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.
Evaluation of microbiological shelf-life of preparations of cytotoxic agents in infusion bags combined with medical devices
Pdf
European Statement
Production and Compounding
Author(s)
Timea Botházi, Lone Madsen
Why was it done?
The purpose was to find data for an increased microbiological shelf-life of preparations of cytotoxic agents in infusion bags combined with medical devices. The aim was to increase microbiological shelf-life from 24 hours to 7 days. Existing data were studied to find evidence to support the prolonged shelf-life.
What was done?
The purpose was to find data for an increased microbiological shelf life of preparations of cytotoxic agents in infusion bags combined with medical devices. The aim was to increase microbiological shelf life from 24 hours to 7 days. Existing data was studied to find evidence to support the prolonged shelf life.
How was it done?
A team from the production and quality assurance departments worked together on writing a report that could provide the rationale for the change of shelf-life.
We collected data from
– supplier qualification of the medical devices
– aseptic process simulations (APS)
– process validations
Data were evaluated and risk assessment was performed.
Six medical devices were included.
All suppliers were qualified as low risk.
APS for the specific production process showed no growth.
Process validation data for two types of medical devices showed no concern regarding sterility of preparations.
What has been achieved?
The increase of shelf life was accepted. First product was Blincyto® in infusion bag with Take Set Swan-Lock ® with shelf life increased to 4 days. Patients now visit the oncology clinic only twice a week instead of daily thus saving time and transportation.
What next?
The result means that new product implementation is quick because the only things to evaluate are the stability of the substance and the compatibility of this with materials in contact with it.
Supply difficulties in oxygen humidifiers: an opportunity to promote good practice
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Margaux DUFOSSE, Claire ANDREJAK, Abir PETIT
Why was it done?
By May 2022, we learned about the sale discontinuation of oxygen humidifiers from one of the two manufacturers in our country, due to the constraints of MDR 2017/745. The second manufacturer restricts its products to hospitals with marketing partnerships. In our hospital, oxygen humidifiers are used regardless of the oxygenation medical device (nasal cannulas, masks, tubes or tracheotomy tube) or oxygen flow rate. We had to define indications and prescriptions to control consumption in our hospital.
What was done?
To promote good use of oxygen humidifiers and control our consumption in a context of shortage we have drawn up a scientific explanatory document, a procedure and a prescription support.
How was it done?
We suppressed services’ allocations for humidifiers, to encourage prescription via the Electronic Patient Record. We set up a working group, including pharmacists, resuscitators, pulmonologists and nurses, to write a good use sheet, underlining high-priority medical indications taking account of scientific literature and respiratory medicine learned societies’ recommendations. To assess its effectiveness, we compared humidifiers’ consumption before and after we set it up and evaluate prescriptions’ number and conformity for the first 4 months, from May to September 2022.
What has been achieved?
The group restricted indications to paediatric patients, patients with tracheotomy and patients with oxygen flow rates above 5L/min and upper respiratory tract lesions such as nose bleeding, nasal discharge congestion, or nasal mucosa’s irritation or lesions. We wrote the good use sheet, mentioning the circuit’s montage and conditions for dispensing humidifiers. Before the new procedure, the mean consumption was 1,415 units per month, versus 39 per month from June. Regarding prescriptions’ conformity, 12 (8.7%) out of 138 were denied: six patients on ambient air, four with nasal cannula, one without any severity criteria, a not nominative prescription.
What next?
This collaborative and multidisciplinary work enabled a change in practices. Supply difficulties, initially seen as challenging, are a great opportunity to promote good use, and secure patient care. Although they have now been resolved, with a new supplier, we maintain our measures to ensure patients’ security and well-being.
Pharmacological support tool in the paediatric emergency room
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
IGNASI SACANELLA ANGLÈS, MARTA MARTIN MARQUÉS, HELENA SUÑER BARRIGA, DAVID PASCUAL CARBONELL, PILAR LÓPEZ BROSETA, JÚLIA BODEGA AZUARA, MARÍA VUELTA ARCE, Mª ÁNGELES ROCH VENTURA, ISABEL PLO SECO, ERIKA ESTEVE PITARCH, ANTONIO GARCÍA MOLINA, SÒNIA JORNET MONTAÑA, CARLA DAIANA CIUCIU, SILVIA CONDE GINER, LAURA CANADELL VILARRASA
Why was it done?
Drug dosages and treatment algorithms in paediatric emergencies must be precise and unambiguous to ensure the safety and well-being of patients. Therefore, the introduction of electronic prescription systems in the Paediatric Emergency Room (PER) has become essential to assist clinical staff in prescribing, preparing, and administering the most commonly used drugs.
What was done?
Design and implementation of pharmacological cards as a supporting tool to standardise and streamline the dosages, preparation, and administration of the most frequently used drugs in paediatric emergencies, ensuring a prompt and safe response.
How was it done?
Pharmacological cards were developed for paediatric emergencies, including scenarios such as cardiopulmonary resuscitation (CPR), seizures, sepsis, hypoglycaemia, anaphylaxis, and respiratory emergencies. These cards included the most commonly prescribed drugs, with input and agreement from paediatricians.
The files were organised based on weight categories (3.5-60 kg) and considered the age range of patients (0-15 years). Information collected included the active ingredient, commercial name and presentation, dose per kilogramme, total dosage, dose (expressed as volume for administration), maximum allowable dose, and administration technique. Certain specific conditions were highlighted in colour.
Both medical and nursing staff underwent training in the utilisation of these tools. An evaluation of the protocols was conducted 12 months after their implementation.
What has been achieved?
We developed a total of 21 pharmacological cards, categorised by weight range, encompassing 33 drugs commonly used in paediatric emergencies.
The pharmacological cards were designed in a tabular format, which included the following information: active principle (highlighted in black), commercial name (in red), drug concentration (in blue), standardised dose (in g, mg, mcg, ml, mEq) per kilogramme, total dosage, total volume for administration, maximum allowable dose, route of administration, and administration technique. Additionally, we used background colours to highlight specific situations, such as red for CPR, black for intravenous administration, green for intramuscular routes, and purple for intranasal administration.
During the 12-month evaluation period, we did not encounter any medication-related errors.
What next?
The development of pharmacological cards has helped to standardise practices and simplify the prescription, preparation, and administration of commonly used drugs in paediatric emergency situations. The protocolisation and implementation of this tool have enhanced drug safety in emergency scenarios by reducing human errors and minimising medication-related harm.
Checklist for optimal pharmaceutical validation in very low-birth-weight preterm newborns in the neonatal intensive care unit
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
IGNASI SACANELLA ANGLÈS, MARTA MARTIN MARQUÉS, JULIA BODEGA AZUARA, PILAR LÓPEZ BROSETA, DAVID PASCUAL CARBONELL, HELENA SUÑER BARRIGA, ALEJANDRO SANJUAN BELDA, CARLA DAIANA CIUCIU, SILVIA CONDE GINER, ERIKA ESTEVE PITARCH, ANTONIO GARCÍA MOLINA, SÒNIA JORNET MONTAÑA, ISABEL PLO SECO, Mª ÁNGELES ROCH VENTURA, MARÍA VUELTA ARCE, LAURA CANADELL VILARRASA
Why was it done?
The NICU is a complex area of paediatric hospitalisation that necessitates specialised healthcare professionals. The role of the NICU pharmacist is vital in ensuring the appropriate and optimised use of medications in various critical situations.
What was done?
To develop a checklist that facilitates pharmacotherapy validation for preterm newborns (PTNB) weighing less than 1000 g and hospitalised in the neonatal intensive care unit (NICU). The primary objective is to ensure a higher quality of hospital care in terms of pharmacotherapy.
How was it done?
We conducted a literature review to identify the pharmacotherapy requirements for preterm newborns (PTNB) weighing less than 1000 g during their first 30 days of life.
In order to design the checklist, we compiled various elements, including drugs, dosages, treatment duration, initiation date, and drug monitoring (when necessary). Additionally, we incorporated recommendations for specific scenarios.
What has been achieved?
The drugs considered for this supportive tool include: pulmonary surfactant, ampicillin, gentamicin, fluconazole, caffeine, ibuprofen, iron (ferrum), dexamethasone, nystatin, vitamin D3, and other vitamins. The checklist was designed to cover the first 30 days of life.
From day 0 to 1: Administer pulmonary surfactant and caffeine citrate. For antibiotic prophylaxis, use ampicillin and gentamicin, and fluconazole for antifungal prevention. In cases of an open ductus arteriosus, intravenous ibuprofen should be added.
Between day 10 to 15: Administer vitamin D3 and a multivitamin complex if the neonate tolerates oral administration. If there is a risk of bronchopulmonary dysplasia, which is characterized by more than 7 days of intubation and difficulty with extubation, consider adding dexamethasone and nystatin.
From day 15 onward: Monitor ferritin and vitamin D3 levels. Begin oral iron supplementation (ferrum) 30 days after birth. Both drugs should be continued for one year.
We have included dose adjustments in case of renal or hepatic dysfunction and pharmacokinetic monitoring for antibiotics. In cases where meningitis is suspected, we have provided recommendations for increasing the dose to ensure adequate penetration into the central nervous system.
What next?
This tool simplifies pharmaceutical validation, particularly for pharmacists who may not specialise in the care of these complex patients. By utilising this tool, we can reduce errors and enhance the quality of care provided to preterm newborns (PTNB) weighing less than 1000 g.
Digital transformation of injectable ophthalmic medication circuit: enhancing safety and efficiency
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Catarina Diogo, Rui Caceiro, Maria Helena Duarte, Armando Alcobia
Why was it done?
The core objective of healthcare institutions is to ensure patient safety and maintain the highest quality of care throughout every medical procedure.
This principle must extend to the drug circuit as well. Within our hospital, pharmaceutical services have a dedicated route for producing injectable ophthalmic medications, serving 795 patients and yielding 3720 solutions, in 2022. However, the existing paper-based procedure for medication management is laborious, time consuming and error-prone, demanding full-time constant pharmacist involvement to ensure the secure progression of these medications.
What was done?
A software application was developed on the Power Apps platform to streamline medication management for injectable ophthalmic medications. This application aimed to replace manual paper-based procedures with digital solutions, enhancing efficiency, reducing errors, and providing a comprehensive platform for patient registration, prescription tracking, schedule management, and oversight of injectable solutions’ production.
How was it done?
Over two months, needs of pharmaceutical and ophthalmology services were assessed, soliciting input from pharmacists, ophthalmologists, nurses and administrative personnel. Subsequently, a software application was developed featuring four distinct interfaces, customised for each professional group involved. This application enables patient registration, medical prescription, schedule management and monitoring the injectable solutions’ production – prescription and agenda validation, batch management and generation of identification labels.
This project is presented, therefore, as a customised digital solution, the result of a multidisciplinary collaboration.
What has been achieved?
It is the authors’ belief that this software has allowed for the development of a safer, more efficient, and integrated workflow, as an alternative to paper – which is more prone to errors. In this manner, from a pharmaceutical perspective, it simplifies the workflow, freeing the pharmacist to focus on other important tasks and optimizing personnel management. Furthermore, it is also valuable for ophthalmologists, enabling prescription repetition and access to patient history, as well as for administrative staff, streamlining schedule management. In conclusion, this software is set to transform our injectable ophthalmic medication circuit.
What next?
Further studies confirming its advantages are needed. Its validation would establish its potential and applicability across healthcare settings.
Sustainable adherence in the sector transition for schizophrenia patients
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Lene Juhl Biltsted, Louise Stilling Rasmussen
Why was it done?
In Denmark, patients with schizophrenia receive free antipsychotic medication for the initial two years post-diagnosis. Post this period, patients transition to the primary sector and assume the medication costs. Historically, the clinic dispensed larger medication quantities, offering short-term relief but not addressing the issue. This approach risks medication waste. The new workflows empower healthcare professionals to help patients establish stable financial arrangements with local pharmacies, curbing fluctuating medication expenses. This enhances patient safety by reducing at-home medication stockpiles. Financial barriers often undermine patient compliance. Healthcare professionals strive to aid patients, curbing relapses and readmissions, through rational, sustainable medication management that minimises resource wastage.
What was done?
Training improved healthcare professional’s understanding of the Danish medication subsidy system and options for deferment in the primary sector.
The healthcare professionals’ new knowledge has provided the foundation for the development of optimised workflows in the treatment process, ensuring a more sustainable medication management during the transition to the primary sector. The project establishes the framework for reducing the risk of medication waste upon the patient’s completion of treatment at the clinic.
It also created a favourable setting for healthcare providers to collaborate with patients, enhancing adherence.
How was it done?
Healthcare professionals received training on deferment arrangements, subsidies, and compliance, with supervision from clinical pharmacists.
Patient cases were analysed to determine factors for future guidelines.
Guidelines were formulated to aid healthcare professionals during the patients’ transition to the primary sector.
A tool (calculator) was created for assessing the patients’ economic choices regarding medication expenses.
What has been achieved?
Healthcare professionals gained confidence in guiding patients on stable medication expenses.
Enhanced rational and sustainable medication use by incorporating the seven rights.
New guidelines now allow an appropriate quality assurance strategy to ensure sustainability and adherence.
Tool to assess medication costs which improves the patients adherence in the sector transition.
Lowered risk of over/under treatment and improper storage.
Diminished treatment failure risk by predicting patient medication expenses during the primary sector transition
What next?
In the next 6 months, the clinic will trial the established guidelines and routines with patients concluding their 2-year treatment.
Integration of Farmis-Oncofarm ® and Oncosafety RC® pharmacy software to improve safety in the administration of antineoplastic drugs with intelligent infusion pumps
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
MARÍA ELENA CÁRDABA GARCÍA, SILVIA FERNÁDEZ PEÑA, AMPARO SALVADOR PALACIOS, MERCEDES FERNÁNDEZ PRIETO, CLAUDIA GONZÁLEZ GONZÁLEZ, MARÍA TERESA SÁNCHEZ SÁNCHEZ
Why was it done?
Antineoplastic drugs, chemotherapy specifically, are a clear example of “high risk” medications. The drug administration phase, within the drug utilisation circuit, is where the highest incidence of errors has been detected, ranging between 38%-81%, so the development and implementation of tools aimed at improving security at this stage is very important.
What was done?
The integration of Farmis-Oncofarm ® and Oncosafety-RC® pharmacy software was done, in order to improve the prevention, detection and reduction of medication errors in the administration phase of antineoplastic treatment in the Onco-Haematology Day Hospital (OHDH).
How was it done?
A Drug Library was created in Farmis-Oncofarm® software (v.4.0.11.107). Dosage units, stability, standard concentrations, maximum and minimum doses, time and infusion rate, and preparation and administration recommendations were parameterised and standardised. Parameters for the implantation of Oncosafety-RC® software (accepted percentage of volume deviation in the mixtures, types of intravenous lines, possible adverse reactions, drugs to be used in case of extravasation) were also defined. When the connectivity between Farmis-Oncofarm® and Oncosafety RC® was validated, Oncosafety RC® was implemented in the OHDC.
To evaluate the results of the implementation of this strategy, a retrospective study from May 2022 to May 2023 was carried out. Collected data, obtained from Oncosafety RC® software were: number of mixtures (antineoplastic, supportive drugs and intravenous fluid therapy) and treatments administered, dose deviations, adverse events, incorrect infusion rates, errors avoided due to incorrect medication.
What has been achieved?
12,294 treatments (44,898 mixtures) have been administered in OHDC.
Dose deviations were registered in the 0.01% of the mixtures, due to adverse events that required termination of the infusion. Only three adverse events happened in the study period.
The infusion rate was incorrect in the 0.5% of the mixtures; this information is useful to improve drugs administration and prevent infusion-associated reactions.
This strategy prevented errors due to incorrect medication on 2,499 occasions.
What next?
The integration between Farmis-Oncofarm® and Oncosafety RC® has improved the security in the administration of onco-haematological treatments, allowing the reduction of administration and medication errors. This strategy can be implemented in hospitals that have assisted electronic prescription software and information management software between different clinical management systems and infusion pumps.
Impact of drug-drug interaction alerts on prescribing patterns in a teaching hospital
European Statement
Patient Safety and Quality Assurance
Author(s)
Joana Pinto, José Feio, Sebastião Silva, Francisco Machado, Ana Dinis, Margarida Abreu, João Peres, Mariana Guia
Why was it done?
Clinical decision support systems comprising information on DDI improve DDI risk detection, avoiding preventable patient harm. The resulting DDI alerts can change prescribers’ behaviour to benefit patient care. However, an excessive number of alerts can lead to alerts’ desensitisation by prescribers.
What was done?
We monitored the drug-drug interactions (DDI) alerts displayed in the prescription system through three subsequent homologous periods, occurring after the integration of a DDI database in the prescribing software system of a teaching hospital to assess its impact on the prescribing pattern.
How was it done?
We developed a DDI database – MedH® – to be integrated into the prescribing software system to support hard stop DDI alerts. only the higher clinical risk DDIs were included in this database in order to restrain the burden of alerts and warrant acceptance by health professionals.
Data of all inpatient hospital prescriptions over a 12-month period prior to MedH® implementation were extracted and intersected with MedH® DDI BD to identify the top 10 co-prescribed binomials at risk of severe DDI. The number of alerts for the same binomials was then monitored through three subsequent, post-implementation, homologous periods.
What has been achieved?
Considered the TOP10 observed in the pre-implementation period, the number of alerts for all binomials has consistently reduced over the three post-implementation periods analysed.
The integration of MedH® DDI BD into the prescribing system, resulted in changes in the prescribing pattern, translated by a decrease, between 67% and 100%, in the number of alerts for a sample of control risk binomials coinciding with the top 10 co-prescribed risk binomials observed in the pre-implementation period. These results reflect the good acceptance by the professionals and the didactic effect achieved by the exposure to alerts.
More importantly, these results are indicative of the effectiveness of the implementation of MedH® Alerts in reducing patient exposure to high-risk combinations of medicines, thus promoting patient safety.
What next?
It will be important to ensure that data from IDD alerts are rigorously analysed to recognise clinical situations in which the co-administration of risk binomials is justified, to ensure consistent application of recommended risk minimisation measures, and the availability of safer therapeutic alternatives whenever possible.
Implementation of automated alert system in high-alert medications in a network of hospitals
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
ROSALIA FERNANDEZ CABALLERO, ALMUDENA GARCÍA GARCÍA, MARTA HERNÁNDEZ SEGURADO, MARTA GÓMEZ PÉREZ, CARMEN MAYO LÓPEZ, ARACELI HENARES LÓPEZ, VIRGINIA COLLADOS ARROYO
Why was it done?
Our aim was to improve the safety of HAM appointed by ISMP Spain (Institute for Safe Medication Practices) specially restricting the prescription, creating automated alerts and advising in administration.
What was done?
The main objective was to identify and standardise in prescription and administration the high-alert medications (HAM), included in pharmacotherapeutic guide (PG) in a network of Spanish hospitals with about 1.330 beds.
How was it done?
Literature about HAM and recommended strategies was reviewed. We divided these drugs into two groups: HAM (heightened risk of causing significant patient harm when they are used in error) and very HAM (an error could cause death of patient). We identified both groups in electronic prescription system as follows:
– HAM: all prescribers are able to prescribe these drugs and they find yellow warning sign in left side of the drug in prescription screen and nursing electronic work plan for administration.
– Very HAM: these drugs need tracheal intubation or monitoring measures when they are administered to patients. Only prescribers in intensive care (ICU) and surgery units (SU) are able to prescribe them. For certain drugs, needed in medical hospitalisation units, all prescribers are able to prescribe them and they must confirm the prescription with confirmation message: “You are prescribing a HAM, an error could cause significant patient harm. Are you sure to continue?”. They find red warning sign in prescription screen and nursing electronic work plan.
Alerts were configured by systems team in our electronic prescription system.
What has been achieved?
We have identified 379 drugs as HAM. 324 drugs were configured with yellow warning sign.
Sixty-five drugs were identified as very HAM. Fifty-eight drugs were disabled to prescribe by all prescribers (only in ICU and SU).
Seven drugs were configured with red warning alert and confirmation message: dobutamine, isoprenaline, ketamine, labetalol, levosimendan, carboprost and methylergometrine.
What next?
As next phase of our project, we must develop a procedure to identify and create alerts in new drugs added to our PG as systematic risk assessment process. Moreover, we must evaluate the real impact of our alert system in prescribers and nurse team, to reduce alert fatigue. We will work in automatic reports with ignored alerts.