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Medicinal Products (medicinal + products)
Kinds of Medicinal Products Selected AbstractsCredible Commitment in Non-Independent Regulatory Agencies: A Comparative Analysis of the European Agencies for Pharmaceuticals and FoodstuffsEUROPEAN LAW JOURNAL, Issue 5 2004Sebastian Krapohl Usually, these agencies evolve from EU committees and take over most of their structures. Accordingly, like most EU committees and the Commission, regulatory agencies are not independent, but act under the control of the member states. The question is, how far do they indicate a credible commitment of the Member States to long-term policy goals like health and consumer protection. This article compares the institutional structures and decision-making rules of the European Agency for the Evaluation of Medicinal Products and of the newly established European Food Safety Authority, in order to clarify the extent of credible commitment that the Member States show through the setting-up of these agencies. It concludes that the commitment of the Member States in the foodstuff sector is not as deep as in the pharmaceutical sector, and that the creation of the European Food Safety Authority will not lead to a success story similar to that of the European Agency for the Evaluation of Medicinal Products. [source] Maximum Residue Limits of Veterinary Medicinal Products and Their Regulation in European Community LawEUROPEAN LAW JOURNAL, Issue 2 2003Robert Ancuceanu This paper proposes a legal analysis of a legal and empirical tool (maximum residue limits (MRLs)) designed to protect the consumers of animal foodstuffs, as it is regulated in European Community law. After introducing the concept of MRLs in its legal context, MRLs are defined and the need for harmonisation in this field is explained. Then the main rules governing the establishment of MRLs at a Europe-wide level are expounded, an important place being devoted to some problems occurred in the cases decided by the European Court of Justice: is it possible to establish an MRL only for certain therapeutic indications? What about the intention of placing on the market in the establishment of an MRL? Is the procedure for the establishment of MRLs a tight or lax one? The answer to some of these questions involves more general aspects of European Community law. [source] ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products (2nd edn)FOCUS ON ALTERNATIVE AND COMPLEMENTARY THERAPIES AN EVIDENCE-BASED APPROACH, Issue 1 2010E Ernst [source] Evidence-based (S3) guideline for the treatment of psoriasis vulgaris , Update: "Therapeutic options" and "Efalizumab"JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, Issue 1 2010Alexander Nast Summary In February 2009, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) had recommended the suspension of efalizumab's (Raptiva®) marketing authorization, because its benefits in the treatment of psoriasis were modest, while there was a risk of serious side effects in patients receiving the medicine, including the occurrence of progressive multifocal leukoencephalopathy (PML). The guideline group has changed the guideline accordingly. [source] Biases affecting the proportional reporting ratio (PRR) in spontaneous reports pharmacovigilance databases: the example of sertindolePHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2003Nicholas Moore Abstract Background Automated measures of reporting disproportionality in databases of spontaneous reports of adverse drug reactions are an emerging tool to identify drug-related alerts. Sertindole, a new atypical neuroleptic known to prolong the QT interval, was suspended in November 1998 because the proportion of reports of fatal reactions suggesting arrhythmia among all reports with sertindole was almost ten times higher than that for other atypical neuroleptics in the UK. This excess risk was not predicted in preclinical data and had not been found in premarketing trials. Method Reporting patterns over time were analysed. Prescription Event Monitoring (PEM) studies and a large retrospective cohort allowed for the comparison of actual death rates with atypical neuroleptics, and to assess which proportion of the deaths that occurred were reported. Results There were indications of possible skewing of reporting related to notoriety, surveillance and market size effects. Death rates in PEM studies were essentially similar between sertindole and other neuroleptics. Cardiac deaths had been two to three times more often reported than other causes of death. Conclusion Proportional reporting ratios indicate differential reporting of possible reactions, not necessarily differential occurrence. There was no indication of an actual increase of risk of all causes or cardiac deaths during sertindole treatment, but only an increased risk of its being reported. The suspension of sertindole was rescinded by Committee on Proprietary Medicinal Products (CPMP) in October 2001. Copyright © 2003 John Wiley & Sons, Ltd. [source] First Exposure in Man: Toxicological ConsiderationsBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 2000Per Spindler Recommendations on the type and extent of preclinical safety studies that should be conducted prior to first dose in man have been developed by the International Conference on Harmonisation, and the European Committee for Proprietary Medicinal Products. These recommendations include studies designed to characterise local tolerance and general toxicity of the drug candidate as well as its genotoxic potential and ability to interfere with reproduction. For trials which can be categorised as low dose PK screening trials and trials with products where rodent and non-rodent (primarily dog) models do not show any biological response (e.g. some biotechnology-derived hormones and cytokines) other testing paradigms should be used. The present recommendations for preclinical testing have had an important impact on the documented impressive safety record of phase I clinical trials. In this spirit we extend our warmest and sincerest thanks to Professor Jens S. Schou for his long and deep engagement in European and International harmonisation of preclinical test recommendations. His efforts have had a substantial impact on the present testing recommendations, which are of obvious benefit to the safety of the patient. [source] Growth and growth hormone in children born small for gestational ageACTA PAEDIATRICA, Issue 10 2005Robert Rapaport Abstract Although most children born small for gestational age catch up in growth by age 2 y, up to 14% remain more than 2 standard deviations below the mean for height. Recombinant growth hormone is approved by the US Food and Drug Administration and by the European Agency for Evaluation of Medicinal Products for the treatment of children born small for gestational age who fail to manifest catch-up growth by 2 y or 4 y, respectively. Conclusion: We conclude from clinical studies that growth hormone therapy can induce catch-up growth in these children. [source] The application of knowledge discovery in databases to post-marketing drug safety: example of the WHO databaseFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 2 2008A. Bate Abstract After market launch, new information on adverse effects of medicinal products is almost exclusively first highlighted by spontaneous reporting. As data sets of spontaneous reports have become larger, and computational capability has increased, quantitative methods have been increasingly applied to such data sets. The screening of such data sets is an application of knowledge discovery in databases (KDD). Effective KDD is an iterative and interactive process made up of the following steps: developing an understanding of an application domain, creating a target data set, data cleaning and pre-processing, data reduction and projection, choosing the data mining task, choosing the data mining algorithm, data mining, interpretation of results and consolidating and using acquired knowledge. The process of KDD as it applies to the analysis of spontaneous reports can be exemplified by its routine use on the 3.5 million suspected adverse drug reaction (ADR) reports in the WHO ADR database. Examples of new adverse effects first highlighted by the KDD process on WHO data include topiramate glaucoma, infliximab vasculitis and the association of selective serotonin reuptake inhibitors (SSRIs) and neonatal convulsions. The KDD process has already improved our ability to highlight previously unsuspected ADRs for clinical review in spontaneous reporting, and we anticipate that such techniques will be increasingly used in the successful screening of other healthcare data sets such as patient records in the future. [source] Current guidelines applicable for the approval of topically applied dermatological drugs in the EUFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 5 2004Myrjam Dorothea Straube Abstract Dermatologicals as well as other medicinal products are submitted to the rules governing medicinal products in the European Union (EU) (Directive 2001/83/EC). With appreciation of the EU enlargement those regulatories deserve a recent consideration with special regard to the peculiarities of external dermatological therapy, recently passed novel and future guidelines. As regards the criteria for authorization of a medicinal product it is set out in Regulation (EEC) 2309/93 Article 11(1) that a marketing authorization shall be refused if it appears that the quality, the safety or efficacy of the medicinal product have not been adequately or sufficiently demonstrated by the applicant. Article 26(1) of Council Directive 2001/83/EC is worded a little differently but the criteria are the same irrespective of the procedure for the marketing authorization. For the final evaluation of the benefit/risk profile of a topically applied dermatological medicinal product not only the active agent but the whole galenic formulation as well has to be taken into account as the extent of penetration of the active compound might be influenced by changing the non-active substances. Furthermore the vehicle itself , independent of the active agent , influence the dermatological disorder, often in dependence on the stage of the dermatopathy. With special concern to safety/tolerability the (photo)toxic and (photo)allergic potential of the dermatological drug have to be taken into consideration too. In case of total body therapy in children the differing percutaneous resorption due to another body surface/body weight relation deserves special concern. The following review gives a survey of the current most important EU-guidelines for the evaluation of the benefit/risk profile of topically applied dermatological medicinal drugs and an outlook on further developments. As systemically applied dermatological medicinal products are assessed like other systemically applied drugs they are not treated in the following contribution. [source] Safety pharmacology in the nonclinical assessment of new medicinal products: definition, place, interest and difficultiesFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 2 2002Jean-Roger Claude Until the year 2000 there was no internationally-accepted definition for the terms used in nonclinical pharmacology (primary, secondary pharmacodynamics, discovery, safety pharmacology, etc). Now, after ICH5 (San Diego, November 2000), a harmonisation of the nomenclature is adopted: safety pharmacology is defined as the studies that investigate the potential undesirable pharmacodynamic effects of a medicinal product on physiological functions in relationship to exposure. Consequently, safety pharmacology studies are a part of the safety assessment for a new product, in the same way than toxicological studies, and a basic battery of tests (core battery) has to be conducted prior to the first administration to humans. Safety pharmacology studies are of peculiar interest: they show a good predictive potential for humans, they do not require a large number of laboratory animals, long-term studies, large amount of products and they are more dynamic and more flexible than toxicological studies. Nevertheless, many difficulties occur for the implementation in industry, related to practical and/or scientific problems: location of the studies, routine activity for the pharmacologists, sometimes difficulties in the relationship between toxicologists and pharmacologists, adaptation to the GLP requirements, elaboration of an early relevant scientific programme, necessity to go to contract-labs or to academic research for unusual or for up to date methods, etc. To conclude, a retrospective timetable of the regulatory evolution for the last 10 years will be provided, as an illustration of the worldwide progress in the concept of `harmonisation' for the assessment of new medicinal products. [source] Environmental risk assessment of human pharmaceuticals in the European Union: A case study with the ,-blocker atenololINTEGRATED ENVIRONMENTAL ASSESSMENT AND MANAGEMENT, Issue S1 2010Anette Küster Abstract ,-Adrenergic receptor blockers (,-blockers) are applied to treat high blood pressure, ischemic heart disease, and heart rhythm disturbances. Due to their widespread use and limited human metabolism, ,-blockers are widely detected in sewage effluents and surface waters. ,-Adrenergic receptors have been characterized in fish and other aquatic animals, so it can be expected that physiological processes regulated by these receptors in wild animals may be affected by the presence of ,-blockers. Because ecotoxicological data on ,-blockers are scarce, it was decided to choose the ,-blocker atenolol as a case study pharmaceutical within the project ERAPharm. A starting point for the assessment of potential environmental risks was the European guideline on the environmental risk assessment of medicinal products for human use. In Phase I of the risk assessment, the initial predicted environmental concentration (PEC) of atenolol in surface water (500,ng L,1) exceeded the action limit of 10,ng L,1. Thus, a Phase II risk assessment was conducted showing acceptable risks for surface water, for groundwater, and for aquatic microorganisms. Furthermore, atenolol showed a low potential for bioaccumulation as indicated by its low lipophilicity (log KOW,=,0.16), a low potential for exposure of the terrestrial compartment via sludge (log KOC,=,2.17), and a low affinity for sorption to the sediment. Thus, the risk assessment according to Phase II-Tier A did not reveal any unacceptable risk for atenolol. Beyond the requirements of the guideline, additional data on effects and fate were generated within ERAPharm. A 2-generation reproduction test with the waterflea Daphnia magna resulted in the most sensitive no-observed-effect concentration (NOEC) of 1.8,mg L,1. However, even with this NOEC, a risk quotient of 0.003 was calculated, which is still well below the risk threshold limit of 1. Additional studies confirm the outcome of the environmental risk assessment according to EMEA/CHMP (2006). However, atenolol should not be considered as representative for other ,-blockers, such as metoprolol, oxprenolol, and propranolol, some of which show significantly different physicochemical characteristics and varying toxicological profiles in mammalian studies. Integr Environ Assess Manag 2010;6:514,523. © 2009 SETAC [source] Good practice in plasma collection and fractionationISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue n1 2010C. Schärer The control strategy to ensure safety of blood products includes a combination of measures focusing on ensuring the quality and safety of starting material by careful donor selection and testing strategies at different levels, together with validated manufacturing processes, including steps to inactivate or remove potential contaminating agents. Using an approach based on good manufacturing practice (GMP) provides a manufacturing model that allows for a documented system of incorporating quality throughout the entire manufacturing process and describes the activities and controls needed to consistently produce products that comply with specifications and are safe for use. There are no doubts that the aim of providing safe and high-quality product to the patients should be the same for all products derived from human blood, independent of its use either as a blood component for direct transfusion or as industrially manufactured product. It would be difficult to justify whether for blood components the good practice standards and for plasma derivatives the GMP standards for manufacturing would not ensure equivalent levels of quality and safety. To ensure a high level of quality and safety of blood components and plasma derivatives, the implementation of double standards in blood establishments and fractionation industry would not be effective and should be avoided. Harmonized standards and good practices for collection and fractionation, based on the principles of GMP, should be envisaged in the whole chain of manufacturing blood components and plasma derivatives. Global initiatives to further promote the implementation of harmonized GMP for the collection in blood establishments and a stringent regulatory control are ongoing. This would further contribute to the global availability of plasma-derived medicinal products. [source] Quality of medical care of patients with acne vulgaris in Germany , nationwide survey of pharmacy clientsJOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, Issue 12 2009Nadine Franzke Summary Background: No empirical "real world" data on the health care of patients with acne vulgaris in Germany currently exist. The objective of this study was to get an informative basis of health care of patients with acne vulgaris in Germany, taking into account both doctor-prescribed medication and self-medication. Patients and Methods: Surveying both medically and self-treated patients, n = 504 patients with acne vulgaris were interviewed in 48 pharmacies nationwide. In addition to socio-demographic data, the duration of illness, localization and therapy as well as patient-relevant outcomes such as patient benefit, psychological strain and markers of compliance were evaluated. The participation and significance of individual treatment providers were also evaluated. Results: A large percentage of the patients found acne vulgaris to be burdensome. Despite the longstanding necessity of treatment and the chronic course of the illness, the treatment of acne vulgaris was deemed a rather satisfactory experience by most of those affected. Dermatologists were most frequently consulted for treatment. A great number of medicinal products were further acquired through self-medication or after consulting with a pharmacist. The medically regulated therapies predominantly complied with the latest guidelines. Conclusions: Acne vulgaris is a burdensome, socio-economically relevant illness, and dermatologists treat most cases in Germany. Surveying across a network of pharmacies offers a unique access to relevant treatment data. Selection effects, particularly by choice of doctors and self-medication, were minimized. [source] The clinical benefit of moisturizersJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 6 2005M Lodén ABSTRACT Moisturizing creams marketed to consumers often contain trendy ingredients and are accompanied by exciting names and attractive claims. Moisturizers are also an important part of the dermatologist's armamentarium to treat dry skin conditions and maintain healthy skin. The products can be regarded as cosmetics, but may also be regulated as medicinal products if they are marketed against dry skin diseases, such as atopic dermatitis and ichthyosis. When moisturizers are used on the so-called dry skin, many distinct disorders that manifest themselves with the generally recognized symptoms of dryness are treated. Dryness is not a single entity, but is characterized by differences in chemistry and morphology in the epidermis depending on the internal and external stressors of the skin. Patients and the society expect dermatologists and pharmacists to be able to recommend treatment for various dry skin conditions upon evidence-based medicine. Learning objective, Upon completing this paper, the reader should be aware of different types of moisturizers and their major constituents. Furthermore, s/he will know more about the relief of dryness symptoms and the functional changes of the skin induced by moisturizers. [source] Medicinal plant species with potential antidiabetic propertiesJOURNAL OF THE SCIENCE OF FOOD AND AGRICULTURE, Issue 5 2007Srinivasa Rao Mentreddy Abstract Diabetes mellitus is one of the world's major diseases. It currently affects an estimated 143 million people worldwide and the number is growing rapidly. In the USA alone, about 20.8 million or 7% of the population suffer from diabetes or related complications. The estimated direct and indirect costs of diabetes exceed US$ 132 billion annually. Plant-based medicinal products have been known since ancient times, and several medicinal plants and their products (active natural principles and crude extracts) have been used to control diabetes in the traditional medicinal systems of many cultures worldwide, including those of the Asian Indians, Chinese and South Americans. A limited number of these plant species have been studied and validated for their hypoglycaemic properties using diabetic animal models and in clinical studies using human subjects. Several oral hypoglycaemic agents are the primary forms of treatment for diabetes. However, prominent side-effects of such drugs are the main reason for an increasing number of people seeking alternative therapies that may have less severe or no side-effects. Thus plant-based herbal drugs or botanicals are emerging as the primary components of holistic approaches to diabetes management. In this review, selected species that have been validated for their hypoglycaemic or antihyperglycaemic properties using laboratory diabetic animal models and in clinical trials using human subjects, and reported in refereed journals are presented. Copyright © 2007 Society of Chemical Industry [source] Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patientsJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 4 2005S. SCHULMAN Summary., A variety of definitions of major bleeding have been used in published clinical studies, and this diversity adds to the difficulty in comparing data between trials and in performing meta-analyses. In the first step towards unified definitions of bleeding complications, the definition of major bleeding in non-surgical patients was discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis. Arising from that discussion, a definition was developed that should be applicable to studies with all agents that interfere with hemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic drugs. The definition and the text that follows have been reviewed and approved by the cochairs of the subcommittee and the revised version is published here. The intention is to also seek approval of this definition from the regulatory authorities. [source] Herbal medicinal products for non-ulcer dyspepsiaALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2002J. Thompson Coon Summary Background : Non-ulcer dyspepsia is predominantly a self-managed condition, although it accounts for a significant number of general practitioner consultations and hospital referrals. Herbal medicinal products are often used for the relief of dyspeptic symptoms. Aims : To critically assess the evidence for and against herbal medicinal products for the treatment of non-ulcer dyspepsia. Methods : Systematic searches were performed in six electronic databases and the reference lists located were checked for further relevant publications. No language restrictions were imposed. Experts in the field and manufacturers of identified herbal extracts were also contacted. All randomized clinical trials of herbal medicinal products administered as supplements to human subjects were included. Results : Seventeen randomized clinical trials were identified, nine of which involved peppermint and caraway as constituents of combination preparations. Symptoms were reduced by all treatments (60,95% of patients reported improvements in symptoms). The mechanism of any anti-dyspeptic action is difficult to define, as the causes of non-ulcer dyspepsia are unclear. There appear to be few adverse effects associated with these remedies, although, in many cases, comprehensive safety data were not available. Conclusions : There are several herbal medicinal products with anti-dyspeptic activity and encouraging safety profiles. Further research is warranted to establish their therapeutic value in the treatment of non-ulcer dyspepsia. [source] Biosimilars: pharmacovigilance and risk management,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2010Leyre Zuñiga Ph.D. Abstract Biosimilars cannot be authorised based on the same requirements that apply to generic medicines. Despite the fact that the biosimilar and reference drug can show similar efficacy, the biosimilar may exhibit different safety profile in terms of nature, seriousness or incidence of adverse reactions. However, the data from pre-authorisation clinical studies normally are insufficient to identify all potential differences. Therefore, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase including continued risk,benefit assessment. The biosimilar applicant must provide the European Medicines Agency (EMEA) with a risk management plan (EU-RMP) and pharmacovigilance programme with its application, including a description of the potential safety issues associated with the similar biological medicinal product that may be a result of differences in the manufacturing process from the reference biologic. The most critical safety concern relating to biopharmaceuticals (including biosimilars) is immunogenicity. Risk management applies scientifically based methodologies to identify, assess, communicate and minimise risk throughout a drug's life cycle so as to establish and maintain a favourable benefit,risk profile in patients. The risk management plan for biosimilars should focus on heightens the pharmacovigilance measures, identify immunogenicity risk and implement special post-marketing surveillance. Although International Nonproprietary Names (INNs) served as a useful tool in worldwide pharmacovigilance, for biologicals they should not be relied upon as the only means of product identification. Biologicals should always be commercialised with a brand name or the INN plus the manufacturer's name. Copyright © 2010 John Wiley & Sons, Ltd. [source] Interactions of Valeriana officinalis L. and Passiflora incarnata L. in a patient treated with lorazepamPHYTOTHERAPY RESEARCH, Issue 12 2009María Consuelo Carrasco Abstract There is an increasing interest in the health risks related to the use of herbal remedies. Although most consumers think that phytomedicines are safe and without side effects, interactions between complementary alternative and conventional medicines are being described. The aim of this clinical case report is to highlight the importance of the safe use of herbal remedies by providing a clinical interaction study between pharmaceutical medicines and herbal medicinal products. The case of a patient self-medicated with Valeriana officinalis L. and Passiflora incarnata L. while he was on lorazepam treatment is described. Handshaking, dizziness, throbbing and muscular fatigue were reported within the 32 h before clinical diagnosis. The analysis of family medical history ruled out essential tremor, Parkinson's disease, Wilson's disease and other symptom-related pathologies. His medical history revealed a generalized anxiety disorder and medicinal plant consumption but no neurological disorder. Appropriate physical examination was carried out. An additive or synergistic effect is suspected to have produced these symptoms. The active principles of Valerian and passionflower might increase the inhibitory activity of benzodiazepines binding to the GABA receptors, causing severe secondary effects. Due to the increase in herbal product self-medication, the use of herbal remedies should be registered while taking the personal clinical history. Multidisciplinary teams should be created to raise studies on medicinal plants with impact on medical praxis. Copyright © 2009 John Wiley & Sons, Ltd. [source] The current global status of chinese materia medicaPHYTOTHERAPY RESEARCH, Issue 10 2009Liu Xinmin Abstract The Chinese government has recently established a national project to improve the standards of Chinese Materia Medica (CMM) products, particularly regarding their quality control and safety evaluation, in order to promote modernization and increase international trade. In 2006, the global sales value of Chinese medicinal products increased to 20 billion US$, and the export value of CMM was up to more than 1 billion US$. However, the standard of these products still needs to be improved to meet the more stringent requirements of the international markets. Over the past decade we have witnessed the increasing growth in popularity of health foods and herbal medicinal products, especially Chinese Materia Medica products (CMM). Copyright © 2009 John Wiley & Sons, Ltd. [source] Intellectual property protection in the natural product drug discovery, traditional herbal medicine and herbal medicinal productsPHYTOTHERAPY RESEARCH, Issue 2 2007Murat Kartal Abstract Traditional medicine is an important part of human health care in many developing countries and also in developed countries, increasing their commercial value. Although the use of medicinal plants in therapy has been known for centuries in all parts of the world, the demand for herbal medicines has grown dramatically in recent years. The world market for such medicines has reached US $ 60 billion, with annual growth rates of between 5% and 15%. Researchers or companies may also claim intellectual property rights over biological resources and/or traditional knowledge, after slightly modifying them. The fast growth of patent applications related to herbal medicine shows this trend clearly. This review presents the patent applications in the field of natural products, traditional herbal medicine and herbal medicinal products. Medicinal plants and related plant products are important targets of patent claims since they have become of great interest to the international drug and cosmetic industry. Copyright © 2006 John Wiley & Sons, Ltd. [source] Latest news and product developmentsPRESCRIBER, Issue 7 2007Article first published online: 11 JUL 200 Poor asthma control with off-licence prescribing Children who are prescribed off-licence medications are more likely to have poor asthma control, according to an analysis from Dundee (Br J Gen Practice 2007;57:220-2). The review of 17 163 consultations identified 1050 (6.1 per cent) who received a prescription for an unlicensed use (defined as not licensed for children or the particular age group, or dose not licensed). High doses (4.5 per cent) were more frequent than unlicensed indications (1.9 per cent). Children who received off-label prescriptions reported statistically significantly more symptoms in the day or night, symptoms during activity, and increased use of daily short-acting beta2-agonists. The authors note that off-label prescribing appears to be increasing. Atkins diet most effective over one year? The ultra low-carbohydrate, high-protein Atkins diet achieved greater weight loss than other popular diets in overweight women over one year, say US investigators (J Am Med Assoc 2007;297:969-77). The study compared the Atkins diet with three diets designed as low- or very high-carbohydrate, or based on USA nutritional guidance, in 311 women with body mass index 27-40. After one year, mean weight loss was 4.7kg with the Atkins diet , significantly greater than with the low- carbohydrate diet (1.6kg) but not compared with very high-carbohydrate (2.2kg) or the nutrition-based diet (2.6kg). Metabolic endpoints were comparable or more favourable in women using the Atkins diet. Androgen therapy linked to gum disease The majority of men treated with androgen deprivation therapy for prostate cancer are more likely to have periodontal disease (J Urol 2007;177:921-4). After controlling for risk factors, the prevalence of periodontal disease was 80.5 per cent among treated men compared with 3.7 per cent in matched controls not receiving treatment. There was no difference in bone mineral density between the groups but plaque scores were significantly higher among treated men. Food Commission rebuts MHRA on additives An independent watchdog has not accepted the MHRA's justification for including certain additives in medicines for children. The Food Commission (www.foodcomm.org.uk) found that most medicines for children contained additives, some of which , including azo dyes and benzoates , are not permitted in food. The Commission called on the pharmaceutical industry to stop using ,questionable additives'. The MHRA stated that the licensing process takes into account the likely exposure to excipients that are considered essential to make medicines palatable to children. Colouring helps children to identify the correct medicine, and preservatives ensure a reasonable shelf-life. A list of additives is included in the product's summary of product characteristics and patient information leaflet. In response, the Commission states: , , it is quite possible to flavour medicines with natural oils or extracts, and natural colourings such as beetroot and beta-carotene can be used instead of azo dyes. If parents were advised to give these medicinal products at mealtimes the manufacturers could also add a little sugar to sweeten their products, rather than relying on artificial sweeteners.' All triptans the same? There is no economic case for choosing one triptan over another and no evidence for preferring a particular triptan for adults, a systematic review has concluded. The Canadian Agency for Drugs and Technologies in Health (www.cadth.ca) found that published trials had compared most triptans with sumatriptan but not with one another, and most economic evaluations were flawed. New drug for HIV Janssen-Cilag has introduced darunavir (Prezista), a new protease inhibitor for the treatment of HIV infection. Licensed for highly pre- treated patients in whom more than one other pro- tease inhibitor regimen has failed, darunavir must be co-administered with ritonavir (Norvir). A month's treatment at the recommended dose of 600mg twice daily costs £446.70. Variation in liquid captopril for children The NHS uses a wide range of liquid formulations of captopril to treat children with heart failure , with no assurance of their bioequivalence (Arch Dis Child 2007; published online 15 March. doi: 10.1136/adc.2006.109389). Specialists in Leicester surveyed 13 tertiary paediatric cardiac centres and 13 hospitals that referred patients to them. Only three tertiary centres supplied the same liquid for-mulation of captopril as their referring hospitals. Four hospitals supplied tablets for crushing and dissolving in water; the other hospitals and centres used a total of nine different formulations. The authors say the formulations had widely varying shelf-lives, determined empirically in all but one case, and were used interchangeably despite a lack of quality control data to establish their bioequivalence. QOF CVD targets not good enough for GPs Two-thirds of GPs want Quality Outcome Framework (QOF) targets for cardiovascular disease brought into line with those of the Joint British Societies latest guidance (JBS2), according to a survey by doctor.net.uk. The survey of 1000 GPs showed that 88 per cent were aware of the JBS2 guidelines and most were already implementing the targets for lipids, blood pressure and blood glucose in some form; however, only 55 per cent were implementing the JBS2 obesity target and 14 per cent were implementing screening for the over-40s. The JBS2 target for lipids in at-risk patients is <4mmol per litre total cholesterol and <2 mmol per litre LDL-cholesterol, compared with <5 and <3mmol per litre respectively in QOF and the NSF. The survey was commissioned by Merck Sharp & Dohme and Schering- Plough. Fracture warning Following warnings in the US that rosiglitazone (Avandia) is associated with an increased risk of fractures in women, Takeda has advised prescribers that pioglitazone (Actos) carries a similar risk. An analysis of the company's clinical trials database has revealed an excess risk of fractures of bones below the elbow and knee. The incidence was similar to the excess risk associated with rosiglitazone and also confined to women. Scottish approvals The Scottish Medicines Consortium (www.scottish medicines.org.uk) has approved for use within NHS Scotland the sublingual tablet formulation buprenorphine/naloxone (Suboxone) for the treatment of opioid dependence. It has also approved the combined formulation of valsartan and amlodipine (Exforge) and the restricted use of the If inhibitor ivabradine (Procoralan). [source] Exposure to antibacterial agents with QT liability in 14 European countries: trends over an 8-year periodBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 1 2009Emanuel Raschi WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT , Several noncardiovascular drugs with QT liability are currently on the market. , Previous epidemiological studies have shown significant exposure of the general population to drugs with QT liability with similar consumption in many European countries. , Several regulatory measures have concerned medicinal products carrying a pro-arrhythmic risk in humans. WHAT THIS STUDY ADDS , The list of antibacterial agents with documented QT liability has grown over the last few years. , Notwithstanding stringent regulatory measures, population exposure to antibiotics with QT liability is still significant in several countries. , The magnitude of the problem is clearly heterogeneous, with remarkable diversity between Northern and Southern countries (lower and higher exposure, respectively). AIMS (i) To classify antibacterial agents with QT liability on the basis of the available evidence, and (ii) to assess trends in their consumption over an 8-year period (1998,2005) in 14 European countries. METHODS Current published evidence on QT liability of antibiotics was retrieved through MEDLINE search and joined to official warnings from regulatory agencies. Each drug was classified according to an already proposed algorithm based on the strength of evidence: from group A (any evidence) to group E (clinical reports of torsades de pointes and warnings on QT liability). Consumption data were provided by the European Surveillance of Antibacterial Consumption (ESAC) project and were expressed as defined daily doses per 1000 inhabitants per day (DID). RESULTS Among 21 detected compounds, nine [six fluoroquinolones (FQs) and three macrolides (MACs)] belonged to group E. Use of group E drugs ranged from 1.3 (Sweden) to 4.1 DID (Italy) in 1998 and from 1.2 (Sweden) to 6.5 DID (Italy) in 2005. Significant exposure was observed in Italy and Spain (6.5 and 3.8 DID, respectively, in 2005). Only Denmark, Sweden and UK showed a slight decrease in use. Exposure to clarithromycin increased in 10 out of 14 countries, with a marked increment in Italy (3 DID in 2005). CONCLUSIONS Notwithstanding regulatory measures, in 2005 there was still significant exposure to antibacterials with strong evidence of QT liability and, in most countries, it was even increased. This warrants further investigation of appropriateness of use and suggests closer monitoring of group E drugs. Physicians should be aware when prescribing them to susceptible patients. [source] In-label and off-label use of respiratory drugs in the Italian paediatric populationACTA PAEDIATRICA, Issue 4 2010P Baiardi Abstract Aim:, To evaluate the prescription rate of respiratory drugs (ATC code R03) in an Italian community setting and to estimate the extent of off-label use by both age and indication. Methods:, A cohort study aimed at evaluating prescriptions of drugs with ATC code R03 was conducted for the period 2002,2006. Data source was the PEDIANET Database. Results:, Ninety percent of R03 prescriptions are covered by 11 active substances or combinations, corresponding to 67 medicinal products. Inhaled corticosteroids are the most prescribed anti-asthmatic agents, followed by short-acting ,2 mimetics. The mean off-label rate is 19 and 56%, by age and indication respectively. The majority of off-label uses is among children under the age of 2. Five active substances are used at dosages not supported by adequate dose-finding studies. Conclusion:, In Italy, many respiratory drugs are approved for the treatment of paediatric respiratory diseases, but a remarkable percentage of their prescriptions is off-label. This pharmaco-utilization study demonstrates that there is a need to perform clinical studies aimed at increasing the current knowledge on marketed paediatric drugs, and to revise and re-label the existing regulatory documents to reduce their off-label uses. [source] | ||||||||||||||||||||||||||||