scholarly journals Prescribing Variation in General Practices in England Following a Direct Healthcare Professional Communication on Mirabegron

2018 ◽  
Author(s):  
Frank Moriarty ◽  
Shegufta Razzaque ◽  
Ronald McDowell ◽  
Tom Fahey
Keyword(s):  
Healthcare Professional ◽  
Interrupted Time Series ◽  
Professional Communication ◽  
European Medicines Agency ◽  
Area Deprivation ◽  
Safety Issues ◽  
Practice Characteristics ◽  
Before And After ◽  
Prescribing Behaviour ◽  
General Practices

Introduction Pharmacovigilance may detect safety issues after marketing of medications, and this can result in regulatory action such as direct healthcare professional communications (DHPC). DHPC can be effective in changing prescribing behaviour, however the extent to which prescribers vary in their response to DHPC is unknown. This study aims to explore changes in prescribing and prescribing variation among GP practices following a DHPC on the safety of mirabegron, a medication to treat overactive bladder (OAB). Methods This is an interrupted time series study of English GP practices from 2014-2017. NHS Digital provided monthly statistics on aggregate practice-level prescribing and practice characteristics (practice staff and registered patient profiles, Quality & Outcomes Framework indicators, and deprivation of the practice area). The primary outcome was monthly mirabegron items as a percentage of all OAB drug items. The exposure was a DHPC issued by the European Medicines Agency in September 2015. Variation between practices in mirabegron prescribing before and after the DHPC was assessed using the systematic component of variation (SCV). Multilevel segmented regression with random effects quantified the change in level and trend of prescribing after the DHPC. Practice characteristics were assessed for their association with a reduction in prescribing following the DHPC. Results This study included 7,408 practices. During September 2015, 88.9% of practices prescribed mirabegron and mirabegron composed a mean of 8.2% (SD 6.8) of OAB items. Variation between practices was classified as very high and the median SCV did not change significantly (p=0.11) in the 6 months after the September 2015 DHPC (12.4) compared to before (11.6). Before the DHPC, there was a monthly trend of 0.294 (95%CI, 0.287, 0.301) percentage points increase in mirabegron percentage. There was no significant change in the month immediately after the DHPC (-0.023, 95% CI -0.105 to 0.058) however there was a significant reduction in trend (-0.036, 95% CI -0.049 to -0.023). Higher numbers of registered patients and patients aged ≥65 years, and practice area deprivation were associated with having a significant decrease in level and slope of mirabegron prescribing post-DHPC. Conclusion Variation in mirabegron prescribing was high over the study period and did not change substantively following the DHPC. There was no immediate prescribing change post-DHPC, although the monthly growth did slow. Knowledge of the degree of variation in and determinants of response to safety communications may allow those that do not change prescribing to be provided with additional supports.

scholarly journals Prescribing Variation in General Practices in England Following a Direct Healthcare Professional Communication on Mirabegron

2018 ◽  
Vol 7 (10) ◽  
pp. 320 ◽  
Author(s):  
Frank Moriarty ◽  
Shegufta Razzaque ◽  
Ronald McDowell ◽  
Tom Fahey
Keyword(s):  
Healthcare Professional ◽  
Interrupted Time Series ◽  
Drug Prescriptions ◽  
Uncontrolled Hypertension ◽  
European Medicines Agency ◽  
Area Deprivation ◽  
Safety Issues ◽  
Practice Characteristics ◽  
Prescribing Behaviour ◽  
Additional Support

Introduction: Pharmacovigilance may detect safety issues after marketing of medications, and this can result in regulatory action such as direct healthcare professional communications (DHPC). DHPC can be effective in changing prescribing behaviour, however the extent to which prescribers vary in their response to DHPC is unknown. This study aims to explore changes in prescribing and prescribing variation among general practitioner (GP) practices following a DHPC on the safety of mirabegron, a medication to treat overactive bladder (OAB). Methods: This is an interrupted time series study of English GP practices from 2014–2017. National Health Service (NHS) Digital provided monthly statistics on aggregate practice-level prescribing and practice characteristics (practice staff and registered patient profiles, Quality and Outcomes Framework indicators, and deprivation of the practice area). The primary outcome was monthly mirabegron prescriptions as a percentage of all OAB drug prescriptions and we assessed the change following a DHPC issued by the European Medicines Agency in September 2015. The DHPC stated mirabegron use was contraindicated with severe uncontrolled hypertension and cautioned with hypertension. Variation between practices in mirabegron prescribing before and after the DHPC was assessed using the systematic component of variation (SCV). Multilevel segmented regression with random effects quantified the change in level and trend of prescribing after the DHPC. Practice characteristics were assessed for their association with a reduction in prescribing following the DHPC. Results: This study included 7408 practices. During September 2015, 88.9% of practices prescribed mirabegron and mirabegron comprised a mean of 8.2% (SD 6.8) of OAB prescriptions. Variation between practices was classified as very high and the median SCV did not change significantly (p = 0.11) in the six months after the September 2015 DHPC (12.4) compared to before (11.6). Before the DHPC, the share of mirabegron over all OAB drug prescriptions increased by 0.294 (95% confidence interval (CI), 0.287, 0.301) percentage points per month. There was no significant change in the month immediately after the DHPC (−0.023, 95% CI −0.105 to 0.058), however there was a significant reduction in trend (−0.036, 95% CI −0.049 to −0.023). Higher numbers of registered patients, patients aged ≥65 years, and practice area deprivation were associated with having a significant decrease in level and slope of mirabegron prescribing post-DHPC. Conclusion: Variation in mirabegron prescribing was high over the study period and did not change substantively following the DHPC. There was no immediate prescribing change post-DHPC, although the monthly growth did slow. Knowledge of the degree of variation in and determinants of response to safety communications may allow those that do not change prescribing habits to be provided with additional support.

scholarly journals Impact of the first national COVID-19 lockdown on referral of women experiencing domestic violence and abuse in England and Wales

2021 ◽  
Author(s):  
Jasmina Panovska-Griffiths ◽  
Eszter Szilassy ◽  
Medina Johnson ◽  
Sharon Dixon ◽  
Anna Simoni ◽  
...  
Keyword(s):  
Domestic Violence ◽  
Incidence Rate Ratio ◽  
Interrupted Time Series ◽  
Access To Services ◽  
Future Planning ◽  
England And Wales ◽  
Before And After ◽  
General Practices ◽  
The Impact ◽  
Domestic Violence And Abuse

Abstract Background The COVID-19 pandemic, with the related lockdown periods to curb transmission, has made it harder for survivors of domestic violence and abuse (DVA) to disclose abuse and access support services. Our study describes the impact of the first COVID-19 wave and the associated national lockdown in England and Wales on the referrals from general practice to the IRIS (Identification and Referral to Improve Safety) DVA programme. We compare this to the change in referrals in the same months in the previous year, during the school holidays in the three years preceding the pandemic and the period just after the first COVID-19 wave. School holiday periods were chosen as a comparator, since families, including the perpetrator, are together, affecting access to services. Methods We used anonymised data on daily referrals received by the IRIS DVA service in 33 areas from general practices over the period April 2017-September 2020. Interrupted-time series and non-linear regression were used to quantify the impact of the first national lockdown in March-June 2020 comparing analogous months the year before, and the impact of school holidays (01/04/2017-30/09/2020) on number of referrals, reporting Incidence Rate Ratio (IRR), 95% confidence intervals and p-values. Results The first national lockdown in 2020 lead to reduced number of referrals to DVA services (27%,95%CI=(21%,34%)) compared to the period before and after, and 19% fewer referrals compared to the same period in the year before. A reduction in the number of referrals was also evident during the school holidays with the highest reduction in referrals during the winter 2019 pre-pandemic school holiday (44%,95%CI=(32%,54%)) followed by the effect from the summer of 2020 school holidays (20%,95%CI=(10%,30%)). There was also a smaller reduction (13%-15%) in referrals during the longer summer holidays 2017–2019; and some reduction (5%-16%) during the shorter spring holidays 2017–2019. Conclusions We show that the COVID-19 lockdown in 2020 led to decline in referrals to DVA services. Our findings suggest an association between decline in referrals to DVA services for woman experiencing DVA and prolonged periods of systemic closure proxied here by both the first COVID-19 national lockdown or school holidays. This highlights the need for future planning to provide adequate access and support for people experiencing DVA during future national lockdowns and during the school holidays.

Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMA

2019 ◽  
pp. 216847901987104 ◽  
Author(s):  
Arnela Boskovic ◽  
Mathias Møllebæk ◽  
Susanne Kaae
Keyword(s):  
Healthcare Professional ◽  
Healthcare Professionals ◽  
Phenomenological Approach ◽  
Professional Communication ◽  
European Medicines Agency ◽  
Risk Minimization ◽  
Regulatory Requirement ◽  
Regulatory Decision ◽  
Legal Obligations ◽  
Local Company

Background: Despite the regulatory requirement for cooperation between marketing authorization holders (MAHs) and European Medicines Agency (EMA) in the direct healthcare professional communication (DHPC) preparation, no literature has explored DHPCs from an industry-regulator perspective. This constitutes a significant knowledge gap as any possibility of improving current DHPC effectiveness depends on decisions in the cooperative preparation phase. Thus, this EU-centered study explores differences in perceptions and experiences of DHPCs of European MAHs and EMA. Methods: European MAHs (n = 6) and EMA representatives (n = 2) were interviewed. The verbatim transcripts were coded into themes using NVivo software. Interview analysis was performed following a phenomenological approach of meaning condensation. Results: The DHPC process was perceived as burdensome by the industry. One company stated the process was time-consuming either due to EMA’s internal lengthy approval process or the translation activities with local company affiliates and national competent authorities. Three companies stated that DHPCs were not effective. One company stated that DHPCs are sent out due to legal obligations and not because of their use as a risk minimization measure (RMM). Newly emerged safety concerns were found difficult to phrase. Optimization proposals included improved timelines, scrutinization of healthcare professionals and better communication tools in clinical practice. Conclusion: DHPCs were not perceived as optimal, although the most effective intervention as it targets healthcare professionals directly. Continuous evaluation by EMA of DHPCs and evaluation on how to reach healthcare professionals are necessary. It is believed that industry perceptions from this study can support EMA with improved regulatory decision making to benefit public health.

354 Trends in the Drug-Sparing Effects for Benzodiazepines and Prescription Opioids among Insomnia Patients on Suvorexant in the US

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A141-A141
Author(s):  
Hrishikesh Kale ◽  
Rezaul Khandker ◽  
Ruchit Shah ◽  
Marc Botteman ◽  
Weilin Meng ◽  
...  
Keyword(s):  
Interrupted Time Series ◽  
Charlson Comorbidity Index Score ◽  
Prescription Opioid ◽  
Prescription Opioids ◽  
Opioid Use ◽  
Before And After ◽  
Prescription Opioid Use ◽  
Incident Cohort ◽  
Over Time ◽  
Post Period

Abstract Introduction Use of benzodiazepines to treat insomnia has been associated with serious side effects and abuse potential. Insomnia patients are at high risk of opioid abuse and better sleep patterns may help to reduce opioid use. This study examined the trend in the use of benzodiazepines and prescription opioids before and after initiation of suvorexant in insomnia patients. Methods The study analyzed 2015–2019, Optum Clinformatics Data Mart. Insomnia patients, identified using ICD-9/10 codes and prescribed suvorexant were included. The study included incident (newly diagnosed) and prevalent cohorts of insomnia patients. The proportion of patients on benzodiazepines or prescription opioids were calculated for 12 monthly intervals before (pre-period) and after initiation of suvorexant (post-period). Interrupted time series (ITS) analysis was conducted to assess trends for use of benzodiazepine or prescription opioids over time. Results A total of 5,939 patients from the incident insomnia cohort and 18,920 from the prevalent cohort were included. For the incident cohort, mean age was 64.47 (SD: 15.48), 63% were females, 71% had Medicare Advantage coverage, 59% had Charlson comorbidity index score (CCI) ≥ 1, 27% had an anxiety disorder and 16% had substance abuse disorder. Prevalent insomnia cohort was similar but had higher CCI. Results from ITS suggested that at the beginning of the pre-period, 28% of incident insomnia patients used either opioids or benzodiazepines with the rate of use in the pre-period increasing by 0.11% per month. In the post-period, the rate of use decreased by 0.33% per month. About 26% patients used benzodiazepines or opioids at 12-month after suvorexant initiation. In the absence of suvorexant, this proportion would have been 31%. Similar findings were observed for the prevalent insomnia cohort. A larger decrease was observed for opioid use than benzodiazepines. Conclusion The rate of benzodiazepines or prescription opioid use decreased over time after the initiation of suvorexant. Suvorexant has the potential to reduce the use of opioids and benzodiazepines among insomnia patients. Further research is needed to confirm these findings. Support (if any) This study was sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

scholarly journals Changes in the Use of Broad-Spectrum Antibiotics after Cefepime Shortage: a Time Series Analysis

2011 ◽  
Vol 56 (2) ◽  
pp. 989-994 ◽  
Author(s):  
C. Plüss-Suard ◽  
A. Pannatier ◽  
C. Ruffieux ◽  
A. Kronenberg ◽  
K. Mühlemann ◽  
...  
Keyword(s):  
Time Series ◽  
Pseudomonas Aeruginosa ◽  
Broad Spectrum ◽  
Interrupted Time Series ◽  
Antibiotic Policy ◽  
Content Type ◽  
Broad Spectrum Antibiotics ◽  
Before And After ◽  
Alternative Antibiotic ◽  
The Impact

ABSTRACTThe original cefepime product was withdrawn from the Swiss market in January 2007 and replaced by a generic 10 months later. The goals of the study were to assess the impact of this cefepime shortage on the use and costs of alternative broad-spectrum antibiotics, on antibiotic policy, and on resistance ofPseudomonas aeruginosatoward carbapenems, ceftazidime, and piperacillin-tazobactam. A generalized regression-based interrupted time series model assessed how much the shortage changed the monthly use and costs of cefepime and of selected alternative broad-spectrum antibiotics (ceftazidime, imipenem-cilastatin, meropenem, piperacillin-tazobactam) in 15 Swiss acute care hospitals from January 2005 to December 2008. Resistance ofP. aeruginosawas compared before and after the cefepime shortage. There was a statistically significant increase in the consumption of piperacillin-tazobactam in hospitals with definitive interruption of cefepime supply and of meropenem in hospitals with transient interruption of cefepime supply. Consumption of each alternative antibiotic tended to increase during the cefepime shortage and to decrease when the cefepime generic was released. These shifts were associated with significantly higher overall costs. There was no significant change in hospitals with uninterrupted cefepime supply. The alternative antibiotics for which an increase in consumption showed the strongest association with a progression of resistance were the carbapenems. The use of alternative antibiotics after cefepime withdrawal was associated with a significant increase in piperacillin-tazobactam and meropenem use and in overall costs and with a decrease in susceptibility ofP. aeruginosain hospitals. This warrants caution with regard to shortages and withdrawals of antibiotics.

scholarly journals Impact of a blended curriculum on nursing handover quality: a quality improvement project

2021 ◽  
Vol 10 (1) ◽  
pp. e001024
Author(s):  
Xavier Losfeld ◽  
Laure Istas ◽  
Quentin Schoonvaere ◽  
Michel Vergnion ◽  
Jochen Bergs
Keyword(s):  
Educational Intervention ◽  
Patient Information ◽  
Professional Communication ◽  
Fit Indices ◽  
Negative Consequences ◽  
Improvement Project ◽  
Face To Face ◽  
Before And After ◽  
Post Test ◽  
E Learning

Context and objectiveThe negative consequences of inadequate nursing handovers on patient safety are widely acknowledged, both within the literature as in practice. Evidence regarding strategies to improve nursing handover is, however, lacking. This study investigates the effect of a tailored, blended curriculum on nurses’ perception of handover quality.MethodsWe used a pre-test/post-test design within four units of a Belgian general hospital. Our educational intervention consisted of an e-learning module on professional communication and a face-to-face session on the use of a structured method for handovers. All nurses completed this blended curriculum (n=87). We used the Handover Evaluation Scale (HES) to evaluate nurses’ perception of handover quality before and after the intervention. The HES was answered by 87.4% of the nurses (n=76 of 87) before and 50.6% (n=44 of 87) after the intervention. Confirmatory factor analysis was used to assess the validity of the HES.ResultsThe original factor structure did not fit with our data. We identified a new HES structure with acceptable or good fit indices. The overall internal consistency of our HES structure was considered adequate. Perception of nurses on Relevance of information showed a significant improvement (M=53.19±4.33 vs M=61.03±6.01; p=0.04). Nurses also felt that the timely provision of patient information improved significantly (M=4.50±0.34 vs M=5.16±0.40; p=0.01).ConclusionThe applied intervention resulted in an improved awareness on the importance of Relevance of information during handovers. After our intervention, the nurses’ perception of the HES item ‘Patient information is provided in a timely manner’ also improved significantly. We are aware that the educational intervention is only the first step to achieve the long-term implementation of a culture of professional communication based on mutual support.

A comparison of global suicide terrorism by region before and after 9/11 terrorist attacks

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Ahmet Guler ◽  
Mustafa Demir
Keyword(s):  
Time Series ◽  
Interrupted Time Series ◽  
Sub Saharan Africa ◽  
Terrorist Attacks ◽  
Suicide Terrorism ◽  
Content Type ◽  
The World ◽  
Before And After ◽  
Sub Saharan ◽  
Global Terrorism Database

Purpose This study aims to examine the effect of the 9/11 terrorist attacks on suicide terrorism in different regions of the world and changes in the trends in suicide terrorism according to regions before and after 9/11. Design/methodology/approach Using the data obtained from the Global Terrorism Database from 1981 to 2019, the descriptive statistics were computed first and then, independent samples t-tests were run to compare the monthly mean percentage of suicide-terrorism incidents that occurred in each region between the pre-9/11 and the post-9/11 periods. Finally, to statistically assess the effect of the 9/11 attacks and changes in the trends for the dependent variables over time, monthly interrupted time-series analyzes were conducted. Findings The results of monthly interrupted time series analyzes showed that after the 9/11 attacks, the trends for suicide-terrorism rates decreased significantly in three regions including South Asia, the Middle East and North Africa and Europe, while the trend for suicide-terrorism rates increased significantly in Sub-Saharan Africa. However, no statistically significant changes in the trends in suicide-terrorism rates occurred in three regions including North America, East Asia and Central Asia and Southeast Asia before 9/11, during November 2001 or after 9/11. Originality/value This study indicates the critical importance of the 9/11 terrorist attacks in suicide terrorism and its impact on these events in different regions of the world. The research also provides some recommendations concerning the effectiveness of defensive and offensive counterterrorism policies against suicide terrorism.

Impact of Legislation on Opioid Prescribing following Hysterectomy and Hysteroscopy in Arizona and Florida

2021 ◽  
pp. 1-9
Author(s):  
Aakriti R. Carrubba ◽  
Amy E. Glasgow ◽  
Elizabeth B. Habermann ◽  
Amanda P. Stanton ◽  
Megan N. Wasson ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Cohort Analysis ◽  
Oral Morphine ◽  
Interrupted Time Series ◽  
Interrupted Time Series Analysis ◽  
Opioid Use ◽  
Prescribing Practices ◽  
Opioid Prescribing ◽  
Before And After ◽  
Legislative Changes

<b><i>Objectives:</i></b> This study aimed to determine the oral morphine equivalents (OMEs) prescribed and refill rates following hysterectomy and hysteroscopy in the setting of opioid prescribing practice changes in 2 states. <b><i>Design:</i></b> This is a retrospective cohort analysis consisting of 2,916 patients undergoing hysterectomy or hysteroscopy between July 2016 and September 2019 at 2 affiliated academic hospitals in states that underwent legislative changes in opioid prescribing in 2018. <b><i>Methods:</i></b> Participants were identified using the Current Procedural Terminology procedure codes in Arizona and Florida. Hysterectomy was chosen as the most invasive gynecologic procedure, while hysteroscopy was chosen as the least invasive. Medical records were abstracted to find opioid prescriptions from 90 days before surgery to 30 days after discharge. Patients with opioid use between 90 and 7 days before surgery were excluded. Prescriptions were converted to OMEs and were calculated per quarter year. Statistical analysis included Wilcoxon rank sum <i>t</i> tests for OMEs and χ<sup>2</sup> <i>t</i> tests for refill rates. Interrupted time-series analysis was used to determine significant change in OMEs before and after legislative change. Statistical analysis was performed using SAS version 9.4 (SAS Institute, Cary, NC, USA). <b><i>Results:</i></b> In Arizona, 1,067 hysterectomies were performed; 459 (43%) vaginal, 561 (52.6%) laparoscopic/robotic, and 47 (4.4%) abdominal. There were 530 hysteroscopies. Overall median OMEs decreased from 225 prior to July 2018 to 75 after July 2018 (<i>p</i> &#x3c; 0.0001). The opioid refill rate remained unchanged at 7.4% (<i>p</i> = 0.966). In Florida, there were 769 hysterectomies; 241 (31.3%) vaginal, 476 (61.9%) laparoscopic/robotic, and 52 (6.8%) abdominal. There were 549 hysteroscopies. Overall median OMEs decreased from 150 prior to July 2018 to 0 after July 2018 (<i>p</i> &#x3c; 0.0001). The opioid refill rate was similar (7.8% before July 2018 and 7.3% after July 2018; <i>p</i> = 0.739). <b><i>Limitations:</i></b> Limitations include involvement of a single hospital institution with a total of 10 fellowship-trained surgeons and biases inherent to retrospective study design. <b><i>Conclusions:</i></b> Legislative and provider-led changes coincided with decreases in opioid prescribing after 2018 in both states without increasing rates of refills and showed actual data reflected in the medical record. Gynecologists must actively participate in safe prescribing practices to decrease opioid dependence and misuse.

scholarly journals Digital cognitive behavioural therapy for insomnia and primary care costs in England: an interrupted time series analysis

BJGP Open ◽  
2021 ◽  
pp. BJGPO.2021.0146
Author(s):  
Chris Sampson ◽  
Eleanor Bell ◽  
Amanda Cole ◽  
Christopher B Miller ◽  
Tracey Marriott ◽  
...  
Keyword(s):  
Primary Care ◽  
Time Series ◽  
Cognitive Behavioural Therapy ◽  
Interrupted Time Series ◽  
Behavioural Therapy ◽  
Interrupted Time Series Analysis ◽  
Cognitive Behavioural ◽  
Before And After ◽  
Quasi Experimental ◽  
Care Costs

BackgroundSleepio is an automated digital programme that delivers cognitive behavioural therapy for insomnia (dCBT-I). Sleepio has been proven effective in improving sleep difficulties. However, evidence for the possible impact of Sleepio use on health care costs in the United Kingdom has not previously been developed.AimWe sought to identify the effect of a population-wide rollout of Sleepio in terms of primary care costs in the National Health Service (NHS) in England.Design & settingThe study was conducted in the Thames Valley region of England, where access to Sleepio was made freely available to all residents between October 2018 and January 2020. The study relies on a quasi-experimental design, using an interrupted time series to compare the trend in primary care costs before and after the rollout of Sleepio.MethodWe use primary care data for people with relevant characteristics from nine general practices in Buckinghamshire. Primary care costs include general practice contacts and prescriptions. Segmented regression analysis was used to estimate primary and secondary outcomes.ResultsFor the 10,704 patients included in our sample, the total saving over the 65-week follow-up period was £71,027. This corresponds to £6.64 per person in our sample or around £70.44 per Sleepio user. Secondary analyses suggest that savings may be driven primarily by reductions in prescribing.ConclusionSleepio rollout reduced primary care costs. National adoption of Sleepio may reduce primary care costs by £20 million in the first year. The expected impact on primary care costs in any particular setting will depend on the uptake of Sleepio.

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