REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-ULTRAVIOLET-BASED APPROACH FOR METHOD DEVELOPMENT AND VALIDATION OF LACOSAMIDE ESTIMATION IN HUMAN SERUM

Objective: The main aim of the study was to develop and validate a simple, accurate, and rapid isocratic reverse phase high-performance liquid chromatographic method with UV detection for the determination of lacosamide, an antiepileptic agent, in human serum. Methods: Chromatographic separation was performed using a reverse phase chromatographic column (Zorbax SB-C18, 5 μm 4.6×250 mm) with a mobile phase being a mixture of potassium dihydrogen phosphate buffer (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile (ratio of 83:17 v/v) at a flow rate of 1.2 mL/min. UV detection was carried out at 210 nm and the sample temperature was maintained at 4°C. Results: Linear calibration curves in the range of 1.012–40.894 μg/ml gave a correlation coefficient of 0.9988. The intra-day (n=6) and inter-day (n=18) precision (expressed as relative standard deviation) were in the range of 0.79–2.485% and from 0.99 to 3.21%, respectively. The retention time (in minutes) of lacosamide and internal standard was approximately 8.785±0.19 and 3.985±0.77, respectively, with no matrix interference. The method was validated for system suitability, specificity, precision, accuracy, robustness, linearity, limit of detection, and limit of quantification following the International Conference on Harmonization guidelines. The method was further validated using sera of epileptic patients consuming lacosamide, and it was observed that the results matched with the patients’ clinical response. Conclusion: Our method developed to estimate serum lacosamide level is simple, cost-effective, and reliable for therapeutic drug monitoring

Evaluation of the efficacy of Brahmi ghrita in scopolamine induced amnesia in rats using Cook’s pole apparatus

Background: Memory is the process, in which information is encoded, stored, and retrieved. Age, overstress, emotions can result in an impairment of memory. This may also be a symptom of various neuro-degenerative disorders. The objective of this study was carried out to evaluate the effect of pre-treatment of Brahmi ghrita on scopolamine-induced amnesia in rats using cook’s pole apparatus.Methods: Following Institutional Animal Ethics Committee permission, the study was conducted in Wistar rats (150-225 gms) of either sex. Brahmi ghrita (450 mg/kg) was administered for 15 days as a pre-treatment. Scopolamine (30 mg/kg bw, i.p.) was injected on day 16 and the effect of Brahmi ghrita was studied using Cook’s pole apparatus. Parameters assessed were number of conditional avoidance responses (CAR), unconditional responses and no response out of 30 sessions, serum MDA, and brain MDA and brain acetylcholine esterase (AChE) activity. Piracetam, a known nootropic was used as a positive control.Results: Scopolamine as expected showed a decrease in CAR as compared to normal control after 4 hours and, after 24 hours. Brahmi ghrita significantly improved the conditioned avoidance response (CAR), at both 4 and 24 hours, demonstrating its memory protective effect. Piracetam also showed decrease in CAR. Brahmi ghrita improved the serum and brain MDA levels significantly as compared to the Scopolamine. However Piracetam further augmented the oxidative stress induced by scopolamine. Brahmi ghrita also decreased the AChE activity (increased by scopolamine administration) emphasizing its memory protective effect. Piracetam was seen to increase the AChE activity.Conclusions: Thus, the study demonstrated the efficacy of Brahmi ghrita as an anti-amnestic, anti-oxidant and AChE inhibitor

Cost analysis of critical patient care at a pediatric intensive care unit of a tertiary care public hospital in an urban metropolis of India

Background: The cost of critical care is widely recognized as being high. However, it remains a challenge to accurately assess the cost of intensive care due to a lack of standardized methodology. There is also considerable heterogeneity with regard to allocation of resources and distribution of critical care services.Methods: We conducted a prospective study to analyse diagnosis-based costs of paediatric patient care at a pediatric intensive care unit (PICU) in a public hospital in Mumbai on the basis of identified cost components; direct (fixed and variable) and indirect costs.Results: Out of 167 (102 boys, 61%) patients enrolled, 65 (39%) were aged 1-7 months. They spent an average of 4±1.46 bed days in the PICU. The cost of direct fixed components (salaries, capital equipment, disposables) was Rs. 64,48,200 for six months. The maximum cost of direct variable components spent by the hospital (physiotherapy intervention, expert opinion, investigations, medicines, blood products, piped gases) amounted to Rs. 548.63/patient/day for treatment of non-infectious diseases. Cost of indirect components (building maintenance) was Rs. 12,500/six months. Linear regression analysis showed 83-99.99% dependency of treatment cost to diagnosis and bed days. The average cost of treatment of infectious and non-infectious diagnoses/patient/day spent by the hospital was Rs. 260 and Rs. 548.63 respectively as compared to Rs. 169.96 and Rs. 356.21 spent by the patients.Conclusions: Our study showed that majority of the treatment costs depended on the diagnosis and number of bed days of the patients. Also being a tertiary care public hospital, 60% of the treatment costs were borne by the hospital. Thus, our study attempts to quantify, in financial terms, the expenditure involved in running a paediatric ICU in a tertiary care public hospital so as to assist doctors and healthcare decision makers in the allocation of resources

A QUESTIONNAIRE BASED SURVEY TO ASSESS THE KNOWLEDGE, ATTITUDE AND PRACTICES OF AYURVEDIC PRACTITIONERS TOWARDS MASANUMASIK KASHAYAS

For a healthy pregnancy and delivery of a normal child, different group of medicines taken for each month of pregnancy is described in Ayurveda as Masanumasik Kashayas (monthly antenatal decoctions). Objectives: To assess the knowledge, attitude and practice of Ayurvedic practitioners regarding Masanumasik Kashayas. Methodology: Following ethical approval, a cross-sectional descriptive survey was conducted among Ayurvedic physicians from Mumbai region. Results: Of 130 questionnaires distributed, 120 physicians responded (92%). Although all the physicians were aware that Masanumasik Kashayasare described in the Samhitas, only 60% knew the number of Kashayas (decoctions). 85% knew the rationale for prescribing these Kashaya s(decoctions) and 93% agreed that these Kashayas (decoctions) improved pregnancy outcome. However, in clinical practice, 45% participants said that they prescribed Kashayas (decoctions) only in patients with bad obstetric history while 52.5% prescribed in regular ante-natal care. 83% preferred Vati (tablet) form rather than Kashaya (decoction) as patient compliance was better. All physicians who prescribed said that there were no adverse complaints and the pregnancy outcome was good. Conclusion: The study thus showed that all Ayurvedic practitioners were still well versed with Masanumasik Kashayas and prescribed these kashayas (decoctions) for a good pregnancy outcome in clinical practice with some modifications like usage of only 9 Kashayas (decoctions) and Vati form (tablet)

A double blind, randomized, placebo controlled, phase IV, proof-of-concept, comparative study to evaluate the efficacy and safety of Swasawin asthaloc tablets when given as add-on therapy in patients suffering from mild to moderate persistent bronchial asthma

Background: Asthma, known as “Tamaka Shwasa” in Ayurveda, as a chronic inflammatory disorder of the airways associated with increased airway hyper-responsiveness, recurrent episodes of wheezing, breathlessness, chest tightness and coughing, particularly at night/early morning. The key component to improving control and preventing attacks is the avoidance of triggers. Swasawin Asthaloc tablet, a polyherbal proprietary medication, is claimed to be effective in asthma. The Objective of the study was to evaluate the safety and efficacy of Swasawin Asthaloc tablets when given as add-on therapy to patients suffering from mild to moderate persistent bronchial asthma.Methods: The study was initiated after receiving Institutional Ethics Committee approval. Patients suffering from mild-to-moderate persistent bronchial asthma were randomized to 2 study groups after written informed consent process for 6 months. Group I received the study medication Swasawin Asthaloc tablet (1 tablet twice daily) in addition to regular anti-asthmatic medications (inhaler ± oral medications). Group II received Placebo tablets in a similar dose as add-on therapy. The study efficacy parameters included spirometry, breath holding time (BHT), Asthma symptom score and Ayurvedic Asthma symptom score.Results: 60 patients were enrolled in the study, of which 50 patients completed the study. In case of spirometry, both FEV1 and PEFR values showed statistically significant improvement at the end of 6 months therapy. Significant improvement in the Breath Holding Time (BHT), Ayurvedic Asthma symptom score and Asthma symptom score was observed in the active group as compared to the baseline (p <0.001).Conclusions: Add-on therapy with Swasawin Asthaloc tablets helped in reducing bronchial inflammation and improving asthmatic symptoms by virtue of its anti-inflammatory, bronchodilatory and antihistaminic properties. Hence it can be used as add-on therapy in patients with mild-to-moderate persistent bronchial asthma and may decrease the need for rescue medications especially steroids

Assessment of the degree of awareness among post-graduate medical physicians and Pharmacists about look-alike, sound-alike drug and potential medication errors

Background: With thousands of drugs currently in the market, the potential for medication errors due to confusing drug names amongst practising physicians, pharmacists and patients is significant. The existence of confusing drug names is one of the most common causes of medication error. There are many look-alikes, sound-alike (LASA) combinations that could potentially result in medication errors. There is insufficient data about medication errors due to LASA. Hence, we conducted the present study to determine the degree of awareness regarding LASA drugs among post graduate medical physicians and Pharmacists.Methods: This study was a cross-sectional, questionnaire-based survey, conducted among 137 year post graduate medical residents of a tertiary care teaching hospital and 121 local pharmacists in an urban metropolitan Indian city.Results: There were 34% resident doctors and 17% pharmacists were aware of concept of LASA drugs. Only 46% resident doctors and 22% pharmacists had knowledge about the full form of LASA. Among resident doctors, 39% came across prescription errors due to LASA drugs. Only 69% of the pharmacists agreed that they consulted their doctors when they faced problems due to prescription errors due to similar looking and similar sounding drugs.Conclusions: Look-Alike, Sound-Alike (LASA) drugs are common source of medication errors. Our study suggests that there is lack of awareness about LASA drugs amongst resident doctors and pharmacists, which may contribute to occurrence of medication errors. Therefore, combined efforts by prescribers, pharmacists, organizations, manufacturers and patients is required to overcome medication errors due to LASA drugs

Understanding the degree of awareness among medical professionals regarding the ethics of pharmaceutical marketing activities in context of revised medical council of India code of ethics

Background: Pharmaceutical marketing activities are regarded as ethically challenging by most medical professionals. This study was planned to understand the extent of the interaction of pharmaceutical companies with healthcare providers & to determine the level of awareness about the ‘Medical Council of India (MCI) Code of Ethics’.Methods: A questionnaire based survey was conducted among 100 consultants and residents. The questionnaire mainly dealt with ethical issues about accepting free gifts, medicines and other sponsorships from pharmaceutical representatives, interactions and expectations from representatives of pharmaceutical companies by doctors and ascertaining among them the level of awareness about the MCI’s code of ethics.Results: 59.4% residents and 58.8% consultants do not consider small gifts (stationery/books/drug samples) as ethically problematic. 88% residents and 85% consultants felt that offers should be limited. 72% of consultants were aware of the revised MCI code of ethics as compared to 28% of residents.Conclusions: Most physicians do maintain a code of ethics with regards to accepting gifts and they felt that inexpensive gifts do not influence clinical judgment. Consultants were of the view that amended MCI code of ethics would not affect their clinical practice significantly

Drug-Induced Severe Cutaneous Adverse Reactions, Diagnostics and Management

Severe cutaneous Adverse Reactions (SCAR) are rare drug hypersensitivity reactions but can be life-threatening if not appropriately and timely managed. Many research studies have shed light on its pathomechanism and triggers that have helped us better understand SCAR. The presence of viral fever and genetics such as HLA genotype with certain drugs have been associated with the occurrence of SCAR. However, the basis of interaction of these causative agents needs further evaluation to understand the predisposition to the reaction occurrence. The different spectrum of SCAR needs to be clinically diagnosed appropriately which includes Drug Reactions with Eosinophilia and Systemic Symptoms (DRESS), Steven Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN), Acute Generalized Exanthematous Pustulosis (AGEP), and generalized bullous fixed drug eruptions (GBFDE). However, due to the rare occurrence of this reaction, there is not sufficient evidence for the best treatment for patients suffering from SCAR. Our review provides detailed information about the disease type, manifestation, pathophysiology, diagnostics, and current treatment aspects of SCAR