What is known and objective: Under-reporting is a major drawback of a voluntary adverse drug reaction reporting system in pharmacovigilance. However, little is known about facilitators and barriers to ADR reporting by healthcare professionals (HCPs) in developing countries. To investigate factors associated with adverse drug reaction (ADR) reporting among HCPs in Vietnam. Methods: A cross-sectional survey of 2091 HCPs was conducted in 2015 at 10 hospitals throughout Vietnam. The binary outcome was ever reporting ADRs. Healthcare professionals knowledge, attitude and practice about ADR reporting were measured. Multiple logistic regression analyses examined factors significantly associated with ever ADR reporting. Results: Overall, 29.3%, 2.2% and 68.4% of the sample were doctors, pharmacists and nurses, respectively. More than half (59.3%) had ever reported any ADR. Facilitators for ADR reporting were educational training (OR = 1.77, 95%CI = 1.42-2.22) and having better knowledge, such as awareness of ADR reporting regulation (OR = 1.63, 95%CI = 1.19-2.21), of reporting time (OR = 1.76, 95%CI = 1.35-2.29) and of necessary information in reporting form (OR = 1.94, 95%CI = 1.53-2.45).Conversely, barriers to non-reporting were unknown of reporting procedure (OR = 0.27, 95%CI = 0.22-0.35), unavailability of reporting form (OR = 0.54, 95%CI = 0.42-0.68) and lack of time (OR = 0.59, 95%CI = 0.46-0.74). What is new and conclusion: Given the low ADR reporting rate among HCPs, educational interventions to improve their knowledge and attitude should be prioritized in Vietnam. Additional interventions addressing obstacles (i.e. availability and complexity of reporting form, lack of time) should be considered to improve both the quantity and quality of ADR reporting.

Objective Management of multidrug-resistant tuberculosis (MDR-TB) is a significant challenge to the global healthcare system due to the complexity and long duration of the MDR-TB treatment. This study analyzed the safety of patients on longer injectable-based MDR-TB treatment regimens using active pharmacovigilance data. Method We conducted an observational, prospective study based on active pharmacovigilance within the national TB program. A total of 659 MDR-TB patients were enrolled and followed up at 9 TB- hospitals in 9 provinces of all 3 regions in Vietnam between 2014 and 2016. Patients received a treatment regimen (standardized or individualized) based on their drug susceptibility test result and their treatment history. Baseline and follow-up information was collected at the start and during treatment. Adverse events (AE) were defined and classified as serious adverse events (SAEs) or otherwise. Multivariate Cox regression following the Iterative Bayesian Model Averaging algorithm was performed to identify factors associated with AE occurrence. Results Out of 659 patients assessed, 71.3% experienced at least one AE, and 17.5% suffered at least one SAE. The most common AEs were gastrointestinal disorders (38.5%), arthralgia (34.7%), and psychiatric disorders (30.0%). The proportion of patients with nephrotoxicity and hearing loss or vestibular disorders were 7.4% and 15.2%, respectively. 13.1% of patients required modifications or interruption of one or more drugs. In 77.7% of patients, treatment was completed successfully, while 9.3% lost to follow-up, in 3.0% treatment failed, and 7.4% died. Some significant risk factors for nephrotoxicity included diabetes mellitus (HR = 8.46 [1.91–37.42]), renal dysfunction (HR = 8.46 [1.91–37.42]), alcoholism (HR = 13.28 [5.04–34.99]), and a higher average daily dose of injectable drugs (HR = 1.28 [1.14–1.43]). Conclusion While a majority of patients on the longer injectable-based regimens experienced non-serious AEs during MDR-TB treatment, one in six patients experienced at least an SAE. Active TB drug-safety monitoring is useful to understand the safety of MDR-TB treatment and explore the risk factors for toxicity. All-oral, shorter MDR-TB regimens might be able to reduce the inconvenience, discomfort, and toxicity of such regimens and increase adherence and likelihood of successful completion.

Misconceptions and pressures have increased the sales of antibiotics without a prescription across countries. There are concerns with such practices in Vietnam given rising antimicrobial resistance rates. A national survey was conducted among 360 private drugstores located in nine provinces in Vietnam. Anonymous interviews were conducted with participants selected by convenience sampling. Subsequently, multivariable logistic regression analyses were undertaken evaluating the relationship between customer characteristics and antibiotic purchases. A total of 480 out of 1626 surveyed participants purchased antibiotics, 81.7% of which did not have a prescription, involving 29 different antibiotics. In 86.4% of these, participants were prescribed antibiotics by drug sellers. Most antibiotics were sold to treat respiratory tract infections (61.4%), with the ‘Access’ antibiotics (amoxicillin and cephalexin) being the most frequently sold. Only one-fifth of participants understood that they were breaking the law by purchasing antibiotics without a prescription. Participants purchasing antibiotics without a prescription had lower awareness concerning antibiotic laws and treatment duration (p < 0.05). Under 50% agreed to having a doctors’ prescription in the future when purchasing antibiotics. Freelancer occupation (OR = 0.52, 95% CI = 0.83–0.96) and a lower educational level (OR = 0.49, 95% CI = 0.25–0.96) were factors related to purchasing antibiotics without a prescription. Overall, we recommend increasing fines and monitoring of drugs stores, greater promotion of the family doctor system as well as increasing media and educational campaigns to limit self-purchasing of antibiotics in Vietnam and reduce resistance.

What Is Known and Objective Allopurinol, the first‐line medication for hyperuricemia is well‐known for its association with severe cutaneous adverse reactions, especially Stevens‐Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). In the current study, we analysed the Vietnamese spontaneous reporting database to identify signals and preventability of allopurinol‐induced SJS/TEN in Vietnam from 2010 to 2019. Methods Signal generation was assessed using the case/non‐case method. Reporting odds ratios (RORs) and 95% confidence intervals (95% CI) were calculated. Results Among 72,822 spontaneous ADR reports submitted to the Vietnam National Drug Information and Adverse Drug Reaction Monitoring Centre, 392 reports were on SJS/TEN, of which, 65 cases (16.6%) were related to allopurinol. The signals of allopurinol‐induced SJS/TEN in Vietnam started in 2014 (ROR of 3.531, 95% CI: 1.830–6.810) and annually increased until 2019 (ROR of 11.923, 95% CI: 8.508–16.710). The preventability assessment showed that no allopurinol‐induced SJS/TEN case was definitely unpreventable. 61.6% of the SJS/TEN cases were avoidable because they were associated with inappropriate prescribing such as unapproved indications, too high initial dose and even rechallenging in patients with a history of allopurinol allergy. What Is New and Conclusion The signals of allopurinol‐induced SJS/TEN in Vietnam started in 2014 and annually increased until 2019. Our first report specifically focusing on the ADR preventability of allopurinol showed that correction of medical errors relating to prescription could prevent more than 60% of SJS/TEN cases in Vietnamese allopurinol users. This is a feasible and practical solution, provided that there would be a systematic change in both healthcare systems and public awareness.