Fixed Versus Free Combinations of Antihypertensive Drugs: Analyses Of Real-World Data Of Persistence With Therapy In Italy

Purpose: To analyse the pattern of use and cost of antihypertensive drugs in new users in an Italian population, and explore the patient/treatment factors associated with the risk of therapy discontinuation. Patients and methods: In this retrospective study, information was collected from a population-based electronic primary-care database. Persistence with medication use 1 year from therapy initiation was evaluated for each user using the gap method. Each new user was classified according to his/her pattern of use as: \u201ccontinuer\u201d, \u201cdiscontinuer\u201d \u201cswitching\u201d or \u201cadd-on\u201d. A Cox regression model was used to analyse the factors influencing therapy discontinuation. Primary-care costs comprised specialists\u2019 visits, diagnostic procedures and pharmacologic therapies. Results: Among 14,999 subjects included in persistence analyses, 55.1% of cases initially started on monotherapy were classified as discontinuers vs 36.5% of cases taking combination therapy (42.3% vs 32.7%, respectively, for free and fixed combinations, P < 0.01). Old age, high cardiovascular risk and being in receipt of fixed-combination therapy were associated with greater persistence. Overall, the primary-care cost/person/year of hypertension management was 3c\u20ac95.3 (IQR, 144.9). The monotherapy cost was \u20ac88 per patient (IQR, 132.9), and that for combination therapy was \u20ac151\ub1148.3. The median cost/patient with a fixed combination was lower than that for a free combination (\u20ac98.4 (IQR, 155.3) and \u20ac154.9 (IQR, 182.6), respectively). Conclusion: The initial type of therapy prescribed influences persistence. Prescribing fixed combinations might be a good choice as initial therapy

Prevalence and Factors Associated with Potential Drug-Drug Interactions in Older Community-Dwelling Adults: A Prospective Cohort Study

Background: Older patients are at increased risk of drug-drug interactions (DDIs) due to polypharmacy. Cardiovascular and central nervous system (CNS) drugs are commonly implicated in serious DDIs. Objectives: This study aimed to determine the prevalence and factors associated with potential ‘severe’ cardiovascular and CNS DDIs among older (≥ 70 years) community-dwellers. Methods: This was a prospective cohort study using linked data from a national pharmacy claims database and waves 1 and 2 of The Irish LongituDinal study on Ageing (TILDA). ‘Severe’ cardiovascular and CNS DDIs were identified using the British National Formulary 77 and Stockley’s Drug Interactions. The prevalence of ‘severe’ DDIs (any DDI vs. none) was calculated. Logistic regression was used to examine the association between sociodemographic, functional ability, and medication-related factors and the risk of DDI exposure between waves 1 and 2. Results: A total of 1466 patients were included [mean age (standard deviation) = 78 (5.5) years; female n = 795, 54.2%]. In total, 332 community-dwellers aged ≥ 70 years [22.65%, 95% confidence interval (CI) 20.58–24.86] were potentially exposed to at least one ‘severe’ cardiovascular or CNS DDI, with more than half (54.82%) of this cohort dispensed the same DDI for a prolonged time (≥ 3 consecutive claims). Aspirin-warfarin was the most frequently dispensed (co-prescribed) DDI (n = 34, 10.24%, 95% CI 7.39–14.00), followed by atorvastatin-clarithromycin (n = 19, 5.72%, 95% CI 3.64–8.81). Polypharmacy [≥ 10 vs. < 5 drugs, odds ratio (OR) 13.40, 95% CI 8.22–21.85] and depression (depressed vs. not, OR 2.12, 95% CI 1.34–3.34) were significantly associated with these DDIs, after multivariable adjustment. Conclusion: ‘Severe’ cardiovascular and CNS DDIs are prevalent in older community-dwellers in Ireland, and those with polypharmacy and depression are at a significantly increased risk

Geographical Variation in Medication Prescriptions: A Multiregional Drug-Utilization Study

Background: Studies have emphasized the importance of geographical factors and general practitioner (GP) characteristics in influencing drug prescriptions. Objectives: To: (i) ascertain the prevalence rate (PR) of use of drugs in six therapeutic categories used for chronic conditions; (ii) assess how geographical characteristics and GP characteristics may influence drug prescribing. Methods: This study is part of the EDU.RE.DRUG Project, a national collaborative project founded by Italian Medicine Agency (AIFA). Cross-sectional analyses were undertaken employing the pharmacy-claim databases of four local health units (LHUs) located in two Italian regions: Lombardy and Campania. Six drug categories were evaluated: proton-pump inhibitors; antibiotics; respiratory-system drugs; statins; agents acting on the renin 12angiotensin system; psychoanaleptic drugs. The PR was estimated according to drug categories at the LHU level. A linear multivariate regression analysis was undertaken to evaluate the association between the PR and geographical area, age and sex of GPs, number of patients, and percentage of patients aged &gt;65 per GP. Results: LHUs in Campania showed a PR that was significantly higher than that in Lombardy. Antibiotics showed the highest PR in all the LHUs assessed, ranging from 32.5% in Lecco (Lombardy) to 59.7% in Naples-2 (Campania). Multivariate linear regression analysis confirmed the association of the PR with geographical area for all drug categories. Being located in Campania increased the possibility of receiving a drug prescription from the categories considered, with estimates more marked for antibiotics, proton-pump-inhibitors, and respiratory-system drugs. Conclusions: This study provides information about the PR of medications used for treating common and costly conditions in Italy and highlighted a significant geographical variation. These insights could help to develop area-specific strategies to optimize prescribing behavior

Pre-exposure prophylaxis with hydroxychloroquine does not prevent covid-19 nor virus related venous thromboembolism

Different and several public health strategies have been planned to reduce transmission of pandemic due to SARS-CoV-2 since it started. None drugs have been confirmed as able to prevent viral transmission. Hydroxychloroquine with its immunomodulatory properties has been proposed as potential anti-viral drug in particular for prevention once viral exposure has been happen or in first phases of infection. Furthermore, in several immunological systemic disease hydroxychloroquine was able to reduce the number of thrombotic complications. So, because COVID-19 was associated to immunological imbalance and to thrombotic complications, we retrospectively analyzed the rate of infection in those patients being under treatment with this drug during COVID-19 epidemic outbreak from 8 March until 28 April in particular comparing those with pre-exposure to this treatment and those that were not taking this medication before SARS-CoV-2 viral infections

PMS66 Determinants of Non-Persistence to Antiosteoporotic Drugs by Using Administrative Database

Osteoporosis treatment involves several therapeutic tools, including long-term drug therapy. Subjects with chronic disorders are more likely to be non-adherent and/or non-persistent to treatment than those with other diseases. Adherence is the extent to which patients take medication as prescribed by their physicians, whereas persistence is the time from treatment initiation to discontinuation. Lack of persistence is common among subjects using oral anti-osteoporotic drugs, and leads to increased risk of fragility fracture

Adaptation of communication assessment tool for community pharmacists in medication adherence and minor diseases management

Aim: To develop two versions of the Communication Assessment Tool (CAT) skilled for the setting of community pharmacy and to pilot test it on a selected sample. Materials: Development of two versions of CAT-tool for community pharmacists. Validity and reliability assessments were required to determine the psychometric properties of developed tool versions. To investigate the construct validity of each adapted tool item, confirmatory factor analysis was performed. Reliability was assessed with the Cronbach’s Alpha evaluation, internal validity by submitting tool versions to patients of eleven pharmacies from North, Center, and South of Italy for pilot testing. Results: Two CAT versions were developed and tested: CAT-Pharm-community Adherence to therapy and Minor Disease Management versions. First to evaluate pharmacist-patient communication following the dispensing of a prescription drug, second a consultation for minor disease management. Conclusion: Communication tools are useful to implement optimal management of chronic diseases to minimize non-adherence and patients’ negative health outcomes

A pragmatic controlled trial to improve the appropriate prescription of drugs in adult outpatients: Design and rationale of the EDU.RE.DRUG study

Introduction: Pharmacological intervention is an important component of patient care. However, drugs are often inappropriately used. It is necessary for countries to implement strategies to improve the rational use of drugs, including independent information for healthcare professionals and the public, which must be supported by well-trained staff. The primary objectives of the EDU.RE.DRUG (Effectiveness of informative and/or educational interventions aimed at improving the appropriate use of drugs designed for general practitioners and their patients) study are the retrospective evaluation of rates of appropriate prescribing indicators (APIs) and the assessment of the effectiveness of informative and/or educational interventions addressed to general practitioners (GPs) and their patients, aimed at improving prescribing quality and promoting proper drug use. Methods and analysis: This is a prospective, multicentre, open-label, parallel-arm, controlled, pragmatic trial directed to GPs and their patients in two Italian regions (Campania and Lombardy). The study data are retrieved from administrative databases (Demographic, Pharmacy-refill, and Hospitalization databases) containing healthcare information of all beneficiaries of the National Health Service in the Local Health Units (LHUs) involved. According to LHU, the GPs/patients will be assigned to one of the following four intervention arms: (1) intervention on GPs and patients; (2) intervention on GPs; (3) intervention on patients; and (4) no intervention (control). The intervention designed for GPs consists of reports regarding the status of their patients according to the APIs determined at baseline and in two on-line Continuous Medical Education (CME) courses. The intervention designed for patients consists in flyers and posters distributed in GPs ambulatories and community pharmacies, focusing on correct drug use. A set of indicators (such as potential drug–drug interactions, unnecessary duplicate prescriptions, and inappropriate prescriptions in the elderly), adapted to the Italian setting, has been defined to determine inappropriate prescription at baseline and after the intervention phase. The primary outcome was a composite API. Ethics and dissemination: The study was approved by the Ethics Committee of the University of Milan on 7th June 2017 (code 15/17). The investigators will communicate trial results to stakeholders, collaborators, and participants via appropriate presentations and publications. Registration details: NCT04030468. EudraCT number 2017-002622-2

Development and validation of a clinical risk score to predict the risk of SARS-CoV-2 infection from administrative data: A population-based cohort study from Italy

Background The novel coronavirus (SARS-CoV-2) pandemic spread rapidly worldwide increasing exponentially in Italy. To date, there is lack of studies describing clinical characteristics of the people at high risk of infection. Hence, we aimed (i) to identify clinical predictors of SARSCoV-2 infection risk, (ii) to develop and validate a score predicting SARS-CoV-2 infection risk, and (iii) to compare it with unspecific scores. Methods Retrospective case-control study using administrative health-related database was carried out in Southern Italy (Campania region) among beneficiaries of Regional Health Service aged over than 30 years. For each person with SARS-CoV-2 confirmed infection (case), up to five controls were randomly matched for gender, age and municipality of residence. Odds ratios and 90% confidence intervals for associations between candidate predictors and risk of infection were estimated by means of conditional logistic regression. SARS-CoV-2 Infection Score (SIS) was developed by generating a total aggregate score obtained from assignment of a weight at each selected covariate using coefficients estimated from the model. Finally, the score was categorized by assigning increasing values from 1 to 4. Discriminant power was used to compare SIS performance with that of other comorbidity scores. Results Subjects suffering from diabetes, anaemias, Parkinson’s disease, mental disorders, cardiovascular and inflammatory bowel and kidney diseases showed increased risk of SARSCoV-2 infection. Similar estimates were recorded for men and women and younger and older than 65 years. Fifteen conditions significantly contributed to the SIS. As SIS value increases, risk progressively increases, being odds of SARS-CoV-2 infection among people with the highest SIS value (SIS = 4) 1.74 times higher than those unaffected by any SIS contributing conditions (SIS = 1). Conclusion Conditions and diseases making people more vulnerable to SARS-CoV-2 infection were identified by the current study. Our results support decision-makers in identifying high-risk people and adopting of preventive measures to minimize the spread of further epidemic waves

Patient Centric Pharmaceutical Drug Product Design&#8212;The Impact on Medication Adherence

Medication adherence is a growing concern for public health and poor adherence to therapy has been associated with poor health outcomes and higher costs for patients. Interventions for improving adherence need to consider the characteristics of the individual therapeutic regimens according to the needs of the patients. In particular, geriatric and paediatric populations as well as dermatological patients have special needs/preferences that should be considered when designing drug products. Patient Centric Drug Product Pharmaceutical Design (PCDPD) offers the opportunity to meet the needs and preferences of patients. Packaging, orodispersible formulations, fixed dose combinations products, multiparticulate formulations, topical formulations and 3D printing are of particular relevance in a PCDPD process. These will be addressed in this review as well as their impact on medication adherence