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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One-third of individual PN solutions being prepared at the hospital’s pharmacy has been replaced by the standardised PN solution.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.

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Author(s)

Mette Lethan, Tove Hansen, Louise Rasmussen Duckert, Trine Schnor

Why was it done?

In the clinic, a need for a NEP, as either a change in an existing product or a new formulation, may arise. Requests are risk assessed by the Hospital Pharmacy Drug Information Centre (DIC) before production is initiated. However, there was no clear process for handling requests, resulting in prolonged process times. NEP may require searching for new raw materials, new packaging or developing of a new formulation, which are time consuming tasks. Therefore, the wish to optimise the process arose.

What was done?

A procedure for handling requests for new extemporaneous products (NEP) in a Good Manufacturing Practice (GMP) regulated production was developed to improve success rate and aligning the process.

How was it done?

A small unit was formed with the purpose of handling requests for NEP. The unit consists of academics employed in the production department with expert knowledge about both sterile and non-sterile production.
A standard operating procedure was formed, in collaboration with DIC, which included a form, to be filled out with information needed for handling the request. This includes drug formulation, strength and dosage, along with any specific requirements.
The unit evaluates the request – is it possible for us to manufacture, sterile or non-sterile, are raw materials available in appropriate quality, analysis requirements, and stability of the product. The evaluation is made in communication with departments like Purchasing, Quality Control/Assurance, Stability as well as the relevant production department.
If a positive outcome, the request is given to the production department, to finalise production. If the outcome is negative a rejection is sent to the requester with a reason.

What has been achieved?

Based on data from the last three years, we now know how many requests we receive, which type of products are requested, processing times, and which products were made and why/why not.
There is a clear path of communication into the pharmacy and between relevant departments, ensuring that essential pharmaceuticals will be developed in a timely manner or a justified rejection is sent enabling the clinic to look for alternatives.

What next?

Some products are difficult to handle, such as cytostatics, antibodies and hormones. Next step is to investigate these product types.

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Author(s)

Betânia Abreu Faria, Sara Barroso, Antonieta Silva, Olga Martins

Why was it done?

Portuguese legislation “The Basic Health Law (No. 95/2019) and the National Plan for Patient Safety 2021-2026 (NPPS 2021-2026) and the goals of the World Health Organization (WHO) are fundamental pillars of healthcare safety. The NPPS has promoted patient safety in the Portuguese National Health Service, focusing on specific issues such as safety culture, unambiguous identification of patients, safe surgery, pressure ulcer prevention, prevention of falls, infections associated with healthcare and incident reporting and drug safety. Thus, it is essential to ensure the training of health professionals (HP) in the field of patient safety and the safe and rational use of medicines. The objectives of the training actions focused on the safe use of medication, promoting patient safety and sharing experiences between the various HP, in order to optimise the circuits and procedures already implemented.

What was done?

Multidisciplinary training actions were carried out within the scope of safe medicine practices.

How was it done?

A team of four pharmacists and one nurse carried out training actions in the context of Safe Medicines Practices. The following topics were addressed: medicine circuit; good practices in drug preparation; identification of medicines: Look-Alike Sound-Alike (LASA) and High-Alert Drugs; physicochemical incompatibilities; factors that modify stability after reconstitution/dilution; fractionation and crushing of Solid Oral Pharmaceutical Forms (SOPF); drug information sources; reporting adverse drug reactions and other incidents; good practices in medication administration. 

What has been achieved?

Training actions were carried out with a total of 29 hours of training and 357 participants. Suggestions for improvement were presented: optimisation of drug signage, compliance with established circuits, logistical aspects, on time drug information, improvement of communication channels, increase in the frequency of training actions. The trainees expressed receptiveness and interest in this initiative, which provided content that was little discussed and very relevant to their daily practice. 

What next?

The correct preparation and administration of medicines is essential to safeguard their effectiveness and patient safety, which is the ultimate goal of every health professional’s daily activity. The Pharmacist, as part of the multidisciplinary team, must promote strategies that safeguard Safe Practices throughout the drug circuit. Hence it is important to ensure the continuity of these trainings.

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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.

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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.

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Author(s)

Carlos Santos Rodríguez, Silvia Irene Corrales Vargas, Maria de los Ángeles Peña Peloche, Alfredo Julian Jover Sáenz, Miguel Ángel Ramos Gil, Arturo Morales Portillo, Marta Mir Cros, Francisco Ignacio Torres Bondia, Lluis Marqués Amat, Joan Antoni Schoenenberger Arnaiz

Why was it done?

Beta-lactam antibiotics are the most commonly used group of antimicrobial drugs but are also the ones with the most significant induction of allergic reactions. However, it is known that many of these patients do not present reactions upon rechallenge or have false allergy warnings in the medical records.

What was done?

To assess the impact of a pharmacist-driven programme for active beta-lactam allergy warning removal in adults in collaboration with the Allergology service.

How was it done?

We identified adults with active beta-lactam allergy warnings among outpatients aged 35 to 45 years over 26 months.
Both in the hospital and primary care setting the pharmacist assessed the current information of the cases in the electronic medical records (EMR) and through personal interviews or by telephone. The following data were retrieved: year of allergy registration, type of reaction described, tolerance of beta-lactam antibiotics, and the existence of Allergology reports.
The pharmacist, previously trained by the Allergology service, could proceed to remove or confirm the allergy label, if applicable, or refer the patient to the Allergology service for allergy tests.

What has been achieved?

We reviewed a total of 1178 cases with active beta-lactam allergy warnings. The most frequently implicated beta-lactam drug was amoxicillin, with 170/1178 (14.4%) cases.
111/1178 (9.4%) of cases had an allergic reaction in childhood, and in 714/1178 cases (60.6%) EMR did not describe the symptomatology or treatment that justifies the allergy.
The allergy warning was directly removed in 93/1178 (7.9%) of patients, as they had previous reports of Allergology, had tolerated antibiotics after the allergic reaction, or did not present symptoms compatible with an allergic reaction.
The review confirmed allergic warnings in 43/1178 (3.65%) cases, according to the symptomatology and the information recorded in the Allergology reports.
One thousand and forty-two cases were referred for beta-lactam allergy test performance in the allergology service, of which 47% yielded a negative result.

What next?

The pharmacist is qualified to remove the warning in cases with a doubtful allergy to beta-lactam antibiotics after a thorough medical record review and informed consent. Moreover, the pharmacist can provide valuable information that allows the classification of warnings according to the detected risk and facilitates subsequent decision-making by the allergist.

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Author(s)

Linda Jeffery, Maria Grønkjær Abrahamsen, Anja Alrø Bøtkjær, Lotte Aggergaard, Ann Brit Andersen

Why was it done?

Our country has a national SMR for every citizen. The SMR shows the current medication that the citizen has been prescribed, from all sectors. All sectors can see the SMR, which is considered/ought to be the ‘truth’ about the patient’s medication. On discharge from the hospital the SMR is updated by the doctor. Afterwards, pharmacy technicians dispense medicines for discharge. The technicians, at this stage, often find discrepancies in the SMR compared to the medication prescribed and given during admission. The SMR is electronically updated but not adequately reconciled. False information in the SMR may ultimately lead to adverse drug safety events in the primary sector.

What was done?

The regional hospital pharmacy patient safety network studied how many patients do not have a reconciled electronic Shared Medication Record (SMR) at discharge, despite the doctor having electronically updated it.

How was it done?

The technician recorded the discrepancies found before contacting the doctor to get the SMR corrected.
Each discrepancy was reported into the national patient safety database.
The technicians do not dispense medicines to all discharged patients, so our results were extrapolated to all discharged patients in the time period (there was no reason to expect bias).
The study was carried out in the whole region (5 hospitals) during the same week in September 2022.

What has been achieved?

Preliminary data shows that 994 patients were discharged from the wards studied.
Technicians dispensed medicines to 278 patients. They found one or more discrepancies in 65 SMRs (23,4%).
Extrapolation of these results revealed that, in the period, there were potentially 232 patients with drug-related problems from these wards (and approx. 17,000/year in the region).

What next?

Our results showed that the SMR is not adequately reconciled in 23% of discharges, despite the doctor feeling that the task is completed. This gives drug related problems in the primary sector, often resulting in calls to the ward etc. that are time consuming and difficult to solve after discharge. Updating the SMR at discharge is essential for patient safety under transition of care. Our results will be brought to the hospital administrations, patient safety organisations and the regional medicines board for further discussion about the problem and possible solutions.

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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.

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Author(s)

Alexandre Benaiche, Mickael Tachon, Nathalie Arnouts, Amandine Gradelle, Kadidja Gribi, Remi Parsy

Why was it done?

The ‘Agrippal’ programme was created to strengthen the anti-influenza herd immunity in our hospital and reduce the risk of nosocomial influenza. It was then necessary to improve both the vaccination rate of the staff and the inhabitants of the institution’s living area who were potential users. The vaccines were previously distributed in departments and injections made by the nursing staff without any traceability. The purpose was also to improve knowledge about anti-influenza vaccination among staff and users.

What was done?

Our Healthcare-Associated Infectious Risk Prevention Unit (made up of hygienist pharmacists and nurses) launched a programme to fight against nosocomial influenza in our institution in winter 2018 to promote vaccination among staff and users and inform them about vaccination inside and outside the hospital.

How was it done?

Information conferences were held inside and outside the walls of the hospital for staff and residents of the city thanks to a partnership with the municipality to finance these events and communicate about their occurrence. Information materials (flyers) have also been made available to departments and some key departments (Emergency, Consultations, Obstetrics) were encouraged to inform patients at risk and their families about the positive impact of vaccination with provision of Health Insurance reimbursement forms. Our Healthcare-Associated Infectious Risk Prevention Unit created a Mobile Vaccination Team to vaccinate staff directly in the departments and encourage those who have not been vaccinated to do so.

What has been achieved?

The staff flu vaccination rate increased sharply, from 19% and 17% respectively in 2016 and 2017 to 34% in 2018 and 39% in 2019. Among vaccinated staff, 25% in 2018 and 17% in 2019 were primary vaccinated. Although the impact of actions aimed at users is difficult to measure, the number of nosocomial flu has been reduced in our hospital from 3.14 per 10,000 days of hospitalisation in 2017 to 0.58 and 0.61 respectively in 2018 and 2019.

What next?

This initiative has made it possible to double the rate of vaccinated staff in our institution and strengthen patient protection by reducing the risk of nosocomial flu. It only required a period of consultation between different actors without creating additional financial and human resources.

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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.