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.
Opioids room of horrors – an interactive learning to improve safety of drug administration
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Sophia Hannou, Cristina Nicorici, Patricia Spitz, Samuel Cotte, Wanda Bosshard, Nancy Perrottet, Pierre Voirol, Farshid Sadeghipour
Why was it done?
Medication use process is at high risk especially for opioids. In our geriatric rehabilitation unit, self-reporting incidents are submitted regularly to our quality system. Among the 44 drugs incidents reported in 2021, 11 included opioids. Prevention with training is a way to reduce these errors. However, theoretical teaching covering the “5 rights” rule remains insufficient. Therefore, an interactive learning with a room of horrors focused on opioids was selected by our unit to prevent these errors. The objective was to cartography and identify the most risky steps and to introduce specific actions to reduce these risks.
What was done?
A room of horrors with a specific focus on opioids has been developed and implemented to reduce errors in medication circuit.
How was it done?
An interprofessional group created the room of horrors based on real incidents. Fictional patient, clinical situation and opioid prescription were created in the medical software. Several drugs and medical devices were available. A model wore an identification bracelet. Ten errors, covering the five rights, were hidden in the room. A pair of healthcare givers had 20 minutes to realise the simulation (5 for the briefing, 10 for the exercise and 5 for debriefing).
What has been achieved?
During the World Patient Safety Day 2022, 38 healthcare professionals (19 nurses, 10 assistant nurses, 9 geriatricians) participated to this training. Errors were detected in variable proportions. For example, 58% of the participants uncover the patient identification error, 53% the pharmaceutical form, 53% the expired date, 47% the allergy contraindication and 47 % used the oral syringe.
What next?
Results and theoretical notions will be presented to all professionals of the unit. This room of horrors is transposable and can be used in other units of the hospital. A video of this simulation was created as an e-learning. It will be implemented as a continuous training or for new collaborators in our unit and can be shared to other units of the institution. Incidents will be continuously monitored and the training will be adjusted in the future. Based on the success of the room of horrors, this interactive learning will be used in other areas with other clinical or technical dimension.
Implementation of a standardised parenteral nutrition solution on a neonatal ward
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Isabelle Sommer, Farshid Sadeghipour
Why was it done?
PN can be composed of 14 different ingredients, including an amino acids admixture. Therefore, PN represents a complex and high risk preparation. Medication errors (ME) are often related to PN management and may include prescription, transcription, preparation, and administration errors. As the treatment with PN is essential for a good cerebral and neurologic development and a postnatal weight gain, ME can result in growth retardation, developmental disturbances, and infections. The implementation of the standardised PN aimed to achieve a reduction of ME having an impact on vulnerable newborns and to improve the security and quality of their nutritional treatment.
What was done?
A multidisciplinary development of a hospital’s neonatology and pharmacy departments as well as of an industrial manufacturer resulted in a standardised parenteral nutrition (PN) solution for neonatal patients. This PN solution was implemented as “standard-of-care” for newborn term and preterm infants requiring nutritional treatment within their first days of life.
How was it done?
The standardised PN solution for a peripheral administration route was developed in accordance with ESPGHAN guidelines (2018).
The neonatologists defined internal guidelines for the PN administration and trained the concerned personnel (physicians and nurses).
The industrial manufacturer delivered the ready-to-use PN solution as a sterile double-chamber infusion bag in accordance with Swiss and European regulatory.
What has been achieved?
The ready-to-use PN solution with a 24/7 availability on ward by means of an 18 months stability at room temperature allowed a considerable reduction (-80%) of on ward preparation of nutritional solutions by nurses.
One-third of individual PN solutions being prepared at the hospital’s pharmacy has been replaced by the standardised PN solution.
This high-quality PN solution allows a secured administration to the vulnerable patients as well as a reduction of ME related the whole PN management resulting in an improvement of the nutritional treatment of neonates and its outcomes on their development.
What next?
This special PN solution is already implemented in two Swiss university hospitals and others will follow. Further standardised PN for a central venous administration to neonates need to be developed to allow the completion of a safe nutritional treatment. On ward PN preparations must be prohibited to prevent undetectable ME.
Development of standard kits with utensils for outpatient parenteral antibiotic therapy
Pdf
European Statement
Production and Compounding
Author(s)
Louise Rasmussen Duckert, Marianne Kjettrup Jensen, Mette Lethan, Trine Schnor
Why was it done?
The hospital pharmacy wishes to support the implementation of OPAT and during the process the need for standardised kits with utensils was identified. The availability of kits with necessary utensils for aseptic handling of parenteral infusion would simplify and standardise the work for hospital and home nurses. Considerations regarding patient safety and sustainability were also in favour of the kits, as choice of utensils could secure compliance to regional guidelines considering use of closed systems and rinse of the line after infusion. Kits containing the exact needed utensils for an administration also reduces the possible waste.
What was done?
The hospital pharmacy has composed standard kits with utensils for outpatient parenteral antibiotic therapy (OPAT).
How was it done?
The kit is composed in collaboration between the pharmacy, hospital nurses and home nurses. The best suited infusion set was chosen – a closed system with two spikes for antibiotic mixing and infusion. Hereby nurses avoid direct contact with antibiotics and avoid antibiotic aerosols in the citizen’s home. The infusion set contains no PVC, phthalates or latex. When fully emptied the infusion set can be discarded as regular waste.
The kit also contains a sterile cover for the workstation, sterile ethanol swabs, gloves, pre-filled saline syringes for rinse of the line after infusion and a written manual. All is packed and labelled by the hospital pharmacy and lot numbers are registered for traceability.
What has been achieved?
The kits have been tested in selected municipalities and the content of the kit has been adjusted. As a result of the feedback a film has been recorded showing the handling of the infusion set. The video is used for training and a QR code on the written manual guides the home nurse to the video if needed. The kit is now used widely in the region and response is positive. With the set-up being identical in all municipalities in the region, handling antibiotics and utensils is simpler for the hospital nurse at discharge.
What next?
As the number of patients in home-based OPAT rises, experiences with the kits will probably result in wishes for adjustments. A new kit with utensils for changing PVK is under development.
Improving people living with HIV therapies compliance: a practical tool customised for patients and designed by hospital pharmacists
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Sabrina Trivellato, Daniele Mengato, Maria Mazzitelli, Anna Maria Cattelan, Francesca Venturini
Why was it done?
An optimal compliance is an essential requirement for people living with HIV (PLWHA) to grant drugs effectiveness and safety. Given the complexity of the therapeutic regimen, and the multiple changes to it due to the clinical status, compliance to therapy may be suboptimal. Patients who are not well educated on how to follow their therapy are more keen on quitting the treatment or facing virological failure. According to previous analysis, we reported that 120 patients out of more than 1500 managed by our centre experienced suboptimal adherence to therapy.
What was done?
We created a user-friendly tool to educate HIV-patients on their drugs’ adherence in our University Hospital.
How was it done?
We studied every drug prescribed in our centre and we analysed it from the patient’s point of view. The question we aimed to answer was: “If I were a PLWHA, what would help me assuming the correct drug, at the proper time, avoiding misunderstandings?”. We analysed the shape, colour and dimensions of both the package and the pills/capsules. We focused on the most appropriate way to take every drug and we investigated possible interactions with OTC drugs or dietary supplements.
What has been achieved?
A poster reporting all the drugs available in our formulary was developed: 34 medicines were described in alphabetical order, specifying for each one the image of the package, the usual dosage, the picture of the pill/capsule compared to the dimension of current coins and special warnings about possible drug-drug interactions. We also adopted practical symbols to indicate whether to assume the drug with or without food. The poster became available starting from April 2022 and during the following 5 months a cohort of 960 patients could rely on it.
What next?
In order to help our patients taking their therapies, we expect to get a digital form of this poster to make it available on the phone scanning a QR code. Alongside, we aim to enlarge and improve this digital version by adding a final section with an interactive survey to closely monitor the compliance of the patients and help them to improve it. Through this project we could also obtain an active pharmacovigilance setting.
Prescription review of digoxin-treated inpatients: Pharmacist involvement in its pharmacokinetic monitoring and dosage adjustment
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
DEL RIO GUTIERREZ JOSE MANUEL, MARTA MIARONS FONT, SONIA GARCIA GARCIA, TONI SORIANO COLOMÉ, ALBA PAU PARRA, ARIADNA GRACIA MOYA, NIEVES HERRANZ MUÑOZ, BRUNO MONTORO RONSANO, PAU RELLO SABATE, GERARD ORISTRELL SANTAMARIA, MARIA QUERALT GORGAS TORNER
Why was it done?
Digoxin is a drug frequently implicated in medication errors due to its difficult clinical management. It has also been observed that digoxin pharmacokinetics could change in acute medical conditions, compromising its effectiveness and safety. As hospital pharmacists, we have the opportunity to review which dose is the most appropriate for every patient.
What was done?
Twice-weekly active and extensive pharmaceutical review of digoxin-treated inpatients was established to identify whether the prescription was adequate and to adjust dosage according to plasma concentrations (PCs) and clinical situation.
How was it done?
1. A multidisciplinary team comprising pharmacists and cardiologists was created to identify possible solutions to improve digoxin prescribing.
2. It was agreed that a twice-weekly extensive review of digoxin-treated inpatients would be conducted by a pharmacist. Candidates for digoxin monitoring were:
a. Patients on chronic digoxin therapy and with at least one of the following risk factors: presence of renal failure (RF), recent surgery, elderly patients (≥65 years), critically ill patients, or patients with suspected toxicity.
3. Once the patients were identified by the pharmacist, they would be discussed with the cardiology team.
4. Digoxin prescriber would be contacted to recommend performing a determination of digoxin PC. PC reference range was set at 0.8–1.2 µg/L for atrial fibrillation (AF) and 0.5–0.8 µg/L for heart failure (HF).
5. PCs would be interpreted using a pharmacokinetic monitoring software (PKS Abbot).
6. Monitoring results and recommended dosage adjustments would be communicated.
What has been achieved?
From August 2021 to May 2022, 190 patients were identified. Sixty-five (33.7%) were considered for monitoring, of whom 21 (32.3%) were women. The average age was 77.9 (SD 11.7). Sixty-five (100%) with AF and 8 (12.3%) also with HF. The most prevalent risk factors warranting monitoring were patients aged 65 years or older (N=57, 61.9%) and RF (N=31, 33.7%). Thirty-three (51%) of monitored patients required a dosage adjustment, of whom 23 (69.8%) required a dose decrease, 5 (15.1%) an increase and 5 (15.1%) to stop the treatment. Median digoxin concentrations were 1.23 µg/L (interquartile range: 0.75-2.03).
What next?
The process described applies to any centre able to monitor digoxin CPs both in inpatient and outpatient settings.
Software tool development for reconstitution and administration of parenteral antibiotics in hospitals: an international project
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Zora Ćetković, Dragana Rajinac, Ivana Baralić , Jelena Marković, Darija Kuruc Poje, Miroslav Kota, Špela Urh, Irina Tegelj, Vesna Bizjak, Dragana Mitrić, Tijana Kovačević, Andrej Pečet, Irena Radivojša, Sanja Filkova, Vesna Bašić-Milošević
Why was it done?
Medication errors regarding reconstitution and administration of parenteral antibiotics are frequent in hospitals. In our study conducted in 12 Southeastern European hospitals in 2021, we demonstrated the need of parenteral antibiotic reconstitution/dilution database in hospital pharmacy practice. Moreover, according to European Statements of Hospital Pharmacy (statement 5.5.), implementation of electronic decision support system by HPs should help to decrease the risk of medication errors. The purpose of software tools is to gather all relevant information regarding parenteral antibiotic reconstitution/dilution and make them easily accessible.
What was done?
A group of hospital pharmacists (HPs) from 6 Southeastern European countries created new software tools (a mobile-responsive website and mobile applications for Android and iOS) for providing information on reconstitution and administration of parenteral antibiotics in collaboration with software developer. These tools contain parenteral antibiotic reconstitution/dilution database in seven different languages (English, Serbian, Croatian, Slovenian, Bosnian, Macedonian and Montenegrin).
How was it done?
Technical requirements for website and mobile applications were designed by HPs. The development of these software tools was carried out by a software developer and funded by European Association of Hospital Pharmacists (EAHP). The final version of the software went through a rigorous evaluation, conducted by HPs during development and all technical problems were resolved consequently.
What has been achieved?
· Designing and developing these software tools helps HPs to provide evidence-based information about parenteral antibiotic reconstitution/dilution at the point of care, thus improving decision-making process and patient safety. · Reconstitution of parenteral antibiotics in wards is efficient and smooth. · Oral and written instructions for parenteral antibiotic reconstitution/dilution are replaced by electronic decision support tools, designed to prevent medication errors. · HP’s interventions are required to support the use of these software tools.
What next?
Our next challenge is wider use of these software tools in order to ensure the appropriate reconstitution/dilution of parenteral antibiotics in wards by nurses and physicians. These software tools are applicable in hospital setting and can be used by all regional hospitals. Additionally, they can be easily incorporated in hospital information system. We also plan to update periodically antibiotic reconstitution/dilution database, as new information becomes available.
Digitization: a key to improve health condition of patients with cancer disease
European Statement
Clinical Pharmacy Services
Why was it done?
the app was developed in order to improve therapeutic adherence, pharmacological counseling, management of adverse events and increase pharmacovigilance’s reports with higher data quality. The World Health Organization recognizes that 20% of health is due to medical care, 20-30% to lifestyle, while the remainder depends on the environmental, social, genetic and psychological conditions of the individual. The goal of this app is to improve patient’s therapeutic path at different levels and breaking down geographical barriers.
What was done?
the Sars-cov-2 pandemic entailed a lot of new challenges for the Hospital pharmacist . As the scenario was completely new, it was developed an app to better manage patients with cancer disease treated with oral chemotherapy.
How was it done?
Patient has been divided into two groups, of which only one group use the app to manage the therapy. The primary endpoint was the improvement of therapeutic adherence, while the secondary endpoints are: improve in the quality of patient life (HRQoL), increase pharmacovigilance’s reports and avoid therapeutic errors.
What has been achieved?
The continuous dialogue between patients and hospital pharmacist througt system’s online messaging app improved the management of patients needed and reduce drug interactions. Digital management led to a 56% increase of pharmacovigilance reports. It was also detected a reduction in overall costs and patient uneasiness.
What next?
the health system has to be reorganized around patient’s needed, by promoting the use of more and more homogeneous, safe, transparent and accessible technologies.
Regulatory authorities should accelerate the adoption of digital solution. In this new framework hospital pharmacist will play a key role in the development of value based medicine and in the process of treatment humanization as a patient’s landmark person too.
Improving medication barcode identification on the smallest unit of use: Start-up first ePIL (electronic leaflet) project for medicines used in hospitals in Spain
European Statement
Patient Safety and Quality Assurance
Author(s)
E Sulleiro, C Garrido, A Santamartina, O Delgado, B Aguado, I Alvarez Novoa, M Amérigo , L Calatayud, M Cardenal, J Carretero , J Corredoira, MA De la Peña, MJ De la Torre, S Domingo-Carranza, M Ercep, E Emili, M Eugui, E Falco, M Garcia , S Hernandez, M Hidalgo, J Hierro, M Jamali, C Joglar, S Juan, N Longás, A Lopez de la Rica, JJ Martínez , M MIllán , P Paris, C Ramirez, M Serrano
Why was it done?
Medication errors are one of the most common causes of preventable adverse events in the healthcare system. A complete identification of a medicine, up to the moment of administration, is therefore a key element of a safe medicines dispensing procedure in hospitals.
Digitization is a trend affecting all levels of our society and medicines are no exception. Increased use of Datamatrix code in the outer packaging of medicines has facilitated many healthcare professionals to become familiar with this technology. It is now possible to easily retrieve online information about a medicine, which raises the possibility of obtaining updated information of medicines without necessarily using a paper leaflet. Moreover, paper leaflets in the hospital setting are very often disposed of without reaching their end user, the patient.
Additionally, hospitals have other needs closely related to digitalization, considering errors in the reconciliation of prescription versus dispensing and administration, that can be reduced due to automated capture of the code linked to a particular medicine in the smallest unit of use, and also when dealing with compounding traceability preparations for patients.
What was done?
Spanish Agency of Medicines and Medical Devices (AEMPS), Spanish Society of Hospital Pharmacy in coordination with Hospital Committee of the General Council of Official Pharmacist Associations , and a series of pharmaceutical companies, mostly integrated in National Trade Association of the Spanish based pharmaceutical industry (Farmaindustria), have launched a project consisting of removing paper leaflet from the packaging components of a series of medicines exclusively administered in hospitals. These medicines will have a Datamatrix code in the primary packaging. When scanned, Datamatrix will allow to capture official PIL text from the information hosted in the Medicine Online Information Center of AEMPS (CIMA), which can be used for patient safety purposes at hospital pharmacy.
How was it done?
The Project began in November 2020 creating an ad-hoc working group on “Technical Regulation of Pharmaceutical Medicines” from Farmaindustria with AEMPS and representatives of Hospital Pharmacists. After 10 TCs and after having the participation of different partners, the main lines were agreed
Stakeholders agreed a proposal for pilot description and AEMPS informed the European Commissionin due course.
What has been achieved?
1. From January, 1 2022, a list of medicines meeting the established requirements will be able to be marketed without paper leaflet
2. Non-serialized Datamatrix will be included in the primary packaging, shall be compliant with GS1 standardization and may be pre-printed. It will contain specific NTIN/GTIN that will enable access through a correspondence table to Marketing Authorization Number (pharmaceutical form and dose) of the medicine hosted in AEMPS Nomenclator for Prescription (a medicine database intended to provide core prescription information to the care information services). In case technically feasible, companies may include also batch variable information such as Batch Number and Expiry date in the Datamatrix on a voluntary basis.
What next?
Assessing the impact of this practice in terms of efficiency, flexibility and safety is a key priority and this pilot project will gather enough data and information to help EC and Member States to revise relevant provisions in the legislation by 2022.
EU citizens will be able to benefit from the development of new technologies, as an underlying driver for delivering timely and easily accessible an up-to-date medicinal product information,