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.

Author(s)

Anna Esposito, Claudia Panico , Loretta Cervi, Emilio Albamonte, Alice Zanolini, Valeria Sansone

Why was it done?

This allows a standardized and safe access to this therapeutic opportunity in close collaboration with the NT formed by child neurologist and neurologists.

What was done?

The hospital pharmacist (HP) supports the neuromuscular team (NT) in submitting the request to access compassionate use with Risdiplam in patients affected by spinal muscular atrophy (SMA). Risdiplam is an orally administered, survival motor neuron 2-directed RNA splicing modifer for the treatment of SMA.1 The HP is involved in Ethics Committee (EC) approval, is responsible for reconstituting and storage of oral solution and is also responsible of re-supply and pharmacovigilance surveillance. This allows a standardized and safe access to this therapeutic opportunity in close collaboration with the NT formed by child neurologist and neurologists.

How was it done?

HP is involved from the initial phases of the compassionate use of the drug. The NT that screens and enrolls the patients in the compassionate use program with Risdiplam by submitting a formal request to the EC. The teams of the EC, which includes the HP, evaluates the appropriateness and inclusion criteria for each patient. Once the patient is considered eligible, and treatment is approved, the HP receives the drug from Pharma, provides quality control and assigns the drug for each patient. HP prepares the oral solution and stores the products at 2-8°C until dispensing. After the initial dispensation it is the HP’s responsibility to work closely with the NT in order to maintain treatment over time, ensuring the right timing for re-supply of the drugs and medical devices.

What has been achieved?

There are currently 30 patients on therapy and they are monitored to ensure re-supply and reporting of any adverse events. Home delivery procedure was implemented in agreement with EC in cases where outpatient dispensing was difficult, especially due to logistical difficulties caused by the Covid-19 pandemic, if clinical conditions were stable. In addition, a strong collaboration between the HP and NT was implemented in order to provide access to an increasing number of patients.

What next?

Risdiplam has recently been approved and the HP is involved in the procurement and maintenance of ongoing therapies and ensures supply to new patients. The drug is under negotiation and HP will be involved in contracting procedures based on the expected number of patients and definitive inclusion criteria to access the drug

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Author(s)

Ana Pelaez Bejarano, Maria de las Aguas Robustillo Cortes, Pilar Villar Santos, Olalla Montero Pérez, Ignacio Garcia Gimenez

Why was it done?

Rheumatologic disorders carry increased risk of infection compared with the general population, so facilitate access to hospital medications is of vital importance.

What was done?

On 14 March 2020, the Spanish government declared a state of alarm to deal with the spread of COVID-19. Medication dispensing protocols were immediately established to deliver drugs to patients who could not come in person to the hospital pharmacy department. These measures were designed to benefit citizens who, due to age or physical fragility, were more vulnerable to contagion. We had the collaboration of community pharmacies actively practicing during the COVID-19 pandemic and a logistics service, with no extra cost to the public healthcare system.

How was it done?

Between 30 March and 1 September 2020, a circuit was designed as follows: First, patient request the delivery service in the community pharmacy of their choice, which sending the request of each patient to college of pharmacists. Later, this institution sending of applications received from all pharmacies to hospital pharmacy. Here, the hospital pharmacist reviewed the patient’s electronic medical record, checking that the medication requested was appropriate, modifying it if deemed necessary (change of drug, dose, and so on). A pharmaceutical cooperative sending antirheumatic drugs to the community pharmacies. Finally, the community pharmacist who received the package checked the medication and, with the patient, reviewed and reinforced the information on the treatment.

What has been achieved?

587 patients were included: 211 rheumatoid arthritis, 173 psoriatic arthritis, 121 psoriasis and 82 ankylosing spondylitis. The delivery service enabled us to provide antirheumatic drugs to patients in their immediate environment through a service that was free for both the patient and the hospital pharmacy service. This contributes to guaranteeing the achievement of the pharmacotherapeutic objectives established for these patients.

What next?

Further action is needed to identify which groups of patients require more intensive pharmaceutical care and, therefore, who could benefit most from telepharmacy, and not only the delivery service.

Author(s)

CAROL ANN JONES, NANNA CHRISTIANSEN

Why was it done?

Starting in mid-April 2020 as a result of the Coronavirus pandemic, a cluster of patients displaying multisystem inflammation and shock were admitted to our hospital. Similar cohorts have subsequently been reported internationally. Over a 6 week period, in which our institution cared for over 70 children with the newly described PIMS-TS, we developed new pharmacological treatment guidelines. Due to the novelty of the disease, treatment options were unclear and decisions were made by a multidisciplinary team (MDT) of clinicians and pharmacists.

What was done?

This good practice initiative describes the rapid and iterative development of a treatment pathway for the newly described Paediatric Inflammatory Multisystem Syndrome – Temporally associated with SARS-CoV-2 (PIMS-TS). Due to the similarity to Kawasaki disease and septic shock, the routine treatments for these conditions were considered as well as the experience of our adult colleagues, especially in terms of anticoagulation and hyper-inflammation seen in patients presenting with COVID-19. This ensured holistic management plans could be made to provide the highest quality of care.

How was it done?

A MDT of clinicians (intensivists, infectious diseases, cardiologists, rheumatologist, haematologists, endocrinologists) and pharmacists arranged daily meetings to discuss admitted patients as well as pulling together information to formulate a treatment guideline to enable the safe management of these patients. Version one of the treatment pathway was approved in April 2020, by beginning of June version 6 was published. The final treatment pathway included intravenous (IV) immunoglobulin, IV methylprednisolone, aspirin, venous thromboembolism (VTE) prophylaxis and immunomodulation therapy including tocilizumab, infliximab and anakinra.

What has been achieved?

A total of 74 patients have been successfully treated against the treatment pathway, and discharged from hospital. Managing a new condition with no published evidence on treatment was a huge challenge, especially given the large numbers and high acuity of patients. Collaborative learning and reflection has enabled us to develop a robust treatment pathway for our patients. We have witnessed MDT working at its best, united with the sole aim of combating this rare condition.

What next?

An ongoing coordinated effort is required to undertake paediatric research to understand PIMS-TS and establish the most effective treatment for this novel disease.

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Author(s)

A. Sonnleitner-Heglmeier, M. Jeske, C. Petter, S. Grimm, S. Kerndler, U. Horvath

Why was it done?

The aim of this initiative was to assess, from December 14, 2018 to February 7, 2019, the practices associated with six high-risk drug classes – opioids, insulin, anticoagulants, methotrexate for non-oncological indications, muscle relaxants, chemotherapeutics – and high-risk drugs in general at the Unversity Hospital Innsbruck using the ISMP Medication Safety Self Assessment® for high-risk drugs. A further reason was to build up a strong and active cooperation amongst interdisciplinary teams with the focus on clinical pharmacy to raise awareness towards the competencies of clinical pharmacists.

What was done?

We translated, adjusted and introduced the Medication Safety Self Assessment® for High-Alert Medications from the Institute for Safe Medication Practice (ISMP) – U.S.A. to our university hospital. With a clinical pharmaceutical approach in multidisciplinary teams, we revealed challenges on different wards in the hospital and discussed and planed appropriate solutions.

How was it done?

The first step was to find an appropriate assessment accreditation programm which was found by the ISMP Medication Safety Self Assessment® for High-Alert Medications. This tool offers the opportunity to assess the safety of systems and practices associated with up to 11 categories of high-alert medications. As the assessment was written in english it had to be translated by us into german for a better basis for discussions. Further, as the ISMP assessment is implemented in the U.S.A., words and processes had to be adjusted to the work in an austrian university hospital. To optimize the outcome of the ISMP, the drug therapy pharmacy department, health care practitioners, and care management, jointly implemented a quality assurance project.

What has been achieved?

Different hazardous workflows and medication handling processes beginning from pharmacy despensing until receiving patients got identified and discussed. The urgent need of a patient data management system was emphasized to safely ensure a closed loop medication management. This would allow a clear and trackable communication in and between different wards and reduction in errors made by clincal staff.

What next?

The foundation was built for compulsory personal trainings done by clinical pharmacists on different wards. The awareness towards the importance of clinical pharmacy was strongly increased leading to more inclusion e.g. developing guidelines.

Pdf

Author(s)

Tania Truelshoej

Why was it done?

Department of infectious diseases at Aarhus Universitetshospital, Denmark, has succesfully implemented OPAT as a standard modality for certain patients requiring long-term intravenous antibiotic therapy e.g. patients with cystic fibrosis. This also include a guideline to OPAT self-administration at home.

To implement the OPAT guidelines throughout the hospital there was a need for an overview of available ready-to-use antibiotics for OPAT. The graphic guide is a help for the physicians in choosing the right drug-delivery-system suitable for OPAT self-administration.

What was done?

A graphic guide showing the ready-to-use antibiotics for outpatient parenteral antimicrobial therapy (OPAT) with special emphasis on drug-delivery-systems suitable for self-administration was developed.

How was it done?

Most information about the available ready-to-use antibiotics were obtained at the hospital pharmacy. In addition, the requirements for the different drug-delivery-system were obtained by interviewing nurses from different wards

What has been achieved?

Available ready-to-use antibiotics was listed in a graphic form with the following information: type of antibiotics, drug-delivery-system, available doses recommendations to time of administration and storage time and temperature. The drug-delivery-system were all illustrated with a photo.

The graphic guide is now part of the implemented guideline for OPAT at the hospital and is also available as a printed poster to place e.g. in the medicine room.
The guide is a help for the physicians in choosing the right drug-delivery-system suitable for OPAT self-administration and helps to raise overall awareness of the possibility of OPAT as self-administration at the hospital.

What next?

Implementation of the OPAT guideline and the included graphic guide has increased awareness of the need for the hospital pharmacy to deliver ready-to-use antibiotics that can match the needs for safe and efficient treatment at home. This is an important strategic focus for the hospital pharmacy in the coming years.

Author(s)

Marianna Rivasi, Gregorio Medici, Lucia Ricchi

Why was it done?

Because of the need to administer DA-EPOCH over a continuous 96-hour period, patients are traditionally hospitalized. Frequently, these admissions may be delayed because of bed shortages. Previous studies have shown that EPOCH-containing regimens can be safely administered in the outpatient setting, thus decreasing inpatient bed use and overall health care costs. Home-based chemotherapy is normally preferred by patients and helps reduce the risk of hospital-acquired infections; furthermore, other aspects such as functional decline and social isolation are minimized. Beginning in August 2019, we introduced an outpatient EPOCH-based chemotherapy model with portable infusion pumps and have already treated 9 patients.

What was done?

DA-EPOCH (etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin) -based chemotherapy is traditionally administered inpatient because of its complex protocol and number of involved medications. These routine admissions are costly, disruptive and isolating to patients. Here we describe our experience transitioning from inpatient to outpatient setting.

How was it done?

We purchased 3 CADD-SOLIS infusion pumps (Smiths Medical) and connected them to the bags containing chemotherapy. One of the main issues we observed in this procedure was the flow disturbances due to the presence of small air bubbles in the pump delivery line so we tried to develop a method aiming to reduce this effect.
We changed the first type of device we used with a new one consisting of an irreversible spike needle-free access to IV bag (BTC, Italia) inserted to the medication port of the bag. Into the spiking port we insert the CADD High-Volume administration set. It is crucial to remove all the air inside the IV bag and make sure there is no extra air injected into the bag when adding medication, finally do not forget to fully prime the tubing.

What has been achieved?

Outpatient EPOCH administration was associated with cost savings of approximately 400.000€ for both chemotherapy costs and hospital day avoidance (45 days). In addition to cost savings, outpatient administration improve patient satisfaction, without any apparent decrement in treatment efficacy.

What next?

Outpatient treatments would lead to changes in how both patients and providers relate to cancer care. Transitioning care out of the hospital and related cost reduction allowed for additional investments in public health.

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Author(s)

Rebeca Iglesias-Barreira, Emilio Rubén Pego-Pérez, Carlos Sandoval-Aquino, Cristina López-Pardo y Pardo, Maria Jesús Rodríguez-Gay

Why was it done?

To guarantee workers safety as well as optimize the use of PPE in the hospital.

What was done?

To develop a protocol for placement and removal of personal protective equipment (PPE), established for contact with possible or confirmed coronavirus SARS-CoV-2 infected patients, taking into account the medical devices (MD) available during the pandemic. Alternatives and strategies were also proposed for resources optimization. Final protocol resulted from a multidisciplinary team work (Hospital Pharmacy Service team and Emergency Service workers). It was finally revised and approved by the Medical and Quality Direction.

How was it done?

1)A systematic bibliographic review was made, for articles selection on the placement / removal of PPE. Technical specifications of the available MD and the sanitary recommendations of the competent organitations were reviewed.
2)Establishment of PPE components, and the order of placement and removal:
a. PPE placement:1-Wash hands (WH).2-Place shims.3-WH.4-Put on the first pair of gloves.5-Put on FFP2 mask.6-Wear waterproof protective overalls from the feet.7-Place garbage bags on feet and adjust them on legs.8-Wash gloves with a hydroalcoholic solution (HS).9-Put on second pair of gloves.10-Put on a standard/reinforced surgical gown.11-Wash HS.12-Put on surgical mask.13-Put on disposable gown.14-Put on third pair of gloves.15-Put on face protection screen. 16-Put on surgical cap and fit it over a face shield.
b. PPE removal: a) Before leaving the isolation room: 1-Remove and discard bags from both feet.2-Remove and discard disposable gown.3-Remove and discard the outermost gloves. b) Outside the isolation room: 1-Wash HS.2-Remove surgical cap and screen (reserve screen).3-Remove and discard surgical mask.4-Wash HS.5-Remove the standard/reinforced surgical gown and reserve it.6-Remove second pair of gloves.7-Wash HS.c) Before entering the clean area:1-Remove shoes.2-Remove third pair of gloves.d)Go to the clean area:1-Disinfect footwear.2-Wash HS.3-Remove monkey and if necessary reserve it. 4-Wash HS.5-Remove FFP2 mask and reserve it if necessary.6-WH.
c. A team member read and check all steps carried out during the all steps procedure.

What has been achieved?

The protocol was followed by 54 (100%) workers. Since its implantation, on March 16 th, only the 3,7% (n=2) of workers were infected by SARS-CoV-2.

What next?

The protocol is under constant revision and modification to adapt it to the available MD in every moment.

Pdf

Author(s)

Tanja Schicksnus

Why was it done?

The team of the geriatric trauma center consists of an orthopedic surgeon, geriatrician, nurse, physiotherapist, occupational therapist and a discharge management and diabetic nutrition expert according to the German society for orthopedic surgery (DGU) and now also a pharmacist who performs risk screening for drug-related problems such as fall, dizziness, cognitive impairment, conspicuous laboratory values, lack of appetite, etc. immediately after admission, in order to optimize drug therapy.

What was done?

The geriatric trauma center aims to provide geriatric patients with the best possible peri- and post-operative care after a fall with a fracture so that they resume their usual life and environment after the hospital stay. The pharmacist joined the interdisciplinary team with the aim of a medication review for the often multi-morbid and multi-prescription patients.

How was it done?

After the patient has been assigned to geriatric complex therapy according to the DGU criteria, the doctor requests a pharmacological consultation for this patient via the digital patient record. The pharmacist carries out a medication analysis with information from the record as well as bed side visits focusing on possible medication based problems.
Results are stored in the consultation report, serving as documentation and as basis for later evaluation. Important information for immediate implementation is highlighted in the digital file and transmitted to the attending physician by telephone.
Once a week, the entire team meets, with the scope for each patient being: What are the remaining problems? How can these be solved (interdisciplinary)?

What has been achieved?

During four months, medication reviews were carried out for about 100 patients. In the areas of bleeding risk, anticholinergic adverse events, antibiotics, malnutrition, dose adjustments and medicines inappropriate for geriatric patients, for one third of patients corrections led to an improvement in patients. For nearly 10% of patients also a prescription cascade was resolved and some medical device training has increased drug therapy safety.

What next?

Future benefit evaluation will be carried out based on resumption of patients due to a fall, in the categories: Time until next hospital admission, reason for next admission, adoption of optimized medication plan.