Background Improperly disposed medicines could adversely affect the environment and increase the risk of drug misuse or accidental poisoning. Objective To evaluate the disposal practices of unused and expired medicines among the general population in Bandung, Indonesia. Method This was a descriptive cross-sectional survey conducted among 497 respondents in Bandung, Indonesia. Data were collected through interviews using a prevalidated structured questionnaire. Descriptive statistics were calculated using the Statistical Package for Social Science (SPSS) version 23. Ethics approval was obtained. Main outcome measure General public knowledge and attitude regarding unused and expired medication disposal practice. Results Approximately 95% of the respondents had unused medicines stored in their homes, with nonsteroidal anti-inflammatory drugs (NSAIDs), vitamins/nutritional supplements, and antibiotics were the most common types of medicines left unused. The majority of the respondents checked the expiration date of the drugs before purchasing (72.8%). The most common disposal method of unwanted medicines was throwing away in household garbage (82.1%). A significant percentage of them never received information about proper medication disposal practice (79.5%). Furthermore, more than half of the respondents were unaware that unsafe medication disposal practices could harm the environment and population health (53.1%). Conclusion Disposal of unwanted pharmaceutical products through environmentally unsafe route was prevalent among the respondents. There is also a lack of awareness of the impact of improperly disposed of medicines for the ecosystem. These findings call upon the strategies to strengthen the pharmaceutical waste management program.

BackgroundThere is no consensus on the preferred method for defining the non-inferiority margin in non-inferiority trials, and previous studies showed that the rationale for its choice is often not reported. This study investigated how the non-inferiority margin is defined in the published literature, and whether its reporting has changed over time.MethodsA systematic PubMed search was conducted for all published randomized, double-blind, non-inferiority trials from January 1, 1966, to February 6, 2015. The primary outcome was the number of margins that were defined by methods other than the historical evidence of the active comparator. This was evaluated for a time trend. We also assessed the under-reporting of the methods of defining the margin as a secondary outcome, and whether this changed over time. Both outcomes were analyzed using a Poisson log-linear model. Predictors for better reporting of the methods, and the use of the fixed-margin method (one of the historical evidence methods) were also analyzed using logistic regression.ResultsTwo hundred seventy-three articles were included, which account for 273 non-inferiority margins. There was no statistically significant difference in the number of margins that were defined by other methods compared to those defined based on the historical evidence (ratio 2.17, 95% CI 0.86 to 5.82, p = 0.11), and this did not change over time. The number of margins for which methods were unreported was similar to those with reported methods (ratio 1.35, 95% CI 0.76 to 2.43, p = 0.31), with no change over time. The method of defining the margin was less often reported in journals with low-impact factors compared to journals with high-impact factors (OR 0.20; 95% CI 0.10 to 0.37, p < 0.0001). The publication of the FDA draft guidance in 2010 was associated with increased reporting of the fixed-margin method (after versus before 2010) (OR 3.54; 95% CI 1.12 to 13.35, p = 0.04).ConclusionsNon-inferiority margins are not commonly defined based on the historical evidence of the active comparator, and they are poorly reported. Authors, reviewers, and editors need to take notice of reporting this critical information to allow for better judgment of non-inferiority trials.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1859-x) contains supplementary material, which is available to authorized users.

Background Adverse drug reactions (ADRs) represent a major cause of iatrogenic morbidity and mortality in patient care. While a substantial body of work has been undertaken to characterise ADRs in the hospital setting, the overall burden of ADRs in the primary care remains unclear. Objectives To investigate the prevalence of ADRs in the primary care setting and factors affecting the heterogeneity of the estimates. Methods Studies were identified through searching of Medline, Embase, CINAHL and IPA databases. We included observational studies that reported information on the prevalence of ADRs in patients receiving primary care. Disease and treatment specific studies were excluded. Quality of the included studies were assessed using Smyth ADRs adapted scale. A random-effects model was used to calculate the pooled estimate. Potential source of heterogeneity, including age groups, ADRs definitions, ADRs detection methods, study setting, quality of the studies, and sample size, were investigated using sub-group analysis and meta-regression. Results Thirty-three studies with a total study population of 1,568,164 individuals were included. The pooled prevalence of ADRs in the primary care setting was 8.32% (95% CI, 7.82, 8.83). The percentage of preventable ADRs ranged from 12.35–37.96%, with the pooled estimate of 22.96% (95% CI, 7.82, 38.09). Cardiovascular system drugs were the most commonly implicated medication class. Methods of ADRs detection, age group, setting, and sample size contributed significantly to the heterogeneity of the estimates. Conclusion ADRs constitute a significant health problem in the primary care setting. Further research should focus on examining whether ADRs affect subsequent clinical outcomes, particularly in high-risk therapeutic areas. This information may better inform strategies to reduce the burden of ADRs in the primary care setting.

PurposeInvestigation of drug safety signals is one of the major tasks in pharmacovigilance. Among many potential signals identified, only a few reflect adverse drug reactions requiring regulatory actions, such as product information (PI) update. Limited information is available regarding the signal characteristics that might predict PI update following signal evaluation. The objective of this study was to identify signal characteristics associated with PI updates following signal evaluation by the European Medicines Agency Pharmacovigilance Risk Assessment Committee during 2012 to 2016.MethodsA comparative study was performed based on data from 172 safety signals. Characteristics of signals were extracted from the European Pharmacovigilance Issues Tracking Tool database. Multivariable logistic regression analysis was used to assess the relationship between signal characteristics and the decision to update the PI.ResultsMultivariable logistic regression analysis showed that the presence of evidence in multiple types of data sources (adjusted odds ratio [OR] 7.8 95% CI [1.5, 40.1]); mechanistic plausibility of the drug‐event association (adjusted OR 3.9 95% CI [1.9, 8.0]); seriousness of the event (adjusted OR 4.2 95% CI [1.3, 13.9]); and age of drugs ≤5 years (adjusted OR 3.9 95% CI [1.2, 12.7]) were associated with the decision to change the PI (P < 0.05).ConclusionsThis study identified 4 characteristics of drug safety signals that have shown to be associated with PI changes as outcome of signal evaluation. These characteristics may be used as criteria for selection and prioritization of potential signals that are more likely to necessitate product information updates.

BackgroundThe geriatric population is particularly vulnerable to being prescribed potentially inappropriate medication (PIM); however, the prevalence of this occurrence remains poorly investigated in Indonesia. Thus in this research, we focused on investigating the prevalence and predictors of PIM among the Indonesian geriatric population in a primary health care setting.MethodsA retrospective observational study was conducted in 25 primary health care facilities in Karawang District, Indonesia. The medical prescriptions of patients aged ≥60 years during January–December 2014 were documented, and the PIM was assessed based on Beers and McLeod criteria. The influence of age, sex, number of diseases, and polypharmacy toward PIM was assessed using a logistic regression model. A P-value of <0.05 defined statistical significance.ResultsA total of 3,819 subjects were included in the study. PIM was highly prevalent (52.2%) among the Indonesian elderly. Chlorpheniramine, mefenamic acid, ibuprofen, and nifedipine were the most commonly prescribed PIM. Polypharmacy (odds ratio: 1.2 [0.6, 2.1]) was the only factor associated with the use of PIM, while sex, age, and multiple diseases did not show significant association.ConclusionPIM is a concern in the Indonesian geriatric population. Health care professionals are encouraged to review the medications of their geriatric patients using updated safety guidelines to prevent risks associated with PIM.

Background and Objectives:Evaluation of health-related quality of life (HRQoL) among tuberculosis (TB) patients could improve understanding about the burden associated with the diseases. There is a paucity of research regarding evaluation of HRQoL among TB population in Indonesia. This study aimed to investigate HRQoL among TB patients in Ciamis, Indonesia.Methods:This was a cross-sectional study conducted at one primary health-care facility in Ciamis, Indonesia. HRQoL was measured using the World Health Organization (WHO) QoL-BREF instrument which covers assessment on physical, psychological, social relationship, and environmental health domains. Multiple regression analysis was used to investigate the association between domain scores with demographic factors of the participants such as age, sex, education years, and types of treatment. Statistical analysis was conducted using SPSS software version 21.Results:Eighty-one participants were recruited in the present study. The total mean score for all domains was 45.35 (±23.3). The mean scores for physical, physiological, social relationship, and environmental health domains were 20.5 (±9.9), 76.4 (±11.9), 36.9 (±9.2), and 46.9 (±10.4), respectively. Education years were significantly associated with improved HRQoL in environmental health domain (P < 0.05).Conclusion:TB had remarkable negative impacts on patients HRQoL, with physical domain was the most affected. This finding calls upon strategies addressing HRQoL problems in the management of TB patients.

BackgroundRational drug use is a critical component in patient care, particularly among the elderly who often have multiple medical problems. The aim of this study was to assess the pattern of medication use among the elderly visiting primary health care facilities.MethodsA retrospective cross-sectional study was conducted at 25 primary health care facilities in Karawang District, Indonesia, and patients aged ≥60 years visiting the facilities from January to December 2014 were included. A systematic random sampling technique was used to select the study samples. Each prescription was assessed using the WHO prescribing indicators.ResultsA total of 10,118 prescriptions with 31,927 drugs were assessed. The average number of drugs prescribed was 3.15 (range: 1–7). Drugs prescribed by generic name comprised 98.09% (n=31,318) of the total number of drugs. Medical appointments wherein an antibiotic was prescribed constituted 23.45% (n=2373) of the total number of prescriptions. No injections were prescribed in this study setting. Drugs prescribed from the essential drug list comprised 83.07% (n=26,522). Paracetamol (13.44%), vitamin B complex (8.05%), and aluminum–magnesium hydroxide (7%) were the most frequently prescribed drugs, whereas amoxicillin (44.03%), chloramphenicol (13.10%), and ciprofloxacin (12.00%) were the most frequently prescribed antibiotics.ConclusionOur findings highlight that polypharmacy and prescription of essential drugs remain subjects of concern in geriatric health care. Regular medication review and promoting the use of the essential drug list among health care professionals are encouraged in primary care settings.

Background Alternative tobacco and nicotine products such as electronic cigarettes (EC), smokeless tobacco, and nicotine replacement therapy (NRT) are currently being assessed as options in tobacco harm reduction due to their potential role in smoking reduction and smoking cessation. Objective To provide the current evidence on the effectiveness and safety of various alternative tobacco and nicotine products for smoking reduction and cessation. Methods A systematic review using databases from MEDLINE (PubMed), EMBASE, and The Cochrane Library was conducted up to December 2020 to identify eligible experimental and observational studies assessing the use of alternative tobacco and nicotine products on smoking reduction and smoking cessation and the safety of these products. The Cochrane Risk of Bias 2 (RoB 2) and ROBINS-I tools were used to assess the risk of bias of the included studies. Results were described through a narrative synthesis of the evidence. Results From 1955 retrieved references, 44 studies (31 randomized controlled trials/RCTs and 13 prospective cohort studies) met the inclusion criteria and were included in the review. Twenty-nine studies were assessing EC, one study evaluated heat-not-burn (HNB) product, five studies were focused on snus, and nine studies assessed NRT in the form of nicotine patch, gum, etc. The overall results suggested that alternative tobacco and nicotine products in the form of EC, snus, and NRT can moderately reduce daily cigarette consumption and has potential to assist smoking cessation attempts, with fewer adverse events. Conclusion The findings suggested that alternative tobacco and nicotine products have a potential role in assisting smoking reduction and cessation, highlighting their role in the tobacco harm reduction approach. Further studies should focus on investigating long-term outcomes, safety, and effectiveness of alternative tobacco and nicotine products to better inform smoking reduction/cessation policy. PROSPERO Registration Number CRD42020205830.