Articles

  1. Pattern of adverse drug reactions reported at a tertiary care teaching hospital in north east India: a retrospective observational study conducted under pharmacology department Download Article

    Datta M, Majumdar G, Ghosh R, Das L
    • Type: Research Article
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    • Pages (304-312)
    • No of Downloads: 42

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    Background

    Adverse Drug Reactions (ADRs) are commonly encountered at hospitals where poly pharmacy is practiced due to increased chances of drug interactions. Nowadays there is growing interest in reporting ADRs. Yet, there is a paucity of data regarding adverse drug reaction monitoring in India.

    Aim

    The present study was done to analyze all the reported ADRs at Tripura Medical College & Dr. BRAM Teaching Hospital (TMC).

    Materials & Methods

    A retrospective, observational study of all the reported cases of ADRs that occurred in both Outpatients Departments (OPD)&In patients Departments(IPD) at TMC in last 18 months (Jan 2017 to June 2018) are included in the study. All the ADRs that were reported by different OPDs & IPDs were recorded in Suspected Adverse Drug Reaction Reporting Forms of Indian Pharmacopoeia Commission (IPC). The reports were recorded as per the standard guidelines fixed by Pharmacovigilance Programme of India (PvPI). WHO-UMC scale was used to assess the causality of suspected ADRs.

    Results/observations

    A total of 204 ADRs were reported from 177 patients. Out of 177 patients, 30 patients were admitted in IPD with different ADRs, 55 ADR cases were treated in OPD and 82 patients developed ADRs during their hospital stay with other ailments. Adult male patients were mostly affected.  Commonest form of manifestation was skin & appendages disorders, second common is gastrointestinal system disorders followed by psychiatric& nervous system disorders.  Maximum cases had mild reactions that recovered after discontinuation of medications, two patients had disability and nine patients developed life threatening ADRs that needed intensive care with prolonged hospital stay.

    Conclusion

    The present study shows ADRs are commonly encountered at this tertiary health care set up. Many ADRs are life threatening type B reactions, but the higher incidence of type A reactions means that these can be avoided.

  2. Losartan in management of hypertension in children Download Article

    Dr. S. Umamaheswara Raju, Dr. J. Margaret Viola, Dr P. Raghunadha Rao
    • Type: Research Article
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    • Pages (313-319)
    • No of Downloads: 28

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    Background

    An increasing number of healthy children and  adolescents  across  the  world  are being   diagnosed   with   hypertension, which  is  an  emerging  problem  that  no pediatrician can afford to ignore. Hypertension in children is defined as systolic BP (SBP) and/or diastolic BP (DBP) ≥95th percentile for sex, age, and height on ≥3 occasions. It occurs in 1%–10% of children and adolescents and, at younger ages, frequently has a cardiac or renal cause. Losartan, an Angiotensin II Receptor Blocker (ARB), is an antihypertensive therapy with demonstrated benefit in children.

    Objectives

    Once-daily Losartan reduces Blood Pressure in a dose-dependent manner and is well tolerated in hypertensive children aged 6–16 years. This study assessed the dose-response relationship, safety, and tolerability of Losartan in hypertensive children aged 61 year to 5 years.

    Design

    This was a 10-week, randomized, open-label, dose-ranging study.

    Duration

    One year (November 2016 - December 2017)

    Setting

    Gandhi Medical College, Hyderabad.

    Participants

    Sixty patients diagnosed at Gandhi Medical College, Hyderabad.

    Methods

    Patients were randomized to Losartan at the following dosages: 0.1 mg/kg per day (low), 0.3 mg/kg per day (medium), or 0.7 mg/kg per day (high). Losartan was titrated to the next dose level (to a 1.4 mg/kg per day maximum dosage, not exceeding 100 mg/d, which was not one of the three original doses offered at randomization) at weeks 3, 6, and 9 for patients who did not attain their goal BP and were not taking the highest dose. Dose response was evaluated by analyzing the slope of change in sitting systolic BP (SBP; primary end point) and diastolic BP (DBP; secondary end point) after 3 weeks compared with baseline. Adverse events (AEs) were recorded throughout.

    Mean sitting BP decreased from baseline in the low, medium, and high-dose groups by 7.2, 7.4, and 6.8 mmHg, respectively, for SBP and 8.0, 5.2, and 6.7 mmHg, respectively, for DBP after 3 weeks. No dose-response relationship was established by the slope analysis on SBP (P=0.74) or DBP (P=0.63). The BP-lowering effect was observed throughout the one year extension.

    Conclusions

    Hypertensive children aged 1 year to 6 years treated with Losartan 0.1–0.7 mg/kg per day had clinically significant decreases from baseline in SBP and DBP, yet no dose-response relationship was evident. Losartan, at a dosage up to 1.5 mg/kg per day, was well tolerated.

  3. A study to evaluate the effect of proton pump inhibitors (PPI’S) on vitamin d levels Download Article

    Dr. Syed Arshaduddin Ahmed, Dr. P. Srujana
    • Type: Research Article
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    • Pages (320-326)
    • No of Downloads: 37

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    Background

    Proton pump inhibitors (PPI's) remain the superior choice worldwide in antisecretory therapy in the evidence-based treatment of upper gastrointestinal disorders including gastroesophageal reflux disease, erosive esophagitis, dyspepsia and peptic ulcer disease. Nonjudicious use of PPIs creates both preventable financial as well as medical concerns. PPIs have been associated with an increased risk of vitamin and mineral deficiencies.

    Objective

    To study the effect of Proton Pump Inhibitors (PPI’s) effect on vitamin D levels.

    Design

    A study To evaluate the effect of PPI's on vitamin D levels in patients who were treated for vitamin D deficiency.

    Duration

    February 2017 to July 2017.

    Setting

    Participants

    One hundred patients treated for vitamin D deficiency at

    Methods

    100 patients were included in the study. 40 patients were taking PPI at the time and during the study. 60 patients were not on any medications. Results were assessed by improvement in repeat serum 25(OH) vitamin D levels obtained after replacement therapy. Demographics, vitamin D levels, medical history and medication lists were obtained. Percentage increase in 25‐OH vitamin D levels from baseline was considered the end point. Results were compared between the two groups. Statistics include unpaired t-test done to compare two groups of subjects and p value less than 0.05 was considered statistically significant.

    Results

    The mean improvement in 25(OH) vitamin D levels for the “PPI” group was 40.9% with a mean raw difference of 9.1. “No PPI” group demonstrated a mean improvement of 59.1 % with a mean difference of 13.8. The improvement in 25(OH) vitamin D levels in the "no PPI" cohort was 64.2% greater than those taking a PPI.

    Conclusion

    PPIs are associated with an increased risk of vitamin D deficiency impacting vitamin D metabolism.

  4. An experimental study on antidepressant activity of methanolic extract of momordica charantia leaves Download Article

    A Haseeb, F Ahmad, A Kumar
    • Type: Research Article
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    • Pages (327-335)
    • No of Downloads: 24

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    Background

    Momordica charantia commonly known as Karela is widely known for its medicinal properties. Its Antidepressant activity is least evaluated. Depression being common psychiatric illness of all age groups. Currently available Antidepressants have their own limitations. The antidepressant activity of Momordica Charantia leaves was evaluated in this study.

    Aim

    The aim of this study is to evaluate the Antidepressant activity of Methanolic extract of Momordica Charantia leaves.

    MATERIAL and METHODS

    This study was done in Department of Pharmacology, JNMC, AMU. Antidepressant activity of MEMC (Methanolic extract of Momordica Charantia leaves) . at doses of 100mg/kg, 200 mg/kg and 300 mg/kg was evaluated in Swiss Albino mice and Albino Wistar rats in Tail suspension test, Forced swim test, Spontaneous motor activity, Learned helplessness test and 5-Hydroxytryptophan induced Head Potentiation tests.

    Results

    MEMC exhibited antidepressant activity by significantly decreasing the immobility time in Tail Suspension test in all doses and in doses of 200 mg/kg and 300 mg/kg in Forced swim test. No significant increase in Spontaneous motor activity was seen in all three doses ruling out psychostimulant activity. In Learned Helplessness test number of Escape failures was decreased at doses of MEMC 200 mg/kg and 300 mg/kg. Increase in Head twitches was seen in both MEMC 200 mg/kg and 300 mg/kg in 5-Hydroxytrytophan induced Head Potentiation in mice.

    Conclusion

    Antidepressant activity was exhibited by Methanolic extract of Momordica Charantia leaves in animal models of Depression.

  5. Effects of local anesthesia with adrenaline on blood pressure and pulse rate of healthy and hypertensive patients undergoing tooth extraction Download Article

    Dr. P. Srujana, Dr. Syed Arshaduddin Ahmed
    • Type: Research Article
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    • Pages (336-339)
    • No of Downloads: 25

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    Background

    Local anesthesia (LA) is the most common form of anesthesia that is used in most dental procedures. It is almost unavoidable in many dental treatments. Lidocaine is usually used with epinephrine in a single cartridge. Epinephrine is added to lidocaine to reduce toxicity, prolong duration of anesthesia and control bleeding. A common belief in medicine, dentistry and even among the patients is that the use of epinephrine is contraindicated in cardiovascular patients as epinephrine suddenly raises the blood pressure (BP) and hearth rate (HR).

    Objective

    The aim of this research is to study the effects of Local Anaesthesia containing adrenaline (vasoconstrictor) on Blood pressure and pulse rate in hypertensive patients and to ascertain the safety of using Local Anaesthesia with adrenaline in such patients.

    Design

    A prospective cross sectional study to analyze the effects of Local Anaesthesia containing adrenaline (vasoconstrictor) on Blood pressure and pulse rate in hypertensive patients

    Duration

    October 2016 to December 2017.

    Setting

    Osmania General Hospital, Hyderabad.

    Participants

    The study was conducted on 200 patients who underwent dental extraction at Osmania General Hospital, Hyderabad.

    Methods

    Out of 200 patients, 100 patients were normotensive patients with systolic blood pressure of <120 mm of Hg and diastolic blood pressure of < 80 mm of Hg and remaining 100 patients were Hypertensive patients out of which 50 patients had Stage I Hypertension (SBP 140 – 159 mm of Hg & DBP 90 – 99 mm of Hg) and 50 patients had Stage 

    II Hypertension (SBP >160 mm Hg & DBP >100 mm Hg). All patients were given Inferior Alveolar Nerve Block followed by Lingual & Long Buccal Nerve Blocks with 2% Lignocaine with 1:2, 00,000 Adrenaline. The Blood pressure and pulse rate were recorded 6 times.

    Results

    All patients showed a considerable increase in Systolic and Diastolic BP recorded at 2 minutes but gradually showed a reduction until 60 minutes post-operatively. The pulse rate also demonstrated a sudden increase followed by gradual reduction to preoperative level.

    Conclusion

    All patients demonstrated a considerable increase in blood pressure and pulse rate but not significantly which may be attributed to stress induced due to dental extraction.

  6. A study on appropriateness of prescribing pattern in geriatric patients with multiple co-morbid conditions Download Article

    Dr. Shivashankar V, Nidhiya Rose J Aruparayil, Nimitha Ann Ipe, Priscilla Ann Prasad, Prisella Mathew
    • Type: Research Article
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    • Pages (340-346)
    • No of Downloads: 18

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    Geriatrics is the group of people who experience many complex health problems. Poly pharmacy increases the incidence of ADRs, drug interactions, non-compliance which leads to increase in hospital admissions and thus increase health expenditure. Therefore, studies on the assessment of appropriateness of prescribing pattern and drug therapy in elderly particularly in our country are needed to better support decision making process. The study can also give insight into trends in using drugs in elderly and in treating their co-morbid conditions. 

    The objectives of the study are to analyse the appropriateness of prescribing pattern in geriatric patients with multiple co-morbid conditions in the selected study population as per inclusion criteria. A prospective observational study was conducted. The data was collected during regular ward rounds and was analyzed. The appropriateness of the prescription was analyzed by using the Beers criteria. WHO core prescribing indicators was used to analyze the prescribing pattern.

    A total of 120 patients were included in the study. The analysis of appropriateness of prescribing pattern as per Beers Criteria shows that 45 (37.5%) were found to be appropriate and 75 (62.5%) were found to be inappropriate prescriptions. A total number of 153 medications prescribed were found to be potentially inappropriate for geriatric use as per Beers criteria. Analyzing prescriptions as per WHO core prescribing indicators were done, the results reveals that there was an average of 12.92 drugs per prescription,  102 (6.58%) drugs were prescribed by generic name, percentage of encounters with antibiotics was 77.5% and percentage of encounters with injections prescribed were 98.3%. From these results, the prescriptions were found to be irrational according to WHO core prescribing indicators. A key role can be played by the clinical pharmacist to manage drug therapy in collaboration with prescribers for preventing drug related problems resulting from inappropriate medication use in geriatric patients. The study concluded that close monitoring of prescriptions can help to avoid majority of drug related problems and improving the quality of care among the geriatric patients.

  7. Comparative analysis of distribution patterns of research protocol: a retrospective, observational study Download Article

    Palvi Kudyar, Roshi, Vishal R. Tandon, Brij Mohan Gupta
    • Type: Research Article
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    • Pages (347-353)
    • No of Downloads: 27

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    BACKGROUND

    Before starting any research study, a review and approval by Institutional Ethics Committee and Institutional Review Board has become mandatory. The ultimate goal of research is to safeguard the public health or population and thus every human has the right to understand the nature besides the risks and benefits of research. Only after approval, a study can be carried out keeping in view any modifications required to meet the regulatory requirements. Both thesis and independent research projects need permission of the IEC & the IRB to safeguard the dignity, rights, safety and well being of all actual and potential research participants. The committee also examines compliance with all regulatory requirements, applicable guidelines and laws.

    OBJECTIVE

    To have an insight into the research pattern for 2 years in a tertiary care teaching hospital this study was undertaken.

    MATERIALS & METHODS

    The present retrospective, observational study was conducted in the Deptt. of Pharmacology, Govt. Medical College, Jammu after taking permission from  Institutional Ethics Committee. IEC record of year 2014 and 2015 was assessed and compared.

    Different patterns of various research proposals both thesis and independent research proposals was assessed. A tertiary care hospital of north india, IEC GMC jmu is registered with the DCGI. An attempt was made to strictly follow the confidentiality while making analysis.

    RESULTS

    A total of 244 research projects were submitted and got approval from IEC. 116 research projects were submitted in 2014 out of which 85 (73.2%) were thesis projects and 31 (26.7%) were independent research projects. 128 research projects were submitted in 2015 out of which 88 (68.7%) were thesis research projects and 40 (31.2%) were independent research projects. Most thesis proposals fell in category B or B/C whereas most independent proposals fell in category B/C or C.

    CONCLUSION

    A similar trend was followed in both the years but a rising trend was seen among the independent research projects. It may be because of the new accredition policy and research rider by Medical Council of India

  8. A cross sectional questionnaire based study of knowledge, attitude and practices of pharmacovigilance programme among staff nurses in a teaching tertiary care hospital Download Article

    Muzaffer Ahmad Pukhta, Zubair Ashai, Urfan Nabi
    • Type: Research Article
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    • Pages (354-359)
    • No of Downloads: 22

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    Background

    Since the inception of Pharmacovigilance programme (PVP) in our institution spontaneous reporting of adverse drug reactions (ADRs) has been minimal. Under reporting of ADRs is a known fact due to variable knowledge, attitude and practices (KAP) of healthcare professionals which prompted us to know the KAP of nursing staff in our institution.

    Material and Methods

    A questionnaire based cross sectional study using a pre designed set of questions. Study included 134 staff nurses from government medical college and associated hospitals Srinagar J&K India.

    Results

    Our study using KAP questionnaire revealed that in knowledge based questions 59% participant were aware of the health care professional responsible for reporting ADR, 70% were aware of PVP, 11% were how to fill ADR form, 38% were knowing ADRs of which drugs to be reported and 27% were knowing the time period within which a serious ADR needs to be reported. All attitude based questions scored high on attitude based questions. Contrary to expectations from knowledge and attitude of participating staff nurses the practice of ADR reporting was very poor.

    Conclusion

    There is a need for curriculum development in order to impart teaching and hands on training to improve knowledge and practices of ADR reporting