Author(s)

Nicola Nigri, Maria Antonietta Calzola, Silvia Di Marco, Elisa Di Maio, Benedetta Fagotti, Martina Savoia, Luciana Negroni, Fausto Bartolini

Why was it done?

The 1st line treatment in RCC provides Pembrolizumab 200mg IV/21 days plus Axitinib (56cps/pack) P.O./BIS meaning two journeys. The PT and or CG have to come back to the hospital at different moments from the infusion date for 9 times/year, affecting negatively: the compliance, the IC, the patient’s follow-up and, the environmental impact.

What was done?

In Italy, the 1st line treatment of advanced renal cell carcinoma (RCC) involves 4791 new diagnoses/year. The most innovative therapies imply the association of intravenous therapy (IV) and oral chemotherapy.
In this case, the Hospital Pharmacist (HP) can assist the compliance and help to minimize the impact linked to indirect costs (IC), often unconsidered, through the reduction of the patient (PT) and or caregiver (CG) trips, improving also their quality of life. The HP can participate in decreasing the CO2 emissions that, in 70% of the cases, are generated by road transportations.

How was it done?

On the IV therapy day, is given to the patient, the oral treatment too (42cps), provided with the necessary documents.
To measure the IC has been considered the organizational costs to the PT and or CG. The time commitment was estimated, in the worst case, in a 2h return journey (150km) between the PT/CG location and the dispensation point. It has been considered 30min as the estimated time to park, arrival, waiting time in pharmacy, drug pick-up and back.
The average hourly earnings considered has been 13,6 €/h. The average diesel-engined utility car emits 95g/km of CO2 emissions.

What has been achieved?

Each avoided trip is 2h x 13,6€ = 34€ for missing productivity or 68€ if both are involved. The total IC avoided/year/PT is the number of avoided journeys/year x 34 = 306€ (612€ if both are involved).
The CO2 emissions are equal to 95g x 150km =14,25kg/distribution/PT, 128,25 kg/year/PT, equal almost to 2,3% of CO2 emission perceived in Italy, that, in the worst case, times the incident PTs/year that will become 614.000tonnes/year.

What next?

The HP shows, even more, its influence on more layers: clinic, economic, and environmental to benefit the patient, our NHS, and our planet, hoping in this approach in more combined therapies.

Pdf

Author(s)

Justine Touchard, Elisabeth Angelier, Isabelle Ferry, Marion Lafay, Jean-Stéphane Giraud, Caroline Giard, Mallory Friou, Laurence Escalup, Thomas Genevée

Why was it done?

For more than 15 years, within the Institut Curie, a pharmaceutical consultation (PC) has been offered to patients undergoing anticancer oral therapy, in addition to a medical announcement consultation and a nurse consultation. The pharmacist secures and optimises drug management through a pharmaceutical analysis of the prescription, an explanation to the patient of drug intake and management of the main side effects.

What was done?

The aim is to assess the Clinical Impact (CI) of Pharmaceutical Interventions (PI).

How was it done?

From 1 January 2020 to 17 March 2020, two types of PI could be collected during each PC. One concerned the prescriber and problems of prescription, while the other concerned patients. Patients could misunderstand some of the information explained by their oncologist. The evaluation of the CI of these PI has been documented by an oncologist based on the Cléo scale v3, validated by a French learned society, Société Française de Pharmacie Clinique. CI of each PI was classified as harmful , null, minor, moderate, major, vital, and not determined.

What has been achieved?

140 PC were carried out. 95% of patients were female and mean age was 62 (±13.73) years. 66 PI were recorded. 39 PI with the prescriber were identified. We noted, among others, 8 risks of possible drug interaction, 9 lacks of prescriptions of support treatment, 3 lacks of drug intake advice and 3 lacks of prescription for blood monitoring.
27 PI with the patient were identified and 21 were relevant. We noted that 7 patients misunderstood drug intake, 5 patients did not know that the previous treatment should have been interrupted, 5 patients misunderstood the monitoring and 4 others were not aware of possible side effects related to their treatment.
The CI was assessed for 83% (n=55) of PI. CI was considered to be minor for 20%, moderate for 53%, major for 14% and vital for 13%. Two prescription errors were associated with vital CI. The first referred to a risk of drug interaction between a proton pump inhibitor and capecitabine. The other error was the risk of loperamide overdosage.

What next?

PC help secure medical care of patients. These results will be presented to our oncologists to improve medical practices.

Pdf

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.

Pdf

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.

Pdf

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.

Pdf

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.

Pdf

Author(s)

Ignacio García Giménez, Natalia Martín Fernández, Olalla Montero Pérez, Ernesto Sánchez Gómez, Isabel María Carrión Madroñal

Why was it done?

The aim is to implement a protocol to follow when these safety notes/alerts are released from the AEMPS. It comprehends the reception of the information, its registration and its communication, when needed, to the rest of the healthcare professionals.

What was done?

A communication circuit of alerts and safety notes related to drugs coming from the “Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)”.

How was it done?

At the reception of an alert from the AEMPS, the first step is to check if the drug has been acquired by the Pharmacy, and then act in accordance with the recommendations, informing the Departments in which the medication had been dispensed. If a drug must be retired and a stock break is generated, the healthcare professionals must be informed as well. Security notes from the AEMPS are published in the local hospital website, where the documents sent by the AEMPS can be found. If this medication is included in the Pharmacotherapeutic guide, a notification is shown when it is prescribed. Finally, all alerts and security notes, with the pharmacist intervention, are registered in a database.

What has been achieved?

Since the implementation of the circuit, 14 alerts and 9 security notes were sent from the AEMPS in a period of 6 months. No interventions regarding the alerts were needed. Healthcare professionals were informed when the security notes were released, pointing to the patients at risk, the precautions required and the alternative therapies available.

What next?

To incorporate it as an indicator of quality of care within the procedures performed by the pharmacy department and detect areas of improvement.

Pdf

Author(s)

Arnaud Potier, Béatrice Demoré, Alexandre Dony, Emmanuelle Divoux, Emmanuelle Boschetti, Laure-Anne Arnoux, Cédric Dupont, Jean-Christophe Calvo, David Piney, Virginie Chopard, Nathalie Cretin, Edith Dufay

Why was it done?

Drug iatrogenia costs global health systems $52 billion annually. The third global patient safety challenge aims at reducing the global burden of iatrogenic medication-related harm by 50% within 5 years [1]. Pharmaceutical analysis is a fundamental activity, a regulatory obligation in many countries but remains a challenge. This practice is highly variable. A graphic definition of the target pharmaceutical analysis has been formalised in December 2017 which sets the basis for its digitalisation, effectively implemented since January 2019. The aim is to build a corpus of the most relevant PA to facilitate clinical pharmacist practice.

What was done?

A computerised clinical pharmacy tool is integrated into the health information system of our group of hospitals (5000 beds) to promote efficiency of pharmaceutical analysis in order to improve patient safety. Pharmaceutical algorithms (PA) are conceptualised to improve drug related problems (DRP) detection and their resolution through pharmaceutical intervention (PI) according to a defined conduct to be held: anamnesis of subjective and objective elements of appreciation, DRP characterisation and PI transmission. Pharmaceutical analysis is performed by the use of PharmaClass® (Keenturtle). This software has been interfaced with 5 health data flow of two health facilities (1000 of the 2000 beds were tested): identity and patient flow, medication data, laboratory results examination, medical history, physiological constants. PA are partially encoded as rules in Pharmaclass® that issues alerts analysed by a pharmacist.

How was it done?

Health data are lacking of semantic interoperability which Pharmaclass® aims at overcoming from Electronical health record (EHR) queries in real time. A corpus of PA has been structured integrating the conduct to be held. PA were created by modeling the pharmaceutical experiment with the thread of criticality. PA were validated by consensus.

What has been achieved?

80 PA were encoded into Pharmaclass®: 40 are targeting serious adverse drug events. 1516 alerts were analysed and 539 PI transmitted during the 9-month test period.

What next?

This practice is applicable to any pharmaceutical analysis that uses data from an EHR. Clinical pharmacy societies should host and take care of updating corpus of PA. Its educational interest should be exploited. A European interest group for artificial intelligence in clinical pharmacy is being created.

Pdf

Author(s)

Francesca Vecchione, Melania Rivano, Patrizia Tadini

Why was it done?

The new process was developed in order to face the significant increase of ID management assigned to the Pharmacy, along with the logistic problems due to the several areas of storage, dispensing and administration. Additionally, it allowed to assure the effective use of ID reducing the risk of failure and improving the patient safety.

What was done?

The Good Clinical Practice guidelines establish that the principal investigator (PI) can delegate the investigational drug management to a pharmacist. In our university teaching hospital with a large amount of clinical trials (CT), pharmacy service proposed an optimisation of ID (investigational drug) management through the elaboration of a form to request the ID. Along with this, we assigned each protocol to a specific type of management and we created an intranet site from where healthcare professionals can download the form.

How was it done?

The pharmacy service created for each CT a specific form organized into 5 sections. Section A, B and C were filled up with protocol information (name, centre code, PI) patient data (initials, patient code) and the treatment schedule. Section C, completed by data manager, showed the quantity of drug to be dispensed and the expected day of administration. Section D was completed with batch and expiry date. The form had to be signed by the pharmacist at the moment of the dispensation and signed back by the committed person who took it. Section E reminded the type of management assigned to the protocol. Five different types of management had been identified, based on the characteristics of storage, the activities required by the protocol (IWRS, unblinded pharmacist, drug preparation) and the dispensing method.

What has been achieved?

Data from January to June 2017 attested 60 ongoing protocols, 722 dispensations for patient, 237 drugs prepared by pharmacists and 986 in Chemotherapy preparation unit. The development of the new procedure ensured the ID tracking, the overcoming of logistical difficulties and an increase of the safety.

What next?

We are going to keep on improving the pharmacist role in CT by ensuring ID are handled, stored and correctly managed. The objective is to enhance the collaboration of clinical research professionals in the management of CT.

Pdf

Author(s)

Antonios Markogiannakis, Georgios Pegkas, Calliope Allagianni, Stavroula Efstathiou, Despoina Makridaki

Why was it done?

The term of AST has been introduced in Greek legislation since 2014 and should become the driving force to optimize antimicrobial therapy, especially for the protected antibiotics (PA): carbapenems, colistin and tigecycline. Unfortunately Greece ranks first in Europe in the consumption of the mentioned PA in hospitals, consequently the activation of AST constitutes national priority. The existing law frame defines that AST consists of four key member physicians (experienced in infectious diseases) plus the hospital pharmacist as coordinator of the group. As the number of serving pharmacists in Greece remains critically low, very few hospitals have actually activated the AST. The Panhellenic Association of Hospital Pharmacists (PEFNI) decided to organize regional meetings to enhance the involvement of pharmacists by sharing the practice of experienced colleagues running antibiotic stewardship programs (ASP) in their hospitals since fall of 2016.

What was done?

We have described the sequential steps for the establishment of multidisciplinary Antibiotic Stewardship Team (AST) in Greek hospitals and prepared training material to increase involvement of hospital pharmacists.

How was it done?

We combined the strategies and procedures implemented in the three hospitals during last year, in a flowchart presenting the establishment, activation and feedback of the AST. We have developed an ASP for hospitals, with initial target to minimize the use of PA:. Functional options in each step have been described, making it flexible for the colleagues to selectively implement them in their hospitals. We also created specific educational material to use in regional meetings that PEFNI organizes.

What has been achieved?

The application of ASP and the education of hospital pharmacists as coordinators results in: • Reliable reporting of controlled use for the PA • Safer antimicrobial management practice • Economy on restricted pharmacotherapy budgets • Acknowledgement of the critical role of pharmacists by other healthcare professionals, the hospital manager and the authorities

What next?

• The basic flowchart can be broadened to include subsequent stewardship activities such as recording proper surveillance of more classes of antibiotics, assessment of antimicrobial surgical chemoprophylaxis and/or antifungal pharmacotherapy.
• Connection of local ASP reports to a national network for all hospitals will help towards the creation of a real-time antibiotics’ consumption database in Greece.