Author(s)

Natalia Toledo Noda, Víctor Quesada Marqués, María Leonor Oliva Hernández, Nayra Sangil Monroy, Marta María Piñero González, María Victoria Morales León

Why was it done?

The implementation would allow access to this novel therapy to patients who have already exhausted all lines of treatment. The Ministry of Health decides to establish an administration point in the hospital, since due to its geographical location (European ultra-periphery) it would avoid the transfer of patients to other reference centers.

What was done?

Development and implementation of a CAR-T cell therapy administration program in adults.

How was it done?

In November 2018, the Ministry of Health authorized the center to use CAR-T treatment in adult patients with relapsed or refractory diffuse large B-cell lymphoma or with B-cell acute lymphoblastic leukemia. The hospital was prepared to meet specific quality criteria (JACIE Accreditation). Interhospital protocols were developed for the referral, transport, and study of candidate patients from other centers.

What has been achieved?

1. A multidisciplinary team was created made up of professionals from Hematology, Intensive Care Medicine, Neurology and Pharmacy Services, with the aim of assessing candidate patients. A qualified team oversees the clinical management, follow-up, analysis of adverse effects and results obtained.
2. The professionals involved were trained to ensure safe administration and to identify and treat possible complications.
3. Due to the special storage conditions of the drug, a circuit was established. It is storage in the Hematology Service under the supervision of the hospital pharmacist specialized in onco-hematology.
4. One of the most frequent complications of the therapy is cytokine release syndrome. Depending on the gravity, drugs such as tocilizumab should be given as soon as possible. To ensure its availability, the Pharmacy Service permanently reserves two doses. At the time of performing a CAR-T, the automated dispensing system of the hematology ward is provided with the first dose, along with a preparation sheet and its corresponding label in order not to delay its administration. The second dose remains in the Pharmacy Service.

To date, 8 infusions have been made. 100% of the patients had diffuse large B-cell non-Hodgkin lymphoma.

What next?

Facilitate access to this therapy to more patients. Generate data that support its efficacy and safety in real life.
Obtain the accreditation of the center to use the new therapies authorized by the European Medicines Agency.

Author(s)

Andreia Fernandes, Mafalda Brito, Tatiana Mendes, Armando Alcobia

Why was it done?

Many patients had their health care needs compromised due to accessibility issues. They could not come to the PS because of the mandatory confinement, prophylactic isolation and medical indication.

What was done?

In the context of the Covid 19 pandemic, between April and June 2020, pharmaceutical Services (PS) instituted several alternatives delivery processes that guaranteed patients’ access to the medication, usually provided on the PS.

How was it done?

Pre-existing accessibility projects to deliver medication in community and hospital pharmacies have been adopted. In order to respond to all requests, new ways and protocols of medication distribution/delivery, like city hall transport, courier services and humanitarian aid (for example, motards), were created. For all deliveries outside PS, pharmaceutical telephone follow-up (teleconsultation) was realized.

What has been achieved?

7448 medication dispensations were registered, of which 80.7% were realized in person in the hospital PS (n = 6679). In the homolog period, 10621 dispensations were registered, of which 95.9% were in person (n = 10183).
438 deliveries were sent to community pharmacies, a total of 219 patients (54.3% female, maximum age 100, minimum 9 years). 41% increase compared to 2019. 198 shipments were realized to different hospitals and others healthcare units, corresponding to 120 patients (56 female, maximum age 85, minimum 8 years). 25% increase over the previous year.
New alternatives: City Hall 66 deliveries for 62 patients (58.0% female, minimum age 18, maximum 97 years), other deliveries 35 users (50.7% male, maximum age 94 and minimum age 10 years).

What next?

The Covid-19 pandemic triggered a need for adaptive evolution of pre-existing accessibility projects, but also the creation of new protocols and alternative means to respond to all patients who may have their healthcare compromised due to accessibility issues. The positive points were the implementation speed, maintenance of adherence to therapy (teleconsultation), traceability, reduced costs, synergy between patients/associations/pharmacists/healthcare professionals and a high degree of satisfaction. In spite of some limitations (dependent on volunteering; need for human resources; structured communication) we aspire to improve the new approaches of medication delivery on a nation level.

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Author(s)

Hana Sakly

Why was it done?

The pharmacy must assess its own activity in order to better manage, to structure, respond to needs. This assessment is necessary in order to measure the productivity.

What was done?

The purpose of our work is to identify the key performance indicators for management and piloting a hospital pharmacy. The aim is to develop dashboards, a real management tool, for the management and monitoring of pharmaceutical activities in order to optimize performance and ensure continuous improvement.

How was it done?

The methodological basis of our study is based on a process-based management of hospital pharmaceutical activities. Our target is to achieve the same approach to these processes, within the various functional and concerned units, in order to harmonize and simplify the quantitative and qualitative monitoring of pharmaceutical activities.

What has been achieved?

Macroscopic cartography of pharmacy processes was established and the most critical processes were selected on the basis of a matrix. In total, eight key processes have been identified. The identity cards for these processes have been drawn up. Quality indicators have been identified. These indicators are intended to assess and monitor the processes. A first design of dashboards with the elements collected was proposed. This dashboard could evolve during the implementation of this project within the Pharmacy department.

What next?

These dashboards have to be finalized, validated and officially put into practice within the Pharmacy department. This methodology must be applied to the discipline of Clinical Pharmacy. Quantitative and qualitative assessment of the activities carried out within the pharmacy should be a subject for priority debate at the national level to finally find agreement on a relevant measurement tool.

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Author(s)

Martina Jeske, Jasmin Stoll, Vanessa Funder, Sabine Bischinger

Why was it done?

Due to the limited number of ports, it is necessary to administer several drug solutions via the same access. Incompatibility reactions can occur and may lead to a reduction or loss of drug efficacy and severe damage to the patient’s health. The objective was to create standardized administration protocols for central venous catheters and verify parenterally administered drugs’ incompatibility reactions. A further purpose was to build multidisciplinary cooperation to improve the drug administration processes.

What was done?

To optimize the drug therapy at four intensive care units (ICUs) of the University Hospital, the pharmacy department, physicians, and care management, jointly implemented a quality assurance project. In multidisciplinary teams, we had to overcome various challenges in different wards to develop standards regarding administering drugs via multi-lumen catheters. We analyzed all frequently used drugs (n=72) for their compatibility and summarized findings in a crosstable.

How was it done?

The current situation was recorded using a questionnaire and collecting individual cases of protocols for central vein catheters. About 2000 drug-drug-combinations were analyzed using three databases, KiK 5.1, Micromedex, Stabilis 4.0, corresponding specialist information, and manufacturer data. Nevertheless, the compatibility check based on the databases is subject to some restrictions. In several cases, the databases give different or contradictory results, and compatibility data are rarely available for some combinations. The project revealed that although infusion therapy is standardized in intensive care units, there are fewer standards regarding administering drugs via multi-lumen catheters. There are significant differences between theory and practice in terms of handling infusion therapy.

What has been achieved?

Different hazardous practices got identified and eradicated. The incompatibility table allows a quick assessment. The advantages/disadvantages of varying software systems were broadly discussed. KiK 5.1 was implemented in the ICUs, Micromedex in the pharmacy department. The team agreed that existing uncertainties must be decided jointly. Different practices in different wards may pose a threat to patient safety. The results were presented in a clinic-wide interdisciplinary training.

What next?

The awareness towards the need for cooperation and hospital pharmacists’ competence concerning incompatibility reactions strongly increased, leading to more standardization in the infusion therapy and avoiding incompatible drug combinations. The aim is to initiate a continuous improvement process.

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Author(s)

Edoardo Calzavara, Elena Galfrascoli, Stefania Vimercati, Lorenzo Gambitta

Why was it done?

The discovering of Coronavirus disease in 2019 and the subsequent outbreak in many countries and regions constituted in the first 5 months of 2020 a prominent issue worldwide: hospital pharmacists as well as other health care personnel were hit by pandemic emergency and faced a great challenge. We as hospital pharmacists had to cope with shortage of drugs, disinfectants, test and reagents, Intensive Care Unit medical devices, personal protective equipment. For this reason, we needed to start interventions to meet the needs of the front-line medical and nurse staff.

What was done?

We decided to start a self-auditing process, we aimed to realize an emergency preparedness plan and a procedure, created from our experience, which will be helpful to face future emergencies.

How was it done?

The starting point was our Hospital Pharmacy process map, which identifies all pharmacy activities. For each one, actions taken during the emergency were described. Regulations at local and national level were analysed together with literature and international statements about hospital pharmacist role during health emergency.

What has been achieved?

We developed a process map in which we split up pharmacy activities into five big areas:

1. DIRECTION AND COORDINATION: team communication, role and responsibilities definition (“role mapping”); multidisciplinary external communication with hospital management facilities;

2. LOGISTICS AND ADMINISTRATION (Purchase, management and distribution of medical products): an inventory of drugs, medical devices and diagnostics was created, especially for the ones essential to challenge SARS-CoV-2 health emergency;

3. RESEARCH, GALENIC, “PATIENT CARE”: therapeutic protocols, galenic preparation, studies, home-therapies distribution and communication with patients;

4. PHARMACOVIGILANCE: close monitoring of potential Adverse Drug Reactions (ADRs);

5. REGULATIONS AND LEGISLATION: Updating and intra-hospital divulgation.

From this emergency process we created an emergency preparedness plan and an internal procedure, in which, for every activity area, we assigned specific roles and responsibilities and set operating instructions.

What next?

The emergency preparedness plan developed from our experience during SARS-CoV-2 emergency, will allow hospital pharmacists to anticipate, plan, and prepare strategies in case of future health emergencies, due to biologic infective agents. Our and other Hospital Pharmacies will be able to overcome priority drugs shortages, to set a drug home delivery service, to offer extemporary solutions, communicate and inform patients.

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Author(s)

Marta Del Vecchio, Federica Chinotti , Claudia Lauria Pantano, Elirosa Minniti, Erika Cataldo, Francesco Guidoni, Vito Ladisa

Why was it done?

The Severe Acute Respiratory Syndrome – Coronavirus – 2 (SARS-CoV-2 ) pandemic made it difficult to monitor the patient’s health condition because many of them were locked down at home, unable to attend routine hospital visits.

What was done?

The hospital pharmacist, focusing on therapeutic continuity, closely collaborated with the clinicians in monitoring patient’s condition using telemedicine and homedelivery services.

How was it done?

In the multidisciplinary team, the pharmacist and the clinician defined the criteria to choose the most suitable patients for the homedelivery service. One of the options was to dispense the drug in a neighboring hospital. Because of the sanitary system regionalization, some of those hospitals could have been located even more than 100 km away, resulting in a problem for the most critical patients. In order to help them, home delivery and telemedicine services has been considered. The clinician used to visit patients on digital platforms, making clinical evaluations based on the results of blood tests, diagnostic tests and imaging techniques. According to clinician’s indications, the pharmacist took contact with patients, in first to collect informations about any residual storage of the drugs, adverse reactions, therapeutic compliance and then to proceed with the delivery. Everything has been done in conformity with the General data protection regulation (GDPR).

What has been achieved?

From March to September 2020, the homedlivery service count 501 speditions all over the Nation, 480 patients has been contacted to recive therapy and 250 of them has been intensively monitored by calling to manage their follow up. Everything has been done in order to protect critical patients from pandemic, safeguarding the therapeutic continuity,in compliance with pharmacovigilance, risk managment and cost saving for the national health system, considering that the suspension of therapies could be considered an additional and not quantifiable cost, but certainly important.

What next?

The hospital pharmacist must collaborate ever more with the clinician even in the post-pandemic phase, remotely managing not only the most weak patients, but extending the telemedicine and homedelivery services to an increasing number of patients, in order to safeguard their health .

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Author(s)

MARINA CORRALES PAZ, CLAUDIA RODRIGUEZ MORETA, INMACULADA LOMARES MANZANO, ANA GANFORNINA ANDRADES

Why was it done?

Due to the health crisis caused by the SARS-COV-2 virus, many hospitals have seen
the necessity to implement a safe dispensing system (telepharmacy) to provide medication to
high risk patients and those infected with Covid-19 in order to prevent interrupting their
treatments.

What was done?

To implement a system that guarantees a sure and effective supply of medical treatments to those vulnerable patients, those at increased risk or with difficult access to the hospital during the coronavirus pandemic.

How was it done?

A database was created with those patients attending our hospital’s outpatient service(OS)to pick up their medication within the next 7 days, verifying through pharmaceutical software and the patient’s medical history records (MHR)their next dispensing date. After checking if the patient had a medical appointmentthat could coincide with the dispensing date, a phone interview was conducted with the patient to schedule the pick-up of the medication through theOS or by telepharmacy(patients’ consent was requiredto use their personal information and we asked how the treatment was going). In our case the patients could pick-up their medication in the referral hospital (RH), a newly created OS in an affiliate hospital or by telepharmacy toprevent the collapse of the hospitals. We registered: number of patients attended in RH, new OS or by telepharmacy and number of dispensations. Patients were grouped in areas based on their city and delivery date for telepharmacy and in the case of patients picking up their own medication they were made an appointment.

What has been achieved?

During the months the state of emergency was in place in Spain (March 14th– June 21st)3385 patients were attended in total and 9316 medicationswere dispensed. 2245(66.3%) patients were attended in the RH (5794 dispensations), 583(17.2%) patients were attended through the new OS (1436 dispensations) and the rest 557(16.5%) had their medication sent to their address (2086 dispensations).

What next?

A safe and effective dispensing system was achieved to outpatients during the Covid-19 pandemic through the implementation of a new telepharmacymethod and the establishment of a new OSthat allows convenient dispensation of medication while minimising the risk of virus spread.

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Author(s)

Robert Baghdarsarian, Karin Hellström, Mattias Paulsson

Why was it done?

The health care providers at the Paediatric Emergency Ward discovered that when opening glass ampoules of morphine by snapping the top off, this did not result in the normal straight cut by the score. A close examination also revealed residual glue and the glass at the ampoule neck not being fully transparent. The sealed outer packaging also seemed manipulated for most of the morphine ampoules stored in the ward medication room. Simultaneously, staff discovered that one of the paediatric patients had not received the anticipated analgesic effect of the ordered morphine infusion.

What was done?

This case report describes how the compounding unit of Uppsala University Hospital (CU) was able to assist in analysing the contents of morphine glass ampoules and infusion solutions, in a case with suspected tampered containers

How was it done?

CU has invested in an easy-to-use spectrophotometer to check the concentration and identity of chemotherapy prepared in the clean rooms. The primary focus is to have an independent system to check preparations done by the chemotherapy robot e.g. in connection with software upgrades. This equipment was within hours adapted to be used for morphine analyses. The results clearly show that the infusion labelled 10 mg/mL was tampered with, containing only 0,4 mg/mL morphine. Samples were also sent to the Microbiological laboratory to check for risks for microbial exposure during infusion of tampered morphine.

What has been achieved?

CU was able to provide results of the contents of all ampoules, and the infusion solution administered to the patient, within a couple of hours and without any cost. The results showed that all ampoules had been emptied from its labelled contents and likely refilled with Sodium Chloride 9 mg/mL. The infusion solution given to patient was also likely prepared from a tampered ampoule. These results were crucial information in the conversation with parents about the incident, and the subsequent report to the police regarding the probable violence offence.

What next?

We recommend that all healthcare settings evaluate the possibility to collaborate closer with the hospital pharmacy, and in new ways.
Thanks to our CU being an integral part of the hospital with close interaction with wards, this rapid handling was possible to stage.

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Author(s)

Rosalia Fernández-Caballero, Virginia Collados Arroyo, Clara Herranz Muñoz, Araceli Henares López

Why was it done?

Every month, an average of 700 patients receive pharmaceutical care in the outpatient consultation (OC) of our first-level hospital. Given the mobility restriction measures applied by the spanish government during the pandemic, access to this consultation was difficult for some patients. The aim of this program is to ensure the access to medication for all patients and prevent them and professionals to virus exposure. Telepharmacy program consists of providing pharmaceutical care based on available means of communication and access to medication through home drug delivery.

What was done?

During the COVID-19 pandemic, we designed and implemented a telepharmacy programm to ensure access to medication for all patients.

How was it done?

Once weekly, the pharmacist contacted the listed patients during the following week in OC by telephone or via the hospital’s electronic platform, to offer the possibility of participating in the program. During teleconsultation, pharmacist provided the same attention as in face-to face consultation: administrative situation of the patient, adequate medical follow-up, assessment of adherence, review of interactions and adverse events and treatment changes. Moreover, we e-mailed the patient’s consent for home drug delivery by and external company. In case the patient didn’t have a web mail, we requested verbal consent. Once a week, one pharmacy technician prepared the medication and the selected company performed the home delivery in guaranteed storage conditions. To minimize the burden of work, the medication was sent for two months per patient. Oncohematological patients, who came to their doctor’s appointment every month, were excluded from this program.

What has been achieved?

Between March 20 and October 9, we have included 595 patients in this program and conducted 1190 teleconsultations and 872 home drug deliveries with a great satisfaction of outpatients.

What next?

Our next step is to improve the web system for sending alerts through our electronic platform to automate the home delivery process and thereby to reduce the logistic burden of the pharmacist and to increase the pharmaceutical care given to patients.

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Author(s)

Grainne D’Ancona, Niall Stewart-Kelcher, Schaya Bains, Andrew Hearn, Joanne Kavangh, Cris Roxas, Linda Green, Linda Thomson, Marianna Fernandes, Brian Kent, Alexandra NanzerKelly, David Jackson, Jaideep Dhariwal

Why was it done?

The COVID-19 pandemic necessitated the rapid transition of benralizumab dependent SEA patients onto home administration to facilitate on-going therapy in a cohort of patients who were “shielding” under UK government guidance.

What was done?

246 severe eosinophilic asthmatic (SEA) patients treated with benralizumab; a biologic agent targeting the human interleukin-5 receptor (IL-5Rα), at a specialist NHS asthma clinic, were transferred to self-administration at home in response to the COVID-19 pandemic. Alongside this, patients continued to need to be newly initiated on benralizumab therapy in spite of the pandemic and innovative pathways were created to ensure rapid initiation of therapy and home administration.

How was it done?

A varied multi-disciplinary team including pharmacists, pharmacy technicians, specialist nurses, doctors, physios and phycologist conducted a variety of in-person and virtual (telephone and video) consultations to consent and train patients on self-administration in their own homes in a rapid transfer to home administration.

What has been achieved?

We have investigated this patient cohort for any unwarranted effects by comparing the last Asthma Control Questionnaire-6 (ACQ6) measured in clinic with that collected by telephone consultation 8-12 weeks after transition to home administration. 246 benralizumab patients were included in the analysis, of whom 49 (20%) were new. There was no significant difference in pre-biologic ACQ6, pre-homecare (baseline) ACQ6 or post-homecare ACQ6 between the new and established patient groups. Both cohorts exhibited a similar magnitude of improvement in their ACQ6 following the transition to home administration (-0.73 in the established group vs -0.73 in the new group, both P<0.0001). We have demonstrated that early transition to home administration in patients treated with benralizumab is not associated with worse clinical outcomes as assessed by ACQ6.

What next?

Evaluation of patient experience on the switch to self-administration is currently being carried out via patient surveys with this data due to be completed in early 2021. Further research is required to understand the potential influence of lockdown and/or telephone vs face-to-face ACQ reporting.