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Added value of centralised compounding of vaccines against SARS-CoV-2 in Hospital Pharmaceutical Services – a quantitative analysis

European Statement

Production and Compounding

Author(s)

Rui Relvas, Rui Pedro Marques, Ana Castro, Sérgio Nobre, João Paulo Lopes da Cruz

Why was it done?

Medicines compounding by the HPS-staff is a primordial activity, and its centralisation allows several benefits in levels such as patient safety, quality, efficiency, and pharmacoeconomics. Despite this recognised importance, it is not always possible to quantify its added value. The fact that vaccines against SARS-CoV-2 are supplied in multi-dose vials and the need to prepare and assure enough doses to vaccinate a broad population presented itself as an excellent opportunity to analyse such indicators.

What was done?

A quantitative analysis of the importance and added value of centralised preparation and compounding of vaccines against SARS-CoV-2 at the Hospital Pharmaceutical Services’ (HPS) Compounding Unit from a Central Hospital in Portugal.

How was it done?

Between 27th December 2020 and 2nd August 2021, 13.030 doses were prepared (96.9% Pfizer/BioNTech; 3.1% AstraZeneca). At the first 3 vaccination sessions, multi-dose vials were diluted at the HPS, and each syringe measured by the nursing-staff previously to the administration.
After these initial sessions, each dose started to be individualised by the HPS-staff on pre-filled, ready-to-use syringes. Each vaccine dose was individualised on a horizontal laminar flow cabinet according to a previously approved operational procedure.
Reception, preparation, and dispensation records were retrospectively analysed. Key performance indicators were quantified.

What has been achieved?

During the first 3 sessions of vaccination, when nursing-staff measured each vaccine volume, a total of 1640 doses were administered. However, it would be possible to measure a total of 1932 doses (84,9%). The daily maximum of people vaccinated was 770.
In the following sessions was possible to prepare 11.390 doses, with a theoretical maximum of 10.892 (104,6%) and a daily maximum of 1.113.
This yield, over 100%, allowed an excess of 498 doses, which translated into the vaccination of 249 extra individuals fully vaccinated with the 2 doses. Factors like needle and syringe selection and preparation beyond an aseptic and validated environment contributed for the yield increase.

What next?

Series-production of compounded medicines in a sterile, validated, and controlled environment allows important benefits and this analysis shows the potentiation of every key performance indicator considered. These data should be considered for the future planning of population-wide activities involving the massive preparation of sterile medicines.

Critical points in the management of intratumoral treatments in oncology clinical trials

European Statement

Clinical Pharmacy Services

Author(s)

Lorena Garcia Basas, Pablo Latorre Garcia, Eugenia Serramontmany Morante, Patricia Garcia Ortega, Pilar Rovira Torres, Laura Maños Pujol, Isabel Cidoncha Muñoz, Maria Queralt Gorgas Torner

Why was it done?

Increasing number of CT with IT, in different pathologies, with different tumor locations, contributes an increase in the complexity of drug compounding and procedures. Their preparation, administration and handling requirements differ from current therapies.

What was done?

Identification of critical points concerning intratumoral treatments (IT) preparation in patients with cancer included in clinical trials (CT).

How was it done?

Ongoing CT with IT in our unit were reviewed to identify critical points regarding prescription and preparation process. 14 trials with IT, 8 (57%) of which have ongoing patients were identified. Two of these trials are “first in human”. The critical points were:

  • Nature of the IT: virus (4, 29%), nanoparticles (3, 21%), ribonucleic acid (2, 14%), cyclic dinucleotides (2, 14%), monosaccharides (1, 7%), phospholipids (1, 7%) and proteins (1,7%).Particularly, virus have special safety measures and transport conditions
  • Dosing units: mcg (4, 29%), plaque-forming unit/mL (PFU/mL)(3, 21%), mL (3, 21%), mg (2 14%), ng (1, 7%), 50% Tissue Culture Infectious Dose (TCID50)(1, 7%).
  •  Prior dilution before filling the syringe: 8 (57%) of our preparations require at least one prior dilution.
  •  Drug volume to prepare according to the tumor size: 8 (57%) IT preparations depend on the tumor size.
  •  Depending on the depth of the target tumor lesion (visceral or superficial), different size of needle is required. This is important because different priming volumes of the needles are necessary.

 

What has been achieved?

The whole information necessary for a complete prescription, validation and correct preparation goes further than information usually needed for current therapies such as chemotherapy. The results of the study of the critical points allow us to elaborate the standardized operational procedures (SOP) for each CT and IT.  These SOPs include the necessary information for a correct preparation for each IT, reducing risk of mistakes and achieving uniformity in the process.

What next?

These types of therapies represent a challenge, and pharmacists have an important role in developing new procedures. Communication between radiology, oncology and pharmacy departments in a multidisciplinary teamwork is essential. This information may be useful to other centers due to the lack of experience and SOPs to work with this type of therapy.

Evaluation of pharmaceutical interventions documented by a pharmacy technician: where do pharmacy technicians have the biggest impact to avoid drug-related problems?

European Statement

Clinical Pharmacy Services

Author(s)

Ruth Borchers, Linda Krampe, Andreas Fischer, Christian Thomas, Holger Knoth

Why was it done?

The aim of this study was to identify the clinical pharmacy services where the integrating of pharmacy technicians have the biggest impact to avoid drug-related problems.

What was done?

In the field of clinical pharmacy services there are activities that are suitable for pharmacy technicians under the supervision of a pharmacist. At the university hospital in Dresden one full-time pharmacist and one half-time pharmacy technician (4h/d) are looking after 80 beds in the department of urology. The main tasks of the pharmacy technician are medication reconciliation as well as clinical prioritisation by using guidelines to identify patients who are at high risk of drug-related problems.

How was it done?

Since 2019 the pharmacy technician is recording the interventions in a categorical excel sheet, there are two documentation weeks per quarter. The categories are drug name, short description of the drug related problem, intervention, classification (dose-related problems, consultation of general practitioner, consultation of patient, electronic prescription, other drug-related problems after discussion with the pharmacist, drug substitution).

What has been achieved?

During 22 documentation weeks from 01/2019 till 09/2020 the pharmacy technician documented 468 interventions. The main interventions are drug substitution on admission considering local guidelines (n=181; 39%), consultation of the general practitioner because of identified discrepancies on the medicine lists (n=138; 29%) and consultation of patients because of identified discrepancies (n=78; 17%). Dose-related interventions and other drug-related problems are detected by the pharmacy technician and discussed with doctors under the supervision of the pharmacist (n=49; 10%).

What next?

Especially in the field of medication reconciliation trained pharmacy technicians can be suitable to prevent drug-related problems. The consultation of general practitioners and patients because of identified discrepancies on the medication lists are time-intensive and probably would not happen in the same way without integration of the pharmacy technician. The drug substitution in consideration of local guidelines and the preparation of the electronic prescription lead to fewer queries from nurses or doctors.
Further research should focus on the quality of pharmaceutical interventions conducted by pharmacy technicians under the supervision of pharmacists.

TELEPHARMACY ANALYTICS AND DATA VISUALIZATION THROUGH BUSINESS INTELLIGENCE

European Statement

Clinical Pharmacy Services

Author(s)

Cristina González Pérez, Laura Llorente Sanz, Ángel Liras Medina, Ana Andrea García Sacristán, María Molinero Muñoz, Lidia Ybañez García, José Alberto Peña Pedrosa, Henar González Luengo, María Luaces Méndez, José Manuel Martínez Sesmero

Why was it done?

Telepharmacy implementation in the context of SARS-CoV-2 pandemic conducted us through the management of a high volume of complex, real-time both clinical and economic data. A multidisciplinary working group (biomedical engineers from the Innovation Unit, clinicians, managers and hospital pharmacists) developed a software tool in April-May 2021.

What was done?

The design of an agile, customizable and dynamic dashboard for the visualization and analysis of Telepharmacy key performance indicators (KPI) through Business Intelligence (BI).

How was it done?

Phases:
1. Situation analysis. KPI definition. Ethics committee approval submission.
2. Extraction and processing of raw databases (Telepharmacy database, outpatient dispensing program, hospital admission database, drug catalog) through data mining.
3. Co-creation of the comprehensive dashboard in PowerBI®, by integrating database sources. Different panels have been designed where filters such as age, time frame, medical service, pathology, etc. can be applied.
• Description of general variables: patients, demography, shipments, time frame, medical department.
• Geolocation of the destinations of the patients’ home delivery.
• Pharmacological profile: top 10 drugs, distribution by active ingredient and drug classification group.
• Relative analysis of the beneficiary patients of Telepharmacy vs global outpatients
4. Pilot project by different types of users (administrative staff, clinicians and managers)
5. Structure design for automatic updating of the panels from the successive updates of the source databases
The quality of the raw databases can be a limitation. It has been necessary to define how to handle missing and duplicate data. Pre-processing, normalization and transformation data processes have been applied too.
Working within the hospital network ensures that there are no security gaps in terms of patient data protection.
For the external use of the dashboard, the granularity of the data is modulated to ensure enough clustering to avoid the identification of individual patients.

What has been achieved?

Processing the huge dataset (more than 2.4 million records) was possible by BI tools that synthesizes data, provides dynamic and engaging visualization (charts and graphs), allows the interactive reports customization for more effective communication of results and apply analysis based on Artificial Intelligence.

What next?

Applying new technologies will help us improve strategic decisions: interactions, behaviors and trends perceiving, weak points identifying, uncertainty reducing and over time monitoring.

EXPERIENCE OF PATISIRAN OPTIMIZATION BUILDING HEALTHCARE TEAM

European Statement

Clinical Pharmacy Services

Author(s)

CRISTINA GONZALEZ PEREZ, LUCIA GALÁN DAVILA, MARTA ORTIZ PICA, ELENA GARCIA SUAREZ, MARIA MOLINERO MUÑOZ, LIDIA YBAÑEZ GARCIA, NATALIA SANCHE-OCAÑA MARTIN, MARIA DE LA TORRE ORTIZ, JAVIER CORAZON VILLANUEVA, JOSE MANUEL MARTINEZ SESMERO

Why was it done?

Our hospital is a reference in our community for this rare disease. Since patisiran was approved, we have treated 19 patients. Due to the high cost of patisiran and the few patients treated, it is necessary to optimize patient treatments in the most efficient way.

What was done?

Transthyretin (TTR) amyloidosis is a rare disease caused by mutations in the TTR gene. These mutations alter the normal function of TTR protein, creating slowly progressive condition characterized by the buildup of abnormal deposits of amyloid in body’s organs and tissues.
Patisiran is a TTR specific small interfering RNA (siRNA) formulation in lipid nanoparticles, which has been shown to substantially reduce the production of abnormal TTR in patients with hereditary amyloidosis TTR.
With this project we look for achieve the greatest possible savings from patisiran drug without affecting the patient’s efficacy.

How was it done?

We created a working group with neurology department, to define patient’s groups according to:
– Prescribed doses (doses per patient weight; 0.3 mg/kg).
– Preparation’s losses because of the filters
– Losses of the extraction process.
– Other individual conditions as posology or personal preferences.
Patients belonging to the same group have to administrate patisiran the same days.
As the patient’s weight can change along the time, we agree with doctors and nurses to weight the patients every six months to perform doses adjustments. Therefore, every six months we should regroup the patients to optimize the most.

What has been achieved?

These clusters have made possible to reduce wasting vials and therefore to permit significant savings. We estimate around 208.115 € savings/year.

What next?

With this practice we look for a more efficient and sustainable rational health system. The savings achieved can be used to treat other patients or promote new investigations. Also, it makes possible a better healthcare team performance, working together for a better attention, health quality, security, and treatments efficiency. Monitoring weights to adjust doses and closer follow-up of patients by the different members of the multidisciplinary team are examples of the achievements.

Preparing for disaster – ensuring and optimizing the supply of medicines to a regional acute Hospital in the event of a major accident

European Statement

Patient Safety and Quality Assurance

Author(s)

Fabrizia Negrini, Giorgia Vella

Why was it done?

The aims of this project were firstly to optimize the content of the stock (choice of medicines and quantity) so that it is suitable for various potential events of different nature that may occur in the region. The second aim was to optimize the management processes in order to reduce costs.

What was done?

To manage extraordinary events (short-lasting phenomenon without contamination) in a region with 1.5 million inhabitants, the hospital pharmacy, in collaboration with a major acute Hospital, manages a designated stock containing medication that may be required during unplanned emergencies.

How was it done?

To achieve these two aims, the first step was to define which major events are possible and most likely to occur in the region. To do this we utilized a risk-based analysis of all disasters and emergencies relevant in the area that was performed by an external company that specializes in developing risk management projects in the context of civil protection1. Based on the identified events, we determined which types of injuries were more likely to occur. The medicine stock was subsequently updated and a process for minimizing the management cost was defined.

What has been achieved?

The hazards that were identified as being of particular importance for the analyzed region are likely to mainly result in blunt, perforating, and burn injuries. In collaboration with the Hospital, a list of 61 different medicines used to treat these types of injuries was established. In order to reduce costs, only drugs which were part of the main stock of the pharmacy were chosen. In this way, it is possible to exchange products with a longer shelf life from the main stock 6 months before expiring and use them without having to discard them.

What next?

In case of extraordinary events in a restricted region, the major acute hospital has an increased need for certain medicines. It is task of the hospital pharmacy to always be ready to supply them with such medicines. This is only possible if the probable emergency scenarios are well understood, and the stock and management processes are well-defined and communicated at all levels.

New frontiers of hospital pharmacy: management and preparation of human tissues used in the surgery room

European Statement

Clinical Pharmacy Services

Author(s)

Andrea Ossato, Giuseppe Giovagnoni, Michele Giannini, Anna Francesca Spada, Francesca Realdon, Valeria Mezzadrelli, Lorenza Cipriano, Nicola Realdon, Teresa Zuppini, Roberto Tessari

Why was it done?

Since 1st October 2019, the regional tissue bank that supplies hospital, stopped sending ready-made tissue to the implant, preferring the shipment of tissues frozen at -80°C. For this reason, the hospital pharmacy developed a procedure for the management of orthopedic allografts ensuring a clear and safe supply chain reducing the waste raised from the obligation of immediate use of the thawed tissue.

What was done?

Hospital pharmacists, in agreement with the hospital administrators and the orthopedic surgery department, developed a new service characterized by procurement, processing, preservation, storage, thawing and preparation of human tissues and cells for orthopedic allografts, according to European and national legislation.

How was it done?

The management of orthopedic allografts took place as follows: was established a dedicated path for communications with orthopedic surgery and bank tissue; tissue thawing and washing was centralized in the clean-room of the hospital pharmacy and were guarantee adequate training of all personnel involved as well as complete standard operating procedure documentation for all stages of the process and appropriate control measures.

What has been achieved?

Evaluation of the process showed that it was favourable in terms of practicality, safety, traceability and cost saving. Especially, the centralization of tissue preparation within clean‐rooms with aseptic technique, allows microbiologically safer setups reducing clinical risk. A further guarantee of safety is given by the sterility process’s validation through Media Fill test. This organisation allowed us to reduce the waste through a more effectively management of the tissues shelf life and any missed surgery with a cost saving and an ethical behaviour.

What next?

Optimise patient outcomes through working collaboratively within multidisciplinary teams and using the limited health systems resources responsibly, are two main goals expressed by the last European Statements of Hospital Pharmacy (ESHP). This study demonstrated how the centralization of tissues management in the hospital pharmacy make the process more efficient and safer and thus comply with the ESHP’s goals; leading to a clinical advantage for patients and better economic impact for the hospital.

The role of pharmacists at a temporary COVID-19 hospital

European Statement

Selection, Procurement and Distribution

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.

Drone delivery of prescription medicines: contact-free, direct-to-consumer shipment reduces risk of Covid-19 infection for vulnerable populations

European Statement

Patient Safety and Quality Assurance

Author(s)

Jon Michaeli, Bryan Li

Why was it done?

The novel delivery method provides an on-demand option for senior citizens at higher risk of serious Covid-19 infections to receive health essentials while maintaining social distancing. The program launched before Covid-19 vaccines were publicly available, and was sustained during a period of especially intense Covid-19 spread in the US from Nov 2020 – Jan 2021.

What was done?

In early May 2020, Matternet, CVS, and UPS launched direct-to-consumer drone delivery of prescription medicines and other health goods to The Villages, the United States’s largest retirement community with more than 135,000 residents. The operations have expanded in scope since and are ongoing

How was it done?

The drone flights were conducted by Matternet’s M2V9 UAV platform and drew upon the companies’ experience operating other US healthcare drone networks. Deliveries are dispatched from CVS store 8381 and flown to New Covenant United Methodist Church, with final delivery to front porches via golf cart. This is an important milestone on the journey to drone delivery to individual homes at scale.

What has been achieved?

Matternet and UPS have completed 2,500+ deliveries to date. The partnership has expanded operations to Elan Buena Vista, another retirement community nearby. The program’s success helped pave the way for other healthcare drone programs, including a new route at Wake Forest Baptist where Matternet and UPS are transporting Pfizer-BioNTech Covid-19 vaccines (first ever in the US).

What next?

Full automation achieved via Matternet’s proprietary drone port, the “Station,” will permit pharmaceutical drone delivery at scale and accelerate the roll-out of city-wide networks that give pharmacists more flexibility around where and how patients receive medicines. These networks will support and accelerate the shift to tele-health and “hospital at home” as well as just-in-time inventory management, with significant potential to reduce medical waste through stock centralization. First commercial deployment of the Station occurred in Lugano, Switzerland in September 2021. The same month, Matternet announced a partnership with the Abu Dhabi Department of Health and the UAE’s General Civil Aviation Authority to launch a city-wide medical network serving 40+ locations by 2023. Similar systems are planned for Europe, in cities such as Zurich, Berlin and Athens.

Implementation of a β-lactam Continuous Infusion Protocol in a Coronary Care Unit

European Statement

Clinical Pharmacy Services

Author(s)

Catarina Oliveira, Ana Mirco, Fátima Falcão

Why was it done?

-lactams have proven to be effective and safe antibiotics over their history, and as a consequence, these drugs are typically among the most frequently prescribed in hospital settings. Optimization of treatment with β-lactams can be achieved by their administration by continuous infusion. Furthermore, this approach leads to a reduction of the nursing time devoted to preparation and administration. However, information regarding continuous infusion of β-lactams is not readily available for most antibiotics, leading to doubts about dosing, renal adjustments and administration, particularly uncertainties related to dilution of the antibiotics as most patients benefit from fluid restriction. Also, it was indispensable to understand which antibiotics had stability to be administered through continuous infusion.

What was done?

A protocol for continuous infusion of β-lactams was established in a coronary care unit (CCU), replacing the previous method of intermittent dosing in most patients.

How was it done?

Firstly, we evaluated which antibiotics benefited from this approach and had, simultaneously, stability. The antibiotics selected were Cefotaxime, Ceftazidime, Cefepime, Cefuroxime, Piperacillin/tazobactam, Penicillin G, Ampicillin and Flucloxacillin. In order to stablish a protocol for continuous infusion of these antibiotics, an extensive literature review was performed. Information about loading and maintenance dose, reconstitution, dilution (solvent and maximum concentration), infusion rate, renal adjustments, stability and storage was collected and summarized in a table.

What has been achieved?

A ready-to-use version of the β-lactams continuous infusion protocol was developed. In addition, dosing adjustments in patients on continuous renal replacement therapy, commonly made in patients in the CCU, were included too. This protocol was made available to all health professionals through the hospital’s intranet as well as posted in the CCU in order to be easily accessible by doctors and nurses. Thus, continuous infusion is now the standard for most patients requiring therapy with β-lactams in the CCU.

What next?

The implementation of this protocol has an education purpose, allowing the best use of documented practices in prescribing, medication review and administration continuous infusion of β-lactams. This protocol can similarly be easily implemented in other medical units. In the near future, we plan to monitor the compliance to the protocol and consider further improvements if necessary.