Evaluation of the Lack of Essential Information in Medical Literature (original) (raw)
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Factors affecting the development of adverse drug reactions (Review article)
Journal of The Saudi Pharmaceutical Society, 2014
Objectives: To discuss the effect of certain factors on the occurrence of Adverse Drug Reactions (ADRs). Data Sources: A systematic review of the literature in the period between 1991 and 2012 was made based on PubMed, the Cochrane database of systematic reviews, EMBASE and IDIS. Key words used were: medication error, adverse drug reaction, iatrogenic disease factors, ambulatory care, primary health care, side effects and treatment hazards. Summary: Many factors play a crucial role in the occurrence of ADRs, some of these are patient related, drug related or socially related factors. Age for instance has a very critical impact on the occurrence of ADRs, both very young and very old patients are more vulnerable to these reactions than other age groups. Alcohol intake also has a crucial impact on ADRs. Other factors are gender, race, pregnancy, breast feeding, kidney problems, liver function, drug dose and frequency and many other factors. The effect of these factors on ADRs is well documented in the medical literature. Taking these factors into consideration during medical evaluation enables medical practitioners to choose the best drug regimen. Conclusion: Many factors affect the occurrence of ADRs. Some of these factors can be changed like smoking or alcohol intake others cannot be changed like age, presence of other diseases or genetic factors. Understanding the different effects of these factors on ADRs enables healthcare professionals to choose the most appropriate medication for that particular patient. It also helps the healthcare professionals to give the best advice to patients. Pharmacogenomics is the most recent science which emphasizes the genetic predisposition of ADRs. This innovative science provides a new perspective in dealing with the decision making process of drug selection.
Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment
Several factors predispose patient to develop adverse drug reactions (ADRs), some of these factors are drug related, patient related, disease related, social and adverse drug related. The contributions of these factors to development of ADRs are very crucial and are well documented in medical literature. It has become necessary for every medical practitioner to consider these factors in order to prescribe the best medication to his patients. The current classification of ADRs is only based on drug known pharmacology and dose dependent of its action. In order to give comprehensive classification, the time course of its appearance and its severity as well as patient susceptibility are taken into consideration. Knowledge of causality assessment enables the medical practitioners to clarify the likelihood that the suspected adverse drug reaction is actually due to the medicine. This requires careful patient monitoring because adverse drug reaction can be difficult and a times impossible to distinguish from patient disease condition. The purpose of this article is to review the factors affecting the development of ADRs, its broader classification and to assess causal relationship between the suspected drug and appearance of ADRs.
IOSR Journals , 2019
Introduction: All drugs have therapeutic effects and none are absolutely devoid of adverse effects and prescription of them should be judicious and with a satisfactory risk/benefit ratio. Pharmacovigilance has perceived several advancements throughout the world, over the past few decades. The WHO defines "Pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems, including herbal materials." Materials and Methods: This study was done in Kurnool Medical College, Kurnool, AP as a retrospective observational study. After getting ethical committee approval and consent from the pharmacovigilance committee of ADR monitoring centre KMC Kurnool, without revealing the identity of the patients, a retrospective data collection was done by collecting different types of ADR reported in this hospital for the previous six months (May 2018-October 2018). Those included were only inpatients from the hospital for whom ADR was reported for the pharmacovigilance program of India. Results: Out of the 313 cases reported, major ADR were for antibiotics (55.5%). The antibiotics which were causing ADR were, antituberculous drugs, cefixime, ceftriaxone, ampicillin, amoxicillin, amoxicillin with clavulunic acid etc. Among the antibiotics the most common adverse drug reaction was rash caused by antituberculous drugs. The second commonest was anticancer agents (18.2%). The anticancer agents which caused adverse drug reactions were carboplatin, paclitaxol, and methotrexate. The ADR were minor and probable in anticancer agents. This result shows that the majority reported ADR were for chemotherapy agents. The analgesics with ADR were 6.6% and the psychiatric drugs were 4.4%. This shows that the next common ADR were the NSAID and the psychiatric drugs. The offending drugs were Diclofenac and lithium respectively for NSAIDs and Psychiatric drugs. These adverse effects were also causality assessed as probable. Conclusion: From this study, it is concluded that the antibiotics has the major ADR pattern. It's also known that the probable and possible causalities are more common when ADR are reported.
Adverse Drug Reactions: An Overview
Drug is single active chemical entity present in a medicine that is used for diagnosis, prevention and treatment of diseases. Adverse drug reaction is unexpected effect of drug on animal and human being and considered as one of causes of morbidity and mortality of hospitalized patients. Although many drug reactions are preventable such as those associated with prescription errors while others are not preventable. The adverse drug reactions are often not discovered until after the drug has been marketed. The occurrence of ADR can be explain on basis of the drug's pharmacology and show apparent dose-response relationship in susceptible animal and human being. Adverse drug reactions caused by immune and non-immune mechanisms are a major cause of morbidity and mortality worldwide. They are the most common iatrogenic illness, complicating 5% to 15% of therapeutic drug courses. Adverse drug reactions can be divided schematically into two major categories: type A and type B. Type A reactions are common, predictable and may occur in any individual. Type B ADRs are uncommon and unpredictable and only occur in susceptible individuals. A critical factor in the drug response such as in ADRs could be the inter-patient differences in plasma concentrations arising from the same drug regimen. Pharmacogenomics is likely to be particularly useful for drugs that have variable kinetics and dynamics, and narrow therapeutic index. Management strategies employed for the ADRs is categorized as drug withdrawal, dose reduction, additional treatment for ADR, and no change in regimen with no additional treatment. Managing these cases should be done immediately after their appearance and those individuals or animals with the problem should be carefully handled with the appropriate medical expertise. Better approaches must be devised for reporting and assessing ADR. In addition, pharmaceutical companies should strive to reduce the adverse effect of a drug. INTRODUCTION Drug is single active chemical entity present in a medicine that is use for diagnosis, prevention and treatment of diseases. (Mererjone, 2003). The person-to-person variability of drug response is a major problem in clinical practice and drug development (Meyer, 2000). It can lead to therapeutic failure or adverse effects of drugs (ADRs) in individuals or subpopulations of patients. Adverse drug reaction is unexpected effect of drug on animal and human being and considered as one of causes of morbidity and mortality of hospitalized patients (Ditto, 2004). A productive hospital-based reporting program can be instrumental in providing valuable information regarding potential problems of drug usage in an institution. Through these efforts, problems are identified and resolved, which results in continuous improvement inpatient Care (Murphy and Frigo, 1993). Spontaneous reporting program, a common method of drug surveillance is capable of recognizing ADRs in the daily medical practice even though under reporting and absence of information on number of people actually exposed to the drug are its disadvantages (Alvarez-Requejo et al., 1998). Although many drug reactions are preventable such as those associated with prescription errors while others are not preventable. The adverse drug reactions are often not discovered until after the drug has been marketed. Pharmaceutical companies strive to work out the adverse effect profile of a drug before it is marketed, but because the complete range of adverse effects is not known, therefore, most severe drug induced reactions cannot be elucidated before licensing, therefore efficient post marketing surveillance is needed. However, even if improved surveillance is carried out the problem will not be resolved. As more drugs are marketed and as more individuals take multiple drugs, the occurrence of adverse drug reactions will probably continue to increase. Adverse drug reaction are still considered as problem of drug therapy in association with considerable morbidity, mortality, decrease compliance and therapeutic success as well as high direct and indirect medical cost (Tripathis,2003). There for the objectives of this seminar paper are: to high light the causality, clinical manifestation and management of ADR, and to recommend further study in the area of ADR.
Prospective Study On Adverse Drug Reactions: A Step Towards Patient Safety
Zenodo (CERN European Organization for Nuclear Research), 2022
To identify the adverse drug reactions in the patients. To increase the reporting and awareness among the staffs. To evaluate the causality assessment and severity of ADRs. A prospective study was conducted for a period of one year from February 2019 to January 2020 in the Inpatients of AJ Hospital and Research Centre. Identified and reported ADRs were analyzed. ADR reporting questionnaire was provided to healthcare professionals to assess the knowledge about ADR. ADR causality assessment was carried out using WHO probability scale. Severity assessment of ADRs was done using modified Hartwig and Siegel severity scale. Paired t-test was applied to find the association between the two phases. A total of 100 ADRs were identified from 1120 patients.Causality assessment indicated that most of the ADRs were probably (85%) drug related. Severity of 79% reactions were reported as moderate. Study was categorized into two phases; Phase I and Phase II. Knowledge rate among respondents was found to be 67% in phase-I which had a remarkable increase in phase-II (92%). Common barrier for underreporting of ADR was lack of knowledge regarding ADR. The study concluded that interventions such as implementation of well-established reporting process and continuous training will help to reduce the current underreporting crisis.