Abstract
Brand substitution should not be encouraged because of various reasons like drug content, formulation stability, difficulty in establishing bio-equivalence, and above all patient and prescriber familiarity with a specific brand etc., as this all may have a bearing on treatment outcome. A wide range of variation is seen as far as drug content of a formulation is concerned, in the Indian market. This wide variation in drug content might result in either inefficacy or toxicity with the drug/ formulation. In this review we are going to discuss about the necessity of using the prescribed brand and not substituting them with others with some examples.
Keywords: Brand, Cost, Efficacy, Safety, Substitution, Generic.
References
- Kairi JK, Sharma AK. Substitutes of Prescription Medicines - A Review of Concerns Relevant to Doctors and Patients. J Clin Diagn Res. 2017; 11(8): FE01-FE05.
- Straka RJ, Keohane DJ, Liu LZ. Potential Clinical and Economic Impact of Switching Branded Medications to Generics. Am J Ther. 2017; 24(3): e278-e289.
- Helmers SL, Paradis PE, Manjunath R, et al. Economic burden associated with the use of generic antiepileptic drugs in the United States. Epilepsy Behav. 2010; 18(4): 437-44.
- Association of the British Pharmaceutical Industry (ABPI). Pharmaceutical Price Regulation Scheme (PPRS), London, 2014. Available at: https://www.gov.uk/government/publications/pharmaceutical-price-regulation-scheme-2014. Accessed: 30th September, 2024.
- Blier P. Generic substitution for psychotropic drugs. CNS Spectr.2009; 14: 1–7.
- Johnston A, Stafylas P, Stergiou GS. Effectiveness, safety and cost of drug substitution in hypertension. Br J Clin Pharmacol.2010; 70: 320–34.
- Crawford P, Feely M, Guberman A, et al. Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure. 2006; 15: 165–76.
- Bulsara C, McKenzie A, Sanfilippo F, et al. Not the full Monty: a qualitative study of seniors' perceptions of generic medicines in Western Australia. Aust J Prim Health.2010; 16: 240–5.
- Heikkilä R, Mäntyselkä P, Ahonen R. Do people regard cheaper medicines effective? Population survey on public opinion of generic substitution in Finland. Pharmacoepidemiol Drug Saf.2011; 20: 185–91.
- Straka RJ, Keohane DJ, Liu LZ. Potential Clinical and Economic Impact of Switching Branded Medications to Generics. Am J Ther. 2017; 24(3): e278-e289.
- Lakkireddy M, Karra ML, Patnala C, al. Efficiency of vitamin D supplementation in patients with mechanical low back ache. J Clin Orthop Trauma. 2019; 10(6): 1101-10.
- Yashwant G, Savita K, Sujata S, et. al. A comparative study of two marketed preparations of Vitamin D for safety and efficacy in Vitamin D deficient children. 2018; 6(12); 970-6.
- Thimma R, Rajkumar A, Abhijit S, et. al. Comparative Efficiency of Three Vitamin D Supplements in Addressing Vitamin D Deficiency in Adults with Chronic Low Back Pain. [Data on File].
- Maheshwar L, Srikanth GG, Malathi RD, et. al. Effect of short term high dose oral vitamin D therapy on the inflammatory markers in patients with COVID 19 disease. Fortune. 2022; 6(4): 623-30.
- Tripathy CD, Kumar R, Krishna LG. Comparative Analysis of Variability in the 25-Hydroxyvitamin D [25(OH)D] Levels in Patients Treated for Vitamin D Insufficiency with Oral Formulations of Vitamin D. [Data on file].
- Roger B, Claudio M, Geert C, et. al. Skeletal and extraskeletal actions of vitamin D: Current evidence and outstanding questions. Endo Rev. 2019; 40(4): 1109-51.
- Sandra W, Karla M, Keith N. Vitamin D and chronic kidney disease. Ethn Dis. 2009; 19(4 Suppl 5): S5-8-11.
- Khadgawat R, Ramot R, Chacko KM, et al. Disparity in cholecalciferol content of commercial preparations available in India. Indian J Endocr Metab 2013; 17:1100-3.
- Roy G Beran. Generic Substitution and Advice to Patients –Potential Legal Medicine Consequences – From A (Australia) to U (United Kingdom or United States of America). Seizure. 2021; 91: 515-9.
- Website of Central Drug Standards Control Organisation, Govt of India. Available at: http://www.cdsco.nic.in/forms/default.aspx. Accessed: 2nd January, 2025.
- Website of Pharmacy Council of India. Available at: http://www.pci.nic.in/Circulars/Pharmacy%20Practice%20Regulations.pdf#page=1&zoom=auto,-104,297. Accessed: 2nd January, 2025.
- Bouillon R, Marcocci C, Carmeliet G, et al. Skeletal and Extraskeletal Actions of Vitamin D: Current Evidence and Outstanding Questions. Endocr Rev. 2019; 40(4): 1109.
- Mazahery H, von Hurst PR. Factors Affecting 25-Hydroxyvitamin D Concentration in Response to Vitamin D Supplementation. Nutrients. 2015; 7(7): 5111-42.
- Garg S, Sabri D, Kanji J, et al. Evaluation of vitamin D medicines and dietary supplements and the physicochemical analysis of selected formulations. J Nutr Health Aging. 2013; 17(2): 158-61.
Corresponding Author
Sangeeta Choudhury
Pulse Pharmaceuticals Pvt. Ltd., Hitech City, Hyderabad - 500 081
DOI: https://dx.doi.org/10.18535/jmscr/v13i01.08
