METHODS: The current research was a cross-sectional study design in which a pre-validated questionnaire was administered to physicians and pharmacists in Abbottabad, Pakistan. The study was conducted for two months from January 2016 to February 2016.
RESULTS: A total of 194 physicians and pharmacists responded with a response rate of 35.3%. All the respondents either strongly agreed or agreed that ADRs reporting is a part of their duty. Half of the respondents agreed that monitoring of drug safety is important. Around three quarters of respondents (74.2%) stated that they did not report ADRs due to unavailability of reporting forms while 70% cited lack of a proper pharmacovigilance center as one of the key barriers. Half of the respondents (52.2%) did not report due to their insufficient knowledge. A large majority (81.8%) said that they would report ADRs if there is pharmacovigilance center. On the point of incentives, opinion seems to be divided. Slightly less than half (47.8%) cited their wish to have few incentives while the remaining 52.2% either preferred to be neutral or disagreed.
CONCLUSION: Based on the study findings, barriers were mostly related to general unfamiliarity with ADRs reporting guidelines and the non-existence of a pharmacovigilance center. It is highlighted that the regulatory body should carve a niche for a properly functional pharmacovigilance center and initiate educational programs for strengthening knowledge and attitudes towards ADR reporting.
METHODS: This cross-sectional survey collected data from May 2014 to December 2015. Questionnaires seeking to collect information on resources, processes, roles and responsibility, and functions of PV systems were sent to relevant persons in the ASEAN countries. Functions of PV centers were measured using the minimum World Health Organization requirements for a functional national PV system. Performances of PV centers were measured by the following: (1) the indicators related to the average number of individual case safety reports (ICSR); (2) presence of signal detection activities and subsequent action; and (3) contribution to the global vigilance database.
RESULTS: Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam completed the survey. PV systems in four surveyed countries (Indonesia, Malaysia, Singapore, and Thailand) achieved all aspects of the World Health Organization minimum requirement for a functional national PV system; the remaining countries were deemed to have unclear communication strategies and/or no official advisory committee. Average numbers of recent ICSR national returns ranged from 7 to 3817 reports/year/million population; three countries (Malaysia, Singapore, and Thailand) demonstrated good performance in reporting system and reported signal detection activities and subsequent actions. All participating countries had submitted ICSRs to the Uppsala Monitoring Center during the survey period (2013-2015).
CONCLUSIONS: Four participating countries had functional PV systems. PV capacity, functionality, and legislative framework varied depending on local healthcare ecosystem networks. Implementing effective communication strategies and/or technical assistance from the advisory committee are needed to strengthen PV in ASEAN. Copyright © 2016 John Wiley & Sons, Ltd.
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.
Methods: A qualitative approach was used to conduct this study. A semi-structured interview guide was developed, 10 hospital pharmacists were recruited and interviewed through convenience sampling technique. All interviews were audio-taped, transcribed verbatim, and were then analyzed for thematic contents analysis.
Results: Thematic content analysis of the interviews resulted in 6 major themes, including (1) Familiarity with medication safety & adverse drug reaction concept (2) Current system of practice and reporting of adverse drug reaction in hospital setting, (3) Willingness to accept the practice change (4) Barriers to adverse drug reaction reporting, (5) Policy change needs and (6) The recognition of the role. Majority of the hospital pharmacists were familiar with the concept of medication safety and ADR reactions reporting however they were unaware of the existence of national ADR reporting system in Pakistan. Several barriers hindering ADR reporting were identified including lack of awareness and training, communication gap between the hospitals and regulatory authorities.
Conclusion: The study revealed that that hospital pharmacists were good in understanding of medication safety and ADR reporting; however they don't practice this in real sense. The readiness of the hospital pharmacist towards the practice change has indicated that they are all set to be actively involved in the provision of medication safety in hospital setting. Involvement of key stake holders from ministry of health, academia, pharmaceutical industry and healthcare professionals is warranted to promote safe and effective use of medicines.
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: 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: A modified questionnaire was sent to the PV team heads of 21 PV agencies based in the APEC countries, between June 28 and September 12, 2017, to gather information on the structure, process, and outcome of PV status in these countries.
RESULTS: Of the 21 APEC countries, 15 responded. We found harmonized laws and regulations for general PV and risk management systems. However, variations were found in PV structure: for example, 11 out of 15 countries had national regulatory representatives responsible for PV in pharmaceutical companies, while four did not. For PV process, discrepancies were also found in the source type of adverse drug reaction (ADR) reports and reporting of medication errors and therapeutic ineffectiveness in cumulative ADR reports. With respect to PV outcomes, among countries that performed active surveillance, the United States of America was more active, with hundreds of projects including additional pharmacoepidemiological studies etc. Among the nine countries that responded, Japan had the greatest number of product label changes followed by Taiwan, Malaysia, and Korea.
CONCLUSION: We have identified substantial variations in the structures, processes, and outcomes of PV status among the countries of the APEC region. Therefore, efforts to reduce variations in the PV administration and regulation are warranted for harmonization of PV within the APEC region.
Methods: This study analyzed all suspected ADEs related to favipiravir reported from 2015. The reports were analyzed based on age, gender, and seriousness of ADEs at the System Organ Classification (SOC) level and the individual Preferred Term (PT) level.
Results: This study is based on 194 ADEs reported from 93 patients. Most frequent ADEs suspected to be caused by the favipiravir included increased hepatic enzymes, nausea and vomiting, tachycardia, and diarrhea. Severe and fatal ADEs occurred more frequently in men and those over the age of 64 years. Blood and lymphatic disorders, cardiac disorders, hepatobiliary disorders, injury poisoning, and procedural complications were more common manifestations of severe ADEs.
Conclusion: This study revealed that favipiravir appears to be a relatively safe drug. An undiscovered anti-inflammatory activity of favipiravir may explain the improvement in critically ill patients and reduce inflammatory markers. Currently, the data is based on very few patients. A more detailed assessment of the uncommon ADEs needs to be analyzed when more information will be available.
OBJECTIVES: We aimed to identify risk factors for allopurinol-induced SCARs and to assess their impact on fatality.
METHODS: Adverse drug reaction (ADR) reports with allopurinol as suspected drug were extracted from the Malaysian pharmacovigilance database from year 2000 to 2018. Multiple logistic regression analysis was used to identify significant predictors of allopurinol-induced SCARs. We further analysed the association between covariates and SCARs-related fatality in a separate model. Level of significance was set at 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