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.

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Author(s)

Majken Nørskov Petersen, Dorthe Bonnerup, Louise Thorsen, Lona Louring Christrup, Sune Puggaard Vogt Straszek, Charlotte Olesen

Why was it done?

Medication review with patient interview provides the opportunity to clarify the patient’s overall drug intake along with identifying the patient’s experienced side effects. Medication review with patient interview we believe gives a more realistic picture of experienced drug related problems (DRP) and potentially DRP. This again makes the medication review more relevant and useful to the doctors.

What was done?

The initiative took place in the Department of Affective Disorders, at Aarhus University Hospital, Denmark. Initially, the medication review was performed by hospital pharmacists without patient interview based only on medical records. We implemented a patient interview to give a more clinically relevant medication review. The interview included a structured questionnaire on typical side effects of antipsychotics.

How was it done?

The cost of a new workflow is always weighed against the outcome. We therefore planned and conducted a pilot study. The cost was measured as the time used for the patient interview and it was 17 minutes on average. We used DRP as the outcome. DRP is an accessible measure for the immediate outcome of a medication review. Sixteen medication reviews without patient interview were conducted and the same 16 patients were interviewed for a second medication review. Patient interview increased the number of identified DRP from 52 to 68. Due to the interview 28 new DRP were identified and 12 DRP found before the interview were withdrawn due to irrelevance.

What has been achieved?

Patient interview has been implemented in one of three inpatient psychiatric wards and in one of four outpatient clinics where the pharmacists conduct medication review. The structured questionnaire has been further developed and now includes common side effects caused by antipsychotics, antidepressants, benzodiazepines and mood stabilizers.

What next?

We still use the pilot study to show how medication review can be more relevant by using patient interview. The hospital pharmacy in Aarhus works on several levels in order to implement medication review, preferably with patient interview.

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Author(s)

Sheena Patel, Sima Purohit, Jennifer Hanna

Why was it done?

• VTE remains the leading cause of direct maternal death, with no evidence of a consistent decrease in mortality over the past 20 years.
• Alongside changes in national guidelines, the maternity population and interventions are changing e.g. women giving birth are now older with more risk factors for thrombosis e.g. obesity. More interventions e.g. caesarean section are undertaken placing women at higher risk of VTE.
• VTE prevention measures were introduced in 2010, and nearly 10 years on further changes were implemented to reduce mortality and morbidity.

What was done?

Venous thromboembolism (VTE) prevention measures introduced and embedded for women in pregnancy and the puerperium, with an aim to reduce potentially preventable hospital-associated events

How was it done?

• Electronic VTE risk assessment introduced with mandatory alerts at relevant time-points e.g. at booking, on admission, post-delivery • Simplification of the national VTE risk scoring system to ensure accurate completion of assessment and user-ability • Clear hospital guidance on VTE prevention for pregnant women, including a pocket guide covering risk assessment and thromboprophylaxis • Staff education on mechanical thromboprophylaxis for correct use and monitoring to avoid adverse effects • VTE patient information leaflet covering signs and symptoms of VTE and when to seek urgent medical attention • Introduction of a ‘mum and baby’ app with information during pregnancy and postpartum • Root cause analysis performed on hospital associated VTE events, with shared learning of root causes and actions to prevent recurrence to multidisciplinary teams • VTE education introduced in medical, midwifery and pharmacy staff training programmes, with regular updates in the maternity risk newsletter

What has been achieved?

• Over 95% of women with VTE risk assessments on admission, with weekly and monthly performance reports for local monitoring • Pharmacy staff perform quarterly audits on appropriate thromboprophylaxis. 97% inpatients received pharmacological thromboprophylaxis, and 88% inpatients were wearing anti-embolism stockings • Pre-printed VTE management plan in maternity documentation to assist with transfer of care • Development of an ‘app’ to provide patient information • Patients counselled on anticoagulant therapy to support medication compliance • VTE education embedded in training programmes • VTE ward rounds for ongoing stewardship

What next?

• Staff engagement to embed VTE prevention measures in practice
• Increasing patient education on VTE prevention
• Robust and sustainable interventions improving patient outcomes

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Author(s)

Clara Estaún-Martínez, Isabel Moya-Carmona, Laila Dani-Ben Abdel-lah, Jose Manuel Fernández-Ovies

Why was it done?

This initiative was taken in order to improve uptake and completion rates of PEP, and to homogenise the healthcare circuit for these patients and the prescribed drugs.

What was done?

A protocol was implemented in order to standardise the prescription and dispensation of postexposure prophylaxis (PEP) after occupational or nonoccupational exposure to human immunodeficiency virus (HIV).

How was it done?

A multidisciplinary team including Infectious Diseases and Preventive Medicine (PM) doctors, pharmacists and Emergency Room (ER) staff developed the following protocol for PEP according to World Health Organisation and national guidelines: – standard three-drug regimen for PEP: Tenofovir disoproxil fumarate/Emtricitabine + Raltegravir for 28 days. The pharmacy service (PS) repackages kits for five, 23 or 28 days that include antiretroviral drugs (AD) and written information about the treatment (use, length of the treatment, main interactions and side effects, contact number). Only 5-day PEP kits will be located in the ER. – Twenty-four-hour access granted to PEP kits as it is strongly recommended to initiate PEP as early as possible (ideally within 72h). –
Established healthcare circuit for patients in the ER:
• Monday–Fridays (8h00–15h00): patients will be immediately referred to PM, then they will go the PS in order to receive a 28-day PEP kit and pharmaceutical care.
• Out of this schedule and bank holidays: ER doctors will give patients a 5-day PEP kit and they will be referred to PM the next working day. After visiting PM, the patient will go to the PS in order to receive the rest of PEP (23-day kit) and pharmaceutical care. –
Several meetings took place in order to explain this new circuit to the health professionals involved and written copies were available on the ER as well as on the intranet.

What has been achieved?

The implementation of this protocol was well embraced by all the staff involved, since it allowed a more efficient healthcare circuit for the patients. It also optimises the evaluation and monitoring of these patients by PM and the pharmacist, and grants prompt PEP initiation and 24h access to the AD. The 28 days (or 5+23 days) kits help to accomplish the proper length of treatment, without using the regular packages which include 30 days of treatment (saving €43.17 per treatment).

What next?

We will monitor the compliance with this protocol and the drugs prescribed for PEP.

Author(s)

VERA DOMINGOS, VERA PIRES, SÍLVIA SANTOS, PATRÍCIA TRINDADE, ANA INÁCIO, ELZA CANDEIAS, SUSANA SIMÕES, PAULO PAIXÃO, NUNO MIRANDA, ANTÓNIO GOUVEIA

Why was it done?

Personalized BU dosing is considered because BU has a narrow therapeutic index and exposure have been associated with important clinical outcomes. High exposures have been associated with an increased risk of toxicities (acute graft-versus-host disease and veno-occlusive disease) and low exposures with graft rejection and relapse.
For this reason, in a multidisciplinary working group, we identified an opportunity to improve the treatment of your patients.

What was done?

Implementation of a TDM procedure for Busulfan (BU) in conditioning therapy for hematopoietic stem cell transplantation (HSCT). Study variability in PK parameters and evaluate TDM efficacy. From this initial period, we perform TDM on all patients under Bu conditioning.

How was it done?

The steps followed were:
1. Pre-implementation: bibliographic research, identify reference centers to perform BU plasma assay. Development and validation of a LC-MS / MS method by the National Institute of Forensic Medicine. PK analysis using ADAPT-5 software.
2. Pilot: Trial and assess the feasibility of the procedure. Cross-validation of the results with UMC Utrecht.
3. Implementation: clinical practice, doing the necessary dose adjustments. Prospective collection of clinical and PK data.

The main obstacle is the lack of analytical methodology in our center and the turnaround time.

What has been achieved?

We performed a preliminary analysis with 21 patients. Mean clearance (CL) was 0,19L/h*kg±0,05L/h*kg and volume of distribution 0,65L*kg±0,22L*kg. Body weight was the most predictive covariance.
CL was significantly different between patients 10 years old (p = 0,024) and over treatment (p=0,0191). The type of conditioning regimen didn’t show relation with the BU CL (p=0,0514).
TDM increased the number of patients with an optimal exposure (target AUC ±10%) from 42% to 83%.Dose was reduced in 10 patients (max 37%) and increased in 3 (max 19%). 1 patient maintained the prescribed dose.

What next?

TDM increased significantly the number of patients with optimal exposure to BU.
This procedure is pioneer at a national level and it relies on a strict protocol which includes collaboration with several hospital departments and other highly-specialized external centers. This can be used as a tool for other drugs and to empower the pharmacist as an active agent in the clinical setting.