Author(s)

Alba María Fernández Varela, Laura López Sandomingo, Nieves Valcarce Pardeiro, Isaura Rodríguez Penín

Why was it done?

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What was done?

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How was it done?

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What has been achieved?

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What next?

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Author(s)

José Luis Revuelta Herrero, Vicente Escudero, Roberto Collado, Belén Marzal, Ana Herranz, María Sanjurjo

Why was it done?

CAR-T cell-based therapies are advanced therapy medicinal products (ATMP) that are considered as drugs by the European regulatory authorities. ATMPs are usually associated with strong logistic and traceability requirements, serious adverse events and a high budget impact. Hospital pharmacists can help ensure a safe and efficient use of these drugs.

What was done?

A chimeric antigen receptor (CAR) T cell Therapy Committee was created in 2019 and it included members from the hematology, oncology, pediatric onco-hematology, hospital pharmacy, neurology, critical care medicine and immunology departments. An operating procedure defined the specific functions of the pharmacy department in the management of these drugs in the CAR-T cell program.

How was it done?

As some responsibilities might be shared with other professionals, it was key to define everyone’s contributions. In our case, an operating procedure with the responsibilities of the pharmacy department was developed based on the national and regional action plans for ATMPs in the national health system and the risk management plans for each drug. This operating procedure was reviewed and approved by the Committee.

What has been achieved?

The operating procedure was fully implemented and included the participation of hospital pharmacists in the following steps:
• Procurement: the inclusion of a patient in the program is agreed upon the Committee. The pharmacists provide a purchase order when all the requirements are met.
• Leukapheresis and shipment to the manufacturer: the apheresis is included in the computerized physician order entry (CPOE) and it is verified to confirm wash-out periods. Before the shipment, the pharmacists record the apheresis unique identifier and patient data.
• Product receipt: the pharmacists verify at receipt that the patient identity chain and the integrity of the product have been preserved.
• Bridge and lymphodepleting chemotherapy, CAR-T administration: specific protocols have been included in the CPOE. Prescriptions are verified by the pharmacists with special attention to the drug-free periods. After transporting the drug to the clinical unit and preparation, a pharmacy label for dispensing and administration is generated. This label includes a barcode for patient identity verification at bedside.
• Outcomes monitoring and pharmacovigilance: kits are provided to the clinical units for the management of CAR-T associated toxicities. Pharmacists are responsible for the adverse reactions reporting in coordination with clinicians.

What next?

We developed verification lists for each of the previous steps that have already been published (DOI: 10.3389/fonc.2021.636068). More ATMPs are expected to come and their management will require the participation of hospital pharmacists from different areas of expertise (procurement, clinical pharmacy, compounding etc).

Author(s)

Laura O’Donnell, Barry Keenan, Laura Loughran, Edel Davidson, Rosemary Donnelly, Sarah McGinnity

Why was it done?

In 2020, it was identified that diabetes specialist pharmacists working within diabetes inpatient teams were able to provide safe, effective and patient-centred care. However, it was equally identified that there was a lack of awareness of these new roles and their potential impact on care improvement. This is a major barrier to ensuring that specialist pharmacists become an integral part of diabetes inpatient teams.

What was done?

Diabetes specialist pharmacists from across Northern Ireland collaborated to define their role, and communicated their scope of practice in improving patient care as an infographic.

How was it done?

Acute hospital trusts in Northern Ireland were allocated temporary funding to demonstrate the benefits of a diabetes specialist pharmacist. There were localised differences in services provided according to the experience, and competence of the individual pharmacist, however as a team, pharmacists across Northern Ireland collaborated to help establish, develop and define the role. Work was mapped to the four guiding principles for medicines optimisation from the Royal Pharmaceutical Society Good Practice Guidance (2013). The comprehensive worklist was then transformed into an infographic to give a quick, visual and easy to understand illustration of the role.

What has been achieved?

The infographic is a unique tool to share the vision of what can be achieved by diabetes specialist inpatient pharmacists, and promotes clinical pharmacy services. The work was used to develop a business case for permanent funding, and is being used to inform a wider diabetes workforce planning strategy within Northern Ireland.

What next?

It is hoped that sharing this work will help inform and inspire teams who would like to incorporate a diabetes specialist pharmacist into their diabetes inpatient team, and provide a roadmap for those who are developing and establishing the role in their own hospital.
Next steps involve expanding the remit to include the other roles in which a diabetes specialist pharmacist can enhance care, for example outpatient clinics, and links with primary and intermediate care, to fully illustrate the role.

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Author(s)

Justine Touchard, Elisabeth Angelier, Isabelle Ferry, Marion Lafay, Jean-Stéphane Giraud, Caroline Giard, Mallory Friou, Laurence Escalup, Thomas Genevée

Why was it done?

For more than 15 years, within the Institut Curie, a pharmaceutical consultation (PC) has been offered to patients undergoing anticancer oral therapy, in addition to a medical announcement consultation and a nurse consultation. The pharmacist secures and optimises drug management through a pharmaceutical analysis of the prescription, an explanation to the patient of drug intake and management of the main side effects.

What was done?

The aim is to assess the Clinical Impact (CI) of Pharmaceutical Interventions (PI).

How was it done?

From 1 January 2020 to 17 March 2020, two types of PI could be collected during each PC. One concerned the prescriber and problems of prescription, while the other concerned patients. Patients could misunderstand some of the information explained by their oncologist. The evaluation of the CI of these PI has been documented by an oncologist based on the Cléo scale v3, validated by a French learned society, Société Française de Pharmacie Clinique. CI of each PI was classified as harmful , null, minor, moderate, major, vital, and not determined.

What has been achieved?

140 PC were carried out. 95% of patients were female and mean age was 62 (±13.73) years. 66 PI were recorded. 39 PI with the prescriber were identified. We noted, among others, 8 risks of possible drug interaction, 9 lacks of prescriptions of support treatment, 3 lacks of drug intake advice and 3 lacks of prescription for blood monitoring.
27 PI with the patient were identified and 21 were relevant. We noted that 7 patients misunderstood drug intake, 5 patients did not know that the previous treatment should have been interrupted, 5 patients misunderstood the monitoring and 4 others were not aware of possible side effects related to their treatment.
The CI was assessed for 83% (n=55) of PI. CI was considered to be minor for 20%, moderate for 53%, major for 14% and vital for 13%. Two prescription errors were associated with vital CI. The first referred to a risk of drug interaction between a proton pump inhibitor and capecitabine. The other error was the risk of loperamide overdosage.

What next?

PC help secure medical care of patients. These results will be presented to our oncologists to improve medical practices.

Author(s)

Fernando Fuertes

Why was it done?

Monitoring of patients on immunomodulators increases the workload of consultants in gastroenterology outpatient clinics. Pharmacist-led monitoring clinics reduces the number of patients who had to discontinue treatment due to myelosuppression, optimises dosage by therapeutic drug monitoring (TDM), and increases adherence to blood monitoring.

What was done?

A creation of a outpatient pharmacist-led Inflammatory Bowel Diseases (IBD) clinic to monitor and optimised immunomodulators and biologic therapy. The role of the specialist pharmacist has added value and clinical oversight to the care of IBD patients as treatment with biologic therapy has become more prevalent. In addition, the pharmacist routinely participate in IBD multidisciplinary team meetings to help with decision-making and treatment optimisation.

How was it done?

The Department of Gastroenterology at Barnsley Hospital, developed the twin roles of a Specialist Gastroenterology Pharmacist and an IBD Specialist Nurse/Non-medical endoscopist in 2012 to augment IBD care. Both roles require accreditation for independent prescribing. The pharmacist has responsibility for therapeutic drug monitoring, the prescription of biologic treatment following induction and immunosuppressants, participate at MDT, patient support and patient education. The nurse oversees the clinical and endoscopic surveillance of patients including the running of the IBD telephone helpline service

What has been achieved?

Robust clinical, biochemical and endoscopic surveillance is crucial for the delivery of effective treatments and quality of care in IBD. Telemedicine and virtual clinics have become part of our mainstream clinical practice to allow our IBD patients rapid access to healthcare services, pathway-driven treatment decision-making processes and endoscopy. IBD specialist Nurse and pharmacist clinics allow efficient management of the Gastroenterology workload and show extremely high levels of patient acceptability and satisfaction.

What next?

IBD is a life-long condition associated with considerable ongoing morbidity. Patient’s social and psychological wellbeing can be affected if the disease is poorly controlled. It is proven the specialist role of the pharmacist adds value to the gastroenterology teams and improves patient’s care. However, there is a need to standardise the specialist IBD pharmacist like in others specialities such as haemato-oncologist pharmacist or anticoagulation pharmacist. A Continuous Professional Development (CPD) course has been launched in partnership with the School of Pharmacy at the University of Bradford (United Kingdom) to initiate this goal. Further recognition and awareness of the role is required with our profession to achieve the goal and improve patients’ quality of care.

Author(s)

Natalia Toledo Noda, Víctor Quesada Marqués, Laura Majuelos Aicart, Milagros Varela González, Maria Victoria Morales León

Why was it done?

Despite advances in the control of HIV infection, the number of people who become infected annually in the island (European ultra-periphery region) remains high. The implementation of a PrEP dispensing program would prevent many of these infections since it is known that there is a high number of undiagnosed infected people. In addition, the implementation would allow legally access to this therapy, being an effective, cheap and easily to use therapy.

What was done?

Development and implementation of a medication dispensing program for HIV pre-exposure prophylaxis (PrEP) in adults.

How was it done?

In 2016, the European Medicines Agency authorized the indication of tenofovir disoproxil fumarate 245mg + emtricitabine 200mg as a preventive treatment. In December 2019 the Ministry of Health incorporated it into the National Health System for people who met certain minimum criteria. The hospital was formed since then with the aim of establishing a prescription and dispensing circuit.

What has been achieved?

The following circuit was established:
1. The primary care physician will screen candidates who want to apply to the program and request an initial study. If the candidate meets the criteria, he will consult the infectious diseases unit.
2. The unit value the entry into the program and carry out clinical follow-up. The request for outpatient dispensing is generated for the Pharmacy Service.
3. The Pharmacy Service informs about how to take the medication and its adverse effects. It is dispensed for a maximum period of 3 months. If any problem related to the drug or lack of adherence is detected, it will be communicated to the doctor.
4. A clinical and analytical follow-up is carried out every 3 months to assess the correct use of the medication as well as the appearance of safety problems (renal function and bone involvement). The continuity in the program is evaluated annually.

Since then, the Pharmacy Service has dispensed medication to 20 users and only one discontinued due to lack of adherence.

What next?

Achieve a reduction in the incidence of HIV, which for years has remained stable. Contribute to generate data that support the efficacy and safety of these therapies in real life. Avoid the illegal sale of these drugs.

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.

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Author(s)

MARIA MUROS ORTEGA, INMACULADA SANCHEZ MARTINEZ, ARANTXA ANDUJAR MATEOS, ISABEL ALARCON FUENTES, FRANSCISCO VALIENTE BORREGO, ANGELA SANCHEZ , ASUNCION SARABIA, ANTONIA RODRIGUEZ, NURIA LUCAS VILLA

Why was it done?

Condylomata acuminata or genital warts are produced by human papillomavirus (HPV). They are considered one of the most common sexually transmitted diseases that must be treated on an individual basis. Imiquimod increases the local immune response mediated by interferon and other cytokines; it is marketed as a 5% cream for topical administration 3 times a week, for a maximum of 16 weeks.

What was done?

The aim of the study is to describe the formulation and results obtained after treatment with imiquimod suppositories manufactured by the Pharmacy Hospital Service.

How was it done?

Suppositories of imiquimod 6.25mg were prepared from Aldara® 5% cream sachets; stearic mass was used as excipient to convey the active principle adding about 2.2g/suppository and molds of 2g for its preparation. The bain-marie was used for fusion and mixing the components. A sterile gauze was included to facilitate extraction if there was anal irritation. The established shelf life was 6 months between 2−8ºC. Suppositories were dispensed individually wrapped in aluminium foil and protected from light added a diptych of information to the patient.

What has been achieved?

The case of a 33-year-old male, VHP 6 positive, with anal condylomatosis and high-grade epithelial dysplasia, most of which had been resected and burned previously without satisfactory results. Imiquimod was added as an adjuvant treatment in suppositories for administration three days a week at night. Twelve suppositories were dispensed each month, and the duration of treatment was 2 months. During treatment the patient reported good tolerance, no itching, no pain in the area of administration. One month after finishing the treatment, no new macroscopic lesions were observed, nor recurrence of previous ones in anoscopic examination.

What next?

The contribution of the Pharmacy Service through the development of imiquimod suppositories has facilitated the achievement of early health results in a complex treatment pathology, allowing rectal administration through suppositories made from a specialty marketed in envelopes for topical use and reducing the duration of treatment to 8 weeks, with very good tolerance on the part of the patient.
References:
1. Bastida C et al. Formulation of imiquimod suppositories for the treatment of intra-anal neoplasms by human papillomavirus. 57th SEFH Congress.
2. PNT elaboration of the Reina Sofía General University Hospital.
3. Lacey C et al. 2012 European guideline for the management of anogenital warts. J Eur Acad Dermatol Venereol 2013 Mar;27(3):e263-70.
4. AEPCC-Guide: Condylomata acuminata. AEPCC Publications, November 2015.

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Author(s)

Marie Keane

Why was it done?

In the ICU there was a lot of misunderstanding around the administration of vancomycin by intermittent dosing, particularly around the timing of pre-dose vancomycin levels and appropriate dose adjustment. It could take several days for a patient to reach the therapeutic range of vancomycin.

What was done?

A protocol for the administration of vancomycin by continuous infusion was developed for patients on ICU, replacing the previous method of giving vancomycin by intermittent dosing; this was developed in consultation with the Anaesthetics and Microbiology Departments.

How was it done?

To develop a vancomycin continuous infusion dosing schedule for patients admitted to ICU, through a review of the available literature and with reference to vancomcyin continuous infusion protocols already established on ICUs in other hospitals. A proposal for administration of vancomycin continuous infusion needs to be included on the electronic clinical information system currently in use in the ICU. An IV drug monograph for vancomcyin by continuous infusion will be included in the ‘ Intravenous Medication Infusion Guidelines’; this will provide information on compatibility with other infusions if required. To recommend vancomycin continuous infusion in patients as agreed with the Anaesthetics and Microbiology Consultants at the daily ward review, this would require the patient to have a dedicated IV line.

What has been achieved?

A finalised version of the Vancomycin Continuous Infusion protocol has been developed in consultation with Anaesthetic and Microbiology Consultants. We have included additional information for patients on CRRT (continuous renal replacement therapy) that has been used in some patients on continuous vancomycin infusion. A standardised prescription for infusion of vancomycin is available on the electronic prescribing system. Vancomycin continuous infusion is now recommended for any patients requiring vancomycin therapy on the ICU.

What next?

We would propose to audit the number of patients on Vancomycin Continuous Infusion in the ICU, including time taken to reach therapeutic range, frequency of sampling and any other cost-saving initiatives perceived.

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Author(s)

Marguerite VAILLANT, Sophie GUILMIN CREPON, Benoit BRETHON , Julie ROUPRET-SERZEC

Why was it done?

In order to obtain a safe patient care pathway, we wish to implement proactive and/or retroactive DR for patients followed in the Hemato-Immunology Department of the University Hospital Center Robert Debre.

What was done?

Formalise and integrate drug reconciliation (DR). Evaluate the feasibility of the project, the impact of DR on the safety of patient care and the satisfaction of patients and health professionals.

How was it done?

Prospective cohort study. The different steps are: identification of eligible patients, collection of information on the patient’s drug history and ongoing treatments from the health partners involved in his or her care, entry drug reconciliation (EDR) during the entry pharmaceutical consultation, conciliation of exit drugs during the return pharmaceutical consultation, transmission of information to the local center and pharmacist or home hospitalisation, evaluation of stakeholder satisfaction and the impact of the intervention.

What has been achieved?

Thirty patients included between August and October 2019, or 30 conciliations performed. Concerning the EDR: all hospitalisation reports and previous prescriptions are consulted (100%), 6 EDR (20%) take place in pro-active mode, the average duration of an EDR is 43 minutes. Concerning the discharge drug reconciliation (DDR): 30 DDR (100%) take place in pro-active mode, the average duration of a DDR is 52 minutes, all prescriptions and intake plans are sent to community centres and pharmacists or home hospitalisation (100%). Of all the conciliations performed: 4 sources of information used by conciliation, 11 drugs prescribed on average per prescription, 8 intentional and 6 unintentional discrepancies identified by prescription. Concerning the evaluation of satisfaction: all community centres are satisfied (100%), 26 city professionals (87%), 21 hospital professionals (70%), 27 patients (90%).

What next?

In order to ensure that DR is permanently included in the service, a communication and information tool must be developed. This, made available to the entire team, will serve as a traceability support, decompartmentalise practices and improve patient care.