Antònia Agustí

An Intervention to Improve Spontaneous Adverse Drug Reaction Reporting by Hospital Physicians : A Time Series Analysis in Spain

AbstractBackground: Spontaneous reporting of adverse drug reactions (ADRs) in hospitals is scarce and several obstacles to such reporting have been identified previously. Objective: To assess the effectiveness of a multifaceted intervention based on healthcare management agreements for improving spontaneous reporting of ADRs by physicians in a hospital setting. Methods: In 2003, the spontaneous reporting of ADRs was included as one of the objectives of hospital physicians at the Vall d’Hebron Hospital, Barcelona, Spain, within the context of management agreements between clinical services and hospital managers. A continuous intervention related to these management agreements, including periodic educational meetings and economic incentives, was then initiated. We carried out an ecological time series analysis and assessed the change in the total number of spontaneous reports of ADRs, and the number of serious ADRs, unexpected ADRs, and ADRs associated with new drugs between a period previous to the intervention (from 1998 to 2002) and the period during the intervention (from 2003 to 2005). A time series analysis with ARIMA (Auto-Regressive Integrated Moving Average) models was performed. Results: The median number of reported ADRs per year increased from 40 (range 23–55) in the first period to 224 (range 98–248) in the second period. In the first period, the monthly number of reported ADRs was stable (3.47 per month; 95% CI 1.90, 5.03), but in the second period the number increased progressively (increase of 0.74 per month; 95% CI 0.62, 0.86). In the second period, the proportion of reported serious ADRs increased nearly 2-fold (63.1% vs 32.5% in the first period). The absolute number of previously unknown or poorly known ADRs increased 4-fold in the second period (54 vs 13 in the first period). There was also an increase in the absolute number of suspected pharmacological exposures to new drugs (97 vs 28) and in the number of different new drugs suspected of causing ADRs (50 vs 19). Conclusion: A continuous intervention based on healthcare management agreements with economic incentives and educational activities is associated with a quantitative and qualitative improvement of spontaneous reporting of ADRs by hospital physicians.

Policies to enhance the efficiency of prescribing in the Spanish Catalan region: impact and future direction.

Aim: To assess the impact of recent national and regional initiatives on the utilization and expenditure of four high-volume classes to provide future guidance. These were proton pump inhibitors, statins and ezetimibe, and renin–angiotensin drugs, as well as newer antidepressants. Methods: An observational study of prescriptions dispensed in ambulatory care in Catalonia was conducted from 2003 to 2007. Utilization was converted into defined daily doses (DDDs) and DDDs per 1000 inhabitants per day, and compared over the study period, as well as with other European countries. Results: As expected, there was increasing utilization of statins and renin–angiotensin drugs during the study period, as well as increased utilization of generics versus originators in each class; the latter figures were substantially greater than those published previously. There was also increased utilization of the proton pump inhibitors, which is a cause for concern. There were substantial reductions in the expenditure/DDDs of generics and originator products in 2007 versus 2003. For instance, expenditure/DDDs of generic and originator simvastatin were 81 and 72%, respectively, below 2003 originator prices. These reductions were much greater than those seen in previous publications. The increased utilization of generics, coupled with lower expenditure/DDDs for the classes, led to reduced reimbursed expenditure for the proton pump inhibitors, statins and newer antidepressants over time. Conclusion: The findings are in line with expectations and do provide direction to other European countries, especially those with higher expenditures/DDDs for generics. There is an opportunity for Catalonia to learn from other countries to further enhance the quality and efficiency of its prescribing, and possible initiatives are discussed.

Inappropriate prescribing to older patients admitted to hospital: A comparison of different tools of misprescribing and underprescribing

PURPOSE This study aims to assess inappropriate prescribing (IP) to elderly patients during the month prior to hospitalization and to compare different IP criteria. METHODS An observational, prospective and multicentric study was carried out in the internal medicine services of seven Spanish hospitals. Patients aged 75years and older were randomly selected after hospital admission for a year. To assess potentially inappropriate medicines (PIMs), the Beers and STOPP criteria were used and to assess potentially prescribing omissions (PPOs), the START criteria and ACOVE-3 medicine quality indicators were used. An analysis to assess factors associated with IP was performed. RESULTS 672 patients [median age (Q1-Q3) 82 (79-86) years, 55.9% female] were included. Median prescribed medicines in the month prior to hospitalization were 10(Q1-Q3 7-13). The prevalence of IP was 87.6%, and 54.3% of patients had PIMs and PPOs concurrently. A higher prevalence rate of PIMs was predicted using the STOPP criteria than with the Beers criteria (p<0.001) and a higher prevalence of PPOs using the ACOVE-3 criteria than using the START criteria (p<0.001) was observed. Polypharmacy (≥ 10 medicines) was the strongest predictor of IP [OR=11.34 95% confidence interval (CI) 4.96-25.94], PIMs [OR=14.16, 95% CI 6.44-31.12], Beers-listed PIMs [OR=8.19, 95% CI 3.01-22.28] and STOPP-listed PIMs [OR=8.21, 95% CI 3.47-19.44]. PIMs was the strongest predictor of PPOs [OR=2.79, 95% CI 1.81-4.28]. CONCLUSIONS A high prevalence of polypharmacy and PIMs and PPOs were reported. More than half the patients had simultaneous PIMs and PPOs. The related factors to PIMs and PPOs were different.

Effect of an intervention on the features of adverse drug reactions spontaneously reported in a hospital

ObjectivesA continuous intervention based on healthcare management agreements was associated in our hospital with an increase in the absolute number of spontaneous reporting of adverse drug reactions (ADRs), and also with an increase in the number of reports of serious or unexpected ADRs and ADRs associated with new drugs. The objective was to analyse the effect of this intervention on the features of ADRs spontaneously reported in a hospital, the drugs involved and the number of signals identified.MethodsA longitudinal study with two periods, the 1st period without intervention from 1998 to 2002 and the 2nd period with intervention from 2003 to 2005, was carried out in a tertiary teaching hospital. Changes between the two periods with regard to the following variables were analysed: the patients’ characteristics, such as gender and age; the reported ADRs, and the medical assistance required; the suspected drugs involved in the ADRs; the main signals identified.ResultsGender and age distribution of patients described in the spontaneous reports were no different in the two periods. During the second period, spontaneously reported cases requiring hospital admission and those occurring in hospital increased (236 from 2 in the first period and 277 from 99 in the first period respectively) and cases from outpatient hospital consultations began to be reported (13.9% of reports). The spontaneous reporting on all kinds of ADRs and drugs increased during the second period. Cutaneous reactions were the most frequently spontaneously reported ADRs in both periods followed by cardiovascular and neurological reactions in the first period, and haematological and gastrointestinal reactions in the second one. However, during the second period the higher increase was for endocrinological, urinary and hepatic reactions. Systemic antibiotics, anti-thrombotics and cardiac therapy drugs were the most common therapeutic subgroups reported to be suspected drugs in both periods, but in the second period the proportion of immunostimulants, beta blocking agents, immunosuppressants and psychoanaleptics increased. No signals were recognised during the first period; however, two signals and one additional safety concern were identified during the second.ConclusionAn intervention based on healthcare management agreements, was associated with an important increase in spontaneous reporting of ADRs by hospital physicians and also with a change in terms of the type of ADRs identified affecting different organs or systems, and the therapeutic groups of drugs involved. Future studies should analyse the effect of different types of intervention on the spontaneous reporting of ADRs in hospitals.

Adverse effects of ACE inhibitors in patients with chronic heart failure and/or ventricular dysfunction : meta-analysis of randomised clinical trials.

AbstractBackground: The evidence-based benefit/risk evaluation of therapeutic interventions in randomised clinical trials should include both the assessment of the benefits and of the adverse outcomes. There is ample evidence that ACE inhibitors improve the symptoms and prognosis of chronic heart failure (CHF) and ventricular dysfunction. However, there is little systematic information on the tolerability and adverse effects associated with their use in these conditions. Objective: To estimate the adverse events related to ACE inhibitor use in the treatment of CHF and ventricular dysfunction. Design and Methods: Description of adverse events in reports of randomised clinical trials of ACE inhibitors in CHF or ventricular dysfunction was examined, and a meta-analysis was performed. Trials were included if they were placebo- or standard treatment-controlled, and if the treatment duration was at least 8 weeks. Relative risks and their 95% CIs were estimated with a random effects model. Results: Only 22 (43%) of 51 original reports contained information on the number of withdrawals and their causes. Missing information from the remaining 29 trials was obtained from the authors. The weighted mean duration of treatment was 100.2 weeks. After excluding administrative reasons, heart failure, myocardial infarction and hypertension, the withdrawal rates attributed to adverse events were 13.8% and 9.4% for the ACE inhibitor and control groups, respectively (RR = 1.54 [95% CI 1.30–1.83]; weighted difference = 3.1 per 100 treated patients [95% CI 1.8–4.4]). Cough, hypotension, renal dysfunction, dizziness, hyperkalaemia, and impotence were all significantly more prevalent among patients treated with ACE inhibitors than among those in the control groups. Conclusions: Among patients with CHF or ventricular dysfunction enrolled in randomised clinical trials, treatment with an ACE inhibitor for an average of 2 years leads to an additional 3% of treatment withdrawals. In a significant proportion of the reports on these randomised clinical trials, information on adverse events leading to treatment withdrawal was inadequate. Proper evidence-based evaluation of the benefit/risk of therapeutic interventions needs a more systematic approach to reporting of adverse events experiences recorded in clinical trials.

Inappropriate prescribing in elderly people with diabetes admitted to hospital.

To assess inappropriate prescribing in older people with diabetes mellitus during the month prior to a hospitalization, using tools on potentially inappropriate medicines (PIMs) and potential prescribing omissions (PPOs) and comparing inappropriate prescribing in patients with without diabetes.

An inter-rater reliability study of the prescribing indicated medications quality indicators of the Assessing Care Of Vulnerable Elders (ACOVE) 3 criteria as a potentially inappropriate prescribing tool.

PURPOSE There are limited tools to assess potential prescribing omissions (PPOs) or underprescribing in the elderly. The ACOVE project defines comprehensive quality care indicators for older people and some of these indicators focused on appropriate use of medicines. The aim of the present study was to assess the inter-rater reliability between observers using the ACOVE 3 prescribing indicated medications indicators and compare it with the inter-rater reliability obtained for the Screening Tool of Older Persons Prescriptions (STOPP)/Screening Tool to Alert Doctors to Right Treatment (START) criteria. METHODS In the context of an observational and multicentric study of a cohort of 672 patients 75 years and older who were hospitalized in Internal Medicine services of seven Spanish hospitals, an inter-rater reliability study using the ACOVE selected indicators and the STOPP/START criteria was carried out between April 2011 and March 2012. Three patients were randomly selected in each participating hospital, one for each four months of study. RESULTS A total of 21 patients (mean (SD) age of 84.3 (5.6) years, 57.1% female) were included in the inter-rater reliability study. For the STOPP, START and ACOVE criteria, the median kappa coefficient for the seven hospital analyses was 0.97, 0.92 and 0.95, respectively. Out of 123 total indicators in only 7 (5.7%) was the kappa coefficient value below 0.75. Only for 2 (5.6%) of the 37 studies selected ACOVE quality indicators was the kappa coefficient value less than 0.75. CONCLUSIONS A high inter-rater reliability was obtained for the selected underprescribing quality indicators of ACOVE 3. These quality indicators may be considered a useful tool in detecting underprescribing to the elderly patients.

Is Aspirin Underused in Myocardial Infarction

SummaryThis article reviews the relevant published literature in order to assess whether aspirin (acetylsalicylic acid; ASA) is underused in myocardial infarction (MI), taking into account: (i) the evidence of efficacy and safety from clinical trials; (ii) authoritative recommendations about its use; and (iii) published drug-utilisation studies.The use of low-dosage aspirin in the acute phase of MI, and as secondary prevention, should be recommended to all patients who do not have contraindications to the drug. This is a solid evidence-based recommendation with potential benefits that are, at least, similar to those obtained with other standard treatments. As this treatment is well tolerated and inexpensive, it is also assumed that net savings can be achieved.No conventionally used prophylactic aspirin regimen seems to be free from the risk of serious gastrointestinal toxicity. This is especially important in primary prevention, in which the benefits are small; there is, as yet, no clear evidence that aspirin is indicated for routine use in patients at low risk of occlusive vascular events.We have identified 21 published drug-utilisation studies, and the potential underuse of aspirin in MI was not properly assessed in most of them. In these studies, fairly high aspirin prescription rates were usually documented. However, it seems clear that there is room for improvement, and that a significant proportion of patients who could have benefited from aspirin did not receive it or received less well-studied and more costly drugs. The prescription rates for other drugs with proven efficacy have been lower, and the potential underuse greater, than those documented for aspirin.

Ácido acetilsalicílico en dosis bajas durante el embarazo

.En humanos, los datos son controvertidos. Los resultadosde algunos estudios de casos y controles y de cohortes hansenalado una asociacion entre el consumo de AAS duranteel embarazo y el incremento del riesgo de determinados ti-pos de malformaciones (defectos cardiovasculares, del tuboneural, de la cavidad oral, del sistema nervioso central ygastrosquisis, entre otros)

Novedades en el tratamiento de la insuficiencia cardíaca

| Aten Primaria 2006;38(2):107-15 | 107 Informacion Esencial en Terapeutica y Salud), disponible en www.sietes.org, con las palabras clave «insuficiencia cardiaca» y «tratamiento» y en PubMed con las palabras «Heart Failure, Congestive», «Clinical Trial», «meta-analysis» y «Review». Se han seleccionado los estudios que, a criterio de los autores, se consideraran mas relevantes. No se han incluido estudios en los que se abordaran dispositivos implantables u otros abordajes quirurgicos por considerarse un aspecto muy especializado.