Awareness about FDA announcement on voluntary recall of ranitidine among physicians and pharmacists in and around Chennai, India: a cross-sectional study

Awareness about FDA announcement on voluntary recall of ranitidine among physicians and pharmacists in and around Chennai, India: a cross-sectional study Rukaiah Fatma Begam Yamuna Ravikumar Ramaiyan Velmurugan http://orcid.org/0000-0002-9399-3579 Abstract Background

Ranitidine is a histamine-2 (H2) blocker, which decreases the amount of acid created by the stomach. In September 2019, the drug was recalled due to impurities N-nitrosodimethylamine (NDMA) by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada. NDMA is a carcinogen based on results from laboratory tests. The objective of the study is to assess the awareness among the physicians and pharmacists in and around Chennai about the ranitidine recall notification and its related issues. A descriptive, cross-sectional study was carried out where a questionnaire was administered on 198 physicians and 113 pharmacists who were enrolled in the study. Awareness, knowledge, and issues related to recall notification were recorded from the participants.
Results

Results showed that only 75% of the study participants were aware of the notification and the issues related, with significantly more participants from the urban area compared with the rural area. When the notification was known by many, the reasons pertaining to the notification were not known.
Conclusion

Overall, the awareness assessed among physicians and pharmacists was not satisfactory. Physicians and pharmacists are the most responsible healthcare providers and to be updated with every notification on medication published by regulatory bodies.
05 28 2021 12 2021 112 267 1 10.1007/springer_crossmark_policy link.springer.com false 23 April 2020 18 May 2021 28 May 2021 The study protocol was reviewed and approved by the Institutional Ethics Committee, School of Pharmaceutical Sciences, Vels Institute of Science Technology and Advanced Studies, Chennai, India 600117. Written informed consent has been obtained from the study participants explaining to them that the data obtained from each of them will be published. Consent was taken from the study participants informing them that the obtained data will be published. 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