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A human albumin (HA) prescription model as strategy to maximise the appropriate use in shortage conditions

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European Statement

Introductory Statements and Governance

Author(s)

Giorgia Babaglioni, Lorenzo Silva, Elena Festa, Daniela Paganotti, Tullio Elia Testa

Why was it done?

In Italy, the rising PDMPs demand had to face the international shortage caused by the SARS-CoV-2 pandemic outbreak. The self-sufficiency level of albumin represents one of the National Blood Centre (NBC) main challenge, in view of the health system sustainability.

What was done?

The hospital pharmacy of a northern Italy centre, in accordance with the Good Use of Blood Committee, introduced a nominal form for human albumin (HA) requests to evaluate and rationalise the HA clinical-therapeutic demand. It represents a pharmacist led intervention approach shared by physicians, in favour of an economically sustainable healthcare contrasting the lack of plasma-derived medicinal products (PDMPs).

How was it done?

Prescription criteria were updated according to the most recent guidelines. The cut-off of blood albumin level above 2.5 g/dl has been introduced as eligibility threshold value and for the daily dose calculation, except for HA calculation based on volumes for plasmapheresis and large volume evacuative paracentesis in hepatic cirrhosis. The pharmacy provides a maximum of five days therapy, then a new revaluation and updating of blood albuminemia was required; 690 total requests were analyzed.

What has been achieved?

In March 2023, HA consumption was 61400 gr, collapsed by 75% in April and then settled at – 58% in May and June. The most important reductions in monthly requirements affected the surgical (- 75%), intensive (- 62%), internist (- 64%) and gastro-hepatological (- 52%) areas. 97,5% of requests were on-label: 20% for plasmapheresis or paracentesis, 21% for liver failure, 16% for cirrhosis of the liver with refractory ascites. 26% of requests (n = 180) reported in-range blood albumin value, while the 14% was unknown or ongoing because administered in emergency phase. 37% of requests has been evaded even if the blood albumin was > 2,5 g/dl due to mandatory clinical need. Thanks to the new prescription model it was possible to save € 91 752 in the second quarter.

What next?

The introduction of the reasoned request allowed to achieve albumin self-sufficiency with voluntary blood donations and reduce the market products purchase. Furthermore, it fostered the clinicians awareness on the HA use appropriateness, considering crystalloids and non-protein colloids as alternative therapeutic strategies as resuscitation fluids.

A strategy to prevent weekly methotrexate medication mistakes in a regional health service

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European Statement

Patient Safety and Quality Assurance

Author(s)

Vanesa Alonso Castro, Pablo Jimenez Moreno, Marta Alcaraz Borrajo, Angel Luis Mataix Sanjuan, Beatriz Casamayor Lázaro, Maria Dolores García Cerezuela , Cristian Rosas Espinoza, Beatriz Santos Mena, Estrella Maroto García, Beatriz López Centeno, Daniele Alioto, María Jose Calvo Alcántara

Why was it done?

MTX is an immunosuppressor drug utilised in certain types of cancer and inflammatory diseases. Its dosage and frequency of administration varies depending on indication.
Throughout the years, medication errors (ME) have been reported at national and supranational levels where patients have received excessive doses (the most common being daily administration of the drug rather than weekly) with severe consequences for the patients, including death.
In our RHS, 222 ME related to MTX have been reported in the last 5 years,seven of them resulted in harm to the patient.

What was done?

An integral strategy to ensure the correct prescribing of weekly Methotrexate (MTX) was developed in a Regional Health Service (RHS).

How was it done?

1st PHASE (May 2021):
a. Monthly reporting to prescribers of their patients affected by duplicated prescriptions or incorrect dosing instructions for review and amending. These reports are available on the IT platform that collates prescribing indicators.
b. Development and dissemination of training materials to correctly prescribe medications with non-daily dosing instructions in the RHS electronic prescription tool.
2nd PHASE (After two years of follow-up):
a. Request to implement ME prevention plans (MEPP) to the hospitals of the RHS.
b. Creation and dissemination of informative material for patients and/or caregivers, where the weekly dosing instructions is emphasized.

What has been achieved?

Incidence of MTX prescribing mistakes: When this strategy was implemented, prescriptions for 2388 patients had been identified as potential mistakes. 1 year later, the incidence had diminished by 78.1% (2146 cases were resolved, 242 were still active and 310 were new). 2 years later, the incidence remained stable with a reduction of 78.5% thoroughout the whole period and 514 patients affected (150 new MTX prescribing mistakes in the last year).
• MEPP implantation (2nd PHASE): In two months, six hospitals (17.6% of all) implemented a MEPP. The key strategies that should be included in the MEPPs were disseminated to all hospitals by our team.

What next?

Thanks to this strategy, MTX prescribing mistakes have fallen by 78.5% in two years. However, prescribing mistakes continue to be made, which demonstrates the need for continuous training and awareness raising among prescribers to prevent ME related to MTX.

Computerised registration of drug prescriptions in the operating room during cardiac surgery: simplicity and traceability

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European Statement

Patient Safety and Quality Assurance

Author(s)

Elisabetta Volpi, Giuseppa Lo Surdo, Mattia Lorenzini, Anna Carmignani, Debora Luccetti, Stefania Baratta, Mario Cossu, Maurizio Mangione, Pierantonio Furfori, Monica Baroni, Paolo Del Sarto, Stefania Biagini

Why was it done?

This implementation was designed to provide a safe tool for the particular context of the operating room, in which prescription and administration are actions usually urgent and concomitant. The program suggests a rapid list of prescriptions standardized for adult patients (i.e. dose, diluent, bolus/drip) and allows to register any other drug or modify default information, respecting the rules for a clear prescription before registration.
Our aim was to demonstrate the possibility to validate this program and prove its functionality.

What was done?

In 2019 a multidisciplinary group (doctors, nurses, pharmacists, computer scientists) created an electronic program dedicated to the Cardiac Operating Room of the Heart Hospital, Fondazione Monasterio (Italy), which allow the prompt registration of drug prescriptions and administrations. Furthermore this program guarantees traceability of the drugs administered by the nurses, in order to improve medication safety practice.

How was it done?

This program was created into the electronic prescribing system available in Fondazione Monasterio. The standardized prescriptions already in use in the operating room were reviewed by a pharmacist, consulting the information in the Summary of Product Characteristics (SmPC), in the literature or by contacting the company that holds the MA. For each discrepancies identified a solution was proposed and shared with the working group, in order to validate a definitive list.
The prescriptions extracted by the IT Systems unit 6 months before and after the implementation of the new program were therefore analyzed.

What has been achieved?

A list of 182 standardized prescriptions was validated and reported in the program.
Among the 10,320 prescriptions made before the new program none had traceability of the drugs administered, while the 8,730 of the following period were complete and 99.6% of them fell within the standardized prescriptions, demonstrating the functionality and correct selection by the working group.
The development of a program for the computerized registration of prescriptions made during the surgery, which respond to the requirements of drug safety and traceability, represents an example of good practice.

What next?

We have implemented this tool in the paediatric population, with particular precautions due to the weight variability (i.e. dose/kg). The next step could be integration with further assessments (e.g., kidney function evaluation) and the transfer to other settings

Medication reconciliation practice at transitions of care: a new challenge or opportunity for the clinical pharmacist?

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European Statement

Clinical Pharmacy Services

Author(s)

Elisabetta Volpi, Giuseppa Lo Surdo, Sara Tonazzini, Stefania Alduini, Maurizio Mangione, Umberto Paradossi, Monica Baroni, Sergio Berti, Stefania Biagini

Why was it done?

Several data suggest that pharmacists and physician collaboration, direct pharmacist interaction with patients or caregivers through medication reconciliation and discharge counselling decreases the number of adverse drug events (ADEs) and plays an overall positive role in transitional care. Our aim is to demonstrate the constant necessity of pharmacist led medication reconciliation in order to maintain a high standard of care and safe medication use.

What was done?

Medication reconciliation at hospital discharge is essential for the prevention of medication discrepancies and patient harm. Hospital pharmacists are recognised as one of main healthcare providers that can support the physicians in this activity.
Since 2016, the medication reconciliation process has been performed by physicians and clinical pharmacists before home discharge from the Heart Hospital, Fondazione Toscana G.Monsaterio in Italy.

How was it done?

We analysed the medication reconciliation activity performed in our hospital over time and we observed that the number of unintentional discrepancies was always around 20%.
A shared pre-discharge prescription review programme has been activated with all doctors, so when the final lists of drug prescriptions are ready, the pharmacist examines them and suggests improvements or corrections to the doctor before the discharge letter is delivered to patients. Among the unintentional discrepancy observed, the most frequent were omissions of chronic therapy, lack of information about suspension for low molecular weight heparin or antibiotics.

What has been achieved?

A strong collaboration between physicians and clinical pharmacists has been achieved as we shared the results of this improvement. The same activity has been required and extended to the paediatric ward where the demand of simple, clear and complete information is even more crucial given the particular inter-individual variability and fragility of this population.

What next?

We would like to improve the prescription review programme also at admission in order to minimise drug omissions and at transition between different wards or different hospitals with the aim of improving communication between health care settings.

Novel specialist uveitis pharmacist role in the uveitis multidisciplinary team (MDT) and evaluation of new dedicated patient email helpline

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European Statement

Clinical Pharmacy Services

Author(s)

Ann-Marie Goacher

Why was it done?

To add expert pharmacy skills to the uveitis MDT. Provide pharmacist led improved education, compliance, monitoring, follow up and access via helpline for uveitis patients on immunosuppression.

What was done?

Expansion of the uveitis (MDT) service to include a specialist pharmacist

How was it done?

COVID allowed us to pilot an innovative service enhancing uveitis patient care. An MDT was established consisting of a specialist consultant, two specialist doctors, optometrist and expert pharmacist in ophthalmology (EPO). The EPO supports weekly MDT sessions through establishing a patient helpline, standardised recorded counselling and on-going follow up of pharmaceutical needs of new and established patients. The main challenge was to obtain funding to maintain this service post COVID. Clinic space remains a challenge due to the limits imposed by the availability of rooms.

What has been achieved?

This innovative pharmacy service provides a blueprint for other specialities to incorporate expert pharmacy skills into the direct care of outpatients. Integration of the EPO into the uveitis MDT benefits clinicians by redirecting prescribing workload, reducing patient enquiries, improvements in clinic flow by moving patient counselling to the EPO and patient safety through instant access to pharmaceutical specialist knowledge. Initial informal MDT feedback has been positive.
Patients profit from access to EPO via the patient helpline. Analysis of 900 emails received over a 2-year period showed the main reasons patients contacted us were for enquires related to blood tests, medication supply, appointments, side effects, worsening symptoms and confirming instructions regarding medication. Feedback from a patient satisfaction survey overall was positive. Patients were asked to rate the service between 1 (poor) and 5 (excellent), with 31 patients responding. The results show access to the team was rated 4.6/5, satisfaction with the speed of the response was 4.29/5 and the quality of response was rated 4.48/5.

What next?

Improved IT databases is something for review, the main barrier being funding. This would make recording and auditing of patient interactions and data more robust. In the future I would like to see national guidance that recommends pharmacists as part of the uveitis MDT as standard.

De-prescription initiative for anti-dementia drugs in a sociosanitary centre

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European Statement

Patient Safety and Quality Assurance

Author(s)

Paula Torrano Belmonte, Lydia Fructuoso González, Juan Antonio Gutierrez Sanchez, María Hernández Sánchez , Adrián Martínez Orea, María Guillén Diaz, Cristina Portero Ponce, Alicia Sánchez Blaya , Teresa Alonso Dominguez

Why was it done?

According to Spanish guidelines, medication deprescription would be recommended in the following situations: in the advanced or terminal phase of the disease with a global loss of cognitive and/or functional abilities; in patients who do not experience any benefit; in the presence of intolerable adverse effects or interactions with concurrent treatments. The dose will be progressively reduced every 4 weeks.

What was done?

We designed a project to deprescribe drugs used for dementia in patients at one of the sociosanitary centers (SSC) affiliated with our hospital. The drugs currently used in Spain are: donepezil, rivastigmine, and galantamine for mild to moderate stages, and memantine for moderate to severe stages.

How was it done?

Pharmacists conducted a search using the Savac® pharmaceutical management programme among all residents of the SSC who were prescribed anti-dementia drugs. Once eligible patients were identified, medical team was notified through the electronic prescription programme.

What has been achieved?

According to the previously detailed criteria, there were a total of four eligible patients: one of them was on rivastigmine patch treatment, and the other three were on oral memantine. The results in the first month were not very positive, as an attempt to withdraw memantine from one patient had to be reversed due to aggression issues. Another patient on memantine sadly passed away, and the remaining two, on memantine and rivastigmine, continued with the medication due to potential benefits.

After 10 months of work, the results have been quite promising, and we have successfully completed more withdrawal protocols for other CSS patients. Medication was deprescribed for three patients: one on donepezil and two on memantine. Another patient on rivastigmine is currently in the dose reduction phase.

What next?

Our goal is to achieve the appropriate prescription of anti-dementia drugs, in order to maximise benefits for patients while minimising adverse effects and rationalising public resources.

Electronic prescription protocols for personalised sterile preparations for the paediatric surgery department

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European Statement

Production and Compounding

Author(s)

Isabel María Carrión Madroñal, Concepción Álvarez del Vayo Benito , Begoña Balboa Huguet , Santiago Lora Escobar , Paloma Barriga Rodríguez

Why was it done?

-Improve security, planning, and access to information for correct prescription, administration, and management.
-Guarantee the traceability of all processes.
-Improve the satisfaction of the services involved, preventing forgetfulness and therefore management of emergency calls, unjustified need for the prescribed preparations, and incorrect packaging.
-Improve communication and the work circuit from PD.

What was done?

To prepare a protocol with the processes of prescription, validation, preparation and dispensing of personalised sterile formulations in the Paediatric Surgery Department (PSD: Otorhinolaryngology, Ophthalmology and Neurosurgery) from the Pharmacy Department (PD).

How was it done?

1. Creation of a multidisciplinary team in which a circuit for the prescription, validation, preparation and dispensing of sterile preparations was agreed.
2. Analysis with the departments involved of the personalised sterile-medications prepared by PD for use in paediatric-surgical-rooms, and the most frequent doses used.
3. Bibliographic review: PubMed®, Cochrane®, Uptodate®, Stabilis® and other sources such as the Good Clinical Practices (GCP) and the book ‘Preparation of Drugs and Magistral Formulation for Ophthalmology (JM Alonso).
4. Creation of electronic prescription protocols in ATHOS-Prisma®, containing:
• help notes and preconditions for the prescription.
• information for the administration and management of waste.
• detailed brew sheet and custom label for the PD.
5. Review of the protocols created and the circuit proposed for the prescription, preparation and dispensing.
6. Start-up of the circuit: review and validation of prescriptions, preparation of sterile formulations centralised in PD through laminar flow hoods and dispensing directly to the surgical-room on the scheduled date.

What has been achieved?

Piloting began with sterile otorhinology formulations in 2021, expanding to ophthalmology and neurosurgery in 2022-2023.
– Creation of three groups of protocols that will contain those related to each specialty to facilitate location and prescription by surgeons:
*Paediatric ophthalmology:
• Mitomycin 0.2mg/ml intraoperative-solution-trabeculectomy
• Fluorouracil 5mg/0.1ml intraoperative-solution-trabeculectomy
• Intracameral-cefuroxime 2mg/0.2ml (antibiotic-prophylaxis)
*Paediatric otorhinology:
• Cidofovir 5mg/ml intralesional (laryngeal-papillomatosis)
• Bevacizumab 2.5mg/ml intralesional (laryngeal-papillomatosis)
• Mitomycin 0.5mg/ml (choanal-atresia)
*Paediatric neurosurgery:
• Interferon-alpha 3MIU/0.6ml intralesional (craniopharyngioma)
– Sixty-two preparations have been prepared and dispensed for a total of 30 children; average age of 4 years (1-10). No adverse events were reported in any patient after the administration of these sterile preparations.
– A study limitation was sample size. Circuit under development.

What next?

The protocol is applicable to any hospital with electronic-prescription and surgical-area.

A new form for the prescription of human albumin as a tool to improve the appropriate use

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European Statement

Patient Safety and Quality Assurance

Author(s)

Maria Elisabetta Uda, Lucia Aledda, Melania Rivano, Monica Enrica Perpignano, Fabio Lombardo

Why was it done?

Albumin has a limited availability, but also has a widespread and often incorrect clinical use, especially in hospitals. The check of daily human albumin prescriptions, revealed that the forms were not filled out correctly, the use was often inappropriate, in terms of quantity and indications, as malnutrition or hypoalbuminemia. Moreover, the previous prescription form was obsolete in view of recent studies. Therefore, it was deemed necessary to immediately update the forms for the request of albumin in terms of indications of use and posology.

What was done?

The hospital pharmacy proposed the introduction of a new form for the prescription of human albumin solutions, in order to improve the appropriate use of this drug.

How was it done?

We carried out a literature review of the latest available evidence on the indications for the use of albumin solutions. The new form includes patient data and albuminemia values, the updated indications and the clinical conditions, in which the use of albumin is strongly encouraged and discouraged and inappropriate. It was authorised and shared with all hospital departments.
In addition, we started the analysis of personalised prescriptions, in paper format, before and after the introduction of the updated forms, and created a summary database of the indications and posology prescribed by clinicians.

What has been achieved?

Between January and August 2022, 24900 g of albumin were used, with a cost of €46.025. The preliminary analysis of 77 human albumin personalised prescriptions, relating to the months January to April 2022, shows that the forms were not filled out correctly (26%), the use of albumin was often inappropriate in terms of indications (30%) and quantity prescribed (83%).The use of the new introduced prescription forms has already enabled better dialogue between pharmacists and clinicians, providing a more complete guiding tool, fundamental for the discussion of prescribed therapy.

What next?

The hospital pharmacy will continue the analysis and discuss the results with the medical management and every hospital department. The aim is to improve the appropriate use of albumin, encouraging the clinicians to focus more accurately to the prescribed therapy. This will improve the quality and safety of patient care, generating significant cost savings.

Romiplostim preparation and distribution in ready to administer weekly syringes to patients

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European Statement

Production and Compounding

Author(s)

BELEN SANCHEZ PASCUAL, IRENE SALVADOR LLANA, ANA MARIA MARTIN DE ROSALES CABRERA, MONTSERRAT PEREZ ENCINAS

Why was it done?

Romiplostim should be administered once weekly as a subcutaneous injection. The initial dose is 1µg/kg. According to platelet response (PR) the dose should be increased until the patient achieves platelet count over 50,000 platelets/µL(maximum dose=10µg/kg). In order to maintain durable PR, weekly doses of romiplostim are prescribed and adjusted every 4-6weeks. Although patients could be trained for the injection preparation, many had reported difficulties to understand instructions and calculations of concentrations/volume. Romiplostim vials have a significant overdose to ensure the extraction of the declared amount. The actual content of the 250µg vial was found to be 360 µg (110µg excess). The 500µg vial contents 600µg. In addition, patients should discard the unused part. The aim is to centralise the preparation/distribution of individualised weekly doses of romiplostim for each patient in RtA syringes that allows them to receive the correct dose and to maximise the use of vials.

What was done?

We develop a procedure for the preparation and distribution of individualised weekly doses of romiplostim prepared in the sterile preparation area in prefilled syringes Ready to Administer (RtA) by the patient.

How was it done?

The Pharmacy service (PS) prepares the individualised doses in syringes RtA in a laminar-flow cabinet. The waste of the vial is kept to be reused.
The main obstacle is the increase in the volume of daily preparations in the PS due to dose individualisation. This obstacle is overcome with fluid communication with the Haematology service that reports prescriptions with a duration of up to 21 days (if the patient´s control is adequate).

What has been achieved?

From the past 3 years (2019-2021), we prepared individualised syringes for 36 patients. The centralised preparation reduces unused romiplostin waste allowing a cost saving of near 50% of drug spending. Specifically, in this 3-year period, €385,759.00 were saved.

What next?

Preparation of RtA syringes of romiplostim under sterile conditions in a laminar-flow cabinet helps patient’s auto-administration (since is an easier dispositive) and allows for greater use and significant economic savings. It is a process that can be easily extrapolated to any PS. Next step would be to carry out stability studies in order to be able to work further in advance and allow to space out hospital visits of well-controlled patients.

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.

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Problems caused by shortages are serious, threaten patient care and require urgent action.

Help us provide an overview of the scale of the problem, as well as insights into the impact on overall patient care.

Our aim is to investigate the causes of medicine and medical device shortages in the hospital setting,  while also gathering effective solutions and best practices implemented at local, regional, and national levels.

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Join us in Prague for the 2nd edition of BOOST!

Secure your spot in the Movement for Shortage-Free World

BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.