Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug 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.
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.
Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale.
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.
Immunologically mediated adverse reactions to medicinal substances used legally or illegally.
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.
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.
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)
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.
A branch of genetics which deals with the genetic variability in individual responses to drugs and drug metabolism (BIOTRANSFORMATION).
The process of observing, recording, or detecting the effects of a chemical substance administered to an individual therapeutically or diagnostically.
Directions written for the obtaining and use of DRUGS.
Child hospitalized for short term care.
The use of DRUGS to treat a DISEASE or its symptoms. One example is the use of ANTINEOPLASTIC AGENTS to treat CANCER.
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))
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.
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.
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.
A medical facility which provides a high degree of subspecialty expertise for patients from centers where they received SECONDARY CARE.
The branch of pharmacology that deals directly with the effectiveness and safety of drugs in humans.
The action of a drug that may affect the activity, metabolism, or toxicity of another drug.
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.
Those persons legally qualified by education and training to engage in the practice of pharmacy.
Hospital department responsible for the receiving, storing, and distribution of pharmaceutical supplies.
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.
Special hospitals which provide care for ill children.
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 engaged in educational and research programs, as well as providing medical care to the patients.
The practice of administering medications in a manner that poses more risk than benefit, particularly where safer alternatives exist.
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.
Persons admitted to health facilities which provide board and room, for the purpose of observation, care, diagnosis or treatment.
Services providing pharmaceutic and therapeutic drug information and consultation.
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.
The confinement of a patient in a hospital.
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.
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.
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.
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.
A narcotic analgesic structurally related to METHADONE. Only the dextro-isomer has an analgesic effect; the levo-isomer appears to exert an antitussive effect.
Persons who receive ambulatory care at an outpatient department or clinic without room and board being provided.
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.
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 maintained by a university for the teaching of medical students, postgraduate training programs, and clinical research.
Drugs used to prevent SEIZURES or reduce their severity.
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.
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.
The process of accepting patients. The concept includes patients accepted for medical and nursing care in a hospital or other health care institution.
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.
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.
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)
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.
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)
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.
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.
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.
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)
The study of the origin, nature, properties, and actions of drugs and their effects on living organisms.
Individuals licensed to practice medicine.
Institutions with an organized medical staff which provide medical care to patients.
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.
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.
Medicines that can be sold legally without a DRUG PRESCRIPTION.
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.
Diseases in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM.
The utilization of drugs as reported in individual hospital studies, FDA studies, marketing, or consumption, etc. This includes drug stockpiling, and patient drug profiles.
The charge levied on the consumer for drugs or therapy prescribed under written order of a physician or other health professional.
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.
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.
Total pharmaceutical services provided to the public through community pharmacies.
Recording of pertinent information concerning patient's illness or illnesses.
Substances that reduce the growth or reproduction of BACTERIA.
Substances that prevent infectious agents or organisms from spreading or kill infectious agents in order to prevent the spread of infection.
Use of sophisticated analysis tools to sort through, organize, examine, and combine large sets of information.
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.
Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion.
Pathological processes of the LIVER.
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
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 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.
Acquired, familial, and congenital disorders of SKELETAL MUSCLE and SMOOTH MUSCLE.
Those areas of the hospital organization not considered departments which provide specialized patient care. They include various hospital special care wards.
A subnormal level of BLOOD PLATELETS.
The individuals employed by the hospital.
Therapy with two or more separate preparations given for a combined effect.
An infant during the first month after birth.
A laxative that undergoes enterohepatic circulation. It may cause jaundice.
Computer-based systems for input, storage, display, retrieval, and printing of information contained in a patient's medical record.
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.
Elements of limited time intervals, contributing to particular results or situations.
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.
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.
Patterns of practice related to diagnosis and treatment as especially influenced by cost of the service requested and provided.
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.
A medical specialty concerned with the provision of continuing, comprehensive primary health care for the entire family.
Attitudes of personnel toward their patients, other professionals, toward the medical care system, etc.
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.
The practice of compounding and dispensing medicinal preparations.
Older adults or aged individuals who are lacking in general strength and are unusually susceptible to disease or to other infirmity.
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.
A republic in western Africa, south of NIGER between BENIN and CAMEROON. Its capital is Abuja.
Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.
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.
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.
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.
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.
Hospital department responsible for the administration and provision of immediate medical or surgical care to the emergency patient.
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.
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.
A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task.
Agents that prevent clotting.
Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.
Agents that promote the excretion of urine through their effects on kidney function.
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.
The giving of drugs, chemicals, or other substances by mouth.
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.
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.
An enzyme that catalyzes the conversion of L-alanine and 2-oxoglutarate to pyruvate and L-glutamate. (From Enzyme Nomenclature, 1992) EC
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)

What are Adverse Events Following Immunization?. Any medical event occurring after immunisation can be classified as an adverse event following immunisation (AEFI) whether the event has any causal relationship to getting the immunisation or not. Adverse events/responses following immunisation can range from mild to severe and from common to very rare. They may occur as a result of the immunisation, a causal relationship between the event and immunisation, or occur after the immunisation by chance, a coincidental relationship between the event and immunisation.. *Please use the forms below to report an adverse event following immunization with any vaccine, including SARS-CoV-2 vaccines. ...
TY - JOUR. T1 - How patient reporters identify adverse drug reactions. T2 - a qualitative study of reporting via the UK Yellow Card Scheme.. AU - Krska, Janet. AU - Anderson, Claire. AU - Avery, Anthony. AU - Watson, Mags. AU - on behalf of the Yellow Card Study Collaboration (including Watson MC. AU - Lee, Amanda Jane. AU - Murphy, Elizabeth. PY - 2011/5/1. Y1 - 2011/5/1. N2 - Direct reporting of suspected adverse drug reactions (ADRs) to authorities is increasing, but questions remain about how patients identify suspected ADRs and their ability to distinguish between ADRs and other symptoms. OBJECTIVE: The aim of the study was to determine how reporters to the Yellow Card Scheme (YCS) identify ADRs. METHODS: We carried out a qualitative analysis of data from three sources, obtained as part of a larger evaluation of patient reporting to the UK YCS: responses to open questions in postal questionnaires sent to all reporters during March 2008-January 2009 (method 1); telephone interviews with a ...
This handbook focuses on adverse drug reactions in tuberculosis treatment. Tuberculosis is a multisystem disease with varied clinical presentations. One-third of the worlds population is infected with Mycobacterium tuberculosis and there is 10% lifetime risk of developing tuberculosis and the risk further increases to 10% annual risk in immunocompromised patients. This book is written with the aim of defining a practical approach to every aspect of adverse drug reaction in tuberculosis treatment. In total, there are 21 chapters in the book. Chapters practically cover all the aspects of adverse drug reaction in TB treatment ranging from pharmacology, interaction between anti-TB drugs with food and other drugs including antiretroviral drugs, monitoring and management of adverse drug reaction of antituberculosis used in new and drug-resistant cases of tuberculosis. Special chapters on case-based approach to treatment of tuberculosis and MDR-TB and XDR-TB in special situation like pregnancy, renal
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 ...
To evaluate the operation status of the adverse events following immunization(AEFI) surveillance system in Jiangsu Province in 2008.The description epidemiological methods were used in this study.6197 AEFI cases reported in 2008 were collected.The cases reaction were classified into vaccine reaction,its incidente is 98.97%,and coincidental,unknown and pending cases account for 0.95%,0.02% and 0.06%,respectively.Fever,absces in injection site and Dants scleroma are dominant clinical reaction of AEFI cases.The incidence rates of allergia rash and sterile abscess is rather higher than orthers.The operation status of AEFI Surveillance System is normal and the indicators are matched the requirements of MOH.Benefiting from the introduction of the standardized AEFI classification,case definition and direct network report,the data quality is being improved step by step.The safety of NIP vaccines and the quality of immunization services is satisfactory.
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.
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2005, and describes reporting trends over the six year period 2000 to 2005.
This report summarises national passive adverse events following immunisation (AEFI) surveillance data for children aged less than 7 years who received vaccines between 1 January and 30 June 2008 and is a supplement to the annual reports for each year.
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.
Prescription drugs have been through a rigorous process of testing to ensure safety, despite this, a minority of individuals will develop side-effects. Side- effects are termed adverse drug reactions by doctors and although the majority of adverse drug reactions are relatively minor and may even allow continuation with the drug, in some cases more severe symptoms can occur.. The majority of adverse drug reactions are predictable and affect susceptible patients e.g. gastric irritation with aspirin, or occur due to an interaction between two drugs, e.g. bleeding with warfarin when taken with some antibiotics. Adverse drug reactions account for approximately 6.5% of hospital admissions and in up to 15% of patients prolong the hospital stay.. A smaller proportion of adverse drug reactions are due to drug allergy and in these cases, the drug causes an unexpected reaction, which is not predictable in a particular individual. Typical symptoms include swelling of any part of the body, including the ...
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: 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: /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 ...
Older adults are more prone to develop adverse drug reactions (ADRs) since they exhibit numerous risk factors. The first aim was to analyse the number of spontaneous ADR reports regarding older adults (| 65) in the ADR database of the German Federal Institute for Drugs and Medical Devices (BfArM) and to set them in relation to i) the number of ADR reports concerning younger adults (19-65), and ii) the number of inhabitants and assumed drug-exposed inhabitants. The second aim was to analyse, if reported characteristics occurred more often in older vs. younger adults. All spontaneous ADR reports involving older or younger adults within the period 01/01/2000-10/31/2017 were identified in the ADR database. Ratios concerning the number of ADR reports/number of inhabitants and ADR reports/drug-exposed inhabitants were calculated. The reports for older (n = 69,914) and younger adults (n = 111,463) were compared using descriptive and inferential statistics. The absolute number of ADR reports involving older
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 ...
Vaccines have been one of the most successful public health interventions to date. The use of vaccination, however, sometimes comes with possible adverse events. The U.S. FDA/CDC Vaccine Adverse Event Reporting System (VAERS) currently contains more than 200,000 reports for post-vaccination events that occur after the administration of vaccines licensed in the United States. Although the data from the VAERS has been applied to many public health and vaccine safety studies, each individual report does not necessarily indicate a casuality relationship between the vaccine and the reported symptoms. Further statistical analysis and summarization needs to be done before this data can be leveraged. This paper introduces our efforts on representing the vaccine-symptom correlations and their corresponding meta-information extracted from the VAERS database using Resource Description Framework (RDF). Numbers of occurrences of vaccine-symptom pairs reported to the VAERS were summarized with corresponding
Notice of Proposed Rulemaking (NPRM) on Significant Disproportionality. Also just released from the Department ... a proposed standard approach for defining significant disproportionality. This new rule, Equity in IDEA, seeks to address widespread racial and ethnic disparities in the treatment of students with disabilities. An analysis of data related to the proposed rule is also…
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. ...
This course discusses the technical section of a COMAH safety report which should describe the Design, Construction, Operation, Maintenance and Modification of the COMAH site. The course covers the Process Safety, Mechanical Engineering, Electrical Control and Instrumentation and Human Factors aspects which form the technical section of a Safety Report.. ...
Background: Adverse drug reactions (ADRs) occur in nearly all patients on chemotherapy, causing morbidity and therapy disruptions. Detection of such ADRs is limited in clinical trials, which are underpowered to detect rare events. Early recognition of ADRs in the postmarketing phase could substantially reduce morbidity and decrease societal costs. Internet community health forums provide a mechanism for individuals to discuss real-time health concerns and can enable computational detection of ADRs. Objective: The goal of this study is to identify cutaneous ADR signals in social health networks and compare the frequency and timing of these ADRs to clinical reports in the literature. Methods: We present a natural language processing-based, ADR signal-generation pipeline based on patient posts on Internet social health networks. We identified user posts from the Inspire health forums related to two chemotherapy classes: erlotinib, an epidermal growth factor receptor inhibitor, and nivolumab and
An observational study to analyze predisposing factors, causality, severity and preventability of adverse drug reactions among multidrug resistant tuberculosis patients treated under RNTCP program in Northern India
The expanded use of multiple drugs has increased the occurrence of adverse drug reactions (ADRs) induced by drug-drug interactions (DDIs). However, such reactions are typically not observed in clinical drug-development studies because most of them focus on single-drug therapies. ADR reporting systems collect information on adverse health effects caused by both single drugs and DDIs. A major challenge is to unambiguously identify the effects caused by DDIs and to attribute them to specific drug interactions. A computational method that provides prospective predictions of potential DDI-induced ADRs will help to identify and mitigate these adverse health effects. We hypothesize that drug-protein interactions can be used as independent variables in predicting ADRs. We constructed drug pair-protein interaction profiles for ~800 drugs using drug-protein interaction information in the public domain. We then constructed statistical models to score drug pairs for their potential to induce ADRs based on drug pair
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 ...
This report includes data from the FDAs Adverse Events Reports for 2018. We removed reports where the subject was taking drugs in addition to Warfarin.
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 ...
Adverse Drug Reaction (ADR): is an injury caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or resu
Among people taking finasteride, there is a disproportionality signal for suicidality, according to a study published online Nov. 11 in JAMA Dermatology.
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 ...
Prepared by the Adverse Drug Reactions Advisory Committee (ADRAC) and the Office of Medicine Safety Monitoring (OMSM) of the TGA.
Prepared by the Adverse Drug Reactions Advisory Committee (ADRAC) and the Office of Medicine Safety Monitoring (OMSM) of the TGA.
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). Download ...
Adverse drug reaction suggests by a clinical vignette Albert J FinestoneTemple University School of Medicine, Philadelphia, PA, USAI had a three-lobe pneumonia and toxic encephalopathy in 2004. A lumbar puncture did not show meningitis. Magnetic resonance imaging showed a macroadenoma of the pituitary gland. Prolactin level was significantly elevated, making the diagnosis a functioning prolactinoma requiring treatment. Initially, I was treated with the dopamineagonist cabergoline, which is also used in much larger doses to treat Parkinsonism. Recent reports have indicated heart valve damage in Parkinsonism patients treated with ergot-derived dopamine-receptor agonists.
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 ...
... 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 ... and to compel health care institutions to report all serious adverse drug reactions to Health Canada. It also, amongst other ... "Better documentation of adverse drug reactions needed for new Bill C-17 to improve drug safety" (Press release). Canadian ...
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 ...
Adverse reactions to benzimidazole drugs, including injury to the small intestine and bone marrow, have been reported in ... The most common clinical signs associated with this disease involve the central nervous system, eyes, and kidneys. Most rabbits ... Polymerase chain reaction (PCR) has long been established as the standard technique for detection of microsporidia in humans, ... Unfortunately the elimination of spores from the central nervous system does not always result in resolution of clinical signs ...
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 ...
... 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 ...
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, ... "Safety Information and Adverse Event Reporting Program." It interacts with the FDA Adverse Event Reporting System (FAERS or ... "Adverse Event Reporting System (AERS) Database". "eHealthMe - Personalized drug monitoring". "FDAble: Search ...
... 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 ...
... investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices. Assess and authorise of ... As part of the European system of approval, the MHRA or other national bodies can be the rapporteur or co-rapporteur for any ... "Public Assessment Report for Pfizer/BioNTech COVID-19 vaccine" (PDF). MHRA. 11 December 2020. Retrieved 16 December 2020. " ... and for inadequately checking drug licensing data. The MHRA and the US Food and Drug Administration were criticised in the 2012 ...
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 reactions, diagnosis, procedures, medications, appointments, clinical note, birth records, immunisation, ... The report also raised doubt on the long-term financial sustainability of the system. The report suggested that, in the short ... A report titled "Improving Hong Kong's Healthcare System: Why and for Whom?" was published. While they suggested that Hong Kong ... The operation of the system and uses of data in the system are governed by the existing and a specific Electronic Health Record ...
Adverse drug reaction Artificial induction of immunity Eczema vacinatum[citation needed] Vaccine Adverse Event Reporting System ... 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 ...
... by the United States in the World Health Organization International System to Monitor and Report Adverse Reactions to Drugs." ... May 9 - In a statement, President Johnson says the Worldwide Drug Reaction Monitoring System "will be a vital health protection ... May 9, 1967) 214 - Statement by the President Upon Authorizing an Agreement for a Worldwide Drug Reaction Monitoring System. ( ... Delegating Authority in Connection With the Worldwide Drug Reaction Monitoring System. (May 9, 1967) 216 - Remarks at the ...
... adverse drug reaction reporting systems MeSH E05.337.800.200 - clinical trials, phase iv MeSH E05.393.183.250 - chromosome ... periodic acid-schiff reaction MeSH E05.200.500.620.670.660 - prussian blue reaction MeSH E05.200.500.620.670.770 - shadowing ( ... periodic acid-schiff reaction MeSH E05.200.750.600.670.660 - prussian blue reaction MeSH E05.200.750.600.670.770 - shadowing ( ... investigational new drug application MeSH E05.337.550.200 - drug screening assays, antitumor MeSH E05.337.550.200.800 - tumor ...
... 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 ...
... 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 - ... hospital medication systems MeSH N02.278.354.700 - product line management MeSH N02.278.388 - hospital units MeSH N02.278. ... clinical pharmacy information systems MeSH N02.421.668.556 - hospital pharmacy service MeSH N02.421.726 - preventive health ... hospital distribution systems MeSH N02.278.354.455 - hospital-patient relations MeSH N02.278.354.458 - hospital-physician ...
Hundreds more patients suffered nonfatal adverse reactions from this drug. This problem, while bringing unwanted attention to ... However, the Young Doctors Association (YDA) of Pakistan reports for death of 12 patients during the attack at hospital. ... Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems (Washington: National Academies Press, 2012), p. ... A problem that occurred in January 2012 at this institution showed a problem with drug packaging. That month more than 100 ...
Common adverse drug reactions associated with daptomycin therapy include: Cardiovascular: low blood pressure, high blood ... injection site reactions, fever, hypersensitivity Less common, but serious adverse events reported in the literature include ... U.S. Food and Drug Administration. Klasco RK, ed. (2006). "Daptomycin". Drugdex System. 129. Greenwood Village (CO): Thomson ... Food and Drug Administration (FDA) approval in September 2003, for use in people older than 18 years, began marketing the drug ...
This class of drugs is usually well tolerated. Common adverse drug reactions (ADRs) include: dizziness, headache, and/or ... In 2008, they were reported to have a remarkable negative association with Alzheimer's disease (AD). A retrospective analysis ... Mirabito Colafella, Katrina M.; Uijl, Estrellita; Jan Danser, A.H. (2019). "Interference With the Renin-Angiotensin System (RAS ... "Angiotensin FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs - Angiotensin ...
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 ... Parker V, Wong AH, Boon HS, Seeman MV (2001). "Adverse reactions to St John's Wort". Can J Psychiatry. 46 (1): 77-9. doi: ... This drug-metabolizing enzyme induction results in the increased metabolism of certain drugs, leading to decreased plasma ...
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 ...
Becquemont L (June 2009). "Pharmacogenomics of adverse drug reactions: practical applications and perspectives". ... from original report by AMA: [1]). "REPORT 2 OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH (A-12): Labeling of Bioengineered ... "Wiley Interdisciplinary Reviews: Systems Biology and Medicine. 2 (1): 3-22. doi:10.1002/wsbm.42. PMC 3894835. PMID 20836007.. ... doi:10.1093/embo-reports/kve142. PMC 1083956. PMID 11463731.. *^ Final Report of the PABE research project (December 2001). " ...
Adverse Drug Reactions Advisory Committee (February 2004). "Australian Adverse Drug Reactions Bulletin, Volume 23, Number 1". ... The most common adverse reactions are related to the liver with 32 reports. Other more commonly reported reactions include ... data from the Spanish pharmacovigilance system". Pharmacoepidemiol Drug Saf. 15 (4): 253-9. doi:10.1002/pds.1168. PMID 16294367 ... "High dose cyproterone and hepatotoxicity". Australian Adverse Drug Reactions Bulletin. 23 (1): 3. 2004. ISSN 1325-8540. High ...
... 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 v t e. ...
Phase III trials showed significant responses although many subjects had mild adverse reactions of bruising, swelling, pain, ... "Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of ... Structural or functional abnormalities of the biliary system result in an increase in bilirubin (jaundice) and in bile acids in ... They bind less specifically to some other receptors and have been reported to regulate the activity of certain enzymes [11] and ...
"The Commissioners believe and have repeatedly stated in this Report that our response should be to hold all systems of health ... d) No adverse effects - Standard treatment is replaced with "alternative" treatment, getting rid of adverse effects, but also ... De Smet, Peter A.G.M. (December 1997). "The Role of Plant-Derived Drugs and Herbal Medicines in Healthcare". Drugs. 54 (6): 801 ... Even low-risk medications such as antibiotics can have potential to cause life-threatening anaphylactic reactions in a very few ...
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 ...
No adverse fetal events have been reported from the topical use of dapsone.[150] If retinoids are used there is a high risk of ... "Drug Trials Snapshots: Aklief". U.S. Food and Drug Administration (FDA). 11 October 2019. Archived from the original on 19 ... C. acnes' ability to bind and activate a class of immune system receptors known as toll-like receptors (TLRs), especially TLR2 ... If the inflammatory reaction is severe, the follicle can break into the deeper layers of the dermis and subcutaneous tissue and ...
Serious adverse events, which can cause death and disability, include:[29] *Severe infusion reaction. ... Rituximab Information from the US Food and Drug Administration. *U.S. National Library of Medicine: Drug Information Portal - ... "Reports of Bowel Obstruction and Perforation with RITUXAN (rituximab)" (PDF). Roche Canada. 2006-11-10. Archived (PDF) from the ... Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system ...
... and found a serious cardiovascular adverse reaction rate of about 1 in 1500.[44] This study reported a cardiovascular-related ... Drug risks[edit]. Filgrastim is typically dosed in the 10 microgram/kg level for 4-5 days during the harvesting of stem cells. ... Operations/surgeries and other procedures of the blood and lymphatic system (ICD-9-CM V3 40-41, ICD-10-PCS 07) ... Adverse reactions during apheresis were experienced in 20 percent of women and 8 percent of men, these adverse events primarily ...
Allergic reactions to the drug are characterized by symptoms such as difficulty breathing, shortness of breath, or swelling of ... "Monitoring FDA MedWatch Reports: Signals for Dabigatran and Metoclopramide" (PDF). QuarterWatch. Institute for Safe Medication ... "The American Society of Health-System Pharmacists. Archived from the original on 21 December 2016. Retrieved 8 December 2016.. ... Adverse events are generally caused by incorrect dosing. Long-term suppression of TSH values below normal values will ...
A landmark report from the U.S. Surgeon General found that even the use of elaborate ventilation systems and smoking rooms fail ... Russia's reaction to tobacco was unique. While most countries banned tobacco upon its arrival, they legalized it shortly ... Drug Testing and Analysis. 11 (1): 140-156. doi:10.1002/dta.2471. hdl:10072/382912. PMID 30109771.. ... "an evaluation of the official hospitality sector data shows there has been no adverse economic effect from the introduction of ...
"Practice parameter: treatment of nervous system Lyme disease (an evidence-based review): report of the Quality Standards ... "Infection and Drug Resistance. 8: 119-128. doi:10.2147/IDR.S66739. PMC 4440423. PMID 26028977.. ... Polymerase chain reaction (PCR) tests for Lyme disease have also been developed to detect the genetic material (DNA) of the ... Transmission can occur across the placenta during pregnancy and as with a number of other spirochetal diseases, adverse ...
... adverse reactions appear to be more common following manipulation than mobilization.[139] The most frequently stated adverse ... A 2016 systematic review concludes that the level of reporting is unsuitable and unacceptable.[143] Reports of serious adverse ... another medical system based on magnetic healing and bonesetting; both systems were founded by charismatic midwesterners in ... American chiropractors found that a slight majority favored allowing them to write prescriptions for over-the-counter drugs.[37 ...
... has been reported to inhibit the oxidation of other molecules and hence is classified as an antioxidant.[17][20] ... In preliminary human studies, oral intake of quercetin in doses up to one gram per day over three months did not cause adverse ... "Inspections, Compliance, Enforcement, and Criminal Investigations, US Food and Drug Administration. Retrieved 29 November 2018. ... "cardiovascular system" (ID 1844), "mental state and performance" (ID 1845), and "liver, kidneys" (ID 1846) pursuant to Article ...
1971). Survey of working conditions: Final report on univariate and bivariate tables, Document No. 2916-0001. Washington, DC: U ... Siegrist, J. (1996). Adverse health effects of high-effort/low-reward conditions. Journal of Occupational Health Psychology, 1 ... DeQuattro, V., & Hamad, R. (1985). The role of stress and the sympathetic nervous system in hypertension and ischemic heart ... Fredrikson M., Sundin O., & Frankenhaeuser M. (1985). Cortisol excretion during the defence reaction in humans. Psychosomatic ...
In March and April, 11 cases were reported in China, the first appearance of the disease in Asia in recorded history.[44][45] ... Ribavirin and other antiviral drugs, as well as treatment with interferons, do not have a positive effect in patients.[18] ... From there, they reach the haemocoel (the blood system of mosquitoes) and from there the salivary glands. When the mosquito ... Barrett AD, Teuwen DE (June 2009). "Yellow fever vaccine - how does it work and why do rare cases of serious adverse events ...
... and reports of suicide or suicidal ideation have been reported as a rare adverse effect of moclobemide.[73] Overall, ... An update on drug interactions". Drug Saf. 14 (4): 219-27. doi:10.2165/00002018-199614040-00002. PMID 8713690.. ... 1998). "cAMP-dependent phosphorylation system after short and long-term administration of moclobemide". J Psychiatr Res. 32 (2 ... except that in doses of 400 mg or higher peripheral reaction time may be impaired.[68] Peripheral oedema has been associated ...
Phentermine/topiramate for weight reduction and treatment of adverse metabolic consequences in obesity. Drugs Today (Review). ... Obesity - Volume 1 - HCP 23-I, Third Report of session 2003-04. Report, together with formal minutes. London, UK: TSO (The ... Björntorp P. Do stress reactions cause abdominal obesity and comorbidities?. Obesity Reviews. 2001, 2 (2): 73-86. PMID 12119665 ... Obesity and workers' compensation: Results from the Duke Health and Safety Surveillance System. Arch. Intern. Med. (Research ...
Adverse effects. Allergic reactions to ginger generally result in a rash.[2] Although generally recognized as safe, ginger can ... including the anticoagulant drug warfarin[40] and the cardiovascular drug nifedipine.[2] ... Dry ginger is most popularly traded between Asian countries through a unique distribution system involving a network of small ... Interim Report". West Lafayette, IN. doi:10.5703/1288284313900.. Cite journal requires ,journal=. (help). ...
Drug testing and reporting of incidents[edit]. Poor practices on the part of drug compounders can result in contamination of ... were aware in 2002 that steroid treatments from the New England Compounding Center could cause adverse patient reactions.[22] ... the Board has been working to put a credentialing system in place. In 2011 the Pharmacy Board convened a Compounding Working ... The drug does not appear on the FDA list of drugs or categories of drugs that present "demonstrable difficulties" for ...
PediaSIM HPS also responds to drug administration with a unique Drug Recognition System that uses barcode technology. New ... Also labelled as "reaction,"[30][31][28] "defusing,"[23] "gather,"[29] and "identify what happened,"[14] the description phase ... With the help of a UCSD School of Medicine student, Computer Gaming World reported that Surgeon (1986) for the Apple Macintosh ... 225,000 deaths annually from medical error including 106,000 deaths due to "nonerror adverse events of medications"[47] ...
Report of the Hillsborough Independent Panel, p. 360, Section 2.12.161 *^ a b c d e f g h i Hillsborough Independent Panel (20 ... The system of ferrying injured from any location within the stadium to the CRP required a formal declaration to be made by ... Reactions. Condolences flooded in from across the world, led by the Queen. Other messages came from Pope John Paul II, US ... The adverse comments of two doctors regarding the emergency response appeared in the media. Their views were not "the maverick ...
Intravenous use has the most reported adverse reactions, including sudden death, but this may reflect greater use rather than ... Kwan AS, Barry C, McAllister IL, Constable I (2006). "Fluorescein angiography and adverse drug reactions revisited: the Lions ... to track water movement in groundwater to study water flow and observe areas of contamination or obstruction in these systems. ... The risk of an adverse reaction is 25 times higher if the person has had a prior adverse reaction.[19] The risk can be reduced ...
2012). Adverse Effects of Herbal Drugs. 3. Springer Science & Business Media. ISBN 978-3642603679. .. ... but its reported clinical benefits were modest and it has largely been superseded by the PDE5 inhibitor class of drugs. ... Rao MR, Palada MC, Becker BN (2013). "Medicinal and aromatic plants in agroforestry systems". In Nain PK, Rao MR, Buck LE (eds ... yohimbine via an enantioselective organocatalytic Pictet-Spengler reaction". The Journal of Organic Chemistry. 76 (21): 8907-12 ...
"Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated ... World Health Organization (2008). WHO Report on the Global Tobacco Epidemic 2008: The MPOWER Package (PDF). World Health ... Many health systems have difficulty ensuring appropriate identification, diagnosis and care of people with COPD; Britain's ... Singh S, Loke YK, Furberg CD (September 2008). "Inhaled anticholinergics and risk of major adverse cardiovascular events in ...
Several studies report that both aged persons and smokers are especially vulnerable to the adverse effects of inhalation injury ... Drugs that reduce the inflammatory response, promote healing of tissues, and prevent the onset of pulmonary edema or secondary ... Inhalation of high doses of this gas causes lesions in the larynx, trachea, and large bronchi with inflammatory reactions and ... Hydrogen sulfide is also a potent cellular toxin, blocking the cytochrome system and inhibiting cellular respiration. More ...
There are various medical conditions, other psychiatric conditions and drug abuse related reactions that may mimic the symptoms ... These criteria use the self-reported experiences of the person and reported abnormalities (unusual occurrences) in the behavior ... and that monitoring for adverse treatment effects continues. Regular monitoring for adverse effects is recommended. For most ... which addresses the whole family system of an individual, might reduce a return of symptoms or the need for hospitalizations ( ...
In a total of 5577 adverse reactions reported to the UK's MHRA up to 31 March 2017, the plurality (1207, or 22%) concerned ... David M, Hodak E, Lowe NJ (1988). "Adverse effects of retinoids". Medical Toxicology and Adverse Drug Experience. 3 (4): 273-88 ... Reproductive system and breast disorders *Sexual dysfunction, including erectile dysfunction and decreased libido ... Its isomer, tretinoin, is also an acne drug. The most common adverse effects are a transient worsening of acne (lasting 1-4 ...
The Hite Report. Twenty-three years later, in 1976, sexologist Shere Hite published a report on the sexual encounters of 3,019 ... The highest rate of transmission of HIV to lesbians is among women who participate in intravenous drug use or have sexual ... A third of the respondents believed disclosing their sexual history would result in a negative reaction, and 30% had received a ... Lesbians of color are often exposed to a range of adverse consequences, including microaggression, discrimination, menace, and ...
"Case Reports in Cardiology. 2014: 1-3. doi:10.1155/2014/265759. ISSN 2090-6404. PMC 4008350. PMID 24826308.. ... Allergic reaction to the dye or anesthesia used during the procedure. Swelling, bruising or bleeding at the generator site, ... The outer casing of pacemakers is so designed that it will rarely be rejected by the body's immune system. It is usually made ... The patient may be given a drug for relaxation before the surgery as well. An antibiotic is typically administered to prevent ...
"Canadian Adverse Reaction Newsletter. 12 (4). 2002.. *^ "Listing of Drugs Currently Regulated as New Drugs (The New Drugs List ... A few notable potential drug interactions are, but are not limited to: *Alcohol: It has been reported that combined use of ... Over centuries, kava has been used in the traditional medicine of the South Pacific Islands for central nervous system and ... Other adverse reactionsEdit. Adverse reactions may result from the poor quality of kava raw material used in the manufacturing ...
"Scientific Reports. Macmillan Publishers. 3. Bibcode:2013NatSR...3E2045R. doi:10.1038/srep02045.. *^ Jessica Shugart. " ... "Food and Drug Administration. Apr 5, 2010.. *^ Leung, R; Ho, A; Chan, J; Choy, D; Lai, CK (March 1997). "Royal jelly ... Bee venom is under laboratory and clinical research for its potential properties and uses in reducing risks for adverse events ... it may cause severe allergic reactions in some individuals.[51] Propolis is also used in wood finishes, and gives a ...
"Drugs@FDA: FDA Approved Drug Products". Archived from the original on 2014-08-13. Retrieved 2016-11-07. ... However, these may increase with severe kidney problems.[20] Pentamidine can remain in the system for as long as 8 months after ... "NebuPent, Pentam (pentamidine) dosing, indications, interactions, adverse effects, and more". Archived ... Eye discomfort, conjunctivitis, throat irritation, splenomegaly, Herxheimer reaction, electrolyte imbalances (e.g. hypocalcemia ...
Adverse drug event reporting: getting the message across. A systematic review of adverse drug event reporting systems. ... adverse drug reactions because the systems failed to reflect the clinical processes through which adverse drug reactions were ... Can reporting of adverse drug reactions create safer systems while improving health data?. Corinne Hohl, Joel R. Lexchin and ... Can reporting of adverse drug reactions create safer systems while improving health data? ...
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 ...
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 ...
The drug reaction dataset contains all "Medical Dictionary for Regulatory Activities" (MedDRA) terms coded for the adverse ... quality complaints and drug-related adverse events that were submitted to FDA (U.S. Food and Drug Administration) in 2018. ... The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, ... FDA Adverse Events Reporting System Drug Reaction 2018. The FDA Adverse Event Reporting System (FAERS) contains information on ...
Adverse drug reaction * Unplanned transfer from general care to intensive care * Unplanned transfer to another acute care ... 8 Some hospitals report hospital acquired infections to systems other than the adverse incident reporting system13; however, ... Review of patient safety incidents reported by routine reporting system. We inspected data on the routine adverse incident ... Fig 2 Group I patient safety incidents reported by case note review (CNR) and adverse incident reporting system (AIRS) ...
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), ...
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 ...
... 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 ...
Articles published between 1966 and 2010 were identified in MEDLINE using the key words adult, adverse drug reaction reportin … ... risk factors and genetic associations of drug allergy. ... Adverse Drug Reaction Reporting Systems * Ambulatory Care ... adverse drug reaction reporting systems, age factors, anaphylactoid, anaphylaxis, anaesthetics, antibiotics, child, drug ... Current epidemiological studies on adverse drug reactions (ADRs) have used different definitions for ADR-related terminology, ...
... to spontaneous reporting systems and to investigate whether there are differences between different types of ADRs. A systematic ... The purpose of this review was to estimate the extent of under-reporting of adverse drug reactions (ADRs) ... Under-reporting of adverse drug reactions : a systematic review Drug Saf. 2006;29(5):385-96. doi: 10.2165/00002018-200629050- ... The purpose of this review was to estimate the extent of under-reporting of adverse drug reactions (ADRs) to spontaneous ...
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]‎. ...
... 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 Reaction Reporting Systems * Aged * Antibodies, Monoclonal / adverse effects* * Antirheumatic Agents / adverse ... Methods: The FDA Adverse Event Reporting System, a passive monitoring system, was reviewed to identify all reports of adverse ... Six deaths were reported. Among patients for whom an indication for use was reported, there were 9 patients (64%) with RA and 5 ... All patients for whom information was reported were receiving concurrent immunosuppressant drugs. ...
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 ...
More accurate reporting of ADRs in children would result in safer use of drugs in such patients. ... Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the ... According to the Naranjo probability criteria, six ADRs were probably, and one possibly, related to the suspected drug. In ... Of the 752 patients enrolled, 86.2% were exposed to one or more drugs during hospitalization. The therapeutic class most ...
... thus transforming adverse events into adverse drug reactions, is a useful and necessary but complicated task. Objective proof ... of a causal relationship between a drug and a specific event is quite exceptional. ... Adverse Drug Reaction Reporting Systems. Causality*. Epidemiologic Methods. Humans. Product Surveillance, Postmarketing*. ... Identifying the adverse effects of drugs, thus transforming adverse events into adverse drug reactions, is a useful and ...
Other adverse drug reactions from post-marketing spontaneous reports.. The following adverse drug reactions have been derived ... Immune system disorders.. Anaphylactic reaction, serum sickness-like reaction.. Psychiatric disorders.. Anxiety and depressive ... Reporting suspected adverse effects.. Reporting suspected adverse reactions after registration of the medicinal product is ... Adverse Medicine Events Line (1300 134 237) Provides consumers with a way to report and discuss adverse experiences with ...
Additional Adverse Reactions Reported With Other Methylphenidate-Containing Products. The list below shows adverse reactions ... Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis. Metabolism and Nutrition Disorders: ... Adverse Reactions Reported With Ritalin And Ritalin-SR. Infections and Infestations: nasopharyngitis ... spontaneous reports, and literature. Because these reactions were reported voluntarily from a population of uncertain size, it ...
... drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. ... Table 3: Postmarketing Reports of Adverse Drug Reactions. Blood and Lymphatic System Disorders:. Leukopenia, neutropenia, ... Adverse Reactions Reported From Other Clinical Trials. In addition, the following adverse reactions were reported in ... Monitor for adverse reactions. Concomitant drug dose reduction may be necessary.. Zopiclonea. Monitor for adverse reactions. ...
Adverse effects Adverse Drug Reaction Reporting Systems; Immunization Stress Related Response; Vaccination ... Severe AE reports (N=39). Non-severe AE reports (N=426)*. Total reports (N=465)*. Reporting rate per year. ... Table 2 Number and reporting rates of adverse events following 4vHPV vaccination reported to the Adverse Events Following ... the National AEFI Information System was in process of transitioning to an online reporting system. At the time the old system ...
... adverse events are frequently due not to medications but to the patients underlying conditions. Mining to detect ADRs from EHR ... are an important source of data for detection of adverse drug reactions (ADRs). However, ... Adverse Drug Reaction Reporting Systems / organization & administration*. Agranulocytosis / chemically induced. Drug Toxicity ... are an important source of data for detection of adverse drug reactions (ADRs). However, adverse events are frequently due not ...
Adverse Drug Reaction Advision Committee (ADRAC): ADRS Report 9. Australian Adverse Drug Reaction System. Department of Health ... Adverse Drug Reaction Advision Committee (ADRAC): ADRS Report 9. Australian Adverse Drug Reaction System. Department of Health ... Australian Adverse Drug Reactions Bulletin Vol 15, No. 2 ; May 1996: 1 4. ... Australian Adverse Drug Reactions Bulletin Vol 15, No. 2 ; May 1996: 1 4. ...
  • According to National Drug Authority, "There are still various delays in the ADRs reporting system in Uganda", because the current system of reporting ADRs in Uganda is paper based spontaneous reporting, this is rather a slow system, uses a lot of human labour, does not enforce confidentiality and security of information. (
  • Current epidemiological studies on adverse drug reactions (ADRs) have used different definitions for ADR-related terminology, often do not differentiate immunologically and non-immunologically mediated drug hypersensitivity, study different study populations (different ethnicities, inpatients or outpatients, adults or children), utilize different methodologies (spontaneous vs. non-spontaneous reporting, cohort vs. case-control studies), different methods of assessing drug imputability and different methods of data analyses. (
  • The purpose of this review was to estimate the extent of under-reporting of adverse drug reactions (ADRs) to spontaneous reporting systems and to investigate whether there are differences between different types of ADRs. (
  • These were expressed as the percentage of ADRs detected from intensive data collection that were not reported to the relevant local, regional or national spontaneous reporting systems. (
  • Five of the ten general practice studies provided evidence of a higher median under-reporting rate for all ADRs compared with more serious or severe ADRs (95% and 80%, respectively). (
  • This systematic review provides evidence of significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs. (
  • A mobile app may increase the reporting of adverse drug reactions (ADRs) and improve the communication of new drug safety information. (
  • Identified factors that may influence the use of the app were the type of feedback given on reported ADRs, how ADR reports are stored and the type of drug news. (
  • Previously, ADRs were primarily reported by healthcare professionals (HCPs). (
  • A major limitation of spontaneous reporting, however, is that many ADRs go unreported. (
  • In the past, reporting of adverse drug reactions (ADRs) to the national agency could only be completed by healthcare professionals. (
  • The use of a list to select ADRs in an online report form could thus reduce the time needed for assessors to code reported ADRs and could ease the process of reporting an ADR. (
  • Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. (
  • According to the Naranjo probability criteria, six ADRs were probably, and one possibly, related to the suspected drug. (
  • In conclusion, this study reveals that ADRs may be under-reported in children hospitalized in the Campania Region. (
  • More accurate reporting of ADRs in children would result in safer use of drugs in such patients. (
  • Electronic health records (EHRs) are an important source of data for detection of adverse drug reactions (ADRs). (
  • Conclusion: Consumer reporting may be important for developing countries to implement a proper and effective pharmacovigilance program that can reduce morbidity and mortality rates, as well as reducing the economic burden of ADRs. (
  • The ICSRs were retrieved from the SafetyWatch System and descriptive statistics used to describe the ADRs by System Organ Classification and Pre- ferred Term. (
  • A strong spontaneous system with the availability of focal persons at the Treatment Centres played a key role in reporting ADRs during the pandemic. (
  • The pro- file of most of the ADRs reported appears consistent with what is expected from the summary of product character- istics. (
  • We collected reports of ADRs connected with mood or emotional symptoms in pediatric patients, excluding drug abuse/accidents. (
  • In March 2007, a legislative amendment was issued in Sweden compelling nurses to report all suspected adverse drug reactions (ADRs) to the national pharmacovigilance system. (
  • The aims of this study were to describe the status of ADR reporting, before and after the implementation of the legislative changes, and to describe the general characteristics of suspected ADRs reported by nurses. (
  • Nurses reporting of serious ADRs was 3 % (seven reports) in 2005 and 7 % (17 reports) in 2010 with reporting of unlabelled ADRs at 4 % (11 reports) in 2005 and 17 % (45 reports) in 2010. (
  • The proportion of serious and/or unlabelled ADRs reported by nurses did however appear to increase during the same period. (
  • Taken together, our data suggests that further pro-active measures should be considered in order to involve nurses in the reporting of suspected ADRs. (
  • Adverse drug reactions (ADRs) are a major burden for patients and the healthcare industry. (
  • Spontaneous reporting systems (SRSs) have been the cornerstone in pharmacovigilance for a long time, and are effective at detecting many types of ADRs. (
  • In addition, 27 ADRs have been reported from hospital physicians. (
  • As an example, figures are given for agranulocytosis (N 30): 28 (93%) ADRs were reported (26 reports from FAKOS and two from hospital doctors). (
  • The current study aims to assess Yemeni pharmacists' knowledge, attitude and practice of adverse drug reactions (ADRs) reporting systems and to determine barriers hindering them from reporting. (
  • In terms of knowledge, 156 (96.3%) were not aware of the existence of ADRs reporting system in Yemen. (
  • Concerning practice, about (140, 87.0%) of pharmacists disclosed that patients reported at least one ADRs annually. (
  • Insufficient clinical knowledge of pharmacist, unavailability of ADRs reporting form and unawareness of existence of the national ADRs reporting system were noticed to be the main barriers towards ADRs reporting. (
  • Most of pharmacists were unaware of the ADRs reporting system in Yemen. (
  • However, advertising, education and intensive training are needed to improve awareness and to ensure an effective ADRs reporting process. (
  • To study the reports of adverse drug reactions (ADRs) in children using antihistamines to provide prescribers with an overview of the possible toxicity. (
  • We studied ADRs in children reported to the Netherlands Pharmacovigilance Centre Lareb in the years 1991-2014, assessed the Naranjo score and, when possible, computed the reporting OR. (
  • Skin eruptions, headache and somnolence were the most frequently reported ADRs. (
  • Background: Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income. (
  • Objective: The aim of the study was to characterize ADRs reported to the WHO-ADR database, VigiBase (TM), and to relate data to national income. (
  • Results: We analysed 1 359 067 ADR reports including 3 013 074 ADRs. (
  • Overall, the majority of ADRs were reported for nervous system medications, followed by cardiovascular medicines. (
  • Low-income countries reported relatively more ADRs for antiinfectives for systemic use than high-income countries, and high-income countries reported more ADRs for antineoplastic and immunomodulating agents than lower-income groups. (
  • Significant differences in ADR reporting rates were only found for ADRs of the type skin and subcutaneous tissue disorders and for the therapeutic groups antiinfectives for systemic use and antineoplastic and immunomodulation agents. (
  • HCQ could increase the CT improvement and adverse reactions (ADRs) significantly though there was considerable heterogeneity among current researches. (
  • It is a World Health Organization (WHO) recommended scheme which has been in practice in many developed and developing countries to prevent adverse drug reactions (ADRs). (
  • These committees will create awareness for reporting serious ADRs within hospital, meet regularly to discuss and scrutinise each ADR report received and will forward it to the provincial PV Centre, health directorate Lahore for necessary action. (
  • Globally, adverse drug reactions (ADRs), one of the leading causes of morbidity and mortality, will continue to pose a threat to public health as long as drugs are being used to treat various ailments. (
  • 6 Similarly, medical-record review using trigger methods has low sensitivity for the identification of adverse drug reactions. (
  • Bericht über die Tagung Unerwünschte Arzneimittelwirkungen Erfassungsmethoden und Bewertung = Report on the Meeting on Methods for the Detection and Study of Unwanted Drug Effects, Kiel, 26. (
  • Report on the Meeting on Methods for the Detection and Study of Unwanted Drug Effects. (
  • proportion and type of patient safety incidents missed by routine incident reporting and case note review methods. (
  • 270 (83%) patient safety incidents were identified by case note review only, 21 (7%) by the routine reporting system only, and 33 (10%) by both methods. (
  • The median under-reporting rate was calculated across all studies and within subcategories of studies using different methods or settings. (
  • Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. (
  • Detection of pharmacovigilance-related adverse events using electronic health records and automated methods. (
  • RESEARCH DESIGN AND METHODS Case/noncase bladder cancer reports associated with antidiabetic drug use were retrieved from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) between 2004 and 2009 and analyzed by the reporting odds ratio (ROR). (
  • We have developed a novel method, the BInary Characteristics Extractor and biomedical Properties Predictor (BICEPP), to classify properties (characteristics) of drugs (scientific entities) and subsequently validated this approach on data collected from traditional analytical methods derived from the knowledge of field experts (a therapeutic drug reference and a drug interaction database). (
  • However, there is clearly room for technical improvement with regard to computational drug safety surveillance methods. (
  • This manuscript investigates and describes a strategy for achieving controlled delivery of corticosteroids, based on a discovery that low molecular weight corticosteroid dimers can be processed into drug delivery implant materials using a broad range of established fabrication methods, without the use of polymers or excipients. (
  • Methods: We analysed ADR reports submitted to VigiBase (TM) from 2000 to 2009 with respect to reporting rate, age and sex of patient, type, seriousness and medications. (
  • Concise, authoritative aid to drug decision-making and an essential publication for pharmacists and physicians who need to make formulary and prescribing decisions. (
  • A qualitative exploration of knowledge, attitudes and practices of hospital pharmacists towards adverse drug reaction reporting system in Lahore, Pakistan. (
  • Due to continual change in the healthcare environment, pharmacists will need to develop adaptive practices and systems in order to advance patient care. (
  • In addition, student pharmacists will gain skills to evaluate drug information resources, systematically approach drug information requests, communicate health information and create a drug monograph. (
  • The aim of this narrative review was to highlight the role of pharmacists in pharmacovigilance and to identify barriers and facilitators toward ADR reporting documented in the literature. (
  • In future research should be done on the attitudes of healthcare providers towards reporting adverse drug reactions. (
  • Hot topics in adverse drug reactions and drug interactions. (
  • Increased plasma concentrations of some of these drugs caused by coadministration with TOLSURA can lead to QT prolongation and/or ventricular tachyarrhythmias, including occurrences of torsades de pointes, a potentially fatal arrhythmia [see CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS ]. (
  • DRUG INTERACTIONS for more information. (
  • 2005). The current emphasis in developing alert systems is on assessing drug interactions rather than adverse drug reactions. (
  • He is thinking of adverse drug interactions. (
  • It became obvious that with the pharmacy data and physician diagnoses entering the computer, we could monitor for drug-drug interactions," Dr. Collen recalled. (
  • To demonstrate its applicability, we evaluated the performance of BICEPP on many drug characteristics, including therapeutic classes, adverse effects, and their potentials for pharmacokinetic drug-drug interactions. (
  • No adverse effects were noted, and her parents reported improved health-related quality of life, scholarly activities, and social interactions. (
  • COVID-19 was first reported in December 2019, and the pathogen was firstly isolated on January 7th, 2020 and then named SARS-CoV-2 by International Committee on Taxonomy of Viruses (ICTV), as it shares great similarity in genomics with the previous emerged SARS-CoV. (
  • Heart disease -Use of omega-3 supplements among adults aged 55 and over diagnosed with coronary heart disease could reduce annual hospital costs by more than $2 billion on average, saving the health care system close to $16.5 billion between 2013 and 2020. (
  • Use of vitamins B6 and B12 among the target population could reduce hospital costs by an average of more than $1.5 billion annually, saving the health care system more than $12.1 billion between 2013 and 2020. (
  • The aim of this review was to describe the current evidence-based knowledge of the epidemiology, prevalence, incidence, risk factors and genetic associations of drug allergy. (
  • His work concerning the characterization, epidemiology, and prevention of adverse drug events is widely cited. (
  • The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to FDA (U.S. Food and Drug Administration) in 2018. (
  • For example, in 2018, Amazon formed an alliance with Perrigo, an over-the-counter drug manufacturer, and acquired PillPack, a pharmacy: moves that marked the e-commerce giant's dramatic entry into the health care market. (
  • The final area Dr. Trontell discussed was outcome-based surveillance of selected health outcomes that are often associated with drug toxicity. (
  • The main toxicity relates to skin eruptions and central nervous system problems. (
  • This audit examined all the studies used in determining the human food safety of rbGH, including the 90-day rat oral toxicity study and the report of the antibody response to oral rbGH upon which the Canadian reviewers relied. (
  • Because of these limitations, determining causal associations between vaccines and adverse events from VAERS reports is usually not possible. (
  • As a national public health surveillance system, VAERS is a key component in ensuring the safety of vaccines. (
  • Although HHE has been less frequently reported to VAERS after increased use of DTaP, HHE does occur after the administration of DTaP and other nonpertussis-containing vaccines. (
  • This system captures prescription and over-the-counter medications, vaccines, vitamins, and nutritional supplements. (
  • VAERS is a post-marketing safety surveillance program, collecting information about adverse events that occur after the administration of US licensed vaccines. (
  • The prime function of this initiative is the reporting of suspected adverse reactions of medicines and vaccines besides unregistered and alternate medicines used in herbal, unani and ayurvedic treatments. (
  • Vaccines are the worst, for adverse reactions, just by their nature - because you are stimulating the immune system. (
  • Today, surveillance exists for many infectious and chronic diseases, injuries, adverse reactions to drugs and vaccines, behavioral risk factors, and animal diseases. (
  • Hypersensitivity reactions and true anaphylaxis are indeed rare with a greater understanding of the nature of labile iron and 'Fishbane' reactions. (
  • There are four types of hypersensitivity, including immediate anaphylactic reaction, and hives can be part of that, along with swelling that shuts off the airways. (
  • We conducted a retrospective, descriptive study of the adverse events that took place after HPV vaccination, reported to the Adverse Events Following Immunization (AEFI) Information System in Sao Paulo State, from March 2014 to December 2016. (
  • Most adverse events following immunization (AEFI) were mild and moderate, mainly injection site reactions such as pain and swelling. (
  • The 3 children reported as not returning to their prevaccination state all had VAERS reports submitted after they developed conditions (autism, complex partial epilepsy, and developmental delays with infantile spasms) that are not known to be causally associated with immunization. (
  • A hypotonic-hyporesponsive episode (HHE) is an adverse event after childhood immunization, usually with a pertussis-containing vaccine. (
  • Administration of calcitonin-salmon has been reported in a few cases to cause serious allergic-type reactions (e.g., bronchospasm, swelling of the tongue or throat, and anaphylactic shock), and in one case, death attributed to anaphylaxis (with injection, no serious allergic-type adverse reactions have been reported with the nasal spray). (
  • In a few cases the injection caused serious allergic-type reactions such as bronchospasm, swelling of the tongue or throat, and anaphylactic shock, and in one case, death attributed to anaphylaxis. (
  • Dr. Trisha Dowling, professor, veterinary clinical pharmacology at the Western College of Veterinary Medicine, and co-director of Canadian gFARAD (a global food animal residue avoidance database), says the worst type of reaction is anaphylaxis. (
  • Lazarou, J., Pomeranz, B.H. and Corey, P.N. (1998) Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. (
  • i.e. 200/100 mg and 400/200 mg) had a similar incidence of adverse events as the comparator agents (Rubinstein, 1996). (
  • The incidence of phototoxicity associated with sparfloxacin appears to be higher than that observed with ciprofloxacin and ofloxacin but less than that reported for fleroxacin, pefloxacin, enoxacin and nalidixic acid. (
  • Where population denominators are known, incidence rates of diseases are reported. (
  • 3 If representative, these data suggest that each acute care hospital in Canada should be documenting and reporting thousands of adverse drug reactions each year to fulfill the goal of Bill C-17. (
  • Although large numbers of patients receive treatment in acute care hospitals for adverse drug reactions, few events are reported to Canada Vigilance (Health Canada's online and paper-based reporting platform that health care professionals and consumers are expected to access) even after they are recognized. (
  • Features, prevention and management of acute overdose due to antidiabetic drugs. (
  • ADEs reported by the Australian Incident Monitoring System 5 (mostly from the acute care sector), and community-based research by Roughead et al, 6 have shed some light on the problem. (
  • When the product is a drug or medical device, it is especially serious since the possibility of personal injury (acute and/or chronic) or death may occur. (
  • On rare occasions, however, the animal may develop an acute allergic reaction to a foreign substance. (
  • Further work is required to assess the impact of under-reporting on public health decisions and the effects of initiatives to improve reporting such as internet reporting, pharmacist/nurse reporting and direct patient reporting as well as improved education and training of healthcare professionals. (
  • Objective of this study is to describe the pattern of stimulated spontaneous adverse drug reaction (ADR) reports received from healthcare professionals for SARS-CoV-2 positive patients in Ghana and lessons learnt partic- ularly for low- and middle-income countries. (
  • We conducted a database study in which we reviewed the list's use for all reported adverse drug reactions by patients and consumers to the pharmacovigilance centre in the UK via the online report form between August and September 2017. (
  • The primary objective of this report is to provide the annual numbers and trends of adverse drug reaction case reports and medical device incident reports to Health Canada between 2008 and 2017. (
  • More than 64,000 unique domestic AR case reports were submitted to Canada Vigilance in 2017, with 6.5% of those adverse drug events resulting in patient deaths and nearly 20% resulting in patient hospitalisation. (
  • The total number of domestic AR cases reported to Health Canada has continued to increase annually from 15,551 in 2008 to 64,617 in 2017. (
  • More than 11,000 MDI reports were submitted to Health Canada in 2017. (
  • The total number of reports has continued to increase annually from 4,008 in 2008 to 11,307 in 2017. (
  • Following the switch to simplified reporting on 22 November 2017, marketing authorisation holders no longer receive ICSRs directly from NCAs. (
  • By modulating spatiotemporal distribution of drugs in the body, these systems minimize systemic side effects, reduce drug loading requirements, and more efficiently target tissue sites. (
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. (
  • ProFeno is a nonsteroidal, anti-inflammatory, antiarthritic drug. (
  • ProFeno is a nonsteroidal, anti-inflammatory, antiarthritic drug that also possesses analgesic and antipyretic activities. (
  • Titchen, T., Cranswick, N. and Beggs, S. (2005) Adverse drug reactions to nonsteroidal anti-inflammatory drugs, COX-2 inhibitors and paracetamol in a paediatric hospital. (
  • There are more serious reactions reported for nonsteroidal anti-inflammatory drugs like ibuprofen or asp rin than for any other drugs, including antipsychotics and benzodiazepines (like Valium). (
  • Can reporting of adverse drug reactions create safer systems while improving health data? (
  • 2 Data from the United States have confirmed that adverse drug reactions are among the most common admitting diagnoses. (
  • 5 Although administrative datasets are invaluable in providing population-level data to answer some questions about drug safety and effectiveness, only a fraction of adverse drug reactions are identifiable within them unless broad coding algorithms are used that have low specificity. (
  • 8 Clinicians never chose to document reactions within paper or electronic systems that requested voluminous (and often duplicate) data unless those data could support immediate and short-term patient safety goals by allowing the retrieval of meaningful patient-level data to inform care. (
  • System design was carried out by use of Data Flow Diagrams (DFDs) and Entity Relation Diagrams (ERDs)in order to model the system processes and entities. (
  • It was able to meet the requirements specifications and address the loopholes of the previous system such as data confidentiality and security. (
  • Design Two stage retrospective review of patients' case notes and analysis of data submitted to the routine incident reporting system on the same patients. (
  • 8 9 The system should, therefore, be able to identify a representative sample of patient safety incidents and provide adequate data about the cause, contributory factors, preventability, and impact of these incidents. (
  • The study consisted of using structured data extraction tools to do a two stage retrospective case note review of the sample admissions and reviewing the patient safety incidents reported by the routine hospital reporting system for the same admissions. (
  • VAERS) are subject to multiple limitations, including underreporting, reporting of temporal associations or unconfirmed diagnoses, and lack of denominator data and unbiased comparison groups. (
  • Examples of the uses of VAERS data for vaccine safety surveillance are included in this report. (
  • Estimates of under-reporting were either extracted directly from the published study or calculated from the study data. (
  • Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the limited number of trials performed in the paediatric population. (
  • Methodological framework to identify possible adverse drug reactions using population-based administrative data. (
  • A document listing the mandatory and optional data elements required to support the collection of comprehensive pan-Canadian oncology drug data. (
  • These data tables examine the number and types of drugs prescribed and potentially inappropriate drug use among seniors in Canada. (
  • We review the definition and requisite claims needed to establish drug product liability, and the role that the medical literature, clinical trial data, and even experimental research data can play in product (drug)-injury litigation. (
  • A ctive surveillance systems screen claims data and notify healthcare providers who then determine if follow-up or adverse event reporting is required. (
  • Analysis of claims data is required to examine suspected new adverse events or modulation in the frequency of common events. (
  • Workshop participants discussed types of surveillance systems, current technology used by these systems, and challenges in obtaining quality data. (
  • data from the US Food and Drug Administration Adverse Event Reporting System pharmacovigilance database, focused on methylphenidate , atomoxetine, amphetamine, lisdexamfetamine, and their derivatives. (
  • Reported data from Canada do not focus on childhood tuberculosis or capture key epidemiologic, clinical and microbiologic details. (
  • Data were entered into an automated system using punch cards read by computers. (
  • The large amounts of clinical data generated by electronic health record systems are an underutilized resource, which, if tapped, has enormous potential to improve health care. (
  • De stora mängder kliniska data som genereras i patientjournalsystem är en underutnyttjad resurs med en enorm potential att förbättra hälso- och sjukvården. (
  • To augment the current systems, there are new ways to conduct pharmacovigilance using expanded data sources including data from electronic health records (EHRs), scientific literature and social media. (
  • BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting data has been used for safety of post-market drug surveillance. (
  • The data are based on reports submitted to Health Canada through Canada Vigilance, the MDS, and CMDSNet. (
  • In some cases, the reported clinical data is incomplete and there is no certainty that the health product caused the reported reaction. (
  • However, this report does provide a data snapshot that highlights serious and non-serious reports received for descriptive purposes. (
  • The FDA collects data on every adverse reaction to prescription drugs reported by pharmaceutical companies, doctors, and the general public. (
  • In this data release, the FDA includes the more than 3.6 million reports the agency received between 2004 and 2013. (
  • Crucially, that means these must be interpreted as a tally of reported drug reactions, not actual drug reactions, which would be impossible to measure without more thorough data collection and validation. (
  • It's hard to say whether drugs are being used as recommended, or if important data is going unreported. (
  • 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. (
  • AERS, the Adverse Event Reporting System ( ) is a data base of drug adverse reactions reported by health professionals and others. (
  • Analyses of AERS and VAERS data must confront several difficulties including adverse event recognition, underreporting, biases, estimation of population exposure, report quality, and, most importantly, no denominator or control group of persons not taking the medication. (
  • develop semi-automatic systems to generate queries based on dynamically changing data, indicating developing epidemiological trends. (
  • On November 5, 1993, following extensive review of the data to support the safety and effectiveness of the product, the Food and Drug Administration (FDA or Agency) approved the Monsanto Companys New Animal Drug Application for Posilac containing a recombinant bovine growth hormone (rbGH) (also known as recombinant bovine somatotropin, rbST, or Sometribove). (
  • With the wider availability of the Internet , many developed countries have implemented automated systems for the exchange, mapping, and analysis of surveillance data. (
  • Surveillance data have the same value to health departments and other interested groups (such as drug companies) as financial data do to commercial enterprises. (
  • Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. (
  • Based on a process that routinely extracts, transforms and loads data (ETL process), the EDBMS is the data source for the EudraVigilance data analysis system (EVDAS). (
  • The cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events. (
  • The system contains all reports of adverse drug events spontaneously reported by health care professionals, manufacturers, and consumers from the U.S. and serious and unlabeled spontaneous reports from non-U.S. countries. (
  • Moore, T.J., Weiss, S.R., Kaplan, S. and Blaisdell, C.J. (2002) Reported adverse drug events in infants and children under 2 years of age. (
  • Clarkson, A. and Choonara, I. (2002) Surveillance for fatal suspected adverse drug reactions in the UK. (
  • In Australia, reporting rates by general practitioners to the Adverse Drug Reactions Advisory Committee of the Therapeutic Goods Administration (TGA) fell from 3314 in 2002 to 2075 in 2004 (Dr P Purcell, Medical Officer, Adverse Drug Reactions Unit, TGA, personal communication). (
  • Chloroquine (CQ) is an old anti-malarial drug with good tolerability, which had proved to be effective in previous SARS-coronavirus, which spread and disappeared between 2002-2003. (
  • FDA has completed a comprehensive, page by page audit of the human food safety sections of the investigational new animal drug file and master file supporting the rbGH approval. (
  • The study was conducted by a Searle laboratory of Monsanto and submitted to FDA pursuant to FDA's requirement that all relevant safety information for an investigational new animal drug be included in the sponsor's application. (
  • Medication errors related to transdermal opioid patches: lessons from a regional incident reporting system. (
  • Medication Errors: Improving Practices and Patient Safety," "Detecting and Managing Adverse Drug Reactions," "Overview of Risk Evaluation and Mitigation Systems (REMS)," "Special Dosing Considerations," and "Educating Patients About Safe Medication Use" comprise the safe medication use articles and provide an overview of the medication safety issues that confront practitioners and patients. (
  • Leading off this series, the medication errors article familiarizes you with the systems issues and clinical situations repeatedly implicated in medication errors and suggests practical means to avoid them. (
  • Medication errors are caused by multiple factors related to health providers, consumers and health system, but most prescribing errors are preventable. (
  • The paper reviews the etiology, prevention strategies, reporting mechanisms and the myriad consequences of medication errors. (
  • On Nov. 6, 2014, the Canadian government passed Bill C-17 (Vanessa's Law), aimed at strengthening the powers of government to recall a drug that is shown to have harmful effects. (
  • Identifying the adverse effects of drugs, thus transforming adverse events into adverse drug reactions, is a useful and necessary but complicated task. (
  • The search for casualty in pharmacovigilance is a necessary scientific goal, but a high degree of suspicion may be all that is necessary to withdraw a drug from the market if it is suspected of causing serious adverse effects. (
  • Our Ritalin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. (
  • You may report side effects to FDA at 1-800-FDA-1088. (
  • Amoxicillin clavulanic acid (A-C) may induce severe adverse effects. (
  • A-C may induce severe adverse effects and death in patients of different age, especially if they are on multidrug regimens. (
  • Effects are usually reversible upon removal of the drug. (
  • The case definition excludes drug withdrawal, drug abuse, self-harm attempts, lack of therapeutic effect, and effects of medications administered in the emergency department. (
  • Irritable Bowel Syndrome drugs are symptom-specific to some side effects such as Wendy used to entice her husband loss of appetite, insomnia or problems underlying brain-gut dysfunction of IBS. (
  • The more common side effects reported when taking Venlor XR capsules 75mg robustness services examination is of the the physiological up predominantly of the. (
  • There are not many more deaths reported in men than in women - women are just even likelier to report other side effects. (
  • This could mean that men experience fewer other side effects, but it could also mean that adverse side effects that affect men are less likely to be reported. (
  • Only two reports of adverse effects of a drug user have thus far been reported. (
  • Most of these effects are thought to result from a facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system. (
  • We have then summarized pharmacological considerations for these drugs so as to provide to the busy clinicians to avoid potential side effects when administered CQ or its analogs to COVID-19 patients, especially in the elderly, pediatrics, and pregnancies. (
  • On the other hand, other studies have shown that those drugs are to be beneficial in the treatment of non-neuropathic pain and improves the analgesic efficacy of opioids both at rest and in movement, reduces analgesic consumption and opioid-related adverse effects. (
  • This analysis, based in large part on a 90-day rat study, challenges the Agency's human health findings and argues that possible adverse health effects of Posilac were not addressed because long term toxicology studies to ascertain human health safety were not required by FDA or conducted by Monsanto. (
  • In the large PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events) study, 14 bladder cancers occurred in the pioglitazone arm (0.5%) versus 6 in the placebo arm (0.2%) ( 2 , 3 ), and in September 2010, the U.S. Food and Drug Administration (FDA) announced an ongoing investigation on the possible risk in humans ( 4 ). (
  • Potentially life-threatening severe cutaneous adverse reactions (SCAR) are associated with a high risk of morbidity and mortality. (
  • Overall, 39 AEFI cases (8.4%) were classified as severe , with a reporting rate of 1.15 per 100,000 vaccine doses administered. (
  • The condition, which is mostly associated with severe arterial hypertension, has also been reported to be induced by several medications. (
  • If the patient responds with severe allergic reactions during the up-dosing phase, it is possible that the highest recommended dose of 100 000 SQ-U is not reached. (
  • The frequency of events and the timing of the event associated with a particular drug will impact the surveillance system's detection ability (Brewer and Colditz, 1999). (
  • In patients with rheumatoid arthritis and osteoarthritis, clinical studies have shown ProFeno to be comparable to aspirin in controlling the aforementioned measures of disease activity, but mild gastrointestinal reactions (nausea, dyspepsia) and tinnitus occurred less frequently in patients treated with ProFeno than in aspirin-treated patients. (
  • Five of these adverse drug reactions (i.e. nausea, diarrhoea, dizziness, insomnia and constipation) were reported significantly more often in reports where the adverse drug reactions were selected from the patient-friendly terms list. (
  • Women, on the other hand, report nausea most frequently, and make more reports in general. (
  • Injection: The injection form of calcitonin-salmon caused nausea with or without vomiting and local inflammatory reactions at the injection site in 10% of patients. (
  • The following adverse reactions associated with the use of all Ritalin, Ritalin-SR, and other methylphenidate products were identified in clinical trials, spontaneous reports, and literature. (
  • Adverse Drug Reactions Related to Mood and Emotion in Pediatric Patients Treated for Attention Deficit/Hyperactivity Disorder: A Comparative Analysis of the US Food and Drug Administration Adverse Event Reporting System Database. (
  • A Comparative Analysis of the US Food and Drug Administration Adverse Event Reporting System Database. (
  • WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. (
  • In the online report form of the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK (i.e. the Yellow Card scheme) [ 8 ], individuals can also select ADR terms from a list that appears after a few letters are entered in addition to having a free-text field to describe their experience. (
  • [5] It is on the World Health Organization's List of Essential Medicines , the most effective and safe medicines needed in a health system . (
  • Whereas the U.S. Food and Drug Administration and the European Medicines Agency routinely publish details of post-market safety reviews of drugs as a basic accountability measure, Canada refuses, citing "confidential business information. (
  • Evaluation experiments were performed to validate BICEPP's performance on 484 characteristics of 857 drugs, identified from the Australian Medicines Handbook (AMH) and the PharmacoKinetic Interaction Screening (PKIS) database. (
  • EudraVigilance is a system for monitoring the safety of medicines. (
  • Antibiotics (44.0%), radiocontrast media (15.1%), and non-steroidal anti-inflammatory drugs (NSAIDs) (14.3%) were the most commonly implicated drugs. (
  • The most commonly used adverse drug reaction (ADR) reporting system worldwide is spontaneous and voluntary reporting, which forms the backbone of reporting systems. (
  • Diane-35 is a controversial acne drug that physicians commonly prescribe off-label as a contraceptive. (
  • Death is the most commonly reported bad reaction to prescription drugs in men, according to information from a newly released Food and Drug Administration database. (
  • We applied the Naranjo Adverse Drug Reaction Probability Scale and the World Health Organization-Uppsala Monitoring Centre system for causality assessment to the present case. (
  • Objective To evaluate the performance of a routine incident reporting system in identifying patient safety incidents. (
  • The objective of this study was to evaluate the actual use of the patient-friendly terms list in the adverse drug reaction report form and its association with the type of adverse drug reactions reported. (
  • Objective proof of a causal relationship between a drug and a specific event is quite exceptional. (
  • OBJECTIVE To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications. (
  • The application of distributional semantics in the clinical domain is here demonstrated in three use cases: (1) synonym extraction of medical terms, (2) assignment of diagnosis codes and (3) identification of adverse drug reactions. (
  • Do not take TAMSIL if you have ever had an allergic reaction to terbinafine, the active ingredient, or to any of the other ingredients listed at the end of this leaflet. (
  • Penicillin is the most notorious for allergic reactions. (
  • The choice of up-dosing schedule depends on the patient's sensitivity since the risk of developing allergic reactions is reduced with a slow up-dosing. (
  • A Novel System to Diagnose Cutaneous Adverse Drug Reactions Employing the Cellscan-Comparison with Histamine Releasing Test and Inf-γ Releasing Test," Clinical and Developmental Immunology , vol. 12, no. 1, pp. 85-90, 2005. (
  • Adverse cutaneous drug reactions (ACDRs) are common and are responsible for increased morbidity, mortality, and socioeconomic costs. (
  • People reporting adverse drug reactions to a pharmacovigilance centre more often describe their experiences using free text rather than by selecting a term from a list. (
  • Despite establishment of a pharmacovigilance centre, no reports have been released by the centre. (
  • In a prospective study published in 2008, 5% of emergency department visits to one Canadian tertiary care centre were due to adverse drug reactions. (
  • 29. November 1990 / Institut für Gesundheits-System-Forschung, Kiel, Gemeinnützige Stiftung, WHO Collaborating Centre for Public Health Research. (
  • Safety information should not be confidential," said Barbara Mintzes, an assistant professor with the Therapeutics Initiative , a research centre at the University of British Columbia that conducts reviews of new drugs. (
  • The committee proposed establishment of adverse reaction reporting system, drug information and poison control centre and pharmacy services in the state-run hospitals. (
  • Drug Information and Poison Control Centre and PV Centre will be established in each hospital. (
  • Reports accepted by provincial PV Centre will be reported to the National PV Centre and WHO adverse drug reactions database at the Uppsala Monitoring Centre, Sweden. (
  • Every ward and OPD department will have ADR forms and on observing even will report immediately to the hospital's PV committee which on scrutinising the information and events will report to the provincial PV centre in Lahore. (
  • Pharmacy students' knowledge and perceptions about adverse drug reactions reporting and pharmacovigilance. (
  • To determine whether an rbGH product had biologically significant oral activity, the Agency required the drugs sponsor to perform short-term toxicology studies to assess whether biologically active rbGH was being absorbed into the body. (
  • According to qualitative research, many systems developed or used to support documentation of adverse drug reactions (e.g., computer-based patient-safety learning systems or paper-based forms) are poorly fitted to clinical practice, time-consuming to complete and not integrated into clinical processes. (
  • There was no significant difference in the median under-reporting rates calculated for general practice and hospital-based studies. (
  • Practice of HCPs on ADR-reporting in Nekemte town from January 2015 to June 2015. (
  • To investigate the frequency, cause, and severity of adverse drug events (ADEs) among general practice patients. (
  • 3 Both these truisms are even more relevant in the apparent black hole of patient-safety incident reporting in Australian general practice. (
  • In early 2001, the Australian Government Department of Health and Ageing, MediConnect section, commissioned the study reported here of patients attending general practice in Australia to establish a baseline measure of the current quantity and severity of ADEs to allow comparison after the introduction of MediConnect. (
  • The FDA Adverse Event Reporting System, a passive monitoring system, was reviewed to identify all reports of adverse events (through December 2001) associated with L monocytogenes infection in patients treated with infliximab or etanercept. (
  • Among patients for whom an indication for use was reported, there were 9 patients (64%) with RA and 5 patients (36%) with CD (information was not reported for 1 patient). (
  • All patients for whom information was reported were receiving concurrent immunosuppressant drugs. (
  • When reporting adverse drug reactions to pharmacovigilance centres, patients and consumers can describe adverse drug reactions experienced in free-text format. (
  • Although the patient-friendly terms list may be a useful feature for some patients or for some adverse drug reactions, it should not replace the option for patients to describe adverse drug reactions in their own words. (
  • Of the 752 patients enrolled, 86.2% were exposed to one or more drugs during hospitalization. (
  • However, adverse events are frequently due not to medications but to the patients' underlying conditions. (
  • Due to consensus-criteria A-C has been associated with drug-induced cholestatic hepatitis in 153 patients. (
  • From 8215 encounters, GPs reported that 852 patients (10.4%) had experienced an ADE in the previous 6 months. (
  • 2 , 4 Adverse drug events (ADEs) are regarded as an important subset of patient-safety incidents that cause, or have the potential to cause, harm to patients undergoing medical care. (
  • Additionally, there is lim- hydroxychloroquine, chloroquine, azithromycin, ited information on the safety of other drugs used to- doxycycline, methylprednisolone, tocilizumab and gether with those issued with emergency use authorisa- remdesivir (if available) for the treatment of patients with tion in the context of COVID-19. (
  • Ninety-seven per cent of the prescriptions were written by general practitioners and gynecologists who reported that most of their patients were using the drug as a contraceptive. (
  • However, significant under-reporting bias inherently leaves patients at risk until sufficient clinical evidence has been granted. (
  • Patients with an allergy to synthetic calcitonin-salmon should not use this drug. (
  • Intervention description, duration and healthcare provider engagement were investigated for their impact on reduction of number of medications, proportions of patients prescribed inappropriate medications, returns to emergency, hospital admission and adverse events. (
  • Since diazepam has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during diazepam therapy. (
  • Long-term moxifloxacin in complicated tuberculosis patients with adverse reactions or resistance to first line drugs. (
  • To test safety and tolerability of long-term moxifloxacin in resistant tuberculosis (TB) patients and patients with intolerance to first line anti-TB drugs. (
  • Twelve (31.6%) patients reported at least an AE due to moxifloxacin, mostly gastrointestinal (8, 21.0%), general (5, 13.2%) and central nervous system (3, 7.9%) AEs. (
  • Despite the fact that a large proportion of patients experienced at least an AE due to moxifloxacin, the drug resulted safe in the long-term administration for complicated TB cases. (
  • This report summarizes the adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) from January 1, 1991, through December 31, 2001. (
  • VAERS was established in 1990 under the joint administration of CDC and the Food and Drug Administration (FDA) to accept reports of suspected adverse events after administration of any vaccine licensed in the United States. (
  • Vaccine safety concerns identified through adverse event monitoring nearly always require confirmation using an epidemiologic or other (e.g., laboratory) study. (
  • The overall dose-based reporting rate for the 27 frequently reported vaccine types was 11.4 reports per 100,000 net doses distributed. (
  • AEFI risk was estimated by dividing the number of reports by the number of vaccine doses administered in the period. (
  • In the three-year period, 3,390,376 HPV vaccine doses were administered and 465 AEFI reports were registered, with 1,378 signs and symptoms. (
  • The reporting rate was 13.72 per 100,000 vaccine doses administered. (
  • To characterize a large number of HHE cases reported to the Vaccine Adverse Event Reporting System (VAERS), to assist clinicians in identifying HHE, and to assist researchers in investigating the risk factors, cause, and pathogenesis of this syndrome. (
  • From 1996 to 1998, the number of HHE reports decreased from 99 to 38, when the predominant pertussis vaccine administered to infants changed from whole-cell to acellular. (
  • VAERS, the Vaccine Adverse Event Reporting System ( ), is a Cooperative Program for Vaccine Safety of the FDA and the Centers for Disease Control and Prevention (CDC). (
  • Occasionally cattle experience a reaction to vaccine or medication (injected, applied topically or given orally). (
  • Vaccine reactions also far outnumber reactions to drugs. (
  • Aagaard, L & Hansen, EH 2013, ' Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011 ', BMC Pharmacology and Toxicology , bind 14, s. 30. (
  • Ritalin ( methylphenidate ) is a central nervous system stimulant prescribed for treating narcolepsy (uncontrollable sleepiness), and attention-deficit hyperactivity disorder ( ADHD ). (
  • Adverse reactions affecting the nervous system were reported in 5.7% of the sparfloxacin group, with insomnia and other sleep disorders the most common events. (
  • Sparfloxacin achieves a high degree of penetration into most tissues, except for the central nervous system. (
  • Several means are at our disposal to achieve causal assessment: spontaneous reporting, clinical trials, cohorts with and without controls, and case-control studies, with each having advantages and limitations. (
  • Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. (
  • The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of short-term trials median duration of 2 months of 11 antidepressant drugs in over 77, but can source fulminant hepatic anThismooth muscle room antibodies. (
  • A hospital pharmacist flagged the acne medication Diane-35 as a possible cause in a report to a Health Canada database. (
  • The most common device medical specialty submitted to health Canada through MDI reporting is General Hospital. (
  • Other members on the committee were Prof Arif Mahmood Siddiqui of the same institute, Prof Dr Afzal Sheikh of Children's Hospital, Mayo Hospital MS Dr Zahid Pervez, Dr Nasir Khan of Children's Hospital, Punjab Institute of Mental Health Deputy Drug Controller Farooq Bashir Butt, Sir Ganga Ram Hospital Deputy Drug Controller Riffat Naz and Punjab Directorate General Health Services Pharmacy Director Ayaz Ali Khan. (
  • Surveillance systems count health events (e.g., deaths from a disease or new cases of a disease) and health services (e.g., visits to a doctor, hospital admissions, vaccination, surgery, provision of prescription drugs) as they occur. (
  • Our aim was to contribute to defining the safety profile of pioglitazone, focusing on cases of bladder cancer recorded in the FDA Adverse Event Reporting System (AERS) database associated with antidiabetic drug treatment. (
  • The reports recorded in FDA AERS from January 2004 to December 2009 were downloaded from the FDA website. (
  • From 2004 to 2009, 86,987 reports involving antidiabetic drugs were recorded in FDA AERS, corresponding to 599,085 drug-reaction pairs (obtained by splitting comedications and multiple reactions reported for each case), with 37,841 reports concerning pioglitazone. (
  • In the US, the two major reporting/surveillance systems are AERS and VAERS. (
  • AERS is administered by the Food and Drug Administration (FDA). (
  • Passive surveillance systems (e.g. (
  • Setting-based surveillance systems in hospitals, emergency room departments, or pharesis centers may help detect relevant drug-related events. (
  • 2.3.4 Infectious disease surveillance systems. (
  • 6 People involved in or witnessing a patient safety incident complete a form that is sent to the local reporting system, where the incident is classified and entered into a database. (
  • Information from the reports is entered into the VAERS database, and new reports are analyzed weekly. (
  • We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. (
  • The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. (
  • The VAERS database is publicly available and contains over 100,000 reports. (
  • The EudraVigilance web application (EVWEB) is the interface to the EudraVigilance database management system (EDBMS) and allows registered users to create, send and view ICSRs, safety and acknowledgement messages. (
  • The EudraVigilance database management system (EDBMS) supports the processing and administration of safety and acknowledgement messages and ICSRs. (
  • Health Canada's primary monitoring mechanisms in this regard are (1) the Canada Vigilance (CV) System for the reporting of adverse drug reactions, (2) the Canada Vigilance - Medical Device Problem Reporting system (CV-MDS) for the reporting of medical device incidents and (3) the Canadian Medical Devices Sentinel Network (CMDSNet) program for the monitoring of medical device incidents in participating hospitals. (
  • Manufacturers and importers of prescription health products and medical devices are mandated by regulation to submit adverse event reports to the Health Canada via Canada Vigilance and CV-MDS. (
  • 8 In a systematic review, none of 105 existing reporting systems examined could use reported information to generate patient-level alerts to assist clinicians in ensuring that absolutely contraindicated culprit drugs were not represcribed or redispensed, a well-documented cause of readmissions. (
  • He considers his eight daily prescription drugs, the eyedrops, and the multivitamins he takes, and he wonders how each affects the others, and what this hodgepodge is doing in his body. (
  • He founded Drug Safety Canada to advocate for safe prescription drugs,[citation needed] and also initiated a hundred million dollar class action lawsuit against Johnson & Johnson and Health Canada in 2000, and an individual lawsuit, later settled after a six-year court battle. (
  • A systematic literature search was carried out to identify studies providing a numerical estimate of under-reporting. (
  • 2) The rx list web site will open here with the drug search completed. (
  • Right now, the system can search adverse drug reaction reports going back to 2004. (
  • Therefore, lack of documentation of adverse drug reactions by health care providers may minimize any gains that might be achieved from compulsory reporting, unless better documentation rates can be achieved. (
  • Risk Evaluation and Mitigation Strategies (REMS)" explains strategies developed by the pharmaceutical industry and required by the Food and Drug Administration (FDA) to minimize adverse drug reactions from potentially dangerous drugs. (
  • Reports concerning antidiabetic drugs were selected, provided that age, sex, and event date were available. (
  • The association between antidiabetic drugs and bladder cancer was analyzed by the case/noncase methodology ( 9 ). (
  • The ratio cases/noncases for each drug were compared with the ratio of cases/noncases for all other antidiabetic drugs. (
  • 8 In a recent study, as soon as clinicians had to exit a computerized patient chart to complete a report, their willingness to document adverse drug reactions declined. (
  • Existing systems further deterred clinicians from documenting adverse drug reactions because the systems failed to reflect the clinical processes through which adverse drug reactions were identified, and because of the ambiguity and uncertainty about what level of suspected reaction should be reported. (
  • Dr. Nebeker directs active research projects on translating theory from the cognitive and social sciences to guide the design of software for clinicians, for real-time surveillance of safe operation and safe use of EHR systems, and for design of information systems for real-time analytics. (
  • Drug-based surveillance occurs when clinicians prescribe a new drug product and actively report on patient safety. (
  • Overviews of drugs and their place in therapy. (
  • Drugs & Therapy Perspectives offers a range of additional features designed to increase the visibility, readership and educational value of the journal's content. (
  • 9.0% to 12.8%) had at least one patient safety incident resulting in patient harm, all of which were detected by the case note review and six (5%) by the reporting system. (
  • Conclusion The routine incident reporting system may be poor at identifying patient safety incidents, particularly those resulting in harm. (
  • Structured case note review may have a useful role in surveillance of routine incident reporting and associated quality improvement programmes. (
  • 9 10 In this paper we evaluate the relative performance of a local routine incident reporting system that feeds into the national reporting and learning system, by comparing it with a well validated method of systematically reviewing case notes. (
  • It includes reporting tools and incident analysis reports for providers in England, Scotland, and Northern Ireland. (
  • Young became a consumer advocate after this incident, and has been fighting for a more stringent and protective drug-monitoring system in Canada. (
  • På denne siden er en oversikt over vitenskapelige publikasjoner der forskere fra Nasjonal kompetansetjeneste har deltatt i årene 2012-2019. (
  • CNS Drugs 2019 Dec;33(12):1187-1199. (
  • 1 The bill is expected to strengthen postmarket surveillance and research, and allow the Minister of Health to compel the release of proprietary information and drug safety studies when a marketed health product is suspected of posing a risk to health. (
  • Pharmacovigilance in general if done poorly, adversely affects the quality, safety and efficacy of drugs as well as public health in general. (
  • International reporting of periodic drug-safety update summaries : final report of CIOMS working group II. (
  • Benefit-risk balance for marketed drugs : evaluating safety signals : report of CIOMS Working Group IV. (
  • 7 The National Patient Safety Agency developed a national reporting and learning system in 2003 to collate reports of patient safety incidents from local organisations. (
  • 8 This system aims to help the NHS to learn from patient safety incidents and to identify trends and patterns relating to patient safety. (
  • This website for independent community pharmacy owners across the United Kingdom features both free and members-only guidance, reporting platforms, and document templates to support patient safety. (
  • 1 Drug Safety Research Unit, Southampton, UK. (
  • Also mentioned were other functions of the app, ease of use, type of language, the source of safety information provided through the app, security of the app, layout, the operating systems on which the app can be used and the costs. (
  • Clavenna, A. and Bonati, M. (2009) Adverse drug reactions in childhood: A review of prospective studies and safety alerts Archives of Disease in Childhood, 94, 724-728. (
  • There is limited information on the safety of drugs used for the treatment of COVID-19. (
  • The ultimate goal of such knowledge is to make better informed decisions about drug safety. (
  • Dr. Trontell also noted that the FDA, in collaboration with the Centers for Disease Control and Prevention (CDC), the Consumer Product Safety Commission (CPSC), and the National Electronic Injury Surveillance System (NEISS), looks at its ability to detect drug-related injuries that present to emergency departments. (
  • In addition to these safety articles, other critical information is highlighted in red throughout the drug monographs. (
  • Active post-market surveillance of drug adverse events and medical devices incidents is essential to ensure ongoing safety and effectiveness of these health products. (
  • He introduced a Private member's bill on April 20, 2009, to establish an independent drug agency for Canada similar to the Canadian Nuclear Safety Commission or the Transportation Safety Board of Canada, focussing solely on prescription drug safety. (
  • Prompt ADR reporting is crucial in ensuring drug safety. (
  • The safety messages contain individual case safety reports (ICSRs). (
  • Technical details are provided in the EU Individual Case Safety Report (ICSR) Implementation Guide . (
  • The rerouting rules are defined in the EU Individual Case Safety Report (ICSR) Implementation Guide and can be further customised by NCAs, if required. (
  • Most people chose to describe adverse drug reactions in their own words rather than selecting adverse drug reactions from a patient-friendly terms list. (
  • The patient-friendly terms list may support some reporters but should not replace the possibility for people to describe an adverse drug reaction in their own words. (
  • In most report forms, individuals can describe the ADR experienced as free text. (
  • Interestingly, it was observed that the keywords used to describe a drug characteristic were not necessarily the most predictive ones for the classification task. (
  • The following sections describe the organization of Davis's Drug Guide for Nurses and explain how to quickly find the information you need. (
  • Although seniors make up only 17% of the Canadian population, they are estimated to account for roughly 40% of all spending on prescribed drugs. (