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What is the impact of regulatory guidance and expiry of drug patents on dementia drug prescriptions in England? A trend analysis in the Clinical Practice Research Datalink.

ABSTRACT: BACKGROUND:Drugs for dementia have been available in England since 1997. Since their launch, there have been several changes to national guidelines and initiatives that may have influenced prescribing. These include changes in National Institute for Health and Care Excellence (NICE) guidance, several government dementia strategies, the addition of dementia to the Quality and Outcomes Framework (QOF), and the expiry of drug patents. Despite this, there has been little research into the effect of these events on prescribing. This paper examines prescribing trends in England using data from the U.K. Clinical Practice Research Datalink since the launch of drugs for dementia up to 1st January 2016. METHODS:We considered the monthly proportion of patients eligible for treatment, with a diagnosis of probable Alzheimer's disease, receiving their first prescription for each drug class-namely, acetylcholinesterase (AChE) inhibitors (donepezil, rivastigmine, galantamine) and N-methyl-D-aspartate (NMDA) receptor antagonists (memantine). Trend analysis using joinpoint models was then applied to identify up to two trend changes per treatment of interest. RESULTS:The overall trend was for increasing prescriptions in each drug class over the period in which they were studied. This was indicated by the average monthly percentage change, which was 6.0% (95% CI, -?6.4 to 19.9; June 1997 to December 2015) for AChE inhibitors and 15.4% (95% CI, -?77.1 to 480.9; January 2003 to December 2015) for NMDA receptor antagonists. Prescriptions of AChE inhibitors increased at the end of 2012, probably in response to the patent expiry of these drugs earlier that year. The Prime Minister's Dementia Challenge launched in May 2012 may also have contributed to the observed increase. However, neither this strategy nor patent expiry appeared to influence prescriptions of NMDA receptor antagonists. Instead trend changes in this drug class were driven by NICE guidance released in 2011 that allowed access to these drugs outside of clinical trials. CONCLUSIONS:Dementia drug prescribing does not always respond to factors such as regulatory guidance, recommendations, or patent expiry, and when it does, not necessarily in a predictable way. This suggests that communication with clinicians may need to be improved to use drugs for dementia more cost-effectively.

SUBMITTER: Walker VM

PROVIDER: S-EPMC5975499 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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What is the impact of regulatory guidance and expiry of drug patents on dementia drug prescriptions in England? A trend analysis in the Clinical Practice Research Datalink.

Walker Venexia M VM Davies Neil M NM Kehoe Patrick G PG Martin Richard M RM

Alzheimer's research & therapy 20180529 1

<h4>Background</h4>Drugs for dementia have been available in England since 1997. Since their launch, there have been several changes to national guidelines and initiatives that may have influenced prescribing. These include changes in National Institute for Health and Care Excellence (NICE) guidance, several government dementia strategies, the addition of dementia to the Quality and Outcomes Framework (QOF), and the expiry of drug patents. Despite this, there has been little research into the ef ...[more]

PMID: 29843807

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Project description:BackgroundThe COVID-19 pandemic and subsequent lockdown measures had serious implications for community-dwelling older people with dementia. While the short-term impacts of the pandemic on this population have been well studied, there is limited research on its long-term impacts. Quantifying the long-term impacts may provide insights into whether healthcare adaptations are needed after the acute phase of the pandemic to balance infection prevention measures with healthcare provision. This study aims to examine patterns of psychotropic drug prescriptions and general practice consultations in community-dwelling older people with dementia during the first two years of the pandemic.MethodsWe utilised routine electronic health records from three Dutch academic general practice research networks located in the North, East, and South, between 2019 and 2021. We (1) compared the weekly prescription rates of five groups of psychotropic drugs and two groups of tracer drugs, and weekly general practice consultation rates per 1000 participants, between the first two years of the pandemic and the pre-pandemic phase, (2) calculated changes in these rates during three lockdowns and two relaxation phases relative to the corresponding weeks in 2019, and (3) employed interrupted time series analyses for the prescription rates. Analyses were performed for each region separately.ResultsThe study population sizes in the North, East, and South between 2019 and 2021 were 1726 to 1916, 93 to 117, and 904 to 960, respectively. Data from the East was excluded from the statistical analyses due to the limited sample size. During the first two years of the pandemic, the prescription rates of psychotropic drugs were either lower or similar to those in the pre-pandemic phase, with differences varying from -2.6‰ to -10.2‰. In contrast, consultation rates during the pandemic were higher than in the pre-pandemic phase, increasing by around 38‰.ConclusionsThis study demonstrates a decrease in psychotropic drug prescriptions, but an increase in general practice consultations among community-dwelling older people with dementia during the first two years of the pandemic. However, reasons for the decrease in psychotropic drug prescriptions are unclear due to limited information on the presence of neuropsychiatric symptoms and the appropriateness of prescribing.

Project description:AimTo evaluate drug therapy for alcohol dependence in the 12 months after first diagnosis in UK primary care.DesignOpen cohort study.SettingGeneral practices contributing data to the UK Clinical Practice Research Database.Participants39,980 people with an incident diagnosis of alcohol dependence aged 16 years or older between 1 January 1990 and 31 December 2013.Main outcome measureUse of pharmacotherapy (acamprosate, disulfiram, naltrexone, baclofen and topiramate) to promote abstinence from alcohol or reduce drinking to safe levels in the first 12 months after a recorded diagnosis of alcohol dependence.FindingsOnly 4,677 (11.7%) of the cohort received relevant pharmacotherapy in the 12 months following diagnosis. Of the 35,303 that did not receive pharmacotherapy, 3,255 (9.2%) received psychosocial support. The remaining 32,048 (80.2%) did not receive either mode of treatment in the first 12 months. Factors that independently reduced the likelihood of receiving pharmacotherapy included: being male (Odds Ratio [OR] 0.74; 95% CI 0.69 to 0.78); older (65-74 years: OR 0.61; 95% CI 0.49 to 0.77); being from a practice based in the most deprived quintile (OR 0.58; 95% CI 0.53 to 0.64); and being located in Northern Ireland (OR 0.78; 95% CI 0.67 to 0.91). The median duration to initiation of pharmacotherapy was 0.80 months (95% CI 0.70 to 1.00) for acamprosate and 0.60 months (95% CI 0.43 to 0.73) for disulfiram. Persistence analysis for those receiving acamprosate and disulfiram revealed that many patients never received a repeat prescription; persistence at 6 months was 27.7% for acomprosate and 33.2% for disulfiram. The median duration of therapy was 2.10 months (95% CI 1.87 to 2.53) for acamprosate and 3.13 months (95% CI 2.77 to 3.36) for disulfiram.ConclusionDrug therapy to promote abstinence in alcohol dependent patients was low, with the majority of patients receiving no therapy, either psychological or pharmacological. When drug therapy was prescribed, persistence was low with most patients receiving only one prescription. Our data show that treatment for alcohol dependence is haphazard, and there is an urgent need to explore strategies for improving clinical management of this patient group.

Dataset Information

What is the impact of regulatory guidance and expiry of drug patents on dementia drug prescriptions in England? A trend analysis in the Clinical Practice Research Datalink.

Publications

What is the impact of regulatory guidance and expiry of drug patents on dementia drug prescriptions in England? A trend analysis in the Clinical Practice Research Datalink.

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