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Acceptance of pharmaceutical interventions in a resuscitation unit

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European Statement

Clinical Pharmacy Services

Author(s)

Xabier Larrea Urtaran, Elisabet Nogué Pujadas, Alba Couso Cruz, Guillem Pla Escriva, Carol Batlle Perales, Carla Subirana Batlle, MIreia Bruguera Teixidor, Carmen Ortí Juan, Anna Dordà Benito, Mireia Vila Curris

Why was it done?

The aim of the study is to analyze pharmaceutical interventions (PI) carried out by a hospital pharmacist in a Resuscitation Unit (RU) in terms of number and degree of acceptance.

What was done?

The integration of a pharmacist in the critical care unit allows optimizing pharmacotherapy, prevent s medication errors in critical patients and working in a multidisciplinary methodology .

How was it done?

It is a prospective study carried out from 1 August 23 to 15 September 23 on weekdays, in which patients with a minimum of 48 hours of admission were included, recording the PIs conducted during the daily clinical activity of a pharmacist at the RU. The variables collected were: age, sex, type of PI, medication involved, acceptance of PI and day since admission. The percentage of acceptance of the PIs and activity indices (PI/patient, PI/days and day of PI in respect to admission to the RU were calculated. For the descriptive analysis, the means and standard deviation (SD) were used.

What has been achieved?

80 patients were included during a total of 31 weekdays, mean age ± SD of 59.6 ± 18.4, 46.3% were women (n=37). Patients had 8.9 ± 3.0 drug prescriptions and 3.8 ± 2.0 infusions and on-demand drugs. There were 5.9 patients admitted per day in the RU .107 IPs were carried out, with activity indices of 1.3 IP/patient, 3.45 IP/day and 3.21 IP days compared to admission to the RU.
The groups of drugs with the highest IP were: anti-infective agents for systemic use (n=57), blood and hematopoietic organs (n=17) and nervous system (n=15).
The interventions carried out were: adjustment of anti-infective therapy (n=21); pharmacokinetic adjustment (n=18); administration (n=17); conciliation (n=16); dose adjustment by glomerular filtration rate (n=16); dose adjustment (n=10); duplicity (n=5); no need (n=2); compounding (n=1) and allergy (n=1).
The degree of acceptance of the IP was 92.5% (n=99).

What next?

The acceptance of PIs in the RU is very high , being greater than 90%, with an activity of more than 3 PIs per day, reinforces the integration of a hospital pharmacist in a multidisciplinary team to ensure patient safety and improve the pharmacotherapeutic profile. It is necessary to have a pharmacists integrate in the RU.

Sustainable adherence in the sector transition for schizophrenia patients

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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.

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.

Setting in situation of pharmaceutical validation of paediatric intensive care prescriptions by fifth year students: state of play and assessment

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European Statement

Education and Research

Author(s)

Omar HANAFIA, Pierre BERTAULT-PERES, Stéphane HONORE

Why was it done?

This internship was proposed to diversify the clinical pharmacy internship opportunities and to allow students to discover and understand paediatrics and intensive care, which are less covered in university courses. It will also be a proof of concept to develop this type of internship in other departments.

What was done?

We have proposed a new clinical pharmacy internship in immersion in paediatric intensive care to 5th year students. It is a hospital internship at the interface between the medical and pharmaceutical teams, the student is responsible for establishing a statement to analyse the drug management, its evaluation and improvement.

How was it done?

The clinical pharmacy student is a full-time employee, fully integrated into the medical team. Their day is divided into two parts: in the morning they attend the relief, the staff and the medical visit. In the afternoon, he/she takes over the patients, compiles the main medical, clinical and biological information in order to pharmaceutically prevalidate the medical prescriptions and propose pharmaceutical interventions (PI) to the pharmacist.

What has been achieved?

Since its opening, the position has been systematically chosen by the students, in 3 years 8 students have chosen it. After a training period of 1 month with the senior pharmacist, all students were able to perform the expected readings, prevalidation and PI. More than 78% of the PIs detected by the students were validated by the senior pharmacist and accepted by the physician.

What next?

This proof of concept shows that students are supportive of this type of initiative and are able to meet the high expectations of this internship.

Establishing a medicine donation circuit for non-governmental organisations at a pharmaceutical service in the Basque country (Spain)

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European Statement

Selection, Procurement and Distribution

Author(s)

Ariadna Martin Torrente , Itziar Palacios Zabalza, María Olatz Ibarra Barrueta, Maialen Palacios Filardo, Garazi Miron Elorriaga

Why was it done?

To optimise the functioning and the management of the procedures and an accessible and effective communication system in the PS. Moreover, the quality of the shipment is guaranteed all the time. The development of a circuit has allowed being faster and more efficient during its preparation than before.

What was done?

Establishing the circuit of execution, preparation, distribution, and delivery of medicine to Non-Governmental Organisations (NGO) from the Pharmaceutical Service (PS) of a tertiary hospital in the Basque Country (Spain). The circuit has been designed taking into account the criteria in a context of humanitarian donations, published and updated by the Spanish Agency of Drugs and Sanitary Products (AEMPS) on 16 March 2022

How was it done?

Since it has been included in the daily activity of the service it has cause and increase its amount of work, hence, daily routine tasks have been slowed down, given the increase of petitions the hospital has had during last year. However, its creation has allowed being faster and more efficient during its preparation.
The circuit begins with the request of NGO, which has to be authorised by the hospital’s directory. Then, in the procedure participate pharmacists; pharmacy technicians and office clerks who prepare the donation rely on the personalised list that the donation has created. Once, the necessary documents are filled out and they are sent to the AEMPS.

What has been achieved?

From November 2021 to September 2022, 7 donations have been carried out; these contained 100 active ingredients, concretely 15.198 units. We could find most of them in the WHO model lists of essential medicines. The NGO’s destinations have been Guatemala, Romania, Ukraine and Senegal. The medications sent most according to the ATC classification were 21% anti-infective medicines, 17% cardiovascular, 13% nervous system, 12% systemic hormonal preparations and 3% alimentary tract and metabolism.

What next?

The project is easily enforceable in any Spanish PS that is willing to process a donation at any given occasion. Some of our ideas for the future are the creation of a standard list including common medications, avoiding personalised lists, in addition to connect it to our internal programme to be faster when preparing the donation.

Homemade personalized 3D printed guides for mandibular reconstruction – A pharmacist feedback

European Statement

Production and Compounding

Author(s)

Quentin Misandeau, Romain Bosc, Muriel Paul, Valérie Archer, Lionel Tortolano

Why was it done?

The plastic surgery department bought two 3D printers in order to design and create custom-made medical devices. The main objective was to decrease the delay between mandibular cancer diagnosis and the surgery. The delays of production in the medical device manufacturers may exceed 2 weeks. Those delays are considered as a lost of chance for the patients.

What was done?

We helped our surgeons to secured the production procedure and reduce the risks for patients. We create a management quality system for supply, production, sterilization and using of our homemade personalized 3D printed guides.

How was it done?

First, we created a task force of pharmacist and surgeons.
The main work was a risk analysis with the FMECA method for all the steps in the procedure (software, tools, actors and materials).

What has been achieved?

Some correctives actions were taken. The riskier points were the plastic materials toxicity risk, the sterilization procedure that has been validated and the production traceability. A biocompatibility evaluation was performed. A clinical evaluation has been initiated in the same period.

What next?

Since the new medical device regulatory (2017 /745 CE) was published in 2017, the article five, that regulate the 3D printing in hospital, changes the possibilities. In fact, as personalized 3D printed guides are available on the EU market, homemade personalized 3D printed guides for mandibular reconstruction could be not authorized anymore. The only way would be for the hospital to obtain the regulatory statut of manufacturer and comply with the essential requirements.

Initial observations on the implementation of a clinical pharmacy service in a rural hospital in Austria

European Statement

Clinical Pharmacy Services

Author(s)

Sonja Guntschnig, Aaron Courtenay, Ahmed Abuelhana, Michael Scott

Why was it done?

The service was established as part of the implementation of a new pharmacy into the hospital. The aim of this good practice initiative was to introduce multidisciplinary work on the wards and provide clinical pharmacy support for the ward personnel. Furthermore, it determined what types of clinical pharmacy interventions are needed at a rural 360-bed hospital in Austria, and assessed the physicians’ acceptance rate of the pharmacists’ suggestions.

What was done?

A new clinical pharmacy service (CPS) was introduced into Tauernklinikum Zell am See.

How was it done?

Data on 550 interventions made by one clinical pharmacist were collected by convenience sampling over a one-year period and rated on a six-point clinical significance scale. A subset of 26 interventions was rated for clinical significance by four independent physicians to determine inter-rater reliability (IRR). A two-way model inter-rater reliability analysis was performed for the four different physician assessments using SPSS to determine intra-class correlation (ICC).

What has been achieved?

Prompt acceptance rate by the physicians involved was 71.3% (392/550). In 26.9% (148/550) of all cases, the physician considered a change. The overall average score for all 550 clinical pharmaceutical interventions taken was 2.2. ICC significance scores were correlated with the pharmacist’s scores, ICC for consistency was 0.732 and 0.732 for absolute agreement, thus both can be considered as “good”. Potential for cost reduction associated with the recommended pharmaceutical changes, namely with medication being stopped or dose reduction was 32.7% (180/550) and 25.1% (138/550), respectively.

What next?

There is great potential and a definite need for the expansion of CPS in Austria. Only 15.8% of Austrian hospitals have a pharmacy department with even less offering CPS. Many countries have demonstrated the benefits of CPS in hospitals over the past 30 and more years. The need for increased pharmacist staffing in Austrian hospitals needs to be demonstrated to Austrian stakeholders.

Patient education after Arthroplasty: what about the implants?

European Statement

Education and Research

Author(s)

Lionel Tortolano, Quentin Misandeau, Muriel Paul, Valérie Archer

Why was it done?

The main objective was to make give more information to the patients and draw their attention on the implant and the signs of adverse events.

What was done?

In 2018, in order to respond to both the sanitary traceability regulatory and the iatrogenic prevention, we initiated a new education session for patients after their hip or knew surgery.

How was it done?

First, the educational tools were developed in collaboration with surgeons, nurses and physiotherapist.
Each patient is seen after his surgery for the educational interview. At the beginning, the pharmacist asks him questions grouped in 4 themes: the implant, adverse events, prohibited movements and medicines.
According to patient answers, the pharmacist gives him complementary information and documents: an implant card and a booklet, which summarized all essential keys about adverse events and the return home.
We measured the efficiency of our education sessions on the knowledge of 80 patients. After the education session, before the return home, the patient was asked a second time to respond to all questions previously asked. The difference of good answers was considered as an increase of awareness.

What has been achieved?

The results show significant impact of this education session on all items especially those regarding the implants and medicines.

What next?

Since this feasibility study, we perpetuate those education sessions. We initiate a randomized prospective study to measure the impact 6 month after surgery on patient knowledge and potential impact on adverse event incidence rate. The result of this second study are expected to spring 2022.

DEVELOPMENT OF NEW PRODUCTION WHEN NEITHER PACKAGING NOR SOME OF THE RAW MATERIALS CONFORM TO EUROPEAN STANDARDS

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European Statement

Production and Compounding

Author(s)

Katrine Bødker Rubach-Larsen, Anne Rungø, Anette Eskildsen, Lone Skovhauge

Why was it done?

A research team at the MR Centre (MRC2) wished to set up the production of Pharmacy Kits, but had no prior experience of, or licence to, manufacture drugs. Thus, the hospital pharmacy was asked to participate in the development of such production.

What was done?

A new MR-scanning technology, hyperpolarisation, for the quantification of metabolic processes with an extremely high sensitivity enables physicians early detection of treatment effects in, for example, cancer and diabetes. A so-called Pharmacy Kit is used in the hyperpolarisation process and consists of a specially designed packaging with tubes, vessels and filters containing the contrast agent and buffer solutions. The objective for the hospital pharmacy1 was to manufacture Pharmacy Kits complying with Good Manufacturing Practice (GMP), though neither packaging nor two of the raw materials conformed to European standards.

How was it done?

The MRC research team presented the hospital pharmacy with the desired combination of compounds and the packaging required for Pharmacy Kit production. The task for the hospital pharmacy was then to set up a manufacturing process that met these requirements and complied with the guidelines for GMP. A production complying with GMP was developed in close collaboration with the MRC and an ongoing contact with the Danish Medicines Agency. During the process the hospital pharmacy carried out its own microbiology test in order to determine if, and for how long, the non-CE-marked packaging could store the contrast agent and buffer solutions. Risk assessment of the raw materials not found in the European Pharmacopeia were conducted. The method investigated by the MRC already takes place at a few other places in and outside of Europe. Experiences from these production sites were implemented and expanded with process optimisation, and specially designed equipment for the production.

What has been achieved?

Due to a strong inter-professional collaboration between the MRC and the hospital pharmacy and due to qualified risk assessments, it was possible to set up a production of Pharmacy Kits according to GMP.

What next?

When researchers contact hospital pharmacies with new ideas, we have to be willing to work with GMP in a different way by applying knowhow and risk assessments in order to ensure developments within the healthcare system.
1. Hospital Pharmacy Central Region, Production, Aarhus, Denmark.
2. MR Centre, Aarhus University Hospital, 8200 Aarhus N, Denmark

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