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Author(s)

Eva Gómez-Costa; María Begoña Feal-Cortizas; María Mateos-Salvador; Sandra Rotea-Salvo; Andrea Luaces-Rodríguez; Laura Caeiro-Martínez; Clara Fernández-Diz; Andrés Torres-Pérez; Luis Margusino-Framiñán; María Isabel Martín-Herranz

Why was it done?

Implement a circuit for the preparation, microbiological control, analytical control of patients, and dispensation of autologous serum eye drops in the Pharmacy Service (PS) of a tertiary-level hospital.

What was done?

Autologous serum eye drops are classified as a special medication that must be prepared in authorized centers with an up-to-date patient registry. This initiative aims to ensure the safe use of autologous serum eye drops, guaranteeing quality and safety in their preparation and administration.

How was it done?

The circuit was established in the PS in 2015. After prescription by the Ophthalmology Service, pharmaceutical validation confirms that the treatment is optimal and complies with regulatory requirements. Blood samples are collected from patients under controlled conditions, and the serum is prepared in a vertical laminar flow hood. Once prepared, the eye drops are stored frozen in the PS until dispensation to the patient. The pharmacist reviews the microbiological control of each batch and the patient’s serological results. When collecting the eye drops, the pharmacist records batch traceability and provides the patient with necessary information on storage and administration.

What has been achieved?

Between January and August 2024, 294 patients were treated, with 477 blood extractions performed and a 11,925 eye drops prepared. Autologous serum concentration: 20%(76.9%), 30%(11.5%), 50%(11.2%), and 100%(0.4%). Microbiological control of the eye drops: 98.1% negative and 1.9% false positives, confirmed by a second negative control. Infectious diseases were detected in the serology of 3 patients: hepatitis C(1), hepatitis B(1) and syphilis(1). These data reflect a high success rate in the preparation and quality control, as well as the effectiveness of the implemented circuit. Additionally, the system has allowed for the early detection of viral infections, reinforcing treatment safety.

What next?

The implementation of this circuit has proven effective in ensuring the safety and efficacy of autologous serum eye drops, providing rigorous control over treatments and the quality of dispensed products. Future steps will involve pharmacists requesting serological tests and developing protocols for managing patients with identified infections. Furthermore, patient surveys will evaluate treatment effectiveness and overall patient experience.

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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.

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Author(s)

ESTEBAN ALONSO, M TERESA; RODRIGUEZ FERNANDEZ, ZULEMA; ALAMO GONZALEZ, OLGA; GUTIERREZ FERNANDEZ, ISABEL; SANCHEZ LUQUE, LAURA; MARTINEZ TOMAS, PAULA; BENITO JUEZ, PILAR; ESPINOSA GOMEZ, M PAZ; GUEMES GARCIA, MAGDALENA.

Why was it done?

This initiative was arose from the need to improve the quality of pharmaceutical care (PC) and stock management to ensure adequate coverage for patients. Without appointments, it was challenging to align consultations with individual patient needs and to prepare medications for the time until the next visit, as patients arrived irregularly. Additionally, multiple patients on the same treatment would often visit on the same day, increasing the risk of stock shortages. This unpredictability led to inefficiencies in both patient care and stock management. The goal was to ensure a smoother patient flow, enhance PC quality, and improve stock control through scheduled visits.

What was done?

An initiative was developed to introduce a scheduled appointment system for Oncology and Hematology patients who need to collect medication from the hospital pharmacy. Previously, patients arrived without appointments, causing unpredictable patient flow and difficulties managing stock. The new system schedules patients around one hour after their medical consultations, with special arrangements for those on long-term stable treatments.

How was it done?

The main challenge was integrating the new appointment system into existing workflows in Oncology and Hematology. Close coordination between pharmacy staff, clinicians, and administrative personnel was essential. Patients were scheduled to pick up their medication around an hour after their consultations. Long-term patients, who need consultations every six months or more, were scheduled during less busy times, such as early mornings. This improved workload management in the pharmacy, ensuring more efficient and higher quality patient care. Effective communication with patients was key to overcoming early hesitation.

What has been achieved?

The system has resulted in a more predictable patient flow, leading to better PC quality through improved preparation and more efficient medication use, reducing shortages and surpluses. Patients now receive more personalized care, as workload is more balanced.

What next?

This initiative serves as an example of good practice, transferable to other hospital pharmacies and healthcare settings facing similar challenges. The next step is to verify patient satisfaction through surveys

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Author(s)

Margot DESCHAMPS, Nejib BORGAAOUI, Jimmy ROSE, Jennifer LE GRAND, Louise NICOLAS

Why was it done?

Digestive cancers represent about 25% of new cancer cases diagnosed in France each year. The medical management of these cancers mainly relies on cytotoxic drugs. Side effects of these medications (fatigue, hair loss, nausea, or digestive issues) can affect negatively patients quality of life. These symptoms can make daily life challenging.

What was done?

As part of a patient therapeutic education program, the goal of our project was to develop an innovative educational tool to help patients better understand these side effects and find ways to manage them.

How was it done?

As part of the implementation of a multidisciplinary therapeutic education program, bringing together oncologists, pharmacists, sophrologists, osteopaths, and nutritionists, designed for patients treated for digestive cancers, the pharmacy is responsible for a workshop focused on the side effects of chemotherapy. The main molecules used to treat digestive cancers were listed, along with their most common side effects. Based on this analysis, playing cards were created, each corresponding to a specific side effect.

What has been achieved?

The developed tool is an educational and interactive board game, consisting of a board, a dice, and 56 cards. These cards are divided into 6 categories: general symptoms, neurology-psychology, heart-lungs, gastroenterology, dermatology, and real-life scenarios. The cards were designed to be understandable and accessible to all patients. The workshop takes place in two parts, with the pharmacist as the main facilitator. In the first part, patients are encouraged to share their personal experiences related to the drawn card. Then, the scenario cards are presented to help patients manage these challenges in their daily lives.

What next?

The decision was made to limit the number of participants to 6, in order to allow everyone to express themselves and exchange freely. The duration of the workshop was theoretically set at 1.5 hours but will need to be adjusted during the first workshops. It will be necessary to implement satisfaction surveys and patient follow-up on various criteria, such as emergency room visits, the number of calls after the session, and the rating of side effects.

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Author(s)

VC Lamprecht, J Pont, SD Brugger, M Dunic, T Stutz, AR Burch

Why was it done?

The preparation of parenteral medication on wards pose a hygienic challenge. It is however imperative that parenteral solutions remain aseptic, as they evade the primary barrier of the human immune defense.
The bioburden of non-preserved parenteral medications after manipulation depends on the setting. Therefore, manufacturers cannot provide guidelines on microbial stability after manipulation and hence limit the retention period to immediate use.
National recommendations concerning this issue range from cautious to restrictive, but often allow exceptions e.g. for emergency medication. These recommendations, are difficult to implement universally due to the non-transferable framework conditions from one hospital to another.

What was done?

A practical framework for the determination of retention time of manipulated parenteral medication was developed, as economic and ecological perspectives stand in contrast to the hygienic ideal.

How was it done?

International recommendations were sighted. Recommendations of the German Commission for Hospital Hygiene and Infection Prevention (KRINKO), as well as the American Society of Anesthesiologists (ASA) and The Society for Healthcare Epidemiology of America (SHEA) were used as references, as well stated sources.

What has been achieved?

Key points were identified to create a directory that enables clinical professionals to use standardized cornerstones while adapting to their individual clinical setting.
The following are indicators for the retention period in which the parenteral medication may be used: (1) primary packaging; (2) type of manipulation; (3) physicochemical properties and (4) storage temperature.

What next?

A collaboration with the Department of Infectious Diseases and Hospital Epidemiology of the University Hospital of Zurich was established to record the hospital specific conditions and to subsequently adapt the clinical practice as well as evaluate cost-effectiveness and patient safety.
Further collaborations with Swiss hospitals are being sought.

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Author(s)

PAULA HERNANDO MARTÍNEZ, VIOLETA LAFARGA LAPIEZA, DAVID JAMES BOARDMAN GONZÁLEZ, GRACIA PICAZO SANCHÍZ, CARIDAD MARTÍ GIL, DOLORES BARREDA HERNÁNDEZ

Why was it done?

The administration of medications through NGT is a common practice in the hospital setting. However, it cannot be assumed that this route of administration shares same properties as the oral route. Proper administration requires considering the pharmacokinetic and pharmacodynamic proper1es and adapting recommendations to the medication’s pharmaceutical form(PF). Incorrect manipulation can lead to undesirable effects, such as a reduction or loss of therapeutic efficacy, as well as an increase in adverse effects, toxicity or mechanical, metabolic, and/or infectious complications.
Despite the wide bibliography on this topic, there is a lack of knowledge among patients, caregivers, and hospital staff when there is not adequate training on the use and care of the NGT.

What was done?

Development of a pharmaceutical care project for patients with nasogastric tubes(NGT) to ensure the proper administration of medications through the tube and their correct handling.

How was it done?

In May 2024, a working group of pharmacists was formed in the Hospital Pharmacy Department (HPD) with the aim of creating a protocol for the adjustment of medications for administered through a NGT in hospitalized patients. A document was developed with general recommendations on maintenance, interactions with drugs, food and enteral nutrition, aimed at patients, caregivers and healthcare professionals to ensure the correct use of the tube. Additionally, a literature review was conducted on the various available manipulation guidelines (Technical sheets, dysphagia Guide from La Paz Hospital 2021 and the Guide for Drug Administration through Tubes Reina Sofía Hospital 2023), as well as validated apps such as (Deglufarm®, Medisonda®) which provide handling and administra1on instructions for each PF.

What has been achieved?

A daily search was conducted for hospitalized patients with nasogastric tubes to identify the need of instructions on medication handling. A fillable document was designed with the necessary recommendations for the handling of each prescribed medication during the hospitalization. During the pharmaceutical validation, patients with NGT were reviewed, and personalized reports were created according to the prescribed treatments.

What next?

To evaluate the level of patient sa1sfaction and including new needs. In addition, the aim is to implement this protocol upon discharge, in order to offer a personalized report with recommendations for the prescribed medications.

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Author(s)

Diana Monteiro
Luísa Álvares
Sara Brandão Madureira
Patrocínia Rocha

Why was it done?

The confirmation of a clinical diagnosis of brain death requires the demonstration of the cessation of brainstem functions and their irreversibility. Therefore, when this evaluation is incomplete or unreliable, it is necessary to support this diagnosis using diagnostic tests such as brain perfusion SPECT. This is performed after the injection of the radiopharmaceutical technetium-99m hexamethylpropyleneamine oxime (99mTc-HMPAO) and by assessing the obtained images for the lack of cerebral perfusion to confirm the diagnosis.
Given the importance of reliable results, a high radiochemical purity of 99mTc-HMPAO is imperative in quality control to prevent false positives.

What was done?

Selection of a method to evaluate the radiochemical purity of 99mTc-HMPAO.

How was it done?

A literature review was conducted to select the most suitable method for the conditions existing in the institution. The research focused on the Summary of Product Characteristics (SmPC), the European Pharmacopoeia (Ph. Eur. 11.0), the United States Pharmacopeia (USP 42) and several published articles.
After selecting the method, three assays were performed to validate it.

What has been achieved?

For evaluating the radiochemical purity of 99mTc-HMPAO, both the SmPC and Ph.Eur. 11.0 recommend a combination of two thin-layer chromatography (TLC) methods with a high-dimension stationary phase, for which the institution does not have a chromatographic tank.
The USP 42 describes a combination of three TLC methods, using acetonitrile as the mobile phase, which is also unavailable at the institution.
In contrast, the miniaturized method by Fuente et al. uses two TLC methods, with a silica gel stationary phase and sodium chloride (0.9%) and methyl ethyl ketone as mobile phases. This method was selected given that the institution has the required phases, the stationary phase dimensions are suitable for the available chromatography tanks and the execution time for the assay is feasible.
For method validation, three assays were conducted, yielding values exceeding 80% (the reference value).
The selected method represents a rapid, reproducible and reliable alternative for evaluating the radiochemical purity of 99mTc-HMPAO. It was implemented in the institution in October 2022.

What next?

In the future, we aim to develop quality control methods for all radiopharmaceuticals in use at the institution, in order to guaranty the quality of all the exams performed.

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Author(s)

Luísa Álvares
Sara Brandão Madureira
Diana Monteiro
Patrocínia Rocha

Why was it done?

Lutetium (177Lu) oxodotreotide is indicated for treating subtype 2 somatostatin receptor-positive (SSTR2) gastroenteropancreatic neuroendocrine tumors, well-differentiated G1 and G2, progressive, inoperable or metastatic. This radiopharmaceutical targets cells with SSTR2 overexpression, emitting radiation that causes cell death.
Initially, the Summary of Product Characteristics (SmPC) included the gravity method for intravenous administration, using a system with two needles, one connected to a NaCl 0.9% solution, with or without a perfusion pump, using gravity to facilitate the flow of the radiopharmaceutical.
This method was adopted and optimized due to incidents during administration.

What was done?

Optimization of the administration method of lutetium (177Lu) oxodotreotide to maximize the administered radioactivity and enhance protection for healthcare professionals.

How was it done?

The first administration using the described method occurred in October 2022.
Subsequent treatments required transferring the radiopharmaceutical to a syringe and using a syringe pump due to incidents during administration.
A perfusion pump was later introduced to manage the flow of NaCl 0.9% solution.
In May 2024, a three-way stopcock was connected to the short needle.

What has been achieved?

Since October 2022, 23 administrations have been conducted. In the first, the percentage of remaining radioactivity in the vial was 2.19%.
The use of a syringe pump increased handling and exposure risks and was rejected due to the lack of protective barriers.
Adding a perfusion pump to the NaCl 0.9% line didn’t fully resolve perfusion issues. This was resolve by adding a three-way stopcock connected to the short needle. The additional third line allows for a syringe to be attached and force air into the system, promoting the radiopharmaceutical flow.
The average remaining radioactivity improved from 1.71% to 0.98% after final optimization.
No incidents, such as leaks or perfusion issues, occurred after optimization.
This optimization reduced the remaining radiopharmaceutical activity values, ensuring complete administration. It also minimizes professional exposure and contamination risks, as the radiopharmaceutical remains in the original vial, as indicated in the SmPC.

What next?

We aim to apply this optimized method in other treatments with the same radionuclide.

Author(s)

Gulseren Lafci
Magali Ferro
Valerie Chaminant

Why was it done?

In accordance with french legislation concerning the quality of drug management in healthcare establishments, an assessment of professional practices was carried out within our nursing home. The aim was to study the compliance of drug preparation and administration methods with good practice in our nursing home.

What was done?

A clinical audit has been set up in our nursing home. It was carried out by 2 hospital pharmacists over 3 half-days to consider the preparation of weekly doses, daily doses, and an administration.

How was it done?

One of the 4 sectors of the nursing home was randomly selected. The medication management of all its residents was evaluated. The evaluation criteria were divided into 2 main parts: “drug preparation” and “drug administration”. The part on drug preparation was divided into 4 sub-sections (person in charge of preparation, room and hygiene, preparation, conditioning). The part on drug administration was also divided into 4 subsections (concordance between prescription and administration, identitovigilance, administration, traceability).

A criterion was defined as compliant if all the responses to the items were in line with the procedure, and as non-conforming if only one of the responses was not.

A conformity rate was defined for the entire audit (overall conformity), for each part (partial conformity) and sub-part (average conformity).

What has been achieved?

The care of the 19 residents in the sector was assessed (23.4% of nursing home residents).

The overall conformity rate of our clinical audit was 38.6%. Partial conformity of the “drug preparation” part was 32.3% (the average conformities of sub sections were: 50% for “person in charge of preparation”, 25% for “premises and hygiene”, 22.5% for “preparation” and 56.25% for “packaging”). Partial conformity of the “drug administration” part was 47.8% (the average conformities of sub-sections were: 100% for “concordance prescription/administration” and “identitovigilance”, 27.3% for “administration” and 42.8% for “traceability”).

What next?

The majority of non-conformities were due to a lack of human and material resources. In addition, a lack of knowledge was observed for substitution equivalence and galenic. The results were presented and proposals for improvement, such as raising staff awareness and providing resources, were made to the hospital’s medical committee.

Why was it done?

The number of patients treated with autologous eye drops has increased significantly in recent years, which has led to the need to create an intra-hospital circuit to ensure the traceability of samples throughout the extraction, processing and dispensing process.

What was done?

Create a circuit to ensure traceability of the patient’s plasma at all times, thus avoiding any confusion.

How was it done?

In order to avoid the transport of samples by patients and consequently the loss of samples or possible errors, the following circuit was developed:
– The extraction and centrifugation of the patient’s blood is agreed with the Biochemistry Service, the orderly is in charge of taking it to the pharmacotechnics laboratory, in the Pharmacy Service, where the time of delivery will be noted.
– If the plasma arrives before 12:00 noon, the patient will be called late in the morning for dispensing. If the delivery is later, it will be scheduled for the following day.
– The eye drops are then prepared.
– Finally, they are dispensed directly from the laboratory by the pharmacists or by the technicians trained for this purpose, always under the supervision of the pharmacist responsible for the area. Traceability is maintained throughout the entire process.
To make everything possible, several training meetings had to be held with Bioquimica.

What has been achieved?

Since the implementation of this circuit at the beginning of 2023, 166 batches of autologous eye drops have been produced for 72 patients, with only one error recorded, where a plasma that was not correctly identified was delivered and discarded.
In addition, the waiting time for dispensing the preparation was reduced by 33%, from 30 minutes to less than 10 minutes, thus achieving greater patient satisfaction.

What next?

The application of this circuit prevents samples from being transported by the patient, avoiding any type of accident, as well as ensuring the correct traceability of the samples. On the other hand, patient waiting times are reduced by dispensing samples directly from the laboratory area, thus avoiding waiting times for consultations.