Adverse effects

An undesirable effect (UE) of a cosmetic product is a harmful reaction attributable to its normal or reasonably foreseeable use. However, the knowledge of UEs, at the population level, is limited by the absence of formal and reliable cosmetovigilance systems, which nevertheless are characterized by underreporting. To test the feasibility of the collection of UEs in our territory we have carried out a pilot project aimed to assess either the notification procedures or the validation/evaluation of the collected forms in our territory. As reporting categories, we have chosen dermatologists and community pharmacists who were asked to notify UEs to cosmetics through a reporting form we have set up. During the period July 2006-December 2007, we have registered 76 reporting forms. Dermatologists who have sent 47 reporting forms represented the main reporting category, followed by community pharmacists (15 reports), other health professionals (9 reports) and consumers (5 reports). Several drawbacks, mainly represented by the incompleteness and inaccuracy of the filled in forms, affected the validation process. Thus, on receipt, we could validate only 34 forms and only after a careful check with each single reporter, we could include in the study other 36 forms. The validation of the collected reports has stressed the importance of a well-structured reporting form, an easy access to notification procedures as well as education and training programme. The evaluation of the validated forms has revealed the need of a controlled term vocabulary for the classification of the observed events and diagnosis, especially with regard to cutaneous reactions that represented almost the totality of the reported events (95.7%). Among the events (n = 45) reported by dermatologists, 22 were diagnosed as allergic contact dermatitis (ACD) and 18 as irritant contact dermatitis (ICD). Facial care products (19.7%), followed by body care products (16.9%), perfumes (12.7%) and eye care products (11.3%) were the cosmetics mainly suspected to be responsible for the observed events. Correspondingly, face (n = 37), including periorbital and perioral area, forehead, ocular mucous membrane and lips, followed by entire body (n = 9) were the body sites reported as more involved. In conclusions, our experience allowed us to identify the main pitfalls of the system we have experienced. These are setting/formulation of the reporting form, notification step, description of the event and diagnosis. A careful settlement of these aspects could substantially contribute to the establishment of an efficient reporting system, although the bias due to underreporting is difficult to eliminate.

Objective-To assess tolerability and short-term efficacy of oral administration of pregabalin as an adjunct to phenobarbital, potassium bromide, or a combination of phenobarbital and potassium bromide for treatment of dogs with poorly controlled suspected idiopathic epilepsy. Design-Open-label, noncomparative clinical trial. Animals-11 client-owned dogs suspected of having idiopathic epilepsy that was inadequately controlled with phenobarbital, potassium bromide, or a combination of these 2 drugs. Procedures-Dogs were treated with pregabalin (3 to 4 mg/kg [1.4 to 1.8 mg/lb], PO, q 8 h) for 3 months. Number of generalized seizures in the 3 months before and after initiation of pregabalin treatment was recorded. Number of responders (≥ 50% reduction in seizure frequency) was recorded, and seizure frequency before and after initiation of pregabalin treatment was compared by use of a nonparametric Wilcoxon signed rank test. Results-Seizures were significantly reduced (mean, 57%; median, 50%) after pregabalin administration in the 9 dogs that completed the study; 7 were considered responders with mean and median seizure reductions of 64% and 58%, respectively. Adverse effects for pregabalin were reported in 10 dogs. Mean and median plasma pregabalin concentrations for all dogs were 6.4 and 7.3 µg/mL, respectively. Conclusions and Clinical Relevance-Pregabalin may hold promise as a safe and effective adjunct anticonvulsant drug for epileptic dogs poorly controlled with the standard drugs phenobarbital or potassium bromide. Adverse effects of pregabalin appeared to be mild. Additional studies with larger numbers of dogs and longer follow-up intervals are warranted.

Antarctic krill, also known as Euphausia superba, is a marine crustacean rich in both eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). We tested the hypothesis that krill oil would increase plasma concentrations of EPA and DHA without adversely affecting indicators of safety, tolerability, or selected metabolic parameters. In this randomized, double-blind parallel arm trial, overweight and obese men and women (N = 76) were randomly assigned to receive doubleblind capsules containing 2 g/d of krill oil, menhaden oil, or control (olive) oil for 4 weeks. Results showed that plasma EPA and DHA concentrations increased significantly more (P b .001) in the krill oil (178.4 ± 38.7 and 90.2 ± 40.3 μmol/L, respectively) and menhaden oil (131.8 ± 28.0 and 149.9 ± 30.4 μmol/L, respectively) groups than in the control group (2.9 ± 13.8 and −1.1 ± 32.4 μmol/L, respectively). Systolic blood pressure declined significantly more (P b .05) in the menhaden oil (−2.2 ± 2.0 mm Hg) group than in the control group (3.3 ± 1.5 mm Hg), and the response in the krill oil group (−0.8 ± 1.4 mm Hg) did not differ from the other 2 treatments. Blood urea nitrogen declined in the krill oil group as compared with the menhaden oil group (P b .006). No significant differences for other safety variables were noted, including adverse events. In conclusion, 4 weeks of krill oil supplementation increased plasma EPA and DHA and was well tolerated, with no indication of adverse effects on safety parameters.

Study Objective: To compare use of the weekly transdermal contraceptive patch (patch) with daily combined hormonal contraceptive pills (pills) in adolescents. Design: Prospective longitudinal study of adolescents' self-selected (non-randomized) use of the patch or pills. Setting: Urban, university hospital-affiliated, adolescent outpatient clinic. Participants: 13e22-year-old female adolescents seeking hormonal contraception, 40 who chose the patch and 40 who chose pills. Interventions: Data were collected via self-report on paper questionnaires at three-cycle intervals for a total of up to nine cycles. Main Outcome Measures: Method continuation, perfect use, method satisfaction, quality of life, and side effects, including menstrual changes and perceived mood changes. Results: After nine cycles, 38% of patch users and 60% of pill users were still using the method they had chosen at enrollment. There were no significant differences between the groups in self-reported perfect use. No differences were found in quality of life or side effects. Both patch and pill users noted menses became lighter and more predictable and reported decreased depression prior to their menses; only the pill group reported improvement in premenstrual anger. Method satisfaction was similar in both groups except patch users were more likely to report that their contraceptive method improved normal daily activities. Conclusions: Despite apparent advantages of the patch over the pill, adolescents using both methods continue to face challenges achieving perfect and sustained contraceptive use.

The Policy Research Working Paper Series disseminates the findings of work in progress to encourage the exchange of ideas about development issues. An objective of the series is to get the findings out quickly, even if the presentations are less than fully polished. The papers carry the names of the authors and should be cited accordingly. The findings, interpretations, and conclusions expressed in this paper are entirely those of the authors. They do not necessarily represent the views of the International Bank for Reconstruction and Development/World Bank and its affiliated organizations, or those of the Executive Directors of the World Bank or the governments they represent.

Recibido el 27 de enero de 2012. Aceptado para su publicación el 28 de marzo de 2012. RESUMEN La prescripción en cascada se produce cuando un nuevo fármaco es prescrito para "tratar" una reacción adversa producida por otro fármaco, basándose en la creencia errónea de que una nueva condición médica se ha desarrollado. Los acontecimientos adversos asociados a la prescripción en cascada se producen cuando el segundo fármaco aumenta la severidad de la reacción adversa producida por el primer fármaco, o cuando el segundo fármaco expone al paciente a la aparición de nuevas reacciones adversas. La clave para prevenir la prescripción en cascada reside en la prevención y rápida detección de las reacciones adversas. Los profesionales de la salud deben ser capaces de reconocer cuándo un medicamento debe ser retirado y cómo hacerlo. La desprescripción debe considerarse cuando existe polimedicación, reacciones adversas a medicamentos, ineficacia del tratamiento, caídas o cuando los objetivos del tratamiento han cambiado. Un enfoque cauteloso de la desprescripción incluye dos principios: retirar los fármacos de uno en uno y disminuir las dosis gradualmente durante semanas o meses. Palabras clave. Cascada de prescripción, Reacción Adversa, Polifarmacia, Retirada de fármacos.

Betalactams are the most frequent cause of hypersensitivity reactions to drugs mediated by a specific immune mechanism. Immediate reactions occur within 1 to 6 hours after betalactam administration, and are generally IgE-mediated. They clinically translate into urticaria, angioedema and anaphylaxis. Non-immediate or delayed reactions occur after 1 hour of administration. These are the most common reactions and are usually mediated by T cells. The most frequent type is the maculopapular or morbilliform exanthematous eruption. Most individuals who report allergies to penicillin and betalactams can tolerate this group of antibiotics. To make diagnosis, a detailed medical history is essential to verify whether it was an immediate or non-immediate reaction. Thereafter, in vivo and/or in vitro tests for investigation may be performed. The challenging test is considered the gold standard method for diagnosis of betalactam hypersensitivity. The first approach when suspecting a reaction to b...

An evidence-based systematic review of gymnema (Gymnema sylvestre R. Br.), including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

Background: Mechanical ventilation (MV) strategies are continuously evolving in an effort to minimize adverse events. The objective of this study was to determine the complications associated with MV in children. Study Design: Prospective observational study. Over a period of 10 consecutive months, 150 patients (median age 0.8 years, IQR 4.4, 59% male) were enrolled in this study. Results: The median duration of MV was 3.1 days (IQR 3.9). A total of 85 complications were observed in 60 (40%) patients (114 complications per 1,000 ventilation days). 16.7% of patients developed atelectasis, 13.3% post-extubation stridor, 9.3% failed extubation, 2.0% pneumothorax, 3.3% accidental extubation, 2.7% nasal or perioral tissue damage and 1.9% ventilator associated pneumonia. Atelectasis occurred most often in the left lower lobe (36%) or in the right upper lobe (26%). The incidence of atelectasis in children <1 year of age was 12% (31 episodes per 1,000 days of ventilation) compared to 18% (57 episodes per 1,000 days of ventilation) in children !1 year of age (P < 0.05). Patients that failed extubation were ventilated for a median of 8.5 (IQR 8.8) days compared to 2.9 days (IQR, 3.8) in patients that were successfully extubated (P < 0.01). The absence of an air leak prior to extubation did not correlate with failed extubation. Accidental extubation was limited to orally intubated patients. Conclusion: MV complications occurred in 40% of patients and most often consisted of atelectasis and post-extubation stridor. Further studies are needed to examine associated risk factors and strategies to reduce their occurrence.

Objective: To assess the impact of including unpublished data on adverse effects in systematic reviews. Study Design and Setting: We carried out a systematic review of methodological evaluations that compared the quantitative reporting of adverse effects data between published and unpublished sources, in particular, the frequency, rate, or risk of reported adverse effects. Included studies were sought from 10 databases as well as by checking references, handsearching, searching citations, and contacting experts.

X-ray contrast media are chemically inert drugs which are given intravascularly in very high amounts within a very short time period. Although they are regarded as relatively safe drugs, adverse reactions can occur: these are normally divided into immediate and delayed reactions. The latter appear hours to days after injection. Immediate reactions have been drastically reduced since the introduction of non-ionic monomers and non-ionic dimers. However, the delayed reactions still occur in a frequency of 1-3% in X-ray contrast media exposed patients. The majority of these reactions are mild and manifest as skin eruption, but severe reactions can also occur. Further improvement of the safety of these drugs is only possible with a better understanding of etiologies behind the observed adverse reactions.

The Policy Research Working Paper Series disseminates the findings of work in progress to encourage the exchange of ideas about development issues. An objective of the series is to get the findings out quickly, even if the presentations are less than fully polished. The papers carry the names of the authors and should be cited accordingly. The findings, interpretations, and conclusions expressed in this paper are entirely those of the authors. They do not necessarily represent the views of the International Bank for Reconstruction and Development/World Bank and its affiliated organizations, or those of the Executive Directors of the World Bank or the governments they represent.

Antipsychotic nonneurological side effects, such as sexual dysfunction, can adversely affect the quality of patients&#39; relationships, their treatment adherence and their quality of life. In the UK CUtLASS (Cost Utility of the Latest Antipsychotics in Severe Schizophrenia) study, nonneurological side effects were assessed using the ANNSERSv1 (Antipsychotic Non-Neurological Side Effects Rating Scale version 1), a new scale to assess the side effects associated with both first- and second-generation antipsychotic drugs. A total of 26 participants also completed the Derogatis Interview for Sexual Functioning (self-report version, DISF-SR). A statistically significant, and specific, correlation was found between scores on the DISF-SR and the sexual side-effect section of the ANNSERS at baseline. The sexual side-effects subscale of the ANNSERS is a valid measure of sexual dysfunction in the treatment of schizophrenia.

Lentinus edodes (Berk.) Sing., known historically in Japan as shiitake and in China as xiang gu, or "fragrant mushroom," is the second most commonly cultivated edible mushroom worldwide. Shiitake is an important ingredient in Chinese and Japanese cuisine, and is increasingly finding its way onto the tables of North Americans, Europeans, and other cultures. The health benefits of shiitake are not so widely known, but the number and quality of scientific studies are rapidly increasing, demonstrating its immune-modulating, antitumor, antiviral, and cholesterol-regulating effects. In North America, one out of three people will have cancer sometime in his or her life. Cancer is the second leading cause of death in technologically developed countries worldwide, and the proven protective effect and use in Japan of shiitake in combination with chemo-and radiation therapy may well increase its production and popularity over the next few years. While some excellent research has come out of Japan in the last 15 years, sparking international interest in the medicinal effects of shiitake, few controlled studies with humans exist. More randomized, double-blind, controlled studies need to be funded and carried out to clarify the benefits, dose, and therapeutic regimens for the use of shiitake in cancer and other diseases. Based on the existing literature, cooked shiitake fruiting bodies, powdered fruiting bodies and mycelium, and purified extracts seem to be extremely safe.

The Bhopal gas tragedy is undoubtedly one of the worst industrial disasters in the history of mankind resulting in mortality of 2500-6000 and debilitating over 200 000 people. Inhabitants in the township were exposed to different degrees and there are more than 500 000 registered victims that survived the tragedy. Clinical studies have shown chronic illnesses such as pulmonary fibrosis, bronchial asthma, chronic obstructive pulmonary disease (COPD), emphysema, recurrent chest infections, keratopathy and corneal opacities in exposed cohorts. Survivors continue to experience higher incidence of reported health problems including febrile illnesses, respiratory, neurologic, psychiatric and ophthalmic symptoms. Inutero exposure to methyl isocyanate in the first trimester of pregnancy caused a persistent immune system hyper-responsiveness, which was in an evident way genetically linked with the organic exposure. Recent experimental studies have provided mechanistic understanding of methyl isocyanate exposure at a molecular level. Immunotoxic implications, toxico-genomic effect, inflammatory response, elicitation of mitochondrial oxidative stress, chromosomal and microsatellite instability have been studied comprehensively in cultured mammalian cells. Besides providing a framework for understanding potential mechanisms of toxicity of a host of other exposures, these studies may also uncover unique abnormalities thereby stimulating efforts to design newer and effective diagnostic and therapeutic strategies. The authors recommend long-term monitoring of the affected area and use of appropriate methods of investigation that include well-designed cohort studies, case-control studies for rare condition, characterization of personal exposure and accident analysis to determine the possible elements of the gas cloud.

Background: During the past decade, there has been some progress in the pharmacotherapy of schizophrenia and schizoaffective disorder. Current evidence supports the use of various second-generation, or atypical, antipsychotic medications, although few of these agents have been associated with long-term efficacy and tolerability. Aripiprazole is an atypical antipsychotic that has been found to improve positive and negative symptoms of schizophrenia with a favorable adverse-effect profile.

Melasma is an irregular brown or grayish-brown facial hypermelanosis, often affecting women, especially those living in areas of intense UV radiation. The precise cause of melasma remains unknown; however, there are many possible contributing factors. Because of its dermal component and tendency to relapse, melasma is often difficult to treat. The use of broad-spectrum (UVA 1 UVB) sunscreen is important, as is topical hydroquinone, the most common treatment for melasma. Other lightening agents include retinoic acid (tretinoin) and azelaic acid. Combination therapies such as hydroquinone, tretinoin, and corticosteroids have been used in the treatment of melasma, and are thought to increase efficacy as compared with monotherapy. Kojic acid, isopropylcatechol, N-acetyl-4-cysteaminylphenol, and flavonoid extracts are other compounds that have been investigated for their ability to produce hypopigmentation, but their efficacy, safety, or trial design indicates that the interventions would need further study before they could be recommended. Chemical peels, laser treatments, and intense pulsed light therapy are additional therapeutic modalities that have been used to treat melasma. ( J Am Acad Dermatol 2006;55:1048-65.)

Recent evidence suggests that the prevalence of bipolar disorder is as much as fivefold higher than previously believed, and may amount to nearly 5% of the population, making it almost as common as unipolar major depression. It is, therefore, not unrealistic to assume that primary care or family physicians will frequently encounter bipolar patients in their practice. Such patients may present with a depressive episode, for a variety of medical reasons, for longer-term maintenance after stabilization, and even with an acute manic episode. Whatever the reason, a working knowledge of current trends in the acute and longer-term management of bipolar disorder would be helpful to the primary care physician. In addition, an understanding of important side-effects and drug interactions that occur with drugs used to treat bipolar disorder, which may be encountered in the medical setting, are paramount. This paper will attempt to review existing and emerging therapies in bipolar disorder, as well as their common drug interactions and side-effects.

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An evidence-based systematic review of cinnamon (Cinnamomum spp.), including written and statistical analysis of scientific literature, expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing, by the Natural Standard Research Collaboration is discussed in this monograph.

Background Screening and monitoring in pregnancy are strategies used by healthcare providers to identify high-risk pregnancies so that they can provide more targeted and appropriate treatment and follow-up care, and to monitor fetal well-being in both low- and high-risk pregnancies. The use of many of these techniques is controversial and their ability to detect fetal compromise often unknown. Theoretically, appropriate management of maternal and fetal risk factors and complications that are detected in pregnancy and labour could prevent a large proportion of the world's 3.2 million estimated annual stillbirths, as well as minimise maternal and neonatal morbidity and mortality. Methods The fourth in a series of papers assessing the evidence base for prevention of stillbirths, this paper reviews available published evidence for the impact of 14 screening and monitoring interventions in pregnancy on stillbirth, including identification and management of high-risk pregnancies, advanced monitoring techniques, and monitoring of labour. Using broad and specific strategies to search PubMed and the Cochrane Library, we identified 221 relevant reviews and studies testing screening and monitoring interventions during the antenatal and intrapartum periods and reporting stillbirth or perinatal mortality as an outcome. Results We found a dearth of rigorous evidence of direct impact of any of these screening procedures and interventions on stillbirth incidence. Observational studies testing some interventions, including fetal movement monitoring and Doppler monitoring, showed some evidence of impact on stillbirths in selected high-risk populations, but require larger rigourous trials to confirm impact. Other interventions, such as amniotic fluid assessment for oligohydramnios, appear predictive of stillbirth risk, but studies are lacking which assess the impact on perinatal mortality of subsequent intervention based on test findings. Few rigorous studies of cardiotocography have reported stillbirth outcomes, but steep declines in stillbirth rates have been observed in high-income settings such as the U.S., where cardiotocography is used in conjunction with Caesarean section for fetal distress. Conclusion There are numerous research gaps and large, adequately controlled trials are still needed for most of the interventions we considered. The impact of monitoring interventions on stillbirth relies on use of effective and timely intervention should problems be detected. Numerous studies indicated that positive tests were associated with increased perinatal mortality, but while some tests had good sensitivity in detecting distress, false-positive rates were high for most tests, and questions remain about optimal timing, frequency, and implications of testing. Few studies included assessments of impact of subsequent intervention needed before recommending particular monitoring strategies as a means to decrease stillbirth incidence. In high-income countries such as the US, observational evidence suggests that widespread use of cardiotocography with Caesarean section for fetal distress has led to significant declines in stillbirth rates. Efforts to increase availability of Caesarean section in low-/middle-income countries should be coupled with intrapartum monitoring technologies where resources and provider skills permit.

Background: The treatment of acne scars with fractional CO 2 lasers is gaining increasing impact, but has so far not been compared side-by-side to untreated control skin. Objective: In a randomized controlled study to examine efficacy and adverse effects of fractional CO 2 laser resurfacing for atrophic acne scars compared to no treatment. Methods: Patients (n ¼ 13) with atrophic acne scars in two intra-individual areas of similar sizes and appearances were randomized to (i) three monthly fractional CO 2 laser treatments (MedArt 610; 12-14 W, 48-56 mJ/pulse, 13% density) and (ii) no treatment. Blinded on-site evaluations were performed by three physicians on 10-point scales. Endpoints were change in scar texture and atrophy, adverse effects, and patient satisfaction. Results: Preoperatively, acne scars appeared with moderate to severe uneven texture (6.15 AE 1.23) and atrophy (5.72 AE 1.45) in both interventional and non-interventional control sites, P ¼ 1. Postoperatively, lower scores of scar texture and atrophy were obtained at 1 month (scar texture 4.31 AE 1.33, P < 0.0001; atrophy 4.08 AE 1.38, P < 0.0001), at 3 months (scar texture 4.26 AE 1.97, P < 0.0001; atrophy 3.97 AE 2.08, P < 0.0001), and at 6 months (scar texture 3.89 AE 1.7, P < 0.0001; atrophy 3.56 AE 1.76, P < 0.0001). Patients were satisfied with treatments and evaluated scar texture to be mild or moderately improved. Adverse effects were minor. Conclusions: In this single-blinded randomized controlled trial we demonstrated that moderate to severe atrophic acne scars can be safely improved by ablative fractional CO 2 laser resurfacing. The use of higher energy levels might have improved the results and possibly also induced significant adverse effects.

The screening and careful selection of excipients is a critical step in paediatric formulation development as certain excipients acceptable in adult formulations, may not be appropriate for paediatric use. While there is extensive toxicity data that could help in better understanding and highlighting the gaps in toxicity studies, the data are often scattered around the information sources and saddled with incompatible data types and formats.

Aortic aneurysms remain a significant problem in the population, and there is a concerted effort to identify, define, image, and treat these conditions to ultimately improve outcomes. The rapid development of diagnostic modalities, operative strategies, and endovascular techniques within the realm of this aortic disease has transformed the field and broadened the spectrum of patients that can be treated with minimally invasive techniques. This investigation has a broad spectrum of normal expected findings that must be differentiated from early or late complications in which intervention is required. In this article, normal and abnormal postoperative and post-TEVAR/EVAR MDCT findings are described.

Introduction Creatine is considered an effective nutritional
ergogenic aid to enhance exercise performance. In
spite of the publication of several reviews in the last
decade on the topic of exercise performance/sports and
creatine there is a need for an update related to the
military given the lack of information in this area. The
aim of this study was to critically assess original research
addressing the use of creatine supplements in the
military.
Methods A search of the electronic databases PubMed
and SPORTDiscus, for the following key words: military
personnel, trainees, recruit, soldier, physical fitness, physical
conditioning, creatine supplementation, creatine
ingestion, nutritional supplements to identify surveys and
randomised clinical trials from journal articles and technical
reports investigating the effect of creatine supplementation
on military populations.
Results Thirty-three out of 19 articles examined the
use of creatine as a dietary supplement in military
personnel. Twenty-one studies were finally selected on
the basis of stated inclusion criteria for military surveys
and randomised clinical trials. Most of the surveys
(15/17) in the military indicate a high popularity of creatine
(average 27%) among supplement users. In contrast,
in most of the exercise protocols used (6/9) during
randomised clinical trials creatine has produced a nonsignificant performance-enhancing effect.
Conclusions Creatine is one of the most widely used
supplemental compounds in the military. It is not considered
a doping infraction or related to any adverse
health effects but its long-term usage needs further investigation. Experimental research suggests that creatine
supplementation does not enhance physical performance in
the military. However, limitations in creatine dosage,
military fitness testing and sample group selection might
have underestimated the ergogenic properties of creatine.
Recent studies also indicate positive effects on various
aspects of total force fitness such as cognitive-psychomotor
performance, bone health, musculoskeletal damage and
neuromuscular function.

Financial intermediation and financial services industries have undergone many changes in the past two decades due to deregulation, technological advances and globalization. The framework for regulating finance has seen many changes as well, with approaches adapting to new issues arising in specific groups of countries or globally. The objectives of this paper are twofold: to review current international thinking on what regulatory framework is needed to develop a financial sector that is stable, yet efficient and provides proper access to households and firms; and to review experiences regarding international financial architecture initiatives, with a special focus on issues arising for developing countries. The paper outlines a number of areas of current debate: the special role of banks, competition policy, consumer protection, harmonization of rules⎯across products, within markets and globally and the adaptation and legitimacy of international standards to the circumstances facing developing countries. It concludes with some areas where more research would be useful.

This aim of this paper is to spur a discussion of the direction of caries-lesion detection activities in clinical dental practice. It is argued that since the dental clinician's caries-related decision making is a script-matching enterprise in which clinical decisions are made on the basis of 'this-lesion-needs-this-kind-of-treatment' reasoning, the methods and strategies employed for caries lesion detection should accommodate this fact. This may be done by employing a clinical visual-tactile method for caries lesion detection that evaluates the two aspects that are crucial for appropriate caries management: lesion activity and surface integrity. The use of diagnostic methods that do not assess these features directly but involve assumptions about activity status and surface integrity should be avoided. This includes the use of bite-wing radiography for the detection of approximal caries lesions, as it may be shown that plain reliance on radiographs leads to considerable overtreatment. If clinical dentistry is to retain its status as a profession committed to doing good, changes in diagnostic practices along these lines are warranted.

Purpose: The Liverpool Adverse Events Profile (LAEP) is used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). This study evaluated LAEP in newly diagnosed seizure patients, and examined the relation between LAEP, anxiety, and depression.