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THE ROLE OF DNA SEQUENCING AND MOLECULAR TUMOR BOARD COUNSELLING IN THE SELECTION OF THE MOST APPROPRIATED THERAPY IN ONCOLOGY

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European Statement

Clinical Pharmacy Services

Author(s)

Marta Anghilieri, Francesco Guidoni, Vito Ladisa

Why was it done?

The new DNA sequencing techniques, globally defined “Next Generation Sequencing (NGS)”, allow the parallel sequencing of many samples producing in short times a big amount of data. To enable comprehensive analysis of the data and develop new specific and clinically useful therapies, we have introduced the approach of evaluating the data by the MTB, which includes pharmacists as experts in drugs and their use.

What was done?

Hospital Pharmacists (HPs) are integrated into the Molecular Tumour Board (MTB), a multidisciplinary group, to select the most appropriated therapy for oncology patients, ensure and facilitate patient access, and demonstrate therapeutic appropriateness found by MTB analisys.

How was it done?

MTB members, including HPs, perform DNA sequencing on each patient using NGS to identify known/unknown alterations. These data are entered into a database available to all MTB members and are the basic tool for selecting potential target therapy. The MTB meets once a week to discuss and integrate the observed DNA alterations with the patient’s clinical history. In this way, the most appropriate target therapy for the patient can ultimately be selected. The HPs then provide the patient with access to medications.

What has been achieved?

In this study, 208 patients affected by Non-Small Cell Lung Cancer were evaluated. DNA sequencing of patients identify 117 altered genes. After an extensive literature search, 15 genes were highlighted as potential targets for available drugs. They marked 116 patients potentially tractable with target therapy, of which 47 patients were candidates to a target therapy already in clinical practice and 69 to a target therapy not in clinical practice. Comparing the two groups, among candidates for drugs in clinical practice, treatment was started in 65% and continued in 53%; among those treated with drugs not in clinical practice, treatment was started in 23% and continued in 69%.

What next?

The inclusion of HPs in MTB allows for more deliberate use and better selection of drugs. HPs provide valid support to select drugs and facilitate access to them: HPs individualise the applicable therapy for a larger number of patients through MTB, they analyse the therapeutic outcome (MTB-selected therapy has a bigger chance to last longer) and the cost impact on the NHS.

Stratification of psoriasis patients according to pharmaceutical care needed using the capacity-motivation-opportunity pharmaceutical care model

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European Statement

Clinical Pharmacy Services

Author(s)

NOELIA VICENTE-OLIVEROS, CARMEN PALOMAR FERNANDEZ, TERESA GRAMAGE-CARO, PAULA BURGOS BORDEL, MARÍA DEL CARMEN CALATAYUD SÁNCHEZ, SANDRA CASADO ANGULO, ANA MARTÍN ÁLVARO, MARÍA BEGOÑA RIVERA MARCOS, SONALI KARNANI KHEMLANI, MANUEL VELEZ-DIAZ-PALLARES, ANA ALVAREZ-DIAZ

Why was it done?

Patients with moderate-severe psoriasis require systemic hospital-dispensed treatments. Hospital pharmacists look for actions to anticipate patients’ needs for achieving health outcomes and the system’s sustainability.

What was done?

We stratified psoriasis patients according to the pharmaceutical care needed and established their pharmaceutical care plan. We calculated the time needed in pharmaceutical care after stratification.

How was it done?

An observational, prospective, cross-sectional study was conducted in a university hospital. One hundred psoriasis patients who received medication in the outpatient hospital pharmacy were randomly chosen between March-May 2022.
Capacity-Motivation-Opportunity (CMO) pharmaceutical care model (SEFH, 2018) was used to stratify patients. This model consisted of 23 variables (demographic, clinical, pharmacological, socio-sanitary, cognitive and functional). Each variable scored between 1-4, depending on patient risk. Patients were classified on three levels which determined the subsequent pharmaceutical care to be provided to each patient:
1. global score≥31 points,
2. 18-30 points and
3 ≤17 points.
Information was collected through patients’ interviews and electronic health records review.
A group of nine pharmacists were set up to adapt the CMO pharmaceutical care model to our hospital.
Total time spent in pharmaceutical care was obtained through patient visits before and after stratification. The scheduled average time for each visit was 10 minutes. The number of visits pre-stratification was the sum of all the visits scheduled for the patients, and for post-stratification was the sum of all the visits with the new CMO model (level 1 (biannual), 2 (annual), 3 (as needed).

What has been achieved?

Most patients were stratified on level 3. A pharmaceutical care plan has been designed to meet the needs of each patient.
Stratification has improved the time pharmacists have to accomplish the needs of each patient (16.3 hours/year (98 visits)). Sixty-two percent of patients had as needed visits (level 3), 36% needed annual visits (level 2) and 2% biannual (level 1). However, during pre-stratification, most the patients (70%) had every nine months visits, 18 % every 12 months, 9% every six months and 3% every three months.

What next?

We will expand the stratification to the rest of the psoriasis patients and other outpatient pathologies.
We will coordinate strategies with Social and Psychological Services, Primary care and Community pharmacy to improve pharmaceutical care.

Impact of drug-drug interaction alerts on prescribing patterns in a teaching hospital

European Statement

Patient Safety and Quality Assurance

Author(s)

Joana Pinto, José Feio, Sebastião Silva, Francisco Machado, Ana Dinis, Margarida Abreu, João Peres, Mariana Guia

Why was it done?

Clinical decision support systems comprising information on DDI improve DDI risk detection, avoiding preventable patient harm. The resulting DDI alerts can change prescribers’ behaviour to benefit patient care. However, an excessive number of alerts can lead to alerts’ desensitisation by prescribers.

What was done?

We monitored the drug-drug interactions (DDI) alerts displayed in the prescription system through three subsequent homologous periods, occurring after the integration of a DDI database in the prescribing software system of a teaching hospital to assess its impact on the prescribing pattern.

How was it done?

We developed a DDI database – MedH® – to be integrated into the prescribing software system to support hard stop DDI alerts. only the higher clinical risk DDIs were included in this database in order to restrain the burden of alerts and warrant acceptance by health professionals.
Data of all inpatient hospital prescriptions over a 12-month period prior to MedH® implementation were extracted and intersected with MedH® DDI BD to identify the top 10 co-prescribed binomials at risk of severe DDI. The number of alerts for the same binomials was then monitored through three subsequent, post-implementation, homologous periods.

What has been achieved?

Considered the TOP10 observed in the pre-implementation period, the number of alerts for all binomials has consistently reduced over the three post-implementation periods analysed.
The integration of MedH® DDI BD into the prescribing system, resulted in changes in the prescribing pattern, translated by a decrease, between 67% and 100%, in the number of alerts for a sample of control risk binomials coinciding with the top 10 co-prescribed risk binomials observed in the pre-implementation period. These results reflect the good acceptance by the professionals and the didactic effect achieved by the exposure to alerts.
More importantly, these results are indicative of the effectiveness of the implementation of MedH® Alerts in reducing patient exposure to high-risk combinations of medicines, thus promoting patient safety.

What next?

It will be important to ensure that data from IDD alerts are rigorously analysed to recognise clinical situations in which the co-administration of risk binomials is justified, to ensure consistent application of recommended risk minimisation measures, and the availability of safer therapeutic alternatives whenever possible.

Setting in situation of pharmaceutical validation of paediatric intensive care prescriptions by fifth year students: state of play and assessment

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European Statement

Education and Research

Author(s)

Omar HANAFIA, Pierre BERTAULT-PERES, Stéphane HONORE

Why was it done?

This internship was proposed to diversify the clinical pharmacy internship opportunities and to allow students to discover and understand paediatrics and intensive care, which are less covered in university courses. It will also be a proof of concept to develop this type of internship in other departments.

What was done?

We have proposed a new clinical pharmacy internship in immersion in paediatric intensive care to 5th year students. It is a hospital internship at the interface between the medical and pharmaceutical teams, the student is responsible for establishing a statement to analyse the drug management, its evaluation and improvement.

How was it done?

The clinical pharmacy student is a full-time employee, fully integrated into the medical team. Their day is divided into two parts: in the morning they attend the relief, the staff and the medical visit. In the afternoon, he/she takes over the patients, compiles the main medical, clinical and biological information in order to pharmaceutically prevalidate the medical prescriptions and propose pharmaceutical interventions (PI) to the pharmacist.

What has been achieved?

Since its opening, the position has been systematically chosen by the students, in 3 years 8 students have chosen it. After a training period of 1 month with the senior pharmacist, all students were able to perform the expected readings, prevalidation and PI. More than 78% of the PIs detected by the students were validated by the senior pharmacist and accepted by the physician.

What next?

This proof of concept shows that students are supportive of this type of initiative and are able to meet the high expectations of this internship.

Towards e-documentation of clinical pharmacist interventions

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European Statement

Clinical Pharmacy Services

Author(s)

Andrea Bor, Nóra Gyimesi, Eszter Erika Nagy

Why was it done?

Intervention-oriented classification systems are helpful tools to document the CPIs in a structured manner. Our aim was to develop a clinical pharmacy platform in the e-documentation system at our institution. This CPI data enables healthcare providers to track medication history, and to systematically analyse the effectiveness and the pharmacoeconomic benefits.

What was done?

A pilot survey was conducted on the traumatology wards to analyse and describe our clinical pharmacist interventions (CPI) based on severity and clinical relevance.

How was it done?

Three clinical pharmacists collected data on the changes of drug therapy at two 31-bed traumatology wards during pre- and postoperative period. We adopted the CPI classification system to our daily practices. This is challenging since the narrow time frame between patient admission and discharge often limits the opportunity to provide clinical pharmacy services. Raw data was previously screened and classified into 5 categories, drug related problems (DRP), clinical pharmacist intervention (CPI), significance (S), outcome (O) and acceptance (A).

What has been achieved?

We have established a data collection process, which allows us to record CPIs in our daily clinical environment in an efficient manner.
The most significant DRPs were incorrect dosage regimen (n=47), untreated indication (n=28), contraindication (n=25), excessive dose (n=19), subtherapeutic dose (n=17), drug interaction (n=15), no indication (n=11), experiencing adverse drug reaction (n=8), failure of drug administration due to shortages (n=5).
CPIs were divided into four groups:
1. Pharmacokinetic cause (dose adjustment, changes of drug dosage regimen, drug discontinuation, drug switch, etc.)
2. Pharmacodynamic cause (adding new drug, drug switch, – discontinuation, etc.),
3. Providing drug information (patient education, new drug, changes of administration route, etc.) and
4. Miscellaneous.
Significance were categorised as major (e.g. oral anticoagulant – LMWH switch, postoperative opioid use), moderate (e.g. loop diuretics – ion supplementation), minor.
Outcomes were therapeutic success, prevention of potential harm (e.g. adverse drug reaction) or cost saving.
73% of the interventions were accepted, the rest were rejected for the first time, but nearly half of them were admitted after minor modifications.

What next?

This CPI platform should be shared in the national digital health system.

Implementation of a clinical pharmaceutical service for ostomates

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European Statement

Clinical Pharmacy Services

Author(s)

Iris Summer, Marina Zakhari-Betros, Alice Poier, Christine Fegerl-Stadlober

Why was it done?

There had been reports from healthcare professionals of the presence of undigested tablets in ostomy pouches and reasonable doubts of adequate drug absorption. In addition, there were recurring inquiries from clinicians about drug related problems in ostomy-patients.

What was done?

Implementation of a clinical pharmaceutical service for patients with an intestinal ostomy following their stoma-surgery. In this service, oral drug therapy of patients with either ileostomy or colostomy was assessed to determine whether possible impairment of drug liberation or absorption could lead to malabsorption of drug therapy.

How was it done?

A project was conducted, where 30 ileostomy and colostomy patients were observed. Simultaneously, a literature review concerning all orally administered drugs of this patient collective was done. During the project time, two interviews were done with the patients. The first one was lead during hospitalisation whereas the second one was conducted within 4 weeks after hospital discharge. To standardise the interviews, two different questionnaires were developed. Medical status of the patient as well as pharmacokinetic properties of the drugs administered orally were thus assessed. It was evaluated whether there are any drugs which may feature any impaired drug liberation or absorption. In case of anomalies presented, such as undigested tablets found in the pouch, a plasma level measurement of the drug was done, if reasonable. In addition, the subjective perception of the patients was also taken into account, to measure whether malabsorption of drugs is recognised or not and if patients are aware of possible impairment of absorption.

What has been achieved?

A strategy was established to help healthcare professionals assess oral drug therapy in ostomates. In addition, awareness in healthcare professionals as well as patients was raised, concerning possible impaired drug liberation because of the use of inappropriate dosage drug form. Moreover, prevention of prospective drug related complications was also achieved.

What next?

1. Modification of our electronic medical record concerning automated pharmaceutical counselling.
2. Integration of a clinical pharmaceutical service within the ostomy care service of our hospital to provide better therapeutic outcome, especially when ostomy-related problems are presented.
3. Providing patient information leaflets to improve health literacy and patient satisfaction.

Implementation of automated alert system in high-alert medications in a network of hospitals

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European Statement

Patient Safety and Quality Assurance

Author(s)

ROSALIA FERNANDEZ CABALLERO, ALMUDENA GARCÍA GARCÍA, MARTA HERNÁNDEZ SEGURADO, MARTA GÓMEZ PÉREZ, CARMEN MAYO LÓPEZ, ARACELI HENARES LÓPEZ, VIRGINIA COLLADOS ARROYO

Why was it done?

Our aim was to improve the safety of HAM appointed by ISMP Spain (Institute for Safe Medication Practices) specially restricting the prescription, creating automated alerts and advising in administration.

What was done?

The main objective was to identify and standardise in prescription and administration the high-alert medications (HAM), included in pharmacotherapeutic guide (PG) in a network of Spanish hospitals with about 1.330 beds.

How was it done?

Literature about HAM and recommended strategies was reviewed. We divided these drugs into two groups: HAM (heightened risk of causing significant patient harm when they are used in error) and very HAM (an error could cause death of patient). We identified both groups in electronic prescription system as follows:
– HAM: all prescribers are able to prescribe these drugs and they find yellow warning sign in left side of the drug in prescription screen and nursing electronic work plan for administration.
– Very HAM: these drugs need tracheal intubation or monitoring measures when they are administered to patients. Only prescribers in intensive care (ICU) and surgery units (SU) are able to prescribe them. For certain drugs, needed in medical hospitalisation units, all prescribers are able to prescribe them and they must confirm the prescription with confirmation message: “You are prescribing a HAM, an error could cause significant patient harm. Are you sure to continue?”. They find red warning sign in prescription screen and nursing electronic work plan.
Alerts were configured by systems team in our electronic prescription system.

What has been achieved?

We have identified 379 drugs as HAM. 324 drugs were configured with yellow warning sign.
Sixty-five drugs were identified as very HAM. Fifty-eight drugs were disabled to prescribe by all prescribers (only in ICU and SU).
Seven drugs were configured with red warning alert and confirmation message: dobutamine, isoprenaline, ketamine, labetalol, levosimendan, carboprost and methylergometrine.

What next?

As next phase of our project, we must develop a procedure to identify and create alerts in new drugs added to our PG as systematic risk assessment process. Moreover, we must evaluate the real impact of our alert system in prescribers and nurse team, to reduce alert fatigue. We will work in automatic reports with ignored alerts.

Introducing a clinical pharmacist in a paediatric palliative care unit: how to optimise complex drug regimens

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European Statement

Clinical Pharmacy Services

Author(s)

Daniele Mengato, Laura Camuffo, Anna Zanin, Fernando Baratiri, Barbara Roverato, Franca Benini, Francesca Venturini

Why was it done?

PPC patients are children with chronic or terminal illnesses requiring a high intensity of care. Because of their criticality, a strict clinical monitoring is needed, as well as personalised therapeutic strategies.

What was done?

The paediatric palliative care (PPC) unit aims to provide paediatric patients with the best possible care in the management of their disease to ensure the optimal quality of life. The pharmacist has joined the interdisciplinary team with the aim of improving drug management in both acute inpatient and chronic therapies.

How was it done?

From August 2021, the clinical pharmacist joined the PPC staff with the aim of improving medicine management. The pharmacist, primarily, took charge of the medication review process. Individual therapies were periodically reviewed by the multidisciplinary team on the basis of admissions and clinical changes. In addition, a formulary manual for healthcare professionals was drafted, with the description of the crushability of the most commonly used pharmaceutical forms in clinical practice by collecting and keeping up-to-date information from national and international handbooks.

What has been achieved?

Over the past eight months, initial drug reviews have been carried out for all 169 patients followed by the PPC unit, with collegial re-evaluations cyclically carried out for the most critical patients (15). These patients had at least 10 drugs to take each day and therefore assessments were made to simplify treatment regimens by providing 37 suggestions to physicians with the aim of reducing the risk of interactions and facilitating home therapy management. With regard to the handling of pharmaceutical forms, many galenic formulations have been proposed in order to reduce the crushing of solid forms as much as possible. Most of the suggestions were discussed and accepted by the medical team.

What next?

Clinical pharmacist’s intervention is crucial in the management of terminal or chronic therapies for critically ill patients. Next step will be the analysis of caregivers’ care burden, through a specific questionnaire that has already been validated, so as to improve the home management of this particular category of patients.

Implementation of a new work circuit in monography consultation of immune-mediated diseases of the pharmacy service

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European Statement

Patient Safety and Quality Assurance

Author(s)

ALBA MARIA MARTINEZ SOTO, MARIA ONTENIENTE CANDELA, CARLES INIESTA NAVALON, PATRICIA ORTIZ FERNANDEZ, PILAR FERNANDEZ-VILLACAÑAS FERNANDEZ, ANABEL HERREROS HERNANDEZ, GEMMA MARTINEZ SOTO, CARMEN CABALLERO REQUEJO, MAYTE GIL CANDEL, ELENA URBIETA SANZ

Why was it done?

– Guide the pharmacist in the development of an individualised follow-up strategy for patient evaluating the frequency with which appointments should be established in the consultation of Pharmaceutical Care.
– Use the information from the specific questionnaires to detect possible failures therapeutic.
– Use the results obtained in the PROs to direct the recommendations pharmacotherapeutic to perform, which will be assessed in a multidisciplinary committee of immune-mediated diseases.
– Promote higher quality pharmaceutical care.

What was done?

Implementation of a circuit to improve pharmaceutical care and follow-up pharmacotherapeutic, incorporating the stratification of
patients according to the “Model of Stratification and Pharmaceutical Care for Diseases Immune-mediated Inflammatory Diseases” (MAPEX) and the use of Patient Reported Outcomes (PROs).

How was it done?

1. Selection of patients to include.
2. Design a database in Access for the collection of stratification data and PROs.
3. Selection of specific and generic PROs.
4. Stratification of active patients according to the MAPEX methodology at the beginning of the implantation and in patients who start during the follow-up period will be stratified at the baseline visit.
5. Establish a strategy for carrying out questionnaires (PROs) in consultation.

What has been achieved?

An Access database has been created that incorporates the blocks established by the MAPEX model with each of its variables broken down, allowing us to obtain the patient global score.
3 pathology-specific PROs have been selected (RAPID3 in rheumatoid arthritis, PSAID12 in Psoriatic Arthritis and BASDAI in Ankylosing Spondylitis) and a generic one, EuroQol-5D-5L.
The follow-up strategy based on the stratification was selected as the one proposed by the MAPEX model.
To carry out the PROs, those patients with arthropathies that are were under treatment with biological drugs.
It was decided to pass a specific PRO according to his pathology and the generic having a baseline intake, another at 16 weeks and another a year.

What next?

Design a study to measure the results in terms of quality of care obtained with this new circuit.

Pharmaceutical care for human immunodeficiency virus pre-exposure prophylaxis users

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European Statement

Clinical Pharmacy Services

Author(s)

NURIA FERNANDEZ PIÑEIRO, CRISTINA GONZALEZ PEREZ, LIDIA YBAÑEZ GARCIA, NATALIA SANCHEZ-OCAÑA MARTÍN, JOSE MANUEL MARTINEZ SESMERO

Why was it done?

In our area all care for PrEP users was centralised in a specialised centre. Here, a multidisciplinary team made up of doctors, nurses and pharmacists integrated in a patient-centred care model. PrEP users are a potentially vulnerable population. Health education and motivation are provided in the PhC consultations to raise awareness about the use of medication and adherence to treatment, which are key to avoiding HIV infection. The use of sex-related drugs is a growing health problem in this population and has been associated with increased HIV transmission risk.

What was done?

Development and implementation of a monographic pharmaceutical care (PhC) consultation for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) users.

How was it done?

On 20 January 2020, the PhC consultation was launched in a monographic STI care centre linked to a tertiary hospital.
– On the same day as the first medical appointment, the user attends a PhC appointment. In this unit the user receives the necessary information to properly take the medication. Possible interactions are reviewed, not only with medications, but also with natural medicine, sports supplements and drugs. All doubts are resolved and the medication is dispensed.
– Every 3 months medical follow-up is carried out and, in the PhC consultation, where not only possible adverse effects are reviewed, but also adherence and related problems are specially monitored. To increase the quality of care, active communication between all health personnel was ensured.

What has been achieved?

Until 30 September 2022, 3,460 initial visits and 13,349 follow-up visits have been made (411 of them through telepharmacy during the lockdown as a result of the global pandemic by SARS-CoV-2). From the users, 98.98% were men who have sex with men (MSM), 0.80% transgender women, 0.04% transgender men and 0.18% were women. 70.3% used sex-related drugs (Chemsex), with the most used substances being Popper (37.1%), mephedrone (28.2%) and gamma hydroxybutyrate (GHB) (24.6%).

What next?

In our experience, the role of hospital pharmacists as a reference health personnel for HIV-PrEP users has become clear, not only as an expert in medication. Given the prevalence of drug use in this population makes the health education that we hospital pharmacists can provide especially important.

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Help us provide an overview of the scale of the problem, as well as insights into the impact on overall patient care.

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BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.