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Category: Volume 06 Issue 04 April 2018
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Title: Evaluation of the adverse drug reaction information for the multidrug resistant tuberculosis (MDR-TB) patients in a TB hospital in Mumbai (India)

Authors: Jaya Bajpai, Dr Rajendra Nanavare, Dr Jagdish Keni, Dr Deepa Arora, Dr Daksha Shah, Dr Nilima A Kshirsagar

 DOI:  https://dx.doi.org/10.18535/jmscr/v6i4.85

Abstract

Introduction: Second line drug treatment regimens for Drug Resistant Tuberculosis (DRTB) are lengthy and toxic, presenting a challenge to patient compliance. Information Education Communication (ICE) material usually lack information on Adverse Drug Reactions (ADRs) and prevention. To bridge this gap patient information sheet (PIS) on ADRs and preventability developed, has been field tested in this pilot study.

Methods: Prospective questionnaire based pilot study in DRTB patients in the TB hospital in Mumbai was conducted. Patients’ response before and after reading the PIS, their knowledge about TB, ADR and preventability was evaluated.

Results: General knowledge about TB was good (>90%) in the 62 patients (primary resistance/ acquired resistance) who responded to the questionnaire before reading PIS. However their knowledge about ADR (50%) and specific ADR (20%) was low, which improved ADR (> 90%) and specific ADR (80%) in the 23 patients who read the PIS and responded to questionnaire. PIS was found to be useful but lengthy.

Conclusion: Patients lack information on ADR and its prevention. PIS especially with pictorial presentation was good for communicating information, however needs to be shorter. Effect of PIS needs to be assessed on ADR incidence and compliance to treatment.

Keywords: Patient Information Sheet (PIS); Adverse Drug Reactions (ADRs); Tuberculosis; Central TB Division (CTD).

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Corresponding Author

Dr Nilima A Kshirsagar

National Chair in Clinical Pharmacology, ICMR, New Delhi

Government of India, Office NIRRH, J.M. Street, Parel, Mumbai, Maharashtra, India

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