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STANDARDISATION OF DILUTED POTASSIUM INTRAVENOUS SOLUTIONS IN NEONATAL CARE UNITS (submitted in 2019)

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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.

IMPACT OF A MEDICATION REQUEST TOOL FROM THE NURSING ADMINISTRATION VIEW IN HOSPITALISATION (submitted in 2019)

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Patient Safety and Quality Assurance

Author(s)

M. T. Barrera, O. Carrascosa, P. Madrid, A. Aguado, R. Martínez , N. Argüello, E. Cuellar, M. Vela, C. Jimenez, S. Payan, O. Sánchez

Why was it done?

Lack of stock delays medication administration by nurses. This situation also generates hospital warden displacements to Pharmacy Service and telephone interruptions of Pharmacy technicians’ work. The main aim was to amend stock lack management to improve patient security during medication preparation and administration. The secondary objectives were: reduce interruptions of other health professionals and automate warehouse exits, avoiding errors of manual updating of Pharmacy stock.

What was done?

This tool is part of “Safe Medication Administration in Hospitalization/Avoid Interruptions” project. A “button” was included in the nursing administration view of the electronic prescription programme, which when activated automatically generates a request to the Pharmacy Service for a dose of required medication. Hospital Information Systems were contacted for the design. All requests generated during the administration of medication were automatically received in Pharmacy Service. They were grouped by plant, listed, deducted from stock and dispensed at the agreed times.

How was it done?

The tool was developed by Hospital Information Systems, in collaboration with nursing, and staff training was carried out for correct handling of the tool. Also, medication dispensing schedules were agreed with the hospital warden. 15 days before tool implementation, the Pharmacy Service analysed all medication requests made from hospitalisation. Data collected were: plant and shift requested, reason, existence of pattern, requested medication, requested units, notice to auxiliaries to collect medication. After the first week of implementation, the same assessment of requests was made during the same period to compare and evaluate the impact of this tool implementation.

What has been achieved?

When both periods were compared, prescribed medication requests decreased from 198 to 15, this difference being statistically significant (Fisher’s exact test p=0.008). This difference meant significant reduction of interruptions in Pharmacy technicians’ daily work. Requests reasons were lack of dose in 43.4% (n=95) of cases, immediate prescriptions in 29.2% (n=64) of cases and treatment change in 20.5% (n=45) of cases. 29.2% of all requested medications belonged to the antimicrobial and antiviral group. 62% (n=135) of the total requests were received in the morning shift. Hospital warden displacements were significantly reduced when comparing both periods from 102 to 3 (Chi square test, p=0.006). This meant a significant reduction in interruptions in hospital warden work. It has been possible to standardise and improve efficiently nursing management of medication stock lack.

What next?

The incidents technical improvement is pending, as well as training of new nursing staff. It is possible to implement this tool in all hospital units that have electronic prescription.

ENHANCING MEDICATION SAFETY BY IMPLEMENTING AND IMPROVING THE USE OF A SMART PUMP DRUG LIBRARY IN A TERTIARY HOSPITAL (submitted in 2019)

European Statement

Patient Safety and Quality Assurance

Author(s)

Mohammed Almeziny, Maha Aljuhanei , Fahad Alkharji

Why was it done?

Smart infusion pumps have been introduced to prevent medication errors and they have been widely adopted by healthcare. They incorporate safeguards such as soft and hard dosage limits.

What was done?

A smart pump was implemented in a tertiary hospital.

How was it done?

A task group was formulated from all involved parties to cover all issues related to practice, and it involved nursing and pharmacy staff to overcome all obstacles that may face the project; in addition the information technology (IT) department was involved to determine the facilitation of all technical issues. At the beginning the group faced two main barriers: creating the initial drug library which was a significant amount of work for the pharmacy, then uploading the drug library. In addition, all these works were to be carried out manually by the medical engineering. The quantitative data available from the smart pump software were used to improve drug library use. The team started to collect feedback from and communicate feedback to direct care nurses about drug library usage via e-mail, staff meetings, a “whatsapp” group and one-on-one conversations. This included asking nurses why the drug library was not being used regularly. The most frequent responses included “The pump is hard to use,” “The list doesn’t have the medications I need and, “It’s just easier to use the rate-based programming feature”.

What has been achieved?

The pump library usage percentage for total infusions was raised from a baseline of 2.85% to 30.97% in the first week. After careful review by the nursing, pharmacy, and medical leadership, some changes to the library were made. These included standardising drug concentrations in the pump library and providing ongoing staff education as well as implementing the best practices cited in the ISMP’s guidelines for the use of smart pumps; and running daily usage and weekly soft limit override reports from the pump library. Furthermore, a new category, “feeding”, was added to pump library; finally all medications and plain fluids were added to the pump library.

What next?

A Bar-Code Medication Administration System is needed (BCMA), to ensure the right patient gets the correct drug, dose and route at the right time.

IMPLEMENTATION OF A MEDICATION RECONCILIATION PROGRAMME UPON DISCHARGE (submitted in 2019)

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Patient Safety and Quality Assurance

Author(s)

José Marco-del Río, María Luisa Ibarra-Mira, Gregorio Romero-Candel, Ana Ramirez-Córcoles, Ana Valladolid-Walsh, Francisco Tomás Pagán-Nuñez

Why was it done?

Our main goal was to improve patient’s safety, because we noticed that many patients did not take actually all the drugs that were prescribed by the physicians, and other times there were drugs that the patients were taking because they had an active prescription, but they were not supposed to. Additionally, we aimed to improve the drug-related information that the patients take home.

What was done?

A programme which includes every patient admitted into the Internal Medicine department. It consists of three steps: clarification of chronic medication that the patients are taking, we handle them and updated schedule of their drugs upon discharge and we check the coherence with the active prescriptions.

How was it done?

We interview the patients during the admission in order to clarify and update the chronic medication that they are taking. When a patient is about to be discharged, the nurses call us, so at this moment we talk to the physician to know what changes are going to be made on the medication. To coordinate with the physicians and nurses, we had two meetings in which we established the timing of the programme, so the patients don’t have to wait too long for us. When we know the changes that the physician is going to make, we update the medication schedule to handle it to the patients or their family, and we explain to them the changes and how they should manage the new drugs. If any discrepancy or medication-related problem is detected, we talk to the physician to solve it.

What has been achieved?

In the last four months, we performed 180 discharges and we solved together with the physicians 20 discrepancies. Patients are now receiving more comprehensive information about their treatment.

What next?

To continue with the programme and broaden it to the rest of our hospital departments. Also we are working on a way of uploading our pharmacy schedules to the electronic medical record of the patients, so they can be available for every healthcare worker, which would improve even more the transitions of care.

PROCEDURE TO ENSURE CORRECT MEDICATION MANAGEMENT IN THE PERIOPERATIVE PROCESS (submitted in 2019)

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Patient Safety and Quality Assurance

Author(s)

Noelia Vicente Oliveros, María Muñoz García, Álvaro Ruigomez Saiz, Montserrat Ferre Masferrer, Teresa Bermejo Vicedo, Eva Delgado Silveira, Lucía Quesada Muñoz, Ana María Alvarez-Diaz

Why was it done?

An analysis of the indicators of the perioperative process reflected the need to improve their quality. One of the causes of scheduled surgery cancellation was the lack of the follow up of the anaesthetist’s medication recommendations. Medications need to be carefully managed to prevent perioperative complications.

What was done?

We designed and implemented a flow chart to ensure the patient compliance of anesthetist’s medication recommendations prior to surgery. We designed a protocol for the perioperative medication management.

How was it done?

A multidisciplinary group was formed with the management of the hospital and representatives of all the services involved in the perioperative process. The group designed the flow chart of the process by consensus. Patients were candidates to enter in this process if they were on treatment with anticoagulant or 2 or more medications from the following groups: antiplatelet, antihypertensives, antidiabetics. A pharmacist called by phone three times (the day before, the day of medication change, and the day after) to the patient to ensure the compliance of anaesthetist recommendations. If there was a lack of compliance, the pharmacist contacted the surgeon who was in charge of deciding if the surgery procedure continued as scheduled. Moreover, the domiciliary medication of these patients were reconcilliated and recorded in their health record. Healthcare professionals could consult it during hospital stay. The group designed a protocol for the perioperative medication management with different medical specialists.

What has been achieved?

The project started in April 2019. The pharmacist called patients with scheduled surgery of lower limbs. A total of 31 patients benefited from the new flow chart. The pharmacist detected 38 medication errors; two involved errors concerning the suspension of anticoagulant drugs prior to surgery and four implied antihypertensive drugs. Once, it was necessary to contact the surgeon. In this case, the surgeon decided to continue with the surgery as schedule. Fifty-seven medications suffered a change in the period between the anaesthestic visit and the surgery, nine of them belonged to the monitored medication group. 

What next?

The next steps are to spread the flow chart to other patients, to distribute the protocol among hospital healthcare professionals and to implement a procedure for the reintroduction of the modified medication.

SAFETY IMPROVEMENT IN PAEDIATRICS: ASSISTED PRESCRIPTION OF INTRAVENOUS MIXTURES (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Iván Maray Mateos, Miguel Alaguero Calero, Adrián Rodriguez Ferreras, Cristina Calzón Blanco, Cristina Álvarez Asteinza, Lucía Velasco Roces, Ana Lozano Blazquez

Why was it done?

Intravenous drugs in the paediatric population bring up additional issues than the usual in adults. In their prescription, not only does the dose have to be adapted to the patient’s weight, the volume in which the drug is diluted must also be adapted to the reduced fluids requirement without jeopardising the stability of the mixture. In view of these facts, IV drug prescription in paediatrics implies a higher risk of medication errors. This new prescribing system simplifies prescription and reduces risks.

What was done?

Development of an assisted prescription system of intravenous mixtures adapted to paediatric patients in which both the drug dose and the diluent volume are automatically calculated according to the patient’s weight.

How was it done?

A literature review of drug dosing in paediatrics and their stability in different diluents was performed. For every drug the following parameters were considered: maximum dose in children (mg/kg), maximum concentration allowed (mg/ml), common doses and volumes in adults. Using these values, a system was built which calculated drug dose and diluent volume according to the patient’s weight and the maximum concentration allowed for stability reasons. For safety and to ease the preparation, the diluent volume in millilitres was rounded up to the next 10. In order to avoid overdosing overweight or older paediatric patients, maximum dose and diluent volume were narrowed down to the usual quantities in adults. Ultimately, this system was integrated in the electronic prescription system. A protocol was created, named “drug name” IV mixture PEDIATRICS. So, by selecting this protocol in a specific patient, the target dose and the diluent volume are automatically calculated.

What has been achieved?

This system was implemented for 38 drugs. From July 2018 to April 2019, 910 IV mixtures have been prescribed from the following Anatomical Therapeutic Chemical (ATC) groups: A02 Drugs for acid related disorders (39), J01 Antibacterials for systemic use (287), J02 Antimycotics for systemic use (3), J05 Antivirals for systemic use (8), A04 Antiemetics and antinauseants (175), N02 Analgesics (395), N03 Antiepileptics (3).

What next?

This method could be implemented in other electronic prescription programmes. The system must be updated by the Pharmacy Department, introducing new drugs and constantly reviewing stability databases, posology regimens, and information regarding dilution of parenteral drugs.

THE OPIOID WORKING GROUP: AN INTERDISCIPLINARY WORKING GROUP TO IMPROVE THE CORRECT PRESCRIPTION AND APPLICATION OF OPIOIDS IN THE HOSPITAL SETTING (submitted in 2019)

European Statement

Patient Safety and Quality Assurance

Author(s)

Imke Willrodt, Delia Bornand, Jimena Ramos, Stojan Petkovic, Giulia Mohr, Anne Leuppi-Taegtmeyer

Why was it done?

Due to critical incidents involving opioids reported internally at the University Hospital Basel in 2018, there was an urgent need to evaluate underlying reasons for these events. The Opioid AG was established with the aim to mitigate risks for the correct prescription and application of opioids, and therefore to improve patient safety.

What was done?

The Opioid Working Group at the University Hospital Basel is an interdisciplinary working group including representatives from different professions (physicians, nurses, pharmacists) and departments (medical, surgery, gynaecology, emergency, pain therapy, palliative care, pharmacology and toxicology, patient safety and information technology).

How was it done?

The thorough analysis of root causes for the critical incidents revealed prescribing and application errors, such as non-observance of kidney failure, pharmacodynamic interactions of opioids with other prescribed drugs, inadvertent overdosing – in particular with liquid drug formulations, or patient mix-ups.

What has been achieved?

Consequently, the following steps are being taken to address these risks: 1. Optimisation of the prescribing software including opioid prescription templates, links to existing opioid unit conversion tables for liquid forms of diamorphine, morphine, hydrocodone and oxycodone (milligrams to millilitres) as well as clearer display of “as required” opioid prescriptions on the patients’ electronic drug charts. 2. Preparation of Standard Medication Preparation Schemes for nursing staff of the emergency department. 3. Development of an additional label (concentration, patient initials, date of reconstitution, date of expiry of reconstituted solution) for parenteral diamorphine. 4. Improvement in detailed written instructions for the correct preparation, labelling, application and disposal of intravenous and oral drugs (to include opioids). 5. Evaluation of a hospital opioid safety self-assessment tracking tool.

What next?

A comprehensive evaluation will take place, 6 months after the implementation of all measures. We will use the number of naloxone prescriptions on the wards as a key performance indicator to measure the success of this project. The reported critical incidents involving opioids will also be assessed before and after the implementation of all measures.

This evaluation will help to identify open questions, potential gaps and further needs for improvement to be addressed by the interdisciplinary team.

IMPLANTATION OF A COMMUNICATION CIRCUIT OF ALERTS AND SAFETY NOTES RELATED TO DRUGS FROM THE PHARMACY DEPARTMENT (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Ignacio García Giménez, Natalia Martín Fernández, Olalla Montero Pérez, Ernesto Sánchez Gómez, Isabel María Carrión Madroñal

Why was it done?

The aim is to implement a protocol to follow when these safety notes/alerts are released from the AEMPS. It comprehends the reception of the information, its registration and its communication, when needed, to the rest of the healthcare professionals.

What was done?

A communication circuit of alerts and safety notes related to drugs coming from the “Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)”.

How was it done?

At the reception of an alert from the AEMPS, the first step is to check if the drug has been acquired by the Pharmacy, and then act in accordance with the recommendations, informing the Departments in which the medication had been dispensed. If a drug must be retired and a stock break is generated, the healthcare professionals must be informed as well. Security notes from the AEMPS are published in the local hospital website, where the documents sent by the AEMPS can be found. If this medication is included in the Pharmacotherapeutic guide, a notification is shown when it is prescribed. Finally, all alerts and security notes, with the pharmacist intervention, are registered in a database.

What has been achieved?

Since the implementation of the circuit, 14 alerts and 9 security notes were sent from the AEMPS in a period of 6 months. No interventions regarding the alerts were needed. Healthcare professionals were informed when the security notes were released, pointing to the patients at risk, the precautions required and the alternative therapies available.

What next?

To incorporate it as an indicator of quality of care within the procedures performed by the pharmacy department and detect areas of improvement.

MULTIDISCIPLINARY CAR-T TEAM (submitted in 2019)

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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)

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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

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