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.
The primary objective of this study was to investigate the prevalence of clinically important potential drug-drug interactions (DDIs) in elderly patients attending the public primary health care ...system in Brazil. The secondary objective was to investigate possible predictors of potential DDIs.
A cross-sectional study was carried out in 5 Brazilian cities located in the Ourinhos Micro-region, Sao Paulo State, between November 2010 and April 2011. The selected sample was divided according to the presence (exposed) or absence (unexposed) of one or more potential DDIs (defined as the presence of a minimum 5-day overlap in supply of an interacting drug pair). Data were collected from medical prescriptions and patients' medical records. Potential DDIs (rated major or moderate) were identified using 4 DDI-checker programs. Logistic regression analysis was used to study potential DDI predictors.
The prevalence of clinically important potential DDIs found during the study period was 47.4%. Female sex (OR = 2.49 95% CI 2.29-2.75), diagnosis of ≥ 3 diseases (OR = 6.43 95% CI 3.25-12.44), and diagnosis of hypertension (OR = 1.68 95% CI 1.23-2.41) were associated with potential DDIs. The adjusted OR increased from 0.90 95% CI 0.82-1.03 in patients aged 60 - 64 years to 4.03 95% CI 3.79 - 4.28 in those aged 75 years or older. Drug therapy regimens involving ≥ 2 prescribers (OR = 1.39 95% CI 1.17-1.67), ≥ 3 drugs (OR = 3.21 95% CI 2.78-3.59), ≥ 2 ATC codes (OR = 1.19 95% CI 1.12-1.29), ≥ 2 drugs acting on cytochrome P450 (OR = 2.24 95% CI 2.07-2.46), and ATC codes B (OR = 1.89 95% CI 1.05-2.08) and C (OR = 4.01 95% CI 3.55-4.57) were associated with potential DDIs.
Special care should be taken with the prescription and therapeutic follow-up of patients who present characteristics identified as predictors. Knowledge of potential DDI predictors could aid in developing preventive practices and policies that allow public health services to better manage this situation.
To examine the effect of a pharmaceutical care program on the coronary heart disease risk in elderly diabetic and hypertensive patients.
A total of 200 elderly (> 60 years) diabetic and/or ...hypertensive patients were recruited into a randomized, controlled, prospective clinical trial with a 36-month follow-up, developed in a public primary health care unit in a municipality in the Brazilian State of Sao Paulo. A range of clinical measurements were evaluated at the baseline and up to 36 months afterwards. The intervention group patients received pharmaceutical care from a clinical pharmacist, whereas the control group patients received their usual care from the medical and nursing staff. The Framingham scoring method was used to estimate changes in the 10-year coronary heart disease risk scores of all the patients.
A total of 194 patients completed the study. Significant reductions (p < 0.05) in the mean values (baseline vs. 36 months) for the systolic blood pressure 156.7 mmHg vs 133.7 mmHg; P < 0.001), diastolic blood pressure (106.6 mmHg vs. 91.6 mmHg; P < 0.001),fasting glucose (135.1 mg/dL vs. 107.9 mg/dL; P < 0.001), hemoglobin A1C (7.7% vs. 7.0%; P <0.001), triglycerides (206.0 mg/dL vs. 152.5 mg/dL; P < 0.001), low-density lipoprotein (LDL)cholesterol (112.4 mg/dL vs. 102.0 mg/dL; P < 0.001), high-density lipoprotein cholesterol (55.5 mg/dL vs. 65.5 mg/dL; P < 0.001), total cholesterol (202.5 mg/dL vs. 185.9 mg/dL; P < 0.001), body mass index (26.2 kg/m2 vs. 26.1 kg/m2; P < 0.001), and abdominal circumference (103.2 cm vs. 102.5 cm; P= 0.001) were observed in the intervention group, whereas no significant changes were verified in the control group. The mean Framingham risk prediction score in the intervention group was 6.8% at baseline and decreased to 4.5%; P < 0.001) after 36 months, but remained unchanged in the control group.
The pharmaceutical care program resulted in better clinical measurements and reduced the cardiovascular risk scores in elderly diabetic and hypertensive patients over a 36-month period.
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.
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.
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).
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.
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.
Cases description
We report two cases of drug rash with eosinophilia and systemic symptoms (DRESS) associated with the use of carbamazepine and phenytoin in Brazilian boys tested for human leukocyte ...antigen (HLA) class I and II alleles. The clinical manifestations were similar: a maculopapular eruption progressing to exfoliative erythroderma, fever, and lymphadenopathy. Leukocytosis, atypical lymphocytes, and liver injury were also observed. Assessment of causality using the Naranjo algorithm established a “probable” relationship (score 6) in both cases. Case 1 patient presented the following results of HLA typing: HLA-A*02,29 B*44,50 C*06,16 DRB1*01,07 DQA1*01,02. Case 2 patient presented the following results of HLA typing: HLAA*23,24 B*39,53 C*04,07 DRB1*04,08 DQA1*03,05 DQB1*03,03.
Conclusion
Neither of the cases reported here presented HLA typing similar to that strongly associated with the occurrence of DRESS in Asian or European patients.
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