Patients in need of medicine information.
CONCLUSIONS: Patients in Armenia need medicine information. They prefer to receive information from sources they trust.Many patients do not understand the content of package information leaflets (PILs) due to barriers, which can be removed by introducing appropriate regulatory provisions for their content and readability. PMID: 26639693 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

CYP3A4 activity and haloperidol effects in alcohol addicts.
Authors: Zastrozhin MS, Smirnov VV, Sychev DA, Savchenko LM, Bryun EA, Matis OA Abstract BACKGROUND: Haloperidol is one of the most commonly used typical antipsychotics [2]. It has a powerful antipsychotic activity blocking mesolimbic postsynaptic dopamine receptors. Unwanted adverse effects accompany the use of haloperidol. Therefore alcohol abusers' attitudes towards haloperidol are ambiguous and often negative, which sometimes limits it's use in patients with addictive disorders [3]. Cytosolic carbonyl reductase reduces haloperidol to reduced form, which has 10-20% of the activity of the parent molecule. It is f...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Pharmacogenetic testing in population of South Ural.
CONCLUSIONS: It was revealed that 75,9% of patients were sensitive to clopidogrel, and for them this drug in its standard dosage will be effective, and 24,1% of patients were not sensitive, therefore, they would require replacement of clopidogrel with another drug. PMID: 26639695 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Clinical and electrophysiological aspects of tics in children.
Authors: Safiullina GI, Safiullina AA Abstract BACKGROUND: Tics are diverse in nature inappropriate movements or vocalizations. They significantly degrade patients' quality of life, lead to social difficulties, and disturbance of learning especially during exacerbations. The prevalence of tics among children ranges from 4% to 24%, thus emphasizing the relevance of the problem. OBJECTIVE: To study clinical and electrophysiological features of tics in children with development of new treatment methods. METHODS: We conducted a comprehensive clinical and electrophysiological examination of 50 patients with tics...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Pharmacovigilance.
Authors: PMID: 26639697 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

The Importance of Evidence: The Legacy of Archie Cochrane.
Authors: Burger EJ PMID: 26639698 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Safety and efficacy of valproic acid preparations.
CONCLUSIONS: Thus, replacement of the original preparation of valproic acid with generics should be considered as an independent risk factor for development of complications of drug therapy. In clinical practice, in case of successful seizure control substitutions of different preparations of valproic acid should be avoided. PMID: 26639699 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Monitoring drug safety in Astrakhan, Russia.
CONCLUSIONS: The results substantiate the need to continue drug safety monitoring in the Astrakhan region. We plan to further improve the software for ADR analysis. PMID: 26639700 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Medical Law.
Authors: PMID: 26639701 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Fighting trafficking of falsified and substandard medicinal products in Russia.
Authors: Fayzrakhmanov NF Abstract BACKGROUND: The trafficking of falsified and substandard medicinal products is a global socio-economic problem, which poses a serious threat to economy and health of populations of most countries, including the Russian Federation. OBJECTIVE: To identify the main achievements and challenges in the fight against trafficking of falsified and substandard medicinal products in the Russian Federation, to formulate possible solutions to these problems. METHODS: The study of criminal cases and statistical information about the level of crime in the Russian Federation; legal analys...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Essential Medicines, Clinical Guidelines and Rational Use of Medicines.
Authors: PMID: 26639703 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Essential medicines for children in Armenia.
CONCLUSIONS: Access to essential medicines for children in Armenia is unsatisfactory. Essential medicines for children recommended by the WHO are only partially covered by the medicines supply system for children in Armenia. Development of the List of Essential Medicines for children in Armenia is an approach to solve this problem. Currently actions are being taken in this direction. It is also considered appropriate to develop national clinical guidelines on the most common childhood diseases in Armenia. PMID: 26639704 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Evidence-based clinical guidelines in Kyrgyz Republic.
CONCLUSIONS: It is very important to ensure equal opportunities in access to medical interventions designed accordingly to the CGs and CPs at all health facilities that will prevent discrimination, depending on territorial distribution, administrative subordination, and other factors in the provision of health care. Implementation of CG and CP recommendations depends not only on the level of health care, knowledge and judgment of a clinician, but also on affordability of a particular diagnostic or therapeutic technologies for a patient. Cases when effective services are not unaffordable for patients should be considered fr...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Rational use of medicines - Indian perspective!
CONCLUSIONS: While some progress has been made for appropriate use of medicines in public health facilities, there are little efforts in private sectors and at community levels. Availability of prescription medicines without much control and free drug advertising are other concerns. Like all other countries irrational use of medicines continues to be of concern in India despite of several attempts of improving use of medicines both in the health system as well as in community. But efforts continue to be made for improving the use of medicines! PMID: 26639706 [PubMed - in process] (Source: International Journal of Risk ...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Furthering benefit/risk ratio and cost effectiveness of anticancer drugs.
CONCLUSIONS: The most rational use of limited resources and cost containment within the framework of state regulation refers to modern trends in the health care of the Russian Federation. There is a need to develop targets aimed at all subjects of the pharmaceutical market, to increase the availability of innovative drugs for melanoma of the skin treatment. This strategy should be based on evidence and assessments of the efficacy, safety and economic viability of anticancer drugs. PMID: 26639707 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Patient Safety.
Authors: PMID: 26639708 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Developing drug formularies for the "National Medical Holding" JSC.
CONCLUSIONS: Summing up, drug applications for 2016 with dosage forms include 802 positions and the total bid in monetary terms was by 4,7% lower than in 2015.For the establishment of NMH rational and balanced system of medicine provision to patients and in order to increase availability of quality, safe and effective drugs, we need to have an open and transparent program of the MMU, developed in accordance with the standards of JCI, with the NMH drug formulary, indicating the reference price values of the lower units (tablet, capsule, ampoule, vial, etc.), including the drug lists for a single distributor.To improve drug ...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Adherence to EBM guidelines in clinical practice.
CONCLUSIONS: Pharmacotherapy of patients aimed at secondary prevention of myocardial infarction did not fully conform to the principles of evidence-based medicine. Standards for rehabilitation after myocardial infarction require revision based on existing clinical guidelines and evidence-based medicine. PMID: 26639710 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Timing of treatment initiation in West's syndrome.
CONCLUSIONS: The timing of initiation of tetracosactide therapy did not influence the outcomes of West syndrome therapy. The early initiation of treatment with antiepileptic drugs (but without tetracosactide) resulted in a greater number of patients achieving remission, compared with late treatment initiation. PMID: 26639711 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Antibiotics for skin and soft tissues infections in type 2 diabetes mellitus.
CONCLUSIONS: There is a vicious circle in patients with type 2 diabetes: the infectious process leads to decompensation of carbohydrate metabolism parameters; in turn, hyperglycemia leads to increase of severity of SSTIs. Normalization of glucose levels promotes prompt relief of symptoms of infection and bacterial eradication, rational treatment of infection contributes to rapid correction of glucose level. Therefore, an essential element of comprehensive treatment of this group of patients should be rational antibiotic therapy; the choice of medication should be based on the severity of the disease and potential etiologic...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Towards the rational use of medicines.
CONCLUSIONS: Introduction of evidence-based principles through educational interventions at a multidisciplinary health facility resulted in a number of changes towards more rational medicine use. Regular educational interventions for practicing physicians and heads of clinical departments of health facilities that promote rational prescribing are needed. PMID: 26639713 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Regional specifics of microbial landscape in outpatients with lower respiratory tract infections.
Authors: Baturin VA, Shchetinin EV, Malykhin FT Abstract BACKGROUND: The last years have witnessed progressive growth of antimicrobial resistance (AMR) both in hospital-acquired and community-acquired respiratory infections. Regional guidelines (2006) presented standard approaches to pharmacotherapy and provided an important contribution to improvement of antimicrobial therapy at healthcare facilities of both the City of Stavropol and the Stavropol Region. At the same time, recent years have witnessed substantial changes in sensitivity to antimicrobials; besides, newer antibiotics have become available now. This su...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Molecular Mechanisms Contributing to the Evidence-Base.
Authors: PMID: 26639715 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Towards effective and stable probiotics.
CONCLUSIONS: Overall, the results strongly support that formulation with polymeric matrices on the basis of SPS represent an appealing technology of probiotics production. It provides slow release of bacteria in target environment and does not alter their viability and NO biosynthesis. However, SPS excipient does not preserve the bacteria from harsh conditions of upper GIT. Therefore, we conclude that for oral administration the composition should be loaded in acid-resistant capsules. PMID: 26639716 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Anti-inflammatory and anti-oxidant properties: Is there a link?
CONCLUSIONS: The effects of studied agents on the intensity of inflammation and lipid peroxidation were inconsistent. The results of the study did not show a clear link between anti-inflammatory and anti-oxidant activity. Further research in potential anti-inflammatory activity of new drugs exhibiting antioxidant properties needs to be done before recommending their use in clinical practice. PMID: 26639717 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

6-Methyluracil derivatives as acetylcholinesterase inhibitors for treatment of Alzheimer's disease.
CONCLUSIONS: Experiments showed that the most potent AChE inhibitor compound 35 (6-methyluracil derivative) permeated the blood-brain barrier, improved working memory in the APP/PS1 transgenic mice and significantly reduced the number and area of Aβ plaques in the brain. Thus, compound 35 is a promising candidate as a bi-functional inhibitor of AChE for treatment of AD. PMID: 26639718 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Mild anemia as a protective factor against pregnancy loss.
CONCLUSIONS: Our data suggest a protective role of mild anemia during pregnancy in relation to pregnancy loss. PMID: 26639719 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Macrocyclic derivatives of 6-methyluracil: New ligands of the peripheral anionic site of acetylcholinesterase.
CONCLUSIONS: In conclusion, it can be stated that pyrimidinophanes are promising lead scaffold structures for further design of specific ligands for the PAS of AChE. Also AChE inhibitors with a 6-methyluracil moiety may be considered as potential drugs for the treatment of pathological muscle weakness syndromes. PMID: 26639720 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Molecular modeling of mechanism of action of anti-myasthenia gravis slow-binding inhibitor of acetylcholinesterase.
CONCLUSIONS: These findings are in good agreement with kinetics study showing that C-547 is a slow-binding inhibitor of type B, i.e. after rapid initial binding of inhibitor, the enzyme-inhibitor complex undergoes an isomerization step. Position obtained by SMD is in good agreement with X-ray data obtained by F. Nachon, IBS, France. PMID: 26639721 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Rat paw oedema modeling and NSAIDs: Timing of effects.
CONCLUSIONS: Single-dose administration of naproxen (15 mg/kg) or indomethacin (10 mg/kg) exerts decrease in rat paw oedema volume at no later than 5 hours after oedema induction by carrageenan. Evaluating anti-inflammatory activity by the areas under the curve «increase in paw volume - time» proves that a single-dose NSAID's administration has no effect on the inflammatory response when evaluated not by single time-point index (at 3 or 5 hours), but by assessing the oedema development and duration over 192 hours (8 days). PMID: 26639722 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Pirimidine derivatives as hepatoprotective agents.
Authors: Vyshtakalyuk AB, Nazarov NG, Zobov VV, Semenov VE, Galyametdinova IV, Tcherepnev GV, Reznic VS Abstract BACKGROUND: Research and development of effective hepatoprotective medicines is one of the priority areas of research in Russia. Literature data shows that active research and development of hepatoprotectors is carried out both in Russian and other countries [1-6]. Pirimidines are used as hepatoprotective medicines stimulating protein synthesis and reparation of hepatocytes in toxical and infectious liver disorders [7]. In our previous work ee have shown hepatoprotective properties of pyrimidine derivati...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Human butyrylcholinesterase polymorphism: Molecular modeling.
CONCLUSIONS: Comparative study of the "silent" Ala328Asp mutant and the catalytically active mutant Ala328Cys shows that MD approach can discriminate between the differential effects of point mutations at a same position. PMID: 26639724 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

ATP-induced changes in rat skeletal muscle contractility.
CONCLUSIONS: 1. Norepinephrine increases half times of the reduction of "fast" and "slow" skeletal muscle.2. In the presence of norepinephrine, inhibitory effect of adenosine on contraction force is maintained.3. Inhibitory effect of ATP on contraction force of studied skeletal muscles becomes twice less pronounced in the presence of norepinephrine.We think that reduction of ATP depressive effect on the skeletal muscle by norepinephrine may be an adaptive response to acute stress. PMID: 26639725 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Approaching Evidence-Based Medicine.
Authors: PMID: 26639726 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Pharmaceutical counseling: Between evidence-based medicine and profits.
CONCLUSIONS: Thus, to ensure the rational use of medicines permitted for free (non-prescription) dispensing at the pharmacies, pharmaceutical information needs standardization on the basis of evidence-based medicine as well as standardization of the pharmaceutical counseling service. The development of practical recommendations on the rational use of over-the counter medicines by doctors and pharmacists with further adoption at the state level, the recommendation of most secure, efficient and cost-effective over-the-counter medications during pharmaceutical counseling in pharmacies will contribute to the restoration and pr...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Meta-analysis: Problems with Russian Publications.
CONCLUSIONS: Russian researchers have to follow internationally recognised standards in study design, selection of endpoint, timelines and therapy regimens, data analysis and presentation of results. Russian journals need to develop consolidate rules for authors of clinical trials and epidemiological research of result reporting close to international standards. In this case the international Network EQUATOR (Enhancing the QUAlity and Transparency Of health Research http://www.equator-network.org/) is one to be taken into account. In addition, Russian Journals have to improve their online information for better interaction...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Acute kidney injury in neonatal intensive care: Medicines involved.
Authors: Safina AI, Daminova MA, Abdullina GA Abstract BACKGROUND: The incidence of acute kidney injury (AKI) in neonates in the intensive care units and neonatal intensive care (NICU) according Plotz et al. ranges from 8% to 22% [3]. According to Andreoli, neonatal death due to AKI in NICU amounts up to 10-61% [1]. It should be in the reasons of AKI emphasize.The role of certain drugs, which are widely used in modern neonatology: nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics (aminoglycosides, glycopeptides, carbapenems, 3rd generation cephalosporins), furosemide, enalapril, in contributing to AKI shou...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Clinical conferences for physicians: Who sets the agenda?
CONCLUSIONS: In 2012-2013 health practitioners were invited to attend medical conferences regularly, at least 2 times a month, with November being the busiest month. The keynote speakers were the opinion leaders from the local medical educational institutions and visitors from Moscow and St. Petersburg; their involvement with the conferences was repetitive. Governmental institutions jointly with big pharma were responsible for organisation of these conferences and attracting audience.Limitations of these observations:Unfortunately, the information on printed-paper conference invitations was not complete because not all tic...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Quality of postgraduate medical education.
CONCLUSIONS: Multidimensional assessment of the results of evaluation in the mentioned levels will allow providing an integrated assessment system of quality of continuous medical education in the country. PMID: 26639731 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Evidence-based medicine Training: Kazakhstan experience.
CONCLUSIONS: Barriers to implementation of Evidence-Based Medicine in education and practice are lack of funding to provide access to reliable sources of information, websites; outdated research methodology skills in medical education, lack of skills in critical evaluation of medical information; tradition of authoritarian relationships, use of past experience stencils; failure to comply with continuing education programs ("from training to professional development"). Knowledge of Evidence-Based Medicine, skills to perform searches for scientific data, to evaluate their validity and to transform scientific data i...
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Evidence-based pharmacogenetics: Is it possible?
CONCLUSIONS: Evidence is often inconsistent. This leads to the fact that clinical use of pharmacogenetic testing seems to be most appropriate for the management of patients with high risk of adverse drug reactions. PMID: 26639733 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Effects of balance training on post-sprained ankle joint instability.
CONCLUSIONS: Balance training is an effective training method for rehabilitation of instable ankle. Different approaches to balance training provide in general similar improvement for sprained ankle.Implications for future studies:More RCTs on chronic ankle instability are needed with large sample size and use of different intensities of exercises. It would be better for the UB FAU to provide access to articles so that students and researches could download articles for free from different electronic sources. PMID: 26639734 [PubMed - in process] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - December 9, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Case histories as evidence.
Authors: Herxheimer A, Healy D, Menkes DB Abstract In courts case histories play a central part when a crime may have resulted from an effect of a prescribed drug; in civil cases where a person may have suffered damage from a drug; and in coroners' enquiries into the cause of unexplained deaths. The court must decide two important questions: 1. Can the suspected medication(s) cause this kind of effect? 2. Did it (or they) do so in this particular case? Many judges and coroners have not addressed these questions clearly and have not used expert witnesses consistently, on occasion disregarding scientific evidence. Co...
Source: International Journal of Risk and Safety in Medicine - November 30, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Epidemiological evidence in forensic pharmacovigilance.
Authors: Persaud N, Healy D Abstract Until recently epidemiological evidence was not regarded as helpful in determining cause and effect. It generated associations that then had to be explained in terms of bio-mechanisms and applied to individual patients. A series of legal cases surrounding possible birth defects triggered by doxylamine (Bendectin) and connective tissue disorders linked to breast implants made it clear that in some instances epidemiological evidence might have a more important role, but the pendulum swung too far so that epidemiological evidence has in recent decades been given an unwarranted prim...
Source: International Journal of Risk and Safety in Medicine - November 30, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Forensic pharmacovigilance and substandard or counterfeit drugs.
Authors: Labadie J Abstract Identification of harm in the form of adverse drug reactions that are caused by counterfeit or other substandard medicinal products by application of standard pharmacovigillance methods of registration, analysis and investigation could be forensic pharmacovigillance. As recent example of this type of forensic pharmacovigilance is the discovery and investigation into the adverse drug reactions caused by contaminated heparin in the USA in 2008 is discussed. PMID: 22436258 [PubMed - indexed for MEDLINE] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - November 30, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Considerations on causality in pharmacovigilance.
Authors: Edwards IR Abstract Causality has been a topic of debate by philosophers, scientists, lawyers and for centuries. It is essential to define as precisely as possible all steps in the logical chain of events, since each may strengthen or confound an argument. Almost always there are issues of missing and conflicting data that need to be addressed specifically. In pharmacovigilance, as in many other situations, there is not just one possible causation for an effect but several. Each must be evaluated in the given context for probability. There is also likely to be a causal chain of events to the adverse effect...
Source: International Journal of Risk and Safety in Medicine - November 30, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Writing reports for the courts.
Authors: Dukes G Abstract In writing an expert report for any court or tribunal, account must be taken of that body's needs and where necessary of its strengths and weaknesses. The essential elements are truth, clarity and conciseness. The expert should indicate the nature and source of any standards that he applies. Above all he must beware of venturing into matters that lie in any sense outside his own defined area of expertise. PMID: 22436260 [PubMed - indexed for MEDLINE] (Source: International Journal of Risk and Safety in Medicine)
Source: International Journal of Risk and Safety in Medicine - November 30, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Presenting evidence for the court.
Authors: Hartigan-Go K Abstract The medical doctor is sometimes called upon to serve in the courts as expert witness. The work is challenging and has serious implications for the legal and justice system. The outcome of a case may adversely affect the lives of real people when the evidence is not presented appropriately. However, there is reluctance from doctors to participate in the court process. The health professional may not be trained in the art of being a court witness and while scientifically qualified, may not provide the due diligence in explaining the issues properly to the members of the court. Some of ...
Source: International Journal of Risk and Safety in Medicine - November 30, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

Pharmacovigilance amongst patent medicine vendors (PMVs) in Ekiti state, Nigeria.
Authors: Awodele O, Adeniran A, Awodele DF Abstract With the current population of Nigeria and the limited number of trained health care providers, PMVs are inevitable and highly needed especially in the rural areas for the supply of drugs in treating minor illnesses. Thus, pharmacovigilance (PVG) activity in Nigeria cannot exclude the roles of PMVs; therefore, this study was aimed to determine the knowledge of PMVs on PVG and adverse drug reaction reporting system. The study was a descriptive cross-sectional survey of the knowledge of Pharmacovigilance and adverse drug reaction reporting system of 96 PMVs in Ekiti...
Source: International Journal of Risk and Safety in Medicine - November 30, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research

The rosiglitazone decision process at FDA and EMA. What should we learn?
Authors: Pouwels KB, van Grootheest K Abstract In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased risk of ischemic heart disease. It is often stated that the first signs of an increased risk of ischemic heart disease were noticed in 2004, however already in 2001 the FDA concluded, based on data available to the EMA at the time of initial approval, that rosiglitazone should ...
Source: International Journal of Risk and Safety in Medicine - November 30, 2015 Category: Drugs & Pharmacology Tags: Int J Risk Saf Med Source Type: research