Implementation of an Antibiotic Stewardship Program in Primary Care
European Statement
Clinical Pharmacy Services
Author(s)
CLARA NOTARIO DONGIL, ALEJANDRO MARCOS DE LA TORRE, MARÍA CARMEN CONDE GARCÍA, MARÍA MAR ALAÑÓN PARDO, BEATRIZ PROY VEGA, NATALIA ANDRÉS NAVARRO
Why was it done?
Most of the cultures performed in outpatients were not reviewed or were reviewed too late. An early detection for an adequate control of multidrug-resistant bacteria and the setting of a targeted antibiotic treatment, in case of being necessary, was the aim of this project. Hence basis for the implementation of an ASP is laid down, giving also advice to medical staff regarding appropriate antibiotic treatments.
What was done?
Multiresistant bacteria containment is a public health priority. Antibiotic Stewardship Programs (ASPs) can help to enhance patient outcomes by improving antibiotic prescribing. ASPs are common in hospitals, but are not usually available in primary care.
How was it done?
1- A circuit between microbiology laboratory staff, preventive medicine and pharmacy service was done. The first two collaborated by presenting data from lab results.
2- Cultures of multidrug-resistant species of outpatients were included. Results were interpreted by a hospital pharmacist on a daily basis.
3- A circuit of telephone calls between pharmacy and primary care was settled in order to communicate high epidemiological impact species detected. Pharmacist collaborates by giving advice regarding the right drug, right dose and right time, only when antibiotic treatment was necessary. Reports were registered on the medical history.
4- Variables collected in database were: age, sex, institutionalized, antibiotics received, kidney disease, culture type, specie.
What has been achieved?
During five months, 52 patients were included (52% male, 48% female). Mean age: 68 years. 11% institutionalized patients. 31% presented kidney disease.
Urine culture (58%),skin culture (13%), bronchial/sputum culture (12%), stool culture (12%), , and other cultures (5%) were analysed. Multidrug-resistant species (spp) were: Klebsiella spp (34%); Pseudomonas spp (8%); Mycobacterium spp (6%); other spp (52%).
17 pharmacist interventions were carried out, all of them related to appropriated treatment. 2 patients were hospitalized in order to receive parenteral antibiotic.
What next?
Optimizing antibiotics use is important to effectively treat infections. Identifying species that generate therapeutic difficulties is essential. Pharmacist advice could reduce treatment failures applying efforts to improve antibiotic use, being link of union between hospital and primary care. Other activities such as providing training to medical staff or spread results regarding to the use of antibiotics will be critical for ASP development.
MEDICATION REGIMEN COMPLEXITY INDEX AMONG SOLID ORGAN TRANSPLANT PATIENTS
European Statement
Clinical Pharmacy Services
Author(s)
Andrea Costa-Navarro, Emilio Monte-Boquet, Mª Jesus Cuellar-Monreal, Ana Garcia-Robles, Eduardo Guerrero-Hurtado, Alejandra Ferrada-Gasco, Octavio Ballesta-Lopez, Andres Cruz-Sanchez, Jose Luis Poveda-Andres
Why was it done?
Complex medication regimens (MR) are associated with worse treatment adherence. The Medication Regimen Complexity Index (MRCI) is a validated tool used to quantify complexity of MR and it is the sum of the score in three sections: Dosage forms (A), dosing frequency (B) and additional directions (C).
What was done?
To assess the relative MR complexity among solid organ transplant patients (SOT; kidney, heart, lung and liver) in a tertiary hospital through the validated MRCI Spanish version.
How was it done?
Transplant patients who collected medication in the Hospital Pharmacy between January and March 2021 were selected. A total amount of 40 patients (ten per transplant) were chosen randomly through Excel®, and a macro with a template of MCRI was created. The qualitative variables were age, sex and type of transplant; the quantitative ones were months from transplant, total amount of medications, sections A, B, C and total MRCI. All prescribed medications documented in medical records at the hospital ambulatory clinics and the electronic medication list were included. Patients were excluded if they were followed-up in other hospitals, were exitus or MR dosage or frequency was missed/unclear. Subgroup analyses was made to assess MRCI among type of transplants through ANOVA. All data analysis were made with SPSS® version 23, with a <0,05 significance level and a confidence interval of 95%.
What has been achieved?
Sample median age was 56,6±14,7 years (95%CI:51,9-61,3), a 40%(16/40) were women, median of time from trasplant was 92,7±69,9 months (95%CI:70,4-115,0) and number of medications 11,1±4,6 (95%CI:9,6-12,6). Subgroup median MCRI were 23,3±10,2 (kidney; [95%CI:16,0-30,5]), 46,2±12,8 (lung; [95%CI:37,1-55,3]), 28,5±11,1 (heart; [95%CI:20,6-36,4]) and 18,7±5,4 (liver; [95%CI:14,8-22,5]). Section B was the most contributor to MCRI (16,6±8,2 [95%CI:14,0-19,2]), followed by C (6,6±4,3 [95%CI:5,2-7,9]) and A (5,7±3,7 [95%CI:4,5-6,9]). Tukey test showed a statistically significant MCRI in lung transplant with p<0,001 when compared to kidney and liver transplants, and p=0,002 compared to heart transplant.
What next?
Medication regiment of our sample was more complex in lung patients than in any other SOT, therefore these patients could benefit more pharmaceutical interventions. Further studies with bigger samples are required to confirm differences among kidney, liver and heart transplants.
Implementation of dose banding strategy for Daptomycin
European Statement
Production and Compounding
Author(s)
Marta García-Queiruga, Begoña Feal-Cortizas, José María Gutiérrez-Urbón, Andrea Luaces-Rodríguez, Alejandro Martínez-Pradeda, Sandra Rotea-Salvo, Carla Fernandez-Oliveira, Víctor Giménez-Arufe, Luis Margusino-Framiñán, Isabel Martín-Herranz
Why was it done?
Daptomycin is an intravenous antibiotic usually prepared in Hospital Pharmacy services. Normally it is dosed based on body weight, which requires each intravenous mixture to be prepared in an individual manner for each patient. This might lead to an increased assistance workload in elaboration areas, a higher number of errors in the preparation and high costs due to waste materials generated during preparation.
What was done?
The aim of this study is to describe the preparation of intravenous daptomycin by dose banding, a system in which daptomycin doses are rounded up or down in order to standardize and protocolize the preparation of intravenous mixtures as much as possible.
How was it done?
In order to improve this situation, dose banding strategy was implemented in February 2019: the obtained final dose was rounded in such a way that only mixtures of 500, 700 and 850 mg were prepared (in agreement with Hospital Pharmacy and Infectious and Microbiology medical teams) , following this scheme:
PRESCRIBED DOSE PREPARED DOSE
< 400 mg Prescribed dose (individualized)
400–599 mg 500 mg
≥600–799 mg 700 mg
≥800 mg 850 mg
What has been achieved?
Previous year before starting dose banding strategy (2018), 5493 individualized doses of daptomycin were prepared for 437 patients in our Pharmacy service. Between June 2020 and June 2021, 2680, 2555 and 997 units of daptomycin 500, 700 and 850 mg, respectively, were prepared for 360 patients. Batches of standardized doses were prepared in advance and kept refrigerated (stability of 10 days in 100 ml of physiological saline) until dispensation. In addition, during the same period, 15 patients (4 from pediatrics) received 209 individualized doses (3.2% of the total doses) due to their low body weight.
What next?
This strategy might decrease the number of errors in preparation and reduce processing times, which is essential since early appropriate antibiotic treatment in severe infection has been associated with better outcomes. Dose banding model could be extrapolated to other drugs with good physical, medical and microbiological stability in dilution, which are frequently prescribed and when few dose bands can cover most of the prescriptions.
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.
Introduction of a new informatics tool to obtain important antimicrobial stewardship data
European Statement
Patient Safety and Quality Assurance
Author(s)
Sonja Guntschnig
Why was it done?
The aim of this good practice initiative (GPI) was to identify local resistance patterns, improve prescribing quality, reduce hospital costs, calculate antibiotic use data, track problem organisms, infection clusters and enable transfer chains tracing.
What was done?
With the introduction of a new antimicrobial stewardship (AMS) group into Tauernklinikum, Zell am See, a new informatics tool called HyBase® by epiNet AG was implemented to establish an interface linking microbiological results, consumption of antimicrobials, the hospital infections surveillance system “Krankenhaus-Infektions-Surveillance-System”(KISS) and the hospitals antimicrobial resistance data. AMS teams need suitable AMS surveillance systems to track intervention changes and measure results.
How was it done?
After purchasing release by the hospital management, HyBase needed an interface with several IT system providers, namely the internal microbiology laboratory (KISS software), System Application and Product in processing (SAP), and two external microbiology laboratories.
What has been achieved?
Antibiotic consumption figures were obtained retrospectively by calculating defined daily doses (DDD). This also gave insight into problematic use of certain antibiotics and indicated potential for antibiotic restriction.
Antimicrobial resistance patterns were displayed, which led to the introduction of infection control and AMS measures. Alert organism surveillance data was obtained and evaluated for different wards.
What next?
Learning from this implementation will enable changes in antimicrobial prescribing which will lead to improvements, both in healthcare quality and patient safety as well as a potential reduction in prescribing costs. Alert organism clusters will be detectable as will be transfer chains in the healthcare setting. It will also allow for the introduction of infection control agent stewardship for example by testing hand disinfection compliance or recording the spread of surface adherent organisms.
This GPI addresses the WHO antimicrobial resistance global action plan and local antimicrobial medicines concerns. It may prove useful for other healthcare settings and can be easily implemented to obtain data necessary for robust effective antimicrobial stewardship.
Assessing the Application of Essential Medication Errors Prevention Strategies in Healthcare Institutes: STOP Medication Error Project
European Statement
Patient Safety and Quality Assurance
Author(s)
Monira Alwhaibi
Why was it done?
This study is the first project of the STOP ME projects which aims to develop a tool that can assess the application of the essential strategies that can stop or minimize MEs in healthcare institutes in Saudi Arabia. Consequently, stakeholders in the healthcare system can identify current gaps that need feature improvement to enhance patient safety
What was done?
Medication Errors (ME) are defined as unintentional drug-induced harm that led to morbidity and mortality. The STOP (ME) project is a comprehensive series of research studies that aim to explore MEs in Saudi Arabia and how to stop such harmful events.
How was it done?
Extensive search of the literature review for the essential strategies to stop or minimize MEs was carried by the research team to develop a draft of the aimed tool. The survey tool was sent in round 1 to the Delphi experts’ panel for review. Based on received recommendations, the tool was updated and sent for round 2 review and consensus. The developed tool was then piloted to test the practicability of the tool before running the survey on large sample size (second project). The study was approved by the King Saud University Medical Centre IRB ethics committee [20/0153/IRB].
What has been achieved?
After using the Delphi technique two major changes happened to the survey. 1) Section A was removed (high alert medications). 2) A new section was added (ISMP publications) with some minor changes. Launching a pilot survey on thirty healthcare practitioners (physicians n=11, pharmacists n=10, nurses n=9) resulted in further minor changes by adding two new columns. The final tool was a survey consists of six sections including Demographics, Prescription, Dispensing, Administration, Monitoring and Quality, and Targeted Medication Safety Best Practices for Hospitals. All combined 86 questions with the determined time to answer the survey is in the range of 25-30 minutes. Overall feedback of the pilot survey was good.
What next?
This initiative “STOP ME” will have a significant impact in the field of medication safety research and will build awareness among institutes in Saudi Arabia that are lacking important strategies that prevent MEs
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.
USE OF PALBOCICLIB IN REAL CLINICAL PRACTICE
European Statement
Clinical Pharmacy Services
Author(s)
SILVIA BOULLOSA LALE, Fernando Bustelo Paz, Claudia Barca Diez, María Francisca Fernández Ribeiro, Lara González Freire, Susana Castro Luaces, Irea Celtia Proupín Cantelar, Carlos Crespo Diz
Why was it done?
The aim of this study is to evaluate the use, duration and safety of palbociclib treatment in real clinical practice in our healthcare area.
What was done?
Palbociclib is a cyclin-dependent kinase 4/6 inhibitor indicated for the treatment of metastatic breast cancer(MBC).
How was it done?
Retrospective observational study. All patients treated with palbociclib between June 2016-March 2021 were included.
Data collection was carried out using the electronic medical record and the pharmacotherapeutic management software application.
The variables collected were: gender, age, metastases, initial date, first/second line of treatment, concomitant treatment, delay of treatment, reason for dose reduction and for discontinuation of treatment.
Neutropenia was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE)4.0.
What has been achieved?
Data from 47 patients was collected, 100% were women. Median age: 60(33-85) years. 100% of patients were diagnosed with MBC:51.1%(24) visceral metastases.
Palbociclib was administered in 36.2%(17) of patients concomitantly with an aromatase inhibitor as first line of hormonal treatment for metastatic disease. 63.8%(30) of patients had already received prior hormonal therapy.
A first dose reduction was required in 42,5%(20) of patients, followed by a second reduction to 75 mg in 37.5%(6) of them. These reductions were due to grade 4 neutropenia in 19.2%(5) of patients and recurrent grade 3 in 80.8% (21). All neutropenias resolved after the respective reductions.
Treatment was definitively discontinued in 76.6%(36) of patients: 77.8% (28) due to progression; 13.9% (5) due to neutropenia; 5.5% (2) due to neutropenia and anaemia; and in 2.8%(1) of the patients the previous line of treatment was restarted for non-compliance.
Median overall progression free survival (PFS) was 11.23 months(CI95%:5.76-30.66).
Median PFS in the first-line treatment group was 30.66 months (CI95%:8.33-34.20). In second line it was 9.1 months(CI95%: 5.76-20.83). No statistically significant differences were shown (p=0.2).
What next?
The profile of palbociclib use in our area is predominant in second line treatment for MBC. The PFS achieved did not show any significant differences between second or first line.
The observed treatment duration was longer in patients who discontinued the treatment due to progression versus toxicity.
It is a safe drug: neutropenia, the most frequent cause of treatment reduction/discontinuation, is in all cases transient.
A novel method to decline the number of inappropriate penicillin allergy alerts in electronic prescription systems
European Statement
Patient Safety and Quality Assurance
Author(s)
Saskia Coenradie, Hans Groot, de, Amy Rieborn, Erna Groot, de, Martti Visbeek, Denise Abswoude, Christian Alderweireld, Annegien Kenter
Why was it done?
Allergies for drugs and especially allergies for antibiotics of the penicillin group are common questions in electronic patient data systems (EPDS) in hospitals. In many cases the verification of an allergy is seldom a thorough process and so many inappropriate penicillin allergies are recorded in EPDS. Literature reports that only 10% of recorded allegies are appropiate. This has a detrimental effect when infections occur and patients have to be treated with antibiotics. When a penicillin allergy is recorded in the EPDS a warning not to prescribe any antibiotic from the penicillin group is given. In most cases the physician has to choose another antibiotic that is normally not first choice. This can have worse patient outcomes. We conducted a feasibility study to investigate if a reported penicillin allergy in a patient’s record was appropriate or not using a standard allergy algorithm consisting of 10 questions with YES or NO as answers.
What was done?
A novel method is tested to decline the number of inappropriate alerts for penicillin allergy in our electronic patient data system
How was it done?
When the reported allergy in a patients record popped up in our EPDS, a pharmacy technician was asked to have a medication – and allergy verification conversation with the patient. Only patients that were admitted to the emergency ward or the acute admittance ward of our hospital were included to test this method on feasibility. The feasibility study started in March 2021 after permission from our board of directors and after a declaration of our medical ethics committee stated that no judgement of this committee was neccessary. We started on the emergency ward in March 2021. Because of slow inclusions we decided in september 2021 that another ward needed to be included in this feasibility study to achieve the number needed to prove this method feasible (80 patients). Statistical analysis was done using IBM SPSS statistics,(vs 25) and the primary outcome was the total number and percentage of inappropriate penicilline allergies.
What has been achieved?
Up till October 2021 29 patients were included in this feasibility study. Most of them had an inappropriate record of penicllin allergy after a pharmacy technician had a medication- and allergy-verfication conversation using the standard algorithm. We will continue with this feasibility study until 80 patients have been included and our statistical analysis can be done appropriately.
What next?
Continue with inclusions until the number needed to statistical analysis has been reached (80 patients). We will then perform our statistical analysis and hope to report back to you at the 27th EAHP congress in 2023 that this method is effective and reproducible. And most importantly, decreases the number of inappropriate penicillin allergy records in hospitals. We are confident that with this method we create a tool to decrease the number of inappropriate allergy records in our electronic prescription system in our hospital.