Kind Of Adverse Drug Reaction Research Articles

Paradoxical adverse drug reactions (ADRs) are defined as being opposing reactions to the pharmacological effect of drugs in relation to its pharmacodynamic properties. Their diagnosis is difficult as they are relatively rare with atypical clinical presentation (with the possibility of being confused with drug ineffectiveness or the worsening of the underlying disease). This kind of ADR may be particularly subject to under-notification. The aim of the present study is to describe paradoxical ADRs using the French PharmacoVigilance DataBase (FPVDB). We analysed all reports recorded in the FPVDB with drugs defined as "suspect" and which included the term "paradoxical reaction" (PR) (according to MedDRA classification) from 01/01/1984 to 12/31/2018. The drugs were classified according to the Chemical Therapeutic Anatomical Classification (ATC). We found 57 reports of PR, with half of them recorded between 2015 and 2018. The median age of patients was 46 years, mainly male (54%). The most frequently involved drugs were immunomodulating agents (n = 28, 49%) and psychotropics (n = 28, 49%). The leading paradoxical ADRs were psychiatric (anxiety, sleep and behavioural disorders) and skin-related. In 19 cases (33%), PR was related to benzodiazepines mainly occurring in patients in extreme ages (five cases in children and patients > 70, respectively, 53%). For psychotropic-induced PR (n = 28), known contributory factors (alcohol consumption, underlying psychiatric diseases) were found in 18 cases (64%). Paradoxical reactions with immunomodulating agents were mainly related to skin ADRs (n = 25). For psychotropics, paradoxical ADRs occurred rapidly after a mean delay of 1 day, predominantly following high doses. We also identified several "unexpected" paradoxical reactions, such as cognitive degradation with donepezil, or a return to impulsive smoking addiction with varenicline. This study highlights that pharmacovigilance databases like the French database make it possible to investigate the main characteristics of paradoxical reactions to drugs. This ADR was mainly found in the FPVDB with psychotropic drugs and immunomodulating agents. Moreover, pharmacovigilance databases enable the identification of some signs of "unexpected paradoxical reactions". In order to identify this type of ADR more effectively, work on awareness and harmonization is required to register these reports. The addition of the term "paradoxical reaction to the drug" to the list of other symptoms would facilitate their identification and analysis.

A continuous intervention based on healthcare management agreements was associated in our hospital with an increase in the absolute number of spontaneous reporting of adverse drug reactions (ADRs), and also with an increase in the number of reports of serious or unexpected ADRs and ADRs associated with new drugs. The objective was to analyse the effect of this intervention on the features of ADRs spontaneously reported in a hospital, the drugs involved and the number of signals identified. A longitudinal study with two periods, the 1st period without intervention from 1998 to 2002 and the 2nd period with intervention from 2003 to 2005, was carried out in a tertiary teaching hospital. Changes between the two periods with regard to the following variables were analysed: the patients' characteristics, such as gender and age; the reported ADRs, and the medical assistance required; the suspected drugs involved in the ADRs; the main signals identified. Gender and age distribution of patients described in the spontaneous reports were no different in the two periods. During the second period, spontaneously reported cases requiring hospital admission and those occurring in hospital increased (236 from 2 in the first period and 277 from 99 in the first period respectively) and cases from outpatient hospital consultations began to be reported (13.9% of reports). The spontaneous reporting on all kinds of ADRs and drugs increased during the second period. Cutaneous reactions were the most frequently spontaneously reported ADRs in both periods followed by cardiovascular and neurological reactions in the first period, and haematological and gastrointestinal reactions in the second one. However, during the second period the higher increase was for endocrinological, urinary and hepatic reactions. Systemic antibiotics, anti-thrombotics and cardiac therapy drugs were the most common therapeutic subgroups reported to be suspected drugs in both periods, but in the second period the proportion of immunostimulants, beta blocking agents, immunosuppressants and psychoanaleptics increased. No signals were recognised during the first period; however, two signals and one additional safety concern were identified during the second. An intervention based on healthcare management agreements, was associated with an important increase in spontaneous reporting of ADRs by hospital physicians and also with a change in terms of the type of ADRs identified affecting different organs or systems, and the therapeutic groups of drugs involved. Future studies should analyse the effect of different types of intervention on the spontaneous reporting of ADRs in hospitals.

Kind Of Adverse Drug Reaction Research Articles

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Kind Of Adverse Drug Reaction Research Articles

Articles published on Kind Of Adverse Drug Reaction

Drug-Related Deaths in a Tertiary Hospital: Characteristics of Spontaneously Reported Cases and Comparison to Cases Detected from a Retrospective Study.

SAFETY REPORTING STUDY OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS

Assessment of Knowledge and Perception of Biological Medicines among Undergraduate Pharmacy Students in North India: A Multi-centric Study

Paradoxical adverse drug reactions: descriptive analysis of French reports.

Psychotic Disorders, Definition, Sign and Symptoms, Antipsychotic Drugs, Mechanism of Action, Pharmacokinetics &amp; Pharmacodynamics with Side Effects &amp; Adverse Drug Reactions: Updated Systematic Review Article

Induced pluripotent stem cells for therapy personalization in pediatric patients: Focus on drug-induced adverse events.

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On the clinical evidence leading to tetrazepam withdrawal

Identification and management of adverse effects of antipsychotics in a tertiary care teaching hospital.

Analysis of adverse reactions and pharmacovigilance research to parenterally administered Shuxuening

Adverse drug reaction monitoring in psychiatry out-patient department of an Indian teaching hospital

Effect of an intervention on the features of adverse drug reactions spontaneously reported in a hospital

A Survey of Knowledge, Attitude and Practice of Nurses towards Pharamacovigilance in Taleqani Hospital.

Psychotic Disorders, Definition, Sign and Symptoms, Antipsychotic Drugs, Mechanism of Action, Pharmacokinetics & Pharmacodynamics with Side Effects & Adverse Drug Reactions: Updated Systematic Review Article