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Elaboration of a Good Practice Guide for the administration of parenteral antibiotics at children’s hospital

European Statement

Patient Safety and Quality Assurance

Author(s)

MOHAMMED ADNANE EL WARTITI, WAFAA ENNEFFAH, BOUCHRA MEDDAH, MUSTAPHA BOUATIA

Why was it done?

The GPG was developed in a concern of practices standardization to guarantee the safety and efficacy of parenteral antibiotics, especially those stored in vials which reuse in possible only if conditions of administration and stability are respected.

What was done?

We developed a Good Practice Guide (GPG) for the usage of major available parenteral antibiotics.

How was it done?

After we listed all parenteral antibiotics available at the hospital pharmacy, we selected the most used ones and we synthesized all manufacturers’ data to establish a GPG for their administration. We also used literature data to complete missing information in “Summaries of Product Characteristics” related to pediatric use of these drugs. Finally we determined the most antibiotics consuming units according to their defined daily doses, where GPG recommendations will be implemented, before their extension to all other units.

What has been achieved?

The GPG concerned the most used antibiotics, which mainly belong to the following classes: Beta-lactam, Glycopeptide and Imidazole antibiotics, Aminoglycosides and Quinolones. It specifies the galenical presentation, used solvents, volume and duration of administration, stability after reconstitution as well as incompatibilities and special measures relating to the use of these drugs. The most antibiotics consuming units are pediatric intensive care units, “IIB” pediatric unit and pediatric surgical emergency department.

What next?

The approach used in this work can be adopted in other similar structures in order to establish GPGs within the framework of a quality control policy aiming to raise the standard of care.

MEDICATION ERRORS RELATING TO ISOAPPEARANCES AT THE EMERGENCY ROOM

European Statement

Patient Safety and Quality Assurance

Why was it done?

To achive the international Organization for Standardization (ISO)´s objectives related to medication errors.

What was done?

A multidisciplinary isoappearances group formed by a clinical pharmacist, a nurse, and two physicians has been set up on site at the ER.

How was it done?

Observational study.

What has been achieved?

In the future, hopefully medication errors at the emergency setting would be reduced.

What next?

Because the Isoappearance group will promote patient safety.

Improving Patient Safety: A step forward in reducing missed medication in the Emergency Department (ED)

European Statement

Patient Safety and Quality Assurance

Why was it done?

Long waiting times and delays in patients leaving ED increase the risk for missed doses. Medication reviews and analysing incident reports identified missed doses as a patient safety issue where the strategies implemented aimed to improve this.

What was done?

Reducing missed doses and improving patient safety was addressed as follows:
 Integrated pharmacy service was established
 Audit completed
 Education model developed
 Stock list reviewed

How was it done?

Integrated pharmacy service:
-Outlined the role of the pharmacy team in ED.
-Pharmacist medication review service established which identified medication incidents particularly missed doses.
-Pharmacy technician role expanded: Reviewed patient charts, identified issues, collaborated with the ED team, and dispensed medication in medication
transfer bags.
-Implemented medication transfer service: Individual patient medication transfer bags were sent from ED to the transfer ward ensuring timely availability
of medication during transitions of care.

Data collection and analysis:
-Quantified missed doses and reviewed the percentage of these which were time-critical. Time-critical medications are medications where timely
administration is crucial to prevent patient harm.

Education model:
-Developed and implemented a pharmacy technician training programme: This ensured an optimal medication management service.
-A local list of time-critical medication was agreed upon. A poster was developed and erected in ED to highlight time-critical medication.
-Structured and targeted multi-disciplinary education was provided on time-critical medication and the impact of missed doses.

Stock list modified so medication was immediately available in ED. Capacity in the automated dispensing unit (ADU) was an obstacle so the ADU was reconfigured to overcome this.

What has been achieved?

 A clinical pharmacy service was established which reduced medication errors.
 Missed doses decreased by 75%.
 Time-critical medications are readily available.
 Medication transfer bags ensured timely availability of medication during transitions of care.
 Education model implemented which improved patient safety.

What next?

 Continue the integrated pharmacy service in ED.
 Missed doses will be assessed through point prevalence surveys, medication reviews, and incident reports.
 Extend the education model to other areas of the hospital and apply learning.
 This initiative can be adapted to other hospital settings.

Improved drug management for surgical inpatients through the presence of a clinical pharmacist at the preoperative clinic

European Statement

Clinical Pharmacy Services

Author(s)

Françoise LONGTON, Olivia Polinard, Linda Mattar, Anna Pauels, Mireille Bourton, Michel Mattens

Why was it done?

A thorough medication history at admission reduces medication errors. The presence of a clinical pharmacist in the preoperative clinic increases the number of inpatients who receive a standardized medication history by a pharmacist.

On admission, the adaptation of home medications to the hospital formulary can also be a source of error or delay. The fact that the patient is seen by a pharmacist prior to hospitalization makes it possible to anticipate drug substitutions and possible orders for non-formulary drugs.

Moreover, surgeons do not always have the possibility to prescribe medications taken at home upon admission, which results in a delayed availability of the medication. Thanks to this multidisciplinary project the continuity of treatment is assured.

What was done?

During the preoperative consultation, a pharmacist takes a medication history and enters it into the computerized medical record, making it available for the anaesthetist.

Upon admission of the patient, the continuity of the medication is ensured by the pharmacy.

Indeed, during the admission, the nurse follows a procedure that informs the pharmacy of any medication changes since the preoperative consultation. Afterwards, the pharmacy encodes the treatment into the computerized intra-hospital prescription and delivers it to the department.

Before any drug administration, this treatment is signed by the doctor responsible for the patient.

How was it done?

Preoperative consultations had to be structured so that each patient was first seen by the pharmacist, second by a nurse and third by the anaesthetist.

Thus, the main obstacle was organizational and it was overcome through the centralized management of preoperative clinic appointments.

What has been achieved?

In 2020, 54% of patients admitted for surgery (elective or emergency surgeries) were seen in the preoperative clinic.

What next?

This is an example of good practice as it ensures a standardized medication history and admission management.

Value of Integrated Inventory Management and Automation Solution for Medical Devices and Supplies: a case study

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European Statement

Patient Safety and Quality Assurance

Author(s)

Serdar Kaya, Ulker Sener

Why was it done?

Despite medical devices and supplies are often high-cost products, they are often sub-optimally managed by hospitals. The objectives of the installation were the optimization and the automation of the inventory, and the charge management workflows, to comply with JCI (Joint Commission International) standards and address current challenges as safety, labor, stock-outs, space, costs and charges accountancy, traceability.

What was done?

An integrated Inventory Management and automation solution was implemented at Amerikan Hospital Istanbul (BD Pyxis™ SupplyStation™ system). 83 automated dispensing cabinets, a central management system, and a data analytics solution, are serving the 278-beds hospital.

How was it done?

The workflows for medical devices/supply inventory, and for patients charge management were mapped pre-installation and major challenges identified. Based on these needs, the decision to automate the hospital supply management was made. The cabinets were installed in the whole hospital but in particular in operating rooms, emergency rooms and intensive care units.

What has been achieved?

The impact of automation was measured one-month pre and one-month post installation, and five major areas of improvements have been identified:
1) Significant decrease in workload: -8% for nurses; -30% for charge secretaries
2) Missing charge rate reduced from 2.5% to 0.1%
3) Improved use of space and material organization
4) Inventory optimization: 0% stock-out, -16% expired items; – 45% on-hand inventory
5) Improved materials and patients’ safety, ensuring that supply were managed in the right way by the right staff. Patients are now protected by the risk of being provided with the wrong device.
All the nurses (n>50) were interviewed, reporting great satisfaction and ease of use with the new system. Furthermore, a positive return on investment was achieved in 4 years.

What next?

Due to legal regulations (MDR Regulation/ UDI Tracking requirements) the hospital is planning to leverage the automated system to achieve a full compliance and traceability of critical medical devices throughout their hospital.
The decision of investing in automation demonstrated important benefits in terms of safety and efficiency, with a positive impact on the hospital’s economy as well.

IMPLEMENTATION DESIGN OF A SECURITY STRATEGY IN THE HANDLING OF HAZARDOUS DRUGS IN A SOCIAL HEALTH CENTRE

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European Statement

Patient Safety and Quality Assurance

Author(s)

CRISTINA MORA HERRERA, VICTORIA VAZQUEZ VELA

Why was it done?

Occupational exposure to HD can cause health damage to exposed healthcare professionals, so protective measures must be taken

What was done?

The hazardousness of drugs can cause damage due to exposure in healthcare workers from Social Health Centers (CSS). As an objective, the design of a security strategy in the handling of hazardous drugs (HD) was proposed with the elaboration of a safety working procedure (SWP) and preventive measures. In addition, the HDs were identified, with proposals for alternatives and recommendations for handling and administration were released.

How was it done?

Observational cross-sectional study to identify employment MPs in a public CSS. The demographic characteristics of the patients and their Pharmacotherapeutic prescription were recorded. A total of 107 residents were included, with a mean age of 78.9 years and 59.8% (64) men. The average stay in the center was 7.4 years (1-27). Regarding functional capacity, 53.3% were considered assisted, 89% of them with grade III -II assessment, that is, large dependents and severe dependents. Of the valid group (46.7%), 70% belonged to socially excluded. The most prevalent pathologies in the center are vascular, neurodegenerative, osteomuscular and respiratory. The mean number of medications per patient was 4.8. Only 6 patients did not receive Pharmacological treatment.
The design of the security strategy was structured in 3 phases; 1st)Elaboration of an SWP with assignment of functions/responsibilities, preventive measures to be adopted in the handling of HDs, description of the circuit and quality indicators of the strategic procedure; 2nd)Carrying out a descriptive observational cross-sectional study to identify the HDs used. The list of active principles (AP) included “NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2014” was compared with those included in the GFT of the center; 3rd)Releasing of recommendations through information sessions/ workshops for healthcare professionals.

What has been achieved?

An effective and safe employment system/circuit is established in the SWP, with relative preventive measures to control associated risks that may occur in handling and/or administration. 22 HDs were identified. A safer alternative was proposed for 9. Recommendations for the handling of HDs, associated risks and proper use of PPE were disseminated through 2 training sessions.

What next?

The identification of hazardous drugs and communication of improvement actions made it possible to implement a standard work procedure guaranteed safety in handling, and to provide an adequate means to avoid exposure due to healthcare workers.

Possible interactions from COVID-19 drug employment: the Hospital Pharmacist’s intervention in a regional hospital

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European Statement

Patient Safety and Quality Assurance

Author(s)

Simone Leoni, Sabrina Guglielmi, Vincenzo Nicola Menditto, Adriana Pompilio, Francesca Vagnoni

Why was it done?

During the pandemic, almost all hospital departments were converted in COVID-19 wards and clinicians of several specializations were asked to work in. In a situation characterized by a great number of patients, mainly old and with several comorbidities, health professionals had to employ quickly drugs never used before and supported by limited scientific evidences. In this context the percentage of possible DDI rises out of proportion exposing patients to potential devastating consequences.

What was done?

During COVID-19 emergency we develop a quick reference tool for clinicians involved in first line assistance to patients. A table summarizing drug-drug interactions (DDI) of the most used therapies was created to allow professionals making the best pharmacological decision.

How was it done?

After a literature review using Micromedex and TERAP (Mario Negri Institute), we have created two table summarizing DDI of lopinavir/ritonavir (LR) and hydroxychloroquine (HC). Those drugs have been grouped according to pharmacological group and clinical relevance. The tables were provided to Infectious Disease, Intensive Care Unit and Emergency Medicine departments.

What has been achieved?

The tables showed 359 DDI for LR (67% contraindicated/severe, 12% major and 21% moderate) and 176 for HC (96% contraindicated/severe, 1% major and 3% moderate). Almost all contraindicated/severe interactions of HC were the same of LR and regarded: protein kinase inhibitors, beta2 agonists, macrolides and fluoroquinolones antibiotics, some antidepressants, phenothiazines, protease inhibitors and antiarrhythmics. Other LR severe interaction were: factor Xa inhibitors, statins and benzodiazepine derivates. Both LR and HC present moderate interactions with acid pump inhibitors, while LP interacts with Ca and vitamin K antagonists and antiepileptics.
Interactions mentioned have a great impact, since they concern drugs commonly used and hypertension, diabetes, respiratory system disease, cardiovascular disease are the most frequent comorbidities linked to COVID-19. Tables provided had a positive impact in avoiding DDI. Pharmacist was consulted for drug dosing and frequency adjustments. The intervention was fully accepted and extended to the rest of COVID-19 wards.

What next?

The project represents a good example of multidisciplinary collaboration able to improve safety and efficacy in pharmacological treatments. The added value of the Pharmacist and the simplicity of the tool make it useful and easy to extend to other healthcare settings.

NEW TECHNOLOGIES TO IMPROVE SAFETY IN PREPARATION AND ADMINISTRATION OF INTRAVENOUS ANTINEOPLASTIC DRUGS

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European Statement

Patient Safety and Quality Assurance

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.

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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European Statement

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.