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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.

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.

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.

Change of local anaesthesia procedure to avoid suture breakage

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European Statement

Education and Research

Why was it done?

A wide range of women sustain a perineal tear after delivery with a need of perineal repair. If the suture material fails to last as expected, women might experience wound rupture, impaired healing, and inferior functional outcome.
A clinical observation of increased risk of early breakage of the suture material in women anaesthetized with Xylocaine spray for perineal tear repair, compared with women anaesthetized with Xylocaine gel led to this study. Thus, in an observation period of 9 months 79% of the women who had to go through early secondary wound repair due to suture failure, had received local anesthesia in the form of Xylocaine spray.
The Clinical Pharmacy was contacted by the Obstetric Department with the following inquiry; whether there is a pharmaceutical interaction between local anaesthetics and the suture material.

What was done?

An in-vitro experiment to compare the tensile strength of fast absorbable suture material when impregnated with various agents for local anaesthesia was performed.

How was it done?

An in-vitro experiment was performed in collaboration between midwives, pharmacists and the Danish Technological Institute. We impregnated 120 suture materials divided in four groups (Xylocaine Spray, Xylocaine gel, Isotonic Sodium Chloride and Ethanol 96%) for 72 hours at 37 degrees and then measured the tensile strength of the suture material.

What has been achieved?

In the experiment we saw that Ethanol and Xylocaine spray weakened the tensile strength of fast absorbable sutures. Use of Xylocaine spray containing ethanol for local anesthesia might lead to early breakdown of the suture material and wound rupture.
After the experiment the majority of obstetric departments in Denmark changed their procedure for local analgesia/anaesthesia during perineal repair from Xylocaine Spray to Xylocaine gel.

What next?

Observing and registering the suture breakage percentage in a period of 9 months after application of Xylocaine gel.
Publishing the results at a broader level.

Stratification of psoriasis patients according to pharmaceutical care needed using the capacity-motivation-opportunity pharmaceutical care model

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European Statement

Clinical Pharmacy Services

Author(s)

NOELIA VICENTE-OLIVEROS, CARMEN PALOMAR FERNANDEZ, TERESA GRAMAGE-CARO, PAULA BURGOS BORDEL, MARÍA DEL CARMEN CALATAYUD SÁNCHEZ, SANDRA CASADO ANGULO, ANA MARTÍN ÁLVARO, MARÍA BEGOÑA RIVERA MARCOS, SONALI KARNANI KHEMLANI, MANUEL VELEZ-DIAZ-PALLARES, ANA ALVAREZ-DIAZ

Why was it done?

Patients with moderate-severe psoriasis require systemic hospital-dispensed treatments. Hospital pharmacists look for actions to anticipate patients’ needs for achieving health outcomes and the system’s sustainability.

What was done?

We stratified psoriasis patients according to the pharmaceutical care needed and established their pharmaceutical care plan. We calculated the time needed in pharmaceutical care after stratification.

How was it done?

An observational, prospective, cross-sectional study was conducted in a university hospital. One hundred psoriasis patients who received medication in the outpatient hospital pharmacy were randomly chosen between March-May 2022.
Capacity-Motivation-Opportunity (CMO) pharmaceutical care model (SEFH, 2018) was used to stratify patients. This model consisted of 23 variables (demographic, clinical, pharmacological, socio-sanitary, cognitive and functional). Each variable scored between 1-4, depending on patient risk. Patients were classified on three levels which determined the subsequent pharmaceutical care to be provided to each patient:
1. global score≥31 points,
2. 18-30 points and
3 ≤17 points.
Information was collected through patients’ interviews and electronic health records review.
A group of nine pharmacists were set up to adapt the CMO pharmaceutical care model to our hospital.
Total time spent in pharmaceutical care was obtained through patient visits before and after stratification. The scheduled average time for each visit was 10 minutes. The number of visits pre-stratification was the sum of all the visits scheduled for the patients, and for post-stratification was the sum of all the visits with the new CMO model (level 1 (biannual), 2 (annual), 3 (as needed).

What has been achieved?

Most patients were stratified on level 3. A pharmaceutical care plan has been designed to meet the needs of each patient.
Stratification has improved the time pharmacists have to accomplish the needs of each patient (16.3 hours/year (98 visits)). Sixty-two percent of patients had as needed visits (level 3), 36% needed annual visits (level 2) and 2% biannual (level 1). However, during pre-stratification, most the patients (70%) had every nine months visits, 18 % every 12 months, 9% every six months and 3% every three months.

What next?

We will expand the stratification to the rest of the psoriasis patients and other outpatient pathologies.
We will coordinate strategies with Social and Psychological Services, Primary care and Community pharmacy to improve pharmaceutical care.

Towards e-documentation of clinical pharmacist interventions

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European Statement

Clinical Pharmacy Services

Author(s)

Andrea Bor, Nóra Gyimesi, Eszter Erika Nagy

Why was it done?

Intervention-oriented classification systems are helpful tools to document the CPIs in a structured manner. Our aim was to develop a clinical pharmacy platform in the e-documentation system at our institution. This CPI data enables healthcare providers to track medication history, and to systematically analyse the effectiveness and the pharmacoeconomic benefits.

What was done?

A pilot survey was conducted on the traumatology wards to analyse and describe our clinical pharmacist interventions (CPI) based on severity and clinical relevance.

How was it done?

Three clinical pharmacists collected data on the changes of drug therapy at two 31-bed traumatology wards during pre- and postoperative period. We adopted the CPI classification system to our daily practices. This is challenging since the narrow time frame between patient admission and discharge often limits the opportunity to provide clinical pharmacy services. Raw data was previously screened and classified into 5 categories, drug related problems (DRP), clinical pharmacist intervention (CPI), significance (S), outcome (O) and acceptance (A).

What has been achieved?

We have established a data collection process, which allows us to record CPIs in our daily clinical environment in an efficient manner.
The most significant DRPs were incorrect dosage regimen (n=47), untreated indication (n=28), contraindication (n=25), excessive dose (n=19), subtherapeutic dose (n=17), drug interaction (n=15), no indication (n=11), experiencing adverse drug reaction (n=8), failure of drug administration due to shortages (n=5).
CPIs were divided into four groups:
1. Pharmacokinetic cause (dose adjustment, changes of drug dosage regimen, drug discontinuation, drug switch, etc.)
2. Pharmacodynamic cause (adding new drug, drug switch, – discontinuation, etc.),
3. Providing drug information (patient education, new drug, changes of administration route, etc.) and
4. Miscellaneous.
Significance were categorised as major (e.g. oral anticoagulant – LMWH switch, postoperative opioid use), moderate (e.g. loop diuretics – ion supplementation), minor.
Outcomes were therapeutic success, prevention of potential harm (e.g. adverse drug reaction) or cost saving.
73% of the interventions were accepted, the rest were rejected for the first time, but nearly half of them were admitted after minor modifications.

What next?

This CPI platform should be shared in the national digital health system.

Design and dissemination of infographics to improve safety in drug handling

European Statement

Patient Safety and Quality Assurance

Author(s)

Paula Hernando Martínez, María Antonia Meroño Saura, Caridad Marti Gil, Lidia Martínez Valdevieso, Jaime Fernández-Bravo Rodrigo, Dolores Barreda Hernández

Why was it done?

There is a wide bibliography on how human errors related to drugs put the patient’s health at risk. Drug preparation and administration errors, dose calculation errors, lack of knowledge about drugs or interactions, to name but a few. There must be protocols to ensure that drugs are safe for patients, including procedures which professionals should fulfill in order to reduce those errors in processes and guarantee, in such cases, that they will not have adverse effects on patients.

What was done?

Development of infographics for assembling drugs which are susceptible to a higher rate of errors in their preparation and administration to hospitalized patients.

How was it done?

During September 2021, a working group was formed in the pharmacy department (PD). Through the nominal group technique, the design and content of drug infographics was proposed as a solution to the raised problem. Subsequently, a bibliographic research of susceptible drugs to human errors during administration or preparation and those which requiring special handling was reviewed through the list of high-alert medication from National Institute for the Safe Use of Medications website and NIOSH list of hazardous drugs. To this end, the PD databases were analysed, obtaining the drugs that required the greatest number of pharmacotherapeutic consultations made by nursing staff on drug administration and recommendations made during pharmaceutical validation.

What has been achieved?

An infographic model has been designed which includes the description of the drug (name of drug, excipients, dose, pharmaceutical form, dosage regimen, route of administration, concentration), the preparation and administration protocol (reconstitution, dilution, infusion rate, premedication), observations (maximum doses, conditioning, incompatibilities, alerts) and storage conditions (conservation and stability). Infographics on dantrolene, intravenous phenytoin solution, intravenous nimodipine solution and potassium chloride solutions are currently being distributed. These documents are available at the nursing controls and on the hospital’s internal website.

What next?

To increase the availability of drug’s infographics and to update those that have already been developed when necessary. In addition, from the PD, the preparation of administration kits for the solicited drugs is proposed so as to ensure that all the necessary materials for the preparation and administration are included along with the corresponding drug and infographic.

Creating a standardized cisplatin hydration protocol

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European Statement

Patient Safety and Quality Assurance

Author(s)

Vera Pires, Maria Teixeira, António Gouveia

Why was it done?

Cisplatin is a cytotoxic agent used in CT regimens in ST. (1) Nephrotoxicity is the main toxicity, and hydration is always indicated to prevent kidney damage. [1,2] In 2018, when we computerized the ST’s CT protocols, we verified the existence of variations in CH protocols. According to the bibliography, this lack of standardization could lead to sub-optimal treatment of patients, errors and unnecessary use of resources. [1,3] Thus, it was necessary to develop a standardized hydration protocol designed by pharmacists with the collaboration of oncologists.

What was done?

Standardize the cisplatin-based hydration (CH) protocols used in the solid tumors (ST) chemotherapy (CT) regimens in adults in our institution.

How was it done?

Audit of CH protocols used in ST in adults in our institution and literature review to build a standardized evidence-based protocol.

What has been achieved?

We gathered 31 CT regimens with cisplatin. Verified the existence of variations in the volume of hydration (VH) before and after cisplatin, in the volumes of drug dilution, perfusion time, in the use of oral hydration (OH) and in ionic supplementation. We found that all of them were indicated to perform cisplatin only “if urine output >100ml/min”, use of mannitol before cisplatin and furosemide in SOS. Through the consulted bibliography, 4 regimens were made and implemented in 2019, according to the dosage of cisplatin: HC1< 40mg/m2 (Hday) and HC21000ml, and mannitol is only administered if cisplatin ≥60 mg/m2 (RCM). All protocols have magnesium and potassium supplementation.

What next?

Thus, despite the lack of consensus in the bibliography, a standardized protocol was created based on the evidence and clinical practice of our Institution. It is our intention to assess the impact of this intervention, from the perspective of the patient and the Institution.

Evaluation of pharmaceutical interventions documented by a pharmacy technician: where do pharmacy technicians have the biggest impact to avoid drug-related problems?

European Statement

Clinical Pharmacy Services

Author(s)

Ruth Borchers, Linda Krampe, Andreas Fischer, Christian Thomas, Holger Knoth

Why was it done?

The aim of this study was to identify the clinical pharmacy services where the integrating of pharmacy technicians have the biggest impact to avoid drug-related problems.

What was done?

In the field of clinical pharmacy services there are activities that are suitable for pharmacy technicians under the supervision of a pharmacist. At the university hospital in Dresden one full-time pharmacist and one half-time pharmacy technician (4h/d) are looking after 80 beds in the department of urology. The main tasks of the pharmacy technician are medication reconciliation as well as clinical prioritisation by using guidelines to identify patients who are at high risk of drug-related problems.

How was it done?

Since 2019 the pharmacy technician is recording the interventions in a categorical excel sheet, there are two documentation weeks per quarter. The categories are drug name, short description of the drug related problem, intervention, classification (dose-related problems, consultation of general practitioner, consultation of patient, electronic prescription, other drug-related problems after discussion with the pharmacist, drug substitution).

What has been achieved?

During 22 documentation weeks from 01/2019 till 09/2020 the pharmacy technician documented 468 interventions. The main interventions are drug substitution on admission considering local guidelines (n=181; 39%), consultation of the general practitioner because of identified discrepancies on the medicine lists (n=138; 29%) and consultation of patients because of identified discrepancies (n=78; 17%). Dose-related interventions and other drug-related problems are detected by the pharmacy technician and discussed with doctors under the supervision of the pharmacist (n=49; 10%).

What next?

Especially in the field of medication reconciliation trained pharmacy technicians can be suitable to prevent drug-related problems. The consultation of general practitioners and patients because of identified discrepancies on the medication lists are time-intensive and probably would not happen in the same way without integration of the pharmacy technician. The drug substitution in consideration of local guidelines and the preparation of the electronic prescription lead to fewer queries from nurses or doctors.
Further research should focus on the quality of pharmaceutical interventions conducted by pharmacy technicians under the supervision of pharmacists.

What role can French hospital Geriatric units play in vaccination coverage of the elderly?

European Statement

Clinical Pharmacy Services

Why was it done?

Vaccination coverage of the French elderly is low. Geriatricians asked for pharmacist’s help in increasing their patients’ vaccination rates.

What was done?

Pharmacist staff investigated the vaccination status of patients admitted to our Short-stay and Long-stay Geriatric Units (SSGU and LSGU). Results of these investigations enabled systematic catch-up vaccinations for patients before discharge.

How was it done?

Pharmacy and medical students were trained to determine SSGU and LSGU patients’ vaccination status and report findings to unit geriatricians. Training and procedures for Admission and Discharge Medication Reconciliation (AMR and DMR) were updated to include the recording of patients’ immunisation status. Furthermore, at discharge patients were supplied with an updated vaccination booklet and apprised of the importance of full vaccination coverage. During 2021, 3 groups were compared to evaluate our practices: before AMR new procedure, after AMR new procedure and after multidisciplinary decisions for AMR and DMR.

What has been achieved?

In SSGU and LSGU, all patient admission leads to an AMR. 45 patients were included in the first group, 39 in the second group and 46 in the final group. Since the 1st of March, AMR help geriatricians regarding vaccination status. Between March and April, 46% (17) of AMR found the entirety of the patient immunisation status compared to 2% (1) in the first group (p<0,01), and 35% (14) of AMR found at least one immunisation status among French recommendation compared to 24% (11) in the first group (p=0,12). In June, multidisciplinary medical team improved AMR et DMR practices to increase patient’s vaccination rates. In July, 51% (23) of all unit patients discharged had an up-to-date vaccination status compared to 2% (1) in the first group (p<0,01). 22 patients required pneumococcal vaccination: 8 received a dose during their stay and 2 had a dose prescribed at discharge. 27 patients required a Tetanus immunisation: 8 were vaccinated during their stay and 1 had a dose prescribed at discharge. Moreover, 46% (21) of patients received a short education from a pharmacist student and an up-date vaccination booklet. To conclude, 42,8% (15 of 35) of SSGU patients with incomplete vaccination coverage benefitted from catch-up vaccinations in July.

What next?

Vaccination coverage of eldery in not only a local public health preoccupation and systematic catch-up vaccination is easy to implement.

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