Why was it done?

Expenditure on medicines is increasing, mainly due to the availability of expensive, innovative medicines. The admission process for expensive medicines to the Dutch market is complicated and available medicines are not always (fully) reimbursed.
At the Martini Hospital, many different parties were involved in the expensive medicines file. However, mutual coordination was limited and there was a lack of direction, monitoring and feedback of information to the prescribers.

What was done?

In collaboration with all parties involved, the process for expensive medicines has been redesigned, from application to monitoring and feedback of information to the prescribers. Responsibilities for parts of the process have been explicitly assigned and a hospital pharmacist is in charge of the process.

How was it done?

Various sub-processes have been defined: contracting, prescription and distribution, screening for new substances/indications, financial handling and monitoring. Tasks and responsibilities have been identified for each process and it has been determined how monitoring takes place.
A digital procedure for applying for new expensive medicines or indications, compassionate use programs and authorizations for individual patients has been developed.
Specific reports have been developed for each group of prescribers and are sent periodically. These reports include, for example, compliance with agreements made about preferred substances, conversion to biosimilars, and correct completion of indication codes (which are required for reimbursement).

What has been achieved?

A clear method for requesting new expensive medicines or indications has been implemented. The average processing time for a new application has decreased significantly (exact figures will be available during the EAHP 2025)
All information regarding reimbursement of expensive medicines is centrally available and transparent to all parties involved.
Physicians’ awareness and knowledge of expensive medicines has increased, and this is reflected in their prescribing behavior.
The amount of unreimbursed medicine costs has been substantially reduced (exact figures will be available during the EAHP 2025)

What next?

Continuous evaluation of the process and further development of the reports to the prescribers.

Author(s)

Morati S 1 , Martignoni I 2, Grotto A 2, Filosofo M 3, Gambera M 2
1. University of Padova – School of Pharmacy
2. P. Pederzoli Hospital – Pharmacy Service
3. University of Milan – Specialization School in Hospital Pharmacy

Why was it done?

It is generally aknowledged that the albumin, as a medication, is overused. As it is also a limited resource, the role of the pharmacist is crucial to guarantee the appropriateness of the prescription and to prevent the use outside the indications approved by AIFA.

What was done?

The aim of the project was to promote the correct use of albumin administered to patients admitted to an Italian hospital and to verify the clinical effectiveness of its administration for therapeutic purposes. The aim should have been reached by the intervention of the hospital pharmacist who evaluated every single hospital department request form of albumin and, in case of doubt, called by phone clinicians.

How was it done?

The pharmacist’s intervention took place between 1 July 2022 and 1 July 2023. Once the albumina request form had been validated by the pharmacist, the vials were delivered and registered in the warehouse application and the excel sheet was updated with the patient’s blood values before and after albumin administration . The final step was to analyse the trends of patients’ blood albumin parameters.

What has been achieved?

373 albumin request forms with 20 different indications were received by the hospital pharmacy. In particular 78 for ‘major surgery’, 65 for ‘large volume paracentesis’, 43 for ‘protein dispersing enteropathies’, 79 for ‘other’.
Extrapolation of consumption showed that, following the pharmacist’s intervention, the use of albumin decreased to 3928 vials delivered compared to the same period in the previous year (1 July 2021 – 1 July 2022) when 14517 vials were delivered. From an economic perspective: the expense of albumina was as follows: €284,553.00 in 2021-22 and €76,998.00 in 2022-23.
The evaluation of the trend of the blood values after albumina administration showed that, if the treatment was appropriate, patients achieved positive results with a return to albumin values of 2.5 g/dl.

What next?

Our results show that a dialogue between hospital pharmacists and physicians, and a high focus on the use of albumin, can lead to more appropriate and effective use of albumin and significant cost savings. We would try the same approach to the use of immunoglobulines, blood derivatives with the same concerns (iperutilization, limited resource, high cost) of albumin.

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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.

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Author(s)

Erica Cusumano, Giorgia Nairi, Cristina Baiamonte, Chiara Schimmenti, Lo Verso Clelia, Carolina Scaccianoce, Marcello Vitaliti, Sceila Affronti, Marco Benanti, Paolo Amari, Patrizia Marrone

Why was it done?

Until 2020, pavilizumab, refunded by National Health System for Respiratory Sincytial Virus (RSV) infection prophylaxis of paediatric patient at risk, was dispensed in 50 mg (FL 50) and/or 100 mg (FL 100) unit packs, regardless of the prescribed dose, with subsequent preparation on the ward and waste of any residual drug. Therefore, the project’s purpose, from November 2021, was to overcome the past distributive criticalities of pavilizumab.

What was done?

In our Hospital, Early Start 2.0 project (E.S-2.0) was implemented in collaboration with the neonatal intensive care unit. The E.S-2.0 purpose was to increase quality and safety of Pavilizumab galenic preparation to guarantee the patient’s health and generate an economic saving with an optimisation of hospital resources.

How was it done?

The E.S.-2.0 involved weekly drug days for the delivery to department staff of personalised galenic preparations of pavilizumab, prepared by hospital pharmacy service in a contamination-controlled environment. Through the hospital management system, prescriptions for the period November 2021 to April 2022 were extrapolated to verify the validity of the project. There were 85 patients. A palivizumab consumption database was created to evaluate the mg saved after E.S.-2.0 and the related economic savings.

What has been achieved?

Project implementation allowed us to obtain an economic saving of 9.33% related to 2339.01 mg that would have been dispensed and wasted without E.S-2.0. The results obtained considering the costs of pavilizumab (FL-50: 10.79 €/mg and FL-100: 8.96 €/mg) and our saving indicators: mg saved= mg that would have been delivered before E.S-2.0 – mg after E.S-2.0; € saved = (mg residues that would have been dispensed and wasted before E.S-2.0 from FL 100 x 8.96 €/mg) + (mg residues that would have been dispensed and wasted before E.S-2.0 from 50 x 10.79 €/mg). In addition, the personalised galenic preparations in controlled contamination pharmacy premises guaranteed a sterile pharmacological manipulation process.

What next?

E.S.-2.0 represents a cost saving policy safeguarding patient security. Practice described is worthy of implementation in hospitals not just for prophylaxis of RVS infection but also for the management of all patients undergoing treatment with therapies that can be prepared in galenical laboratory.

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Author(s)

Giorgia Babaglioni, Lorenzo Silva, Elena Festa, Daniela Paganotti, Tullio Elia Testa

Why was it done?

In Italy, the rising PDMPs demand had to face the international shortage caused by the SARS-CoV-2 pandemic outbreak. The self-sufficiency level of albumin represents one of the National Blood Centre (NBC) main challenge, in view of the health system sustainability.

What was done?

The hospital pharmacy of a northern Italy centre, in accordance with the Good Use of Blood Committee, introduced a nominal form for human albumin (HA) requests to evaluate and rationalise the HA clinical-therapeutic demand. It represents a pharmacist led intervention approach shared by physicians, in favour of an economically sustainable healthcare contrasting the lack of plasma-derived medicinal products (PDMPs).

How was it done?

Prescription criteria were updated according to the most recent guidelines. The cut-off of blood albumin level above 2.5 g/dl has been introduced as eligibility threshold value and for the daily dose calculation, except for HA calculation based on volumes for plasmapheresis and large volume evacuative paracentesis in hepatic cirrhosis. The pharmacy provides a maximum of five days therapy, then a new revaluation and updating of blood albuminemia was required; 690 total requests were analyzed.

What has been achieved?

In March 2023, HA consumption was 61400 gr, collapsed by 75% in April and then settled at – 58% in May and June. The most important reductions in monthly requirements affected the surgical (- 75%), intensive (- 62%), internist (- 64%) and gastro-hepatological (- 52%) areas. 97,5% of requests were on-label: 20% for plasmapheresis or paracentesis, 21% for liver failure, 16% for cirrhosis of the liver with refractory ascites. 26% of requests (n = 180) reported in-range blood albumin value, while the 14% was unknown or ongoing because administered in emergency phase. 37% of requests has been evaded even if the blood albumin was > 2,5 g/dl due to mandatory clinical need. Thanks to the new prescription model it was possible to save € 91 752 in the second quarter.

What next?

The introduction of the reasoned request allowed to achieve albumin self-sufficiency with voluntary blood donations and reduce the market products purchase. Furthermore, it fostered the clinicians awareness on the HA use appropriateness, considering crystalloids and non-protein colloids as alternative therapeutic strategies as resuscitation fluids.

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Author(s)

Julie Featherstone, Alice Lo, Golnaz Douraghi-Zadeh

Why was it done?

The dashboard was initiated to provide accurate and timely expenditure data to the Medicines Value Team (MVT) which could then be appropriately interrogated and fed back to all relevant Trust and pharmacy staff. The aim was to quickly identify unexpected variance and progress on CIPs that allowed review with clinical and procurement teams.

What was done?

With the informatics team, a dashboard was developed to monitor medicines expenditure and Cost Improvement Plan (CIP) savings on a monthly basis. The dashboard incorporated varying tracking methods to provide timely data on biosimilar switching, contract price changes and individual medicine optimisation schemes at East Kent Hospitals University Foundation Trust (EKHUFT).

How was it done?

The dashboard required many hours working with the informatics team to ensure good understanding of the information required. Different CIPs had to be tracked and reported in different ways. A mixture of reporting and visual styles were needed to represent the data in a user-friendly way. It was recognised that data validation was required to ensure the accuracy of the dashboard, using a variety of recognised resources, e.g. RX Info.

What has been achieved?

A full, multi-tabular dashboard is available on the Trust Information Portal. Tracked expenditure data is reported monthly by the MVT at pharmacy and Trust meetings. This has enabled realistic and timely data to be included in overall financial forecasting and feedback to clinical teams on their CIPS. The dashboard has been designed to support the rapid addition of new schemes as they are identified to track potential savings and report at the earliest opportunity. The combined use of the dashboard with close MVT oversight has resulted in closer working with clinical and procurement teams. This has led to better identification, tracking and reporting of all medicines saving opportunities in the Trust, saving over £1 million in 2022/23.

What next?

The dashboard will continue to be developed further by the MVT to maximise the capture and reporting of CIPs at EKHUFT. It will also be used to support regular medicines value reviews with senior clinical pharmacists and their teams to help identify future medicines savings opportunities – essential in this challenging financial climate in the National Health Service (NHS).

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Author(s)

Saúl Herrera Carranza, Carlos Sanz Sánchez, Sira Sanz Márquez, José Francisco Valverde Cánovas, Leonor Moreno Núñez, Ana Vegas Serrano, Rafael Hervás Gómez, Oriol Martín Segarra, Juan Emilio Losa García, Montserrat Pérez Encinas

Why was it done?

Spanish Society of Hospital Pharmacy(SEFH) proposed 13 indicators(bibliography:Gutiérrez-Urbón JM, Gil-Navarro MV, Moreno-Ramos F, Núñez-Núñez M, Paño-Pardo JR, Periáñez-Párraga L. Indicators of the hospital use of antimicrobial agents based on consumption. Farm Hosp. 2019;43(3):94-100) which could help to improve the quality of antimicrobial use.
Indicators are related directly(dir): higher value-better practices; indirectly(ind):lower value-better practices; or heterogeneity: homogeneous percentages(%)-better practices.

What was done?

The creation of a tool for calculating new indicators of antimicrobial agents based on consumption using Defined Daily Dose per 100 hospital stays(DDD/100s).

How was it done?

We built an Excel tool to input required data in order to calculate the indicators with the formulas defined for their automated estimation:
-Overall antibacterial consumption(ind)
-Overall consumption of antifungals(ind)
-Consumption of carbapenemics(ind)
-Consumption of fluoroquinolones(ind)
-Ratio macrolides-p/fluoroquinolones-p(dir)
-Ratio metronidazole-p/piperacillin-tazobactam+carbapenemics(dir)
-Fosfomycin consumption(dir)
-Sequential therapy(dir)
-Ratio anti-SRSA/anti-MRSA agents(dir)
-Ratio amoxicillin/amoxicillin-clavulanic acid(dir)
-Ratio amoxicillin-clavulanic acid/piperacillin-tazobactam(dir)
-Diversification of anti-pseudomonas beta-lactam(heterogeneity): %anti-pseudomonal carbapenemics, %piperacillin-tazobactam and %anti-pseudomonal cephalosporins+aztreonam.
— Ratio fluconazole/equinocandins (dir)
DDD/100s for the years 2018-2022 were calculated in order to see the annual evolution. Required data: antibiotic (ATC Group: J01) and antifungal (ATC Group: J02) consumption by drug and route of administration (oral (o), parenteral (p) and others). Calculation of DDD/100s according to grammes consumed (obtained with Hospital Pharmacy software) and ATC/DDD-Index (World Health Organization). To visually analyse results, graphs were included.

What has been achieved?

We realised that our hospital improved by decreasing consumption of antibacterial, antifungal, carbapenemics and fluoroquinolones; and so, an early parenteral-oral switch.
However, the other ratio-based indicators are stable or worsening yearly: macrolides-p/fluoroquinolones-p, metronidazole-p/piperacillin-tazobactam+carbapenemics, fosfomycin consumption, anti-SRSA/anti-MRSA agents, amoxicillin/amoxicillin-clavulanic acid, amoxicillin-clavulanic acid/piperacillin-tazobactam, fluconazole/equinocandins and diversification of anti-pseudomonas beta-lactam.

What next?

These indicators provide possible improvement actions to enhance the use of antimicrobial agents. Consumption of fosfomycin or amoxicillin/amoxicillin-clavulanic acid ratio should be cautiously analysed due to outpatient (or in emergencies) management of uncomplicated infections. As improvement actions in our hospital, increase the use of metronidazole-p in anaerobic infections or cloxacillin and cefazolin de-escalation can be promoted as soon as sensitivity is confirmed by antibiogram-test. Diversify antibiotic pressure on pseudomonas, trying to reduce piperacillin-tazobactam by prescribing ceftazidime or cefepime, and reserving aztreonam for beta-lactams allergics. Similarly, decrease piperacillin-tazobactam use by prescribing amoxicillin-clavulanic acid if anti-pseudomonal coverage is not necessary.

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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.

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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.

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Author(s)

Dorian Protzenko, Vincent Hoang, Guillaume Hache

Why was it done?

We unveiled during an audit that, in the past 2 years, 19% of our hospital DAOCs prescriptions were underdosed: due to the population profile (old, frail), the conventional bleeding risk scores were consistently high and, as such, not informative. To avoid a hypothetical bleeding risk, physicians were randomly underdosing patients beyond guidelines, without any evidence regarding the efficacy.

What was done?

Using machine learning, we unveiled that underdosing direct oral anticoagulants [DAOCs] to prevent bleeding risk in an old and frail population had no significant impact on drug-related hospitalization [DRH] nor death, and cannot be supported. To help targeting patients for whom extra care would be more beneficial rather than underdosed DAOCs, we built a predictive model of bleeding events and provided risk factors among our population.

How was it done?

We performed a retrospective study, based on data collected during the audit, of patients treated between October 2020 and April 2022 with Apixaban or Rivaroxaban for atrial fibrillation [AF]. Demographic and clinical criterias (i.e., GFR, polypathology, co-medications, prescribed DAOC, respecting dosage and scheduling) were collected. The occurrence of specific outcomes (i.e., bleeding and thrombosis that led to medical care and drug seizure, DRH and death) were retrieved from the patients’ medical records. Machine learning explorations were performed using RStudio®.

What has been achieved?

119 patients were included. We modeled using logistic regression the impact on selected outcomes of underdosing DAOCs. We found out that underdosed DAOCs were associated with a lower bleeding risk (OR=0.30, CI95%[0.07;0.95]), a higher thrombosis risk (OR=6.67, CI95%[1.23;50.0]), but without any impact on DRH nor death. Unsupervised algorithms unveiled that DAOC choice (Rivaroxaban: OR=2.80, CI95%[1.15;7.13]), sex (Male: OR=0.44, IC95%[0.16;1.12]) and using dosages from guidelines (OR=3.32, CI95% [1.05;14.80]) were predominant explanatory variables regarding bleeding risk. The choice of DAOC was the only covariate that impacted DRH (Rivaroxaban: OR=2.78, CI95%[1.22;6.56]). Finally, using a gradient-boosting algorithm, bleeding risk was predicted with a 0.73 roc-auc, superior to conventional models.

What next?

Therapeutic education of patients and caregivers, telephone follow-up or pharmaceutical consultations will be implanted for patients at high bleeding risk. An audit will be performed next year to measure underdosed prescriptions rate, and improve the model with new data.