Challenges for the National Institute for Clinical Excellence

Rationing health care is inevitable, and NICE should inform NHS decision making. Adoption of new technologies by NHS clinicians should be informed by costs as well as effectiveness. The NHS needs better information from NICE on the equity implications of new and existing technologies. NICE appraisal should focus not only on service enhancement but also on withdrawal of existing ineffective or inefficient therapies. Giving NICE a real budget to fund its recommendations would encourage it to examine the effect of its decisions on the whole NHS

Impact of NICE guidance on laparoscopic surgery for inguinal hernias: analysis of interrupted time series

After the introduction of Bassini's procedure in the late 19th century, methods of repairing hernias changed little until the 1990s, when synthetic mesh and laparoscopic methods arrived. In contrast to the open mesh technique, laparoscopic surgery remains uncommon. In January 2001, the National Institute for Clinical Excellence (NICE) issued guidance that stated, "For repair of primary inguinal hernia, open [mesh] should be the preferred surgical procedure." We describe patterns of surgical repair of inguinal hernias and assess the impact of NICE's guidance

Randomised controlled trial of clinical medication review by a pharmacist of elderly patients receiving repeat prescriptions in general practice

Objective: To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice. Design: Randomised controlled trial of clinical medication review by a pharmacist against normal general practice review. Setting: Four general practices. Participants: 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community. Intervention: Patients were invited to a consultation at which the pharmacist reviewed their medical conditions and current treatment. Main outcome measures: Number of changes to repeat prescriptions over one year, drug costs, and use of healthcare services. Results: 590 (97%) patients in the intervention group were reviewed compared with 233 (44%) in the control group. Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions (mean number of changes per patient 2.2 v 1.9; difference=0.31, 95% confidence interval 0.06 to 0.57; P=0.02). Monthly drug costs rose in both groups over the year, but the rise was less in the intervention group (mean difference £4.72 per 28 days, -£7.04 to -£2.41); equivalent to £61 per patient a year. Intervention patients had a smaller rise in the number of drugs prescribed (0.2 v 0.4; mean difference -0.2, -0.4 to -0.1). There was no evidence that review of treatment by the pharmacist affected practice consultation rates, outpatient consultations, hospital admissions, or death rate. Conclusions: A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs. Such review results in significant changes in patients' drugs and saves more than the cost of the intervention without affecting the workload of general practitioners

Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014

INTRODUCTION: The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. OBJECTIVE: To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). METHODS: Drug approval data were downloaded from the EMA website and the 'Drugs@FDA' database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. RESULTS: Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. DISCUSSION: Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators

Opportunities to reduce antibiotic prescribing for patients with COPD in primary care: a cohort study using electronic health records from the Clinical Practice Research Datalink (CPRD)

Background In primary care there is uncertainty about which patients with acute exacerbations of COPD (AECOPD) benefit from antibiotics. Objectives To identify which types of COPD patients get the most antibiotics in primary care to support targeted antibiotic stewardship. Methods Observational study of COPD patients using a large English primary care database with 12 month follow-up. We estimated the incidence of and risk factors for antibiotic prescribing relative to the number of AECOPD during follow-up, considering COPD severity, smoking, obesity and comorbidity. Results From 157 practices, 19594 patients were diagnosed with COPD, representing 2.6% of patients and 11.5% of all prescribed antibiotics. Eight hundred and thirty-three (4.5%) patients with severe COPD and frequent AECOPD were prescribed six to nine prescriptions per year and accounted for 13.0% of antibiotics. Individuals with mild to moderate COPD and zero or one AECOPD received one to three prescriptions per year but accounted for 42.5% of all prescriptions. In addition to COPD severity, asthma, chronic heart disease, diabetes, heart failure and influenza vaccination were independently associated with increased antibiotic use. Conclusions Patients with severe COPD have the highest rates of antibiotic prescribing but most antibiotics are prescribed for patients with mild to moderate COPD. Antibiotic stewardship should focus on the dual goals of safely reducing the volume of prescribing in patients with mild to moderate COPD, and optimizing prescribing in patients with severe disease who are at significant risk of drug resistance