National Adverse Drug Reaction Surveillance

Faich, Gerald A.; Dreis, Michael W.; Tomita, Dianne

doi:10.1001/archinte.1988.00380040025005

Cited by 25 publications

(6 citation statements)

References 13 publications

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“…In fact, the Food and Drug Administration has reported that consumer-initiated reports comprise an increasing proportion of the ADR reports submitted. Forty-one percent of the FDA reports received in 1996 were from consumers, contrasted with approximately 10% in 1986 (35,36). In addition, nearly one-third of the FDA reports originating from physicians may be prompted by patient reports of symptoms and their attribution to a drug (37).…”

Section: Discussionmentioning

confidence: 99%

A Model for Understanding Patient Attribution of Adverse Drug Reaction Symptoms

DeWitt

Sorofman

1999

Drug Information J

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The study uddressed issues surrounding the pntient j . recognition of whether a symptom is d r u g or niseiise-related. Studies have demonstrated that the infornmtion the Iaypopulation has about illness can be organized into Jive categories: identity (symptoms and label), cause. time course. consequences. and cure. These elements, termed illness representations or prototyes. facilitate patient interpretation and response to symptoms as they occur the ore tic ally^ patients may have such a framework f o r interpretation of symptoms thrit thev considered adverse drug reactions. The purpose of this study was to explore whether ( i n adverse drug reaction ( A I M ) prototype esists. A self-administered questionnaire wus used t o elicit the subject i perceptions and awareness of adverse drug reactions. Subjects n'ere also asked to make judgments about severity of ADRs and frequency of piirticulur symptoms as drug-related effects. The study population was a sample of 338 adults visiting afnmi1.v practice clinic over a four-week period. A majority of the respondents reported personal e.rperienc-e of an ADR and described the event with information nhich was consistent with the Jive categories. Subjects who reported ADR e-rperience believed drug reactions occur more frequently and are less severe than those without such crperience. Results also indicated that people have knowledge about ADR symptoms that is substantially accurate. and may use a protofipe to facilitate identification of svmptonis as iin adverse ej'ect.

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Section: Discussionmentioning

confidence: 99%

A Model for Understanding Patient Attribution of Adverse Drug Reaction Symptoms

DeWitt

Sorofman

1999

Drug Information J

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“…As the largest organ of the human body, the skin is one of the most common targets of adverse drug reactions. Adverse cutaneous drug reactions (ACDRs) comprise 10–50% of all reported adverse drug reactions, 1–3 with an incidence of 2–3% among all hospitalized patients 4–6 . Stevens–Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which represent opposite ends of a single clinical spectrum, are the most severe forms of ACDR.…”

Section: Introductionmentioning

confidence: 99%

Association of HLA‐B*1502 allele with carbamazepine‐induced toxic epidermal necrolysis and Stevens–Johnson syndrome in the multi‐ethnic Malaysian population

et al. 2011

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“…This may alter the risk-to-benefit ratio which might lead to a subsequent label change, new precautions or warnings, reduced dosage, restriction, or possible withdrawal of the drug product from the market. Because of these issues, active postmarketing surveillance has long been an important aspect of the life cycle of a drug product (4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17).…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999

et al. 2001

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10.5%), cardiovascular (8.7%), dermatologic (6.3%), and carcinogenic (6.3%) issues. Among the 87products for which the timing of marketing was available, the median time on the marker was 5.4 years with about one-third withdrawn within the first two years. It is hoped that the current review will stimulate other future research into this important topic. However, due to the intrinsic limitations of the descriptive analysis design, our observations are subject to the availability of data in the public domain. Readers are cautioned to be objective and careful when approaching data of this nature in order not to misinterpret the results due to potential data gaps.

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National Adverse Drug Reaction Surveillance

Cited by 25 publications

References 13 publications

A Model for Understanding Patient Attribution of Adverse Drug Reaction Symptoms

A Model for Understanding Patient Attribution of Adverse Drug Reaction Symptoms

Association of HLA‐B*1502 allele with carbamazepine‐induced toxic epidermal necrolysis and Stevens–Johnson syndrome in the multi‐ethnic Malaysian population

Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999

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