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Taylor D.,Maudsley Hospital | Taylor D.,Kings College London | Cornelius V.,Drug Safety Research Unit
Journal of Psychopharmacology | Year: 2010

We examined factors associated with hospital admissions and bed stay for 211 patients prescribed risperidone long-acting injection (RLAI) in clinical practice. Hospital bed days increased by a median of 74 days in the 3 years after RLAI initiation compared with the 3 years before initiation (P < 0.0001). Only subjects starting RLAI as outpatients showed no increase in bed days after RLAI initiation. A greater than expected number of bed days was observed in women (36% increase), patients prescribed >25 mg/2 weeks (70% increase) and patients previously treated with clozapine (118% increase). Overall, number of hospital admissions did not increase, although those previously prescribed clozapine saw a 31% increase in admissions compared with patients not previously exposed to clozapine. This and other analyses of the same patient cohort indicate that RLAI produces most favourable outcomes in outpatients and those not previously treated with clozapine. © The Author(s), 2010. Source


Osborne V.,Drug Safety Research Unit
Adverse Drug Reaction Bulletin | Year: 2013

Hypoactive sexual desire disorder (HSDD) is a common sexual disorder in postmenopausal women. Testosterone therapy is a possible option for treatment of HSDD in postmenopausal women, although there are concerns over the safety of testosterone use. Clinical trial data have been limited so far, although more trial results are awaited. Additionally, there is a lack of larger long-term observational studies which have addressed this issue, identifying research gaps in this topic. Androgenic disorders, such as hirsutism, are established adverse effects of testosterone use in women. However, the relationship between breast cancer, endometrial cancer, ovarian cancer and cardiovascular events with testosterone therapy is unclear in postmenopausal women, given the available evidence. As such, any preexisting risk factors for these events may be considered in patients treated with testosterone, along with the acceptability of potential androgenic adverse effects that the patient may experience. Overall, there is still a lack of clarity on the safety of using testosterone therapy for HSDD in postmenopausal women and data from further studies are needed to draw a firm conclusion. © 2013 Lippincott Williams &Wilkins. Source


McLernon D.J.,University of Aberdeen | Bond C.M.,University of Aberdeen | Hannaford P.C.,University of Aberdeen | Watson M.C.,University of Aberdeen | And 3 more authors.
Drug Safety | Year: 2010

Background: In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports. Objective: To compare patient characteristics, suspected drugs and suspected ADRs reported by patients with those reported by healthcare professionals using the YCS. Design and Setting: Retrospective observational study in the UK. Methods: Participants were patients reported to the Medicines and Healthcare products Regulatory Agency (MHRA), either by themselves, a representative or a healthcare professional, as having one or more suspected ADRs between October 2005 and September 2007. The main outcome measures were ADRs and time taken to report. Results: In total, 26 129 Yellow Card reports from patients and healthcare professionals were received from the MHRA for the 2-year study period (19.8% patient and 80.2% healthcare professional). More Yellow Card reports were made for female than male patients (p < 0.001). Patients reported a significantly higher number of suspected ADRs per report than healthcare professionals (median [interquartile range {IQR}] of 3 [2-5] vs 2 [1-3], respectively; p < 0.001). A higher proportion of patient reports (16.1%) contained more than one suspect drug than healthcare professional reports (9%; p < 0.001). Healthcare professional reports had a higher proportion of ADRs that caused hospitalization (18.8% vs 12.9%), were life threatening (11.1% vs 6.2%) or caused death (2.6% vs 0.7%) than patient reports (all p < 0.001). Patient reporters took a significantly longer time to report their reaction than healthcare professionals (median [IQR] of 104 [27-463] vs 28 [13-75] days respectively; p < 0.001). Direct comparisons of the seriousness of the ADRs were not possible because of important differences between patient and healthcare professional versions of the Yellow Cards. Conclusions: This is the first substantial, published study in the UK to compare Yellow Card reports from patients and healthcare professionals. Whilst patients report more suspected ADRs to more suspect drugs than healthcare professionals, healthcare professionals tend to report more serious reactions that result in hospitalization, are life threatening or cause death. Further research is required to investigate the extent to which the extra information from patient reporters contributes to signal identification when assessing drug safety. © 2010 Adis Data Information BV. All rights reserved. Source


Margulis A.V.,RTIHealth Solutions | Pladevall M.,RTIHealth Solutions | Riera-guardia N.,RTIHealth Solutions | Varas-lorenzo C.,RTIHealth Solutions | And 5 more authors.
Clinical Epidemiology | Year: 2014

Methods: We tailored both tools and added four questions to the RTI-IB. Two reviewers assessed the quality of the 44 included studies with both tools, (independently for the RTI-IB) and agreed on which responses conveyed low, unclear, or high risk of bias. For each question in the RTI-IB (n=31), the observed interrater agreement was calculated as the percentage of studies given the same bias assessment by both reviewers; chance-adjusted interrater agreement was estimated with the first-order agreement coefficient (AC1) statistic.Background: The study objective was to compare the Newcastle-Ottawa Scale (NOS) and the RTI item bank (RTI-IB) and estimate interrater agreement using the RTI-IB within a systematic review on the cardiovascular safety of glucose-lowering drugs.Results: The NOS required less tailoring and was easier to use than the RTI-IB, but the RTI-IB produced a more thorough assessment. The RTI-IB includes most of the domains measured in the NOS. Median observed interrater agreement for the RTI-IB was 75% (25th percentile [p25] =61%; p75 =89%); median AC1 statistic was 0.64 (p25 =0.51; p75 =0.86).Conclusion: The RTI-IB facilitates a more complete quality assessment than the NOS but is more burdensome. The observed agreement and AC1 statistic in this study were higher than those reported by the RTI-IB’s developers. © 2014 Margulis et al. Source


Hazell L.,Drug Safety Research Unit | Hazell L.,University of Portsmouth | Cornelius V.,Drug Safety Research Unit | Cornelius V.,University of Portsmouth | And 4 more authors.
Drug Safety | Year: 2013

Background: In 2005, spontaneous reporting of adverse drug reactions (ADRs) to the UK's Yellow Card Scheme (YCS) was extended to include patient reports. Here, we investigate the potential pharmacovigilance impact of patient reporting. Objectives: The aim of the study was to investigate the relative contribution of patient reporting to signal detection through disproportionality analysis. Methods: Data were analysed from all reports submitted directly to the YCS between October 2005 and September 2007. Three datasets of drug-ADR pairs were created: one for patient reports, one for healthcare professional (HCP) reports and one for all reports combined. The proportional reporting ratio (PRR) method was used to identify signals of disproportionate reporting (SDRs) in each dataset. The number of SDRs identified from patient and HCP reports were compared, as well as the type of ADR and suspect drug involved. A sensitivity analysis was performed to examine how combining the patient and HCP reports may affect the SDRs identified. Results: Data were received for 5,180 patient and 20,949 HCP reports, relating to 16,566 and 28,775 drug-ADR pairs, respectively, with 4,340 (10.6 %) pairs found in both datasets. A significantly higher proportion of the SDRs identified from HCP reports involved reactions classified as serious by the Medicines and Healthcare products Regulatory Agency (MHRA), compared with patient reports (n = 931, 48.0 % vs. n = 185, 28.5 %), or involved newly marketed drugs (n = 596, 30.7 % vs. n = 71, 10.9 %). The proportion of SDRs assessed as not listed on the Summary of Product Characteristics (SPC) was similar in each group (~15 %, based on a random sample). After combining the patient and HCP reports, 278 (~11 %) of the SDRs identified when each group was analysed separately no longer met the SDR criteria, including 12 potentially serious ADRs not listed on the product's SPC. On the other hand, the combined dataset identified an additional 508 SDRs that were not identified when patient or HCP reports were analysed separately. Approximately 10 % (n = 47) of these additional SDRs were assessed as serious ADRs and were not listed on the product's SPC. Conclusions: Although this study is limited to the UK experience, overall, the results suggest that patient reporting may provide a positive complementary contribution to that of HCPs. Patient reporting may make an important contribution to drug safety by identifying different SDRs not identified from HCP reports alone. The combination of reports from patients and HCPs, however, when used for the purposes of signal detection through disproportionality analysis, may result in the loss of some information. One possible strategy is to conduct such analyses using reports from patients and HCPs combined, as well as separately for each group. © 2013 Springer International Publishing Switzerland. Source

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