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Author(s)

Sophia Hannou, Cristina Nicorici, Patricia Spitz, Samuel Cotte, Wanda Bosshard, Nancy Perrottet, Pierre Voirol, Farshid Sadeghipour

Why was it done?

Medication use process is at high risk especially for opioids. In our geriatric rehabilitation unit, self-reporting incidents are submitted regularly to our quality system. Among the 44 drugs incidents reported in 2021, 11 included opioids. Prevention with training is a way to reduce these errors. However, theoretical teaching covering the “5 rights” rule remains insufficient. Therefore, an interactive learning with a room of horrors focused on opioids was selected by our unit to prevent these errors. The objective was to cartography and identify the most risky steps and to introduce specific actions to reduce these risks.

What was done?

A room of horrors with a specific focus on opioids has been developed and implemented to reduce errors in medication circuit.

How was it done?

An interprofessional group created the room of horrors based on real incidents. Fictional patient, clinical situation and opioid prescription were created in the medical software. Several drugs and medical devices were available. A model wore an identification bracelet. Ten errors, covering the five rights, were hidden in the room. A pair of healthcare givers had 20 minutes to realise the simulation (5 for the briefing, 10 for the exercise and 5 for debriefing).

What has been achieved?

During the World Patient Safety Day 2022, 38 healthcare professionals (19 nurses, 10 assistant nurses, 9 geriatricians) participated to this training. Errors were detected in variable proportions. For example, 58% of the participants uncover the patient identification error, 53% the pharmaceutical form, 53% the expired date, 47% the allergy contraindication and 47 % used the oral syringe.

What next?

Results and theoretical notions will be presented to all professionals of the unit. This room of horrors is transposable and can be used in other units of the hospital. A video of this simulation was created as an e-learning. It will be implemented as a continuous training or for new collaborators in our unit and can be shared to other units of the institution. Incidents will be continuously monitored and the training will be adjusted in the future. Based on the success of the room of horrors, this interactive learning will be used in other areas with other clinical or technical dimension.

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Author(s)

Leila Costa, Rui Marques, Ana Castro, João Paulo Cruz

Why was it done?

Cytotoxic medicines are drugs used mainly in the treatment of neoplasms. Their preparation is a key activity of Hospital Pharmacy, carried out in a Class II Type B2 Vertical Flow Chamber (VFC). With the emergence of new cytotoxic drugs, the increase in the number of patients (2100 in 2010 to 3168 in 2021), and preparations (from 30000 in 2010 to 40000 in 2021), the time spent by Pharmacists in routine work and in the organisation and research of information also increased, and innovative approaches in terms of resources optimisation are deemed.

What was done?

Evaluate the performance of cytotoxic compounding after the implementation of relevant operational interventions designed to optimise drug preparation and delivery, between 2018 and 2021 in a University Hospital Centre.
Retrospective analysis of the average waiting times of patients for treatment delivery in some day hospitals (DH), after implementation of the operational interventions.

How was it done?

We began with the computerisation of the chemotherapy protocols, in order to standardise the prescribed treatments, which allows to reduce transcription and prescription time and associated errors. A comprehensive database was also created with the main characteristics of cytotoxic drugs and their physicochemical stability, in order to support pharmaceutical validation. In partnership with DH nursing team, every patient’s treatment schedule was determined beforehand, which allowed an enhanced organisational workflow, and the grouping of more complex drugs to prepare at the same time, and the preparation of drugs with adequate stability in the day before. This resulted in a reduction of average waiting times from 2 hours to only 30 minutes. The DH that benefited the most from these changes was Haematology, which adopted all proposed changes from the start after a multidisciplinary team meeting. Currently, about 45% of treatments are prepared the day before. Since the compounding unit is structured in rotating shifts, this practice allows to minimise drug wastage and to reduce preparation time, which improves the organisational capacity and agility in response to patient needs. When available, preference was given to ready-to-use drug solutions instead of powder formulations, e.g. pemetrexed and bortezomib, reducing preparation time and increasing operator safety. Also, in Gastroenterology DH, we promoted switch from original infliximab to its biosimilar by centrally preparing the biosimilar. We used two pharmacy technicians in the same cabinet instead of one, increasing the preparation yield. The last intervention was in the transportation of the compounded preparations, through the implementation of the delivery of treatments via a pneumatic tube system. This system ensures the integrity of the material and the conformity of the transport, thus allowing the safety and stability of the material transported, without bumps and avoiding changes in physical properties. It was possible to obtain a higher frequency of transportation and better workflow at peak times.

What has been achieved?

With the same human resources and the operational changes described, it was possible to improve the compounding unit performance, and to reduce patient waiting times in 75%, saving time and money.

What next?

With the increasing number of patients and cytotoxic preparations, it was necessary to reorganise the compounding unit in several key features.

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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.

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Author(s)

Trine R. H. Andersen

Why was it done?

In Region Zealand, 1 of 5 regions in Denmark, clinical pharmacist services have been developed and implemented for the past decade. Especially in the acute wards, clinical pharmacists are an integrated part of the team when receiving, assessing and admitting patients to the hospital. As stated by the EAHP, “Clinical pharmacy services should continuously evolve to optimise patients’ outcomes” (EAHP statement 4.8), and a new approach was taken to further optimise the existing collaboration between the physicians and pharmacists on patients’ medication.

What was done?

The clinical pharmacy department of Region Zealand Hospital Pharmacy engaged a project with a senior year anthropology student. The anthropology student observed clinical pharmacists working with clinical pharmacist services in three acute wards. The observations on the collaboration of patients’ medication processes were disseminated to the pharmacists and physicians at the wards. This will aid in further strengthening of the collaboration and utilisation the healthcare professionals’ individual competencies in the hospital wards.

How was it done?

A senior year anthropology student was engaged to do objective observations of the pharmacists and physicians when collaborating in the acute wards. An anthropologist is trained to suppress subjective opinions and has no previous inception of the healthcare professionals’ work in the acute ward, and hence can do low biased observations. For 4 months the anthropologist made objective observations several times a week at each ward, and towards the end of the studies also supplemented the observations with individual interviews to further understand observed situations.

What has been achieved?

After the field observations and interviews, recurrent observation points were extracted from data and presented to the pharmacist and physicians in plenum. Discussions on the presented observations was found enlightening and strengthened the teamwork by better understanding the differences in the pharmacists’ and physicians’ responsibilities in the medication process respectively. Take home messages were visibility as well as accessibility of the pharmacist, and respect of each other’s contributions to the team.

What next?

The data will further be analysed and processed during the anthropology student’s final year and master’s thesis. The take home messages will be combined in a short introduction leaflet aimed for newly employed clinical pharmacists.

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Author(s)

Cathrine Noergaard Peulicke, Michelle Lyndgaard Nielsen

Why was it done?

The process of building a new hospital has led to development and rethinking the drug concept. At the hospital we always have “the patient first” in mind. This is our codex. That is why we are changing the concept for delivery, dispensing and administration of medication. We wanted to ensure that the concept functioned from a patient safety perspective, patient flow perspective, patient involvement perspective, professional development perspective and perspective of a healthy operation. The vision is the right medication, from the right hand at the right time.

What was done?

At the new hospital, the medication logistics will undergo major changes. There will only be medication for acute use at the wards, the rest will be delivered ready-to-use from the main pharmacy or from a decentralised unit, called Pharmaservice. Here IV-solutions with short expiration are being reconstituted and oral solutions are dosed according to the prescription. Tablets and capsules are dispensed in the multi-dose robot at the main pharmacy. The multi-dose medication is equipped with a bar code which is scanned at administration and full electronic documentation is obtained. The majority of the medication will be dispensed daily for 24 hours and delivered in boxes for each patient to the wards.
In order to ease the transformation, we have built a mock up of a Pharmaservice unit where this set-up is enrolled to all inpatient wards in the hospital on the geriatric ward, children’s ward and gynaecology and obstetrics ward.

How was it done?

A steering group was founded and membered by managers from the involved wards including the hospital Pharmacy. Frequent meetings with the involved wards has been necessary to ensure competences and communication. Post-implementation we are closely evaluating the initiative.

What has been achieved?

Patient safety is in focus and with the multi-dose dispensing robot we have achieved full electronic documentation from the prescription, dispensing and administration process, and thereby have reached closed loop medication.

What next?

Having implemented the initiative on three wards, we are now working on enrolling this to the entire new hospital when it is ready in 2024. At the new hospital, we will have five Pharmaservice units servicing all inpatient wards.

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Author(s)

Trine Birkholm, Trine Rune Høgh Andersen

Why was it done?

The Danish Ministry of Health has declared which healthcare professionals should handle medication such as dispensing and administration to patients in hospitals. Traditionally, primarily nurses and physicians handle administration of medicines in the Danish hospitals. In recent years a massive shortage of nurses in Danish healthcare has called for other professions to participate in administration of medicines. As Denmark has employed less than one clinical pharmacist per 100 beds in hospitals, pharmacists are not able to contribute to the task. However, clinical pharmacists can have an important role in educating other healthcare professionals e.g. HCAs in handling medicines.

What was done?

Because of massive lack of nurses and thereby healthcare professionals to administer medicine in psychiatric wards in Region Zealand, Denmark, the pharmacists developed and implemented a training course for social and healthcare assistants (HCAs) to participate in the task.

How was it done?

As hospital pharmacists should ensure that the information needed for safe medicines use, including both preparation and administration, is accessible at the point of care (EAHP statement 5.9), aiding in the development of a training course for HCAs was ideal for the clinical pharmacists. The training course has a duration of 3 days followed by a mentored trainee period. The course includes psychopharmacology lessons to teach HCAs to observe and react to overdoses, lack of effect or side effects as declared in medicine handling guidelines.

What has been achieved?

Approximately 150 HCAs have attended the course since 2020. Eight out of ten state that the course has enabled them to take on the new work tasks. Nine out of ten believe that they can use the newly acquired knowledge and practical skills for their new work tasks. Today, the administration of medicines in the psychiatry ward is also managed by HCAs, thus relieving the nurses’ time needed for more specialised tasks.

What next?

There is also a shortage of nurses in the somatic hospitals. To ensure patient safety and enough staff to dispense and administer medicines, several hospital wards have requested similar training for HCAs. It is believed that similar training courses with modifications can target somatic wards as well.

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Author(s)

MARIA DE LA TORRE ORTIZ, ESTEFANIA ROSON, LIDIA YBAÑEZ, NATALIA SANCHEZ-OCAÑA, JAVIER CORAZON, PALOMA PASTOR, MARIA FERNANDEZ-VAZQUEZ, JOSE MANUEL MARTINEZ SESMERO

Why was it done?

The demand and use of immunoglobulins (IgGs) is growing, and there are many difficulties in obtaining supplies. This situation has been worsened during and especially after COVID-19 pandemic. A low number of blood donations and apheresis procedures, caused a shortage of IgGs worldwide. The measures implemented (dose and period optimisation) ensured the achievement of an adequate balance between supply and demand, enabling an increase of plasma fractionation industry.

What was done?

A rationalisation plan of human IgGs use was implemented in a tertiary hospital through the multidisciplinary groups, in which Pharmacy Department (PD) participated.

How was it done?

Inside hospital working groups were created between the different IgGs prescribing departments (paediatrics, haematology, immunology and neurology) and PD during a period between 1 May 2021 and 31 October 2021. All patients on regular treatment with IgGs were identified and each one was reviewed: indication, dose, regimen and treatment alternatives. Based on the document “Criteria for the rational use of human immunoglobulins” published by the Madrid Health Service in 2021 and taking into account the clinical circumstances of each patient, decisions were made regarding: continuation or discontinuation of treatment and dose or regimen adjustments.

What has been achieved?

After identifying 184 patients treated with IgGs, a set of pharmaceutical policies has been drawn up in conjunction with stakeholders. Evidence-based intervention focused on assessing the clinical adequacy of actual treatments, optimising indications and dosing, to ensure an equitable supply was done. A total of 34 patients (%) discontinued IgGs, 24 patients reduced doses and 15 increased time between administrations.
As a result, it has been possible to continue the treatment in those patients for whom its use was a vital urgency during shortage period.

What next?

Long-term follow-up is necessary to better analyse the impact of the established measures. Registries play an important role in collection of systematic data to analyse, synthetise, and obtain valuable information for decision support. five patients had to restart IgGs treatment and seven patients had to come back to the initial regimen. Even so, politic rationalisation in special situations is a key factor of pharmaceutical activity to ensure treatments for patients who need it the most.

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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)

Betânia Abreu Faria, Sara Barroso, Antonieta Silva, Olga Martins

Why was it done?

Portuguese legislation “The Basic Health Law (No. 95/2019) and the National Plan for Patient Safety 2021-2026 (NPPS 2021-2026) and the goals of the World Health Organization (WHO) are fundamental pillars of healthcare safety. The NPPS has promoted patient safety in the Portuguese National Health Service, focusing on specific issues such as safety culture, unambiguous identification of patients, safe surgery, pressure ulcer prevention, prevention of falls, infections associated with healthcare and incident reporting and drug safety. Thus, it is essential to ensure the training of health professionals (HP) in the field of patient safety and the safe and rational use of medicines. The objectives of the training actions focused on the safe use of medication, promoting patient safety and sharing experiences between the various HP, in order to optimise the circuits and procedures already implemented.

What was done?

Multidisciplinary training actions were carried out within the scope of safe medicine practices.

How was it done?

A team of four pharmacists and one nurse carried out training actions in the context of Safe Medicines Practices. The following topics were addressed: medicine circuit; good practices in drug preparation; identification of medicines: Look-Alike Sound-Alike (LASA) and High-Alert Drugs; physicochemical incompatibilities; factors that modify stability after reconstitution/dilution; fractionation and crushing of Solid Oral Pharmaceutical Forms (SOPF); drug information sources; reporting adverse drug reactions and other incidents; good practices in medication administration. 

What has been achieved?

Training actions were carried out with a total of 29 hours of training and 357 participants. Suggestions for improvement were presented: optimisation of drug signage, compliance with established circuits, logistical aspects, on time drug information, improvement of communication channels, increase in the frequency of training actions. The trainees expressed receptiveness and interest in this initiative, which provided content that was little discussed and very relevant to their daily practice. 

What next?

The correct preparation and administration of medicines is essential to safeguard their effectiveness and patient safety, which is the ultimate goal of every health professional’s daily activity. The Pharmacist, as part of the multidisciplinary team, must promote strategies that safeguard Safe Practices throughout the drug circuit. Hence it is important to ensure the continuity of these trainings.

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Author(s)

Kirsten Lykke Vorbeck, Laila Rabbani, Somia Mohammad, Anne Bøiehøj, Lene Sehested, Majken Cardel, Lone Skovhauge, Lisbet Emmery Jørgensen

Why was it done?

Having different sponsors with individual requirements and interpretations of rules, means a lot of work. The brochure aims to save time on answering questions by describing to every sponsor how Danish Hospital Pharmacies proceed. By demonstrating that we all do many things in the same way and ultimately have the same requirements, we hope to be able to encourage sponsors to adopt a more unified or aligned approach.

What was done?

Through a collaboration of Danish hospital pharmacies, a working group on clinical trials meet regularly to discuss general procedures and challenges to our handling of clinical trials. Via this a common presentation of how we handle clinical trials and what we can offer has been described in a brochure that is given out to sponsors, investigators, clinical trial units (CTUs), clinical wards, monitors etc. The brochure also serves as an inspiration catalogue to hospital pharmacy colleagues.

How was it done?

In the working group we have discussed processes and which administrative and quality requirements we find reasonable and called for (from our point of view and that of our sponsors). We appreciate that we cannot do everything in exactly the same way, but we have tried to include as much as possible in the brochure leaving it up to the individual pharmacy to supplement with local procedures.

What has been achieved?

The brochure is evidence of our cooperation within Denmark. It has been distributed to relevant partners and to “Trial Nation”, a national entry point for companies who wish to conduct clinical trials in Denmark. It is intended as general information and to be handed out to new potential sponsors. It has resulted in an aligned and time-saving procedure.

What next?

Hospital pharmacies are small players in the field of clinical trials but nonetheless important ones. Working together to find general procedures not only helps ourselves to identify good practices but also means we can create a smoother handling of the trials and that we stand stronger when meeting the different requirements from sponsors. This cooperative approach has met with a good response. It promotes further cooperation between all parties, and it is recommended to be implemented in other healthcare settings.