini
Why was it done?
This implementation was designed to provide a safe tool for the particular context of the operating room, in which prescription and administration are actions usually urgent and concomitant. The program suggests a rapid list of prescriptions standardized for adult patients (i.e. dose, diluent, bolus/drip) and allows to register any other drug or modify default information, respecting the rules for a clear prescription before registration.
Our aim was to demonstrate the possibility to validate this program and prove its functionality.
What was done?
In 2019 a multidisciplinary group (doctors, nurses, pharmacists, computer scientists) created an electronic program dedicated to the Cardiac Operating Room of the Heart Hospital, Fondazione Monasterio (Italy), which allow the prompt registration of drug prescriptions and administrations. Furthermore this program guarantees traceability of the drugs administered by the nurses, in order to improve medication safety practice.
How was it done?
This program was created into the electronic prescribing system available in Fondazione Monasterio. The standardized prescriptions already in use in the operating room were reviewed by a pharmacist, consulting the information in the Summary of Product Characteristics (SmPC), in the literature or by contacting the company that holds the MA. For each discrepancies identified a solution was proposed and shared with the working group, in order to validate a definitive list.
The prescriptions extracted by the IT Systems unit 6 months before and after the implementation of the new program were therefore analyzed.
What has been achieved?
A list of 182 standardized prescriptions was validated and reported in the program.
Among the 10,320 prescriptions made before the new program none had traceability of the drugs administered, while the 8,730 of the following period were complete and 99.6% of them fell within the standardized prescriptions, demonstrating the functionality and correct selection by the working group.
The development of a program for the computerized registration of prescriptions made during the surgery, which respond to the requirements of drug safety and traceability, represents an example of good practice.
What next?
We have implemented this tool in the paediatric population, with particular precautions due to the weight variability (i.e. dose/kg). The next step could be integration with further assessments (e.g., kidney function evaluation) and the transfer to other settings
Implementation of a multidisciplinary circuit for the management of haematologic patients under treatment with bispecific antibodies
Pdf
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.
A new medication-use process implemented in the perioperative setting
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Almudena Ribed, Alvaro Gimenez-Manzorro, Beatriz Torroba-Sanz, Ana De Lorenzo-Pinto, Maite Portas-Gonzalez, Maria Dolores Ginel-Feito, Pilar Cabrerizo-Torrente, Maria Luisa Martin-Barbero, Ana Herranz-Alonso, Javier Hortal-Iglesias, María Sanjurjo-Saez
Why was it done?
There is a high prevalence of medication errors in the perioperative setting. Health organizations highlight the need for effective practices to ensure safe medication use. A group of pharmacists, surgeons, anaesthesiologists, nurses, and IT technicians coordinated by the management was formed in 2020. Failure mode and effects analysis (FMEA) of the perioperative use of drugs was performed in 2021. The group detected up to 25 failure modes and conducted a bibliographic review to gather and prioritise the implementation of safety practices.
What was done?
We re-engineered the process of medication use in the perioperative setting, from pre-admission to discharge, and implemented safety practices to improve safe medication use in the daily practice.
How was it done?
Obstacles were overcome as a result of the multidisciplinary teamwork, management support and the safety culture existing in our hospital. In addition, we listened to health professionals’ opinions, provided monthly information sessions in the Anaesthesia and Pharmacist Department in 2022 and disseminated information through the hospital website.
What has been achieved?
Eight safety practices were implemented in daily practice:
1.Eight safety practices were implemented in daily practice:
1. Implementation of automated dispensing cabinets.
2. Identification and recommendations for high risk drugs.
3. Standardisation of anaesthesia and difficult airway trolleys.
4. Preparation of general anaesthesia trays with ready to administer drugs.
5. Design, development, and implementation of a one-step computerised provider order entry (CPOE) in the operating room, with bar code administration technology.
6. Implementation of a pharmaceutical care programme for surgical patients based on medication reconciliation in all transitions of care.
7. Implementation of new alerts in the clinical decision support system linked to the CPOE to improve pain, anticoagulation, and antibiotic management in the surgical patient during follow-up.
8. Development of new protocols for perioperative management of chronic medications, anticoagulation, diabetes, and antibiotic prophylaxis in the surgical setting.
What next?
The new medication-use process describes a practical and real approach to promote perioperative patient safety in the daily practice. Transfer into other centres is achievable by motivating healthcare professionals, engaging in safety culture and creating multidisciplinary alliances. There is a need to assess the impact and evaluate these safety practices to ensure ongoing improvement.
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.
Safety Team, a team to promote a safety culture in the Pharmacy Service
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Laura Doménech Moral, Raquel López Martínez, Maria Eugenia Palacio Lacambra, Emili Vallvé Alcon, Ángel Arévalo Bernabé, María Guerra González, Maria Queralt Gorgas Torner
Why was it done?
At PS Vall d’Hebron, one of our strategic objectives is to enhance the patient safety culture internally and externally within PS.
What was done?
Establishment of a core safety team within the Pharmacy Service (PS) with representatives from various areas and positions, along with established activities and indicators: the Safety Team.
How was it done?
By organising internal meetings of the Safety team to manage, lead, and plan activities related to medication safety. These activities include:
Advising on and/or managing medication safety incidents reported to the Patient Safety Incident Notification System of Catalonia (SNiSP) Vall d’Hebron.
Conducting biweekly “5 minutes of safety” meetings between pharmacy technicians and a member of the Safety team in the General, Maternal-Infant, Trauma, Outpatient, and Oncology-Haematology areas. In each meeting, the minutes from the previous one are reviewed to report on agreements and progress related to the topics discussed. Incidents reported to SNiSP related to medication dispensing and logistics are discussed, and there is an open discussion for technicians to share safety issues, questions, and medication-related incidents. These situations (reported incidents and those detected by technicians) are collectively analysed to propose prevention measures. Minutes of each meeting are documented and made available in a shared resource.
Weekly “safety pearls” presentations where sentinel medication incidents are presented, along with root cause analysis, by a representative of the Safety team. Situations that have led to medication incidents/errors in prescription and treatment validation are also discussed, along with proposed prevention measures by other PS members.
Conducting sessions related to safety during PS Sessions to present the actions taken by the safety core team and its collaboration with the Hospital’s Error Prevention Subcommittee.
What has been achieved?
More than 100 medication incidents reported to SNiSP have been managed.
Over 50 meetings with PS technicians, resulting in more than 45 improvement actions derived from notifications and detected issues, such as creating infographics for proper medication identification (everolimus, vitamin D), improving the urgent medication dispensing process without a prescription, or enhancing the management of “off-label” medications.
Around 20 safety pearls involving all pharmacists, leading to the creation of protocols, default guidelines, and updates to prescription and administration advice in the prescription programme.
Two annual patient safety-related sessions.
What next?
Continuing to enhance the safety culture through sessions and meetings involving various stakeholders, implementing an online medication error prevention course, and expanding the team.
De-prescription initiative for anti-dementia drugs in a sociosanitary centre
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Paula Torrano Belmonte, Lydia Fructuoso González, Juan Antonio Gutierrez Sanchez, María Hernández Sánchez , Adrián Martínez Orea, María Guillén Diaz, Cristina Portero Ponce, Alicia Sánchez Blaya , Teresa Alonso Dominguez
Why was it done?
According to Spanish guidelines, medication deprescription would be recommended in the following situations: in the advanced or terminal phase of the disease with a global loss of cognitive and/or functional abilities; in patients who do not experience any benefit; in the presence of intolerable adverse effects or interactions with concurrent treatments. The dose will be progressively reduced every 4 weeks.
What was done?
We designed a project to deprescribe drugs used for dementia in patients at one of the sociosanitary centers (SSC) affiliated with our hospital. The drugs currently used in Spain are: donepezil, rivastigmine, and galantamine for mild to moderate stages, and memantine for moderate to severe stages.
How was it done?
Pharmacists conducted a search using the Savac® pharmaceutical management programme among all residents of the SSC who were prescribed anti-dementia drugs. Once eligible patients were identified, medical team was notified through the electronic prescription programme.
What has been achieved?
According to the previously detailed criteria, there were a total of four eligible patients: one of them was on rivastigmine patch treatment, and the other three were on oral memantine. The results in the first month were not very positive, as an attempt to withdraw memantine from one patient had to be reversed due to aggression issues. Another patient on memantine sadly passed away, and the remaining two, on memantine and rivastigmine, continued with the medication due to potential benefits.
After 10 months of work, the results have been quite promising, and we have successfully completed more withdrawal protocols for other CSS patients. Medication was deprescribed for three patients: one on donepezil and two on memantine. Another patient on rivastigmine is currently in the dose reduction phase.
What next?
Our goal is to achieve the appropriate prescription of anti-dementia drugs, in order to maximise benefits for patients while minimising adverse effects and rationalising public resources.
Application of new indicators of antimicrobial agent use based on consumption in a tertiary hospital
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Saúl Herrera Carranza, Carlos Sanz Sánchez, Sira Sanz Márquez, José Francisco Valverde Cánovas, Leonor Moreno Núñez, Ana Vegas Serrano, Rafael Hervás Gómez, Oriol Martín Segarra, Juan Emilio Losa García, Montserrat Pérez Encinas
Why was it done?
Spanish Society of Hospital Pharmacy(SEFH) proposed 13 indicators(bibliography:Gutiérrez-Urbón JM, Gil-Navarro MV, Moreno-Ramos F, Núñez-Núñez M, Paño-Pardo JR, Periáñez-Párraga L. Indicators of the hospital use of antimicrobial agents based on consumption. Farm Hosp. 2019;43(3):94-100) which could help to improve the quality of antimicrobial use.
Indicators are related directly(dir): higher value-better practices; indirectly(ind):lower value-better practices; or heterogeneity: homogeneous percentages(%)-better practices.
What was done?
The creation of a tool for calculating new indicators of antimicrobial agents based on consumption using Defined Daily Dose per 100 hospital stays(DDD/100s).
How was it done?
We built an Excel tool to input required data in order to calculate the indicators with the formulas defined for their automated estimation:
-Overall antibacterial consumption(ind)
-Overall consumption of antifungals(ind)
-Consumption of carbapenemics(ind)
-Consumption of fluoroquinolones(ind)
-Ratio macrolides-p/fluoroquinolones-p(dir)
-Ratio metronidazole-p/piperacillin-tazobactam+carbapenemics(dir)
-Fosfomycin consumption(dir)
-Sequential therapy(dir)
-Ratio anti-SRSA/anti-MRSA agents(dir)
-Ratio amoxicillin/amoxicillin-clavulanic acid(dir)
-Ratio amoxicillin-clavulanic acid/piperacillin-tazobactam(dir)
-Diversification of anti-pseudomonas beta-lactam(heterogeneity): %anti-pseudomonal carbapenemics, %piperacillin-tazobactam and %anti-pseudomonal cephalosporins+aztreonam.
— Ratio fluconazole/equinocandins (dir)
DDD/100s for the years 2018-2022 were calculated in order to see the annual evolution. Required data: antibiotic (ATC Group: J01) and antifungal (ATC Group: J02) consumption by drug and route of administration (oral (o), parenteral (p) and others). Calculation of DDD/100s according to grammes consumed (obtained with Hospital Pharmacy software) and ATC/DDD-Index (World Health Organization). To visually analyse results, graphs were included.
What has been achieved?
We realised that our hospital improved by decreasing consumption of antibacterial, antifungal, carbapenemics and fluoroquinolones; and so, an early parenteral-oral switch.
However, the other ratio-based indicators are stable or worsening yearly: macrolides-p/fluoroquinolones-p, metronidazole-p/piperacillin-tazobactam+carbapenemics, fosfomycin consumption, anti-SRSA/anti-MRSA agents, amoxicillin/amoxicillin-clavulanic acid, amoxicillin-clavulanic acid/piperacillin-tazobactam, fluconazole/equinocandins and diversification of anti-pseudomonas beta-lactam.
What next?
These indicators provide possible improvement actions to enhance the use of antimicrobial agents. Consumption of fosfomycin or amoxicillin/amoxicillin-clavulanic acid ratio should be cautiously analysed due to outpatient (or in emergencies) management of uncomplicated infections. As improvement actions in our hospital, increase the use of metronidazole-p in anaerobic infections or cloxacillin and cefazolin de-escalation can be promoted as soon as sensitivity is confirmed by antibiogram-test. Diversify antibiotic pressure on pseudomonas, trying to reduce piperacillin-tazobactam by prescribing ceftazidime or cefepime, and reserving aztreonam for beta-lactams allergics. Similarly, decrease piperacillin-tazobactam use by prescribing amoxicillin-clavulanic acid if anti-pseudomonal coverage is not necessary.