Drug Safety Information Research Articles

Reported Adverse Drug Reactions in Infants: A Nationwide Analysis in Malaysia.

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.

Clinical Characteristics of Patients with Drug-induced Liver Injury.

Background:Drug is an important cause of liver injury and accounts for up to 40% of instances of fulminant hepatic failure. Drug-induced liver injury (DILI) is increasing while the diagnosis becomes more difficult. Though many drugs may cause DILI, Chinese herbal medicines have recently emerged as a major cause due to their extensive use in China. We aimed to provide drug safety information to patients and health carers by analyzing the clinical and pathological characteristics of the DILI and the associated drug types.Methods:A retrospective analysis was conducted in 287 patients diagnosed with DILI enrolled in our hospital from January 2011 to December 2015. The categories of causative drugs, clinical and pathological characteristics were reviewed.Results:Western medicines ranked as the top cause of DILI, accounting for 163 out of the 287 DILI patients (56.79%) in our study. Among the Western medicine, antituberculosis drugs were the highest cause (18.47%, 53 patients) of DILI. Antibiotics (18 patients, 6.27%) and antithyroid (18 patients, 6.27%) drugs also ranked among the major causes of DILI. Chinese herbal medicines are another major cause of DILI, accounting for 36.59% of cases (105 patients). Most of the causative Chinese herbal medicines were those used to treat osteopathy, arthropathy, dermatosis, gastropathy, leukotrichia, alopecia, and gynecologic diseases. Hepatocellular hepatitis was prevalent in DILI, regardless of Chinese herbal medicine or Western medicine-induced DILI.Conclusions:Risks and the rational use of medicines should be made clear to reduce the occurrence of DILI. For patients with liver injury of unknown origin, liver tissue pathological examination is recommended for further diagnosis.

A day in the life of a pharmacovigilance case processor.

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word “pharmacovigilance” are “Pharmakon” (Greek for drug) and “Vigilare” (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study

IntroductionA mobile app may increase the reporting of adverse drug reactions (ADRs) and improve the communication of new drug safety information. Factors that influence the use of an app for such two-way risk communication need to be considered at the development stage.ObjectiveOur aim was to reveal the factors that may influence healthcare professionals (HCPs) and patients to use an app for two-way risk communication.MethodsFocus group discussions and face-to-face interviews were conducted in the Netherlands, Spain and the UK. Patients with type 2 diabetes mellitus, patients with a rare disease or their caregivers and adolescents with health conditions were eligible to participate. HCPs included pharmacists, paediatricians, general practitioners, internists, practice nurses and professionals caring for patients with a rare disease. Patients and HCPs were recruited through various channels. The recorded discussions and interviews were transcribed verbatim. The dataset was analysed using thematic analysis and arranged according to the Unified Theory of Acceptance and Use of Technology.ResultsSeven focus group discussions and 13 interviews were conducted. In total, 21 HCPs and 50 patients participated. Identified factors that may influence the use of the app were the type of feedback given on reported ADRs, how ADR reports are stored and the type of drug news. Also mentioned were other functions of the app, ease of use, type of language, the source of safety information provided through the app, security of the app, layout, the operating systems on which the app can be used and the costs.ConclusionsFurther research is needed to assess associations between user characteristics and the direction (positive or negative) of the factors potentially influencing app use.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-016-0494-x) contains supplementary material, which is available to authorized users.

Public Knowledge and Desire for Knowledge about Drug Safety Issues: A Survey of the General Public in New Zealand

Introduction Effective communication of drug safety information is essential for individuals to make informed decisions about their use of therapeutic medicines.

A quantitative approach to segmentation for prescription drug safety programs

Purpose The aim of this paper is to enhance the effectiveness of pharmacovigilance programs that provide information about medical products to benefit consumers, aid health care professional’s decision-making and improve community health. This research sought to determine whether distinct segments of consumers can be identified for prescription drug safety social marketing and communication activities and if these segments would respond differently to information about prescription drug products. Design/methodology/approach Theories of risk information-seeking behavior were used to develop questions for respondents in an online survey panel. Latent class analyses identified clusters that were similar in their ability to accurately interpret risks and benefits, preferred sources of health information, medication use and other related factors. Multinomial logistic regression models identified demographic and psychographic differences across the segments. Logistic and linear regression models were then used to compare each segment’s responses to a specific drug safety information product. Findings The 1,244 respondents were clustered into four segments: not engaged (12 per cent), low-involvement users (29 per cent), careful users (50 per cent) and social information seekers (9 per cent). These segments were distinguished by perceived seeking control, self-appraisal of skill, information insufficiency, self-efficacy, information competency and health literacy. Sources of health information and health-seeking behaviors were also different across the four segments. Significant differences were found among the segments in their comprehension and perceived utility of the content and their intentions to take relevant actions. Practical implications From an array of potential behavioral influences, adults can be segmented by risk information-seeking constructs and related behaviors. These segments respond differently to drug safety information. Use of the personas developed in this work can help pharmacovigilance programs around the world develop more relevant and tailored social marketing products, services and content. Originality/value A social marketing approach using empirically tested theoretical constructs can be useful for drug safety or pharmacovigilance programs. The results were used to create personas that quickly convey relevant information to drug safety program managers and staff.

Japan Pharmacogenomics Data Science Consortium Database and Its Application for Drug Safety Analyses

Severe adverse drug reactions (ADRs) are significantly influenced by the genetic background of an individual, and pharmacogenomics (PGx) is strongly expected to reveal the cause of severe ADRs. Genome-wide association studies (GWASs) for severe ADRs have been conducted worldwide, and a genomic database of representative samples of the ethnic population can be used as controls for GWAS for severe ADRs. Six Japanese pharmaceutical companies, Astellas, Daiichi Sankyo, Mitsubishi Tanabe, Otsuka, Taisho, and Takeda, therefore established the Japan Pharmacogenomics Data Science Consortium (JPDSC) and built a Japanese genomic database in 2009. This database promotes the application of PGx in drug development by each member company and PGx researches for expanding Japanese drug safety information at the genomic level.

Trends in the coprescription of proton pump inhibitors with clopidogrel: an ecological analysis.

In early 2009, 2 observational studies and a US Food and Drug Administration (FDA) advisory addressed the drug interaction between proton pump inhibitors (PPIs) and clopidogrel. One study suggested that pantoprazole could be used safely in this setting, whereas the other study and the FDA advisory did not distinguish among PPIs. We examined trends in PPI prescribing among clopidogrel recipients in the period following these events. We conducted a population-based time series analysis of Ontario residents aged 66 years or older for whom clopidogrel was prescribed between Apr. 1, 1999, and Sept. 30, 2013. We determined the proportion of clopidogrel recipients dispensed a PPI during each quarter and the proportions who received pantoprazole or other PPIs. The outcome of interest was change in the use of pantoprazole. In the final quarter of 2008, pantoprazole represented 23.7% of all PPI prescriptions dispensed to patients receiving clopidogrel. Following the publications and FDA advisory in early 2009, pantoprazole use increased substantially. By the end of 2009, this medication accounted for 52.5% of all PPI prescriptions issued to patients receiving clopidogrel; by the end of the study period, it accounted for 71.0% of all PPI prescriptions dispensed to such patients (p < 0. 001). We also observed a modest drop in overall PPI use among clopidogrel recipients beginning in early 2009. In 2009, the prescribing of PPIs with clopidogrel changed substantially in Ontario, with pantoprazole rapidly becoming the most commonly prescribed agent in its class. However, a modest decline in overall PPI use also occurred that may reflect suboptimal translation of emerging drug safety information to clinical practice.

Feasibility and cost of using mobile phones for capturing drug safety information in peri-urban settlement in Ghana: a prospective cohort study of patients with uncomplicated malaria

BackgroundThe growing need to capture data on health and health events using faster and efficient means to enable prompt evidence-based decision-making is making the use of mobile phones for health an alternative means to capture anti-malarial drug safety data. This paper examined the feasibility and cost of using mobile phones vis-à-vis home visit to monitor adverse events (AEs) related to artemisinin-based combination therapy (ACT) for treatment of uncomplicated malaria in peri-urban Ghana.MethodsA prospective, observational, cohort study conducted on 4270 patients prescribed ACT in 21 health facilities. The patients were actively followed by telephone or home visit to document AEs associated with anti-malarial drugs. Call duration and travel distances of each visit were recorded. Pre-paid call cards and fuel for motorbike travels were used to determine cost of conducting both follow-ups. Ms-Excel 2010 and STATA 11.2 were used for analysis.ResultsOf the 4270 patients recruited, 4124 (96.6 %) were successfully followed up and analyzed. Of these, 1126/4124 (27.3 %) were children under 5 years. Most 3790/4124 (91.9 %) follow-ups were done within 7 days of ACT intake. Overall, follow up by phone (2671/4124—64.8 %) was almost two times the number done by home visits (1453/4124—35.2 %). Duration of telephone calls ranged from 38 s to 53 min, costing between GH¢0.26 (0.20USD) and GH¢41.70 (27.USD). On the average, the calls lasted 3 min 51 s (SD = 3 min, 21 s) costing GH¢2.70 (0.77USD). Distance travelled for home visit ranged from 0.65 to 62 km costing GH¢0.29 (0.20USD) and GH¢279.00 (79.70USD). Thirty-two per cent (1128/4124) of patients reported AEs. In total, 1831 AE were reported, 1016/1831(55.5 %) by telephone and 815/1831 (44.5 %) by home visits. Events such as nausea, dizziness, diarrhoea, and vomiting were commonly reported.ConclusionMajority of patients was successfully followed up by telephone and reported the most AEs. The cost of telephone interviewing was almost two times less than the cost of home visit. Telephone follow up should be considered for monitoring drug adverse events in low resource settings.

An overview of pregnancy-related issues in patients with multiple sclerosis.

Although pregnancy in women with multiple sclerosis (MS) is not generally considered high risk, there are some associated therapeutic challenges. The pregnancy-associated reduction in the relapse rate, especially in the third trimester, is followed by a sharp increase in the first few months postpartum. Nevertheless, retrospective evidence for pregnant women with and without MS followed for up to 10years indicates that pregnancy has no perceptible effect on long-term disease course or disability progression. Likewise, MS has noapparent effects on the pregnancy course or fetal outcomes. All disease-modifying therapies (DMTs) have potential adverse effects on fertility and pregnancy outcomes, but the level of risk varies amongst agents. There is some support for continued use of interferon-β and glatiramer acetate throughout pregnancy to reduce the risk of relapse. Use of DMTs during breastfeeding is best avoided if possible. Close evaluation of drug safety information is imperative when managing women with MS who are pregnant or wish to become pregnant. Decision-making should be a shared experience between patient and physician, and the approach must be individualized for each patient.

Future Proofing Adverse Event Monitoring.

‘‘The world is full of signals that we don’t perceive’’ wrote Stephen Jay Gould in ‘‘The Panda’s Thumb’’ [1]. He was suggesting that physical limits of human perception (hearing, smell, touch, taste) lead us to miss signals all around us that other animals with more acute senses can use to their advantage. The fundamental challenge of signal detection [simultaneously heightening both perception (sensitivity) and discrimination (specificity)] is embodied in this quotation, and the paper by Li and colleagues [2] in this issue of Drug Safety aims to turn up the volume in an effort to improve signal detection while screening out excess noise that comes with it. The ‘‘sound’’ on which the authors seek to improve signal detection is not the mating call from a far-away member of the same species, but rather the occurrence of an adverse event resulting from medication use. Patients take medications with the expectation that the benefits will outweigh the risks, and the public expects a positive benefit-risk balance for marketed drugs, provided they are used appropriately. The evidence for both benefits and risks that serves as a foundation for this assessment is constantly being updated and each new piece of information might alter the balance. Adverse event monitoring contributes to these assessments, and the adverse event reports received by the Food and Drug Administration Adverse Event Reporting System (FAERS) represent an ongoing engagement of practitioners, patients, and manufacturers with the US Food and Drug Administration (FDA). The FDA receives more than a million adverse event reports per year, a number that has increased substantially over recent years [3]. This expanding resource for drug safety information is only beneficial if put to constructive use, and the number of reports received by the FAERS rules out certain approaches; reviewing individual case reports and discerning patterns across them becomes impractical at numbers much smaller than the FAERS. Various statistical signal detection methods (such as disproportionality analyses and others) are available to mine this wealth of data and identify potential signals, permitting more targeted investigation, and efficient allocation of limited resources [4]. If a signaling approach generates too many alarms, alarm fatigue might follow, with the consequence of inaction when truly needed. Filtering the signals to reduce false positives is an approach to refining a signaling method, and of greater value with increasing numbers of adverse event reports. However, Evans [4] points out that tinkering with the signaling methods or simply increasing the size of an existing data source will likely only produce marginal gains and that substantial improvement in signal detection requires new types of data, such as might be obtained by combining different types of existing data sources. Li and colleagues [2] extend the framework of adverse event signal detection across data sources by applying their methods in a combined way across different data sources, including a spontaneous reporting system, an inpatient electronic health record system, an outpatient electronic health record system, and a health insurance claims database. They compared the databases across four categories of adverse event (acute myocardial infarction, gastrointestinal bleed, acute renal failure, and acute liver injury), & John D. Seeger jdseeger@partners.org; http://www.drugepi.org

Analysis of reference sources used in drug-related Wikipedia articles.

References from drug-related Wikipedia articles and a drug information database were compared. Drugs in Food and Drug Administration (FDA) MedWatch alerts from January-July 2013 were searched in Wikipedia and Lexicomp to compare reference types and to assess the time for drug safety information to be incorporated into Wikipedia articles. Wikipedia most commonly cited peer-reviewed journal articles (49.2%) and news articles (12.0%). MedWatch citations were incorporated into Wikipedia on average in 5.9 days. Wikipedia cited various sources but may not be a reliable, up-to-date resource for drug safety information.

Conforming Intellectual Property and Privacy Restraints to the Right to Health and the Right to Information in Clinical Trials Data

This paper aims to define a legal framework of clinical trials data, by testing international the European rules of data secrecy against the expanding demands for disclosure. We argue that information embedded in clinical trial protocols turn out to be a precious source for evaluation of drug's safety and efficacy, the awareness of which is thus to be considered essential for protecting patients' and consumers' health. However, clinical trials data do not only have an important public informational value, but also an intrinsic regulatory - and therefore commercial - value, being key to granting of drugs' marketing license. We compare the general disclosure provision provided by art. 84 of the recent European Clinical Trials Regulation, establishing a publicly accessible European clinical trials database, with specific intellectual property measures, providing guarantees of exclusivity to clinical testing data used to obtain marketing approval.Research-based companies aiming to protect their 'sweat of the brow' from the competitors' free-riding, have invoked art. 39.3 TRIPS and the European data exclusivity regimes, as a legal basis for regulatory agencies' non-disclosure obligation. Also privacy concerns have been called upon as a legal barrier to disclosure, due to the vast amount of personal data embedded in the results of test data.Building on these premises, the paper illustrates that clinical trials protection rules or the privacy normative framework do not prevent drug's safety information disclosure. To the contrary we demonstrate a systemic justification for disclosure. In our analysis we read public interest of transparency and accountability in clinical trials information through the subsequent lenses of the human right to health as defined by International Human Rights Treatises and the Human rights case law, of public goods dimension of research and knowledge production, and finally of the legal framework protecting consumer rights as defined by the correspondent European Directives.

The effectiveness of risk communication regarding drug safety information: a nationwide survey by the Japanese public health insurance claims data.

We evaluated the effectiveness of warning letters published by the pharmaceutical regulatory agency in Japan on communication of drug safety and risk by quantitative analysis of the national health insurance claims database (NHICD). We then explored what factors may have affected risk communication. We measured the implementation rate of the hepatitis virus-monitoring test among methotrexate (MTX)-treated patients; a warning letter had been issued regarding the use of MTX, as it apparently activates the hepatitis virus. Data from the NHICD, which include 99·3% of Japanese residents, were used. A total of 4,933,481 patients with rheumatoid arthritis (RA) (January-June, 2010) were the focus of this study. The implementation rate of the hepatitis virus-monitoring test increased from 1·4% before to 1·8% after the warning letter announcement. Logistic regression analysis suggested that the installation of a drug information management room is one of the important factors affecting risk communication. Further analysis revealed that the hepatitis virus monitoring rates in hospitals without drug information management rooms increased from 2·3% to 4·1% due to the issue of the warning letter. The warning letter from the regulatory agency plays an important role in risk communication in hospitals without drug information management rooms.

Mining hidden knowledge for drug safety assessment: topic modeling of LiverTox as a case study.

BackgroundGiven the significant impact on public health and drug development, drug safety has been a focal point and research emphasis across multiple disciplines in addition to scientific investigation, including consumer advocates, drug developers and regulators. Such a concern and effort has led numerous databases with drug safety information available in the public domain and the majority of them contain substantial textual data. Text mining offers an opportunity to leverage the hidden knowledge within these textual data for the enhanced understanding of drug safety and thus improving public health.MethodsIn this proof-of-concept study, topic modeling, an unsupervised text mining approach, was performed on the LiverTox database developed by National Institutes of Health (NIH). The LiverTox structured one document per drug that contains multiple sections summarizing clinical information on drug-induced liver injury (DILI). We hypothesized that these documents might contain specific textual patterns that could be used to address key DILI issues. We placed the study on drug-induced acute liver failure (ALF) which was a severe form of DILI with limited treatment options.ResultsAfter topic modeling of the "Hepatotoxicity" sections of the LiverTox across 478 drug documents, we identified a hidden topic relevant to Hy's law that was a widely-accepted rule incriminating drugs with high risk of causing ALF in humans. Using this topic, a total of 127 drugs were further implicated, 77 of which had clear ALF relevant terms in the "Outcome and management" sections of the LiverTox. For the rest of 50 drugs, evidence supporting risk of ALF was found for 42 drugs from other public databases.ConclusionIn this case study, the knowledge buried in the textual data was extracted for identification of drugs with potential of causing ALF by applying topic modeling to the LiverTox database. The knowledge further guided identification of drugs with the similar potential and most of them could be verified and confirmed. This study highlights the utility of topic modeling to leverage information within textual drug safety databases, which provides new opportunities in the big data era to assess drug safety.

Hospital pharmacists' roles and attitudes in providing information on the safety of non-steroidal anti-inflammatory drugs in Thailand.

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for patients to manage pain and inflammation, especially in older adults. Failure to cope with some adverse drug reactions (ADRs) of NSAIDs could lead to more serious symptoms, therefore, providing useful information about medicine is an important step in protecting patients from developing serious ADRs. The pharmacy service should be a frequent source of medicine information for patients, however in Thailand, little is known about pharmacists' provision of safety information to patients for management and prevention of these ADRs. Aims of this study were to determine Thai hospital pharmacists' roles in providing drug safety information and to assess their attitudes towards the importance of giving drug safety education to patients. All government hospitals in north-eastern Thailand. This study was a cross-sectional survey. A total of 761 pharmacists in 287 hospitals in north-eastern Thailand were selected by stratified random sampling. Self-administered questionnaires were sent by post, with two reminders. Proportion of hospital pharmacists providing ADR information on NSAIDs to patients, factors affecting this provision, and pharmacist attitudes towards drug safety education for patients. The response rate was 54.8% (N = 417), the majority of respondents worked in community hospitals (57.2%). A total of 347 pharmacists (83.6%) had informed patients about ADRs, although less than half had informed patients about ADR monitoring and management (36.6% and 44.1% respectively). The proportion of time spent in direct patient contact, type of hospital, and other routine work were associated with the frequency of drug safety information provision. Pharmacists had moderately good attitudinal scores towards drug safety education (62.2 ± 5.4), with significantly higher scores found in those who provided most ADR information to patients (60.3 ± 5.2 vs. 62.6 ± 5.4, P = 0.002). The majority (82.2%) agreed that patient information leaflets should be provided. Thai hospital pharmacists' provision of ADR information for NSAIDs may occur less frequently than is desirable. However, their positive attitude towards provision of ADR information suggests that drug safety education by pharmacists should be routinely provided to patients, particularly patients at high risk of NSAID use.

Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).

BackgroundThe US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that “stimulated reporting” of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA.ObjectiveTo determine the extent of “stimulated reporting” in the modern-day FAERS database.MethodsOne hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA’s MedWatch and main websites. Publicly available FAERS data were used to assess the “primary suspect” AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert.ResultsA few drugs did demonstrate “stimulated reporting” trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham “control alert”, the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase.ConclusionsOur results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-014-0225-0) contains supplementary material, which is available to authorized users.

Improving postapproval drug safety surveillance: getting better information sooner.

Adverse drug events (ADEs) are an important public health concern, accounting for 5% of all hospital admissions and two-thirds of all complications occurring shortly after hospital discharge. There are often long delays between when a drug is approved and when serious ADEs are identified. Recent and ongoing advances in drug safety surveillance include the establishment of government-sponsored networks of population databases, the use of data mining approaches, and the formal integration of diverse sources of drug safety information. These advances promise to reduce delays in identifying drug-related risks and in providing reassurance about the absence of such risks.

New initiatives for pharmacovigilance in South Korea: introducing the Korea Institute of Drug Safety and Risk Management (KIDS)

Pharmacovigilance plays a vital role in ensuring that patients receive appropriate medical products that are safe and effective. This paper aims to describe the history of pharmacovigilance in Korea and introduce the establishment and goal of the KIDS. In Korea, the adverse drug reactions (ADR) reporting system was launched in 1988 by the Korea Ministry of Food and Drug Safety (MFDS) and spontaneous ADR reports have been collected from health care professionals and the general public. Although the ADR reporting system has begun, the reporting rate was very low in the first 10 years, and safety actions were done passively in response to the US Food and Drug Administration (FDA) or European Medicines Agency (EMA)'s safety alert and communications. Therefore, the Korea Institute of Drug Safety and Risk Management (KIDS) was established in April 2012 as a new initiative for pharmacovigilance. The KIDS will continue to contribute to the improvement of Korean pharmacovigilance by collecting, managing, and analyzing consumer-centered drug safety information.

Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform.

BackgroundThere is limited safety information on most drugs used during pregnancy. This is especially true for medication against tropical diseases because pharmacovigilance systems are not much developed in these settings. The aim of the present study was to demonstrate feasibility of using Health and Demographic Surveillance System (HDSS) as a platform to monitor drug safety in pregnancy.MethodsPregnant women with gestational age below 20 weeks were recruited from Reproductive and Child Health (RCH) clinics or from monthly house visits carried out for the HDSS. A structured questionnaire was used to interview pregnant women. Participants were followed on monthly basis to record any new drug used as well as pregnancy outcome.Results1089 pregnant women were recruited; 994 (91.3%) completed the follow-up until delivery. 98% women reported to have taken at least one medication during pregnancy, mainly those used in antenatal programmes. Other most reported drugs were analgesics (24%), antibiotics (17%), and antimalarial (15%), excluding IPTp. Artemether-lumefantrine (AL) was the most used antimalarial for treating illness by nearly 3/4 compared to other groups of malaria drugs. Overall, antimalarial and antibiotic exposures in pregnancy were not significantly associated with adverse pregnancy outcome. Iron and folic acid supplementation were associated with decreased risk of miscarriage/stillbirth (OR 0.1; 0.08 – 0.3).ConclusionAlmost all women were exposed to medication during pregnancy. Exposure to iron and folic acid had a beneficial effect on pregnancy outcome. HDSS proved to be a useful platform to establish a reliable pharmacovigilance system in resource-limited countries. Widening drug safety information is essential to facilitate evidence based risk-benefit decision for treatment during pregnancy, a major challenge with newly marketed medicines.