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
Pdf
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.
Implementation and follow-up of an Assisted Electronic Prescription Program
European Statement
Patient Safety and Quality Assurance
Author(s)
Juan Campillo, Manuel Bonete, Marta Zayas, Maria Molina, Laura Barrajón, Cristina Martínez, Ángela Rizo, Maria Ángeles Bernabeu, Maria Teresa Aznar
Why was it done?
Medication errors (ME) occur in different phases of the drug circuit: prescription (16%), transcription (27%), validation, preparation, dispensing (48%) and administration (9%). The AEP is a tool to guarantee the safety of this circuit, being able to avoid up to 65% of ME. There is also a learning curve in new users of an AEP, confirming the need for support to reduce ME.
What was done?
1-Maintenance of the Assisted Electronic Prescription Program (AEP)
2-Implementation in 11 wards and in the Emergency Department of a 396-bed tertiary hospital
3-Training
4-To set a pilot AEP
5-Reeducation strategies
How was it done?
1- 1465 drugs included in the Pharmacotherapeutic Guide were configured. 3 levels of danger were created for Hazardous Drugs (HD) and the recommendations for their preparation / administration were agreed upon. The Therapeutic Exchange Guide was integrated into 443 drugs (761 exchange proposals).
2- It started in the Emergency Department and every week a new ward with AEP was opened.Paper was eliminated throughout the circuit, drug dispensing trolleys were modified and a computer was fitted to record administrations at the bedside.114 pharmacotherapeutic protocols were created.
3- A technical training program, changes in procedures, schedules and training documents were designed. 72 sessions were given to 346 physicians and 88 sessions to 543 nurses.
4- 490 incidents were reported, prioritizing the most urgent (compromising patient safety). 224 claims to expedite resolutions. We also collaborated with other hospitals.
5- Welcome plan to train new staff and annual sessions. A tutorial video to focus on the points that caused the most errors was recorded. Preparation of new documents to report the changes.
What has been achieved?
First hospital to implement computerized administration. Elimination of transcription errors. Improved administration security. Greater visibility of the pharmacist and participation in decision-making. Contribution to development of the AEP and its implementation in 15 more hospitals.
What next?
Monitoring the necessary interventions to develop educational strategies when a growing trend is observed. Improve the welcome plan. Continue piloting the new AEP versions Follow the evolution of pending incidents. Evaluate the impact of the educational strategy of the tutorial video.
Do we provide patients with sufficient information for the safe use of thermolabile medicines?
European Statement
Clinical Pharmacy Services
Author(s)
Miguel Angel Carvajal-Sanchez, Josefa Leon-Villar, Pilar Pacheco-Lopez, Javier Ibañez-Caturla, Paula Torrano-Belmonte, Lydia Fructuoso-Gonzalez, Juan Antonio Gutierrez-Sanchez, Maria Hernandez-Sanchez
Why was it done?
In recent years, we have witnessed a significant increase in the number of thermolabile pharmaceutical specialities, which makes it necessary to keep strict control of the storage temperature from manufacture to administration.
In this context, patient education is a fundamental step in ensuring that these medicines are administered effectively and safely.
What was done?
A study was carried out to determine the quality of the information provided by Hospital Pharmacy Service (HPS) professionals to patients regarding the storage of thermolabile medicines (TM) at home.
After analysing the variability of the results, we established in a protocolised manner the necessary and sufficient information items to be included in the pharmaceutical advice to patients regarding the storage of this type of medicines.
How was it done?
A random selection of 28 HPS professionals (13 nurses, 10 specialist pharmacists and 5 resident pharmacists) was made. Each participant, in isolation and individually, made a selection of criteria to be contained in the patient information regarding the transport and storage of TM.
The results obtained were:
General information:
o Informing that it is a TM: 89.28%.
o Telephone number for incidents: 10.71%.
o Keep out of the reach of children: 3.57%.
o Return if discontinuation of treatment: 3.57%.
Storage:
o Specify location in refrigerator: door/indoor distinction 28.57%; Avoid contact with walls: 28.57%; specific place in refrigerator 3.57%.
o Do not store next to food: 17.85%.
o Refrigerator/freezer distinction: 10.71%.
Transport:
o Recommendations for correct transport: 50%.
o Time elapsed from dispensing to refrigerator storage: 39.29%.
Administration:
o Tempering prior to administration (when necessary): 39.28%.
o Visual inspection: 7.14%.
o Check expiry date: 7.14%.
o Frecuency of administration: 3.57%.
What has been achieved?
Completion, standardisation and systematisation of the provision of information to patients on TM.
What next?
Training sessions will be given to all HPS professionals involved, including new recruits and pharmacy assistants. This is an initiative applicable to all HPS.
Securing the care pathway of patients in the new experimentation of medical cannabis through pharmaceutical interviews
European Statement
Clinical Pharmacy Services
Author(s)
Marie Guedon, Maëliss Laurent, Thibault Vallecillo, Catherine Mennesson, Mélanie Jennesson Lyver, Dominique Hettler, Céline Mongaret
Why was it done?
In March 2021, the “Agence Nationale de Sécurité du Médicament” initiated an experiment to evaluate the relevance and feasibility of the availability of MC as a narcotic drug, in France. In our hospital, we included children to treat drug-resistant epilepsy, and performed a dispensing process to secure the patient care pathway and strengthen collaboration between hospital pharmacists and primary care professional.
What was done?
The aim of this study is to secure the care pathway of patients included in a national experimentation of medical cannabis (MC) by developing pharmaceutical interviews. Thus, to optimize the continuity of patient care, a pharmaceutical report was developed, and addressed to the community pharmacists of the patient.
How was it done?
A working group was created including clinical pharmacists, a neuropediatrician and a coordination nurse. During medical consultations, pharmaceutical interviews were conducted and led to pharmaceutic reports, sent to the community pharmacies of the patients. In order to evaluate this report, a satisfaction survey was carried out.
What has been achieved?
During the first six months of the experimentation, three children were included. The clinical pharmacist team (two senior pharmacists and two pharmacy residents) performed ten dispensing processes. During the eight pharmaceutical interviews, four pharmaceutical interventions were performed. Firstly, the interaction between clobazam and MC (noticed in one patient) required a dosage adjustment. Then, the association between MC and hepatotoxic drugs (found in two patients) requires hepatic monitoring. A pharmacovigilance statement was also drafted to report side effects (digestive disorders). The satisfaction survey of community pharmacists showed that the transmitted information, mostly related to the medication review, was considered as useful for the community pharmacies of the patients. This data helped to guide the pharmaceutical interviews during their dispensing process.
What next?
Pharmaceutical interviews and their reports lead to secure the patient care pathway and improve the communication amongst health care professionals. Those measures provide an optimal case management and avoid therapeutic breakdown. Nevertheless, difficulties have been reported, mostly due to delay in the supply chain of the community pharmacies. Therefore, this system requires some adjustments before it can be applied on a larger scale. One of the suggestions is a provisional calendar of consultations and dispensations.
Medical supply vending machines – a direct-to-patient distribution method that offers flexibility to outpatients
European Statement
Selection, Procurement and Distribution
Author(s)
Louise Refsgaard, Linda Skovsted, Nina Bøggild
Why was it done?
The medical supply vending machines were implemented during 2021 as a way of direct-to-patient distribution of medicine with more flexibility. The aim was to offer 24-hour access to collect medicine at a location that suits the patient, e.g. close to the patient’s home.
What was done?
Medical supply vending machines were implemented in the Capital Region of Denmark. The vending machines allow patients to collect their medicine whenever and wherever it suits them. It is the patient’s healthcare professional that controls and orders the medicine. The hospital pharmacy staff consults the prescription and labels, dispenses and records the medicine and places it in the vending machine for collection.
Patient and staff satisfaction was surveyed.
How was it done?
The implementation of this new direct-to-patient distribution method was carried out by the Capital Region Hospital Pharmacy in close collaboration with the region’s hospitals and outpatient departments. Installing the machines was fast but a full implementation requires that the clinical staff rethink their practice and accept that dispensing is no longer their responsibility. This has been the biggest obstacle along with creating patient safe procedures.
What has been achieved?
7 medical supply vending machines were installed centrally in hospitals in the Capital Region of Denmark. The machines are now used to distribute medicine to some of the region’s outpatients.
The patient satisfaction survey showed that the patients are very satisfied with the vending machines: 100 % are either ‘highly satisfied’ (86 %) or ‘satisfied’ (14 %) with the new service, and 97 % would like to use it again. The staff was also satisfied with the new service.
Additionally, the quality of medicine dispensing is increased due to hospital pharmacy staff dispensing the medicine rather than nurses.
What next?
In order to offer flexibility to patients and increase the quality of dispensing of medicine, we aim to increase the number of patients that collect their medicine from the vending machines by using the current machines in their full capacity and installing more machines. We also aim to collaborate with Denmark’s other 4 regions, so that patients, who are treated outside their home region, can collect their medicine in a vending machine closer to their home.
Renewal in pharmaceutical compounding sterile preparations circuit in Pharmacy Service
European Statement
Production and Compounding
Author(s)
PILAR RANZ ORTEGA, MARÍA ARRIETA LOITEGUI, DANIEL GONZALEZ ANDRES, ANA MARÍA AGUI CALLEJAS, MARIA TERESA POZAS DEL RIO
Why was it done?
– Optimize the workflow:Nursing staff are independent in final product quality control.Dissapear the manual register of compounding sterile preparations.Fewer mixtures are discarded.Also in Pharmacy Service only elaborate the sterile preparations with an economic and safety impact.
– Improve the safety of drug administration in pediatric patients: there are ready-to-use commercial parenteral presentations, which can lead to errors when dosing per kilo,fe: enoxaparin…
– Optimize economic savings:all excess vials are reused
What was done?
Previously,some parenteral drugs were compounded at Pharmacy Service.The rest of the vials were discarded daily,so the pharmacist had to anticipated some elaborations not to throw,so then some were suspended.
Also, the pharmacists done the final product quality control,it could be delayed the dispensing and specially when it´s necessary to repeat the mixture.
The changes were:
– Re-selection of the parenteral drugs compounded at Pharmacy Service by:
• Economic criterio:the cost of drug has to be >20 euros/vial
• Safety for the pediatric patient:redose individually parenteral drugs “readytouse”
– Review the storage conditions:physicochemical (technical data sheet drug,Stabilis web) and microbiological stability (Good practices for preparation drugs in hospital pharmacy services publised by Spain Goverment) of all parenteral drugs previously selected.Although the physicochemical stability is higher,the final stability will be limited by the microbiological stability and the risk level microbial contamination(USP 2004).
– Standard Operating Procedures with structured and updated information
– Reuse of partially used multi dose vials:we reviewed the physicochemical and microbiological stability of open vial
– Final product quality control by nursing staff
– Save time to pharmacist:daily scheduling instead of anticipated elaboration of sterile preparations
How was it done?
– A nurse involved in the circuit change giving her feedback on the changes
– Traceability of the rests of the vials:stickers are affixed to the opened vials indicating the reconstitution data and the expiration date
– Final product quality control should be done by a diferente nurse to elaborated to detect potencial errors
What has been achieved?
The total cost savings for this year is 295.778€. After the circuit´s change, the savings have increased by 55% for liposomal amphotericin b, 51% defibrotide, 24% micafungin.
What next?
Compounding sterile preparations individualized in Pharmacy Service to patients hospitalized at home, transplanted of hematopoietic progenitors and immunocompromised