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Author(s)

Francesca Baldi (1), Irene Bosoni (1), Sofia Filippini (1), Annamaria Valcavi (1), Gradellini Federica (1)
Alessia Rondini (3), Monica Salsi (3), Silvia Tanzi (2), Sara Alquati (2), Corrado Bacchi (3)
1. Pharmacy Department, Azienda USL-IRCCS, Reggio Emilia, Italy.
2. Palliative Care Unit, Azienda USL-IRCCS, Reggio Emilia, Italy.
3. Hospice Unit, Azienda USL-IRCCS, Reggio Emilia, Italy.

Why was it done?

Palliative care (PC) involves a network of hospitals and healthcare facilities supported by teams of nurses, specialists, general practitioners, and pharmacists. Off-label drugs are used to manage symptoms that do not respond to standard therapies, as permitted by law when no alternatives are available and under medical supervision. The National Health Service reimburses these drugs, but their use requires authorization based on proven safety and efficacy, potentially limiting patient access. Identifying essential drugs for symptom management is crucial to ensure a good quality of life.

What was done?

The AUSL of Reggio Emilia – IRCCS developed the “Local formulary of Palliative Care in Adult Patients” to support pharmacological management in PC. This formulary outlines key symptoms and provides evidence-based pharmacological options derived from scientific literature and clinical guidelines.

How was it done?

A multidisciplinary team of pharmacists, palliative care specialists, and nurses developed the formulary, defining essential treatments for palliative care across various local care settings. First published in 2019 and updated in 2022, the formulary specifies for each drug the indication, dosage, main side effects, and route of administration. Besides, it clarifies whether the use is in-label or off-label, based on the latest studies, accredited guidelines, and Italian legislation on off-label drug use. Off-label treatments are included to address multiple clinical needs when no approved therapeutic options exist, reducing empirical prescribing practices.

What has been achieved?

The formulary covers 16 symptoms, 99 drugs, and 30 active ingredients, ensuring continuity of care across the PC network. It allows PC specialists to prescribe listed medications, facilitating patient access to necessary therapies. This evidence-based system supports off-label use when approved options are unavailable, ensuring both patient safety and legal protection for healthcare providers. The tool is accessible to healthcare professionals through an electronic prescribing and administration system and in the company’s intranet section, promoting information sharing and continuity of care in hospital, community and home settings.

What next?

Clinical pharmacists play a critical role in ensuring appropriate prescribing and the proper implementation of the electronic system. Future steps include updating the formulary and expanding pharmacist training in palliative care

Author(s)

G. Penocchio, F. Bertola, F. Bozza, F. Caravaggio, M. Ferrighi, M.P. Ghilardi, A. Pozzi, G. Trainini, C. Galloni, T.E. Testa.

Why was it done?

Epidermolysis bullosa (EB) comprises a group of rare disorders with multisystem effects. In the postnatal period, a 37-week -old infant presented with dysepithelialized lesions on the body, as well as involvement of the oral cavity, characterized by discoloration of the hard palate and gums. The multidisciplinary team diagnosed EB and deemed it necessary to apply lidocaine gel because the infant was unable to feed due to pain from the sores. Initially, several commercially available products were used, but their irritating excipients led to poor tolerance. Consequently, it was necessary to prepare an extemporaneous formulation devoid of preservatives and flavorings.

What was done?

This intervention presents the development of an extemporaneous preparation of lidocaine hydrochloride 0.5% w/w viscous oral topical gel, free of preservatives and flavors. The gel was distributed to the neonatal intensive care unit staff in pre-filled syringes and applied to the oropharyngeal mucosa of a neonate diagnosed with EB.

How was it done?

The components of the preparation included lidocaine hydrochloride, carboxymethylcellulose sodium (CMC), and sterile water. CMC was chosen for its hydrophilic properties and excellent gelling capabilities. The gel was prepared using a high-shear magnetic stirrer, with increasing concentrations of CMC (0.75%, 2.25%, 3%, and 4%). After discussions with the multidisciplinary team, the pharmacist recommended using the 4% gel, as its density allowed it to adhere well to the oropharyngeal mucosa. This adherence is crucial for preventing absorption and minimizing potential cardiac side effects of lidocaine.

What has been achieved?

The gel was successfully prepared with 0.5% lidocaine and 4% CMC, and packaged in pre-filled syringes with the daily dosage. Due to the absence of preservatives and stability data, the shelf life was established at 15 days when stored at 2-8°C. The viscous oral gel was administered three times a day, 20 minutes before feeding, to exert its anesthetic effect and facilitate breastfeeding.

What next?

The hospital pharmacist’s extensive expertise was instrumental in determining the optimal concentration of CMC and customizing the formulation to meet the patient’s unique requirements. This pivotal contribution led to a highly personalized therapy, ultimately resulting in the successful discontinuation of artificial nutrition in this critically ill patient.”

Author(s)

JLV, Johanne Lundgaard Vedersø; CEGP Constance Eline Grandjean Poulsen; SLO, Sigrid Linnemann Otnes

Why was it done?

Pediatric medication poses challenges due to frequent off-label drug use in this population. Managing pediatric medications requires close interdisciplinary collaboration. The aim of a strategic network was to improve knowledge sharing and collaboration across hospitals and organizations, finding common solutions to challenges related to pediatric medication.

What was done?

The Pediatric Pharmacist Group (PPG) in the Capital Region of Denmark and Region Zealand established a strategic network.

How was it done?

Many hospitals, only have one pharmacist assigned to the pediatric department. This creates challenges for managing complex issues, with hospitals potentially opting for different solutions to a common issue. Cross-hospital knowledge sharing is therefore crucial. PPG has members across hospitals as well as in the pharmacy’s Department of Implementation and Information. This allows easy access to clinical teams, pharmacologists, and the hospital pharmacy, including the production department.
PPG was organized with a clear mandate, structured communication channels, meeting frameworks, and a knowledge-sharing system. This structure combined with the large interface of PPG, resulted in a strategic network which can quickly mobilize relevant experts to discuss pediatric medication challenges of common interest.
An example is a seminar on 3D-printed medicine, hosted by PPG and the pediatric team from the Department of Clinical Pharmacology. The hospital pharmacy’s production department is working on developing 3D-printed medicine. The seminar was used to share knowledge and discuss the clinical need for such medications in pediatrics. Stakeholders included representatives from the pharmacy, hospitals, two Danish regions, and various professional disciplines (pharmacists, clinical pharmacologists, nurses, and pharmacy technicians).

What has been achieved?

A strategic network has been established, enabling the rapid mobilization of experts to find common solutions to complex challenges across hospitals and organizations.
During the 3D-printed medicine seminar, knowledge was successfully shared across organizations, providing insights into clinical needs and production possibilities. These discussions will guide future work on 3D-printed medicine.

What next?

The “strategic network” concept can be applied to other clinical areas e.g., intensive care units and the area of antibiotics.
The long-term goal for PPG’s strategic network is to evolve into a national network, enhancing knowledge sharing and finding solutions to pediatric medication challenges across Denmark.

Author(s)

RBH, Rie Bager Hansen (presenting author), rie.bager.hansen@regionh.dk
ALK, Annabel Lee Krarup
The Capital Region Pharmacy, Hvidovre, Denmark and Department of Orthopaedic Surgery, Amager og Hvidovre Hospital, Copenhagen

Why was it done?

Patients undergoing acute orthopaedic surgery experience significant pain. The choice of pain-relieving treatment is based on national guidelines and regulatory actions. Considering the U.S. Opioid Crisis and the risk of opioid addiction, it was in 2022 politically decided by the Capital Region of Denmark to focus on consumption patterns of opioids within the region’s hospitals. Morphine is considered an opioid with a lower risk of misuse and was recommended as the first-line opioid. At the start of 2022, the Department of Orthopaedic Surgery at Hvidovre Hospital accounted for approximately 30% of the total oral opioid consumption with oxycodone being the preferred opioid. Thus, a strategy was initiated to shift opioid use towards morphine.

What was done?

The Department of Orthopaedic Surgery initiated a strategy to shift opioid use in hospitalised patients towards morphine. The strategy included including education, revision of guidelines and technical modifications to promote appropriate prescribing practices.

How was it done?

Opioid consumption was continuously monitored and evaluated. At the same time, administration of the antidote naloxone was recorded. The initiative included 1) education about the risk of opioid misuse, 2) e-mail follow-up to clinicians reinforcing that morphine was the first-line opioid, 3) revision of pre-filled electronic prescription packages used at the ward and operating room, 4) publication and implementation of a regional guideline specifically aimed at acute pain management in the orthopaedic surgery setting, and 5) ongoing support from pharmacists to facilitate appropriate selection of opioids.

What has been achieved?

Opioid consumption effectively shifted towards morphine, with the proportion of patients receiving oral morphine increasing from about 40% to approximately 80% of patients administered oral opioids. Moreover, the shift has remained stable for the past 10 months following the last intervention and there has been no trend toward increased usage of naloxone.

What next?

Future efforts will aim to identify reasons behind patients being prescribed non-morphine opioids and to investigate the specific circumstances under which naloxone is administered. This will enable further refinement of opioid prescribing practices and enhance patient safety.

Author(s)

K. Joyce, D. Jukes, F. Stewart

Why was it done?

In 2023, the drug formularies across Northeast and North Cumbria integrated care system were merged, with amiodarone allocated an ‘amber’ shared care status.

NHS England guidance recommends that existing patients taking amiodarone in primary care should be reviewed to ensure prescribing remains safe and appropriate and that a shared care agreement is introduced.

The pharmacy team aimed to implement this guidance, with minimum impact on clinician workload. The approach was steered by NHS England’s comments, in June 2024, regarding the importance of teams working together to meet the pressures and demands of primary and secondary care under the direction of the integrated care board (ICB).

What was done?

County Durham and Darlington Foundation Trust (CDDFT) pharmacy team worked collaboratively across the primary-secondary care interface to implement shared care agreements.

How was it done?

The ICB medicines optimisation team worked with the CDDFT pharmacists to engage GPs and cardiologists across the interface, creating a work-plan to share resources.

An audit tool was designed to capture patients prescribed amiodarone in the 61 GP practices across County Durham, which was completed by pharmacy staff within primary care networks.

Cardiology pharmacists in secondary care reviewed the data, triaging patients according to: indication, monitoring requirements, those requiring consultant review and those who could potentially stop treatment.

What has been achieved?

The audit, returning data for 129 patients, identified 93 patients without shared care. For half of these, discontinuation was considered as the National Institute for Health and Care Excellence explicitly recommends against use in atrial fibrillation. For the remaining, shared care agreements have been implemented with minimal impact on clinician time, primary care capacity and secondary care referrals.

The audit found 21% of patients without a shared care agreement were not receiving the recommended monitoring, compared to 100% receiving correct monitoring when one was in place. It may be anticipated that implementation will improve patient safety and experience through detection and avoidance of adverse events.

What next?

This initiative demonstrates the ICB and pharmacy successfully bridging care settings to improve patient care and experience and overcome challenges.

Building on these established relationships across the interface this work provides a model for sustainable collaboration on future shared care work.

Author(s)

V. Mureddu, G. Ledda, G. Adamu, M. Rivano, A. Cadeddu. Hospital Pharmacy Department, Azienda Ospedaliero Universitaria, Cagliari.

Why was it done?

Mifepristone and misoprostol are provided for Voluntary Pregnancy Interruption (VPI) and Spontaneous Miscarriage (SM) according to different reimbursement schemes, based on different gestational age. According to Summary of Product Characteristics (SPC), the use of mifepristone and misoprostol is approved only within the first 63 days of pregnancy. Recently, access to treatment for VPI and SM has been extended by the Italian Medicines Agency by the I trimester of pregnancy. VPI within the first 49 days of gestation, the use of mifepristone and misoprostol is authorized according to SPCs. From 50th to 63th days is guaranteed under the law 649/96, that allows and reimburses the use of medicines for off-label indications. From 63th to 90th is considered an off-label prescription. Regarding SM, mifepristone and misoprostol can be used within the I trimester under the law 648/96. All these different reimbursement schemes are used as part of the Italian pricing-reimbursement system.

What was done?

To ensure appropriateness, a specific prescription form has been drafted to support clinicians in prescribing according to the correct reimbursement scheme gestational age, therapeutic indication and dosage must be reported in the prescription form.

How was it done?

The development of the prescription form required a deep knowledge of both the law under which the right of abortion is guaranteed and Italian reimbursement schemes. The prescription form was introduced in October 2022.
Prescriptions of all pharmacological treatments are ordinarily made through electronic software; therefore the prescription form was uploaded. Prescriptions from 01/01/2024 to 30/06/2024 were collected and retrospectively analyzed.

What has been achieved?

Prescription forms analysis showed that a total of 83 women were treated. In 53 cases the treatment was used for VPI and in 30 for SM. In 27% of cases, prescriptions were considered as per in-label. In 66% cases, prescriptions were allowed according to Law 648/96. In 7% of cases, prescriptions were off-label.

What next?

According to the development of reimbursement schemes, the prescription form will be implemented. Italy provides universal coverage for all citizens and residents; keeping it sustainable is one of the hardest challenges of these day. The contribution of hospital pharmacists in monitoring prescriptions has a pivotal role in making equal access to these treatments.

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Author(s)

Carlos José Cortés Sánchez, Josefina Giménez Castellanos, Mónica Abdilla Bonías, Arantxa Valdivia Piqueres, José María Gómez Portolés, Irene Toledo Guasp, Eva García Cortés

Why was it done?

Proper use of antimicrobials is essential to ensure their efficacy and minimize the emergence of resistance. The evaluation of antibiotic prescription in a district hospital can provide information about clinical practice, adherence to local protocols, and the possibility of addressing antimicrobial resistance issues.

What was done?

Review the appropriateness of antibiotic prescription according to local guidelines and protocols.

How was it done?

This is 4-month prospective observational study(May to August 2023) in a district hospital. A daily list of admitted patients on antibiotic treatment was obtained through OrionClinic® electronic prescription. Each patient was reviewed and discussed for appropriateness with antimicrobial stewardship team in a Microsoft-TEAMS© chat. The following data were recorded: registration date, patient identification, hospitalization unit, microbiological culture, treatment modality (prophylaxis, empirical, or targeted) and appropriateness using a Microsoft FORMS©.
Descriptive analysis expressed as number and percentage and relationships derived from registration: percentage of patients by hospitalization unit, treatment modality, and appropriateness. Percentage of patients on empirical treatment with microbiological culture. And appropriateness according to treatment modality.

What has been achieved?

A total of 172 patients were analysed, of which 83(48.25%) were surgical patients (orthopaedic surgery, general surgery, urology, gynaecology, otolaryngology), 64(37.2%) are from internal medicine,MIN, 17(9.9%) from intensive care unit,ICU, and 8(4.7%) from paediatrics,PED. Of the total of patients, 95(55.2%) had requested a microbiological culture. About 52(30.2%) patients were on prophylactic treatment, 103(59.9%) empirically, and 17(9.9%) on targeted treatment. In conclusion, 119(69.2%) antibiotic treatments were appropriate (prophylactic 26/50%, empiric 80/77.67% and targeted treatment 13/76.5%).
Breaking-down data by hospitalization unit and treatment, of the 83 surgical (49 prophylactic, 28 empirical, and 6 targeted) 47(56.6%) were appropriate. Among the 64 MIN patients(1 prophylactic, 56 empirical, and 7 targeted), 54(84.4%) were appropriate. In ICU of 17 patients(2 prophylactic, 12 empirical, and 3 targeted), 11(64.7%) were appropriate. In PED of 8 patients(7 empirical and 1 targeted), 7(87.5%) were appropriate. Of the total of patients on empirical treatment(103), in 28(27.2%) there isn’t microbiological sample.

What next?

This is a preliminary analysis of our hospital’s situation in order to assess where interventions are needed for those patients who are not appropriate. It also helps us identify the hospitalisation units in which it is more necessary to implement strategic non-imposing measures to improve antibiotic prescription.

Author(s)

Greta DUSABE, Jonathan DE GREGORI, Teo TODESCO, Vanessa GOMES, Hélène FEYEUX, Marine AGULLO, Cyril BORONAD

Why was it done?

Chronic Obstructive Pulmonary Disease (COPD) and asthma represent a significant public health issue. Medications are administered using inhaler devices (ID) that require prior demonstration to ensure their proper use. Incorrect usage of inhaler devices might have a major influence on the clinical effectiveness of the delivered drug.

What was done?

The goal of our study was to detect potential errors in the manipulation of inhaler devices (ID) and to provide patients with appropriate information on their correct use in order to improve medication management.

How was it done?

For this study, every hospitalised adult patient with an ongoing treatment with ID underwent a pharmaceutical interview during their hospitalisation.
This interview was done using a questionnaire assessing the patient’s knowledge of their medications and a 12-items evaluation grid covering every step of proper inhalation technique.

What has been achieved?

Between June and August 2023, 27 patients were interviewed: the average age was 73 years. 34 ID manipulations were observed. Dry powder inhalers were the most prescribed DIs (68%), followed by pressurized metered dose inhalers (23%) and soft mist inhaler (9%). For 10 DIs (29%), no explanation was given to the patient. Furthermore, inhaler technique instructions were provided by a pulmonologist (65%), general practitioner (23%), pharmacist (4%), nurse (4%) and therapeutic education program (4%). The interviews revealed that 71% of patients were not familiar with the prescribed molecules or their mechanism of action. Out of the 34 DI manipulations, only 15% were performed perfectly, and 27% were not executed properly. The steps of deep exhalation before inhalation and breath-holding after inhalation were not performed in 70% and 62% of observations, respectively. Finally, 50% of patients did not rinse their mouths after using inhaled corticosteroids.

What next?

This study has highlighted the improper use of DIs, which can lead to a loss of therapeutic effectiveness. Therefore, we have developed 9 information booklets on the correct use of the DIs that describe different handling procedures for proper inhalation. These booklets are provided at the end of the interview. Educating patients on the proper use of these inhalation devices during the initial prescription or dispensing should lead to an overall improvement in patient care.

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Author(s)

RAQUEL AGUILAR SALMERÓN, LÍDIA MARTÍNEZ SÁNCHEZ, ANNA MARIA JAMBRINA ALBIACH, NEUS RAMS PLA, MANEL RABANAL TORNERO, MARIA ÀNGELS GISPERT AMETLLER, MILAGROS GARCÍA PELÁEZ, NÚRIA PI SALA, SANTIAGO NOGUÉ XARAU

Why was it done?

HTDs in infants are defined as those that might cause severe or lethal poisoning in children. Some HTDs are considered “one pill killers”: those in which the ingestion of one unit, a single tablet or tablespoon, in an infant with a body weight of 10 kg, could be fatal. In Spain, there are 29 active ingredients (from seven therapeutic groups) considered “one pill killers”. Counseling and information are crucial activities developed by pharmacists that could help to avoid fatal intoxications.

What was done?

A virtual and interactive course for pharmacists was designed to improve knowledge about highly toxic drugs (HTDs) in infants and potentially fatal intoxications. The education platform integrates microlearning and gamification methodologies, and the course could be followed via web or smartphone.

How was it done?

A group of experts, including toxicologist paediatricians and clinical pharmacists, carried out a literature review and determined the toxic dose for HTDs. They also determined the number of units (considering the most concentrated presentation) needed to achieve the potentially fatal dose in a 10 kg infant. A virtual microlearning platform (Snackson®) was chosen, and specific training content was designed. It will be offered to community pharmacists by our Catalan Ministry of Health.

What has been achieved?

This project has enhanced the collaboration between the group of experts and the Catalan Ministry of Health. An agreement has been signed, and, in this frame, the educational activity has been offered (Autumn 2023) to 250 community pharmacists.
A list of HTDs has been published (DOI: 10.1016/j.anpede.2020.02.007).
A video was recorded, addressed to the general population to inform them about the existence of HTDs. This video is a divulgation tool with recommendations to prevent drug poisoning and is periodically broadcast in the waiting rooms of health centers.
(https://www.youtube.com/watch?v=uSHDRte7Nr8&t=14s).

What next?

The next objective will be to evaluate the impact of the training activity on community pharmacists and the usability of the virtual microlearning platform. Future plans also include the expansion of this education tool to other regions in Spain, and to explore the application of microlearning methodology to other areas of knowledge.

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Author(s)

Lucija Tominović Gjivić, Gabrijela Kos, Anita Šimić

Why was it done?

In order to ensure correct use of voretigene neparvovec and minimise the risks associated with its administration, the product can be distributed only through treatment centres where qualified staff (vitreoretinal surgeons and pharmacists) have participated in the mandatory risk management plan (RMP) education program required by EMA.
Since voretigene neparvovec has to be transported and stored frozen at ≤-65 ºC, has short shelf life after dilution (4 hours), contains genetically modified organisms and must be handled according to local biosafety guidelines, there was a need for establishing standard operating procedures (SOPs) for each step of the treatment process.

What was done?

The University Eye Clinic, University Hospital Sveti Duh in Zagreb, Croatia, was designated as the world’s 6th gene therapy centre in 2020.
Hospital pharmacists, as part of a multidisciplinary team, play an important role in preparation and administration of the gene therapy product voretigene neparvovec which is indicated for the treatment of patients with vision loss due to inherited retinal dystrophy caused by biallelic RPE65 (retinal pigment epithelium-specific 65 kilodalton protein) mutations.

How was it done?

The multidisciplinary team consists of a paediatric ophthalmologist, an inherited retinal disease specialist, retinal surgeons, pharmacists and nurses.
SOPs were created for: ordering process, storage of the product, coordination between members of the multidisciplinary team, preparation of the product, administration and disposal of waste.
Preparation of voretigene neparvovec is performed under aseptic conditions in a Class II vertical laminar flow biological safety cabinet (BSC) according to Pharmacy Manual which was ensured by the manufacturer.

What has been achieved?

Since 2020. there had been 47 dose applications of voretigene neparvovec (26 patients, Croatian and nonCroatian citizens).
The prevalence of inherited retinal dystrophy associated with biallelic RPE65 mutation is 1:200 000 and it is expected that there are 19 individuals (population of 3,8, million) with biallelic RPE65 mutation in Croatia, and 13 of them were detected since 2020.
There were no registered side effects which could be associated with errors during the preparation or administration of voretigene neparvovec.

What next?

With the increasing number of gene and cell-based therapies, the need for continuous education of hospital pharmacists and exchange their experiences is greater than ever.