Search

Contraindications (CIs) in Summaries of Product Characteristics (SmPCs)/Prescribing Information (PI) that lack clarity may pose a risk to medication safety and increase the risk for adverse drug reactions. We assessed and compared SmPCs/PI from three major drug markets regarding comprehensibility from the prescriber perspective, as well as usability in clinical decision support systems. 158 drugs met the following inclusion criteria: marketed in Germany (DE), United Kingdom (UK) and United States (US) and belonged to the 100 most recently FDA approved and/or 100 most frequently prescribed drugs in either country. In the 474 (3 × 158) SmPCs/PI all expressions for absolute CIs were identified, divided into 3999 stand-alone terms and evaluated according to 'clarity' and 'codability'. The average number of absolute CIs per drug differed drastically between the three markets (DE: 11.7, UK: 9.0, US: 4.6). Expressions were frequently unclear (DE: 27.2% (95% CI 25.2–29.2%), UK: 28.5% (26.2–30.9%), US: 22.6% (19.7–25.8%)). Moreover, 60.9% (58.6–63.1%), 63.6% (61.0–66.0%), and 64.7% (61.2–68.1%) of the expressions were not codable in DE, UK, and US, respectively. Taken together, in three major drug markets, statements regarding CIs in SmPCs/PI substantially differ in frequency and frequently lack clarity and codability which poses an unnecessary obstacle to medication safety. [ABSTRACT FROM AUTHOR]

Background: Underuse of anticoagulants in atrial fibrillation (AF) is an international problem, which has often been attributed to the presence of contraindications to treatment. No studies have assessed the influence of contraindications on anticoagulant prescribing in the UK.Aim: To determine the influence of contraindications on anticoagulant prescribing in patients with AF in the UK.Design and Setting: Cross-sectional analysis of primary care data from 645 general practices contributing to The Health Improvement Network, a large UK database of electronic primary care records.Method: Twelve sequential cross-sectional analyses were carried out from 2004 to 2015. Patients with a diagnosis of AF aged ≥35 years and registered for at least 1 year were included. Outcome measure was prescription of anticoagulant medication.Results: Over the 12 study years, the proportion of eligible patients with AF with contraindications who were prescribed anticoagulants increased from 40.1% (95% confidence interval [CI] = 38.3 to 41.9) to 67.2% (95% CI = 65.6 to 68.8), and the proportion of those without contraindications prescribed anticoagulants increased from 42.1% (95% CI = 41.6 to 42.6) to 67.7% (95% CI = 67.2 to 68.1). In patients with a recent history of major bleeding or aneurysm, prescribing rates increased from 44.3% (95% CI = 42.2 to 46.5) and 34.8% (95% CI = 29.4 to 40.6) in 2004 to 71.7% (95% CI = 69.9 to 73.5) and 63.2% (95% CI = 58.3 to 67.8) in 2015, respectively, comparable with rates in patients without contraindications.Conclusion: The presence or absence of recorded contraindications has little influence on the decision to prescribe anticoagulants for the prevention of stroke in patients with AF. The study analysis suggests that, nationally, 38 000 patients with AF with contraindications are treated with anticoagulants. This has implications for patient safety. [ABSTRACT FROM AUTHOR]

This article describes the contraceptive methods available for women across the age groups, and supports prescribers in safely assessing and reviewing women who require contraception; advising women on the choices available; advising on the emergency contraception available; and determining whether or not Fraser guidelines must be applied for girls younger than 16 years of age. [ABSTRACT FROM AUTHOR]

Purpose: Not all patients with stage III non-small cell lung cancer (NSCLC) are suitable for concurrent chemoradiation therapy (CRT). Local failure rate is high for sequential concurrent CRT. As such, there is a rationale for treatment intensification., Methods and Materials: Isotoxic intensity modulated radiation therapy (IMRT) is a multicenter feasibility study that combines different intensification strategies including hyperfractionation, acceleration, and dose escalation facilitated by IMRT. Patients with unresectable stage III NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2, and unsuitable for concurrent CRT were recruited. A minimum of 2 cycles of platinum-based chemotherapy was compulsory before starting radiation therapy (RT). Radiation dose was increased until a maximum dose of 79.2 Gy was reached or 1 or more of the organs at risk met predefined constraints. RT was delivered in 1.8-Gy fractions twice daily, and an RT quality assurance program was implemented. The primary objective was the delivery of isotoxic IMRT to a dose >60 Gy equivalent dose in 2-Gy fractions (EQD2 assuming an α/β ratio of 10 Gy for acute reacting tissues)., Results: Thirty-seven patients were recruited from 7 UK centers. Median age was 69.9 years (range, 46-86 years). The male-to-female ratio was 17:18. ECOG PS was 0 to 5 in 14.2% of patients; PS was 1 to 27 in 77.1% of patients; PS was 2 to 3 in 8.6% of patients. Stage IIIA:IIIB ratio was 22:13 (62.9%:37.1%). Of 37 patients, 2 (5.4%) failed to achieve EQD2 > 60 Gy. Median prescribed tumor dose was 77.4 Gy (range, 61.2-79.2 Gy). A maximum dose of 79.2Gy was achieved in 14 patients (37.8%). Grade 3 esophagitis was reported in 2 patients, and no patients developed grade 3 to 4 pneumonitis. There were 3 grade 5 events: acute radiation pneumonitis, bronchopulmonary hemorrhage, and acute lung infection. Median follow-up at time of analysis was 25.4 months (range, 8.0-44.2) months for 11 of 35 survivors. The median survival was 18.1 months (95% confidence interval [CI], 13.9-30.6), 2-year overall survival was 33.6% (95% CI, 17.9-50.1), and progression-free survival was 23.9% (95% CI, 11.3-39.1)., Conclusions: Isotoxic IMRT is a well-tolerated and feasible approach to treatment intensification., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Coronavirus disease-2019 (COVID-19) has generated a need to rapidly increase online consulting in secondary care, an area in which it has previously been underutilised. We sought to review the guidance on conducting remote consultations and found that while there is a large amount of information about the implementation of remote consultations at an organisation level, there is a paucity of high-quality papers considering the guidelines for online consultations alongside practical advice for their implementation at the individual level. We reviewed guidelines from reputable medical sources and generated practical advice to assist practitioners to perform safe and effective video consultation. Additionally, we noted reports in the literature of a lack of transparency and resulting confusion regarding the choice of telemedicine platforms. We, therefore, sought to summarise key characteristics of a number of major telemedicine platforms. We recognised a lack of clarity regarding the legal status of performing remote consultations, and reviewed advice from medico-legal sources. Finally, we address the sources of these individual uncertainties, and give recommendations on how these might be addressed systematically, so the practitioners are well trained and competent in the use of online consultations, which will inevitably play an increasingly large role in both primary and secondary care settings in the future., (Copyright © 2020 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Codeine is a drug that until recently was widely used in children. It was endorsed by the WHO as the second step on the analgesic ladder for cancer pain and has been used routinely for postoperative and breakthrough pain. Recently, its safety and efficacy have been called into question, following deaths after adenotonsillectomy was associated with its use. This has led to regulation by the US Food and Drug Administration, European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency to place significant restrictions on its use, and some centres have stopped using it altogether.In this article, we discuss the developmental pharmacology underpinning its action, reviewing what is known about the pharmacokinetics, pharmacodynamics and pharmacogenetics in children, how this relates to prescribing, as well as the practical issues and the recent regulatory framework surrounding its use., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

There are several well-established guidelines for the treatment of psoriasis. Guidelines have been proposed in the United States by the American Academy of Dermatology (AAD), in Europe by the European S3, in the United Kingdom by the National Institute for Health and Care Excellence (NICE), and in Canada by the Canadian Dermatology Association. These guidelines are predominantly evidence-based, supported by expert panel consensus where evidence is lacking. Cyclosporine, a potent calcineurin inhibitor that acts selectively on T-cells, revolutionized the world of immunosuppression upon its discovery in 1970. Since its approval in 1997 by the U.S. Food and Drug Administration for the treatment of psoriasis, cyclosporine has been used with great efficacy in the treatment of not only psoriasis but also a wide consortium of dermatological diseases. However, in the past decade or so, many dermatologists have become increasingly hesitant to use this important drug because of its potent toxicity profile. The purpose of this article is to review and compare the current evidence-based guideline recommendations for the use of cyclosporine in the treatment of psoriasis. Although the various guidelines are similar in their initial treatment recommendations, significant differences exist in recommendations on maximal treatment duration (1 year versus 2 years), intermittent short-term versus continuous therapy, use in erythrodermic and palmoplantar psoriasis, as well as recommendations on managing cyclosporine-associated side effects. By following guideline recommendations, cyclosporine remains an excellent and indispensable tool for the dermatologist treating moderate-to-severe psoriasis.

This is the first of a two-part unit on syncope and the value of tilt table testing. This part discusses background information on syncope, physiology, the procedure of tilt table testing, and indications and contraindications for it.

Lymphoedema may be triggered by any type of injection. This is not just an issue for the cured breast cancer patient but for any patient who has undergone under-arm (axillary) lymph node removal to any degree for any type of cancer. Standard advice given to patients following axillary node removal is to avoid any injection or blood pressure measurement on the ipsilateral arm. The evidence base in this area is severely lacking. Patients have reported frustration that nurses are not informed of contraindications in carrying out such procedures on patients at risk of developing swelling. This article discusses the current evidence available on the subject of non-accidental skin puncture (NASP) relating to the patient at risk of lymphoedema and provides guidelines for any professionals conducting such procedures for patients with a history of cancer. The results from a small audit of the guidelines are cited and they reveal that out of 14 patients who underwent NASP procedures in the at risk arm, no patients reported swelling to that limb within a month of these procedures.

Nitrous oxide gas, mixed 50:50 with oxygen, is an effective and safe analgesic which, although widely used in many areas of clinical practice, has not been fully recognized in the community setting for painful procedures. The reasons why it has not been implemented and used to the patient's advantage have been suggested as apathy, lack of confidence, lack of knowledge and lack of resources. The author describes how, following a review of the literature pertaining to its use in other clinical areas, she has successfully introduced nitrous oxide/oxygen into her trust, with positive results.

Several social and medical attributes are associated with both avoidance or delay of vaccination and an increased risk of adverse events such as sudden infant death syndrome or childhood encephalopathy. Studies that fail to control adequately for such confounding factors are likely to underestimate the risks of adverse events attributable to vaccination. This paper reviews the literature on studies of severe adverse events after the administration of pertussis antigen-containing vaccines, with particular attention to the measures taken by different investigators to avoid this problem. Most published studies have reported a deficit of sudden infant death syndrome among vaccinees, which may reflect confounding in their study designs. An expression is derived to explore the extent of underestimation that may be introduced in such studies, under different sets of conditions. Confounding of this sort is a general problem for studies of adverse reactions to prophylactic interventions, as they may be withheld from some individuals precisely because they are already at high risk of the adverse event.