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

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)

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

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)

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

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)

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

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)

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

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)

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

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)

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

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)

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

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)

*  Antimicrobial stewardship
... especially patient safety decrease adverse drug reactions such as hypersensitivity reactions or kidney or heart damage (e.g., ... The system of "prior approval" of antimicrobials by infectious diseases has been used first historically. It is very time- and ... other laboratory data Advise on appropriate duration of antimicrobial therapy annual report to administration, calculation of ... "drug-bug mismatches" IV to oral conversion Optimal dosing Stopping redundant therapy Reducing adverse events Overall compliance ...
*  Pharmacogenetics
Comparisons of the list of drugs most commonly implicated in adverse drug reactions with the list of metabolizing enzymes with ... The Nuffield Council reported that patients and health professionals have adequate information about pharmacogenetics tests and ... As part of the inborn system for clearing the body of xenobiotics, the cytochrome P450 oxidases (CYPs) are heavily involved in ... Driving this trend are the 106,000 deaths and 2.2 Million serious events caused by adverse drug reactions in the US each year.[ ...
*  Terence Young (politician)
"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 ...
*  MedWatch
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 ...
*  Xiyanping
... 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, ...
*  Adverse Drug Reactions Advisory Committee
... 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. ...
*  Bill Inman
... 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, ...
*  List of MeSH codes (N02)
... 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 ...
*  Pharmacoepidemiology
... 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 ...
*  List of vaccine topics
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 ...
*  Ibn Sina Academy of Medieval Medicine and Sciences
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 ...
*  Research on Adverse Drug Events and Reports
The aims of RADAR are to disseminate safety reports for serious adverse drug reactions (sADRs) and to identify barriers to ... Thus, the RADAR project has developed into an important adjunct to the current pharmaceutical drug and device safety system. ... Between 1998 and 2007, 33 serious adverse drug or device reactions have been reported by RADAR investigators. The toxicities ... Research on Adverse Drug Events and Reports (RADAR) is a pharmacovigilance team of 25 doctors who receive calls about possible ...
*  Sparfloxacin
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 ... The overall rates of drug-related adverse reactions for sparfloxacin 400/200 mg versus comparators and 200/100 mg versus the ... Sparfloxacin achieves a high degree of penetration into most tissues, except for the central nervous system. Following a single ...
*  Cinoxacin
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 ...
*  Postmarketing surveillance
... 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 ...
*  Ivabradine
... 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 ...
*  Electronic health record
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. ...
*  Medicines and Healthcare products Regulatory Agency
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 ...
*  VigiBase
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 ...
*  Adverse effect
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 ...
*  Daptomycin
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 ...
*  Yellow Card Scheme
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 - ...
*  Hypericum perforatum
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 ...
*  Cefixime
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. " ...
*  EudraVigilance
... 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 ...
*  Childbirth
National Vital Statistics Reports. National Vital Statistics System, National Center for Health Statistics, Centers for Disease ... Even women who show little reaction to labour pains, in comparison to other women, show a substantially severe reaction to ... Su, M.; Hannah, W. J.; Willan, A.; Ross, S.; Hannah, M. E. (2004). "Planned caesarean section decreases the risk of adverse ... Anaesthetists or anesthesiologists are medical doctors who specialise in pain relief and the use of drugs to facilitate surgery ...
*  Terbinafine
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 ...
Standard Operating Procedure for Recording, Management and Reporting of Adverse Drug Reaction | Management Sciences for Health  Standard Operating Procedure for Recording, Management and Reporting of Adverse Drug Reaction | Management Sciences for Health
... that are reported through the Afghanistan national spontaneous reporting system. Reporting suspected adverse events is an ... management and reporting of suspected adverse drug reactions (ADRs) and other suspected adverse events (AEs) ... Related to Standard Operating Procedure for Recording, Management and Reporting of Adverse Drug Reaction. Countries * ... Standard Operating Procedure for Recording, Management and Reporting of Adverse Drug Reaction. Publication ...
more infohttps://www.msh.org/resources/standard-operating-procedure-for-recording-management-and-reporting-of-adverse-drug?field_resource_type%5B0%5D=Publication&page=9
Formats: Text / Subjects: Adverse Drug Reaction Reporting Systems / Genre: Technical Report - Digital Collections - National...  Formats: Text / Subjects: Adverse Drug Reaction Reporting Systems / Genre: Technical Report - Digital Collections - National...
Adverse Drug Reaction Reporting Systems ✖Remove constraint Subjects: Adverse Drug Reaction Reporting Systems Genre Technical ... Adverse Drug Reaction Reporting Systems. Drugs, Investigational -- adverse effects. Drugs, Investigational -- therapeutic use. ... Adverse Drug Reaction Reporting Systems. Anticoagulants -- administration & dosage. Anticoagulants -- therapeutic use. Length ... Investigational new drugs: FDA has taken steps to improve the expanded access program but should further clarify how adverse ...
more infohttps://collections.nlm.nih.gov/?f%5Bdrep2.format%5D%5B%5D=Text&f%5Bdrep2.subjectAggregate%5D%5B%5D=Adverse+Drug+Reaction+Reporting+Systems&f%5Bdrep2.subjectGenre%5D%5B%5D=Technical+Report
Petition for FDA Mandatory Adverse Reaction Reporting System! « Stevens Johnson Syndrome Foundation  Petition for FDA Mandatory Adverse Reaction Reporting System! « Stevens Johnson Syndrome Foundation
Petition for FDA Mandatory Adverse Reaction Reporting System!. Tell the FDA we need a mandatory adverse drug reaction reporting ... Over 200 thousand people each year die from adverse drug reactions but the cases are probably higher […] ... system by medical professionals of all severe drug reactions including Stevens-Johnson Syndrome! ... Please visit our facebook page to help spread awareness of severe allergic drug reactions. Find out about Steven's Johnson ...
more infohttp://sjsupport.org/?cat=3&paged=7
The incident reporting system does not detect adverse drug events: a problem for quality improvement.  - PubMed - NCBI  The incident reporting system does not detect adverse drug events: a problem for quality improvement. - PubMed - NCBI
Red man syndrome and the red button system: where next for inpatient adverse drug reaction reporting? [Jt Comm J Qual Improv. ... The incident reporting system does not detect adverse drug events: a problem for quality improvement.. Cullen DJ1, Bates DW, ... and staff nurses to determine whether an adverse drug event should have been reported and would have been reported. ... Of 54 adverse drug events identified by the study, only 3 patients (6%) had a corresponding incident report submitted to the ...
more infohttps://www.ncbi.nlm.nih.gov/pubmed/8556111?dopt=Abstract
WHO Drug Information Vol. 15, No. 3 & 4, 2001: Regulatory and Safety Matters*  WHO Drug Information Vol. 15, No. 3 & 4, 2001: Regulatory and Safety Matters*
... serious and unexpected adverse drug reactions. A signal is defined as "reported information on a possible causal relationship ... Spontaneous monitoring systems are useful in detecting signals of relatively rare, ... between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a ... WHO Drug Information Vol. 15, No. 3 & 4, 2001. (2001; 76 pages) Table of Contents ...
more infohttp://apps.who.int/medicinedocs/en/d/Jh2989e/7.html
Pulse+IT - Adverse drug reaction reporting goes online  Pulse+IT - Adverse drug reaction reporting goes online
MIMS has introduced new functionality to allow users to report unexpected adverse drug reactions to the Therapeutic Goods ... reporting system that allows consumers as well as health professionals and pharmaceutical companies to report adverse drug ... Adverse drug reactions are typically reported to the TGA advisory committee on the safety of medicines (ACSOM) by TGA Blue ... This allows reporting on adverse reactions from over-the- counter and complementary medicines as well as prescribed drugs. ...
more infohttps://www.pulseitmagazine.com.au/news/australian-ehealth/982-adverse-drug-reaction-reporting-goes-online
Results  Results
Description: Provides a consumer reporting system for medication errors, preventable adverse drug reactions or hazardous ... Description: Provides a consumer reporting system for medication errors, preventable adverse drug reactions or hazardous ...
more infohttps://www.minnesotahelp.info/SpecialTopics/Seniors/20074
KAKEN - Research Projects | Study for mechanisms of drug-induced severe cutaneous reactions (KAKENHI-PROJECT-15K19168)  KAKEN - Research Projects | Study for mechanisms of drug-induced severe cutaneous reactions (KAKENHI-PROJECT-15K19168)
This system would be useful for estimation of drug adverse reactions. Report (3 results) ... In this project, we developed a system for determination of affinity between drug and HLA protein. ... Presentation] Drugs and HLA types associated with Stevens–Johnson syndrome/toxic epidermal necrolysis with severe ocular ... Journal Article] Drugs causing severe ocular surface involvements in Japanese patients with StevenseJohnson syndrome/toxic ...
more infohttps://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-15K19168/
Pharmacy | Brooklyn Medical Care  Pharmacy | Brooklyn Medical Care
Clinical Pharmacists detect, report and manage over 800 adverse drug reactions annually. The Pharmacy Department also chairs ... Pharmacists detect, report and manage 500 - 1,000 medication errors annually. We operate an American Society of Health-System ... avoiding drug-drug and drug-food interactions, avoiding toxic medications, avoiding drug-disease contraindications, avoiding ... The Pharmacy Department chairs the Adverse Drug Reaction Committee. ...
more infohttps://www.kingsbrook.org/Programs-Services/Pharmacy.aspx
Learn About Our Program for Hospitals and Health Systems, Antimicrobial Stewardship Program
    		
    	
	 | UW Health |...  Learn About Our Program for Hospitals and Health Systems, Antimicrobial Stewardship Program | UW Health |...
... interdisciplinary system for the optimization of antibiotic use at UW Health. ... minimize the risk of medication toxicities and adverse drug reactions while improving patient- and family-centered outcomes ... Reporting. *Education. Our philosophy is to use evidence-based best practice guidelines to slow the emergence of antimicrobial ... Stewardship programs aim to continuously improve patient care by mitigating adverse reaction risk and encouraging optimal ...
more infohttps://www.uwhealth.org/antimicrobial-stewardship/regional-outreach-program-for-hospitals-and-health-systems/52717
Improving Healthcare Quality and Cost with Six Sigma: Trends in the Healthcare Industry | The Quality Crisis in Healthcare |...  Improving Healthcare Quality and Cost with Six Sigma: Trends in the Healthcare Industry | The Quality Crisis in Healthcare |...
Adverse drug reactions (wrong or incorrect quantity of a drug given to the patient) ... healthcare system of about $9.3 billion. This is considerably lower than the 1999 study on medical errors reported by the ... According to the Institute of Medicine, a total of 2 percent of hospital patients experience an adverse drug reaction, ... Australia's adverse event rate is 16.6 percent (the Quality in Australian Healthcare Study Report). ...
more infohttp://www.informit.com/articles/article.aspx?p=711820&
Adverse Drug Reactions (ADRS) monitoring at tertiary care Hospital
							| Journal of Drug Delivery and Therapeutics
			  Adverse Drug Reactions (ADR'S) monitoring at tertiary care Hospital | Journal of Drug Delivery and Therapeutics
1. Esch AF, The planning of a national drug monitoring system. WHO. Technical Report Series. 1972; 498:44‐7.. 2. Handler SM, ... Adverse reaction and adverse drug reaction monitoring training course 31st May to 11th June 1999.. 8. American Psychiatric ... The adverse drug reactions (ADR) reported by physician of dermatology department of SVSMH were collected and then causality, ... Preventability and severity assessment in reporting adverse drug reactions. Am J hosp pharm. 1992; 49:2229-31. Mahapatra S., ...
more infohttp://jddtonline.info/index.php/jddt/article/view/2207
Subjects: Pharmacy Service, Hospital -- organization & administration - Digital Collections - National Library of Medicine...  Subjects: Pharmacy Service, Hospital -- organization & administration - Digital Collections - National Library of Medicine...
Adverse Drug Reaction Reporting Systems. Anticoagulants -- administration & dosage. Anticoagulants -- therapeutic use. Length ... Anticoagulants -- adverse effects. Drug Monitoring -- methods. Medication Therapy Management. Patient Care Management. Safety. ...
more infohttps://collections.nlm.nih.gov/?f%5Bdrep2.subjectAggregate%5D%5B%5D=Pharmacy+Service%2C+Hospital+--+organization+%26+administration
Encouraging a learning culture by reporting errors - GMC  Encouraging a learning culture by reporting errors - GMC
You must report suspected adverse drug reactions to the UK-wide Yellow Card Scheme run by the Medicines and Healthcare products ... Adverse and patient safety incidents in England and Wales are reported to the National Reporting and Learning System.29 ... A number of reporting systems and schemes exist around the UK for reporting adverse incidents and near misses. ... You must report adverse incidents involving medical devices to the UK-wide MHRA reporting system.31 ...
more infohttps://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/candour---openness-and-honesty-when-things-go-wrong/encouraging-a-learning-culture-by-reporting-errors
Machine Translation of Medicine Quality Control Specifications (China)  Machine Translation of "Medicine Quality Control Specifications" (China)
... in accordance with the relevant provisions of the adverse drug reaction reporting system, collection, reporting adverse drug ... 15) adverse drug reaction reporting requirements;. (16) computer system management;. (17) the provisions of implementation of ... 14) is responsible for the reporting of adverse drug reactions;. (15) the Organization's quality management system audits and ... I) is responsible for reports of counterfeit medicines;. (10) is responsible for the reporting of adverse drug reactions;. (11 ...
more infohttps://www.global-regulation.com/translation/china/159494/medicine-quality-control-specifications.html
An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance.  - PubMed - NCBI  An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance. - PubMed - NCBI
Pharmacoepidemiol Drug Saf. 2018 Jan;27(1):38-45. doi: 10.1002/pds.4344. Epub 2017 Nov 16. Evaluation Studies ... Adverse Drug Reaction Reporting Systems/organization & administration*. *Adverse Drug Reaction Reporting Systems/statistics & ... Drug-Related Side Effects and Adverse Reactions/epidemiology. *Drug-Related Side Effects and Adverse Reactions/prevention & ... EudraVigilance; European Medicines Agency; abuse; adverse drug reaction; medication error; misuse; pharmacoepidemiology; ...
more infohttps://www.ncbi.nlm.nih.gov/pubmed/29143393
Stop Iatrogenesis - The number three killer in America is preventable - NaturalNews.com  Stop Iatrogenesis - The number three killer in America is preventable - NaturalNews.com
Drug-drug interaction. Iatrogenesis now. The FDA, through its Adverse Events Reporting System, keeps a record of adverse events ... who suffered a serious adverse drug reaction within the 12 months prior to the study, 100,000 died from their reaction. Of ... Adverse drug reactions. A University of Toronto study found that pharmaceuticals kill more people in the U.S. than motor- ... According to JAMA, the most common causes of adverse drug events (without counting the inherent danger certain drugs pose) are ...
more infohttps://www.naturalnews.com/034569_iatrogenesis_accidental_death_medicine.html
Using routinely collected prescribing data to determine drug persistence for the purpose of pharmacovigilance<...  Using routinely collected prescribing data to determine drug persistence for the purpose of pharmacovigilance<...
Adverse Drug Reaction Reporting Systems Pharmacoepidemiology Ramipril Pharmacovigilance Simvastatin Medication Adherence ... Naina Mohamed, I, Helms, PJ, Simpson, CR & McLay, JS 2011, 'Using routinely collected prescribing data to determine drug ... Using routinely collected prescribing data to determine drug persistence for the purpose of pharmacovigilance. / Naina Mohamed ... Using routinely collected prescribing data to determine drug persistence for the purpose of pharmacovigilance. Journal of ...
more infohttps://ukm.pure.elsevier.com/en/publications/using-routinely-collected-prescribing-data-to-determine-drug-pers
Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis | Scicchitano | Journal of Research in...  Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis | Scicchitano | Journal of Research in...
Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis ... key words: Adverse drug reaction reporting systems, adverse effects, calabria, drugtoxicity, Italy, pharmacovigilance ... its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs).The Italian drug agency (AIFA; Agenzia ... Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis. Francesca Scicchitano, Chiara Giofrè, ...
more infohttp://jrms.mui.ac.ir/index.php/jrms/article/view/8625
Follow-Up Medication Post-Marketing  Follow-Up Medication Post-Marketing
Adverse Drug Reactions Reporting System - download​. • Medication Errors Symposium - download​​. • Drug Quality Reporting ... 9) of the 54th GCC Council of Ministers of Health held in Abu Dhabi that includes 'approving that the post-marketing drug ... the directions outlined in the Post-Marketing Drug Tracking Manual when communicating with the Gulf Health Council on reports ...
more infohttp://ghc.sa/en-us/pages/crpms.aspx
Genetic testing company agrees to $42.6M settlement and 25-year ban in Medicare fraud case | FierceHealthcare  Genetic testing company agrees to $42.6M settlement and 25-year ban in Medicare fraud case | FierceHealthcare
... purportedly in return for their participation in a clinical trial known as the Diagnosing Adverse Drug Reactions Registry (DART ... Reuters reported that the company ceased operations in 2017 because of whistleblower allegations and an ensuing probe, citing a ... "The payment of kickbacks in exchange for medical referrals undermines the integrity of our healthcare system. Today's ... Hospitals turn to specialty drug revenue as profits shrink. Outpatient specialty drugs can be a lucrative income source for not ...
more infohttps://www.fiercehealthcare.com/tech/genetic-testing-company-agrees-to-pay-42-6m-and-25-year-ban-federal-kickback-settlement
Drug & Product Safety Reporting Management Software (PSUR / DSUR) | Appian  Drug & Product Safety Reporting Management Software (PSUR / DSUR) | Appian
Appian's Safety Reporting solution can create timely reports by unifying different data sources to gain real time updates and ... A life sciences organization is obligated by the health authorities to report any side effects or adverse drug reactions with ... Data migrations from outdated and disjointed systems to create a single unified data repository ... Appian's Safety Reporting solution can create timely reports by unifying different data sources to gain real time updates and ...
more infohttps://www.appian.com/industries/solutions/life-sciences/safety-reporting-psur-dsur-rmp/
Are Homeopathic Treatments Safe? | Prevention  Are Homeopathic Treatments Safe? | Prevention
... the FDA's drug-safety monitoring system has received more than 400 reports of adverse reactions to using homeopathic teething ... "If I listened to everyone who wanted to give me drugs, I would be taking acid reflux medicine, an inhaler three times a day for ... "Homeopathy is medicine, and any medicine can have side effects or adverse effects if someone is sensitive to it or if the ... Homeopathic drugs intended for serious conditions not covered by OTC treatments must be prescribed by homeopathic practitioners ...
more infohttps://www.prevention.com/health/a20457667/are-homeopathic-treatments-safe/
Zofran uk, Zofran zydis 8mg  Zofran uk, Zofran zydis 8mg
A report from the Adverse Drug Reaction Reporting System».. My guess is it is embarrassing and no one want to be associated it ... "Lack of disulfiram-like reaction with metronidazole and ethanol".? I started using it in the evenings twice a week then up to ... retin a cream price in sri lanka tough Talon sabotaged the Mynock's flight systems and then rigged it with explosives.? " ...
more infohttps://www.theatlanticcenter.com/27508-zofran-uk.html
US Patent Application for INTEGRATED PATIENT MANAGEMENT AND CONTROL SYSTEM FOR MEDICATION DELIVERY Patent Application ...  US Patent Application for INTEGRATED PATIENT MANAGEMENT AND CONTROL SYSTEM FOR MEDICATION DELIVERY Patent Application ...
... and a medication administration system, the medication administration system receiving the dosing information from the ... If the sample set is adapted for blood draw, the system advantageously is performed in conjunction with a pneumatic pressure ... An integrated patient monitoring and control system is provided which includes a sample set, the sample set being adapted for ... 9 MEDMARX® is a national database that tracks and trends adverse drug reactions and medication errors. ...
more infohttps://patents.justia.com/patent/20100036310
  • Our philosophy is to use evidence-based best practice guidelines to slow the emergence of antimicrobial resistance organisms, reduce antibiotic expenditures, minimize the risk of medication toxicities and adverse drug reactions while improving patient- and family-centered outcomes through improved drug selection, dosing and treatment duration. (uwhealth.org)
  • 11th Enterprise shall, on drug suppliers to evaluate the quality management system, purchase units, in recognition of their quality assurance and quality reputation, site visits, if necessary. (global-regulation.com)
  • Intravenous medications are administered via the Alaris ® System wireless infusion devices. (kingsbrook.org)
  • Decentralized Clinical Pharmacists validate medication orders, attend daily patient care rounds, provide drug information, dose medications based on age, weight, hepatic and renal function, and other pharmacokinetic parameters, provide medication reconciliation services, administer medication histories and discharge counseling, and attend codes including rapid response and hypothermia codes. (kingsbrook.org)
  • First to improve medicine quality control, standardize drug business, ensure medication is safe and effective, according to the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law implementing regulations, development of this specification. (global-regulation.com)
  • 14th head of an enterprise is the primary responsibility of pharmaceutical quality, overall responsibility for the daily management of enterprises, and is responsible for providing the necessary conditions, quality assurance management and quality management staff to efficiently carry out their duties to ensure achievement of the quality objectives, and in accordance with the specification requirements for drugs. (global-regulation.com)
  • Physicians sometimes knowingly prescribe highly toxic drugs to people who are critically ill. (naturalnews.com)
  • Nineth analysis of enterprise internal audit should be carried out, based on the analysis and conclusions to develop the quality management system improvement, and constantly raise the level of quality control to ensure continued effective operation of the quality management system. (global-regulation.com)
  • and 2) to determine if there were differences between quality assurance administrators, nurse leaders in quality assurance, and staff nurses as to whether an incident report should or would be filed for each adverse drug event. (nih.gov)
  • Consensus voting was used by senior hospital administrators, nursing leaders, and staff nurses to determine whether an adverse drug event should have been reported and would have been reported. (nih.gov)
  • Article fifth enterprises shall, in accordance with the relevant laws and regulations and the regulations called for the establishment of quality management system, determine the quality policy, develop the quality management system documentation, quality planning, quality control, quality assurance, quality improvement and quality risk management activities. (global-regulation.com)
  • A University of Toronto study found that pharmaceuticals kill more people in the U.S. than motor-vehicle accidents (as reported by the Cancer Cure Foundation). (naturalnews.com)
  • Count data were determined at drug-event combination. (nih.gov)
  • The Pharmacy Department has a hybrid medication dispensing system, which utilizes the McKesson Robot-Rx ™ and Omnicell ® automated dispensing machines. (kingsbrook.org)
  • The adverse drug reactions (ADR) reported by physician of dermatology department of SVSMH were collected and then causality, severity and preventability assessment was done. (jddtonline.info)
  • The Justice Department accused the company and its three principals of paying physicians from 2013 to 2017 to induce them to order pharmacogenetic tests, purportedly in return for their participation in a clinical trial known as the Diagnosing Adverse Drug Reactions Registry (DART). (fiercehealthcare.com)
  • A signal is defined as "reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. (who.int)
  • We operate an American Society of Health-System Pharmacists-accredited pharmacy residency program for PGY-1 and PGY-2 residents. (kingsbrook.org)
  • Our comprehensive AMS services can be tailored to the needs of each regional partner hospital or health system to identify opportunities to improve patient outcomes associated with antimicrobial use and achieve compliance with accreditation standards, including CMS conditions of participation and fulfillment of the CDC 7 core elements of hospital antimicrobial stewardship. (uwhealth.org)
  • Stewardship programs aim to continuously improve patient care by mitigating adverse reaction risk and encouraging optimal antimicrobial choice. (uwhealth.org)
  • Tenth review of the enterprise should be in forward or, on the quality of drug distribution in the process of risk assessment, control, communications, and auditing. (global-regulation.com)
  • Sixth corporate quality policy document should be clear total quality objectives and requirements, and carry out drug operations in the whole process. (global-regulation.com)
  • Journal Article] A Modified Murine Embryonic Stem Cell Test for Evaluating the Teratogenic Effects of Drugs on Early Embryogenesis. (nii.ac.jp)
  • The second standard is fundamental to drug management and quality control guidelines, an enterprise shall, in drug procurement, Stockpiling, sale, transport and other sectors to take effective quality control measures, to ensure the quality of drugs. (global-regulation.com)
  • Seventh enterprise quality management system should be commensurate with its business scope and scale, including organizational structure, personnel, facilities, equipment, quality management system documents and corresponding computer system. (global-regulation.com)
  • Eighth enterprise should periodically and when significant changes in the key elements of the quality management system, organizations to carry out internal audits. (global-regulation.com)
  • 15th corporate quality Director should be held by senior management, responsible for drug quality control and independent performance of their functions, in the internal quality control of drugs has the right to rule. (global-regulation.com)
  • If your organisation does not have such a system in place, you should speak to your manager and - if necessary - raise a concern in line with our guidance. (gmc-uk.org)
  • If you do not feel supported to report, and in particular if you are discouraged or prevented from reporting, 37 you should raise a concern in line with our guidance. (gmc-uk.org)
  • Graphical representation of the identification of historical concerns with counts of cases at MedDRA PT and substance level, including literature, for 2 reactions (cerebral infraction and deep vein thrombosis) reported to human normal immunoglobulin. (nih.gov)
  • Reuters reported that the company ceased operations in 2017 because of whistleblower allegations and an ensuing probe, citing a spokeswoman for the UTC principals said. (fiercehealthcare.com)