Author(s)

LEONOR GOMEZ-SAYAGO, INMACULADA LOMARES MANZANO, LUCIA JIMENEZ PICHARDO

Why was it done?

Biosimilar medicines have demonstrated their bioequivalence with the original biologic and there is ample scientific evidence to support this.
Our Hospital had a degree of implementation of biosimilars of 8,16% (the lowest in its autonomous community), so it was decided to develop an intervention plan to increase the use of biosimilars and improve this indicator.

What was done?

Develop a plan to increase the use of biosimilar medicines in a tertiary hospital.

How was it done?

It was decided to intervene on these drugs that had commercialized biosimilar drugs: etanercept, adalimumab, trastuzumab, bevacizumab, enoxaparin, epoetin. For the introduction of biosimilars of etanercept and adalimumab, the medical records of all patients with these prescriptions were reviewed and all those that were prescribed by active ingredient and not by brand-name drug, were changed to a biosimilar medication after consensus with the patients. For the new prescriptions of these drugs and of enoxaparin, trastuzumab, and bevacizumab, a document was prepared supported by the medical direction of our Hospital that would start with biosimilar molecules. Regarding epoetin, in our hospital we had epoetin beta that does not have a biosimilar, so it was decided, agreeing with oncology and hematology and based on the evidence, to change the molecule to epoetin alfa with its biosimilar medicine.
The degree of introduction of biosimilars was measured with the formula: nº Definid daily dose of biosimilar drugs dispensed/nº Definid daily dose of biosimilar drugs dispensed+Definid daily dose of the original biologic *100.

What has been achieved?

Before the implementation of the protocol for the introduction of biosimilars, the degree of introduction was 8,16%, 3 months after implementation the result had reached 21,10% and at 6 months it was 30%. This represents an economic impact of 286.295,53 € per year in savings.

What next?

The implementation of protocols agreed with the prescribers for the introduction of biosimilars should be a common practice of the hospital pharmacists to contribute to the sustainability of the health system.

Author(s)

Louise Refsgaard, Linda Skovsted, Nina Bøggild

Why was it done?

The medical supply vending machines were implemented during 2021 as a way of direct-to-patient distribution of medicine with more flexibility. The aim was to offer 24-hour access to collect medicine at a location that suits the patient, e.g. close to the patient’s home.

What was done?

Medical supply vending machines were implemented in the Capital Region of Denmark. The vending machines allow patients to collect their medicine whenever and wherever it suits them. It is the patient’s healthcare professional that controls and orders the medicine. The hospital pharmacy staff consults the prescription and labels, dispenses and records the medicine and places it in the vending machine for collection.
Patient and staff satisfaction was surveyed.

How was it done?

The implementation of this new direct-to-patient distribution method was carried out by the Capital Region Hospital Pharmacy in close collaboration with the region’s hospitals and outpatient departments. Installing the machines was fast but a full implementation requires that the clinical staff rethink their practice and accept that dispensing is no longer their responsibility. This has been the biggest obstacle along with creating patient safe procedures.

What has been achieved?

7 medical supply vending machines were installed centrally in hospitals in the Capital Region of Denmark. The machines are now used to distribute medicine to some of the region’s outpatients.
The patient satisfaction survey showed that the patients are very satisfied with the vending machines: 100 % are either ‘highly satisfied’ (86 %) or ‘satisfied’ (14 %) with the new service, and 97 % would like to use it again. The staff was also satisfied with the new service.
Additionally, the quality of medicine dispensing is increased due to hospital pharmacy staff dispensing the medicine rather than nurses.

What next?

In order to offer flexibility to patients and increase the quality of dispensing of medicine, we aim to increase the number of patients that collect their medicine from the vending machines by using the current machines in their full capacity and installing more machines. We also aim to collaborate with Denmark’s other 4 regions, so that patients, who are treated outside their home region, can collect their medicine in a vending machine closer to their home.

Pdf

Author(s)

BERTA MONTERO-PASTOR, ELSA IZQUIERDO-GARCÍA, LORENA DE AGUSTÍN SIERRA, ISMAEL ESCOBAR RODRIGUEZ

Why was it done?

The unprecedented mass COVID-19 vaccination has highlighted the need to develop strategies that prioritize and optimize the use of resources. Strategies have been established at the national and community levels, however, each center must implement its own plan according to needs and capabilities for its target population.

What was done?

A Pharmacy Department (PD) vaccination plan including strategies to optimize human and material resources available to deal with mass COVID-19 vaccination.

How was it done?

In plan development, we considered the type of vaccines, storage requirements, the need for specific equipment and workflows, limited vaccine vial supply, and aspects related to staff in the PD.
A standard operating procedure (SOP) was developed for logistic management of vaccine orders, including an SOP for nursing staff if the shipment arrived outside the PD schedule.
For storage, specific space was provided considering the different storage requirements.
The doses corresponding to the vaccination of health professionals and patients from group 7 of the national vaccination strategy (onco-hematologic patients with active treatment, hemodialysis patients, primary immunodeficiencies, HIV -CD4<200cel/ml, Down Syndrome ≥40 years) were prepared centrally in the PD. For the general population, a centralized preparation in PD is not feasible. So, alternatively, PD developed a dispensing circuit and informative material for nursing staff for the correct dosage and traceability of vial batches. In all stages, the use of vials was optimized with strategies such as the selection of adequate packaging material, the grouping of patients, or the exchange of vials between vaccination centers.

What has been achieved?

We received 16230 vaccine vials from four different commercial brands. There have been no incidents related to the receipt and storage of vaccines.
A total of 9753 doses were made. In the whole elaboration process, we only wasted a vial on one occasion and a dose on another.
We dispensed 11911 vaccine vials to the general population. Of these, 13 vials were discarded due to errors in the preparation.

What next?

The development of a specific plan has made it possible to optimize the COVID-19 vaccination process in our hospital. The plan will be adapted and updated according to the updates of the national and community vaccination strategies.

Author(s)

Francesco Falbo, Oscar Martinazzoli, Agnese Bruni, Rosanna Lettieri, Simona Polito, Luisa Zampogna, Valentina Marini, Michela Mazzucchelli, Marcello Sottocorno

Why was it done?

The involvement of the pharmacist featured:
– Drug supply and storage
– Medical devices (MD) and personal protective equipment supply
– The creation of a catalog of required drugs
– Medication supply chain management and dispensing
– Management of medical gases
– Evaluation of the effectiveness and safety of drug therapy.

What was done?

As the COVID-19 epidemic spread, temporary critical care hospitals have been opened in order to attend the incoming burden of infected patients. In April 2020, one of the largest ever temporary healthcare structure was created in only 10 days. The ark hospital was opened for nearly 10 months and hospital pharmacists supported the effort for the pharmacy management.

How was it done?

The development of a catalog of required drugs has been accomplished using the consumption analysis on drugs and MD in March 2020 of the permanent hospital Covid unit. Thus, we created a dynamic catalog – constantly updated – consisting of 530 drugs and 345 medical devices. The medical staff members of the temporary hospital filled a special form for extra-catalog material. Running a cost-effectiveness analysis, the pharmacist managed to evaluate the purchase, rather than recommend a valid alternative from the material on the catalog.
The pharmacy warehouse was planned by dividing the MDs categories. Likewise, the drugs were stored according to their pharmaceutical form and their alphabetical order.

What has been achieved?

The materials requirements planning was achieved in 15 days, including medical supply ordering and the pharmacy warehouse organization. Pharmacists ensured the optimization of resources, the availability, safety and optimal use of medicines and MDs, as well as the monitoring of the adverse drug reactions (ADR). Hence, all patients received the appropriate pharmacotherapy. The pharmacist played a key role in the good functioning of the ark hospital in collaboration with all the medical team.

What next?

In conclusion, a new protocol and standard of care for managing health emergency will be the following and challenging step.

Author(s)

Alina Shramko, Veronika Haziahmetova

Why was it done?

Based on the results of the analysis, it is possible to answer the question whether it is advisable to spend financial resources, using the example of one healthcare facility; what steps should be taken to rationalize drug procurement; which drugs should be considered first of all for inclusion/exclusion from the procurement list.

What was done?

Currently, ABC/VEN analysis is one of the most effective pharmacoeconomical methods recommended by WHO for the use in the healthcare system. The use of pharmacoeconomic methods is carried out in accordance with the inherent effective use of drugs, and is carried out strictly in accordance with the principles of evidence-based medicine.

How was it done?

The ABC/VEN analysis was conducted based on data from the pharmacy of the LPI containing the costs of purchasing medicines during 2020. The VEN category was determined after a thorough review of the evidence available to us about the effectiveness, safety and cost of drugs.

What has been achieved?

The cost of drug provision to healthcare facilities in 2020 amounted to 62 943 951,38 rubles. The number of international generic name purchased and used was 355. About 35% of the funds were used for a group of vital medicines. The cost of the necessary medicines amounted to 43% of the funds – this corresponds to WHO recommendations.
In accordance with the ATX-classification, drugs affecting blood formation and blood are in the lead in terms of the volume of costs – 40.9% of all costs.
The drug is enoxaparin sodium, the leader in terms of costs in 2020. It is a direct anticoagulant (low molecular weight heparins with a molecular weight about 4500 daltons), which has an antithrombotic effect (2.38% of the total budget).
Also, the top ten leaders in terms of costs included saline sodium chloride solution – 6.1% of the annual budget, which probably indicates irrational excessive use of infusion therapy.

What next?

The application of pharmacoeconomical methods and principles of evidence-based medicine allowed us to assess the feasibility of drug procurement and serves to rationalize the use of medicines.

Author(s)

Francisco José Toja Camba, Carmen Lopez Doldan, Laura Casado Vazquez, Aron Misa García, Pilar Rodriguez Rodriguez, Maria Elena Gonzalez Pereira

Why was it done?

Hospital Pharmacy must develop new models of pharmaceutical care (PC), improving patients quality of life and enhancing care services. One type of these strategies are non face-to-face PC, such as telepharmacy and home delivery, achieving a new integrated and patient-centered healthcare model.
COVID-19 health crisis and the need to ensure the delivery of medicines to susceptible people and guarantee home isolation, has motivated a paradigm shift in health care.

What was done?

• Guarantee quality of care in pharmacy consultations (PCC) due to COVID-19 pandemic.
• Implantation of telepharmacy and home delivery of hospital medication.

How was it done?

Three different circuits were designed:
1. Single healthcare act of face-to-face visits in PCC coinciding with other medical appointments. Prior appointment, non-contact consultation agendas and extension of service hours were reinforced.
2. Informed home delivery of hospital medication at home, after prior teleconsultation: pharmacotherapeutic follow-up and request for informed consent. Management and preparation of packages, including motivational messages, to humanize the process. Distribution logistics model based on defined routes and schedules. The confidentiality, security and traceability of the entire process was certified.
3. Open and permanent communication channel between patient and pharmacist that enabled individualized PC.
Patients with mobility problems, home isolation or chronic processes with a higher risk of COVID-19 infection were prioritized.

What has been achieved?

From March to May 2020, 1,938 pharmacotherapeutic follow-up teleconsultations were carried out (291 patients had been attended in person due to having another medical appointment or due to personal preferences). Medication was home delivered to a total of 1,647 patients. A total of 120 routes were made between the four established routes (average of 15 shipments per working day). Percentage of satisfaction expressed by the patients was 95%.

Main limitations were:
1. Operational challenge: changes in workflows, organization of schedules and work times, increase in telephone lines, route management in a very dispersed geographic area, technology gap (mean age ≥ 60 years) …
2. Human resources.
3. Medication shipping cost.

What next?

• Development of new management tools: telepharmacy and home delivery and pharmacotherapeutic follow-up of patients guarantee continuity of non-face-to-face PC.
• We must support initiatives that certify efficient and safe care as well as humanitarian care.

Author(s)

Marie O Halloran, Siobhán Nestor

Why was it done?

This project was undertaken in reaction to an evolving healthcare environment. It was important to identify patterns to improve the efficiency of the purchasing and dispensing process, and to ensure that PN levels held in the Pharmacy Department respond to requested use within the hospital. The aim was to reduce the amount of PN bags expiring with associated cost savings and waste avoidance.

What was done?

The Pharmacy Department is responsible for dispensing Parenteral Nutrition (PN) in the Mater Misericordiae University Hospital (MMUH). PN is purchased from a third party manufacturer. On receipt by the hospital, the standard PN bag has an expiry date of approximately 60 days. Given the need for rapid turnover of PN to avoid expiration and wastage, coupled with the rapidly changing healthcare landscape, the pharmacy instigated a review of the factors contributing to PN waste and opportunities to improve and optimise the associated processes.

How was it done?

• PN Stock Holding Review
Due to surgery volumes and the complexity of the patient cohort in MMUH, the Pharmacy Department are required to hold a stock of PN bags for patients to access in a timely manner. The agreed levels of stock held was identified as a key target to reduce waste. The quantity of each stock bag held was reviewed between Pharmacy and Clinical Dietetics utilising recent usage pattern reports. This resulted in removing certain bags from MMUH stock entirely and reducing the stock quantity of slow-moving bags.
• Improved communication to dietitians
A standard email template was devised to send to all stakeholders, by a Dispensary Pharmacist, detailing the stock of each bag on hand and highlighting bags which would expire in the following two weeks. The Dietitians endeavour to utilise this short-dated stock for suitable patients to avoid waste.

What has been achieved?

Through the improvement initiatives outlined above, PN waste reduced by 74% (117 bags versus 31 bags) in Q1-Q3 2021, compared to the same period in 2020. This resulted in a considerable associated cost saving.

What next?

We will continue our collaborative work with Clinical Dietetics to further reduce PN waste. We now have a dynamic stock management process, which responds to the changing patient cohort in MMUH.

Author(s)

Mª Ángeles Parro Martín, Beatriz Montero Llorente, Teresa Gramage Caro, Manuel Vélez Díaz-Pallarés, Miguel Ángel Rodríguez Sagrado, Hilario Martínez Barros, Ana María Álvarez Díaz

Why was it done?

To ensure continuity of treatment and pharmacotherapeutic follow-up in patients vulnerable to SARS-CoV-2 infection included in a home delivery and telepharmacy program.

What was done?

Implementation and adaptation of home delivery and telepharmacy during the first year of the COVID-19 pandemic.

How was it done?

A work procedure was designed to detail the new functions to be performed by administrative assistants (AA), pharmacy technicians (PT) and pharmacists (PH). A first procedure was designed, which was adapted and improved after 6 months of experience, giving rise to procedure 2.

Procedure 1

– AA phone call to patients scheduled to obtain consent for home delivery and confirm delivery data.
– The PH grouped patients who had confirmed home delivery in the appointment manager.
– The PH reviewed the electronic prescription of all patients and performed telepharmacy to those who were due and/or had incidents.
– The PT prepared the packages.

Procedure 2

Phase 1

– The AA called all patients scheduled until the end of the year to offer them the option of remaining in the home delivery and telepharmacy program permanently. If they accepted, their consent and delivery data were recorded. From this point on, the call to offer home delivery and telepharmacy was discontinued; it was only offered to patients when they attended in person.
– A specific diary for home delivery patients was created.
– The telepharmacytelepharmacy was added to the PH diary.

Phase 2

– Trained PT in home delivery incident resolution (address changes, absent patients, package rejection) to reduce FAR’s working hours.

Phase 3

– Development of a computer application: computerization of manual processes (labels, identification of refrigerated shipments, SMS delivery confirmation sent to patients, and request for appointment changes).

What has been achieved?

31,066 home delivery have been performed on 7,170 different patients. 7,443 telepharmacy consultations have been performed.

PT training and computer development has reduced the PH dedication from 7 hours to 3 hours.

What next?

Establish criteria for prioritization of patients who are candidates for home delivery and telepharmacy.
Implementation of video call instead of telepharmacy

Author(s)

Liselotte Kamper

Why was it done?

To ensure optimal price negotiations and tenders based on an up-to-date product overview including both pharmaceutical, therapeutic, and commercial knowledge.

What was done?

Team Horizon Scanning (HS) in Amgros has developed a comprehensive report covering all important information for a new medicine about to be marketed within the EU – an Extended Product Overview (EPO).

How was it done?

Following every meeting in the Committee for Medicines for Human Use (CHMP) at the European Medicines Agency (EMA), information on applications for marketing authorisation on new medicines is identified in the agenda and minutes. The following information is compiled:
• Name of the active substance
• (Commercial) name of medicine
• EMA procedure number
• Date of application
• Type of application (Orphan/Accelerated review/PRIME)
• Name of the marketing-authorisation applicant
• Therapeutic indication
The information is supplemented with:
• ATC-code
• Mechanism of action
• Incidence/Prevalence
• Potential impact for the patients and the health care system
• Already approved medicines to treat the same disease

The information is presented and discussed at an internal meeting in Amgros between the HS team and representatives from health economics, tendering and negotiations. At the meeting it is decided for which medicines it is relevant to produce an EPO. The EPO contains the above-mentioned information as well as the following information:
• A description of the disease
• A status of the current standard treatment of the disease
• Information from the clinical studies supporting the indication/application
• Other medicines in pipeline for the same indication, with a status on the timeline for applying for marketing authorization
• Analysis of the market into which the medicine will be launched
The final document is confidential.

What has been achieved?

The EPO-document ensures that Amgros is prepared in the best way in negotiations to agree on a price level that gives a reasonable match between the effect of the medicine and its costs compared with the current standard treatment. Thereby more cost-effective health solutions and possibility to achieve more health for money in the Danish hospital setting can be secured.

What next?

The HS team wish to expand the EPOs to also cover specific therapeutic areas of interest e.g., multiple myeloma and other complexed therapeutic indications.

Author(s)

José Luis Revuelta Herrero, Vicente Escudero, Roberto Collado, Belén Marzal, Ana Herranz, María Sanjurjo

Why was it done?

CAR-T cell-based therapies are advanced therapy medicinal products (ATMP) that are considered as drugs by the European regulatory authorities. ATMPs are usually associated with strong logistic and traceability requirements, serious adverse events and a high budget impact. Hospital pharmacists can help ensure a safe and efficient use of these drugs.

What was done?

A chimeric antigen receptor (CAR) T cell Therapy Committee was created in 2019 and it included members from the hematology, oncology, pediatric onco-hematology, hospital pharmacy, neurology, critical care medicine and immunology departments. An operating procedure defined the specific functions of the pharmacy department in the management of these drugs in the CAR-T cell program.

How was it done?

As some responsibilities might be shared with other professionals, it was key to define everyone’s contributions. In our case, an operating procedure with the responsibilities of the pharmacy department was developed based on the national and regional action plans for ATMPs in the national health system and the risk management plans for each drug. This operating procedure was reviewed and approved by the Committee.

What has been achieved?

The operating procedure was fully implemented and included the participation of hospital pharmacists in the following steps:
• Procurement: the inclusion of a patient in the program is agreed upon the Committee. The pharmacists provide a purchase order when all the requirements are met.
• Leukapheresis and shipment to the manufacturer: the apheresis is included in the computerized physician order entry (CPOE) and it is verified to confirm wash-out periods. Before the shipment, the pharmacists record the apheresis unique identifier and patient data.
• Product receipt: the pharmacists verify at receipt that the patient identity chain and the integrity of the product have been preserved.
• Bridge and lymphodepleting chemotherapy, CAR-T administration: specific protocols have been included in the CPOE. Prescriptions are verified by the pharmacists with special attention to the drug-free periods. After transporting the drug to the clinical unit and preparation, a pharmacy label for dispensing and administration is generated. This label includes a barcode for patient identity verification at bedside.
• Outcomes monitoring and pharmacovigilance: kits are provided to the clinical units for the management of CAR-T associated toxicities. Pharmacists are responsible for the adverse reactions reporting in coordination with clinicians.

What next?

We developed verification lists for each of the previous steps that have already been published (DOI: 10.3389/fonc.2021.636068). More ATMPs are expected to come and their management will require the participation of hospital pharmacists from different areas of expertise (procurement, clinical pharmacy, compounding etc).