Role In Adverse Drug Reactions Research Articles

Identifying strategies to improve adverse drug reporting through key informant interviews among community pharmacists in a developing country

Reporting adverse drug reactions (ADRs) is fundamental in improving medication safety. Community pharmacists (CPs) being the first point of contact for individuals seeking healthcare in a community, play a significant role in ADR reporting. However, this has been poorly implemented in many countries including Nigeria. This paper aims to explore stakeholders’ perspectives on current reporting practices and suggest ways to enhance ADR reporting among CPs in Nigeria. This qualitative study employed a purposive sampling approach to identify key informants. Key informant interviews (KIIs) were conducted with 25 carefully selected pharmacists, using a semi-structured interview guide between July 2023 and August 2023. The interview transcripts were analyzed using a thematic content approach. While a low ADR reporting trend was observed among all participating pharmacists, it was notably higher among those with less than five years of experience. The main barriers to ADR reporting, as identified by the interviewed community pharmacists were lack of awareness and knowledge, absence of motivation, and insufficient feedback from National Agency for Food Drug Administration and Control (NAFDAC). Training and awareness campaigns were the most frequently suggested methods for improving ADR reporting. Other proposed strategies included providing motivation, regular feedback, establishing mandatory reporting, and simplifying the reporting process. The study has highlighted the suboptimal ADR reporting practices among CPs in Anambra state. It underscores the significance of training, sensitization, advocacy, and other related interventions as pivotal means to enhance ADR reporting in this group. Furthermore, there is a pressing need for intervention-based studies to delve into and implement these approaches effectively.

Immunological Mechanisms in Cutaneous Adverse Drug Reactions.

Adverse drug reactions (ADRs) are an inherent aspect of drug use. While approximately 80% of ADRs are predictable, immune system-mediated ADRs, often unpredictable, are a noteworthy subset. Skin-related ADRs, in particular, are frequently unpredictable. However, the wide spectrum of skin manifestations poses a formidable diagnostic challenge. Comprehending the pathomechanisms underlying ADRs is essential for accurate diagnosis and effective management. The skin, being an active immune organ, plays a pivotal role in ADRs, although the precise cutaneous immunological mechanisms remain elusive. Fortunately, clinical manifestations of skin-related ADRs, irrespective of their severity, are frequently rooted in immunological processes. A comprehensive grasp of ADR morphology can aid in diagnosis. With the continuous development of new pharmaceuticals, it is noteworthy that certain drugs including immune checkpoint inhibitors have gained notoriety for their association with ADRs. This paper offers an overview of immunological mechanisms involved in cutaneous ADRs with a focus on clinical features and frequently implicated drugs.

A Systematic Review of Healthcare Professionals' Knowledge, Attitudes, and Practices Regarding Adverse Drug Reaction Reporting in Ethiopia.

Adverse drug reactions (ADRs) are a prominent cause of morbidity and mortality and higher healthcare expenditures. Healthcare professionals (HCPs) play a crucial role in ADR reporting through spontaneous reporting systems, but under-reporting is their major limitation. The goal of this study is to evaluate HCPs' knowledge, attitude, and practice regarding ADR reporting as well as the factors that influence reporting using research papers that are currently available. A literature search was conducted using sources such as PubMed, Scopus, and Google Scholar to find studies that evaluated HCPs' knowledge, attitudes, and practices regarding ADRs reporting in Ethiopia. A standard procedure of systematic review protocol was used to conduct this review. Demographic factors, sample size, response rate, survey delivery, HCP working setting, and encouraging and discouraging factors of ADR reporting were extracted from articles. A total of 17 articles were included in the systematic review out of 384. The number of HCPs in the included studies ranged from 62 to 708. Response rate ranges from 76.1% to 100%. Most of the research included in this evaluation looked at HCPs, who worked in hospitals. When pharmacists were compared to other HCPs, they were more likely to report ADRs; because they had higher knowledge, attitude, and practice. Lack of understanding, unavailability of reporting forms, uncertainty about the causal relationship between the drug and ADR, and failure to report because the ADR was well known were among the common hurdles to ADR reporting identified in research. To improve reporting, educational initiatives and continued training in pharmacovigilance and ADRs are frequently recommended considerations. In Ethiopia, there is a pressing need to close the gap in HCP knowledge, attitudes, and practice regarding PV and ADR reporting. To address this point, specific educational interventions based on existing gaps in ADR reporting should be developed and integrated into the health education curriculum or provided as in-service training after graduation.

Thionamide-induced Agranulocytosis: A Retrospective Analysis of 36 Patients With Hyperthyroidism

ObjectiveAgranulocytosis is a rare but serious adverse drug reaction (ADR) of thionamide antithyroid drugs (ATDs). We explored the characteristics of ADRs in patients with hyperthyroidism. MethodsThis retrospective study included 3558 inpatients with Graves disease treated in a Class A Grade 3 hospital between 2015 and 2019. The clinical presentation and laboratory workup of patients with antithyroid drug (ATD)-induced agranulocytosis was analyzed. ResultsAgranulocytosis was thought to be caused by ATDs in 36 patients. The hospital length of stay was 12 (10-16) days, and hospitalization costs were approximately $2810.89 ($2156.50-$4164.67). The median duration of ATD therapy prior to agranulocytosis development was 30 (20-40) days. Fever (83.33%) and sore throat (75%) were the most common symptoms as early signs of agranulocytosis. The lowest neutrophil counts were 0.01 (0.00-0.03) × 109/L and 0.14 (0.02-0.29) × 109/L in the methimazole and propylthiouracil groups, respectively (P = .037). The recovery times of agranulocytosis were 9.32 ± 2.89 days and 5.60 ± 4.10 days in the methimazole and propylthiouracil groups, respectively (P = .016). Patients with severe agranulocytosis required a longer time to recover (P < .001) and had closer to normal serum thyroxine and triiodothyronine levels. The interval between the first symptom of agranulocytosis and ATD withdrawal was 1 (0-3) day. ConclusionsPatients with agranulocytosis needed a long hospital length of stay and incurred high costs. Methimazole was prone to causing a more serious agranulocytosis than propylthiouracil. High thyroid hormone was unlikely to play a role in adverse drug reactions. Patient education is important.

Survey of knowledge, attitudes and practice regarding adverse drug reaction (ADR) reporting among community pharmacists in Selangor, Malaysia

AbstractBackgroundCommunity pharmacists play a pivotal role in adverse drug reaction (ADR) reporting because they provide services to a large proportion of the community. Although ADR reporting by healthcare providers in Malaysia is increasing, few ADR reports are submitted by community pharmacists.AimThis study assessed the knowledge, attitudes and practice of ADR reporting, as well as barriers and facilitators of ADR reporting, among community pharmacists in Malaysia.MethodsA cross‐sectional 52‐item validated questionnaire was distributed to 278 community pharmacists in Selangor, Malaysia, in 2015. Multistage sampling was performed whereby community pharmacists from three of the nine administrative districts in the region were eligible for inclusion. Community pharmacies were then randomly sampled from the selected districts. Data are reported using descriptive statistics.ResultsA total of 219 pharmacists responded to the survey, giving a response rate of 78.8%. These community pharmacists self‐reported a positive attitude towards ADR reporting. Nevertheless, less than half (34.2%; n = 75) had previously reported an ADR. Lack of information provided by the patient, insufficient clinical knowledge and uncertainty relating to the association between the adverse reaction and the drug were the main barriers to ADR reporting.ConclusionsThe attitude and practices among community pharmacists indicates there is room for improvement in ADR reporting in Malaysia. Ongoing education and training on ADR reporting for community pharmacists is required to ensure delivery of high‐quality care to the community.

Preventable statin adverse reactions and therapy discontinuation. What can we learn from the spontaneous reporting system?

ABSTRACTBackground: Statin treatment is often associated with poor adherence, which may be due to the onset of adverse drug reactions (ADRs). We investigated on potential risk factors related to preventable cases of statin-induced ADRs and to the discontinuation of statin therapy.Methods: We performed a study using the database of Italian spontaneous reporting. The target population for the preventability assessment was all patients with suspected statin-induced ADRs deriving from Campania Region (a territory of Southern Italy) between 2012 and 2017. Additionally, a local sentinel surveillance site involving General Practitioners was selected to countercheck in routine clinical practice the role of ADRs for statin discontinuation.Results: In total, 34 of 655 (5.19%) regional cases were preventable and among detected risk factors 90.0% was related to healthcare professionals’ practices and 10.0% to patient behaviour. In 81.4% (533/655) of cases, statin therapy was discontinued due to ADRs, mainly classified as not serious and associated with a positive prognosis. These results were also confirmed in the active sentinel site.Conclusions: Our findings suggest an inappropriate use of statins among the identified preventable cases and a potential inappropriate statin discontinuation due to ADRs. These factors may be useful for targeting interventions to improve statin adherence.

Adverse drug reaction reporting among physicians working in private and government hospitals in Kuwait

IntroductionTo improve patient safety and care, the identification and reporting of adverse drug reactions (ADRs) should be systematic and mandatory for all healthcare professionals (HCPs). Physicians remain the main HCPs with direct patient care whose role in ADRs reporting should not be ignored. ObjectiveTo document the awareness and attitude of physicians working in private and government hospitals in Kuwait with regard to pharmacovigilance (PV) and ADR reporting and to identify their practices of reporting ADRs. Material and methodsA cross-sectional study was conducted using a paper-based 25-item questionnaire. The Statistical Package for Social Science (SPSS) was used for data analysis. ResultsA total of 1017 questionnaires were distributed to the eligible physicians in the government and private hospitals, giving a response rate of 84.2% and 83.0%, respectively (an overall response rate of 83.8%). Private physicians exhibited a better knowledge profile with regards to the purpose of PV (75.2% vs 64.8%; p=0.002) and the correct ADR definition (75.8% vs 65.3%; p=0.001). The majority of physicians showed good attitude towards reporting ADRs, nevertheless, private physicians had a significantly stronger belief that reporting ADRs is a professional obligation (93.4% vs 85.5%; p=0.001). Three quarters of the study population (74.6%) had identified an ADR during their daily practice, however, only a small proportion (34.2%) confirms having ever reported ADRs. Regardless, significantly more private physicians had done so (42.4% vs 29.6%; p<0.001). ADR reporting was significantly higher in physicians who knew the correct ADRs to be reported (adjusted OR=1.86, p=0.036), and those who were aware of any center or ADR reporting system in Kuwait (adjusted OR=2.88, p=0.020). ConclusionsA national PV center empowered by clear legislation on “how” and “what” to report should improve physicians’ reporting practices and hence is required in the country. This should be combined with constant training and education in this regard.

Medication safety knowledge, attitudes and practices among community pharmacists in Lebanon

Background: The effectiveness of a national post-marketing surveillance program depends directly on the active participation of all health professionals. There is no current comprehensive and active pharmacovigilance program available in Lebanon.Objectives: To assess the knowledge, attitudes, and practices (KAP) among community pharmacists in Lebanon with respect to potential pharmacovigilance and adverse-drug-reaction reporting in Lebanon.Methods: A cross-sectional descriptive study, using a self-administered KAP questionnaire and conducted between March and July 2016, included 1857 pharmacists practicing in community settings. Statistical analysis included χ2 test for dichotomous or multinomial qualitative variables, and Wilcoxon test for quantitative variables with non-homogeneous variances or non-normal distribution.Results: The majority of responders had good knowledge concerning the concept and purpose of pharmacovigilance as well as adverse drug reactions (how to report these/the importance of reporting adverse events/the definition of an adverse event and pharmacovigilance). Concerning community pharmacists’ attitudes and practice towards pharmacovigilance, the majority described having a positive attitude towards their role in adverse drug reaction reporting and this activity was even seen as one of their core duties. The questionnaire revealed a lack of practice and training regarding pharmacovigilance. Nonetheless, the pharmacists agreed on the Order of Pharmacists in Lebanon and the Ministry of Health’s role in promoting this practice and helping them be more involved in reporting adverse drug reactions (ADRs). The pharmacists thought that they are well positioned regarding patient-safety practice in their pharmacies and the results were not statistically different between pharmacy employers and employees.Conclusion: Lebanese pharmacists have the required knowledge and positive attitude to start reporting ADRs, were aware of ADRs occurring with various medicines post-marketing, yet were currently not able to disseminate this information widely or to record it centrally, emphasizing the importance of establishing a national ADR reporting system.

Attitudes and knowledge of community pharmacy professionals regarding the spontaneous reporting of adverse drug reactions: a preliminary study in Coimbra, Portugal

Spontaneous reporting of adverse drug reactions (ADRs) remains one of the most efficient methods to detect new, unusual, and severe ADRs. Community pharmacy professionals (CPPs) play a fundamental role in the reporting of spontaneous ADRs. The aim of this study was to describe the attitudes and knowledge of different CPP groups regarding the spontaneous reporting of ADRs and to identify the factors that can influence ADR under-reporting. A cross-sectional descriptive study was conducted in CPPs (156 pharmacists and 40 pharmacy technicians) working in 49 pharmacies in Coimbra, Portugal. A survey of the knowledge and attitudes of CPPs towards reporting ADRs and the factors that encourage and discourage ADR reporting was constructed and personally delivered to the pharmacies. The response rate was 82.0%. The seriousness and the unusualness of the reaction were the most important motives to report ADRs (98.0 and 97.4% of respondents, respectively). CPPs also considered ADR reporting to be a professional obligation (96.4%), but “don’t feel the need to report well-known ADRs” (54.1%). Other attitudes associated with under-reporting were lack of time (50.0%), method of reporting (38.3%), and fear of legal liability (29.6%). CPPs’ knowledge and behavior play a significant role in ADR reporting. Despite the differences in their educational syllabus, there were no statistical differences between pharmacists and pharmacy technicians with regard to their perception of the importance of ADR reports or the factors that affect their reporting. It may be possible to reduce the under-reporting of ADRs by introducing educational interventions based on the attitudes related to under-reporting that have been identified in this study.

An Educational Intervention To Improve Nurses Reporting of Adverse Drug Reactions

AN EduCATioNAl iNTErVENTioN To improVE NurSES rEporTiNg of AdVErSE drug rEACTioNS S. Marquez; M.T. Herdeiro; and I. Ribeiro-Vaz University of Aveiro, Aveiro, Portugal; and Northern Pharmacovigilance Centre, Porto, Portugal Introduction: Adverse drug reactions (ADR) are an important cause of mortality and morbidity leading to additional costs with health. Drug safety data before commercialization is limited and incomplete, which is the reason why pharmacovigilance is important. ADR reporting system is efficient in drug safety monitoring. Nurses can have an important role in ADR reporting due to their daily activities of drugs administration (including vaccines). However, among these professionals, there a high rate of underreporting. Based on the reasons proposed by Inman for underreporting ADR, it was concluded that the main obstacles to ADR reporting among nurses were indifference (the belief that a single case cannot contribute to medical knowledge) and the lack of knowledge about the pharmacovigilance system. The aim of this study is to evaluate the quantitative and qualitative increase of ADR reports by nurses after an educational intervention. Methods: A quasiexperimental study was performed in nurses working in primary care in Braga district, Portugal. One hundred thirteen individuals were placed in the intervention group while the control group included 590 nurses. Two educational interventions were performed to nurses working in primary care in ACES Cavado II (intervention group) that focused on the problem of adverse drug reaction, the impact on public health and spontaneous reporting. Statistical analysis were based on absolute and relative frequencies. Results: Between January 2013 and September 2014 the Northern Pharmacovigilance Centre received 8 reports/100 nurses from the intervention group and 5 reports/100 nurses from control group. Conclusions: The educational intervention increased 1.6 times the number of reports during the study period. The second intervention had more impact than the first one. There was no significant increase in the quality of ADR reports in the intervention group. In the second intervention the number of reports increased only at the intervention day.

Factors that condition the spontaneous reporting of adverse drug reactions among nurses: an integrative review.

To describe and synthesise previous research on factors conditioning the spontaneous reporting of adverse drug reactions among nurses. Spontaneous reports of adverse drug reactions by health-care providers, are a main instrument for the continuous evaluation of the risk-benefit ratio of every drug. Under-reporting of adverse drug reactions by all health-care providers, in particular by nurses, is a major limitation to this system. An integrated review of the literature was conducted using MEDLINE, CINAHL, Embase, Scopus databases and Google Scholar. After evaluation for appropriateness related to inclusion/exclusion criteria, 16 studies were included in the final analysis and synthesis. Two factors emerged from the study: (1) intrinsic factors related to nurses' knowledge and attitudes; (2) extrinsic factors related to nurses' interaction with health-care organisations and to the relationship between nurses and physicians. Nurses' attitudes that hinder reporting include ignorance, insecurity, fear and lethargy. Nurses are not fully aware of their role in adverse drug reaction reporting. Nurses must acquire greater knowledge to implement specific skills into their daily clinical practice. To improve nurses' reporting of adverse drug reactions, it is necessary to develop management approaches that modify both intrinsic and extrinsic factors.

Nurses' reporting of suspect adverse drug reactions: a mixed-methods study.

To assess nurses' knowledge, attitudes and practices (KAP) towards spontaneous adverse drug reactions (ADRs) reporting. The mixed-method study was conducted following a quanti-qualitative sequential approach: a survey (using a KAP questionnaire) followed by a focus group was performed. In the quantitative findings, responders (570 hospital nurses) declared that they were unaware of the pharmacovigilance system (58.1%, n = 331); where to find the reporting form (63.5%, n = 362); how fill it in (71.6%, n = 408); to whom and how to send it (65.8%, n = 375). Only 11.1% (n = 63) reported ADRs. The qualitative phase supported the quantitative findings and provided new information about other factors that condition ADR reporting: misinterpretation of the meaning of "reporting", unawareness of nurses' autonomy in ADR reporting and fear of consequences after ADR reporting. Nurses are not fully aware of their role in ADR reporting. We recommend educational interventions and management changes.

Genome-wide discovery of drug-dependent human liver regulatory elements.

Inter-individual variation in gene regulatory elements is hypothesized to play a causative role in adverse drug reactions and reduced drug activity. However, relatively little is known about the location and function of drug-dependent elements. To uncover drug-associated elements in a genome-wide manner, we performed RNA-seq and ChIP-seq using antibodies against the pregnane X receptor (PXR) and three active regulatory marks (p300, H3K4me1, H3K27ac) on primary human hepatocytes treated with rifampin or vehicle control. Rifampin and PXR were chosen since they are part of the CYP3A4 pathway, which is known to account for the metabolism of more than 50% of all prescribed drugs. We selected 227 proximal promoters for genes with rifampin-dependent expression or nearby PXR/p300 occupancy sites and assayed their ability to induce luciferase in rifampin-treated HepG2 cells, finding only 10 (4.4%) that exhibited drug-dependent activity. As this result suggested a role for distal enhancer modules, we searched more broadly to identify 1,297 genomic regions bearing a conditional PXR occupancy as well as all three active regulatory marks. These regions are enriched near genes that function in the metabolism of xenobiotics, specifically members of the cytochrome P450 family. We performed enhancer assays in rifampin-treated HepG2 cells for 42 of these sequences as well as 7 sequences that overlap linkage-disequilibrium blocks defined by lead SNPs from pharmacogenomic GWAS studies, revealing 15/42 and 4/7 to be functional enhancers, respectively. A common African haplotype in one of these enhancers in the GSTA locus was found to exhibit potential rifampin hypersensitivity. Combined, our results further suggest that enhancers are the predominant targets of rifampin-induced PXR activation, provide a genome-wide catalog of PXR targets and serve as a model for the identification of drug-responsive regulatory elements.

Self-Medication with Over-the-Counter and Prescribed Drugs Causing Adverse-Drug-Reaction-Related Hospital Admissions: Results of a Prospective, Long-Term Multi-Centre Study

Self-medication, including both the use of over-the-counter (OTC) drugs and the use of formerly prescribed drugs taken without a current physician's recommendation, is a public health concern; however, little data exist regarding the actual risk. We aimed to analyse self-medication-related adverse drug reactions (ADRs) leading to hospitalisation. In a multi-centre, observational study covering a hospital catchment area of approximately 500,000 inhabitants, we analysed self-medication-related ADRs leading to hospital admissions in internal medicine departments. Data of patients with ADRs were comprehensively documented, and ADR causality was assessed using Bégaud's algorithm. The included ADRs occurred between January 2000 and December 2008 and were assessed to be at least 'possibly' drug related. Of 6,887 patients with ADRs, self-medication was involved in 266 (3.9 %) patients. In 143 (53.8 %) of these patients, ADRs were due to OTC drugs. Formerly prescribed drugs and potential OTC drugs accounted for the remaining ADRs. Most self-medication-related ADRs occurred in women aged 70-79 years and in men aged 60-69 years. Self-medication-related ADRs were predominantly gastrointestinal complaints caused by non-steroidal anti-inflammatory drugs (most frequently OTC acetylsalicylic acid [ASA, aspirin]). In 102 (38.3 %) of the patients with self-medication-related ADRs, a relevant drug-drug interaction (DDI), occurring between a self-medication and a prescribed medication, was present (most frequently ASA taken as an OTC drug and prescribed diclofenac). In the general population, self-medication plays a limited role in ADRs leading to hospitalisation. However, prevention strategies focused on elderly patients and patients receiving interacting prescribed drugs would improve patient safety.

Adverse Drug Event Reporting: Awareness is Not Enough

Most drugs are used in a larger and more heterogenous population after they are brought to market than initially was evaluated in preapproval trials. Postmarketing pharmacovigilance provides data that enhance the rational and safe use of medications. In particular, the safety profile of drugs is dynamic; new information is continually assessed regarding use and outcomes. Among postmarketing surveillance methods, national voluntary reporting systems are an important conduit for the collection of information about specific adverse events involving medications. In the United States, the Food and Drug Administration’s (FDA) MedWatch program collects voluntary reports from health care professionals and consumers about adverse drug reactions and errors related to drugs, biologics, nutritionals, and devices.1 Data regarding voluntary reports on adverse events associated with vaccines are collected via the Vaccine Adverse Event Reporting System (VAERS), a program co-sponsored by the FDA and the Centers for Disease Control and Prevention (CDC).2 Information about medication and vaccine errors are also collected via other voluntary programs founded by the Institute of Safe Medication Practices: Medication Errors Reporting (ISMP MERP) and National Vaccine Reporting Program (ISMP VERP).3 All programs allow for individuals to confidentially report an incident, for the analyses of data to identify potential trends and problems, and for the provision of information to the global health community for optimizing patient safety. Because these national reporting programs depend upon voluntary participation, they are limited by under-reporting and a variance in the quality of the reports received. In addition, inference regarding incidence data is limited by the lack of denominator information on overall use. Despite these limitations, MedWatch, VAERS, and ISMP programs positively impact patient care by promoting safe health care practices. The continued participation of health care professionals in the voluntary reporting of adverse events associated with medications and devices is essential in the promotion of patient safety. Because of the nature of the pharmacy profession and its involvement in patient care regarding medications, pharmacists play an important role in adverse drug reaction (ADR) reporting. Participation first requires knowledge and awareness of such programs. Recent studies that evaluated the knowledge and attitudes of US pharmacists regarding ADR show that, despite favorable attitudes toward reporting, many pharmacists have never reported an adverse drug event to the MedWatch program or admit to having inadequate knowledge regarding reporting mechanisms.4–6 The United States is not alone in this; several international studies have documented a lack of pharmacist awareness of or experience with ADR reporting, which is a deterrent to participation in similar national programs.7–10 Because of this low incidence of pharmacist participation, it is essential for pharmacy school curricula to include information about adverse drug reaction and medication error reporting. Students need to gain awareness, experience, and confidence in recognizing adverse drug reactions and knowing which reactions necessitate a report to a facility or national monitoring event program. Surveys about current curricula reveal that pharmacy students’ awareness with ADR and MERP programs is improving, but they do not know how to report and do not have experience with actual reporting of serious events. 11–13 International reports indicate that pharmacy curricula in other countries have the same shortcomings.14–16 Knowledge is not enough. Awareness is not enough. Experience with assessment of adverse reactions and reporting of appropriate reactions is necessary. Faculty, instructors, and preceptors are encouraged to include ADR assessment and reporting experiences in the didactic and experiential curricula. The FDA has released a new MedWatch training program, MedWatch Learn,17 that is directed at teaching health professionals, students, and patients how to complete the online FDA forms necessary to report various types of problems (eg, adverse drug reaction, product problem, medication error). Each form is accompanied by a case scenario that requires assessment of patient variables to complete the process. The user may prompt for helpful tips that aid in the completion of the form and define and explain the importance of the specific parameter for reporting purposes. Feedback via an answer key is provided for each case. This model is a useful approach for improving familiarity with reporting mechanisms. A similar model is used for patient reporting. Increasing health professional and student participation in national medication reporting programs remains an important goal in promoting safe health care practices. Opportunities for improvement in pharmacy curricula and practice sites toward interactive experiences with reporting programs should be continually evaluated.

Do community pharmacists in Nepal have a role in adverse drug reaction reporting systems?

Community pharmacies in Nepal serve both rural and urban populations and are an integral part of the Nepalese healthcare system. These community pharmacies are run by non-pharmacist professionals with orientation training on pharmacology and drug dispensing. Graduate pharmacists' involvement in community pharmacy will help with patient counselling, dispensing of medication and promotion of safe and appropriate medicine use. Nepal has an organised pharmacovigilance system which incorporates adverse drug reaction (ADRs) from hospitals and tertiary care centres but not from the community. Involvement of pharmacists in community pharmacy will help in ADR reporting and, monitoring at community level and will help in promoting medication safety in the community. This article describes the community pharmacovigilance program in Nepal and the prospects for community pharmacists.

A qualitative study exploring barriers and facilitators for reporting of adverse drug reactions (ADRs) among community pharmacists in Malaysia

Objective The objective of this study was to ascertain the perception of practising community pharmacists (CPs) towards adverse drug reactions (ADRs) reporting and to identify the problems with the current system in place for ADR reporting in Malaysia. Methods A qualitative study utilizing face-to-face interviews was carried out with a sample of 16 CPs, aged 24–38 years old, all living in Penang, Malaysia. The transcripts of all the interviews were generated from audio tapes and were analysed for issues and themes emerging from the text which was independently coded and verified by two researchers. Key findings A total of 16 CPs were interviewed and analysis of the interviews revealed three major themes: familiarity with the ADR reporting process, attitudes and behaviours of the CPs towards ADR reporting, and barriers associated with ADR reporting. In terms of the familiarity with the pharmacovigilance system and ADR reporting, the majority of the pharmacists were not aware that the pharmacovigilance system was already in place in Malaysia. The majority of the CPs had a positive attitude and behaviour towards their role in ADR reporting and the main reason given for this was that reporting of ADRs was seen as one of their core duties. The major barrier to ADR reporting was a lack of knowledge about ADR reporting processes. To increase ADR reporting rates, some participants suggested that educational interventions are needed from organizations such the Malaysian Adverse Drug Reaction Advisory Committeee (MADRAC) and academia. Conclusion Most of the pharmacists interviewed were confused about ADR reporting and had very little knowledge about it. The information gained from this study emphasizes the importance of establishing and continuing efforts to promote the ADR reporting system in Malaysia.

A survey of adverse drug reaction reporting by hospital pharmacists to the Committee on Safety of Medicines — the role of pharmacy departments

Abstract Objectives To identify: (1) how adverse drug reaction (ADR) reporting by hospital pharmacists is managed, (2) the education of pharmacy personnel on ADR reporting, (3) pharmacy personnel with a specific role in ADR reporting, (4) the numbers of ADR reports sent to the Committee on Safety of Medicines (CSM) and (5) barriers to reporting Method Postal questionnaire survey of 250 hospital-based drug information (DI) departments Setting All hospital-based DI departments listed in the United Kingdom Drug Information Pharmacists' Group directory Key findings A total of 185 questionnaires was returned (74 per cent response). Thirty-five per cent of respondents had a procedure for the reporting of ADRs by pharmacists; 62 per cent of departments actively promoted reporting; 44 per cent of departments reviewed reports before they were sent to the CSM. DI pharmacists were frequently involved in the review of the reports and were usually the designated ADR person. Education on ADR reporting was provided by 69 per cent of departments. Few specialist pharmacists (n=9) were identified as having established a direct link with the CSM. The majority of departments had submitted five or fewer ADR reports to the CSM. The presence of a procedure, promotion of reporting, education and the presence of a designated ADR person were found to be associated with above average rates of ADR reporting (chi-square test) Conclusion The survey showed that the role played by pharmacy departments in the area of hospital pharmacist ADR reporting varied considerably but in most cases was insufficiently developed

An introduction to adverse drug reaction reporting systems in different countries

Abstract Objective To review adverse drug reaction (ADR) reporting schemes in selected developed countries, with emphasis on identifying community pharmacists' roles in ADR reporting. Setting International comparison between eight developed countries, with respect to ADR reporting systems and developments. Method Review of published articles on ADR reporting by pharmacists. Health and medical sciences databases including International Pharmaceutical Abstracts, MEDLINE and ProQuest were searched for relevant publications from 1993 to 2003. Websites specific to ADR reporting schemes in the selected countries were also searched. Key findings ADRs impact significantly on a nation's healthcare costs. Voluntary reporting by health professionals is currently considered the cornerstone to the detection and management of ADRs and makes a valuable contribution to the safe use of medicines. ADR reporting systems are managed by national ADR or pharmacovigilance reporting centres, and differ internationally. In general, medication-related problems are reported more commonly in hospitals than in the community. Physicians are the main contributors, except in the Netherlands and Canada, where community pharmacists play the major role in ADR reporting. Time pressure, no remuneration for reporting, and confusion about what to report were identified as some of the main deterrents for reporting by pharmacists. Conclusion Most international reporting systems for ADRs are either hospital based, or physician based. The opportunity therefore exists to further develop reporting systems that are accessible by community pharmacists, as they are in an ideal situation to detect and report ADRs through contact with patients.

Cytochrome b5 and NADH cytochrome b5 reductase: genotype–phenotype correlations for hydroxylamine reduction

NADH cytochrome b5 reductase (b5R) and cytochrome b5 (b5) catalyze the reduction of sulfamethoxazole hydroxylamine (SMX-HA), which can contribute to sulfonamide hypersensitivity, to the parent drug sulfamethoxazole. Variability in hydroxylamine reduction could thus play a role in adverse drug reactions. The aim of this study was to characterize variability in SMX-HA reduction in 111 human livers, and investigate its association with single nucleotide polymorphisms (SNPs) in b5 and b5R cDNA. Liver microsomes were assayed for SMX-HA reduction activity, and b5 and b5R expression was semiquantified by immunoblotting. The coding regions of the b5 (CYB5A) and b5R (CYB5R3) genes were resequenced. Hepatic SMX-HA reduction displayed a 19-fold range of individual variability (0.06-1.11 nmol/min/mg protein), and a 17-fold range in efficiency (Vmax/Km) among outliers. SMX-HA reduction was positively correlated with b5 and b5R protein content (P<0.0001, r=0.42; P=0.01, r=0.23, respectively), and expression of both proteins correlated with one another (P<0.0001; r=0.74). A novel cSNP in CYB5A (S5A) was associated with very low activity and protein expression. Two novel CYB5R3 SNPs, R59H and R297H, displayed atypical SMX-HA reduction kinetics and decreased SMX-HA reduction efficiency. These studies indicate that although novel cSNPs in CYB5A and CYB5R3 are associated with significantly altered protein expression and/or hydroxylamine reduction activities, these low-frequency cSNPs seem to only minimally impact overall observed phenotypic variability. Work is underway to characterize polymorphisms in other regions of these genes to further account for individual variability in hydroxylamine reduction.