Design and dissemination of infographics to improve safety in drug handling
European Statement
Patient Safety and Quality Assurance
Author(s)
Paula Hernando Martínez, María Antonia Meroño Saura, Caridad Marti Gil, Lidia Martínez Valdevieso, Jaime Fernández-Bravo Rodrigo, Dolores Barreda Hernández
Why was it done?
There is a wide bibliography on how human errors related to drugs put the patient’s health at risk. Drug preparation and administration errors, dose calculation errors, lack of knowledge about drugs or interactions, to name but a few. There must be protocols to ensure that drugs are safe for patients, including procedures which professionals should fulfill in order to reduce those errors in processes and guarantee, in such cases, that they will not have adverse effects on patients.
What was done?
Development of infographics for assembling drugs which are susceptible to a higher rate of errors in their preparation and administration to hospitalized patients.
How was it done?
During September 2021, a working group was formed in the pharmacy department (PD). Through the nominal group technique, the design and content of drug infographics was proposed as a solution to the raised problem. Subsequently, a bibliographic research of susceptible drugs to human errors during administration or preparation and those which requiring special handling was reviewed through the list of high-alert medication from National Institute for the Safe Use of Medications website and NIOSH list of hazardous drugs. To this end, the PD databases were analysed, obtaining the drugs that required the greatest number of pharmacotherapeutic consultations made by nursing staff on drug administration and recommendations made during pharmaceutical validation.
What has been achieved?
An infographic model has been designed which includes the description of the drug (name of drug, excipients, dose, pharmaceutical form, dosage regimen, route of administration, concentration), the preparation and administration protocol (reconstitution, dilution, infusion rate, premedication), observations (maximum doses, conditioning, incompatibilities, alerts) and storage conditions (conservation and stability). Infographics on dantrolene, intravenous phenytoin solution, intravenous nimodipine solution and potassium chloride solutions are currently being distributed. These documents are available at the nursing controls and on the hospital’s internal website.
What next?
To increase the availability of drug’s infographics and to update those that have already been developed when necessary. In addition, from the PD, the preparation of administration kits for the solicited drugs is proposed so as to ensure that all the necessary materials for the preparation and administration are included along with the corresponding drug and infographic.
A prospective observational study of medication prescribing errors in an Emergency Department.
European Statement
Patient Safety and Quality Assurance
Author(s)
Carmen Ortí Juan, Cristina Toro Blanch, Maria Àngels Gispert Ametller, Ana Perez Plasencia, Cristina Lecha Ochoa, Anna Dordà Benito, Rosa Sacrest Güell
Why was it done?
Prescribing errors (PE) are an important cause of medication-related adverse events in the Emergency Departments (ED) but limited data are available in ED with electronic prescribing and administration (ePA) systems. Knowing the frequency and types of PE can help healthcare professionals to prevent and reduce the risk of them occurring.
What was done?
To determine the rate of PE in the ED, to classify incident types and to identify critical points where measures should be implemented to improve patient safety.
How was it done?
Prospective, observational and cross-sectional study in an ED with ePA system during 6 working days (May-June 2021). The inclusion criteria were patients stayed more than 8 hours in the ED and all patients awaiting hospitalization. Prescriptions were analyzed by a multidisciplinary team made up of two pharmacists, an emergency physician and the person in charge of the hospital’s medication errors committee. PE were reported to the hospital’s patient safety-related incident notification system.
What has been achieved?
Of the 65 prescriptions revised during the study period, PE were reported in 84 cases and 15 situations with the capacity to cause errors were detected. The average age of patients was 67 ± (SD=17,9) years and each prescription had an average of 8.4 medications. The rate of PE was 1.52 errors per patient, being higher in less severe patients than monitored patients (1.09 vs 2.0 PE per patient, respectively). The most common types of EP were omission of the usual medication (60.7%), wrong dose (15.5%), wrong frequency (7.1%) and drug is not indicated (7.1%). No adverse reactions related to EP were detected. According to the Spanish consensus about Medication Reconciliation in Emergency Units, 47.1% of omissions of usual medication were drugs that should be reconciled during the first 4 hours in the ED. The results of the study and the importance of medication reconciliation are highlighted in a session in the ED.
What next?
The PE rate in the ED was 1.52 per patient and the main type was omission of the usual medication. A cross sectional study will be made in the future and compared to the current one to establish the impact of the implemented measures on the PE rate.
EVALUATION OF RENAL DRUG DOSING ADJUSTMENT IN CHRONIC KIDNEY DISEASE PATIENTS
European Statement
Patient Safety and Quality Assurance
Author(s)
Pilar Fernández-Villacañas Fernández, Manuel Ríos Saorín, Patricia Ortiz Fernández, Alba María Martínez Soto, Consolación Pastor Mondéjar, Carmen Caballero Requejo, Lorena Rentero Redondo, Alberto Quesada Asencio, Elena Urbieta Sanz
Why was it done?
Due to kidney pathologies affect the normal pharmacokinetics of many drugs, it is necessary to adjust the dose of the drug for each patient. It is also necessary to ensure effectiveness and safety for the hospitalized patients with renal failure, associated with higher morbidity and mortality. The main objective is to minimise validation and prescription errors.
What was done?
A review of drug dosing according to the patient´s creatinine clearance was performed. This dose adjustment was included as alerts in the electronic prescription system.
How was it done?
For each drug, the data of the dosage adjustment in patients with renal impairment were compiled by consulting the technical data sheets and the national guidelines. In the case of antimicrobials, the information was obtained from the Antimicrobial Therapy Guide 31th Edition March 2021. The data were organized in an Excel table to later integrate them into the hospital’s electronic prescription system.
What has been achieved?
The dose adjustment was made for 848 presentations of different drugs: antibacterials (186), antipsychotics and antidepressants (109), antiepileptics (63), opiates (57), antivirals (49), NSAIDs (26), diuretics (24), anticoagulants (22), antimycotics (21), antidiabetics (15), antiparasitics (11), antiemetics (11), antitumors (4), among others. A large number of drugs are highly dependent on kidney function, especially antibacterials, antipsychotics and antidepressants, making that an incorrect dosage of renal drugs can worsen kidney function and produce toxic effects due to their accumulation.
What next?
This dosage adjustment for patients with renal failure should be periodically reviewed by the hospital’s pharmacy service in order to keep the alerts of the electronic prescription system up-to-date. Additionally, this system can be implemented for other pathologies such as liver failure, or to avoid overdose by establishing the maximum dose limit allowed. In conclusion, the importance of an adequate electronic prescription program that facilitates daily clinical practice is established, preventing possible medication errors.
Expanding hospital pharmacy services by centralizing the preparation of non-cytotoxic intravenous medications: A preliminary overview of the Italian community of APOTECA users
European Statement
Production and Compounding
Author(s)
Alessandro D’Arpino, Fiorenza Enrico, Caterina Donati, Simone Leoni, Giorgia Longobardo, Marco Bellero, Alessandra Bianco, Giuseppe Zacchi, Anna Zaltieri, Stefano Monica, Nicolò Squartini, Matteo Federici
Why was it done?
In most of Italian healthcare organizations, the large majority of non-cytotoxic IV medications are prepared in clinical environment by nursing staff. This is recognized as a complex and labour-intensive process that entails various risks of potential medication errors (microbial contamination, wrong reconstitution/dosing). Centralizing the preparation from the clinical environment to the pharmacy in order to provide ready-to-administer IV medications represents a strategy to improve safety and prevent medication errors.
What was done?
The community of APOTECA technology users is committed to fostering co-de¬sign of technology based on the hospitals’ needs and sharing best practices for improving hospital pharmacy services. During a meeting taken place in September 2021, a panel of hospital pharmacists belonging to APOTECA community laid the groundwork for centralized preparation of non-cytotoxic intravenous (IV) drugs and establishment of Central Intravenous Additive Service (CIVAS) in Italian hospital pharmacies.
How was it done?
The following methodology was adopted to promote a standard profile of centralization: (1) definition of criteria for the selection of drugs suitable for centralized preparation, (2) identification of IV medication classes for which preparation should be centralized due to intrinsic risks and demand, (3) evaluation of potential benefits, (4) discussion on organizational challenges regarding the establishment of CIVAS, (5) assessment of the role of automated preparation with robotics.
What has been achieved?
Five selection criteria to centralize drugs were mentioned: long-term stability data, frequency of use, cost, complexity of preparation, microbial contamination risk. Continuous infusion of antibiotics, vasoactive drugs, anaesthetics, pain medications, intravitreal injections, and patient-individual doses for paediatric patients were chosen as eligible IV medication classes to implement centralized preparation. Major benefits of centralization were pointed out, i.e. proper aseptic preparation, perspective quality controls, process traceability, reduced drug wastage, and releasing nursing time to care. Logistics, inventory management, limited space, and inadequate quality control units were identified as main challenges to the CIVAS establishment. Participants agreed that robotics plays an important role to minimize repetitive manual activities, optimize working efficiency, and increase pharmacy production capacity, thereby streamlining the introduction of CIVAS.
What next?
A close collaboration between healthcare staff and hospital pharmacy will be essential to evaluate the feasibility of centralized preparation as well as its clinical and cost-effectiveness.
Re-using mendeliome data to explore pharmacogenomics implementation: pitfalls and opportunities.
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Eline Coene , Catharina Olsen, Mathijs Swaak, Freya Vaeyens , Frederik Hes , Stephane Steurbaut, Sonia Van Dooren , Pieter-Jan Cortoos
Why was it done?
Pharmacogenomics has a large potential to optimize individual patients’ both current and future drug therapies. In Belgian hospitals however, pharmacogenomics is still rarely used in clinical practice posing great opportunities for hospital pharmacies to explore this field and setting up new services.
What was done?
The Centre for Medical Genetics (CMG) of UZ Brussel, a 721-bed tertiary hospital in Brussels (Belgium), has been performing next-generation sequencing of mendeliomes for diagnostic purposes since 2016. Pharmacogenomic data is thus potentially available, but currently not further used. As hospital pharmacists, we wanted to explore the possibility of reporting pharmacogenomic information as ‘secondary findings’, in particular prevalence of actionable pharmacogenes and gene-drug interactions (GDIs) in our own population, and to determine required features and opportunities of a future pharmacogenomics project
How was it done?
Firstly, 14 pharmacogenes comprising 626 loci were selected based on available guidelines, clinical relevance and whether the gene was included in the mendeliome gene set. With the support of CMG, we then reviewed available data for patients with a mendeliome analysis between 01/03/2016 and 30/06/2020. To enable haplotype assignment, a Python script was developed displaying possible haplotypes with corresponding ‘matching score’ and ‘completeness score’. Where possible, phasing was done using pedigree information. Resulting phenotypes were finally further linked with medication histories, abstracted from patients’ electronic medical records in order to identify possible GDIs.
What has been achieved?
Pharmacogenomic data could be re-used for 536 individual patients, revealing that at least 76.9% had one or more actionable phenotype while 60 GDIs with varying relevance were found. CYP2C9 had the most actionable phenotypes (174/536) and was involved in 42 GDIs. However, not all phenotypes (e.g. copy-number variants) were detectable for CYP2C19 and CYP2D6 due to limitations of current mendeliome data and used platform.
What next?
Reusing genomic data has great potential and can be an ideal stepping-stone towards developing and implementing pharmacogenomics in other hospital pharmacies but requires a good interplay between pharmacists, geneticists and bio-informaticians. In our hospital this initiative has led to in-depth collaboration between pharmacy and medical genetics department focusing on validation and implementation of a pharmacogenomics-array coupled with implementation of a pharmacogenomics service, next to pharmacological use of whole-genome sequencing data.
Disposable Closed System for Sterile Drug Preparation and administration
European Statement
Patient Safety and Quality Assurance
Why was it done?
Our proposed system comes from the idea of a large clean room with pressure regimes, and airlock, hoods and other ancillary equipment, Which we made from it a very small clean room that is our box, when there will be no need for us as operators to get into it, or very simply take only those parts that are supposed to be sterile, and only those parts that are the two ends of the infusion bag and the end of the medicine vial
What was done?
“Closed” and airtight system for preparation (reconstitution, measurement, dilution) and injection of IV drugs at the patient’s bedside, in the various clinics and further home treatment, Disposable system, All its parts come in one piece without the need for threading, or assembly and disassembly
Estimated dimensions: 10 cm length, 5 cm width and 3.5 cm depth or similar, its shape can be rectangular or any shape convenient for use operation storage and destruction at the end of the process
Intended for a wide range of types of drugs – such as intravenous antibiotics, cytotoxic drugs, biological drugs, etc.
Designed according to its different variations for different types of vials and different amounts of drugs that come as a dry powder for dissolution, and are also suitable for drugs that come in the dissolved liquid form.
It is also intended for use with glass ampoules and there is a wide range of drugs that still come in glass ampoules
Intended for administration of drugs that do not need to be diluted in an infusion bag given in IV PUSH
How was it done?
We designed the device with 3D software (solid wark). It consists of a number of functional parts,
The sterile closed system comprises an airtight enclosure, which is shaped so as to define an enclosure interior; and an infusion-bag receptacle. An infusion-bag seal is configured, when in a sealing state, to make an airtight seal with respective external surfaces of a medication port and an IV tubing port of a bottom region of the infusion bag, when the medication port and an IV tubing port are inserted into the infusion-bag receptacle.
What has been achieved?
The proposed solution and its advantage
– A single-use system built in one piece, without the need for assemblies, disassembles, etc.
It will be possible to perform the entire process in one place, such as at the patient’s bedside or in the clinic, starting with the powdered drug dissolving process, mixing a measured dose, mixing it in an infusion bag and injecting it into the patient’s vein safely and accurately.
Maintains the perfect process under sterile conditions without fear of contamination of the injected drug
– Preparation in a system that is safe for the immediate environment and safe for the caregiver himself from contamination of drugs such as cytotoxic drugs, antibiotics and more
Savings in building very expensive infrastructure of clean rooms
Saving on very expensive disposables, such as closed system transfered deviced, robes and more
Save valuable work time dedicated team of pharmacists, nurses work time, work time transportation, storage places and more
Minimize the chance of errors in administering medications and confusion between different medications
Working with non-exposed needles reduces the chance of needle prick injury
What next?
Applied research will be carried out by pharmacists and nurses, in order to test the efficacy and safety of the device (by using a basic prototype), these experiments will use different IV administration drugs, we will test the method of dilution from a drug vials and glass ampoules, measure the exact dose and transfer to the infusion bag, and remove through the IV line, the accuracy of the preparation, the sterility of the preparation, the quality in terms of leakage or drip, comfort, safety and more are measured.
Assessing the Application of Essential Medication Errors Prevention Strategies in Healthcare Institutes: STOP Medication Error Project
European Statement
Patient Safety and Quality Assurance
Author(s)
Monira Alwhaibi
Why was it done?
This study is the first project of the STOP ME projects which aims to develop a tool that can assess the application of the essential strategies that can stop or minimize MEs in healthcare institutes in Saudi Arabia. Consequently, stakeholders in the healthcare system can identify current gaps that need feature improvement to enhance patient safety
What was done?
Medication Errors (ME) are defined as unintentional drug-induced harm that led to morbidity and mortality. The STOP (ME) project is a comprehensive series of research studies that aim to explore MEs in Saudi Arabia and how to stop such harmful events.
How was it done?
Extensive search of the literature review for the essential strategies to stop or minimize MEs was carried by the research team to develop a draft of the aimed tool. The survey tool was sent in round 1 to the Delphi experts’ panel for review. Based on received recommendations, the tool was updated and sent for round 2 review and consensus. The developed tool was then piloted to test the practicability of the tool before running the survey on large sample size (second project). The study was approved by the King Saud University Medical Centre IRB ethics committee [20/0153/IRB].
What has been achieved?
After using the Delphi technique two major changes happened to the survey. 1) Section A was removed (high alert medications). 2) A new section was added (ISMP publications) with some minor changes. Launching a pilot survey on thirty healthcare practitioners (physicians n=11, pharmacists n=10, nurses n=9) resulted in further minor changes by adding two new columns. The final tool was a survey consists of six sections including Demographics, Prescription, Dispensing, Administration, Monitoring and Quality, and Targeted Medication Safety Best Practices for Hospitals. All combined 86 questions with the determined time to answer the survey is in the range of 25-30 minutes. Overall feedback of the pilot survey was good.
What next?
This initiative “STOP ME” will have a significant impact in the field of medication safety research and will build awareness among institutes in Saudi Arabia that are lacking important strategies that prevent MEs
IMPROVING HIGH-RISK DRUG PRACTICES IN THE EMERGENCY DEPARTMENT – A MULTIDISCIPLINARY APPROACH
European Statement
Patient Safety and Quality Assurance
Why was it done?
Review of the 2019 Health Information and Quality Authority (HIQA) Medication Safety Monitoring Programme, and in-house Emergency Department (ED) medication variances review identified that risk reduction strategies for specific high-risk drugs and high-risk situations were required.
What was done?
A multidisciplinary team reviewed and implemented initiatives to improve medication safety practices for procedural sedation, emergency tray drugs and ketamine use in emergency settings was undertaken.
How was it done?
• Multidisciplinary teams (MDT) of key stakeholders were formed to review each high-risk drug / practice requiring improvement.
• The MDT developed the required procedures and policies that were further reviewed and approved by the relevant hospital committees.
• The MDT supported roll out of the improvement initiatives through communication, staff education and process review.
What has been achieved?
• A hospital wide procedural sedation policy and patient information leaflet was developed. Competencies for staff that perform procedural sedation have been identified. A specific procedural sedation incident report form has been piloted. A poster detailing the process for sedation reversal is in development.
• Emergency tray drug preparation, storage and use has been standardised across all hospital settings, including the introduction of dedicated emergency drug bags. The bags enable prompt drug retrieval during emergencies and supports safe storage, documentation and disposal of used /unused emergency drugs.
• A protocol for ED use of ketamine was developed. The protocol supports safe use of ketamine for specific emergency indications for which there is little published information, e.g. procedural sedation, analgesia and agitation.
• The initiatives were implemented and included in ED simulation training.
What next?
The described medication safety initiatives have considered the practice challenges for high risk drug access and use in emergency settings. The initiatives have standardised processes for specific high-risk drugs, supporting safer use. MDT collaboration ensured early and ongoing staff engagement from applicable disciplines, facilitating implementation and practice changes. Evaluation of the initiatives in practice is currently under review. The initiatives and learnings are transferrable to other emergency clinical settings.
Stewardship initiative for COVID-19 monoclonal antibodies led by clinical pharmacists
European Statement
Clinical Pharmacy Services
Author(s)
Petra Rozsívalová, Věra Zdanovcová, Lenka Beková, Martina Maříková, Marcela Heislerová, Vladimír Koblížek, Petr Šmahel
Why was it done?
By implementing systematic monitoring in our institution, CPs ensure appropriate and safe use of unlicensed treatment available under Emergency Use Authorisation. The secondary goal is mandatory data input to national register and patient clinical outcome feedback to physicians and hospital management.
What was done?
It is vital to bring focus on appropriate use of COVID-19 monoclonal antibodies (mAbs) in high-risk population when safety and efficacy data are scarce. A team of clinical pharmacists (CPs) helped to set up process flow, monitor prescribing of mAbs and provide systematic follow-up on time course of symptoms reported by SARS-COV-2 positive outpatients since March 2021.
How was it done?
Ethics committee approval was obtained for monitoring of patients. Consented patient data are extracted from electronic prescribing system and patients score subjective symptoms using questionnaire on days 7, 29 and 90 after the infusion. The prescriber, indication criteria, infusion application day with regards to PCR positivity and symptom onset and vaccination status are recorded.
What has been achieved?
Currently our small dataset includes 59 bamlanivimab and 63 casirivimab/imdevimab patients. On average, mAbs are administered within 2 days of positive PCR test and 5 days of COVID-19 symptoms onset. Our patients report subjective improvement in symptoms by 7 days post infusion. None of our patients clinically deteriorated because of COVID-19. 100 % of mAbs administered are reported in the national database. In October 2021 we achieved that laboratory confirmed positive patients receive text message with infectionist contact to discuss eligibility for mAbs on 24/7 basis. CPs also implemented information leaflets on mAbs for patients with chronic conditions.
What next?
To date, there are no published descriptive data on real-life utilisation of COVID-19 mAbs in terms of patient characteristics, disease outcome and vaccination status. Our initiative shows na excellent opportunity for CPs to enhance timely and rational mAbs use.
MEDICATION REVIEW IN FALL-RELATED HOSPITAL ADMISSIONS
European Statement
Patient Safety and Quality Assurance
Why was it done?
Falls in older people are a significant public health problem due to their high prevalence, the injuries they cause and the associated economic burden. They are often caused by multifactorial risks, being the Fall-Risk-Increasing-Drugs (FRIDs) one of the most significant ones. The aim of this initiative is to reduce FRIDs prescriptions among elderly at risk of falling, by assessing their individual Benefit-Risk Balance.
What was done?
A circuit was designed and implemented to review and optimize the medication of patients admitted to hospital after a fall.
How was it done?
On an everyday basis, the Health Management Unit of our tertiary university hospital sends a list of fall-related hospital admissions to the clinical pharmacists (CP), who review those patients’ medication and identify FRIDs (drugs affecting central nervous system, hypoglycemic/antihypertensive agents, among others). Electronic Health Records (EHR) are consulted to evaluate if medication could have had a role in those falls. When a patient’s medication is subject to any optimization, CP contact the referring physician to propose therapeutic modifications. This pharmacist-doctor communication is carried out during the hospitalization period in case of Internal Medicine admissions and by an administrative appointment with the primary care physician (PCP) when patients are admitted in other units, such as Traumatology or Neurosurgery. The PCP evaluates the medication review report attached by CP in patients’ EHR and modifies medication if necessary.
What has been achieved?
Between May and September 2021, 114 patients were admitted to hospital due to a fall. After excluding 10 institutionalized patients (pharmaceutical care provided by their own team), 6 patients having fallen after alcohol consumption or intentional drug overdose, and 7 palliative patients, the medication of 91 patients was reviewed. The mean age was 80 and the 64.8% were female. An average of 3 FRIDs was identified per patient. 52 pharmaceutical interventions were made, mainly dose reductions and FRIDs deprescribing suggestions.
What next?
This initiative is feasible and potentially beneficial for patients’ health care. Medication review leads to the identification of not only FRIDs, but also different drug related problems. We look forward to assessing the impact of our practice in terms of interventions accepted; drug-related negative outcomes avoided and decreased hospital readmissions.