Immunoglobulin rationalisation plan in a tertiary hospital during shortage by COVID-19 pandemic
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
MARIA DE LA TORRE ORTIZ, ESTEFANIA ROSON, LIDIA YBAÑEZ, NATALIA SANCHEZ-OCAÑA, JAVIER CORAZON, PALOMA PASTOR, MARIA FERNANDEZ-VAZQUEZ, JOSE MANUEL MARTINEZ SESMERO
Why was it done?
The demand and use of immunoglobulins (IgGs) is growing, and there are many difficulties in obtaining supplies. This situation has been worsened during and especially after COVID-19 pandemic. A low number of blood donations and apheresis procedures, caused a shortage of IgGs worldwide. The measures implemented (dose and period optimisation) ensured the achievement of an adequate balance between supply and demand, enabling an increase of plasma fractionation industry.
What was done?
A rationalisation plan of human IgGs use was implemented in a tertiary hospital through the multidisciplinary groups, in which Pharmacy Department (PD) participated.
How was it done?
Inside hospital working groups were created between the different IgGs prescribing departments (paediatrics, haematology, immunology and neurology) and PD during a period between 1 May 2021 and 31 October 2021. All patients on regular treatment with IgGs were identified and each one was reviewed: indication, dose, regimen and treatment alternatives. Based on the document “Criteria for the rational use of human immunoglobulins” published by the Madrid Health Service in 2021 and taking into account the clinical circumstances of each patient, decisions were made regarding: continuation or discontinuation of treatment and dose or regimen adjustments.
What has been achieved?
After identifying 184 patients treated with IgGs, a set of pharmaceutical policies has been drawn up in conjunction with stakeholders. Evidence-based intervention focused on assessing the clinical adequacy of actual treatments, optimising indications and dosing, to ensure an equitable supply was done. A total of 34 patients (%) discontinued IgGs, 24 patients reduced doses and 15 increased time between administrations.
As a result, it has been possible to continue the treatment in those patients for whom its use was a vital urgency during shortage period.
What next?
Long-term follow-up is necessary to better analyse the impact of the established measures. Registries play an important role in collection of systematic data to analyse, synthetise, and obtain valuable information for decision support. five patients had to restart IgGs treatment and seven patients had to come back to the initial regimen. Even so, politic rationalisation in special situations is a key factor of pharmaceutical activity to ensure treatments for patients who need it the most.
Pharmacist prescriber embedded within medical team improves patient care by timely and accurate discharge medication prescribing
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Fiona Watson, Amanda Plummer, Aqleema Akhter
Why was it done?
For discharge medication to be dispensed a medicines list plus discharge letter, often referred to as a To-Take-Out (TTO) is required. The letter section communicates information for safe patient transfer and provides context for the pharmacist clinical verification. With increasing demands on junior doctors, the production of TTOs is often delayed until after all urgent clinical duties are completed, so dispensing commences late in the working day. in addition, junior doctors’ prescribing errors cause delay while queries are resolved. The late completion of TTOs slows patient flow across the whole system. It was accepted that a different strategy, using a PP to prioritise prescribing, needed exploration.
What was done?
A prescribing pharmacist (PP) was embedded within a specialist medical team, to perform prescribing activities in a timely manner, with a focus on discharge prescriptions. The PP was additional to the standard ward pharmacy establishment, allowing prescribing to be the focus of the role.
How was it done?
A PP was embedded within the Respiratory team and another within Gastroenterology with the primary aim of producing TTOs as early as possible. There was a requirement for the PP to learn how to write the discharge letter, via training with junior doctors. The PP prioritised any prescribing to facilitate discharge, but also attended the consultant ward round undertaking medicines optimisation for each patient. Rather than the junior doctor returning later to prescribe, the PP made any necessary medication changes during the ward round, facilitating the timely receipt of appropriate therapy.
What has been achieved?
Both pilots reduced the time from medically fit for discharge to the TTO written by approximately 3 hours. There was a reduction in prescribing error rate of 37% to 1% in Respiratory and 9.5% to 0.7% in the Gastroenterology project.
What next?
The “Embedded Prescribing Pharmacist” role is now permanent within the two pilot specialities, with plans for further extension under consideration. The role demonstrates the “Right first time” concept and a modernised model of hospital pharmacist practice.
Re-using mendeliome data to explore pharmacogenomics implementation: pitfalls and opportunities.
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Eline Coene , Catharina Olsen, Mathijs Swaak, Freya Vaeyens , Frederik Hes , Stephane Steurbaut, Sonia Van Dooren , Pieter-Jan Cortoos
Why was it done?
Pharmacogenomics has a large potential to optimize individual patients’ both current and future drug therapies. In Belgian hospitals however, pharmacogenomics is still rarely used in clinical practice posing great opportunities for hospital pharmacies to explore this field and setting up new services.
What was done?
The Centre for Medical Genetics (CMG) of UZ Brussel, a 721-bed tertiary hospital in Brussels (Belgium), has been performing next-generation sequencing of mendeliomes for diagnostic purposes since 2016. Pharmacogenomic data is thus potentially available, but currently not further used. As hospital pharmacists, we wanted to explore the possibility of reporting pharmacogenomic information as ‘secondary findings’, in particular prevalence of actionable pharmacogenes and gene-drug interactions (GDIs) in our own population, and to determine required features and opportunities of a future pharmacogenomics project
How was it done?
Firstly, 14 pharmacogenes comprising 626 loci were selected based on available guidelines, clinical relevance and whether the gene was included in the mendeliome gene set. With the support of CMG, we then reviewed available data for patients with a mendeliome analysis between 01/03/2016 and 30/06/2020. To enable haplotype assignment, a Python script was developed displaying possible haplotypes with corresponding ‘matching score’ and ‘completeness score’. Where possible, phasing was done using pedigree information. Resulting phenotypes were finally further linked with medication histories, abstracted from patients’ electronic medical records in order to identify possible GDIs.
What has been achieved?
Pharmacogenomic data could be re-used for 536 individual patients, revealing that at least 76.9% had one or more actionable phenotype while 60 GDIs with varying relevance were found. CYP2C9 had the most actionable phenotypes (174/536) and was involved in 42 GDIs. However, not all phenotypes (e.g. copy-number variants) were detectable for CYP2C19 and CYP2D6 due to limitations of current mendeliome data and used platform.
What next?
Reusing genomic data has great potential and can be an ideal stepping-stone towards developing and implementing pharmacogenomics in other hospital pharmacies but requires a good interplay between pharmacists, geneticists and bio-informaticians. In our hospital this initiative has led to in-depth collaboration between pharmacy and medical genetics department focusing on validation and implementation of a pharmacogenomics-array coupled with implementation of a pharmacogenomics service, next to pharmacological use of whole-genome sequencing data.
Implementation of a β-lactam Continuous Infusion Protocol in a Coronary Care Unit
European Statement
Clinical Pharmacy Services
Author(s)
Catarina Oliveira, Ana Mirco, Fátima Falcão
Why was it done?
-lactams have proven to be effective and safe antibiotics over their history, and as a consequence, these drugs are typically among the most frequently prescribed in hospital settings. Optimization of treatment with β-lactams can be achieved by their administration by continuous infusion. Furthermore, this approach leads to a reduction of the nursing time devoted to preparation and administration. However, information regarding continuous infusion of β-lactams is not readily available for most antibiotics, leading to doubts about dosing, renal adjustments and administration, particularly uncertainties related to dilution of the antibiotics as most patients benefit from fluid restriction. Also, it was indispensable to understand which antibiotics had stability to be administered through continuous infusion.
What was done?
A protocol for continuous infusion of β-lactams was established in a coronary care unit (CCU), replacing the previous method of intermittent dosing in most patients.
How was it done?
Firstly, we evaluated which antibiotics benefited from this approach and had, simultaneously, stability. The antibiotics selected were Cefotaxime, Ceftazidime, Cefepime, Cefuroxime, Piperacillin/tazobactam, Penicillin G, Ampicillin and Flucloxacillin. In order to stablish a protocol for continuous infusion of these antibiotics, an extensive literature review was performed. Information about loading and maintenance dose, reconstitution, dilution (solvent and maximum concentration), infusion rate, renal adjustments, stability and storage was collected and summarized in a table.
What has been achieved?
A ready-to-use version of the β-lactams continuous infusion protocol was developed. In addition, dosing adjustments in patients on continuous renal replacement therapy, commonly made in patients in the CCU, were included too. This protocol was made available to all health professionals through the hospital’s intranet as well as posted in the CCU in order to be easily accessible by doctors and nurses. Thus, continuous infusion is now the standard for most patients requiring therapy with β-lactams in the CCU.
What next?
The implementation of this protocol has an education purpose, allowing the best use of documented practices in prescribing, medication review and administration continuous infusion of β-lactams. This protocol can similarly be easily implemented in other medical units. In the near future, we plan to monitor the compliance to the protocol and consider further improvements if necessary.
A PHARMACEUTICAL CARE PROJECT TO IMPROVE INPATIENTS’ TREATMENT
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
SILVIA CONDE, ÁNGEL MARCOS, JOSEP TORRENT, CLARA SALOM, LAURA CANADELL
Why was it done?
Prior to the start of the project, inpatient treatments were not validated. The objective of this pharmaceutical care project was to improve the pharmacotherapy of the patients admitted to the hospital in terms of efficacy and safety.
What was done?
We implemented a pharmaceutical care project in a 153-bed regional hospital.
How was it done?
The pharmaceutical care project was based on 2 main strategies. The first of them was the validation of the treatment prescribed to inpatients according to their clinical situation. We planned to validate inpatient’s treatment from Monday to Friday during working hours.
The second one was the incorporation of the clinical pharmacist to hospital’s antimicrobial stewardship program. We established 2 meetings per week with the antimicrobial stewardship group. Revisions were focused on prescriptions of broad-spectrum antibiotics for more than 48 hours, antibiotic treatments longer than 7 days and prescriptions of aminoglycosides, vancomycin, and linezolid, among others.
What has been achieved?
During the 6 first months (January-June 2021), a total of 222 pharmaceutical interventions were performed, being the most frequent:
– “Discontinue medication” (22.97%), mainly because of “Undue duration” (31.37%) and “Therapeutic duplication” (29.41%)
– “Modify dose” (31.62%)
– “Change medication” (17.12%), mainly due to “Adjustment to antibiogram” (26.32%), “Medication exchange” (18.42%) and “Inadequate medication for the clinical situation of the patient” (15.79%).
The pharmaceutical intervention acceptance rate was 81.10%.
Related to the antimicrobial stewardship program, a total of 171 revisions were performed, making any treatment advice in 51 of them (29.82%). The most frequent recommendation was to “Discontinue treatment because of undue duration” (25.49%), followed by “Adjustment to antibiogram” (15.69%), “De-escalate treatment” (11.76%) and “Increment of antibiotic dose” (11.76%). Acceptance rate was 94%.
What next?
The pharmaceutical care program allows both the early identification of possible medication errors and upgrades in inpatients’ treatment.
FOUR YEARS OF A REGIONAL MEDICINES OPTIMISATION INNOVATION CENTRE – WHAT HAS BEEN ACHIEVED? (submitted in 2019)
Pdf
European Statement
Introductory Statements and Governance
Author(s)
Michael Scott, Glenda Fleming, Catherine Harrison
Why was it done?
There is a wide recognition that there are significant issues with regard to the issue of medicines, such as the fact that 30−50% of medicines are not taken as required. Thus the DoH decided to set up MOIC as a vehicle to focus activities in order to address this issue and optimise medicines use.
What was done?
A Regional Medicines Optimisation Innovation Centre (MOIC) was set up in 2015 by the Department of Health (DoH) in Northern Ireland as a key enabler for the Government policy document namely the Medicines Optimisation Quality Framework.
How was it done?
The DoH requested the Northern Health and Social Care Trust to locate the centre within the Trust based on the fact that there had been a long standing academic practice centre with the School of Pharmacy at Queens University of Belfast. Barriers that had to be addressed were highlighting the regional nature of the centre, to get engagement with all sectors of the service and building relationships with other key organisations, including the private sector. Initial core funding was provided by the DoH.
What has been achieved?
MOIC has successfully evaluated improved systems with regard to hospital pharmacy such as doctor-light discharge (90 minutes faster), post-discharge telephone follow-up (30 day readmission rate reduced by 9.9%), and medicines optimisation in older people service in care home settings (reduced Emergency Department attendances and medicines costs). In addition MOIC has been successful in 3 EU funding bids relating to medicines optimisation and has published over 30 papers. It has also been accredited as a Statement Implementation Learning Collaborative Centre (SILCC) site and also a Centre of Excellence by the Spanish Hospital Pharmacists Association. MOIC has also successfully worked with the private sector including pharmaceutical, device and technology companies. It has also been accredited as a knowledge provided by Invest NI.
What next?
MOIC has delivered on its key initial objectives, related to medicines optimisation with good collaborative work across health, academia and commercial organisations, in the UK and Europe. It will have a key role in meeting the WHO Global Challenge of reducing medication-related harm by 50% by 2023 for the region and further optimising medicines systems.
This approach with government policy support could be relatively easily established in any other region.
IMPLEMENTATION OF A NEW CLINICAL PHARMACY SERVICE WITHIN A NEWLY LAUNCHED SURGICAL ADMISSIONS PROCESS
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Dora Mueller, Maria-Theresia Pichler, Karin Kirchdorfer, Kora Koch
Why was it done?
Prior to the implementation, insufficient time resources did not allow for clinical pharmacy services (CPS) on all surgical wards. Existing cover was not efficient or effective as drug-charts were often not available or patients discharged before pharmacy suggestions were implemented. The integration of the CPS into the centralised admission process instead of the wards resolved these shortcomings and facilitated pharmacy input to all surgical patients using this admission process.
What was done?
A central surgical admissions process was launched at a 450-bed teaching-hospital in April 2018 in which patients are seen five days before surgery by an interdisciplinary team. A new clinical pharmacy service (CPS) was implemented on-site to review patients’ medical history comprising three consecutive steps:
1. Medicines reconciliation is completed based on existing patient-consultation records.
2. Recommendations for switching drugs to the hospital formulary on admission are noted on the drug chart.
3. Medication review is carried out to improve inpatient medication safety, and changes are communicated to medical staff via e-consult.
How was it done?
This proactive concept highlighting the advantages of interdisciplinary CPS and reflecting international evidence (e.g. patient safety, patient care, workload reduction for medical and nursing staff) convinced hospital management of its need. Resource implications included allocation of a pharmacy office on-site, development of a standard operation procedure and support for interdisciplinary teamwork on-site.
What has been achieved?
Between April and September 2018, records of all patients using the new process (n = 1527) were reviewed by a clinical pharmacist. At least one drug-related recommendation was made for 38.6% (n = 589) of all patients taking medication. This development enhances the clinical pharmacy workforce at our hospital and contributes to the quality of the admission process. Feedback from medical and nursing staff, hospital and quality management was positive throughout. We observed an improved level of awareness, higher numbers of requests for other CPS and a better understanding of the clinical pharmacists’ role within the healthcare team.
What next?
This initiative reflects how CPS can be expanded and optimised by seizing the opportunity and using existing resources. This model may be adapted for other hospital inpatient settings.
DRUG-FOOD INTERACTION GUIDE PREPARATION FOR OUTPATIENT CONSULTATION
European Statement
Patient Safety and Quality Assurance
Author(s)
Gregorio Romero Candel, Paula Ruiz Belda, Carmen Caballero Requejo, Maria Jesus Sanchez Cuenca, Jose Marco del Rio, Juilan Castillo Sanchez, Luna Carratala Herrera
Why was it done?
Some drugs dispensed in the outpatient office present interactions with food, leading to changes in their bioavailability. These changes which can result in a decrease in therapeutic activity or an increase in adverse effects, when dealing with narrow therapeutic margin drugs, may lead to alterations in their efficacy and/or toxicity. Developing the quick and accessible consultation table, we improved the quality and effectiveness of the treatment.
What was done?
Preparation of the drug and food interaction guide for outpatient consultations.
How was it done?
The technical specifications of all drugs that are dispensed in the hospital outpatient office were consulted, and the possible interactions with food of every one of them were analysed by consulting the following electronic databases: Technical sheet, Bot Plus, Micromedex, Pubmed, UpToDate and Online Medicine Information Centre of the AEMPS. A database was developed with drugs that presented some type of restriction with meals, designing a quick reference table for outpatient consultation.
What has been achieved?
One-hundred specialities were reviewed, of which 22 were to be taken without food, 43 with food and 35 could be taken with or without food. The information given to the patient was quick and efficient, improving the effectiveness and safety of the treatment.
What next?
Our goal is to continue developing tools that allow us to provide quality information to the patient, improving the effectiveness and safety of treatments.
PERSONALIZED BUSULFAN THERAPY: IMPLEMENTATION OF A THERAPEUTIC DRUG MONITORING PROGRAM (TDM)
European Statement
Clinical Pharmacy Services
Author(s)
VERA DOMINGOS, VERA PIRES, SÍLVIA SANTOS, PATRÍCIA TRINDADE, ANA INÁCIO, ELZA CANDEIAS, SUSANA SIMÕES, PAULO PAIXÃO, NUNO MIRANDA, ANTÓNIO GOUVEIA
Why was it done?
Personalized BU dosing is considered because BU has a narrow therapeutic index and exposure have been associated with important clinical outcomes. High exposures have been associated with an increased risk of toxicities (acute graft-versus-host disease and veno-occlusive disease) and low exposures with graft rejection and relapse.
For this reason, in a multidisciplinary working group, we identified an opportunity to improve the treatment of your patients.
What was done?
Implementation of a TDM procedure for Busulfan (BU) in conditioning therapy for hematopoietic stem cell transplantation (HSCT). Study variability in PK parameters and evaluate TDM efficacy. From this initial period, we perform TDM on all patients under Bu conditioning.
How was it done?
The steps followed were:
1. Pre-implementation: bibliographic research, identify reference centers to perform BU plasma assay. Development and validation of a LC-MS / MS method by the National Institute of Forensic Medicine. PK analysis using ADAPT-5 software.
2. Pilot: Trial and assess the feasibility of the procedure. Cross-validation of the results with UMC Utrecht.
3. Implementation: clinical practice, doing the necessary dose adjustments. Prospective collection of clinical and PK data.
The main obstacle is the lack of analytical methodology in our center and the turnaround time.
What has been achieved?
We performed a preliminary analysis with 21 patients. Mean clearance (CL) was 0,19L/h*kg±0,05L/h*kg and volume of distribution 0,65L*kg±0,22L*kg. Body weight was the most predictive covariance.
CL was significantly different between patients 10 years old (p = 0,024) and over treatment (p=0,0191). The type of conditioning regimen didn’t show relation with the BU CL (p=0,0514).
TDM increased the number of patients with an optimal exposure (target AUC ±10%) from 42% to 83%.Dose was reduced in 10 patients (max 37%) and increased in 3 (max 19%). 1 patient maintained the prescribed dose.
What next?
TDM increased significantly the number of patients with optimal exposure to BU.
This procedure is pioneer at a national level and it relies on a strict protocol which includes collaboration with several hospital departments and other highly-specialized external centers. This can be used as a tool for other drugs and to empower the pharmacist as an active agent in the clinical setting.
IMPLEMENTATION OF GUIDELINES FOR THE ACTIVATION OF EFFECTIVE ANTIBIOTICS’ STEWARDSHIP TEAM IN GREEK HOSPITALS – THE ROLE OF HOSPITAL PHARMACIST
Pdf
European Statement
Clinical Pharmacy Services
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.