Deprivation and NHS General Ophthalmic Service sight testing activity in England in 2022-2023.

Purpose: Socioeconomic deprivation is associated with an increased incidence of sight-loss. To inform potential developments in eyecare, General Ophthalmic Service (GOS) sight-testing activity was explored in relation to deprivation for GOS contractors submitting National Health Service (NHS) claims in England.

Methods: Data on NHS sight-test claims for the financial year 2022-2023 were sought from NHS England (NHSE), including number of sight-tests by GOS contractors, their unique Organisation Data Service codes and postcodes and age-bands of patients accessing sight-testing.

Design and use of vignettes to investigate referral decision-making by optometrists.

Purpose: This study describes the design and application of a range of online clinical vignettes for measuring the impact of Continuing Education and Training (CET) and identifying unwarranted variation in optometric decision-making concerning referrals to secondary care.

Methods: Twenty computerised vignettes were developed to assess clinical and referral management decisions taken in primary care optometry. The online system was specifically designed to present vignettes (ten pre-CET and ten post-CET) that avoided prompting correct answers.

The relationship between unwarranted variation in optometric referrals and time since qualification.

Purpose: To investigate variation in optometric referral decision-making and the influence of experience and continuing education and training (CET).

Methods: To gain insight into unwarranted variation in referral activity in the United Kingdom (UK): (1) triage data were audited to investigate source of referral, provisional diagnosis, and outcome; (2) an online system was developed to present two sets of 10 vignettes, designed to avoid prompting answers. Participating optometrists completed 10 pre-CET vignettes, recording their tests and management decisions.

Inhalation devices and patient interface: human factors.

The development of any inhalation product that does not consider the patient needs will fail. The needs of the patients must be identified and aligned with engineering options and physical laws to achieve a robust and intuitive-to-use inhaler. A close interaction between development disciplines and real-use evaluations in clinical studies or in human factor studies is suggested.

Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report.

The purpose of this article is to document the discussions at the 2010 European Workshop on Equivalence Determinations for Orally Inhaled Drugs for Local Action, cohosted by the International Society for Aerosols in Medicine (ISAM) and the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS). The article summarizes current regulatory approaches in Europe, the United States, and Canada, and presents points of consensus as well as ongoing debate in the four major areas: in vitro testing, pharmacokinetic and pharmacodynamic studies, and device similarity. Specific issues in need of further research and discussion are also identified.

Establishing bioequivalence for inhaled drugs; weighing the evidence.

Introduction: During drug development and product life-cycle management, it may be necessary to establish bioequivalence between two pharmaceutical products. Methodologies to determine bioequivalence are well established for oral, systemically acting formulations. However, for inhaled drugs, there is currently no universally adopted methodology, and regulatory guidance in this area has been subject to debate.

Comparison of the effectiveness of two enhanced glaucoma referral schemes.

Purpose: To compare the clinical and financial effectiveness of two optometric-led enhanced glaucoma referral schemes in the Bexley Care Trust area.

Methods: Over a 12-month period all suspect glaucoma/Ocular Hypertension (OHT) referrals from optometrists relating to patients registered with Bexley GPs were analysed. All these patients were examined under one of two schemes.

Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report.

This March 2009 Workshop Summary Report was sponsored by Product Quality Research Institute (PQRI) based on a proposal by the Inhalation and Nasal Technology Focus Group (INTFG) of the American Association of Pharmaceutical Scientists (AAPS). Participants from the pharmaceutical industry, academia and regulatory bodies from the United States, Europe, India, and Brazil attended the workshop with the objective of presenting, reviewing, and discussing recommendations for demonstrating bioequivalence (BE) that may be considered in the development of orally inhaled drug products and regulatory guidances for new drug applications (NDAs), abbreviated NDAs (ANDAs), and postapproval changes. The workshop addressed areas related to in vitro approaches to demonstrating BE, biomarker strategies, imaging techniques, in vivo approaches to establishing local delivery equivalence and device design similarity.

Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 microg and fluticasone propionate 250 microg: implications for establishing bioequivalence of inhaled products.

Background: The use of dry-powder inhalers (DPIs) to administer respiratory medicines is increasing, and new DPIs are likely to be developed because of expiring patents. However, there is considerable debate concerning the extent to which DPIs are interchangeable without altering disease control or the safety profile of the treatment.

Objective: This study was designed to compare the pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety data for 2 DPIs delivering a combination of salmeterol 50 microg plus fluticasone propionate (FP) 250 microg (SFC 50/250) to investigate assumptions of bioequivalence.

Pseudomembranous supraglottitis with airway compromise in a patient with recurrent tonsillar carcinoma.

Purpose: In this report, we discuss a patient with acute pseudomembranous supraglottitis complicating recurrent tonsillar carcinoma and describe the ramifications of these disorders on perioperative management.

Clinical Features: The patient was an acutely ill man with a history of right tonsillar carcinoma originally treated with chemoradiation therapy and a radical neck dissection who presented with a brief history of fever, dyspnea, and stridor. The soft tissue of his neck was very stiff, his neck mobility was limited, and his mouth opening was restricted by pain and radiation-induced fibrosis.

Central giant cell granuloma.

Central giant cell granuloma, a fibro-osseous lesion, is more commonly found in the mandible and mainly in children and young adults. The lesion, which has a greater incidence in females, may be uni or multilocular. On the basis of clinical, radiological and histologic features, central giant cell granulomas can be classified as "non-aggressive" or "aggressive".

The formulation of biopharmaceutical products.

Biopharmaceutical products represent a diverse group of products that includes proteins, peptides, nucleic acids, whole cells, viral particles and vaccines. The conformation of the macromolecule or cell must be maintained to retain biological activity, and animal models for biological activity and characterization assays are often developed in tandem with initial formulation studies. This presents the formulation scientist with a unique set of challenges when compared to those for small molecules.

Statistical modelling of the formulation variables in non-viral gene delivery systems.

Traditionally, optimisation of a gene delivery formulation utilises a study design that involves altering only one formulation variable at any one time whilst keeping the other variables constant. As gene delivery formulations become more complex, e.g.

Mucus altering agents as adjuncts for nonviral gene transfer to airway epithelium.

Nonviral vectors have been shown to be a safe and valid alternative to recombinant viruses for gene therapy of cystic fibrosis (CF). Nevertheless, gene transfer efficiency needs to be increased before clinical efficacy is likely in man. One barrier to increased efficacy is normal airway mucus.

Studies on amidated pectins as potential carriers in colonic drug delivery.

Amidated pectins have been assessed, in-vitro, for their potential value in colonic drug delivery. The monitoring of the release of a model soluble drug, paracetamol, gives a sensitive indication of the behaviour of the pectins under simulated gastrointestinal conditions. Inclusion of calcium as a cross-linking agent increased the viscosities of amidated pectin gels to a maximum value.