METHODS: A cross-sectional study involving members of the Malaysian public was carried out using the convenience sampling method. Descriptive statistics were used to summarise the socio-demographic characteristics of the respondents. Associations between knowledge items/scores and other items were assessed using Spearman's rank correlations and Cramer's V. Regression analyses were carried out to determine whether the socio-demographic characteristics of the respondents influenced knowledge and practice relating to unregistered medications.
KEY FINDINGS: A total of 649 respondents completed the questionnaire with the majority being female (66.1%), unmarried (66.5%), Malay (52.5%) and possessing a bachelor's degree (53.5%). The knowledge of the public surveyed regarding unregistered (unlicensed) medications was lacking, especially in being able to identify a registered health product in Malaysia and formally complaining if necessary. The respondents agreed that currently, there are insufficient laws and educational programmes to tackle the issue. The respondents exhibited good practice habits by purchasing their medications from healthcare professionals. Mean knowledge score was positively correlated to practice scores at rs = 0.423 (P-value
METHODS: A cross-sectional questionnaire-based survey was employed, and a convenience sampling was opted to collect the data among physicians, pharmacists and nurses working in tertiary care public hospitals of Lahore, Pakistan from September 2018 to January 2019.
RESULTS: Of the 384 questionnaires distributed, 346 health care professionals responded to the questionnaire (90.10% response rate). Most participants had good knowledge about ADR reporting, but pharmacist had comparatively better knowledge than other HCPs regarding ADR (89.18%) pharmacovigilance system (81.08%), its centres (72.97%) and function (91.89%). Most of the participants exhibited positive attitude regarding ADR reporting, such as 49.1% of physicians (P
Methods: Four electronic databases including Embase, Medline (via Ovid), Scopus and Google Scholar were searched from inception until October 2019 to identify the studies reporting fentanyl related deaths. Two independent reviewers screened and selected the titles and then evaluated the full texts. Only case studies and case series were included. A structured data extraction tool was used to extract data on the number of deaths, routes of administration, concomitant drug use and toxicological data. The Joanna Briggs Institute quality assessment tool was used to evaluate the quality of included studies. Data were synthesized narratively.
Results: Of 1251 articles identified during initial search, 8 case reports and 9 case series met the inclusion criteria. A total of 1969 deaths were reported in the included studies. Deaths were concentrated in the north American region (n = 1946) and the Nordic region (n = 22). Reported causes of death included fentanyl overdose (n = 321, 56.4%), mixed drug toxicity (n = 196, 34.5%), natural (n = 28, 4.9%), other drug toxicity (n = 10, 1.8%), fentanyl and ethanol intoxication (n = 8, 1.4%), incidental (n = 5, <1%) and aspiration (n = 1). Most common routes of use were intravenous (70.5%) and transdermal routes (23.0%). Deaths came swiftly via the intravenous route. Mean level of blood fentanyl amongst all reported deaths was 0.024 µg/mL.
Conclusion: Literature related to fentanyl-associated deaths predominantly come from North America. Deaths are comparatively lower or not reported in peer-reviewed publications from the rest of the world. Abuse through intravenous administration, mixed drug toxicities and self-treatment of breakthrough pain are mainly responsible for majority of the reported deaths.
Methods: A cross-sectional, questionnaire-based study was conducted among 103 pharmacists from 74 different community pharmacies to assess their knowledge about the use of herbal medicines and its adverse drug reaction reporting by using a pre-validate knowledge questionnaire consisting of 12 questions related to it. The pharmacists' responses were measured at a 3-point Likert scale (Poor=1, Moderate=2, and Good=3) and data was entered in SPSS version 22. The minimum and maximum possible scores for knowledge questionnaires were 12 and 36 respectively. Quantitative data was analyzed by using One Way ANOVA and Paired t-test whereas Chi-square and Fisher exact test were used for qualitative data analysis. A p-value of less than 0.05 was considered statistically significant for all the analyses.
Results: About 92% of the pharmacist had good knowledge regarding the use of herbal medicines and its adverse drug reaction reporting with a mean knowledge score of 32.88±3.16. One-way ANOVA determined a significant difference of employment setting (p<0.043) and years of experience (<0.008) with mean knowledge scores of Pharmacists. Pharmacists' knowledge was significantly associated with their years of experience with the Chi-square test.
Conclusion: Pharmacists exhibit good knowledge regarding the use of herbal medicines and its adverse drug reaction reporting. However, with an increasing trend of herbal medicine use and its adverse drug reaction reporting it recalls the empowerment of experienced pharmacists with training programs in this area for better clinical outcomes.
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.
METHODS: A cross-sectional study was conducted using a validated self-administered questionnaire. A convenience sample of 147 community pharmacists working in community pharmacies in Riyadh, Saudi Arabia.
RESULTS: The questionnaire was distributed to 147 pharmacists, of whom 104 responded to the survey, a 70.7% response rate. The mean age of participants was 29 years. The majority (n = 101, 98.1%) had graduated with a bachelorette degree and worked in chain pharmacies (n = 68, 66.7%). Only 23 (22.1%) said they were familiar with the ADR reporting process, and only 21 (20.2%) knew that pharmacists can submit ADR reports online. The majority of the participants (n = 90, 86.5%) had never reported ADRs. Reasons for not reporting ADRs most importantly included lack of awareness about the method of reporting (n = 22, 45.9%), misconception that reporting ADRs is the duty of physician and hospital pharmacist (n = 8, 16.6%) and ADRs in community pharmacies are simple and should not be reported (n = 8, 16.6%). The most common approach perceived by community pharmacists for managing patients suffering from ADRs was to refer him/her to a physician (n = 80, 76.9%).
CONCLUSION: The majority of community pharmacists in Riyadh have poor knowledge of the ADR reporting process. Pharmacovigilance authorities should take necessary steps to urgently design interventional programs in order to increase the knowledge and awareness of pharmacists regarding the ADR reporting process.
SETTING: The study was conducted at a tertiary hospital in the northern region of Peninsular Malaysia. Methods Action research methodology was used.
MAIN OUTCOME MEASURE: Pharmaceutical care issues.
RESULTS: The prevalence of diabetes mellitus among newly diagnosed tuberculosis patients was 15% (53/352). Out of 53 patients identified, 35 participated in the study. Patients' ages ranged between 29 and 73 years (mean of 52 ± 10 years). The male: female ratio was 1.7:1. Pharmaceutical care issues identified by pharmacists were nonadherence, uncontrolled diabetes mellitus, adverse drug reactions and individual patient's medication related problems. Pharmacists were able to intervene and resolve some of the pharmaceutical care issues.
CONCLUSION: Pharmacists played an important role in integrating the provision of care for tuberculosis and diabetes mellitus by providing individualised pharmaceutical care management. There still remains a need to address logistic barriers that impinged on the ability to conduct the pharmaceutical care service to its full potential.
METHOD: Structured interviews with community pharmacists. Informed consent was obtained and interviews were audio-recorded and transcribed verbatim.
MAIN OUTCOME MEASURES: Content analysis of themes on awareness of ADR reporting, reporting activities, attitudes and views on patient reporting.
RESULTS: All pharmacists claimed to have some knowledge of a reporting system but only one had submitted a report directly to the regulatory authority. Despite the low level of reporting activities, all participants agreed that it was part of their professional obligation to report an ADR. Most participants were not aware of the direct patient reporting scheme and were skeptical about its success. Lack of awareness and patients' limited knowledge about their medications were viewed as barriers to patient reporting. Local attitudinal issues including pharmacists' attitude towards ADR reporting were described as possible contributing factors.
CONCLUSION: Community pharmacists have an important role in reporting ADRs. Many Malaysian patients are still perceived to be ill-informed of their medications, an important determinant to the success of patient reporting. There is a need for further training about ADRs and ADR reporting for health professionals and further education for patients.
METHODS: A randomized controlled trial was conducted in 3 district hospitals in Sabah, Malaysia to compare the efficacy of AL against chloroquine (CQ) for uncomplicated knowlesi malaria. Participants were included if they weighed >10 kg, had a parasitemia count <20000/μL, and had a negative rapid diagnostic test result for Plasmodium falciparum histidine-rich protein 2. Diagnosis was confirmed by means of polymerase chain reaction. Patients were block randomized to AL (total target dose, 12 mg/kg for artemether and 60 mg/kg for lumefantrine) or CQ (25 mg/kg). The primary outcome was parasite clearance at 24 hours in a modified intention-to-treat analysis.
RESULTS: From November 2014 to January 2016, a total of 123 patients (including 18 children) were enrolled. At 24 hours after treatment 76% of patients administered AL (95% confidence interval [CI], 63%-86%; 44 of 58) were aparasitemic, compared with 60% administered CQ (47%-72%; 39 of 65; risk ratio, 1.3 [95% CI, 1.0-1.6]; P = .06). Overall parasite clearance was shorter after AL than after CQ (median, 18 vs 24 hours, respectively; P = .02), with all patients aparasitemic by 48 hours. By day 42 there were no treatment failures. The risk of anemia during follow-up was similar between arms. Patients treated with AL would require lower bed occupancy than those treated with CQ (2414 vs 2800 days per 1000 patients; incidence rate ratio, 0.86 [95% CI, .82-.91]; P < .001). There were no serious adverse events.
CONCLUSIONS: AL is highly efficacious for treating uncomplicated knowlesi malaria; its excellent tolerability and rapid therapeutic response allow earlier hospital discharge, and support its use as a first-line artemisinin-combination treatment policy for all Plasmodium species in Malaysia.
CLINICAL TRIALS REGISTRATION: NCT02001012.
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: Data on allopurinol ADR reports (2000-2018) were extracted from the Malaysian ADR database. We identified RMMs implemented between 2000 and 2018 from the minutes of relevant meetings and the national pharmacovigilance newsletter. We obtained allopurinol utilization data (2004-2018) from the Pharmaceutical Services Programme. To determine the impact of RMMs on ADR reporting, we considered ADR reports received within 1 year of RMM implementation. We used the Pearson χ2 test to examine the relation between the implementation of RMMs and allopurinol ADR reports.
RESULTS: The 16 RMMs for allopurinol-related SCARs implemented in Malaysia involved nine risk communications, four prescriber or patient educational material, and three health system innovations. Allopurinol utilization decreased by 21.5% from 2004 to 2018. ADR reporting rates for all drugs (n = 144 507) and allopurinol (n = 1747) increased. ADR reports involving off-label use decreased by 6% from 2011. SCARs cases remained between 20% and 50%. RMMs implemented showed statistically significant reduction in ADR reports involving off-label use for August 2014 [χ2(1, N = 258) = 5.32, P = .021] and October 2016 [χ2(1, N = 349) = 3.85, P = .0499].
CONCLUSIONS: RMMs to promote the appropriate use of allopurinol and prescriber education have a positive impact. We need further measures to reduce the incidence and severity of allopurinol-induced SCARs, such as patient education and more research into pharmacogenetic screening.
METHODS: All ADR associated with the use of CAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR.
RESULTS AND DISCUSSION: From a total of 74 997 reports in the database, 930 (1.2%) involved CAM products, and 242 (26%) were serious with 36 deaths. About a third of the reports involved used CAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the CAM products were used for chronic illnesses (odds ratio [OR] 1.99, confidence interval [CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02).
WHAT IS NEW AND CONCLUSIONS: The prevalence of serious ADR associated with CAM products is high. Factors identified with serious ADR included ethnicity, CAM users with pre-existing diseases, use of CAM for chronic illnesses and concomitant use of CAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of CAM products.
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.