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INTRODUCTION OF REGULATORY AND HEALTH WATCH IN THE CLINICAL TRIALS AREA

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European Statement

Patient Safety and Quality Assurance

Author(s)

Diane Le

Why was it done?

When the case for a study sponsored by the hospital has been filed a few months ago, the national agency authorizing trials raised the issue of health waltch, particularly the management of drug recalls. With the research department, which alerted us on the lack of resources for health alerts, and at the same time facing an international cease of some drugs, we set up a health alert and a regulatory watch system, to improve the quality of product and the patient’s safety.

What was done?

We set up a daily health and regulatory watch to stay abreast of any news. Regarding health watch, we included : studies for which the hospital is the sponsor ; studies for which the experimental treatments are not provided by the sponsor ; treatments used for adverse events and authorized by the sponsor.

How was it done?

Daily regulatory watch is carried out on the national legislation website with daily updates of national texts. If a new rule applies, it is written in a table to alert everyone.
Daily health watch is also carried out on the site of the national agency of drugs. Four types of information are recorded: drug shortages, alerts, recalls and releases.

What has been achieved?

Tables collecting those information are available on the pharmacy’s network so that anyone can read them, and can be shared with clinical research officers. To that day, some information has been collected due to a european legislation update on the clinical trials and has allowed us to anticipate what will change next year. We have not yet faced a drug recall but what has been done will allow us to react in the best way when this will happen.

What next?

The aim for carrying out regulatory and health watch is to allow us to quickly react and anticipate future problems, while keeping in mind the patient’s safety and the pharmacy practices improvement. This work was therefore completed with success, demonstrating the ability to react and the desire to deploy continuous improvement initiatives to strive for operational excellence and pharmaceutical. We now want to implement this work in the daily activity and extend it to other sectors.

Parameters involved in medication dispensing automation security and performance

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European Statement

Patient Safety and Quality Assurance

Author(s)

Hind Bouami, Dorine Castillo

Why was it done?

The human-machine system designer has to make decisions to secure and improve the automation process, and handle organization’s complexity. Documenting human agent’s situation awareness is crucial to support human-machine designers’ decision-making. Knowledge about risks, critical parameters and factors that can impact and threaten automation system’s performance and security are valuable for human agents, and should be collected using preventive and retrospective approaches.The evaluation of Macon hospital center’s automation performance enables to identify critical parameters to control in order to secure the human-machine system.

What was done?

An automation evaluation approach has been conducted in Macon hospital center, a hospital equipped with automated drug dispensing solutions for more than 5 years. The analysis of Macon hospital center automation’s feedback provides relevant information to enhance the perception and the comprehension of the system’s complexity fully, environmental factors that interact with the system, and to identify critical parameters in the automation process. Therefore, agents can design a projection of a secure and performant automated organization. This information will enable hospitals to make effective decisions to improve their automation project performance.

How was it done?

We deployed an anthropocentric approach for automated system evaluation in Macon hospital center.
Our approach integrates six steps that are run in automated hospital pharmacies to analyze their feedback [6]:
1) The identification of pharmacy’s automation needs and objectives, and the analysis of operational environment and existing equipment,
2) The analysis of automated equipment functional specifications formalized by the pharmacy,
3) The evaluation of automation deployment results and related gains,
4) The evaluation of specific actions implemented by the pharmacy during automation process,
5) The analysis of the parameters to control for automated equipment integration security and performance,
6) The analysis of factors influencing human-machine interaction.

What has been achieved?

The analysis of Macon hospital center pharmacy’s automation specifications revealed that 66.22% of automation requirements are technical, 29.73% concern human-machine interaction, and 4.05% relate to human aspects.
80.95% of automation specification related to the chosen Sinteco’s automated solution are met. The performance of the chosen automated solution is involved in 28.38% of automation specifications performance in Macon hospital center. The remaining systemic parameters involved in automation specifications performance need to be controlled.
Critical systemic parameters involved in automated solutions specifications and performance that have been identified through Macon hospital’s automation feedback are: the specificities of the chosen automated solution, hospital’s strategic decisions and budgetary constraints, the complexity of the hospital’s organization, the complexity of hospital’s information system, the constraints related to the packaging of drugs by pharmaceutical firms, users training, the complexity of the automated system, and users’ requirements and constraints.
The five parameters influencing human-machine interaction that should be managed to secure automated systems are: understanding the system’s complexity, defining relevant levels of automation, determining human and automated agents’ authority, determining human and automated agents’ autonomy, and understanding the human complexity.

What next?

Handling life-critical systems complexity such as medication delivery activity requires to be equipped with appropriate technology, and to control automation risks. The integration of human-machine principles is crucial to secure automation in hospitals, and to maintain a good balance between automation and human skills.

Improving medication barcode identification on the smallest unit of use: Start-up first ePIL (electronic leaflet) project for medicines used in hospitals in Spain

European Statement

Patient Safety and Quality Assurance

Author(s)

E Sulleiro, C Garrido, A Santamartina, O Delgado, B Aguado, I Alvarez Novoa, M Amérigo , L Calatayud, M Cardenal, J Carretero , J Corredoira, MA De la Peña, MJ De la Torre, S Domingo-Carranza, M Ercep, E Emili, M Eugui, E Falco, M Garcia , S Hernandez, M Hidalgo, J Hierro, M Jamali, C Joglar, S Juan, N Longás, A Lopez de la Rica, JJ Martínez , M MIllán , P Paris, C Ramirez, M Serrano

Why was it done?

Medication errors are one of the most common causes of preventable adverse events in the healthcare system. A complete identification of a medicine, up to the moment of administration, is therefore a key element of a safe medicines dispensing procedure in hospitals.
Digitization is a trend affecting all levels of our society and medicines are no exception. Increased use of Datamatrix code in the outer packaging of medicines has facilitated many healthcare professionals to become familiar with this technology. It is now possible to easily retrieve online information about a medicine, which raises the possibility of obtaining updated information of medicines without necessarily using a paper leaflet. Moreover, paper leaflets in the hospital setting are very often disposed of without reaching their end user, the patient.
Additionally, hospitals have other needs closely related to digitalization, considering errors in the reconciliation of prescription versus dispensing and administration, that can be reduced due to automated capture of the code linked to a particular medicine in the smallest unit of use, and also when dealing with compounding traceability preparations for patients.

What was done?

Spanish Agency of Medicines and Medical Devices (AEMPS), Spanish Society of Hospital Pharmacy in coordination with Hospital Committee of the General Council of Official Pharmacist Associations , and a series of pharmaceutical companies, mostly integrated in National Trade Association of the Spanish based pharmaceutical industry (Farmaindustria), have launched a project consisting of removing paper leaflet from the packaging components of a series of medicines exclusively administered in hospitals. These medicines will have a Datamatrix code in the primary packaging. When scanned, Datamatrix will allow to capture official PIL text from the information hosted in the Medicine Online Information Center of AEMPS (CIMA), which can be used for patient safety purposes at hospital pharmacy.

How was it done?

The Project began in November 2020 creating an ad-hoc working group on “Technical Regulation of Pharmaceutical Medicines” from Farmaindustria with AEMPS and representatives of Hospital Pharmacists. After 10 TCs and after having the participation of different partners, the main lines were agreed
Stakeholders agreed a proposal for pilot description and AEMPS informed the European Commissionin due course.

What has been achieved?

1. From January, 1 2022, a list of medicines meeting the established requirements will be able to be marketed without paper leaflet
2. Non-serialized Datamatrix will be included in the primary packaging, shall be compliant with GS1 standardization and may be pre-printed. It will contain specific NTIN/GTIN that will enable access through a correspondence table to Marketing Authorization Number (pharmaceutical form and dose) of the medicine hosted in AEMPS Nomenclator for Prescription (a medicine database intended to provide core prescription information to the care information services). In case technically feasible, companies may include also batch variable information such as Batch Number and Expiry date in the Datamatrix on a voluntary basis.

What next?

Assessing the impact of this practice in terms of efficiency, flexibility and safety is a key priority and this pilot project will gather enough data and information to help EC and Member States to revise relevant provisions in the legislation by 2022.
EU citizens will be able to benefit from the development of new technologies, as an underlying driver for delivering timely and easily accessible an up-to-date medicinal product information,

Rationalising prescribing of unlicensed specials to children

European Statement

Clinical Pharmacy Services

Author(s)

Helen Cooper, Sheatha Abumehdi

Why was it done?

A lack of licensed formulations for children means that use of unlicensed and off-label medicines is often the only appropriate alternative [1]. Local prescribing data demonstrates wide variability in concentrations of unlicensed specials supplied, at significant cost. This project aims to standardise medicines prescribing for children, improve patient safety by reducing inadvertent dose misadministration due to varying concentrations, reduce spend, and improve the effectiveness of working relationships between hospital and community healthcare teams.

What was done?

Prescribing and procurement data were used to analyse, review and harmonise paediatric prescribing practices in a UK clinical commissioning group, with focus on rationalising use of unlicensed specials.

How was it done?

A target list of ten medicines was identified, based on variability of strengths and formulations available, and cost. A team of two dedicated specialist paediatric hospital pharmacists was funded to set out strategies to standardise prescribing of those target medicines, and to improve understanding of prescribing and supply of unlicensed medicines to children. Various methods were used, including; email communications advertising the roles and support offered; establishing a Paediatric Formulary Group; promoting the local Paediatric Formulary; creating paediatric prescribing pathways; reviewing specials prescribing and supporting switches to alternative formulations; and delivering a paediatric prescribing webinar.

What has been achieved?

Reviews of specials prescribing were initially undertaken in two of the six boroughs in the region. 138 switches to a preferred formulation for safety and/or cost-effectiveness were identified and discussed between July-October 2021. Risks associated with prescribing multiple concentrations of liquid medicines were identified and measures were put in place to prevent patient harm. The webinar was well attended, and although it cannot be quantified, awareness of the Paediatric Formulary has improved. The project is on-going and at this time the impact on spend cannot be shown but will be reported later this year.

What next?

The specific knowledge and skills of specialist paediatric hospital pharmacists are highly valuable in driving specials medicines rationalisation for children in the community. Future plans for expanding the project include extending the service to other boroughs in the region and widening the target list of medicines.

References: 1.Rawlence E et al. Is the provision of paediatric oral liquid unlicensed medicines safe? Arch Dis Child Educ Pract Ed. 2018;103(6):310-3. 2.Neonatal and Paediatric Pharmacists Group. Position Statement 18-01 Using Standardised Strengths of Unlicensed Liquid Medicines in Children. Version 5, April 2020.

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.

FOLLOW-UP OF OFF-LABEL TOCILIZUMAB PRESCRIPTIONS IN COVID-19 IN A FRENCH UNIVERSITY HOSPITAL

European Statement

Education and Research

Author(s)

Caroline TRAN VAN HO, Marie-Anne ESTEVE, Pierre BERTAULT-PERES, Marjorie ROUDOT

Why was it done?

SARS-CoV-2 infection leads to pro-inflammatory molecules production (in particular IL-6). If the immune system is overwhelmed and cytokine production spikes, a hyper-inflammatory phenomenon occurs: the cytokinic storm, which can bring lead to the admission in an intensive care unit. Due to the absence of authorized treatment, several clinical trials (CTs) and off-label use of drugs have been set up.

What was done?

The aim of this study is to analyse the off-label use of tocilizumab in a French university hospital in comparison with different CTs.

How was it done?

A retrospective study of tocilizumab prescriptions in Covid-19 was conducted between 01/03/2020 and 30/04/2021 by extracting data from Computerised Physician Order Entry and Pharmacy Management software (Pharma®). History of patients was recovered by electronic medical records (Axigate®).
Results were compared to (1) RECOVERY Collaborative Group. Lancet. 2021, (2) Hermine O. JAMA. 2021, (3) Rosas IO. N Engl J Med. 2021, (4) Salama C. N Engl J Med. 2021.

What has been achieved?

Between 01/03/2020 and 30/04/2021, 68 patients received tocilizumab.
Seventy-seven percent of patients were in the intensive care unit and 42.6% died, whereas 31.0%, 19.7%, 11.1% and 10.4% died according to (1), (3), (2) and (4), respectively. Mechanical or invasive ventilation at the time of tocilizumab prescription was widely used (84%) compared to CTs (54.0%, 27.9%, 24.0%, 12.2% for (1), (3), (2), (4)). According to (1), there is a synergistic action between tocilizumab and dexamethasone. Eighty-four percent of patients received at least one dose of corticosteroids in agreement with (1) and (4).

What next?

The increase in off-label use of tocilizumab is related to the results of CTs. Because of the low number of patients, the differences in COVID-19 stages at tocilizumab initiation, and the absence of a control group, it is difficult to explain our data. Given the weak iatrogenic effects revealed in CTs and in-label use, the benefit/risk seems in favor of tocilizumab use against COVID-19. Further studies are needed to confirm the first hopes. Since Casirivimab / imdevimab, and amlanivimab / etesevimab have been granted early access in France, the therapeutic strategy will be updated.

A prospective observational study of medication prescribing errors in an Emergency Department.

European Statement

Patient Safety and Quality Assurance

Author(s)

Carmen Ortí Juan, Cristina Toro Blanch, Maria Àngels Gispert Ametller, Ana Perez Plasencia, Cristina Lecha Ochoa, Anna Dordà Benito, Rosa Sacrest Güell

Why was it done?

Prescribing errors (PE) are an important cause of medication-related adverse events in the Emergency Departments (ED) but limited data are available in ED with electronic prescribing and administration (ePA) systems. Knowing the frequency and types of PE can help healthcare professionals to prevent and reduce the risk of them occurring.

What was done?

To determine the rate of PE in the ED, to classify incident types and to identify critical points where measures should be implemented to improve patient safety.

How was it done?

Prospective, observational and cross-sectional study in an ED with ePA system during 6 working days (May-June 2021). The inclusion criteria were patients stayed more than 8 hours in the ED and all patients awaiting hospitalization. Prescriptions were analyzed by a multidisciplinary team made up of two pharmacists, an emergency physician and the person in charge of the hospital’s medication errors committee. PE were reported to the hospital’s patient safety-related incident notification system.

What has been achieved?

Of the 65 prescriptions revised during the study period, PE were reported in 84 cases and 15 situations with the capacity to cause errors were detected. The average age of patients was 67 ± (SD=17,9) years and each prescription had an average of 8.4 medications. The rate of PE was 1.52 errors per patient, being higher in less severe patients than monitored patients (1.09 vs 2.0 PE per patient, respectively). The most common types of EP were omission of the usual medication (60.7%), wrong dose (15.5%), wrong frequency (7.1%) and drug is not indicated (7.1%). No adverse reactions related to EP were detected. According to the Spanish consensus about Medication Reconciliation in Emergency Units, 47.1% of omissions of usual medication were drugs that should be reconciled during the first 4 hours in the ED. The results of the study and the importance of medication reconciliation are highlighted in a session in the ED.

What next?

The PE rate in the ED was 1.52 per patient and the main type was omission of the usual medication. A cross sectional study will be made in the future and compared to the current one to establish the impact of the implemented measures on the PE rate.

Development of a clinical pharmacy program for very frail elderly hospitalized patients

European Statement

Clinical Pharmacy Services

Author(s)

Baptiste Fulbert, Florian Poncelet, Marilyne Legrand, Céline Mongaret, Dominique Hettler

Why was it done?

Very frail elderly patients are a particularly high-risk population due to their frequent multi-medication and the risk of associated adverse effects.
Clinical hospital pharmacists play an increasingly important role in patient care.

What was done?

We developed a program comprising several clinical pharmacy services for very frail elderly hospitalization.

How was it done?

We conducted a 3 month prospective study in short and middle geriatric stay included patients admitted in emergency department aged at least 75 with a Short Emergency Geriatric Assessment (SEGA) frailty score above 11. We performed, as clinical pharmacy services, best possible medication history (BPMH) in the emergency department and medication reconciliation at admission (MRA) in hospital ward and medication review during hospitalization. Medication reconciliation at discharge (MRD) was carried out on a geriatric medicine unit over 2 months. All activities were performed by pharmacy students, two residents and a pharmacist.

What has been achieved?

120 patients were included. 96 BPMHs were performed : 62 in emergency department and 34 in hospital ward.
MRA was performed for 81 patients (68%), identifying 774 discrepancies of which 19 (3%) were unintentional discrepancies (UD), 6 (32%) involving Digestive Tract and Metabolism drugs. 9 (47%) of these UDs concerned omissions.
During the 163 medication reviews, pharmacist performed 98 pharmaceutical interventions (PIs) for 53 patients, with an acceptance rate of 56%. Most of drugs involved with the acceptance rate was Nervous System drugs (20;36%) and Digestive Tract and Metabolism drugs (16;29%). Among the accepted PIs, 22 (40%) relate to dosage adjustment.
Finally, MRD was performed for 25 (21%) of patients identifying 256 discrepancies, 8 of which (3%) were UDs, mainly involving Digestive Tract and Metabolism drugs (5;63%). 5 (63%) of these UDs concern omissions.

What next?

The high number and nature of the discrepancies support the idea that this population is a relevant target for a clinical pharmacy program.
This program could be applied in other hospitals with the hospital pharmacists and provide a better care for these patients.
The development of MRD in geriatric wards and collaboration between hospital pharmacists and primary care professionnals, by a discharge summary to handover the changes between the entry and the exit prescription can complete this study.

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.

How to be in friendzone: geriatric and pharmacy ?

European Statement

Clinical Pharmacy Services

Author(s)

François TISSERAND, Pierre MENAGER, Alexandre NAVID, Léa ROUSSET, Adeline BANNIER, Julie MORIO, Hélène PERRIER, Elsa JOUHANNEAU

Why was it done?

The geriatricians contacted the pharmacy to deliver training courses to the geriatric residents. This has enabled pharmacists to develop a close relationship with geriatricians to offer them clinical pharmacy activities in their ward. Geriatricians were familiar with clinical pharmacy, in particular the medication reconciliation, which is used to perform the former in other hospitals. Geriatricians are concerned with iatrogenic illness and therefore see medication reconciliation and pharmaceutical analysis as a relevant approach to clinical pharmacy.

What was done?

A successful model of partnership between Geriatrics and Pharmacy has been created and developed.

How was it done?

A first meeting was held between geriatricians and pharmacists. It was decided a pharmacy resident would be dedicated to a given geriatrician. This first resident’s objectives are to follow the medical rounds and to carry out medication reconciliations upon admission and discharge. Pharmaceutical support has enabled real-time validation for the prescription of the appropriate drugs. As the internship progressed, the resident became the privileged interlocutor for a Pharmacy-Unit relationship.

What has been achieved?

To date, 37 medication reconciliations were carried out, where the resident followed 2 medical rounds per week over 17 weeks. All unintentional discrepancies were corrected (n=13). Concerning the appropriateness of prescriptions, 16 inappropriate medications were stopped. During the medical rounds, 34% of the therapeutic problems (n=35) were related to inappropriate drug according to guidelines, 17% to dosing errors, 14% to drugs without indication. More than 50% of pharmaceutical interventions were judged capable of preventing harm that requires increased monitoring or treatment or lengthening of the hospital stay (63%). During this period, 54 questions were asked and discussed between the resident and the geriatrician to improve patient care. At the geriatricians’ request, two courses were organized about non mastered topics. On the ward, the resident acted as a go-between for a number of issues such as referencing medical devices, rearranging the storage of medicines or finding the right contact person for information activities.

What next?

What has been done needs to be continued and improved. A pharmacist-geriatrician cross-training should be implemented soon. New activities with pharmacist-geriatrician interactions are being created, such as day hospitalization for falls in the elderly population and a geriatric emergency unit.

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BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.