Displaying publications 1 - 20 of 26 in total

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  1. Hussain R, Hassali MA, Hashmi F, Akram T
    J Pharm Policy Pract, 2021 Jan 04;14(1):5.
    PMID: 33397478 DOI: 10.1186/s40545-020-00287-3
    BACKGROUND: Spontaneous reporting of adverse drug reactions (ADRs) is a method of monitoring the safety of drugs and is the basic strategy for the post-marketing surveillance of the suspected drugs. Despite its importance, there is very little reporting of ADRs by healthcare professionals. The present study has evaluated the knowledge, attitude and practices of health care professionals (HCPs) regarding pharmacovigilance activities in Lahore, Pakistan.

    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 

    Matched MeSH terms: Pharmacovigilance
  2. Mahmoud MA, Alsowaida Y, Alshammari T, Khan TM, Alrasheedy A, Hassali MA, et al.
    Saudi Pharm J, 2014 11;22(5):411-8.
    PMID: 25473329 DOI: 10.1016/j.jsps.2013.07.005
    OBJECTIVE: To assess community pharmacists' knowledge, behaviors and experiences relating to Adverse Drug Reaction (ADR) reporting in Saudi Arabia.

    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.

    Matched MeSH terms: Pharmacovigilance
  3. Panickar R, Wo WK, Ali NM, Tang MM, Ramanathan GRL, Kamarulzaman A, et al.
    Pharmacoepidemiol Drug Saf, 2020 10;29(10):1254-1262.
    PMID: 33084196 DOI: 10.1002/pds.5033
    PURPOSE: To describe risk minimization measures (RMMs) implemented in Malaysia for allopurinol-induced severe cutaneous adverse drug reactions (SCARs) and examine their impact using real-world data on allopurinol usage and adverse drug reaction (ADR) reports associated with allopurinol.

    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.

    Matched MeSH terms: Pharmacovigilance
  4. Shaikh Abdul Rahman S, Aziz Z
    J Clin Pharm Ther, 2020 Oct;45(5):946-958.
    PMID: 31925959 DOI: 10.1111/jcpt.13106
    WHAT IS KNOWN AND OBJECTIVE: Complementary and alternative medicine (CAM) is widely used worldwide for health maintenance, disease prevention and treatment. The objective of the study was to identify adverse drug reactions (ADR) associated with the use of CAM in Malaysia and factors which are associated with the more serious reactions.

    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.

    Matched MeSH terms: Pharmacovigilance
  5. Hariraj V, Aziz Z
    Ther Innov Regul Sci, 2018 11;52(6):757-763.
    PMID: 29714567 DOI: 10.1177/2168479017745025
    BACKGROUND: Many countries incorporate direct patient reporting of adverse drug reactions (ADRs) into their pharmacovigilance systems as patients provide a different insight into drug safety compared to health care professionals. This study aimed to examine public awareness about ADR reporting in Malaysia and patients' confidence in reporting ADRs.

    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.

    Matched MeSH terms: Pharmacovigilance
  6. Hussain R, Hassali MA, Ur Rehman A, Muneswarao J, Atif M, Babar ZU
    PMID: 32349339 DOI: 10.3390/ijerph17093039
    The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient's response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.
    Matched MeSH terms: Pharmacovigilance
  7. Balan S
    Int J Pharm Pract, 2021 Aug 11;29(4):308-320.
    PMID: 34289016 DOI: 10.1093/ijpp/riab030
    OBJECTIVE: Healthcare professionals have an important role in ensuring that adverse drug reactions are well documented and reported. The key determinants of adverse drug reactions reporting are the knowledge, attitude and practice of healthcare professionals. A systematic review of the literature was undertaken to identify, critically evaluate and summarise the findings on the knowledge, attitude and practice of Malaysian healthcare professionals towards adverse drug reaction reporting.

    METHODS: Literature search using electronic databases including PubMed, Google Scholar and National Medical Research Register was conducted. Additional articles were identified by reviewing the bibliography of the retrieved articles. The articles were searched with any of the Medical Subject Headings (MeSH) terms in the title: adverse drug reaction, attitude, awareness, behaviour, experience, knowledge, Malaysia, perspectives, pharmacovigilance, practice and view. Studies were selected based on fulfilment of inclusion and exclusion criteria. The articles were scrutinised using thematic analysis.

    KEY FINDINGS: Nine studies conducted among doctors, pharmacists and nurses met the inclusion criteria. Five themes emerged which included knowledge, attitude, practice, barriers and facilitators of adverse drug reaction reporting among healthcare professionals.

    CONCLUSION: In general, healthcare professionals in Malaysia have good knowledge on and positive attitudes towards adverse drug reaction reporting. However, the practice of adverse drug reaction reporting was found to be unsatisfactory among healthcare professional in Malaysia. The approaches taken to enhance ADR reporting among Malaysian healthcare professionals should focus on alleviating lethargy and ignorance associated with ADR reporting.

    Matched MeSH terms: Pharmacovigilance
  8. Hussain R, Hassali MA, Hashmi F, Farooqui M
    PMID: 30034811 DOI: 10.1186/s40545-018-0143-0
    Background: Medication safety is a major public health concern and there are well established pharmacovigilance programmes in developed countries. However, there is scarcity of literature on the issue in low and middle income countries. In this context, the current study was aimed to evaluate the knowledge, attitudes and practices of hospital pharmacists towards medication safety and ADR reporting in Lahore, Pakistan.

    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.

    Matched MeSH terms: Pharmacovigilance
  9. Aung AK, Tang MJ, Adler NR, de Menezes SL, Goh MSY, Tee HW, et al.
    J Clin Pharmacol, 2018 10;58(10):1332-1339.
    PMID: 29733431 DOI: 10.1002/jcph.1148
    We describe adverse drug reaction (ADR) reporting characteristics and factors contributing to length of time to report by healthcare professionals. This is a retrospective study of voluntary reports to an Australian healthcare ADR Review Committee over a 2-year period (2015-2016). Descriptive and univariate models were used for outcomes, employing standardized ADR definitions. Hospital pharmacists reported 84.8% of the 555 ADRs: 70.3% were hospital onset reactions, and 71.7% were at least of moderate severity. Immunologically mediated reactions were most commonly reported (409, 73.7%). The median time to submit an ADR report was 3 (interquartile range 1-10) days. Longer median times to reporting were associated with multiple implicated agents and delayed hypersensitivity reactions, especially severe cutaneous adverse reactions. A total of 650 medications were implicated that involved multiple agents in 165/555 (29.7%) reports. Antimicrobials were the most commonly implicated agents. Immunologically mediated reactions were most commonly associated with antimicrobials and radiocontrast agents (P < .0001, odds ratio [OR] 3.6, 95%CI 2.4-5.5, and P = .04, OR 4.2, 95%CI 1.2-18.2, respectively). Opioids and psychoactive medications were more commonly implicated in nonimmunological reported ADRs (P = .0002, OR 3.9, 95%CI 1.9-7.9, and P < .0001, OR 11.4, 95%CI 4.6-27.8, respectively). Due to the predominant reporting of immunologically mediated reactions, a targeted education program is being planned to improve identification and accuracy of ADR reports, with the overall aim of improved management to ensure quality service provision and patient safety.
    Matched MeSH terms: Pharmacovigilance*
  10. Elkalmi RM, Hassali MA, Ibrahim MI, Widodo RT, Efan QM, Hadi MA
    Am J Pharm Educ, 2011 Jun 10;75(5):96.
    PMID: 21829270 DOI: 10.5688/ajpe75596
    To assess senior pharmacy students' knowledge of and perceptions about pharmacovigilance and reporting of adverse drug reactions (ADRs) at 5 public universities in Malaysia.
    Matched MeSH terms: Pharmacovigilance*
  11. Charan J, Dutta S, Kaur R, Bhardwaj P, Sharma P, Ambwani S, et al.
    Expert Opin Drug Saf, 2021 Sep;20(9):1125-1136.
    PMID: 34162299 DOI: 10.1080/14740338.2021.1946513
    BACKGROUND: Elevated inflammatory cytokines in Coronavirus disease 2019 (COVID-19) affect the lungs leading to pneumonitis with a poor prognosis. Tocilizumab, a type of humanized monoclonal antibody antagonizing interleukin-6 receptors, is currently utilized to treat COVID-19. The present study reviews tocilizumab adverse drug events (ADEs) reported in the World Health Organization (WHO) pharmacovigilance database.

    RESEARCH DESIGN AND METHODS: All suspected ADEs associated with tocilizumab between April to August 2020 were analyzed based on COVID-19 patients' demographic and clinical variables, and severity of involvement of organ system.

    RESULTS: A total of 1005 ADEs were reported among 513 recipients. The majority of the ADEs (46.26%) were reported from 18-64 years, were males and reported spontaneously. Around 80%, 20%, and 64% were serious, fatal, and administered intravenously, respectively. 'Injury, Poisoning, and Procedural Complications' remain as highest (35%) among categorized ADEs. Neutropenia, hypofibrinogenemia were common hematological ADEs. The above 64 years was found to have significantly lower odds than of below 45 years. In comparison, those in the European Region have substantially higher odds compared to the Region of Americas.

    CONCLUSION: Neutropenia, superinfections, reactivation of latent infections, hepatitis, and cardiac abnormalities were common ADEs observed that necessitate proper monitoring and reporting.

    Matched MeSH terms: Pharmacovigilance*
  12. Hussain R, Hassali MA, Ur Rehman A, Muneswarao J, Hashmi F
    PMID: 32218355 DOI: 10.3390/ijerph17072209
    Developed countries have established pharmacovigilance systems to monitor the safety of medicines. However, in the developing world, drug monitoring and reporting are facing enormous challenges. The current study was designed to explore the challenges related to the understanding and practices of physicians in reporting adverse drug reactions in Lahore, Pakistan. Through the purposive sampling technique, 13 physicians were interviewed. All interviews were audio-recorded, transcribed verbatim, and analyzed for a thematic content analysis. The thematic content analysis yielded six major themes: (1) Familiarity with medication safety and adverse drug reaction (ADR) concept, (2) Knowledge about pharmacovigilance activities, (3) Practices related to ADR reporting, (4) Barriers impeding ADR reporting, (5) Acknowledgement of the pharmacist's role, and (6) System change needs. The majority of the physicians were unaware of the ADR reporting system; however, they were ready to accept practice changes if provided with the required skills and training. A lack of knowledge, time, and interest, a fear of legal liability, poor training, inadequate physicians' and other healthcare professionals' communication, and most importantly lack of a proper reporting system were reported as barriers. The findings based on emerging themes can be used to establish an effective pharmacovigilance system in Pakistan. Overall, physicians reported a positive attitude towards practice changes, provided the concerned authorities support and take interest in this poorly acknowledged but most needed component of the healthcare system.
    Matched MeSH terms: Pharmacovigilance
  13. Shrestha S, Danekhu K, Kc B, Palaian S, Ibrahim MIM
    Ther Adv Drug Saf, 2020;11:2042098620922480.
    PMID: 32587678 DOI: 10.1177/2042098620922480
    Background: Bibliometric analyses have been used previously to study the measures of quality and impact of research performed in several health-related areas such as adverse drug reactions (ADRs) and pharmacovigilance (PV), etc. This method can assess the research performance of publications quantitatively and statistically. There is no evidence of bibilometric studies analyzing ADRs and PV from Nepal. Therefore, the present study aimed to assess scientific output on ADRs and PV-related research activities in Nepal using a bibliometric analysis of publications from 2004 January to December 2018, that is, 15 years.

    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.

    Matched MeSH terms: Pharmacovigilance
  14. Sapkota B, Palaian S, Shrestha S, Ibrahim MIM
    Ther Innov Regul Sci, 2023 Jul;57(4):886-898.
    PMID: 37106236 DOI: 10.1007/s43441-023-00514-4
    Materiovigilance (Mv) has the same purpose and approach in ensuring patient safety as pharmacovigilance but deals with medical devices associated with adverse events (MDAEs) and their monitoring. Mv has been instrumental in recalling many defective or malfunctioning devices based on their safety data. All MDAEs, such as critical or non-critical, known, or unknown, those with inadequate or incomplete specifications, and frequent or rare events should be reported and evaluated. Mv helps to improve medical devices' design and efficiency profile and avoid device-related complications and associated failures. It alerts consumers and health professionals regarding counterfeit or substandard devices. Common events reported through Mv are device breakage and malfunction, entry- and exit-site infections, organ perforations or injuries, need for surgery and even death, and life cycle assessment of devices. Health authorities globally have developed reporting frameworks with timeframes for MDAEs, such as MedWatch in the USA, MedSafe in New Zealand, and others. Health professionals and consumers need to be made aware of the significance of Mv in ensuring the safe use of medical devices and getting familiar with the reporting procedures and action plans in case of a device-induced adverse event.
    Matched MeSH terms: Pharmacovigilance*
  15. Al-lela OQ, Elkalmi RM, Jamshed SQ
    Am J Pharm Educ, 2013 Jun 12;77(5):106.
    PMID: 23788817 DOI: 10.5688/ajpe775106
    Matched MeSH terms: Pharmacovigilance*
  16. Suwankesawong W, Dhippayom T, Tan-Koi WC, Kongkaew C
    Pharmacoepidemiol Drug Saf, 2016 09;25(9):1061-9.
    PMID: 27174034 DOI: 10.1002/pds.4023
    PURPOSE: This study aimed to explore the current landscape and identify challenges of pharmacovigilance (PV) among Association of Southeast Asian Nations (ASEAN) countries.

    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.

    Matched MeSH terms: Pharmacovigilance*
  17. Shin JY, Shin E, Jeong HE, Kim JH, Lee EK
    Pharmacoepidemiol Drug Saf, 2019 03;28(3):362-369.
    PMID: 30648304 DOI: 10.1002/pds.4717
    PURPOSE: Regulatory discrepancies may exist in pharmacovigilance (PV) structure, process, and outcome status worldwide. Our study's objective was to survey the current status of PV in each regulatory body in the Asia-Pacific Economic Cooperation (APEC) region.

    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.

    Matched MeSH terms: Pharmacovigilance
  18. Rosli R, Dali AF, Aziz NA, Ming LC, Manan MM
    Front Pharmacol, 2017;8:30.
    PMID: 28239351 DOI: 10.3389/fphar.2017.00030
    Spontaneous adverse drug reactions (ADRs) reporting is a useful source of drug safety information in infants as only adult patients are routinely tested in clinical trials. This study was aimed to evaluate the spontaneously reported ADRs using WHO Adverse Reaction Terminology and to identify the common drugs associated with ADRs in children under 2 years of age. A retrospective analysis of ADR data for children below 2 years old from 2000 to 2013 was conducted using the data extracted from Malaysia's national pharmacovigilance database, QUEST2 System. From 2000 to 2013, Malaysia's National Pharmaceutical Control Bureau received a total of 11,932 reports for children from various healthcare facilities in Malaysia. 14.0% (n = 1667) of the ADRs reported for those children were related to children under 2 years old. The data retrieved was analyzed in terms of age, gender, source of reporting, type of reporters, suspected medicines and characteristics of ADRs (category, onset, severity, and outcomes). A total of 1312 ADRs reported in 907 ADR reports were analyzed. The most common ADRs reported were skin appendage disorders (60.1%), and the most frequently reported symptoms were rash (n = 215), maculopapular rash (n = 206), urticaria (n = 169), erythematous rash (n = 76), and pruritus (n = 58). In general, drugs from antibacterials for systemic use (58.8%) appeared to be the most common contributors to ADRs in children below 2 years old. Penicillins and other β-Lactam Antibacterials accounted for more than 40% of all drugs implicated in ADRs. The majority of ADRs were subacute reactions that occurred within 24 h of exposure to the drug. A high proportion of ADRs was classified as mild, and most victims had no sequela. Only one fatality was seen. There were 10 cases for each symptom, namely erythema multiforme and Stevens-Johnson Syndrome, observed in this study. A large proportion of ADRs in children under 2 years old were mainly caused by drugs from antibacterial for systemic use, with most of the ADRs manifesting in skin reactions. This study also reveals rare cutaneous ADRs experienced by Malaysian children under the age of 2, which constitutes a crucial cause of harm among children.
    Matched MeSH terms: Pharmacovigilance
  19. Kaur RJ, Charan J, Dutta S, Sharma P, Bhardwaj P, Sharma P, et al.
    Infect Drug Resist, 2020;13:4427-4438.
    PMID: 33364790 DOI: 10.2147/IDR.S287934
    Background: COVID-19 caused by SARS-CoV-2 virus emerged as an unprecedented challenge to discover effective drugs for its prevention and cure. Hyperinflammation-induced lung damage is one of the poor prognostic indicators causing a higher rate of morbidity and mortality of COVID-19 patients. Favipiravir, an antiviral drug, is being used for COVID-19 treatment, and we currently have limited information regarding its efficacy and safety. Thus, the present study was undertaken to evaluate the adverse drug events (ADEs) reported in the WHO pharmacovigilance database.

    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.

    Matched MeSH terms: Pharmacovigilance
  20. Nafeeza Mohd Ismail
    Medical Health Reviews, 2010;2010(1):65-76.
    MyJurnal
    The safety and efficacy of drugs may be different in children compared to adults. The available documentation at the time of approval for drug use in humans invariably lack data for use in children as generally children are not exposed to medicines in clinical trials. As such, in order to clarify a safety profile in children and to limit the occurrence of adverse drug reactions (ADR), long term data collection is necessary. There is a need to consider how pharmacovigilance is conducted for medicines used by children. It is the ethical responsibility of all health professionals to report ADR. Currently, ADRs in children does not appear to be at a critical level. Certainly, a high standard of care could be a reason but the possibility of health professionals underreporting ADRs has to be considered. Furthermore, many drugs used in children are not licensed for use in this age group. This may further limit the reporting of suspected ADRs to the pharmacovigilance systems.
    Matched MeSH terms: Pharmacovigilance
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