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Redispensing of expensive oral anticancer medicines: a practical application

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European Statement

Clinical Pharmacy Services

Why was it done?

OAM are widely used in the treatment of solid tumors and are administered orally in cycles that require self-administration at home. However, dose adjustments and discontinuations often lead to leftover medication which is discarded as waste. Therefore, the increasing use of expensive OAM comes with the downside of a financial and environmental burden. To reduce this waste, returned OAM to the pharmacy could be considered for redispensing to other patients providing guaranteed quality.

What was done?

We defined quality criteria for redispensing of oral anticancer medicines (OAM) in our hospital pharmacy. These criteria were laid down in a Standard Operating Procedure (SOP) to assess the eligibility for redispensing of returned OAM. This SOP was implemented in daily pharmacy practice.

How was it done?

A systematic risk analysis was conducted to determine eligibility of OAM for redispensing taking relevant guidelines and product information into account. The defined quality criteria were translated into a SOP and implemented in daily pharmacy practice. Over a year period, the number of returned OAM accepted for redispensing was quantified, and the reduction in financial waste and environmental burden calculated.

What has been achieved?

From the systematic risk analysis, four categories of quality aspects were identified: product presentation suitability (stability characteristics, storage requirements), physical condition (unopened or opened secondary or primary packaging, visual appearance), authentication (Falsified Medicines Directive, confirmation of initial dispense, recall), and additional aspects (remaining shelf life, period of storage under uncontrolled conditions). The first category identified that in principle, 75% of the licenced OAM (n=..products) dispensed at our institute is eligible for redispensing. From all combined quality aspects, a flow chart was created according to which each individual returned OAM is assessed . During the study period, 10,415 OAM dose units out of 13,210 returns (79%) were accepted for redispensing. The total value of OAM accepted for redispensing was €483,301, accounting for 0.9% of the total value dispensed during this period. Furthermore, the potential reduction in environmental burden was estimated at 1132.1 g of potent active pharmaceutical ingredient.

What next?

We established an easily implementable, comprehensive quality assessment of returned OAM for redispensing. Wide implementation of this approach would result in serious OAM cost and waste reduction.

Improving efficiency in the infusion unit through a critical review of medication protocols

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European Statement

Clinical Pharmacy Services

Author(s)

Jesper van Breeschoten, Chang Chui, Bert Storm, Grootswagers-Sobels Annemieke

Why was it done?

After the introduction of new medications in a hospital, it is uncommon for local treatment and administration protocols to be reevaluated in light of the latest scientific evidence. Infusion units are facing numerous challenges today, including staffing shortages and a growing number of patients receiving intravenous treatments. It may prove beneficial to periodically conduct a comprehensive review of the current protocols, with the objective of minimizing the time patients spend in the infusion unit and to prevent unnecessary use of medication while upholding the delivery of high-quality care.

What was done?

We performed an extensive review of treatment protocols for all medications administered at our infusion unit.

How was it done?

We performed an extensive review of treatment protocols for all medications administered at our infusion unit, drawing insights from the most recent literature. Our evaluation covered a range of factors, including premedication, infusion rates, observation periods, line flushing, administration routes, hydration strategies, and anti-emetic regimens. To provide additional data supporting protocol refinements, we utilized an electronic health record text mining tool known as CTcue, which facilitated the collection of retrospective patient information. Subsequently, these protocol modifications received unanimous approval from both pharmacist and attending specialist.

What has been achieved?

Treatment and administration protocols of 17 medications were optimized. We decreased infusion times for atezolizumab, bevacizumab, carboplatin, doxorubicine, durvalumab, folinic acid, irinotecan, panitimumab, vinblastine and vincristine. Vital sign assessment during infusion were omitted from protocols. Premedication and anti-emetic medication were converted to oral administration. Intravenous administration was converted to subcutaneous administration for abatacept, daratumumab, infliximab, tocilizumab, trastuzumab + pertuzumab and vedolizumab. Observation time after infusion was omitted for daratumumab, infliximab and vedolizumab. Based on the current literature, hydration schemes of cisplatin were shortened from 20 hours to 4 hours. The implementation of all optimization measures resulted in a reduction of ± 6000 hours of bed occupancy by patients annually. Based on our estimation, this has resulted in a reduction of approximately 16% in total time that beds were occupied.

What next?

We aim to periodically review our treatment and administration protocols and share our experiences with other hospital pharmacists. Other infusion units that also face challenges in shortness of staff may copy this blueprint to mitigate these problems.

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.

Development of a professional competency framework for clinical pharmacy in Sweden

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European Statement

Education and Research

Author(s)

Matts Balgard, Jeanette Andersson, Per Nydert, Niral Patel, Anna Skrinning, Matilda Soderberg, Simon Tekmen, Celina Sving

Why was it done?

A growing number of pharmacists in Sweden are working in a clinical setting. They often have different responsibilities and tasks, which may seem confusing to other healthcare professionals. There is an interprofessional need to describe different roles for hospital pharmacists. Equally important, there is an intraprofessional need to establish core competencies and progression of those roles and develop a professional framework to advance career structure for hospital pharmacists.

What was done?

Two associations for health system pharmacists in Sweden took the initiative to collaboratively develop a national professional competency framework for clinical pharmacy practice.

How was it done?

A working group of experienced clinical pharmacists was tasked with drafting a first role description and professional framework for clinical pharmacy practice.
The development of the role description was influenced by, and drew upon, previous similar efforts in Sweden – primarily Stockholm, the UK Advanced Pharmacy Framework (APF) and the EAHP Competency Framework for Hospital Pharmacy. A reference group of approximately 40 Swedish clinical pharmacist volunteers provided feedback on the first draft, which improved the revised final role description.

What has been achieved?

The national role description for clinical pharmacy consists of an overview of the role, an outline of formal educational requirements and a competency framework strongly influenced by the APF. The framework has six competency clusters: clinical pharmacy practice, working relationships and communication, leadership and motivation, service development, education and training, research and evaluation and lists four stages of experience: junior, intermediate, senior and consultant.
The role description was launched in April 2022 with an open invitation to practitioners, employers and local union clubs to begin to adopt and try out the professional competency framework. It is too early to evaluate impact, but the initiative has been met with support from employers and the clinical pharmacy community.

What next?

The organisations will further promote and support implementation of the published role description. A revision is planned in 2023–2024 based on real-world feedback. New working groups are being formed to develop similar role descriptions for drug preparation and drug distribution. There is still a need to develop a system of credentialing progression between the experience stages of the professional framework.

Digitization: a key to improve health condition of patients with cancer disease

European Statement

Clinical Pharmacy Services

Why was it done?

the app was developed in order to improve therapeutic adherence, pharmacological counseling, management of adverse events and increase pharmacovigilance’s reports with higher data quality. The World Health Organization recognizes that 20% of health is due to medical care, 20-30% to lifestyle, while the remainder depends on the environmental, social, genetic and psychological conditions of the individual. The goal of this app is to improve patient’s therapeutic path at different levels and breaking down geographical barriers.

What was done?

the Sars-cov-2 pandemic entailed a lot of new challenges for the Hospital pharmacist . As the scenario was completely new, it was developed an app to better manage patients with cancer disease treated with oral chemotherapy.

How was it done?

Patient has been divided into two groups, of which only one group use the app to manage the therapy. The primary endpoint was the improvement of therapeutic adherence, while the secondary endpoints are: improve in the quality of patient life (HRQoL), increase pharmacovigilance’s reports and avoid therapeutic errors.

What has been achieved?

The continuous dialogue between patients and hospital pharmacist througt system’s online messaging app improved the management of patients needed and reduce drug interactions. Digital management led to a 56% increase of pharmacovigilance reports. It was also detected a reduction in overall costs and patient uneasiness.

What next?

the health system has to be reorganized around patient’s needed, by promoting the use of more and more homogeneous, safe, transparent and accessible technologies.
Regulatory authorities should accelerate the adoption of digital solution. In this new framework hospital pharmacist will play a key role in the development of value based medicine and in the process of treatment humanization as a patient’s landmark person too.

Dose a clinical pharmacy service in emergency department improve the safety of eldery patient ?

European Statement

Clinical Pharmacy Services

Author(s)

Ugo CARRERE, Charles-Henri BLANCHER, Julien ARCIZET, Serge BENETEAUD, Caroline ALLIX-BEGUEC, Benoit LE FRANC

Why was it done?

EDs are the main entry point for hospitalizations. Medication errors are a major threat to patients safety. They are exacerbated by the high flow of patient admitted, the increase in polypharmacy in eldery patients, lack of knowledge of medication and time constraints.

What was done?

We have implemented proactive medication reconciliations (MR) for eldery patients in our emergency department (ED). Retroactive MR was performed in downstream departments (DD) for similar patients. Goals were to save physicians’ and nurses’ times, to improve patient safety.

How was it done?

A pharmacist provided MR in the ED unit three half-days per week. In agreement with the emergency physicians, we targeted patients aged 75 years and over and/or 65 years and over with multiple medications remained hospitalized. Pharmacists collected patients’ medication history and shared the information to ED prescribers. The drug assessment was recorded in a prescription support software. Prescribers, in the DD, could use it to prescribed without transcription and save time.
Our study was based on the comparison of the two groups : the proactive MR group in the ED and the control group with retroactive MR in downstream departements. Discrepancies were recorded and rated as intentional and unintentional in the two groups.

What has been achieved?

Between February and April 2021, 139 medication reconciliations were performed (proactive group n=61 ; retroactive group n=78). The age (about 83 years) and mean number of drugs per patient (about seven) of the two groups were not statistiquely different. We observed a statistically significant reduction in the number of unintentional discrepancies with proactive reconciliation in the ED (7% in the proactive group versus 20% in the retroactive group, p-value = 0.0034). Drugs for the nervous system and the cardiovascular system were the most affected by discrepancies. These discrepancies were mainly detected in prescriptions for patients taken care in the orthopedic surgery, the hepato-gastrology and the polyvalent medicine departments.

What next?

Clinical, economic and organizational scoring of unintentional discrepancies will be performed by a physician-pharmacist pair (CLEO scale of the French Society of Clinical Pharmacy)
Downstream departments with the most UD will be encouraged to use medication reconciliation.
A satisfaction survey will be conducted among the teams.

Optimizing information on the fecal microbiota transplantation circuit

European Statement

Patient Safety and Quality Assurance

Author(s)

Julia Santucci, Céline Vaesken, Guillaume Saint-Lorant

Why was it done?

FMT is a therapy introduced in 2016 at the hospital. It is indicated for the management of recurrent and refractory Clostridioides difficile (CD) infections. In November 2020, with the resumption of the activity, we note a lack of knowledge of the different actors on this circuit: physician, nurses, fellows, patients himself.
The objective of the study is to reinforce the understanding and safety of the FMT circuit in a university hospital after the evaluation of the knowledge of the different actors.

What was done?

Implementation of a document to represent the circuit of fecal microbiota transplantation (FMT) in a French university hospital.

How was it done?

In this context, two questionnaires containing less than five questions on the functioning of the circuit were carried out with the nurse coordinators (NC) and the interns of the hepato-gastrology department. Subsequently, a document was drafted in consultation with the referring physician, the head of department and the pharmaceutical team to represent the FMT circuit.

What has been achieved?

With regard to the questionnaires, we obtained six answers from the NC, with 42% correct answers, 25% partial answers and 33% incorrect answers, and then six answers from the residents, with 20% correct answers, 7% partial answers and 77% incorrect answers.
These questions made it possible to draw up a diagram adapted to A4 format intended for all the actors in the circuit. It defines the different missions of all the actors with the corresponding deadlines and associated procedures.
In order to improve information, two interventions were carried out by the pharmacy: a staff meeting dedicated to the management of CD infections with the interns, co-hosted with the referring physician, and a presentation of the circuit to the NC.

What next?

Finally, this study made it possible to reinforce the safety of the FMT activity for the patient and to improve the management of the circuit for the various health professionals involved in this specialized therapy.

Croatian hospital pharmacists managing earthquake(s) medical consequences during lockdown(s)

European Statement

Clinical Pharmacy Services

Author(s)

Mirna Momcilovic, Anita Simic, Petra Turcic

Why was it done?

Croatia was hit by 2 big earthquakes in 2020, both happened just right after 1st and 2nd lockdown due to high number of COVID-19 cases. Since most of the hospitals were strategically built on the hills, it was more destructive for them. It also hit a number of community pharmacies responsible for drugs supply to specific areas in the country. There was no electricity, no heating, no drugs supply, no fridge to store drugs, for days, so quick back-up plan was needed to provide minimal healthcare.

What was done?

Croatian hospital pharmacists organised a temporary pharmacy in a tent, filled it with drugs and medical products donated from community pharmacies, hospitals and wholesalers from Croatia and other European countries and started supplying patients with it.

How was it done?

It was modified way of dispensing, without prescription because there was no doctors and no place to prescribe it, based on patient’s medical documentation, if available, and patient’s medication history according to what patient said only. Pharmacists needed to use their knowledge about dosing, duration of action – difference between immediate release or modified release formulations, possibility of splitting tablets into equal parts to get the needed dose and, most important, substituting drugs from the same pharmacologic class (ex. switching from one inhaler for treatment of asthma containing ICS + LABA to another one that was available at the moment), taking into consideration patient’s needs and avoiding drug to drug interactions. Pharmacists provided patients with OTC drugs, free of charge, followed by an advice of how to use it. Non having prescription problem was solved afterwards by Croatian Health Insurance Fund. Also, all the supply of vaccine against COVID-19 available in Croatia at that point, was sent to an area hit by the earthquake. Vaccination was done by doctors, and pharmacists assisted by supplying them with all the equipment needed (needles, alcohol, cotton wool, etc.).

What has been achieved?

Patients were supplied by all the drugs/medical products needed in the first, critical week after an earthquake.

What next?

Following the Croatian example of handling an earthquake situation, there is an idea of organising a medical crisis team, would include pharmacist, in each European country.

GUIDE TO SUPPORT THE VALIDATION OF PHARMACOLOGICAL TREATMENT IN LUNG TRANSPLANTATION

European Statement

Clinical Pharmacy Services

Author(s)

ANA SANGRADOR, MARIA RIOJA, VICTOR MORA, MARTA VALERO

Why was it done?

reduce the variability of the process, standardize decisions, reduce medication errors, and quantify and measure results, among pharmacists who care for lung transplant patients in the hospital.

What was done?

Prepare a guide to support the pharmaceutical validation of treatment in lung transplantation

How was it done?

The circuit that has served as the script to develop the guide has been the Manual for the Preparation of Clinical Practice Guidelines in the Spain National Health System.

• Initial meeting of pharmacists with the LTx team: presentation of the need and definition of the desirable contents according to the proposals of pharmacists and pulmonologists.
• Task assignment meeting among participating pharmacists.
• Subsequent pharmacist-pulmonologist meetings to outline the aspects that could generate more doubts and controversies.
• Inclusion of the pharmacist in the TX team, to know in situ all the phases of the TX process (from the visit during the pre-TX study, going through the surgery and its subsequent recovery stage in the plant, until the subsequent follow-up in consultations).
• Put in common of the elaborated contents.
• Review by the multidisciplinary team of Ltx.
• Publication of the guide.

What has been achieved?

• Introduction to lung transplantation (LTx): idiosyncrasies of it and transplanted patients, inclusion on the waiting list, common diseases that lead to LTx.
• Most common pretransplant Disease : cystic fibrosis, autoimmune diseases, occupational diseases, obstructive diseases, etc …
• Reference laboratory values and most common deviations in LTx.
• Clinical pharmacokinetics: immunosuppressants and other drugs monitored.
• Clinical immunology of LTx.
• Pharmacology of LTx: Immunosuppression (induction and long-term), antibacterial, antiviral and antifungal infectious prophylaxis, pain treatment, prevention of osteoporosis and treatment of the most common comorbidities in post-PTx: arterial hypertension, supraventricular fibrillation, hyperglycemia and post-transplant dyslipidaemia.
• Inclusion of current pharmacological treatment protocols: initial and subsequent treatment of LTx, cytomegalovirus infection according to the donor-recipient pairing, humoral and cellular rejection, anticoagulation and osteoporosis.
• Treatment validation criteria.
• Drug-drug and drug-food interactions with clinical significance.
• Most common chronological complications in post-LTx.
• Nutrition in the post-LTx.
• Reconciliation of medication.
• Information on medicines and healthy lifestyle habits.
• Usual documentation: informed consents, uses outside the technical data sheet, etc …

What next?

This guide will help to other pharmacist.

RESHAPING OF CLINICAL PRACTICE AND REORGANISATION OF CHEMOTHERAPEUTIC PROTOCOLS DURING COVID-19 PANDEMIC: THE INITIATIVE OF THE NATIONAL INSTITUTE OF TUMORS

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European Statement

Clinical Pharmacy Services

Author(s)

Giuliana Lo Cricchio, Margherita Galassi, Ernesto Ruffino, Claudia Tirone, Vito Ladisa

Why was it done?

In accordance with regional provisions and national guidelines, the initiative has had the dual objective of reducing hospital access, and potential infections, and ensuring therapeutic continuity for cancer patients.

What was done?

Some therapy protocols have been modified for the treatment of blood, gastrointestinal, lung, breast, head and neck tumors, in order to obtain equally effective patterns but with longer intervals between doses.

How was it done?

Patients have been stratified on the basis of the neoplasia location and biology, the general conditions and the treatments characteristics and they have been shifted to modified treatment regimes, even outside the indications temporarily authorized by regional decision: Nivolumab from 240 mg Q2W to 480 mg Q4W for Hodgkin lymphoma, non-small-cell lung-cancer, squamous cell carcinoma of the head and neck; from weekly Paclitaxel to Docetaxel Q3W for breast cancer; Pembrolizumab from 200 mg Q3W to 400 mg Q6W for lung cancer and melanoma; remodulation of protocols including fluoropyridines and platinum coordination compounds for gastroenteric tumors.

What has been achieved?

The schedule modification allowed a reshaping of agendas to reduce the frequency of day-hospital access and the risk of infection with Sars-Cov-2 for patients, carers and health professionals, in addition to reducing the costs of outpatient services. Treatment interruption rate, with possible consequent progression of disease, as reported by early Chinese data in the literature, has been reduced.

What next?

The extraordinary health emergency changed the clinical practice and aroused interest especially in oncology, where the evaluation of the relationship between benefits and risks associated with therapies has required greater attention because they are life-saving therapies that cause immunosuppression in patients for which the adverse course of viral infection is more frequent than that of the non-neoplastic population.
The possibility of using the modified therapy schemes has been limited only to the emergency period and has not yet resulted in an extension of the indications. The achievement of the therapeutic objective, together with the feedback that the new dosages have not led to a significant increase in adverse events compared to normal clinical practice, encourage us to hope that the indications can be extended in Italy, as has already happened in Canada and USA for the Nivolumab.

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