Pdf

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.

Pdf

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.

Pdf

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.

Pdf

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.

Pdf

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.

Pdf

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.

Pdf

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.

Pdf

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.

Pdf

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.

Pdf

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.