<p class="abstract"><strong>Background:</strong> Any undesirable change in the structure or function of the skin and its appendages related to drug eruption regardless of the aetiology is called the cutaneous adverse drug reaction (CADR). Manifestations are varied with diverse morphological pattern ranging from trivial urticarial to severe form of vasculitis which are fatal. Identifying the culprit drug in this new era with advanced development of multi drugs is a challenging task and can help in prevention of further complications and provide safer drugs. Objective of the study was to assess the clinical profile and causality of CADR among patients in a tertiary care hospital of Hyderabad.</p><p class="abstract"><strong>Methods:</strong> An observational hospital-based study was undertaken over a 6 months period among patients attending dermatology OPD of medical college and hospital located at Hyderabad. Patients presenting with suspected drug-related cutaneous lesions were included where the drug responsible was ascertained. Drug history was recorded in a format specified in Indian National Pharmacovigilance Programme and causality assessment carried out as per world health organization-uppsala monitoring centre criteria.<strong></strong></p><p class="abstract"><strong>Results:</strong> The study population consisted of females (52.4%) and males (47.6%). Majority of them were in the age group of 51-60 years. Most common pattern of CADR noted were urticaria (19.05%) followed by erythema multiforme (17.46%) and morbilliform rash (17.46%). The common drugs categorised for these reactions comprised of antibiotics (39%), nonsteroidal anti-inflammatory drugs (26%) followed by anti tubercular treatment (18%).</p><p class="abstract"><strong>Conclusions:</strong> CADR contribute to significant morbidity among industrial workers and role of pharmacovigilance should be further emphasized to reduce such reactions. </p>
INTRODUCTIONPharmacovigilance is the branch of science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Good Pharmacovigilance programs help in identifying the risks and risk factors associated with drugs in the shortest possible time so that harm can be avoided or minimized. Without the Pharmacovigilance programme, many adverse effects of the drugs have not been known and the banned drugs would be still in the market causing potential harm. 1When communicated effectively, this informationallows for the intelligent, evidence-based use ofmedicines and has the potential for preventing manyadverse reactions. Physicians, pharmacists, nurses and the consumers play a key role in Pharmacovigilance programs, but in many studies underreporting was observed. An estimated median underreporting rate (defined as percentage of ADRs detected from intensive data collection that were not reported to relevant spontaneous reporting systems) of 94% and occurs frequently for serious and unlabelled reactions. 2,3 This can delay detection of important ADRs. Studies from different settings indicate inadequate knowledge about pharmacovigilance among healthcare professionals as well as attitudes that are associated with ABSTRACT Background: Lack of knowledge and awareness of reporting adverse drug reactions is common among the nursing staff. As the nursing staffs are more close to the patients, this study was undertaken to evaluate their knowledge, attitude and perception about pharmacovigilance and ADR reporting. The objective of this study was to assess the knowledge, attitude and perception of nursing staff about pharmacovigilance programme and finding out the ways of improving the ADR reporting rate. Methods: Across-sectional, anonymous, questionnaire based study was conducted at the Government hospital, Nizamabad among the nursing staff. A predesigned, pretested and validated questionnaire consisting of 15 questions and 8 statements on knowledge, attitude and practice aspects of Pharmacovigilance programme in India. All the nursing staffs were explained about the purpose of the study and the questionnaire was distributed. Adequate time was given to fill them. Data spread on the excel sheet and the results were analysed using Microsoft office 2007 version. Results: Out of 65 students, 74.1% were aware of the term pharmacovigilance, 44.4% of the pharmacovigilance programme in India and 70.4% of the pharmacovigilance cell in their institute. 22.2%stated that known reactions, 14.8% unknown and 63% that all ADRs are to be reported.63% stated herbal drugs are safe, 44.4% that over the counter drugs are safe. Reporting system stated was by making call/by e-mail (25.9), written form (29.6%). Underreporting was due to lack of awareness (51.9%), lack of time (22.2%), feeling of creating negative impression on heath personnel (11.1%), or due to the feeling of waste of time (14.8%). Conclusions: Lack of facilities and clinical knowledge about ADR discourages...
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