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Author(s)

Carlos Aparicio Carreño, Arantxa Gándara Ande, Beatriz Fernández González, Andrea Forneas Sangil, Belén Rodríguez de Castro, Rubén Pampín Sánchez, Cristina Martínez-Múgica Barbosa, Paloma NIeves Terroba Alonso

Why was it done?

To improve safety during preparation and administration of IAD.

What was done?

A new computerized system was established to improve quality control and traceability in preparation and administration of intravenous antineoplastic drug (IAD).

How was it done?

The software currently in use was updated, checking densities of IAD, weights of diluents and consumables. Protocols in pharmacology were adapted and maximum permissible error rates during elaboration were established. The Aseptics Pharmacy Department was equipped with a barcode label printer (BLP), a barcode scanner (BS), a precision scale and an All In One computer for the biological safety cabinet (BSC). The Haematology and Oncology Day Treatment Unit (DTU) was equipped with a BLP (for hospital bracelets) and portable computers with BS.
Regarding elaboration, a qualitative control was performed in the BSC by scanning data matrix or barcodes, recording batches and expiration dates, both of the diluent and antineoplastic agents. A quantitative gravimetric test was also performed using weight measurement of the diluent and devices before and after adding the drug. When the mixture was correctly prepared a label was printed with an identifying barcode.
Administration of the right bag to the right patient was also ensured by scanning barcodes in DTU: A hospital bracelet with a barcode was printed to identify each patient at their arrival to DTU. Prior to administration, double scan confirmation was made, checking patient´s bracelet and treatment (label), by using BS, ensuring that each patient received the drug, at the right dose, on time and by the correct route of administration.

What has been achieved?

All intravenous cancer therapies have been administered with double scan confirmation in DTU since the new system was established (November 2019).
This new way of processing IAD has been completely installed, but not all the antineoplastic treatments have been prepared with quality control.
The whole process has also left a complete computer record of the staff, task performed, time, duration and potential incidents.

What next?

We will gradually implement quality control while processing all intravenous antineoplastic treatments.

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Author(s)

Elodie Delavoipière, Laura Fazilleau, Carine Lehoussel, Isabelle Goyer, François-Xavier Roth, Julien Mourdie, Agnès Bobay-Madic, Simon Rodier, Bernard Guillois, Albane Cherel

Why was it done?

360° virtual room of errors is an innovative educational tool which can be included in strategies of ME risk management. NICUs are high-risk areas and consequently, a priority target. Therefore, we developed and evaluated a virtual reality-training program based on medication error management in the NICU of a university hospital centre.

What was done?

A virtual reality-training course was developed and evaluated, regarding prevention and management of medication errors (ME) in NICUs.

How was it done?

A multidisciplinary working group was set up (2 pharmacists, 2 neonatologists, 1 pharmacy resident and 3 NICU nurses) to define: the target audience, the training model, the assessment methods (pre-training and post-training evaluations), training days and educational materials.

What has been achieved?

The program was intended for professionals involved in the medication circuit in the NICU: physicians, residents, and nurses. Weekly sessions have been scheduled in order to train 99 professionals. Every session was run by 3 professionals (physician, nurse and pharmacist) and lasted two hours and a half. The session was divided into 5 stages: 1/pre-training evaluation, 2/briefing, 3/360° digital simulation allowing ME detection, 4/debriefing, 5/ post-training evaluation. Although, it was a digital-training, a pedagogical formula with “classroom” training sessions has been chosen in order to promote interactivity between learners and trainers particularly during the debriefing. This virtual reality-training course was assessed by Kirkpatrick’s four levels of training evaluation model: satisfaction questionnaires, knowledge evaluation and skills self-assessment, audits of practices, monitoring of indicators (adverse event reports). Assessments were done before each session, immediately after and within 3 months of the session, to both evaluate and enhance educational impact.

What next?

This concept promotes the link between clinicians from the NICU and the multi-disciplinary approach concerning the risk management of ME. By directly involving all the healthcare professionals, this innovative training provides a patient-safety culture development and the implementation of safety measures. The implementation of this training concept in a multi-centric assessment of professional practices should enable to confirm pedagogical interest of such innovative sessions and his deployment in other health facilities.

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Author(s)

Xando Díaz-Villamarín, Ana Pozo-Agundo, Paloma García-Navas, Alba Antúnez-Rodríguez, Celia Castaño-Amores, Cristina Lucía Dávila-Fajardo

Why was it done?

Nowadays, it is known that at least 33% of patients show variable response to drugs. Of those, genetic polymorphisms explain around 15-30% of these cases, single nucleotide polymorphisms (SNP) being the genetic markers most clinically relevant. In 2013, 40 million SNPs were identified in humans and some have been observed to determine drug response. These observations lead to the incorporation of genotyping some of these SNPs as a recommendation in many drug labels before treatment initiation.
Since patient´s drug response may be determined by certain SNPs in different genes it is necessary to develop CDSS based on pharmacogenetic (PGx) information that makes feasible its application in clinical routine, translating genotypes into phenotypes and dosing recommendations.

What was done?

We have developed a local Clinical Decision Support Systems (CDSS) that informs the physician on the availability of a PGx test in our hospital for certain prescribing drugs. This system will also be able to translate the genetic information into dosing recommendations.

How was it done?

We selected all the SNPs affecting drug response for which there is already a PGx test available in our hospital. All of them have been previously validated, and, only genes/SNPs related to drug response with the highest level of evidence, available in the Dutch Pharmacogenomics Working Group (DPWG) and Clinical Pharmacogenetics Implementation Consortium (CPIC) dosing guidelines with a minor allele frequency higher than 0,1% in our population have been included. We have considered all the different genotypes according to the SNPs included and linked them to a phenotype and dossing recommendation according to CPIC/DPWG guidelines.

What has been achieved?

Our CDSS connects different drugs with available PGx test in our unit, showing which gene should be genotyped before prescription. It translates genotypes into phenotypes and also provides dosing recommendations once PGx results are received, according to the CPIC and/or DPWG guidelines. Nowadays, this system facilitates the workflow for the implementation of pharmacogenetic tests in our hospital.

What next?

We have developed a CDSS that manages PGx information facilitating the implementation of pharmacogenetics in daily clinical routine. It will also allow us to expand our services to other medical departments within our hospital.

Author(s)

Joanne Rhodes, Chris Bidad

Why was it done?

There was concern that there was a risk of reconstitution errors, missed doses or variation in dosing intervals which could impact on treatment efficacy and patient safety due to:
• a sudden increase in demand for IV antibiotics,
• depleted numbers of front-line nursing staff, and
• nurses being deployed to unfamiliar clinical environments and encumbered by PPE.
The emergency IV antibiotic reconstitution service was designed to mitigate these risks.

What was done?

In the absence of aseptic dispensing facilities an emergency intravenous (IV) antibiotic reconstitution service was set up in a laminar flow operating theatre. Nurses who could not work in a patient-facing role during the pandemic prepared ready-to-use infusions under the direct supervision of a pharmacist.

How was it done?

It was determined that a manufacturer’s licence was not required under part one, section three of the Human Medicines Regulations 2012 providing strict criteria were adhered to. Stability data was collated for the most frequently used IV antibiotics. Even where stability data supported a longer period, a maximum expiry of 24 hours after preparation was assigned. Processes were designed to adhere as closely as possible to the GMP principles described within The Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017. Specially tailored IV reconstitution training was delivered to the nurses.

What has been achieved?

Over a period of 4 weeks at the peak of the pandemic 1000 doses of IV antibiotics were prepared and supplied, enabling ward-based nurses to focus directly on patients. There were no reports of any incidents of delayed or missed doses, or administration errors relating to IV antibiotics supplied to the wards involved during this period. The time saved on the wards was equivalent to having 3 additional nurses on the wards each day.

What next?

With a reduction in the number of COVID-19 positive patients now presenting to the hospital the service has been paused but placed on standby so that it can be resumed in the event of a second wave. Work is underway to determine if there would be value in the team preparing a wider range of products, particularly those which may be of particular use in critical care areas such as sedatives and inotropes.

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Author(s)

Serena Logrippo, Giulia Bonacucina, Matteo Sestili, Alessandro Caraffa, Marco Cespi, Roberta Ganzetti

Why was it done?

Dysphagia is a well-known community issue that affects primarily aged people [1]. The availability of appropriate dosage forms for dysphagic patients is essential to guarantee therapy adherence. Extemporaneous compounding of SODSs (e.g. crushing tablet or opening capsules and dispersing the obtained powder in an appropriate base or vehicle) is a common practice due to the unavailability of different dosage forms to satisfy the current needs of patient. However, compounding practice is neither risk-free nor error-free [2]. The aim of the work was to realise a web application to support HCPs in drug therapy management of dysphagic patients.

What was done?

To properly manage oral therapy in dysphagic patients, a multidisciplinary team developed an algorithm and applied it to over 8000 medicinal products available as solid oral dosage forms (SODSs). A web-based, decision-making tool was launched to support healthcare providers (HCPs) during the prescription, compounding and administration of SODFs to dysphagic patients.

How was it done?

An extensive review of the Italian pharmaceutical market database, product characteristic summaries and scientific literature were used for data collection. For each prescription drug formulated as SODF, an information sheet was elaborated and continuously updated.

What has been achieved?

DysPharma (www.dyspharma.it) is an on-line support currently available and under restyling. By registering and logging-in, it is possible to access technical content that comprises medicinal product details, drug-food interactions, extemporaneous compounding methods, and risk symbols. Medicinal products can be searched by active ingredient name, medicinal product name, and marketing authorisation.
Customised symbols are reported for: do not crush tablets or open capsules, do not split tablets, to wear personal protection devices in case of manipulation of hazardous drugs, and drug associated with dry mouth.

What next?

This decision support tool may be integrated with computerised medical records to reduce medication-prescribing and administering errors and to improve clinical outcomes of dysphagic patients.

References:
[1] Clavé, Pere, and Reza Shaker. “Dysphagia: current reality and scope of the problem.” Nature Reviews Gastroenterology & Hepatology 12.5 (2015): 259. [2] Logrippo, Serena, et al. “Oral drug therapy in elderly with dysphagia: between a rock and a hard place!” Clinical interventions in aging 12 (2017): 241.

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Author(s)

Mª Antonia Meroño-Saura, María López-Morte, Taida Rodríguez-Martínez, Pilar Pacheco-López, Consuelo García-Motos

Why was it done?

The publication of the NIOSH list and its application by INSHT in Spain has changed the concept of “Hazardous drug” in terms of its handling and administration, as well as personnel training involved in its management.

What was done?

The main objective is to label every drug considered “Hazardous” and to review the medication included in the Emergency Department kit in a tertiary hospital.

How was it done?

Literature about Hazardous drugs was reviewed. All the drugs included in the Emergency Department kit belonging were identified and classified according to their level published in the NIOSH list. A kit’s review was carried out on site, as well as a Hazardous drugs’ categorisation by adequate labels.

What has been achieved?

6 out of 239 drugs included in the emergency kit were labelled as Hazardous drugs, and could be found in 9 different presentations. Regarding its risk level according to the NIOSH list; chloramphenicol, risperidone and all different presentations of phenytoin were classified as level 2. Acenocoumarol, colchicine/dicycloverine and all different presentations of valproic acid were classified as level 3.
The following incidents were detected;
– Lack of identification: 8 out of the total number of drugs presented identification errors.
– Location error: 4 out of the total number of drugs were not well located.
– Photosensitive: 56 out of the total drugs were photosensitive, of which 11 were not correctly identified or stored.
– Expired drugs: 12 drugs, whose total stock was 399 units. 51 out of the total amount were expired.
After this review, the following measures were carried out:
– Orange labelling for Hazardous drugs’ identification, regardless of their risk level.
– Misidentified drugs were re-labelled, and those that were misplaced were placed in their assigned spot.
– Photosensitive drugs were correctly identified by blue labels and properly preserved.
– Expired drugs were withdrawn.

What next?

Simplifying Hazardous drugs’ identification by a categorisation following a colour code could lead to a safer manipulation by the professionals. During the review of the kit, several incidents were detected and sorted out, which avoided possible medication-related errors. Therefore, it is necessary to establish several control measures in emergency kits in order to avoid errors and improve the safety in the use of drugs.

Author(s)

Alice Oborne, Mark Kinirons, Virginia Aguado, Steve Wanklyn, Laura Watson, Jaymi Mistry, Duncan McRobbie, Abhiti Gulati, Emma Ritchie, David Wood, Niall Stewart-Kelcher, Adrian Hopper, Patricia Snell, Tony West

Why was it done?

Medicines are common interventions but have inherent dangers: 9% inpatient prescriptions contain errors, and medication errors occur at an estimated rate of one per patient per day [1-3]. Medication incident reporting was low, with high proportions of harmful incidents.

What was done?

Senior and junior staff collaborated to systematically improve safe medication processes and outcomes in a 1200-bedded multi-site hospital. The work aimed to reduce harm from medicines and improve medication safety culture.

How was it done?

Pharmacists, doctors, nurses and governance staff set up a Medication Safety Forum which met monthly to focus on high risk drugs, processes and patients. Published literature and international guidance were reviewed [1-3]. Twelve subgroups worked on safer opioid, insulin, anticoagulant, allergy and injectable medicine use and paediatric, elderly, critical care and peri-operative care. Subgroups published guidelines on the hospital intranet. External aviation and patient safety experts reviewed processes. Medication incident data were reported to staff monthly from June 2008. A monthly medication safety newsletter (total 68), screensaver messages, podcasts, mouse-mats, ‘safety days’, audit, training and senior staff promoted best practice. Electronic prescribing and medication administration (EPMA) with decision support was introduced in 2015.

What has been achieved?

The Medication Safety Forum met monthly 2009−2019. Medication incident reporting increased from 60 to over 400 per month (total 31330 over 11 years), whilst harmful incidents all reduced (Figure). Incidents with harm reduced from 51 to 24 in the first to last 20 months. Dose omissions reduced by 10% despite an increase in patient acuity, anticoagulant use and insulin use. The most common incident type was wrong dose, agreeing with national incident data. New guidelines included 30 for insulin, 28 anticoagulation and 19 opioid use. Medication incident reporting increased from 10th to highest in similar hospitals [3].

What next?

Multidisciplinary leadership, multimedia guidance, technology, audit and feedback in medication safety can be applied in any healthcare setting to enhance patient safety. Further system enhancements are planned.

References:
[1]National Patient Safety Agency 2004. Seven steps to patient safety
[2]Prescribing report, 2010. www.rcpLondon.ac.uk
[3]NHS Improvement organisational data reports

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Author(s)

Luis Pérez de Amezaga Tomás, María Magdalena Parera Pascual, Mónica Sanz Muñoz, Catalina March Frontera, Gonzalo González Morcillo, Alejandra Mandilego Garcia, Álvaro Medina Guerrero, Ana Filgueira Posse, Montserrat Vilanova Boltó

Why was it done?

Administration of intravenous KCl produces hyperkalaemia and this can result in cardiac arrest and death. The Institute for Safe Medication Practices (ISMP) as well as other security agencies have recommended the withdrawal of KCl 2M from ward stock. This project was born as a response to these recommendations. We focused on a group of patients where these practices have not been extensively implemented. The aim of the protocol was to standardise the prescription, preparation, dispensation and administration of KCl to neonates in our hospital.

What was done?

Development of a protocol that standardises diluted potassium intravenous solutions for neonates (including those preterm over 28 weeks of gestation). This allowed us to remove concentrated potassium chloride (KCl) 2M from neonatal care units in our hospital. For this purpose, the hospital pharmacy centralised the preparation and distribution of KCl ready-to-use infusions.

How was it done?

The elaboration of the protocol took place as follows: • A multidisciplinary team designed KCl ready-to-use solutions that met the requirements of the newborn: – Glucose 10% 250mL with 5 mEq KCl (20mEq/L solution) – Glucose 10% 250mL with 10 mEq KCl (40mEq/L solution). • The hospital pharmacy centralised the preparation of these solutions. A risk assessment was performed and determined an expiration date of 7 days. • These solutions were stocked at all neonatal care units: Intensive Care Unit, Hospitalized Paediatric Unit and Paediatric Emergency Unit. • Weekly, the hospital pharmacy distributes these solutions and disposes of the expired ones. • Only ready-to-use KCl solutions were able to prescribe at the electronic prescription programme. • A formation plan was implemented to train all the professionals involved in neonatal care.

What has been achieved?

The protocol was implemented in November 2016. Since then, 65 patients have been treated with 20mEq/L solution and only 1 patient with 40mEq/L solution. No remarkable imbalances in electrolytes have been detected resulting from the standardisation of the fluid therapy with KCl. Only 3 incidents have been registered. All of them were prescription errors (solution selection); they reached the patient but without damage.

What next?

Nowadays, we are developing a stability study of the KCl solutions in order to assess the appropriateness of the expiration date.

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Author(s)

M. T. Barrera, O. Carrascosa, P. Madrid, A. Aguado, R. Martínez , N. Argüello, E. Cuellar, M. Vela, C. Jimenez, S. Payan, O. Sánchez

Why was it done?

Lack of stock delays medication administration by nurses. This situation also generates hospital warden displacements to Pharmacy Service and telephone interruptions of Pharmacy technicians’ work. The main aim was to amend stock lack management to improve patient security during medication preparation and administration. The secondary objectives were: reduce interruptions of other health professionals and automate warehouse exits, avoiding errors of manual updating of Pharmacy stock.

What was done?

This tool is part of “Safe Medication Administration in Hospitalization/Avoid Interruptions” project. A “button” was included in the nursing administration view of the electronic prescription programme, which when activated automatically generates a request to the Pharmacy Service for a dose of required medication. Hospital Information Systems were contacted for the design. All requests generated during the administration of medication were automatically received in Pharmacy Service. They were grouped by plant, listed, deducted from stock and dispensed at the agreed times.

How was it done?

The tool was developed by Hospital Information Systems, in collaboration with nursing, and staff training was carried out for correct handling of the tool. Also, medication dispensing schedules were agreed with the hospital warden. 15 days before tool implementation, the Pharmacy Service analysed all medication requests made from hospitalisation. Data collected were: plant and shift requested, reason, existence of pattern, requested medication, requested units, notice to auxiliaries to collect medication. After the first week of implementation, the same assessment of requests was made during the same period to compare and evaluate the impact of this tool implementation.

What has been achieved?

When both periods were compared, prescribed medication requests decreased from 198 to 15, this difference being statistically significant (Fisher’s exact test p=0.008). This difference meant significant reduction of interruptions in Pharmacy technicians’ daily work. Requests reasons were lack of dose in 43.4% (n=95) of cases, immediate prescriptions in 29.2% (n=64) of cases and treatment change in 20.5% (n=45) of cases. 29.2% of all requested medications belonged to the antimicrobial and antiviral group. 62% (n=135) of the total requests were received in the morning shift. Hospital warden displacements were significantly reduced when comparing both periods from 102 to 3 (Chi square test, p=0.006). This meant a significant reduction in interruptions in hospital warden work. It has been possible to standardise and improve efficiently nursing management of medication stock lack.

What next?

The incidents technical improvement is pending, as well as training of new nursing staff. It is possible to implement this tool in all hospital units that have electronic prescription.

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Author(s)

Noelia Vicente Oliveros, María Muñoz García, Álvaro Ruigomez Saiz, Montserrat Ferre Masferrer, Teresa Bermejo Vicedo, Eva Delgado Silveira, Lucía Quesada Muñoz, Ana María Alvarez-Diaz

Why was it done?

An analysis of the indicators of the perioperative process reflected the need to improve their quality. One of the causes of scheduled surgery cancellation was the lack of the follow up of the anaesthetist’s medication recommendations. Medications need to be carefully managed to prevent perioperative complications.

What was done?

We designed and implemented a flow chart to ensure the patient compliance of anesthetist’s medication recommendations prior to surgery. We designed a protocol for the perioperative medication management.

How was it done?

A multidisciplinary group was formed with the management of the hospital and representatives of all the services involved in the perioperative process. The group designed the flow chart of the process by consensus. Patients were candidates to enter in this process if they were on treatment with anticoagulant or 2 or more medications from the following groups: antiplatelet, antihypertensives, antidiabetics. A pharmacist called by phone three times (the day before, the day of medication change, and the day after) to the patient to ensure the compliance of anaesthetist recommendations. If there was a lack of compliance, the pharmacist contacted the surgeon who was in charge of deciding if the surgery procedure continued as scheduled. Moreover, the domiciliary medication of these patients were reconcilliated and recorded in their health record. Healthcare professionals could consult it during hospital stay. The group designed a protocol for the perioperative medication management with different medical specialists.

What has been achieved?

The project started in April 2019. The pharmacist called patients with scheduled surgery of lower limbs. A total of 31 patients benefited from the new flow chart. The pharmacist detected 38 medication errors; two involved errors concerning the suspension of anticoagulant drugs prior to surgery and four implied antihypertensive drugs. Once, it was necessary to contact the surgeon. In this case, the surgeon decided to continue with the surgery as schedule. Fifty-seven medications suffered a change in the period between the anaesthestic visit and the surgery, nine of them belonged to the monitored medication group. 

What next?

The next steps are to spread the flow chart to other patients, to distribute the protocol among hospital healthcare professionals and to implement a procedure for the reintroduction of the modified medication.