Prescription review of digoxin-treated inpatients: Pharmacist involvement in its pharmacokinetic monitoring and dosage adjustment
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
DEL RIO GUTIERREZ JOSE MANUEL, MARTA MIARONS FONT, SONIA GARCIA GARCIA, TONI SORIANO COLOMÉ, ALBA PAU PARRA, ARIADNA GRACIA MOYA, NIEVES HERRANZ MUÑOZ, BRUNO MONTORO RONSANO, PAU RELLO SABATE, GERARD ORISTRELL SANTAMARIA, MARIA QUERALT GORGAS TORNER
Why was it done?
Digoxin is a drug frequently implicated in medication errors due to its difficult clinical management. It has also been observed that digoxin pharmacokinetics could change in acute medical conditions, compromising its effectiveness and safety. As hospital pharmacists, we have the opportunity to review which dose is the most appropriate for every patient.
What was done?
Twice-weekly active and extensive pharmaceutical review of digoxin-treated inpatients was established to identify whether the prescription was adequate and to adjust dosage according to plasma concentrations (PCs) and clinical situation.
How was it done?
1. A multidisciplinary team comprising pharmacists and cardiologists was created to identify possible solutions to improve digoxin prescribing.
2. It was agreed that a twice-weekly extensive review of digoxin-treated inpatients would be conducted by a pharmacist. Candidates for digoxin monitoring were:
a. Patients on chronic digoxin therapy and with at least one of the following risk factors: presence of renal failure (RF), recent surgery, elderly patients (≥65 years), critically ill patients, or patients with suspected toxicity.
3. Once the patients were identified by the pharmacist, they would be discussed with the cardiology team.
4. Digoxin prescriber would be contacted to recommend performing a determination of digoxin PC. PC reference range was set at 0.8–1.2 µg/L for atrial fibrillation (AF) and 0.5–0.8 µg/L for heart failure (HF).
5. PCs would be interpreted using a pharmacokinetic monitoring software (PKS Abbot).
6. Monitoring results and recommended dosage adjustments would be communicated.
What has been achieved?
From August 2021 to May 2022, 190 patients were identified. Sixty-five (33.7%) were considered for monitoring, of whom 21 (32.3%) were women. The average age was 77.9 (SD 11.7). Sixty-five (100%) with AF and 8 (12.3%) also with HF. The most prevalent risk factors warranting monitoring were patients aged 65 years or older (N=57, 61.9%) and RF (N=31, 33.7%). Thirty-three (51%) of monitored patients required a dosage adjustment, of whom 23 (69.8%) required a dose decrease, 5 (15.1%) an increase and 5 (15.1%) to stop the treatment. Median digoxin concentrations were 1.23 µg/L (interquartile range: 0.75-2.03).
What next?
The process described applies to any centre able to monitor digoxin CPs both in inpatient and outpatient settings.
Software tool development for reconstitution and administration of parenteral antibiotics in hospitals: an international project
Pdf
European Statement
Patient Safety and Quality Assurance
Author(s)
Zora Ćetković, Dragana Rajinac, Ivana Baralić , Jelena Marković, Darija Kuruc Poje, Miroslav Kota, Špela Urh, Irina Tegelj, Vesna Bizjak, Dragana Mitrić, Tijana Kovačević, Andrej Pečet, Irena Radivojša, Sanja Filkova, Vesna Bašić-Milošević
Why was it done?
Medication errors regarding reconstitution and administration of parenteral antibiotics are frequent in hospitals. In our study conducted in 12 Southeastern European hospitals in 2021, we demonstrated the need of parenteral antibiotic reconstitution/dilution database in hospital pharmacy practice. Moreover, according to European Statements of Hospital Pharmacy (statement 5.5.), implementation of electronic decision support system by HPs should help to decrease the risk of medication errors. The purpose of software tools is to gather all relevant information regarding parenteral antibiotic reconstitution/dilution and make them easily accessible.
What was done?
A group of hospital pharmacists (HPs) from 6 Southeastern European countries created new software tools (a mobile-responsive website and mobile applications for Android and iOS) for providing information on reconstitution and administration of parenteral antibiotics in collaboration with software developer. These tools contain parenteral antibiotic reconstitution/dilution database in seven different languages (English, Serbian, Croatian, Slovenian, Bosnian, Macedonian and Montenegrin).
How was it done?
Technical requirements for website and mobile applications were designed by HPs. The development of these software tools was carried out by a software developer and funded by European Association of Hospital Pharmacists (EAHP). The final version of the software went through a rigorous evaluation, conducted by HPs during development and all technical problems were resolved consequently.
What has been achieved?
· Designing and developing these software tools helps HPs to provide evidence-based information about parenteral antibiotic reconstitution/dilution at the point of care, thus improving decision-making process and patient safety. · Reconstitution of parenteral antibiotics in wards is efficient and smooth. · Oral and written instructions for parenteral antibiotic reconstitution/dilution are replaced by electronic decision support tools, designed to prevent medication errors. · HP’s interventions are required to support the use of these software tools.
What next?
Our next challenge is wider use of these software tools in order to ensure the appropriate reconstitution/dilution of parenteral antibiotics in wards by nurses and physicians. These software tools are applicable in hospital setting and can be used by all regional hospitals. Additionally, they can be easily incorporated in hospital information system. We also plan to update periodically antibiotic reconstitution/dilution database, as new information becomes available.
Digitization: a key to improve health condition of patients with cancer disease
European Statement
Clinical Pharmacy Services
Why was it done?
the app was developed in order to improve therapeutic adherence, pharmacological counseling, management of adverse events and increase pharmacovigilance’s reports with higher data quality. The World Health Organization recognizes that 20% of health is due to medical care, 20-30% to lifestyle, while the remainder depends on the environmental, social, genetic and psychological conditions of the individual. The goal of this app is to improve patient’s therapeutic path at different levels and breaking down geographical barriers.
What was done?
the Sars-cov-2 pandemic entailed a lot of new challenges for the Hospital pharmacist . As the scenario was completely new, it was developed an app to better manage patients with cancer disease treated with oral chemotherapy.
How was it done?
Patient has been divided into two groups, of which only one group use the app to manage the therapy. The primary endpoint was the improvement of therapeutic adherence, while the secondary endpoints are: improve in the quality of patient life (HRQoL), increase pharmacovigilance’s reports and avoid therapeutic errors.
What has been achieved?
The continuous dialogue between patients and hospital pharmacist througt system’s online messaging app improved the management of patients needed and reduce drug interactions. Digital management led to a 56% increase of pharmacovigilance reports. It was also detected a reduction in overall costs and patient uneasiness.
What next?
the health system has to be reorganized around patient’s needed, by promoting the use of more and more homogeneous, safe, transparent and accessible technologies.
Regulatory authorities should accelerate the adoption of digital solution. In this new framework hospital pharmacist will play a key role in the development of value based medicine and in the process of treatment humanization as a patient’s landmark person too.
Improving medication barcode identification on the smallest unit of use: Start-up first ePIL (electronic leaflet) project for medicines used in hospitals in Spain
European Statement
Patient Safety and Quality Assurance
Author(s)
E Sulleiro, C Garrido, A Santamartina, O Delgado, B Aguado, I Alvarez Novoa, M Amérigo , L Calatayud, M Cardenal, J Carretero , J Corredoira, MA De la Peña, MJ De la Torre, S Domingo-Carranza, M Ercep, E Emili, M Eugui, E Falco, M Garcia , S Hernandez, M Hidalgo, J Hierro, M Jamali, C Joglar, S Juan, N Longás, A Lopez de la Rica, JJ Martínez , M MIllán , P Paris, C Ramirez, M Serrano
Why was it done?
Medication errors are one of the most common causes of preventable adverse events in the healthcare system. A complete identification of a medicine, up to the moment of administration, is therefore a key element of a safe medicines dispensing procedure in hospitals.
Digitization is a trend affecting all levels of our society and medicines are no exception. Increased use of Datamatrix code in the outer packaging of medicines has facilitated many healthcare professionals to become familiar with this technology. It is now possible to easily retrieve online information about a medicine, which raises the possibility of obtaining updated information of medicines without necessarily using a paper leaflet. Moreover, paper leaflets in the hospital setting are very often disposed of without reaching their end user, the patient.
Additionally, hospitals have other needs closely related to digitalization, considering errors in the reconciliation of prescription versus dispensing and administration, that can be reduced due to automated capture of the code linked to a particular medicine in the smallest unit of use, and also when dealing with compounding traceability preparations for patients.
What was done?
Spanish Agency of Medicines and Medical Devices (AEMPS), Spanish Society of Hospital Pharmacy in coordination with Hospital Committee of the General Council of Official Pharmacist Associations , and a series of pharmaceutical companies, mostly integrated in National Trade Association of the Spanish based pharmaceutical industry (Farmaindustria), have launched a project consisting of removing paper leaflet from the packaging components of a series of medicines exclusively administered in hospitals. These medicines will have a Datamatrix code in the primary packaging. When scanned, Datamatrix will allow to capture official PIL text from the information hosted in the Medicine Online Information Center of AEMPS (CIMA), which can be used for patient safety purposes at hospital pharmacy.
How was it done?
The Project began in November 2020 creating an ad-hoc working group on “Technical Regulation of Pharmaceutical Medicines” from Farmaindustria with AEMPS and representatives of Hospital Pharmacists. After 10 TCs and after having the participation of different partners, the main lines were agreed
Stakeholders agreed a proposal for pilot description and AEMPS informed the European Commissionin due course.
What has been achieved?
1. From January, 1 2022, a list of medicines meeting the established requirements will be able to be marketed without paper leaflet
2. Non-serialized Datamatrix will be included in the primary packaging, shall be compliant with GS1 standardization and may be pre-printed. It will contain specific NTIN/GTIN that will enable access through a correspondence table to Marketing Authorization Number (pharmaceutical form and dose) of the medicine hosted in AEMPS Nomenclator for Prescription (a medicine database intended to provide core prescription information to the care information services). In case technically feasible, companies may include also batch variable information such as Batch Number and Expiry date in the Datamatrix on a voluntary basis.
What next?
Assessing the impact of this practice in terms of efficiency, flexibility and safety is a key priority and this pilot project will gather enough data and information to help EC and Member States to revise relevant provisions in the legislation by 2022.
EU citizens will be able to benefit from the development of new technologies, as an underlying driver for delivering timely and easily accessible an up-to-date medicinal product information,
Design and dissemination of infographics to improve safety in drug handling
European Statement
Patient Safety and Quality Assurance
Author(s)
Paula Hernando Martínez, María Antonia Meroño Saura, Caridad Marti Gil, Lidia Martínez Valdevieso, Jaime Fernández-Bravo Rodrigo, Dolores Barreda Hernández
Why was it done?
There is a wide bibliography on how human errors related to drugs put the patient’s health at risk. Drug preparation and administration errors, dose calculation errors, lack of knowledge about drugs or interactions, to name but a few. There must be protocols to ensure that drugs are safe for patients, including procedures which professionals should fulfill in order to reduce those errors in processes and guarantee, in such cases, that they will not have adverse effects on patients.
What was done?
Development of infographics for assembling drugs which are susceptible to a higher rate of errors in their preparation and administration to hospitalized patients.
How was it done?
During September 2021, a working group was formed in the pharmacy department (PD). Through the nominal group technique, the design and content of drug infographics was proposed as a solution to the raised problem. Subsequently, a bibliographic research of susceptible drugs to human errors during administration or preparation and those which requiring special handling was reviewed through the list of high-alert medication from National Institute for the Safe Use of Medications website and NIOSH list of hazardous drugs. To this end, the PD databases were analysed, obtaining the drugs that required the greatest number of pharmacotherapeutic consultations made by nursing staff on drug administration and recommendations made during pharmaceutical validation.
What has been achieved?
An infographic model has been designed which includes the description of the drug (name of drug, excipients, dose, pharmaceutical form, dosage regimen, route of administration, concentration), the preparation and administration protocol (reconstitution, dilution, infusion rate, premedication), observations (maximum doses, conditioning, incompatibilities, alerts) and storage conditions (conservation and stability). Infographics on dantrolene, intravenous phenytoin solution, intravenous nimodipine solution and potassium chloride solutions are currently being distributed. These documents are available at the nursing controls and on the hospital’s internal website.
What next?
To increase the availability of drug’s infographics and to update those that have already been developed when necessary. In addition, from the PD, the preparation of administration kits for the solicited drugs is proposed so as to ensure that all the necessary materials for the preparation and administration are included along with the corresponding drug and infographic.
Development of a clinical pharmacy program for very frail elderly hospitalized patients
European Statement
Clinical Pharmacy Services
Author(s)
Baptiste Fulbert, Florian Poncelet, Marilyne Legrand, Céline Mongaret, Dominique Hettler
Why was it done?
Very frail elderly patients are a particularly high-risk population due to their frequent multi-medication and the risk of associated adverse effects.
Clinical hospital pharmacists play an increasingly important role in patient care.
What was done?
We developed a program comprising several clinical pharmacy services for very frail elderly hospitalization.
How was it done?
We conducted a 3 month prospective study in short and middle geriatric stay included patients admitted in emergency department aged at least 75 with a Short Emergency Geriatric Assessment (SEGA) frailty score above 11. We performed, as clinical pharmacy services, best possible medication history (BPMH) in the emergency department and medication reconciliation at admission (MRA) in hospital ward and medication review during hospitalization. Medication reconciliation at discharge (MRD) was carried out on a geriatric medicine unit over 2 months. All activities were performed by pharmacy students, two residents and a pharmacist.
What has been achieved?
120 patients were included. 96 BPMHs were performed : 62 in emergency department and 34 in hospital ward.
MRA was performed for 81 patients (68%), identifying 774 discrepancies of which 19 (3%) were unintentional discrepancies (UD), 6 (32%) involving Digestive Tract and Metabolism drugs. 9 (47%) of these UDs concerned omissions.
During the 163 medication reviews, pharmacist performed 98 pharmaceutical interventions (PIs) for 53 patients, with an acceptance rate of 56%. Most of drugs involved with the acceptance rate was Nervous System drugs (20;36%) and Digestive Tract and Metabolism drugs (16;29%). Among the accepted PIs, 22 (40%) relate to dosage adjustment.
Finally, MRD was performed for 25 (21%) of patients identifying 256 discrepancies, 8 of which (3%) were UDs, mainly involving Digestive Tract and Metabolism drugs (5;63%). 5 (63%) of these UDs concern omissions.
What next?
The high number and nature of the discrepancies support the idea that this population is a relevant target for a clinical pharmacy program.
This program could be applied in other hospitals with the hospital pharmacists and provide a better care for these patients.
The development of MRD in geriatric wards and collaboration between hospital pharmacists and primary care professionnals, by a discharge summary to handover the changes between the entry and the exit prescription can complete this study.
How to be in friendzone: geriatric and pharmacy ?
European Statement
Clinical Pharmacy Services
Author(s)
François TISSERAND, Pierre MENAGER, Alexandre NAVID, Léa ROUSSET, Adeline BANNIER, Julie MORIO, Hélène PERRIER, Elsa JOUHANNEAU
Why was it done?
The geriatricians contacted the pharmacy to deliver training courses to the geriatric residents. This has enabled pharmacists to develop a close relationship with geriatricians to offer them clinical pharmacy activities in their ward. Geriatricians were familiar with clinical pharmacy, in particular the medication reconciliation, which is used to perform the former in other hospitals. Geriatricians are concerned with iatrogenic illness and therefore see medication reconciliation and pharmaceutical analysis as a relevant approach to clinical pharmacy.
What was done?
A successful model of partnership between Geriatrics and Pharmacy has been created and developed.
How was it done?
A first meeting was held between geriatricians and pharmacists. It was decided a pharmacy resident would be dedicated to a given geriatrician. This first resident’s objectives are to follow the medical rounds and to carry out medication reconciliations upon admission and discharge. Pharmaceutical support has enabled real-time validation for the prescription of the appropriate drugs. As the internship progressed, the resident became the privileged interlocutor for a Pharmacy-Unit relationship.
What has been achieved?
To date, 37 medication reconciliations were carried out, where the resident followed 2 medical rounds per week over 17 weeks. All unintentional discrepancies were corrected (n=13). Concerning the appropriateness of prescriptions, 16 inappropriate medications were stopped. During the medical rounds, 34% of the therapeutic problems (n=35) were related to inappropriate drug according to guidelines, 17% to dosing errors, 14% to drugs without indication. More than 50% of pharmaceutical interventions were judged capable of preventing harm that requires increased monitoring or treatment or lengthening of the hospital stay (63%). During this period, 54 questions were asked and discussed between the resident and the geriatrician to improve patient care. At the geriatricians’ request, two courses were organized about non mastered topics. On the ward, the resident acted as a go-between for a number of issues such as referencing medical devices, rearranging the storage of medicines or finding the right contact person for information activities.
What next?
What has been done needs to be continued and improved. A pharmacist-geriatrician cross-training should be implemented soon. New activities with pharmacist-geriatrician interactions are being created, such as day hospitalization for falls in the elderly population and a geriatric emergency unit.
Implementation and follow-up of an Assisted Electronic Prescription Program
European Statement
Patient Safety and Quality Assurance
Author(s)
Juan Campillo, Manuel Bonete, Marta Zayas, Maria Molina, Laura Barrajón, Cristina Martínez, Ángela Rizo, Maria Ángeles Bernabeu, Maria Teresa Aznar
Why was it done?
Medication errors (ME) occur in different phases of the drug circuit: prescription (16%), transcription (27%), validation, preparation, dispensing (48%) and administration (9%). The AEP is a tool to guarantee the safety of this circuit, being able to avoid up to 65% of ME. There is also a learning curve in new users of an AEP, confirming the need for support to reduce ME.
What was done?
1-Maintenance of the Assisted Electronic Prescription Program (AEP)
2-Implementation in 11 wards and in the Emergency Department of a 396-bed tertiary hospital
3-Training
4-To set a pilot AEP
5-Reeducation strategies
How was it done?
1- 1465 drugs included in the Pharmacotherapeutic Guide were configured. 3 levels of danger were created for Hazardous Drugs (HD) and the recommendations for their preparation / administration were agreed upon. The Therapeutic Exchange Guide was integrated into 443 drugs (761 exchange proposals).
2- It started in the Emergency Department and every week a new ward with AEP was opened.Paper was eliminated throughout the circuit, drug dispensing trolleys were modified and a computer was fitted to record administrations at the bedside.114 pharmacotherapeutic protocols were created.
3- A technical training program, changes in procedures, schedules and training documents were designed. 72 sessions were given to 346 physicians and 88 sessions to 543 nurses.
4- 490 incidents were reported, prioritizing the most urgent (compromising patient safety). 224 claims to expedite resolutions. We also collaborated with other hospitals.
5- Welcome plan to train new staff and annual sessions. A tutorial video to focus on the points that caused the most errors was recorded. Preparation of new documents to report the changes.
What has been achieved?
First hospital to implement computerized administration. Elimination of transcription errors. Improved administration security. Greater visibility of the pharmacist and participation in decision-making. Contribution to development of the AEP and its implementation in 15 more hospitals.
What next?
Monitoring the necessary interventions to develop educational strategies when a growing trend is observed. Improve the welcome plan. Continue piloting the new AEP versions Follow the evolution of pending incidents. Evaluate the impact of the educational strategy of the tutorial video.
Renewal in pharmaceutical compounding sterile preparations circuit in Pharmacy Service
European Statement
Production and Compounding
Author(s)
PILAR RANZ ORTEGA, MARÍA ARRIETA LOITEGUI, DANIEL GONZALEZ ANDRES, ANA MARÍA AGUI CALLEJAS, MARIA TERESA POZAS DEL RIO
Why was it done?
– Optimize the workflow:Nursing staff are independent in final product quality control.Dissapear the manual register of compounding sterile preparations.Fewer mixtures are discarded.Also in Pharmacy Service only elaborate the sterile preparations with an economic and safety impact.
– Improve the safety of drug administration in pediatric patients: there are ready-to-use commercial parenteral presentations, which can lead to errors when dosing per kilo,fe: enoxaparin…
– Optimize economic savings:all excess vials are reused
What was done?
Previously,some parenteral drugs were compounded at Pharmacy Service.The rest of the vials were discarded daily,so the pharmacist had to anticipated some elaborations not to throw,so then some were suspended.
Also, the pharmacists done the final product quality control,it could be delayed the dispensing and specially when it´s necessary to repeat the mixture.
The changes were:
– Re-selection of the parenteral drugs compounded at Pharmacy Service by:
• Economic criterio:the cost of drug has to be >20 euros/vial
• Safety for the pediatric patient:redose individually parenteral drugs “readytouse”
– Review the storage conditions:physicochemical (technical data sheet drug,Stabilis web) and microbiological stability (Good practices for preparation drugs in hospital pharmacy services publised by Spain Goverment) of all parenteral drugs previously selected.Although the physicochemical stability is higher,the final stability will be limited by the microbiological stability and the risk level microbial contamination(USP 2004).
– Standard Operating Procedures with structured and updated information
– Reuse of partially used multi dose vials:we reviewed the physicochemical and microbiological stability of open vial
– Final product quality control by nursing staff
– Save time to pharmacist:daily scheduling instead of anticipated elaboration of sterile preparations
How was it done?
– A nurse involved in the circuit change giving her feedback on the changes
– Traceability of the rests of the vials:stickers are affixed to the opened vials indicating the reconstitution data and the expiration date
– Final product quality control should be done by a diferente nurse to elaborated to detect potencial errors
What has been achieved?
The total cost savings for this year is 295.778€. After the circuit´s change, the savings have increased by 55% for liposomal amphotericin b, 51% defibrotide, 24% micafungin.
What next?
Compounding sterile preparations individualized in Pharmacy Service to patients hospitalized at home, transplanted of hematopoietic progenitors and immunocompromised
IMPROVING HIGH-RISK DRUG PRACTICES IN THE EMERGENCY DEPARTMENT – A MULTIDISCIPLINARY APPROACH
European Statement
Patient Safety and Quality Assurance
Why was it done?
Review of the 2019 Health Information and Quality Authority (HIQA) Medication Safety Monitoring Programme, and in-house Emergency Department (ED) medication variances review identified that risk reduction strategies for specific high-risk drugs and high-risk situations were required.
What was done?
A multidisciplinary team reviewed and implemented initiatives to improve medication safety practices for procedural sedation, emergency tray drugs and ketamine use in emergency settings was undertaken.
How was it done?
• Multidisciplinary teams (MDT) of key stakeholders were formed to review each high-risk drug / practice requiring improvement.
• The MDT developed the required procedures and policies that were further reviewed and approved by the relevant hospital committees.
• The MDT supported roll out of the improvement initiatives through communication, staff education and process review.
What has been achieved?
• A hospital wide procedural sedation policy and patient information leaflet was developed. Competencies for staff that perform procedural sedation have been identified. A specific procedural sedation incident report form has been piloted. A poster detailing the process for sedation reversal is in development.
• Emergency tray drug preparation, storage and use has been standardised across all hospital settings, including the introduction of dedicated emergency drug bags. The bags enable prompt drug retrieval during emergencies and supports safe storage, documentation and disposal of used /unused emergency drugs.
• A protocol for ED use of ketamine was developed. The protocol supports safe use of ketamine for specific emergency indications for which there is little published information, e.g. procedural sedation, analgesia and agitation.
• The initiatives were implemented and included in ED simulation training.
What next?
The described medication safety initiatives have considered the practice challenges for high risk drug access and use in emergency settings. The initiatives have standardised processes for specific high-risk drugs, supporting safer use. MDT collaboration ensured early and ongoing staff engagement from applicable disciplines, facilitating implementation and practice changes. Evaluation of the initiatives in practice is currently under review. The initiatives and learnings are transferrable to other emergency clinical settings.