Author(s)

LYG Lidia Ybañez García, VPG Virginia Puebla García, ERS Estefanía Rosón Sanchez, NSO Natalia Sánchez Ocaña, JCV Javier Corazón Villanueva, MTO María de la Torre Ortiz, TBG Teresa Benitez Gimenez.

Why was it done?

Dual antiplatelet therapy with clopidogrel and ASA is standard for acute coronary syndrome and post-stent patients. ASA hypersensitivity occurs in approximately 1.5–2.6% of coronary patients, requiring rapid desensitization. The previous capsule-based protocol involved up to 10 strengths in batches of 100 capsules, many of which were discarded.
A literature search identified only capsule-based protocols or preparations made from dispersible tablets at the ward. To minimize the risk of errors from bedside manipulation, we developed a pharmacy-prepared oral suspension from the active ingredient, allowing centralized, standardized, and safer compounding.

What was done?

A new ASA desensitization protocol was implemented using an extemporaneous pharmacy-prepared oral suspension. It replaced multiple-strength capsules, which were laborious to produce and generated considerable waste. The suspension allowed faster preparation, simplified administration of incremental doses (standardized in the protocol), and offered a more patient-centered approach. It also eliminated the need for ward-based dilutions from dispersible tablets, enhancing safety through centralized pharmacy preparation.

How was it done?

A bibliographic review (RUESA, PubMed, SEFH, Compounding Today, Trissel’s) and analysis of existing protocols were conducted. No suitable aqueous formulations were available, and oily preparations were discarded due to poor palatability. The suspension was prepared according to national pharmacy compounding and quality guidelines.
Composition: ASA 100 mg, glycerin 3 g, carboxymethylcellulose gel 1.5% (35 mL), and purified water q.s. to 100 mL (1 mg/mL). Stable for 24 hours, packaged in individualized oral syringes

What has been achieved?

Since 2017, thirteen patients (median age 83, eight males) have undergone desensitization using the oral suspension. All tolerated the process, allowing initiation of ASA therapy. Compared with the previous protocol, the new approach is faster to prepare and administer, reduces waste, simplifies the process, and maintains patient safety and treatment effectiveness. Centralized preparation eliminated bedside dilutions and enabled safe, standardized incremental dosing.

What next?

This initiative highlights the role of hospital pharmacists in developing practical solutions to optimize patient care. The approach is easily transferable to other hospitals facing similar challenges with ASA desensitization

Author(s)

Carlota Mestres Gonzalvo
Juan José Lázaro Alcay
Ángela Pieras López
Marta Duero Adrados
Carlos Javier Moreno Pérez

Why was it done?

Children with ASD frequently reject standard oral medications due to sensory sensitivities, which increases distress and drives the use of invasive routes (intramuscular and/or intravenous), undermining safety, family wellbeing, and perioperative efficiency. Current forms are not adapted to ASD needs; the aim is to maximize acceptability and minimize distress through patient-friendly formulations and calming environments, ensuring equitable, high‑quality preanesthesia care.

What was done?

The project is creating and preparing to clinically evaluate novel, palatable oral formulations—such as sensory-friendly gummies—co-designed by hospital pharmacists, anesthesiologists, and university formulation experts using advanced flavor–texture modification. In parallel, dedicated sensorial rooms with direct street-access entry, adjustable lighting and sound, and tactile comfort features are being incorporated to reduce overstimulation during preanesthetic preparation.

How was it done?

The first phase addresses obstacles such as heterogeneity in ASD sensory profiles and stringent pharmaco-technical and safety requirements. The team is overcoming these through stakeholder engagement with families, sensory mapping, iterative prototyping with in‑house stability and sensory testing, and multidisciplinary collaboration for rapid, compliant development. Hospital infrastructure supports integration, regulatory documentation, and implementation of sensorial rooms and staff training.

What has been achieved?

A multidisciplinary team has been established, equipment and consumables planned, and formulation development initiated, alongside design parameters for sensorial rooms and workflow integration. Expected outcomes include improved medication acceptance, reduced preanesthetic distress, fewer invasive interventions, greater perioperative efficiency, and higher staff confidence in ASD care, with internal dissemination and readiness for pilot evaluation.

What next?

The ADAPTA initiative is developing tailored oral drug formulations and implementing sensorial rooms to improve preanesthesia care for children with autism spectrum disorder (ASD), integrating pharmaceutical innovation with patient-centered strategies in a multidisciplinary hospital setting.
ADAPTA represents good practice by uniting pharmaceutical innovation with environmental and behavioral adaptations, offering a scalable, replicable model for inclusive pediatric anesthesia. Next steps include completing prototype validation, pilot clinical and sensory acceptability studies within sensorial rooms, standardizing operating procedures, and preparing for scale‑up across additional services and pediatric populations.

Author(s)

A. Telma Leal, António Daniel Mendes, Teresa Cunha, Paula Barbeita, Patrocínia Rocha

Why was it done?

Lennox-Gastaut syndrome is a severe, drug-resistant epilepsy with childhood onset, characterised by irregular brain activity, cognitive impairment and behavioural changes. Given its complexity and major impact on quality of life, therapy requires continuous adjustment, possibly involving valproate, clobazam, lamotrigine, rufinamide, topiramate, felbamate or cannabidiol.
No clobazam formulations are commercially available for paediatric use and data on extemporaneous oral formulations are limited. Regarding this, stability evaluation is essential to ensure quality and safety before therapeutic application.

What was done?

Galenic development, preparation and stability evaluation of a Compounded Formulation (CF) with clobazam for paediatric treatment of Lennox-Gastaut syndrome and other refractory epilepsies.

How was it done?

Development began with a literature review on the pharmacological and physicochemical properties of the drug, followed by election of an oral liquid formula.
Two samples were prepared and assessed for physical stability by an internal protocol on days 7, 14, 21, and 28: one (CF1) stored at Room Temperature (RT) <25 °C, the other (CF2) refrigerated (2–8°C).

What has been achieved?

Based on our findings, a clobazam suspension was designed using xanthan gum as a suspending agent, with pH around 5. According to literature-reported shelf lives and usage periods of CF and raw materials, one batch was refrigerated and the other stored at RT. Also, CFs were prepared at 1 mg/mL concentration (suitable for Paediatrics), packaged in 100 mL type III amber glass bottles and the final product should be whitish suspensions, homogeneous after shaking, with pH around 4–6.
Evaluation showed CF1 developed microbiological contamination on day 14, with gas, fermented odour and pH 6–7 by day 21, then 5–6 (day 28). Other features — sedimentation time, dispersibility, homogeneity and crystal growth—remained normal. CF2 kept colour and appearance until day 28. Mold odour occurred at day 21. pH rose from 6–6.5 to 6.5–7 after day 14. Other parameters remained normal.

What next?

Clobazam CF proved to be suitable for paediatric Lennox-Gastaut syndrome or refractory epilepsy use. Stability evaluation demonstrated physical appropriateness for up to 14 days under refrigeration; for longer use is not recommended.

Author(s)

Vanusa Barbosa Pinto, Cleuber Esteves Chaves, Andréa Cássia Pereira Sforsin, , Priscila Faria França, Mayara Araújo Dias, Erik Magnus Lindh, Caroline Sandoli de Almeida Souza, Maria Cleusa Martins, Maristela Barros De Sousa, Rafael Alves de Souza,

Why was it done?

We implemented a structured, interprofessional Innovation Committee within the hospital pharmacy to systematically manage the entire innovation pipeline. The team, comprising pharmacists, nutritionists, physicians, and Information Technology (IT) specialists, established a formal process to guide high-potential projects from initial ideation to final submission for competitive funding. This governance model was successfully applied in 2025 at the pharmacy of a public teaching hospital.

What was done?

Innovation often lacks strategic coordination in hospital pharmacy, limiting the translation of valuable ideas into robust projects. Our objective was to overcome this unstructured environment by creating a governance framework. The committee began its work by specifically focusing on identifying deep clinical “pain points,” such as fragmentation in antimicrobial management, difficulty in customizing medication dosages, and low adherence to training programs for Generation Z staff.

How was it done?

Projects were prioritized based on a methodology that weighed clinical impact, economic feasibility, and technical executability. The team utilized agile management tools, including the value-versus-effort matrix and the problem-solution canvas, complemented by sprint rituals to ensure progress and alignment. The committee successfully generated and developed three large, scalable proposals, validating the model’s capacity to identify and mature high-impact ideas. These proposals were submitted to a competitive institutional innovation grant (In.Cube-InovaHC).

What has been achieved?

The structured process resulted in a robust innovation pipeline with three high-potential proposals: PrintPharma (3D-printed personalized medications), FarmáciaLab (a gamified platform for team training), and Sentinela-ATB (an antimicrobial stewardship hub). The PrintPharma project, which aimed to develop an in-hospital 3D printing solution for personalized medicines, was ranked 8th among 134 highly competitive proposals in a major institutional innovation grant (In.Cube-InovaHC). This ranking validated the quality and maturity of the committee’s output.

What next?

This structured, pharmacy-managed innovation pipeline is a feasible and high-impact strategy that significantly strengthens the institution’s capacity to drive change. It should be considered a best practice example because the governance model and its agile tools are fully replicable and adaptable by any other hospital pharmacy, establishing the pharmacist as a protagonist in healthcare innovation.

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Author(s)

Saldaña Soria Raquel, Florit Sánchez María, Yunquera Romero Lucía, Fernández Martín Jesús, Gallego Fernández Carmen, Tortajada Goitia Begoña

Why was it done?

The aim of this protocol is to evaluate and quantify the cost saving of the optimisation of the use of emicizumab vials through repackaging into syringe under aseptic conditions.

What was done?

Emicizumab is indicated for routine prophylaxis of bleeding episodes in patients with hemophilia A. This drug has a significant economic impact, so it has been decided to initiate a protocol for the use of emicizumab in which it has been established to group patients and dispense pre-filled syringes of repackaged emicizumab for each patient, dividing the vials according to the patient’s dose in the syringes as a savings strategy.

How was it done?

Two male patients, aged 4 and 5 years, with hemophilia A, have been treated with emicizumab in our hospital from February 2022 to September 2024. A protocol was implemented consisting of dispensing repackaged pre-filled syringes of emicizumab (expiry date 7 days according to the Good Practice Guide for the preparation of medicines) to each patient, grouping the patients receiving treatment with emicizumab on the same day for dispensing and dividing the vial into syringes to adjust it to the recommended dose according to the Technical Data Sheet in a laminar flow cabinet.

What has been achieved?

This treatment would have cost 337.125,95€ from February 2022 to September 2024. However, since patients (grouped on the same day of the week) were dispensed repackaged emicizumab pre-filled syringes and emicizumab repackaging was performed under aseptic conditions, the total cost has been 168.562,98€. Therefore the cost savings would be 168.562,98€ (63.211,12 €/year).
In conclusion, this new way of working can allow us to save 63.211,12€ (43 vials of 30 mg) every year. For this reason, the repackaging could represent a significant economic saving in patients with hemophilia A, while contributing to maintaining the sustainability of the national health system.

What next?

We hope to include all patients from our hospital in the emicizumab optimization protocol to continue contributing to the sustainability of the national health system.

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Author(s)

Castejón Grao, I; García Zafra, V; RodrÍguez Morote, M; Jiménez Pulido, IP; Andujar Mateos, A; Murcia López, AC.

Why was it done?

The pharmacist is responsible for magistral formulations in hospitals. Paper-based methods can lead to errors so the software was integrated between 07/2022-06/2023 aiming to reduce human errors,optimize preparation times,standardize procedures,improve stock management, formula traceability and enable statistical analysis capabilities of the area.

What was done?

CPFarma® software was implemented to control the programming, preparation, validation, and dispensing of magistral formulas. It facilitated proper management of the processes involved in galenic preparations at a tertiary-level university hospital.

How was it done?

The implementation of CPFarma® software involved the following stages:
1. Creation of user accounts and permissions.
2. Introduction of active pharmaceutical ingredients and raw materials, including batch and expiry details.
3. Inclusion of packaging materials,tools and required clothing for each preparation.
4. Transfer of Standard Operating Procedures(SOPs) in three phases:
4.1. Integration of the original SOP for each formula.
4.2. Revision and validation of SOPs and associated calculations.
4.3. Determination of active and passive SOPs.
5. Association of patient information sheets.
6. Drafting of a programme use protocol.
7. Training personnel on software use.
8. Validation in daily practice situations.

What has been achieved?

Until August 31, 2024, 249 SOPs (averaging 85 monthly) have been incorporated into the database, 74,7%(186) active and 25,3%(63) passive status, standardizing procedures. The system also includes 67 primary packaging materials and 275 components (185 active ingredients,16 base formulations and 74 excipients), improving stock control.
A total of 1279 magistral formulas have been prepared and validated by a pharmacist:54%(693) for usual stock,40%(510) for specific patients and 6%(76) with no record available. Each formula includes a preparation guide that includes detailed records to ensure traceability, such as patient information,prescriber details and preparation order number. There is also a computerized recipe book with histories filterable for statistical analysis.
No human errors have been detected in the preparation since the program’s implementation, and the patient information sheet helps prevent medication errors.

What next?

Efforts are being made to improve the system by adding features like a barcode reader for batch entry and registering personnel that dispense and collect medication. CPFarma® has optimized magistral formulation management, so Pharmacy Services without specialized software could benefit to improve their practices through its implementation.

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Author(s)

VIRGINIA PUEBLA GARCIA, MARIA MOLINERO MUÑOZ, ANA ANDREA GARCIA SACRISTAN, JAVIER CORAZON VILLANUEVA, LIDIA YBAÑEZ GARCIA, NATALIA SANCHEZ-OCAÑA MARTIN, PALOMA PASTOR VARA, MARIA FERNANDEZ-VAZQUEZ CRESPO, JOSE MANUEL MARTINEZ SESMERO

Why was it done?

Calciphylaxis is a vascular disorder characterised by the accumulation of calcium in the small blood vessels of the skin and adipose tissue. There is an imbalance in calcium metabolism which causes calcium to be deposited in the arterioles favouring thrombosis in the residual lumen of these vessels. It presents with severe painful skin lesions which progress to ulcers. It mostly affects patients on renal replacement therapy.

What was done?

To describe the making process of a 25% sodium thiosulphate ointment (ST25%) requested by the Nephrology Department as an off-label use for the topical treatment of calciphylaxis in a patient who was unable to use intravenous sodium thiosulphate (ST) due to haemodynamic instability.

How was it done?

We initially performed an online literature search of databases related to raw materials and excipients, experience of use with formulas prepared by other hospitals as well as articles related to calciphylaxis.
For the production and quality control, the Standard Operating Procedure (SOP) for ointments described in the National Formulary was followed. To establish the risk level of the preparation and the expiry date, a risk matrix was used according to the Guide to Good Pharmacy Preparation Practice (GBPP).

What has been achieved?

It was decided to make a ST25% ointment. Composition for 100 g: ST 25 g (active ingredient), glycerine 10 g (humectant, cosolvent), pure lanolin 32.5 g and white filmy petrolatum 32.5 g (vehicles).
Production: the ST crystals were pulverised in a mortar. Glycerine was gradually added on top of the ST until a uniform whitish paste free of crystals was formed. At the same time, lanolin and filmy petrolatum was mixed in the final container with the help of an emulsifier. Finally, the paste formed with ST and glycerine was added to the lanolin-Vaseline mixture and stirred in the emulsifier until a homogeneous ointment was obtained.
A yellowish ointment with a homogeneous appearance, oily texture and no crystals was obtained.
Expiry date: 30 days after opening. Low-risk preparation.

What next?

Calciphylaxis could be treated after intolerance to intravenous sodium thiosulphate by developing an ointment. The pharmacist through magistral formulation can provide pharmaceutical alternatives in situations where the use of commercially available medicines is not possible.

Author(s)

María Molinero, Virginia Puebla, Cristina González, Lidia Ybáñez, Gonzalo Hernando, Natalia Sánchez-Ocaña, Javier Corazón, María de la Torre, Jose Manuel Martínez

Why was it done?

This technique provides autonomy to the patient allowing to adjust the dose based on the intensity of pain. It has been demonstrated that small on-demand doses of analgesia provide a reduction in the final dose, thus reducing side effects. In addition, by minimizing the possible delay in the administration of analgesia, the anxiety associated with pain and exacerbations is reduced.

What was done?

Hospital Pharmacy Service in collaboration with Acute Pain Unit has developed a protocol for an analgesic mixture for intravenous administration in continuous infusion based on tramadol, dexketoprofen and haloperidol. It is a patient-controlled analgesia (PCA) administered by pump for the treatment of acute postoperative pain.

How was it done?

We performed a bibliographic search of stability studies in order to standardize the analgesic mixture, guaranteeing its physical-chemical and microbiological stability.

What has been achieved?

A mixture of 600mg tramadol, 300mg dexketoprofen and 5mg haloperidol was prepared and it was filtered through a 5-micron filter. It was diluted in 100mL of 0.9% sodium chloride, obtaining a mixture of 125mL. It was sealed and bagged in a photoprotective bag. After the bibliographic search on stability data and physical-chemical compatibility of the mixture, a stability of 14 days at 2-8 ºC was established. Once elaborated, quality control was performed by gravimetry. It was dispensed weekly by stock to the post-anesthesia resuscitation unit. The established perfusion rate is 1.3 mL/h or 1.7 mL/h for 48h. With each rescue, 8mg of tramadol and 4mg of dexketoprofen are released per hour or 4mg and 2mg every 30min, respectively. The maximum dose that can be administered is 400mg tramadol, 150mg dexketoprofen and 2mg haloperidol, except if the patient weighs less than 50kg: 8mg/kg tramadol. If renal insufficiency, dose adjustment was mandatory.

What next?

The centralization of the preparation of intravenous admixtures from the pharmacy service allow us to adjust the expiry date based on stability studies reported in the literature, to maintain the asepsis of the mixture as it is prepared in horizontal laminar flow cabinets, to increase the safety and to secure the traceability.

Author(s)

Mette Lethan, Tove Hansen, Trine Schnor, Louise Rasmussen Duckert

Why was it done?

Oral vancomycin 125 mg four times a day for 10 days, is the common treatment for antibiotic-associated clostridium difficile colitis. As solid oral formulations are unsuitable due to strong diarrhea, an i.v. formulation in a diluted form (10 mg/ml) is used. However, several issues with that use, required the need for creating a new formulation.
The product is used for treatment of kids and adults, often with nausea. The low strength requires large volumes of solution and with no flavoring the liquid is very bitter.
Furthermore, the current solution has a limited stability causing difficulties as it is often desired to treat the patients at home. Therefore, a wish arose for a new formulation with a higher concentration, better stability and improved organoleptic qualities.

What was done?

A new oral formulation of Vancomycin was developed to improve the treatment of antibiotic-associated clostridium difficile colitis. The new formulation consists of the active ingredient (API) Vancomycin as a powder with a solvency for dissolving prior to use.

How was it done?

To obtain the best stability it was selected to make a new formulation consisting of a premeasured API, with a solvency ready to mix before use, to obtain a final strength of 50 mg/ml and a volume equivalent to 48 hours of doses.
Vancomycin in pharmacopeia quality was acquired and analyzed. A solvency was formulated mostly consisting of water, conservation and orange flavoring. A test was conducted with a weighed-out API to ensure that it was dissolvable with the solvency in the selected packaging.

What has been achieved?

A product achieving the wanted changes was tested and made. Making a formulation consisting of a premeasured powder creates the possibility of a higher durability. When mixed with the flavored solvency, the wanted strength is achieved.
The new formulation can be stored at room temperature before dissolving. It can be dissolved by the patient before use and kept refrigerated until the full volume is used. The product is easy for the patient to handle and therefore enables treatment in the patients own home.

What next?

A new product was made. Final use by patients will be tested for ease of use and potential home treatment.

Author(s)

Marianna Rivasi, Gregorio Medici, Lucia Ricchi

Why was it done?

Because of the need to administer DA-EPOCH over a continuous 96-hour period, patients are traditionally hospitalized. Frequently, these admissions may be delayed because of bed shortages. Previous studies have shown that EPOCH-containing regimens can be safely administered in the outpatient setting, thus decreasing inpatient bed use and overall health care costs. Home-based chemotherapy is normally preferred by patients and helps reduce the risk of hospital-acquired infections; furthermore, other aspects such as functional decline and social isolation are minimized. Beginning in August 2019, we introduced an outpatient EPOCH-based chemotherapy model with portable infusion pumps and have already treated 9 patients.

What was done?

DA-EPOCH (etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin) -based chemotherapy is traditionally administered inpatient because of its complex protocol and number of involved medications. These routine admissions are costly, disruptive and isolating to patients. Here we describe our experience transitioning from inpatient to outpatient setting.

How was it done?

We purchased 3 CADD-SOLIS infusion pumps (Smiths Medical) and connected them to the bags containing chemotherapy. One of the main issues we observed in this procedure was the flow disturbances due to the presence of small air bubbles in the pump delivery line so we tried to develop a method aiming to reduce this effect.
We changed the first type of device we used with a new one consisting of an irreversible spike needle-free access to IV bag (BTC, Italia) inserted to the medication port of the bag. Into the spiking port we insert the CADD High-Volume administration set. It is crucial to remove all the air inside the IV bag and make sure there is no extra air injected into the bag when adding medication, finally do not forget to fully prime the tubing.

What has been achieved?

Outpatient EPOCH administration was associated with cost savings of approximately 400.000€ for both chemotherapy costs and hospital day avoidance (45 days). In addition to cost savings, outpatient administration improve patient satisfaction, without any apparent decrement in treatment efficacy.

What next?

Outpatient treatments would lead to changes in how both patients and providers relate to cancer care. Transitioning care out of the hospital and related cost reduction allowed for additional investments in public health.