Deepak Ramdas1, Ananya Chakraborty2, Swaroop Hs1, Syed Faizan3, Praveen Kumar V3, Srinivas Bn4. 1. Post Graduate Student, Department of Pharmacology, Vydehi Institute of Medical Sciences and Research Centre Whitefield, Bangalore, India . 2. Associate Professor, Department of Pharmacology, Vydehi Institute of Medical Sciences and Research Centre Whitefield, Bangalore, India . 3. Undergraduate Student, Second Year, Vydehi Institute of Medical Sciences and Research Centre Whitefield, Bangalore, India . 4. Professor and HOD, Department of Pharmacology, Vydehi Institute of Medical Sciences and Research Centre Whitefield, Bangalore, India .
Abstract
INTRODUCTION: Package insert is an officially approved document that accompanies a drug. It is intended to provide information for the safe and effective use of a drug and contains information based on regulatory guidelines. Sometimes, information provided in the package inserts is suboptimal which can led to medication errors. This study was undertaken to assess the presentation and completeness of clinical information provided in the currently available package inserts for anti-diabetic, anti-hypertensive and hypolipedemic drugs in India. MATERIAL AND METHODS: Around 130 package inserts were collected from pharmacies located at different areas of Bangalore. They were analyzed based on criteria mentioned in Schedule D of Drug and Cosmetic act 1945. RESULTS AND OBSERVATIONS: Out of 134 package inserts, 64 were anti-diabetics, 40 anti-hypertensives, and 30 hypolipedemics. Out of them, 31 (23.14%) belonged to Grade 'A' (including all injectable preparations) and remaining 76.86% to Grade 'B'. None of the PIs belonged to Grade 'C'. The inserts were inadequate in many aspects; for example, they had unclear instructions about generic name of other ingredients used, about handling, undesirable effects, pediatric and geriatric use, and guidelines for use of the drugs. CONCLUSION: This study indicated that information relevant to the safe and effective use of medication was not mentioned in the analyzed package inserts. It is, therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.
INTRODUCTION: Package insert is an officially approved document that accompanies a drug. It is intended to provide information for the safe and effective use of a drug and contains information based on regulatory guidelines. Sometimes, information provided in the package inserts is suboptimal which can led to medication errors. This study was undertaken to assess the presentation and completeness of clinical information provided in the currently available package inserts for anti-diabetic, anti-hypertensive and hypolipedemic drugs in India. MATERIAL AND METHODS: Around 130 package inserts were collected from pharmacies located at different areas of Bangalore. They were analyzed based on criteria mentioned in Schedule D of Drug and Cosmetic act 1945. RESULTS AND OBSERVATIONS: Out of 134 package inserts, 64 were anti-diabetics, 40 anti-hypertensives, and 30 hypolipedemics. Out of them, 31 (23.14%) belonged to Grade 'A' (including all injectable preparations) and remaining 76.86% to Grade 'B'. None of the PIs belonged to Grade 'C'. The inserts were inadequate in many aspects; for example, they had unclear instructions about generic name of other ingredients used, about handling, undesirable effects, pediatric and geriatric use, and guidelines for use of the drugs. CONCLUSION: This study indicated that information relevant to the safe and effective use of medication was not mentioned in the analyzed package inserts. It is, therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.
Authors: Sandra A Qatmosh; Amer A Koni; Baraa G Qeeno; Dina A Arandy; Maysa W Abu-Hashia; Bahaa M Al-Hroub; Sa'ed H Zyoud Journal: BMC Public Health Date: 2017-09-25 Impact factor: 3.295
Authors: Dina A Arandy; Maysa W Abu-Hashia; Bahaa M Al-Hroub; Sandra A Qatmosh; Amer A Koni; Baraa G Qeeno; Samah W Al-Jabi; Sa'ed H Zyoud Journal: BMC Health Serv Res Date: 2019-11-27 Impact factor: 2.655
Authors: Haftom Gebregergs Hailu; Mengistie Yirsaw Gobezie; Khalid Beshir Tuem; Hildana Tewolde Gebremichael; Solomon Ahmed Mohammed Journal: J Environ Public Health Date: 2022-01-19