Adverse drug reactions and causality: the Turkish version of Naranjo Adverse Drug Reactions Probability Scale

Background: Adverse Drug Reactions are the recognized hazards of drug therapy and they can occur with any class of drugs. The main aim of the study was to detect and analyze Adverse Drug Reactions in inpatients of medicine department in tertiarycare hospital. The study assesses the incidence and pattern of ADRs, identifying co-morbidities, past and present illness, assess causality and the offending drugs, monitoring and documenting suspected adverse drug reactions.Methods: A prospective study was conducted over a period of 6 months. The WHO definition of an ADR was adopted. Each ADR was assessed for its causality by using WHO probability scale. The severity of each ADR was assessed by using modified Hartwig et al, and Siegel scale.Results: A total 58 ADR were reported during study period out of which 28 (48.27%) were male and 30 (51.72%) were female patients. The assessment by WHO probability scale showed that out of 58 ADR 22 (37.93%) were probable and 17 (29.31%) were possible and 6 (10.34%) were certain. Most commonly involved system was gastrointestinal system with 24 (41.37%) ADRs. Severity assessment by modified Hartwig and Siegel scale showed that 22 (37.93%) were moderate, 32 (55.17%) were mild and 4 (6.89%) were severe ADRs. No lethal effects were observed or produced.Conclusions: The study concluded that Adverse Drug Reactions are common and some of them resulted in increased health care cost due to need of some interventions and increased length of hospital stay. The health system should promote the reporting of Adverse Drug Reactions, proper documentation and periodic reporting to regional pharmacovigilance centers to ensure drug safety.

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A Retrospective Evaluation of Cutaneous Adverse Drug Reactions (CADRs) Due to Antibiotics Using Naranjo Adverse Drug Reactions (ADRs) Probability Scale

Journal of Young Pharmacists ◽

10.5530/jyp.2018.10.25 ◽

2018 ◽

Vol 10 (1) ◽

pp. 113-116

Author(s):

Mohammed Helmy Faris Shalayel ◽

Ietimad Abdelsalam Mohamed Ayed ◽

Mohammed Ayed Huneif ◽

Yousif Mohammed Kordofani

Keyword(s):

Adverse Drug Reactions ◽

Retrospective Evaluation ◽

Drug Reactions ◽

Probability Scale

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Adverse drug reactions in hospitalized cardiac patients: Characteristics and risk factors

Vojnosanitetski pregled ◽

10.2298/vsp140710104m ◽

2015 ◽

Vol 72 (11) ◽

pp. 975-981 ◽

Cited By ~ 5

Author(s):

Snezana Mugosa ◽

Zoran Bukumiric ◽

Aleksandra Kovacevic ◽

Aneta Boskovic ◽

Dragana Protic ◽

...

Keyword(s):

Risk Factors ◽

Adverse Drug Reactions ◽

Health Care Professionals ◽

Cardiac Patients ◽

World Health ◽

Drug Reactions ◽

Probability Scale ◽

Clinical Centre ◽

Health Organization ◽

Symptoms And Signs

Background/Aim: Adverse drug reactions (ADRs) appear more frequently than actually reported and registered. The main goal of our work was to analyze risk factors, incidence and characteristics of ADRs in hospitalized cardiac patients. Methods. This prospective study included 200 patients, hospitalized at Cardiology Center of the Clinical Centre of Montenegro. ADRs were collected using specially designed questionnaire, based on the list of symptoms and signs that could point out to potential ADRs. Data from medical charts of patients, lab tests and other available parameters were observed and combined with the data from questionnaire. Severity of ADRs were assessed as serious or nonserious according to the World Health Organization criteria. Causality was assessed using the Naranjo probability scale. Results. A total of 34% of all the patients experienced at least one ADR. The most common ADRs occurred as nervous system disorders, less frequent were cardiovascular disorders, while the immune system disorders were the rarest. Sixteen percent of all ADRs were characterized as serious, most often caused by carvedilol and amiodarone. The majority of patients (97.3%) recovered without consequences. The multivariate analysis showed independent significant associations between ADRs and age, gender, comorbidities and polypragmasia. Conclusion. ADRs represent a significant issue in hospitalized cardiac patients population. The most significant predictors for ADRs in observed population were age, comorbidity, number of medications used during hospitalization and patients? gender. Preventive measures such as pharmacotherapy rationalization and continual education of health care professionals could reduce the frequency of ADRs appearance in patients with detected risk factors.

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A study on incidence of adverse drug reactions with commonly prescribed drugs and causality assessment in Silchar Medical College and Hospital

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20171673 ◽

2017 ◽

Vol 6 (5) ◽

pp. 1175

Author(s):

Jahirul Islam Laskar ◽

Pinaki Chakravarty ◽

Babul Dewan

Keyword(s):

Adverse Drug Reactions ◽

Health Care Professionals ◽

Prospective Observational Study ◽

Indian Population ◽

Hospital Admissions ◽

Causality Assessment ◽

Drug Reactions ◽

Probability Scale ◽

Medical College ◽

One Year

Background: Present study was carried out to assess the incidence of adverse drug reactions (ADRs) and assessment of causality, severity with reported suspected ADRs.Methods: A prospective observational study was conducted over a period of one year in inpatients and out patients hospitalization due to ADRs, at Silchar Medical College & Hospital, Silchar, Assam. WHO–UMC Probability scale was used for causality assessment. Reported ADRs were classified according to Wills and Brown classification and assessed for severity using scale developed by Hartwig et al. All data were calculated by ‘Descriptive statistics’ analysis as percentage of patient population who encountered ADRs.Results: A total of 192 suspected ADRs were reported and Overall incidence of ADRs during the study period was found to be 0.41% of which 0.22% of ADRs had lead to hospital admissions and 0.19% of ADRs occurred during the hospital stay. Most common drug class associated with ADRs were Antimicrobials [101(52.6%)], which was found to have mostly affected the Skin system followed by NSAIDs [24(13.54%)], Haematinics [21(10.93%)]. Severity of the ADRs were found to be moderate [79(41.14%)], followed by [71 (36.97%)] ADRs which were severe and [42(21.87%)] which were mild.Conclusions: Present study revealed that, more awareness about the importance of Pharmacovigilance have to be provided among the health care professionals by way of ADR bulletins, seminars and workshops. Also, more studies need to be conducted in Indian population to know the exact prevalence of ADRs in Indian hospitals.

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