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IMPROVING MEDICATION SAFETY IN PATIENTS WITH HEPATIC CIRRHOSIS

European Statement

Patient Safety and Quality Assurance

Author(s)

ANDREA RODRÍGUEZ ESQUÍROZ, AMAYA ECHEVERRÍA GORRITI, Mª CONCEPCIÓN CELAYA LECEA, MARTA MARÍN MARÍN, LOREA SANZ ÁLVAREZ, PATRICIA GARCÍA GONZÁLEZ, JAVIER GORRICHO MENDIVIL, JAVIER GARJÓN PARRA.

Why was it done?

A prescription alert system was developed in our region for the management of drugs in patients with hepatic cirrhosis.

What was done?

A preliminary study made in our region showed that around one in four prescribed medications in cirrhotic patients are contraindicated or overdosed. Besides, it is estimated that around 38% of cirrhotic patients suffer any adverse effect despite approximately 70% of them are preventable.
In addition, safety problems can emerge due to the lack of data regarding drugs management in patients with cirrhosis.
For these reasons, it was essential to develop a tool that helped clinicians during the prescription process and pharmacists while pharmaceutical validation and medication review.

How was it done?

A computer-generated prescription alert system was developed. This system provides security data and dosing recommendations according to Child-Pugh classification of each patient. Besides, the tool suggests safer alternatives when an unsafe drug is prescribed. These recommendations were extracted from the product information and three databases: UpToDate, RxCirrhosis and Geneesmiddelen bij.
According to last laboratory data available from the electronic medical records such as bilirubin, prothrombin time and albumin, this tool estimates the Child-Pugh score, that must be completed with ascites and encephalopathy grade.
At this time, this tool is only available for clinical pharmacists for validation, and it is expected to be implemented for physicians soon.

What has been achieved?

From May to September 2024, a total of 202 drugs were included, 59 (29.2%) were considered contraindicated in some degree of cirrhosis, so it was recommended not to use. Dose adjustment was proposed in 109 (54.0%) drugs, while in 13.9% the tool recommended a safer alternative drug.
In order to complement this issue, information and training sessions were given about safe management of drugs in cirrhotic patients.

What next?

We are working in order to include safety data about more drugs in this alert system.
We hope this tool can help professionals of other regions and countries.

SEMI-AUTOMATED PHARMACEUTICAL CARE CIRCUIT IN NURSING HOMES: EXCEEDING MAXIMUM DOSE PRESCRIPTIONS IN ELDERLY PEOPLE

European Statement

Patient Safety and Quality Assurance

Author(s)

Amaia Martiarena Ayestaran, Ane Ros Olaso, Iosu Barral Juez, Cristina Saiz Martinez, Ane Latasa Berasategui.

Why was it done?

Detection of potentially inappropriate prescriptions (PIPs) exceeding maximum dose in elderly patients. Communicate these findings to nursing home´s (NH) medical staff adding information to make easier the review. Evaluate the results obtained after the pharmaceutical intervention (PI).

What was done?

Pharmaceutical care provided in NH includes systemic reviews and drug adjustments in collaboration with clinical team to enhance the rational use of drugs.
It is designed a semi-automated pharmaceutical care circuit to detect exceeding maximum dose PIPs due to high prevalence in this population. The objective of this practice is to reduce, after a PI, PIPs to improve patient’s safety.

How was it done?

Selection of the most prevalent exceeding maximum dose PIPs based on STOPP-START criteria, safety notes and technical sheets from Spanish Agency for Medicines and Health Products: omeprazole, esomeprazole and rabeprazole ≥ 40 mg/day, pantoprazole ≥ 80 mg/day, lansoprazole ≥ 60 mg/day (PPIs); zolpidem (ZLP) > 5 mg/day; acetylsalicylic acid > 100 mg/day (AAS); citalopram > 20 mg/day; escitalopram > 10 mg/day (SSRIs); iron > 200 mg/day (Fe).
Automatic data extraction.
Registration in medical records and email notification to NH´s physicians including drug and dosage, adjustment recommendation and bibliographic reference.
Results evaluation after 2 weeks.
Limitations: way of communication and drug prescribing doctor different from NH´s doctor. To solve the first issue, an email has been sent after 1 week. On the second case, no action could be taken.

What has been achieved?

155 residents with one or more exceeding maximum dose PIPs are included from 22 centers with 2,223 elderly people linked to hospital pharmacy service. The mean age is 85.3 years and 69.7% are women.
After PI, PIPs are reduced by 66.5%.

PIPs TOTAL PPI ZLP Fe SSRI AAS
INITIAL 164 73 51 18 17 5
AFTER PI 55 20 21 5 8 1

Dose reduction and prescription discontinuation are the reasons of the PIPs reductions. Physicians justify don´t change prescriptions on 8 cases.

What next?

This semi-automated circuit is focused on PIPs. That is why the tool allows easy and rapid detection of a higher amount of patients with drug safety problems at once. In the future, it will be used for other PIPs and other NH.

Clinical and economic optimisation for the management of patient at risk of respiratory syncytial virus infection

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European Statement

Clinical Pharmacy Services

Author(s)

Erica Cusumano, Giorgia Nairi, Cristina Baiamonte, Chiara Schimmenti, Lo Verso Clelia, Carolina Scaccianoce, Marcello Vitaliti, Sceila Affronti, Marco Benanti, Paolo Amari, Patrizia Marrone

Why was it done?

Until 2020, pavilizumab, refunded by National Health System for Respiratory Sincytial Virus (RSV) infection prophylaxis of paediatric patient at risk, was dispensed in 50 mg (FL 50) and/or 100 mg (FL 100) unit packs, regardless of the prescribed dose, with subsequent preparation on the ward and waste of any residual drug. Therefore, the project’s purpose, from November 2021, was to overcome the past distributive criticalities of pavilizumab.

What was done?

In our Hospital, Early Start 2.0 project (E.S-2.0) was implemented in collaboration with the neonatal intensive care unit. The E.S-2.0 purpose was to increase quality and safety of Pavilizumab galenic preparation to guarantee the patient’s health and generate an economic saving with an optimisation of hospital resources.

How was it done?

The E.S.-2.0 involved weekly drug days for the delivery to department staff of personalised galenic preparations of pavilizumab, prepared by hospital pharmacy service in a contamination-controlled environment. Through the hospital management system, prescriptions for the period November 2021 to April 2022 were extrapolated to verify the validity of the project. There were 85 patients. A palivizumab consumption database was created to evaluate the mg saved after E.S.-2.0 and the related economic savings.

What has been achieved?

Project implementation allowed us to obtain an economic saving of 9.33% related to 2339.01 mg that would have been dispensed and wasted without E.S-2.0. The results obtained considering the costs of pavilizumab (FL-50: 10.79 €/mg and FL-100: 8.96 €/mg) and our saving indicators: mg saved= mg that would have been delivered before E.S-2.0 – mg after E.S-2.0; € saved = (mg residues that would have been dispensed and wasted before E.S-2.0 from FL 100 x 8.96 €/mg) + (mg residues that would have been dispensed and wasted before E.S-2.0 from 50 x 10.79 €/mg). In addition, the personalised galenic preparations in controlled contamination pharmacy premises guaranteed a sterile pharmacological manipulation process.

What next?

E.S.-2.0 represents a cost saving policy safeguarding patient security. Practice described is worthy of implementation in hospitals not just for prophylaxis of RVS infection but also for the management of all patients undergoing treatment with therapies that can be prepared in galenical laboratory.

The European Paediatric Formulary: a reinforced approach for improved monographs

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European Statement

Production and Compounding

Author(s)

Théo Henriet, Jane Francomb, Dirk Leutner, Jörg Breitkreutz

Why was it done?

The PaedForm project was launched as a bibliographical exercise, with the aim of collecting age-appropriate formulations from existing formularies or from established sources in Europe and incorporating them into the PaedForm.
However, the data underpinning existing monographs were not as complete as expected and errors in the source data were observed. Adding an experimental verification step was therefore crucial to ensuring the reliability and the appropriate quality of the formulations described in PaedForm and demonstrating that the monographs could be used in practice.

What was done?

A decision to add an experimental verification to the elaboration process for monographs to be published in the European Paediatric Formulary (PaedForm) was recommended by the experts from the PaedF working party (PaedF WP) – assisted by the European Directorate for the Quality of Medicines & Healthcare (EDQM) – and supported by the European Committee on Pharmaceuticals and Pharmaceutical Care and the European Pharmacopoeia Commission.
This verification step involved checking the preparation against the description in the monograph and, where necessary, completing it. Samples prepared during this step were then tested to check that the quality control methods included in the monograph were suitable. The findings were used to determine whether the monograph could be completed.
Where necessary, this experimental verification would include tests such as the microbial challenge test as described in European Pharmacopoeia (Ph. Eur.) general chapter 5.1.3.

How was it done?

Experts from the PaedF WP support the need for practical verification and perform the experimental verification if needed. The EDQM supported this work by sourcing active substances and consumables and by organising analytical testing for techniques not available to the experts.

What has been achieved?

This approach enabled the enhancement of a furosemide oral formulation. The composition of this formulation as described in the source material did not meet the Ph. Eur. requirements for antimicrobial preservation, so it was changed to include a higher concentration of the preservative and comply with the Ph. Eur. requirements.

What next?

The PaedF WP will continue to expand PaedForm by elaborating new monographs covering unmet therapeutic needs. Users are invited to contribute to this process by commenting on texts published in the PaedForm Pharmeuropa public consultation platform.

Design, build and implementation of electronic prescribing and medicines administration in neonatal units across four UK hospital trusts

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European Statement

Introductory Statements and Governance

Author(s)

Holly Jones, Nicola Vosser

Why was it done?

Neonatal units were out of scope during the initial EPMA go-lives due to the complexities in prescribing and the specialist resource required for implementation. This project therefore brought neonatal units in line with all other areas, transitioning from paper drug charts to EPMA. In addition, it supported an ICS wide goal to align practice between trusts, standardising prescribing and facilitating effective use of digital systems in healthcare.

What was done?

A neonatal formulary was developed on an existing Electronic Prescribing and Medicines Administration (EPMA) system shared by four hospital trusts that make up a regional Integrated Care System (ICS). This involved interdisciplinary collaboration and shared decision making to align practice and prescribing guidelines. Complex protocols included continuous variable rate drug infusions, intravenous fluids and parenteral nutrition.

How was it done?

Key guidelines were shared with a collaborative approach to identify and harmonise differences in local practice, including syringe volumes and dose calculation ‘factors’. The EPMA team (comprising specialist pharmacists and medicines management technicians) completed a thorough gap analysis of the existing adult and paediatric drug catalogue and managed all new build work for neonates. Clinical decision making and validation were multidisciplinary tasks with input from specialist clinicians, pharmacists and nurses. Training, go-live planning and implementation were led by the EPMA team.

What has been achieved?

A bespoke neonatal medication build has been successfully implemented, supporting safe and efficient prescribing in neonates across the ICS. The development provides the ability to prescribe medications and document administration clearly and safely, including adjustment of infusion rates. Clinical pharmacists have full visibility of this information and are able to accurately complete pharmacy reviews, interventions and verification. In addition, alignment of practice and standardisation of care has been reached across the ICS, with benefits to both staff and patients.

What next?

The neonatal build is updated and optimised based on feedback from users to maintain the usability and safety of the system. Development of electronic fluid balance charts for neonates, including drug infusion volumes, is also in progress. Details of the neonatal project are being shared with other UK hospital sites using the same EPMA system.

Implementation of therapeutic drug monitoring active proposal in the hospitalised patient

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European Statement

Clinical Pharmacy Services

Author(s)

Alba María Fernández Varela, María Isaura Pedreira Vázquez, Sandra Koprivnik, Ana María Montero Hernández, Isaura Rodríguez Penín

Why was it done?

Therapeutic drug monitoring (TDM) allows an optimised pharmacological treatment and increases safety. Lately, we detected low interest in TDM which was confirmed from our annual activity report. An observational prospective study was carried out in a second- level hospital attending an area of 175 930 patients. The study included all inpatients prescribed a drug eligible for TDM from November 2020 to January 2021. The aim was to improve treatment individualisation of hospitalised patients through an active proposal for drug level determination of drugs susceptible for TDM at our institution: digoxin, vancomycin, antiepileptic drugs (carbamazepine, phenytoin, phenobarbital and valproic acid).

What was done?

The pharmacist encouraged therapeutic drug monitoring of susceptible treatments by an active proposal for drug level determination in the prescriptions programme.

How was it done?

Daily, a list of eligible patients was obtained. To this end, a filtering software was used. Taking into account patient’s demographics, clinical and analytical variables (creatinine clearance, the last TDM result, diagnosis) and active prescriptions (treatment initiation, interactions), the pharmacist makes a recommendation for plasma drug level determination.
Data sources: electronic prescription program, pharmacokinetic validation program and electronic medical record.

What has been achieved?

119 proposals of TDM were made in 107 patients: 79 digoxin, 31 vancomycin, 4 valproic acid, 3 carbamazepine and 2 phenytoin. 45,8% women.
74 drugs were discontinued before possible sample extraction and 5 monitorisations could not be performed due to patient death. Of the 40 remaining proposals, the physician requested monitoring of 35 drugs, which meant 87,5% acceptance rate.
It was observed that 17 levels were low or at a lower limit (a dose increase with subsequent verification of levels was proposed in 8 cases and accepted in all of them), 13 levels were in range, 4 were high or at an upper limit (in 3 of them the dose was decreased). One sample was extracted after the drug administration (vancomycin) therefore without value.

What next?

Pharmacists can contribute to treatment optimisation by being proactive. Many resources are not needed unless the burden of care was a limiting factor. The education and promotion of TDM would be interesting to improve the use of this service.

Removing false beta-lactam allergy warnings: role of the clinical pharmacist in collaboration with the allergology service

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European Statement

Clinical Pharmacy Services

Author(s)

Carlos Santos Rodríguez, Silvia Irene Corrales Vargas, Maria de los Ángeles Peña Peloche, Alfredo Julian Jover Sáenz, Miguel Ángel Ramos Gil, Arturo Morales Portillo, Marta Mir Cros, Francisco Ignacio Torres Bondia, Lluis Marqués Amat, Joan Antoni Schoenenberger Arnaiz

Why was it done?

Beta-lactam antibiotics are the most commonly used group of antimicrobial drugs but are also the ones with the most significant induction of allergic reactions. However, it is known that many of these patients do not present reactions upon rechallenge or have false allergy warnings in the medical records.

What was done?

To assess the impact of a pharmacist-driven programme for active beta-lactam allergy warning removal in adults in collaboration with the Allergology service.

How was it done?

We identified adults with active beta-lactam allergy warnings among outpatients aged 35 to 45 years over 26 months.
Both in the hospital and primary care setting the pharmacist assessed the current information of the cases in the electronic medical records (EMR) and through personal interviews or by telephone. The following data were retrieved: year of allergy registration, type of reaction described, tolerance of beta-lactam antibiotics, and the existence of Allergology reports.
The pharmacist, previously trained by the Allergology service, could proceed to remove or confirm the allergy label, if applicable, or refer the patient to the Allergology service for allergy tests.

What has been achieved?

We reviewed a total of 1178 cases with active beta-lactam allergy warnings. The most frequently implicated beta-lactam drug was amoxicillin, with 170/1178 (14.4%) cases.
111/1178 (9.4%) of cases had an allergic reaction in childhood, and in 714/1178 cases (60.6%) EMR did not describe the symptomatology or treatment that justifies the allergy.
The allergy warning was directly removed in 93/1178 (7.9%) of patients, as they had previous reports of Allergology, had tolerated antibiotics after the allergic reaction, or did not present symptoms compatible with an allergic reaction.
The review confirmed allergic warnings in 43/1178 (3.65%) cases, according to the symptomatology and the information recorded in the Allergology reports.
One thousand and forty-two cases were referred for beta-lactam allergy test performance in the allergology service, of which 47% yielded a negative result.

What next?

The pharmacist is qualified to remove the warning in cases with a doubtful allergy to beta-lactam antibiotics after a thorough medical record review and informed consent. Moreover, the pharmacist can provide valuable information that allows the classification of warnings according to the detected risk and facilitates subsequent decision-making by the allergist.

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.

ANTIMICROBIAL DOSING IN OBESE PATIENTS: ADJUSTMENT GUIDE TO HELP IN PRESCRIPTION AND VALIDATION

European Statement

Clinical Pharmacy Services

Author(s)

ANA CASTRO BALADO, MARÍA TERESA RODRÍGUEZ JATO, IRIA VARELA REY, MANUEL BUSTO IGLESIAS, FRANCISCO CAJADE PASCUAL, MARIA PUENTE IGLESIAS, IRENE ZARRA FERRO

Why was it done?

The prevalence of obesity has increased considerably in last decades. Pathophysiological changes in obese patients (body mass index >30kg/m2) produce pharmacokinetic and pharmacodynamic alterations that can condition the correct exposure to drugs if standard dosages are used. Incorrect dosing in obese patients can lead to toxicity or therapeutic failure. Usually, it is difficult to find information on drug dosing in this population, being sometimes contradictory.

What was done?

To develop an antimicrobial dosage infographic guide for obese patients to facilitate the correct prescription and validation in our hospital.

How was it done?

Initially, the pharmacy service established the antimicrobial groups to be included in the infographic guide, and within each of them, the most used in hospitalized patients were identified. A bibliographic search was carried out using the keywords “obese”, “dosing”, “antimicrobial” and “patient”. Technical data sheets, PubMed, Google Scholar, UpToDate, Micromedex and other hospital guidelines were consulted. A peer review was carried out and a table with antimicrobial groups and subgroups was designed, stablishing the body weight recommended for the adjustment if needed (total weight (TBW), ideal weight (IBW) and adjusted weight (ABW)), doses, and observations (monitoring of plasma levels, administration in extended/continuous infusion and/or special considerations). The table consisted of a total of 38 antibiotics, 10 antifungals, 6 antivirals and 4 antituberculous drugs. Of the total antimicrobials reviewed, 40% were dosed in obese patients by maximum dose, 38% were dosed based on weight (21% by ABW, 10% by IBW, and 7% by TBW) and 22% by standard doses. Equations for body weight descriptors were added in the infographic.

What has been achieved?

The protocol was validated by the hospital’s infectious diseases commission. Dosing information was then entered into the hospital’s electronic prescribing program facilitating the correct antimicrobial prescription and validation in obese patients. Training was provided in the intensive care unit, and the final document was disseminated through the hospital intranet and via email to all prescribing physicians in the center, being well embraced.

What next?

We will continue making formative sessions, as well as possible updates that may be beneficial for a better antimicrobial dosing in obese patients to avoid toxicities and/or therapeutic failure.

IMPLEMENTATION AND ADEQUACY OF HOME DELIVERY AND TELEPHARMACY DURING THE FIRST YEAR OF THE COVID-19 PANDEMIC

European Statement

Selection, Procurement and Distribution

Author(s)

Mª Ángeles Parro Martín, Beatriz Montero Llorente, Teresa Gramage Caro, Manuel Vélez Díaz-Pallarés, Miguel Ángel Rodríguez Sagrado, Hilario Martínez Barros, Ana María Álvarez Díaz

Why was it done?

To ensure continuity of treatment and pharmacotherapeutic follow-up in patients vulnerable to SARS-CoV-2 infection included in a home delivery and telepharmacy program.

What was done?

Implementation and adaptation of home delivery and telepharmacy during the first year of the COVID-19 pandemic.

How was it done?

A work procedure was designed to detail the new functions to be performed by administrative assistants (AA), pharmacy technicians (PT) and pharmacists (PH). A first procedure was designed, which was adapted and improved after 6 months of experience, giving rise to procedure 2.

Procedure 1

– AA phone call to patients scheduled to obtain consent for home delivery and confirm delivery data.
– The PH grouped patients who had confirmed home delivery in the appointment manager.
– The PH reviewed the electronic prescription of all patients and performed telepharmacy to those who were due and/or had incidents.
– The PT prepared the packages.

Procedure 2

Phase 1

– The AA called all patients scheduled until the end of the year to offer them the option of remaining in the home delivery and telepharmacy program permanently. If they accepted, their consent and delivery data were recorded. From this point on, the call to offer home delivery and telepharmacy was discontinued; it was only offered to patients when they attended in person.
– A specific diary for home delivery patients was created.
– The telepharmacytelepharmacy was added to the PH diary.

Phase 2

– Trained PT in home delivery incident resolution (address changes, absent patients, package rejection) to reduce FAR’s working hours.

Phase 3

– Development of a computer application: computerization of manual processes (labels, identification of refrigerated shipments, SMS delivery confirmation sent to patients, and request for appointment changes).

What has been achieved?

31,066 home delivery have been performed on 7,170 different patients. 7,443 telepharmacy consultations have been performed.

PT training and computer development has reduced the PH dedication from 7 hours to 3 hours.

What next?

Establish criteria for prioritization of patients who are candidates for home delivery and telepharmacy.
Implementation of video call instead of telepharmacy

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