STANDARDISATION OF DILUTED POTASSIUM INTRAVENOUS SOLUTIONS IN NEONATAL CARE UNITS (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Luis Pérez de Amezaga Tomás, María Magdalena Parera Pascual, Mónica Sanz Muñoz, Catalina March Frontera, Gonzalo González Morcillo, Alejandra Mandilego Garcia, Álvaro Medina Guerrero, Ana Filgueira Posse, Montserrat Vilanova Boltó
Why was it done?
Administration of intravenous KCl produces hyperkalaemia and this can result in cardiac arrest and death. The Institute for Safe Medication Practices (ISMP) as well as other security agencies have recommended the withdrawal of KCl 2M from ward stock. This project was born as a response to these recommendations. We focused on a group of patients where these practices have not been extensively implemented. The aim of the protocol was to standardise the prescription, preparation, dispensation and administration of KCl to neonates in our hospital.
What was done?
Development of a protocol that standardises diluted potassium intravenous solutions for neonates (including those preterm over 28 weeks of gestation). This allowed us to remove concentrated potassium chloride (KCl) 2M from neonatal care units in our hospital. For this purpose, the hospital pharmacy centralised the preparation and distribution of KCl ready-to-use infusions.
How was it done?
The elaboration of the protocol took place as follows: • A multidisciplinary team designed KCl ready-to-use solutions that met the requirements of the newborn: – Glucose 10% 250mL with 5 mEq KCl (20mEq/L solution) – Glucose 10% 250mL with 10 mEq KCl (40mEq/L solution). • The hospital pharmacy centralised the preparation of these solutions. A risk assessment was performed and determined an expiration date of 7 days. • These solutions were stocked at all neonatal care units: Intensive Care Unit, Hospitalized Paediatric Unit and Paediatric Emergency Unit. • Weekly, the hospital pharmacy distributes these solutions and disposes of the expired ones. • Only ready-to-use KCl solutions were able to prescribe at the electronic prescription programme. • A formation plan was implemented to train all the professionals involved in neonatal care.
What has been achieved?
The protocol was implemented in November 2016. Since then, 65 patients have been treated with 20mEq/L solution and only 1 patient with 40mEq/L solution. No remarkable imbalances in electrolytes have been detected resulting from the standardisation of the fluid therapy with KCl. Only 3 incidents have been registered. All of them were prescription errors (solution selection); they reached the patient but without damage.
What next?
Nowadays, we are developing a stability study of the KCl solutions in order to assess the appropriateness of the expiration date.
MULTIDISCIPLINARY CAR-T TEAM (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
MARGHERITA GALASSI, CHIARA DELLA COSTANZA , CLAUDIA TIRONE, SARA BERTOLI, ERNESTO RUFFINO, ELEONORA FERRARI, ELENA ALIPRANDI , VITO LADISA
Why was it done?
CAR-T cell therapies are a new advanced type of personalised immunotherapy against cancer. In the EU the authorised therapies are tisagenlecleucel and axicabtagene ciloleucel, both used in our centre as third line for the registered indication of diffuse large B-cell lymphoma. CAR-T therapies production and administration process consists of multiple stages: patient’s leukapheresis, genetic engineering of lymphocytes, lymphodepleting chemotherapy (LC), CAR-T cell infusion, monitoring of the patient. Considering the complexity of the procedure and the observance of specific schedules, these therapies should be administered in highly specialised centres complying with specific organisational requirements, with disposal of an adequate multidisciplinary team.
What was done?
A multidisciplinary team (CAR-T team) was constituted for the management of CAR-T therapies (Chimeric Antigen Receptor T). The pharmacist was included in the team for the planning and organisational phase of the process.
How was it done?
The pharmacist is responsible for the approval of the physician’s prescription, the LC preparation according to Good Manufacturing Practice (GMP), the LC distribution on scheduled time, the making available of treatments for supporting the patient until CAR-T infusion, and treatments after infusion for management of adverse events. At the arrival of the CAR-T product, the pharmacist is responsible for the check and release of it in good condition. The LC protocols foresee the administration of cyclophosphamide and fludarabine on the 5th, 4th and 3rd day before the CAR-T infusion, and are defined on the basis of the summary-of-product characteristics. The medications are provided locally and refunded by the national health system.
What has been achieved?
In our center 8 patients were treated with compassionate use of axicabtagene ciloleucel. The pharmacist’s presence in the multidisciplinary team was advantageous because, through validation of the therapies and verification of dosages, they guarantee further security to the patients. The high-tech automated centralisation and computerisation of chemotherapies at our centre ensured quality and safety of the preparations.
What next?
The realisation of defined paths and codified proceedings, the respect of fundamental timings for the success of the process and the chemotherapy preparation centralisation could lead to increased investment, decisive for obtaining a high quality product and process level. The experience, now limited to haematology, could be used for future CAR-T applications.
A QUALITY IMPROVEMENT PROJECT ON HEPARIN INFUSION SAFETY IN AN ACUTE TEACHING HOSPITAL (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Anthony Hackett, Alice Oborne, Emma Ritchie, Caroline Broadbent, Rebecca Chanda, Karen Breen
Why was it done?
Anticoagulants such as UFH are recognised as high risk drugs. UFH requires frequent monitoring of the activated partial thromboplastic time ratio (APTTr), ensuring therapeutic anticoagulation and minimising adverse effects. UFH infusions and the APTTr were recorded using a paper based system. Incident reporting identified by the paper system resulted in inappropriate monitoring and management of UFH infusions, and dose omissions which could have resulted in harm.
What was done?
A Trust-wide electronic prescribing and medicines administration (EPMA) system was implemented in 2015. Complex infusions, e.g. unfractionated heparin (UFH) infusions, remained on paper due to EPMA functionality limitations. The complex infusion function was added into later EPMA upgrades. A multidisciplinary team (MDT) involving nursing, medical and pharmacy staff working within anticoagulation, EPMA and medication safety sought to design UFH infusions in EPMA.
How was it done?
Baseline audit (Paper-March 2016): Patients prescribed UFH infusions (n=14) were identified using SharePoint (e-reporting) by searching for the UFH infusion placeholder. Performance was measured against eight audit standards.
Re-audit (EPMA-March 2019): Patients prescribed UFH infusions (n=26) were identified using SharePoint by searching for those prescribed a UFH infusion on EPMA. Performance was measured against the same eight audit standards.
Chi square applied to results to test for statistical significance.
Incident rate per prescription: The Datix system was searched to identify heparin incidents reported during the data collection periods.
What has been achieved?
Audit standard 2016 audit v 2019 audit
1-Baseline APTTr checked before starting infusion 93% v 100%, p=0.1
2-Received correct loading dose of heparin based on APTTr 79% v 96%, p=0.07
3-APTTr checked 6 hours after infusion started 72% v 100%, p<0.05
4-APTTr checked 6 hours after infusion titrations 86% v 96%, p=0.2
5-APTTr in target range within 24 hours 50% v 70%, p=0.2
6-APTTr checked 24 hourly after 2 consecutive APTTr’s in range 100% v 100%=no change
7-Patient receives a medical review 24 hrly 65% v 100%, p<0.05
8-Heparin syringe and giving set changed 24 hrly 65% v 100%, p<0.05
UFH related incidents reduced from one incident per 1.6 infusions, to one incident per 6.5 infusions following the implementation of an EPMA system.
UFH incidents as a proportion of all anticoagulant incidents reduced from 43% (March-2016) to 20% (March-2019).
What next?
Electronic solution’s for high-risk, complex infusions such as heparin prescribing and monitoring improved care, quality and safety. Further high-risk infusions such as insulin are being developed
IMPLEMENTATION OF A MEDICATION SAFETY AGENDA AT TWO HOSPITAL SITES IN RESPONSE TO WORLD HEALTH ORGANISATION (WHO) PATIENT SAFETY CHALLENGE ‘MEDICATION WITHOUT HARM’ (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Meenal Patel, Sheena Patel, Peta Longstaff
Why was it done?
• Initiative introduced and on-going since 2017
• To increase and embed medication safety awareness
• To address under-reporting of medication-related incidents, with feedback
• To embed medication safety in education programmes and clinical practice
What was done?
A local medication safety agenda implemented across two hospital sites in response to World Health Organisation (WHO) patient safety challenge ‘Medication without Harm’.
How was it done?
• Medication safety group (MSG) introduced with local strategy, involving junior medical staff for frontline feedback • Medication safety metrics changed to allow benchmarking with peers as per NHS Improvement’s Model Hospital data • ‘Plan, Do, Study, Act’ model applied to improve transfer of care from hospital to rehabilitation unit following external incidents • Monthly analysis of incidents with harm, exploring reasons for under-reporting • Optimisation of incident reporting system to improve staff feedback following investigations • Near miss error log introduced in pharmacy with shared learning • Mitigation of medication-related risks e.g. medications safe storage action plan • Medication safety bulletins, patient safety newsletters and top tips guide introduced covering focal themes • ‘Safe prescribing’ mandatory induction training for junior doctors to support prescribing of high risk medicines and compliance to patient safety alerts • Hospital-wide education on lessons learnt from incidents • Medication safety resources for staff to access • Nursing quality round on medication safety • Electronic missed doses realtime report developed to tackle omitted/delayed critical medication doses • Medication safety awareness (MSA) week held to increase awareness on focal themes
What has been achieved?
• Multidisciplinary MSG with assurance on meeting WHO global challenge. • Monthly analysis of medication safety data to allow learning, collaboration and benchmarking against peers. • Positive staff feedback on bulletins/newsletters with staff involvement/engagement. • Training programmes embedded with safe prescribing education. • Improved hospital safety metrics: Following MSA week, a 5% and 21% increase in medication-related incident reporting occurred at each site which has been sustained. Reporting rates doubled at one site following success of MSA week. • In 2018-19, local target achieved for reported medication-related incidents per 100,000 finished consultant episodes and medication-related incidents with harm
What next?
• Collaborative multidisciplinary working raising the profile of pharmacists acting as medication safety officers
• Implementing medication safety measures from NHS Patient Safety Strategy 2019
• Initiatives for safer culture, safer systems and safer patients
IMPLEMENTING THE PRODUCTION OF STERILISED SYRINGES IN THE HOSPITAL: IMPROVING MEDICATION SAFETY AND SAVING HEALTHCARE COSTS
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Karin Larmene-Beld, Rommert Wijnsma, Gerrit de Weerd, Maarten Postma, Erik Frijlink, Katja Taxis
Why was it done?
Medication administration errors are common in hospital practice. Meta-analyses suggest that about 10% of administrations are erroneous, with much higher error rates occurring during intravenous drug administrations. It has been demonstrated that 21% of the errors can be eliminated when prepared syringes are used. Many countries struggle with the problem of optimising the process of safe parenteral medication in hospitals. Different guidelines across countries outline how preparation of parenteral medication in the clinical environment should be done. Recently the Council of Europe published a resolution about preparation of medication which encourage the supply of ready-to-administer products by the pharmacy. Moving the activities of preparation of medication from the clinical environment to the pharmacy requires investments in pharmacy equipment but will result in efficacy, better quality and reduction in preparation medication errors in the hospital.
What was done?
Development and implementation of sterilisable plastic syringes produced in the hospital pharmacy for large-scale production of ready-to-administer products.
How was it done?
A new development in this area are ready-to-administer pre-filled sterilised syringes (PFSS) produced by the pharmacy. PFSS are produced on stock under GMP conditions by the hospital pharmacy using (semi) automatic filling and closing machines whereby quality and safety are embedded in the whole process of manufacturing. A total cost of ownership analysis is performed showing PFSS prepared in the hospital pharmacy yielded cost savings compared to conventional preparation on the ward. The process of production, filling, closing and sterilisation has been validated using newly acquired equipment. With the introduction of the cyclic olefin polymer (COP) syringes a new type of primary container is implemented in the pharmacy. To ensure patient safety and product quality a science- and risk-based strategy has been developed for testing extractables and leachables to qualify the new container as primary packaging material.
What has been achieved?
Introducing PFSS is cost saving for the healthcare system:– COP syringes are suitable as primary packaging material; –enhancement styles for better readability of labels are established; and – already, 15 products are validated and available for use in the hospital.
1. KHM Larmené-Beld KHM, Touwen-Spronk J, Luttjeboer J, et al. A cost minimization analysis of ready-to-administer pre-filled sterilized syringes in a Dutch hospital.. Submitted for publication in Clinical Therapeutics.
2. Larmené-Beld K, Kuiper A, van Berkel S, et al. A science- and risk-based strategy to qualify sterilized prefilled syringes as primary packaging material in a hospital pharmacy. Abstract submitted for 24th EAHP Congress.
3. Larmené-Beld KHM, Kim Alting E, Taxis K. A systematic literature review on strategies to avoid look-alike errors of labels. Eur J Clin Pharmacol 2018 74:985–93.
What next?
Introducing more drugs as ready-to-administer products. Optimising the label of ready-to-administer syringes to avoid look-alike errors based on the results of the review.
PREPARATION OF A CYTOSTATIC STABILITY GUIDE AFTER RECONSTITUTION AND DILUTION
European Statement
Patient Safety and Quality Assurance
Author(s)
Gregorio Romero Candel, Paula Ruiz Belda, Maria del Carmen Caballero Requejo, Maria Jesus Sanchez Cuenca, Jose Marco del Rio , Julian Castillo Sanchez, Luna Carratala Herrera
Why was it done?
In common clinical practice, the stability of medications is an area of interest to obtain maximum security and efficiency. After reconstitution and dilution, knowing the validity period is very important for the effectiveness and safety of the treatment, since it must be administered to the patient under the appropriate conditions. In recent years, a large number of high-impact cytostatic medicines with limited stability data have been registered and incorporated into clinical practice. Frequently, the stability data results are contradictory or insufficient. The main goal is to make a reliable quick guide of reference with the validity periods of the reconstituted and diluted active principles according to physicochemical stability, therefore increasing safety, reducing queries for these doubts and improving the management of unused remains that have high economic impact.
What was done?
A cytostatic stability guide after reconstitution and dilution has been made. The active principles and commercial presentations that are used in the intravenous mixtures area were reviewed.
How was it done?
The obtaining of the physical-chemical stability data has been done by reviewing the information available in Stabilis, Pubmed, Lexicomp and technical data sheets.
What has been achieved?
Fifty-four pharmaceutical specialities from 44 active principles, all in the cytostatic group, were checked. Tables of reference for the elaboration sites were made for consultation. It has reduced the number of consultations conducted and improved the time of preparation of these products. The rest of the elaborations for other administrations have been taken advantage of, making a better use of the pharmacotherapeutic resources.
What next?
The next step is to keep developing consultation tools that improve the safety and management of hospital drugs.
A SET OF QUALITY IMPROVEMENT INTERVENTIONS TO INCREASE THE PERCENTAGE OF STAT IV MEDICINES, MEETING THE GOAL OF BEING READY WITHIN 30 MINUTES
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
MELINDA LITAO, HANY ELATROUSH , KHATHLEEN ESER, ARWA AFANA, AHMED BAIBRAHIM, JAYSON DE JUZMAN, BAYAN RAMBO, DERI PASCUAL, MA ENCARNACION DELOS ANGELES, MANAL SALLAM, MALIK KHUWAJA
Why was it done?
STAT orders have always been a priority, however there are some areas which require some modification in the workflow to attain higher efficiency and to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.
What was done?
A set of quality improvement interventions to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.
How was it done?
This was a pre-post study in a government hospital between January and September 2018. LEAN and FOCUS-PDCA models were implemented to design the process of improvement. A medication-tracking system (MedBoard) was used to collect the data to measure the number of STAT IV medicines ready within 30 minutes. Data was also collected from the number of phone calls and faxes received from the day procedure unit (DPU) and home health care unit (HHC).
What has been achieved?
The cumulative data showed an increase in the percentage of STAT IV medicines being ready by 7%, equivalent to 707 orders per month (90% vs 97%), a reduction in the number of phone calls by 87.5% (48 vs six calls per day) and fax by 100% from the DPU and HHC units, which means that implementing the set of interventions were associated with an increase in percentage of STAT IV medicines being ready within 30 minutes. Additionally, there was a significant decrease in the number of phone calls and faxes, which allowed pharmacists to focus more on STAT IV orders.
What next?
Since the hospital pharmacy receives numerous orders on a day-to-day basis, this will facilitate prioritisation during the entire process. This aligns with the hospital goal of attaining ‘zero harm’, and is therefore a good example of good practice in a hospital setting. The use of Medboard in tracking medications and monitoring performance can be applied to allow any healthcare setting to ensure that goals are reached, and performance is maintained at the highest level. Designing a list of eligible medications that can be ordered as STAT can be used as a guide to avoid the abuse of STAT orders and can help in prioritising order preparation in the STAT IV room.
OPIOID ROTATION IN PEDIATRICS: A CONVERSION CHART FOR CHILDREN OLDER THAN 1 YEAR
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Sabina Hiltbrunner, Dalibor Panis, Jörg Thomas, Eva Bergsträsser, Angela Caduff Good
Why was it done?
Opioids are widely used for acute pain management in pediatrics after surgery, for sedation on the intensive care unit, and chronic pain management in palliative care and many other conditions. In some patients, it is necessary to change the opioid during therapy, due to tolerance development or due to side effects. Although conversion tables for adults are well established, they are not readily available for pediatric use.
What was done?
To simplify the process of opioid rotation in pediatrics, an opioid conversion chart with easily memorable conversion factors was generated.
How was it done?
A literature search was performed to collect conversion factors and equivalent doses of opioids with different application routes. We searched specifically for conversion factors in pediatrics. Except for Oxycodone and Remifentanil, for all other opioids in our chart conversion factors for pediatric patients were found. Data for adults were used for these two substances. For all conversion factors experts confirmed their adequacy for clinical use in pediatrics. The conversion factors were rounded up to whole numbers, which was considered reasonably based on long-term experience in pediatric pain manage-ment.
What has been achieved?
This conversion chart is now part of a drug information document about opioid dosing in children older than 1 year in our hospital. For every substance, starting doses were set according to www.pediatric-dosages.ch and based on clinical experience. When necessary, details about the therapy with the indi-vidual substance were added. For illustration purposes, a sample calculation of the change from oral Morphine to oral Oxycodone was included.
The immature metabolism in children younger than 1 year makes the opioid action often unpredictable. Therefore we restrict the use of the chart for children older than 1 year and in younger children specialists in pain management should be consulted.
What next?
Our opioid conversion chart, with easily memorable conversion factors and starting doses, supports all healthcare professionals in pediatric pain management and may also help to reduce critical incidences due to mistakes in calculation. This is the first time an opioid conversion chart is established for pediatric purpose. Its impact on patient safety has to be shown in the future.
HIGH-ALERT MEDICATIONS, A STEP FORWARD TO IMPROVE PATIENT SAFETY
Pdf
European Statement
Patient Safety and Quality Assurance
Why was it done?
The implementation of safe medication practices plays a key role to prevent medication errors (ME) in the hospital setting. High-alert medications (HAMs) are those that bear a heightened risk of causing significant patient harm when they are used in error. Institutions such as the Joint Commission requires that hospitals define institution-specific HAMs and implement good processes.
Our objective was to ensure safe medication hospital practices and to eliminate medication errors that may cause harm, which is a priority to achieve patient´s safety goals.
What was done?
A program for identifying and handle high-alert medications in a terciary hospital has been implemented.
How was it done?
The project was carried out in different stages:
-First of all, it was consulted the updated list (published in 2012) by the Institute for Safe Medication Practices. Therefore, a total of 186 drugs were HAMs.
-The second step was identified them using auxiliary red colour labels to warn health professionals of their potential danger.
-Finally, we defined general and specific strategies to take up with HAMs. In general strategies, plant kits were reviewed to remove unnecessary stock and limiting access to HAMs. It was also standardized HAM handling practices. In this way, specific strategies focused on: methotrexate, insulin and heparin. Regarding methotrexate administered orally, it was distributed a fact sheet indicating rules to promote it proper administration. Regarding insulin, a working group was formed to determine the available presentations, reserving the insulin pen for diabetic debuts. For the unfractionated heparin, a procedure for standardized dilution of 5% heparin was performed being the 1% heparin restricted to certain services.
What has been achieved?
A total of 186 medications were identifyed as HAMs and different strategies to prevent ME with those was defined. The main objective we have accomplished is becoming aware of their potential danger in case of error.
What next?
In the near future, our main objetives are asses the long-term impact of the implemented strategies, monitor ME involving HAMs and reassess the current list of HAMs to promote a needed safety culture in the hospital setting.