Divaldo Pereira de Lyra Júnior

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.

Prescription errors in Brazilian hospitals: a multi-centre exploratory survey

In Brazil, millions of prescriptions do not follow the legal requirements necessary to guarantee the correct dispensing and administration of medication. This multi-centre exploratory study aimed to analyze the appropriateness of prescriptions at four Brazilian hospitals and to identify possible errors caused by inadequacies. The sample consisted of 864 prescriptions obtained at hospital medical clinics in January 2003. Data was collected by three nurse researchers during one week using a standard data sheet that included items about: the type of prescription; legibility; completeness; use of abbreviations; existence of changes and erasures. There were statistically significant differences between incomplete electronic prescriptions at hospital A, and handwritten ones from hospitals C (C2 = 12.703 and p < 0.001) and D (C2 = 14.074 and p < 0.001). Abbreviations were used in more than 80% of prescriptions at hospitals B, C and D. Changes were found in prescriptions at all hospitals, with higher levels at hospitals B (35.2%) and A (25.3%). This study identified a range of vulnerable points in the prescription phase of the medication system at the hospitals. Physicians, pharmacists and nurses should therefore jointly propose strategies to avoid these prescription errors.

Effect of a 36-month Pharmaceutical Care Program on the Coronary Heart Disease Risk in Elderly Diabetic and Hypertensive Patients

PURPOSE To examine the effect of a pharmaceutical care program on the coronary heart disease risk in elderly diabetic and hypertensive patients. METHODS 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. RESULTS 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. CONCLUSION 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.

Exploring the Quality of Systematic Reviews on Pharmacist Interventions in Patients With Diabetes An Overview

Objective: To assess the reporting and methodological quality of systematic reviews and meta-analysis studies on pharmacist interventions in patients with diabetes. Data Sources: A comprehensive literature search was performed in MEDLINE, Scopus, and LILACS databases for systematic reviews and meta-analysis studies published from January 1990 to June 2013. The standardized search strategy included the use of MeSH terms or text words related to pharmacist interventions, diabetes, and systematic reviews. Study Selection and Data Extraction: The overview included systematic reviews and meta-analysis studies published in English, Portuguese, or Spanish that evaluated the effect of pharmacist intervention on outcomes for diabetic patients. Two independent authors performed study selection, data extraction, and quality assessment with a consensus process to address disagreements. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and Assessment of Multiple Systematic Reviews (AMSTAR) checklists were used to assess reporting characteristics and methodological quality, respectively. Data Synthesis: The literature search yielded 101 records of potential interest, of which 7 satisfied the inclusion criteria. The total average (SD) for PRISMA and AMSTAR scores were 17.4 (5.6) out of 27 and 6.9 (2.0) out of 11, respectively. The most frequent problems included nonregistration of study protocol, absence of a list of excluded studies, and unclear acknowledgment of conflicts of interests. Conclusion: The reporting and methodological quality of systematic reviews and meta-analysis studies were suboptimal, with some areas needing further improvement. It is necessary to ensure better transparency and reproducibility in the literature of clinical pharmacy services for diabetic patients.

Aderência autorreferida a medicamentos prescritos durante a gestação

PURPOSE To assess medication adherence therapeutic during pregnancy in a sample of Brazilian women during the post-partum period. METHODS We conducted a cross-sectional study in the obstetric unit of a university hospital, Brazil, between August and November 2010. We recruited patients aged 18 years or more, with a gestational age of more than 22 weeks whose newborns weighed more than 500 g. Patients were excluded if they used sedatives or other mind-altering drugs. Data were collected after labor using a structured questionnaire containing questions about sociodemographic characteristics, medication use, number of previous pregnancies, contraceptive methods, prenatal care, and medication adherence. Medication adherence was assessed using the four-item Morisky medication adherence scale - MMAS-4, groups were compared by the Fisher exact Test and Kruskal-Wallis Test and Χ2 de Pearson Test. RESULTS Mean age was 22.5 years (SD=6.5), and 53.8% of the pregnant women had initiated prenatal care during the first trimester of pregnancy. Of the 130 patients interviewed, 96.9% had used at least one prescribed drug during pregnancy, with an average of 2.8 drugs per patient. The major classes prescribed were antianemics (55.1%), analgesics, anti-inflammatories, and antipyretics (19.0%) and anti-infectives (7.2%). 71.6% took two to four drugs. Only 19.2% of patients were considered adherent. The variables that showed a negative influence on adherence were: higher level of education, having ones own income, earlier prenatal care and previous abortion. CONCLUSION Our findings indicate that, although most of the patients used prescribed drugs during pregnancy, the rate of medication adherence was low, which indicates the need for further investigation about the impact of non-adherence during pregnancy and its causes.

Understanding of pictograms from the United States Pharmacopeia Dispensing Information (USP-DI) among elderly Brazilians

Objective To assess the understanding and cultural acceptability of the United States Pharmacopeia Dispensing Information (USP-DI) in a group of elderly Brazilians. Methods The study participants were individuals between 60 and 90 years old, of both sexes, with different levels of education and income. Fifteen of 81 pictograms from the USP-DI were presented to the elderly subjects, individually, without subtitles and in random order, so that the participants’ understanding of the pictograms could be evaluated. Results The study included 116 participants. Only one of the selected pictograms reached the comprehension criterion established by the International Organization for Standardization 3864. With regard to the relationship between understanding and sociodemographic characteristics, age, wage income, and level of education were all found to be significantly associated with participants’ understanding of some of the pictograms. Conclusion Most of the USP-DI pictograms evaluated were not well understood by the elderly Brazilians. This finding indicates that such pictograms need to be culturally adapted for the Brazilian context if they are to serve their purpose effectively in this country.

Perceptions of a group of hospital pharmacists and other professionals of the implementation of clinical pharmacy at a high complexity public hospital in Brazil

BackgroundDuring the process of implementation of clinical pharmacy services, internal and external factors may favor or hinder the incorporation of care into the hospital routine. This study aimed to understand the perceptions of a group of hospital pharmacists and other professionals of the implementation of clinical pharmacy at a high complexity public hospital in Brazil.MethodsA focus group with 16 pharmacists and interviews with tree key stakeholders including managers in the pharmaceutical, medical, and nursing profession were conducted to understand their perceptions of the implementation clinical pharmacy services in a high complexity public hospital in Brazil. The service proposal was presented to the selected participants before conducting the focus group. Professionals with an overview of the hospital and influence on the relevant departments for the implementation of clinical pharmacy at the institution were selected. Data collected were transcribed and analyzed using the Bardin Content Analysis technique. Data analyzed were systematized into categories and registration units. The methodology involves the organization and analysis of reported content to make inferences.ResultsThe data obtained were divided into four categories: “Perception of the current situation”, “Implementation expectations”, “Barriers to implementation”, “Implementation facilitators”. Participants discussed the stagnation of clinical activities of the pharmaceutical profession in Brazil, a reality that results from a lack of clinical training in the country. Pharmacists expressed their expectations for changes in professional performance. According to the managers, such services would positively affect clinical outcomes for patients. Gaps in academic education, lack of knowledge, and poor communication skills were barriers reported in this study. Pharmacists’ clinical experience has been reported to facilitate the provision of services.ConclusionsThis study highlights factors that may influence the implementation of clinical pharmacy services in the institution analyzed, such as resistance, fear, and frustration as barriers, as well the experience in clinical pharmacy of some pharmacists in the institution was one of the facilitators most cited by participants. This knowledge may aid future planning for the implementation of clinical pharmacy in hospitals.

An analysis of the quality of studies that evaluate potentially inappropriate drug therapy

In the elderly population, increased predisposition to chronic diseases and consequent use of various medications increases the chances of using a potentially inappropriate drug therapy. The purpose of this review was to analyze research that uses tools to study potentially inappropriate drug therapy through the strengthening the reporting of observational studies in epidemiology (STROBE) initiative. A systematic review was undertaken between February and March, 2013. The studies were selected from different combinations of the Medicines controlled vocabulary thesaurus (MESH) terms - “aged,” “elderly,” “inappropriate prescribing,” and “drug utilization” in English, Spanish and Portuguese, in the Literatura Latino-Americana e do Caribe em Ciencias da Saude, PubMed, Scopus, and Web of Science databases. The papers that satisfied the inclusion criteria for data extraction were examined regarding the following variables: country, sample size, duration, type of study, practice scenario, study limitations and fulfillment of the items proposed by the STROBE initiative. At the end of the selection process, 119 articles met the specific criteria. The US had the highest number of publications in this area. The samples observed were heterogeneous, ranging from patient to database samples, and most studies were cross-sectional. The most frequently used study practice scenarios were hospitals or outpatient clinics. No article completely met the STROBE criteria. It was found that potentially inappropriate drug therapy is studied primarily in developed countries, which reinforces the need for further studies in developing countries. These findings should guide future research in this subject area, providing a more complete approach on aspects related to the use of medications by this specific population. Key words: Potentially inappropriate drug therapy, inappropriate prescribing, elderly, study quality assessment.

A system to help the teaching of pharmaceutical care

The communication between patients and pharmacists is an essential tool for the identification and reduction of drug related problems. This article presents an educational web tool that simulates a patient, which can be applied in the education of pharmacotherapeutic skills. The tool allows the storage and analysis (by the students) of clinical cases of pharmacy community. The system has been validated by students of Pharmacy and has received a positive and satisfactory assessment.

Bulas de medicamentos usados por idosos com hipertensão: adequação da informação à regulamentação sanitária e possíveis implicações para a saúde

The medication leaflets represent the main source of written information supplied to the patients, in special to the elderly. This study aimed to analyze the content of the leaflets of drugs often prescribed for elderly people with hypertension, as well as their adequacy to the sanitary regulations and possible health implications. A descriptive study was conducted in two stages: A, in July 2002, and B, in July 2007. In each stage were analyzed 34 medication leaflets of seven antihypertensive drugs of the National Essential Drugs List (2006). Among the 68 leaflets analyzed, most did not contain all the information required by Portaria no 110/1997 (89.5%) in the stage A and the RDC no 140/2003 (100%) in B. In 100% of the leaflets, the legislation had not been fulfilled. Some important topics as way of administration, how to use and overdose had been absent in 76% of the leaflets, the lack of this information has an impact in the security of the antihypertensive users. Based on these data, it was possible to evidence inadequate contents of the medication leaflets. So, it is necessary greater surveillance by Anvisa, to ensure the rational use of medicines and the reduction of the risks to the elderly health.