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,

Author(s)

Helen Cooper, Sheatha Abumehdi

Why was it done?

A lack of licensed formulations for children means that use of unlicensed and off-label medicines is often the only appropriate alternative [1]. Local prescribing data demonstrates wide variability in concentrations of unlicensed specials supplied, at significant cost. This project aims to standardise medicines prescribing for children, improve patient safety by reducing inadvertent dose misadministration due to varying concentrations, reduce spend, and improve the effectiveness of working relationships between hospital and community healthcare teams.

What was done?

Prescribing and procurement data were used to analyse, review and harmonise paediatric prescribing practices in a UK clinical commissioning group, with focus on rationalising use of unlicensed specials.

How was it done?

A target list of ten medicines was identified, based on variability of strengths and formulations available, and cost. A team of two dedicated specialist paediatric hospital pharmacists was funded to set out strategies to standardise prescribing of those target medicines, and to improve understanding of prescribing and supply of unlicensed medicines to children. Various methods were used, including; email communications advertising the roles and support offered; establishing a Paediatric Formulary Group; promoting the local Paediatric Formulary; creating paediatric prescribing pathways; reviewing specials prescribing and supporting switches to alternative formulations; and delivering a paediatric prescribing webinar.

What has been achieved?

Reviews of specials prescribing were initially undertaken in two of the six boroughs in the region. 138 switches to a preferred formulation for safety and/or cost-effectiveness were identified and discussed between July-October 2021. Risks associated with prescribing multiple concentrations of liquid medicines were identified and measures were put in place to prevent patient harm. The webinar was well attended, and although it cannot be quantified, awareness of the Paediatric Formulary has improved. The project is on-going and at this time the impact on spend cannot be shown but will be reported later this year.

What next?

The specific knowledge and skills of specialist paediatric hospital pharmacists are highly valuable in driving specials medicines rationalisation for children in the community. Future plans for expanding the project include extending the service to other boroughs in the region and widening the target list of medicines.

References: 1.Rawlence E et al. Is the provision of paediatric oral liquid unlicensed medicines safe? Arch Dis Child Educ Pract Ed. 2018;103(6):310-3. 2.Neonatal and Paediatric Pharmacists Group. Position Statement 18-01 Using Standardised Strengths of Unlicensed Liquid Medicines in Children. Version 5, April 2020.

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.

Author(s)

Caroline TRAN VAN HO, Marie-Anne ESTEVE, Pierre BERTAULT-PERES, Marjorie ROUDOT

Why was it done?

SARS-CoV-2 infection leads to pro-inflammatory molecules production (in particular IL-6). If the immune system is overwhelmed and cytokine production spikes, a hyper-inflammatory phenomenon occurs: the cytokinic storm, which can bring lead to the admission in an intensive care unit. Due to the absence of authorized treatment, several clinical trials (CTs) and off-label use of drugs have been set up.

What was done?

The aim of this study is to analyse the off-label use of tocilizumab in a French university hospital in comparison with different CTs.

How was it done?

A retrospective study of tocilizumab prescriptions in Covid-19 was conducted between 01/03/2020 and 30/04/2021 by extracting data from Computerised Physician Order Entry and Pharmacy Management software (Pharma®). History of patients was recovered by electronic medical records (Axigate®).
Results were compared to (1) RECOVERY Collaborative Group. Lancet. 2021, (2) Hermine O. JAMA. 2021, (3) Rosas IO. N Engl J Med. 2021, (4) Salama C. N Engl J Med. 2021.

What has been achieved?

Between 01/03/2020 and 30/04/2021, 68 patients received tocilizumab.
Seventy-seven percent of patients were in the intensive care unit and 42.6% died, whereas 31.0%, 19.7%, 11.1% and 10.4% died according to (1), (3), (2) and (4), respectively. Mechanical or invasive ventilation at the time of tocilizumab prescription was widely used (84%) compared to CTs (54.0%, 27.9%, 24.0%, 12.2% for (1), (3), (2), (4)). According to (1), there is a synergistic action between tocilizumab and dexamethasone. Eighty-four percent of patients received at least one dose of corticosteroids in agreement with (1) and (4).

What next?

The increase in off-label use of tocilizumab is related to the results of CTs. Because of the low number of patients, the differences in COVID-19 stages at tocilizumab initiation, and the absence of a control group, it is difficult to explain our data. Given the weak iatrogenic effects revealed in CTs and in-label use, the benefit/risk seems in favor of tocilizumab use against COVID-19. Further studies are needed to confirm the first hopes. Since Casirivimab / imdevimab, and amlanivimab / etesevimab have been granted early access in France, the therapeutic strategy will be updated.

Author(s)

Carmen Ortí Juan, Cristina Toro Blanch, Maria Àngels Gispert Ametller, Ana Perez Plasencia, Cristina Lecha Ochoa, Anna Dordà Benito, Rosa Sacrest Güell

Why was it done?

Prescribing errors (PE) are an important cause of medication-related adverse events in the Emergency Departments (ED) but limited data are available in ED with electronic prescribing and administration (ePA) systems. Knowing the frequency and types of PE can help healthcare professionals to prevent and reduce the risk of them occurring.

What was done?

To determine the rate of PE in the ED, to classify incident types and to identify critical points where measures should be implemented to improve patient safety.

How was it done?

Prospective, observational and cross-sectional study in an ED with ePA system during 6 working days (May-June 2021). The inclusion criteria were patients stayed more than 8 hours in the ED and all patients awaiting hospitalization. Prescriptions were analyzed by a multidisciplinary team made up of two pharmacists, an emergency physician and the person in charge of the hospital’s medication errors committee. PE were reported to the hospital’s patient safety-related incident notification system.

What has been achieved?

Of the 65 prescriptions revised during the study period, PE were reported in 84 cases and 15 situations with the capacity to cause errors were detected. The average age of patients was 67 ± (SD=17,9) years and each prescription had an average of 8.4 medications. The rate of PE was 1.52 errors per patient, being higher in less severe patients than monitored patients (1.09 vs 2.0 PE per patient, respectively). The most common types of EP were omission of the usual medication (60.7%), wrong dose (15.5%), wrong frequency (7.1%) and drug is not indicated (7.1%). No adverse reactions related to EP were detected. According to the Spanish consensus about Medication Reconciliation in Emergency Units, 47.1% of omissions of usual medication were drugs that should be reconciled during the first 4 hours in the ED. The results of the study and the importance of medication reconciliation are highlighted in a session in the ED.

What next?

The PE rate in the ED was 1.52 per patient and the main type was omission of the usual medication. A cross sectional study will be made in the future and compared to the current one to establish the impact of the implemented measures on the PE rate.

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.

Pdf

Author(s)

Vera Pires, Maria Teixeira, António Gouveia

Why was it done?

Cisplatin is a cytotoxic agent used in CT regimens in ST. (1) Nephrotoxicity is the main toxicity, and hydration is always indicated to prevent kidney damage. [1,2] In 2018, when we computerized the ST’s CT protocols, we verified the existence of variations in CH protocols. According to the bibliography, this lack of standardization could lead to sub-optimal treatment of patients, errors and unnecessary use of resources. [1,3] Thus, it was necessary to develop a standardized hydration protocol designed by pharmacists with the collaboration of oncologists.

What was done?

Standardize the cisplatin-based hydration (CH) protocols used in the solid tumors (ST) chemotherapy (CT) regimens in adults in our institution.

How was it done?

Audit of CH protocols used in ST in adults in our institution and literature review to build a standardized evidence-based protocol.

What has been achieved?

We gathered 31 CT regimens with cisplatin. Verified the existence of variations in the volume of hydration (VH) before and after cisplatin, in the volumes of drug dilution, perfusion time, in the use of oral hydration (OH) and in ionic supplementation. We found that all of them were indicated to perform cisplatin only “if urine output >100ml/min”, use of mannitol before cisplatin and furosemide in SOS. Through the consulted bibliography, 4 regimens were made and implemented in 2019, according to the dosage of cisplatin: HC1< 40mg/m2 (Hday) and HC21000ml, and mannitol is only administered if cisplatin ≥60 mg/m2 (RCM). All protocols have magnesium and potassium supplementation.

What next?

Thus, despite the lack of consensus in the bibliography, a standardized protocol was created based on the evidence and clinical practice of our Institution. It is our intention to assess the impact of this intervention, from the perspective of the patient and the Institution.

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.

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.

Author(s)

Miguel Angel Carvajal-Sanchez, Josefa Leon-Villar, Pilar Pacheco-Lopez, Javier Ibañez-Caturla, Paula Torrano-Belmonte, Lydia Fructuoso-Gonzalez, Juan Antonio Gutierrez-Sanchez, Maria Hernandez-Sanchez

Why was it done?

In recent years, we have witnessed a significant increase in the number of thermolabile pharmaceutical specialities, which makes it necessary to keep strict control of the storage temperature from manufacture to administration.

In this context, patient education is a fundamental step in ensuring that these medicines are administered effectively and safely.

What was done?

A study was carried out to determine the quality of the information provided by Hospital Pharmacy Service (HPS) professionals to patients regarding the storage of thermolabile medicines (TM) at home.

After analysing the variability of the results, we established in a protocolised manner the necessary and sufficient information items to be included in the pharmaceutical advice to patients regarding the storage of this type of medicines.

How was it done?

A random selection of 28 HPS professionals (13 nurses, 10 specialist pharmacists and 5 resident pharmacists) was made. Each participant, in isolation and individually, made a selection of criteria to be contained in the patient information regarding the transport and storage of TM.

The results obtained were:

General information:

o Informing that it is a TM: 89.28%.

o Telephone number for incidents: 10.71%.

o Keep out of the reach of children: 3.57%.

o Return if discontinuation of treatment: 3.57%.

Storage:

o Specify location in refrigerator: door/indoor distinction 28.57%; Avoid contact with walls: 28.57%; specific place in refrigerator 3.57%.

o Do not store next to food: 17.85%.

o Refrigerator/freezer distinction: 10.71%.

Transport:

o Recommendations for correct transport: 50%.

o Time elapsed from dispensing to refrigerator storage: 39.29%.

Administration:

o Tempering prior to administration (when necessary): 39.28%.

o Visual inspection: 7.14%.

o Check expiry date: 7.14%.

o Frecuency of administration: 3.57%.

What has been achieved?

Completion, standardisation and systematisation of the provision of information to patients on TM.

What next?

Training sessions will be given to all HPS professionals involved, including new recruits and pharmacy assistants. This is an initiative applicable to all HPS.