A risk-based choice of syringes and associated equipment for compounding and intravitreal administration of drugs for wet age-related macular degeneration
Pdf
European Statement
Production and Compounding
Author(s)
Espen Gleditsch, Dag Fossum
Why was it done?
There are no available syringes with CE approval for intravitreal administration. The CE approval for sterile single use syringes covers dosage and sterility, but not the special needs associated with intravitreal administration. The choice of syringe and associated equipment therefore have to be based on a risk assessment. The intravitreal administration includes increased patient risk regarding sterility (infection), particles (inflammation), injection volume (ocular pressure), silicone oil (floaters in the vision) and technical performance (leakage and compatibility with needle). The aim of this work was to find the syringes, associated equipment and compounding process that present least risk to the patients.
What was done?
Oslo hospital pharmacy delivers ready to use syringes for intravitreal administration of drugs for wet age-related macular degeneration. The pharmacy has in cooperation with the eye department at Oslo university hospital done a risk assessment in 2023 to decide syringes and associated equipment for compounding and administration.
How was it done?
The syringes historically used for intravitreal administration in Norway are Insulin syringes with prefixed needles (BD), Inject F syringes (BBraun) and Zero Residual syringes (SJJ Solutions). The needles used are TSK Low Dead Space needles and Zero Residual needles. The compounding methods are filling of the ready to use syringe from a bulk syringe by a needle or use of a Zero Residual bubble adaptor. All ready to use syringes are compounded in isolators with grade A in the working chamber, delivered with needle or cap, and packed in sterile bags. The risks associated with each syringe, needle and compounding process were assessed with a Failure Mode Effects Analysis Method.
What has been achieved?
The risk assessment shows that the risk to the patients are lowest when administering drugs for wet age-related macular degeneration with Zero Residual syringes and needles, filling the syringes with bubble adaptor and deliver with cap. This will give the lowest risk score regarding sterility, particles, injection volume, silicone oil and technical performance.
What next?
This work is relevant for other pharmacists and prescribing practitioners when assuring that syringes and associated equipment are of appropriate quality and suitable for intended use.
Application of new indicators of antimicrobial agent use based on consumption in a tertiary hospital
Pdf
European Statement
Patient Safety and Quality Assurance
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.
Checklist for optimal pharmaceutical validation in very low-birth-weight preterm newborns in the neonatal intensive care unit
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
IGNASI SACANELLA ANGLÈS, MARTA MARTIN MARQUÉS, JULIA BODEGA AZUARA, PILAR LÓPEZ BROSETA, DAVID PASCUAL CARBONELL, HELENA SUÑER BARRIGA, ALEJANDRO SANJUAN BELDA, CARLA DAIANA CIUCIU, SILVIA CONDE GINER, ERIKA ESTEVE PITARCH, ANTONIO GARCÍA MOLINA, SÒNIA JORNET MONTAÑA, ISABEL PLO SECO, Mª ÁNGELES ROCH VENTURA, MARÍA VUELTA ARCE, LAURA CANADELL VILARRASA
Why was it done?
The NICU is a complex area of paediatric hospitalisation that necessitates specialised healthcare professionals. The role of the NICU pharmacist is vital in ensuring the appropriate and optimised use of medications in various critical situations.
What was done?
To develop a checklist that facilitates pharmacotherapy validation for preterm newborns (PTNB) weighing less than 1000 g and hospitalised in the neonatal intensive care unit (NICU). The primary objective is to ensure a higher quality of hospital care in terms of pharmacotherapy.
How was it done?
We conducted a literature review to identify the pharmacotherapy requirements for preterm newborns (PTNB) weighing less than 1000 g during their first 30 days of life.
In order to design the checklist, we compiled various elements, including drugs, dosages, treatment duration, initiation date, and drug monitoring (when necessary). Additionally, we incorporated recommendations for specific scenarios.
What has been achieved?
The drugs considered for this supportive tool include: pulmonary surfactant, ampicillin, gentamicin, fluconazole, caffeine, ibuprofen, iron (ferrum), dexamethasone, nystatin, vitamin D3, and other vitamins. The checklist was designed to cover the first 30 days of life.
From day 0 to 1: Administer pulmonary surfactant and caffeine citrate. For antibiotic prophylaxis, use ampicillin and gentamicin, and fluconazole for antifungal prevention. In cases of an open ductus arteriosus, intravenous ibuprofen should be added.
Between day 10 to 15: Administer vitamin D3 and a multivitamin complex if the neonate tolerates oral administration. If there is a risk of bronchopulmonary dysplasia, which is characterized by more than 7 days of intubation and difficulty with extubation, consider adding dexamethasone and nystatin.
From day 15 onward: Monitor ferritin and vitamin D3 levels. Begin oral iron supplementation (ferrum) 30 days after birth. Both drugs should be continued for one year.
We have included dose adjustments in case of renal or hepatic dysfunction and pharmacokinetic monitoring for antibiotics. In cases where meningitis is suspected, we have provided recommendations for increasing the dose to ensure adequate penetration into the central nervous system.
What next?
This tool simplifies pharmaceutical validation, particularly for pharmacists who may not specialise in the care of these complex patients. By utilising this tool, we can reduce errors and enhance the quality of care provided to preterm newborns (PTNB) weighing less than 1000 g.
Revolutionising pharmacy recognition: evolution of the Australian and New Zealand College of Advanced Pharmacy
Pdf
European Statement
Education and Research
Author(s)
Tom Simpson, Kristin Michaels, Kylee Hayward, Nick Sharp-Paul
Why was it done?
The need to establish a recognition framework that resonated with pharmacists, aligned with their career journeys, and held tangible benefits prompted the inception of ANZCAP. Recognising that existing programmes lacked broad appeal, ANZCAP aimed to redefine recognition in a way that was meaningful, inclusive, and motivated pharmacists towards continuous development.
What was done?
The Australian and New Zealand College of Advanced Pharmacy (ANZCAP) represents a pioneering advancement in pharmacy recognition and career progression. Addressing the limitations of previous models that struggled to gain broad support, ANZCAP emerged as a strategic response to bridge the recognition gap within the pharmacy profession.
How was it done?
The development of ANZCAP commenced with the acquisition of the Advancing Practice (AP) credentialing programme by the Society of Hospital Pharmacists of Australia (SHPA). Previous efforts to engage pharmacists with the programme were reassessed, and a comprehensive review process was initiated to devise an innovative and pragmatic model of recognition. Development comprised multiple phases, including qualitative surveys, workshops, focus groups, and expert consultations. An iterative approach was adopted to refine the model, culminating in a prospective, merit-based system that recognises specialty areas and levels of practice. The focus shifted from individual competencies to broader domains within the National Competency Standards Framework for Pharmacists in Australia 2016, fostering flexibility and practicality.
What has been achieved?
ANZCAP has already recognised pharmacists at all levels – Resident, Registrar, and Consultant – through a Prior Professional Experience process. The college also extends its reach globally, welcoming international pharmacists to join its transformative community.
What next?
ANZCAP’s future involves strengthening the alignment of recognition with promotion and remuneration mechanisms, enhancing engagement among pharmacists. By seamlessly integrating learning experiences with Continuing Professional Development (CPD) activities, ANZCAP aims to foster a culture of lifelong learning and advancement. In the broader landscape, ANZCAP’s journey involves cultivating partnerships with international pharmacy associations, leveraging collective expertise, and fostering an inclusive recognition culture. The programme’s evolution will be guided by feedback, research, and a commitment to advancing pharmacy practice globally.
Implementation in a pharmacy service of a big data analysis programme for successful treatment
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
LUCIA SOPENA, ALBERTO FRUTOS, VICENTE GIMENO, OLGA PEREIRA, RAQUEL FRESQUET, ARITZ MERCHAN, REYES GARCIA, PAULA GOMEZ, ALBERTO APESTEGUIA, MARIA ANGELES ALLENDE, TRANSITO SALVADOR
Why was it done?
The growing technological development of pharmacy services involves the coexistence of traditional warehouses with automated medicine dispensing systems controlled by different computer programs. The information is split into different systems and databases giving rise to possible errors due to the greater complexity. This is a threat but also an opportunity for the hospital pharmacist to lead the development, review, and improvement of medicine use processes and the use of health technologies to improve quality of care, patients’ safety and reduce costs. KNIME data analysis covered the need of our Pharmacy Service to blend data from any source in a single file simplifying the process.
What was done?
The Pharmacy Service of a university hospital has implemented Konstanz Information Miner (KNIME) data analysis and develop successful treatment project to optimise the stock management of several medicines.
How was it done?
An initial algorithm was designed by the union of seven files and can be executed at any time to obtain the updated data.
What has been achieved?
This file provides up-to-date information about the stocks, stock-outs, consumptions, orders and purchasing data of all medicines (average price, laboratory, date and number of orders, units to be received).
In addition, KNIME calculated the coverage time in days and months from weekly and monthly consumption, and the current stock in the warehouses, obtaining a global vision of highest turnaround pharmaceuticals drugs.
The program also allows to link and merge data of the list for shortages of medicines, supply disruptions and restocking time, and to improve the storing, delivering and administering of COVID-19 vaccines.
KNIME program has been especially important in our Pharmacy Service to get better care outcomes and more precise medication ordering, which allows significantly higher patient safety.
What next?
KNIME is a tool that could be successfully implemented and appropriately generalised as recommended to all Pharmacy Services that use different data sources and want to have a generalised view of the information. KNIME represents an advance in the stock and purchase management of medicines specialties to work more efficiently, which improve patient care and safety. Digital medication management also contributes to greener pharmacies by preventing unnecessary overstocking and thus excessive disposal arising from expired medications.
“Clinical research helpdesk”: an active support for investigators in a large university hospital
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Roberto Brunoro, Mariassunta Miscio, Girolama Iadicicco, Lorenzo Codato, Domenica Condello, Elisa Danieli, Viola Donadello, Alice Osto, Federica Pace, Giulia Valente, Francesca Venturini
Why was it done?
In our Italian University Hospital, we established the “Clinical Research Helpdesk” managed by the Clinical Research Unit. According to a daily schedule all personnel with an active role in clinical research can reserve an appointment with a pharmacist and administrative staff to ask questions for the submission of the necessary documentation for the Ethics Committee (EC) and for the evaluation of the study feasibility.
What was done?
In our Italian University Hospital, we established the “Clinical Research Helpdesk” managed by the Clinical Research Unit. According to a daily schedule all personnel with an active role in clinical research can reserve an appointment with a pharmacist and administrative staff to ask question for the submission of the necessary documentation for the Ethics Committee (EC) and for the evaluation of the study feasibility
How was it done?
The schedule is a Google Calendar tool which permits to generate slots of appointments. Researchers can access it by a link spread during a presentation event of the initiative. At each appointment the presence of a pharmacist for scientific counselling and a member of the EC scientific secretariat is guaranteed.
What has been achieved?
Since March 2022 the helpdesk accounts for 120 appointments with an average of 17 appointments/month. Typical questions are related to documental forms clinical trials rules and regulation counselling; in the last period support was requested also for practical issues, e.g., CE marking for investigational medical devices, feasibility evaluation, contract agreement and informed consent. After the helpdesk activation, the processing time for all the evaluation steps from the document presentation until EC submission, decreased by 50% compared to the previous year. The service increased study submission: the requests for evaluation of interventional studies received by the helpdesk increased by 15%, whilst for observational studies the percentage increase was 10%.
What next?
We are planning to expand this service to reach a complete management of clinical trials introducing a “RedCap team”, consisting of clinical pharmacists and biostatisticians who will help researchers in study design, Clinical Research Forms (CRFs) creation, statistical evaluation and data interpretation. A legal team for legal issues and contract agreement counselling will also be offered. The aim is to increase the visibility of our hospital, making it more attractive for clinical research.
A 3-Year transformation of a Belgian clinical trial pharmacy team
Pdf
European Statement
Education and Research
Author(s)
Marie Coenen, Stefanie Goris, Thomas De Rijdt, Isabel Spriet
Why was it done?
These changes were necessitated by the increasing number of (complex) clinical trials conducted at UHL. This Belgian 1995-bed, tertiary care hospital constitutes an attractive setting for clinical trials and a coveted partner for sponsors, due to its specialisation in a wide range of medical fields to treat complex pathologies. Adopting the changing research field whilst ensuring the highest regulatory compliance was challenging.
What was done?
Since 3 years, the clinical trial team of the University Hospitals Leuven (UHL) pharmacy has gone through several metamorphoses. These were realised by introducing an activity based costing (ABC) model enabling financing of staff expansion, extension of the infrastructure, and extensive digitalisation.
How was it done?
In 2016, an ABC-analysis was conducted by the Belgian Association of Hospital Pharmacists to determine the cost of various pharmacy activities within a clinical trial. In 2019, the outcome of the analysis was revised to concur the fast-growing clinical research field.
To affirm the need to apply these updated prices, a retrospective evaluation was performed in 2020 documenting the number of clinical trial protocols, pharmacy staffing and applied prices over the past 4 years.
What has been achieved?
Rapid growth of pharmacy research activities was shown by an increase in the total number of active clinical trial protocols from 964 in 2017 to 1256 in 2020. Until then, quantitative expansion was not followed by qualitative growth since staffing remained steady at 13 full-time equivalents (FTE) and the applied costs were outdated and not cost-effective. To enable this transition, an up-to-date pharmacy budget table was developed based on the latest ABC-analysis and, along with an estimate of future income, approved by the hospital board in 2020. This allowed the pharmacy research staff to be reinforced to 19 FTE and the infrastructure to be extended to integrate extra storage capacity and research dedicated clean rooms. Starting from 2021, the budget table was implemented into practice using computerised support enabling automated billing.
What next?
Future directions include further digitalisation by automating accountability and compounding and focusing on qualitative growth by advancing the role of clinical trial pharmacists into a specialised member of the hospital research development team and of the clinical pharmacy team.
Optimising the process for incoming requests for new extemporaneous products
Pdf
European Statement
Production and Compounding
Author(s)
Mette Lethan, Tove Hansen, Louise Rasmussen Duckert, Trine Schnor
Why was it done?
In the clinic, a need for a NEP, as either a change in an existing product or a new formulation, may arise. Requests are risk assessed by the Hospital Pharmacy Drug Information Centre (DIC) before production is initiated. However, there was no clear process for handling requests, resulting in prolonged process times. NEP may require searching for new raw materials, new packaging or developing of a new formulation, which are time consuming tasks. Therefore, the wish to optimise the process arose.
What was done?
A procedure for handling requests for new extemporaneous products (NEP) in a Good Manufacturing Practice (GMP) regulated production was developed to improve success rate and aligning the process.
How was it done?
A small unit was formed with the purpose of handling requests for NEP. The unit consists of academics employed in the production department with expert knowledge about both sterile and non-sterile production.
A standard operating procedure was formed, in collaboration with DIC, which included a form, to be filled out with information needed for handling the request. This includes drug formulation, strength and dosage, along with any specific requirements.
The unit evaluates the request – is it possible for us to manufacture, sterile or non-sterile, are raw materials available in appropriate quality, analysis requirements, and stability of the product. The evaluation is made in communication with departments like Purchasing, Quality Control/Assurance, Stability as well as the relevant production department.
If a positive outcome, the request is given to the production department, to finalise production. If the outcome is negative a rejection is sent to the requester with a reason.
What has been achieved?
Based on data from the last three years, we now know how many requests we receive, which type of products are requested, processing times, and which products were made and why/why not.
There is a clear path of communication into the pharmacy and between relevant departments, ensuring that essential pharmaceuticals will be developed in a timely manner or a justified rejection is sent enabling the clinic to look for alternatives.
What next?
Some products are difficult to handle, such as cytostatics, antibodies and hormones. Next step is to investigate these product types.
Optimised and sustainable distribution and handling of medicines to psychiatric outpatients
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Louise Stilling Rasmussen, Lene Juhl Biltsted, Majken Nørskov Petersen
Why was it done?
To implement EAHP statements on Patient Safety and Quality Assurance the hospital pharmacist carried out the intervention in one of the largest psychiatric clinics in the region. The following challenges were observed: Lack of transparency for healthcare professionals. Inflexible and time consuming workflow which did not accommodate the needs in the medical treatment at the clinic. The workflow caused waste of medicine. Changes in the medical treatment, which caused medicine being surplus and ended up expiring. The distribution was expensive and not sustainable.
What was done?
By changing the handling and distribution of medication for psychiatric patients who are entitled to free medicine from the hospital, we now have an agile, streamlined, patient-safe and transparent workflow that ensures patient safety by accommodation of the seven rights, increases the flexibility and availability of medicine to the patient’s current treatment and gives a more sustainable handling of medicine. Furthermore, resulted in direct and indirect financial savings (estimated direct savings 8%, DKK 250,000).
How was it done?
A medication room was reorganised by the pharmacist according to ATC codes, shelf fronts, active ingredients and expiry date.
Establishment of a computer and scanner, linked to the national Shared Medication Record containing all patients’ prescriptions.
Medicine is ordered online from the hospital pharmacy.
What has been achieved?
New modern quality assured medication room with electronic registration of medicines dispensed to the patients. This provides transparency of the medical treatment across the healthcare sector. The medicines are stored correctly, and the integrity is maintained until immediate use and permit correct administration. Elimination of medication waste and reduced time consumption for healthcare personnel gave an estimated direct savings of approx. DKK 250,000 plus an uncalculated saving of staff time. Finally, a more sustainable management of medicines and reduced the risk of errors regarding medical distribution was achieved.
What next?
The results of this project have scaling potential. A presentation for decision-makers about implementing the solution elsewhere is ongoing. The handling and distribution has been changed from patient-labelled medication to secure digital registration of the medication dispensing from the medicine room, which now allows complete traceability of all medicines dispensed by the pharmacy.
Establishing a medicine donation circuit for non-governmental organisations at a pharmaceutical service in the Basque country (Spain)
Pdf
European Statement
Selection, Procurement and Distribution
Author(s)
Ariadna Martin Torrente , Itziar Palacios Zabalza, María Olatz Ibarra Barrueta, Maialen Palacios Filardo, Garazi Miron Elorriaga
Why was it done?
To optimise the functioning and the management of the procedures and an accessible and effective communication system in the PS. Moreover, the quality of the shipment is guaranteed all the time. The development of a circuit has allowed being faster and more efficient during its preparation than before.
What was done?
Establishing the circuit of execution, preparation, distribution, and delivery of medicine to Non-Governmental Organisations (NGO) from the Pharmaceutical Service (PS) of a tertiary hospital in the Basque Country (Spain). The circuit has been designed taking into account the criteria in a context of humanitarian donations, published and updated by the Spanish Agency of Drugs and Sanitary Products (AEMPS) on 16 March 2022
How was it done?
Since it has been included in the daily activity of the service it has cause and increase its amount of work, hence, daily routine tasks have been slowed down, given the increase of petitions the hospital has had during last year. However, its creation has allowed being faster and more efficient during its preparation.
The circuit begins with the request of NGO, which has to be authorised by the hospital’s directory. Then, in the procedure participate pharmacists; pharmacy technicians and office clerks who prepare the donation rely on the personalised list that the donation has created. Once, the necessary documents are filled out and they are sent to the AEMPS.
What has been achieved?
From November 2021 to September 2022, 7 donations have been carried out; these contained 100 active ingredients, concretely 15.198 units. We could find most of them in the WHO model lists of essential medicines. The NGO’s destinations have been Guatemala, Romania, Ukraine and Senegal. The medications sent most according to the ATC classification were 21% anti-infective medicines, 17% cardiovascular, 13% nervous system, 12% systemic hormonal preparations and 3% alimentary tract and metabolism.
What next?
The project is easily enforceable in any Spanish PS that is willing to process a donation at any given occasion. Some of our ideas for the future are the creation of a standard list including common medications, avoiding personalised lists, in addition to connect it to our internal programme to be faster when preparing the donation.