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Journal Cover Drug Safety
  [SJR: 1.359]   [H-I: 103]   [117 followers]  Follow
    
   Full-text available via subscription Subscription journal
   ISSN (Print) 0114-5916 - ISSN (Online) 1179-1942
   Published by Adis Homepage  [20 journals]
  • Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza
           Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study
    • Abstract: Introduction and Aim A trivalent live attenuated influenza vaccine (Nasovac-S®) was developed and licensed in India. A phase 4 study was conducted to assess safety. Methodology This non-randomized, open-label, single-arm study among individuals ≥ 2 years of age involved administration of 0.5 mL of Nasovac-S intranasally, with a 1-month follow-up after vaccination. Adverse events (AEs) were collected via structured diaries. Results Among 500 vaccinated subjects, 160 were between 2 and 17 years of age, 240 were 18–49 years old and 100 were 50 years and older. A total of 533 solicited reactions were reported. The majority of these reactions were mild, and almost all of them resolved without any sequelae. A total of 20% of subjects reported at least one local solicited reaction, and 23% reported at least one systemic solicited reaction. None of the 45 unsolicited AEs reported by 37 subjects (7.4%) were causally related to the study vaccine. Conclusions The data from the study adds to the existing safety database of Nasovac-S. Registry Clinical Trials Registry of India (CTRI/2015/08/006074).
      PubDate: 2017-10-12
       
  • Utilisation and Safety of Deferasirox: Results from an Observational
           Cohort Study in England
    • Abstract: Introduction Deferasirox (EXJADE®, Novartis, UK) is an oral iron-chelating agent primarily used to reduce chronic iron overload in patients receiving blood transfusions for various chronic anaemias and some non-transfusion dependant anaemias. Objective The aim of this study was to examine the utilisation and safety of deferasirox used in general practice in England. Method A single exposure observational cohort study design was used. Patients were identified from dispensed prescriptions for deferasirox between September 2006 and September 2014. Outcome data were collected via postal questionnaires sent to prescribers ≥ 6 months after first dispensed prescription for an individual patient. Summary descriptive statistics were calculated. Results The evaluable cohort consisted of 122 patients, of which 41.8% were aged 2–17 years. Frequent reasons for prescribing were sickle cell anaemia (27/103 where specified, 26.2%) and beta thalassaemia (26, 25.2%). The majority of patients (43/51, 84.3%) were prescribed the licensed doses of 10 or 20 mg/kg/day at start. Prior measurements of serum creatinine were only reported for a small proportion this study (18/122, 14.8%). In total, 91 incident events were reported, including two of raised serum creatinine. Conclusion These results show that deferasirox is largely being prescribed for its licensed indications in general practice in England and events reported were consistent with the known safety profile.
      PubDate: 2017-10-10
       
  • An Update on ISoP Special Interest Groups (SIGs)
    • PubDate: 2017-10-04
       
  • Overview of Pharmacovigilance System in Vietnam: Lessons Learned in a
           Resource-Restricted Country
    • Abstract: Drug safety issues in developing countries are complex and sensitive, and health authorities cannot always simply implement decisions from developed countries because the health system, disease patterns, and lists of marketed drugs all differ. A system for proactive and effective surveillance of drugs in each nation is needed to identify and manage the exact drug-related problems faced by patients in these countries. Vietnam launched its university-based National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) in 2009, a significant step towards catching up with international trends. Although the center is still in its infancy and has limited resources, it has attained some achievements and largely met the minimum World Health Organization requirements for a functional pharmacovigilance center. The number of reports has increased rapidly, with some important signals generated from the national database leading to regulatory actions at a national level. In addition, this system can help detect drug-quality problems that are less common in developed countries. The success of the quantity and quality of reporting, risk assessment, and communication is still limited compared with more developed systems. A number of opportunities remain to enhance the system, particularly in risk communication and evaluation of the impact of pharmacovigilance, and to apply reporting outcomes to reduce drug-related risks throughout the country. More internal and external support is needed to develop a stronger and more comprehensive pharmacovigilance system.
      PubDate: 2017-10-03
       
  • The New Phase of ISoP
    • PubDate: 2017-10-01
       
  • Lipophilic Statins and the Risk of Intracranial Hemorrhage Following
           Ischemic Stroke: A Population-Based Study
    • Abstract: Background Statins are commonly prescribed for the secondary prevention of ischemic stroke, but there is conflicting evidence as to whether they increase the risk of intracranial hemorrhage. Lipophilic statins cross the blood–brain barrier more freely than hydrophilic statins and may therefore increase the risk of intracranial hemorrhage. Objective To determine whether, in older patients following ischemic stroke, receipt of lipophilic statins was associated with differences in the risk of intracranial hemorrhage. Methods We conducted a population-based nested case-control study linking multiple healthcare databases between 1 April, 2001 and 31 March, 2015 in Ontario, Canada. Cases were Ontarians aged 66 years or older receiving a statin within 100 days preceding the development of intracranial hemorrhage within 1 year following ischemic stroke. Each case was matched with up to four controls who experienced ischemic stroke not complicated by intracranial hemorrhage but who also received a statin. We classified statins as lipophilic (atorvastatin, simvastatin, lovastatin, fluvastatin, and cerivastatin) or hydrophilic (pravastatin and rosuvastatin) based on their octanol/water partition coefficients. We calculated the odds ratio for the association between intracranial hemorrhage and receipt of lipophilic statins, with hydrophilic statins as the reference group. Results We identified 2766 individuals who experienced intracranial hemorrhage during statin therapy after ischemic stroke and 11,060 matched controls. Relative to hydrophilic statins, lipophilic statins were not associated with an increased risk of intracranial hemorrhage (adjusted odds ratio 1.07; 95% confidence interval 0.97–1.19). Conclusion Among patients treated with a statin following ischemic stroke, the risk of intracranial hemorrhage is not influenced by statin lipophilicity.
      PubDate: 2017-10-01
       
  • Comment on “Patient Reporting in the EU: Analysis of EudraVigilance
           Data”
    • PubDate: 2017-10-01
       
  • Brian A. Baldo, Safety of Biologics Therapy: Monoclonal Antibodies,
           Cytokines, Fusion Proteins, Hormones, Enzymes, Coagulation Proteins,
           Vaccines, Botulinum Toxins, 1st Edition, Springer, 2016, Print Book ISBN:
           978-3-319-30470-0, e-Book ISBN 978-3-319-30472-4
    • PubDate: 2017-10-01
       
  • Statin Therapy and Risk of Intracranial Hemorrhage in Patients with
           Ischemic Stroke
    • PubDate: 2017-10-01
       
  • Promoting and Protecting Public Health: How the European Union
           Pharmacovigilance System Works
    • Abstract: This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks. The main objectives of the system are to promote and protect public health by supporting the availability of medicines including those that fulfil previously unmet medical needs, and reducing the burden of adverse drug reactions. These are achieved through a proactive, risk proportionate and patient-centred approach, with high levels of transparency and engagement of civil society. In the European Union, pharmacovigilance is now fully integrated into the life cycle of medicinal products, with the planning of pharmacovigilance activities commencing before a medicine is placed on the market, and companies encouraged to start planning very early in development for high-innovation products. After authorisation, information on the safety of medicines continues to be obtained through a variety of sources, including spontaneous reports of adverse drug reactions or monitoring real-world data. Finally, the measurement of the impact of pharmacovigilance activities, auditing and inspections, as well as capacity building ensure that the system undergoes continuous improvement and can always rely on the best methodologies to safeguard public health.
      PubDate: 2017-10-01
       
  • Updating the Evidence of the Interaction Between Clopidogrel and
           CYP2C19-Inhibiting Selective Serotonin Reuptake Inhibitors: A Cohort Study
           and Meta-Analysis
    • Abstract: Introduction We previously found that patients who initiate clopidogrel while treated with a cytochrome P450 (CYP) 2C19-inhibiting selective serotonin reuptake inhibitor (SSRI) have a higher risk of subsequent ischemic events than patients treated with other SSRIs. It is not known whether initiating an inhibiting SSRI while treated with clopidogrel will also increase risk of ischemic events. Objective The aim of this study was to assess clinical outcomes following initiation of a CYP2C19-inhibiting SSRI versus initiation of other SSRIs among patients treated with clopidogrel and to update existing evidence on the clinical impact of clopidogrel–SSRI interaction. Methods Using five US databases (1998–2013), we conducted a cohort study of clopidogrel initiators who encountered treatment with SSRI during their clopidogrel therapy. Patients were matched by propensity score (PS) and followed for as long as they were exposed to both clopidogrel and index SSRI group. Outcomes were a composite ischemic event (myocardial infarction, ischemic stroke, or a revascularization procedure, whichever came first) and a composite major bleeding event (gastrointestinal bleed or hemorrhagic stroke, whichever came first). Results were combined via random-effects meta-analysis with previous evidence from subjects initiating clopidogrel while on SSRI therapy. Results The PS-matched cohort comprised 2346 clopidogrel users starting CYP2C19-inhibiting SSRI therapy and 16,115 starting other SSRIs (mean age 61 years; 59% female). Compared with those treated with a non-inhibiting SSRI, the hazard ratio (HR) for patients treated with a CYP2C19-inhibiting SSRI was 1.07 (95% confidence interval [CI] 0.82–1.40) for the ischemic outcome and 1.00 (95% CI 0.42–2.36) for bleeding. The pooled estimates were 1.11 (95% CI 1.01–1.22) for ischemic events and 0.80 (95% CI 0.55–1.18) for bleeding. Conclusions We observed similar estimates of association between the two studies. The updated evidence still indicates a small decrease in clopidogrel effectiveness associated with concomitant exposure to clopidogrel and CYP2C19-inhibiting SSRIs.
      PubDate: 2017-10-01
       
  • Patients’ Perspectives on Adverse Drug Reaction Reporting in a
           Developing Country: A Case Study from Ghana
    • Abstract: Introduction Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients’ perspectives regarding adverse drug reaction reporting in developing countries. Objective The objective of this study was to explore patients’ knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana. Methods A cross-sectional study using questionnaires administered through face-to-face interviews was carried out from 25 August, 2016 to 20 September, 2016 with 442 patients aged 18 years and above selected by convenience sampling from two community pharmacies in urban and rural Ghana. Reasons and opinions on patients’ reporting on adverse drug reactions were surveyed using a 5-point Likert scale. The Pearson chi-square test was used to determine associations between background variables and responses on knowledge of adverse drug reaction reporting. Results Responses from 434 patients (86.7%) were included in the analysis. Among those interviewed, there was a high level of awareness regarding the existence of the National Pharmacovigilance Centre (81.6%). Approximately half of the respondents (49.5%) were aware that patients were able to report adverse drug reactions associated with medicinal products directly to the National Pharmacovigilance Centre. Of the respondents, 46.3% stated that they had an adverse drug reaction to their medicines in the past; of these, 53.2% reported to healthcare professionals and 36.9% failed to report because they stopped their medication. The three main reasons for patients’ reporting were desire for extra information (92.4%), desire to share experiences with other people (91.7%) and expectation for the National Pharmacovigilance Centre to inform others about the possible adverse drug reactions (88.0%). Patients’ opinions were to contribute to research/knowledge (96.5%) and improvements in drug safety (96.5%). Patients’ behaviour towards adverse drug reaction reporting was affected by the likely consequences of reporting, influence of others and the ease of reporting. Conclusion Patients have a positive attitude and good knowledge on adverse drug reaction reporting to the National Pharmacovigilance Centre and report because they expect extra information and to contribute to drug safety. Patients’ positive attitude towards adverse drug reaction reporting could be sustained by hosting periodic public awareness campaigns addressing the importance of adverse drug reaction reporting and by providing timely feedback to patients on regulatory decisions taken as a result of the reports that they submitted.
      PubDate: 2017-10-01
       
  • 17th ISoP Annual Meeting “Pharmacovigilance in the 21st Century”
           Liverpool, UK 15–18 October, 2017
    • PubDate: 2017-10-01
       
  • Frequency and Nature of Medication Errors and Adverse Drug Events in
           Mental Health Hospitals: a Systematic Review
    • Abstract: Introduction Little is known about the frequency and nature of medication errors (MEs) and adverse drug events (ADEs) that occur in mental health hospitals. Objectives This systematic review aims to provide an up-to-date and critical appraisal of the epidemiology and nature of MEs and ADEs in this setting. Method Ten electronic databases were searched, including MEDLINE, Embase, CINAHL, International Pharmaceutical s, PsycINFO, Scopus, British Nursing Index, ASSIA, Web of Science, and Cochrane Database of Systematic Reviews (1999 to October 2016). Studies that examined the rate of MEs or ADEs in mental health hospitals were included, and quality appraisal of the included studies was conducted. Result In total, 20 studies were identified. The rate of MEs ranged from 10.6 to 17.5 per 1000 patient-days (n = 2) and of ADEs from 10.0 to 42.0 per 1000 patient-days (n = 2) with 13.0–17.3% of ADEs found to be preventable. ADEs were rated as clinically significant (66.0–71.0%), serious (28.0–31.0%), or life threatening (1.4–2.0%). Prescribing errors occurred in 4.5–6.3% of newly written or omitted prescription items (n = 3); dispensing errors occurred in 4.6% of opportunities for error (n = 1) and in 8.8% of patients (n = 1); and medication administration errors occurred in 3.3–48.0% of opportunities for error (n = 5). MEs and ADEs were frequently associated with psychotropics, with atypical antipsychotic drugs commonly involved. Variability in study setting and data collection methods limited direct comparisons between studies. Conclusion Medication errors occur frequently in mental health hospitals and are associated with risk of patient harm. Effective interventions are needed to target these events and improve patient safety.
      PubDate: 2017-10-01
       
  • Muscular Adverse Drug Reactions Associated with Proton Pump Inhibitors: A
           Disproportionality Analysis Using the Italian National Network of
           Pharmacovigilance Database
    • Abstract: Introduction Proton pump inhibitors (PPIs) have been implicated in the occurrence of moderate to severe myopathies in several case reports. Aim This study was performed to assess the reporting risk of muscular adverse drug reactions (ADRs) associated with PPIs in the Italian National Network of Pharmacovigilance database. Methods A disproportionality analysis (case/non-case) was performed using spontaneous reports collected in the database between July 1983 and May 2016. Reporting odds ratio (ROR) and 95% confidence intervals (CIs) were calculated as a measure of disproportionality. In a secondary and tertiary analysis, we explored the association of PPIs with muscular ADRs after taking into account the masking effect of statins. Moreover, the possibility of an interaction between PPIs and statins, leading to the occurrence of muscular ADRs, was also tested. Results The study was carried out on 274,108 reports. The ROR of muscular ADRs for PPIs, adjusted for age and gender, was 1.484 (95% CI 1.204–1.829; p < 0.001), whereas the ROR for rhabdomyolysis was 0.621 (95% CI 0.258–1.499). Similar results were obtained in the secondary analysis. The tertiary analysis, where PPIs were considered regardless of whether their role was suspected or concomitant, showed a potential disproportionate reporting for the combination PPIs–rhabdomyolysis (ROR 1.667, 95% CI 1.173–2.369; p < 0.01). The PPIs–statins combination was not associated with an enhanced ROR of muscular ADRs/rhabdomyolysis compared with statins alone. Conclusions This explorative study suggests that the class of PPIs could be involved in reports of muscular ADRs, rather than any other ADR, more frequently than any non-statin drug. Our results must be corroborated by further studies.
      PubDate: 2017-10-01
       
  • Preferences of Patients and Pharmacists with Regard to the Management of
           Drug–Drug Interactions: A Choice-Based Conjoint Analysis
    • Abstract: Introduction The management of drug–drug interactions (DDIs) is a complex process in which risk–benefit assessments should be combined with the patient’s perspective. Objective The aim of this study was to determine patients’ and pharmacists’ preferences regarding DDI management. Methods We conducted a choice-based conjoint survey about a fictitious DDI concerning the combination of a cardiovascular drug and an antibiotic for pneumonia. Patients and pharmacists had to choose 12 times between two management options. The options were described by five attributes, including risk, benefit and practical consequences. Each attribute could have two different levels, which were varied over the choice tasks. Latent class analysis was used to identify potential classes of respondents with distinct patterns of similar preferences. Results In total, 298 patients and 178 pharmacists completed the questionnaire. The latent class model for both patients and pharmacists resulted in three classes. For patients, in one class the most importance was attached to avoiding switch of medication (class probability 20%), in a second class to fewer adverse events (41%), and in a third class to blood sampling (39%). For pharmacists, again one class attached the highest importance to avoiding switch of medication (31%). The other classes gave priority to curing pneumonia (31%) and avoiding blood sampling (38%). Conclusion The results showed diverging preferences regarding DDI management among both patients and pharmacists. Different groups attached different value to risk and benefit versus practical considerations. Awareness of existing variability in preferences among and between pharmacists and patients is a step towards shared decision making in DDI management.
      PubDate: 2017-09-30
       
  • All-Cause and Drug-Related Medical Events Associated with Overuse of
           Gabapentin and/or Opioid Medications: A Retrospective Cohort Analysis of a
           Commercially Insured US Population
    • Abstract: Introduction Overuse of gabapentin and/or opioids occurs in a small percentage of patients at > 3-fold labeled dosages. Gabapentin may potentiate opioid effects. Objective The aim was to assess patient harm, defined as use of inpatient hospital (IPH) or emergency department (ED) services, associated with overuse of gabapentin with or without concomitant overuse of opioids. Data source Data were sourced from the Truven Health MarketScan® Commercial Claims and Encounters database, for the years 2013–2015. Eligibility criteria The eligibility criteria were two or more claims (billed encounters) and ≥120 days of treatment with gabapentin and/or opioids. Methods Cohort identification was based on daily-dosage thresholds of 50 morphine-milligram equivalents and 3600 mg of gabapentin in a 12-month follow-up: (1) no overuse; (2) mild overuse (two or more claims or two or fewer calendar quarters over threshold); and (3) sustained overuse (three or more over-threshold calendar quarters). IPH and ED use were measured for 6 months after the first overuse date (cohorts 2 and 3) or a randomly assigned date (cohort 1). Logistic regression analyses controlled for pre-treatment IPH/ED utilization, indication, addiction diagnosis, concomitant sedative/hypnotic use, and demographics. Results All-cause and drug-related IPH/ED utilization increased monotonically with degree of overuse, particularly of more than one medication. Sustained overuse of gabapentin multiplied odds of all-cause IPH by 1.366 [95% confidence interval (CI) 1.055–1.769], drug-related IPH by 1.440 (95% CI 1.010–2.053), and IPH/ED for altered mental status (e.g., euphoria, anxiety) by 1.864 (95% CI 1.324–2.624). Sustained overuse of both medications quadrupled odds of all-cause IPH, drug-related IPH, and IPH/ED for altered mental status or respiratory depression. Conclusion Despite modest effects of gabapentin overuse alone, overuse of gabapentin with opioids may increase risk of harm and health-service utilization, supporting calls to make gabapentin a controlled substance in the USA.
      PubDate: 2017-09-27
       
  • Can SGLT2 Inhibitors Cause Acute Renal Failure' Plausible Role for
           Altered Glomerular Hemodynamics and Medullary Hypoxia
    • Abstract: Sodium–glucose co-transporter-2 inhibitors (SGLT2i) provide outstanding long-term cardiovascular and renal protection in high-risk patients with type 2 diabetes mellitus. Yet, despite encouraging renal safety outcomes reported in the EMPA-REG study, scattered reports suggest that there might be a risk for acute kidney injury (AKI), which may occasionally be fatal or might require renal replacement therapy. Reduced trans-glomerular pressure with a modest decline in kidney function, an inherent characteristic of SGLT2i therapy, conceivably forms the basis for the long-term renal protection, resembling agents that block the renin–angiotensin–aldosterone (RAAS) axis. Yet, a major decline in kidney function occasionally occurs, often associated with an acute illness or with specific co-administered medications. SGLT2i may lead to AKI by (a) effective volume depletion, due to excessive diuresis, particularly in hemodynamically unstable and volume-depleted patients; (b) excessive decline in trans-glomerular pressure, specifically in patients on RAAS blockade; and (c) induction of renal medullary hypoxic injury, related to enhanced distal tubular transport, especially with concomitant use of agents impairing medullary oxygenation, such as non-steroidal anti-inflammatory drugs and radiocontrast agents. The risk of developing renal impairment with SGLT2i and the role of these suggested mechanisms are yet to be defined, as there are conflicting data and inconsistent reporting with the various agents currently in use.
      PubDate: 2017-09-26
       
  • Safety Concerns Reported by Patients Identified in a Collaborative Signal
           Detection Workshop using VigiBase: Results and Reflections from Lareb and
           Uppsala Monitoring Centre
    • Abstract: Introduction Patient reporting in pharmacovigilance is important and contributes to signal detection. However, descriptions of methodologies for using patient reports in signal detection are scarce, and published experiences of how patient reports are used in pharmacovigilance are limited to a few individual countries. Objective Our objective was to explore the contribution of patient reports to global signal detection in VigiBase. Methods Data were retrieved from VigiBase in September 2016. Drug–event-combination series were restricted to those with >50% patient reports, defined as reporter type “Consumer/non-health professional” per E2B reporting standard. vigiRank was applied to patient reports to prioritize combinations for assessment. Product information for healthcare professionals (HCPs) as well as patient information leaflets (PILs) were used as reference for information on adverse drug reactions (ADRs). Staff from the Uppsala Monitoring Centre and the Netherlands Pharmacovigilance Centre Lareb categorized the combinations. Potential signals proceeded to a more in-depth clinical review to determine whether the safety concern should be communicated as a “signal.” Results Of the 212 combinations assessed, 20 (9%) resulted in eight signals communicated within the World Health Organization (WHO) programme for international drug monitoring. Review of PILs revealed insufficient ADR descriptions for patients and examples of poor consistency with product information for HCPs. Patient narratives provided details regarding the experience and impact of ADRs and evidence that patients make causality and personal risk assessments. Conclusions Safety concerns described in patient reports can be identified in a global database including previously unknown ADRs as well as new aspects of known ADRs. Patient reports provide unique information valuable in signal assessment and should be included in signal detection. Novel approaches to highlighting patient reports in statistical signal detection can further improve the contribution of patient reports to pharmacovigilance.
      PubDate: 2017-09-20
       
  • A New Erice Report Considering the Safety of Medicines in the 21st Century
    • Abstract: Pharmacovogilance policy, methods and practice require transformation at all levels to create an integrated, comprehensive, continuously improving system, fulfilling the broader remit of overall healthcare vigilance. In pursuit of this vision, energetic measures, including active engagement with patients, are needed to reduce our ignorance about many aspects of patients’ experience of medical therapies and their outcomes, including the benefits, but especially the extensive harm known to be caused by medical interventions. More information and communication in this domain will help set more accurate and realistic public expectations about the benefits and harm of therapy. All aspects of medicines development, regulation and use must be characterized by openness, transparency, ethical practice and a primary focus on the benefit and self-determined choices of patients. Notwithstanding, progress has been made in medicines safety information and communication but significant gaps and deficiencies remain. Promotion of the most beneficial use of medicines and the prevention of harm have not advanced sufficiently. This paper is a report from a group of experts, following previous similar decade reviews: the Erice Declaration (1996) and the Erice Manifesto (2006).
      PubDate: 2017-08-17
       
 
 
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