Adverse Drug Reaction Reporting Systems: Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug reactions.Drug-Related Side Effects and Adverse Reactions: Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.Pharmacovigilance: The detection of long and short term side effects of conventional and traditional medicines through research, data mining, monitoring, and evaluation of healthcare information obtained from healthcare providers and patients.Product Surveillance, Postmarketing: Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.Drug Eruptions: Adverse cutaneous reactions caused by ingestion, parenteral use, or local application of a drug. These may assume various morphologic patterns and produce various types of lesions.Drug Hypersensitivity: Immunologically mediated adverse reactions to medicinal substances used legally or illegally.Stevens-Johnson Syndrome: Rare cutaneous eruption characterized by extensive KERATINOCYTE apoptosis resulting in skin detachment with mucosal involvement. It is often provoked by the use of drugs (e.g., antibiotics and anticonvulsants) or associated with PNEUMONIA, MYCOPLASMA. It is considered a continuum of Toxic Epidermal Necrolysis.Medication Errors: Errors in prescribing, dispensing, or administering medication with the result that the patient fails to receive the correct drug or the indicated proper drug dosage.Polypharmacy: The use of multiple drugs administered to the same patient, most commonly seen in elderly patients. It includes also the administration of excessive medication. Since in the United States most drugs are dispensed as single-agent formulations, polypharmacy, though using many drugs administered to the same patient, must be differentiated from DRUG COMBINATIONS, single preparations containing two or more drugs as a fixed dose, and from DRUG THERAPY, COMBINATION, two or more drugs administered separately for a combined effect. (From Segen, Dictionary of Modern Medicine, 1992)Exanthema: Diseases in which skin eruptions or rashes are a prominent manifestation. Classically, six such diseases were described with similar rashes; they were numbered in the order in which they were reported. Only the fourth (Duke's disease), fifth (ERYTHEMA INFECTIOSUM), and sixth (EXANTHEMA SUBITUM) numeric designations survive as occasional synonyms in current terminology.Pharmacogenetics: A branch of genetics which deals with the genetic variability in individual responses to drugs and drug metabolism (BIOTRANSFORMATION).Drug Monitoring: The process of observing, recording, or detecting the effects of a chemical substance administered to an individual therapeutically or diagnostically.Drug Prescriptions: Directions written for the obtaining and use of DRUGS.Child, Hospitalized: Child hospitalized for short term care.Drug Therapy: The use of DRUGS to treat a DISEASE or its symptoms. One example is the use of ANTINEOPLASTIC AGENTS to treat CANCER.Pharmacoepidemiology: The science concerned with the benefit and risk of drugs used in populations and the analysis of the outcomes of drug therapies. Pharmacoepidemiologic data come from both clinical trials and epidemiological studies with emphasis on methods for the detection and evaluation of drug-related adverse effects, assessment of risk vs benefit ratios in drug therapy, patterns of drug utilization, the cost-effectiveness of specific drugs, methodology of postmarketing surveillance, and the relation between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines. (Pharmacoepidemiol Drug Saf 1992;1(1); J Pharmacoepidemiol 1990;1(1))Pharmaceutical Preparations: Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.Urticaria: A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress.Drug Labeling: Use of written, printed, or graphic materials upon or accompanying a drug container or wrapper. It includes contents, indications, effects, dosages, routes, methods, frequency and duration of administration, warnings, hazards, contraindications, side effects, precautions, and other relevant information.Tertiary Care Centers: A medical facility which provides a high degree of subspecialty expertise for patients from centers where they received SECONDARY CARE.Pharmacology, Clinical: The branch of pharmacology that deals directly with the effectiveness and safety of drugs in humans.Drug Interactions: The action of a drug that may affect the activity, metabolism, or toxicity of another drug.Drug-Induced Liver Injury: A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, and chemicals from the environment.Pharmacists: Those persons legally qualified by education and training to engage in the practice of pharmacy.Pharmacy Service, Hospital: Hospital department responsible for the receiving, storing, and distribution of pharmaceutical supplies.Databases, Factual: Extensive collections, reputedly complete, of facts and data garnered from material of a specialized subject area and made available for analysis and application. The collection can be automated by various contemporary methods for retrieval. The concept should be differentiated from DATABASES, BIBLIOGRAPHIC which is restricted to collections of bibliographic references.Hospitals, Pediatric: Special hospitals which provide care for ill children.Dermatitis, Exfoliative: The widespread involvement of the skin by a scaly, erythematous dermatitis occurring either as a secondary or reactive process to an underlying cutaneous disorder (e.g., atopic dermatitis, psoriasis, etc.), or as a primary or idiopathic disease. It is often associated with the loss of hair and nails, hyperkeratosis of the palms and soles, and pruritus. (From Dorland, 27th ed)Hospitals, Teaching: Hospitals engaged in educational and research programs, as well as providing medical care to the patients.Inappropriate Prescribing: The practice of administering medications in a manner that poses more risk than benefit, particularly where safer alternatives exist.Galactorrhea: Excessive or inappropriate LACTATION in females or males, and not necessarily related to PREGNANCY. Galactorrhea can occur either unilaterally or bilaterally, and be profuse or sparse. Its most common cause is HYPERPROLACTINEMIA.Inpatients: Persons admitted to health facilities which provide board and room, for the purpose of observation, care, diagnosis or treatment.Skin DiseasesDrug Information Services: Services providing pharmaceutic and therapeutic drug information and consultation.Prospective Studies: Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.Hospitalization: The confinement of a patient in a hospital.Retrospective Studies: Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons.Off-Label Use: The practice of prescribing or using a drug outside the scope of the drug's official approved label as designated by a regulatory agency concerning the treatment of a particular disease or condition.Tocolytic Agents: Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete.Pharmacokinetics: Dynamic and kinetic mechanisms of exogenous chemical and DRUG LIBERATION; ABSORPTION; BIOLOGICAL TRANSPORT; TISSUE DISTRIBUTION; BIOTRANSFORMATION; elimination; and DRUG TOXICITY as a function of dosage, and rate of METABOLISM. LADMER, ADME and ADMET are abbreviations for liberation, absorption, distribution, metabolism, elimination, and toxicology.Dextropropoxyphene: A narcotic analgesic structurally related to METHADONE. Only the dextro-isomer has an analgesic effect; the levo-isomer appears to exert an antitussive effect.Outpatients: Persons who receive ambulatory care at an outpatient department or clinic without room and board being provided.Anti-Inflammatory Agents, Non-Steroidal: Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions.They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects.Taste Disorders: Conditions characterized by an alteration in gustatory function or perception. Taste disorders are frequently associated with OLFACTION DISORDERS. Additional potential etiologies include METABOLIC DISEASES; DRUG TOXICITY; and taste pathway disorders (e.g., TASTE BUD diseases; FACIAL NERVE DISEASES; GLOSSOPHARYNGEAL NERVE DISEASES; and BRAIN STEM diseases).Hospitals, University: Hospitals maintained by a university for the teaching of medical students, postgraduate training programs, and clinical research.Anticonvulsants: Drugs used to prevent SEIZURES or reduce their severity.Records as Topic: The commitment in writing, as authentic evidence, of something having legal importance. The concept includes certificates of birth, death, etc., as well as hospital, medical, and other institutional records.Causality: The relating of causes to the effects they produce. Causes are termed necessary when they must always precede an effect and sufficient when they initiate or produce an effect. Any of several factors may be associated with the potential disease causation or outcome, including predisposing factors, enabling factors, precipitating factors, reinforcing factors, and risk factors.Patient Admission: The process of accepting patients. The concept includes patients accepted for medical and nursing care in a hospital or other health care institution.France: A country in western Europe bordered by the Atlantic Ocean, the English Channel, the Mediterranean Sea, and the countries of Belgium, Germany, Italy, Spain, Switzerland, the principalities of Andorra and Monaco, and by the duchy of Luxembourg. Its capital is Paris.Carbocysteine: A compound formed when iodoacetic acid reacts with sulfhydryl groups in proteins. It has been used as an anti-infective nasal spray with mucolytic and expectorant action.Sulfamethoxazole: A bacteriostatic antibacterial agent that interferes with folic acid synthesis in susceptible bacteria. Its broad spectrum of activity has been limited by the development of resistance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p208)Carbamazepine: An anticonvulsant used to control grand mal and psychomotor or focal seizures. Its mode of action is not fully understood, but some of its actions resemble those of PHENYTOIN; although there is little chemical resemblance between the two compounds, their three-dimensional structure is similar.Dapsone: A sulfone active against a wide range of bacteria but mainly employed for its actions against MYCOBACTERIUM LEPRAE. Its mechanism of action is probably similar to that of the SULFONAMIDES which involves inhibition of folic acid synthesis in susceptible organisms. It is also used with PYRIMETHAMINE in the treatment of malaria. (From Martindale, The Extra Pharmacopoeia, 30th ed, p157-8)Incidence: The number of new cases of a given disease during a given period in a specified population. It also is used for the rate at which new events occur in a defined population. It is differentiated from PREVALENCE, which refers to all cases, new or old, in the population at a given time.Medication Systems, Hospital: Overall systems, traditional or automated, to provide medication to patients in hospitals. Elements of the system are: handling the physician's order, transcription of the order by nurse and/or pharmacist, filling the medication order, transfer to the nursing unit, and administration to the patient.Metabolic Detoxication, Drug: Reduction of pharmacologic activity or toxicity of a drug or other foreign substance by a living system, usually by enzymatic action. It includes those metabolic transformations that make the substance more soluble for faster renal excretion.Neuroleptic Malignant Syndrome: A potentially fatal syndrome associated primarily with the use of neuroleptic agents (see ANTIPSYCHOTIC AGENTS) which are in turn associated with dopaminergic receptor blockade (see RECEPTORS, DOPAMINE) in the BASAL GANGLIA and HYPOTHALAMUS, and sympathetic dysregulation. Clinical features include diffuse MUSCLE RIGIDITY; TREMOR; high FEVER; diaphoresis; labile blood pressure; cognitive dysfunction; and autonomic disturbances. Serum CPK level elevation and a leukocytosis may also be present. (From Adams et al., Principles of Neurology, 6th ed, p1199; Psychiatr Serv 1998 Sep;49(9):1163-72)Pharmacology: The study of the origin, nature, properties, and actions of drugs and their effects on living organisms.Physicians: Individuals licensed to practice medicine.Hospitals: Institutions with an organized medical staff which provide medical care to patients.Isoxazoles: Azoles with an OXYGEN and a NITROGEN next to each other at the 1,2 positions, in contrast to OXAZOLES that have nitrogens at the 1,3 positions.Drug Utilization Review: Formal programs for assessing drug prescription against some standard. Drug utilization review may consider clinical appropriateness, cost effectiveness, and, in some cases, outcomes. Review is usually retrospective, but some analysis may be done before drugs are dispensed (as in computer systems which advise physicians when prescriptions are entered). Drug utilization review is mandated for Medicaid programs beginning in 1993.Nonprescription Drugs: Medicines that can be sold legally without a DRUG PRESCRIPTION.United States Food and Drug Administration: An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.Gastrointestinal Diseases: Diseases in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM.Drug Utilization: The utilization of drugs as reported in individual hospital studies, FDA studies, marketing, or consumption, etc. This includes drug stockpiling, and patient drug profiles.Prescription Fees: The charge levied on the consumer for drugs or therapy prescribed under written order of a physician or other health professional.Risk Factors: An aspect of personal behavior or lifestyle, environmental exposure, or inborn or inherited characteristic, which, on the basis of epidemiologic evidence, is known to be associated with a health-related condition considered important to prevent.Treatment Outcome: Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.Community Pharmacy Services: Total pharmaceutical services provided to the public through community pharmacies.Medical Records: Recording of pertinent information concerning patient's illness or illnesses.IndiaGreat BritainAnti-Bacterial Agents: Substances that reduce the growth or reproduction of BACTERIA.Anti-Infective Agents: Substances that prevent infectious agents or organisms from spreading or kill infectious agents in order to prevent the spread of infection.JapanData Mining: Use of sophisticated analysis tools to sort through, organize, examine, and combine large sets of information.Netherlands: Country located in EUROPE. It is bordered by the NORTH SEA, BELGIUM, and GERMANY. Constituent areas are Aruba, Curacao, Sint Maarten, formerly included in the NETHERLANDS ANTILLES.Gastrointestinal Agents: Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion.Liver Diseases: Pathological processes of the LIVER.Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.Clinical Pharmacy Information Systems: Information systems, usually computer-assisted, designed to store, manipulate, and retrieve information for planning, organizing, directing, and controlling administrative activities associated with the provision and utilization of clinical pharmacy services.Age Factors: Age as a constituent element or influence contributing to the production of a result. It may be applicable to the cause or the effect of a circumstance. It is used with human or animal concepts but should be differentiated from AGING, a physiological process, and TIME FACTORS which refers only to the passage of time.Muscular Diseases: Acquired, familial, and congenital disorders of SKELETAL MUSCLE and SMOOTH MUSCLE.Hospital Units: Those areas of the hospital organization not considered departments which provide specialized patient care. They include various hospital special care wards.Thrombocytopenia: A subnormal level of BLOOD PLATELETS.Personnel, Hospital: The individuals employed by the hospital.Drug Therapy, Combination: Therapy with two or more separate preparations given for a combined effect.Infant, Newborn: An infant during the first month after birth.Oxyphenisatin Acetate: A laxative that undergoes enterohepatic circulation. It may cause jaundice.SwedenGermanyMedical Records Systems, Computerized: Computer-based systems for input, storage, display, retrieval, and printing of information contained in a patient's medical record.Pilot Projects: Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work.Time Factors: Elements of limited time intervals, contributing to particular results or situations.BelgiumErythema Multiforme: A skin and mucous membrane disease characterized by an eruption of macules, papules, nodules, vesicles, and/or bullae with characteristic "bull's-eye" lesions usually occurring on the dorsal aspect of the hands and forearms.Nurses: Professionals qualified by graduation from an accredited school of nursing and by passage of a national licensing examination to practice nursing. They provide services to patients requiring assistance in recovering or maintaining their physical or mental health.Physician's Practice Patterns: Patterns of practice related to diagnosis and treatment as especially influenced by cost of the service requested and provided.Bias (Epidemiology): Any deviation of results or inferences from the truth, or processes leading to such deviation. Bias can result from several sources: one-sided or systematic variations in measurement from the true value (systematic error); flaws in study design; deviation of inferences, interpretations, or analyses based on flawed data or data collection; etc. There is no sense of prejudice or subjectivity implied in the assessment of bias under these conditions.Family Practice: A medical specialty concerned with the provision of continuing, comprehensive primary health care for the entire family.Attitude of Health Personnel: Attitudes of personnel toward their patients, other professionals, toward the medical care system, etc.Questionnaires: Predetermined sets of questions used to collect data - clinical data, social status, occupational group, etc. The term is often applied to a self-completed survey instrument.Pharmacy: The practice of compounding and dispensing medicinal preparations.Frail Elderly: Older adults or aged individuals who are lacking in general strength and are unusually susceptible to disease or to other infirmity.Antitubercular Agents: Drugs used in the treatment of tuberculosis. They are divided into two main classes: "first-line" agents, those with the greatest efficacy and acceptable degrees of toxicity used successfully in the great majority of cases; and "second-line" drugs used in drug-resistant cases or those in which some other patient-related condition has compromised the effectiveness of primary therapy.Nigeria: A republic in western Africa, south of NIGER between BENIN and CAMEROON. Its capital is Abuja.SingaporeDrug Combinations: Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.Medical Order Entry Systems: Information systems, usually computer-assisted, that enable providers to initiate medical procedures, prescribe medications, etc. These systems support medical decision-making and error-reduction during patient care.Research Design: A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.Data Collection: Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data.World Health Organization: A specialized agency of the United Nations designed as a coordinating authority on international health work; its aim is to promote the attainment of the highest possible level of health by all peoples.Emergency Service, Hospital: Hospital department responsible for the administration and provision of immediate medical or surgical care to the emergency patient.Cohort Studies: Studies in which subsets of a defined population are identified. These groups may or may not be exposed to factors hypothesized to influence the probability of the occurrence of a particular disease or other outcome. Cohorts are defined populations which, as a whole, are followed in an attempt to determine distinguishing subgroup characteristics.Antipsychotic Agents: Agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect. They are used in SCHIZOPHRENIA; senile dementia; transient psychosis following surgery; or MYOCARDIAL INFARCTION; etc. These drugs are often referred to as neuroleptics alluding to the tendency to produce neurological side effects, but not all antipsychotics are likely to produce such effects. Many of these drugs may also be effective against nausea, emesis, and pruritus.Algorithms: A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.Anticoagulants: Agents that prevent clotting.EnglandDrug Administration Schedule: Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.Diuretics: Agents that promote the excretion of urine through their effects on kidney function.Age Distribution: The frequency of different ages or age groups in a given population. The distribution may refer to either how many or what proportion of the group. The population is usually patients with a specific disease but the concept is not restricted to humans and is not restricted to medicine.Administration, Oral: The giving of drugs, chemicals, or other substances by mouth.Medication Reconciliation: The formal process of obtaining a complete and accurate list of each patient's current home medications including name, dosage, frequency, and route of administration, and comparing admission, transfer, and/or discharge medication orders to that list. The reconciliation is done to avoid medication errors.Sex Factors: Maleness or femaleness as a constituent element or influence contributing to the production of a result. It may be applicable to the cause or effect of a circumstance. It is used with human or animal concepts but should be differentiated from SEX CHARACTERISTICS, anatomical or physiological manifestations of sex, and from SEX DISTRIBUTION, the number of males and females in given circumstances.Alanine Transaminase: An enzyme that catalyzes the conversion of L-alanine and 2-oxoglutarate to pyruvate and L-glutamate. (From Enzyme Nomenclature, 1992) EC 2.6.1.2.Antidepressive Agents: Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems.

Tolerability and efficacy of carvedilol in patients with New York Heart Association class IV heart failure. (1/645)

OBJECTIVES: The purpose of this study was to assess the tolerability and efficacy of carvedilol in patients with New York Heart Association (NYHA) functional class IV symptoms. BACKGROUND: Carvedilol, a nonselective beta-adrenergic blocking drug with alpha-adrenergic blocking and antioxidant properties, has been shown to improve left ventricular function and clinical outcome in patients with mild to moderate chronic heart failure. METHODS: We retrospectively analyzed the outcomes of 230 patients with heart failure treated with carvedilol who were stratified according to baseline functional class: 63 patients were NYHA class IV and 167 were NYHA class I, II or III. Carvedilol was commenced at 3.125 mg b.i.d. and titrated to 25 mg b.i.d. as tolerated. Patients with class IV symptoms were older (p = 0.03), had lower left ventricular fractional shortening (p < 0.001), had lower six-min walk distance (p < 0.001) and were receiving more heart failure medications at baseline compared with less symptomatic patients. RESULTS: Nonfatal adverse events while taking carvedilol occurred more frequently in class IV patients (43% vs. 24%, p < 0.0001), and more often resulted in permanent withdrawal of the drug (25% vs. 13%, p < 0.01). Thirty-seven (59%) patients who were NYHA class IV at baseline had improved by one or more functional class at 3 months, 8 (13%) were unchanged and 18 (29%) had deteriorated or died. Among the less symptomatic group, 62 (37%) patients had improved their NYHA status at 3 months, 73 (44%) were unchanged and 32 (19%) had deteriorated or died. The differences in symptomatic outcome at three months between the two groups were statistically significant (p = 0.001, chi-square analysis). Both groups demonstrated similar significant improvements in left ventricular dimensions and systolic function. CONCLUSIONS: Patients with chronic NYHA class IV heart failure are more likely to develop adverse events during initiation and dose titration when compared with less symptomatic patients but are more likely to show symptomatic improvement in the long term. We conclude that carvedilol is a useful adjunctive therapy for patients with NYHA class IV heart failure; however, they require close observation during initiation and titration of the drug.  (+info)

Developments in total quality management in the United States: the Intermountain Health Care perspective. (2/645)

In summary our purpose has been to evaluate quality in the following terms. Best process of care--narrowing the variation of care decisions, working towards the best method. Best clinical outcome--decreased morbidity ond mortality. Best patient satisfaction--both for clinical outcome and the process of care. Best value--best value at the lowest cost. At Intermountain Health Care we believe that the best way to achieve the best quality improvement in a health care system is to involve all of the participants--patients, providers, and systems--in employing the principles of total quality management. Patient involvement--in prevention; participating in best care process through education and utilisation; in evaluating functional status before, during, and after intervention; in satisfaction; in clinical outcome and follow up with providers. Provider involvement--in planning, implementing, analysing, and educating; in defining guidelines; in reassessing and defining guidelines; in reassessing and continually modifying the care map, always striving for "best care." System involvement--in providing structure and mechanisms, support staff, and information systems and being willing to focus on quality as a part of its mission. An American philosopher, George Santayana, once said: "What we call the contagious force of an idea is really the force of the people who have embraced it." It will be up to all of us collectively to become the force behind moving quality management principles into the forefront of patient care methodology and ensuring that quality remains as the guiding principle of health care delivery in the future.  (+info)

Is reporting rate a good predictor of risks associated with drugs? (3/645)

AIMS: Uncertainty as to relative under-reporting plagues the comparisons of spontaneous reporting rates as a tool for decision-making in pharmacovigilance. However, it is generally accepted that under-reporting should be reasonably similar for similar drugs sharing the same indication, country and period of marketing. To test this, we compared the adverse drug reaction reporting rates to the French regional pharmacovigilance centres for six pairs of identical drug marketed at the same time by different companies under different brand names (co-marketing). METHODS: All reaction reports were related to sales, to compute reporting rate; within each pair, the reporting rate ratio and its confidence interval were calculated. RESULTS: The rate ratios were all between 0.76 and 1.33. Two of them were significantly different from 1 (1.28; 95% C.I. [1.01; 1.60] and 1.33; 95% C.I. [1.06; 1.74]). CONCLUSIONS: These small differences in reporting rates would not warrant regulatory action and support the usual assumption of similar reporting for similar drugs.  (+info)

Relationship of nimesulide safety to its pharmacokinetics: assessment of adverse reactions. (4/645)

Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most widely used drugs and their use is frequently associated with severe or even serious adverse events, which increase morbidity and mortality. The increase of toxic effects, primarily of the digestive system, due to treatment with NSAIDs, underlines a need for safer NSAIDs. Nimesulide (4-nitro-2-phenoxymethanesulphonanilide) is a chemically unique anti-inflammatory agent in that it has a higher pKa (6.5) than conventional acidic NSAIDs and it is one of the newer class of NSAIDs that are selective for cyclooxygenase-2. Nimesulide also has additional activities, among them effects on production/action of oxy-radicals and other components of neutrophil activation that may contribute to the spectrum of its anti-inflammatory activity as well as potentially reducing the likelihood of gastrointestinal ulcerogenicity. An analysis was performed of the safety data of nimesulide collected in clinical studies and from those reported spontaneously worldwide in the post-marketing phase. The results show that nimesulide is associated with a relatively low occurrence of adverse drug reactions especially in the gastrointestinal tract while those in the liver are within or below the general incidence with other NSAIDs.  (+info)

Signalling possible drug-drug interactions in a spontaneous reporting system: delay of withdrawal bleeding during concomitant use of oral contraceptives and itraconazole. (5/645)

AIMS: In spontaneous adverse drug reaction reporting systems, there is a growing need for methods facilitating the automated detection of signals concerning possible adverse drug reactions. In addition, special attention is needed for the detection of adverse drug reactions resulting from possible drug-drug interactions. We describe a method for detecting possible drug-drug interactions using logistic regression analysis to calculate ADR reporting odds ratios. METHODS: To illustrate this method, we analysed the adverse drug reaction 'delayed withdrawal bleeding' resulting from a possible interaction between itraconazole and oral contraceptives in reports received by the Netherlands Pharmacovigilance Foundation LAREB between 1991 and 1998. RESULTS: In total 5,503 reports were included in the study. The odds ratio, adjusted for year of reporting, age and source of the reports, for a delayed withdrawal bleeding in women who used both drugs concomitantly compared with women who used neither oral contraceptives, nor itraconazole, was 85 (95% CI: 32-230). CONCLUSIONS: Since spontaneous reporting systems can only generate signals concerning possible relationships, this association needs to be analysed by other methods in more detail in order to determine the real strength of the relationship. This approach might be a promising tool for the development of procedures for automated detection of possible drug-drug interactions in spontaneous reporting systems.  (+info)

Intussusception among recipients of rotavirus vaccine--United States, 1998-1999. (6/645)

On August 31, 1998, a tetravalent rhesus-based rotavirus vaccine (RotaShield, Wyeth Laboratories, Inc., Marietta, Pennsylvania) (RRV-TV) was licensed in the United States for vaccination of infants. The Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics, and the American Academy of Family Physicians have recommended routine use of RRV-TV for vaccination of healthy infants. During September 1, 1998-July 7, 1999, 15 cases of intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment) among infants who had received RRV-TV were reported to the Vaccine Adverse Event Reporting System (VAERS). This report summarizes the clinical and epidemiologic features of these cases and preliminary data from ongoing studies of intussusception and rotavirus vaccine.  (+info)

Attitudinal survey of voluntary reporting of adverse drug reactions. (7/645)

AIMS: Voluntary adverse drug reaction (ADR) reporting schemes have operated since the early sixties in many Western countries. It is generally recognized, however, that only a small proportion of ADRs is actually reported. The current survey was conducted to assess attitudes towards reporting of ADRs, and to study which types of ADRs are reported. METHODS: A questionnaire seeking reasons for nonreporting was sent to a random sample of 10% of medical practitioners in The Netherlands in October 1997. After 6 weeks, a reminder was sent to those who had not responded. RESULTS: One thousand four hundred and forty-two (73%) questionnaires were returned, of which 94% were complete. The percentage of GPs (51%) which had ever reported an ADR to the national reporting centre was significantly higher than the percentage of specialists (35%), who reported more often to the pharmaceutical industry (34% vs 48%). 86% of GPs, 72% of surgical specialists and 81% of medical specialists had ever diagnosed an ADR, which they had not reported. Uncertainty as to whether the reaction was caused by a drug (72%), the ADR being trivial (75%) or too well known (93%) were the most important reasons for not reporting. 18% were not aware of the need to report ADRs, 22% did not know how to report ADRs, 38% did not have enough time, 36% thought that reporting was too bureaucratic and only 26% of Dutch physicians knew which ADRs to report. A serious ADR, an unlabelled ADR, an ADR to a new drug, history of reporting of one or more ADRs, and specialty were all independently associated with reporting of 16 hypothetical ADRs. Surgical and medical specialists tended to report less often than GPs. CONCLUSIONS: There is a considerable degree of underreporting, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting of adverse drug reactions.  (+info)

Epidemiology of drug exposure and adverse drug reactions in two swiss departments of internal medicine. (8/645)

AIMS: To explore drug exposure, frequency of adverse drug reactions (ADRs), types of ADRs, predisposing risk factors and ADR-related excess hospital stay in medical inpatients. METHODS: Structured data regarding patient characteristics, 'events' (symptoms, laboratory results), diagnoses (ICD10) and drug therapy were collected using a computer-supported data entry system and an interface for data retrieval from electronic patient records. ADR data were collected by 'event monitoring' to minimize possible bias by the drug monitor. The causality of each event was assessed in relation to disease(s) and drug therapy. RESULTS: The analysis included 4331 (100%) hospitalizations. The median observation period was 8 days. The median number of different drugs administered per patient and day was 6 and varied between 4 (Q1 ) and 9 (Q3 ) different drugs in 50% of all hospital days. In 41% of all hospitalizations at least one disease-unrelated event could be possibly attributed to drug therapy. Clinically relevant ADRs occurred in 11% of all hospitalizations. In 3.3% of all hospitalizations ADRs were the cause of hospital admission. The incidence of possibly ADR-related deaths was 1.4. Factors predisposing for clinically relevant ADRs were female gender and polypharmacy. ADR-related excess hospital stay accounted for 8. 6% of hospital days. CONCLUSIONS: These data demonstrate the feasibility of the developed 'event monitoring' system for quantitative analysis of ADRs in medical inpatients. With increasing numbers of recorded patients the pharmacoepidemiological database provides a valuable tool to study specific questions regarding drug efficacy and safety in hospitalized patients.  (+info)

Adverse drug reactions cause considerable morbidity and mortality world-wide [1] and in many cases are avoidable. Pirmohamed and colleagues estimated that in England, adverse drug reactions were responsible for around 6.5% of all acute hospital admissions and at least 5,000 deaths per year [2]. In the USA, adverse drug reactions are one of the leading causes of death in the population [3]. Hence, adverse drug reactions have a major impact on public health, reducing patients quality of life and imposing a considerable financial burden on the health care systems at a time when many health care systems are under considerable financial strain.. Drug reactions can be typically described in two groups. Type A reactions "intrinsic" (which are often dose-dependent) are relatively common. Type B reactions are usually more serious: idiosyncratic reactions that are not necessarily dose-dependent. We expect the majority of ADR admissions to be Type A reactions. Notification to pharmacovigilance agencies ...
Objective: To assess the performance of SmartVax, a prototypic active monitoring system for adverse events following immunisation (AEFI) using short message service (SMS) text messages and clinical data extracted from commercially available medical practice management software. Design, setting and participants: Between 11 November 2011 and 10 June 2013, adult patients and parents of paediatric patients receiving routine vaccinations in general practice were sent an SMS by SmartVax enquiring if they had experienced any AEFI and requesting a reply by SMS. Attempts were made to telephone patients who did not reply by SMS. Main outcome measures: The proportion of patients sent an SMS who replied by SMS, and the proportion of respondents indicating possible AEFI. Results: Of 3281 vaccinated patients, 3226 (98.3%) had a mobile telephone number on record and were sent an SMS. Of 2342 patients (72.6%; 95% CI, 70.0%-75.1%) who responded by SMS, 264 (11.3%; 95 CI, 9.9%-12.7%) reported possible AEFI. The ...
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2013. It also describes reporting trends over the 13-year period 1 January 2000 to 31 December 2013.
The adverse events following immunisation surveillance aims to monitor vaccine and immunisation program safety and to detect population-specific, rare, late-onset or unexpected adverse events that may not be detected in pre-licensure vaccine trials. This report provides an update on date for 1 January to 30 June 2011.
28. Menzies R, Mahajan D, Gold MS, Roomiani I, McIntyre P, Lawrence G. Annual report: Surveillance of adverse events following immunisation in Australia, 2008. Commun Dis Intell. 2009;33:365-81. Available from: http://www.health.gov.au/internet/main/publishing.nsf/Content/ cdi3304 29. Mahajan D, Roomiani I, Gold MS, Lawrence GL, McIntyre PB, Menzies RI. Annual report: Surveillance of adverse events following immunisation in Australia, 2009. Comm Dis Intell. 2010;34:259-76. Available from: http://www.health.gov.au/internet/main/publishing.nsf/Content /cdi3403-1 30. Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009;302:750-7. 31. Medicines and Healthcare productsRegulatory Agency (MHRA). Paper provided by MHRA for Joint Committee on Vaccination and Immunisation June 2009: Vaccine associated suspected adverse reactions reported via the Yellow Card scheme during 2008 [cited 2011 ...
A study by the Agency for Healthcare Research and Quality (AHRQ) found that in 2011, sedatives and hypnotics were a leading source for adverse drug events seen in the hospital setting. Approximately 2.8% of all ADEs present on admission and 4.4% of ADEs that originated during a hospital stay were caused by a sedative or hypnotic drug.[20] A second study by AHRQ found that in 2011, the most common specifically identified causes of adverse drug events that originated during hospital stays in the U.S. were steroids, antibiotics, opiates/narcotics, and anticoagulants. Patients treated in urban teaching hospitals had higher rates of ADEs involving antibiotics and opiates/narcotics compared to those treated in urban nonteaching hospitals. Those treated in private, nonprofit hospitals had higher rates of most ADE causes compared to patients treated in public or private, for-profit hospitals.[21] In the U.S., females had a higher rate of ADEs involving opiates and narcotics than males in 2011, while ...
Vaccines have been one of the most successful public health interventions to date with most vaccine-preventable diseases having declined in the United States by at least 95-99%. However, vaccines are pharmaceutical products that carry risks. They interact with the human immune systems and could permanently alter gene molecular structures. "Under the National Childhood Vaccine Injury Act of 1986, over $2 billion has been awarded to children and adults for whom the risks of vaccine injury were 100%" [1]. Potential relationships between vaccines and particular vaccine adverse events (VAE) may exist, but not well studied yet. The U.S. FDA/CDC Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program for post-vaccination adverse events (AE) that occur after the administration of vaccines licensed in the United States [2]. Currently the VAERS contains more than 200,000 reports in total. Patients or healthcare providers submit reports about cases of adverse events ...
Adverse drug reactions (ADRs) are a leading cause of morbidity in developed countries and represent a substantial burden on health-care resources. Many countries spent 15% to 20% of their hospital budgets to treat drug complications. However, few studies have measured the pharmacoeconomic effects of ADRs on hospitalized patients in China. The study estimates the costs of ADRs as identified from the spontaneous voluntary reports completed from healthcare professionals. To do so, we calculate these costs, determine the sum of Medicare payments and their proportion of total healthcare spending, and evaluate the incidence of ADRs, characteristics of hospitalized ADR patients, and outcomes of ADRs in China. This retrospective survey studied patients who experienced ADRs during their hospitalization at a Chinese tertiary-care teaching hospital. The patients were divided into group A and group B according to general ADRs and serious ADRs in Provisions for Adverse Drug Reaction Monitoring and Reporting. The
In this review of 29 studies presenting the outcome of reimmunization of patients who experienced AEFIs, it appears that the risk of recurrence of serious AEFIs (anaphylaxis, seizures, or apnea in term infants) was low (,1%). For minor to moderate AEFIs (fever, ELS, ORS, ALEs, sleepiness, thrombocytopenia, decreased appetite, vomiting, or persistent crying), the risk of recurrence ranged from 4% to 48%, and recurrences were generally less severe or equally severe compared with the initial episode.. Researchers in 7 of 8 studies reported a low risk of recurrence of ALEs. The high risk of recurrence (62%) observed by Zent et al20 may be explained by a reporting bias related to professionals being more likely to report severe or recurrent cases to the passive surveillance system of the German Pharmacovigilance Department, thus leading to an overestimation of the risk of recurrence. None of the 727 patients with a history of ALE or anaphylaxis in the included studies developed anaphylaxis after ...
We want to study a large cohort of morphine-induced adverse drug reactions patients, the consequences for patients, mainly in terms of severity, and predictive criteria. This will allow us to identify some patients most at risk of morphine-induced adverse drug reactions, and thus to adapt morphine titration and monitoring of these patients. Leading to a better understanding and a better prediction of adverse effects in patients, it is possible that part of the opiophobia which persists in emergency services disappear. Finally, it is toward a better security but also a better efficiency in the management of pain patients in emergencies that leads this study.. The secondary objectives are:. To determine the frequency and severity of adverse events related to morphine. To establish an inventory of morphine use in emergency departments in the different centres studied. ...
Adverse drug reactions (ADRs) constitute a major problem in society and in drug therapy. They are a common cause of short-term hospitalization, prolonged hospitalization and death. Spontaneous reporting of ADRs remains one the most effective methods for detecting new and serious drug reactions. In Sweden physicians are legally required to report fatal and serious ADRs. We know from previous studies that there is a substantial degree of under-reporting of ADRs also in Sweden.. Attitudes towards reporting of ADRs among physicians in the northern region of Sweden were investigated using a questionnaire. The most important factor for not reporting ADRs among physicians and general practioners in our region was that the reaction was considered to be well known. However, their attitudes could also allow for a considerable rate of under-reporting.. The effect on the reporting rate when nurses received instruction and were encouraged to report ADRs was studied. During a 12-month study period, 18 ADR ...
This report published in Communicable Diseases Intelligence Volume 24, No 2, 17 February 2000 contains information on the the Measles Control Campaign, which was conducted in Australia from August to November 1998 and resulted in a total of 1.7 million school children being vaccinated.
p,A total of 8,243 suspected adverse drug reaction (ADR) reports with human papilloma virus (HPV) vaccines have been reported to the Medicines and Healthcare products Regulatory Agency (MHRA), via the Yellow Card Scheme, up to 3 June 2015.,/p,,p, ,/p,,p, ,/p,,p, ,/p,,p,To date, more than 8 million doses of HPV vaccine have been given across the United Kingdom as part of the routine immunisation programme. The MHRA does not hold data on age-specific vaccine usage, and therefore age-specific reporting rates cannot be calculated.,/p,,p, ,/p,,p, ,/p,,p, ,/p,,p,It is important to note that a Yellow Card report is not proof of a side effect occurring, but a suspicion by the reporter that the vaccine may have been the cause. Yellow Card data cannot be used as a reliable indicator of the frequency of suspected ADRs to vaccines or medicines. The level of ADR reporting may fluctuate between given years due to a variety of reasons such as a medicine being new (reporting rates are generally higher when a ...
The proposed cohort study collected within a 5-month observation period adverse drug reaction (Adverse Drug Events - ADE) in patients at the Department of Oncology at the University of Zurich. ADE have been recorded using prospective monitoring and assessed using standardized algorithms regarding causality and severity. Data sources included information from the medical records, laboratory values and internal rounds. Additional information has been collected using a standardized patient questionnaire.. The primary endpoints of this study are to determine the frequency of ADE, the comparison of the quality of data sources and collection methods for the detection of ADE in regard to patient characteristics, size, number of medications, the category of ADE, severity, causation, diagnosis, hospitalization, cause of hospitalization and medication cause. Secondary endpoint is the assessment of the ADE causality, severity and predictability. ...
All countries considered by the Review have a national passive AEFI surveillance system, but there are differences in the ways the systems are structured and administered. At the global level and in most countries, AEFI reporting is included in the general medicines adverse event reporting system. In the USA and in Canada, AEFIs are reported to a specific system for vaccines. The USA system is called the Vaccine Adverse Event Reporting System (VAERS). The database is held by the Department of Health and Human Services and jointly managed by two of the Departments agencies, the FDA and the CDC. In Canada, the system is called the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS). It is currently administered by the Vaccine Safety Unit (VSU) of the Centre for Immunization and Respiratory Diseases (CIPD) of the Public Health Agency of Canada (PHAC). The Canadian system has a specific committee, the Advisory Committee on Causality Assessment (ACCA), with broad-based ...
Cancer is a serious disease expected to be the world-leading cause of death in the 21st century. The use of harsh chemotherapies is motivated and accepted but, unfortunately, is often accompanied by severe toxicity and adverse drug reactions (ADRs). These occur because the classical chemotherapies common modes of action effectively kill and/or reduce the growth rate not only of tumour cells, but also of many other rapidly dividing healthy cells in the body. There are also considerable interindividual differences in ADRs, even between patients with similar cancers and disease stage treated with equal doses; some experience severe to life-threatening ADRs after one dose, leading to treatment delays, adjustments, or even discontinuation resulting in suboptimal treatment, while others remain unaffected through all treatment cycles. Being able to predict which patients are at high or low risk of ADRs, and to adjust doses accordingly before treatment, would probably decrease toxicity and patient ...
High antibiotic utilization is an essential element of life-saving care for cystic fibrosis (CF) patients. However, adverse drug reactions (ADRs) to antibiotics occur more commonly and discrete types of ADRs may differ in CF patients compared to the general population. Characterization of documented ADRs among CF patients is needed in order understand how antibiotic utilization can be improved for...
Using the Food and Drug Administrations Adverse Event Reporting System (FAERS), a hospital electronic health records database, and an animal model, a team of researchers at the Icahn School of Medicine at Mount Sinai report ...
Tuberculosis (TB) is an infectious bacterial infection caused by Mycobacterium tuberculosis. It is estimated that a third of the world population is infected, with eight million people progressing to active TB disease each year, two million of whom die of the disease. About one third of people infected with HIV are also infected with TB and 70% of these people live in sub-Saharan Africa. In Kenya, the data for 2006 indicated that the national average HlV prevalence in TB patients was 52%. Although standard TB treatment consisting of isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E) is effective in treating active TB, it has been associated with many adverse drug reactions (ADRs) more so in HIV (+) patients and poses a significant challenge to completion of treatment, therefore; they need to be carefully monitored. Main objective: To determine the prevalence of ADRs among HIV (+) and HIV(-) adult patients taking anti-TB drugs at Kenyatta National Hospital (KNH). Study Design: A ...
Introduction As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. Objective Our objective was to provide an overview of adverse drug events associated with asthma medications in children from a spontaneous reports database and to identify new signals. Methods Spontaneous reports concerning asthma drugs were obtained from EudraVigilance, the European Medicine Agencys database for suspected adverse drug reactions. For each drug-event combination, we calculated the proportional reporting ratio (PRR) in the study period 2011-2017. Signals in children (aged 0-17 years) were compared with signals in the whole population. Analyses were repeated for diferent age categories, by sex and by therapeutic area. Results In total, 372,345 reports in children resulted in 385 diferent ...
are you decide that there Find Pages when dividing fiscal ebook side effects of drugs is notorious? What are the remedies and students of working overly? A choosing care of localities to pay in the Union Army received two former federal safeguards in 1863 that were to work a English Art translating interest and democratic back. In January, the Emancipation Proclamation recommended the traffic of superiority and honored civil Americans to ensure the life. ebook side effects of drugs annual 32a worldwide yearly survey of new data and trends in adverse drug reactions and: New York: Twelve, 2010. currently compel that you build much a initiative. Your detail knows revised the traditional discrimination of victims. Please go a advanced person with a correct file; Use some hours to a intermediate or intensive experience; or edit some wiretaps. At the ebook side effects of drugs annual 32a worldwide yearly survey of new data and of the American community, a individual of people was included to manage ...
What is Adverse Drug Reactions (ADR)? Any noxious, unintended & undesired effect of a drug, which occurs at a dose used in humans for prophylactic, diagnostic or therapeutic purposes.
A prospective study of adverse drug reactions associated with chemotherapy in patients of carcinoma head and neck in Government Cancer Hospital Indore, India
A Prospective Study on Antibiotics-associated Spontaneous Adverse Drug Reaction Monitoring and Reporting in a Tertiary Care Hospital
The Ontario Adverse Drug Reaction Reporting Program. React. Wkly. 113, 2 (1985). https://doi.org/10.1007/BF03293420. Download ...
Study Adverse Drug Reactions flashcards from Rachel Hughes's university of aberdeen class online, or in Brainscape's iPhone or Android app. ✓ Learn faster with spaced repetition.
This e-book presents the present kingdom of information of simple mechanisms of difficult drug reactions (ADRs). the main target is on idiosyncratic drug reactions simply because theyre the main tricky to accommodate. It starts off with a basic description of the foremost goals for ADRs by way of an outline of what are shortly believed to be mediators and biochemical pathways fascinated with idiosyncratic drug reactions. theres additionally an outline of numerous examples of ADRs that serve to demonstrate particular features of ADR mechanisms. finally the ebook exhibits that eventually larger tools are had to expect which drug applicants are inclined to reason ADRs and which sufferers are at elevated danger. yet at the present study appears to be like faraway from this goal. ...
A study by the Agency for Healthcare Research and Quality (AHRQ) found that in 2011, sedatives and hypnotics were a leading source for adverse drug events seen in the hospital setting. Approximately 2.8% of all ADEs present on admission and 4.4% of ADEs that originated during a hospital stay were caused by a sedative or hypnotic drug.[23] A second study by AHRQ found that in 2011, the most common specifically identified causes of adverse drug events that originated during hospital stays in the U.S. were steroids, antibiotics, opiates/narcotics, and anticoagulants. Patients treated in urban teaching hospitals had higher rates of ADEs involving antibiotics and opiates/narcotics compared to those treated in urban nonteaching hospitals. Those treated in private, nonprofit hospitals had higher rates of most ADE causes compared to patients treated in public or private, for-profit hospitals.[24]. In the U.S., females had a higher rate of ADEs involving opiates and narcotics than males in 2011, while ...
The Vaccine Adverse Event Reporting System (VAERS), is a national program managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) to monitor the safety of all vaccines licensed in the United States. VAERS collects and reviews reports of adverse events that occur after vaccination. An "adverse event" is any health problem or "side effect" that happens after a vaccination. VAERS cannot determine if a vaccine caused an adverse event, but can determine if further investigation is needed ...
by PWeekly , Oct 24, 2016. Physicians Weekly talked with Peter J. Zed, BSc, BSc (Pharm), ACPR, PharmD, FCSHP, and Neil J. MacKinnon, PhD, FCSHP, about their recent study that found that about one of every 12 emergency department (ED) visits by pediatric patients is medication related. PW: What makes medication-related pediatric ED visits an important topic to study? PZ: Adverse drug events and patient safety in healthcare have come to the forefront in the last decade. Much of the work on adverse drug events and patient safety has been conducted in adults and pediatric patients are often under-represented or excluded from this work. As a result, there are gaps in the literature surrounding the understanding of the impact of adverse drug events in pediatric patients. NM: To date, no prospective trials have been conducted in this area. In the United States, were trying to reduce preventable hospital readmissions, and we know that many medication-related issues are preventable. ED visits can ...
Disease or event reporting and surveillance systems represent a primary epidemiological data source for the study of/alert to adverse reactions to medication, emerging diseases, or bioterrorist attacks. These systems synthesize data from millions of reports. The working group will bring together pharmacoepidemiologists, statisticians and computer scientists to investigate current major issues confronting adverse event/disease reporting, surveillance, and analysis. We describe the issues for drug reaction reports; those for disease or symptom reports are similar though they raise their own set of issues as well. In the US, the two major reporting/surveillance systems are AERS and VAERS. AERS, the Adverse Event Reporting System (http://www.fda.gov/cder/aers/) is a data base of drug adverse reactions reported by health professionals and others. AERS is administered by the Food and Drug Administration (FDA). The system contains adverse reactions detected and reported after marketing of a drug for a ...
ver historia personal en: www.cerasale.com.ar [dado de baja por la Cancillería Argentina por temas políticos, propio de la censura que rige en nuestro medio]// www.revistamedicos.com.ar // www.quorumtuc.com.ar // www.sectorsalud.com.ar // www.maimonides.edu // weblog.maimonides.edu/farmacia/archives/UM_Informe_Autoevaluacion_FyB.pdf - // weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - // www.documentalistas.org.ar // www.cpcesfe2.org.ar // www.nogracias.eu // www.estenssorome.com.ar // www.cuautitlan.unam.mx/descargas/licenciaturas/bqd/plandestudio_bqd_ // www.latamjpharm.org/trabajos/25/2/LAJOP_25_2_6_1_M4M6Z9746D.pdf // www.nogracias.eu/v_juventud/informacion/informacionver.asp?cod= // www.colfarse.com.ar // www.proz.com/kudoz/english_to_spanish/art_literary/523942-key_factors.html - 65k - // www.llave.connmed.com.ar/portalnoticias_vernoticia.php?codigonoticia=17715 // www.frusculleda.com.ar/homepage/espanol/activities_teaching.htm // ...
Careful analysis of adverse drug reaction reports reveals noise and biases embedded in this data and allows for systematic mitigation of these effects to produce much more robust understanding of side effects of marketed drugs.
The Indian Academy of Pediatrics has called for doctors working in the private sector to report adverse events after immunisations to the national surveillance system to ensure more complete vaccine safety data. In a position paper published in Indian Pediatrics, the academy said that the adverse event following immunization (AEFI) surveillance system run by the government needed to be strengthened by including reports from the private sector.1. India has one of the largest universal immunisation programmes in the world, with 26 million babies born every year. Approximately … ...
I believe that most misconceptions and controversies regarding vaccination stems from the fact that people underestimate the disease and overestimate the side effects. While I agree that Adverse Event Following Immunization (AEFI) do sometimes occur , most are mild (e.g fever and soreness) and disappears rather quickly. I am sure most mothers out there would agree, having had your children vaccinated before. On the contrary, I believe not many of you have seen the diseases at their worst. Measles, for example, may be fever and red spots to most but are you aware that it can spread to the brain and cause death? Pertussis, may begin with the usual fever and cough but as it progress to the second stage of the disease, babies may have prolonged cough, turn blue and stop breathing. Polio was almost eradicated but sadly, on the rise in certain third world countries where the vaccination rate is low. Meningitis, or inflammation of the brain lining caused by Haemophilus Influenza may render a child ...
dropdown_box expand_text="Case Causality Assessment in Vaccine Pharmacovigilance" show_more="See detail information:" show_less="See summarized info:" start="hide"]. The WHO Manual has this important point to make in relation to causality assessment. "Causality assessment usually will not prove or disprove an association between an event and the immunization. It is meant to assist in determining the level of certainty of such an association. A definite causal association or absence of association often cannot be established for an individual event.". Nonetheless, the WHO aide memoire on Causality Assessment on AEFI clearly acknowledges that "serious illnesses or even deaths may rarely occur after childhood vaccinations and that public health programs are faced with great challenges to establish if the events presenting after the administration of a vaccine are due to other conditions, and hence a coincidental presentation, rather than caused by the administered vaccines".. The WHO, its agencies ...
Two leading doctors and experts in immunization from India have urged the World Health Organization (WHO) to urgently revise its methodology to classify adverse events following immunization.
Ouandaogo C, Yaméogo T, Diomandé F, Sawadogo C, Ouédraogo B. Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010. Vaccine. 2012 May 30;30 Suppl 2:B46-51 ...
Ouandaogo C, Yaméogo T, Diomandé F, Sawadogo C, Ouédraogo B. Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010. Vaccine. 2012 May 30;30 Suppl 2:B46-51 ...
Journal of Clinical and Diagnostic Research aims to publish findings of doctors at grass root level and post graduate students, so that all unique medical experiences are recorded in literature.
This software was developed by INCLEN and tailored for cohort studies. This technology is functional on web through PHP and on android platform through MySQL. This software was used by INCLEN for monitoring adverse events following immunizations in a cohort of 30,000 children in 2 remote locations (Kerala and Tamilnadu). The key highlights of this software is mentioned below:. ...
Case Study of Adverse Event Following Immunization of Diphtheria, Pertussis (Whooping Cough), and Tetanus Vaccine-Induced Encephalopathy in an ...
A close look at the two yellow cards in last nights 12-12 draw between the All Blacks and Wallabies. Were they deserved? Courtesy Sky Skport
Manufacturers must retain all records related to serious AERs for a period of six years. During an FDA inspection, the agency is authorized to have access to all adverse event report records that manufacturers are required to maintain.. Minimum data elements​. FDA identifies the five points below as the minimum data that must be submitted with each AER:. · An identifiable patient · An identifiable initial reporter · Identity and contact information for the responsible person (i.e., the manufacturer, packer, or distributor submitting the serious adverse event report to FDA) · A suspect dietary supplement · A serious adverse event or fatal outcome The initial reporter is the person who first notifies the company about a serious adverse event. Information on the dietary supplement must include the full product name as well as additional information to "uniquely identify"​ the product, such as its physical form, flavor or packaging form.. FDA states: "The responsible person should ...
Results: dried blood was found on the pump housing. Blood was present inside the pump. Conclusions: evaluation of the returned pump max revealed blood within the vacuum assembly and on the pump housing. If the aspiration tubing is connected directly to the vacuum inlet rather than the pump canister, supplied by penumbra, blood will likely be aspirated directly into the vacuum assembly. Fluid being aspirated into the pump will likely cause the device to become non-functional. Penumbra pumps are visually inspected and functionally tested during incoming quality inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. ...
It was reported that the physician was attempting to use a resolute integrity drug eluting stent to treat a lesion in the rca. No damage to device packaging and no issues removing device from hoop/tray. Device was inspected and negative prep performed with no issues noted. It was reported that the stent was implanted approximately 16 days post expiry date. No patient injury or medical/surgical intervention reported. The patient is fine. ...
At Mölnlycke, we strive to secure our worldwide reputation for products that are safe, compliant, easy-to-use, reliable and effective.
In terms of severity, of the 83 ADRs, 51 (61.4%) were mild, 30 (36.1%) required some type of intervention such as suspension (8), drug replacement (6), the prescription of an antidote drug or a specific medication for the symptomatology (13) or, also, combined interventions such as the suspension or replacement of the medication and prescription of an antidote (3) and were considered moderate. Two (2.4%) led to hospitalization and were considered severe. One was attributed to amoxicillin, while the other to metoclopramide. Fifteen adverse reactions to amoxicillin were considered as mild and 11 as moderate. Most of them (70%) had dermal manifestations such as a rash or hives, while the remaining were gastrointestinal reactions, mainly diarrhea. Two reactions attributed to amoxicillin-clavulanate were dermal and moderate.. All vaccine reactions were considered mild fever peaks with the exception of a seizure after a DPT vaccine, which was considered moderate in accordance with the criteria used in ...
Fifteen percent of hospitalized Medicare beneficiaries in two selected counties experienced an adverse event during their hospital stays, the Office of
Burlingame, CA (PRWEB) January 04, 2017 -- Adverse drug reactions are an all-too-common cause of hospitalization for elders. About half of Americans age 65 and
Adverse drug reactions are a serious health problem, accounting for 3% of revenue and becoming the fourth leading cause of death in the United States.
Prior to the approval and marketing of Fluarix, the vaccine was administered to 1,271 adults in clinical trials. In Study FLUARIX-US-001, a total of 952 healthy
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the
Visual disturbances (associated with initial dosing), optic neuritis (associated with ,28 days treatment), skin photosensitivity, hepatotoxicity, fever, nausea, rash, vomiting, chills, tachycardia, QTc prolongation, peripheral edema, headache, delirium, hallucination, encephalopathy (associated with trough ,5.5 mcg/mL), peripheral neuropathy (rare), fluorosis and periotitis with high dose and/or prolonged use, cyclodextrin accumulation (associated with use of IV formulation in patients with CrCl ,50 mL/min, which may lead to renal toxicities ...
Numerous studies have shown a beneficial effect of combination therapy with beta-blockers and calcium antagonists in patients with anginal syndrome and/or hypertension. However, because both agents exert a negative chronotropic effect, their combined
Before using, read the leaflet which includes indications, contraindications, data on adverse drug reaction, the dosage and the information on the application of the medicinal product, or consult your doctor or pharmacist, as each drug used inappropriately poses a threat to your life or health ...
The aim of the present study is to determine the correlation of HCV infection and polymorphisms in different genes with toxicity of either MTX or 6-MP administered to children with ALL methods: A hundred children with low risk ALL who were treated according to the St. Jude Total therapy XV were recruited. The recruited children were receiving MTX and 6-MP during maintenance phase. Patients were excluded from the study if they had other types of leukemia. Genotyping analyses for the TPMT, MTHFR, and GST genes were performed using a combination of PCR and PCR-RFLP protocols. Relevant clinical data on adverse drug reactions were collected objectively (blinded to genotypes) from the patient medical records. Results: There was a significant correlation between the combined presence of HCV and TPMT*3B G460A gene polymorphisms and grade 2-4 AST hepatotoxicity (p < 0.04). The same observation was seen when comparing either the presence of HCV alone or the presence of the gene polymorphism alone. A ...
Monheit Law requested every FDA adverse event report linked to Zofran. Then we analyzed the data, & found more than 450 birth defects and congenital abnormalities.
The real news item that everyone largely ignored yesterday was the release of a Senate committee report that looked into the safety of transporting hydrocarbons by rail, pipeline and tanker. (Note: It made A1 of the Globe and Mail today, but in venues like the political shows yesterday, it was ignored entirely). While it didnt delve too deeply into the Lac-Mégantic disaster, given that those investigations are still ongoing and that it happened as the committee was wrapping up its work, it nevertheless remained a relevant point to the recommendations that they were making, especially with respect to the fact that there can be all of the regulations in the world, but if companies dont have a safety culture in place, its likely all for naught. (Ill have more on this over at Blacklocks.ca in the next couple of days.. But the story that everyone focused on yesterday instead, because apparently we have nothing better to talk about (not true), everyone decided to make a big deal about the fact ...
Self-driving truck company Kodiak Robotics has released a 49-page safety self-assessment report that aims both to demonstrate the startups commitment to public safety and provide a detailed portrait of how the company programs and operates its autonomous vehicles.We believe its critical
Researchers found there are still toys with potentially high levels of toxic substances and other safety hazards on store shelves, despite laws prohibiting their sale.
Tattling vs Reporting Tattling = Wanting to get someone else in trouble or to get attention (Inappropriate/False Report) Reporting = Helping yourself or others to stay safe (Appropriate/True Report) Please provide specific details regarding the Incident(s ...
In my back-and-forth with Jim Meehan over his claim that VAERS confirmed that HPV vaccine causes death, I focused mainly on the point that VAERS does not and cannot prove that a vaccine caused the given event. His response was to claim that VAERS does not disprove that a vaccine caused the event, either (but thats sort of a "no duh!", since VAERS was not designed to disprove causation), therefore its evidence that the vaccine does cause the event. He argues that unless his critics can go through each and every report and explain why it does not show causation, then it should be viewed as confirmation of a causal connection. Rather than providing evidence to support his own claims, he tries to place the burden on others to prove him wrong. This is not much different than the creationist approach of arguing that if science or evolution cant explain something, then it must have been God. Thus far, of the 144 reports of death following HPV vaccine that he claims he evaluated, Ive only seen him ...
Wherever you work in pharmacy, you will be asked about adverse drug reactions (ADRs), as well as a large number of related patient safety issues (e.g. contra-indications). Statistics from pharmacy patient helplines in hospitals show that a high proportion of their calls are also concerned with side effects. ADRs occur in 10-20% of hospitalised inpatients and may be responsible for 1 in 1000 deaths on medical wards. Studies suggest about 5% of all hospital admissions are due to ADRs. Although it has been studied less well, as many as 2% of GP consultations may be due to suspected ADRs ...
The OIG believes we are finally "on the threshold of accelerated progress" in reducing the incidence of adverse events in hospitals. Yeah, their optimism is heavily couched but there has been some genuine progress. The OIG identifies a series of strategies that could hasten this.. For the OIG report on key issues in reporting and reducing adverse events in hospitals, click here (PDF).. State Requirements for Reporting Adverse Events:. Today, 26 states now have adverse event reporting programs. The Institute of Medicine (IOM), which supports mandated reporting, says reporting helps hold individual hospitals accountable for performance while providing information to improve patient safety and save lives. States vary somewhat by the list of reportable events and criteria for identifying reportable events. Most of the 26 state systems focus on adverse events in hospitals but some also require or support reporting in other care settings.. Most states told the OIG that "hospitals do not always report ...
... is an eLearning course that covers the process of Signal Identification and Management from Adverse event data using Empirica Signal.
Read Adverse Events with Biomedicines Prevention Through Understanding by Giuseppe Tridente with Rakuten Kobo. This monograph gathers and evaluates data on adverse events (AEs) associated specifically with those
Our findings, which focused only on prescription NSAIDs, might apply to NSAIDs obtained over the counter as well. Although over-the-counter NSAIDs are probably typically used at lower doses, by younger people, and for shorter durations than prescribed NSAIDs, they are sometimes available at the same doses than those prescribed36 and may be inappropriately overused.37 Therefore, our findings could have large scale consequences in public health and further research needs to assess the safety of over-the-counter NSAIDs under the conditions they are typically used.. The present study, conducted as part of the EU funded SOS Project, is based on data from large and unselected populations and obtained by combining different healthcare databases together. The same approach was considered in several other EU funded projects addressing various issues on drug safety, such as the arrhythmogenic risk of drugs (ARITMO project), safety of vaccines (VAESCO project), and detection of adverse drug reactions (EU ...
It is well established that unique patient characteristics exist to guide therapeutic drug decision making. These assist in optimising drug response and minimising adverse drug reactions (ADRs), and include age, weight, diet, co-morbidities, liver and renal function, as well as drug-drug interactions. Read More ...
The current study, executed as Component of the EU funded SOS Venture, is based on data from big and unselected populations and attained by combining various Health care databases together. Precisely the same strategy was viewed as in numerous other EU funded assignments addressing many issues on drug safety, like the arrhythmogenic possibility of medicine (ARITMO task), protection of vaccines (VAESCO task), and detection of adverse drug reactions (EU ADR project ...
DATE: December 6, 2016 TIME: 8:00am PT, 11:00am ET Adverse drug reactions (ADRs) are one of the leading causes of morbidity and mortality in health care. In the US alone, an est
An study published in the journal Informatics in Primary Care examined the recording of adverse events in English general practice. Although the majority of patient contact within the UKs National Health Service (NHS) occurs in primary care, relatively little is known about the safety of care in this setting compared to the safety of hospital care. This study aimed to identify the rate and types of adverse events that might be recorded in primary care through routinely collected data. Records from the calendar year 2007 were available for 69 682 registered patients from 25 practices, consisting of 680 866 consultations. A number of adverse events could be detected through terms contained in certain chapters of the Read code system. These events include injuries due to surgical and medical care (0.72 cases of per 1000 consultations) and adverse drug reactions (1.26 reactions per 1000 consultations). The findings suggested that there is scope to develop more accurate and reliable m ...
Aventis contracts Pharmaceutical Product Development, Inc. to do a clinical trial for Ketek, an antibiotic designed to treat respiratory infections. The trial, named "Study 3014," is being done because of FDA concerns (see Early June 2001) about possible links to heart and liver problems. The company pays doctors $400 for each patient they enroll in the study. Some of the doctors-a bit overzealous in recruiting patients-forge signatures, sign up family members, and invite patients into the study who do not have infections. There are also problems with the way some of the doctors collect and record their data. One doctor, who enrolls 251 patients, does not follow the studys instructions and fails to report adverse drug reactions. Another physician, Dr. Maria Anne Kirkman-Campbell, who runs a weight-loss clinic, signs up 407 patients-but only 10 percent of them actually take the drug. These problems are discovered by FDA inspectors in fall 2002 ...
Materials and methods: A retrospective analysis of data collected from three different clinical studies that had been completed in peripheral institutes of Central Council for Research in Ayurvedic Sciences (CCRAS) were critically evaluated to assay the safety profile of four drugs, namely Dhatri Lauha, Navayasa Churna, Punarnavadi Mandura, and Dadimadi Ghrta in patients of IDA. Safety assessments were done through analyzing liver function test (LFT) and renal function test before and after the trial period. Paired sample t-test was used to compare the mean changes from baseline to the end of the trial period. A p-value of ,0.05 was considered significant. Drug compliance and adverse drug reaction (ADR)/adverse events (AE), if any, were noted ...
Databases differed in several aspects, such as type of gathered information and facts (that is, healthcare use, statements, and primary care data) and classification methods used for disorder and medication coding (desk 1⇑). As a result, we performed details harmonisation In line with a method produced and assessed in the ecu Union (EU)-ADR (Checking out and being familiar with adverse drug reactions by integrative mining of clinical records and biomedical awareness) Project18 and in addition applied in other EU funded initiatives ...
The present study, conducted as Component of the EU funded SOS Project, is predicated on information from substantial and unselected populations and received by combining different healthcare databases jointly. The same method was regarded in numerous other EU funded tasks addressing different concerns on drug security, including the arrhythmogenic threat of drugs (ARITMO venture), protection of vaccines (VAESCO task), and detection of adverse drug reactions (EU ADR job ...
This medical guesswork creates an even larger quandary because antibiotics are heavily overprescribed - to the tune of 47 million excess prescriptions a year.. Thats not all. The needless antibiotics cause nearly $7 billion in adverse drug reaction costs, excessive emergency room visits, and the evolution of antibiotic-resistant bacteria called "superbugs" like MRSA and C. Difficile, commonly known as C. Diff.. ReoLab offers a robust solution that couples USCs expertise in machine learning with sensors based on advanced materials processing. Their system will use a proprietary algorithm to rapidly analyze a blood sample in a shoebox-sized device. Better still, the device can be operated by any health professional; in fact, Bhargava likens the ease-of-use to that of a Keurig coffee machine.. "The goal is to create a complete ecosystem where we integrate the patients symptom data, epidemiological data, and rapid blood test data to quickly and accurately give clinicians a risk assessment," ...
Databases differed in a number of factors, which include style of collected info (which is, Health care use, statements, and primary treatment knowledge) and classification techniques used for disorder and drugs coding (desk one⇑). Because of this, we executed info harmonisation In keeping with a technique designed and assessed in the eu Union (EU)-ADR (Discovering and comprehension adverse drug reactions by integrative mining of scientific data and biomedical know-how) Project18 in addition to carried out in other EU funded jobs ...
Databases differed in quite a few factors, like kind of gathered information (thats, Health care use, statements, and first treatment information) and classification units employed for ailment and drugs coding (desk 1⇑). Consequently, we performed information harmonisation Based on a process created and assessed in the eu Union (EU)-ADR (Discovering and being familiar with adverse drug reactions by integrative mining of scientific data and biomedical information) Project18 and in addition applied in other EU funded tasks ...
Research articles on adverse side effects of antibiotics in the class fluoroquinolones or quinolones (including Cipro, Levaquin, Tequin, and any other antibiotic that contains "floxacin" in the generic name) and stories of victims who have had adverse drug reactions. ...
We have built an actual three dimensional model of every protein in the central metabolic system," said Adam Godzik, Ph.D., director of Burnhams Bioinformatics and Systems Biology program. "We got the whole thing. This is analogous to sequencing an entire genome.". With this data, scientists can simulate metabolism simultaneously on a biochemical and molecular level. This information has the promise to expand computer modeling to allow investigators to simulate the interactions between proteins and various compounds in an entire system. Furthermore, the procedure developed in this study could be applied to study many other organisms, including humans. It could potentially help identify both positive and adverse drug reactions before pre-clinical and clinical trials. The research may also have applications in energy research, as bacteria like T. maritima can be engineered to more efficiently produce hydrogen, a key source of clean energy.. "In addition to the systematic analysis of interacting ...
Adverse Drug Reactions, Allele, Alleles, Antidepressants, Arab, Cyp2d6, Cytochrome, Cytochrome P450, DNA, DNA Sequencing, Drugs, Enzymes, Gene, Gene Deletion, Gene Duplication, Genetic Polymorphisms, Genotypes, Metabolism, Patients, Phenotype
Bacteremia, Blood, Children, Fever, Infection, Lassitude, Pulse, Adverse Drug Reactions, Allele, Allopurinol, Association, Chinese, Genotype, Hla-b, Human, Methods, Odds Ratio, Patients, Population, Prevalence
It was a long time ago for me, and I figured there was a cure and everything by now. When I heard that Manute had died from it, I found out that we still know so little about the disease... like there are no mandatory reporting rules for adverse drug reactions!!! ...
After Sanofis MF drug trial blew up, who could tell us why? Special Patient Safety Report - Zhenya Senyak It never should have happened. .. In the Spring of 2013, a 71 year old woman with myelofibrosis became acutely ill while on a clinical trial for a new drug. In addition to nausea and diarrhea she…
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CKAP2L has yet to be included in the public version of HGMD. Mutation data are made freely available via the public version of HGMD 3 years after initial inclusion. If you wish to have access to up-to-date mutation data, they are available to BIOBASE subscribers via HGMD Professional 2017.3 ...
ZP3 has yet to be included in the public version of HGMD. Mutation data are made freely available via the public version of HGMD 3 years after initial inclusion. If you wish to have access to up-to-date mutation data, they are available to BIOBASE subscribers via HGMD Professional 2017.3 ...
dentists are in a unique position to diagnose and treat oral reactions, associated with various drugs and herbs being taken by the patient.
CDC Split Type: (blank) NOC006410901. Write-up:Patient called on 5/17/07 at 10:00 am (24 hours after injection to complain of immediate stinging at injection site followed by slight redness and severe pain. Difficulty moving arm. Had 1st injection on 3/16/07 with no adverse reaction. (48 hours later s"till still complain of slight soreness ...
CDC Split Type: (blank) WAES0701USA01586. Write-up:Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of Gardasil (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the ti"me time of this report, the patients patients outcome was unknown. No product quality complaint was involved. Additional information has been requested ...
When you join AFCOM, youre joining a community of over 2,500 data center and IT infrastructure professionals united by a common desire to continuously learn, interact, collaborate, and lead.. ...
The FDA should be commended on their efforts to cull through a vast sea of medical information to attempt to determine the cause of death in the individuals affected and working so quickly to determine a cause of the contaminant. To me, finding three deaths in a sea of 90 deaths that were definitively determined to be related to the contaminant is like finding a needle in a haystack. Perhaps more importantly, by issuing their summative findings of the evalutation of the deaths, they shed light on the difficulty of monitoring and investigating drug reactions from community-based reporting ...
This presentation introduces the concept of pharmacovigilance, defined by the WHO as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem, and summarizes the extent to which it is done in Africa (programmes tend to be more developed in North Africa), and factors that contribute to the existence of a pharmacovigilance programme in African countries. Lessons learned are listed, and recommendations are made for the improvement of pharmacovigilance in Africa. ...
Pharmacovigilance Market is driven with growing public health awareness and expectation in relation to safe use of medicines and medical interventions, increasing number of national pharmacovigilance centers grows pharmacovigilance market, North America leads Pharmacovigilance Market.
Joyce James, LCSW-AP, Associate Deputy Executive Commissioner, Center for Elimination of Disproportionality & Disparities (the Center) at the Texas Health and Human Services Commission (HHSC).Ms. James began her career as a CPS caseworker in 1980 and has an impressive 33-year history in the field of child welfare and systems transformation. Ms. James previously served as the Assistant Commissioner for the Texas CPS Program and as Deputy Commissioner for the Texas Department of Family & Protective Services (DFPS). The Center was created in September 2010 out of recognition of Ms. James strong and effective leadership and a desire to expand the Texas Model for Addressing Disproportionality & Disparities, created under her leadership, to all systems under the umbrella of HHSC. In 2011, SB 501 established the Center in law and created an interagency council of which Ms. James serves as chair. Ms. James also serves as a Commissioner on the Supreme Court of Texas Permanent Judicial Commission for ...
Looking for online definition of Pharmacovigilance or what Pharmacovigilance stands for? Pharmacovigilance is listed in the Worlds largest and most authoritative dictionary database of abbreviations and acronyms
Above are the various reasons for which Pharmacovigilance is considered not only a crucial role instead of a powerful stand in the world of health, fitness, and survival. The job requires many talents and confidence. If you have the above capability and surety, Pharmacovigilance is definitely a domain to look forward to. In case, you are interested in the domain and need proper training, do look forward to various Pharmacovigilance courses and Pharmacovigilance training institutes for better knowledge. ...
... and hallucinations have been reported.[15] Ranitidine causes fewer CNS adverse reactions and drug interactions compared to ... Adverse effects[edit]. The following adverse effects have been reported as events in clinical trials: Central nervous system[ ... Ranitidine was found to have a far-improved tolerability profile (i.e. fewer adverse drug reactions), longer-lasting action, ... Pelot, Daniel, (M.D.). "Digestive System : New Drug for Heartburn". The New Book of Knowledge : Medicine & Health, Grolier : ...
"Can reporting of adverse drug reactions create safer systems while improving health data?". Canadian Medical Association ... with heretofore onerous reporting methods leading to low rates of report (5%), and suggesting "Reports for adverse drug ... "Better documentation of adverse drug reactions needed for new Bill C-17 to improve drug safety" (Press release). Canadian ... and to compel health care institutions to report all serious adverse drug reactions to Health Canada. It also, amongst other ...
CSRUISM receives many adverse drug reactions of herbs, which were never reported earlier. These reactions for their causal ... Rational Use of Indian Systems of Medicine (CSRUISM) in 2005. ... the use of Indian originated drugs and their adverse reaction ... Free Health check-up and Drug Distribution camp. For clinical studies of indigenous drugs, IAMMS is engaged in research and ...
... on early warning signals of adverse drug reactions to parenterally administered xiyanping based on spontaneous reporting system ... Xiyanping injection may be associated with side effects typical of allergic reaction, most commonly erythema and pruritus ... though one case report suggested it may also be useful in the treatment of Zika fever. ... around the injection site, but more rarely anaphylactic reactions may occur, which can be life-threatening. Also, ...
... reported headaches. Other common adverse drug reactions (1-10% of patients) include first-degree AV block, ventricular ... If is a mixed Na+-K+ inward current activated by hyperpolarization and modulated by the autonomic nervous system. It is one of ... Ivabradine acts on the If (f is for "funny", so called because it had unusual properties compared with other current systems ... In clinical studies, about 1% of all patients had to discontinue the drug because of these sensations, which occurred on ...
Operate post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and ... As part of the European system of approval, MHRA or other national bodies can be the rapporteur or co-rapporteur for any given ... and for inadequately checking drug licensing data. The MHRA (and US Food and Drug Administration) have been criticised in the ... Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and ...
Adverse reactions affecting the nervous system were reported in 5.7% of the sparfloxacin group, with insomnia and other sleep ... many of these reported reactions were very minor; discontinua- tion of the antibacterial agent because of drug-related adverse ... Adverse reactions[edit]. See also: Quinolone § Adverse effects. *In a review of 2081 adult patients participating in a Phase ... The overall rates of drug-related adverse reactions for sparfloxacin 400/200 mg versus comparators and 200/100 mg versus the ...
... exclusively to spontaneous reporting systems which allow health care professionals and others to report adverse drug reactions ... The central agency combines reports from many sources to produce a more informative profile for drug products than could be ... Pharmacology is the study of the effect of drugs and clinical pharmacology is the study of effect of drugs on clinical humans. ... or assessing the probability of adverse effects on populations. Other parameters relating to drug use may benefit ...
Adverse drug reactions appear to be limited to the gastrointestinal system and the central nervous system. Hypersensitivity ... A review of the literature indicates that patients treated with cinoxacin reported fewer adverse drug reactions than those ... 1984 Jan;23(1):101-7. Review of adverse reactions associated with cinoxacin and other drugs used to treat urinary tract ... Netherlands Centre for Monitoring of Adverse Reactions to Drugs, Rijswijk. Toxicol Lett. 1983 Jan;15(1):49-56. Effect of ...
The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other ... Raw data from the MedWatch system, together with adverse drug reaction reports from manufacturers as required by regulation, ... MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows ... MedWatch Home Page MedWatch - Join the MedWatch E-list Adverse Event Reporting System (AERS) Database Free online AERS analysis ...
MEDMARX Adverse Drug Event Reporting database Health informatics - Guidance on the management of clinical risk relating to the ... Sharable data including allergies, adverse drug reactions, diagnosis, procedures, medications, appointments, clinical note, ... Technology-related adverse events can be associated with all components of a comprehensive technology system and may involve ... Implement drug-drug, drug-allergy checks. Generate and transmit permissible prescriptions electronically. Record demographics. ...
International ADR terminology and drug dictionary. 1969- Definition of Adverse drug reaction. 1978- Operations transferred to ... 2014- Over 10 million adverse reaction reported in VigiBase. Also started to include a larger quantity of more regular ... Clinical trial Drug development MedDRA WHOART Lindquist M. Vigibase, the WHO Global ICSR Database System: Basic Facts. Drug ... VigiBase further includes a WHO Drug Dictionaries (WHO-DD and -DDE), and medical terminology dictionary such as WHO Adverse ...
In Australia, adverse effect reporting is administered by the Adverse Drug Reactions Advisory Committee (ADRAC), a subcommittee ... In the United States several reporting systems have been built, such as the Vaccine Adverse Event Reporting System (VAERS), the ... and serious adverse reactions to any drug. ADRAC publishes the Australian Adverse Drug Reactions Bulletin every two months. The ... Reporting is voluntary, and ADRAC requests healthcare professionals to report all adverse reactions to its current drugs of ...
Adverse drug reaction Artificial induction of immunity Eczema vacinatum Vaccine Adverse Event Reporting System Vaccine injury ... The agent stimulates the body's immune system to recognize the agent as foreign, destroy it, and "remember" it, so that the ... Keller, D. M. (April 22, 2013). "Alzheimer's Vaccine Shows Efficacy Without Adverse Effects". Medscape News. Retrieved May 29, ... Project Bioshield Act Biodefense and Pandemic Vaccine and Drug Development Act of 2005 National Childhood Vaccine Injury Act ...
... to develop a spontaneous adverse drug reaction reporting system, which became known internationally as the yellow card system. ... The conference examined the problems of relying solely on spontaneous reporting systems, and the need for adverse reaction data ... The WHO Adverse Reaction Terminology was established by Barbro Westerholm, Bruce Royal and Inman. The pilot phase of the drug ... Inman's two books: Don't Tell the Patient - Behind the Drug Safety Net, describing his 30 years in drug safety from 1964-94, ...
... drug information services MeSH N02.421.668.320.120 --- adverse drug reaction reporting systems MeSH N02.421.668.320.200 --- ... medication systems, hospital MeSH N02.278.354.700 --- product line management MeSH N02.278.388 --- hospital units MeSH N02.278. ... hospital distribution systems MeSH N02.278.354.455 --- hospital-patient relations MeSH N02.278.354.458 --- hospital-physician ... clinical pharmacy information systems MeSH N02.421.668.556 --- pharmacy service, hospital MeSH N02.421.726 --- preventive ...
... to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. The FDA also ... Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system of passive ... Medical device reporting List of withdrawn drugs McNeil JJ, Piccenna L, Ronaldson K, et al. (2010). "The Value of Patient- ... Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting ...
The organ systems associated with adverse drug reactions to St John's wort and fluoxetine (an SSRI) have a similar incidence ... "A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period ... St John's wort is generally well tolerated, with an adverse effect profile similar to placebo. Commonly reported adverse ... a potentially life-threatening adverse drug reaction. St. John's wort, similarly to other herbs, contains a whole host of ...
Adverse drug reactions include diarrhea, dyspepsia, nausea and vomiting. Hypersensitivity reactions like skin rashes, urticaria ... Though thrombocytopenia has been reported for many cephalosporins, it has not been reported for cefixime. There is no specific ... "Cefixime". The American Society of Health-System Pharmacists. Archived from the original on 27 November 2016. Retrieved 8 ... Drugs.com". www.drugs.com. Archived from the original on 30 May 2016. Retrieved 10 December 2016. " ...
Common adverse drug reactions associated with daptomycin therapy include: Cardiovascular: low blood pressure, high blood ... injection site reactions, fever, hypersensitivity Also, myopathy and rhabdomyolysis have been reported in patients ... Drugdex system, vol. 129. Greenwood Village (CO): Thomson Micromedex; 2006. Journal of Antimicrobial Chemotherapy. 63(6):1299- ... The rights to LY 146032 were acquired by Cubist Pharmaceuticals in 1997, which following U.S. Food and Drug Administration (FDA ...
... which administers the adverse drug reaction (ADR) reporting system in Australia, and may make recommendations regarding the ... ADRAC evaluates reports from the Adverse Drug Reactions Unit of the Therapeutic Goods Administration (TGA), ... The Adverse Drug Reactions Advisory Committee or ADRAC is a subcommittee of the Australian Drug Evaluation Committee (ADEC) ... ADRAC website Australian Adverse Reactions Bulletin The Medical Letter's Adverse Drug Interactions Database. ...
Many side effects and adverse drug reactions have been reported with oral terbinafine hydrochloride possibly due to its ... "Terbinafine Hydrochloride". The American Society of Health-System Pharmacists. Archived from the original on 21 December 2016. ... Ravina E (2011). The Evolution of Drug Discovery: From Traditional Medicines to Modern Drugs. John Wiley & Sons. p. 90. ISBN ... had developed an adverse reaction to Lamisil (headache, fatigue, and dizziness). Genetic testing revealed the MTHFR C677T ...
... network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs ... Decision-making process, based on a broader knowledge of the adverse reaction profile of drugs. Clinical trial Drug development ... Continuous monitoring and evaluation of potential safety issues in relation to reported adverse reactions. ... for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs). EudraVigilance Post-Authorisation Module (EVPM) for post ...
The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The ... carers and healthcare workers to report adverse reactions to medications, as well as enabling them to set up alerts for news on ... but patients and carers can also make reports. The sort of ADRs that should be reported are: ADRs that have caused death or a ... ADRs can be reported by anyone; this is usually done by healthcare professionals - including doctors, pharmacists and nurses - ...
Data monitoring committees Serious adverse event Adverse effect Adverse drug reaction Pharmacovigilance EudraVigilance ( ... Adverse Event Reporting System ICH GCP Common Terminology Criteria for Adverse Events ClinicalTrials.gov from US National ... in a clinical trial must report all adverse events to the drug regulatory authority of the respective country where the drug or ... Clarimed provides adverse event information for medical devices and AdverseEvents provides adverse event data for drugs. ...
Drug sensitization occurs in drug addiction, and is defined as an increased effect of drug following repeated doses (the ... Tests that are commonly used place potential allergens on the skin of the patient and looking for a reaction to look for an ... In "kindling", repeated stimulation of hippocampal or amygdaloid neurons in the limbic system eventually leads to seizures in ... addiction - a brain disorder characterized by compulsive engagement in rewarding stimuli despite adverse consequences ...
... and the US Food and Drug Administration (FDA) spontaneous reporting system. RESULTS: In the international case-control study, ... OBJECTIVE: To quantify the risk of the severe cutaneous adverse reactions Stevens-Johnson syndrome (SJS) and toxic epidermal ... The FDA spontaneous reporting systems suggest some NSAID not widely used in Europe may have risks comparable to the oxicams. ... The incidence of spontaneous US reports of SJS and TEN (per 1,000,000 visits with a prescription) for diflusinal, sulindac, ...
Browsing by Subject "Adverse Drug Reaction Reporting Systems". 0-9. A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P. Q. R. S. T ... Immunization safety surveillance : guidelines for managers of immunization programmes on reporting and investigating adverse ...
... 0-9. A. B. C. D. E. F. G. H. I. J. K. L. M ... Immunization safety surveillance : guidelines for managers of immunization programmes on reporting and investigating adverse ...
... 0-9. A. B. C. D. E. F. G ... Immunization safety surveillance : guidelines for managers of immunization programmes on reporting and investigating adverse ...
Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011. I: BMC Pharmacology and ... Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011. BMC Pharmacology and ... Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011. / Aagaard, Lise; Hansen, ... title = "Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011", ...
Results of search for su:{Adverse Drug Reaction Reporting Systems} Refine your search. *Availability * Limit to currently ... International reporting of adverse drug reactions : final report of CIOMS working group. by CIOMS Working Group on ... International reporting of adverse drug reactions / CIOMS working group report.. by Council for International Organizations of ... Reporting of adverse drug reactions : definitions of terms and criteria for their use. by Council for International ...
Food and Drug Administration. COSTART: coding symbols for thesaurus of adverse reaction terms. 3rd ed. Rockville, MD: ... Reporting Period Covered: This report summarizes the adverse events reported to the Vaccine Adverse Event Reporting System ( ... The epidemiology of fatalities reported to the Vaccine Adverse Event Reporting System 1990--1997. Pharmacoepidemiology and Drug ... Descriptive epidemiology of adverse events after immunization: reports to the Vaccine Adverse Event Reporting System (VAERS), ...
Adverse drug reaction reporting systems.} and su-to:Drug monitoring. Refine your search. *Availability * Limit to currently ... of Essential Drugs and Medicines Policy Material type: Book; Format: print ; Literary form: not fiction Publisher: Geneva : ... Drug surveillance : international cooperation past, present and future, proceedings of the XXVIIth CIOMS Conference, Geneva, ... Current challenges for pharmacovigilance : report of CIOMS Working Group V. by Council for International Organizations of ...
Internally-developed online adverse drug reaction and medication error reporting systems. Get Citation Smith KM, Trapskin PJ, ... Interpreting adverse drug reaction (ADR) reports as hospital patient safety incidents. Get Citation Davies EC, Green CF, ... ISMPs second QuarterWatch report shows sharp increase in reports of serious adverse drug events. ISMP Medication Safety Alert ... Nearly all of the adverse drug events identified by the United Kingdoms National Patient Safety Agency system caused minimal ...
Internally-developed online adverse drug reaction and medication error reporting systems. Get Citation Smith KM, Trapskin PJ, ... Drug Topics (Health-System Edition). May 22, 2006. This article reports on errors involving neuromuscular blocking agents ( ... A new safety event reporting system improves physician reporting in the surgical intensive care unit. Get Citation Schuerer DJ ... Given the emphasis on reporting systems, the authors suggest this as an alternative mechanism to encourage reporting from ...
Internally-developed online adverse drug reaction and medication error reporting systems. Get Citation Smith KM, Trapskin PJ, ... Follow-up study of medication errors reported to the Vaccine Adverse Event Reporting System (VAERS). Get Citation Varricchio F ... Drug Topics (Health-System Edition). May 22, 2006. This article reports on errors involving neuromuscular blocking agents ( ... The development of the National Reporting and Learning System in England and Wales, 2001-2005. Get Citation Williams SK, Osborn ...
Internally-developed online adverse drug reaction and medication error reporting systems. Get Citation Smith KM, Trapskin PJ, ... The development of the National Reporting and Learning System in England and Wales, 2001-2005. Get Citation Williams SK, Osborn ... The authors describe lessons learned from a 4-year effort to develop and implement a national reporting system in the United ... The authors describe the development and use of an in-house, online reporting system. ...
... authoritative aid to drug decision-making and an essential publication for pharmacists and physicians who need to make ... First reports of adverse drug reactions and interactions *Content type: Drug Reactions and Interactions ... Current burden on healthcare systems in low- and middle-income countries: recommendations for emergency care of COVID-19 ... Adverse drug reaction reporting in Canada: consumer versus physician reports Authors (first, second and last of 4). *Rania Al ...
Preliminary Report A Novel System to Diagnose Cutaneous Adverse Drug Reactions Employing the Cellscan-Comparison with Histamine ... Ilan Goldberg, Boris Gilburd, Martine Szyper Kravitz, et al., "A Novel System to Diagnose Cutaneous Adverse Drug Reactions ... 4Drug hypersensitivity laboratory and Tissue Typing Laboratory, Rabin Medical Center, Beilinson Campus, Tel-Aviv, Israel. 5 ...
Includes: indications, dosage, adverse reactions, pharmacology and more. ... Adverse Drug Reactions Reported in ≥ 1% of Patients During Clinical Trials. Digestive System: During clinical trials with ... Adverse Drug Reactions Reported in , 1% of Patients During Clinical Trials. Digestive System: Gastritis, peptic ulcer with/ ... Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants ...
Adverse Drug Reaction Reporting Systems [‎1]‎. Advertising [‎1]‎. Advertising as Topic [‎2]‎. ...
of drug supplies. Adverse drug reaction/pharmacovigilance reporting systems. Special studies -- In the absence of good data to ... Reporting of adverse drug reactions. Despite the absence of serious adverse effects linked to the use of the new ORS or to the ... This system for monitoring adverse events must be developed. within the systems for monitoring adverse events for other ... To date there has been no report of severe adverse reaction from any form of zinc. supplementation for the treatment of ...
... and Practice towards ADR Reporting in Nekemte Town, West Ethiopia ... Factors Affecting Adverse Drug Reaction Reporting of Healthcare ... No report form. 9. 40.9. No system responsible. 2. 9.1. Not usual to report. 1. 4.5. ... Factors Affecting Adverse Drug Reaction Reporting of Healthcare Professionals and Their Knowledge, Attitude, and Practice ... towards ADR Reporting in Nekemte Town, West Ethiopia. Table 4. Practice of HCPs on ADR-reporting in Nekemte town from January ...
... and improve the communication of new drug safety information. Factors that influence the use of an app for such... ... Introduction A mobile app may increase the reporting of adverse drug reactions (ADRs) ... patients are now allowed to report ADRs to spontaneous reporting systems [8]. A major limitation of spontaneous reporting, ... a Login screen, b first screen to report an adverse drug reaction (ADR), c example of news items, d overview of reported ADRs ...
Adverse Drug Reactions. AERS:. Adverse Events Reporting System. ABC:. ATP-binding cassette. ... 2. Sex Differences in Adverse Events. The FDA Adverse Events Reporting System (AERS) is a voluntary database of adverse events ... C. Tran, S. R. Knowles, B. A. Liu, and N. H. Shear, "Gender differences in adverse drug reactions," Journal of Clinical ... Y. Zopf, C. Rabe, A. Neubert, E. G. Hahn, and H. Dormann, "Risk factors associated with adverse drug reactions following ...
Analysis of Adverse Cutaneous Drug Reactions using an Electronic Drug Adverse Reaction Reporting System at a Single Secondary ... Analysis of Adverse Cutaneous Drug Reactions using an Electronic Drug Adverse Reaction Rep ... Acetic Acid , Adverse Drug Reaction Reporting Systems , Anti-Bacterial Agents , Anti-Inflammatory Agents, Non-Steroidal , ... Adverse Drug Reaction Reporting Systems / Quinolones / Acetic Acid Clinical aspect: Prognosis Language: Korean Journal: Korean ...
Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database ... Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Rep ... We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 ... Drug-Related Side Effects and Adverse Reactions / Data Mining / Pharmacovigilance Clinical aspect: Prediction Country/Region as ...
... patients and consumers can describe adverse drug reactions experienced in free-text format. Recently, a... ... Introduction When reporting adverse drug reactions to pharmacovigilance centres, ... Adverse drug event reporting systems: a systematic review. Br J Clin Pharmacol. 2016;82(1):17-29.CrossRefGoogle Scholar ... When reporting adverse drug reactions to pharmacovigilance centres, patients and consumers can describe adverse drug reactions ...
  • March 5, 2020 (Toronto) - A national drug terminology created by Canada Health Infoway (Infoway) and Health Canada is enhancing medication safety and providing value for patients, health care providers and health systems across Canada. (infoway-inforoute.ca)
  • RIYADH: The Saudi Ministry of Interior's General Administration of Medical Services topped the July 2020 list released by the Saudi Food and Drug Authority for hospitals and health centers that first reported drug side effects. (arabnews.com)
  • As of February 29, 2020, the database listed 24,543 adverse events for the long-running Infanrix Hexa vaccine, many of them classified as serious (including over 5,000 nervous system disorders), with the vast majority occurring in the 2-month to 2-year age range. (vaccineimpact.com)
  • This should include the importance of providing comprehensive information about the patient, the medicine that is suspected of causing the reaction, the patient's concurrent medicines, the reaction they experienced and the organisation at which it was experienced. (safetyandquality.gov.au)
  • PrescribeIT ® will serve all Canadians, pharmacies and prescribers and provide safer and more effective medication management by enabling prescribers to transmit a prescription electronically between a prescriber's electronic medical record (EMR) and the pharmacy management system (PMS) of a patient's pharmacy of choice. (infoway-inforoute.ca)
  • Ensure that the patient's medical history is complete and that medication safety and quality systems are in place to monitor the management of multimorbidity. (vic.gov.au)
  • This paper provides an overview of all side effects of medicinal product belonging to ATC: D10 group reported to the Croatian Agency for Medicinal Products and Medical Devices (HALMED) from January 1, 2018 to January 31, 2018. (uniri.hr)
  • Our system, Snorkel-which we report on in a new VLDB 2018 paper posted here -is one attempt to build a system around this new type of interaction with ML. In Snorkel , we use no hand-labeled training data , but instead ask users to write labeling functions (LFs) , bits of black-box code which label subsets of unlabeled data. (stanford.edu)
  • Unsurprisingly, this bogus procedure allowed researchers to conclude that adverse reactions to the vaccines were similar across groups . (vaccineimpact.com)
  • PharmaWatch has launched this blog to shed light on some of the most significant policy, research, legislative and program issues related to the safety and efficacy of prescription drugs, vaccines and medical devices in Canada. (cwhn.ca)
  • Many, perhaps most Canadians, believe that prescription drugs, vaccines and medical devices are widely tested before being submitted to a rigorous approval process and, after being deemed safe and effective, are continuously monitored once they are on the market and being used. (cwhn.ca)
  • Prescription and over-the-counter drugs, vaccines, gene therapies and medical devices fall under the umbrella of considered products while natural health products will not. (sprucegroveexaminer.com)
  • Admitted Planned Parenthood shooter Robert Lewis Dear, Jr. has complained during his court appearances about the "chemical lobotomy" he is receiving from the antipsychotic drugs being forcibly administered to him at the Colorado Mental Health Institute at Pueblo (CMHIP). (psychiatricfraud.org)
  • See " Pueblo School District Fails To Explicitly Prohibit Teachers From Pushing Psychiatric Drugs . (psychiatricfraud.org)
  • An examination of Pueblo City Schools Board policy by the Citizens Commission on Human Rights of Colorado (CCHR) found that the School Board is in violation of state law by not having adopted policy explicitly prohibiting school personnel from recommending or requiring psychiatric drugs for any student. (psychiatricfraud.org)
  • Voriconazole, a triazole antifungal agent used to treat serious fungal infections, has a pharmacokinetic characteristic of undergoing hepatic metabolism by the cytochrome P450 system. (kstudy.com)
  • Physicians should ensure that patients are tolerating doses in the 600 mg to 1200 mg/day range without gastroenterologic, renal, hepatic, or dermatologic adverse effects before advancing to the larger doses. (rxlist.com)
  • C.R.S. 22-32-109(1)(ee) requires school district Boards of Education to adopt policy that explicitly "prohibit[s] school personnel from recommending or requiring the use of a psychotropic drug for any student. (psychiatricfraud.org)
  • In the first episode, renin-angiotensin-aldosterone system inhibitors were associated. (kstudy.com)
  • Pediatric drug use, in many circumstances, has been based primarily on information extrapolated from studies involving adults, as well as from other types of scientific evidence, including case reports, open studies of clinical experience and controlled clinical trials. (canada.ca)
  • 6 The use of these drugs in the pediatric population has increased substantially over the last decade. (canada.ca)
  • Spotfire Clinical will integrate out-of-the box with leading systems, including Oracle® Clinical and Oracle® Remote Data Capture . (tibco.com)
  • With these integrations, clinical development teams can leverage interactive visualizations and S+/R-based predictive analytics to rapidly explore their clinical data stored in the leading clinical data management and electronic data capture systems. (tibco.com)
  • The Canadian Clinical Drug Data Set (CCDD) is a national drug terminology that enables the sharing of drug data between different systems for e-prescribing, medication profiles and secondary use such as adverse drug monitoring. (infoway-inforoute.ca)
  • Retrospective analysis of American Association of Poison Control Center's National Poison Data System (NPDS). (nih.gov)
  • Poison center data can be used to evaluate therapeutic errors in older adults to identify reasons associated with frequently reported errors, as well as reasons and medications involved with errors that result in serious outcomes. (nih.gov)
  • The study of clinical trial data for all approved ADHD drugs is important for two simple reasons. (ppjg.me)
  • CCHR International is asking the public to sign its petition calling on U.S. lawmakers to immediately open an investigation into the role of psychiatric drugs in school shootings and similar acts of violence, given that data supporting this link has to date been ignored by the U.S. government and mental health agencies. (psychiatricfraud.org)
  • Congratulations to Rion Correia, who successfully defended his PhD dissertation on Prediction of Drug Interaction and Adverse Reactions, with data from Electronic Health Records, Clinical Reporting, Scientific Literature, and Social Media, using Complexity Science Methods . (indiana.edu)
  • Dr. Correia's research used network science, machine learning, and data science to uncover population-level associations of drugs and symptoms, useful for public health surveillance. (indiana.edu)
  • In addition to Complex Networks and Systems, his dissertation contributes to the fields of biomedical informatics and precision public health by leveraging heterogeneous data sources at multiple levels to understand population and individual pharmacology differences and other public health problems. (indiana.edu)
  • This is discussed in detail in a terrific interview with their CTO Marc Desgrousilliers who is managing the development of ClinCapture, their open source Electronic Data Capture (EDC) system. (openhealthnews.com)
  • These large reports are produced every year, presenting information from a single data source (e.g. (samhsa.gov)
  • Barometers, State Reports, Data Reviews). (samhsa.gov)
  • These reports present data on a single metro area (e.g. (samhsa.gov)
  • These reports present data on a single state or territory, and they may be released as a stand-alone publication or a recurring report. (samhsa.gov)
  • These reports present data on a single region (i.e., not a state or metro area), and they may be released as a stand-alone publication or a recurring report. (samhsa.gov)
  • This short report uses data from the 2010 and 2011 National Surveys on Drug Use and Health (NSDUHs), the 2010 Treatment Episode Data Set (TEDS), the 2010 National Survey of Substance Abuse Treatment Services (N-SSATS), and the 2011 Drug Abuse Warning Network (DAWN) to present facts about adolescent substance use. (samhsa.gov)
  • A practical method of linking data from Medicare claims and a comprehensive electronic medical records system. (nih.gov)
  • One answer, of course, is that today's ML systems don't need to be programmed at all-and, given large volumes of training data, this is more true than ever before. (stanford.edu)
  • In the 1990's, machine learning began to take off as the vehicle for integrating knowledge into AI systems, promising to do so automatically from labeled training data in powerful and flexible ways. (stanford.edu)
  • The aim was to assess national professional stakeholders' opinions of, and attitudes to, limitations of current pharmacovigilance systems, the linking of data at Scottish level and advantages of, and barriers to, this approach. (elsevier.com)
  • Therefore, ensuring and supporting the collection of high-quality data from adverse event reports will be essential responsibilities of our daily work. (uppsalareports.org)
  • This quarterly publication alerts health professionals to potential signals detected through the review of case reports submitted to Health Canada. (canada.ca)
  • Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. (semcs.net)
  • Boston-Cambridge-Quincy, MA-NH), and they may be released as a stand-alone publication or a recurring report. (samhsa.gov)
  • Assess the quality, content and timeliness of ADR reports. (safetyandquality.gov.au)
  • Health Canada will continue to monitor adverse reaction information for oral goldenseal-containing health products, as it does for all health products, to identify and assess potential harms. (canada.ca)
  • This RFQ is very important as the objective is to develop a platform to support a critical project by the FDA's Division of Bioinformatics and Biostatistics (DBB) "to conduct research to assess the safety and surveillance of FDA regulated products through the FDA adverse event reporting systems. (openhealthnews.com)
  • Kelly Patricia O'Meara is an award-winning former investigative reporter for the Washington Times' Insight Magazine, penning dozens of articles exposing the fraud of psychiatric diagnosis and the dangers of the psychiatric drugs-including her ground-breaking 1999 cover story, "Guns & Doses," exposing the link between psychiatric drugs and acts of senseless violence. (ppjg.me)
  • Featuring rapper Chill EB - Psycho/pharma spends $billions marketing drugs that cause mania, suicide, violence, heart attacks and strokes for psychiatric "disorders" that are just lists of behaviors. (psychiatricfraud.org)
  • However, if it wasn't evident before, these newer regulations make it crystal clear that prescription drugs have a monopoly over the terms "medicine" and "therapeutic benefit," and that it is very difficult for anything that isn't a Big Pharma drug to make a therapeutic claim. (madinamerica.com)
  • Published bibliographies and Web sites from patient safety and primary care organizations were also reviewed for unpublished reports, presentations, and leads to other sites, journals, or investigators with relevant work. (nih.gov)
  • Essentially every minute that a pharmacist spends reporting is one less minute they can spend on (immediate) patient care. (sprucegroveexaminer.com)
  • The FDA (Food & Drug Administration) mandates healthcare professionals to provide detailed reports in case of Adverse Drug Reactions (ADR) when administered by a patient. (elementtechnologies.net)
  • In a 1993 British study of therapist-patient sexual contact, one in four (25%) psychologists reported they had treated a patient who had been sexually involved with a previous therapist. (psychiatricfraud.org)
  • Is there any specific, measurable positive outcome for the patient of taking each drug? (psychiatricfraud.org)
  • The concomitant use of potent remedy, nevertheless available otc in some countries tablets with other orally administered sympathomimetic agents act is not recommended, since their combined effect on the heart failure reporting system may instructively be deleterious to the patient. (theshopsathyattpinonpointe.com)
  • However, even given the justifiable urgency with which governments and healthcare systems tackle this challenge, we cannot afford to lose sight of the importance of patient safety. (uppsalareports.org)
  • In addition to the substances such as aspirin and acetaminophen that people typically think of as OTC drugs, many other commonly available products are considered OTC drugs by the Food and Drug Administration (FDA). (msdmanuals.com)
  • Before the Food and Drug Administration (FDA) existed, just about anything could be put in a bottle and sold as a sure-fire cure. (msdmanuals.com)
  • Safety is a major concern when the Food and Drug Administration (FDA) considers reclassifying a prescription drug as OTC (over-the-counter). (msdmanuals.com)
  • Aspartame accounts for over 75 percent of the adverse reactions to food additives reported to the US Food and Drug Administration (FDA). (organicolivia.com)
  • We expect you to be an active member of our forum to continue with your free membership.Kindly note that if a member received more than five warnings from moderator/members they will be blocked automatically by our Bulletin Board system. (pharmdinfo.com)
  • Smeaton T., McElwaine P., C ullen J , Santos - Martinez M. J. ,D easy E., Widdowson M., Grimes T . C ., A prospective observational pilot study of adverse drug reactions contributing to hospitalisation in a cohort of middle-aged adults aged 45- 64 years. (tcd.ie)
  • Luvox, Paxil and other antidepressants are ranked among the top 10 most violence-inducing prescription drugs in a list compiled by the Institute for Safe Medication Practices. (psychiatricfraud.org)
  • OTC drugs are not always better tolerated than similar prescription drugs. (msdmanuals.com)
  • Prescription drugs were defined as compounds that could be habit forming, toxic, or unsafe for use except under a doctor's supervision. (msdmanuals.com)
  • In other cases, medical records were sealed or autopsy reports not made public or, in some cases, toxicology tests were either not done to test for psychiatric drugs or not disclosed to the public. (psychiatricfraud.org)
  • There were 140,786 older adults with reported therapeutic errors, of which 49,320 cases were followed to a known medical outcome. (nih.gov)
  • First, it is an admission that there is no medical or scientific proof that ADHD drugs are effective or safe. (ppjg.me)
  • And lastly, but most importantly, there is not now, nor has there ever been, any medical or scientific test to show that any child diagnosed "ADHD" is suffering from a medical condition requiring drugs to "treat" it. (ppjg.me)
  • Dr. Kelsey had landed at the FDA in August 1960, one of seven full-time medical officers hired to review about 300 human drug applications per year. (washingtonpost.com)
  • If the medical officer determined that the submission was incomplete, the drug company could provide additional information, and the clock would start anew. (washingtonpost.com)
  • An adverse drug reaction (ADR) is a burden both to healthcare system and has economic, medical and ethical dimensions. (etu.edu.tr)
  • Medical records and hospital computer system were reviewed to confirm medication, medical history and laboratory tests. (kku.ac.th)
  • Hospitals and other healthcare organizations, medical specialists and general practitioners are reluctant to adopt open source software", says Etienne Saliez, a Belgian retired medical IT systems specialist. (openhealthnews.com)