Supplementation of Vitamin C Reduces Blood Glucose and Improves Glycosylated Hemoglobin in Type 2 Diabetes Mellitus: A Randomized, Double-Blind Study

No study has ever examined the effect of vitamin C with metformin on fasting (FBS) and postmeal blood glucose (PMBG) as well as glycosylated hemoglobin (HbA1c) in the treatment of type 2 diabetes mellitus (DM). The goal was to examine the effect of oral vitamin C with metformin on FBS, PMBG, HbA1c, and plasma ascorbic acid level (PAA) with type 2 DM. Seventy patients with type 2 DM participated in a prospective, double-blind, placebo-controlled, 12-week study. The patients with type 2 DM were divided randomly into placebo and vitamin C group of 35 each. Both groups received the treatment for twelve weeks. Decreased PAA levels were found in patients with type 2 diabetes mellitus. This level was reversed significantly after treatment with vitamin C along with metformin compared to placebo with metformin. FBS, PMBG, and HbA1c levels showed significant improvement after 12 weeks of treatment with vitamin C. In conclusion, oral supplementation of vitamin C with metformin reverses ascorbic acid levels, reduces FBS, PMBG, and improves HbA1c. Hence, both the drugs in combination may be used in the treatment of type 2 DM to maintain good glycemic control

Fatal Stevens-Johnson syndrome induced by phenytoin: a case report

Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) are rare (one to two per 10,00,00 population per year) but  life threatening adverse drug reactions. Drugs commonly implicated are anti-epileptics, anti-microbials and non-steroidal anti-inflammatory drugs (NSAIDS). Amongst anti-epileptics, carbamazepine and phenytoin are the major culprits. We report here a fatal case of SJS due to phenytoin

Paracetamol induced fixed drug eruption: a case report

Fixed drug eruption (FDE) is a type of drug-induced skin reaction pattern that characteristically recurs at the same skin or mucosal site. Paracetamol is one of the common drugs prescribed as analgesic–antipyretic agent in all age group of patients. FDE is a well-reported, but uncommon side-effect of paracetamol, usually the classic, pigmenting type most commonly found in children and adolescents. We present a case of 52 years old male patient who developed FDE over the glans penis following paracetamol use

Acute muscle dystonia resulting from medication error: a case report

Acute Muscle Dystonia (AMD) due to medication error is rarely reported in the literature. We are reporting a case of adverse drug reaction due to a single dose of haloperidol. Patient was free from any psychiatric illness and still he developed AMD with use of haloperidol because of medication error. The patient recovered completely from AMD symptoms in one hour after receiving the treatment. This case report intends to improve the awareness among clinicians to be cautious while writing the prescriptions

The irrational fixed dose combinations in the Indian drug market: an evaluation of prescribing pattern using WHO guidelines

Background: Evaluation of the pattern of fixed dose combinations (FDCs) prescribing amongst the practitioners in a tertiary care hospital in Central India. Methods: Nine hundred and ninety four prescriptions, containing 639 FDCs were scrutinized in the tertiary care hospital. After excluding the total and the interdepartmental repetitions, the numbers of FDCs were 278, which were considered for final analysis. Inclusion criteria were FDCs from the major out-patient department (OPD) of the tertiary care hospital from January 2011 to December 2011. FDCs from the wards, casualty, infectious disease unit, intensive cardiac care unit (ICCU), tuberculosis and chest and HIV unit were excluded from the study. FDCs were analysed for the different pattern of prescribing and rationalism. Results were expressed as percentages. Results: Out of 639 FDCs, the most commonly prescribed FDCs were B complex (12.20%), pantoprazole plus domperidone (9.55%) and amoxicillin plus clavulanic acid (7.35%). Seventy percent of the FDCs were prescribed to the age group of 21-60 years. The FDCs were maximum from the department of medicine (25.59%), followed by surgery (15.47%) and ENT 13.69%. Out of 278 FDCs, only 5.4% were rational, and rest of the FDCs were irrational. Ninety five percent of all FDCs were brand names. The physicians were unaware of the active pharmacological ingredients (APIs) of 20.86% FDCs. Ninety two percent FDCs were available as over the counter (OTCs). Forty eight percent FDCs were costing from Rs. 0-50. There were 2.87% FDCs whose price was above Rs. 500.Conclusions: Irrational FDCs are prescribed by all the departments. Physicians were ignorant about the essential drugs and FDCs. Patients didn’t have access to rational medicines. Therefore, physicians and regulators should be alerted in time. Regulatory actions or government laws should be made mandatory. Availability and access to 348 essential medicines for basic health care should be the priority of the government. Implementation of central drug standard control organisations (CDSCO) guidelines on industries for manufacture of FDCs must be made compulsory

Comparison of Indian package inserts in public and private sector: an urgent need for self regulation

Background: Package inserts are the authentic source of information for the new molecules in the market. Incomplete and incorrect product information may promote irrational prescribing and may have serious consequences. Hence, our aim was to analyse and compare the information supplied in the package insert according to the section 6.2 and section 6.3 of schedule D of Drugs and Cosmetic Act, 1940 in public (government) and private (non-government) sector.Methods: Package inserts of allopathic drugs which were supplied by government from drug store of tertiary care centre and hospital and from pharmacies on request were collected. A total of 270 package inserts in English were collected that is 38 from government hospital and 232 from the pharmacies nearby the hospital. The package inserts were analysed for the presentation of completeness of the information as per section 6.2 and 6.3.Results: The presentation of information on analysing 233 package inserts (28 government and 205 non government) was not uniform and it was difficult to locate and retrieve information easily due to lack of common layout and heading. Moreover, the package inserts were of variable shape and size with different font size which made it inconvenient for analysing as well as for reference. Posology and method of administration was incomplete in 3% package insert in non- government cases whereas in government supply it was 7%. Use of drug in pregnancy and lactation was deficient in 11% and 14% packages inserts of non-government sources and government sources respectively. Instructions for use were lacking in 25% and 29% package inserts of government and non-government sources respectively.Conclusions: The need of the hour is to further refine contents of the circulated package inserts to make them complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society

Impact of accreditation on registered ethics committees in terms of quality and governance in India: A cross-sectional study

Background: Ethics Committee accreditation is a process to assess the performance against a set of standards. Very few studies have shown that process of accreditation results in the improvement of the overall functioning of ECs. in terms of quality and governance. Hence, the present study was planned to evaluate the impact of accreditation on registered EC in terms of quality and governance and to compare functioning of accredited versus non accredited EC in terms of quality and governance. Materials and Methods Study Design: This was a cross sectional, observational, questionnaire-based survey conducted on 28 registered Ethics Committee in India after approval from the Institutional Ethics Committee. Results: Accredited EC’s (n = 12) were compared for NABH standard for accreditation before and after accreditation in terms of percentage. It was found that majority of the standards related to structure and composition, adherence to specific policies , completeness of review and after approval process were met by majority of EC’s after accreditation. Only a few EC ‘s fulfilled some of the criteria before accreditation. There was a statistically significant difference with reference to adherence to specific policies by accredited and non-accredited EC’s like updating SOP according to changing requirements (P < 0.0237), process for preparing SOP (P < 0.0237), categorization of review process mentioned in SOP (P < 0.0237) procedure to be followed for vulnerable population (P < 0.0103) , process of handling issues related to complaints by participants and other stakeholders violation (P < 0.0103) etc. Conclusion: Accreditation results in improving of EC functioning in terms of quality and governance

Analysis of clinical trial agreement and insurance policy submitted to the ethics committee of a tertiary care teaching institute in central India

Purpose: Very few studies conducted in India have analyzed insurance policies and clinical trial agreement (CTA) submitted to ethics committee (EC). This study was conducted to review and find out deficiencies in it. Materials and Methods: This was a retrospective observational study. All the protocols for regulatory clinical trials and academic research sponsored by the Indian Council of Medical Research or other funding agency were included. Insurance documents and CTA submitted with the study protocols were analyzed. Results: A total of seventy CTA and insurance policies were analyzed. CTA mentioned that parties involved in 60 (86%) forms, scope of the agreement in 15 (21%) forms, responsibilities of the party in 68 (97%) forms, and payment details in 58 (83%) forms. Nearly 88.5% of the insurance policies mentioned whether the policy covers the participants for injury due to all clauses and 91% of the policies mentioned the validity period of insurance. Conclusion: It was found that both the documents contained almost all the required elements. This was probably because this institutional EC insisted on and thoroughly reviewed the documents to ensure that adequate compensation of research-related injuries has been provided for and this fact is informed to the trial subject. As very few studies are available in the literature, we could not compare majority of the findings of this study with others

Comparison of safety, efficacy, and cost effectiveness of benzyl benzoate, permethrin, and ivermectin in patients of scabies

Objective: To compare three treatment modalities in scabies for safety, efficacy, and economy in a local population of Nagpur. Materials and Methods: This was a prospective, randomized, comparative clinical trial conducted in 103 participants, randomly allocated to three groups. First group received benzyl benzoate (BB) 25% lotion, second group received permethrin 5% cream, whereas third group received tablet ivermectin 200 µg/kg as a single dose. The participants were recalled after one week for follow-up evaluation. If there were no signs of cure, the same intervention was repeated. The participants were followed up for two weeks for cure rate, adverse drug reaction (ADR) monitoring, and postintervention observation. The follow-up was stopped after two weeks. Statistics: Fischer′s exact test using Graph pad Instat v 3.05. Results: Ivermectin showed 100% cure rate after two weeks of treatment. Permethrin decreased pruritus by 76% at the end of one week and had significantly better cure rate than ivermectin. At the end of two weeks treatment, this finding was reversed, that is, cure rate in ivermectin group was 100%. For cost-effectiveness analysis, treatment regimens were formulated hypothetically for comparison from Markov population tree for decision analysis. It was found that BB and ivermectin each consecutively for two weeks were most cost effective regimens giving complete cure in four weeks, while ivermectin was the fastest regimen giving the same results in two weeks. Conclusion: Benzyl benzoate as first line intervention and ivermectin in the remaining gave best cost-effective results in the study patients of scabies