Adverse drug reactions caused by drug-drug interactions in elderly outpatients: a prospective cohort study.

PURPOSE: Although the prevalence of drug-drug interactions (DDIs) in elderly outpatients is high, many potential DDIs do not have any actual clinical effect, and data on the occurrence of DDI-related adverse drug reactions (ADRs) in elderly outpatients are scarce. This study aimed to determine the incidence and characteristics of DDI-related ADRs among elderly outpatients as well as the factors associated with these reactions. METHODS: A prospective cohort study was conducted between 1 November 2010 and 31 November 2011 in the primary public health system of the Ourinhos micro-region, Brazil. Patients aged ≥60 years with at least one potential DDI were eligible for inclusion. Causality, severity, and preventability of the DDI-related ADRs were assessed independently by four clinicians using validated methods; data were analysed using descriptive analysis and multiple logistic regression. RESULTS: A total of 433 patients completed the study. The incidence of DDI-related ADRs was 6 % (n = 30). Warfarin was the most commonly involved drug (37 % cases), followed by acetylsalicylic acid (17 %), digoxin (17 %), and spironolactone (17 %). Gastrointestinal bleeding occurred in 37 % of the DDI-related ADR cases, followed by hyperkalemia (17 %) and myopathy (13 %). The multiple logistic regression showed that age ≥80 years [odds ratio (OR) 4.4; 95 % confidence interval (CI) 3.0-6.1, p < 0.01], a Charlson comorbidity index ≥4 (OR 1.3; 95 % CI 1.1-1.8, p < 0.01), consumption of five or more drugs (OR 2.7; 95 % CI 1.9-3.1, p < 0.01), and the use of warfarin (OR 1.7; 95 % CI1.1-1.9, p < 0.01) were associated with the occurrence of DDI-related ADRs. With regard to severity, approximately 37 % of the DDI-related ADRs detected in our cohort necessitated hospital admission. All DDI-related ADRs could have been avoided (87 % were ameliorable and 13 % were preventable). The incidence of ADRs not related to DDIs was 10 % (n = 44). CONCLUSIONS: The incidence of DDI-related ADRs in elderly outpatients is high; most events presented important clinical consequences and were preventable or ameliorable.

Incidence and predictors of adverse drug reactions caused by drug-drug interactions in elderly outpatients: a prospective cohort study.

PURPOSE: The primary objective of this study was to investigate the incidence of drug-drug interactions (DDIs) related to adverse drug reactions (ADRs) in elderly outpatients who attended public primary healthcare units in a southeastern region of Brazil. The secondary objective was to investigate the possible predictors of DDI-related ADRs. METHODS: A prospective cohort study was conducted between November 1, 2010, and November 31, 2011, in the primary public healthcare system in the Ourinhos micro-region in Brazil. Patients who were at least 60 years old, with at least one potential DDI, were eligible for inclusion in the study. Eligible patients were assessed by clinical pharmacists for DDI-related ADRs for 4 months. The causality of DDI-related ADRs was assessed independently by four clinicians using three decisional algorithms. The incidence of DDI-related ADRs during the study period was calculated. Logistic regression analysis was used to study DDI-related ADR predictors. RESULTS: A total of 433 patients completed the study. The incidence of DDI-related ADRs was 6.5%. A multivariate analysis indicated that the adjusted odds ratios (ORs) rose from 0.91 (95% confidence interval [CI] = 0.75-1.12, p = 0.06) in patients aged 65-69 years to 4.40 (95% CI = 3.00-6.12, p < 0.01) in patients aged 80 years or older. Patients who presented two to three diagnosed diseases presented lower adjusted ORs (OR = 0.93 [95% CI = 0.68-1.18, p = 0.08]) than patients who presented six or more diseases (OR = 1.12 [95% CI = 1.02-2.01, p < 0.01]). Elderly patients who took five or more drugs had a significantly higher risk of DDI-related ADRs (OR = 2.72 [95% CI = 1.92-3.12, p < 0.01]) than patients who took three to four drugs (OR = 0.93 [95% CI = 0.74-1.11, p = 0.06]). No significant difference was found with regard to sex (OR = 1.08 [95% CI 0.48-2.02, p = 0.44]). CONCLUSION: The incidence of DDI-related ADRs in elderly outpatients was significant, and most of the events presented important clinical consequences. Because clinicians still have difficulty managing this problem, highlighting the factors that increase the risk of DDI-related ADRs is essential. Polypharmacy was found to be a significant predictor of DDI-related ADRs in our sample.

Cost-effectiveness analysis of a pharmacotherapeutic empowerment strategy for patients with type 2 diabetes mellitus.

Background: The economic feasibility of pharmacotherapeutic empowerment of patients with type 2 diabetes mellitus (DM2) is still not well established. Objectives: To evaluate the cost-effectiveness of an individual pharmacotherapeutic empowerment strategy (IPES) for patients with DM2. Methods: This is a cost-effectiveness study nested in a non-randomized clinical trial with patients ≥18 years of age, of both genders, with low and moderate cardiovascular risks. This study was carried out from the perspective of the municipal health system of Divinópolis in Minas Gerais state, and compared patients submitted to an IPES and patients who received only traditional care, 1 year before the beginning of the intervention (baseline) and 1 year after its completion (follow-up). The costs of the services offered by the municipality were computed, and in the intervention group IPES costs were included. Glycated hemoglobin (A1c) was the effectiveness parameter adopted. Cost-effectiveness ratio analyses, incremental cost-effectiveness ratio (ICER), and sensitivity analysis were performed. Results: In the analysis of cost-effectiveness, it is observed that a reduction of 0.359 in A1c costs US$708.47 in the intervention group and a reduction of 0.170 costs US$1927.13 in the control group. Thus, the ICER is US$387.66 per patient/year. In the sensitivity analysis, it was observed that the IPES was dominant in 19.8% of the simulated scenarios and cost-effective in 80.2%. Conclusions: The IPES is an alternative that presents economic feasibility for the municipal public health system scenario. The absence of randomization in patient selection is a limitation of this study.

Patients participation in pharmaceutical care consultations in Brazil.

Background The effectiveness of pharmaceutical care has already been evidenced in several studies and scenarios; the lack of patient's consultation has been little explored in the literature. Unprovided care is a missed opportunity to offer care to another individual who needs attention to their health. The need for investigation of missed consultations in a Brazilian pharmaceutical care service arises. Objective To evaluate the participation and characteristics of patients in pharmaceutical care consultations in a university outpatient unit in the Brazilian city of Divinópolis. Methods A descriptive study was carried out from a secondary source of information. The socio-demographic profile of the patients who were absent from the pharmacy consultations from January to December 2017 was outlined. Results Of the 832 scheduled appointments from January to December 2017, 501 were not attended by patients, revealing 60.2% missed consultations. The female gender was predominant, corresponding to 67.8% of the patients. A total of 63.8% of the absentees were over 60 years of age. Most of the patients had two comorbidities (32.5%) and came from an active identification by the Outpatient unit pharmacists (86.60%). Furthermore, the patients who were more absent from the consultations had their primary health care units farther away from the outpatient unit, and this could be one of the causes of the high number of absent patients from the pharmaceutical consultations. Conclusion The lack of participation in patient's consultations is high. It is necessary to articulate new strategies aimed at reducing absences from consultations, since this is a source of waste of financial resources and opportunities to improve the patients' health and quality of life.

A Distance-Learning Course to Improve Drug-Dispensing Behaviors Among Brazilian Community Pharmacists.

Objective. To evaluate the effectiveness of a distance-learning course in the training of pharmacists in drug dispensing. Methods. This interventional study was carried out with community pharmacists throughout Brazil. A 12-week distance-learning course was conducted. Pharmacists' knowledge and performance during drug dispensing were evaluated before and after completion of the course. Results. Community pharmacists' knowledge of drug dispensing was greater after completing the distance-learning course than before (mean=5.7, SD=2.8 points vs mean=3.8, SD=1.9 points, respectively). However, no improvement was observed in pharmacists' drug-dispensing practice. Almost all participants (96.5%) considered that they were more qualified to perform the drug dispensing after the course. There were 1492 pharmacists enrolled in the course, of which 1061 were included in the study, and 472 completed the surveys. Only pharmacists from Ribeirão Preto, Brazil, were invited to take the mytery shopper evaluation (n=26). However, 10 pharmacists completed the mystery shopper encounter. Conclusion. A distance-learning course was effective in improving community pharmacists' knowledge. However, the course did not seem to improve overall drug-dispensing performance. Additional educational strategies should be adopted in future studies to address this gap.

A Systematic Review of the Effects of Continuing Education Programs on Providing Clinical Community Pharmacy Services.

Objective. To summarize the effects of media methods used in continuing education (CE) programs on providing clinical community pharmacy services and the methods used to evaluate the effectiveness of these programs. Methods. A systematic review was performed using Medline, SciELO, and Scopus databases. The timeline of the search was 1990 to 2013. Searches were conducted in English, Portuguese, and Spanish. Results. Nineteen articles of 3990 were included. Fourteen studies used only one media method, and the live method (n=11) was the most frequent (alone or in combination). Only two studies found that the CE program was ineffective or partially effective; these studies used only the live method. Most studies used nonrobust, nonvalidated, and nonstandardized methods to measure effectiveness. The majority of studies focused on the effect of the CE program on modifying the knowledge and skills of the pharmacists. One study assessed the CE program's benefits to patients or clients. Conclusion. No evidence was obtained regarding which media methods are the most effective. Robust and validated methods, as well as assessment standardization, are required to clearly determine whether a particular media method is effective.

Use of simulated patients to evaluate combined oral contraceptive dispensing practices of community pharmacists.

BACKGROUND: Combined oral contraceptive (COC) use is the most commonly used reversible method of birth control. The incorrect use of COCs is frequent and one of the most common causes of unintended pregnancies. Community pharmacists (CPs) are in a strategic position to improve COC use because they are the last health professional to interact with patients before drug use. OBJECTIVE: To evaluate the COC dispensing practices of CPs in a developing country. METHOD: A cross-sectional study was conducted in community pharmacies of Assis and Ourinhos microregions, Brazil, between June 1, 2012, and October 30, 2012. Four simulated patients (SPs) (with counseled audio recording) visited community pharmacies with a prescription for Ciclo 21(®) (a COC containing ethinyl estradiol 30 mcg + levonorgestrel 15 mcg). The audio recording of every SP visit was listened to independently by 3 researchers to evaluate the COC dispensing practice. The percentage of CPs who performed a screening for safe use of COCs (i.e., taking of patients' medical and family history, and measuring of blood pressure) and provided counseling, as well as the quality of the screening and counseling, were evaluated. RESULTS: Of the 185 CPs contacted, 41 (22.2%) agreed to participate in the study and finished the study protocol. Only 3 CPs asked the SP a question (1 question asked by each professional), and all of the questions were closed-ended, viz., "do you smoke?" (n = 2) and "what is your age?" (n = 1). None of the CPs measured the patient's blood pressure. Six CPs provided counseling when dispensing COCs (drug dosing, 5 CPs; possible adverse effects, 2 CPs), and one CP provided counseling regarding both aspects. CONCLUSION: The CPs evaluated did not dispense COC appropriately and could influence in the occurrence of negatives therapeutic outcomes such as adverse effects and treatment failure.

Effect of a 36-month pharmaceutical care program on pharmacotherapy adherence in elderly diabetic and hypertensive patients.

OBJECTIVE: The primary objective of this study was to evaluate the effect of a pharmaceutical care program on pharmacotherapy adherence in elderly diabetic and hypertensive patients. The clinical outcomes of this pharmacotherapy adherence approach were the secondary objective of the study. SETTING: Public Primary Health Care Unit in a municipality in the Brazilian State of Sao Paulo. METHOD: A 36-month randomized, controlled, prospective clinical trial was carried out with 200 patients divided into two groups: control (n = 100) and intervention (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultancies). The patients randomized into the intervention group received pharmaceutical care intervention besides the usual care offered. MAIN OUTCOME MEASURE: Pharmacotherapy adherence (Morisky-Green test translated into Portuguese and computerized dispensed medication history) and clinical measurements (blood pressure, fasting glucose, A1C hemoglobin, triglycerides and total cholesterol) were evaluated at the baseline and up to 36 months. A P value <0.05 was considered statistically significant. RESULTS: A total of 97 patients from the intervention group and 97 patients from the control group completed the study (n = 194). Significant improvements in the pharmacotherapy adherence were verified for the intervention group according to the Morisky-Green test (50.5% of adherent patients at baseline vs. 83.5% of adherent patients after 36 months; P < 0.001) and the computerized dispensed medication history (52.6% of adherent patients at baseline vs. 83.5% of adherent patients after 36 months; P < 0.001); no significant changes were verified in the control group. Significant improvements in the number of patients reaching adequate values for their blood pressure (26.8% at baseline vs. 86.6% after 36-months; P < 0.001), fasting glucose (29.9% at baseline vs. 70.1% after 36 months; P < 0.001), A1C hemoglobin (3.3% at baseline vs. 63.3% after 36 months; P < 0.001), triglycerides (47.4% at baseline vs. 74.2% after 36 months; P < 0.001) and total cholesterol (59.8% at baseline vs. 80.4% after 36 months; P = 0.002) were verified in the intervention group, but remained unchanged in the control group. CONCLUSION: These results indicated the effectiveness of pharmaceutical care in improving pharmacotherapy adherence, with positive effects in the clinical outcomes of the patients studied.