A surveillance study of cutaneous adverse drug reactions in a tertiary care teaching hospital in India

Background: Skin is one of the most common targets of adverse drug reactions (ADRs) The practice of pharmacovigilance all over the world is 5% whereas in India, it is below 1%. Hence, the purpose of our study is to monitor and analyze the suspected cutaneous adverse drug reactions (ACDRs) reported at our tertiary care teaching hospital, to characterize the nature and predictability, severity and preventability of ACDRs and identify most common drugs causing cutaneous ACDRs so that they can be given cautiously and with keen surveillance.Methods: An observational study was conducted in patients attending outpatient and inpatient department for a period of 3 years. All ACDRs of patients were referred by health care professionals and the diagnosis were made by concern doctors. The recorded data was filled in the ADR form obtained from pharmacovigilance program of India (2011) and Central Drug Standard Control Organization (CDSCO) website.Results: Out of 1399 ADR reports analyzed, 564 reports (40.31%) were of ACDRs, female to male ratio was 0.85. Redness (44.32%) was most common symptom, followed by itching (44.14%) and rash (19.14%). Antimicrobials (43.97%), NSAIDS (21.63%), Anti-retroviral therapy drugs (13.65%) were common groups. As per WHO-UMC causality classification, modified Hartwig and Siegel severity scale, Thornton and Schumock preventability scale, ACDRs were probable, mild and possibly preventable respectively.Conclusions: Effective ADR monitoring plays a role in safety of medicines. So, awareness regarding early diagnosis and prompt treatment should be created among the health care professionals and reporting of ACDRs should be regularly practiced by all the departments.

Study of knowledge, attitude and practice amongst medical professionals about antimicrobial stewardship in tertiary care teaching hospital in India: a questionnaire based study

Background: Appropriate selection of antimicrobial drugs is critical to optimize treatment of infections ad limit the spread of antimicrobial resistance. Antimicrobial resistance is a serious global problem of antimicrobial abuse and there is a growing consensus to urgently develop new strategies for prevention of resistance of bacteria to antimicrobial agents. Relatively few studies of knowledge, attitude and practice are published regarding antimicrobial resistance.Methods: To explore the perceptions of knowledge, attitude and practice of antimicrobial agent use and its resistance in medical professionals in a tertiary teaching care hospital in India. This study was a cross-sectional, questionnaire based study conducted in tertiary care teaching hospital in India for a duration of three months and on a sample size of 300. All medical teachers, residents and interns were included in studies. Questionnaire included 8 questions of knowledge, 10 questions of attitude and 8 questions of practice. The parameters on which the data was analysed were, gender-wise distribution of data, Age-wise distribution of data, hierarchy-wise distribution- Residents, Lecturers, Assistant Professors, Associate Professors, Professors, according to years of experience, Departmental survey. Some questions were assessed by Likert scale, whose responses ranged from always to never. Some questions were of yes and no type, others were multiple choice questions.Results: The majority of respondents were males (65.66%). Most of the participants were from 21-30years (44%) followed by 31-40 years (32.66%). Almost 77.6% participants had upto 5 years of experience in their respective field. Participants had good knowledge, positive attitude and followed a rational and fair practice about antimicrobial stewardship.Conclusions: Adequate training should be given to UGs and PGs about antimicrobial chemotherapy and its usage. It should be part of their curriculum- proper prescribing, dispensing and usage of AMA so as to promote judicious use of AMA.

Nevirapine-induced Stevens-Johnson syndrome from a tertiary care hospital in Central India.

A 42 year old man, a known case of AIDS receiving antiretroviral therapy – stavudine, lamivudine, and nevirapine since 4 weeks, was admitted with erythematous rash, with blisters, and abnormal liver function test. A diagnosis of Steven-Johnson syndrome was made excluding other opportunistic infection and differential diagnosis. Nevirapine was discontinued until the patient recovered. After recovery patient was started with stavudine, lamivudine, and efavirenz treatment without re-challenge with nevirapine.

A case of Stevens-Johnson syndrome due to rifampicin.

A 25 year old female known case of category II pulmonary Tuberculosis was on anti-coch’s treatment in the FDC of rifampicin, isoniazid, pyrazinamide, ethambutol and Streptomycin. Fifteen days after the commencement of Cat II anti TB treatment she developed diffuse erythematous rash on face, trunk and both extremities which turned into blisters. There were ulcers on oral and genital cavity. A diagnosis of Stevens Johnson’s syndrome was made. The patient had a history of cat I pulmonary TB and treated for 8 months and at the end of 8th month she was sputum smear negative. Four months later she had a relapse of sputum smear positive for pulmonary TB. She responded to the stoppage of drugs and oral/inj. Corticosteroids, antihistaminics and antibiotics.

Cognitive and psychomotor effects of adjunctive aripiprazole or paliperidone in patients of schizophrenia receiving olanzapine: a double blind placebo controlled clinical study.

Background: Emergence of atypical antipsychotics has revolutionized the treatment of schizophrenia by exploiting dual actions on serotonin as well as dopaminergic receptors. Still, monotherapy with these agents is insufficient to control cognitive and psychomotor as well as positive and negative symptoms. Hence combination therapy with antipsychotics is common in clinical practice. Objective of current study is to compare the effects of addition of aripiprazole or paliperidone on cognition and psychomotor functions in schizophrenia receiving olanzapine. Methods: This is prospective, double blind, placebo controlled, parallel group study in 90 patients of schizophrenia showing partial or no response to olanzapine measured by Positive And Negative Symptoms Score (PANSS) scale. They were randomly divided to receive adjuvant aripiprazole, paliperidone or placebo for 6 weeks. Results: Combination of aripiprazole and olanzapine shows significant improvement in most of the cognition and psychomotor parameters like attention, perception, verbal memory, thinking and processing as well as motor speed while combination of paliperidone and olanzapine is associated with improvement in only some of the cognitive and psychomotor parameters such as attention, perception and verbal memory only. Both the combinations are efficacious in controlling positive and negative symptoms of schizophrenia as assessed by PANSS scale. Conclusions: The best augmenting strategy with for olanzapine nonresponsive patients will be D2 receptor partial agonist like aripiprazole rather than D2 antagonist like paliperidone and other atypical antipsychotic agents for better improvement in cognition and psychomotor domains.