Objectives: The objective was to check the compliance of regulatory requirements of drug labeling in India according to guidelines given under the Drug and Cosmetic Rules (D & CRs) 1945, Section 96, 97; drug samples were collected from government drug supply and private practitioners (PPs). Materials and Methods: A total of 100 drugs were selected randomly from schedule H. They were divided into two groups, each containing 50 drugs: (1) drug samples from drug store of a government hospital, manufactured for Gujarat government and (2) drug samples from PPs which are given to them by pharmaceutical companies. Each drug label was checked according to the criteria given under the D & CRs 1945, Section 96, 97. Data entry was done in Microsoft Excel 2013 and analysis was done. Results: Major deficiencies were seen in criteria of pharmacopeia (absent in 8% samples from government supply [GS] and 64% in samples from PPs), schedule (absent in 18% GS samples and 32% in PP samples), warning of schedule (absent in 6% GS samples and 4% in PP samples), Rx (absent in 22% GS samples and 28% in PP samples), red line (absent in 14% GS samples), and drug warning (absent in 84% GS samples and 72% in PP samples). Conclusion: As the study results show lacunae in the contents of the labeling of prescribed drugs in samples from both the groups, there should be strict enforcement of D & CR 1945 and monitoring of drug labels for better and safer use of medicines.
Objective: The objective of the study is to study drug utilization in patients with breast carcinoma receiving systemic chemotherapy in government as well as private set-up. Methods: This was a record-based, retrospective-prospective study, analyzing the prescription pattern of drugs used for systemic chemotherapy in patients diagnosed with carcinoma breast at government teaching hospital (GTH) and private trust hospital (PTH) for 1 year in 600 patients. Patient’s demographic, clinical, and therapeutic data were collected from the files and personal interviews and analyzed in Microsoft Excel. Results: Diagnosis of breast carcinoma was highest in age bracket of 40–49 years (32.33% GTH and 32.67% PTH), and the most common presenting symptom was painless lump (76.33% GTH and 83% PTH). In GTH, most frequently prescribed regimen was 4AC → 4T → RT (17.33%). In PTH, most commonly prescribed regimen was 6FEC → RT (19.33%). Highest prescribed drugs were A (32.8%), C (29.12%), and F (20.24%) in GTH and A (32.26%), F (31.68%), and E (16.45%) in PTH. Average number of drugs prescribed per prescription was 12.55 and 11.37; percentage of chemotherapeutic agents prescribed by generic name was 100 and 95.02, and from the WHO essential drug list (2015) was 96.43 and 82.77 in GTH and PTH, respectively (A= Cyclophosphamide, C= Doxorubicin, T=Taxanes [Paclitaxel/Docetaxel], F=5-fluorouracil, E=Epirubicin, RT=Radiotherapy, → followed by, the number indicates chemotherapy cycle). Conclusion: The study results can help in generating local data regarding drug use pattern of the systemic chemotherapeutic agents in breast cancer patients and promote rational drug use.
Background: The objective of the present study was to analyze the prices of metformin, losartan, atorvastatin, paracetamol and aspirin for the doses which are included in the list of Drug Price Control Order (DPCO) 2013.Methods: Current index medical specialties India, 37th year, April-July 2015 issue was used for analysis. The retail prices of the drugs in INR were tabulated in Microsoft Office Excel 2013. The prices of the above listed drugs were compared with prices of DPCO 2013 for the same doses of drugs. The analysis of drugs costing more than the prices listed in the DPCO with the margin of the difference in percentage was carried out.Results: Out of 25 brands of metformin 500 mg tablet, 11 (44%) brands had price higher than listed in DPCO 2013. Similarly, prices for losartan 25 mg and 50 mg tablets, 8 (25%) out of 32 and 11 (31.42%) out of 35 were higher respectively. For atorvastatin 5 mg and 10 mg tablets, 2 (9.52%) out of 21 and 8 (13.55%) out of 59 brands had higher prices. For paracetamol 500 mg tablet, 12 (63.15%) out of 19 brands were priced higher than DPCO list. For aspirin 100 mg tablet and 325 mg tablet, 3 (100%) out of 3 brands and 1 (100%) out of 1 brand had higher prices.Conclusions: Many of the brand formulations have higher prices than the DPCO 2013 issued by government of India. The clinicians prescribing these drugs should be aware of these brand formulations to reduce the cost of the drug therapy.
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