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POST-CONSTRUCTION CLEANROOM COMMISSIONING AND OPERATIONAL IMPACT: A COMPLIANCE-DRIVEN APPROACH TO USP STANDARDS

European Statement

Production and Compounding

Author(s)

Natalie Kuchik PharmD, MS, BCSCP and Jacalyn Rogers PharmD, MS, BCPS, CPEL, FASHP and Victoria Lubarsky RPh, MBA., BCACP

Why was it done?

Due to evolving and increasingly stringent USP requirements, multiple cleanroom construction and renovation projects were necessary to ensure continued compliance. These upgrades were critical to maintaining sterile compounding capabilities, keeping pharmacy operations uninterrupted, and safeguarding patient care.

What was done?

Each cleanroom underwent a structured post-construction commissioning process, including environmental certification, workflow validation, staff re-training, and installation of continuous monitoring systems. Pharmacy operations were strategically coordinated to minimize disruption during each phase.

How was it done?

Third-party experts conducted ISO-class environmental testing and microbial sampling. Pharmacy teams performed workflow simulations to assess layout and aseptic technique. Updated SOPs were implemented, and staff received targeted training. Real-time monitoring tools were installed to track pressure, temperature, and particle counts.

What has been achieved?

All renovated cleanrooms achieved full USP compliance prior to go-live. Pharmacy operations remained efficient, with no delays in patient care. Staff confidence improved, and workflow efficiency increased by 25%. No adverse events or regulatory citations were reported.

What next?

We plan to develop a standardized cleanroom commissioning protocol for future projects and share it across our hospital network. Ongoing monitoring, periodic revalidation, and continuous staff education will support sustained compliance and operational excellence.

CONTINUITY OF PHARMACEUTICAL CARE BETWEEN HOSPITAL AND COMMUNITY: AN INTEGRATED ANALYSIS

European Statement

Introductory Statements and Governance

Author(s)

Chiara Cardinali, Massimo Fioretti, Carlo Polidori

Why was it done?

In some realities, recent laws allow the administration of hospital medications in outpatients setting by defining two dedicated paths: protected discharge and taking charge directly on the territory. This therapeutic approach is made possible by the collaboration between the clinicians and the community doctors.
The project aims to examine the continuity of pharmaceutical care in our reality taking into account some clinical outcomes, management implications as well as economic aspects.

What was done?

The Pharmacy Unit analysed all documentation, including prescriptions, from 2022 to the beninning of 2025, aiming to assess safety and adherence outcomes.

How was it done?

A written survey was conducted among community doctors and clinicians in order to evaluate their level of knowledge of the law and to collect their feedback.
Analysis of the 2023 final balance sheet enabled us to make some economic considerations.
Finally, we interviewed home nurses to find out their perception of risk related to the administration of hospital medications in outpatients setting.

What has been achieved?

There were 45 total runs, and the Infectious Diseases Unit was the most active department; consistently,77% of prescriptions included antimicrobials. None of the 140 pharmacovigilance reports was related to this pharmaceutical approach.
51 doctors completed the survey: among them, only 24 doctors were familiar with this law. Both community doctors and clinicians claim that the difficulty in collaborating with each other undermines the feasibility of the approach and they require greater support from hospital pharmacists.
A total of 678 days of hospitalisation were avoided: the financial savings amounted to EUR 1,130,904 over the three-year period.
Safety and collaboration were the themes that emerged from the 11 interviews that have been collected: nurses mentioned the risk of storing medicines at home, the transcription of therapies on several documents and the lack of protocols for managing emergencies at home.

What next?

In conclusion, this law represents an important opportunity for the quality and sustainability of pharmaceutical care, but it requires a collaboration between hospital doctors, community doctors and nurses that should be implemented with a solid and tailored organisational model.

PHARMACY TECHNICIANS SATISFACTION SURVEY ABOUT PROCEDURE IMPROVEMENT PROCESS IN SAFE DISPENSING MEDICATION

European Statement

Patient Safety and Quality Assurance

Author(s)

L. DE AGUSTIN SIERRA, P. FLOX BENITEZ, B. MONTERO PASTOR, A. SUCH DIAZ, P. TEJEDOR PRADO, E.A. ALVARO ALONSO, E. IZQUIERDO GARCIA, N. FONT TARRES, M. SANCHEZ LORENZO, I. ESCOBAR RODRIGUEZ.

Why was it done?

Medication dispensing errors were detected more frequently in our Pharmacy Department. This errors were related with procedures among pharmacy technicians (PT).
Formation programs bettween PT are implemented in our Pharmacy Department in other critical areas such as compounding or cytotoxic drugs but not dispensing.
It its known that a lack of knowledge of established work procedures among pharmacy technicians (PT) can contribute to a potential increase in medication dispensing errors. On the other hand, medication dispensing errors are preventable incidents in the process of distributing and administering drugs that can cause avoidable harm to patients.

What was done?

Implementation of a procedure manual to define operative procedures carried out by PT that need improvement in the safe dispensing medications and establish appropriate measures for safer and efficient work.

How was it done?

Observational, prospective, descriptive study conducted by pre and post survey (1-5) during July and september 2025 among PT.  The total number of surveys was 28 (15 pre and 13 post).
A structured questionnaire was developed with closed question (pre and post) about: (1) medication distribution and dispensing, (2) knowledge of stablished operative procedures, (3) clinical pharmacy services and medicine information, (4) personal abillities and skilss and (5) necesity for training and information.
Surveys included 11 questions using Google Forms Likert scale of 1-5, being 5 maximum score.
Post-survey was conducted after three-months period training for PT.

What has been achieved?

In pre-survey, medication distribution and dispensing received the lowest score (3 on five-point scale). The rest of responses showed a satisfaction degree (4) also for necesity for training and information.
After manual implementation, post-survey questionnaire shows that manual enhanced work procedures and medication distribution, dispensing (3 pre Vs 4 post), self-confidence and autonomy in established procedures. (4 on five-point scale). Moreover, overall satisfaction about was satisfied (4).

What next?

The implementation of a procedure manual has enhanced generally satisfied between PT. Although our survey shown this enhances, we are conscious about importance and necessity of reglated formation in Pharmacy Department in order to safe dispensing medications and safer and efficient work. For that reason, reglated formation has been scheduled among PT.

REDUCING MEDICATION WASTE IN HOSPITALS: DATA-DRIVEN SOLUTIONS AT THE SOURCE

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European Statement

Selection, Procurement and Distribution

Author(s)

Minke Jongsma, hospital pharmacist, Tjongerschans Hospital, Heerenveen, The Netherlands
Marja Bogaards, hospital pharmacist, Haaglanden Medisch Centrum, Den Haag, The Netherlands
Annemiek Zwetsloot, ICT consultant, Panacea Informatics, Oosterbeek, The Netherlands
Folkert Botma, ICT consultant, Panacea Informatics, Oosterbeek, The Netherlands

Why was it done?

A significant proportion of valuable medications, often produced far from where they are used, ends up discarded without ever being administered. Due to limited visibility into actual medication use, hospitals face challenges in understanding which drugs contribute to waste.
Analyzing internal data allowed us to gain insight into different aspects of medication waste. Addressing these aspects successfully improved sustainable use of medication.

What was done?

We developed a medication waste dashboard to promote sustainable decision-making across medication policies, purchasing, prescribing, distribution, administration, and waste management.

How was it done?

Daily, hospital pharmacies register all medication orders and dispensations (to patients or for stock), while nursing staff document actual administrations. The discrepancy between dispensed and administered drugs provides useful insight into unnecessary medication waste.

What has been achieved?

We integrated dispensing and administration data into a dashboard, offering real-time visibility at the organizational, departmental, ward, and drug group levels. This tool allows our multidisciplinary team to conduct trend analyses and implement greener practices. Key outcomes include: 1) reduction of medication waste, 2) preventing excessive stock accumulation, 3) optimizing internal processes, and 4) maximizing reuse. Additionally, these data supports effective management during drug shortages and provides critical insights into missing opioids.

What next?

Utilizing data allows us to retrospectively analyze trends and project future scenarios, unlike traditional waste-bin audits. This data-driven approach empowers us to make proactive adjustments, guiding hospitals toward long-term medication waste reduction and facilitating benchmarking across healthcare institutions.

OPTIMISING PATIENT ADHERENCE IN HEART TRANSPLANTATION: A PHARMACIST-LED EDUCATIONAL APPROACH

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European Statement

Clinical Pharmacy Services

Author(s)

Lucie Malečová, Daniela Seberová, Blanka Zelená, Markéta Hanulíková, Kornélia Chrapková, Stanislav Gregor, Michal Hojný

Why was it done?

Adherence to immunosuppressive medication is crucial for long-term graft survival. Patients receive substantial information from various healthcare professionals regarding new medications and lifestyle choices during hospitalisation and post-discharge. Frequent non-adherence indicated that the existing educational approach led by physicians was insufficient. Our objective was to create optimal conditions for providing these instructions to patients before discharge.

What was done?

In collaboration with the cardiology department, hospital pharmacists created and implemented a new educational project to improve adherence among heart transplant patients. The main activity involves hospital pharmacists conducting educational visits at the patient’s bedside, supported by new educational brochures, materials, and questionnaires.

How was it done?

We created a questionnaire and collected baseline data by assessing the knowledge of transplant patients educated by the existing educational approach. Afterwards, we designed and implemented a six-visit educational program and prepared new educational materials and brochures. A new record system was integrated into the hospital information system to facilitate communication between doctors and pharmacists, documenting educational visits and questionnaire results. The initial three visits, scheduled during hospitalisation, cover the correct use of immunosuppressants and other medications, their interactions, and potential adverse effects. Guidance on recommended lifestyle changes post-transplantation, such as hygiene, diet, and infection prevention, is also included. The remaining three visits occur within one year post-discharge to assess patient knowledge with the previously mentioned questionnaire and adherence to the treatment plan with BAASIS©. During these visits, the pharmacist conducts a comprehensive review of adherence, addresses any drug-related issues, and guides medication changes.

What has been achieved?

Since the project’s initiation, 120 visits have been completed, involving more than 30 patients. The education significantly improved patient knowledge, with educated patients scoring an average of 94% correct answers on the knowledge questionnaire compared to 59% correct answers of patients educated by the existing educational approach. Only three educated patients were non-adherent, with the most common type of non-adherence being failure to take medication at the prescribed time.

What next?

As more patients participate in the project, we aim to correlate their knowledge and adherence with tacrolimus levels and the incidence of rejection. Additionally, we intend to extend this educational initiative to other departments within the hospital.

Collaborative network between healthcare settings: hospital and community pharmacy

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European Statement

Clinical Pharmacy Services

Author(s)

Carmen Redondo Galán, Cristina Ortega Navarro, Ana de Lorenzo Pinto, Beatriz Torroba Sanz, Cecilia Martínez Fernández-Llamazares, Silvia Manrique Rodríguez, Álvaro Narrillos Moraza, Carmen Rodríguez González, Ana Herranz Alonso , María Sanjurjo Sáez

Why was it done?

Transitions of care put the patients at risk for medication error as a result of poor communication and information loss. Treatment beginnings, complex treatment and medication reconciliation errors are an important cause of morbidity and have a predominant role in chronic complex patients (CCP). In this sense, collaboration and effective communication between hospital and community pharmacy are considered essential elements to guarantee continuity of patient care, obtaining better health results in terms of safety, effectiveness and efficiency.

What was done?

Create and implement a collaborative network with direct communication between the Hospital Pharmacy Service of a tertiary hospital and the community pharmacies responsible for patient follow -up.

How was it done?

A multidisciplinary group of hospital pharmacists dedicated to different clinical areas was created: three pharmacists from the Emergency Department, two from the Paediatrics Department, one from the Neurology Department and one from the Outpatients area. They selected and contacted by telephone the 40 community pharmacies responsible for 25% of patient prescriptions in the area. Periodic meetings were scheduled and possible strategic lines of collaboration were shared. The following priority groups were identified: Group 1: CCP (paediatric patients and fragile elderly patients) and Group 2: patients treated in the hospital emergency department. We addressed logistical aspects (supplies and preparation of formulations), pharmacotherapeutic monitoring (adherence, adverse drug reactions and collaboration in the management of CCP). The main limitations were small population and short follow-up time.

What has been achieved?

From March 2023 to September 2023, the hospital Pharmacy Service has received 50 consultations on 45 patients from community pharmacies: 85% were classified as group 1 and 15% group 2. Pharmaceutical interventions were related to medical shortages (28%), reconciliation errors at discharge (22%), information about formulations (20%), information about new treatments (15%), prescribing errors (12%) and adverse drug reactions (3%). Community pharmacists appreciated accessibility and value of information provided by hospital pharmacists. 50% of patients avoided a hospital visit to solve their queries.

What next?

Our first results show the importance of pharmacist interventions with patients and other healthcare professionals.This collaborative network can be applicable to all services that work with community pharmacies to guarantee greater coordination and integration in the different healthcare settings.

Redispensing of expensive oral anticancer medicines: a practical application

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European Statement

Clinical Pharmacy Services

Why was it done?

OAM are widely used in the treatment of solid tumors and are administered orally in cycles that require self-administration at home. However, dose adjustments and discontinuations often lead to leftover medication which is discarded as waste. Therefore, the increasing use of expensive OAM comes with the downside of a financial and environmental burden. To reduce this waste, returned OAM to the pharmacy could be considered for redispensing to other patients providing guaranteed quality.

What was done?

We defined quality criteria for redispensing of oral anticancer medicines (OAM) in our hospital pharmacy. These criteria were laid down in a Standard Operating Procedure (SOP) to assess the eligibility for redispensing of returned OAM. This SOP was implemented in daily pharmacy practice.

How was it done?

A systematic risk analysis was conducted to determine eligibility of OAM for redispensing taking relevant guidelines and product information into account. The defined quality criteria were translated into a SOP and implemented in daily pharmacy practice. Over a year period, the number of returned OAM accepted for redispensing was quantified, and the reduction in financial waste and environmental burden calculated.

What has been achieved?

From the systematic risk analysis, four categories of quality aspects were identified: product presentation suitability (stability characteristics, storage requirements), physical condition (unopened or opened secondary or primary packaging, visual appearance), authentication (Falsified Medicines Directive, confirmation of initial dispense, recall), and additional aspects (remaining shelf life, period of storage under uncontrolled conditions). The first category identified that in principle, 75% of the licenced OAM (n=..products) dispensed at our institute is eligible for redispensing. From all combined quality aspects, a flow chart was created according to which each individual returned OAM is assessed . During the study period, 10,415 OAM dose units out of 13,210 returns (79%) were accepted for redispensing. The total value of OAM accepted for redispensing was €483,301, accounting for 0.9% of the total value dispensed during this period. Furthermore, the potential reduction in environmental burden was estimated at 1132.1 g of potent active pharmaceutical ingredient.

What next?

We established an easily implementable, comprehensive quality assessment of returned OAM for redispensing. Wide implementation of this approach would result in serious OAM cost and waste reduction.

RutiCar: an outpatient medication dispensing point

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European Statement

Clinical Pharmacy Services

Why was it done?

This service emerged as a result of the COVID-19 pandemic, when the collection of hospital medication posed patients, many of whom were immunocompromised, at higher risk for COVID-19 and other infections, as they had to enter the hospital facilities. Over time, it was observed that this service was not only beneficial during periods of high SARS-CoV-2 transmission. RutiCar enabled medication pickup from the patient’s own private vehicle, avoiding necessity for parking as well as entering the hospital.

What was done?

In June 2021, the Pharmacy Department of Germans Trias i Pujol University Hospital(HUGTP) established an outpatient medication dispensing point located outside the hospital premises, “RutiCar”. This initiative facilitated patients in collecting their chronic treatments without entering the hospital, enabling direct access from their vehicles.

How was it done?

A new preparation and dispensing circuit was established. The patients specify their preferred date for medication pickup by telephone, e-mail or by a form after scanning a QR code. Pharmacy technicians undertake the responsibility of scheduling the appointment and preparing the medications one day prior to the designated dispensing day. The prepared medications are transported early in the morning to a temporary medication storage facility situated within the hospital’s parking area. Finally, the patient arrives at RutiCar at their scheduled appointment time and, without the need to exit their vehicle, collects their medication.

This service is aimed at patients with chronic treatments who have been on their medication for an extended period (>6 months) and show adherence. Pharmacists play an important role in this context, by ensuring that patients meet the criteria to initiate RutiCar service, reviewing treatments to validate their continuation and overseeing medication pickups to enhance patient adherence.

What has been achieved?

This service has led to an improvement in the medication dispensing process, assisting 10.46%(282) of the monthly average of patients who collect hospital medication(2695) and extending the hours for medication pickup, facilitating the work-life balance for patients and enhancing access to patients from remote areas.

What next?

In the future, improvements can be considered, such as implementing reminders for patients who have not yet scheduled their appointments and are projected to run out of medication soon, or automated appointment systems.

Medication waste in a hospital setting; counts, concerns and considerations

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European Statement

Selection, Procurement and Distribution

Author(s)

Minke Jongsma, Marja Bogaards

Why was it done?

The use of medication is related to almost one-fifth of the total CO2 emission caused by the public health sector. Conservative estimates reveal that the amount of medication distributed by public pharmacies but wasted (thrown away unused) by patients in the Netherlands equalizes a total amount of 100 million euro. Data regarding medication waste in Dutch hospitals is not yet available.

What was done?

We analyzed the stream of medication waste in our hospital and tried to reduce this by addressing the main causes.

How was it done?

In our hospital setting, medication for each in-hospital patient is distributed daily for the next 24 hours by the hospital pharmacy. All unused medication is returned to the hospital pharmacy. We quantified and analyzed all returned unused medication in our hospital on 9 separate days.

What has been achieved?

On average, 27,9% of all medication distributed to in-hospital patients is daily returned to the hospital pharmacy. The largest part of this returned medication, 83.5% (23.3% of all medication distributed to in-hospital patients) is wasted daily. This equalizes a total amount of 87.500 counts yearly, representing a value of 41.000 euro. In terms of waste, 60 medical waste bins of 50 liter (a total volume of 3000 L) are needed to dispose of this medical waste.
Analysis of the main causes reveal that distributing both parenteral medication and medication prescribed ‘as needed’ to in-hospital patients contribute largely to medication waste, as well as the inability to adequately anticipate on the discharge of patients.

What next?

By addressing the main causes we can decrease medication waste by 45%. Further reduction can be achieved by considering re-uptake of returned medication in our main stock. Our medication distribution process, however, is mainly based on financial and quality based decisions, which excludes re-uptake. But should impact on planetary health not also be considered? To realise this, though, both ecotoxicologic data as well as information related to environmental impact of medication production should be available and easily accessible.

Development of an oral ketamine: compounding and creation of a pharmaceutical care circuit for phantom limb syndrome

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European Statement

Clinical Pharmacy Services

Author(s)

Javier Corazón Villanueva, Natalia Sanchez-Ocaña MartínPast, Virginia Puebla García, Lidia Ybañez García, Maria De la Torre Ortíz, Paloma Pastor Vara, Maria Fernandez-Vazquez Crespo, José Manuel Martínez Sesmero

Why was it done?

The PLS is the perception of a non-existent limb that may occur in up to 80% of amputees. The management of this syndrome is complex and alternative drugs are sometimes used for the treatment. The absence of a marketed formulation, off-label use of drugs and the complex treatment of pain make the role of the pharmacist essential.

What was done?

Development and validation of an oral ketamine compound and a specific pharmaceutical care circuit (PCC) as a part of the treatment of phantom limb syndrome (PLS).

How was it done?

A literature search was carried out on the preparation of this compounding, as well as on the use of oral ketamine (bioavailability, dosage, adverse reactions).
An oral solution of 10mg/ml was prepared (final volume 50ml: 500 mg of injectable ketamine solution or raw material, 20 ml of simple syrup with a sufficient amount of purified water and 2 drops of lemon essence). To establish the expiration date recommendations of Good Manufacturing Practice Guideline were followed and the organoleptic characteristics were evaluated for quality control.

The PCC created consists of the following stages:
1. Setting up a first presential visit to provide pharmaceutical care during admission: to inform the storage conditions, most common adverse effects and recommendations about medication intake.
2. Dispensing at discharge and initially appointments every 7 days for a closer follow-up: control of adverse reactions (confusion, agitation, nausea, etc.), monitoring of the appropriate use of ketamine and other analgesic medication (avoiding possible abuse and addictive behaviour) and pain control. Pharmaceutical interventions are communicated to the pain management unit (PMU).
3. Spacing of visits fortnightly once the treatment is well-stablished and proposing a telepharmacy service.

What has been achieved?

The ketamine formulation developed has been used in our hospital in three patients with satisfactory results. The interventions carried out were: pain control problems, possible inappropriate use, reduction in the number or dosage of concomitant medication or ketamine itself.

What next?

The capacity to provide therapeutic alternatives and a more exhaustive pharmacological control of pain in collaboration with the PMU can improve the safety and effectiveness of these treatments.