MANAGING THE RISK OF MEDICATION ERRORS: A MULTI-DISCIPLINARY CONTINUING PROFESSIONAL DEVELOPMENT PROGRAMME
Pdf
European Statement
Education and Research
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.
DEFINING DOSAGE REGIMENS OF ERLOTINIB AND GEFITINIB IN NON-SMALL CELL LUNG CANCER PATIENTS USING MODELLING AND SIMULATION (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
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.
DYSPHARMA: AN ITALIAN WEB-APPLICATION FOR DRUG THERAPY MANAGEMENT IN DYSPHAGIC PATIENTS (submitted in 2019)
Pdf
European Statement
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.
ALGORITHM OF SAFE AND CORRECT PREPARATION OF CHEMOTHERAPY (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
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.
BUILDING THE FOUNDATIONS OF A MEDICATION SAFETY PROGRAMME IN AN ACUTE HOSPITAL (submitted in 2019)
Pdf
European Statement
Patient Safety and Quality Assurance
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.
IMPLEMENTATION OF AN ASSISTED ELECTRONIC PRESCRIPTION SYSTEM IN A CRITICAL CARE UNIT (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
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.
DESIGN AND ELABORATION OF AN INTELLIGENT INTRAVENOUS INFUSION PUMPS GUIDE FOR THE INTENSIVE CARE UNIT (submitted in 2019)
Pdf
European Statement
Clinical Pharmacy Services
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.
SAFE PRESCRIBING METRICS FOR HOSPITAL PHARMACY (submitted in 2019)
European Statement
Patient Safety and Quality Assurance
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.
DRUG-FOOD INTERACTION GUIDE PREPARATION FOR OUTPATIENT CONSULTATION
European Statement
Patient Safety and Quality Assurance
Author(s)
Gregorio Romero Candel, Paula Ruiz Belda, Carmen Caballero Requejo, Maria Jesus Sanchez Cuenca, Jose Marco del Rio, Juilan Castillo Sanchez, Luna Carratala Herrera
Why was it done?
Some drugs dispensed in the outpatient office present interactions with food, leading to changes in their bioavailability. These changes which can result in a decrease in therapeutic activity or an increase in adverse effects, when dealing with narrow therapeutic margin drugs, may lead to alterations in their efficacy and/or toxicity. Developing the quick and accessible consultation table, we improved the quality and effectiveness of the treatment.
What was done?
Preparation of the drug and food interaction guide for outpatient consultations.
How was it done?
The technical specifications of all drugs that are dispensed in the hospital outpatient office were consulted, and the possible interactions with food of every one of them were analysed by consulting the following electronic databases: Technical sheet, Bot Plus, Micromedex, Pubmed, UpToDate and Online Medicine Information Centre of the AEMPS. A database was developed with drugs that presented some type of restriction with meals, designing a quick reference table for outpatient consultation.
What has been achieved?
One-hundred specialities were reviewed, of which 22 were to be taken without food, 43 with food and 35 could be taken with or without food. The information given to the patient was quick and efficient, improving the effectiveness and safety of the treatment.
What next?
Our goal is to continue developing tools that allow us to provide quality information to the patient, improving the effectiveness and safety of treatments.
PREPARATION OF A CYTOSTATIC STABILITY GUIDE AFTER RECONSTITUTION AND DILUTION
European Statement
Patient Safety and Quality Assurance
Author(s)
Gregorio Romero Candel, Paula Ruiz Belda, Maria del Carmen Caballero Requejo, Maria Jesus Sanchez Cuenca, Jose Marco del Rio , Julian Castillo Sanchez, Luna Carratala Herrera
Why was it done?
In common clinical practice, the stability of medications is an area of interest to obtain maximum security and efficiency. After reconstitution and dilution, knowing the validity period is very important for the effectiveness and safety of the treatment, since it must be administered to the patient under the appropriate conditions. In recent years, a large number of high-impact cytostatic medicines with limited stability data have been registered and incorporated into clinical practice. Frequently, the stability data results are contradictory or insufficient. The main goal is to make a reliable quick guide of reference with the validity periods of the reconstituted and diluted active principles according to physicochemical stability, therefore increasing safety, reducing queries for these doubts and improving the management of unused remains that have high economic impact.
What was done?
A cytostatic stability guide after reconstitution and dilution has been made. The active principles and commercial presentations that are used in the intravenous mixtures area were reviewed.
How was it done?
The obtaining of the physical-chemical stability data has been done by reviewing the information available in Stabilis, Pubmed, Lexicomp and technical data sheets.
What has been achieved?
Fifty-four pharmaceutical specialities from 44 active principles, all in the cytostatic group, were checked. Tables of reference for the elaboration sites were made for consultation. It has reduced the number of consultations conducted and improved the time of preparation of these products. The rest of the elaborations for other administrations have been taken advantage of, making a better use of the pharmacotherapeutic resources.
What next?
The next step is to keep developing consultation tools that improve the safety and management of hospital drugs.