Self-reported Adverse Drug Reactions Research Articles

Sex differences in incidence of self-reported adverse drug reactions after percutaneous coronary intervention

Abstract Background Despite experiencing adverse drug reactions (ADRs) more often than men, the proportion of women participating in clinical drug trials is low. Thus, evidence for sex differences in the incidence of ADRs is limited. Aim To determine sex differences in incidence of self-reported ADRs after percutaneous coronary intervention (PCI). Further, to determine whether receiving information about ADRs is associated with sex. Methods CONCARDPCI is a prospective multicentre cohort study (N=3417) conducted at seven referral PCI centres in two Nordic countries. Clinical data were collected from patients’ medical records. Socio-demographic characteristics were obtained by self-report after PCI. Two questions from the Heart Continuity of Care Questionnaire (HCCQ) were used to determine if information about potential ADRs was received before hospital discharge. De novo created questions were used to determine if patients reported ADRs from prescribed therapy. Questionnaires were distributed two- (T1), six- (T2), and twelve months (T3) after hospital discharge to assess the incidence of self-reported ADRs in a longitudinal perspective. Logistic regression was utilised to scrutinize the aims, reported as odds ratios (ORs) with 95% confidence intervals (CIs). Results Patients were predominantly male (78%), with a mean age of 65 years (SD 11). Female patients were older (68, SD 10). Acute coronary syndrome was the most frequent cause of admission for PCI (62%). At T1, 2656 of the included patients responded to the questions from the HCCQ. Of these, 1019 patients (39%) reported being informed of potential ADRs from prescribed therapy, 1075 patients (42%) reported not having been informed, 511 patients (20%) reported ‘Hard to decide’, and 51 (2%) reported ‘Not applicable’. Patients reporting ‘Hard to decide’ or ‘Not applicable’ were excluded from further analysis. Women were less likely to receive information than men (OR 0.58, CI 0.45 – 0.75, p<0.001). For the total study population, 42%, 49% and 40% reported ADRs at T1-T3 respectively. After adjusting for sociodemographic and clinical variables, the incidence of self-reported ADRs were significantly higher in women compared to men at T1 (OR 1.71, CI 1.36 – 2.15, p<0.001), T2 (OR 1.89, CI 1.49 – 2.38, p<0.001), and T3 (OR 1.79, CI 1.40 – 2.28, p<0.001). Conclusion Women report significantly more ADRs from prescribed therapy than men after PCI. However, they are less likely to receive information about potential ADRs compared to men. Efforts to improve communication on ADRs and gender equity should be a priority.

Informing patients about potential adverse drug reactions after percutaneous coronary intervention reduces the occurrence of self-reported adverse drug reactions

Abstract Background Healthcare providers are commonly reluctant to inform patients about potential adverse drug reactions (ADRs) from prescribed therapy to avoid increasing the incidence of ADRs through the nocebo effect. However, patients need information on all aspects of prescribed therapy to facilitate informed decision-making and take ownership of their care. Purpose To describe wether patients received information about potential ADRs from prescribed therapy before hospital discharge after percutaneous coronary intervention (PCI). Furthermore, to determine whether receiving information about ADRs is associated with incidence of self-reported ADRs. Methods CONCARDPCI is a prospective multicentre cohort study including 3417 patients after PCI. The study was conducted between June 2017 and May 2020 at seven large referral PCI centres in Norway and Denmark. Clinical data were collected from patients' medical records. Socio-demographic characteristics were obtained by self-report during index hospitalization after PCI. Two questions from the Heart Continuity of Care Questionnaire were used to determine if information about potential ADRs was received before hospital discharge. De novo created questions were used to determine if patients reported ADRs from prescribed therapy. Questionnaires were distributed two (T1), six (T2), and twelve months (T3) after hospital discharge to assess the incidence of self-reported ADRs in a longitudinal perspective. Logistic regression was utilised to scrutinize the aims, reported as odds ratios (ORs) with 95% confidence intervals (CIs). Results Patients were predominantly men (78%), with a mean age of 66 years (SD 11, range 20–96 years), and married or living with a partner (75%). Stable coronary artery disease was the most frequent cause of admission for PCI (30%). Before hospital discharge, 59% were informed of potential ADRs from prescribed therapy and 50% were informed what to do if ADRs occurred. The incidence of self-reported ADRs were significantly lower for those who were informed of potential ADRs compared to those who were not informed at T1 (OR 0.54, CI: 0.45–0.65, p<0.001), T2 (OR 0.56, CI: 0.46–0.70, p<0.001) and T3 (OR 0.51, CI: 0.42–0.67, p<0.001) (Figure 1). After controlling for socio-demographic and clinical variables, the incidence of self-reported ADRs were similar at T1 (OR 0.58, CI: 0.47–0.71, p<0.001), T2 (OR 0.56, CI: 0.46–0.70, p<0.001) and T3 (OR 0.53, CI: 0.42–0.66, p<0.001). Those less likely to receive information about ADRs were living alone (OR 0.75, CI: 0.59–0.97; p=0.029), women (OR 0.58, CI: 0.45–0.75, p<0.001) and those with three or more comorbidities (OR 0.68, CI: 0.47–0.98, p=0.029) compared to their counterparts. Conclusion Our study showed that informing patients about potential ADRs after PCI reduces the occurrence of self-reported ADRs. Information about potential ADRs should be provided regardless of cohabitation status, sex and comorbidities. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Western Norway Health Authority

Five Years of Direct Oral Anticoagulants Use in Italy: Adverse Drug Reactions from the Italian National Pharmacovigilance Network.

Background: Direct oral anticoagulants (DOACs) are the preferred anticoagulant drugs for the prevention of atrial fibrillation (AF)-related thromboembolic complications and for the treatment and the prevention of recurrences of venous thromboembolism (VTE). The evaluation of self-reported adverse drug reactions (ADRs) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision making. Objective: To assess the safety profile of DOACs by analyzing ADR rates in the real-world Italian scenario. Methods: Post-marketing surveillance data recorded by the National Pharmacovigilance Network were retrieved for the time period 2017–2021 from the AIFA online site. The following data were collected for each DOAC: total ADR number, serious ADR number, gastrointestinal (GI) ADR, intracranial hemorrhage events (ICH ADR), and more frequently reported ADR for the study year. The safety profile was expressed by the risk index (RI). Results: Rivaroxaban use was associated with consistent and stable low rates of serious ADR, GI ADR, and ICH ADR across the 5-year study period. Rivaroxaban and apixaban showed the lowest RI for serious ADR and GI ADR, while rivaroxaban use was associated with significantly lower ICH events as compared to apixaban. Dabigatran was related to the highest RIs for every ADR class, in particular GI ADRs. Conclusions: DOACs presented an acceptable safety profile in the current post-market analysis. However, rivaroxaban and apixaban were associated with more favorable safety profiles as compared to dabigatran, while rivaroxaban provoked statistically significantly fewer ICH events as compared to apixaban.

Assessment of the Radio-contrast Media-Induced Self-Reported Adverse Drug Reactions in a Tertiary Care Hospital of North India: A Prospective Study.

Background:Radio-contrast media are the agents which are used on daily basis in the radiological practice for either diagnostic or therapeutic purpose. Currently used agents are considered to be safe but not devoid of side effects.Objectives:Objectives of the study were to assess the incidence of adverse drug reactions (ADRs) in the patients who receive radiographic contrast media for computed tomography (CT) and intravenous pyelography (IVP), to stratify the ADRs into different types based on their time of appearance and as per their severity.Materials and Methods:A prospective and observational study of 1-year duration was done on all the patients who received radio-contrast media (Iohexol) intravenously for CT and IVP in the radiodiagnosis department. Patients who experienced ADRs were recorded for the basic demographic characteristics and types of ADRs. Stratification of ADRs as per their severity was done using common terminology criteria for adverse events scale and Modified Hartwig and Siegel ADR Severity Assessment Scale, and casualty assessment was done using Naranjo's Algorithm.Results:Out of the total 3522 patients who were included in the study, eight patients got 12 suspected ADRs with some of the patients having more than one type of ADR. The most frequent ADR was nausea and vomiting (25%), followed by fever, chills, or sweating. Incidence of ADRs was 0.23%. All the ADRs were acute and occurred within 30 min of contrast administration. As per the severity scales used, all the ADRs were mild (75%) to moderate (25%) in nature with none of the reactions to be severe. Causality assessment showed 87.5% of the reactions to be “probable” in nature.Conclusion:Low osmolar nonionic radio contrast media are associated with very low incidence of ADRs in the North Indian population.

Adverse drug reactions amongst admitted advanced age Africans

Background: Medical therapy amongst advanced age adults sometimes have its inherent significant risks such as adverse drug reactions (ADRs) resulting from the drug itself or drug-drug interactions or interactions from other substances such as alcohol. Aim: The main aim of this study is to highlight ADRs noticed by the older adult while on admission either in the past or present with the goal of preventing them and improving treatment outcomes. Methods: A purposive cross-sectional sampling of 126 elderly patients that were admitted to the different wards of the hospital within a 3-month period was carried out of which 25 older adults who met the criteria of being able to recall ADRs in the past or during current admission were included in the study. Results: ADR was reported in a ratio of M: F ratio of 1:1.08 with a prevalence of 19.8% of the total older patients evaluated. Conclusion: Self-reported ADRs amongst these advanced age in-patients were high. The actual number of adverse drug events may be higher if they actually looked out for by the physicians or other health care workers. The use of screening tools by physicians and other prescribing health workers can help in curbing adverse drug events in older adults.

The potential of training specialist oncology nurses in real-life reporting of adverse drug reactions

Specialist oncology nurses (SONs) have the potential to play a major role in monitoring and reporting adverse drug reactions (ADRs); and reduce the level of underreporting by current healthcare professionals. The aim of this study was to investigate the long term clinical and educational effects of real-life pharmacovigilance education intervention for SONs on ADR reporting. This prospective cohort study, with a 2-year follow-up, was carried out in the three postgraduate schools in the Netherlands. In one of the schools, the prescribing qualification course was expanded to include a lecture on pharmacovigilance, an ADR reporting assignment, and group discussion of self-reported ADRs (intervention). The clinical value of the intervention was assessed by analyzing the quantity and quality of ADR-reports sent to the Netherlands Pharmacovigilance Center Lareb, up to 2 years after the course and by evaluating the competences regarding pharmacovigilance of SONs annually. Eighty-eight SONs (78% of all SONs with a prescribing qualification in the Netherlands) were included. During the study, 82 ADRs were reported by the intervention group and 0 by the control group. This made the intervention group 105 times more likely to report an ADR after the course than an average nurse in the Netherlands. This is the first study to show a significant and relevant increase in the number of well-documented ADR reports after a single educational intervention. The real-life pharmacovigilance educational intervention also resulted in a long-term increase in pharmacovigilance competence. We recommend implementing real-life, context- and problem-based pharmacovigilance learning assignments in all healthcare curricula.

The Burden Of Self-Reported Adverse Drug Reactions in Patients Referred To An Outpatient Allergy Practice At A Tertiary Referral Center

Adverse drug reactions (ADRs) play a significant role in patient care. With the use of electronic health records (EHR) patients self-report ADRs, but these are not always confirmed/validated by healthcare providers. Studies have described the prevalence in outpatient (11.4%)/inpatient (15.9%) settings, but to our knowledge, no data is available to describe self-reported ADRs in patients referred to an allergy practice. We aimed to describe such patients referred to our tertiary referral center.

Adverse drug reactions among new sputum positive pulmonary tuberculosis patients on daily treatment regimen: a prospective study from Haryana, India

Background: Daily regimen anti-tuberculosis treatment was adopted by Revised National Tuberculosis Control Programme (RNTCP) as a step to achieve tuberculosis elimination by 2025 in India. The change was implemented prior to completion of pilot study, which necessitated this study to note the self-reported Adverse Drug Reactions (ADRs).Methods: A prospective study with concurrent sampling design was carried on from June 2018 to June 2020 in the state of Haryana, India. Pre-tested semi-structured schedule was used to collect data based on RNTCP outcome definitions through two monthly (four visits) home visits. Mean±standard deviation, percentage, proportion and chi-square test was used. The p-value of <0.05 was considered as statistically significant.Results: Amongst 122 study participants 74 (60.7%) were males and 48 (39.3%) were females with mean age of 39.4±18.9 years. Majority were urban residents 87 (71.3%) and 35 (28.7%) rural residents. There were 25 (20.5%) tobacco smokers, nine (7.4%) alcohol consumers, and three (2.5%) smokeless tobacco users. Forty-five participants had ADRs and 54 ADR events had occurred, but none required change in treatment regimen. Sixteen (13.1%) reported loss of appetite followed by 10 (8.2%), flu-like symptoms, eight (6.6%) nausea, seven (5.7%) pain in joints, three (2.5%) abdomen pain, three (2.5%) headache, two (1.6%) itching and rash, one (0.8%) burning in hands and feet and one (0.8%) giddiness. Daily regimen ADR cases (36.9%) and events (44.3%) when comparatively higher than intermittent regimen (25.6%).Conclusions: The ADRs cases and events had occurred in higher proportion but were mild and hence did not require any regimen change.

Frequency and Severity of Adverse Drug Reactions to Medications Prescribed for Alzheimer's Disease in a Brazilian City: Cross-Sectional Study.

Background: There is lack of national studies that assess the risks associated with the drugs provided under the Brazilian public health system for treating Alzheimer’s disease. Then, this study determined the prevalence and severity of self-reported adverse drug reactions (ADRs) prescribed to patients with Alzheimer’s disease in the Brazilian public health system. Methods: A cross-sectional study was carried out based on public data from the MEDEX system (information on dispensing data, known as exceptional dispensing medications) and interviews with patients and/or caregivers who get access to Alzheimer’s drugs at a public pharmacy in a large Brazilian city, between July and September 2017, inquiring about ADRs and serious adverse events (SAEs). Results: The subjects were asked about ADRs and SAEs related to the use of donepezil, galantamine, rivastigmine and memantine. Out of 285 patients enrolled on the database, 250 participated in the study (87.7%). Among the participants, approximately 63.0% were female, 70.3% aged ≥75 years and 70.3% had comorbidities. Overall, 209 patients (83.6%) reported at least one ADR (total 1,149 ADRs) and rivastigmine was associated with the largest number of ADRs per patient (7.9 ADRs/patient). The predominant adverse effects were psychiatric disorders with common frequency (57.1%) and mild severity (89.0%). Six patients (2.4%) had SAEs that required hospitalization. The use of antipsychotics was the variable associated with ADR (OR = 4.95; 95% CI: 1.45–16.93; p = 0.011). Conclusion: There was a large number of reported ADRs and most of them were of common frequency and mild severity, being mainly related to psychiatric disorders. Considering the fragility of these patients, it is important to improve safety-related care in the use of drugs for treating this disease.

Impact of reported NSAID “allergies” on opioid use disorder in back pain

It is crucial to identify patients at highest risk for opioid use disorder (OUD) and to address challenges in reducing opioid use. Reported nonsteroidal anti-inflammatory drug (NSAID) allergies may predispose to use of stronger pain medications and potentially to OUD. We sought to investigate the clinical impact of reported NSAID allergy on OUD in patients with chronic back pain. We conducted a retrospective study of adults receiving care at a tertiary health care system from January 1, 2013, to December 31, 2018. Back pain and OUD were identified using administrative data algorithms. We used propensity score matching and logistic regression to estimate the impact of self-reported NSAID adverse drug reactions (ADRs) on risk of OUD, adjusting for other relevant clinical information. Of 47,114 patients with chronic back pain, 3,620 (7.7%) had a reported NSAID ADR. In an adjusted propensity score-matched analysis, patients with NSAID ADRs had higher odds (odds ratio, 1.34; 95% CI, 1.07-1.67) of developing OUD as compared with those without NSAID ADRs. Additional risk factors for OUD included younger age, male sex, Medicaid insurance, Medicare insurance, higher number of inpatient and outpatient visits in the previous year, and comorbid anxiety and depression. Patients with listed NSAID ADRs also had higher odds of a documented opioid prescription during the study period (odds ratio, 1.22; 95% CI, 1.11-1.34). Adults with chronic back pain and reported NSAID ADRs are at a higher risk of developing OUD and receiving opioid analgesics, even after accounting for comorbidities and health care utilization. Allergy evaluation is critical for potential delabeling of patients with reported NSAID allergies and chronic pain.

Study of self-reported adverse drug reactions and factors influencing it among human immunodeficiency virus/acquired immunodeficiency syndrome patients on antiretroviral therapy

Background: Human immunodeficiency virus (HIV) is the causative agent of acquired immunodeficiency syndrome (AIDS). HIV/AIDS is a significant worldwide medical issue. Patients on highly active antiretroviral therapy (HAART) generally encounter adverse drug reactions (ADRs). Various aspects of HAART such as adherence of the patient to the therapy, results of the therapy, and their treatment alternatives are considerably influenced by the presence of ADRs. Aim and Objectives: To estimate the commonly encountered self-reported ADRs among the patient on HAART, to know the various factors which influence the ADRs, the reasons behind missing ART doses and to know the relationship among ADRs and different factors to HAART. Materials and Methods: The present study was conducted in HIV/AIDS patients on HAART attending ART center at Raichur Institute of Medical Sciences, Raichur, after getting the ethical clearance. This was a cross-sectional, observational study conducted among the two hundred and seventy HIV/AIDS patients on HAART during the 12-month study period from December 2013 to November 2014. After obtaining the informed consent, the information pertaining to the sociodemographic profile of the patient, ADRs to HAART, and explanations behind missing ART dose were collected using a semi-structured interview questionnaire. The patient treatment record was used to collect the information regarding variables related to HAART and the laboratory values. Data were interpreted by applying descriptive analysis after collecting in Microsoft Excel sheet. The relationships of dependent variables to ADRs were determined by logistic regression analysis. Results: Of 270 enrolled patients, 135 (50%) patients aged less than 40 years, 190 (70.4%) were literate, 142 (52.6%) were male, and 194 (71.9%) were from rural background. Zidovudine based regimens 117 (43.3%) were the most commonly prescribed regimen in this study. The most frequently self-reported ADRs were burning sensation in stomach 40 (14.8%). The two most normal explanations behind missing ART dosages were simply forgot 35 (70%) trailed by ADRs 17 (34%) to HAART. Two variables were found to have a significant relationship to the self-reported ADRs on bivariate analysis. These were patients on HAART who aged more than or equal to 40 years (24.4%, P = 0.04) and when the duration of HAART was under 2 years (17.8%, P = 0.028). Conclusions: The most common self-reported ADR was a burning sensation in stomach. The ADR encounter was more common when the duration of HAART was lesser than 2 years. Aside from the age of the patient, no other sociodemographic variable has an impact on ADR occurrence. Therefore, it is the responsibility of the health care service providers to have the knowledge of frequently occurring ADRs and the factors influencing it to enhance the effectiveness of HAART.

Evaluation of adverse drug reactions associated with direct oral anticoagulants recorded in the Italian Pharmacovigilance Network database using a specifically developed risk index

The introduction into clinical practice of direct oral anticoagulants (DOAC) has widened the scenario in the prevention and treatment of thromboembolism. However, the evaluation of the balance between the thrombotic and hemorrhagic risks is a critical issue in the choice of an oral anticoagulant agent. The availability of safety and efficacy data for each drug represents the basis to operate treatment choices. As there are no head-to-head studies comparing the different DOACs in terms of safety and efficacy, and considering the differences in registrative trial designs and characteristics of enrolled populations, several meta-analyses and real-life studies have tried to trace the safety and efficacy profiles on DOACs, but at present no definitive conclusions can be drawn due to numerous existing biases. One possible aid to help clinicians in their treatment choice is the evaluation of self-reported adverse drug reactions (ADRs) available in drug regulatory agency databases such as the Italian Medicines Agency (AIFA) pharmacovigilance database. We conducted a search in the National Pharmacovigilance Network database, available on AIFA website, in order to retrieve all the ADRs related to oral anticoagulants occurred in the period 2016-2017. We then calculated an ADR risk index (RI) for each drug, where an RI =1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI <1 indicates a rate of ADR lower than the rate of market share (more safe DOAC). The results showed that rivaroxaban is the DOAC with the lowest RI among the four molecules available today in Italy. Despite the limitations of this study, we believe that ADR RI can be a valuable adjunctive tool to help clinicians in their everyday clinical practice.

Medication Allergy and Adverse Drug Reaction Documentation Discrepancies in an Urban, Academic Emergency Department.

Medication histories, including knowledge of allergies and adverse drug reactions (ADRs), are a nationally recognized quality measure. Medication histories in the emergency department (ED) are often inaccurate or incomplete. Our objective was to determine the prevalence and nature of medication allergy and ADR discrepancies in an urban ED. This was a prospective observational descriptive study, enrolling a convenience sample of adults over 7months at a single academic urban ED. Trained personnel recorded patient demographics and number of daily medications. Patients listed any prior drug allergies or non-allergic ADRs. Following the ED encounter, the patients' self-reported allergies and ADRs were compared to the electronic medical record (EMR) to identify and describe discrepancies. A sample of 1014 patients, predominantly black (81%), female (60%), and in the 18- to 59-year-old range (69%), was recruited. Most patients were taking at least one daily medication (74%). Three hundred fifteen patients reported at least one allergy (31%), and 252 (25%) at least one ADR. Four hundred sixteen patients (41%) had a discrepancy between their self-report of allergy or ADR and the EMR. Omissions were the most frequent discrepancy. Full descriptions of allergies or ADR were present in 18.4% of charts. Fifty-seven patients (5.6%) were administered a medication which could have interacted with a documented allergy or ADR; none of the allergy EMR records were updated to reflected this. In this cross-sectional ED study, drug allergies and ADRs were both highly prevalent. There were significant discrepancies in documentation of allergies and ADRs between patient self-report and the EMR.

Adverse reactions associated with first-line regimens in patient initiating antiretroviral therapy.

To evaluate the prevalence of adverse drug reactions (ADR) and associated factors during the use of Highly Active Antiretroviral Therapy (HAART) in patients initiating treatment. This is a cross-sectional analysis of a prospective study conducted in three public referral services specialized in HIV/AIDS care in Belo Horizonte, Brazil. Self-reported ADR and explanatory variables were obtained from face-to-face interview and from Information Systems. Associated factors with ADR were evaluated by logistic regression in SPSS software v.22. We included 399 patients, of which 85.5% reported at least one and 72.7% up to 5 ADRs after HAART initiation. Neurological reactions were the most frequent, with self-reported ADRs being distinct according to HAART regimen used. The global model showed higher chance of ADRs among females (OR = 3.52) and illicit drug users (OR = 2.28). Lower chance of ADRs was found for patients aged > 33years (OR = 0.37), DTG/TDF/3TC users (OR = 0.41), and higher physical domain of quality of life (OR = 0.78). The model restricted to patients using the single-tablet regimen EFV/TDF/3TC showed lower ADRs among patients with CD4+ T lymphocyte count > 200 cells/mm3 (OR = 0.23) and higher independence domain of quality of life (OR = 0.74). The model restricted to DTG/TDF/3TC and to other regimens showed lower ADRs with higher physical domain of quality of life (OR = 0.74 and OR = 0.55, respectively). The prevalence of self-reported ADRs to first-line antiretroviral regimens was high and patients using DTG/TDF/3TC had a smaller number of ADRs. In addition to HAART regimen, sociodemographic, clinical, and quality of life characteristics were associated with ADRs.

Corrigendum to "Self-Reported Adverse Drug Reactions, Medication Adherence, and Clinical Outcomes among Major Depressive Disorder Patients in Ethiopia: A Prospective Hospital Based Study".

[This corrects the article DOI: 10.1155/2017/5812817.].

Predicting the Need for Third-Line Antiretroviral Therapy by Identifying Patients at High Risk for Failing Second-Line Antiretroviral Therapy in South Africa.

Although third-line antiretroviral therapy (ART) is available in South Africa's public sector, its cost is substantially higher than first and second line. Identifying risk factors for failure on second-line treatment remains crucial to reduce the need for third-line drugs. We conducted a case–control study including 194 adult patients (≥18 years; 70 cases and 124 controls) who initiated second-line ART in Johannesburg, South Africa. Unconditional logistic regression was used to assess predictors of virologic failure (defined as 2 consecutive viral load measures ≥1000 copies/mL, ≥3 months after switching to second line). Variables included a social instability index, ART adherence, self-reported as well as diagnosed adverse drug reactions (ADRs), HIV disclosure, depression, and factors affecting access to HIV clinics. Overall 60.0% of cases and 54.0% of controls were female. Mean ages of cases and controls were 41.8 ± 9.6 and 43.3 ± 8.0, respectively. Virologic failure was predicted by ART adherence <90% [odds ratio (OR) 4.7; 95% confidence interval (95% CI): 2.1–10.5], younger age (<40 years of age; OR 0.6; 95% CI: 0.3–1.1), high social instability (OR 3.8; 95% CI: 1.30–11.5), self-reported ADR (OR 1.9; 95% CI: 1.0–3.5), disclosure to friends/colleagues rather than partner/relatives (OR 3.4; 95% CI: 1.3–9.1), and medium/high depression compared to low/no depression (OR 4.4; 95% CI: 1.5–13.4). Our results suggest complex socioeconomic factors contributing to risk of virologic failure, possibly by impacting ART adherence, among patients on second-line therapy in South Africa. Identifying patients with possible indicators of nonadherence could facilitate targeted interventions to reduce the risk of second-line treatment failure and mitigate the demand for third-line regimens.

Self-Reported Adverse Drug Reactions, Medication Adherence, and Clinical Outcomes among Major Depressive Disorder Patients in Ethiopia: A Prospective Hospital Based Study.

Background There is paucity of data on prevalence of Adverse Drug Reactions (ADRs) and adherence and clinical outcomes of antidepressants. The present study determined the magnitude of ADRs of antidepressants and their impact on the level of adherence and clinical outcome. Methods A prospective cross-sectional study was conducted among depression patients from September 2016 to January 2017 at Gondar University Hospital psychiatry clinic. The Naranjo ADR probability scale was employed to assess the ADRs. The rate of medication adherence was determined using Morisky Medication Adherence Measurement Scale-Eight. Results Two hundred seventeen patients participated in the study, more than half of them being males (122; 56.2%). More than one-half of the subjects had low adherence to their medications (124; 57.1%) and about 186 (85.7%) of the patients encountered ADR. The most common ADR was weight gain (29; 13.2%). More than one-half (125; 57.6%) of the respondents showed improved clinical outcome. Optimal level of medication adherence decreased the likelihood of poor clinical outcome by 56.8%. Conclusion ADRs were more prevalent. However, adherence to medications was very poor in the setup. Long duration of depression negatively affects the rate of adherence. In addition, adherence was found to influence the clinical outcome of depression patients.

Consumer reporting of adverse drug reactions: Systems that allow patients to report side effects of the drugs they are taking have yielded valuable information for improving drugs safety and health care.

Consumer reporting of adverse drug reactions: Systems that allow patients to report side effects of the drugs they are taking have yielded valuable information for improving drugs safety and health care.

Experiences relating to adverse drug reactions in the community: a cross-sectional survey among patients and the general public in Thailand

ABSTRACTObjective: To determine the frequency and characteristics of adverse drug reactions (ADRs), experiences of receiving and desire for information about medicines, and attitudes toward ADR knowledge and reporting among the community-dwelling Thai population.Methods: A cross-sectional self-administered survey conducted during October 2013 to December 2014 by convenience sampling. The study was conducted in three settings in the second-largest city, North-eastern Thailand: primary care units, community pharmacies and public areas.Results: Of 2400 respondents, 414 (17.3%) reported experiencing an ADR; two-thirds of which involved mild symptoms (66.7%) and 55.6% occurred within the last year. Self-reported ADR knowledge was low (4.1 ± 2.5 on a scale of 0 to 10). Pharmacists and physicians were the most common sources of information about medicines, but only 28.5% had received information about ADRs. Over 40% wanted information about ADRs and drug interactions, with healthcare professionals and information leaflets being desirable sources. The majority of individuals had positive views towards both receiving information and reporting their ADR experiences.Conclusions: To enable the Thai public to report their experiences of ADRs more effectively, they require more medicines information. Information leaflets should be more widely available, while healthcare professionals should provide more detailed information of ADRs.

Reporting patterns of adverse drug reactions over recent years in China: analysis from publications

Purpose: The goal of this study was to clarify the reporting patterns of self-reported adverse drug reactions (ADRs) in China.Methods: A variety of sources were searched, including the official website of China FDA, the national center for ADR monitoring center, publications from PubMed, and so on. We retrieved the relevant information and made descriptive and comparative analysis from the year 2009 to 2013.Results: The ADR reporting numbers were 638,996, 692,904, 852,799, 1,200,000 and 1,317,000 from 2009 to 2013, respectively. Healthcare professionals contributed significantly, and their proportion always exceeded 80% before 2012. The average report per million inhabitants has increased from 479 to 983 from 2009 to 2013. However, the proportion of new or serious report was always below 25%. The reports mainly concern anti-infective agents and traditional Chinese medicine (TCM), especially TCM injection. The proportion of ADR reports in geriatric patients has increased for 4 consecutive years.Conclusions: ADR report numbers and reporting rates in China are on the rise. However, the proportion of new or serious reports as well as the proportion of reports contributed by consumers and pharmaceutical companies are still quite low. More attention should be paid to the elderly, anti-infective agents and TCM, especially TCM injections.