Early Advice Research Articles

Pulmonary hypertension and pregnancy outcomes: data from the Registry Of Pregnancy and Cardiac Disease (ROPAC) of the European Society of Cardiology.

To describe the outcomes of pregnancy in women with pulmonary hypertension. In 2007 the European Registry on Pregnancy and Heart Disease was initiated by the European Society of Cardiology. Consecutive patients with all forms of cardiovascular disease, presenting with pregnancy, were enrolled with the aim of investigating the pregnancy outcomes. This subgroup of the cohort included 151 women with pulmonary hypertension (PH) either diagnosed by right heart catheterization or diagnosed as possible PH by echocardiographic signs, with 26% having pulmonary arterial hypertension (PAH), in three subgroups: idiopathic (iPAH), associated with congenital heart disease (CHD-PAH), or associated with other disease (oPAH), and 74% having PH caused by left heart disease (LHD-PH, n = 112). Maternal mean age was 29.2 ± 5.6 years and 37% were nulliparous. Right ventricular systolic pressure was <50 mmHg in 59.6% of patients, 50-70 mmHg in 28.5% and >70 mmHg in 11.9%. In more than 75% of patients, the diagnosis of PH had been made before pregnancy. Maternal death up to 1 week after delivery occurred in five patients (3.3%), with another two out of 78 patients who presented for follow-up (2.6%), dying within 6 months after delivery. The highest mortality was found in iPAH (3/7, 43%). During pregnancy, heart failure occurred in 27%. Caesarean section was performed in 63.4% (23.9% as emergency). Therapeutic abortion was performed in 4.0%. Complications included miscarriage (5.6%), fetal mortality (2%), premature delivery (21.7%), low birth weight (19.0%), and neonatal mortality (0.7%). Mortality in this group of patients with various forms of PH was lower than previously reported as specialized care during pregnancy and delivery was available. However, maternal and fetal mortality remains prohibitively high in women with iPAH, although this conclusion is restricted by limited numbers. Early advice on contraception, pregnancy risk and fetal outcome remains paramount.

The balanced diet - why so difficult to achieve?

The balanced diet - why so difficult to achieve?

Innovative biomarkers for predicting type 2 diabetes mellitus: relevance to dietary management of frailty in older adults.

Type 2 diabetes mellitus (T2DM) increases in prevalence in the elderly. There is evidence for significant muscle loss and accelerated cognitive impairment in older adults with T2DM; these comorbidities are critical features of frailty. In the early stages of T2DM, insulin sensitivity can be improved by a "healthy" diet. Management of insulin resistance by diet in people over 65years of age should be carefully re-evaluated because of the risk for falling due to hypoglycaemia. To date, an optimal dietary programme for older adults with insulin resistance and T2DM has not been described. The use of biomarkers to identify those at risk for T2DM will enable clinicians to offer early dietary advice that will delay onset of disease and of frailty. Here we have used an in silico literature search for putative novel biomarkers of T2DM risk and frailty. We suggest that plasma bilirubin, plasma, urinary DPP4-positive microparticles and plasma pigment epithelium-derived factor merit further investigation as predictive biomarkers for T2DM and frailty risk in older adults. Bilirubin is screened routinely in clinical practice. Measurement of specific microparticle frequency in urine is less invasive than a blood sample so is a good choice for biomonitoring. Future studies should investigate whether early dietary changes, such as increased intake of whey protein and micronutrients that improve muscle function and insulin sensitivity, affect biomarkers and can reduce the longer term complication of frailty in people at risk for T2DM.

Silent Shock: The Men Behind the Thalidomide Scandal and an Australian Family's Long Road to Justice by Michael Magazanik

166 BOOK REVIEWS an eye to what was going on there. Information was shared between antipodean mining conglomerates, with each watching anxiously the progression of mining regulations and legislation in the other country. There is no reference to the 1915 Miners’ Phthisis Act in New Zealand. Possibly this was below the radar for Western Australia, but from my perspective I would be intrigued to learn more of the differences between, and parallels with, these two neighbouring countries. LINDA BRYDER UNIVERSITY OF AUCKLAND Michael Magazanik, Silent Shock: The Men Behind the Thalidomide ScandalandanAustralianFamily’sLongRoadtoJustice(Melbourne: Text Publishing, 2015). ISBN 978-1-92218-209-8 (PB). 368pp. Michael Magazanik’s Silent Shock offers a new and engaging account of the well-known medical tragedy caused by the drug thalidomide. Marketed between 1957 and late 1961 as a remarkably safe sedative and treatment for morning sickness in pregnancy, the drug caused severe physical malformations—most typically dramatically truncated limbs—and death in more than ten thousand babies worldwide. Silent Shock tells the story through Australian victim of the drug Lyn Rowe’s 2011 legal claim against its German manufacturer Grünenthal, and British based Australian distributer Distillers. Magazanik is in a unique position to tell this story. A lawyer with Slater & Gordon, the firm that handled Rowe’s claim, he worked closely with Rowe and her family for years, building up the case against the two companies. After Rowe successfully won a multimillion-dollar settlement from Distillers in 2012, Magazanik decided to use his background in journalism to tell Rowe’s story, and to reveal both the corporate negligence and greed that brought about the worldwide thalidomide tragedy, and the subsequent callous denial of responsibility or fair compensation to the drug’s victims. Magazanik weaves together several narratives in the book: the history of thalidomide’s development in Germany, and the worldwide discovery of its teratogenic effects; the hardship experienced by the Rowe family as a result of the drug; and the worldwide legal action brought against thalidomide’s manufacturer and distributors, Health & History ● 18/1 ● 2016 167 leading up to the 2011 Australian litigation. A significant focus is on disproving Grünenthal and Distillers’ claim that thalidomide was an unavoidable tragedy: that they responsibly followed the state-ofthe -art of pharmaceutical research and development at the time of the drug’s development, that such research was unable to identify the drug’s dangers, and that they recalled thalidomide as soon as its effects became apparent. This claim had been widely accepted in the decades since the tragedy, resulting in limited litigation and compensation. Magazanik convincingly shows that in the late 1950s medical science was amply advanced to demonstrate the teratogenic effects of thalidomide through animal research, and that although such testing was not specifically required by law, it was conducted routinely by many pharmaceutical companies. Furthermore, he charts the numerous occasions on which Grünenthal was alerted to the potential dangers, or questioned as to the effect of the drug on the foetus, and chose not to investigate but instead make baseless claims as to its remarkable safety in pregnancy. The book also does well at highlighting thalidomide’s lesserknown side effect of causing severe peripheral nerve damage. Complaints of these effects flooded into Grünenthal prior to the discovery of the drug’s effects on foetal development. Rather than withdrawing the drug or properly investigating its danger, the company instead denied and attempted to suppress the claims, in order to minimise the damage they could do to the drug’s popularity. The story of Lyn Rowe and her family remains central throughout the book, ensuring that the consequences of Grünenthal and Distillers’ actions are starkly apparent. By the time Lyn’s mother took thalidomide in mid-1961, both companies had received reports blaming babies’ severe malformations on the drug, yet they had decided not to act. Lyn was born without limbs. This not only severely restricted her capacity to lead a normal, independent life, but also required her parents to commit to providing her aroundthe -clock care for the rest of their lives. Early medical advice had suggested that a virus had caused Lyn’s condition, therefore she had missed...

Urethro Vaginal Reflux - A Case Report

Abstract Objective The purpose of this study was to describe a case of day time incontinence due to Urethro vaginal reflux. Methods This is a case report of a 18 yr old girl who had presented to the out patient department with day time incontinence and post void dribbling. Ultrasound suggested an urethral diverticulum but the actual diagnosis was arrived by performing a MCU which is suggestive of a Urethro Vaginal reflux. Results She improved significantly by proper toilet training and is predominantly dry at 1 yr follow-up. Conclusions Urethro vaginal reflux can produce vaginal distension that is sonographically identical to obstructive hydrocolpos and may present with day time incontinence in young girls. This may be due to dysfunctional voiding issues. Postvoid sonography allows proper diagnosis and it can be treated by early clinical suspicion, proper diagnosis and advice.

Investigation of the oral status and microorganisms in children with phenylketonuria and type 1 diabetes.

The aim of this study was to investigate the oral parameters that influence the caries risk and risk of developing periodontal disease in children with phenylketonuria (PKU) and type 1 diabetes compared to healthy children. Two hundred and thirty-eight children between the ages of 3 and 18years were recruited in the PKU, diabetes and healthy group. The decayed, missing and filled surfaces (dmfs/DMFS) index, papillary bleeding index (PBI) and the Silness & Löe Index were assessed. Quantitative real-time polymerase chain reaction (PCR) was used for the detection of Streptococcus mutans (Sm), Lactobacillus casei (Lca), Lactobacillus species (Lac), Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg) and Tannerella forsythensis (Tf). A statistically significant difference in the dmfs index value was found between the three groups. The mean dmfs index value for the PKU children (4.18) was found to be relatively high. Comparing the three groups, diabetics showed statistically significant higher values for the Silness and Löe Index. Comparing the diabetics to just the healthy children, the diabetics revealed a small statistically significant difference in the PBI score. A statistically significant difference was found between Lac, Lca and Pg in the three groups. Counts of Lac were the lowest in the PKU children. The diabetics showed the highest counts of Lca but lowest for Pg. Comparing the three groups, children with PKU revealed a higher caries experience in their primary dentition. While the diabetic children showed a lower one in their primary dentition, they were found to possess a slightly higher risk of developing periodontal disease. It is proposed that both groups of child patients be encouraged to seek early dental advice and be incorporated in a meticulous prevention programme.

What's new with common genetic skin disorders?

Common genetic disorders such as neurofibromatosis type I (NF1), tuberous sclerosis, basal cell nevus syndrome (BCNS), incontinentia pigmenti, and X-linked ichthyosis have recognizable, cutaneous features. In children, cases often present without a prior diagnosis. This review highlights new information about diagnostic signs and care of affected patients. Disruption of key regulatory pathways causes disorders such as BCNS, NF1, and tuberous sclerosis. The discovery of associated mutations in these pathways has led to molecular targeted therapies. For example, use of drugs such as vismodegib in BCNS and rapamycin in tuberous sclerosis complex is being studied. Also, patient review has refined the diagnostic criteria for tuberous sclerosis and incontinentia pigmenti and expanded the phenotype of X-linked ichthyosis. Preimplantation genetic diagnosis for disorders such as NF1 and incontinentia pigmenti is available. Identification of nevus anemicus or juvenile xanthogranuloma in a young child may lead to an early diagnosis of NF1. Rapamycin offers noninvasive treatment for problematic skin lesions in pediatric patients with tuberous sclerosis. Providers can give early advice to affected families that reproductive technologies such as preimplantation genetic diagnosis are a consideration for future pregnancies.

Viewpoint: ‘Doctor, Doctor, have you elicited my expectations?’

A couple of years ago I was asked to talk at my children’s primary school in some kind of (very) early careers advice programme. The brief was broad — ‘What it’s like being a GP’ — but I knew immediately where to focus my efforts. This was a group of 10-year-old kids. What a perfect and unique opportunity to legitimately explore the grosser side of clinical practice! Pus. Vomit. Poo! In particular, a chance to dispel (or reinforce, depending on how mischievous I felt at the time), some of those entrenched lay myths about health and illness. That sitting on cold concrete gives you piles. …

In New Territory: Consent and the Extended Duties Dental Nurse

With the introduction of direct access to treatment from dental care professionals (DCPs) in 2013, dental nurses are being trained to support the wider dental team in a number of additional skills. The name for this expanded team role is Extended Duties Dental Nurse (EDDN). These new duties take the EDDN into new territories, one of which includes the issue of consent. This article explains the background to direct access and the extra responsibilities for EDDNs in terms of consent and indemnity. It explores the new knowledge required to gain valid consent and presents a scenario for consideration. The article concludes that it is important for EDDNs to develop their professional approach, taking early advice from the referring dentist and/or professional indemnity adviser if faced with an unfamiliar scenario.

Gendering Pathos on the Early Modern Stage:

Abstract In the early modern drama of John Webster, representations of pathos invite the interrogation of rhetorical theory as a comprehensive account of the role of emotion in persuasion. A White Devil and The Duchess of Malfi reveal unexpected trajectories of passionate appeal and persuasive effect, particularly in the ways female rhetors undercut early modern rhetorical advice regarding the deployment of pathos. While contemporary rhetorical treatises, such as Thomas Wilson's The Art of Rhetoric, insist that arguments based on emotion render immediate and undeniable the connection between rhetor and audience, the female rhetors' male audiences do not acknowledge emotional persuasion as confirmation of consensus or likeness. Instead, gender difference elides the possibility for commiseration, rendering any effectiveness of female passionate appeal the product of male evaluation, and not its source. This article charts a nuanced understanding of gendered pathos in Webster's drama by employing an analysis of the treatment of pathos in rhetorical theory and the considerations of pathos in representing female sexual desire on the early modern stage.

Rewards and challenges of a career in research and teaching at a liberal arts college.

As recently as a couple of decades ago, the career goals of most PhD students in the sciences were to get a tenure-track jobat ahigh-powered researchuniversity and maintain multiple R01s. In those days, an alternative career meant getting a job in industry. Although it is still possible to have that high-powered research job in academics, the landscape has changed and made obtaining that tenure-track research job much more competitive, and it is exceedingly difficult to maintain multiple R01s. In further support of a shifting landscape, there are now countless workshops on alternative careers in science (which did not exist two to three decades ago) that reveal a variety of opportunities for scientists. For example, since 2007 the Endocrine Society has sponsored a wonderful day-long EndoCareers Early Career Forum (formerly called the Endocrine Trainee Day) that precedes the Endocrine Society meeting and offers workshops on early career advice and alternative careers in endocrinology to graduate students and postdocs. One of the topics at this Early Career Forum has been the nontraditional path of working at a liberal arts college. This commentary will discuss how a faculty position at a liberal arts college can enable one to engage in both meaningful research and undergraduate teaching. Most liberal arts colleges are predominately private institutions, have a relatively small student body (1000– 3000 students) and have little or no graduate program, and thus focus on undergraduate education. At liberal arts colleges, the number of courses in a major is kept relatively low so that students can take a variety of courses outside of their major. Therefore, these colleges attract students who have varied interests and produce students who can think broadly in an interdisciplinary fashion and maintain a big-picture perspective (1). Because of these traits, liberal arts colleges produce a disproportionately high number of graduates, compared with large research universities, who go on to obtain PhDs in science (1–2). Although faculty responsibilities at some liberal arts colleges consist of 100% teaching and involve no research, at the other end of the spectrum are colleges in which faculty spend 50% of their time teaching and 50% doing research (and a wide variation in between these two ends of the spectrum). The 50/50 teaching/research split tends to be present at the highly ranked liberal arts colleges (3). This commentary will focus on these more research-oriented colleges that offer meaningful research opportunities for faculty and undergraduates.

Factors affecting cost estimate accuracy: Evidence from Palestinian construction projects

Estimating the cost of construction projects with high accuracy at the early phase of project development is crucial for project planning and financing. Construction clients require early and accurate cost advice prior to site acquisition and commitment to build in order to enable them to take the correct decision concerning whether to construct the project or not. However, many factors might affect the accuracy of a cost estimate. This study aims at identifying the factors affecting the accuracy of cost estimating construction projects in the West Bank in Palestine. A survey of 60 contractors and 45 consultants from the West Bank in Palestine was performed. Forty-one factors are identified in the study. The study investigates the impact of those factors measured by level of importance and ranked according to an importance index from both the contractors' and the consultants' points of view. The degree of agreement between the participating parties on the importance ranking of the factors affecting cost estimating accuracy in construction projects is presented. The findings reveal that the top five affecting factors according to the surveyed contractors are: fluctuation in currency exchange rate; contract management; number of competitors; financial status of owners; and fluctuation of prices of materials. While the top five factors according to the surveyed consultants are: the political situation; fluctuation of prices of materials; economic instability; poor planning; and previous experience of the contractor.

Self-Declared Seafood Eco-Labels

The credibility and veracity of an environmental claim depends on a high degree of transparency, clarity and trust. Businesses that utilize eco-labels to market the environmental performance of their seafood products often turn to third party certifications to minimize the potential for greenwashing and provide a level of verification and independence. Others rely on a riskier approach by developing their own “self-declared” or “first-party” eco-labels. Seafood retailers and suppliers considering the creation and use of an eco-label, certification, or seal to be used in the marketing of seafood products should ensure compliance with applicable FDA and USDA labeling rules. Furthermore, entities pursuing “self-declared” or “first-party” seafood eco-labels should consult the FTC’s Green Guides, closely follow developments in greenwashing litigation under federal and state consumer protection and unfair competition laws, and heed the early advice of legal experts in the field.

The Rhetoric of Pregnancy by Marika Seigel (review)

Reviewed by: The Rhetoric of Pregnancy by Marika Seigel Heather Latimer (bio) Marika Seigel, The Rhetoric of Pregnancy. Chicago: University of Chicago Press, 2013, 200 pp. $35.00 cloth. Marika Seigel’s The Rhetoric of Pregnancy begins and ends with a description of the author’s own childbirth experiences, using personal reflection as a jumping-off point for a rhetorical analysis of American pregnancy manuals and advice. Seigel recounts how the handbooks she read when pregnant told her that her body was risky, that she needed medical supervision, and that she must be compliant to the medical system in order to birth a healthy baby. She knew that something was wrong with how this advice positioned her, but it was not until she was in the midst of labor that she realized the problem: she had not been instructed on how to question the medical system, “only how to comply,” and was therefore unable to understand her rights, know when she could ask for more information, or understand which procedures she could refuse (p. 3). This experience made her realize that “learning how to question the experts, how and when to disengage from the system, and what one’s rights are, should be routine prenatal care instruction for both pregnant women and their partners” (ibid.). One of the main goals of The Rhetoric of Pregnancy is uncovering why this is not routine advice, therefore, in the hopes of reframing prenatal care to help facilitate pregnant women’s critical access to the medical system. In order to understand how pregnancy manuals position readers as needing functional rather than critical advice, Seigel uses rhetorical theory and criticism. She analyzes how pregnancy manuals developed “alongside of, out of, and sometimes in opposition to the technological system of prenatal care” (p. 6) by studying early written manuals from the 1900s to current online forms of instruction and advice. This temporal structure provides an opportunity for Seigel to historicize pregnancy advice, and to trace the development of pregnancy manuals in relation to the medicalization of prenatal care. Her methodology focuses on uncovering the rhetorical and material effects of these manuals, and on analyzing how the manuals articulate pregnancy, or, following Kenneth Burke’s concept of piety, how they are organized by assumptions about the identities of their audience. What she uncovers is that many commonsense ideas about what constitutes good prenatal care today have their roots in early 1900s medical advice, which was itself attached to eugenics movements concerned with the betterment of the nation through better “breeding” practices. For instance, early pregnancy manuals made assumptions that a pregnant woman should adequately discipline herself in order to ensure the health of her future child, and that when she did not do so it was the role of husbands, doctors, and other patriarchal figures to do this work in her stead. This was because the end-goal of every pregnancy, as articulated in these manuals, was not only a healthy baby or mother, but also a “normal” baby. In other words, from the first instance, pregnancy manuals have positioned pregnancy as a social event connected to national interests, and the pregnant body as in need of institutionalized support and supervision. [End Page 297] If the end-goal of prenatal care has consistently been to produce normal babies, this helps to explain why pregnant women have been figured as “at risk” in mainstream pregnancy manuals, both from the advice of those outside the medical establishment and from within. From J. W. Ballantyne’s Expectant Motherhood: Its Supervision and Hygiene (1914), discussed in chapter 3, to the current popular website <www.babycenter.com> (run by BabyCenter LLC, a subsidiary of Johnson & Johnson), discussed in chapter 8, Seigel reveals that the pious pregnant woman has consistently been figured as a nonexpert. Even as mainstream manuals have shifted away from seeing the ideal pregnant woman as totally submissive and compliant, several pieties have remained constant. For instance, the fetus (and not the mother) has remained the primary patient of prenatal care, and the pregnant body has remained unreliable, dangerous, and in need of medical surveillance. In fact, whereas early manuals suggested one’s doctor as the source of specialized knowledge...

An Integrated Approach for the Application of the Enhanced Oil Recovery Projects

This work presents an integrated approach for screening and application of the most suitable enhanced oil recovery (EOR) method to the oil fields. The proposed approach can be used to support the decision making during the critical technology selection phase. By providing early stage advice through detailed design, the approach can provide a bridging service to bring the EOR projects from screening and laboratory stages into the field applications. EOR screening for some of the Egyptian oil fields is presented. The screening procedure and criteria are based on field results and previous experiences, and involve the analysis of both surface and subsurface fields’ conditions. The results indicate that the most appropriate EOR methods for the studied oil fields appear to be CO2 and alkali-surfactant-polymer injection methods. The study shows that CO2-EOR could help Egypt simultaneously to reduce the emissions of CO2 and increase the recovery factor by 5 to 15 %. The study then identifies the main technological barriers to the implementation of CO2-EOR, and indicates key areas that require further research and development. In addition, the challenges and the main technical concerns in applying CO2-EOR technologies are discussed in the light of the lessons learnt from large scale worldwide EOR projects. Such study is an original contribution to achieve successful EOR applications and could significantly increase the reserves of the mature oil fields.

Winter pressures funding

14 November 2014: The government announced that a further £300m is being invested to help the NHS in England deal with winter pressures this year. As part of the announcement, patients are being encouraged to make more use of pharmacists and seek early advice from them. The Royal Pharmaceutical Society (RPS) featured on a number of […]

ICES advisory framework 1977–2012: from Fmax to precautionary approach and beyond

Abstract Lassen, H., Kelly, C., and Sissenwine, M. 2014. ICES advisory framework 1977–2012: from Fmax to precautionary approach and beyond. – ICES Journal of Marine Science, 71: 166–172. The International Council for the Exploration of the Sea (ICES) provides fishery advice in the context of international agreements and addressing the policy and legal needs of ICES Member Countries. This advice is often formulated for an annual total allowable catch based on decisions made by the North East Atlantic Fisheries Commission (NEAFC) during the first half of the 1970s. Although this early advice was initially focused on the best usage of the growth potential of the fish stocks, the collapse of important pelagic stocks in the late 1960s and the early 1970s suggested that the biological advice should include serious considerations of the spawning–stock biomass (SSB). ICES responded with a new advisory framework in 1976. Over the next 30 years, the advisory framework evolved, with increasing emphasis placed on ensuring SSB to avoid impairing recruitment. The Plan of Implementation of the 2002 UN World Summit on Sustainable Development (WSSD) calls for the restoration and maintenance of fish stocks to levels than can produce the fisheries that provide maximum sustainable yield (MSY). In 2009, ICES revised its advisory framework now formulated as a harvest control rule aimed at achieving MSY.

Early Scientific Advice Obtained Simultaneously from Regulators and Payers: Findings from a Pilot Study in Australia

ObjectiveThere is scope for better interaction between regulators, payers/HTA agencies, and medicines developers in their common objective of getting new medicines to patients. This paper reports on a tripartite early scientific advice pilot conducted by a pharmaceutical company (developer), the Therapeutic Goods Administration (TGA: regulator) and the Pharmaceutical Benefit Advisory Committee (PBAC) Secretariat (HTA agency) in Australia. The objective was to explore the practicality, feasibility, and sustainability of means of obtaining simultaneous scientific advice from both a regulatory and reimbursement perspective. MethodsAdvice was sought for two development compounds in different disease areas. The focus was on matters of common interest to the TGA and the PBAC (i.e. the clinical evidence). Briefing books were prepared by the developer and supplied eight weeks prior to the meeting and only verbal advice was provided. ResultsThe pilot meeting took place in 2009. Each session lasted for approximately two hours and was structured around the questions in the briefing books. The representatives from the TGA and PBAC Secretariat provided well-informed, considered and careful advice for both compounds, which was predominantly actionable and practical. DiscussionThe sessions proved highly informative and permitted better alignment of the possible positioning of new medicines with the clinical evidence that regulators and HTA agencies might subsequently require for favorable assessment. The process provided early and clear signals to inform major development investments and the probability of successful market access. A number of challenges need to be addressed before tripartite scientific advice can be provided on continual basis.

The scottish model: Scottish medicines consortium (SMC)

UK health care is provided by a national health service (NHS), within which medicines are a major and growing cost. Concerns from patients, politicians, medical practitioners, and the press about “postcode” prescribing (marked regional differences in availability of newly licensed medicines) led to the creation of the Scottish Medicines Consortium (SMC). Run by NHS clinicians, SMC provides rapid advice on all new medicines, including new indications/formulations for existing therapies. A streamlined 2-stage pharmacy and health economic, and then strategic, review of submissions from industry by SMC provides an objective review of the data and a wider societal view of need. A patient perspective is included. Comparative cost-effectiveness is assessed, preferably by using QALY ICERs, and advice given close to UK licensing (usually within 4 months). This early advice means that physicians are prepared to wait for the decision from SMC, and prescribing is relatively uncommon outside the guidance. Three outcomes are possible: (1) accept for general use; (2) accept with restriction (by specialist prescriber, or only for a subgroup within the license); or (3) do not recommend for use in Scotland. Appeals can be heard and resubmissions can be made if the evidence base changes. Around 1000 submissions have now been made, including abbreviated submissions for minor license changes, since 2002. Around two thirds of all medicines were accepted for use in NHS Scotland but many in a way more restrictive than the license. Around 50% of resubmissions are accepted. Evidence suggests SMC decisions are not influenced by budget impact (affordability) but are strongly influenced by whether the drug provides value for money to the NHS in Scotland. Accepted modifiers of decisions include orphan indications, end-of-life treatment, bridging to a definitive treatment, and the development of licensed treatment where only an unlicensed preparation previously existed. Drug utilization data suggest that early advice influences prescribing patterns, in a positive way for approved drugs, and by lack of uptake (or reduction of existing prescribing) for those not recommended (with some exceptions). Benchmarking shows a high level of consistency with subsequent decisions from the National Institute for Health and Clinical Excellence (NICE), and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia. SMC has an ongoing horizon scanning program, created a Scottish Management of Antimicrobial Resistance action Plan (ScotMARAP; 2008), and now runs a Patient Access Scheme to make high-cost drugs affordable to Scottish patients. An open and inclusive process, involving key stakeholders, can produce useful, rigorous, evidence-based advice to a health care system in a way that is acceptable to the NHS and to the pharmaceutical industry, and occurs sufficiently early after the launch of a new drug to inform and influence subsequent prescribing patterns. None declared.

Postoperative pyoderma gangrenosum in association with renal cell carcinoma and chronic lymphocytic leukemia.

IntroductionPyoderma gangrenosum (PG) is a rare sterile neutrophilic dermatosis characterized by painful recurrent ulcerations. It is frequently associated with inflammatory bowel disease, rheumatoid arthritis, or malignancies. PG is a diagnosis of exclusion, and it is based on clinical presentation, histology, history of an underlying disease, and exclusion of other causes of ulceration.Case ReportThe authors report a 62-year-old male who developed a nonhealing ulcer at the site of incision following nephrectomy for renal cell carcinoma. Past medical history included chronic lymphocytic leukemia treated with rituximab. Histology of the skin lesion showed a phlegmonous nonspecific inflammation without being able to differentiate between a necrotizing wound infection and PG. The patient’s condition was initially diagnosed as an infectious process and treated accordingly. After unsuccessful results with systemic antibiotics, high-dose corticosteroids induced prompt healing of the wound. On these bases, the diagnosis of postoperative PG within chronic lymphocytic leukemia and renal cell carcinoma was made.ConclusionFaced with postoperative necrotizing ulceration resistant to correctly administered antibiotics, PG must be considered. In such condition, the diagnosis must not be guided primarily by histology and early advice of a dermatologist is recommended.