Author(s)

Sonja Guntschnig

Why was it done?

The aim of this good practice initiative (GPI) was to identify local resistance patterns, improve prescribing quality, reduce hospital costs, calculate antibiotic use data, track problem organisms, infection clusters and enable transfer chains tracing.

What was done?

With the introduction of a new antimicrobial stewardship (AMS) group into Tauernklinikum, Zell am See, a new informatics tool called HyBase® by epiNet AG was implemented to establish an interface linking microbiological results, consumption of antimicrobials, the hospital infections surveillance system “Krankenhaus-Infektions-Surveillance-System”(KISS) and the hospitals antimicrobial resistance data. AMS teams need suitable AMS surveillance systems to track intervention changes and measure results.

How was it done?

After purchasing release by the hospital management, HyBase needed an interface with several IT system providers, namely the internal microbiology laboratory (KISS software), System Application and Product in processing (SAP), and two external microbiology laboratories.

What has been achieved?

Antibiotic consumption figures were obtained retrospectively by calculating defined daily doses (DDD). This also gave insight into problematic use of certain antibiotics and indicated potential for antibiotic restriction.
Antimicrobial resistance patterns were displayed, which led to the introduction of infection control and AMS measures. Alert organism surveillance data was obtained and evaluated for different wards.

What next?

Learning from this implementation will enable changes in antimicrobial prescribing which will lead to improvements, both in healthcare quality and patient safety as well as a potential reduction in prescribing costs. Alert organism clusters will be detectable as will be transfer chains in the healthcare setting. It will also allow for the introduction of infection control agent stewardship for example by testing hand disinfection compliance or recording the spread of surface adherent organisms.
This GPI addresses the WHO antimicrobial resistance global action plan and local antimicrobial medicines concerns. It may prove useful for other healthcare settings and can be easily implemented to obtain data necessary for robust effective antimicrobial stewardship.

Author(s)

Emilio Monte-Boquet, Mª Jesus Cuellar-Monreal, Mª Vicenta Tarazona-Casany, Ana Alejandra Garcia-Robles, Eduardo Guerrero-Hurtado, Inmaculada Beltran-Garcia, Patricia Polo-Montanero, Antonio Solana-Altabella, Jose Luis Poveda-Andres

Why was it done?

Ivermectin is used as a therapeutic alternative for permethrin-resistant scabies. The recommended treatment consists of administering two single doses (SD) separated by 7-14 days. An increased incidence and resistance to permethrin was observed in late 2020 possibly influenced by SARS-CoV-2 pandemic.

What was done?

To assess the effectiveness of oral ivermectin as a treatment for topical 5% permethrin-resistant scabies in patients from a tertiary hospital and to analyze the characteristics of the sample and the treatment.

How was it done?

An observational, retrospective and descriptive study was done including patients who collected Ivermectin 3mg tablets in the Outpatient Pharmaceutical Care Unit of the hospital between April 2020 and April 2021. All patients were previously treated with 5% permethrin and had failed. Treatment with ivermectin was considered effective in patients who were discharged from Dermatology Clinics or did not consult for itching or other symptoms 4 weeks after the last dose. Other variables were: number of doses received, age, sex and antecedents within family nucleus or cohabiting cases were also collected.

What has been achieved?

A total of 37 patients were included and 39 applications were made. There were 16 applications from April 2020 to December 2020 (mean of 1.78±1.79 applications/month [95%CI:0,41-3,05), and 23 from January to April 2021 (mean of 4,6±2.6 applications/month [95%CI:1,37-7,83]). Ivermectin was effective in 87,2%(34/39) patients and in the remaining 12,8%(5/39) therapeutic failure happened, so they required treatment for a second time. A patient was excluded because it was unclear if treatment had been ineffective or reinfestation happend. The 56,4%(22/39) of patients received two SD separated for 7–14 days. The 58,5%(24/39) of patients were women and the mean age of the sample was 31,1±19,3 years old (95%CI:26,8-37,4). The 54,0%(21/39) of the patients had between 11-30 years old, and the 74,4%(29/39) had a history or cohabitants within their family nucleus.

What next?

In our study sample, effectiveness of Ivermectin was greater than 90% in scabies resistant to topical 5% permethrin and seems independent of the number of doses received. Results suggest that scabies mainly affects women and Young people. Infections in cohabitants seem to have an increased frequence and may had been influenced by confinament and delays of treatments during SARS-CoV-2 pandemic.

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Author(s)

BERTA MONTERO-PASTOR, ELSA IZQUIERDO-GARCÍA, LORENA DE AGUSTÍN SIERRA, ISMAEL ESCOBAR RODRIGUEZ

Why was it done?

The unprecedented mass COVID-19 vaccination has highlighted the need to develop strategies that prioritize and optimize the use of resources. Strategies have been established at the national and community levels, however, each center must implement its own plan according to needs and capabilities for its target population.

What was done?

A Pharmacy Department (PD) vaccination plan including strategies to optimize human and material resources available to deal with mass COVID-19 vaccination.

How was it done?

In plan development, we considered the type of vaccines, storage requirements, the need for specific equipment and workflows, limited vaccine vial supply, and aspects related to staff in the PD.
A standard operating procedure (SOP) was developed for logistic management of vaccine orders, including an SOP for nursing staff if the shipment arrived outside the PD schedule.
For storage, specific space was provided considering the different storage requirements.
The doses corresponding to the vaccination of health professionals and patients from group 7 of the national vaccination strategy (onco-hematologic patients with active treatment, hemodialysis patients, primary immunodeficiencies, HIV -CD4<200cel/ml, Down Syndrome ≥40 years) were prepared centrally in the PD. For the general population, a centralized preparation in PD is not feasible. So, alternatively, PD developed a dispensing circuit and informative material for nursing staff for the correct dosage and traceability of vial batches. In all stages, the use of vials was optimized with strategies such as the selection of adequate packaging material, the grouping of patients, or the exchange of vials between vaccination centers.

What has been achieved?

We received 16230 vaccine vials from four different commercial brands. There have been no incidents related to the receipt and storage of vaccines.
A total of 9753 doses were made. In the whole elaboration process, we only wasted a vial on one occasion and a dose on another.
We dispensed 11911 vaccine vials to the general population. Of these, 13 vials were discarded due to errors in the preparation.

What next?

The development of a specific plan has made it possible to optimize the COVID-19 vaccination process in our hospital. The plan will be adapted and updated according to the updates of the national and community vaccination strategies.

Author(s)

ANA CASTRO BALADO, MARÍA TERESA RODRÍGUEZ JATO, IRIA VARELA REY, MANUEL BUSTO IGLESIAS, FRANCISCO CAJADE PASCUAL, MARIA PUENTE IGLESIAS, IRENE ZARRA FERRO

Why was it done?

The prevalence of obesity has increased considerably in last decades. Pathophysiological changes in obese patients (body mass index >30kg/m2) produce pharmacokinetic and pharmacodynamic alterations that can condition the correct exposure to drugs if standard dosages are used. Incorrect dosing in obese patients can lead to toxicity or therapeutic failure. Usually, it is difficult to find information on drug dosing in this population, being sometimes contradictory.

What was done?

To develop an antimicrobial dosage infographic guide for obese patients to facilitate the correct prescription and validation in our hospital.

How was it done?

Initially, the pharmacy service established the antimicrobial groups to be included in the infographic guide, and within each of them, the most used in hospitalized patients were identified. A bibliographic search was carried out using the keywords “obese”, “dosing”, “antimicrobial” and “patient”. Technical data sheets, PubMed, Google Scholar, UpToDate, Micromedex and other hospital guidelines were consulted. A peer review was carried out and a table with antimicrobial groups and subgroups was designed, stablishing the body weight recommended for the adjustment if needed (total weight (TBW), ideal weight (IBW) and adjusted weight (ABW)), doses, and observations (monitoring of plasma levels, administration in extended/continuous infusion and/or special considerations). The table consisted of a total of 38 antibiotics, 10 antifungals, 6 antivirals and 4 antituberculous drugs. Of the total antimicrobials reviewed, 40% were dosed in obese patients by maximum dose, 38% were dosed based on weight (21% by ABW, 10% by IBW, and 7% by TBW) and 22% by standard doses. Equations for body weight descriptors were added in the infographic.

What has been achieved?

The protocol was validated by the hospital’s infectious diseases commission. Dosing information was then entered into the hospital’s electronic prescribing program facilitating the correct antimicrobial prescription and validation in obese patients. Training was provided in the intensive care unit, and the final document was disseminated through the hospital intranet and via email to all prescribing physicians in the center, being well embraced.

What next?

We will continue making formative sessions, as well as possible updates that may be beneficial for a better antimicrobial dosing in obese patients to avoid toxicities and/or therapeutic failure.

Author(s)

Mariosa Kieran

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.

Author(s)

SILVIA CORNEJO-UIXEDA, M JOSE MARTINEZ-PASCUAL

Why was it done?

The anticholinergic burden is the cumulative effect of concomitantly taking multiple drugs with anticholinergic properties. It estimates the risk of suffering anticholinergic adverse effects. Anticholinergic scales are lists that rank the anticholinergic potential of drugs into categories.

What was done?

Our aim is to know the use of drugs with anticholinergic effect (ACD) in a regional hospital.

How was it done?

Observational study in patients older than 70 years admitted to a regional hospital from January to September 2021. We reviewed the medication of the patients looking for ACD. Then, we calculated anticholinergic burden with the “Drug Burden Index” available in: http://www.anticholinergicscales.es/calculate. The variables collected were: age, gender, number of drugs with anticholinergic effect, if ACD were prescribed before hospitalization, readmission, anticholinergic burden, risk of suffering anticholinergic effect and anticholinergic symptoms.

What has been achieved?

average 81 years (70-100), 102 (56% woman), 46 (25%) did not have any ACD. 58 patients had 1 ACD, 56 patients 2 ACD, 12 patients 3 ACD, 8 patients 4 ACD, 2 patients 5 ACD. Of patients with ACD, anticholinergic burden average was 0.98 in surgical patients (medium risk) and 1 in medical patients (elevated risk). 68 patients had medium risk and 68 patients elevated risk. We found constipation in 17 patients, somnolence in 6 patients, and disorientation in 2 patients. ACD used were the following (surgical vs. medical patients): Antidepressants: 3 vs.10, benzodiazepines: 28 vs. 33, opioids: 17 vs. 27, antiemetics: 13 3 vs. 38, Antipsychotics: 4 3 vs. 49, antihistamines: 2 vs. 2, antiepileptic: 0 vs 9, other: 0 vs. 3.
56 patients (31%) were prescribed the same ACD that they took before hospitalization. Only 17 patients were readmitted in hospital in less than a month.
We just made 2 interventions. We proposed to lower the dose in one case. In another, we proposed give metoclopramide just if necessary.

What next?

Most of hospitalized patients have ACD prescribed. Half of them had a high risk. However, just a few had anticholinergic reactions. This could be explained because we only had the information of electronic history and maybe some of them were not collected.

Author(s)

Irene Lizano, Ferran Montpart, Elisenda Pomares, Guillem Saborit-Canals, Míriam Fernández

Why was it done?

Treprostinil is a prostacyclin analogue indicated for the treatment of PAH. A recent retrospective study analyzed drug safety events observed in the clinical trials of oral and subcutaneous (SC) treprostinil. This analysis showed that higher treprostinil doses were associated with lower PAH-related hospitalization rates, compared to lower doses.

What was done?

To estimate annual pulmonary arterial hypertension (PAH)-related hospitalization costs in patients treated with different treprostinil doses in nine European countries (Belgium, France, Germany, Italy, Poland, Portugal, Spain, The Netherlands and the United Kingdom).

How was it done?

A cost estimation model was developed to calculate hospitalization costs in patients with PAH who were treated with treprostinil at different doses. Annual hospitalization rates were gathered from a retrospective analysis of an oral and SC treprostinil global safety database. Patients were categorized into three groups based on total daily dose: low, medium and high. Low dose was defined as <4.0 and <1.9 mg/day (9.0 and >7.6 mg/day (>30 ng/kg/min). PAH-related hospitalization costs were included and, when not available, heart failure-related costs were considered as it is the main cause of hospitalization in PAH patients. Mean annual hospitalization costs per dose were calculated using annual PAH-related hospitalization rates (0.9 for low dose, 0.4 for medium dose, and 0.3 for high dose) and unit costs per hospitalization in each country. All costs were obtained from national databases or published literature and were expressed in 2021 euros.

What has been achieved?

Mean annual PAH-related hospitalization costs ranged from €1,649 to €8,382 for low dose, from €733 to €3,726 for medium dose, and from €550 to €2,794 for high dose. Thus, hospitalization costs for high-dose patients were 3 times lower than for low-dose patients (mean difference €2,610) and 1.3 times lower than those for medium-dose patients (€435).

What next?

High doses of treprostinil result in lower hospitalization costs than low and medium doses in patients with PAH. Therefore, an appropriate drug titration might lead to potential cost savings in various European settings.

Author(s)

Carla Pinto, João Godinho, Luzia Fernandes, Patricia Vieira, Isabel Ferreira, Inês Sousa, Carolina Vieira, Ana Sardinha

Why was it done?

To promote a more effective notification process than the spontaneous reporting of suspected adverse drug reactions and contribute to the knowledge of the safety profile of medicines.
Covid-19 vaccines are medicines under additional monitoring, labelled with a black inverted triangle and expected to play a major role in the control of COVID-19 pandemic due to SARS-Cov2 virus.
This new medicine was administrated in a short time period and simultaneously to a large number of individuals in the beginning of vaccination period in Portugal (January 2021), to patients and healthcare professionals of our haemodialysis centers.

What was done?

Development and implementation of a proactive pharmacovigilance program to identify suspected adverse drug reactions (ADRs) to a covid-19 vaccine administration in haemodialysis centers patients and healthcare professionals.

How was it done?

Maintaining spontaneous report for immediate suspected ADRs, pharmaceutical services developed a form to collect suspected ADRs in the following 7 days after each dose administration. It was applied to each vaccinated exactly 7 days after the administration of each dose. To simplify its filling and application, overcoming workload and lack of resources in this pandemic setting, information was displayed with check mark boxes, including the list of described ADRs sorted by frequency, duration intervals and blank space for unexpected reactions.
Due to the large amount and variability of individuals and centers, the form was distributed in paper and online formats and applied to vaccinated patients by doctors or nurses.
Pharmacists validated the forms to notify the national pharmacovigilance system for serious or unexpected ADRs.

What has been achieved?

From the 9469 covid-19 vaccine administrations we obtained 6962 filled forms (74% of vaccinations) from which 38% (2666 forms) had suspected ADRs. 2nd dose had a lower participation rate of about 10%. These participation rates where due to no filled forms in cases of no symptoms.

What next?

Apply this proactive pharmacovigilance model in the integration in the institution of future medicines under additional monitoring will allow better knowledge of occurrence of adverse reactions, improving safety of medicines.
For the best outcomes program must be adapted to each medicine’s specification, considering even simpler tools to obtain information when there are no symptoms to report.

Author(s)

Alba María Fernández Varela, Laura López Sandomingo, Nieves Valcarce Pardeiro, Isaura Rodríguez Penín

Why was it done?

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What was done?

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How was it done?

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What has been achieved?

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What next?

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Author(s)

Nikolaus Lindner, Katharina Heitzeneder, Nora Hummer, Elisenda Pichler, Doris Haider

Why was it done?

Due to the lack of long-term safety data, the principal goal was to assure a safe and effective use of the available vaccines by coordinating stringent logistical operating procedures as well as by facilitating early detection and evaluation of possible safety signals. A further objective of this initiative was to increase the awareness among healthcare workers regarding the possible health risks associated with a SARS-CoV-2 infection and Covid-19 vaccines as preventable countermeasures.

What was done?

A Covid-19 vaccination pharmacovigilance campaign was implemented in a clinical setting with the focus on patient safety and quality assurance as part of an employee vaccination rollout. The pharmacy department set up a pharmacovigilance service-point to assess vaccine safety as well as potential adverse events and assure patient care by close follow up.

How was it done?

Assessing and reacting to individual safety signals on time represented a critical challenge. Pharmacists designed questionnaires capturing possible adverse events. In order to lower the barriers for participation it was decided to take a paper-based approach instead of electronic distribution. A pharmacovigilance service-point was continuously managed by two pharmacists directly at the vaccination site to achieve a high response rate. Throughout the campaign the completed questionnaires were simultaneously evaluated, as rapid action was key to detect safety signals early and implement measures accordingly.

What has been achieved?

The results showed a high response rate to the questionnaire of 95% and 53% after the first and second dose, respectively. A significant increase of symptoms after the second dose compared to the first dose reflected the findings of the marketing authorisation study. Based on the analysis no further safety precautions were needed. However, appointments before night or weekend shifts had to be discouraged as well as the vaccination of the whole staff from one department on the same day. As a result, disruptions to patient care could be avoided successfully.

What next?

This initiative serves as a valuable model for upcoming vaccination campaigns and especially for pharmacovigilance projects aiming to assess adverse events of recently approved medicines. Moreover, the successfully implemented multi-disciplinary approach represents the basis for further hospital-wide pharmacy projects and may facilitate the implementation of pharmacist-provided vaccination services.