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Author(s)

Pauline Barreau, Joséphine Courouble, Pierre Pilven, David Vandecapelle, Thibault Stala, Geoffrey Strobbe, Guillaume Marliot, Frédéric Feutry

Why was it done?

Two prescription assistance software are using in the hospital: DXCare®, for global drug management, and Chimio®, specific to the prescription and preparation of injectable chemotherapies. Clinical pharmacists (DXCare®) and pharmacists in charge of preparation (Chimio®) carry out the pharmaceutical analysis independently and they may not detect potential pharmacokinetics/pharmacodynamics drugs interactions or pathophysiological contraindications, slowing down the pharmaceutical analysis. Pharmaclass® can improve that by crossing all data flows between DXCare® and Chimio® and alerting the pharmacist. The objective were to select and code priority alerts and evaluate the detectability of drugs interactions and pathophysiological contraindications by the software Pharmaclass®.

What was done?

Pharmaclass® is a software based on rules created by the pharmacist, from pharmaceutical algorithms. This rules engine crosses in real time all data flows of several software and sends alerts that must be analyzed by a pharmacist. It was applied in oncology for injectable chemotherapies.

How was it done?

An interface was set up between DXCare®/Chimio® and Pharmaclass® to allow the creation of requests. An analysis of drug consumptions and drugs at risk of interactions helped to select seven molecules (Methotrexate, Bevacizumab, Fluorouracil, Ifosfamide, Irinotecan, Cisplatin, Pemetrexed). A study of the summaries of the product characteristics and the drug interaction thesaurus and a bibliography was conducted and the rules were coded. These were checked by creating test patients with false prescriptions.

What has been achieved?

Eleven rules were created and, after some tests and coding readjustments, all was detected. Nine rules are about drugs interactions: three contraindications (Methotrexate/Trimethoprim, Methotrexate/Acetylsalicylic acid, Bevacizumab/Naloxegol), three associations not recommended (Methotrexate/Amoxicillin, Methotrexate/Ciprofloxacin, Fluorouracil/Antivitamin K), one precaution of use (Ifosfamide/Aprepitant) and two other rules concern enzymatic induction and inhibition of the metabolism of Irinotecan. The last two rules link the glomerular filtration rate with Cisplatin and Pemetrexed.

What next?

Following these creations, Pharmaclass® has allowed to detect drug interactions and pathophysiological contraindications that were not previously detectable. Thereafter, objective will be to establish an organization for the management of alerts and evaluate the number and the relevance of these alerts. New rules will be created for all injectable chemotherapies used in the hospital. Other center of Unicancer will be able to use these rules.

Author(s)

Cyril Magnan, Elise Betmont, Guillaume Saint Lorant, Hubert Benoist

Why was it done?

Evaluate the economic impact of improvement actions taken since 2017 on TSPs management.

What was done?

Cold chain is a major issue in the pharmaceutical industry as a growing number of its products are temperature-sensitive and also in hospitals. In 2017, 27 cold chain breaks were declared by care units (CU) within a French teaching hospital, resulting in a risk for patient care and a potential loss of 40,363 euros, of which 18,505 euros (45%) could be avoided. Following this first study, a set of measures have been implemented in our establishment in order to secure the cold chain.

How was it done?

Potential losses and avoided losses of TSPs have been analyzed continuously since 2017 according to the same methods in a teaching hospital with 1,600 beds. In case of a thermal excursion (ET), the pharmacy is, according to the institutional procedure, immediately warned by an electronic alarm day and night or by a call from the care service, making it possible to define the action required from the service concerning the methods of keeping TSPs.

What has been achieved?

Since 2017, a mobile isothermal enclosure has been implemented for the transport of TSPs during the day in the CU. Connected temperature-monitoring sensors have been installed on so-called “at-risk” refrigerators. The alarm reports to the pharmacy was instituted in order to intervene as quickly as possible. Part of the refrigerators has been renewed and awareness has been raised among all CUs for the good traceability of temperature readings, allowing a drop from 24% in 2018 to 65% of compliant traceability in 2019. Following these improvement actions, 53 ETs with a potential loss of 53,769 euros were declared in 2019, of which 39,753 euros of losses could be avoided. Currently, 74% of ET losses can be avoided compared to 43% in 2017.

What next?

This economic assessment of the potential losses and the avoided losses of PTs shows the positive impact of the various improvement measures taken since 2017 as well as education of the UDS to secure TSPs. A regional awareness was implemented thanks to a collaboration with the regional health agency in order to promote TSPs management in the hospitals.

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Author(s)

Elodie Delavoipière, Marianne Pavard, Anne-Laure Richard, Julien Montreuil, Albane Cherel, Céline Bouglé

Why was it done?

Every year in our country, 10,000 preventable deaths and more than 130,000 preventable hospitalizations are related to drug misuse. This issue is a priority of the national health strategy. Therefore, we developed a CPD training program on the issues and methods of managing the risk of ME.

What was done?

A regional multi-disciplinary Continuing Professional Development (CPD) program was developed, dealing with the risk management of medication errors (ME).

How was it done?

This program was submitted to the National CPD Agency and accepted as a continuing education measure, corresponding to the national orientation: “control of risks associated with healthcare acts and pathways”. The program and the training materials were developed by a 13-member regional working group, including hospital pharmacists and quality managers, the drug observatory and the regional health quality network.

What has been achieved?

The training is intended for any health professional involved in the medication circuit in a health or medico-social institution: physicians, pharmacists, residents, nurses, pharmacy technicians… The first part is an e-learning slide presentation with voice commentary, on the theoretical aspects of ME and on the principles of a priori and a posteriori risk management. Concrete examples of ME are integrated throughout the slide presentation. This e-learning is divided into 4 parts and is accessible for 1 month. It must be validated by the learner before participating in the second part of the training: a face-to-face simulation session with 15 learners and 2 hospital trainers (pharmacist and health quality professional). During half a day, the learners apply a posteriori risk management by analysing a fictional adverse event (ME). The case addresses several themes: never events, drug reconciliation, city-hospital link, lack of communication, human factors. Questionnaires completed before, during and after the training allow for the evaluation of learners’ satisfaction as well as the impact of the training on their knowledge and skills.

What next?

This regional training will promote the link between actors from different institutions and the multi-disciplinary approach around the management of the risks of ME. In addition, we provide an awareness kit on ME reporting, including a customizable slide show and a quiz, which allows short sessions to be conducted in any health facility.

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Author(s)

SOFIA KONSTANTINIDOU, VANGELIS KARALIS

Why was it done?

Tyrosine kinase inhibitors (TKIs), like erlotinib and gefitinib, are widely used in anticancer therapy. However, after long term administration of TKIs, resistance is observed in the majority of patients. Thus, it is necessary to be able to define individualised dosage regimens for TKIs in cancer patients. Nowadays, modelling and simulation approaches represent the most powerful tool in the hands of clinical pharmacists towards precision medicine.

What was done?

Population pharmacokinetic (PK) – pharmacodynamic (PD) modelling was utilised to simulate erlotinib and gefitinib dosage regimens for non-small cell lung cancer. In silico clinical trials with virtual patients, of several resistance levels, were simulated in order to optimise pharmacotherapy and get better therapeutic outcomes.

How was it done?

The utilised PK/PD model and average parameter values were obtained from the study of Eigenmann and colleagues. This model was fully validated using statistical criteria and goodness of fit plots. In order to simulate many possible conditions that may occur in clinical practice, several different values of erlotinib and gefitinib clearance, absorption rate, pharmacodynamic characteristics (like tumor volume), and resistance were assessed. In addition, several dosage schemes were simulated. The entire modelling work was performed in Monolix® 2019R1.

What has been achieved?

Concentration vs. time and effect vs. time plots for the virtual patients were simulated for a variety of conditions and tumour resistance levels. For both TKIs, decrease of body clearance led to higher plasma concentrations, as well as more intense and longer duration of the effect (i.e. tumour volume shrinkage). Enhanced drug effect on resistant cells resulted in a decrease in tumour volume. In addition, a variety of concentration-time profiles were simulated, making it possible to choose the best regimen for each patient.

What next?

In this study, the use of modelling techniques led to the simulation of many conditions of patients and adjustment of dosage regimens according to their needs. Wider application of in silico methods using virtual patients will allow the design of the most appropriate individualised dosage schemes tailored to the patients’ requirements.

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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)

Marijana Fortuna, Petra Tavčar, Jure Dolenc, Monika Sonc

Why was it done?

To support us in understanding our role in the preparation of chemotherapy products. To prevent the risk of harm to patients. Recognise prescribed error in pre-documented chemotherapy protocols

What was done?

Cytostatics are carcinogenic, mutagenic and teratogenic drugs. Handling requires a number of organisational and technical systems. All products should be safely and accurately prepared with special care to ensure the highest possible product quality, correct dose, the right patient, the right medicine, the right carrier solutions and right administration, without microbiological and particle contamination. The prescription and preparation of cytostatic drugs must be closely monitored. The most important factor in achieving this is the constant training of pharmacists in pharmaceutical techniques.

How was it done?

This year started with monthly reviews and training in the following subjects by using a written algorithm. Risk to product: Drugs reconstitution negative pressure isolators, leakage/damage or defects of vials, particles, transport and storage. Risk to patient: Incorrect calculations, microbiological contamination, incorrect administration, extravasation, incorrect administration route, incorrect labelling. Risk to operators: Contamination, toxicity, equipment, gloves, cleaning, occupational exposure. All checks have been made throughout the whole of preparation process, adhering to standard operating procedures (SOP-s).

What has been achieved?

We concluded that continuing education by using a writhen algorithm is useful practice. It helps prevent automatic work, remind us to check each step in process and know how to recognise errors in chemotherapy prescriptions and preparation. In 25 cases of prescribed chemotherapy, intervention of a pharmacist was required. In 5 cases of chemotherapy preparation, pharmaceutical techniques have detected a discrepancy in the prescribed therapy.

What next?

Regardless of experience at work, it is necessary to constantly repeat how to work properly, and awareness why we are doing this.

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Author(s)

Bernie Love, Tracy McFadden, Patrick Martin, Val Connolly, Deirdre Brennan, Michelle Griffin, Danielle Bracken, Siobhan Maguire, James Carr

Why was it done?

Avoidable harm caused by medication is one of the most commonly reported adverse events in healthcare settings.

What was done?

Connolly Hospital Blanchardstown launched a formal Medication Safety Programme in November 2017 by appointing a Medication Safety Facilitator and establishing a multidisciplinary Medication Safety Committee to promote and support the safe use of medications. The Medication Safety Committee undertook a number of activities to establish the programme in the hospital.

How was it done?

-An evidence-based literature review to define and guide the scope, breadth and direction of the programme. -A baseline in-depth analysis of locally reported medication incidents (2016/2017) on the National Incident Management System (NIMS) was conducted to identify initial targets for improvement. Analysis was undertaken using NCC-MERP, a recognised and validated tool used specifically for medication incidents. -An annual work-plan, incorporating necessary elements of a medication safety programme, was devised by the committee defining goals for the year.

What has been achieved?

Safety Culture: • Prominent commitment from hospital management to medication safety. • Investigations into medication errors aligned to a just and fair systems approach. • Promotion and encouragement of medication safety reporting and learning with a Medication Safety Awareness Day. • Implementation of the ‘Know, Check, Ask’ campaign to enhance medication safety by empowering patients. Governance: • Organogram updated to reflect reporting relationship of new committee. • Medication Safety made standing item at Quality & Safety Executive meetings. • Annual report submitted to Hospital Executive Committee Measurement & Monitoring of medication incidents: • Quarterly report produced and disseminated to front-line staff tracking and trending medication incidents including narratives. • Performance indicators established for: -No. of incidents reported (2018 reporting increased by 32% over 2017); -Reporter of incidents; -Category of harm; -Stage of medication use process where incidents have occurred. Education & Training: • Regular face-to-face education sessions arranged with front-line staff. • Quarterly medication safety bulletin devised and disseminated, informed by audit findings and incident reports. • The successful Medication Safety Minute initiative from St James’s Hospital was adopted and implemented, with content informed by local incidents. Development, Updating and Dissemination of PPPGs. • New IV drug administration guides (n=53) developed and updated. • Introduction of one-page ‘Medicines Information Sheet’ as quick reference guides for key topics. • DOAC prescription and administration guide developed and circulated. Audit: • Audit programme established informed by incident analysis, complaints and best-practice including introduction of an ‘audit window’ to gather hospital-wide data. Quality Improvement: • Informed by incident analysis, best-practice and audit findings, a number of moderate-high leverage quality improvement projects were initiated including removal of concentrated potassium from general clinical areas, introduction of an insulin & glucose monitoring record and introduction of an automated dispensing cabinet for out-of-hours access to medication.

What next?

The structural aspects established for the Medication Safety Programme have been successful in establishing a programme in the hospital and are reproducible by other centres.
Work continues in Connolly Hospital to identify themes of incidents, audit of practice and implementation of quality improvement initiatives.

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Author(s)

MARTA VALERA-RUBIO, ROSARIO MORA-SANTIAGO, MARIA ISABEL SIERRA-TORRES, JOSE LUIS ORTIZ-LATORRE, ISABEL MOYA-CARMONA

Why was it done?

The existence of different prescription systems could lead to validation errors when the pharmacist responsible for the ICU is not available. Furthermore, ICU physicians could not benefit from all the advantages that the official prescription system included. The presence of a common integrated prescription system among all units allow the exchange of prescription drug information between the ICU and the rest of the units, in accord with the health situation of the patient. Moreover, with this new system they can have access to allergies, renal adjustment doses, recommended posologies, therapeutic exchanges, and pharmacy validation, among other items.

Moreover, with this new system they can have access to allergies, renal adjustment doses, recommended posologies, therapeutic exchanges, and pharmacy validation, among other items.

What was done?

The intensive care unit (ICU) used a computerised physician order entry system different from all the hospital units. The pharmacy service, along with the ICU physicians and nurses, have tried to adapt the special features of this unit to integrate it with the clinical decision prescription system that is official in the hospital.

How was it done?

A multidisciplinary team formed by ICU staff (doctors and nurses) and pharmacists met to discuss the points that should be followed when implementing the new electronic prescription programme. In these working meetings, especially with physicians, we tried to agree on what and how the infusion protocols would be included in the new system, based on the infusion pumps guides made by both units. A pilot phase was established by the end of July 2019 to detect possible errors in the process of prescription, and mostly, when a patient changed from two units, from the ICU to another health care service and vice versa. All errors or discordances found were discussed between the pharmacist and the physician or the nurse, and in order to solve them we contacted the managers of the prescription system or we modified the parameters that are included in the system such as names of drugs, dosage guidelines, new nurses’ orders, etc.

What has been achieved?

The implementation of this new system has been well embraced by the staff, since it allowed a more efficient and secure health care circuit for the patients. All physicians are now able to use this system while the other one is no longer used.

What next?

We will continue making formative sessions with both physicians and nurses, in order to solve all the doubts that can appear during the training period. We will update periodically the available data and make improvements in the programme configuration.

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Author(s)

MARTA VALERA-RUBIO, MARIA ISABEL SIERRA-TORRES, ELENA SÁNCHEZ-YAÑEZ, JOSE LUIS ORTIZ-LATORRE, ISABEL MOYA-CARMONA

Why was it done?

Critically ill patients often require the administration of several intravenous drugs and that includes infusion pumps. New infusion pumps offer the ability to build a drug library within the infusion system itself. This allows intravenous infusion medication safety to be improved. Because of that, it is highly important to have an updated administration guide and an IV smarts pumps library for the everyday clinical practice. This guide was developed in order to help ICU staff to practice safe prescribing and managing of medicines and to reduce the incidence of adverse drug events and administration errors.

What was done?

We developed an updated guide on intravenous drug administration including infusion parameters for intelligent intravenous infusion pumps, so called “IV smarts pumps”, used in the intensive care unit (ICU).

How was it done?

A database with the most important intravenous drugs used was created by a multidisciplinary working team (pharmacists, physicians and nurses). The drugs included were divided into therapeutic groups and were distributed among the participating members for the drug information review process. The therapeutics groups included were: sedatives, analgesics, antihypertensives, vasopressors, anti-arrhythmics and others such as insulin, heparin, etc. For each drug, a bibliographic research was conducted, gathering information from manufacturers, intravenous drugs databases (Uptodate®, Micromedex®, Stabilis®) and other hospital guidelines. The data collected included: drug name, lower and upper hard limit, default dilution, flow rate, default rate, rate upper soft and hard limit, bolus default, flow rate and volume upper limit, loading dose, duration, dilution volume, default, and lower and upper hard limit.

What has been achieved?

This guideline promotes, mainly, the safe use of drugs usually administered in critically ill patients, and is available for all the staff in this unit. Its elaboration has made it possible to avoid medication errors and to establish a narrower bound between the pharmacy service and the critical care unit, developing new partnerships which could lead to new projects.

What next?

We are still working on improving this guide, making it easier to understand and with a unified vocabulary. We will update it periodically in order to include new evidence and new drugs if necessary.

Author(s)

Oran Quinn, Anna Marzec

Why was it done?

Errors of miscalculation, doses inappropriate for renal function and at extremes of weight were reported when doses of medication were written as ‘mg/kg’ without stating the dose to be given e.g. Gentamicin 5mg/kg, Vancomycin 15mg/kg and Enoxaparin 1.5mg/kg.

What was done?

A quality improvement initiative to resolve issues with prescribing medications dosed by weight. Nursing staff were identified as ‘gate-keepers’ who could refuse to administer medication inappropriately prescribed. Identification, agreement, education and feedback were necessary to change prescribing practice and support nursing staff. Hospital doctors were required to calculate and prescribe the total dose to be given. Feedback was given by monthly bulletin.

How was it done?

Support from key stakeholders was sought to endorse the initiative. Verbal and written education was given to nursing, medical and pharmacy staff to implement the initiative on an agreed date. Refusal to administer medication unsafely prescribed was key to successful implementation. Patient’s weight was not always available and additional equipment was provided to overcome this problem. The risk of withholding treatment was considered and an escalating referral process was recommended contacting the Senior House Officer, then Registrar and ultimately the patients Consultant to avoid lengthy delays to patient treatment. Nurses felt supported in refusing to administer medication.

What has been achieved?

A point prevalence study of all inpatients was carried out monthly to ascertain the level of compliance Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 % of patients with total dose prescribed correctly 67.0 86.7 96.7 100.0 100.0 88.9 87.5. Results showed overall improvement from March to August and full compliance in May and June. Success was achieved through a multidisciplinary approach involving all key stakeholders, a forcing function and support from and for front line staff.

What next?

This initiative has been further developed to become ‘Monthly Safe Prescribing Metrics’.
Other prescribing metrics such as using ‘iu’ dosing for Insulin, prescribing appropriately for patients at extremes of weight and using the abbreviation ‘mcg’ for medications dosed in ‘micrograms’ were included. Initiatives to improve all metrics are ongoing.
Safe prescribing metrics could help to positively influence prescribing culture in other healthcare settings.