A qualitative and quantitative comparison of adverse drug reaction data of anti-epileptic drugs in various sources of drug information

Background: It is essential to spread awareness about known adverse drug reactions (ADRs) for identification, prevention and their proper management. The aim of this study is to assess disparities in documented ADRS of antiepileptic drugs in various sources of drug information.Methods: An observational, cross sectional study was done to compare different drug information sources for ADRs. Six sources of information namely: National Formulary India (2011), Drug Today (2018), Current index of medical specialties (CIMS), and some textbooks like Lippincott’s illustrated reviews: Pharmacology (2012), Brenner and Stevens' Pharmacology (2018) and George and Goodman and Gilman's (GG): The pharmacological basis of therapeutics (2018) were critically analysed for ADRs of a total of 34 drugs. Prototype drugs and most commonly prescribed antiepileptic drugs, were chosen for study. They were categorized according to therapeutic classification and guidelines by Indian Society of Epilepsy. ADRs were categorized according to various body systems, and serious and life threatening ADRs, then were tabulated and compared. Qualitative and quantitative analysis of this data was also done.Results: None of analysed sources mentioned all antiepileptic drugs. GG contained information for maximum number of drugs studied (76.4%) and National Formulary of India gave information for (52.9%) drugs only. There was wide variability among various resources while listing ADRs. CIMS listed maximum number of ADRs (85.5%) while minimum was included in Brenner and Stevens' Pharmacology (13%) for all antiepileptic drugs. The quality of data though limited was relatively better in CIMS, but none of sources studied were found to be complete.Conclusions: No source of information provided complete information about adverse effects of all 34 anti-epileptic drugs. Academicians and policymakers can work towards providing complete ADR information in all sources of information and updating it from time to time. Thus, making drug use safer in patients of epilepsy

A prospective, randomised, open label study to compare efficacy and safety of hydroxychloroquine and teneligliptin in patients of type 2 diabetes mellitus refractory to concomitant metformin and glimepiride

Background: Diabetes mellitus is chronic, metabolic disease characterized by hyperglycemia, which over time causes both microvascular and macrovascular complications. If HbA1c target is not achieved with dual therapy then 3rd drug is added. Aims of present study were to compare efficacy and safety of Hydroxychloroquine (HCQ) and Teneligliptin in patients of T2DM who are refractory to concomitant Metformin and Glimepiride. Methods: It was interventional, randomized, prospective, parallel and open-label study. Patients were randomly divided into 2 groups either HCQ 400mg OD or Teneligliptin 20mg OD were added to their current treatment using Metformin 1gm BD and Glimepiride 4 mg OD as 3rd drug. Follow up was done every 15 days for 12 weeks and underwent assessment of glycaemic parameters (FBS, PPG, HbA1c), LFT, RFT, CBC, ADRs and VAS in addition to anthropometric parameters. Results: After 12 weeks of treatment, HCQ group showed statistically (p<0.05) better improvement in BMI than Teneligliptin group. Both groups showed comparable improvement (p>0.05) from baseline in FBS, HbA1c, PPG and VAS score. In HCQ group there was significant number (p<0.05) of patients who achieved target glycaemic control (HbA1c ≤7.5%) i.e., 56.6%, compared to 37% with Teneligliptin group. Both groups had comparable (p>0.05) safety profile with no serious adverse effects and no significant change (p>0.05) in hepatic, renal and complete blood profiles. Conclusions: On the basis of effects of HCQ on the glycaemic parameters and BMI, HCQ may be preferred over Teneligliptin in patients of T2DM who are refractory to concomitant Metformin and Glimepiride

A critical evaluation of information in drug promotional brochures for validity as per WHO criteria

Background: Promotion of drugs through publication of promotional literature is a standard practice of pharmaceutical companies. This study is aimed at critically analyzing the drug promotional brochures.Methods: Observational study was conducted in Department of Pharmacology, Government Medical College Amritsar according to WHO guidelines. 100 brochures of different pharmaceutical companies were collected at random from various OPDs of a tertiary care hospital.Results: Only 14 % of total brochures demonstrated overall adherence to WHO guidelines. Safety information was lacking in 88%. Irrelevant pictures were found in 66% brochures while relevant illustrated information was included in only 23 % of brochures. Out of total illustrations found relevant (n=44), 45.5% did not quote any reference, and results didn’t match with original study in 11.4%.Conclusions: Our study points towards big lacuna in drug promotional brochures, an important source of drug information. Low percentage of adherence to the guidelines in the study reflects commercial interest of pharmaceutical companies and lack of will to correctly disseminate the drug related information

Evaluation of indoor prescriptions of depression in psychiatry department of a tertiary care hospital in North India

Background: Depression is one of most common psychiatric illnesses affecting the human population and poses significant economic burden to society. Prescription for depression usually involves multiple medications sometime irrationally prescribed.Methods: Present study involved evaluation of 65 indoor prescriptions of patients diagnosed with depression from Psychiatry Department in a tertiary care hospital. The prescriptions were evaluated on basis of WHO Core Indicators for writing a good prescription. The demographic characteristics of the patient population were studied. Number of drugs prescribed per prescription and the average number per prescription were calculated to assess polypharmacy. The cost involved in treatment using latest market data from drug information source and the rationality of prescriptions were also evaluated.Results: 80% of the prescriptions were not in accordance with the WHO Core Indicators. An average of 2.415±1.102 medications were prescribed per prescription indicating polypharmacy. Insignificant difference was observed in cost per prescription per month of medicines when compared with lowest priced products available in market.Conclusions: Polypharmacy was found in most prescriptions and monotherapy was instituted in five prescriptions only, with clonazepam as the most prescribed antidepressant drug. Majority of prescriptions did not conform to WHO core indicators for prescription writing

A study of vitamin D supplementation with directly observed treatment short course for Pulmonary Tuberculosis

Background: Tuberculosis remains one of major global health problems due to growing resistance in TB bacilli against anti-tubercular treatment (ATT). Vitamin D3 has been reported to have immunostimulatory effect. Aim was to study effect of Vitamin D3 on efficacy and safety of ATT / Directly Observed Treatment, short course regimen.Methods: Prospective, randomized and interventional study of 90 days was carried out in 60 newly diagnosed sputum positive pulmonary tuberculosis patients on DOTS strategy. Study was conducted in Government Medical College, Amritsar, Punjab, India. 30 patients each were randomly divided into two groups, A and B, with group A - vitamin D3 and DOTS regimen and Group B - DOTS alone. Patients were evaluated on day 0, 30, 60 and 90 by TB score, sputum microscopy, laboratory investigations, and adverse drug events. At the end of 90 days, results were tabulated and data analyzed statistically applying relevant tests.Results: Statistically non-significant improvement in symptoms, sputum conversion and decrease in mean TB scores was seen in Group A vs B at 90 days. Significant increase in mean Vitamin D levels was seen in Group A at end of study. Insignificant difference in safety profile was observed in group A which showed additional adverse events suspected to be due to Vitamin D. Equivocal hepatoprotective effect of Vitamin D was observed.Conclusions: Vitamin D as adjuvant to ATT does not confer additional benefit to newly diagnosed pulmonary tuberculosis patients. Large multi-centric trials are required to find any benefit of Vitamin D supplementation with ATT

A Critical Analysis of Claims and Their Authenticity in Indian Drug Promotional Advertisements

Introduction. Drug promotional advertisements (DPAs) form a major marketing technique of pharmaceutical companies for promoting their products and disseminating ambiguous drug information which can affect prescribing pattern of physicians. Drug information includes product characteristics, various marketing claims with references in support to increase its credibility and authenticity. Material and Methods. An observational study was carried out on fifty printed drug advertisement brochures which were collected from different OPDs of Guru Nanak Dev Hospital attached to Government Medical College, Amritsar, India. These advertisements were analyzed and claims were categorized into true, false, exaggerated, vague, and controversial on criteria as reported by Rohraa et al. (2006). References of DPAs in support of the claims were critically analyzed for their retrievability from web and validity pertaining to claims. Results. Out of 209 claims from 50 advertisements, only 46% were found to be true, 21% false, 16% vague, 7% exaggerated, and 10% controversial in nature. Out of 160 references given in support of claims, 49 (30%) of references were irretrievable. Out of 111 (70%) retrievable references, 92 (83%) references were found valid. Conclusion. Drug information provided in the DPAs was biased, incomplete, unauthentic, and unreliable with references exhibiting questionable credibility

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