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Author(s)

JOSE MANUEL DEL RIO GUTIERREZ, EUGENIA SERRAMONTMANY MORANTE, SARA GIMENEZ GINER, PILAR ROVIRA TORRES, PATRICIA GARCIA ORTEGA, CARLOTA VARON GALCERA, ISABEL CIDONCHA MUÑOZ, MARIA QUERALT GORGAS TORNER

Why was it done?

One of the most important challenges we currently face is the increase of clinical trials (CTs) including CBMPs. These drugs require special storage, preparation, delivery and administration; so developing standard operating procedures (SOPs) and ensuring proper coordination between all professionals involved, including pharmacists, is essential.

What was done?

Management of cell-based medicinal products (CBMPs) was protocolised in an onco-haematology clinical trials unit.

How was it done?

Pharmacists, doctors and nurses participate in a multidisciplinary team to standardise CBMPs handling. The following protocol was agreed:
1.The entire multidisciplinary team is notified when a CBMP prescription is planned to ensure proper coordination.
2.The CBMP is manufactured by the CT sponsor. Then, it is transferred to the blood bank for cryopreservation. CBMPs usually require a temperature between -80ºC and -200ºC and expire in some weeks.
3.Before CBMP administration, patients undergo lymphodepletion. The lymphodepletion regimen is performed according to the CT protocol or arranged between medical and pharmacy teams. Chemotherapy, serum therapy and antiemetic regimen are discussed and specified.
4.Once the treatment is prescribed, it is verified by a pharmacist who ensures its suitability.
5.On the infusion day, the blood bank delivers the CBMP. Then, a pharmacist checks if it arrives in proper condition and it is defrosted. The pharmacy department reconditions the CBMP in another infusion bag or syringe if required. This is the most critical point because CBMP expires after some minutes of defrosting, requiring extensive coordination.
6.CBMP is administered according to the CT protocol.

What has been achieved?

72 patients were recruited in 15 CT. 8 of them use as CBMP Chimeric Antigen Receptor T-Cells (CAR-T-CELLS), 4 Specific Peptide-Enhanced Affinity Receptor T-Cells (SPEAR-T-CELLS), 2 Tumour-Infiltrating Lymphocytes (TILs) and one cytokine-stimulated Natural-Killer-Cells (CS-NK-CELLS). Seven assays are intended for haematological neoplasms and eight for solid malignant neoplasms. One assay requires CBMP syringe reconditioning in the pharmacy department.
The described process optimises CBMPs handling, avoids delays in administration and reduces the risk of misuse.

What next?

CBMPs represent a novel therapy, and pharmacists have an essential role in developing new procedures to incorporate them into clinical practice. This protocol may be helpful for other centres to implement guidelines to work with CBMPs.

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Author(s)

Chloé JADOUL, Audrey DURAND, Rémy TORDJEMAN, Isabelle MADELAINE, Romain de JORNA

Why was it done?

With the development of advanced therapy medicinal products (ATMPs), a specific pharmaceutical process is necessary to secure the handling of genetically modified organisms. Gene therapy includes Chimeric Antigen Receptor T (CAR-T) cell therapy as well as clinical trials with oncolytic viruses and nucleic acids. Limited experience on these new activities and high staff turnover based on resident pharmacist explain the need of additional training material to supplement written procedures. Multimedia support seems to be the most appropriate didactic tool.

What was done?

The objective of this work is to create pedagogical tools as short video clips. The final aim is to standardise hands-on training in order to improve ATMPs circuit safety.

How was it done?

All steps of each activity were listed and filmed in order to create a video database. Clinical trial mock preparations were performed to create the clinical trial tutorials whereas CAR-T cell activities were filmed in real conditions.
Clipchamp (Microsoft) video editing software is used to create tutorial videos. Repetitive parts were edited once and reused for other videos. They are part of the database videos.
As a validation, all staff members’ approbation was required.

What has been achieved?

Activities include, to this day, five gene therapy clinical trials and the CAR-T cell activities: reception, shipment to the pharmaceutical hub, thawing and distribution.
We filmed 55 step clips and edited six repetitive parts. Finally, eight tutorial videos were created: three for clinical trials and four for different CAR-T cell activities.

To make the training more meaningful, we made dynamic videos that last no more than 5 minutes. The average time of a tutorial was 2 minutes 17 seconds.

What next?

The tutorial videos bank is created to be dynamic and can be easily adjusted. Videos of repetitive parts will be reused for new clinical trials implementation. These video tutorials allow new resident, student or technicians to be trained faster and in a more innovative way. They also allow permanent teams to benefit from a quick refresh. In order to assess the efficiency of this new process, next operators will have to read the procedure, watch the videos and will be evaluated in practice.

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Author(s)

Rachel Huey, Catherine Goudy, Michael Scott

Why was it done?

The assessment process was developed in partnership with the Business Services Organisation Procurement and Logistics Service (BSOPaLS) and regional Infection Prevention and Control (IPC) colleagues in response to the outbreak of COVID-19 and escalating demand for PPE. In March 2020, early World Health Organization (WHO) guidance formed the basis of COVID-19 PPE ensemble recommendations. Prior to the COVID-19 pandemic, BSOPaLS procured such items from reputable market leaders. However, during this time of unprecedented demand on supply chains, there were many new manufacturers and suppliers with no previous experience of appropriate supply to healthcare. There were also many counterfeit goods being placed on the healthcare market.

What was done?

During the COVID-19 pandemic, the Medicines Optimisation Innovation Centre (MOIC) utilised pharmacist skills to undertake technical assessment of all Personal Protective Equipment (PPE) items procured for use across Health and Social Care Northern Ireland (HSCNI).

How was it done?

MOIC reviewed and validated all technical documentation associated with each PPE product to ensure that items procured were genuine, fit for purpose and met the relevant standards and regulations. Benchtop assessments were carried out by IPC colleagues and BSOPaLS carried out all procurement due diligence checks on potential suppliers. Early data from 1 April 2020 to 15 May 2020 showed that only 98 (16.5%) PPE offers reviewed met the required standard for approval, while 264 (44.6%) were rejected and a further 230 (38.9%) remained open. Some reasons for rejection included documentation deficiencies and misleading labelling.

What has been achieved?

This process resulted in procurement of only safe and effective products, putting safety of HSCNI staff and patients at the forefront. In addition, BSOPaLS worked closely with local manufacturers with no previous PPE experience, to establish more resilient supply chains for the future. Products manufactured locally were also assessed via this process, to ensure suitability for use within healthcare.

What next?

This efficient assessment process has now been implemented into the PPE procurement pathway for all future HSCNI purchases, enabling the application of due diligence in a transparent, robust and evidence-based manner. Provided there is opportunity to develop an appropriate knowledge base of the relevant regulations and standards, this process is transferable across many healthcare organisations.

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Author(s)

Andersen Lilli Moeller, Hansen Tove Solveig, Schnor Trine

Why was it done?

The QMS for the hospital pharmacy did not previously include primary packaging systems regulated by MDR. These packaging systems are a prerequisite for supply to patients of vital medicines like Total Parental Nutrition (TPN) and ready-to-use products such as antibiotics, cytostatics and pain reliefs.

What was done?

Several actions to combine Good Manufacturing Practice (GMP) and Medical Device Regulations (MDR1) were implemented.  Among others, comprehensive training programmes were conducted, and quality standards as well as supply chain mappings were included in Quality Management Systems (QMS).

How was it done?

A national strategic initiative was launched with actions decided in open dialogue with the Competent Authority and suppliers.

Priority was given to the most GMP-critical devices as TPN-bags and elastomeric pumps. Specifications were established and supply chains mapped.

To fast roll out competences across hospital pharmacies similar workshops with participation of a consultant with special competences within MDR were given.

What has been achieved?

Due to knowledge of the Supply Chain and extended cooperation with suppliers, a quick and effective reaction in relation to for example recalls is obtained.

Easier to explain suppliers how they can support our need for documentation to fulfill GMP related demands New clinical or political demands to ad-hoc compounding can be met fast and effective.

GMP related issues are part of a current national tender for elastomeric pumps.

What next?

More medical devices like transfer-sets, syringes used as utensils and gloves to be included in the supplier qualification program.
GMP related requirements to be a part of tenders on medical devices used as packaging systems.
Continued cooperation with suppliers to develop solutions in the interface between MDR and GMP.

Author(s)

Morgane HOUIX, Valérie VIAUD, Cécilia HURLUPE, Yannick POIRIER

Why was it done?

The pooling of stock for the 5 rooms required a referent for stock management. In order to free up caregivers from the administrative and logistical tasks related to pharmaceutical products, pharmacy has been directly integrated into the project of ITP.

What was done?

In May 2021, interventional cardiology, rhythmology and coronary angiography have been gathered in an interventional technical platform (ITP) of 5 operating rooms. A full-time hospital pharmacy preparer (HPP) position has been set up within the ITP.

How was it done?

For the success of the project, the 2 chosen PPH had to easily becoming part of ITP’s teams and must learn specifics of medical devices of each speciality. For this purpose an immersion in each sector was carried out during the installation of the ITP and continues today by participating in interventions. They shared in the process of installing the PTI’s arsenal of pharmaceuticals with careteams by grouping the initials allocations of products of each speciality. The products common to each endowment were gathered and harmonized after discussion with caregivers. Each sector has kept a stock of specific devices, called “out-of-stock”.

What has been achieved?

The installation took about 632 hours of HPP time. The allocations for each sector were respectively 68, 69 and 83 references, not including out-of-stock. The HPP’s work allowed reducing the common endowment from 220 to 134 products references. A satisfaction survey of PTI teams (doctors, nurses,…) after 4 months of practice showed a level of 78% of satisfaction. 1.3% of the responses concerned activities related the management of devices affected by production delay or stoppage and information on product changes to be unsatisfactory or moderately satisfactory. Every ITP teams now considers their presence essential, believes that it has improved relations with the pharmacy and management of stocks. A saving in nursing time was also noted.

What next?

The creation of this HPP position seems to satisfy all the ITP teams. A quantitative analysis of the benefits measuring the impact on care time, the amount of over-storage and the compliance indicators of the implantable medical device circuit will be carried out during 1 year, in order to assess the impact of the creation of HPP positions within the PTI.

Author(s)

PATRICIA ORTIZ FERNANDEZ, Alba Maria Martinez Soto, PILAR FERNANDEZ-VILLACAÑAS FERNANDEZ, IGNACIO SALAR VALVERDE

Why was it done?

The objective is to improve patient safety, detecting mistake in real time. Review good work practices and achieve greater effectiveness. Improve the communication of the work team.

What was done?

Improve the quality of the reception, conditioning and storage processes that are carried out in the pharmacy service using tools that in the field of quality have shown great effectiveness. Simplify processes and update work instructions and standardize these. Establish quality indicators.

How was it done?

ing the `Lean healthcare´methodology based on eliminating inefficiencies in work processes and identifying opportunities for improvement which are specific, measurable, achievable, relevant and time bounded. Another of the methodologies used is the `5S´ (five basic elements: selection, systematization, cleaning, normalization and self-discipline) and `PDCA´(plan, do, check, act).
1. Establish a multidisciplinary group.
2. Training on the methodology developed in 5 sessions.
3. Elaboration of a project charter with the objetives, the scope and the planning.
4. Analyze the chosen processes with the following dynamics: a) Team visit to the work area, b) Interview an expert from each process, c) Registration of inefficiencies and process data in a value steam mapping, d) Compilation of possible improvement actions, e) Meeting for consensus and realization of an action plan to prioritize and assign those responsible for carrying out the improvement actions.

What has been achieved?

Number of meetings with the multidisciplinary team: 10
Reception process: improvements implemented(II): 11, pending improvements (PI): 2, indicators evaluated (IE): 4
Conditioning process: II: 4, PI: 0, IE: 2
Storage process: II: 13, PI: 2, IE: 2

What next?

Must be maintained and evaluated over time and anytime there that may be a change. These improvements allowed a better anticipation. The process improvement approach aimed to identify solutions was very fruitful and led to outcome practical. This method could be applied to improve other types of processes in our pharmacy service.

Author(s)

Hilario Martinez-Barros, Maria Muñoz-Garcia, David Gonzalez-de-Olano, Silvia Sanchez-Cuellar, Enrique Blitz-Castro, Gonzalo De-los-Santos-Granados, Dario Antolin-Amerigo, Ana de-Andres-Martin, Patricia Fernandez-Martin, Elena Gemeno-lopez, Ana Maria Alvarez-Diaz

Why was it done?

• To understand directly and holistically the patients’ vision of their illness, treatment, healthcare experience and how they impact their daily lives.
• To define the ideal SAU by identifying innovations and changes that satisfy patients’ needs.

What was done?

ASfarMA is a hospital pharmacist-led project within a multidisciplinary Severe Asthma Unit (SAU) that aims to apply different innovative measures encompassing humanization to improve treatment related results and patient experiences.

How was it done?

Human-Centered Design (HCD) is an approach to problem-solving that aims to make systems usable and useful by focusing on the users and their needs.

A core group was constituted with at least one member from each of the specialities that are part of our SAU. Members of an HCD-team devised and contributed to organize the following activities:

• A first core group session was held in which, using different dynamics, 4 patient archetypes were identified, and the patients´ journey through the Unit was described.
• HCD-team members interviewed both SAU professionals and 8 patients who matched the previously defined archetypes. The latter was also given a patient diary designed to obtain descriptive and emotional information within the SAU.
• Utilizing the previously obtained data, a co-creation workshop was held by the HCD-team involving both the core group and the participating patients.

What has been achieved?

A series of proposed measures that respond to patients and professionals’ reported needs were made. They were classified as either “transformative solutions” or “quick wins”:

– 7 transformative solutions, which provide holistic responses that require greater development, effort and resources, were identified. E.g. Two-way communication APP, onboarding kit, design of common spaces for SAU members, patient coordinator.

– 14 quick wins, which provide significant benefits but can be implemented with lesser effort and resources, were identified. E.g. Non-urgent consultation mailbox, pediatric-adult patient transition consultation, asthma-specific emergency department circuits, coordinated consultation agendas between severe asthma unit members, expert patient workshops.

What next?

This project, which has a qualitative nature and is based on the experiences of both patients and professionals, has allowed us to understand their needs and identify innovative solutions that will be applied progressively to our SAU and other hospitals.

Author(s)

LUCÍA SOPENA, VICENTE GIMENO, OLGA PEREIRA, Mª ANGELES ALLENDE, RAQUEL FRESQUET, RAQUEL GRACIA, BEATRIZ BONAGA, MERCEDES ARENERE, TRÁNSITO SALVADOR, ALBERTO FRUTOS

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 was splitted 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.
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 tertiary-level hospital has implemented Konstanz Information Miner (KNIME) data analysis and treatment program to optimize the stock management of several medicines.

How was it done?

An initial algorithm was designed by the union of 7 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 from consumption, and the current stock in the warehouses, obtaining a global vision of highest turnaround pharmaceuticals drugs.
The program also allows linking and merging data of the list for shortages of medicines, supply disruptions and restocking time provided by the Spanish Agency of Medicines and Medical Devices (AEMPS).
KNIME program has been especially important in our Pharmacy Service during the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Big data analysis has allowed the hospital pharmacist to anticipate missing specialties and to make a rapid response in ensuring the availability of Essential Medicines List (EML) composed by 75 proposed by AEMPS and 138 by our hospital (e.g. antiinfectives, analgesics, muscle relaxants, anesthetics).

What next?

KNIME is a tool that could be successfully implemented and appropriately generalized as recommended to all Pharmacy Services that use different data sources, and want to have a generalized view of the information.
KNIME represents an advance in the stock and stockpiling management of medicines specialties to work more efficiently, which improve patient care and safety.

Author(s)

Joan-Candy MABIN , Aïssé DIALLO, Hortense LANNELUC-BEAUJARD, Xavier DEVIOT

Why was it done?

The aim of this work is to find a cheaper alternative, reducing the analysis duration and allowing the pharmacy to be laboratory independent.

What was done?

The opening of the production unit (PU) leads to reorganize the parenteral nutrition mixtures (PNM) dosing. Primarily carried out in the biochemistry laboratory of our hospital, potentiometry and colorimetry analysis were long (more than an hour) and costly. PNM composition accelerates the aging of one of the device components that costs 1400 euros and have to be changed every 3 weeks, raising the total around 24300 euros per year only for this component.

How was it done?

Hospitals producing PNM in the region were identified and approached. They were asked about the type of dosed elements, the analysis method and the equipment used, about the analysis duration and localization (laboratory or pharmacy departments) and their overall cost estimation.

What has been achieved?

Five hospitals with different dosing equipment answered. Four of them analyze cations: calcium, magnesium, sodium and potassium by capillary electrophoresis, potentiometry or spectrometry, three of them analyze glucose by chromatography or colorimetry, and two of them determine osmolarity of the PNM mixtures. Dosages are performed by the pharmacy department in three PU where technician are required. Results are provided in about an hour when the activity depends on the laboratory and around five to ten minutes when it is managed by the pharmacy department. The average cost to purchase the equipment for each hospital was around 50000 euros (without the associated materials and the labour cost).

What next?

To conclude, no hospital interviewed can be a model because of either the high costs or the unadapted equipment size to the scale of the room of our PU. Nevertheless, during discussions, an equipment that might answer our needs was suggested, because no technician is needed for analysis, and it is described simple and easy to use. The manufacturer has been reached out asking for demonstration and information before any purchase. If accepted, the device will be qualified before going into production.

Author(s)

Marta García-Queiruga, Begoña Feal-Cortizas, José María Gutiérrez-Urbón, Andrea Luaces-Rodríguez, Alejandro Martínez-Pradeda, Sandra Rotea-Salvo, Carla Fernandez-Oliveira, Víctor Giménez-Arufe, Luis Margusino-Framiñán, Isabel Martín-Herranz

Why was it done?

Daptomycin is an intravenous antibiotic usually prepared in Hospital Pharmacy services. Normally it is dosed based on body weight, which requires each intravenous mixture to be prepared in an individual manner for each patient. This might lead to an increased assistance workload in elaboration areas, a higher number of errors in the preparation and high costs due to waste materials generated during preparation.

What was done?

The aim of this study is to describe the preparation of intravenous daptomycin by dose banding, a system in which daptomycin doses are rounded up or down in order to standardize and protocolize the preparation of intravenous mixtures as much as possible.

How was it done?

In order to improve this situation, dose banding strategy was implemented in February 2019: the obtained final dose was rounded in such a way that only mixtures of 500, 700 and 850 mg were prepared (in agreement with Hospital Pharmacy and Infectious and Microbiology medical teams) , following this scheme:
PRESCRIBED DOSE PREPARED DOSE
< 400 mg Prescribed dose (individualized) 400–599 mg 500 mg ≥600–799 mg 700 mg ≥800 mg 850 mg

What has been achieved?

Previous year before starting dose banding strategy (2018), 5493 individualized doses of daptomycin were prepared for 437 patients in our Pharmacy service. Between June 2020 and June 2021, 2680, 2555 and 997 units of daptomycin 500, 700 and 850 mg, respectively, were prepared for 360 patients. Batches of standardized doses were prepared in advance and kept refrigerated (stability of 10 days in 100 ml of physiological saline) until dispensation. In addition, during the same period, 15 patients (4 from pediatrics) received 209 individualized doses (3.2% of the total doses) due to their low body weight.

What next?

This strategy might decrease the number of errors in preparation and reduce processing times, which is essential since early appropriate antibiotic treatment in severe infection has been associated with better outcomes. Dose banding model could be extrapolated to other drugs with good physical, medical and microbiological stability in dilution, which are frequently prescribed and when few dose bands can cover most of the prescriptions.