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)

There are several types of drug-related side effects and adverse reactions, including:

1. Common side effects: These are side effects that are commonly experienced by patients taking a particular medication. Examples include nausea, dizziness, and fatigue.
2. Serious side effects: These are side effects that can be severe or life-threatening. Examples include allergic reactions, liver damage, and bone marrow suppression.
3. Adverse events: These are any unwanted or harmful effects that occur during the use of a medication, including side effects and other clinical events such as infections or injuries.
4. Drug interactions: These are interactions between two or more drugs that can cause harmful side effects or reduce the effectiveness of one or both drugs.
5. Side effects caused by drug abuse: These are side effects that occur when a medication is taken in larger-than-recommended doses or in a manner other than as directed. Examples include hallucinations, seizures, and overdose.

It's important to note that not all side effects and adverse reactions are caused by the drug itself. Some may be due to other factors, such as underlying medical conditions, other medications being taken, or environmental factors.

To identify and manage drug-related side effects and adverse reactions, healthcare providers will typically ask patients about any symptoms they are experiencing, perform physical exams, and review the patient's medical history and medication list. In some cases, additional tests may be ordered to help diagnose and manage the problem.

Overall, it's important for patients taking medications to be aware of the potential for side effects and adverse reactions, and to report any symptoms or concerns to their healthcare provider promptly. This can help ensure that any issues are identified and addressed early, minimizing the risk of harm and ensuring that the patient receives the best possible care.

Types of Drug Eruptions:

1. Maculopapular exanthema (MPE): This is a common type of drug eruption characterized by flat, red patches on the skin that may be accompanied by small bumps or hives. MPE typically occurs within 1-2 weeks of starting a new medication and resolves once the medication is discontinued.
2. Stevens-Johnson syndrome (SJS): This is a more severe type of drug eruption that can cause blisters, skin sloughing, and mucosal lesions. SJS typically occurs within 2-4 weeks of starting a new medication and can be life-threatening in some cases.
3. Toxic epidermal necrolysis (TEN): This is a severe, life-threatening type of drug eruption that can cause widespread skin death and mucosal lesions. TEN typically occurs within 2-4 weeks of starting a new medication and requires immediate hospitalization and treatment.

Causes of Drug Eruptions:

1. Allergic reactions to medications: This is the most common cause of drug eruptions. The body's immune system overreacts to certain medications, leading to skin symptoms.
2. Adverse effects of medications: Certain medications can cause skin symptoms as a side effect, even if the person is not allergic to them.
3. Infections: Bacterial, fungal, or viral infections can cause drug eruptions, particularly if the medication is used to treat the infection.
4. Autoimmune disorders: Certain autoimmune disorders, such as lupus or rheumatoid arthritis, can increase the risk of developing drug eruptions.

Diagnosis and Treatment of Drug Eruptions:

1. Medical history and physical examination: A thorough medical history and physical examination are essential to diagnose a drug eruption. The healthcare provider will look for patterns of skin symptoms that may be related to a specific medication.
2. Skin biopsy: In some cases, a skin biopsy may be necessary to confirm the diagnosis of a drug eruption and to rule out other conditions.
3. Medication history: The healthcare provider will ask about all medications taken by the patient, including over-the-counter medications and supplements.
4. Treatment: Depending on the severity of the drug eruption, treatment may include stopping the offending medication, administering corticosteroids or other immunosuppressive medications, and providing supportive care to manage symptoms such as itching, pain, and infection. In severe cases, hospitalization may be necessary.
5. Monitoring: Patients with a history of drug eruptions should be closely monitored by their healthcare provider when starting new medications, and any changes in their skin should be reported promptly.

Prevention of Drug Eruptions:

1. Allergy testing: Before starting a new medication, the healthcare provider may perform allergy testing to determine the patient's sensitivity to specific medications.
2. Medication history: The healthcare provider should take a thorough medication history to identify potential allergens and avoid prescribing similar medications that may cause an adverse reaction.
3. Gradual introduction of new medications: When starting a new medication, it is recommended to introduce the medication gradually in small doses to monitor for any signs of an adverse reaction.
4. Monitoring: Patients should be closely monitored when starting new medications, and any changes in their skin or symptoms should be reported promptly to their healthcare provider.
5. Avoiding certain medications: In some cases, it may be necessary to avoid certain medications that are more likely to cause a drug eruption based on the patient's medical history and other factors.


Drug eruptions can present with various symptoms and can be challenging to diagnose. A thorough medical history and physical examination are essential to diagnose a drug eruption. Treatment depends on the severity of the reaction and may include stopping the offending medication, administering corticosteroids, and providing supportive care. Prevention is key, and healthcare providers should be aware of potential allergens and take steps to minimize the risk of adverse reactions. By being vigilant and proactive, healthcare providers can help prevent drug eruptions and ensure the best possible outcomes for their patients.

There are several different types of drug hypersensitivity reactions, including:

1. Maculopapular exanthema (MPE): This is a type of allergic reaction that causes a red, itchy rash to appear on the skin. It can be caused by a variety of medications, including antibiotics and nonsteroidal anti-inflammatory drugs (NSAIDs).
2. Exfoliative dermatitis: This is a more severe form of MPE that can cause widespread scaling and peeling of the skin. It is often associated with reactions to antibiotics and other medications.
3. Stevens-Johnson syndrome (SJS): This is a rare but potentially life-threatening condition that can be caused by certain medications, including antibiotics and NSAIDs. SJS can cause blisters to form on the skin and mucous membranes, as well as fever and fatigue.
4. Toxic epidermal necrolysis (TEN): This is a severe and potentially life-threatening condition that can be caused by certain medications, including antibiotics and NSAIDs. TEN can cause widespread peeling of the skin, as well as fever and fatigue.
5. Anaphylaxis: This is a severe allergic reaction that can be caused by a variety of medications, including antibiotics and NSAIDs. It can cause symptoms such as hives, itching, swelling, and difficulty breathing.

Drug hypersensitivity reactions can be diagnosed through a combination of physical examination, medical history, and laboratory tests. Treatment typically involves discontinuing the medication that is causing the reaction, as well as providing supportive care to manage symptoms such as fever, itching, and pain. In severe cases, hospitalization may be necessary to monitor and treat the reaction.

Prevention of drug hypersensitivity reactions can be challenging, but there are several strategies that can help reduce the risk. These include:

1. Gradual dose escalation: When starting a new medication, it is important to gradually increase the dose over time to allow the body to adjust.
2. Monitoring for signs of a reaction: Patients should be monitored closely for signs of a reaction, such as hives, itching, or difficulty breathing.
3. Avoiding certain medications: In some cases, it may be necessary to avoid certain medications that are known to cause hypersensitivity reactions.
4. Skin testing: Skin testing can be used to determine whether a patient is allergic to a particular medication before starting treatment.
5. Desensitization: In some cases, desensitization therapy may be used to gradually expose the patient to the medication that is causing the reaction, with the goal of reducing the risk of an adverse event.

The symptoms of SJS typically begin with a fever, sore throat, and general feeling of illness within 1 to 3 weeks after exposure to the causative agent. Over the next few days, the patient develops painful blisters on the skin and mucous membranes, which eventually become crusted and form scabs. The blisters may be more prominent on the face, lips, hands, and feet.

In addition to skin symptoms, SJS can also affect other parts of the body such as the eyes, mouth, and genital area. Patients with SJS may experience eye inflammation, mouth ulcers, and vaginal or penile erosions. In severe cases, the condition can lead to life-threatening complications such as infection, organ failure, and death.

The exact cause of Stevens-Johnson Syndrome is not known, but it is believed to be an autoimmune reaction to certain medications or infections. The disorder is more common in children and young adults, and people with a family history of the condition are at higher risk.

Treatment for SJS typically involves withdrawal of any suspected medications and supportive care to manage symptoms such as fever, pain, and infection. Patients may also receive antiviral or antibacterial medications if an infection is suspected. In severe cases, hospitalization may be necessary to monitor and treat complications.

The prognosis for Stevens-Johnson Syndrome varies depending on the severity of the condition and the presence of any underlying health conditions. Mortality rates range from 5% to 20%, with higher mortality rates associated with more severe cases and delayed treatment. However, with prompt and appropriate treatment, many patients with SJS can recover fully or with minimal scarring.

Exanthema is often used interchangeably with the term "rash," but it specifically refers to a type of rash that is accompanied by other symptoms such as fever, headache, or joint pain. Exanthematous rashes can be contagious and may require treatment with antiviral or antibacterial medications, depending on the underlying cause.

Some common types of exanthema include:

* Measles: a highly contagious viral infection that causes a characteristic rash and other symptoms such as fever and cough.
* Roseola: a viral infection that causes a high fever followed by a rash.
* Fifth disease: a mild viral infection that causes a rash on the face and body.
* Hand, foot and mouth disease: a viral infection that causes a rash on the hands, feet, and mouth.

It's important to note that exanthema can be a symptom of various conditions, so it's important to seek medical attention if you or your child experiences a rash with other symptoms, especially if it's accompanied by fever, headache, or joint pain. A healthcare professional can diagnose the underlying cause and recommend appropriate treatment.

The symptoms of urticaria can vary in severity and may include:

* Appearance of hives or wheals on the skin, often in a patterned or widespread distribution
* Itching or burning sensations on the skin
* Redness, swelling, or warmth of the affected area
* In some cases, angioedema (swelling of the deeper layers of skin)

Urticaria can be caused by a variety of factors, including:

* Allergies to foods, drugs, or insect bites
* Exposure to environmental allergens such as pollen, dust mites, or animal dander
* Infections, such as colds or flu
* Physical stimuli, such as pressure, cold, or heat
* Certain medications, such as antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs)
* Hormonal changes, such as those that occur during pregnancy or menstruation

Urticaria can be diagnosed through a physical examination and medical history, and may require further testing to determine the underlying cause. Treatment for urticaria typically involves avoiding triggers, using antihistamines or corticosteroids to reduce symptoms, and addressing any underlying conditions that may be contributing to the condition. In severe cases, hospitalization may be necessary to manage the symptoms and prevent complications.

The definition of DILI has been revised several times over the years, but the most recent definition was published in 2013 by the International Consortium for DILI Research (ICDCR). According to this definition, DILI is defined as:

"A clinically significant alteration in liver function that is caused by a medication or other exogenous substance, and is not related to underlying liver disease. The alteration may be biochemical, morphological, or both, and may be acute or chronic."

The ICDCR definition includes several key features of DILI, including:

1. Clinically significant alteration in liver function: This means that the liver damage must be severe enough to cause symptoms or signs of liver dysfunction, such as jaundice, nausea, vomiting, or abdominal pain.
2. Caused by a medication or other exogenous substance: DILI is triggered by exposure to certain drugs or substances that are not related to underlying liver disease.
3. Not related to underlying liver disease: This means that the liver damage must not be caused by an underlying condition such as hepatitis B or C, alcoholic liver disease, or other genetic or metabolic disorders.
4. May be acute or chronic: DILI can occur as a sudden and severe injury (acute DILI) or as a slower and more insidious process (chronic DILI).

The ICDCR definition provides a standardized way of defining and diagnosing DILI, which is important for clinicians and researchers to better understand the cause of liver damage in patients who are taking medications. It also helps to identify the drugs or substances that are most likely to cause liver injury and to develop strategies for preventing or treating DILI.

The symptoms of dermatitis, exfoliative include:

* Intense redness and scaling or blistering of the skin
* Itching, which can be severe
* Burning sensation on the skin
* Dry, rough skin that may flake off
* Small, raised bumps or hives on the skin
* Crusting or oozing of the skin

The diagnosis of dermatitis, exfoliative is based on the appearance of the skin and the patient's medical history. A skin biopsy may be performed to confirm the diagnosis and rule out other conditions. Treatment typically involves topical medications, such as corticosteroids or immunomodulators, and may also include oral medications or phototherapy.

In addition to these symptoms and treatments, it is important to note that dermatitis, exfoliative can be a chronic condition and may recur over time. It can also lead to complications such as skin infections or scarring. Therefore, it is important for individuals with this condition to work closely with their healthcare provider to manage their symptoms and prevent complications.

Galactorrhea can cause embarrassment and distress for men who experience it, and it may also be a sign of an underlying medical issue that needs to be addressed. Treatment options for galactorrhea depend on the underlying cause and may include hormone therapy, medications to reduce prolactin levels, or surgery to remove a pituitary tumor.

It is important for men who experience galactorrhea to seek medical attention to determine the underlying cause and receive appropriate treatment.

Some common types of skin diseases include:

1. Acne: a condition characterized by oil clogged pores, pimples, and other blemishes on the skin.
2. Eczema: a chronic inflammatory skin condition that causes dry, itchy, and scaly patches on the skin.
3. Psoriasis: a chronic autoimmune skin condition characterized by red, scaly patches on the skin.
4. Dermatitis: a term used to describe inflammation of the skin, often caused by allergies or irritants.
5. Skin cancer: a type of cancer that affects the skin cells, often caused by exposure to UV radiation from the sun or tanning beds.
6. Melanoma: the most serious type of skin cancer, characterized by a mole that changes in size, shape, or color.
7. Vitiligo: a condition in which white patches develop on the skin due to the loss of pigment-producing cells.
8. Alopecia: a condition characterized by hair loss, often caused by autoimmune disorders or genetics.
9. Nail diseases: conditions that affect the nails, such as fungal infections, brittleness, and thickening.
10. Mucous membrane diseases: conditions that affect the mucous membranes, such as ulcers, inflammation, and cancer.

Skin diseases can be diagnosed through a combination of physical examination, medical history, and diagnostic tests such as biopsies or blood tests. Treatment options vary depending on the specific condition and may include topical creams or ointments, oral medications, light therapy, or surgery.

Preventive measures to reduce the risk of skin diseases include protecting the skin from UV radiation, using sunscreen, wearing protective clothing, and avoiding exposure to known allergens or irritants. Early detection and treatment can help prevent complications and improve outcomes for many skin conditions.

There are several types of taste disorders, including:

1. Ageusia: A complete loss of the sense of taste.
2. Hypogeusia: A decreased ability to perceive tastes.
3. Dysgeusia: A distorted perception of tastes, often described as a metallic or bitter taste.
4. Parageusia: A change in the sense of taste, such as a sweetness that is perceived as sour or salty.
5. Taste blindness: The inability to distinguish between different tastes.

Taste disorders can have a significant impact on an individual's quality of life, as they can affect not only the enjoyment of food but also the ability to detect potentially harmful substances. Treatment options for taste disorders depend on the underlying cause and may include medication, therapy, or dietary changes.

The exact cause of NMS is not fully understood, but it is believed to be related to an immune-mediated response to the neuroleptic drug. The syndrome typically develops within 1 to 2 weeks of starting or increasing the dose of the medication, and it can progress rapidly if left untreated.

The symptoms of NMS can include:

* Fever (usually above 38°C)
* Muscle rigidity and stiffness
* Altered mental status, such as confusion, disorientation, or agitation
* Autonomic dysfunction, such as changes in heart rate, blood pressure, or respiration
* Delirium or coma
* Seizures or convulsions

The diagnosis of NMS is based on a combination of clinical findings and laboratory tests, such as electrolyte imbalances, liver function tests, and muscle enzymes. Treatment typically involves stopping the neuroleptic medication and providing supportive care, such as intravenous fluids, oxygen therapy, and sedation to manage agitation or seizures. In severe cases, hospitalization in an intensive care unit may be necessary.

Preventing NMS is important, and it involves careful monitoring of patients who are taking neuroleptic medications, particularly during the early stages of treatment. Regular check-ups with a healthcare provider can help identify any potential problems before they become severe. Additionally, it is essential to report any new or worsening symptoms promptly, as early intervention can improve outcomes.

Overall, neuroleptic malignant syndrome is a rare but potentially life-threatening side effect of neuroleptic medications. Prompt recognition and treatment are crucial to preventing serious complications and improving outcomes for affected individuals.

Types of Gastrointestinal Diseases:

1. Irritable Bowel Syndrome (IBS): A common condition characterized by abdominal pain, bloating, and changes in bowel movements.
2. Inflammatory Bowel Disease (IBD): A group of chronic conditions that cause inflammation in the digestive tract, including Crohn's disease and ulcerative colitis.
3. Gastroesophageal Reflux Disease (GERD): A condition in which stomach acid flows back into the esophagus, causing heartburn and other symptoms.
4. Peptic Ulcer Disease: A condition characterized by ulcers in the lining of the stomach or duodenum.
5. Diverticulitis: A condition in which small pouches form in the wall of the colon and become inflamed.
6. Gastritis: Inflammation of the stomach lining, often caused by infection or excessive alcohol consumption.
7. Esophagitis: Inflammation of the esophagus, often caused by acid reflux or infection.
8. Rectal Bleeding: Hemorrhage from the rectum, which can be a symptom of various conditions such as hemorrhoids, anal fissures, or inflammatory bowel disease.
9. Functional Dyspepsia: A condition characterized by recurring symptoms of epigastric pain, bloating, nausea, and belching.
10. Celiac Disease: An autoimmune disorder that causes the immune system to react to gluten, leading to inflammation and damage in the small intestine.

Causes of Gastrointestinal Diseases:

1. Infection: Viral, bacterial, or parasitic infections can cause gastrointestinal diseases.
2. Autoimmune Disorders: Conditions such as Crohn's disease and ulcerative colitis occur when the immune system mistakenly attacks healthy tissue in the GI tract.
3. Diet: Consuming a diet high in processed foods, sugar, and unhealthy fats can contribute to gastrointestinal diseases.
4. Genetics: Certain genetic factors can increase the risk of developing certain gastrointestinal diseases.
5. Lifestyle Factors: Smoking, excessive alcohol consumption, stress, and lack of physical activity can all contribute to gastrointestinal diseases.
6. Radiation Therapy: Exposure to radiation therapy can damage the GI tract and increase the risk of developing certain gastrointestinal diseases.
7. Medications: Certain medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids can cause gastrointestinal side effects.

There are many different types of liver diseases, including:

1. Alcoholic liver disease (ALD): A condition caused by excessive alcohol consumption that can lead to inflammation, scarring, and cirrhosis.
2. Viral hepatitis: Hepatitis A, B, and C are viral infections that can cause inflammation and damage to the liver.
3. Non-alcoholic fatty liver disease (NAFLD): A condition where there is an accumulation of fat in the liver, which can lead to inflammation and scarring.
4. Cirrhosis: A condition where the liver becomes scarred and cannot function properly.
5. Hemochromatosis: A genetic disorder that causes the body to absorb too much iron, which can damage the liver and other organs.
6. Wilson's disease: A rare genetic disorder that causes copper to accumulate in the liver and brain, leading to damage and scarring.
7. Liver cancer (hepatocellular carcinoma): Cancer that develops in the liver, often as a result of cirrhosis or viral hepatitis.

Symptoms of liver disease can include fatigue, loss of appetite, nausea, abdominal pain, dark urine, pale stools, and swelling in the legs. Treatment options for liver disease depend on the underlying cause and may include lifestyle changes, medication, or surgery. In severe cases, a liver transplant may be necessary.

Prevention of liver disease includes maintaining a healthy diet and lifestyle, avoiding excessive alcohol consumption, getting vaccinated against hepatitis A and B, and managing underlying medical conditions such as obesity and diabetes. Early detection and treatment of liver disease can help to prevent long-term damage and improve outcomes for patients.

1. Muscular dystrophy: A group of genetic disorders characterized by progressive muscle weakness and degeneration.
2. Myopathy: A condition where the muscles become damaged or diseased, leading to muscle weakness and wasting.
3. Fibromyalgia: A chronic condition characterized by widespread pain, fatigue, and muscle stiffness.
4. Rhabdomyolysis: A condition where the muscle tissue is damaged, leading to the release of myoglobin into the bloodstream and potentially causing kidney damage.
5. Polymyositis/dermatomyositis: Inflammatory conditions that affect the muscles and skin.
6. Muscle strain: A common injury caused by overstretching or tearing of muscle fibers.
7. Cervical dystonia: A movement disorder characterized by involuntary contractions of the neck muscles.
8. Myasthenia gravis: An autoimmune disorder that affects the nerve-muscle connection, leading to muscle weakness and fatigue.
9. Oculopharyngeal myopathy: A condition characterized by weakness of the muscles used for swallowing and eye movements.
10. Inclusion body myositis: An inflammatory condition that affects the muscles, leading to progressive muscle weakness and wasting.

These are just a few examples of the many different types of muscular diseases that can affect individuals. Each condition has its unique set of symptoms, causes, and treatment options. It's important for individuals experiencing muscle weakness or wasting to seek medical attention to receive an accurate diagnosis and appropriate care.

There are several possible causes of thrombocytopenia, including:

1. Immune-mediated disorders such as idiopathic thrombocytopenic purpura (ITP) or systemic lupus erythematosus (SLE).
2. Bone marrow disorders such as aplastic anemia or leukemia.
3. Viral infections such as HIV or hepatitis C.
4. Medications such as chemotherapy or non-steroidal anti-inflammatory drugs (NSAIDs).
5. Vitamin deficiencies, especially vitamin B12 and folate.
6. Genetic disorders such as Bernard-Soulier syndrome.
7. Sepsis or other severe infections.
8. Disseminated intravascular coagulation (DIC), a condition where blood clots form throughout the body.
9. Postpartum thrombocytopenia, which can occur in some women after childbirth.

Symptoms of thrombocytopenia may include easy bruising, petechiae (small red or purple spots on the skin), and prolonged bleeding from injuries or surgical sites. Treatment options depend on the underlying cause but may include platelet transfusions, steroids, immunosuppressive drugs, and in severe cases, surgery.

In summary, thrombocytopenia is a condition characterized by low platelet counts that can increase the risk of bleeding and bruising. It can be caused by various factors, and treatment options vary depending on the underlying cause.

Erythema multiforme (EM) is a type of skin rash that can occur as an adverse reaction to certain medications, infections, or other triggers. It is characterized by flat, red lesions with a distinctive "target" or "bull's-eye" pattern.

The condition is relatively common and can affect people of all ages, but it is most commonly seen in young adults and children. Women are more likely to be affected than men.

There are several types of erythema multiforme, including:

1. Erythema multiforme minor (EM minor): This type of EM is mild and self-limiting, and it typically resolves on its own within a few days without scarring.
2. Erythema multiforme major (EM major): This type of EM can be more severe and may lead to scarring. It can also be associated with other systemic symptoms such as fever, headache, and joint pain.
3. Stevens-Johnson syndrome (SJS): This is a more severe form of EM that can be life-threatening. It is characterized by widespread skin blisters and mucous membrane lesions, and it can lead to serious complications such as infections and organ failure.

The exact cause of erythema multiforme is not fully understood, but it is believed to be an immune-mediated reaction to certain triggers. Common triggers include:

1. Medications: Certain medications such as antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), and blood pressure medications can cause EM.
2. Infections: Bacterial, viral, and fungal infections can trigger EM.
3. Other triggers: Other triggers of EM include exposure to the sun, stress, and certain foods or substances.

The diagnosis of erythema multiforme is based on the appearance of the skin rash and a thorough medical history. Laboratory tests may be performed to rule out other conditions and identify any underlying infections. Treatment for EM typically involves addressing any underlying triggers, such as stopping medications or treating infections, and supporting the body's immune system with antibiotics and/or corticosteroids. In severe cases, hospitalization may be necessary to monitor and treat complications.

The prognosis for erythema multiforme is generally good, but it can be challenging to predict the course of the condition. In most cases, the rash will resolve on its own within a few weeks, but in severe cases, the rash may persist or lead to complications. With proper treatment and supportive care, most people with EM can expect a full recovery. However, in rare cases, the condition can progress to more serious complications such as scarring, permanent disfigurement, or organ failure.

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... 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 ...
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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 ...
... 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 ...
... to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. The FDA also ... Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system of passive ... Medical device reporting List of withdrawn drugs McNeil JJ, Piccenna L, Ronaldson K, et al. (2010). "The Value of Patient- ... Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting ...
The organ systems associated with adverse drug reactions to St John's wort and fluoxetine have a similar incidence profile; ... "A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period ... St John's wort may cause allergic reactions and can interact with some prescription drugs. St John's wort is generally well- ... This drug-metabolizing enzyme induction results in the increased metabolism of certain drugs, leading to decreased plasma ...
Serious adverse event Adverse drug reaction Biosafety Emily's Law Fatal Care: Survive in the U.S. Health System (book) Medical ... Hanlon, Carrie; Sheedy, Kaitlin; Kniffin, Taylor; Rosenthal, Jill (2015). "2014 Guide to State Adverse Event Reporting Systems ... The resulting adverse drug reactions are estimated to cause around 700 deaths a year in England and to contribute to around ... Disconnected reporting systems within a hospital can result in fragmented systems in which numerous hand-offs of patients ...
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 ... 2006). "Daptomycin". Drugdex System. Vol. 129. Mo Y, Nehring F, Jung AH, Housman ST (June 2016). "Possible Hepatotoxicity ... Two nonproteinogenic amino acids exist in the drug, the unusual amino acid L-kynurenine (Kyn), only known to daptomycin, and L- ...
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 ...
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 ...
Alternative mechanisms explain continued tobacco use: The majority of first time users of cigarettes report adverse reactions, ... Arguing that If drugs and sugar (and other energetically dense foods) stimulate dopamine in the mesolimbic reward system with ... Drug toxicity and aversion exist in humans and are at odds with the theory of drug reward. Chronic drug use is harmful in ... Why do humans seek out and consume drugs that harm them? The paradox of drug reward refers to the puzzling ability of drugs to ...
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 ...
... are less likely than traditional drugs to cause gastrointestinal adverse effects, but could cause cardiovascular events, such ... PTGS2 is linked with the inflammatory system and has been observed in inflammatory leukocytes. It has been noted that there is ... The conversion of arachidonic acid to PGG2 can be shown as a series of radical reactions analogous to polyunsaturated fatty ... a review and report of personal experience". World J. Gastroenterol. 12 (9): 1336-45. doi:10.3748/wjg.v12.i9.1336. PMC 4124307 ...
Drug selection by means of the System of Objectified Judgement Analysis (SOJA) method". PharmacoEconomics. 10 (2): 152-63. doi: ... Rebound effects have been reported after chronic use including rebound REM. In one clinical trial with patients who had prior ... Shorter acting benzodiazepine compounds are generally associated with a more intense and immediate withdrawal reaction compared ... receptor which in turn enhances the effect of the GABAA receptor producing its therapeutic effects as well as adverse effects. ...
The majority of adverse reactions to the 17D vaccine result from allergic reaction to the eggs in which the vaccine is grown. ... However, in August it was reported that about one million doses of six million shipped in February had been sent to the wrong ... "YF-Vax". U.S. Food and Drug Administration (FDA). 6 August 2019. Retrieved 28 December 2019. World Health Organization (July ... The article begins by stating that of the seven people who developed system failure within two to five days of the vaccine in ...
Control beyond stall can be provided by reaction control systems (e.g. NF-104A), vectored thrust, as well as a rolling ... It has been reported that a Boeing 727 entered a deep stall in a flight test, but the pilot was able to rock the airplane to ... For high-powered aircraft, the loss of lift (and increase in drag) beyond the stall angle is less of a problem than maintaining ... This yawing moment can be aerodynamic (sideslip angle, rudder, adverse yaw from the ailerons), thrust related (p-factor, one ...
... kidney inflammation due to the drug. The common adverse reactions have been fatigue (24%), rash (19%), itchiness (pruritus) (17 ... "Pembrolizumab Monograph for Professionals". American Society of Health-System Pharmacists. Archived from the ... In 2015, Merck reported results in 13 cancer types; much attention was given to early results in head and neck cancer. As of ... People have had severe infusion-related reactions to pembrolizumab. There have also been severe immune-related adverse effects ...
... as well as other problems of public-health relevance such as adverse drug reactions. While sentiment analysis has been popular ... For a recommender system, sentiment analysis has been proven to be a valuable technique. A recommender system aims to predict ... "Exploring attitude and affect in text: Theories and applications." In AAAI Spring Symposium, Technical report SS-04-07. AAAI ... "Analysis of the effect of sentiment analysis on extracting adverse drug reactions from tweets and forum posts". Journal of ...
Adverse drug reactions in the community health setting: approaches to recognizing, counseling, and reporting. Fam Community ... It is often compared to the WHO-UMC system for standardized causality assessment for suspected adverse drug reactions (ADRs). ... for determining the likelihood of whether an ADR (adverse drug reaction) is actually due to the drug rather than the result of ... Electronic medical record systems can be programmed to fire alerts when a potential adverse drug event is about to occur or has ...
Allergic reactions to the drug are characterized by symptoms such as difficulty breathing, shortness of breath, or swelling of ... Adverse events are generally caused by incorrect dosing. Long-term suppression of TSH values below normal values frequently ... "Monitoring FDA MedWatch Reports: Signals for Dabigatran and Metoclopramide" (PDF). QuarterWatch. Institute for Safe Medication ... "Levothyroxine Sodium". The American Society of Health-System Pharmacists. Archived from the original on 21 December 2016. ...
Although not frequent, adverse reactions have been reported for herbs in widespread use. On occasion serious untoward outcomes ... or lack of understanding of plant and drug interactions have led to adverse reactions that are sometimes life threatening or ... In Ladakh, Lahul-Spiti, and Tibet, the Tibetan Medical System is prevalent, also called the "Amichi Medical System". Over 337 ... "Herb-Drug Interactions". NCCIH. 10 September 2015. Retrieved 26 June 2019. Kuhn MA (April 2002). "Herbal remedies: drug-herb ...
... treatment of nervous system Lyme disease (an evidence-based review): report of the Quality Standards Subcommittee of the ... of adults after three doses with only mild or moderate and transient adverse effects. On 21 December 1998, the Food and Drug ... Polymerase chain reaction (PCR) tests for Lyme disease have also been developed to detect the genetic material (DNA) of the ... Report of a case observed in Brazil]" [Lyme disease. Report of a case observed in Brazil]. Revista do Hospital das Clinicas (in ...
... adverse reactions, clinically significant drug interactions, information about use in specific populations (pregnancy, ... Drug Establishment Registration and Drug Listing (PDF) (Report). Food and Drug Administration. Retrieved 2015-07-18. Kass-Hout ... Biosimilar Drug Substance Indexing, Warning Letter Indexing, and REMS Shared System Indexing. In 2009 the FDA and National ... The Highlights of Prescribing Information includes a toll-free number and URL for reporting suspected adverse events and a ...
... including anticholinergic and nervous system adverse effects, while decreased concentrations may reduce the drug's efficacy. ... Co-treatment with thyroid hormones may also increase the potential for adverse reactions. Doxepin is a tricyclic antidepressant ... Current Pain and Headache Reports. 21 (3): 15. doi:10.1007/s11916-017-0615-y. PMC 5340828. PMID 28271334. Media related to ... "Doxepin Hydrochloride". American Society of Health-System Pharmacists. Retrieved 20 March 2019. "Silenor (doxepin) ...
Aronson, Jeffrey K. (2015). Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and ... The GACVS evaluates and interprets reports of adverse effects of vaccines that impact on international vaccination programmes, ... strengthening systems for monitoring, management and the role of GACVS". Expert Review of Vaccines. 8 (6): 705-716. doi:10.1586 ... A Worldwide Yearly Survey of New Data and Trends in Adverse Drug Reactions. Elsevier. pp. 374-377. ISBN 978-0-444-52767-7. ISSN ...
Several areas of the nervous system (such as the autonomic nervous system and numerous regions of the brain) can be affected by ... The reported dream enactment behaviors are frequently violent, and involve a theme of being chased or attacked. People with RBD ... benefits, adverse effects, and longer-term usage. Strategies for future intervention involve modifying the course of the ... No medications for DLB are approved by the US Food and Drug Administration (FDA) as of 2020, although donepezil is licensed in ...
A social work report and, in mothers admitted to hospital, nursing observations are information sources of great value. A ... Started after the birth its adverse effects are minimal, even in breast-fed infants. The cause of postpartum bipolar disorder ... name="Bergink 2013, p75-82." Dazzan P, Fuste M, Davies W. (2018) Do defective immune system-mediated myelination processes ... Jacobs B (1943) Aetiological factors and reaction types in psychoses following childbirth. Journal of Mental Science 89: 242- ...
While there have been no reported cases or evidence of the virus outside China as of July 2020, Smithsonian Magazine reported ... "What You Should Know About Flu Antiviral Drugs". Centers for Disease Control and Prevention. Archived from the original on 23 ... The vaccination should not be taken by people who have had a severe allergic reaction to the influenza vaccination. ... "Pandemic OBGYN". Sarasota Memorial Health Care System. Archived from the original on 3 February 2014. Retrieved 31 January 2014 ...
On the other hand, those with the diagnosis of BPD have reported that the term "BPD" felt like a pejorative label rather than a ... Adherence to medication regimens is also a problem, due in part to adverse effects, with drop-out rates of between 50 percent ... However, the authors warned that total BPD severity is not significantly influenced by any drug and that the evidence generated ... Fallon P (August 2003). "Travelling through the system: the lived experience of people with borderline personality disorder in ...
A report prepared for the Australian National Council on Drugs concluded cannabis and other cannabinoids are contraindicated in ... and recent research has identified the endogenous cannabinoid system to be the first neural system to display complete control ... Cannabidiol (CBD), another cannabinoid found in cannabis in varying amounts, has been shown to ameliorate the adverse effects ... Other functions such as reaction time, attention, language, reasoning ability, perceptual and motor skills were unaffected. The ...
... hypersensitivity reactions; kidney, liver, and pancreas damage; trouble with vision; and adverse effects in skin including ... Pfizer brought the drug to market as Vfend. A generic version of the tablet form of voriconazole was introduced in the US in ... "Voriconazole". The American Society of Health-System Pharmacists. Retrieved 8 December 2017. Kendig EL, Wilmott RW, Chernick V ... AACE Clinical Case Reports. 8 (5): 191-193. doi:10.1016/j.aace.2022.05.001. PMC 9508586. PMID 36189133. Guarascio AJ, Bhanot N ...
The Research on Adverse Drug Events and Reports (RADAR) Project, JAMA Petersdorf, Stephen H.; Kopecky, Kenneth J.; Slovak, ... The most common grade 3 and higher adverse reactions that occurred during Induction 1 and Intensification 2 in ≥ 5% of people ... disorder of the respiratory system, tumor lysis syndrome, Type III hypersensitivity, venous occlusion, and death.[medical ... Antibody-drug conjugates, Hepatotoxins, Monoclonal antibodies for tumors, Orphan drugs, Pfizer brands, Withdrawn drugs, Wyeth ...
Adverse effects of fluoroquinolones: irreversible neuropathy is a serious adverse reaction of fluoroquinolone drugs ... non-sensory nervous system (i.e., the autonomic nervous system), affecting mostly the internal organs such as the bladder ... One uncontrolled study did before/after comparisons with a minimum of one-year follow-up and reported improvements for pain ... After ruling out a lesion in the central nervous system as a cause, diagnosis may be made on the basis of symptoms, laboratory ...
Reports of adverse effects regarding herbal tonics are at a minimum, largely because they are not treated as regulated ... This translates respectively to the principle drug, the associate drug, the adjuvant drug and the messenger drug. Not all ... Ekor M (January 2014). "The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring ... In herbal medicine, an herbal tonic (also tonic herbs, tonic herbalism) is used to help restore, tone and invigorate systems in ...
In October 2018, USA Today reported that federal drug-trafficking prosecutions on the Southern border plummeted, as ... were numerous reports of separated parents not being able to locate or contact their children due to lack of a proper system in ... A case study of 91 U.S. born citizens ages 6 to 12, using the UCLA Posttraumatic Stress Disorder Reaction Index and found that ... "forced parent-child separation and parental loss are PTEs with adverse effects on child mental health and academic functioning ...
The most common adverse drug reactions (ADRs) are dose-related and arise from the effect of loop diuretics on diuresis and ... Without such a concentrated medulla, water has less of an osmotic driving force to leave the collecting duct system, ultimately ... Line, Malha; Samuel, J Mann (7 March 2016). "Loop Diuretics in the Treatment of Hypertension". Current Hypertension Reports. 18 ... This risk is stated on drug packaging inserts. However, the actual risk of crossreactivity is largely unknown and there are ...
Adverse reactions were similar among treatment groups and serious adverse events were rare for all treatments. Most chondroitin ... "Contaminated heparin associated with adverse clinical events and activation of the contact system". The New England Journal of ... as a dietary supplement by the Food and Drug Administration. In Europe, chondroitin sulfate formulations are approved as drugs ... reported that chondroitin sulfate is not rapidly absorbed in the gastro-intestinal tract and a high content of labeled ...
... the drug clonidine hydrocloride swept the market as a novel agent for hypertension; however, the reported side-effects (nausea ... Czech biologist Alfred Kohn reported his discovery of the paraganglia system, which would later become crucial to the diagnosis ... While the adverse side-effects with clonidine are inconvenient, the most dangerous aspect of clonidine is withdrawal rebound ... which mimicked the reaction of the adrenal medulla. Just four years later, German pathologist Ludwig Pick coined the term " ...
The report estimated that over half a million children in the United States suffer adverse behavioral reactions as a result of ... The report urges the Food and Drug Administration to take action to ban or curtail the use of such dyes. Readers are reminded ... The elderly are vulnerable from exposure to chemicals that may impair their weak immune system, and cause heart disease among ... For existing chemicals, manufacturers need to generate and report data on risk, manufacturing and processing, adverse health ...
... there have been numerous reported cases of adverse perceptual reactions. One of these cases discusses an anorexic woman's ... Overall, there have not been very many reports of macropsia induced by certain drugs, specifically zolpidem and citalopram. ... creating a weak telescope system with contact lenses and spectacles, and changing the power of one of the spectacle lenses. ... No evidence of drugs was found, which eliminates the possibility of the macropsia in the adolescents being drug-induced. It is ...
These have also been confirmed in both recent and past studies to have no adverse effects on the liver, blood, nervous system, ... One study showed that patients reported very high levels of subjective sedation when first taking the drug, but that levels of ... Several reactions have been noted in manufacturer guidelines-deep sleep, incoordination, sedation, calmness, and dizziness have ... "Drugs@FDA: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 5 August 2020. Hubbard JR, Martin PR (2001 ...
Adverse effects associated with the MMR vaccine include fever, rash, injection site pain and, in rare cases, red or purple ... No more than 220 cases were reported in any year from 1997 to 2013, and the disease was believed no longer endemic in the ... "MEASLES VACCINE - Essential drugs". Retrieved 28 April 2022. Centers for Disease Control and ... "Information Sheet Observed Rate of Vaccine Reactions" (PDF). World Health Organization (WHO). Archived (PDF) from the original ...
... 0-9. A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P. Q. R. ... Clinical and pharmacological evaluation of drugs: report of the working party  Executive Board, 31 (‎World Health Organization ...
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 ...
MMR Vaccine Adverse Drug Reactions Reports in the CDC WONDER System, 1989-2019. ... MMR Vaccine Adverse Drug Reactions Reports in the CDC WONDER System, 1989-2019. ... allows health care workers to access the large-linked electronic health record database Vaccine Adverse Event Reporting System ... The dissemination of false and misleading information regarding vaccine adverse reactions online has led to negative ...
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), ...
... reviews present recommendations to reduce patient risk for adverse events resulting from deficiencies in the medication-use ... Reviews all medication errors, adverse drug reaction reports. Initiates/implements appropriate medication system changes.. ... Drug class: when more than one drug class is involved, put code of class most likely to produce an adverse event as "Drug #1". ... Drug-drug interaction program. Reduce patient risk of important drug-drug interaction.. Pharmacy computer alerts prompt ...
Adverse Childhood Experiences [‎1]‎. Adverse Drug Reaction Reporting Systems [‎16]‎. * * Browsing Journal Articles by Subject * ...
drug-induced abnormalities OR occupational accidents OR adverse drug reaction reporting systems OR Drug-Induced Akathisia OR ... Drug Recalls OR drug therapy/ae [MH] OR Drug-Induced Dyskinesia OR ecotox* OR Ecotoxicology OR Endocrine System Diseases/CI [MH ... Digestive System Diseases/CI [MH] OR Disorders of Environmental Origin/CI [MH] OR Drug Interactions OR ... Immune System Diseases/CI [MH] OR immunotox* OR Metabolic Inactivation OR Inorganic Chemicals/ae [MH] OR Integumentary System ...
... the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 (BNT162b2) ... Adverse Drug Reaction Reporting Systems * Advisory Committees * Aged * Aged, 80 and over ... On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer- ...
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/ ... Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) ... Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants ...
Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from ... Severe Adverse Drug Reactions to Quetiapine in Two Patients Carrying CYP2D6*4 Variants: A Case Report. Stäuble CK, Lampert ML, ... Adverse drug reactions in older adults: a retrospective comparative analysis of spontaneous reports to the German Federal ... Age and adverse drug reactions from psychopharmacological treatment: data from the AMSP drug surveillance programme in ...
... is the assessment of severe or new adverse drug reactions (ADRs). Here we report on 53,042 of 122,562 patients treated with ... The goal of the German drug safety program in psychiatry AMSP (Arzneimittelsicherheit in der Psychiatrie) ... Adverse Drug Reaction Reporting Systems* Actions. * Search in PubMed * Search in MeSH ... Severe Adverse Drug Reactions to Quetiapine in Two Patients Carrying CYP2D6*4 Variants: A Case Report. Stäuble CK, Lampert ML, ...
Categories: Adverse Drug Reaction Reporting Systems Image Types: Photo, Illustrations, Video, Color, Black&White, PublicDomain ...
... studies have looked at social media and internet health forums for information on drug use and to detect adverse drug reactions ... An analysis showed online information compared favorably with traditional reporting systems in the two countries. ... They report on the opportunities and challenges associated with three types of data: medical encounter files, such as records ... A European surveillance system that began collecting crowdsourced data on influenza as part of a research project is now ...
The Bureau also maintains a drug reporting system for recording adverse reactions and complaints. Only two reports of adverse ... effects of a drug user have thus far been reported. The first concerns a veterinarian who swallowed horse worm medicine while ... The Bureau of Veterinary Medicine is responsible for regulating the use of animal drugs and of feed additives by livestock ... Drug-interactions; Food-additives; Cattle; Food-processing; Food-processing-industry; Veterinarians; Medical-personnel; ...
The paper reviews the etiology, prevention strategies, reporting mechanisms and the myriad consequences of medication errors. ... Medication errors are caused by multiple factors related to health providers, consumers and health system, but most prescribing ... Adverse drug reactions in patients admitted to hospital identified by discharge ICD-10 codes and by spontaneous reports. ... Potential risks and prevention, Part 4: reports of significant adverse drug events. American Journal of Health-System Pharmacy, ...
S. D. Lee, The Study for Activation and Development of Herbal Adverse Reaction Reporting System , Korea Food and Drug ... R.-S. Wedemeyer and H. Blume, "Pharmacokinetic drug interaction profiles of proton pump inhibitors: an update," Drug Safety, ... Although effectiveness can be obtained with these clinical drugs, their potential side effects, limited efficacy, and drug ... 18]. 2.4 mL of 0.1 mM DPPH in ethanol was mixed with 1.6 ml of extracts at different concentrations (0-200 μg/ml). The reaction ...
Exploring Mongolian healthcare professionals experience adverse drug reaction reporting: part of a questionnaire survey (RSC- ... A case of central nervous system adverse reactions caused by using scopolamine injection to soften the cervix for vaginal ... Adherence and adverse drug reactions in metastatic breast cancer patients treated with CDK 4/6 inhibitors (PPM-001) ... Comparing adverse drug reactions on TB regimens: a case study in KZN, South Africa (HPS-059) ...
ADR REPORT SYSTEMS. Entry Term(s). Adverse Drug Reaction Reporting System Drug Reaction Reporting Systems, Adverse NLM ... and other sources on adverse drug reactions.. Terms. Adverse Drug Reaction Reporting Systems Preferred Term Term UI T050623. ... Adverse Drug Reaction Reporting Systems Preferred Concept UI. M0025727. Scope Note. Systems developed for collecting reports ... Drug Information Services [N02.421.668.320] * Adverse Drug Reaction Reporting Systems [N02.421.668.320.120] ...
... or spontaneous adverse drug reaction reporting systems within the hospitals. Two authors (C.H.W. and S.C.L.) confirmed ... Case series and reports can indicate safety issues and outline clinical features of diseases, but they cannot establish robust ... We conducted a multi-institutional study in Taiwan and a systematic review of the literature for reports of Guillain-​Barré ... After a systematic review of published literature (Figure), we included 17 publications reporting an additional 38 cases of GBS ...
MeSH Terms: Adverse Drug Reaction Reporting Systems*; Antibodies, Monoclonal/adverse effects; Humans; Pilot Projects; Protein ... reporting in the US Food and Drug Administration Adverse Event Reporting System (FAERS). The ontology of adverse events (OAE) ... provides a semantic framework to link clinical phenotypes of adverse drug events to biological mechanisms. ... Published In Drug Saf, (2016 Jul). Abstract: A translational bioinformatics challenge exists in connecting population and ...
... registries of adverse events (e.g., the FDA Adverse Drug Reaction Reporting System); and multi-center, large-scale clinical ... The same indication may be shared by a multitude of drugs or classes of drugs. Serious, but rare, adverse reactions, as well as ... drug versus surgery), or cost. The FDA may require comparative studies of drug safety. An approved drug may enter the market ... The FDAs laws and regulations for drug approval do not contain a requirement for studies of comparative drug effectiveness ( ...
Adverse Reactions. Gastrointestinal disorders are the most common adverse reactions with colchicine. They are often the first ... Fatal drug interactions have been reported when colchicine is administered with clarithromycin, a dual inhibitor of CYP3A4 and ... and central nervous system. These most often occur with excessive accumulation or overdosage [see Overdosage (10)]. ... in a drug-drug interaction study, the drug-drug interaction potential of colchicine with strong or moderate CYP3A4 inhibitors ...
However, probably only 10% of serious adverse reactions are reported to the Committees.1 Why is reporting reactions important, ... with their major source of information on the occurrence of adverse drug reactions. Of the many forms of post-marketing ... Three-quarters of the 23,000 reports received by the Committees in 1978 and 1979 were through the yellow card system. ...
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. View ADR ... Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification ... Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is ... Tabulated list of adverse reactions: The table as follows lists the adverse reactions observed in placebo-controlled clinical ...
Mechanisms of Adverse Drug Reactions in Children (R01) PAR-11-051. NICHD ... Reporting System (FSRS) available at on all subawards over $25,000. See the NIH Grants Policy Statement for ... Adverse drug reaction (ADR)-dependent toxicity caused by drugs of abuse in children is a major problem in this country. ... exposure to drugs of abuse can lead to toxicity of various organs/systems in children. The adverse effects on nervous system ( ...
One commonly recognized problem of the system in many countries is under-reporting of adverse drug reactions. The national ... Spontaneous reporting of adverse drug reactions is one of the most important methods to collect post-approval safety data of ... Some of the healthcare professionals were also aware that they had not reported all suspected adverse drug reactions that came ... The results of this study support the hypothesis that under-reporting of suspected adverse drug reactions is also present in ...
... according to a new report by Grand View Research, Inc. It is anticipated to witness growth at a CAGR of 7.0% during the ... "Characterization of Seriousness and Outcome of Adverse Drug Reactions in Patients Receiving Cancer Chemotherapy Drugs - A ... The market for technologically advanced and user-friendly software systems, like cloud-based PV and drug safety platforms, is ... We can customize every report - free of charge - including purchasing stand-alone sections or country-level reports, as well as ...
  • All along, DH has a pharmacovigilance system in place and conducts causality assessment on reports of Adverse Event Following Immunization (in particular serious adverse events) submitted by drug registration certificate holders and healthcare professionals to ascertain whether they are associated with the vaccination. (
  • Rapid global approval of coronavirus disease 2019 (COVID-19) vaccines and concurrent introduction in high-income countries and low- and middle-income countries (LMIC) highlights the importance of equitable safety surveillance of adverse events following immunization (AEFIs). (
  • The African region reported fewer adverse events following immunization than the rest of the world. (
  • We analyzed electronic medical records data from Taiwan's largest multi-institutional healthcare system, including 9 branches of Chang Gung Memorial Hospital ( 2 ), where healthcare workers received first-priority COVID-19 ChAdOx1-S vaccine (Oxford/AstraZeneca, ) starting March 22, 2021. (
  • To summarize clinical features of published cases from literature, we searched PubMed and Embase for reports posted through August 17, 2021, using relevant key terms such as "COVID-19," "Guillain-​Barré syndrome," and "vaccine" with suitable MeSH terms. (
  • 5. [Drug reaction with eosinophilia and systemic symptoms]. (
  • 8. Drug reaction with eosinophilia and systemic symptoms (DRESS): a clinical update and review of current thinking. (
  • 11. Recognition and Management of Severe Cutaneous Adverse Drug Reactions (Including Drug Reaction with Eosinophilia and Systemic Symptoms, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis). (
  • Although effectiveness can be obtained with these clinical drugs, their potential side effects, limited efficacy, and drug interactions represent a major problem in therapy [ 4 , 5 ]. (
  • Hypotension has been reported post-marketing with other PDE5 inhibitors, and dizziness, a symptom commonly caused by lowered blood pressure, has been reported in clinical trials with avanafil (see Interactions). (
  • This is contrary to a real life, pragmatic situation wherein the drug could be consumed by the elderly and young alike and the adverse effects of long term use of the drug, along with drug-drug interactions can be captured. (
  • Of reported ADRs, 63.2%, 8.2% and 19.3% occurred in patients on Zidovudine-based, Stavudine-based and Tenofovir-based regimens, respectively. (
  • 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. (
  • Furthermore, a February 2022 article published in the Journal of Current Medicine Research and Practice titled "Characterization of Seriousness and Outcome of Adverse Drug Reactions in Patients Receiving Cancer Chemotherapy Drugs - A Prospective Observational Study" revealed that serious ADRs in the U.S. result in over 100,000 deaths annually and have been a major health concern since the past decade. (
  • ADRs, such as fatal arrhythmia and liver failure, can result in drug withdrawal from the market as the risks related to the drug usage outweigh its associated benefits. (
  • Although 23.1% of physicians observed often/very often Adverse Drug Reactions (ADRs) after antibiotic administration during their clinical practice, however, 47.6% of the pediatricians declared that they did not report them. (
  • As per available scientific literature, the major obstacles to under reporting are inadequate knowledge and awareness among health professionals, clinicians' perceptions towards reporting, problems with establishing pharmacovigilance systems in hospitals and insufficient training to recognize ADRs. (
  • Some measures to improve the situation include involvement of nurses, pharmacists as well as consumers in the reporting of ADRs, making the process easier and faster through electronic means, introducing educational interventions and training programs for health care providers and spreading awareness about the reporting system amongst caregivers and receivers alike. (
  • Due to these evident drawbacks, it is essential to monitor and report ADRs consistently throughout the duration of use of a medicine in a population, to evaluate if the risks outweigh the benefits, detect ADRs early, predict their frequency and ensure safe and efficacious use of medicines. (
  • This study evaluated the suspected adverse drug reactions (ADR) reported from a spontaneous reporting program in Human Immunodeficiency Virus (HIV) positive patients receiving antiretroviral therapy (ART) in Nigeria. (
  • This is the first experience with spontaneous reporting during COVID-19 pandemic in Ghana. (
  • The identification of adverse drug events (ADE) is made, mainly, by health professionals´ spontaneous reporting. (
  • Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (
  • to verify the active principle and type of drugs related to ADE, seriousness, causality, production mechanism and clinical manifestation of the events identified. (
  • A proportional reporting ratio (PRR) analysis subgrouped by either age, sex, ADE report type, seriousness of ADE, or reporter was compared to the crude PRR analysis using sensitivity, specificity, precision, and c-statistic. (
  • Subgrouping by report type or seriousness resulted in fewer signals (n = 50, −13.8% for both). (
  • The cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events. (
  • Some adverse events are unlikely to be detected in prelicensure clinical trials because of their low frequency, the limited numbers of enrolled subjects, and other study limitations. (
  • No cases were reported during clinical trials of avanafil (see Precautions). (
  • Clinical trials capture only short term data on the drug action and adverse effects since they are conducted in highly controlled settings. (
  • Adverse events after vaccinations occur but are generally rare. (
  • Therefore, postmarketing monitoring of adverse events after vaccinations is essential. (
  • 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. (
  • VAERS is a passive surveillance system: reports of events are voluntarily submitted by those who experience them, their caregivers, or others. (
  • Because of these limitations, determining causal associations between vaccines and adverse events from VAERS reports is usually not possible. (
  • A total of 14.2% of all reports described serious adverse events, which by regulatory definition include death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability. (
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. (
  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration and perforation of stomach or intestines, which can be fatal. (
  • The reinstatement of smallpox vaccination in the United States in response to possible bioterrorism renewed concerns about vaccine-related adverse neurologic events. (
  • We assessed reports of adverse events obtained through active case reporting and review of data reported to the Vaccine Adverse Event Reporting System among 665,000 persons vaccinated against smallpox by the Departments of Defense (n = 625,400 [corrected]) and Health and Human Services (n = 39,400 [corrected]) during the 2002-2004 US Smallpox Vaccination Program. (
  • Adverse neurologic events temporally associated with smallpox vaccination. (
  • Linking MedDRA(®)-Coded Clinical Phenotypes to Biological Mechanisms by the Ontology of Adverse Events: A Pilot Study on Tyrosine Kinase Inhibitors. (
  • The ontology of adverse events (OAE) represents AEs as pathological processes occurring after drug exposures.The aim of this work was to establish a semantic framework to link biological mechanisms to phenotypes of AEs by combining OAE with MedDRA(®) in FAERS data analysis. (
  • Can adverse reactions or adverse events occur from the use of cosmetics? (
  • Yes, it is possible, the correct cosmetovigilance term for cosmetic adverse events is adverse incident and you should report it, too. (
  • Computerized surveillance of adverse drug events in hospital patients. (
  • With 87,351 out of 14,671,586 AEFIs, Africa had the second-lowest crude number and a reporting rate of 180 adverse events (AEs) per million administered doses. (
  • There is low reporting of the adverse events (AEs) of pharmaceutical interventions (medicines and vaccines) in many countries across the world, particularly in low- and middle-income countries (LMICs) [ 1 , 2 , 3 ]. (
  • Pharmacovigilance is a practice aimed to monitor drug safety in real life conditions and capture adverse drug events during the post marketing phase of its life cycle. (
  • It is quintessential for both the consumers as well as health care professionals to detect those ill effects that can further be used to generate "warnings" regarding unexpected drug associated events and establish its safety. (
  • Post authorization, a significant amount of the information on drug safety is acquired through 'pharmacovigilance', a practice aimed primarily at protecting public from serious and unusual adverse events. (
  • We identified GBS cases on the basis of code G610 from the International Classification of Disease, 10th Revision, Clinical Modification, or spontaneous adverse drug reaction reporting systems within the hospitals. (
  • Medical Dictionary for Regulatory Activities (MedDRA) in its latest version for coding medical information, ISO catalogue of country codes, WHO-Drug Dictionary and Anatomi-cal Therapeutic Chemical (ATC) classification to deal with the huge amount of drugs existing globally]. (
  • An Adverse Drug Reaction (ADR) as defined by the WHO is a "response to a drug that is noxious and unintended and that occurs at doses used in humans for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function. (
  • The most common adverse reactions reported in clinical studies were headache, flushing, nasal and sinus congestion and back pain. (
  • Gastrointestinal disorders are the most common adverse reactions with colchicine. (
  • 17. Severe drug-induced skin reactions: clinical pattern, diagnostics and therapy. (
  • 19. Adverse Skin Reactions with Antiepileptic Drugs Using Korea Adverse Event Reporting System Database, 2008-2017. (
  • anaphylaxis, serious skin reactions (e.g. (
  • But under reporting of adverse reactions of the drug is a major cause of concern and a threat to the pharmacovigilance system. (
  • Providing a momentum to the pharmacovigilance system and ensuring a robust reporting process is a challenge but proper planning, feasible solutions and focussed efforts can help bring about the change, making healthcare a better experience for the patients. (
  • This descriptive study analyzed individual case safety reports (ICSRs) in HIV-positive patients receiving ART between January 2011 and December 2011 in 38 secondary hospitals. (
  • In patients with rheumatoid arthritis and osteoarthritis, clinical studies have shown fenoprofen 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 fenoprofen than in aspirin-treated patients. (
  • 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. (
  • 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. (
  • 18. Severe Cutaneous Adverse Drug Reactions in Pediatric Patients: A Multicenter Study. (
  • Most of the reported case-patients received ChAdOx1-S (25/39), followed by BNT162b2 (12/39) (Pfizer-BioNTech, ), Ad26.COV2.S (1/39) (Johnson & Johnson, ), and CoronaVac (1/39) (Sinovac Biotech, ). (
  • In the long term clinical study, the percentage of patients who experienced adverse reactions decreased with increasing length of exposure. (
  • Background: The inappropriate, irrational use or misuse of antibiotics is observed in all health systems and in all patients' groups worldwide, especially for children, where antibiotics continue to be the drugs most commonly prescribed. (
  • Minocycline Hydrochloride Extended-Release Tablets are a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (
  • Effects of two commercial electronic prescribing systems on prescribing error rates in hospital in-patients: a before and after study. (
  • Every pharmaceutical drug that enters the market is expected to have some adverse effects when used by patients outside clinical trial settings. (
  • Clinical development process involves at most few thousand carefully selected patients exposed to the test drug for a short duration, and is conducted under test tube like situation including protocolized care and strict monitoring. (
  • The majority of ADR were classified as type A (82.8%), mild (81.3%), possible (57.8%), according to causality assessment, and related to brand name drugs (20/35). (
  • It is not possible to determine severe adverse drug event (ADE) risks from the few people thus far exposed to anthrax prophylaxis. (
  • Neurologic illness is an infrequent but severe adverse event associated with smallpox vaccination. (
  • 1. Current Perspectives on Severe Drug Eruption. (
  • 2. Severe Cutaneous Adverse Drug Reactions: Presentation, Risk Factors, and Management. (
  • 4. Severe cutaneous adverse reactions: A 5-year retrospective study at Hospital Melaka, Malaysia, from December 2014 to February 2020. (
  • 6. Systematic review of BRAF/MEK inhibitors-induced Severe Cutaneous Adverse Reactions (SCARs). (
  • 7. Aetiopathogenesis of severe cutaneous adverse reactions (SCARs) in children: A 9-year experience in a tertiary care paediatric hospital setting. (
  • 9. A retrospective, 5-year, clinicoepidemiological study of severe cutaneous adverse reactions (SCARs). (
  • 10. Severe cutaneous adverse reactions related to systemic antibiotics. (
  • 12. A 10-years retrospective study on Severe Cutaneous Adverse Reactions (SCARs) in a tertiary hospital in Penang, Malaysia. (
  • 13. A multicentre study to determine the value and safety of drug patch tests for the three main classes of severe cutaneous adverse drug reactions. (
  • 14. Severe Cutaneous Adverse Drug Reactions at a Tertiary Care Center in Saudi Arabia. (
  • 15. Drug-induced severe cutaneous adverse reactions: Determine the cause and prevention. (
  • Note: It is suggested once an adverse event has occurred, it is necessary to refer the patient immediately to his treating physician or to the nearest emergency service, in case the reaction is severe. (
  • Inhibition of both CYP3A4 and P-gp by dual inhibitors such as clarithromycin has been reported to produce life-threatening or fatal colchicine toxicity due to significant increases in systemic colchicine levels. (
  • The Food and Drug Administration (FDA) requires pharmaceutical manufacturers to provide evidence of safety and efficacy as a condition for the marketing of drugs. (
  • The FDA's laws and regulations for drug approval do not contain a requirement for studies of comparative drug effectiveness (although comparison with a control, which is often a placebo but may be an active drug, is required to demonstrate efficacy), alternative therapies (e.g., drug versus surgery), or cost. (
  • DH also monitors the latest safety and efficacy assessment issued by drug regulatory authorities of advanced countries and jurisdictions and the references promulgated by the World Health Organization. (
  • Defining and clarifying the legal responsibility for the emergency use of COVID-19 vaccines will help Hong Kong obtain COVID-19 vaccines which fulfil the requirements of safety and efficacy as soon as possible, but this does not mean that the drug manufacturer is immune from all relevant responsibilities with regards to the vaccine (including quality assurance etc. (
  • Using pharmacogenetics to improve drug safety and efficacy. (
  • A pharmaceutical drug undergoes various phases of the drug development process to assess its safety and efficacy, before entering the market. (
  • Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug reactions. (
  • The 2016-2017 Biennial Report describes a number of other important activities undertaken by ICCVAM and ICCVAM agencies to advance the ICCVAM mission. (
  • NICEATM Deputy Director Nicole Kleinstreuer, Ph.D., was honored in 2016 with the F. Clarke Fraser New Investigator Award from the Teratology Society and the Lush Cosmetics Young Researcher - Americas Prize for her research on mathematical and computational modeling of biological systems. (
  • To determine clinical features of GBS associated with COVID-19 vaccination, we conducted hospital-based investigations in Taiwan along with a systematic review of published case reports. (
  • Another important objective will be to determine whether there are periods of increased vulnerability to drug toxicity within the developmental continuum, between birth and adolescence. (
  • Yellow cards provide the Committees on Safety of Medicines (CSM) and Dental and Surgical Materials (CDSM) with their major source of information on the occurrence of adverse drug reactions. (
  • Three-quarters of the 23,000 reports received by the Committees in 1978 and 1979 were through the yellow card system. (
  • However, probably only 10% of serious adverse reactions are reported to the Committees. (
  • The objective of this announcement includes research on the role of ontogeny and the characterization of pharmacogenetic and developmental variations of drug metabolizing enzymes (DMEs), transporters, ion channels, receptors and signaling pathways that are responsible for drug toxicity in the pediatric population. (
  • The proposed legislative framework will empower the Secretary for Food and Health, on the premise that the relevant vaccine has received the endorsement of one drug regulatory authority, in accordance with objective medical data of the individual vaccine, including making reference to the expert views of an independent expert advisory panel, to allow the relevant vaccine to be put to designated use in Hong Kong. (
  • 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. (
  • The dissemination of false and misleading information regarding vaccine adverse reactions online has led to negative consequences, including raising parents ' concerns about vaccine safety and fostering a growing opposition to the use of vaccines . (
  • Vaccine safety concerns identified through adverse event monitoring nearly always require confirmation using an epidemiologic or other (e.g., laboratory) study. (
  • Examples of the uses of VAERS data for vaccine safety surveillance are included in this report. (
  • As a national public health surveillance system, VAERS is a key component in ensuring the safety of vaccines. (
  • There is limited information on the safety of drugs used for the treatment of COVID-19. (
  • This RFA, The Study of Patient Outcomes Associated with Pharmaceutical Therapy, is related to the section on "Food and Drug Safety" (Objectives 12.5 and 12.6). (
  • The FDA may require comparative studies of drug safety. (
  • The market for technologically advanced and user-friendly software systems, like cloud-based PV and drug safety platforms, is anticipated to support industry growth over the forecast period. (
  • It covered crucial topics, such as Healthcare and Pharmacovigilance Overview, Drug Safety & Management, and Patient Safety Culture. (
  • Within the pharma, techno and cosmetovigilance actions to carry out the monitoring of the safety profile, we have established the "Reporting Adverse Drug Reactions System" that may arise during the commercialization period. (
  • We profiled AEFIs to COVID-19 vaccines, explored reporting differences between Africa and the rest of the world (RoW), and analyzed policy considerations that inform strengthening of safety surveillance in LMICs. (
  • Using a convergent mixed-methods design we compared the rate and profile of COVID-19 vaccines' AEFIs reported to VigiBase by Africa versus the RoW, and interviewed policymakers to elicit considerations that inform the funding of safety surveillance in LMICs. (
  • Introduction: Post-marketing surveillance of drugs aims to detect problems related to safety, effectiveness and quality. (
  • Conclusion: The results of the ADE report contribute for proposition of trigger tools for intensive monitoring of drug safety, as well as for the supplier qualification and for the improvement of quality products. (
  • You must take part in systems of quality assurance and quality improvement to promote patient safety. (
  • Ramipril, an inhibitor of the angiotensin-converting enzyme (ACEI), is a drug commonly used in the therapy of hypertension. (
  • The law recognizes drug therapy as an important form of treatment and refers specifically to the need to investigate the appropriate use of prescription drugs. (
  • 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. (
  • The ICCVAM Biennial Report is prepared by the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), with support from the NTP Office of Liaison, Policy, and Review. (
  • Research design and methods: The publicly available US Food and Drug Administration Adverse Event Reporting System quarterly data extract files from 1 January 2015 through 30 September 2017 were utilized. (
  • ADR imposes a significant load on healthcare systems and is one of the evident grounds for morbidity in developed nations. (
  • This national regulation became valid on 20 October 2005, and it offers the possibility of switching to electronic reporting not at a defined date but over a period giving companies as well as regulators the chance to cope with challenges the new technology imposes. (
  • VAERS) are subject to multiple limitations, including underreporting, reporting of temporal associations or unconfirmed diagnoses, and lack of denominator data and unbiased comparison groups. (
  • Here, we present the first case of ramipril-induced liver injury proven by positive rechallenge and a review of the literature including the data from the US Food and Drug Administration adverse event reporting system (FAERS). (
  • Patient data were collected in the Berlin Case-Control Surveillance Study for adverse drug reactions. (
  • and data generated by the use of social media, the internet and mobile phones, which may include self-reporting of health, behavior and travel information to help elucidate disease transmission. (
  • Most importantly, any novel data stream must be validated against established infectious disease surveillance data and systems, the authors said. (
  • In the United States, researchers found what they describe as "excellent alignment" between medical insurance claim data for flu-like illnesses and proven influenza activity reported by the Centers for Disease Control and Prevention. (
  • A European surveillance system that began collecting crowdsourced data on influenza as part of a research project is now considered an adjunct to existing surveillance activities. (
  • We described basic characteristics, laboratory data, pathologic reports, treatment patterns, and prognosis of GBS cases associated with COVID-19 vaccination. (
  • The data integration to provide insights into molecular mechanisms of drug-associated AEs was performed by including linkages in OAE for all related AE terms to MedDRA(®) and the existing ontologies, including the human phenotype ontology (HP), Uber anatomy ontology (UBERON), and gene ontology (GO). (
  • The system is fully compatible with international standards defined in the International Conference on Harmoni-sation (ICH)-E2B/M2 guidelines and supports manual data entry as well as electronic reporting according to these standards. (
  • The new database is not only a data entry and storage system. (
  • This includes entry screens for single case assessment, views on the data fields in a structured way as well as access to scanned images of paper-based reports. (
  • The first phase of the transition period towards electronic reporting is focused on the major companies with a high number of reports so that BfArM is able to handle the huge amount of data better than before. (
  • Don't capture data from the Adverse drug reaction reporting form manually, let AI do it for you. (
  • Manual Adverse drug reaction reporting form data entry and traditional OCR solutions are slow, expensive and error-prone. (
  • Rossum's unique computer vision technology reads the Adverse drug reaction reporting form in a way that ensures fast data capture and greater accuracy with repeated use. (
  • Process: an agent from our call center will assist you, take the data from your report and assign the Pharmacovigilance Unit of the country where you are. (
  • Lack of ADR data can result in possible signals being missed, which would lead to unsafe drugs being marketed for human consumption. (
  • Designing highly reliable adverse-event detection systems to predict subsequent claims. (
  • The development of adequate animal and in vitro models to spur discovery of the mechanisms of hypersensitivity reactions in children and the identification of toxicity biomarkers are an important part of this initiative. (
  • The Medical Dictionary for Regulatory Activities (MedDRA(®)) is the default dictionary for adverse event (AE) reporting in the US Food and Drug Administration Adverse Event Reporting System (FAERS). (
  • This was the beginning of the Bureau of Chemistry, the predecessor of the Food and Drug Administration. (
  • Occupational physicians also play an important role in the reporting of occupational diseases that occur in workplaces for which they have responsibility. (
  • For instance, in December 2020, EVERSANA, a commercial services provider in the life sciences industry, collaborated with ArisGlobal, a life sciences software company specializing in automating drug development processes. (
  • MMR Vaccine Adverse Drug Reactions Reports in the CDC WONDER System, 1989-2019. (
  • The overall dose-based reporting rate for the 27 frequently reported vaccine types was 11.4 reports per 100,000 net doses distributed. (
  • This condition, mostly the classic form and the acute inflammatory demyelinating polyneuropathy subtype, has been reported in 39 cases and has occurred within 2 weeks of vaccine administration. (
  • If the benefits of the vaccine are considered to be outweighed by the risks, DH will take appropriate actions including referral of the relevant information to the Pharmacy and Poisons Board of Hong Kong for review and consideration on the necessity to suspend or revoke the drug registration of the vaccine. (
  • Federal controls over the drug supply began with inspection of imported drugs in 1848, although the first federal biologics law, which addressed the provision of reliable smallpox vaccine to citizens, was passed in 1813. (
  • Multiple studies have looked at social media and internet health forums for information on drug use and to detect adverse drug reactions. (
  • Only two reports of adverse effects of a drug user have thus far been reported. (
  • Unfortunately, some prokinetic drugs may produce serious adverse effects that complicate their use. (
  • ACEI-induced hepatotoxicity is rare, and most of the reported cases are associated with captopril. (
  • ADAMAS is an international consultancy that offers quality assurance services in pharmaceutical manufacturing, clinical trial auditing, and PV systems. (
  • This FOA also invites applications that will investigate 1) the underlying molecular and biochemical mechanisms, including genetic vulnerability, by which drugs of abuse induce toxicity in children as stated in the FOA and 2) those that were exposed to drugs of abuse maternally (intrauterine, milk etc). (
  • Drugs or herbal products that induce certain enzymes including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. (
  • These drugs are well tolerated and do not induce perpetual or excessive motility. (
  • Neuromuscular toxicity and rhabdomyolysis have been reported from chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect. (
  • In U.S. v. Johnson , the Supreme Court rules that the 1906 Food and Drugs Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug. (
  • A total of 1679 ADR cases were reported, a mean (± Standard Deviation, SD) of 1.5 (± 0.8) ADR cases per patient. (
  • An approved drug may enter the market with relatively little information available for the practitioner, the third party payer, or the patient about how the drug compares with the array of other therapies available. (
  • Systems, Inc., received the award in 2017 for his work as principal investigator on the NICEATM support contract. (
  • The paper reviews the etiology, prevention strategies, reporting mechanisms and the myriad consequences of medication errors. (
  • To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Minocycline Hydrochloride Extended-Release Tablets should be used only as indicated. (
  • Eleven physicians meet in Washington, D.C., to establish the U.S. Pharmacopeia , the first compendium of standard drugs for the United States. (
  • Influenzanet uses standardized online surveys to gather information from volunteers who self-report their symptoms on a weekly basis. (
  • After definitely discontinuing ramipril, a rapid decline in LEs was observed, suggesting a certain causal relationship between drug intake and hepatic damage. (
  • Toxic manifestations associated with colchicine include myelosuppression, disseminated intravascular coagulation, and injury to cells in the renal, hepatic, circulatory, and central nervous system. (
  • We acknowledge the challenges faced by healthcare systems under pressure from rising demands and recognize concerns over the affordability of innovative medicines. (
  • Harmonizing the use of adverse-drug-reaction terms : definitions of terms and minimum requirements for their use, respiratory and skin disorders. (
  • Reporting of adverse drug reactions : definitions of terms and criteria for their use. (
  • causality was imputed with Naranjo algorithm and the mechanism of occurrence was analyzed according to Rawlins e Thompson definitions (A or B). Results: There were 103 ADE reports in the period, of which 39 comprised TF and 64 ADR. (
  • With appropriate consent, the occupational physician should ensure that the employer is able to report occupational disease under the Reporting of Injuries, Diseases and Dangerous Occurrences (RIDDOR) Regulations. (
  • While there are technical and ethical challenges, the authors suggest internet search logs and social media posts can provide information more quickly than traditional physician-based reporting systems. (
  • Reporting suspected adverse reactions after authorisation of the medicinal product is important. (