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A state-of-the-art on medical devices in Italian clinical pharmacy practice: results from the Italian Society of Clinical Pharmacy and Therapeutics (SIFaCT) survey

European Statement

Clinical Pharmacy Services

Author(s)

Lorenzo Di Spazio, Daniele Mengato, Andrea Ossato, Vera Damuzzo, Marco Chiumente, Giulia Dusi, Sabrina Trippoli, Andrea Messori, Maria Cecilia Giron, Maria Chiara Silvani, Francesca Venturini

Why was it done?

Pharmacist’s activities on MDs are mainly linked to governance, management and vigilance but little to clinical pharmacy practice. In order to study and develop interventions aimed at optimizing the use and compliance of medical devices on patients, a national survey was conducted to identify the clinical pharmacy experiences already consolidated in this field.

What was done?

Clinical pharmacy activities that demand specialized expertise in medical devices (MD) constitute a relatively uncharted territory for hospital pharmacists. Our aim, through a nationwide survey, was to delineate the clinical responsibilities overseen and handled by hospital pharmacists that necessitate a specific focus on MDs.

How was it done?

A 54-question survey, available from 1 October 2022 to 31 December 2022, was created by a pool of experts from an Italian scientific society (Italian Society of Clinical Pharmacy and Therapeutics – SIFaCT) and shared through Google Forms. The questions, divided into six sections, were related to five clinical areas defined by the working group: surgery room (SR), wound care (WC), vascular access management (VAM), patient education on diabetes treatment technologies (DTT) and MD in oncology and artificial nutrition (ON).
The questionnaire allowed us to define the state-of-the-art of clinical pharmacy on MDs, highlighting the activities and training needs of the participants.

What has been achieved?

We received 142 responses. In particular, emerged that 42% of participants adopted standard kits in the SR and 76% of them declared the pharmacist involvement.
A specific team for WC was created for 35% of participants, with the involvement of the pharmacist in 90% of cases, in particular as consultant role in 22%.
37% of participants declared the presence of a team dedicated to VAM, with the involvement of the pharmacist in 40% of cases and patient counselling in 9%. Finally, in DTT and ON the pharmacist was involved in 8% and 10% of the responses, respectively.

What next?

This first national survey shows that the pharmacist is often involved in multidisciplinary groups in the five analyzed areas, but less involved in patient’s counselling probably due to the sub-optimal training in the field of MDs. Indeed, almost all the participants declared the need to improve their knowledge in this field and create a network among colleagues.

Empowering home hospitalisation with comprehensive pharmaceutical care: a model programme for medication management and patient monitoring

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European Statement

Clinical Pharmacy Services

Author(s)

Beatriz Somoza-Fernández, Vicente Escudero-Vilaplana, Cristina Ortega-Navarro, Ana de Lorenzo-Pinto, Ana Herranz-Alonso, María Sanjurjo-Sáez

Why was it done?

HH units have experienced an extraordinary period of growth over the past few years and are already considered the preferred option of care model for most patients. However, its full potential is actually limited by some challenges both demanding and ripe with opportunities for pharmacy engagement, such as patient clinical complexity (usually elderly and chronic patients at greater risk of poor adherence and suffering from medication errors) and lack of medical staff physically available for monitoring patients’ evolution.

What was done?

We developed and implemented a comprehensive pharmaceutical care programme in a home hospitalisation (HH) unit.

How was it done?

The project was conceived by a multidisciplinary team (physicians, pharmacists, and nurses) that conducted a literature review and developed a new home medication management standardised operating procedure. The team worked in the design of a HH pharmaceutical care guideline and the implementation of an e-health care tool for remote patient monitoring.

What has been achieved?

1. HH pharmaceutical care guideline: it included the directions for the following measures: (1) a comprehensive pharmaceutical assessment and medication reconciliation, (2) standardised recommendations for optimising acute and chronic treatments at home, (3) daily interviews with patients or caregivers to explain medication changes, and (4) follow-up calls 7 days after discharge in order to assess medication adherence.
2. HH monitoring app: this new tool ensures pharmacotherapeutic monitoring by setting medication schedules and intake notifications. The platform includes a patient recording for vital signs, side effects, medication intake, and health status (functional status and quality of life). The system enables online access for pharmacists and physicians in real-time and continuous two-way communication.

What next?

Since our programme is easily applicable to any HH unit, we are working on implementing it in other hospitals in our country, in order to overcome HH medication management complexity nationally. We aim to conduct a multicentre study to evaluate its external validity in terms of increasing medication errors detected and optimising hospital resources.

Enhance prescription review: artificial intelligence to improve efficiency and safety drug therapies

European Statement

Clinical Pharmacy Services

Author(s)

Ana Helena Ulbrich, Amanda Fonseca, Catherine Isoppo, Henrique Dias

Why was it done?

The motivation behind NoHarm stemmed from the time-consuming nature of the prescription review process, which required clinical pharmacists to assess not only drug interactions but also factors such as appropriateness, effectiveness, safety, adherence, and affordability of drug therapies. NoHarm was envisioned as a solution to systematize the workflow and provide cross-referencing of essential drug and inpatient information, thereby addressing these issues.

What was done?

The NoHarm initiative was developed to address challenges faced by clinical pharmacy teams during the prescription review process in a hospital setting. This open-source intelligent system was introduced to enhance the medication review process. The initiative was executed in a 420-bed public hospital in Brazil over a 17-month period to evaluate its impact on prescription reviews.

How was it done?

The implementation of NoHarm involved integrating the system with the hospital’s electronic health records to collect and compute all inpatient data. NoHarm utilized a drug knowledge base and intelligent algorithms to identify and alert healthcare professionals about inpatient risks. The algorithms were designed to cross-reference patient laboratory results with drug thresholds, adjust for liver and renal function, analyze drug usage patterns at the hospital, and extract patient risk factors from clinical notes, including diseases, adverse events, symptoms, and biometric data.

What has been achieved?

The number of medications assessed increased dramatically from 17,000 to 2,643,957 within the 17-month period, all while maintaining the same team size. Improved prescription review rates, rising from 65% to 94%, demonstrate the effectiveness of the system. Furthermore, these improvements in prescription reviews resulted in better clinical pharmacy services and contributed to reducing medication errors and associated risks in patient care at the hospital.

What next?

NoHarm is an open-source solution and an example of good practice in healthcare due to its achievements in streamlining prescription reviews and enhancing patient safety. Its successful implementation led to increased efficiency, higher prescription review rates, and substantial cost savings, showing its potential as a model for other healthcare settings. Its prospective global applicability makes it a solution to address medication errors and elevate the standard of care in healthcare institutions worldwide.

FarmaCenter: a platform for resolving pharmacotherapeutic queries after discharge from the emergency department

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European Statement

Clinical Pharmacy Services

Author(s)

BEATRIZ TORROBA-SANZ, CRISTINA ORTEGA-NAVARRO, ANA DE LORENZO-PINTO, CARMEN REDONDO-GALAN, JUAN ANTONIO ANDUEZA-LILLO, MARTA SANCHEZ-CELAYA POZO, ANA HERRANZ-ALONSO, MARÍA SANJURJO-SAEZ

Why was it done?

Almost half of the patients discharged from the ED receive incomplete information at discharge and they forget approximately 60% of the medical information received when they leave the hospital. All these hinders the proper management of medication at home, generating anxiety to patients and favoring the appearance of adverse events and new visits to the hospital.

What was done?

We have designed, implemented and evaluated a tool to resolve pharmacotherapeutic queries of patients discharged from the Emergency Department (ED).

How was it done?

Patients with doubts about the pharmacological treatment prescribed upon discharge can contact FarmaCenter through the instructions included in the discharge report (telephone/email). The pharmacist will then analyze each query, gathering information from the clinical history and, if necessary, contact the care-team for resolution. Finally, the pharmacist will contact the patient, resolve the query and offer the opportunity to complete a satisfaction survey.

What has been achieved?

766 consultations were received (November 2022- 31 August 2023), mean age was 49.8 years and 49.3% were men. The majority (96%) contacted by telephone and the mean time of resolution was 1.5 hours. Half of the cases (53.7%) were resolved by the hospital pharmacist without the necessity of contacting the rest of the healthcare team. The main reasons for consultation were: medication not prescribed (28.3%), drug administration (8.7%), management of adverse reactions (6.9%), shortages (6.8%), dosage (5.9%) and duration of treatment (5.7%). 15.5% of consultations were not related to medication. The satisfaction survey was sent to 288 patients and 40% responded. The overall rating was 4.9/5 and the most highly valued aspects were the individualized attention, fast resolution of the query and the pharmacist’s kindness. In addition, 95% of patients considered that FarmaCenter had helped them to avoid a visit to a healthcare center.

What next?

Developing improvement strategies to reduce the number of patients with medication-related concerns from the ED.

Using virtual reality to introduce newly hired nurses

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European Statement

Education and Research

Author(s)

Stine Hygum Sørensen, Henrik Nielsen, Ulla Kloster, Anne Grethe Nørgaard Kyndi, Maja Vad Mortensen, Dorthe Ludvigsen

Why was it done?

The concept of medicine at Gødstrup Hospital is based on Patient involvement in the medicine process. Consequently, the patients bring their own medicine, which is stored in the patient’s room, and additional medicine is supplied in original packages. Medicine dispensing is performed in the patient’s room to allow patient participation. The medicine rooms at the hospital are quite small, because the majority of the medicine is with the patient, but it also makes medicine rooms unsuited for on-site training of new nurses.

What was done?

Virtual Reality (VR) technology was applied for introduction of newly hired nurses to medicine rooms at the hospital.

Newly hired nurses are given a four hour introduction to the concept of medicine at Gødstrup Hospital, Denmark. The introduction is given by an interdisciplinary team of a clinical pharmacist, a pharmacologist and an experienced nurse. The introduction is given in collaboration with the Centre for Research and Education (NIDO) once a month. This ensures that newly hired nurses are given the same, relevant introduction when needed.

Introduction to medicine rooms is part of the training for nurses in introductory positons. Using VR newly hired nurses are given a different and exciting introduction to medicine rooms.

How was it done?

In collaboration with the simulation unit at NIDO we made a VR-video to enable up to 20 new nurses to see the same introduction at the same time. Hospital Pharmacy staff is featured in the VR recording and guides viewers to specific parts of the medicine room, explaining important topics such as waste disposal, hygiene and anatomical therapeutic chemical (ATC) groups.

What has been achieved?

The participants are positive and give the following feedback to the VR segment of the introduction: “It was significantly easier to deal with as a newbie”. “It was very visual as being there in reality”. “There was time to learn in a calm environment”, “It worked fine as a lesson” and “It is a good change from backboard teaching.”

What next?

The monthly introductions continues and further collaboration with NIDO will result in lessons with topics such as pharmaceutical formulations and drug calculations. Perhaps VR will be included in this too.

Can my medicine be returned to the refrigerator? Minimisation of wastage in case of storage incidents of cold-chain homecare medications

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European Statement

Clinical Pharmacy Services

Author(s)

Hilde Omestad, Maria Grønkjær Abrahamsen, Fatima Afif Mouaanaki, Charlotte Mosbæk Dybdahl, Anne Wulff Petersen, Emil Dalsgaard Züricho, Philip Hojrizi, Charlotte Arp Sørensen

Why was it done?

The sustainability strategy of the Central Denmark Region include less consumption and less waste. Our Pharmacy delivers an increasing amount of high-cost homecare medications, requiring refrigerator storage. In case of an accidental temperature exposure, patients may ask whether their medicine can be used or not. There may be a delay during transport or a breakdown of their refrigerator at home. During these medicines’ shelf-lives, most products can be kept at room temperature for days, weeks or months. When SmPC and the insert package leaflet says that the product should not be returned to the refrigerator, high-cost medicines sometimes are wasted, only because of this warning, instead of giving them a shorter shelf-life. When we hesitate to return packages to the refrigerator, time can elapse while waiting for the manufacturer’s or pharmacist’s answers to the patient’s questions after storage incidents.

What was done?

The Hospital Pharmacy categorized 47 Blood Coagulation Factors and Monoclonal Antibody Products requiring storage at 2-8 °C if Summary of Product Characteristics (SmPC) had any warning of returning a product to the refrigerator or not, after an unwanted time at room temperature

How was it done?

We asked manufacturers if a return of their product to the refrigerator would cause any harm. Should their product be disposed of because it has been put back into a refrigerator after being left out? Our findings were documented in a local guideline and in the Danish national information database (SAID).
Drug Information Pharmacists discussed several cases of real-world handling situations to be more confident to reduce medicine wastage.

What has been achieved?

Being aware of the reasons for these warnings, reduced medicine wastage in certain cases of incidental storage. The pharmacists have been given tools for pharmaceutical professional assessments in cases of temperature challenges.

What next?

Spread the good news. Improve communication between manufacturer and pharmacy, because manufacturer can’t be responsible for storage different from their SmPC. Inspire manufacturers to improve their storage warnings in SmPC

Too good to go – sharing medication near expiry with a digital solution

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European Statement

Clinical Pharmacy Services

Author(s)

Charlotte Sørensen, Karin Aagot Møller Jørgensen, Anne Grethe Nørgaard Kyndi, Charlotte Lund Madsen, Line Scriver Poulsen, Charlotte Hjorth, Gitte Slyngborg Morbjerg, Janni Østergaard Jensen, Mette Juul-Gregersen, Rune Dalsenni Rask

Why was it done?

A sustainability project in 2020 highlighted manual and time-consuming workflows when checking expiry dates in hospital medicine rooms. For example, manual reading, interpretation and notation of expiry dates in paper forms every half year. Therefore, a smartphone application was developed and implemented in a large university hospital in 2022. The application was a huge success and colleagues from other Clinical Pharmacy departments in other hospitals within the same region wanted to be part of the success of the initiative.

What was done?

A smartphone application for managing expiry dates in medicine rooms was applied in one hospital in 2022 and in four other hospitals in 2023. The data-matrix of medicine packages is scanned with a smartphone camera and the application gives a sorted overview of medication near expiry. In the application you can register a medicine package as either used, discarded or released. By releasing medicine packages, the medicine is made available to colleagues in other medicine rooms.

How was it done?

The smartphone application was implemented in Clinical Pharmacy departments in four other hospitals, one by one from February 2023. After implementation the application is used in 373 medicine rooms.

What has been achieved?

Clinical Pharmacy staff are happy with the application. It takes significantly less time to check and scan expiry dates with the digital solution.
From February to September 2023 (five hospitals)
• 47491 packages were scanned
• 5251 packages were released (11%)
• 2664 packages were moved between medicine rooms to avoid medicine wastage (51%; 147000 €). Most activity (78%) was seen at the hospital that had been using the application since 2022. Most packages were moved between medicine rooms at the same hospital; however, in 215 cases (8%), medicines were exchanged between hospitals as well (20.000 €)
• 10918 packages were discarded due to expiry (743168 €; 0.5% of bought medicine).

What next?

The full potential of the digital solution remains to be achieved.
Pharmaconomists have to release medicine in the application a few months earlier than they do now. To go shopping in the application before ordering from the pharmacy, will probably also result in discarding less medicine. Sharing medication across hospitals to a greater extent will also be relevant to consider.

Medication reconciliation practice at transitions of care: a new challenge or opportunity for the clinical pharmacist?

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European Statement

Clinical Pharmacy Services

Author(s)

Elisabetta Volpi, Giuseppa Lo Surdo, Sara Tonazzini, Stefania Alduini, Maurizio Mangione, Umberto Paradossi, Monica Baroni, Sergio Berti, Stefania Biagini

Why was it done?

Several data suggest that pharmacists and physician collaboration, direct pharmacist interaction with patients or caregivers through medication reconciliation and discharge counselling decreases the number of adverse drug events (ADEs) and plays an overall positive role in transitional care. Our aim is to demonstrate the constant necessity of pharmacist led medication reconciliation in order to maintain a high standard of care and safe medication use.

What was done?

Medication reconciliation at hospital discharge is essential for the prevention of medication discrepancies and patient harm. Hospital pharmacists are recognised as one of main healthcare providers that can support the physicians in this activity.
Since 2016, the medication reconciliation process has been performed by physicians and clinical pharmacists before home discharge from the Heart Hospital, Fondazione Toscana G.Monsaterio in Italy.

How was it done?

We analysed the medication reconciliation activity performed in our hospital over time and we observed that the number of unintentional discrepancies was always around 20%.
A shared pre-discharge prescription review programme has been activated with all doctors, so when the final lists of drug prescriptions are ready, the pharmacist examines them and suggests improvements or corrections to the doctor before the discharge letter is delivered to patients. Among the unintentional discrepancy observed, the most frequent were omissions of chronic therapy, lack of information about suspension for low molecular weight heparin or antibiotics.

What has been achieved?

A strong collaboration between physicians and clinical pharmacists has been achieved as we shared the results of this improvement. The same activity has been required and extended to the paediatric ward where the demand of simple, clear and complete information is even more crucial given the particular inter-individual variability and fragility of this population.

What next?

We would like to improve the prescription review programme also at admission in order to minimise drug omissions and at transition between different wards or different hospitals with the aim of improving communication between health care settings.

Clinical radiopharmacy: implementation of pharmaceutical interviews for patients treated by radioligand therapy

European Statement

Clinical Pharmacy Services

Author(s)

Nina RANJIT, Matthieu GALLET, Anthony TRIPLET, Myriam QUERMONNE , Alexandre COCHET

Why was it done?

The rise of RLT is seeing the emergence of new treatments, using radioisotopes such as 177Lu or 223Ra. The radioactive nature of these treatments raises questions from patients. The aim of pharmaceutical consultations (PCs) is to respond to them by providing appropriate information on treatment modalities, adverse effects (AEs) and radiation protection rules. Thus, we carry out a PC at the initiation of an RIV for all new patients from January 2022 for PLUVICTO.

What was done?

Radioligand therapy (RLT) consists of the administration of a radioactive drug. It makes it possible to treat cancer patients by specifically targeting tumour cells and destroying them using ionising radiation.
These particular treatments raise questions from patients. This is why we have implemented pharmaceutical interviews since 2022 and the beginning of RLT by PLUVICTO® during the first treatment, for all patients concerned. Subsequently, these consultations were extended to other therapies (lutathera, xofigo).

How was it done?

Before initiating RLT to a new patient, radiopharmacists check the eligibility of patients and the conformity of the indication. A few days before the first treatment, the patient’s file is consulted and important information is noted (urinary or fecal incontinence, digestive problems, biological assessment, co-medications). The day of the treatment, a personalized care plan is drawn up by the radiopharmacist and an information sheet bringing together information on the treatment (interval of treatments, dose, etc.), side effects and their management and the rules of radiation protection are provided. to the patient.

What has been achieved?

Collaboration with nuclear doctors has been set up to optimise patient care and information.
When necessary, pharmaceutical interventions are formulated directly to the clinician and plotted in a table.
Facing the success of these PCs we implement them for lutathera and xofigo, the two other RLT available.
In case of side effects, we also declare it to the pharmacovigilance service and give advice to patients and/or clinicians for manage them.
All documents are recorded in the computerised patient file.

What next?

The next step is to evaluate patient’s comprehension before the first interview to adapt its content to the patient.
We also would like to evaluate the patient’s satisfaction and expectations.
Discussions are underway to financially promote these tripartite consultations as exists for oral chemotherapy consultations.

Pharmacy residents in the intensive care unit: education and training

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European Statement

Clinical Pharmacy Services

Author(s)

Pilar Lalueza Broto, Laura Domenech Moral, Alba Pau Parra, Ángel Arévalo Bernabé, Danae Anguita Domingo, Anna Rey Pérez, Jacinto Baena Caparrós, Marcelino Baguena Martínez, María Queralt Gorgas Torner, Mónica Rodriguez Carballeira

Why was it done?

The four-year specialist training program for Hospital Pharmacy in Spain includes one year of clinical training, involving rotations through various medical units where residents develop their clinical skills. This forms an essential component of clinical proficiency and integration into the healthcare team.

The Intensive Care Unit (ICU) was chosen because the presence of a pharmacist during rounds as a full member of the care team has been associated with a reduced rate of adverse drug events.

What was done?

We developed a standardized medication audit tool to ensure uniform pharmaceutical care delivery, aligned with the Hospital Pharmacy Specialty training program.

How was it done?

We designed a pharmacotherapeutic monitoring chart containing biodemographic and clinical data, analytical parameters, and clinical issues for each patient. A multidisciplinary team, comprising staff physicians and pharmacy resident tutors, identified the most common clinical problems or key issues for different types of patients admitted to critical care units, as well as specific clinical problems related to particular pathologies. Pharmacotherapeutic recommendations were based on clinical evidence or internal protocols. Common key issues included nutritional support, fluid resuscitation, thromboembolic prophylaxis, hemodynamic monitoring, infection management, drug monitoring, and sedative and analgesic therapy. We defined specific efficacy and safety indicators for each clinical problem. Additionally, we monitored specific outstanding problems in particular patient types.

We also implemented a model for recording and coding pharmaceutical interventions.

What has been achieved?

The pharmacotherapeutic monitoring chart has enabled us to establish standards for pharmaceutical care in the ICU, promoting consistency among the entire care team and optimizing pharmacotherapy outcomes in patients. It also facilitates the assessment of residents’ skill acquisition during their training.

What next?

In the future, assessing the tool’s usefulness and its impact on residents’ training benefits will be of interest. Moreover, it may serve as a reference model for other clinical rotations.