[Therapeutic drug plans: how many and which ones? Overview of a prescriptive and care appropriateness tool.] / Piani Terapeutici dei farmaci: quanti e quali? Fotografia di uno strumento di appropriatezza prescrittiva e assistenziale.

Therapeutic plans (TPs) were introduced in Italy in 2004 in order to ensure the continuity in the prescription of new drugs between specialist physicians and general practitioners (GPs). Over the years this prescription tool was updated several times: starting from a paper form without any template ("paper TP") to a template defined by AIFA to collect specific clinical information, up to a web-based form to collect all information into a database. Over time-critical issues concerning its usefulness have been raised, especially when AIFA established several extensions for TP validity to ensure the social distancing required by the covid-19 pandemic. Therefore, after several years from their establishment, pending adoption of necessary implementing of Ministerial Decree of 25th March 2020, a check of the actual impact of TPs is required, in order to plan their review. This study provide a detailed overview of all TPs active in Italy at the 11th May 2020. From Farmadati database, all drugs reimbursed by the National Health Service (class A drugs) and requiring TP were selected. The consumption of these drugs has been derived from OsMed Reports that make available data of medicines consumption and expenditure in the general population in Italy. The analysis showed that TP is required for the prescription of 935 medicinal products (9.6% of class-A drugs) and 147 different active substances (belonging to 34 different Therapeutic Groups and 66 subgroups). Out of these, 67 (46%) required a paper TP without any template, 72 (49%) a paper TP on AIFA template, and 8 (5%) a web-based TP. The Therapeutic Group with the largest number of active ingredients with TP were antidiabetics (19.7%), followed by immunomodulating and immunosuppressants (9.5%) and medications for asthma and COPD (6.8%). Consumption analysis of drugs with TP showed that this prescription tool covers 943,899,598 DDD per year, equal to 2,586,026 DDD/day. This means that TPs have a very high impact in terms of the prevalence of patients treated on the entire care process. Of all annual DDDs prescribed on TP, 46.8% concerned drugs with TP on template AIFA, 34.5% drugs with web-based TP, while the remaining 18.7% drugs with paper TP without a template. This analysis may provide the basis for an analytical case-by-case review of TP maintenance needs, trying to maximize the benefits of this tool and to reduce its possible adverse effects. This review could be helpful to ensure the appropriateness in the drug uses, to enhance the role of general medicine, and to simplify the pathways of millions of patients ensuring the continuity of their care.

Antidepressant and antipsychotic use in an Italian pediatric population.

BACKGROUND: The safety and effectiveness of psychotropic drug use in the paediatric population is widely debated, in particular because of the lack of data concerning long term effects.In Italy the prevalence of psychotropic drug prescriptions increased in the early 2000s and decreased afterwards. In such a context, a study with the aim to estimate the incidence and prevalence of psychotropic drug prescription in the paediatric population and to describe diagnostic and therapeutic approaches was performed. METHODS: The study population was composed of 76,000 youths less than 18 years and living in the area covered by the local health unit of Verona, Italy. The data source was the Verona local health unit's administrative prescription database. Prevalence and incidence of antidepressant and/or antipsychotic drug prescriptions in the 2004-2008 period were estimated. Children and adolescents receiving antidepressant and/or antipsychotic drug prescriptions between 1 January 2005 and 31 December 2006 were identified and questionnaires were sent to the prescribers with the aim to collect data concerning diagnostic and therapeutic approaches, and care strategies. RESULTS: The prevalence of psychotropic drug prescriptions did not change in the 2004-2008 period, while incidence slightly increased (from 7.0 in 2005 to 8.3 per 10,000 in 2008). Between 1 January 2005 and 31 December 2006, 111 youths received at least one psychotropic drug prescription, 91 of whom received antidepressants. Only 28 patients attended child and adolescent psychiatry services. Information concerning diagnostic and therapeutic approaches, and care strategies was collected for 52 patients (47%). Anxiety-depressive syndrome and attention disorders were the diseases for which psychotropic drugs were most commonly prescribed. In all, 75% youths also received psychological support and 20% were prescribed drugs for 2 or more years. CONCLUSIONS: Despite the low drug prescription prevalence, the finding that most children were not cared for by child and adolescent psychiatric services is of concern and calls for a systematic, continuous monitoring of psychopharmacological treatments.

Quality assessment of information about medications in primary care electronic patient record (EPR) systems.

BACKGROUND: Many different brands of primary care electronic patient record (EPR) software are available to general practitioners (GPs). Their ability to support GPs in improving prescribing varies greatly. OBJECTIVE: To assess, using a ten-item tool, the quality of drug information provided by EPR software to support the appropriateness of prescriptions and to propose a list of quality standards for this type of application. METHODS: The eight EPR programmes most used in general practice in Italy were assessed by a multidisciplinary team using the ten-item tool. The tool evaluated information on single drugs and drug safety and information on prescription rules in force. RESULTS: Out of eight EPR programmes assessed, none scored more than 55% of the maximum possible score. Two achieved scores higher than 50%, one scored 48%, four ranged from 32% to 39% and one obtained 22%. Information on drug safety, such as the ability to detect interactions, to monitor laboratory parameters or to get updated information on drug safety was particularly limited. None of the eight EPR programmes contained drug information for patients, but two of them contained drug advertising. CONCLUSIONS: This project highlighted the poor quality of drug information provided by these EPR programmes. The ten-item tool seems suitable for assessing their quality. Based on this analysis, we have proposed a set of ten quality standards for prescribing software.

Antidepressant drug prescription and risk of abnormal bleeding: a case-control study.

This study assessed the risk of any bleeding abnormalities, including the risk of gastrointestinal bleeding, associated with antidepressant exposure. We used a case-control methodology. Case patients were individuals admitted with a diagnosis of abnormal bleeding. Control subjects were individuals admitted on the same date without evidence of abnormal bleeding. During the study period, 11,025 case patients were admitted for bleeding abnormalities (matched with 21,846 eligible control subjects), and 1008 were admitted for gastrointestinal bleeding (matched with 1990 eligible control subjects). With respect to any bleeding abnormalities, antidepressants as a group were not associated with an increased risk (adjusted odds ratio [OR], 0.99; 95% confidence interval [CI], 0.90-1.08). Similarly, selective serotonin reuptake inhibitors as a group, the group of tricyclic and related antidepressants, and the group of other antidepressants were not associated with an increased risk of bleeding. With respect to gastrointestinal bleeding abnormalities, antidepressants as a group were associated with a modestly increased risk (adjusted OR, 1.34; 95% CI, 1.01-1.80). Whereas the group of tricyclic and related antidepressants was not associated with an increased risk of bleeding, the group of selective serotonin reuptake inhibitors was associated with a nonsignificant trend toward an increased risk of bleeding (adjusted OR, 1.31; 95% CI, 0.91-1.88) and the group of other antidepressants with a statistically significant increase in the risk of bleeding (adjusted OR, 1.74; 95% CI, 1.04-2.93). In a population with a low baseline risk of bleeding, we detected a significant increase in the risk of gastrointestinal bleeding only.

[A cross-sectional survey to evaluate the cardiovascular risk profile in subjects referred to the Verona-ASL 20 general practitioners]. / Indagine trasversale per la valutazione del profilo di rischio cardiovascolare nella popolazione di soggetti assistibili afferenti ai medici di medicina generale nell'area della ASL 20 di Verona.

BACKGROUND: Most of the studies on the identification of cardiovascular risk factors have been conducted either in northern Europe or in the United States. However, genetic as well as dietary factors may vary across different countries and geographical areas and there are few data about the cardiovascular risk profile in our country. METHODS: A sample of 3144 subjects (1463 males, 1681 females aged 35-74 years) were randomly selected among the population qualifying for healthcare assistance, registered with 170 general practitioners. Demographic data, clinical information, lab tests and current pharmacological treatments were collected using an electronic case report form. RESULTS: The prevalences of cardiovascular risk factors in the population were: smoking habit 22.7%, obesity 12.8%, hypertension 39.2%, hypercholesterolemia 25.5%, hyperglycemia and diabetes 5.5%. Thirty-five point four percent of the subjects presented a low absolute 10-year cardiovascular risk level (< 5%), 31.1% an intermediate risk (5-9%), 24.9% a moderate risk (10-19%), and 8.6% a high risk (> or = 20%) of developing cardiovascular diseases. CONCLUSIONS: In the area of Verona approximately 20,000 out of 231,592 subjects, aged 35-74 years, may present an absolute 10-year cardiovascular risk level > or = 20%. These results represent the epidemiological basis for planning and implementing preventive interventions toward cardiovascular diseases.