Evaluation of a pharmacist-led intervention to reduce drug-related problems in patients included in a home healthcare program: study protocol for a pragmatic randomized clinical trial.

BACKGROUND: ATDOM is the Catalan home healthcare program at primary care level. Patients in the home care program are usually frail, elderly people with multiple comorbidities. They are often polymedicated, leading to a high risk of drug-related problems (DRPs). Our hypothesis is that the pharmacist-led individualized review of the pharmacotherapeutic plans of ATDOM patients will be effective in improving the quality of treatments by reducing DRPs in terms of indication, adequacy, effectiveness, and safety. METHODS: Aim: To compare the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients with usual management practice. DESIGN: Pragmatic randomized clinical trial with a comparable control group, with prospective follow-up regarding the intervention on the adequacy of the pharmacological treatment of patients in the ATDOM program. SETTING: Primary care teams in the Camp de Tarragona Primary Care Area, Tarragona, Spain. PARTICIPANTS: Four hundred and thirty-two ATDOM patients will be recruited, those who are over 65 years old and who are currently undergoing pharmacological treatment. MEASURES: Effectiveness of a six-month long intervention in reducing DRPs per patient and polypharmacy. Additionally, in the intervention group we will evaluate the implementation of the proposals for change or improvement made by the responsible physician. ANALYSIS: The outcomes will be analyzed on an intent-to-treat basis and the analysis units will be the individual patients. Logistic regression and linear regression models will be used to evaluate the effects of the intervention on dichotomous and continuous variables versus the control arm. ETHICS: The protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAPJGol), Barcelona, (19/141-P). DISCUSSION: If the results of the pharmaceutical intervention are favorable, widespread implementation of the program could be possible. It could be extended to all ATDOM patients or outpatients in general. Interdisciplinary teamwork could be strengthened as a result, which would improve the healthcare continuum. TRIAL REGISTRATION: Retrospectively registered. CLINICALTRIALS: gov Identifier NCT05820945; Registered 21 March, 2023.

[Impact of a primary care pharmacy unit on the optimization of pharmacological treatment of type 2 diabetic patients]. / Impacto de una unidad de farmacia de atención primaria en la optimización del tratamiento farmacológico de pacientes diabéticos tipo 2.

OBJECTIVE: To evaluate the impact of a pharmaceutical intervention on treatment optimization in patients with type 2 diabetes mellitus. DESIGN: Before-after intervention study. SITE: Health centers of the Primary Care Department of Camp de Tarragona. PARTICIPANTS: Patients aged ≥ 18 years, diagnosed with type 2 diabetes mellitus and under treatment with antidiabetic drugs. INTERVENTIONS: Review of pharmacological treatment for type 2 diabetes mellitus and issuance of proposals for its adequacy. MAIN MEASUREMENTS: Demographic and clinical variables were collected to assess the adequacy of antidiabetic treatment. A consensus meeting was arranged with the patients' primary care physician to evaluate the proposals for improvement. The implementation of the proposals and the variation in postintervention glycemic control were assessed. RESULTS: A total of 907 patients (59% men) were included. A total of 782 proposals for intervention were made in 65.8% of the patients reviewed. Of the proposals, 43.5% corresponded to drug discontinuation, 16% to intensification of dosing and 12.6% to exchange for a therapeutic equivalent. Of the consensual proposals, 54.7% were implemented. HbA1c was reduced by 0.2% after the intervention (7.4 vs 7.2%). CONCLUSIONS: Review of the pharmacological treatment of patients with type 2 diabetes mellitus by a pharmacist or pharmacologist facilitates its optimization.

[Patient safety incidents reported before and after the start of the COVID-19 pandemic in Primary Care in Tarragona]. / Incidentes de seguridad del paciente notificados antes y después del inicio de la pandemia de COVID-19 en atención primaria en Tarragona.

OBJECTIVE: To analyse and compare the epidemiology of patient safety incidents reported in Primary Health Care, before and after the start of the COVID-19 pandemic. DESIGN AND SETTING: Analytical descriptive study comparing reported incidents from March 1st 2019 to February 28th 2020, and from March 1st 2020 to February 28th 2021, notified through the TPSC Cloud™ platform accessible from the Intranet corporative in 25 Primary Health Care centres from Tarragona district, in Catalonia (Spain). MEASUREMENTS: Data obtained from voluntary notifications, through electronic, standardized and anonymized forms. VARIABLES: Centre, professional, incident type, risk matrix, causal factors and contributing factors, and avoidability. STATISTICAL ANALYSIS: Every notification was included in descriptive analysis, and another one specifically for adverse events, comparing both periods. RESULTS: 2231 incidents were reported. Comparing both periods, during the pandemic a reduction in the number of reported incidents was observed (only represented 20% of the total). However, the percentage of reported notifications from health care professionals and adverse events that required observation were increased. Causal factors related to attendance and diagnosis were incremented whereas the causal factors related to medication were decreased. In addition, an increase in contributing factors related to the professional was observed. Avoidability was high (>95%) in both periods. CONCLUSIONS: During the pandemic, fewer patient safety incidents have been reported, but proportionally more adverse events, most of which are preventable. The professional himself becomes the main contributing factor.

Patient Safety Incidents in Primary Care: Comparing APEAS-2007 (Spanish Patient Safety Adverse Events Study in Primary Care) with Data from a Health Area in Catalonia (Spain) in 2019.

The initial APEAS study, conducted in June 2007, examined adverse events (AEs) in Spanish Primary Healthcare (PHC). Since then, significant changes have occurred in healthcare systems. To evaluate these changes, a study was conducted in the Camp de Tarragona PHC region (CTPHC) in June 2019. This cross-sectional study aimed to identify AEs in 20 PHC centres in Camp de Tarragona. Data collection used an online questionnaire adapted from APEAS-2007, and a comparative statistical analysis between APEAS-2007 and CTPHC-2019 was performed. The results revealed an increase in nursing notifications and a decrease in notifications from family doctors. Furthermore, fewer AEs were reported overall, particularly in medication-related incidents and healthcare-associated infections, with an increase noted in no-harm incidents. However, AEs related to worsened clinical outcomes, communication issues, care management, and administrative errors increased. Concerning severity, there was a decrease in severe AEs, coupled with an increase in moderate AEs. Despite family doctors perceiving a reduction in medication-related incidents, the overall preventability of AEs remained unchanged. In conclusion, the reporting patterns, nature, and causal factors of AEs in Spanish PHC have evolved over time. While there has been a decrease in medication-related incidents and severe AEs, challenges persist in communication, care management, and clinical outcomes. Although professionals reported reduced severity, the perception of preventability remains an area that requires attention.

Effectiveness of New Tools to Define an Up-to-Date Patient Safety Risk Map: A Primary Care Study Protocol.

BACKGROUND: Reducing incidents related to health care interventions to improve patient safety is a health policy priority. To strengthen a culture of safety, reporting incidents is essential. This study aims to define a patient safety risk map using the description and analysis of incidents within a primary care region with a prior patient safety improvement strategy organisationally developed and promoted. METHODS: The study will be conducted in two phases: (1) a cross-sectional descriptive observational study to describe reported incidents; and (2) a quasi-experimental study to compare reported incidents. The study will take place in the Camp de Tarragona Primary Care Management (Catalan Institute of Health). In Phase 1, all reactive notifications collected within one year (2018) will be analysed; during Phase 2, all proactive notifications of the second and third weeks of June 2019 will be analysed. Adverse events will also be assessed. Phases 1 and 2 will use a digital platform and the proactive tool proSP to notify and analyse incidents related to patient safety. EXPECTED RESULTS: To obtain an up-to-date, primary care patient safety risk map to prioritise strategies that result in safer practices.

Analysis of Patient Safety Incidents in Primary Care Reported in an Electronic Registry Application.

OBJECTIVES: (1) To describe the epidemiology of patient safety (PS) incidents registered in an electronic notification system in primary care (PC) health centres; (2) to define a risk map; and (3) to identify the critical areas where intervention is needed. DESIGN: Descriptive analytical study of incidents reported from 1 January to 31 December 2018, on the TPSC Cloud™ platform (The Patient Safety Company) accessible from the corporate website (Intranet) of the regional public health service. SETTING: 24 Catalan Institute of Health PC health centres of the Tarragona region (Spain). PARTICIPANTS: Professionals from the PC health centres and a Patient Safety Functional Unit. MEASUREMENTS: Data obtained from records voluntarily submitted to an electronic, standardised and anonymised form. Data recorded: healthcare unit, notifier, type of incident, risk matrix, causal and contributing factors, preventability, level of resolution and improvement actions. RESULTS: A total of 1544 reports were reviewed and 1129 PS incidents were analysed: 25.0% of incidents did not reach the patient; 66.5% reached the patient without causing harm, and 8.5% caused adverse events. Nurses provided half of the reports (48.5%), while doctors reported more adverse events (70.8%; p < 0.01). Of the 96 adverse events, 46.9% only required observation, 34.4% caused temporary damage that required treatment, 13.5% required (or prolonged) hospitalization, and 5.2% caused severe permanent damage and/or a situation close to death. Notably, 99.2% were considered preventable. The main critical areas were: communication (27.8%), clinical-administrative management (25.1%), care delivery (23.5%) and medicines (18.4%); few incidents were related to diagnosis (3.6%). CONCLUSIONS: PS incident notification applications are adequate for reporting incidents and adverse events associated with healthcare. Approximately 75% and 10% of incidents reach the patient and cause some damage, respectively, and most cases are considered preventable. Adequate and strengthened risk management of critical areas is required to improve PS.

Influence of prior comorbidities and chronic medications use on the risk of COVID-19 in adults: a population-based cohort study in Tarragona, Spain.

OBJECTIVE: To investigate possible relationships between pre-existing medical conditions (including common comorbidities and chronic medications) and risk for suffering COVID-19 disease in middle-aged and older adults. DESIGN: Population-based retrospective cohort study. SETTING: Twelve primary care centres (PCCs) in Tarragona (Spain). PARTICIPANTS: 79 083 people (77 676 community-dwelling and 1407 nursing-home residents), who were all individuals aged >50 years affiliated to the 12 participating PCCs. OUTCOMES: Baseline cohort characteristics (age, sex, vaccinations, comorbidities and chronic medications) were established at study start (1st. March 2020) and primary outcome was time to COVID-19 confirmed by PCR among cohort members throughout the epidemic period (from 1st. March 2020 to 23rd. May 2020). Risk for suffering COVID-19 was evaluated by Cox regression, estimating multivariable HRs adjusted for age, sex, comorbidities and medications use. RESULTS: During the study period, 2324 cohort members were PCR-tested, with 1944 negative and 380 positive results, which means an incidence of 480.5 PCR-confirmed COVID-19 cases per 100 000 persons-period. Assessing the total study cohort, only age (HR 1.02; 95% CI 1.01 to 1.03; p=0.002), nursing-home residence (HR 21.83; 95% CI 16.66 to 28.61; p<0.001) and receiving diuretics (HR 1.35; 95% CI 1.04 to 1.76; p=0.026) appeared independently associated with increased risk. Smoking (HR 0.62; 95% CI 0.41 to 0.93; p=0.022), ACE inhibitors (HR 0.68; 95% CI 0.47 to 0.99; p=0.046) and antihistamine (HR 0.47; 95% CI 0.22 to 1.01; p=0.052) were associated with a lower risk. Among community-dwelling individuals, cancer (HR 1.52; 95% CI 1.03 to 2.24; p=0.035), chronic respiratory disease (HR 1.82; 95% CI 1.08 to 3.07; p=0.025) and cardiac disease (HR 1.53; 95% CI 1.06 to 2.19; p=0.021) emerged to be also associated with an increased risk. Receiving ACE inhibitors (HR 0.66; 95% CI 0.44 to 0.99; p=0.046) and influenza vaccination (HR 0.63; 95% CI 0.44 to 0.91; p=0.012) was associated with decreased risk. CONCLUSION: Age, nursing-home residence and multiple comorbidities appear predisposing for COVID-19. Conversely, receiving ACE inhibitors, antihistamine and influenza vaccination could be protective, which should be closely investigated in further studies specifically focused on these concerns.

Use of distinct anti-hypertensive drugs and risk for COVID-19 among hypertensive people: A population-based cohort study in Southern Catalonia, Spain.

The use of some anti-hypertensive drugs in the current COVID-19 pandemic has become controversial. This study investigated possible relationships between anti-hypertensive medications use and COVID-19 infection risk in the ambulatory hypertensive population. This is a population-based retrospective cohort study involving 34 936 hypertensive adults >50 years in Tarragona (Southern Catalonia, Spain) who were retrospectively followed through pandemic period (from 01/03/2020 to 30/04/2020). Two data sets including demographic/clinical characteristics (comorbidities and cardiovascular medications use) and laboratory PCR codes for COVID-19 were linked to construct an anonymized research database. Cox regression was used to calculate multivariable hazard ratios (HRs) and estimate the risk of suffering COVID-19 infection. Across study period, 205 PCR-confirmed COVID-19 cases were observed, which means an overall incidence of 586.8 cases per 100 000 persons-period. In multivariable analyses, only age (HR: 1.03; 95% CI: 1.02-1.05; P < .001) and nursing home residence (HR: 19.60; 95% CI: 13.80-27.84; P < .001) appeared significantly associated with increased risk of COVID-19. Considering anti-hypertensive drugs, receiving diuretics (HR: 1.22; 95% CI: 0.90-1.67; P = .205), calcium channel blockers (HR: 1.29; 95%CI: 0.91-1.82; P = .148), beta-blockers (HR: 0.97; 95% CI: 0.68-1.37; P = .844), and angiotensin-converting enzyme inhibitors (HR: 0.83; 95% CI: 0.61-1.13; P = .238) did not significantly alter the risk of PCR-confirmed COVID-19, whereas receiving angiotensin II receptor blockers was associated with an almost statistically significant reduction risk (HR: 0.67; 95% CI: 0.44-1.01; P = .054). In conclusion, our data support that receiving renin-angiotensin-aldosterone system inhibitors does not predispose for suffering COVID-19 infection in ambulatory hypertensive people. Conversely, receiving angiotensin II receptor blockers could be related with a reduced risk.

Drug-resistance in Streptococcus pneumoniae isolates among Spanish middle aged and older adults with community-acquired pneumonia.

BACKGROUND: Pneumococcal diseases remain a major cause of morbidity and mortality worldwide. Updated data on drug-resistance from different populations may be important to recognize changes in disease patterns. This study assessed current levels of penicillin resistance among Streptococcus Pneumoniae causing pneumonia in Spanish middle age and older adults. METHODS: Antimicrobial susceptibility was tested for 104 consecutive isolates of Streptococcus pneumoniae recovered from patients 50 years or older with radiographically confirmed pneumonia in the region of Tarragona (Spain) between 2002 and 2007. According to the minimum inhibitory concentration of tested antimicrobials (penicillin, erythromycin, cefotaxime and levofloxacin) strains were classified as susceptible or resistant. Antimicrobial resistance was determined for early cases (2002-2004) and contemporary cases (2005-2007). RESULTS: Twenty-seven (25.9%) were penicillin-resistant strains (19 strains with intermediate resistance and 8 strains with high resistance). Penicillin-resistance was higher in 2002-2004 than in 2005-2007 (39.5% vs 18.2%, p = 0.017).Of 27 penicillin-resistant strains, 10 (37%) were resistant to erythromycin, 8 (29.6%) to cefotaxime, 2 (7.4%) to levofloxacin, and 4 (14.8%) were identified as multidrug resistant. Case-fatality rate was higher among those patients who had an infection caused by any penicillin susceptible strain (16.9%) than in those with infections due to penicillin-resistant strains. CONCLUSION: Resistance to penicillin among Streptococcus pneumoniae remains high, but such resistance does not result in increased mortality in patients with pneumococcal pneumonia.

[Increased benzodiazepine use in elderly women attending urban primary health care centers]. / Elevado consumo de benzodiacepinas en mujeres ancianas asignadas a centros de salud urbanos de atención primaria.

OBJECTIVE: To determine the overall prevalence of the chronic use of benzodiazepines and similar drugs in primary care. DESIGN: Observational, cross-sectional study. SETTING: Healthcare centres of the Reus-Altebrat Primary Care Service, Tarragona, Spain. PARTICIPANTS: Patients older than 15 years, on prolonged treatment with benzodiazepines or similar drugs. MEASUREMENTS: The variables studied were age, sex, type of healthcare centre (rural or urban), benzodiazepine, or similar drug administered and duration of treatment. RESULTS. There were 6885 patients who were on prolonged benzodiazepine or similar drug treatment, of which 70.9% were female, 73.4% were 65 years or older, and 73% attended an urban centre. The overall prevalence was 6.9%, and was higher among women than men (9.7% and 4%, respectively), and increased with age up to 27.3% among patients of 75 years or more. The stratified results showed that chronic consumption was higher among women 75 years of age or older attached to urban healthcare centres, with a prevalence of 35.7%. CONCLUSIONS: A high percentage of our population, which includes the most fragile patients, use benzodiazepines or a similar drug in a way that is not consistent with the recommendations of clinical practice guidelines.

Estilos de vida de los sujetos que toman fármacos para dos o más factores de riesgo cardiovascular. Estudio TAR-RISC / Lifestyles of subjects who take drugs for two or more cardiovascular risk factors. TAR-RISC Study

Objetivo: Describir las características basales y los estilos de vida de la población de una regiónsanitaria con medicación para 2 o más factores de riesgo cardiovascular.Diseño: Estudio descriptivo transversal.Emplazamiento: Atención primaria de Tarragona.Participantes: Los sujetos, menores de 65 años, se identificaron a partir de los datos dedispensación de especialidades farmacéuticas antihipertensivas, hipoglucemiantes e hipocolesterolemiantes.Mediciones y resultados principales: Se diseñaron cuestionarios estructurados específicos paracada agrupación de fármacos y la información se recogió telefónicamente. Se analizaron edad,sexo, sedentarismo, hábito enólico, tabáquico, dietético e índice de masa corporal.Se entrevistó a 1.201 personas, con una edad media de 58,9±7,6 a˜nos. El 54,2% eranhombres. Tomaban fármacos antihipertensivos e hipocolesterolemiantes 636 sujetos (53,0%),antihipertensivos e hipoglucemiantes 212 (17,7%), hipocolesterolemiantes e hipoglucemiantes128 (10,8%) y fármacos de los 3 grupos 225 sujetos (18,7%). El 19,2% declararon ser fumadoresactivos y el 5,7% manifestaron un consumo excesivo de alcohol. Doscientos sesenta y seis sujetos(22,2%) aseguraron no seguir ninguna dieta. El 15% declararon ser sedentarios o hacer una mínima actividad física. El índice de masa corporal medio fue de 29,9±4,9 kg/m2, siendo más alto entre los sujetos que tomaban antihipertensivos e hipoglucemiantes (p<0,001). Un 44,2% presentaba obesidad. Conclusiones: Aproximadamente 1/5 de los sujetos que toman al menos 2 grupos farmacológicosson fumadores activos, 1/4 del total no hace dieta, 1/2 son obesos y 2/3 partes realizan poca onula actividad física. Estos resultados muestran el bajo cumplimiento de las medidas higiénicodietéticas por parte de los pacientes con riesgo cardiovascular elevado(AU)

Objective: To describe the basic characteristics and lifestyles of the population of a HealthRegion, on medication for two or more cardiovascular risk factors.Design: Cross-sectional descriptive study.Setting: Tarragona Primary Care.Participants: The subjects, less than 65 years-old, were identified by the dispensing data ofhypertensive, glucose-lowering and lipid-lowering pharmaceutical drugs.Main measurements and results: Specific structured questionnaires were designed for eachdrugs group, and the information was gathered by telephone. Age, sex, sedentarism, alcoholand tobacco habits, diet and body mass index were analysed.A total of 1201 patients, with a mean age of 58.9±7.6 years, were interviewed. There were54.2% males. A total of 636 (53.0%) subjects took anti-hypertensive and cholesterol loweringdrugs, 212 (17.7%) anti-hypertensive and glucose lowering drugs, and 128 (10.8%) cholesterollowering and glucose lowering drugs, and 225 (18.7%) patients took drugs from the three groups.There were 19.2% active smokers, 5.7% stated excessive alcohol consumption, 266 (22.2%) statedthat they did not follow any diet, and 15% were sedentary or did a minimum of physicalactivity. The mean body mass index was 29.9±4.9 kg/m2, being highest among the subjects whotook anti-hypertensive and glucose lowering drugs (P<0.001), and 44.2% were obese.Conclusions: Approximately one fifth of the subjects who took at least 2 pharmacological groupswas an active smoker, one quarter of the total did not follow a diet, half were obese and twothirdsdid little or no physical activity. These results show low compliance to hygienic-dieteticmeasures by patients with an increased cardiovascular risk(AU)

Elevado consumo de benzodiacepinas en mujeres ancianas asignadas a centros de salud urbanos de atención primaria / Increased benzodiazepine use in elderly women attending urgan primary health care centers

Objetivo. Determinar la prevalencia globaldel consumo crónico de benzodiacepinasy sus análogos en atención primaria.Diseño. Estudio transversal observacional.Emplazamiento. Centros de salud del Serviciode Atención Primaria Reus-Altebrat.Participantes. Pacientes con edad superiora 15 años, en tratamiento prolongadocon benzodiacepinas o sus análogos.Mediciones. Las variables analizadas fueron laedad, el sexo, el tipo de centro de salud (ruralo urbano), la benzodiacepina o el análogoadministrados y la duración del tratamiento.Resultados. Habían utilizado unabenzodiacepina o un análogo de formaprolongada 6.885 pacientes. El 70,9% eranmujeres, el 73,4% tenía 65 años o más, y el73% estaba adscrito a un centro urbano. Laprevalencia global fue del 6,9%, mayor entrelas mujeres que entre los varones (9,7% y 4%,respectivamente), y aumentó con la edadhasta un 27,3% entre los pacientes de 75 omás años. En los resultados estratificados seobservó que el consumo crónico era superiorentre las mujeres de 75 o más años de edadadscritas a centros de salud urbanos, conuna prevalencia del 35,7%.Conclusiones. Un porcentaje elevado de lapoblación, que comprende a los pacientesmás frágiles, está siendo tratado conbenzodiacepinas o análogos, lo que no seajusta a las recomendaciones de las guíasde práctica clínica

Objective. To determine the overallprevalence of the chronic use ofbenzodiazepines and similar drugsin primary care.Design. Observational, cross-sectional study.Setting. Healthcare centres of the Reus-Altebrat Primary Care Service,Tarragona,Spain.Participants. Patients older than 15 years, onprolonged treatment with benzodiazepinesor similar drugs.Measurements. The variables studied wereage, sex, type of healthcare centre (rural orurban), benzodiazepine, or similar drugadministered and duration of treatment.Results. There were 6885 patients who wereon prolonged benzodiazepine or similardrug treatment, of which 70.9% werefemale, 73.4% were 65 years or older, and73% attended an urban centre. The overallprevalence was 6.9%, and was higher amongwomen than men (9.7% and 4%,respectively), and increased with age up to27.3% among patients of 75 years or more.The stratified results showed that chronicconsumption was higher among women75 years of age or older attached to urbanhealthcare centres, with a prevalence of35.7%.Conclusions. A high percentage of ourpopulation, which includes the most fragilepatients, use benzodiazepines or a similardrug in a way that is not consistent withthe recommendations of clinical practiceguidelines

Traslado de los resultados de los ensayos clínicos con estatinas a la práctica: del riesgo relativo al riesgo absoluto / Transferring to the practice the results of the clinical trials with statins: from the relative risk to the absolute risk

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