Author(s)

Dorothea Strobach, Ute Chiriac, Sigrun Klausner, Claudia Langebrake, Christiane Querbach, Carolin Schuhmacher

Why was it done?

Although guidelines for DI demand regular quality assurance procedures, no method of evaluation is internationally agreed on. The tool should be feasible, reproducible and reflect real-life quality of DI. It should allow to identify areas for quality improvement in general and for every participant.

What was done?

We developed a tool for annual quality assessment of drug information (DI) provided by hospital pharmacies on behalf of the German Association of Hospital Pharmacists ADKA e.V.. The tool has been successfully implemented for four years.

How was it done?

We developed a new tool for quality assessment of DI using a fictitious test enquiry and simulated real-life conditions and proved it representative for real-life quality [1]. The answers for the test enquiry are evaluated by blinded experts for content and formal requirements. For four years, 2017-2020, annual assessment of DI was offered to German language hospital pharmacies with changing topics and enquiry levels. Participants receive their own result in comparison to average of all regarding content-related and formal requirements. A proposal for an answer is published afterwards for educational purposes.

What has been achieved?

The annual DI quality assessment tool was successfully implemented as shown by increasing numbers of participating hospital pharmacies (45/71/79/118). Areas for improvement have been identified in general and can be identified by each participant as well. As an example, presentation of references has improved over the years [2]. Since 2018, a certificate of participation is offered as document for quality assurance audits thereby underlining the importance of this hospital pharmacy service.

What next?

Annual quality assessment for DI by hospital pharmacies will be further offered. Results over years will be evaluated for overall effect of the annual test tool on quality improvement regarding content-related and formal requirements. This method for annual quality assessment of DI provided by hospital pharmacies could be implemented by other countries.

References
1. Strobach D et al. EJHP 2020 online ahead of print. doi: 10.1136/ejhpharm-2020-002409
2. Strobach D et al. Krankenhauspharmazie 2020;41:187-91

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Author(s)

Simone Leoni, Sabrina Guglielmi, Vincenzo Nicola Menditto, Adriana Pompilio, Francesca Vagnoni

Why was it done?

During the pandemic, almost all hospital departments were converted in COVID-19 wards and clinicians of several specializations were asked to work in. In a situation characterized by a great number of patients, mainly old and with several comorbidities, health professionals had to employ quickly drugs never used before and supported by limited scientific evidences. In this context the percentage of possible DDI rises out of proportion exposing patients to potential devastating consequences.

What was done?

During COVID-19 emergency we develop a quick reference tool for clinicians involved in first line assistance to patients. A table summarizing drug-drug interactions (DDI) of the most used therapies was created to allow professionals making the best pharmacological decision.

How was it done?

After a literature review using Micromedex and TERAP (Mario Negri Institute), we have created two table summarizing DDI of lopinavir/ritonavir (LR) and hydroxychloroquine (HC). Those drugs have been grouped according to pharmacological group and clinical relevance. The tables were provided to Infectious Disease, Intensive Care Unit and Emergency Medicine departments.

What has been achieved?

The tables showed 359 DDI for LR (67% contraindicated/severe, 12% major and 21% moderate) and 176 for HC (96% contraindicated/severe, 1% major and 3% moderate). Almost all contraindicated/severe interactions of HC were the same of LR and regarded: protein kinase inhibitors, beta2 agonists, macrolides and fluoroquinolones antibiotics, some antidepressants, phenothiazines, protease inhibitors and antiarrhythmics. Other LR severe interaction were: factor Xa inhibitors, statins and benzodiazepine derivates. Both LR and HC present moderate interactions with acid pump inhibitors, while LP interacts with Ca and vitamin K antagonists and antiepileptics.
Interactions mentioned have a great impact, since they concern drugs commonly used and hypertension, diabetes, respiratory system disease, cardiovascular disease are the most frequent comorbidities linked to COVID-19. Tables provided had a positive impact in avoiding DDI. Pharmacist was consulted for drug dosing and frequency adjustments. The intervention was fully accepted and extended to the rest of COVID-19 wards.

What next?

The project represents a good example of multidisciplinary collaboration able to improve safety and efficacy in pharmacological treatments. The added value of the Pharmacist and the simplicity of the tool make it useful and easy to extend to other healthcare settings.

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Author(s)

DESPOINA MAKRIDAKI, KALLIOPI ALLAGIANNI, NIKOLAOS SKORDAS

Why was it done?

In our hospital is located the main CF Unit for Adults in the country. Ensuring that as many as possible young patients benefit from accessing the new and crucial treatment, even during COVID-19 period, reflects our commitment to improve patients’ outcomes and overall survival,

What was done?

A Phase 3, open-label clinical trial (CT) with 3 enrolled patients runs since April 2019 and two early access (EA) programs with 23 enrolled patients run since the end of July 2020 to permit the access of cystic fibrosis (CF) patients with the F508del mutation in the innovative combination therapy of ivacaftor, tezacaftor and elexacaftor (IVA/TEZA/ELEXA) in our hospital.

How was it done?

3 outpatients enrolled in the CT and procedures regarding the protocol have been followed strictly. Medication dispensing is conducted every 12 weeks.
In the EA procedure, 2 parallel programs have been approved by authorities, one for the homozygous including 19 patients and one for the heterozygous including 4 patients. Dispensing is programmed every 4 weeks, although an initial stock for 3 months was shipped to pharmacy.
The role of HPs was decisive for the quick start of the EA programs during COVID-19 period. Roadmap was designed at the beginning by HPs in collaboration with the physicians to accelerate approval and shipment procedures and also regarding licensing for each patient, drug receipt, storage, dispensing, accountability, electronic registry in designated EA platform and additional electronic recording and follow up in the electronic Pharmacy platform for both the IVA/TEZA/ELEXA and supporting therapies (e.g. inhaled antibiotics, a-dornase)
For 17 EA patients with chronic obstructive pulmonary disease in exacerbation, hospitalization before starting the IVA/TEZA/ELEXA therapy was necessary. HPs monitored closely their cartexes to avoid adverse reactions and delays in therapy.
HPs served all outpatients on personal afternoon appointments, to avoid overcrowding in the hospital during the pandemic.

What has been achieved?

Critically ill patients have been able to receive in priority the IVA/TEZA/ELEXA treatment, without cost, and valuable scientific experience has been gained.

What next?

EA programs have received 3 months extension until reimbursement negotiations are completed by authorities. In the meantime, we design a cost affordable procedure to ensure continuity of access for our patients.

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Author(s)

MARGARITA BELTRAN GARCÍA, NATALIA MARTÍN FERNÁNDEZ, MERCEDES SALGUEIRO LAZO, SANTIAGO SANDOVAL FERNÁNDEZ DEL CASTILLO, MIGUEL ÁNGEL CALLEJA HERNÁNDEZ, ANTONIO LEÓN JUSTEL

Why was it done?

AKI is an underdiagnosed syndrome due to delay in detection and late referral to the nephrology unit. A real-time electronic alert system integrated into a multidisciplinary protocol could be useful for early identification and diagnosis.
Among the risk factors associated with AKI is the use of nephrotoxic drugs such as NSAIDs and COX-2, ACE inhibitors and ARA-II, Cyclosporine and Tacrolimus.

What was done?

A multidisciplinary protocol was established for the detection and early action of prerenal AKI inpatients with hospital and Primary Care monitoring.

How was it done?

An authomatic electronic tool, agreed between Biochemistry and Nefrology units, was designed for the selection of AKI patients. The pharmacist was contacted when a prerenal AKI was detected, who generated an alert in the electronic prescription system in order to recommend actions related to prescribed nephrotoxics drugs. An analysis was request to check renal function in these patients, after 48 hours in the hospital and after 1 month of discharge from the Primary Care.
There were many previous meetings and the leadership of each unit was maintained in the participation of strategies.

What has been achieved?

The aim was to improve the detection of prerenal AKI in inpatients and increase the quality of healthcare in these patients.
For this 3-month pilot phase, were selected 3 clinical unit and 9 prerenal AKI cases have been detected. The most frequent risk factors were: 9 cases due to volume deplection, 6 due to nephrotoxic drugs use and 3 due to chronic kidney damage (CKD). The measures adopted were: add fluid therapy in all cases, cancel nephrotoxic drugs and modify the diuretic drugs prescription in 6 of 7 cases. There was only 1 death.

What next?

This strategy will be extended to all hospital clinical units. Data will be obtained on incidence and morbidity and mortality in these patients, as well as on length of hospital stay.

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Author(s)

OLIVIA FERRÁNDEZ, CRISTINA RODRIGUEZ, NURIA CARBALLO, ZARA CORINNE, MARTA DE ANTONIO, MIQUEL OJEDA, RITA PUIG, JORDI DE DALMASES, JORDI CASAS, SANTIAGO GRAU

Why was it done?

It was established as a primary strategy against COVID-19 and to demonstrate the benefits of shared care of the patient, by hospital and community pharmacists, as regards to the improvement in their health status.

What was done?

In March 14th 2020, the Spanish Government declared the state of alarm which restricted citizens’ mobility due to the SARS-CoV-2 coronavirus pandemic. The Catalan Health Service (CatSalut), which provides health support to an autonomous community of 7.5 million people, issued a series of strategies to protect vulnerable patients from commuting to the hospital to collect their Outpatient Hospital Medicines (OHM).
One of these strategies established a shared pharmaceutical care program involving both hospital and community pharmacists. Thus patients collect their OHM at their local community pharmacy and avoid commuting to the hospital.

How was it done?

An official standard operating procedure reflecting this strategy was drawn up by CatSalut, Barcelona Pharmacists Association (COFB) and Hospital del Mar de Barcelona (HMar).
This project was initiated in March 23rd 2020 and it has been offered to all publicly funded hospitals in Catalonia.
A safe cloud-based web application, designed between COFB and HMar, was available to monitor all the medicines delivered using this circuit. Patients are included in this platform and are notified when their OHM has been sent to the community pharmacy selected by them. The computer application also includes a communication channel between community and hospital pharmacists to assess any medication-related incidence detected, as well as a telepharmacy service for patients.

What has been achieved?

In October 9th 2020, 3,293 patients, from 22(34.9%) hospitals in Catalonia, have been included to this system. The number of participating community pharmacies is 2,851(88.6%). A total of 8,806 treatments were delivered to the patients by community pharmacists. 10.2% of treatments are delivered through community pharmacies sharing the same postal code of the Hospital; 41.6% are delivered in the same municipality; 35.9%, in the same province and 12.3% are delivered through community pharmacies which are in a different province.

What next?

Establishing optimal communication channels between both professionals results in a better understanding of patients’ pharmacotherapeutic treatment and being able to act efficiently in those cases that are necessary.

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Author(s)

Pauline Barreau, Joséphine Courouble, Pierre Pilven, David Vandecapelle, Thibault Stala, Geoffrey Strobbe, Guillaume Marliot, Frédéric Feutry

Why was it done?

Two prescription assistance software are using in the hospital: DXCare®, for global drug management, and Chimio®, specific to the prescription and preparation of injectable chemotherapies. Clinical pharmacists (DXCare®) and pharmacists in charge of preparation (Chimio®) carry out the pharmaceutical analysis independently and they may not detect potential pharmacokinetics/pharmacodynamics drugs interactions or pathophysiological contraindications, slowing down the pharmaceutical analysis. Pharmaclass® can improve that by crossing all data flows between DXCare® and Chimio® and alerting the pharmacist. The objective were to select and code priority alerts and evaluate the detectability of drugs interactions and pathophysiological contraindications by the software Pharmaclass®.

What was done?

Pharmaclass® is a software based on rules created by the pharmacist, from pharmaceutical algorithms. This rules engine crosses in real time all data flows of several software and sends alerts that must be analyzed by a pharmacist. It was applied in oncology for injectable chemotherapies.

How was it done?

An interface was set up between DXCare®/Chimio® and Pharmaclass® to allow the creation of requests. An analysis of drug consumptions and drugs at risk of interactions helped to select seven molecules (Methotrexate, Bevacizumab, Fluorouracil, Ifosfamide, Irinotecan, Cisplatin, Pemetrexed). A study of the summaries of the product characteristics and the drug interaction thesaurus and a bibliography was conducted and the rules were coded. These were checked by creating test patients with false prescriptions.

What has been achieved?

Eleven rules were created and, after some tests and coding readjustments, all was detected. Nine rules are about drugs interactions: three contraindications (Methotrexate/Trimethoprim, Methotrexate/Acetylsalicylic acid, Bevacizumab/Naloxegol), three associations not recommended (Methotrexate/Amoxicillin, Methotrexate/Ciprofloxacin, Fluorouracil/Antivitamin K), one precaution of use (Ifosfamide/Aprepitant) and two other rules concern enzymatic induction and inhibition of the metabolism of Irinotecan. The last two rules link the glomerular filtration rate with Cisplatin and Pemetrexed.

What next?

Following these creations, Pharmaclass® has allowed to detect drug interactions and pathophysiological contraindications that were not previously detectable. Thereafter, objective will be to establish an organization for the management of alerts and evaluate the number and the relevance of these alerts. New rules will be created for all injectable chemotherapies used in the hospital. Other center of Unicancer will be able to use these rules.

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Author(s)

Olga Nedopilkova, Stanislav Gregor

Why was it done?

The project was created to increase quality and maintain continuity of a health care provided in the Czech Republic and to prevent any discontinuity which could endanger the patient. Emergency dispensing of a drug is enabled by new functionality which is the patient’s drug record (PDR) which was only launched in the CZE in June 2020. Last but not least it is about expanding existing competencies of pharmacists and strengthening pharmacists’ position in the healthcare system.

What was done?

The Association of Young Pharmacists, with support of the Czech Chamber of Pharmacists, created a project which is focusing on a possibility of dispensing a chronically used prescription drug in case a patient cannot obtain a prescription for various reasons (“emergency dispensing of a drug”). In hospital pharmacies in the Czech Republic (CZE), it is possible to dispense medicines to the public. A concept has been developed that describes all the essentials that must be followed.

How was it done?

A project proposal describing specific situations when the pharmacist can proceed to emergency dispensing, rules of the actual implementation and also cost analysis has been prepared). A search for experience from abroad has been conducted as well. Subsequently, a survey among pharmacists was conducted. The purpose of the survey was to determine whether pharmacists are interested in this competence and have comments on it. Then a comprehensive concept was submitted to the Ministry of Health. Specific legislative changes will now be needed.

What has been achieved?

Among pharmacists in the CZE, a considerable agreement was reached with the draft. According to the survey 94% of pharmacists agree with the prepared proposal, 3.2% disagree, and the remaining 2.8% agree with minor modifications to the request. Furthermore, we managed to develop a concept that describes detailed conditions for dispensing drugs in emergency mode. The concept was submitted to the Ministry of Health, with which the details of this proposal will now be gradually negotiated.

What next?

This project represents only one of the new competencies that pharmacists could achieve. We want to follow up on this step with another project that would enable pharmacists to prescribe chronically used drugs under specific conditions even outside emergency situations.

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Author(s)

Elodie Delavoipière, Marianne Pavard, Anne-Laure Richard, Julien Montreuil, Albane Cherel, Céline Bouglé

Why was it done?

Every year in our country, 10,000 preventable deaths and more than 130,000 preventable hospitalizations are related to drug misuse. This issue is a priority of the national health strategy. Therefore, we developed a CPD training program on the issues and methods of managing the risk of ME.

What was done?

A regional multi-disciplinary Continuing Professional Development (CPD) program was developed, dealing with the risk management of medication errors (ME).

How was it done?

This program was submitted to the National CPD Agency and accepted as a continuing education measure, corresponding to the national orientation: “control of risks associated with healthcare acts and pathways”. The program and the training materials were developed by a 13-member regional working group, including hospital pharmacists and quality managers, the drug observatory and the regional health quality network.

What has been achieved?

The training is intended for any health professional involved in the medication circuit in a health or medico-social institution: physicians, pharmacists, residents, nurses, pharmacy technicians… The first part is an e-learning slide presentation with voice commentary, on the theoretical aspects of ME and on the principles of a priori and a posteriori risk management. Concrete examples of ME are integrated throughout the slide presentation. This e-learning is divided into 4 parts and is accessible for 1 month. It must be validated by the learner before participating in the second part of the training: a face-to-face simulation session with 15 learners and 2 hospital trainers (pharmacist and health quality professional). During half a day, the learners apply a posteriori risk management by analysing a fictional adverse event (ME). The case addresses several themes: never events, drug reconciliation, city-hospital link, lack of communication, human factors. Questionnaires completed before, during and after the training allow for the evaluation of learners’ satisfaction as well as the impact of the training on their knowledge and skills.

What next?

This regional training will promote the link between actors from different institutions and the multi-disciplinary approach around the management of the risks of ME. In addition, we provide an awareness kit on ME reporting, including a customizable slide show and a quiz, which allows short sessions to be conducted in any health facility.

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Author(s)

Daniele Mengato, Federica Milani, Laura Agnoletto, Nicoletta Freddi, Roberta Rampazzo, Vera Damuzzo, Nicola Realdon

Why was it done?

Recently, the national monitoring of Hospital Pharmacy Students (SHP) highlighted a lack of education in clinical research and in designing of independent studies among students. To fill this gap, we established a collaboration between Scientific Associations and Student Organisations.

What was done?

In 2017 the Italian Society for Clinical Pharmacy and Therapeutics (SIFaCT) and the National Association of Hospital Pharmacy Students (ReNaSFO) established a join action to improve students’ research competencies. To this end, we designed the QOSMOS study: “Quality Of life (QoL) in Multiple Sclerosis (MS): a Multicentre Observational Study”.

How was it done?

The study has both educational and scientific objectives. Scientific objectives were to update data on QoL in MS and to correlate QoL to drug therapy. Regarding the educational challenge, every SHP participant received, by a panel of expert colleagues, the methodologic basis on observational studies and how to arrange teamwork activities. SHP could participate either as co-investigators or as members of teams which managed ethical approval, case report form (CRF), study monitor and data analysis. Investigators enrolled patients, collected clinical data and administrated a CRF, consisting of a questionnaire on QoL (MSQoL54).

What has been achieved?

22 SHP from 16 Italian centres, equally distributed from Southern to Northern Italy, joined the project. 20 SHP participated as co-investigators, one was included in the Scientific Committee of the study and 1 participated in the team dedicated to the Ethical Committee. We enrolled 341 patients with relapsing/remitting MS from May 2018 to June 2019 (median=20 per centre). The study achieved primary and secondary endpoints and pointed out a significant decrease in QoL related to physical health in patients treated with teriflunomide compared to other oral drugs (p=0.002).

What next?

Results will be presented in a scientific paper for submission to a peer-reviewed journal. This final aspect of the project has an educational goal once again, namely to bring young colleagues closer to writing and disseminating science. As QOSMOS gained good results, a new study investigating the role of clinical pharmacist in the Infectious Disease Department is starting with the goal to investigate optimisation strategies for treatment of HIV-positive patients.

Author(s)

Chiara Inserra, Antonio Solinas, Chiara Panciroli, Branden Nemecek, David Zimmerman, J.Douglas Bricker, Piera Polidori

Why was it done?

Successful implementation of clinical pharmacy services are associated with improved prescribing practices. SIFO includes clinical pharmacy in their mission to line up with Section 4 of the European Statement on Hospital Pharmacy and is striving for implementation through advanced trainings for IHPs. The aim of this EP was to provide real world clinical pharmacy training to IHPs.

What was done?

Through international collaboration between Duquesne University School of Pharmacy in Pittsburgh (PA-USA) and the Italian Society of Hospital Pharmacy (SIFO) a clinical pharmacy exchange programme (EP) was established to provide clinical education to Italian pharmacists interested in advancing the profession. From 2010 to 2018, SIFO provided several grants to allow Italian hospital pharmacists (IHPs) to participate. In 2018, three IHPs from across Italy were selected for a 1 month experience to gain experience and insight into practices that they may use in their facilities.

How was it done?

The clinical training was created by Duquesne University to provide IHPs educational and first-hand clinical skills based on American clinical pharmacy practice and education. The training was individualised for IHPs’ interests including didactics and practical training. Sessions to discuss IHPs’ progress were conducted with the Dean and faculty of the programme.

What has been achieved?

IHPs had the chance to observe American pharmacy education and compare it to the Italian one. American university training was practical, well-coordinated with clinical activities, and based on a trustful teacher-student relationship. During practical training IHPs shadowed American Clinical Pharmacists (ACP) specialized in different areas: Infectious Disease, Cardiology, Oncology, Emergency Medicine, Internal Medicine, Community Pharmacy, Ambulatory Care. They were able to observe how ACPs validate prescriptions and are actively engaged in direct patient care, participating in bedside multidisciplinary rounds and making recommendations on therapies (drug interactions, dose adjustments, antibiotic selection). IHPs saw how technology investments, prioritisation of care, and availability of skilled personnel underlie American hospital pharmacy practice.

What next?

IHPs gained baseline clinical pharmacy skills to enhance care at their facilities; however, the widespread implementation of clinical pharmacy in Italy requires education reform, enhanced resources and integration of pharmacists within a multidisciplinary team. Implementation of small projects through collaboration with universities should be considered in the Italian hospital setting.