Underreporting of recognized adverse drug reactions by primary care physicians: an exploratory study.

PURPOSE: This study evaluated the magnitude of underreporting of adverse drug reactions (ADRs) and investigated possible reporting patterns according to patient characteristics and the type of reaction based on the integration of information obtained from primary care electronic medical records (EMRs) and the Spanish Pharmacovigilance System. METHODS: This investigation was a descriptive retrospective study analysing ADRs recorded in 2005 in the EMRs from six health centers in Zaragoza (Aragon, Spain) with a covered population of 126,838 subjects. The associations between the probability of reporting and the reaction and drug type were studied using logistic regression models adjusted by age and sex. RESULTS: The total number of ADRs recorded in the EMRs was 543, of which 65.7% were reported to the Spanish Pharmacovigilance System. Positive associations were found between the probability of reporting an ADR and advanced age of patients (OR for ≥76 years = 2.0; 95%CI 1.1-3.6), involvement of the reproductive system (OR = 7.9; 95%CI 1.02-60.2) and involvement of psychiatric disorders (OR = 4.0; 95%CI 1.4-11.6). Negative associations were found between reporting an ADR and early age of patients (OR for 0-14 years = 0.2; 95%CI 0.1-0.6) and the use of antimicrobial drugs (OR = 0.6; 95%CI 0.4-0.9). CONCLUSIONS: This study tackles an important public health problem directly related to patients' safety and highlights the utility of EMRs for investigating the current significance of ADR underreporting. It also makes us think that primary care physicians seem to have selective reporting patterns based on their familiarity with the reaction type and the drug causing the reaction as well as on the age of patients.

Does the pharmacy expenditure of patients always correspond with their morbidity burden? Exploring new approaches in the interpretation of pharmacy expenditure.

BACKGROUND: The computerisation of primary health care (PHC) records offers the opportunity to focus on pharmacy expenditure from the perspective of the morbidity of individuals. The objective of the present study was to analyse the behaviour of pharmacy expenditure within different morbidity groups. We paid special attention to the identification of individuals who had higher values of pharmacy expenditure than their morbidity would otherwise suggest (i.e. outliers). METHODS: Observational study consisting of 75,574 patients seen at PHC centres in Zaragoza, Spain, at least once in 2005. Demographic and disease variables were analysed (ACG 8.1), together with a response variable that we termed 'total pharmacy expenditure per patient'. Outlier patients were identified based on boxplot methods, adjusted boxplot for asymmetric distributions, and by analysing standardised residuals of tobit regression models. RESULTS: The pharmacy expenditure of up to 7% of attendees in the studied PHC centres during one year exceeded expectations given their morbidity burden. This group of patients was responsible for up to 24% of the total annual pharmacy expenditure. There was a significantly higher number of outlier patients within the low-morbidity band which matched up with the higher variation coefficient observed in this group (3.2 vs. 2.0 and 1.3 in the moderate- and high-morbidity bands, respectively). CONCLUSIONS: With appropriate validation, the methodologies of the present study could be incorporated in the routine monitoring of the prescribing profile of general practitioners. This could not only enable evaluation of their performance, but also target groups of outlier patients and foster analyses of the causes of unusually high pharmacy expenditures among them. This interpretation of pharmacy expenditure gives new clues for the efficiency in utilisation of healthcare resources, and could be complementary to management interventions focused on individuals with a high morbidity burden.

Identificación de pacientes hiperconsumidores de farmacia en atención primaria / Identification of pharmacy cost outliers in primary care

ObjetivoIdentificar pacientes hiperconsumidores de farmacia en atención primaria, describir las diferencias epidemiológicas entre pacientes normoconsumidores e hiperconsumidores e investigar la capacidad explicativa del sistema de ajuste de riesgos ACG (Adjusted Clinical Groups) sobre la variabilidad del gasto farmacéutico para ambos grupos de pacientes.DiseñoEstudio observacional retrospectivo.Emplazamiento23 centros de salud de Aragón, Baleares y Cataluña.ParticipantesSe incluyeron 286.450 pacientes atendidos al menos una vez en 2005.MedicionesSe analizaron variables demográficas, de consumo farmacéutico y de casuística (ACG® 7.1). Se identificaron pacientes hiperconsumidores a partir del rango intercuartílico. Se construyó un modelo de regresión lineal, para conocer la capacidad explicativa del ACG sobre el consumo farmacéutico. El mismo modelo se aplicó para la estratificación según variables del profesional, centro de salud y comunidad autónoma.ResultadosUno de cada 10 pacientes se clasificó como hiperconsumidor. Este grupo fue el causante del 60% del gasto farmacéutico. Se trata de pacientes con 26,3 años más y con mayor comorbilidad que los pacientes normoconsumidores. La capacidad explicativa del ACG sobre el gasto farmacéutico fue llamativamente inferior para el grupo de hiperconsumidores (3 frente a 26% en pacientes normoconsumidores).ConclusionesHan de investigarse las causas que provocan la falta de adaptación de los ACG al grupo de pacientes hiperconsumidores. Puede que haya circunstancias sociales que influyen sobre la situación clínica de estos pacientes. O, más probablemente, el método utilizado para detectar el hiperconsumo no permita diferenciar adecuadamente, de entre todos los pacientes hiperconsumidores, a aquéllos en los que la enfermedad justifica el gasto realizado(AU)

ObjectiveTo identify pharmacy cost outlier patients in Primary Care, describing epidemiological differences between normal users and outliers; and to study the explanatory power of risk adjustment tools based on Adjusted Clinical Groups (ACG) as regards the variability of pharmacy expenditure for both groups of patients.DesignObservational, retrospective study.Setting23 health centres located in the regions of Aragon, Catalonia and the Balearic Islands.ParticipantsThe study sample consisted of 286,450 patients who were seen at least once in 2005.MeasurementsVariables related to demographic features, pharmacy cost, and case-mix (ACG® 7.1) were collected. Pharmacy cost outliers were selected according to the inter-quartile range method. A linear regression model was developed to measure the explanatory power of ACG. This same model was applied stratifying the population by variables of the physician, the health centre and the region.ResultsOne out of ten patients was classified as an outlier. This group was responsible for 60% of the total pharmacy expenditure. These outlier patients were 26.3 years older than normal users and had a higher comorbidity. The explanatory power of the ACG classification system was markedly lower −3% vs. 26.4% for normal users-.ConclusionsFurther research should be done on factors causing a lack of adequacy of ACG among pharmacy outlier patients. Although it could be thought that social circumstances might play a role in the clinical state of patients, it is more likely that the applied trimming method does not allow outliers with justifiable clinical reasons for higher costs to be distinguished from those without them(AU)

[Identification of pharmacy cost outliers in primary care]. / Identificación de pacientes hiperconsumidores de farmacia en atención primaria.

OBJECTIVE: To identify pharmacy cost outlier patients in Primary Care, describing epidemiological differences between normal users and outliers; and to study the explanatory power of risk adjustment tools based on Adjusted Clinical Groups (ACG) as regards the variability of pharmacy expenditure for both groups of patients. DESIGN: Observational, retrospective study. SETTING: 23 health centres located in the regions of Aragon, Catalonia and the Balearic Islands. PARTICIPANTS: The study sample consisted of 286,450 patients who were seen at least once in 2005. MEASUREMENTS: Variables related to demographic features, pharmacy cost, and case-mix (ACG 7.1) were collected. Pharmacy cost outliers were selected according to the inter-quartile range method. A linear regression model was developed to measure the explanatory power of ACG. This same model was applied stratifying the population by variables of the physician, the health centre and the region. RESULTS: One out of ten patients was classified as an outlier. This group was responsible for 60% of the total pharmacy expenditure. These outlier patients were 26.3 years older than normal users and had a higher comorbidity. The explanatory power of the ACG classification system was markedly lower -3% vs. 26.4% for normal users-. CONCLUSIONS: Further research should be done on factors causing a lack of adequacy of ACG among pharmacy outlier patients. Although it could be thought that social circumstances might play a role in the clinical state of patients, it is more likely that the applied trimming method does not allow outliers with justifiable clinical reasons for higher costs to be distinguished from those without them.

¿Es el tabaquismo una epidemia pediátrica? / Is the tabaqism a pediatric epidemic?

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