scholarly journals How innovative are new drugs launched in the UK? A retrospective study of new drugs listed in the British National Formulary (BNF) 2001–2012

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e006235 ◽  
Author(s):  
Derek J Ward ◽  
Angharad Slade ◽  
Tracey Genus ◽  
Orsolina I Martino ◽  
Andrew J Stevens
Keyword(s):  
Unintended Consequences ◽  
New Drugs ◽  
British National Formulary ◽  
Secondary Outcome ◽  
National Formulary ◽  
Biological Drugs ◽  
New Drug ◽  
New Chemical Entities ◽  
The Uk ◽  
Innovative Drugs

ObjectivesInnovative new drugs offer potential benefits to patients, healthcare systems, governments and the pharmaceutical industry. Recent data suggest annual numbers of new drugs launched in the UK have increased in recent years, and we sought to understand whether this represents increasing numbers of highly innovative drugs being made available or the introduction of increasing numbers of drugs with limited additional therapeutic value.Design and settingRetrospective observational study of new drug entries in the British National Formulary (BNF).Primary and secondary outcome measuresNumber of new drugs launched in the UK each year (based on first appearance in the BNF) from 2001 to 2012, including new chemical entities and new biological drugs, categorised by degree of innovativeness according to published criteria that incorporate both clinical usefulness and the nature of the innovation.ResultsHighly innovative, moderately innovative and slightly innovative drugs made up 26%, 18% and 56% of all newly launched drugs, respectively, for the study period (n=290). There was an upward trend in annual numbers of slightly innovative drugs from 2004 onwards (R2=0.44), which aligned closely with the recovery in total numbers of new drugs launched each year since that time. There were no discernible time trends in the highly or moderately innovative categories. New drugs for malignancy and skin disease were most likely to be characterised as highly innovative (44% and 57%, respectively).ConclusionsHighly innovative new drugs comprise only around a quarter of all new drug launches in the UK. In contrast, drugs categorised as only slightly innovative comprised well over half of all new drugs and annual numbers in this category are increasing. Current policy initiatives that seek to increase the supply of innovative new drugs have long-lead times to impact, and will need careful assessment to ensure they deliver their aims without unintended consequences.

scholarly journals Trends in the costs of drugs launched in the UK between 1981 and 2015: an analysis of the launch price of drugs in five disease areas

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e027625 ◽  
Author(s):  
Derek J Ward ◽  
Lucy Doos ◽  
Andrew Stevens
Keyword(s):  
Colorectal Cancer ◽  
Cross Sectional Study ◽  
New Drugs ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Biological Drugs ◽  
Cross Sectional ◽  
Medical Benefits ◽  
Using Data ◽  
The Uk

ObjectivesTo investigate the trend in the launch price of new drugs for five common health conditions.DesignCross-sectional study using data on new drugs launched in the UK between 1981 and 2015 for hypertension, asthma, rheumatoid arthritis, schizophrenia and colorectal cancer.Data and sourcesAll drugs marketed in the UK between 1981 and 2015 (inclusive), and licensed specifically for the treatment of one of the five chosen conditions were included in the study. Newly launched medicines and their launch prices were identified by hand-searching all editions of the British National Formulary in addition to searching the websites of relevant regulatory agencies (European Medicines Agency and Medicines and Healthcare products Regulatory Agency). The launch price in UK pounds for a 28-day supply of each medicine at a typical or usual maintenance dose was adjusted for the effects of general inflation using the gross domestic product deflator series.Results104 drugs were included in our study with a mean inflation-adjusted 28-day launch price of £288 (SD £678). The launch price of new drugs varied significantly across the five conditions, with drugs for hypertension having the lowest mean price (£27) and drugs for colorectal cancer having the highest mean price (£1590) (p<0.001). There were large increases in launch prices across the study period, but the magnitude and pattern was markedly different between therapeutic areas. Biological drugs represented 13.5% of all included drugs and had a significantly higher launch price than non- biological drugs (£1233 vs £141, p<0.001). 22.1% of included drugs were first-of-kind and had a significantly higher launch price than follow-on drugs (£768 vs £151) (p<0.0001).ConclusionDrugs prices continue to increase across different therapeutic areas. This has some association with novelty, but, it is not clear if this increase in price is associated with medical benefits.

scholarly journals Doses of carbamazepine and valproate in bipolar affective disorder

1997 ◽  
Vol 21 (4) ◽  
pp. 221-223 ◽  
Author(s):  
David Taylor ◽  
Denise Duncan
Keyword(s):  
Affective Disorder ◽  
Acute Treatment ◽  
Bipolar Affective Disorder ◽  
Depressive Illness ◽  
British National Formulary ◽  
National Formulary ◽  
Manic Depressive Illness ◽  
Manic Depressive ◽  
The Uk

Carbamazepine and valproate are now well established treatments for bipolar affective disorder (BAD). Both drugs are used in the acute treatment of mania and, more frequently, as longer-term mood stabilisers. The British National Formulary (BNF, Vol. 32, 1996) provides information on the use of carbamazepine in the ‘prophylaxis of manic depressive illness' and suggests that the ‘usual range’ of doses is between 400 mg and 600 mg daily. No guidance on the use of valproate in BAD is given in the BNF because the drug is not licensed for this indication in the UK.

scholarly journals Evaluation of instructions in patient information leaflets for the use of intranasal corticosteroid sprays: an observational study

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e026710 ◽  
Author(s):  
Corine Rollema ◽  
Eric M van Roon ◽  
Anne GM Schilder ◽  
Tjalling W de Vries
Keyword(s):  
Observational Study ◽  
Patient Information ◽  
Regulatory Agency ◽  
British National Formulary ◽  
National Formulary ◽  
Intranasal Corticosteroid ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
The Uk

ObjectivesIn this study, we analysed patient information leaflets (PILs) of intranasal corticosteroid sprays (INCS) of different manufacturers in the UK to determine if instructions for the use of INCS are complete and uniform.SettingPILs of all INCS of all manufacturers, available for patients in the UK, were collected from the British National Formulary website and the Medicines and Healthcare products Regulatory Agency website. All instructions in these PILs were analysed.ParticipantsWe identified PILs of INCS from 21 different manufacturers, available for patients in the UK.ResultsWe analysed the instructions for the use of INCS in 21 different PILs and there is large variation in the PIL instructions for the technique of using INCS across PILs.ConclusionComplete and uniform instructions for the use of INCS are lacking in PILs for registered preparations in the UK. Structured and standardised instructions to be used by both professionals and patients are essential in order to optimise daily use of INCS.

Synthesis and Biological Activity of Hydrazones and Derivatives: A Review

2020 ◽  
Vol 20 (5) ◽  
pp. 342-368 ◽  
Author(s):  
Juliana de Oliveira Carneiro Brum ◽  
Tanos Celmar Costa França ◽  
Steven R. LaPlante ◽  
José Daniel Figueroa Villar
Keyword(s):  
Biological Activity ◽  
Medicinal Chemistry ◽  
Biological Activities ◽  
New Drugs ◽  
New Drug ◽  
Cancer Inflammation

Hydrazones and their derivatives are very important compounds in medicinal chemistry due to their reported biological activity for the treatment of several diseases, like Alzheimer’s, cancer, inflammation, and leishmaniasis. However, most of the investigations on hydrazones available in literature today are directed to the synthesis of these molecules with little discussion available on their biological activities. With the purpose of bringing lights into this issue, we performed a revision of the literature and wrote this review based on some of the most current research reports of hydrazones and derivatives, making it clear that the synthesis of these molecules can lead to new drug prototypes. Our goal is to encourage more studies focused on the synthesis and evaluation of new hydrazones, as a contribution to the development of potential new drugs for the treatment of various diseases.

scholarly journals How Risky Is That Risk Sharing Agreement? Mean-Variance Tradeoffs and Unintended Consequences of Six Common Risk Sharing Agreements

2021 ◽  
Vol 6 (1) ◽  
pp. 238146832199040
Author(s):  
Gregory S. Zaric
Keyword(s):  
Risk Sharing ◽  
Financial Risk ◽  
Unintended Consequences ◽  
Drug Costs ◽  
New Drugs ◽  
Total Drug ◽  
Number Of Patients ◽  
Clinical Benefits ◽  
The Impact ◽  
Mean Variance

Background. Pharmaceutical risk sharing agreements (RSAs) are commonly used to manage uncertainties in costs and/or clinical benefits when new drugs are added to a formulary. However, existing mathematical models of RSAs ignore the impact of RSAs on clinical and financial risk. Methods. We develop a model in which the number of patients, total drug consumption per patient, and incremental health benefits per patient are uncertain at the time of the introduction of a new drug. We use the model to evaluate the impact of six common RSAs on total drug costs and total net monetary benefit (NMB). Results. We show that, relative to not having an RSA in place, each RSA reduces expected total drug costs and increases expected total NMB. Each RSA also improves two measures of risk by reducing the probability that total drug costs exceed any threshold and reducing the probability of obtaining negative NMB. However, the effects on variance in both NMB and total drug costs are mixed. In some cases, relative to not having an RSA in place, implementing an RSA can increase variability in total drug costs or total NMB. We also show that, for some RSAs, when their parameters are adjusted so that they have the same impact on expected total drug cost, they can be rank-ordered in terms of their impact on variance in drug costs. Conclusions. Although all RSAs reduce expected total drug costs and increase expected total NMB, some RSAs may actually have the undesirable effect of increasing risk. Payers and formulary managers should be aware of these mean-variance tradeoffs and the potentially unintended results of RSAs when designing and negotiating RSAs.

scholarly journals Impact of COVID-19 pandemic social restriction measures on people with rheumatic and musculoskeletal diseases in the UK: a mixed-methods study

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048772
Author(s):  
Toby O Smith ◽  
Pippa Belderson ◽  
Jack R Dainty ◽  
Linda Birt ◽  
Karen Durrant ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Qualitative Study ◽  
Online Survey ◽  
Musculoskeletal Diseases ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Healthcare Provision ◽  
Social Restriction ◽  
The Uk ◽  
The Impact

ObjectivesTo determine the impact of COVID-19 pandemic social restriction measures on people with rheumatic and musculoskeletal diseases (RMDs) and to explore how people adapted to these measures over time.DesignMixed-methods investigation comprising a national online longitudinal survey and embedded qualitative study.SettingUK online survey and interviews with community-dwelling individuals in the East of England.ParticipantsPeople in the UK with RMDs were invited to participate in an online survey. A subsection of respondents were invited to participate in the embedded qualitative study.Primary and secondary outcome measuresThe online survey, completed fortnightly over 10 weeks from April 2020 to August 2020, investigated changes in symptoms, social isolation and loneliness, resilience and optimism. Qualitative interviews were undertaken assessing participant’s perspectives on changes in symptoms, exercising, managing instrumental tasks such a shopping, medication and treatment regimens and how they experienced changes in their social networks.Results703 people with RMDs completed the online survey. These people frequently reported a deterioration in symptoms as a result of COVID-19 pandemic social restrictions (52% reported increase vs 6% reported a decrease). This was significantly worse for those aged 18–60 years compared with older participants (p=0.017). The qualitative findings from 26 individuals with RMDs suggest that the greatest change in daily life was experienced by those in employment. Although some retired people reported reduced opportunity for exercise outside their homes, they did not face the many competing demands experienced by employed people and people with children at home.ConclusionsPeople with RMDs reported a deterioration in symptoms when COVID-19 pandemic social restriction measures were enforced. This was worse for working-aged people. Consideration of this at-risk group, specifically for the promotion of physical activity, changing home-working practices and awareness of healthcare provision is important, as social restrictions continue in the UK.

scholarly journals To assess the role of addition of bevacizumab therapy to carboplatin and paclitaxel as frontline treatment of epithelial ovarian cancer

2016 ◽  
Author(s):  
Richa Vatsa ◽  
Sunesh Kumar ◽  
Lalit Kumar
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Disease Progression ◽  
Safety Profile ◽  
Haematological Toxicity ◽  
Progression Free Survival ◽  
New Drugs ◽  
Secondary Outcome ◽  
Vegf Receptor ◽  
Persistent Proteinuria

Introduction: Efforts are going on for development of new drugs for epithelial ovarian cancer (EOC). We assessed safety profile of bevacizumab, a VEGF receptor blocking antibody in treatment of EOC. Methods: We assigned women with EOC to carboplatin (area under curve, 5 or 6) and paclitaxel (175 mg/square meter of body-surface area), given every 3 weeks for 6 cycles, or to this regimen plus bevacizumab (15 mg/kilogram body weight), given concurrently every 3 weeks for 5 or 6 cycles and continued for 30 additional cycles. Primary outcome measures was safety profile of bevacizumab and secondary outcome was to see progression free survival (PFS). Results: Out of 30 patients, 10 were in Bevacizuma arm (Arm A) and 20 in conventional chemotherapy arm (Arm B). Haematological toxicity, GI perforation and proteinuria was similar in both. Other toxicities e.g. bleeding complication (p = 0.002) and hypertension (p = 0.04) was more in Arm A. PFS was similar in both arms; 24 months in Arm A and 22 months in Arm B (p = 0.565). 4 (40%) patients in arm A discontinued treatment, two (20%) because of disease progression after PFS of 9 and 6 months, two because of development of toxicity considered to be due to bevacizumab; of which one developed jejenal perforation and disease progression after PFS of 6 months and 1 because of development of persistent proteinuria of grade 3 after 18 months. Conclusion: Bevacizumab therapy does not improve PFS in EOC but increases toxicity spectrum of chemotherapy.

scholarly journals An interview study to determine the experiences of cellulitis diagnosis amongst health care professionals in the UK

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e034692
Author(s):  
Mitesh Patel ◽  
Siang Ing Lee ◽  
Nick J Levell ◽  
Peter Smart ◽  
Joe Kai ◽  
...  
Keyword(s):  
Clinical Features ◽  
Clinical Experience ◽  
Lower Limb ◽  
Health Care Professionals ◽  
Secondary Outcome ◽  
Snowball Sampling ◽  
Acute Medicine ◽  
Common Diagnosis ◽  
The Uk ◽  
National Networks

ObjectivesTo explore healthcare professionals (HCPs) experiences and challenges in diagnosing suspected lower limb cellulitis.SettingUK nationwide.Participants20 qualified HCPs, who had a minimum of 2 years clinical experience as an HCP in the national health service and had managed a clinical case of suspected cellulitis of the lower limb in the UK. HCPs were recruited from departments of dermatology (including a specialist cellulitis clinic), general practice, tissue viability, lymphoedema services, general surgery, emergency care and acute medicine. Purposive sampling was employed to ensure that participants included consultant doctors, trainee doctors and nurses across the specialties listed above. Participants were recruited through national networks, HCPs who contributed to the cellulitis priority setting partnership, UK Dermatology Clinical Trials Network, snowball sampling where participants helped recruit other participants and personal networks of the authors.Primary and secondary outcomesPrimary outcome was to describe the key clinical features which inform the diagnosis of lower limb cellulitis. Secondary outcome was to explore the difficulties in making a diagnosis of lower limb cellulitis.ResultsThe presentation of lower limb cellulitis changes as the episode runs its course. Therefore, different specialties see clinical features at varying stages of cellulitis. Clinical experience is essential to being confident in making a diagnosis, but even among experienced HCPs, there were differences in the clinical rationale of diagnosis. A group of core clinical features were suggested, many of which overlapped with alternative diagnoses. This emphasises how the diagnosis is challenging, with objective aids and a greater understanding of the mimics of cellulitis required.ConclusionCellulitis is a complex diagnosis and has a variable clinical presentation at different stages. Although cellulitis is a common diagnosis to make, HCPs need to be mindful of alternative diagnoses.

scholarly journals Cardiovascular-related deaths at the beginning of the COVID-19 outbreak: a prospective analysis based on the UK Biobank

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046931
Author(s):  
Junren Wang ◽  
Jianwei Zhu ◽  
Huazhen Yang ◽  
Yao Hu ◽  
Yajing Sun ◽  
...  
Keyword(s):  
Primary Diagnosis ◽  
Secondary Outcome ◽  
Hospital Inpatient ◽  
Reference Period ◽  
Stress Reactions ◽  
Uk Biobank ◽  
The Uk ◽  
The Impact ◽  
Distinct Increase ◽  
Related Mortality

ObjectiveTo assess the impact of the COVID-19 outbreak on cardiovascular disease (CVD) related mortality and hospitalisation.DesignCommunity-based prospective cohort study.SettingThe UK Biobank.Participants421 372 UK Biobank participants who were registered in England and alive as of 1 January 2020.Primary and secondary outcome measuresThe primary outcome of interest was CVD-related death, which was defined as death with CVD as a cause in the death register. We retrieved information on hospitalisations with CVD as the primary diagnosis from the UK Biobank hospital inpatient data. The study period was 1 January 2020 to June 30 2020, and we used the same calendar period of the three preceding years as the reference period. In order to control for seasonal variations and ageing of the study population, standardised mortality/incidence ratios (SMRs/SIRs) with 95% CIs were used to estimate the relative risk of CVD outcomes during the study period, compared with the reference period.ResultsWe observed a distinct increase in CVD-related deaths in March and April 2020, compared with the corresponding months of the three preceding years. The observed number of CVD-related deaths (n=218) was almost double in April, compared with the expected number (n=120) (SMR=1.82, 95% CI 1.58 to 2.07). In addition, we observed a significant decline in CVD-related hospitalisations from March onwards, with the lowest SIR observed in April (0.45, 95% CI 0.41 to 0.49).ConclusionsThere was a distinct increase in the number of CVD-related deaths in the UK Biobank population at the beginning of the COVID-19 outbreak. The shortage of medical resources for hospital care and stress reactions to the pandemic might have partially contributed to the excess CVD-related mortality, underscoring the need of sufficient healthcare resources and improved instructions to the public about seeking healthcare in a timely way.

scholarly journals Modelling the impact of the tier system on SARS-CoV-2 transmission in the UK between the first and second national lockdowns

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e050346
Author(s):  
Daniel J Laydon ◽  
Swapnil Mishra ◽  
Wes R Hinsley ◽  
Pantelis Samartsidis ◽  
Seth Flaxman ◽  
...  
Keyword(s):  
Real Time ◽  
Reproduction Number ◽  
Secondary Outcome ◽  
Bayesian Hierarchical ◽  
Time Reproduction ◽  
Tier System ◽  
The Uk ◽  
National Trends ◽  
Tier 3 ◽  
The Impact

ObjectiveTo measure the effects of the tier system on the COVID-19 pandemic in the UK between the first and second national lockdowns, before the emergence of the B.1.1.7 variant of concern.DesignThis is a modelling study combining estimates of real-time reproduction number Rt (derived from UK case, death and serological survey data) with publicly available data on regional non-pharmaceutical interventions. We fit a Bayesian hierarchical model with latent factors using these quantities to account for broader national trends in addition to subnational effects from tiers.SettingThe UK at lower tier local authority (LTLA) level. 310 LTLAs were included in the analysis.Primary and secondary outcome measuresReduction in real-time reproduction number Rt.ResultsNationally, transmission increased between July and late September, regional differences notwithstanding. Immediately prior to the introduction of the tier system, Rt averaged 1.3 (0.9–1.6) across LTLAs, but declined to an average of 1.1 (0.86–1.42) 2 weeks later. Decline in transmission was not solely attributable to tiers. Tier 1 had negligible effects. Tiers 2 and 3, respectively, reduced transmission by 6% (5%–7%) and 23% (21%–25%). 288 LTLAs (93%) would have begun to suppress their epidemics if every LTLA had gone into tier 3 by the second national lockdown, whereas only 90 (29%) did so in reality.ConclusionsThe relatively small effect sizes found in this analysis demonstrate that interventions at least as stringent as tier 3 are required to suppress transmission, especially considering more transmissible variants, at least until effective vaccination is widespread or much greater population immunity has amassed.

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