METHODS: Four attributes (ie, the scientific proof of effectiveness, the scientific proof of safety, the source of recommendation, and cost) were identified from a systematic review and focus group interviews. They were used to develop a DCE questionnaire. Consumers at community pharmacies in Malaysia were asked to respond to 8 DCE choice sets. A conditional logit model was employed to obtain the relative importance of each attribute and to estimate respondents' WTP for nutraceuticals.
RESULTS: A total of 111 valid responses were analyzed. A negative constant term in the developed model indicated that generally the respondents preferred not to use nutraceuticals before they considered the study attributes. The respondents preferred nutraceuticals with no side effect, clear evidence of effectiveness, and recommendation of a healthcare professional. The respondents were willing to pay $252/month more for nutraceuticals proven with no side effect than for those without proof of safety, and $102/month more for nutraceuticals proven with clear effectiveness than for those without proof of effectiveness.
CONCLUSIONS: Consumers weighed relatively high on the availability of safety and effectiveness proofs when they chose nutraceuticals. The study highlights on the crucial need to inform consumers using clinical evidences of nutraceuticals as the information is highly preferred by consumers.
METHODS: Using a cross-sectional design and convenient sampling, data were collected in public areas within Kuala Lumpur, Malaysia, via face-to-face interview with a structured questionnaire. Multivariate logistic regression analysis was used to identify the significant predictors of patients' confidence in ADR reporting.
RESULTS: Out of 860 consented respondents achieving a response rate of 73.5%, only 69 (8%) were aware of the Malaysian ADR monitoring system. The majority (60%) of the respondents indicated they had the confidence to report ADRs. Multivariate logistic regression analysis revealed that ease in completing the ADR reporting form was the strongest variable predictive of confidence to report ADRs (odds ratio [OR], 18.45; 95% confidence interval [CI], 10.55-32.25). Increased confidence in ADR reporting was also associated with education level. Respondents with a higher education level were more likely to be confident to report ADRs compared to those with primary or no formal education (OR, 2.49; 95% CI, 0.77-8.1).
CONCLUSIONS: Lack of awareness of the ADR monitoring system is still prevalent among Malaysian patients. The ease of completing the ADR form and education level are predictive of patient confidence to report ADRs. These factors should be considered in designing public promotional activities to encourage patient contributions to pharmacovigilance.
Methods: A systematic search was conducted in PubMed, Web of Science, Google Scholar, Scopus and Nepal Journal Online (NepJOL) databases. 'Adverse Drug Reactions' or 'ADRs' or 'ADR' or 'Adverse drug reaction' or 'AE' or 'Adverse Event' or 'Drug-Induced Reaction' or 'Pharmacovigilance' or 'PV' and 'Nepal'. The search covered 15 years (January 2004 to December 2018) of study on ADRs and PV in Nepal. Only articles retrieved from databases were included, whereas published/unpublished drug bulletins, pharmacy newsletters and thesis were excluded. The articles thus retrieved were recorded, and thereafter analyzed. Word count code was used for the analysis of keywords used in the retrieved articles.
Results: A total of 124 articles were retrieved, with the highest rate of publications in 2006 and 2007, with 16 papers each. Among the articles, 10 (8.1%) were published in Kathmandu University Medical Journal (KUMJ). Single papers were published in 38 different journals. Brief reports (1.6%), case reports (31.2%), case series (0.8%), education forums (0.8%), letters to the editor (5.6%), original research articles (41.9%), review articles (9.7%), short communications and short reports (8.1%) on ADRs and PV were recorded. Out of 124 papers, 52 (41.9%) were original research publications. The majority (74.1%) of research was done in the category of ADR incidence, types, prevention, and management, followed by policy and suggestions for strengthening national and regional pharmacovigilance centers of Nepal (14.5%).
Conclusions: During the study years, there was an increase in scientific publications on drug safety. A total of 124 published articles were found during bibliometric analysis of ADRs and PV research activities in Nepal.
Methods: The development of the model involved a systematic review of the literature using PubMed and Embase databases. Studies reporting the risk factors associated with ADE-related ED visits were included. The methodological qualities of the included studies were assessed using the Mixed Methods Appraisal Tool (MMAT). The model was mapped and validated using face and content validity by an expert panel. Deficiencies and targeted interventions were identified, and steps for the design and implementation were recommended.
Results: The literature search generated 1361 articles, of which 38 were included in the review; 41 risk factors associated with ADE-related ED visits were identified. All factors were mapped, and the model was validated through face and content validity. The model consisted of six concepts related to sociodemographic factors, clinical factors, ADE-related to ED visits, ADE while in the ED, outcomes, and consequences. Interventions could be targeted at the factors identified in each concept to prevent ADE-related ED burden.
Conclusion: A conceptual model to guide the successful design and implementation of strategies to prevent ADE-related ED visits and the occurrence of ADE at ED was developed. Clinicians should take these factors into consideration to prevent untoward events, especially when treating high-risk patients.
METHODS: Children enrolled in the TREAT Asia Pediatric HIV Observational Database who had SM (weight-for-height or body mass index-for-age Z score less than -3) at ART initiation were analyzed. Generalized estimating equations were used to investigate poor weight recovery (weight-for-age Z score less than -3) and poor CD4% recovery (CD4% <25), and competing risk regression was used to analyze mortality and toxicity-associated treatment modification.
RESULTS: Three hundred fifty-five (11.9%) of 2993 children starting ART had SM. Their median weight-for-age Z score increased from -5.6 at ART initiation to -2.3 after 36 months. Not using trimethoprim-sulfamethoxazole prophylaxis at baseline was associated with poor weight recovery [odds ratio: 2.49 vs. using; 95% confidence interval (CI): 1.66-3.74; P < 0.001]. Median CD4% increased from 3.0 at ART initiation to 27.2 after 36 months, and 56 (15.3%) children died during follow-up. More profound SM was associated with poor CD4% recovery (odds ratio: 1.78 for Z score less than -4.5 vs. -3.5 to less than -3.0; 95% CI: 1.08-2.92; P = 0.023) and mortality (hazard ratio: 2.57 for Z score less than -4.5 vs. -3.5 to less than -3.0; 95% CI: 1.24-5.33; P = 0.011). Twenty-two toxicity-associated ART modifications occurred at a rate of 2.4 per 100 patient-years, and rates did not differ by malnutrition severity.
CONCLUSION: Trimethoprim-sulfamethoxazole prophylaxis is important for the recovery of weight-for-age in severely malnourished children starting ART. The extent of SM does not impede weight-for-age recovery or antiretroviral tolerability, but CD4% response is compromised in children with a very low weight-for-height/body mass index-for-age Z score, which may contribute to their high rate of mortality.
METHODS: This is a nationwide retrospective audit on the documentation of Dabigatran Prescribing and Dispensing Checklist for a period of two years from January 2013 till December 2014. Data from these Dabigatran Checklists (indication, dose, duration, renal function and adverse drug reactions encountered) were extracted by the pharmacist at MOH healthcare facilities.
RESULTS: A total of 52 out of 56 (92.9%) of MOH facilities complied to usage of checklist at their centres involving a total of 582 patients of which 569 (97.7%) patients were initiated on dabigatran for the approved indications. The recommended dose of dabigatran was used correctly in 501 (99.6%) of patients. Reason for switching to DOACs use was only documented in 76.7% (131/171) of patients. The most common reason for switching from warfarin was poor INR control (n=39), history of bleeding/overwarfarinisation (n=22) and unable to attend regular INR clinic (n=21). There were 75 cases of adverse events reported. The most common adverse event reported were abdominal discomfort (n=10) followed by gum bleeding (n=9) and dizziness (n=5).
CONCLUSIONS: Compliance to the dabigatran check list was high with 70% of patients prescribed the appropriate dosing.
Methods: This cross-sectional study was conducted via retrospective review of outpatients' medical records. Details regarding ADRs were identified by a pharmacist and verified by a consultant respiratory physician.
Results: A total of 91 cases, out of 210 patients enrolled in this study, were detected with 75 patients (35.7%) experienced at least one ADR. The three most common ADRs detected were cutaneous adverse drug reactions (CADRs) (21.0%), drug-induced hepatitis (DIH) (7.1%) and gastrointestinal disturbance (4.8%). Pyrazinamide was the most common causative agent and 15.7% of all TB patients required treatment modification due to ADRs. Females were shown to have a higher tendency to develop ADRs than the males in this study (P = 0.009). The development of ADRs was shown not to affect the TB treatment outcomes (P = 0.955).
Conclusion: The incidence of ADRs in this study was high so it is important to identify the risk factors for ADRs and the individuals who have those risk factors when initiating anti-TB drugs. These individuals require special attention when anti-TB drugs are initiated.