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Rationalising prescribing of unlicensed specials to children

European Statement

Clinical Pharmacy Services

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.

Implementation of dose banding strategy for Daptomycin

European Statement

Production and Compounding

Author(s)

Marta García-Queiruga, Begoña Feal-Cortizas, José María Gutiérrez-Urbón, Andrea Luaces-Rodríguez, Alejandro Martínez-Pradeda, Sandra Rotea-Salvo, Carla Fernandez-Oliveira, Víctor Giménez-Arufe, Luis Margusino-Framiñán, Isabel Martín-Herranz

Why was it done?

Daptomycin is an intravenous antibiotic usually prepared in Hospital Pharmacy services. Normally it is dosed based on body weight, which requires each intravenous mixture to be prepared in an individual manner for each patient. This might lead to an increased assistance workload in elaboration areas, a higher number of errors in the preparation and high costs due to waste materials generated during preparation.

What was done?

The aim of this study is to describe the preparation of intravenous daptomycin by dose banding, a system in which daptomycin doses are rounded up or down in order to standardize and protocolize the preparation of intravenous mixtures as much as possible.

How was it done?

In order to improve this situation, dose banding strategy was implemented in February 2019: the obtained final dose was rounded in such a way that only mixtures of 500, 700 and 850 mg were prepared (in agreement with Hospital Pharmacy and Infectious and Microbiology medical teams) , following this scheme:
PRESCRIBED DOSE PREPARED DOSE
< 400 mg Prescribed dose (individualized) 400–599 mg 500 mg ≥600–799 mg 700 mg ≥800 mg 850 mg

What has been achieved?

Previous year before starting dose banding strategy (2018), 5493 individualized doses of daptomycin were prepared for 437 patients in our Pharmacy service. Between June 2020 and June 2021, 2680, 2555 and 997 units of daptomycin 500, 700 and 850 mg, respectively, were prepared for 360 patients. Batches of standardized doses were prepared in advance and kept refrigerated (stability of 10 days in 100 ml of physiological saline) until dispensation. In addition, during the same period, 15 patients (4 from pediatrics) received 209 individualized doses (3.2% of the total doses) due to their low body weight.

What next?

This strategy might decrease the number of errors in preparation and reduce processing times, which is essential since early appropriate antibiotic treatment in severe infection has been associated with better outcomes. Dose banding model could be extrapolated to other drugs with good physical, medical and microbiological stability in dilution, which are frequently prescribed and when few dose bands can cover most of the prescriptions.

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.

Formation and empowerment for pharmaceutical interview focused on opioids in acute non-cancerous pain

European Statement

Clinical Pharmacy Services

Author(s)

Esteban CHAUMET, Johanna RAYMOND, Eric BARAT, Catherine CHENAILLER, Rémi VARIN

Why was it done?

A clinical study, including a PI focused on the management of acute non-cancerous pain with opioids, was implemented in post-emergency units of our teaching hospital. Formation and empowerment procedures for PIs are little or not described in the literature. Given the multiplicity of actors, which could perform those PIs, it appeared necessary to standardize our practices and key messages delivered to the patient.

What was done?

Create an adapted formation allowing standardization of practices between various actors performing a pharmaceutical interview (PI) focused on the management of acute non-cancerous pain with opioids.

How was it done?

Creation of different tools : a resource pack with opioids literature to train learners; a theoretical and practical formation schedule and an empowerment procedure, supervised by a qualified tutor; an interview frame with topics to be addressed during the PI; two audio simulations of patient interviews; complex questions that the patient might ask during the PI.

What has been achieved?

The resource pack contains 11 documents that provide the learner with relevant concepts and the key messages to deliver to patients. The formation schedule consists of several stages. Firstly, theoretical formation : learning with the resource pack; written restitution of knowledge on the interview frame and identification of the points to be improved with the tutor; completion of the e-learning on performing a PI (currently being created by the French Society of Clinical Pharmacy); listening to the two audio simulations and oral restitution of information to the tutor; restitution by the learner, during a reversed class, of knowledge on opioids and key messages for the patient; answering complex questions. The practical formation consists of observing the tutor during a PI, then performing PIs with a qualified tutor.

What next?

The formation and empowerment will be implemented in November 2021. As part of a quality approach, learner’s satisfaction and general appreciation will be collected in order to optimise the formation. The creation of this procedure will guarantee a uniform, complete and modern formation based on a quality system thus minimising the biases induced by the multiplicity of actors performing the PIs. In the future, this formation schedule and empowerment could be adapted to other PI topics.

Dose a clinical pharmacy service in emergency department improve the safety of eldery patient ?

European Statement

Clinical Pharmacy Services

Author(s)

Ugo CARRERE, Charles-Henri BLANCHER, Julien ARCIZET, Serge BENETEAUD, Caroline ALLIX-BEGUEC, Benoit LE FRANC

Why was it done?

EDs are the main entry point for hospitalizations. Medication errors are a major threat to patients safety. They are exacerbated by the high flow of patient admitted, the increase in polypharmacy in eldery patients, lack of knowledge of medication and time constraints.

What was done?

We have implemented proactive medication reconciliations (MR) for eldery patients in our emergency department (ED). Retroactive MR was performed in downstream departments (DD) for similar patients. Goals were to save physicians’ and nurses’ times, to improve patient safety.

How was it done?

A pharmacist provided MR in the ED unit three half-days per week. In agreement with the emergency physicians, we targeted patients aged 75 years and over and/or 65 years and over with multiple medications remained hospitalized. Pharmacists collected patients’ medication history and shared the information to ED prescribers. The drug assessment was recorded in a prescription support software. Prescribers, in the DD, could use it to prescribed without transcription and save time.
Our study was based on the comparison of the two groups : the proactive MR group in the ED and the control group with retroactive MR in downstream departements. Discrepancies were recorded and rated as intentional and unintentional in the two groups.

What has been achieved?

Between February and April 2021, 139 medication reconciliations were performed (proactive group n=61 ; retroactive group n=78). The age (about 83 years) and mean number of drugs per patient (about seven) of the two groups were not statistiquely different. We observed a statistically significant reduction in the number of unintentional discrepancies with proactive reconciliation in the ED (7% in the proactive group versus 20% in the retroactive group, p-value = 0.0034). Drugs for the nervous system and the cardiovascular system were the most affected by discrepancies. These discrepancies were mainly detected in prescriptions for patients taken care in the orthopedic surgery, the hepato-gastrology and the polyvalent medicine departments.

What next?

Clinical, economic and organizational scoring of unintentional discrepancies will be performed by a physician-pharmacist pair (CLEO scale of the French Society of Clinical Pharmacy)
Downstream departments with the most UD will be encouraged to use medication reconciliation.
A satisfaction survey will be conducted among the teams.

Implementation of a telepharmacy service in outpatient’s pharmaceutical consultation

European Statement

Clinical Pharmacy Services

Author(s)

QUERALT LOPEZ NOGUERA, ÀNGELA CASTELLÓ NÒRIA, CRISTINA DIEZ VALLEJO, LAURA VIÑAS SAGUÉ, MARTA COMA PUNSET, SILVIA CABARROCAS DURAN, MIREIA VILA CURRIUS, ANNA DORDÀ BENITO, EDUARDO TEJEDOR TEJADA, CRISTINA TORO BLANCH, ROSA NURIA ALEIXANDRE CERAROLS, ROSA SACREST GÜELL

Why was it done?

The declaration of the state of emergency by SARS-CoV-2 pandemic on March of 2020 had an impact on hospital PC.
During that period, it was advised by Healthcare Authorisations to minimize the risk of infection or spread of SARS-CoV-2 in order to protect vulnerable groups. For that reason, it was not recommended to assist in the hospital if it was not necessary. This fact caused some organizational changes in OPC to adapt to the current situation.

What was done?

Our hospital Pharmacy Department created a telepharmacy service in outpatient’s pharmaceutical consultation (OPC) after state of emergency declaration by SARS-CoV-2. We created a standard operating procedure working together with communitarian pharmacists and the Region Pharmacist’s College. The main aim was to ensure pharmaceutical care (PC) quality in vulnerable patients and the correct medication distribution and conservation. Pharmaceutical care was developed by telephone call and medication was send to communitarian pharmacy.
A comprehensive analysis was made to concern the impact on drugs delivery selecting certified distribution company which ensured drug traceability, custody and conservation.

How was it done?

In 2020, approximately 60 patients per day used to attend in OPC. According to the large number of patients, we defined which patients could take advantage of this programme. The selection criteria were adherent patients with pulmonary pathologies (cystic fibrosis, asthma, bronchiectasis, etc.), multiple sclerosis, amyotrophic lateral sclerosis, reduced mobility or patients over 65 years old who lived in more than 30km closed to the hospital or without any family member that could come.
In order to ensure the process traceability, an informatics tool has been created by Region Pharmacist’s College. Pharmacy Department, community pharmacy and the distribution company assumed all expenses.

What has been achieved?

369 of 2.346 patients were included in our telepharmacy service during the state of emergency. There was high level of acceptance by all patients. Only low-risk patients or patients who had an on-site doctor visit were attends in OPC. Nowadays, 196 patients still benefit from the initiative.

What next?

Telepharmacy program avoids patient’s displacements that are particularly susceptible to COVID-19 negatives effects. Moreover, it guarantees PC quality, patient’s adherence, process traceability and correct medication conservation from hospital to patient’s home.

Homemade personalized 3D printed guides for mandibular reconstruction – A pharmacist feedback

European Statement

Production and Compounding

Author(s)

Quentin Misandeau, Romain Bosc, Muriel Paul, Valérie Archer, Lionel Tortolano

Why was it done?

The plastic surgery department bought two 3D printers in order to design and create custom-made medical devices. The main objective was to decrease the delay between mandibular cancer diagnosis and the surgery. The delays of production in the medical device manufacturers may exceed 2 weeks. Those delays are considered as a lost of chance for the patients.

What was done?

We helped our surgeons to secured the production procedure and reduce the risks for patients. We create a management quality system for supply, production, sterilization and using of our homemade personalized 3D printed guides.

How was it done?

First, we created a task force of pharmacist and surgeons.
The main work was a risk analysis with the FMECA method for all the steps in the procedure (software, tools, actors and materials).

What has been achieved?

Some correctives actions were taken. The riskier points were the plastic materials toxicity risk, the sterilization procedure that has been validated and the production traceability. A biocompatibility evaluation was performed. A clinical evaluation has been initiated in the same period.

What next?

Since the new medical device regulatory (2017 /745 CE) was published in 2017, the article five, that regulate the 3D printing in hospital, changes the possibilities. In fact, as personalized 3D printed guides are available on the EU market, homemade personalized 3D printed guides for mandibular reconstruction could be not authorized anymore. The only way would be for the hospital to obtain the regulatory statut of manufacturer and comply with the essential requirements.

A prospective observational study of medication prescribing errors in an Emergency Department.

European Statement

Patient Safety and Quality Assurance

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.

Pharmaceutical Consultation in Primary Care Multidisciplinar Team

European Statement

Clinical Pharmacy Services

Author(s)

Claudia Elias, Nadine Ribeiro, Anacleto Mariana, Amaral Daniel, Cimadeira Fátima, Abreu Ana Paula, Vaz Filomena, Martinho Helena , Bernardo Mónica , Mateus Rita , Martins Sandra

Why was it done?

The care of elderly patients with multi-morbidities is a great challenge faced by the our National HealthCare System, due to the complexity of the most vulnerable in society. When the medication risks begin to outweigh benefits, polypharmacy may become inappropriate. Management of polypharmacy is an essential element of patient safety and adherence, preventing medicines harm and infectivity. In the primary care setting there was no integrated multidisciplinary pharmacotherapy management service.

What was done?

Clinical Pharmacist was included in multidisciplinary team in Primary Care for Pharmaceutical Consultation implementation.

How was it done?

The Pharmacy Department and of the Regional Team, supported by the Board of Directors, joined efforts for the implementation of a Program for the Management of Polymedication in Complex and Chronic Fragile. It implies patients with medication problems referral by physicians to the pharmacist. Pharmacist schedules a face-to-face, or telephone, interview, inviting them to bring all drug packages. During consultation, patient’s health literacy, therapeutic adherence and drug management skills are assessed. Doubts are clarified and information on drugs best use and non-pharmacological measures benefits are provided. The pharmacist then makes the pharmacotherapeutic review looking up for any unaddressed medication related problem. In conjunction with the attending physician, they agree in the best pharmacotherapeutic plan for the patient.

What has been achieved?

The project started 2.5 years ago, being implemented in four primary care units. We had 124 patient referrals and made 171 consultations. Before Covid pandemic, all the contacts were face-to-face now 60% are teleconsultation. The median age is 76 years, 59% female with an average of 11 comorbidities and 11 medicines prescribed/patient, being cardiovascular and endocrine pathologies the most commons. Only 33% of patients took medicines has prescribed and of them, only 61% could identify their indication. The most prevalent drug problems were safety (42%) and need (25%). Off the 539 interventions, 48% addressed desprescription, drug substitution and dose adjustment by physicians; 14,3% aimed drug education use by patients or caregivers; 88% of the suggested interventions were accepted.

What next?

We expect to expand the project to other health care units briefly.
Even though the inclusion of a clinical pharmacist in primary care units is currently centered in the management of polypharmacy, it may encourage involvement in other activities that enhance the pharmacist role in the primary care units.

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.