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BACKGROUND: Adverse drug reactions (ADRs) represent a significant barrier to achieve optimal treatment outcomes. Cardiovascular drugs, including antihypertensive drugs, lipid-lowering drugs, and antithrombotic drugs, are among the most prescribed medications in the primary care setting. OBJECTIVES: To estimate the prevalence of cardiovascular drug-related ADRs consultations in United Kingdom (UK) primary care and identify risk factors of these ADRs. METHODS: This was a cross-sectional study of cardiovascular drug users between 2000-2019 using UK IQVIA Medical Research Data. ADRs consultations were identified using database screening method employing standardised designated codes. The overall and annual age-standardised prevalence was estimated using direct standardisation method using 2019 mid-year UK population. Risk factors of ADRs consultations were estimated using logistic regression model stratified by therapeutic areas. RESULTS: The standardised prevalence of consultations related to cardiovascular drugs ADRs was 10.60 (95% CI. 10.46, 10.75) per 1000 patients. Patients aged 70-79 years had the highest occurrence of ADRs consultations. The most frequently drug classes implicated in the ADRs consultations were statins (n = 9,993 events, 27.09%), beta-blockers (n = 8,538 events, 23.15%), ACEIs/ARBs (n = 8,345 events, 22.62%), and aspirin (n = 6,482 events, 17.57%). Risk factors of ADRs consultations were previous history of cardiovascular diseases, e.g., myocardial infarction and stroke; advanced age, comorbidities; diabetes and dyslipidaemia; and polypharmacy. CONCLUSIONS: The burden of cardiovascular drug-related ADRs consultations in primary care was considerable. Statins, beta-blockers, ACEIs/ARBs, and aspirin were the most frequently implicated drug classes. Closer clinical monitoring should be performed for patients affected by the ADRs to mitigate the risk of suboptimal treatment outcomes.

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BACKGROUND: Adverse drug reaction (ADR) related to angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) may negatively affect patients' treatment outcomes. AIM: To investigate the impact of ACEIs/ARBs-related ADR consultation on cardiovascular disease (CVD) events and all-cause mortality. DESIGN AND SETTING: Propensity score-matched cohort study of ACEIs/ARBs between 2004 and 2019 using UK IQVIA medical research data. METHOD: ADR consultations were identified using standardised designated codes. Propensity scores were calculated based on comorbidities, concomitant medications, frailty, and polypharmacy. Cox's proportional hazard regression model was used to compare the outcomes between patients in ADR and non-ADR groups. In the secondary analysis, treatment- pattern changes following the ADR were examined and the subsequent outcomes were compared. RESULTS: Among 1 471 906 eligible users of ACEIs/ARBs, 13 652 (0.93%) patients had ACEIs/ARBs- related ADR consultation in primary care. Patients with ACEIs/ARBs-related ADR consultation had an increased risk of subsequent CVD events and all- cause mortality in both primary prevention (CVD events: adjusted hazard ratio [aHR] 1.22, 95% confidence interval [CI] = 1.05 to 1.43; all-cause mortality: aHR 1.14, 95% CI = 1.01 to 1.27) and secondary prevention cohorts (CVD events: aHR 1.13, 95% CI = 1.05 to 1.21; all-cause mortality: aHR 1.15, 95% CI = 1.09 to 1.21). Half (50.19%) of patients with ADR continued to use ACEIs/ARBs, and these patients had a reduced risk of mortality (aHR 0.88, 95% CI = 0.82 to 0.95) compared with those who discontinued using ACEIs/ARBs. CONCLUSION: This study provides information on the burden of ADR on patients and the health system. The findings call for additional monitoring and treatment strategies for patients affected by ADR to mitigate the risks of adverse clinical outcomes.

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Introduction: Digital health technology (DHT) has the potential to enhance remote health care delivery. However, little is known about the effectiveness of DHTs and factors that contribute to the limited uptake of DHTs in low- and middle-income countries (LMICs). Therefore, the objective of this study was to systematically review the effectiveness and evaluation process concerning the use of DHTs in pharmaceutical care in LMICs. Methods: A literature search on PubMed and Embase was conducted to identify experimental, descriptive, qualitative, and mixed-method studies that focused on the use of DHTs in pharmaceutical care as the main intervention, reported on the effects and/or the process of the DHT intervention, were performed by pharmacists, were conducted in LMICs, and had been published in English. Two reviewers independently conducted the study selection process. A qualitative narrative review of the effectiveness of using DHTs was conducted evaluating the population, intervention, comparators, and outcomes. We summarized the content and identified themes of the evaluation process under two categories-challenges and opportunities. Results: The search produced 589 studies, of which 16 met the eligibility criteria. The most common type of DHT was mobile health application (mHealth app; n = 8), followed by mobile phone call (n = 6) and mobile video call (n = 2). Eight studies assessed the effectiveness of using DHTs in pharmaceutical care. mHealth app, mobile phone call, mobile video call, text messages, home telemonitoring, and internet-based drug information centers improved some health-related outcomes. Two of these eight studies, however, did not find significant effects of a phone call or an mHealth app on certain health-related outcomes. Of the seven quantitative studies conducting a process evaluation, all showed that patients were satisfied with the use of DHTs in pharmaceutical care provided by pharmacists. Of the two mixed-methods and one qualitative study assessing the process evaluation concerning DHT usage, three distinct themes of challenges (patient-, DHT-, and health care system-related challenges) and opportunities (patient-, DHT-, and pharmacist-related opportunities) were identified. Conclusions: DHT is a promising approach in pharmaceutical care toward improving health-related outcomes in LMICs, despite the variable intervention effects. The challenges and opportunities identified are important considerations when developing and implementing DHTs in pharmaceutical care in LMICs.

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AIMS: To investigate the risk of cardiovascular disease (CVD) events and all-cause mortality in patients with statin-related adverse drug reaction (ADR) consultation in primary care and examine whether different treatments following the ADR affect subsequent outcomes. METHODS: This was a retrospective cohort study of statin users between 2004 and 2019 using IQVIA Medical Research Data (formally known as the THIN database). Patients with statin-related ADR consultation were matched by propensity score (1:1) to statin users without ADR consultation based on demographics, comorbidities and concomitant medication. Cox proportional hazard regression was used to compare the risk of subsequent CVD event and all-cause mortality, stratified by history of CVD. In the secondary analysis among patients with statin-related ADR, treatment changes within a 1-year period following the ADR were examined and the outcomes were compared between different treatment groups. RESULTS: Among 1 564 687 statin users, 19 035 (1.22%) had a statin-related ADR consultation in primary care. The mean (standard deviation) follow-up time was 6.32 (3.74) years and 5.31 (3.83) years for CVD primary and secondary prevention cohorts, respectively. Statin-related ADR consultation was associated with subsequent CVD events in both cohorts (adjusted hazard ratio [HR] of 1.39 [95% CI 1.23, 1.57] and 1.34 [95% CI 1.25,1.42], respectively). In the secondary analysis among patients with statin-related ADR consultation, we found that (i) continued statin prescription or combination of any statin with additional lipid-lowering treatment (LLT) and (ii) other LLT only were associated with lower risks of CVD event (adjusted HR 0.71 [95% CI 0.64, 0.78] and 0.75 [95% CI 0.62, 0.92], respectively) and all-cause mortality (adjusted HR 0.46 [95% CI 0.42, 0.50] and 0.52 [95% CI, 0.43, 0.64], respectively), compared to discontinuation of all LLT. CONCLUSION: Statin-related ADR was associated with an increased risk of subsequent CVD event, indicating that these patients should be monitored more closely. Continued lipid-lowering medication is of importance to protect against CVD events and mortality.

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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.

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Introduction: Disposal of unused medications through environmentally unsafe routes is common in Indonesia. The lack of awareness of the impact of improperly disposed of medications is a significant contributing factor. The objectives of this study were to identify factors associated with lack of awareness of the impact of improperly disposed of unused medications and to assess the associations of awareness with medication disposal practices among the general population in Indonesia. Patients and methods: An observational cross-sectional survey was conducted using nonprobability sampling in Bandung, Indonesia, from November 2017 to January 2018 among respondents who were older than 18 years, had used any medication in the past, were literate, and had signed an informed consent document. Disposal practices and awareness regarding the impact of improperly disposed of unused medications were collected using an online- and a paper-based pre-validated questionnaire. The paper-based questionnaires were distributed to respondents in public places such as city center, markets, and religious places. Binary logistic regression was performed to assess associations of sociodemographic and other related factors with a lack of awareness. Odds ratios (ORs) with 95% confidence intervals (CIs) are reported. Results: Of 497 participating respondents, 433 and 64 respondents filled an online- or a paper-based questionnaire, respectively. Most respondents were female, aged between 18 and 30 years, and students/university students. Of 497 respondents, more than half (53.1%) were not aware that improper medication disposal could harm the environment and population health. Most respondents (79.5%) had never received information about proper medication disposal practices. The education level, the number of stored medications at home, and previous education about medication disposal practices were significantly associated with awareness of proper practices. In the multivariate analysis, only those with previous education about medication disposal practices were less likely to report a lack of awareness (OR: 0.043; 95% CI: 0.02-0.09). Respondents with a lack of awareness tended to dispose of their unused medications in the garbage or shared them with friends or relatives. Conclusion: There is a clear need to increase awareness of the importance of proper medication disposal practices, in particular among the student population of Bandung city, Indonesia. Healthcare providers can play an important role by educating this specific population on the proper disposal of unused medications.

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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.

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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.

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Background: Evidence on costs and health benefits of pneumococcal conjugate vaccine (PCV) for children in Asian countries is limited but growing. As a region with a considerably high burden of pneumococcal disease, it is prominent to have a comprehensive overview on the cost-effectiveness of implementing and adopting a PCV vaccination program. Methods: We conducted a systematic review from Pubmed and Embase to identify economic evaluation studies of PCV for children in Asian countries up to May 2020. Data extraction included specific characteristics of the study, input parameters, cost elements, cost-effectiveness results, and key drivers of uncertainty. The Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) statement was followed for this systematic review. The reporting quality of the included studies was evaluated using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Results: After the screening process on both the title and abstract and full text of 518 records, a total of 25 studies fulfilled the inclusion criteria, and were included in the review. The majority of included studies demonstrates that PCV for children is cost-effective in most of the Asian region, and even cost-saving in some countries. Most of the included studies implemented cost utility analysis (CUA) using either quality-adjusted life years (QALYs) or disability-adjusted life years (DALYs). Overall, the main drivers affecting the cost effectiveness were vaccine price, burden regarding pneumonia-related parameters, and the inclusion of herd effects. Conclusion: The children pneumococcal vaccination program appears to be a cost-effective intervention in Asia, and even cost-saving in certain conditions. Vaccine price, pneumonia-related disease burden, and the inclusion of the herd effect are observed as important key drivers in estimating cost-effectiveness in this region. Incorporating PCV in vaccination programs in this region was found to be highly favorable.

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BACKGROUND: Rational 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. METHODS: A 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. RESULTS: A 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. CONCLUSION: Our 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.

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BACKGROUND: The 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. METHODS: A 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. RESULTS: A 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. CONCLUSION: PIM 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.

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PURPOSE: Investigation 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. METHODS: A 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. RESULTS: Multivariable 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). CONCLUSIONS: This 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.

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BACKGROUND: There 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. METHODS: A 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. RESULTS: Two 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). CONCLUSIONS: Non-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.

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