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Pharmacological reconciliation as an improvement chance: a hospital ward experience

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European Statement

Patient Safety and Quality Assurance

Author(s)

Annamaria Tesse, Cataldo Procacci, Domenica Ancona, Salvatore Lenti

Why was it done?

Often the elderly patient suffers from several pathologies at once and commonly he is in polytherapy. According to the Italian Ministerial Recommendation No. 17, errors in drug therapy can cause serious harm to the patient. By increasing the patient’s awareness and reducing the number of potentially inappropriate prescriptions, it will be possible to improve the effectiveness of therapies and to reduce side effects.

What was done?

In an Internal Medicine department, the concurrence between doctors and pharmacists has led to a project that aims to reduce duplications of therapy and to improve the health status of the patients. This through pharmacological recognition and subsequent therapeutic reconciliation carried out on patients in discharge.

How was it done?

In Internal Medicine ward, from June to August 2022, we gather the terapies for 48 hospitalised patients aged over 65 years and suffering from two or more chronic diseases. Reconciliation boards were then developed using Intercheck Web a “Mario Negri” Institute of Pharmacological Research’s software. Sequentially the physician, according to the chemist, proceeded to remodulate the therapies especially in those cases where there were serious interactions.

What has been achieved?

140 drug interactions were detected, on average 2.91 interactions per patient. Especially, 16 class D (very serious), 22 class C (major), 83 class B (moderate), 19 class A (minor) reactions were archived. The modified or partially modified therapies at discharge were 71%. This restriction bought to a curtailment of drugs taken and a removal of unnecessary drugs.

What next?

The team are doing a patient follow-up to six months and a year so earlier results will be soon available. Reducing drug intake is possible, and it involves a downsizing in side effects and in an increase in patient compliance. Information to the patient is essential and, by using this procedure on a large scale, it will be possible to optimise the management of the chronic patient at home and inpatient care.

Opioids room of horrors – an interactive learning to improve safety of drug administration

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European Statement

Patient Safety and Quality Assurance

Author(s)

Sophia Hannou, Cristina Nicorici, Patricia Spitz, Samuel Cotte, Wanda Bosshard, Nancy Perrottet, Pierre Voirol, Farshid Sadeghipour

Why was it done?

Medication use process is at high risk especially for opioids. In our geriatric rehabilitation unit, self-reporting incidents are submitted regularly to our quality system. Among the 44 drugs incidents reported in 2021, 11 included opioids. Prevention with training is a way to reduce these errors. However, theoretical teaching covering the “5 rights” rule remains insufficient. Therefore, an interactive learning with a room of horrors focused on opioids was selected by our unit to prevent these errors. The objective was to cartography and identify the most risky steps and to introduce specific actions to reduce these risks.

What was done?

A room of horrors with a specific focus on opioids has been developed and implemented to reduce errors in medication circuit.

How was it done?

An interprofessional group created the room of horrors based on real incidents. Fictional patient, clinical situation and opioid prescription were created in the medical software. Several drugs and medical devices were available. A model wore an identification bracelet. Ten errors, covering the five rights, were hidden in the room. A pair of healthcare givers had 20 minutes to realise the simulation (5 for the briefing, 10 for the exercise and 5 for debriefing).

What has been achieved?

During the World Patient Safety Day 2022, 38 healthcare professionals (19 nurses, 10 assistant nurses, 9 geriatricians) participated to this training. Errors were detected in variable proportions. For example, 58% of the participants uncover the patient identification error, 53% the pharmaceutical form, 53% the expired date, 47% the allergy contraindication and 47 % used the oral syringe.

What next?

Results and theoretical notions will be presented to all professionals of the unit. This room of horrors is transposable and can be used in other units of the hospital. A video of this simulation was created as an e-learning. It will be implemented as a continuous training or for new collaborators in our unit and can be shared to other units of the institution. Incidents will be continuously monitored and the training will be adjusted in the future. Based on the success of the room of horrors, this interactive learning will be used in other areas with other clinical or technical dimension.

Preparation of monoclonal antibodies on the pharmacy benchtop – risk assessment and practical considerations

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European Statement

Production and Compounding

Author(s)

Aidan Morris, Louise Byrne

Why was it done?

• mAbs were considered hazardous if handled by staff – prepared in a dedicated isolator in the PAU in TUH.
• No widely accepted standards for safe handling of mAbs, although more recent guidance allows preparation of some mAbs outside of PAUs once risks appropriately assessed.
• Significant reduction in production capacity in the PAU in early 2022 for planned repair work. Benchtop preparation of mAbs implemented to maintain patients’ treatment regimens and to reduce costs associated with outsourcing.

What was done?

• Preparation of monoclonal antibodies (mAbs) on the pharmacy benchtop temporarily introduced in the Pharmacy Aseptic Unit (PAU) of Tallaght University Hospital (TUH).
• Guidance from Ireland’s National Cancer Control Programme (NCCP) on Pharmacy Benchtop Preparation of mAbs reviewed and implemented.
• Risk assessment carried out for individual mAbs. List of mAbs suitable for benchtop preparation prepared.

How was it done?

• Implementation of the NCCP guidance on Pharmacy Benchtop Preparation of mAbs. Advice on risk assessments and safety, equipment and facilities, and staffing and training when preparing mAbs on the benchtop.
• Literature review of the hazards associated with handling mAbs – toxicity, immunogenicity, risk reduction measures. Individual mAbs assessed for suitability for benchtop preparation using Health Service Executive (HSE) risk assessment tool. This considered toxicity, immunogenicity and closed system transfer device (CSTD)-compatibility of mAbs, and personal protective equipment required.
• CSTD vial adaptor based on air cleaning (filter) technology replaced with vial adaptor with physical barrier (balloon) – additional safety measure. Dedicated area assigned for benchtop preparation – well-ventilated, clutter-free and easy-to-clean.
• Additional training on new vial adaptor provided to pharmacy technicians already experienced in aseptic compounding.

What has been achieved?

• List of mAbs suitable for benchtop preparation prepared. Conjugated antibody-drug complexes, mAbs of fully murine origin and mAbs not CSTD-compatible deemed unsuitable.
• mAbs prepared on the benchtop during period of reduced capacity, maintaining patients’ treatment regimens and reducing outsourcing costs, wastage.
• Facilitated by risk assessment and risk reduction using PPE, training and CSTDs.

What next?

• Although safety and handling requirements of mAbs not fully known, prudent to handle them with more care than most drugs but less than for cytotoxics.
• Contingency plan for benchtop preparation of mAbs in case of future reduced PAU capacity.
• Can be applied to other organisations experiencing periods of reduced capacity.

Implementation of a standardised parenteral nutrition solution on a neonatal ward

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European Statement

Patient Safety and Quality Assurance

Author(s)

Isabelle Sommer, Farshid Sadeghipour

Why was it done?

PN can be composed of 14 different ingredients, including an amino acids admixture. Therefore, PN represents a complex and high risk preparation. Medication errors (ME) are often related to PN management and may include prescription, transcription, preparation, and administration errors. As the treatment with PN is essential for a good cerebral and neurologic development and a postnatal weight gain, ME can result in growth retardation, developmental disturbances, and infections. The implementation of the standardised PN aimed to achieve a reduction of ME having an impact on vulnerable newborns and to improve the security and quality of their nutritional treatment.

What was done?

A multidisciplinary development of a hospital’s neonatology and pharmacy departments as well as of an industrial manufacturer resulted in a standardised parenteral nutrition (PN) solution for neonatal patients. This PN solution was implemented as “standard-of-care” for newborn term and preterm infants requiring nutritional treatment within their first days of life.

How was it done?

The standardised PN solution for a peripheral administration route was developed in accordance with ESPGHAN guidelines (2018).
The neonatologists defined internal guidelines for the PN administration and trained the concerned personnel (physicians and nurses).
The industrial manufacturer delivered the ready-to-use PN solution as a sterile double-chamber infusion bag in accordance with Swiss and European regulatory.

What has been achieved?

The ready-to-use PN solution with a 24/7 availability on ward by means of an 18 months stability at room temperature allowed a considerable reduction (-80%) of on ward preparation of nutritional solutions by nurses.
One-third of individual PN solutions being prepared at the hospital’s pharmacy has been replaced by the standardised PN solution.
This high-quality PN solution allows a secured administration to the vulnerable patients as well as a reduction of ME related the whole PN management resulting in an improvement of the nutritional treatment of neonates and its outcomes on their development.

What next?

This special PN solution is already implemented in two Swiss university hospitals and others will follow. Further standardised PN for a central venous administration to neonates need to be developed to allow the completion of a safe nutritional treatment. On ward PN preparations must be prohibited to prevent undetectable ME.

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.

Prescription review of digoxin-treated inpatients: Pharmacist involvement in its pharmacokinetic monitoring and dosage adjustment

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European Statement

Clinical Pharmacy Services

Author(s)

DEL RIO GUTIERREZ JOSE MANUEL, MARTA MIARONS FONT, SONIA GARCIA GARCIA, TONI SORIANO COLOMÉ, ALBA PAU PARRA, ARIADNA GRACIA MOYA, NIEVES HERRANZ MUÑOZ, BRUNO MONTORO RONSANO, PAU RELLO SABATE, GERARD ORISTRELL SANTAMARIA, MARIA QUERALT GORGAS TORNER

Why was it done?

Digoxin is a drug frequently implicated in medication errors due to its difficult clinical management. It has also been observed that digoxin pharmacokinetics could change in acute medical conditions, compromising its effectiveness and safety. As hospital pharmacists, we have the opportunity to review which dose is the most appropriate for every patient.

What was done?

Twice-weekly active and extensive pharmaceutical review of digoxin-treated inpatients was established to identify whether the prescription was adequate and to adjust dosage according to plasma concentrations (PCs) and clinical situation.

How was it done?

1. A multidisciplinary team comprising pharmacists and cardiologists was created to identify possible solutions to improve digoxin prescribing.
2. It was agreed that a twice-weekly extensive review of digoxin-treated inpatients would be conducted by a pharmacist. Candidates for digoxin monitoring were:
a. Patients on chronic digoxin therapy and with at least one of the following risk factors: presence of renal failure (RF), recent surgery, elderly patients (≥65 years), critically ill patients, or patients with suspected toxicity.
3. Once the patients were identified by the pharmacist, they would be discussed with the cardiology team.
4. Digoxin prescriber would be contacted to recommend performing a determination of digoxin PC. PC reference range was set at 0.8–1.2 µg/L for atrial fibrillation (AF) and 0.5–0.8 µg/L for heart failure (HF).
5. PCs would be interpreted using a pharmacokinetic monitoring software (PKS Abbot).
6. Monitoring results and recommended dosage adjustments would be communicated.

What has been achieved?

From August 2021 to May 2022, 190 patients were identified. Sixty-five (33.7%) were considered for monitoring, of whom 21 (32.3%) were women. The average age was 77.9 (SD 11.7). Sixty-five (100%) with AF and 8 (12.3%) also with HF. The most prevalent risk factors warranting monitoring were patients aged 65 years or older (N=57, 61.9%) and RF (N=31, 33.7%). Thirty-three (51%) of monitored patients required a dosage adjustment, of whom 23 (69.8%) required a dose decrease, 5 (15.1%) an increase and 5 (15.1%) to stop the treatment. Median digoxin concentrations were 1.23 µg/L (interquartile range: 0.75-2.03).

What next?

The process described applies to any centre able to monitor digoxin CPs both in inpatient and outpatient settings.

Creation of an ‘Agrippal’ programme to fight against nosocomial flu

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European Statement

Introductory Statements and Governance

Author(s)

Alexandre Benaiche, Mickael Tachon, Nathalie Arnouts, Amandine Gradelle, Kadidja Gribi, Remi Parsy

Why was it done?

The ‘Agrippal’ programme was created to strengthen the anti-influenza herd immunity in our hospital and reduce the risk of nosocomial influenza. It was then necessary to improve both the vaccination rate of the staff and the inhabitants of the institution’s living area who were potential users. The vaccines were previously distributed in departments and injections made by the nursing staff without any traceability. The purpose was also to improve knowledge about anti-influenza vaccination among staff and users.

What was done?

Our Healthcare-Associated Infectious Risk Prevention Unit (made up of hygienist pharmacists and nurses) launched a programme to fight against nosocomial influenza in our institution in winter 2018 to promote vaccination among staff and users and inform them about vaccination inside and outside the hospital.

How was it done?

Information conferences were held inside and outside the walls of the hospital for staff and residents of the city thanks to a partnership with the municipality to finance these events and communicate about their occurrence. Information materials (flyers) have also been made available to departments and some key departments (Emergency, Consultations, Obstetrics) were encouraged to inform patients at risk and their families about the positive impact of vaccination with provision of Health Insurance reimbursement forms. Our Healthcare-Associated Infectious Risk Prevention Unit created a Mobile Vaccination Team to vaccinate staff directly in the departments and encourage those who have not been vaccinated to do so.

What has been achieved?

The staff flu vaccination rate increased sharply, from 19% and 17% respectively in 2016 and 2017 to 34% in 2018 and 39% in 2019. Among vaccinated staff, 25% in 2018 and 17% in 2019 were primary vaccinated. Although the impact of actions aimed at users is difficult to measure, the number of nosocomial flu has been reduced in our hospital from 3.14 per 10,000 days of hospitalisation in 2017 to 0.58 and 0.61 respectively in 2018 and 2019.

What next?

This initiative has made it possible to double the rate of vaccinated staff in our institution and strengthen patient protection by reducing the risk of nosocomial flu. It only required a period of consultation between different actors without creating additional financial and human resources.

Sustainability initiative: dose banding of paclitaxel to minimise drug waste

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European Statement

Production and Compounding

Author(s)

Peder Nygard, Helle-Brit Fiebrich-Westra, Elise Smolders

Why was it done?

The aim of this project was to reduce paclitaxel waste caused by cancellation of administrations. Standardised dose bands make interchangeability of already reconstituted paclitaxel bags easier, as more patients use the same dose. This could potentially save drug- and material waste and costs even as manpower.

What was done?

Paclitaxel fixed dose bands were created for patients treated with a weekly dose of 80 mg/m2.

How was it done?

In consultation with prescribers the dose bands for paclitaxel where created (see table). These dosages were implemented as a dose-rounding rules in the drug preparation software (Hix 6.2, ChipSoft BV). The maximum deviation for dose-rounding rules for paclitaxel in our hospital is 10% of the prescribed dose. Dosage ≤72mg or >200mg were rounded as normal.

Prescribed dose (mg) Dose-band (mg) m2 (dose 80 mg/m2
>72 ≤88 78 1.0
>88 ≤102 96 1.2
>102 ≤116 114 1.4
>116 ≤136 126 1.6
>136 ≤152 144 1.8
>152 ≤168 162 2.0
>168 ≤184 174 2.2
>184 ≤200 192 2.4

What has been achieved?

These rules were implemented in April 2022. Data from 1 May 2022 to 31 August 2022 is compared with the same time period in 2021. In 2022, a total of 729 infusions where prepared compared with 872 infusions in 2021.
In this 4 month time period in 2022 a total of 14 different dosages were prescribed, compared with 24 in the same time period in 2021. Additionally, interchangeability was improved as the top 3 dosages prepared by the pharmacy were: 144 mg (36%), 162 mg (22%), and 126 mg (19%) compared with 144 mg (17%), 138 mg (14%), and 126 mg (10%) in 2021.
Furthermore, in 2021 we discarded 33 prepared dosages of paclitaxel of which three infusions could be reused. Compared to 13 discarded dosages in 2022 of which eight were reused giving a reduction of 25 infusions less waste (83% reduction, savings ~2500 euros).

What next?

Pharmacists need to be instructed to adapt these rounding rules, which must decrease the variation in dosages and thus waste. Secondly, this project will be monitored the upcoming year and evaluated together with prescribers. The aim is to implement dose bands for paclitaxel dosages 175 mg/m2 and other chemotherapeutic drugs (eg, oxaliplatin, docetaxel, cyclophosphamide).

DESIGNING A PROTOCOL TO IDENTIFY AND IMPROVE ADHERENCE IN PATIENTS WITH ANTIRETROVIRAL THERAPY IN THE HOSPITAL SETTINGS.

European Statement

Clinical Pharmacy Services

Author(s)

Luis Díaz Suárez, Elena Sánchez-Yanez , Raquel López Escoz, Mercedes Gómez Delgado, Nuria Martínez Casanova, Isabel Moya Carmona

Why was it done?

The hospital pharmacist plays a role obtaining therapeutic success by improving the adherence. Our unit attends around 1900 HIV patients, so the interventions we make to improve adherence will have a positive impact on patients and community.

What was done?

The Pharmacy Service has developed a protocol for the identification of non-adherent HIV patients to treatment along with the pharmaceutical attendance strategies designed to improve the adherence to ART.

How was it done?

The protocol was drawn up with the recommendations of the National AIDS Plan(PNS), the Spanish Society of Hospital Pharmacy(SEFH) and the AIDS Study Group(GeSIDA). Thus, we wanted to provide a multidisciplinary approach for non-adherent patients. The relevant aspects of the protocol are described below:

1.-Identification of patients: Technical staff and pharmacists identify patients with poor adherence through dispensing records, a history of previous voluntary abandonment of ART or the presence of risk factors for poor adherence to ART.

2.-Pharmaceutical attendance following the CMO model.

· Data such as viral load, CD4, prescribed ART, pharmacotherapeutic complex index, home medication, polypharmacy, pluripathology and risk factor have
been collected. Adherence was calculated using dispensing records and adherence questionnaire(SMAQ).

· Health education and motivational interviewing.

· Personalised planning of patient care following face-to-face and non-face-to-face programs. Every 6months adherence will be re-evaluated to assess the
success of the pharmaceutical care offered.

What has been achieved?

The protocol was implemented in March-2021, and to date, 68patients have been included. 73.5%(n=50) of them have been followed for more than 6 months. 88% of whom(n=44) improved their adherence to both ART, all of them achieving an undetectable viral load and an elevation of the CD4 count.

What next?

Our desire is to continue detecting patients and to contribute to the improvement of the adherence to their treatment. We are aware of the challenge that lies ahead in the near future, as the progressive ageing of the HIV population means an increase in associated comorbidities and polypharmacy, which may have a negative impact on the adherence.

Securing the care pathway of patients in the new experimentation of medical cannabis through pharmaceutical interviews

European Statement

Clinical Pharmacy Services

Author(s)

Marie Guedon, Maëliss Laurent, Thibault Vallecillo, Catherine Mennesson, Mélanie Jennesson Lyver, Dominique Hettler, Céline Mongaret

Why was it done?

In March 2021, the “Agence Nationale de Sécurité du Médicament” initiated an experiment to evaluate the relevance and feasibility of the availability of MC as a narcotic drug, in France. In our hospital, we included children to treat drug-resistant epilepsy, and performed a dispensing process to secure the patient care pathway and strengthen collaboration between hospital pharmacists and primary care professional.

What was done?

The aim of this study is to secure the care pathway of patients included in a national experimentation of medical cannabis (MC) by developing pharmaceutical interviews. Thus, to optimize the continuity of patient care, a pharmaceutical report was developed, and addressed to the community pharmacists of the patient.

How was it done?

A working group was created including clinical pharmacists, a neuropediatrician and a coordination nurse. During medical consultations, pharmaceutical interviews were conducted and led to pharmaceutic reports, sent to the community pharmacies of the patients. In order to evaluate this report, a satisfaction survey was carried out.

What has been achieved?

During the first six months of the experimentation, three children were included. The clinical pharmacist team (two senior pharmacists and two pharmacy residents) performed ten dispensing processes. During the eight pharmaceutical interviews, four pharmaceutical interventions were performed. Firstly, the interaction between clobazam and MC (noticed in one patient) required a dosage adjustment. Then, the association between MC and hepatotoxic drugs (found in two patients) requires hepatic monitoring. A pharmacovigilance statement was also drafted to report side effects (digestive disorders). The satisfaction survey of community pharmacists showed that the transmitted information, mostly related to the medication review, was considered as useful for the community pharmacies of the patients. This data helped to guide the pharmaceutical interviews during their dispensing process.

What next?

Pharmaceutical interviews and their reports lead to secure the patient care pathway and improve the communication amongst health care professionals. Those measures provide an optimal case management and avoid therapeutic breakdown. Nevertheless, difficulties have been reported, mostly due to delay in the supply chain of the community pharmacies. Therefore, this system requires some adjustments before it can be applied on a larger scale. One of the suggestions is a provisional calendar of consultations and dispensations.