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IatroMed 360°#Neonat: methodology to develop and evaluate a virtual reality-training course on medication error prevention and management in neonatal intensive care units (NICUs)

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European Statement

Patient Safety and Quality Assurance

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.

A PHARMACOGENETIC CLINICAL DECISION SUPPORT SYSTEM (CDSS)

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Patient Safety and Quality Assurance

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.

Role of pharmacists during COVID-19 pandemic in a Belgian general hospital

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European Statement

Patient Safety and Quality Assurance

Author(s)

Lotte Deschepper, Kenny Noerens, Nilgün Kizilmese

Why was it done?

The COVID-19 pandemic caused limited availability of critical drugs and rapidly evolving treatment guidelines. Patient safety must be guaranteed at all times. However, the pandemic took the follow-up of drug shortages to an unprecedented level, increasing the risk of errors. Fulfilling this task was therefore difficult and new strategies needed to be implemented.

What was done?

In our hospital one pharmacist was dedicated fulltime to the COVID-19 drug management. Another pharmacist was committed to ensure the safe and efficacious use of drugs by conducting medication reviews and giving relevant drug and laboratory recommendations.

How was it done?

Microsoft Power BI ©, a tool to analyze data, was used to monitor the specific drug needs on the COVID-wards. Higher drug consumption was more rapidly detected and more specific actions could be executed. The available stocks in the hospital were also registered in a database and this information was updated and reported daily to the medical staff. In this way treatment guidelines could be proactively adjusted if necessary. Medication alerts were sent regularly by mail to ensure that all health care providers were informed about (temporary) changes in order to reduce the risk of medication errors.
Additionally, pharmacists collected evidence‐based drug information concerning indications, dosing, possible side effects, drug‐drug interactions and other precautions based on (inter)national guidelines. This information was used to develop a back-office validation tool that supported pharmacists to conduct medication reviews in a uniform manner. Daily updated reports from Microsoft Power BI © were used to analyze relevant interactions and contra-indications. Pharmaceutical recommendations were promptly documented and reported in the medical record of the patient and the physician was contacted immediately if urgent.

What has been achieved?

Due to the multi-disciplinary approach and guided medication use, therapy continuation could be guaranteed for all patients. Our validation tool resulted in the early detection and interception of medication errors ensuring patient safety.

What next?

A retrospective risk assessment will be done to evaluate our approach and a disaster plan concerning medication will be established based on our experience. The development of a computer-based analytical tool will be encouraged to maximize patient safety while minimizing risk of medication errors.

THE APPLICATION OF AN EHEALTH MODEL IN THE HEALTH CARE SYSTEM

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European Statement

Clinical Pharmacy Services

Author(s)

MAR GOMIS-PASTOR, ANNA DE DIOS LÓPEZ, MARIA ANTONIA MANGUES, MIRIAM ORS, MERITXELL CUCALA, CATERINA SANPOL, VICTOR ROBERT, XAVIER BORRAS, GEMMA CRAYWINCKEL

Why was it done?

HTP are therapeutically complex patients who may benefit from an intensive telematic follow-up. Moreover, human relations among patients and health providers may be enhanced to improve patients’ empowerment with their health care. Additionally, interdisciplinary eHealth projects lead to increased interaction among health providers, expanding advanced patient-centered care in healthcare systems.

What was done?

An eHealth program directed to heart transplant patients (HTP) was implemented. The software developed was called mHeart and consists on a mobile phone application complemented by a website(https://n9.cl/ajut). A pilot study to validate the software and a clinical trial were conducted. This tool is now extended into clinical practice.

How was it done?

This project and its potential scalability has achieved the creation of a well-established framework involving among relevant others the Legal Department, the Information Systems Department, the patient data protection supervisor, and the Innovation Research Institute.
The success and the scalability of these innovative projects in our centre depended on health providers’ engagement with eHealth, new interoperability solutions, adequate institutional support, and government reimbursement models.

What has been achieved?

The clinical trial conducted in 134HTP has demonstrated to improve recipients’ adherence to immunosuppressants (85% mHeart follow-up vs 46% conventional follow-up)[OR=6.7 (2.9;15.8),P-value=.000], to improve patients’ experience of therapeutic regimens and to reduce in-clinic facilities because the mHeart follow-up. (65% mHeart follow-up vs 35% conventional follow-up)[OR=3.4 (1.7;6.9),P-value=.001].

What next?

This eHealth experience has allowed continuing creating evidence on the use of the eHealth in other populations: an onco-hematological platform, EMMA(Ehealth Medical self-Management Aid), has been designed including diverse profiles depending on the clinical specifications (e.g. multiple myeloma or bone marrow transplant conditions); MyPlan has been adapted to perform an interdisciplinary follow-up of any multimorbid population with polypharmacy. Thus, the system can be used in any multimorbid patients by activating or omitting certain modules that define the target patients’ specific comorbidities (e.g. glycemia module or blood pressure module).
The new EMMA and MyPlan will be clinically tested in diverse trials in 2020 including several health care interdisciplinary teams, including the emergency setting, onco-hematology, migraine, dyslipidemia and cardiovascular risk, among relevant others. In addition, other Spanish centers are implementing the eHealth model and the software in their Institutions assisted by the experience gathered.

Implementation of pharmacological consultation as part of geriatric trauma treatment

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European Statement

Introductory Statements and Governance

Author(s)

Tanja Schicksnus

Why was it done?

The team of the geriatric trauma center consists of an orthopedic surgeon, geriatrician, nurse, physiotherapist, occupational therapist and a discharge management and diabetic nutrition expert according to the German society for orthopedic surgery (DGU) and now also a pharmacist who performs risk screening for drug-related problems such as fall, dizziness, cognitive impairment, conspicuous laboratory values, lack of appetite, etc. immediately after admission, in order to optimize drug therapy.

What was done?

The geriatric trauma center aims to provide geriatric patients with the best possible peri- and post-operative care after a fall with a fracture so that they resume their usual life and environment after the hospital stay. The pharmacist joined the interdisciplinary team with the aim of a medication review for the often multi-morbid and multi-prescription patients.

How was it done?

After the patient has been assigned to geriatric complex therapy according to the DGU criteria, the doctor requests a pharmacological consultation for this patient via the digital patient record. The pharmacist carries out a medication analysis with information from the record as well as bed side visits focusing on possible medication based problems.
Results are stored in the consultation report, serving as documentation and as basis for later evaluation. Important information for immediate implementation is highlighted in the digital file and transmitted to the attending physician by telephone.
Once a week, the entire team meets, with the scope for each patient being: What are the remaining problems? How can these be solved (interdisciplinary)?

What has been achieved?

During four months, medication reviews were carried out for about 100 patients. In the areas of bleeding risk, anticholinergic adverse events, antibiotics, malnutrition, dose adjustments and medicines inappropriate for geriatric patients, for one third of patients corrections led to an improvement in patients. For nearly 10% of patients also a prescription cascade was resolved and some medical device training has increased drug therapy safety.

What next?

Future benefit evaluation will be carried out based on resumption of patients due to a fall, in the categories: Time until next hospital admission, reason for next admission, adoption of optimized medication plan.

The introduction of an emergency intravenous antibiotic reconstitution service during the COVID-19 pandemic.

European Statement

Patient Safety and Quality Assurance

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.

DYSPHARMA: AN ITALIAN WEB-APPLICATION FOR DRUG THERAPY MANAGEMENT IN DYSPHAGIC PATIENTS (submitted in 2019)

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Patient Safety and Quality Assurance

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.

IDENTIFICATION OF HAZARDOUS DRUGS IN EMERGENCY DEPARTMENT: DRUGS CABINET INSPECTION (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

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.

REVIEW OF THE HOSPITAL HIGH-ALERT MEDICATIONS LIST USING HOSPITAL AND INTERNATIONAL DATA (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Božena Bürmen

Why was it done?

In University Medical Centre Ljubljana (UMCL) a HAM list was created in 2008 and has not been significantly changed since then. Our aim was to develop a systematic strategy to review the list by including local data.

What was done?

We comprehensively updated the hospital list of high-alert medications (HAM) and identified hospital specific medications not yet present on HAM lists. We joined international HAM data supported by medication error (ME) reports and expert opinion with data from the hospital ME reporting system.

How was it done?

We analysed 390 MEs submitted to the UMCL ME reporting system from 2016 to 2018. We compared the HAM list from Institute for Safe Medication Practices (ISMP) and the UMCL HAM list. The criteria such as frequency of the reported ME, severity of harm for the patient, affected population, novelty, etc, were used to identify potential HAM. Furthermore, we calculated the probability of the ME report for the individual medications from the reported MEs and the hospital medication consumption data. The calculation was done for the medications involved in 3 or more reported MEs (Tyynismaa et al, 2017) and for the medications involved in MEs which caused harm to the patient.

What has been achieved?

The joined results from the comparison of HAM lists and reported MEs showed that several other medications could be added to the UMCL HAM list, e.g. individualised parenteral nutrition for the paediatric population, oral sedation agents for children, dialysis solutions, lidocaine IV, methadone, bupivacaine, and nusinersen. The probability-based HAM identifying method supported our previous suggestions to extend the UMCL HAM list. Additionally, the method unexpectedly revealed medications with a high probability of ME and/or harm for the patients, that are not included in any HAM list (ISMP, UMCL), such as romiplostim, parenteral iron preparations, ampicillin with sulbactam, and others.

What next?

In future we plan to develop a paediatric specific HAM list based on the same strategy; i.e. considering international suggestions and analysing paediatric ME reports in UMCL.

THE ACTIVITIES AND IMPACT OF A HOSPITAL-WIDE MEDICATION INITIATIVE (submitted in 2019)

European Statement

Patient Safety and Quality Assurance

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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