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Stewardship initiative for COVID-19 monoclonal antibodies led by clinical pharmacists

European Statement

Clinical Pharmacy Services

Author(s)

Petra Rozsívalová, Věra Zdanovcová, Lenka Beková, Martina Maříková, Marcela Heislerová, Vladimír Koblížek, Petr Šmahel

Why was it done?

By implementing systematic monitoring in our institution, CPs ensure appropriate and safe use of unlicensed treatment available under Emergency Use Authorisation. The secondary goal is mandatory data input to national register and patient clinical outcome feedback to physicians and hospital management.

What was done?

It is vital to bring focus on appropriate use of COVID-19 monoclonal antibodies (mAbs) in high-risk population when safety and efficacy data are scarce. A team of clinical pharmacists (CPs) helped to set up process flow, monitor prescribing of mAbs and provide systematic follow-up on time course of symptoms reported by SARS-COV-2 positive outpatients since March 2021.

How was it done?

Ethics committee approval was obtained for monitoring of patients. Consented patient data are extracted from electronic prescribing system and patients score subjective symptoms using questionnaire on days 7, 29 and 90 after the infusion. The prescriber, indication criteria, infusion application day with regards to PCR positivity and symptom onset and vaccination status are recorded.

What has been achieved?

Currently our small dataset includes 59 bamlanivimab and 63 casirivimab/imdevimab patients. On average, mAbs are administered within 2 days of positive PCR test and 5 days of COVID-19 symptoms onset. Our patients report subjective improvement in symptoms by 7 days post infusion. None of our patients clinically deteriorated because of COVID-19. 100 % of mAbs administered are reported in the national database. In October 2021 we achieved that laboratory confirmed positive patients receive text message with infectionist contact to discuss eligibility for mAbs on 24/7 basis. CPs also implemented information leaflets on mAbs for patients with chronic conditions.

What next?

To date, there are no published descriptive data on real-life utilisation of COVID-19 mAbs in terms of patient characteristics, disease outcome and vaccination status. Our initiative shows na excellent opportunity for CPs to enhance timely and rational mAbs use.

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.

Pharmacoeconomical methods (ABC/VEN – analysis) for rationalization of medicines

European Statement

Selection, Procurement and Distribution

Author(s)

Alina Shramko, Veronika Haziahmetova

Why was it done?

Based on the results of the analysis, it is possible to answer the question whether it is advisable to spend financial resources, using the example of one healthcare facility; what steps should be taken to rationalize drug procurement; which drugs should be considered first of all for inclusion/exclusion from the procurement list.

What was done?

Currently, ABC/VEN analysis is one of the most effective pharmacoeconomical methods recommended by WHO for the use in the healthcare system. The use of pharmacoeconomic methods is carried out in accordance with the inherent effective use of drugs, and is carried out strictly in accordance with the principles of evidence-based medicine.

How was it done?

The ABC/VEN analysis was conducted based on data from the pharmacy of the LPI containing the costs of purchasing medicines during 2020. The VEN category was determined after a thorough review of the evidence available to us about the effectiveness, safety and cost of drugs.

What has been achieved?

The cost of drug provision to healthcare facilities in 2020 amounted to 62 943 951,38 rubles. The number of international generic name purchased and used was 355. About 35% of the funds were used for a group of vital medicines. The cost of the necessary medicines amounted to 43% of the funds – this corresponds to WHO recommendations.
In accordance with the ATX-classification, drugs affecting blood formation and blood are in the lead in terms of the volume of costs – 40.9% of all costs.
The drug is enoxaparin sodium, the leader in terms of costs in 2020. It is a direct anticoagulant (low molecular weight heparins with a molecular weight about 4500 daltons), which has an antithrombotic effect (2.38% of the total budget).
Also, the top ten leaders in terms of costs included saline sodium chloride solution – 6.1% of the annual budget, which probably indicates irrational excessive use of infusion therapy.

What next?

The application of pharmacoeconomical methods and principles of evidence-based medicine allowed us to assess the feasibility of drug procurement and serves to rationalize the use of medicines.

EXPANDING OPPORTUNITIES FOR PHARMACISTS IN ONCO-HEMATOLOGIC CLINICAL TRIALS: DESIGN AND IMPLEMENTATION OF THE OUTPATIENT SERVICE MODEL

European Statement

Clinical Pharmacy Services

Author(s)

Eugenia Serramontmany Morante, Patricia Garcia Ortega, Lorena Garcia Basas, Pablo Latorre Garcia, Pilar Rovira Torres, Laura Maños Pujol, Isabel Cidoncha Muñoz, M. Queralt Gorgas Torner

Why was it done?

The provision of outpatient oncology services by pharmacists is still limited, but it is an emerging role. It can add value while increasing the quality of patient care required, maximizing the likelihood of achieving positive outcomes and thus improving the patient’s quality of life. It is important to incorporate clinical pharmacists into outpatient clinics to ensure the safe use of investigational drugs and guarantee the best treatment for the patient.

What was done?

The oncology clinical trials pharmacy team initiated an outpatient clinic at a tertiary hospital. This enabled review of patients’ medications, monitoring of interactions, appropriate oral chemotherapy counseling, design of medication diaries and instructions, discussion of side effects, as well as other dietary and daily living recommendations.

How was it done?

A multidisciplinary team was formed: pharmacy, medical, nursing, ancillary and administrative staff, to discuss circuits and strategies to address outpatient pharmacy clinic.
The pharmaceutical care program was implemented gradually during 6 months, first in phase I, then phases II and III clinical trials.
Factors including appointment scheduling, patient prioritization, clinic room availability as well as detailed definition of pharmaceutical activity were discussed, in order to have a standard procedure for all patients included in a clinical trial.
The group continued to meet weekly to further discuss the progress of the pharmaceutical care program and any obstacles and unforeseen events.

What has been achieved?

Medication has been dispensed to 8447 patients in the outpatient pharmacy, of which 1172 patients have been attended by the clinical pharmacist during the first 8 months (January-August 2021) of the programme’s implementation.
Pharmaceutical care at the first day of treatment has been provided to 275 patients to explain how to take the treatment and resolve doubts. The concomitant medication of 312 patients has been reviewed for the screening and 425 telephone queries about concomitant medication have been resolved.

What next?

The evolutionary change in cancer care along with the increase in the number of clinical trials and its complexity will emphasize the need to include the oncology pharmacist in the cancer care team. The role of a clinical pharmacist is vital to ensure the safety and controlled use of the drug, ensuring the best possible outcomes.

Optimizing information on the fecal microbiota transplantation circuit

European Statement

Patient Safety and Quality Assurance

Author(s)

Julia Santucci, Céline Vaesken, Guillaume Saint-Lorant

Why was it done?

FMT is a therapy introduced in 2016 at the hospital. It is indicated for the management of recurrent and refractory Clostridioides difficile (CD) infections. In November 2020, with the resumption of the activity, we note a lack of knowledge of the different actors on this circuit: physician, nurses, fellows, patients himself.
The objective of the study is to reinforce the understanding and safety of the FMT circuit in a university hospital after the evaluation of the knowledge of the different actors.

What was done?

Implementation of a document to represent the circuit of fecal microbiota transplantation (FMT) in a French university hospital.

How was it done?

In this context, two questionnaires containing less than five questions on the functioning of the circuit were carried out with the nurse coordinators (NC) and the interns of the hepato-gastrology department. Subsequently, a document was drafted in consultation with the referring physician, the head of department and the pharmaceutical team to represent the FMT circuit.

What has been achieved?

With regard to the questionnaires, we obtained six answers from the NC, with 42% correct answers, 25% partial answers and 33% incorrect answers, and then six answers from the residents, with 20% correct answers, 7% partial answers and 77% incorrect answers.
These questions made it possible to draw up a diagram adapted to A4 format intended for all the actors in the circuit. It defines the different missions of all the actors with the corresponding deadlines and associated procedures.
In order to improve information, two interventions were carried out by the pharmacy: a staff meeting dedicated to the management of CD infections with the interns, co-hosted with the referring physician, and a presentation of the circuit to the NC.

What next?

Finally, this study made it possible to reinforce the safety of the FMT activity for the patient and to improve the management of the circuit for the various health professionals involved in this specialized therapy.

ADAPTING CLINICAL PHARMACY SERVICE PROVISION TO THE EMERGENCY DEPARTMENT DURING THE COVID19 PANDEMIC

European Statement

Clinical Pharmacy Services

Author(s)

Dearbhla Murphy, Mariosa Kieran, Jennifer Brown

Why was it done?

The Emergency Department (ED) at our institution is one of the busiest in Ireland. In 2019, there over 84,000 attendances. The ED CPS is multifaceted and involves clinical review of prescribed drugs, consultation with medical and nursing colleagues to ensure safe, effective and rational prescribing, drug supply and Medicines Reconciliation (MR). In order to meet patient requirements during the COVID19 pandemic, the ED was re-configured. The departmental changes necessitated realignment of the CPS to ensure evolving institutional requirements were being met while maintaining service provision.

What was done?

• ED Stock lists were reviewed and modified to ensure prompt availability of COVID19 treatments.
• Drug lists were devised for new ED zones to ensure availability of emergency and antidote medicines on a 24/7 basis.
• ED requirements for COVID critical medicines e.g. neuromuscular blockers, propofol, midazolam and antivirals were implemented in response to emerging evidence.
• Appropriate drug and fluid storage locations were reviewed in line with legislative requirements.
• Pharmacy technician top-ups were modified and standing orders introduced.
• Technician staff received Personal Protective Equipment (PPE) training to facilitate topping-up of drug presses in high-risk patient-facing areas.
• Access to critical care and COVID19 Respiratory Infection treatment protocols was expanded to ensure point of care access
• All associated SOPs were updated
• CPS provision was reviewed, changes introduced include:
1. fixed zone staffing allocations to reduce cross-contamination of staff
2. guidance on Infection Prevention and Control measures for completing MR patient interviews
3. electronic transfer of Clinical Pharmacist handover to ward based pharmacists

How was it done?

• A multidisciplinary team (MDT) of stakeholders was formed of Nursing Management, ED Consultants and the Pharmacy Department.
• The ED pharmacist coordinated the Pharmacy review.
• The procedures and policies governing CPS provision and ED drug stock holdings, storage and availability were reviewed and adapted.
• The MDT supported roll out of the changes in practice through communication and staff training.

What has been achieved?

Continuity of the CPS provision to the ED during COVID19 pandemic was ensured.

What next?

Through this review, the multidisciplinary ED team collaborated to successfully review CPS provision to adapt for the unique and evolving clinical needs of patients during the COVID19 pandemic. This ensured the safe delivery of a high quality CPS and continuity of drug supply.

Improving Patient Safety: A step forward in reducing missed medication in the Emergency Department (ED)

European Statement

Patient Safety and Quality Assurance

Why was it done?

Long waiting times and delays in patients leaving ED increase the risk for missed doses. Medication reviews and analysing incident reports identified missed doses as a patient safety issue where the strategies implemented aimed to improve this.

What was done?

Reducing missed doses and improving patient safety was addressed as follows:
 Integrated pharmacy service was established
 Audit completed
 Education model developed
 Stock list reviewed

How was it done?

Integrated pharmacy service:
-Outlined the role of the pharmacy team in ED.
-Pharmacist medication review service established which identified medication incidents particularly missed doses.
-Pharmacy technician role expanded: Reviewed patient charts, identified issues, collaborated with the ED team, and dispensed medication in medication
transfer bags.
-Implemented medication transfer service: Individual patient medication transfer bags were sent from ED to the transfer ward ensuring timely availability
of medication during transitions of care.

Data collection and analysis:
-Quantified missed doses and reviewed the percentage of these which were time-critical. Time-critical medications are medications where timely
administration is crucial to prevent patient harm.

Education model:
-Developed and implemented a pharmacy technician training programme: This ensured an optimal medication management service.
-A local list of time-critical medication was agreed upon. A poster was developed and erected in ED to highlight time-critical medication.
-Structured and targeted multi-disciplinary education was provided on time-critical medication and the impact of missed doses.

Stock list modified so medication was immediately available in ED. Capacity in the automated dispensing unit (ADU) was an obstacle so the ADU was reconfigured to overcome this.

What has been achieved?

 A clinical pharmacy service was established which reduced medication errors.
 Missed doses decreased by 75%.
 Time-critical medications are readily available.
 Medication transfer bags ensured timely availability of medication during transitions of care.
 Education model implemented which improved patient safety.

What next?

 Continue the integrated pharmacy service in ED.
 Missed doses will be assessed through point prevalence surveys, medication reviews, and incident reports.
 Extend the education model to other areas of the hospital and apply learning.
 This initiative can be adapted to other hospital settings.

MEDICATION REVIEW IN FALL-RELATED HOSPITAL ADMISSIONS

European Statement

Patient Safety and Quality Assurance

Why was it done?

Falls in older people are a significant public health problem due to their high prevalence, the injuries they cause and the associated economic burden. They are often caused by multifactorial risks, being the Fall-Risk-Increasing-Drugs (FRIDs) one of the most significant ones. The aim of this initiative is to reduce FRIDs prescriptions among elderly at risk of falling, by assessing their individual Benefit-Risk Balance.

What was done?

A circuit was designed and implemented to review and optimize the medication of patients admitted to hospital after a fall.

How was it done?

On an everyday basis, the Health Management Unit of our tertiary university hospital sends a list of fall-related hospital admissions to the clinical pharmacists (CP), who review those patients’ medication and identify FRIDs (drugs affecting central nervous system, hypoglycemic/antihypertensive agents, among others). Electronic Health Records (EHR) are consulted to evaluate if medication could have had a role in those falls. When a patient’s medication is subject to any optimization, CP contact the referring physician to propose therapeutic modifications. This pharmacist-doctor communication is carried out during the hospitalization period in case of Internal Medicine admissions and by an administrative appointment with the primary care physician (PCP) when patients are admitted in other units, such as Traumatology or Neurosurgery. The PCP evaluates the medication review report attached by CP in patients’ EHR and modifies medication if necessary.

What has been achieved?

Between May and September 2021, 114 patients were admitted to hospital due to a fall. After excluding 10 institutionalized patients (pharmaceutical care provided by their own team), 6 patients having fallen after alcohol consumption or intentional drug overdose, and 7 palliative patients, the medication of 91 patients was reviewed. The mean age was 80 and the 64.8% were female. An average of 3 FRIDs was identified per patient. 52 pharmaceutical interventions were made, mainly dose reductions and FRIDs deprescribing suggestions.

What next?

This initiative is feasible and potentially beneficial for patients’ health care. Medication review leads to the identification of not only FRIDs, but also different drug related problems. We look forward to assessing the impact of our practice in terms of interventions accepted; drug-related negative outcomes avoided and decreased hospital readmissions.

Implementation of a workshop about the role of the hospital pharmacist role during the clinical clerkship in medical training

European Statement

Education and Research

Author(s)

Vincent ARCANI, Stéphane HONORÉ, Guillaume HACHE

Why was it done?

Interprofessional collaboration as an effective means for improving healthcare outcomes. In order to achieve an effective level of collaborative healthcare practice, health care educators must focus attention on interprofessional education in undergraduate programs. Knowledge of professional role of others is a key competency for interprofessional practices and there is a lack of knowledge on hospital pharmacists’ roles among other health care professionals.

What was done?

We developed a workshop focused on the role of hospital pharmacists, to be integrated into the curricula of other health professionals.

How was it done?

The workshop was developed by a resident in hospital pharmacy and a senior hospital pharmacist, and we first targeted medical curriculum. The session integrated: students’ perception of hospital pharmacists’ role, didactic learning on the role of hospital pharmacists according to the European statements in hospital pharmacy, immersion in practice and evaluation. The assessment of the learning effect was performed by a pre-/post-workshop questionnaire, assessing satisfaction, metacognition and acquired knowledge. In addition, students provided open feedback on the workshop.

What has been achieved?

We implemented the workshop during the first year of clinical clerkship in medical education. Preliminary results highlighted (i) a high satisfaction, illustrating the relevance of the initiative; (ii) an increase in perceived knowledge and (iii) an increase in knowledge about hospital pharmacists’ roles, especially about pharmaceutical technologies and medical devices. Verbatim analysis of the feedback suggested that the workshop modified medical students’ perceptions on the role of hospital pharmacists, and that they may be more inclined to seek collaboration with hospital pharmacists.

What next?

To integrate the workshop into the curricula of the other professions in order to raise awareness on hospital pharmacy and promote interprofessional teamwork.

ncrease in the prescription of Benzodiazepines in the context of the SARS COV 2 pandemic.

European Statement

Clinical Pharmacy Services

Author(s)

Elena Elvira Ladrón de Guevara, Belen Sanchez Rodriguez, Misael Rodriguez Goicoechea, Marina Sanchez Valera, Diego Gámez Torres, Francisca Verdejo Reche, Inmaculada Alférez García

Why was it done?

The main aim of this study is to find out the prescriptions of benzodiazepine derivatives from 2018 to 2021 in the context of the SARS COV 2 pandemic and the variation in them. As a secondary objective, we will learn which benzodiazepine derivatives varied more.

What was done?

The most frequently recorded mental health problem is anxiety disorder and in the context of the SARS COV 2 pandemic, where an increase in anxiety cases has been evidenced, benzodiazepine derivatives (N05BA) have been one of the most prescribed pharmacological groups in most developed countries for this problem. Although its short-term benefits have been demonstrated, increasing its consumption may have long-term risks.

How was it done?

Retrospective, observational and cross-sectional study. The study period includes June 2018, June 2019, June 2020 and June 2021. The study population includes the 710.581 inhabitants associated with the prescribing doctors of benzodiazepine derivatives, from the study province.

What has been achieved?

N = 710,581, 21.61% (153,574) with a benzodiazepine prescription, 67.33% (103,416) women, between June 2018-June 2021. The prescribed benzodiazepine derivatives: alprazolam, Diazepam, diazepam / priridoxine, clotiazepam, lorazepam, ketazolam, clobazam, pinazepam, clorazepatodipotassium, bromazepam, bentazepam, diazepam / sulpiride, diazepam / sulpiride / pyridoxine.
June 2018: 35,800 prescriptions, 67’30% (24,085) women, June 2019: 37,601, 67.20% (25,262) women, June 2020: 39,547, 67.30% (26,622) women and June 2021: 40,626, 67, 60% (27,477) women.
From June 2018 to June 2019 prescriptions increased 5.03% (1,801), from June 2019 to June 2020 they increased 5.20% (1,946), from June 2020 to June 2021 they increased 2.73% ( 1,079), which represented a 13.48% increase in prescriptions from June 2018 to June 2021 (4,826).
The largest prescription increases were diazepam + 23%, lorazepam + 18%, bromazepam + 12.5%, and alprazolam + 12.3%. The largest prescription decreases were clotiazepam and bentazepam -100%, pinazepam -96’43% and clobazazam -22’45%.

What next?

Currently, the consumption of benzodiazepine derivatives has been increasing due to an increase in stress and anxiety situations and, in the context of the SARS VOC 2 pandemic, we have seen a progressive increase of 13.48% (4,826 prescriptions) from June 2018 to June 2021, with women being the user of 67.33% of prescriptions on average. These data allow us to know the current situation of the prescription of benzodiazepine derivatives to the population and to focus on mental health both in the validation of treatments and in pharmaceutical care.