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Implementation of a new work circuit in monography consultation of immune-mediated diseases of the pharmacy service

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European Statement

Patient Safety and Quality Assurance

Author(s)

ALBA MARIA MARTINEZ SOTO, MARIA ONTENIENTE CANDELA, CARLES INIESTA NAVALON, PATRICIA ORTIZ FERNANDEZ, PILAR FERNANDEZ-VILLACAÑAS FERNANDEZ, ANABEL HERREROS HERNANDEZ, GEMMA MARTINEZ SOTO, CARMEN CABALLERO REQUEJO, MAYTE GIL CANDEL, ELENA URBIETA SANZ

Why was it done?

– Guide the pharmacist in the development of an individualised follow-up strategy for patient evaluating the frequency with which appointments should be established in the consultation of Pharmaceutical Care.
– Use the information from the specific questionnaires to detect possible failures therapeutic.
– Use the results obtained in the PROs to direct the recommendations pharmacotherapeutic to perform, which will be assessed in a multidisciplinary committee of immune-mediated diseases.
– Promote higher quality pharmaceutical care.

What was done?

Implementation of a circuit to improve pharmaceutical care and follow-up pharmacotherapeutic, incorporating the stratification of
patients according to the “Model of Stratification and Pharmaceutical Care for Diseases Immune-mediated Inflammatory Diseases” (MAPEX) and the use of Patient Reported Outcomes (PROs).

How was it done?

1. Selection of patients to include.
2. Design a database in Access for the collection of stratification data and PROs.
3. Selection of specific and generic PROs.
4. Stratification of active patients according to the MAPEX methodology at the beginning of the implantation and in patients who start during the follow-up period will be stratified at the baseline visit.
5. Establish a strategy for carrying out questionnaires (PROs) in consultation.

What has been achieved?

An Access database has been created that incorporates the blocks established by the MAPEX model with each of its variables broken down, allowing us to obtain the patient global score.
3 pathology-specific PROs have been selected (RAPID3 in rheumatoid arthritis, PSAID12 in Psoriatic Arthritis and BASDAI in Ankylosing Spondylitis) and a generic one, EuroQol-5D-5L.
The follow-up strategy based on the stratification was selected as the one proposed by the MAPEX model.
To carry out the PROs, those patients with arthropathies that are were under treatment with biological drugs.
It was decided to pass a specific PRO according to his pathology and the generic having a baseline intake, another at 16 weeks and another a year.

What next?

Design a study to measure the results in terms of quality of care obtained with this new circuit.

ORAL IVERMECTIN EFFECTIVENESS IN THE TREATMENT OF PERMETRIN-RESISTANT SCABIOSIS: A DESCRIPTIVE, RETROSPECTIVE AND OBSERVATIONAL STUDY

European Statement

Clinical Pharmacy Services

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.

ncrease in the prescription of Benzodiazepines in the context of the SARS COV 2 pandemic.

European Statement

Clinical Pharmacy Services

Author(s)

Elena Elvira Ladrón de Guevara, Belen Sanchez Rodriguez, Misael Rodriguez Goicoechea, Marina Sanchez Valera, Diego Gámez Torres, Francisca Verdejo Reche, Inmaculada Alférez García

Why was it done?

The main aim of this study is to find out the prescriptions of benzodiazepine derivatives from 2018 to 2021 in the context of the SARS COV 2 pandemic and the variation in them. As a secondary objective, we will learn which benzodiazepine derivatives varied more.

What was done?

The most frequently recorded mental health problem is anxiety disorder and in the context of the SARS COV 2 pandemic, where an increase in anxiety cases has been evidenced, benzodiazepine derivatives (N05BA) have been one of the most prescribed pharmacological groups in most developed countries for this problem. Although its short-term benefits have been demonstrated, increasing its consumption may have long-term risks.

How was it done?

Retrospective, observational and cross-sectional study. The study period includes June 2018, June 2019, June 2020 and June 2021. The study population includes the 710.581 inhabitants associated with the prescribing doctors of benzodiazepine derivatives, from the study province.

What has been achieved?

N = 710,581, 21.61% (153,574) with a benzodiazepine prescription, 67.33% (103,416) women, between June 2018-June 2021. The prescribed benzodiazepine derivatives: alprazolam, Diazepam, diazepam / priridoxine, clotiazepam, lorazepam, ketazolam, clobazam, pinazepam, clorazepatodipotassium, bromazepam, bentazepam, diazepam / sulpiride, diazepam / sulpiride / pyridoxine.
June 2018: 35,800 prescriptions, 67’30% (24,085) women, June 2019: 37,601, 67.20% (25,262) women, June 2020: 39,547, 67.30% (26,622) women and June 2021: 40,626, 67, 60% (27,477) women.
From June 2018 to June 2019 prescriptions increased 5.03% (1,801), from June 2019 to June 2020 they increased 5.20% (1,946), from June 2020 to June 2021 they increased 2.73% ( 1,079), which represented a 13.48% increase in prescriptions from June 2018 to June 2021 (4,826).
The largest prescription increases were diazepam + 23%, lorazepam + 18%, bromazepam + 12.5%, and alprazolam + 12.3%. The largest prescription decreases were clotiazepam and bentazepam -100%, pinazepam -96’43% and clobazazam -22’45%.

What next?

Currently, the consumption of benzodiazepine derivatives has been increasing due to an increase in stress and anxiety situations and, in the context of the SARS VOC 2 pandemic, we have seen a progressive increase of 13.48% (4,826 prescriptions) from June 2018 to June 2021, with women being the user of 67.33% of prescriptions on average. These data allow us to know the current situation of the prescription of benzodiazepine derivatives to the population and to focus on mental health both in the validation of treatments and in pharmaceutical care.

USE OF PALBOCICLIB IN REAL CLINICAL PRACTICE

European Statement

Clinical Pharmacy Services

Author(s)

SILVIA BOULLOSA LALE, Fernando Bustelo Paz, Claudia Barca Diez, María Francisca Fernández Ribeiro, Lara González Freire, Susana Castro Luaces, Irea Celtia Proupín Cantelar, Carlos Crespo Diz

Why was it done?

The aim of this study is to evaluate the use, duration and safety of palbociclib treatment in real clinical practice in our healthcare area.

What was done?

Palbociclib is a cyclin-dependent kinase 4/6 inhibitor indicated for the treatment of metastatic breast cancer(MBC).

How was it done?

Retrospective observational study. All patients treated with palbociclib between June 2016-March 2021 were included.
Data collection was carried out using the electronic medical record and the pharmacotherapeutic management software application.
The variables collected were: gender, age, metastases, initial date, first/second line of treatment, concomitant treatment, delay of treatment, reason for dose reduction and for discontinuation of treatment.
Neutropenia was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE)4.0.

What has been achieved?

Data from 47 patients was collected, 100% were women. Median age: 60(33-85) years. 100% of patients were diagnosed with MBC:51.1%(24) visceral metastases.
Palbociclib was administered in 36.2%(17) of patients concomitantly with an aromatase inhibitor as first line of hormonal treatment for metastatic disease. 63.8%(30) of patients had already received prior hormonal therapy.
A first dose reduction was required in 42,5%(20) of patients, followed by a second reduction to 75 mg in 37.5%(6) of them. These reductions were due to grade 4 neutropenia in 19.2%(5) of patients and recurrent grade 3 in 80.8% (21). All neutropenias resolved after the respective reductions.
Treatment was definitively discontinued in 76.6%(36) of patients: 77.8% (28) due to progression; 13.9% (5) due to neutropenia; 5.5% (2) due to neutropenia and anaemia; and in 2.8%(1) of the patients the previous line of treatment was restarted for non-compliance.
Median overall progression free survival (PFS) was 11.23 months(CI95%:5.76-30.66).
Median PFS in the first-line treatment group was 30.66 months (CI95%:8.33-34.20). In second line it was 9.1 months(CI95%: 5.76-20.83). No statistically significant differences were shown (p=0.2).

What next?

The profile of palbociclib use in our area is predominant in second line treatment for MBC. The PFS achieved did not show any significant differences between second or first line.
The observed treatment duration was longer in patients who discontinued the treatment due to progression versus toxicity.
It is a safe drug: neutropenia, the most frequent cause of treatment reduction/discontinuation, is in all cases transient.

IDENTIFICATION OF HAZARDOUS DRUGS IN EMERGENCY DEPARTMENT: DRUGS CABINET INSPECTION (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Mª Antonia Meroño-Saura, María López-Morte, Taida Rodríguez-Martínez, Pilar Pacheco-López, Consuelo García-Motos

Why was it done?

The publication of the NIOSH list and its application by INSHT in Spain has changed the concept of “Hazardous drug” in terms of its handling and administration, as well as personnel training involved in its management.

What was done?

The main objective is to label every drug considered “Hazardous” and to review the medication included in the Emergency Department kit in a tertiary hospital.

How was it done?

Literature about Hazardous drugs was reviewed. All the drugs included in the Emergency Department kit belonging were identified and classified according to their level published in the NIOSH list. A kit’s review was carried out on site, as well as a Hazardous drugs’ categorisation by adequate labels.

What has been achieved?

6 out of 239 drugs included in the emergency kit were labelled as Hazardous drugs, and could be found in 9 different presentations. Regarding its risk level according to the NIOSH list; chloramphenicol, risperidone and all different presentations of phenytoin were classified as level 2. Acenocoumarol, colchicine/dicycloverine and all different presentations of valproic acid were classified as level 3.
The following incidents were detected;
– Lack of identification: 8 out of the total number of drugs presented identification errors.
– Location error: 4 out of the total number of drugs were not well located.
– Photosensitive: 56 out of the total drugs were photosensitive, of which 11 were not correctly identified or stored.
– Expired drugs: 12 drugs, whose total stock was 399 units. 51 out of the total amount were expired.
After this review, the following measures were carried out:
– Orange labelling for Hazardous drugs’ identification, regardless of their risk level.
– Misidentified drugs were re-labelled, and those that were misplaced were placed in their assigned spot.
– Photosensitive drugs were correctly identified by blue labels and properly preserved.
– Expired drugs were withdrawn.

What next?

Simplifying Hazardous drugs’ identification by a categorisation following a colour code could lead to a safer manipulation by the professionals. During the review of the kit, several incidents were detected and sorted out, which avoided possible medication-related errors. Therefore, it is necessary to establish several control measures in emergency kits in order to avoid errors and improve the safety in the use of drugs.

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