Skip to content

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

Pdf

PDF Icon

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

Pdf

PDF Icon

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

Pdf

PDF Icon

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.

Implementation of an opioid stewardship programme (OSP) at San Ignacio University Hospital

Pdf

PDF Icon

European Statement

Patient Safety and Quality Assurance

Author(s)

Viviana Andrea Pinzon Garcia, Paula Camila Murcia Jaramillo, Reinaldo Grueso Angulo

Why was it done?

In 2018, concerned with the opioid crisis in USA, the pharmacy and therapeutic committee began to work on safer opioid use; an initial diagnosis showed an increase in the use of in hospital opioids and a lack of protocol for the disposal of the resultant remnants. Standard single-dose syringes (SSDS) were devised to avoid remnants, subsequently noticing that the strategies to be used should involve the whole medication order cycle (MOC). This gave rise to the OSP, which involves physician’s pain management and prescribing practices, pharmacy preparing and dispensing process, nurse’s custody, administration and disposing protocols.

What was done?

An Opioid Stewardship Programme (OSP) led by a multidisciplinary team: scientific direction, pharmacy and pain clinic, was implemented to ensure adequate and safe opioid prescription, dispensation, administration and disposing practices in San Ignacio University Hospital (HUSI), a tertiary level hospital in Bogota, Colombia.

How was it done?

Institutional pain practice guidelines were assessed, unifying the titration doses with SSDS and developing disposal protocols in which care staff is constantly being trained ever since. To trace the impact of the OSP, indicators for IV opioid consumption, SSDS prescription, naloxone use and guideline adherence were created.
Main obstacles on SSDS: <10% prescribing adherence, availability failures and dose expiration. In response, the whole ampoule prescription was narrowed to only pain specialists to face SSDS expiration costs and avoid shortage.

What has been achieved?

SSDS prescription proportion above 70% by July 2022, decreased milligram morphine equivalent (MME) consumption per hospital discharge (January 2019: 37, January 2020: 47, January 2021 (COVID 2nd surge): 39, January 2022: 25, July 2022 (COVID 3rd surge):16) and monthly costs decrease in 1997 USD, between 2019 and 2022.
An opioid shortage during the COVID surges, deepened in Colombia due to a hydromorphone recall, was avoided.

What next?

The OSP initiative could be replied in healthcare institutions considering our achievements. To keep working in a safer opioid MOC, our OSP has formulated new strategies with an active role of pharmacists, pain specialists and nurses oriented to: remnants disposal protocol, prescribing policies, medication error detection and healthcare staff and patient education.

Implementation of a multidisciplinary personalised medicine unit for pharmacogenetic testing

Pdf

PDF Icon

European Statement

Clinical Pharmacy Services

Author(s)

Jorge Fernández-Fradejas, Matías Morín-Rodríguez, Eva Delgado-Silveira, Miguel Ángel Moreno-Pelayo, Ana María Álvarez-Díaz

Why was it done?

There is an increasing number of gene-drug interactions that have the potential to predict patient response. Although the study of some genetic variants can be a useful tool to achieve a safer and more effective pharmacotherapy, the integration of personalised medicine in clinical practice has been challenging over the years, mainly due to prescriber’s scepticism and lack of clinical guidelines and protocols.

What was done?

We have implemented a multidisciplinary Personalised Medicine Unit (PMU) at a third- level hospital to facilitate preemptive pharmacogenetic testing.

How was it done?

The PMU provides its service with the involvement of Pharmacy and Genetics Department according to the following workflow:
1. Physicians order the pharmacogenetic test in the first contact with a patient expected to be treated with a drug with an available pharmacogenetic test.
2. A peripheral blood sample is drawn for DNA extraction and analysed by the Genetics Department.
3. An integrated pharmacogenetics report is generated and uploaded to the patient’s electronic medical record. This report contains the molecular information and its interpretation (responsibility of Genetics Department) and the clinical pharmacotherapeutic recommendation according to the results obtained (responsibility of Pharmacy Department). Dose adjustment recommendations follow the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines and Dutch Pharmacogenomics Working Group (DPWG) guidelines.
4. Pharmacy Department follows up pharmacotherapeutic recommendation acceptance and clinical outcomes.

What has been achieved?

Since July 2021 we have implemented pharmacogenetic testing for seven drug-gene interactions:
July 2021. CYP2C9 – Siponimod.
November 2021. DPYD – Fluoropyrimidines (capecitabine, fluorouracil, tegafur).
April 2022. UGT1A1 – Irinotecan, liposomal pegylated irinotecan, sacituzumab govitecan.
Three hundred and seventy patients have benefited from pharmacogenetics testing. These tests have been requested by three different clinical departments and had a mean turnaround time of less than 10 days, preventing any potential treatment delays. An integrated Pharmacy-Genetics report with individualised pharmacotherapeutic recommendations was generated for every patient. These recommendations had an acceptance rate of 100%.

What next?

Since the creation of the PMU, we have been able to implement pharmacogenetic testing in clinical practice with a high level of acceptance. Our next challenges are introducing next- generation sequencing for the study of new gene-drug interactions in the unit portfolio and achieve a deeper integration of pharmacogenetic information in clinical decision support systems.

Determination of dihydropyrimidine dehydrogenase genotypes to guide physicians in the dosing of fluoropyrimidines

Pdf

PDF Icon

European Statement

Clinical Pharmacy Services

Author(s)

Aina Oliver Noguera, Luis Pérez de Amezaga Tomáss, Margarita Nigorra Caro, Fernando Do Pazo Oubiña, Esther Falcó Ferrer, Teresa Fernández Rodriguez, Maria Fiorella Sarubbo, Antònia Obrador de Hevia, Montserrat Vilanova Boltó

Why was it done?

Treatment with fluoropyrimidine produces severe toxicity in about 30% of the patients. This toxicity has been related to a reduction in the activity of DPD, the rate-limiting enzyme for fluoropyrimidine catabolism. This is due to certain genetic variants of DPYD, the gene encoding DPD. For this reason, regulatory agencies such as the European Medicines Agency (EMA) recommend determining DPD deficiency in all patients who are candidates for treatment with fluoropyrimidines.

What was done?

Design of a protocol for the Implementation of dihydropyrimidine dehydrogenase (DPD) genotype tests in our hospital so that the results can be clinically interpreted by the pharmacists, and then used to guide physicians in the dosing of fluoropyrimidines (5-fluorouracil/capecitabine). The project was done with the collaboration of the Genetic and Genomic Laboratory (GGL) located in the reference hospital of our territory.

How was it done?

The elaboration of the protocol took place as follows, coordinated by the oncology pharmacist:
– Informatics. They created a formulary at the electronic prescription programme (HP-HCIS®) for the inclusion of the patients in the testing protocol.
– Oncologists and nursing service. They were trained in the implementation of this new determination, as well as in the procedure for obtaining and sending samples to the GGL.
– GGL. They conducted the DPYD genotype tests and report the results to the oncology pharmacist.
– Oncology pharmacist. They did the clinical interpretation of the result based on the following European Society for Medical Oncology (ESMO) recommendations for heterozygous DPYD variant allele carriers:
-DPYD*2A (rs3918290): dose reduction of 50%
-c.1679T>G (rs55886062): 50%
-c.2846A>T (rs67376798): 25%
-c.1236G>A/HapB3 (rs56038477): 25%

What has been achieved?

Since the implementation of the protocol, 73 determinations of DPYD polymorphisms have been performed (November 202 to August 2022). Three patients (4.1%) were found to be heterozygous DPYD gene variant carriers (two DPYD*2A and one c.2846A>T).
The average time for obtaining the results was 17.5 days. For this reason, in most cases the treatment was started before the result was obtained.

What next?

We are working on the implementation of a new fluorescence technique that will allow us to shorten the time of obtaining the genotype result.

Initiative to introduce database of compounded pharmacy preparations at the University Hospital Centre Zagreb

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

Mateja Ljubičić, Mirela Sadiković Tvorić, Mirela Ganza, Mirna Alebić

Why was it done?

Minimising quality and safety differences between commercially available medicines and compounded pharmacy preparations depends on the pharmacists’ professional education and skills. The purpose of this initiative is to specify the most common pharmacists’ adjustments of the commercially available medicines and to determine the level of quality assurance and safety measures which should be applied to the hospital pharmacy throughout planning the procurement of installations and equipment.

What was done?

Our existing computer system does not have the ability to provide information on the compounded pharmacy preparations made in the hospital pharmacy from raw material or commercially available medicines. We have introduced a database for keeping up-to-date records of pharmacy preparations compounded by pharmacists for special needs of paediatric population in the University Hospital Centre Zagreb in a period of 6 months.

How was it done?

The following information on pharmacy preparations were added to the new database: dosage form, dosage strength, shelf life and serial number of the commercial drug or raw material that was used; patient data: name and hospital department unit; and identification of the pharmacist. Data was structured as presented in Table 1. and Table 2.
Pharmacists’ adjustments Total Number
dosage strength Oral divided powders (DPs) 628
dosage form Extemporaneous oral liquids 473
In total 1101
Preparations with HD Aseptic processing Containment Complexity of process
0.05% Cyclosporine eye drops + + 2
1% 5-FU eye drops + + 2
1% Voriconazole ear drops – + 1
Vemurafenib DPs – + 1
Imatinib DPs – + 1
Capecitabine DPs – + 1
Hydroxycarbamide oral suspension – + 1
Tretinoin oral solution – + 1

What has been achieved?

Keeping up-to-date records improved the traceability inpatient care and reduced the incidence of adverse events. Specific requirements for procurement of equipment for aseptic processing and containment of Hazardous Drug (HD) were successfully recognised.

What next?

Harmonisation of standards of pharmacy preparations throughout the country could be enabled by creating a national portfolio of preparations from all hospital pharmacies. This initiative of creating an overview of the pharmacy preparation practice should be considered in other hospitals to guide the pharmacy departments in the developing quality assurance programme.

6 months after the implementation of a Good Practice Form (GPF): the example of Versatis

Pdf

PDF Icon

European Statement

Selection, Procurement and Distribution

Author(s)

Laetitia ALRIC, Isabelle PLOCCO-DESMONTS, Anne-Laure DUBOIS, Sophie TOUQUET-ARNAUD, Kim NGUYEN, Blandine ARMAND, Isabelle HERMELIN, Audrey LEFRANCOIS

Why was it done?

Versatis is a lidocaine patch used in case of post-zona neuralgia. In June 2021, after a note of concern raised by the OMEDIT (Observatoires du MEdicament, des Dispositifs médicaux et de l’Innovation Thérapeutique) regarding its overuse by staff members of the CHRO (Centre Hospitalier Régional d’Orléans).

What was done?

We analysed the change in prescriptions and consumption since the implementation of a Good Practice Form (GPF) in September 2021, concerning Versatis created in collaboration with the CLUD (Comité de LUtte contre la Douleur).

How was it done?

Analysis of nominative dispensations between 09/21 and 02/22.
Consultation of shared electronic patient records.
Medical evaluation of prescriptions by rheumatology and pain-management physicians.
Methodological strategy validated by the physician in charge of professional practices evaluation.

What has been achieved?

Before the implementation, 3839 patches would have been consumed over a 6-month period versus 1541 after, marking a 59.9% decrease.
The population under scrutiny was made up of 106 patients (male-to-female ratio = 1,3; average age = 64 years). The average number of patches delivered per patients was of 15 (min=5; max=160), with 1,1 patches per localisation, for an average length of treatment of 14,4 days. 97 GPF were archived, representing 91,5% of use.
In-label prescriptions (post zona neuralgia with localised allodynia) concerned 14 (13,2%) patients.
Regarding pertinent off-label prescriptions (neuropathic pain with localised allodynia, with a maximum of 1 patch/zone/day): 36% of patients exhibited neuropathic pain, including 9% with allodynia, with 4% 1 patch/zone/day. 9,4% benefited from rheumatological or pain management consultations.
48% of prescriptions respected the 12/24h rest-time, and 79% the limit of 1 patch/zone/day off-label.
After medical expertise, 3 prescriptions were found to be unjustified – 2 due to lack of information and 1 concerning post-gout crisis pain.

What next?

Despite the patch’s small price, the implementation was of significant impact over the hospital’s consumption (and by extension, over the hospital prescribing dispensed in the community), due to its adoption by over 90% of medical prescribers. This, despite a majority of off-label prescriptions, which were rated as pertinent over 90% of the time. The GPF will have been optimised since this evaluation took place, notably with a more precise definition of allodynia.

Improving people living with HIV therapies compliance: a practical tool customised for patients and designed by hospital pharmacists

Pdf

PDF Icon

European Statement

Patient Safety and Quality Assurance

Author(s)

Sabrina Trivellato, Daniele Mengato, Maria Mazzitelli, Anna Maria Cattelan, Francesca Venturini

Why was it done?

An optimal compliance is an essential requirement for people living with HIV (PLWHA) to grant drugs effectiveness and safety. Given the complexity of the therapeutic regimen, and the multiple changes to it due to the clinical status, compliance to therapy may be suboptimal. Patients who are not well educated on how to follow their therapy are more keen on quitting the treatment or facing virological failure. According to previous analysis, we reported that 120 patients out of more than 1500 managed by our centre experienced suboptimal adherence to therapy.

What was done?

We created a user-friendly tool to educate HIV-patients on their drugs’ adherence in our University Hospital.

How was it done?

We studied every drug prescribed in our centre and we analysed it from the patient’s point of view. The question we aimed to answer was: “If I were a PLWHA, what would help me assuming the correct drug, at the proper time, avoiding misunderstandings?”. We analysed the shape, colour and dimensions of both the package and the pills/capsules. We focused on the most appropriate way to take every drug and we investigated possible interactions with OTC drugs or dietary supplements.

What has been achieved?

A poster reporting all the drugs available in our formulary was developed: 34 medicines were described in alphabetical order, specifying for each one the image of the package, the usual dosage, the picture of the pill/capsule compared to the dimension of current coins and special warnings about possible drug-drug interactions. We also adopted practical symbols to indicate whether to assume the drug with or without food. The poster became available starting from April 2022 and during the following 5 months a cohort of 960 patients could rely on it.

What next?

In order to help our patients taking their therapies, we expect to get a digital form of this poster to make it available on the phone scanning a QR code. Alongside, we aim to enlarge and improve this digital version by adding a final section with an interactive survey to closely monitor the compliance of the patients and help them to improve it. Through this project we could also obtain an active pharmacovigilance setting.

Pharmacist prescriber embedded within medical team improves patient care by timely and accurate discharge medication prescribing

Pdf

PDF Icon

European Statement

Clinical Pharmacy Services

Author(s)

Fiona Watson, Amanda Plummer, Aqleema Akhter

Why was it done?

For discharge medication to be dispensed a medicines list plus discharge letter, often referred to as a To-Take-Out (TTO) is required. The letter section communicates information for safe patient transfer and provides context for the pharmacist clinical verification. With increasing demands on junior doctors, the production of TTOs is often delayed until after all urgent clinical duties are completed, so dispensing commences late in the working day. in addition, junior doctors’ prescribing errors cause delay while queries are resolved. The late completion of TTOs slows patient flow across the whole system. It was accepted that a different strategy, using a PP to prioritise prescribing, needed exploration.

What was done?

A prescribing pharmacist (PP) was embedded within a specialist medical team, to perform prescribing activities in a timely manner, with a focus on discharge prescriptions. The PP was additional to the standard ward pharmacy establishment, allowing prescribing to be the focus of the role.

How was it done?

A PP was embedded within the Respiratory team and another within Gastroenterology with the primary aim of producing TTOs as early as possible. There was a requirement for the PP to learn how to write the discharge letter, via training with junior doctors. The PP prioritised any prescribing to facilitate discharge, but also attended the consultant ward round undertaking medicines optimisation for each patient. Rather than the junior doctor returning later to prescribe, the PP made any necessary medication changes during the ward round, facilitating the timely receipt of appropriate therapy.

What has been achieved?

Both pilots reduced the time from medically fit for discharge to the TTO written by approximately 3 hours. There was a reduction in prescribing error rate of 37% to 1% in Respiratory and 9.5% to 0.7% in the Gastroenterology project.

What next?

The “Embedded Prescribing Pharmacist” role is now permanent within the two pilot specialities, with plans for further extension under consideration. The role demonstrates the “Right first time” concept and a modernised model of hospital pharmacist practice.