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   2017| November-December  | Volume 49 | Issue 6  
    Online since March 26, 2018

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Adverse drug reactions at adverse drug reaction monitoring center in Raipur: Analysis of spontaneous reports during 1 year
Preeti Singh, Manju Agrawal, Rajesh Hishikar, Usha Joshi, Basant Maheshwari, Ajay Halwai
November-December 2017, 49(6):432-437
DOI:10.4103/ijp.IJP_781_16  PMID:29674797
BACKGROUND: India is a developing country and adverse drug reactions (ADRs) influence most of the diseases in our population, and monitoring is required due to the paucity of ADRs. The present study was done to analyze the ADRs at the ADR monitoring center (AMC) of tertiary care hospital in Raipur during 1 year. MATERIALS AND METHODS: Study of ADR monitoring of outpatient and inpatient was a prospective and observational study carried out between September 2015 and August 2016. The ADRs in the form of Individual Case Safety Report (ICSR) was sent to the Indian database (Vigiflow®). RESULTS: Total ICSRs reported to Vigiflow® were 232 during 1 year. Among them, 63.79% were found to be nonserious and 36.21% were serious. Nearly 45% of ADRs were implicated only due to antimicrobials, which is highest among all other groups of drugs. A maximum number of ADRs were observed in 31–60 years of age group (52.15%). In causality assessment, the probable cases had a higher incidence (67.24%), followed by possible (27.58%) and certain (4.74%). The frequency of ADR reporting at our AMC was low (0.043%) compared to national average. Our AMC shared 0.35% of total ICSRs, which is insignificant (P < 0.001) compared to the JSS, Mysore and PGIMER, Chandigarh, AMCs, which have shared most of the ICSRs in Vigiflow®. CONCLUSIONS: The frequencies of ADRs reporting in our study are less compared to those reported with other similar studies. Underreporting is a very serious concern in Raipur, and Pharmacovigilance Programme of India must intercede to pick up ADRs across the country.
  14 9,667 361
Prescriber and dispenser perceptions about antibiotic use in acute uncomplicated childhood diarrhea and upper respiratory tract infection in New Delhi: Qualitative study
Anita Kotwani, PC Joshi, Urmila Jhamb, Kathleen Holloway
November-December 2017, 49(6):419-431
DOI:10.4103/ijp.IJP_508_17  PMID:29674796
OBJECTIVE: The objective of the study was to explore the prescribing practices, knowledge, and attitudes of primary care doctors and community pharmacists, regarding antibiotic use in acute upper respiratory tract infections (URTI) and diarrhea in children to better understand causes of misuse and identify provider suggestions to change such behavior. MATERIALS AND METHODS: Two focus group discussions (FGDs) each were conducted with primary care government doctors (GDs), private general practitioners (GPs), pediatricians, and community pharmacists in Delhi. Each FGD had 8–12 participants and lasted 2 h. Furthermore, 22 individual face-to-face semi-structured interviews were conducted with providers of varying type and experience at their workplaces. Thematic and summative qualitative content analysis was done. RESULTS: All groups admitted to overusing antibiotics, GPs appearing to use more antibiotics than GDs and pediatricians for URTI and diarrhea in children. Pharmacists copy the prescribing of neighborhood doctors. Antimicrobial resistance (AMR) knowledge was poor for all stakeholders except pediatricians. Causes for prescribing antibiotics were patient pressure, profit motive, lack of follow-up and in addition for GDs, workload, no diagnostic facility, and pressure to use near-expiry medicines. Knowledge was gained through self-experience, copying others, information from pharmaceutical companies, and for some, training, continuous medical education/conferences. All groups blamed other professional groups/quacks for antibiotic overuse. Interventions suggested were sensitizing and empowering prescribers through training of providers and the public about the appropriate antibiotic use and AMR and implementing stricter regulations. CONCLUSIONS: A package of interventions targeting providers and consumers is urgently needed for awareness and change in behavior to reduce inappropriate community antibiotic use.
  13 5,919 233
Immunomodulatory properties of titanium dioxide nanostructural materials
T Sree Latha, Madhava C Reddy, Prasad V R. Durbaka, Shankar V Muthukonda, Dakshayani Lomada
November-December 2017, 49(6):458-464
DOI:10.4103/ijp.IJP_536_16  PMID:29674801
OBJECTIVES: Although titanium dioxide (TiO2) nanostructural materials have been widely used in Biology and Medicine, very little is known about immunomodulation mechanism of these materials. Objectives of this study are to investigate in vitro immunomodulatory effects of TiO2.Immunosuppressant may lower immune responses and are helpful for the treatment of graft versus host diseases and autoimmune disorders. MATERIALS AND METHODS: In this study, we used H2Ti3O7titanium dioxide nanotubes (TNT) nanotubes along with commercial TiO2nanoparticles (TNP) and TiO2fine particles (TFP). We investigated the in vitro immunomodulatory effects of TNP, TNT, and TFP using mixed lymphocyte reaction (MLR). Suppression was studied by 3-(4, 5-dimethylthiazol-2yl)-2, 5-diphenyl tetrazolium bromide (MTT) assay. Cytokine profile was measured by enzyme-linked immunosorbent assay (ELISA). RESULTS AND CONCLUSIONS: The results from this study illustrated that the TiO2nanostructural materials strongly suppressed splenocytes proliferation in MLR. For TNP and TNT, at 50 μg/ml suppression of 20%–25% and 30%–35%, respectively, and for TFP at 100 μg/ml suppression was 25%–30% was observed. Suppression of splenocytes proliferation in the presence of TNP, TNT, and TFP demonstrated that these nanostructural materials probably block T-cell-mediated responses in vitro. Our ELISA results confirmed that significantly lower levels of Th1 type cytokines (interleukin-2, interferon-γ) in the 48 h MLR culture supernatants. Our data suggest that TiO2nanostructural materials suppress splenocytes proliferation by suppressing Th1 cytokines.
  8 3,956 129
Assessment of nonsteroidal anti-inflammatory drug use pattern using world health organization indicators: A cross-sectional study in a tertiary care teaching hospital of Chhattisgarh
PR R. Vaishnavi, Nitin Gaikwad, SP Dhaneria
November-December 2017, 49(6):445-450
DOI:10.4103/ijp.IJP_189_17  PMID:29674799
OBJECTIVE: The objective of this study is to assess drug utilization pattern of nonsteroidal anti-inflammatory drugs (NSAIDs) in a tertiary care teaching hospital, Raipur, Chhattisgarh. MATERIALS AND METHODS: A prospective, cross-sectional observational study was conducted in the outpatient department during 2-month period. After informed consent, the patients visiting pharmacy shop with a prescription were enrolled in the study. Their demographic details and prescription data were recorded in a case record form. The data were analyzed to determine the drug utilization pattern of NSAIDs, using the World Health Organization (WHO) prescribing indicators. RESULTS: A total of 600 prescriptions were analyzed. Of them, NSAIDs were prescribed in 30.83% encounters. In general, nonselective COX inhibitors were most commonly prescribed. The most commonly prescribed form of NSAID was paracetamol (39.45%). The percentage of NSAIDs prescribed with generic names were almost identical (91.15%), whereas the percentage of NSAIDs prescribed from the National List of Essential Medicine (India) – 2015 (49.72%) was not identical with the WHO standard (100%) which serves as an ideal. In 13.51% encounters, a fixed-dose combination (FDC) of NSAIDs was prescribed. Co-administration of gastroprotective agent with NSAIDs was observed in 24.32% encounters. CONCLUSION: The prescribing practices of NSAIDs indicate some deviation from the WHO standard. In addition, FDCs of NSAIDs with gastroprotective agents as well as other NSAIDs was also prescribed, which are irrational. This baseline data will be useful to plan further targeted research and to improve prescribing practices at the center. Various strategies such as face-to-face periodic training programs of prescribers, establishing drug and therapeutic committee; drug information centers; and drug bulletins can serve beneficial in improving prescribing practices.
  8 7,045 310
Olanzapine versus aprepitant for the prophylaxis of chemotherapy-induced nausea and vomiting in breast cancer patients receiving doxorubicin-cyclophosphamide regimen: A prospective, nonrandomized, open-label study
G Shivaprakash, Karthik S Udupa, V Sarayu, Joseph Thomas, Vishal Gupta, LC Pallavi, Sudhakar Pemminati
November-December 2017, 49(6):451-457
DOI:10.4103/ijp.IJP_846_16  PMID:29674800
OBJECTIVE: Despite the guideline-directed therapy, complete absence of nausea was noted only in 33% of breast cancer patients on anthracycline-cyclophosphamide regimen. Hence, we sought to compare the efficacy of aprepitant (APT) versus olanzapine (OLP) in preventing chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients on doxorubicin-cyclophosphamide regimen. PATIENTS AND METHODS: A prospective, open-label, nonrandomized study was conducted at the Department of Oncology. Eighty-three patients completed the study with 43 in the APT group and 40 in OLP group. Data about nausea and vomiting were collected using Multinational Association of Supportive Care in Cancer Antiemesis Tool (MAT). The severity of nausea and vomiting was assessed by the MAT and Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, respectively. RESULTS: Complete response (no emesis and no rescue medication) was achieved in 81% of the patients in APT group and 85% in the OLP group in the acute period (P = 0.661); 74% of patients in APT group and 85% in OLP group had no nausea during the same period (P = 0.233). Among the OLP patients who had nausea, 67% had moderately severe and 33% had Severe grade, and in the APT group, severity was equally distributed in mild, moderate, and severe grades. Among the patients who had vomiting, severe (CTCAE) vomiting was noticed in 81% of patients who were treated with APT compared to 50% in OLP group. CONCLUSION: OLP was found to be an equally effective alternative to APT in the antiemetic prophylaxis of CINV in breast cancer patients receiving chemotherapy with doxorubicin-cyclophosphamide regimen.
  5 5,424 400
Dried urine spots for detection of benzodiazepines
Raka Jain, Rizwana Quraishi, Atul Ambekar, Arpita Verma, Pratibha Gupta
November-December 2017, 49(6):465-469
DOI:10.4103/ijp.IJP_578_16  PMID:29674802
Background and Aim: Benzodiazepines (BZD) are widely prescribed to substance users. However, the nonmedical use of prescription BZD often leads to abuse and dependence. Therefore, it is important to detect BZD among substance users seeking treatment. The aim of the present study was to develop an efficient method for testing BZD on dried urine spot (DUS) and evaluating its clinical applicability. Methods: This involved optimization of conditions for the detection, recovery, and stability of BZD from dried urine, spotted on filter paper. Enzyme linked immuno-sorbent assay was used for screening whereas confirmation was done by gas chromatography. For clinical applicability, urine samples of BZD users were tested. Results: The recovery was found to be 99.7% in de-ionized water from 20 μl spotted urine samples. Limit of detection, inter-day and intra-day CV were found to be 100 ng/ml, 4.22% and 3.83%, respectively. BZD were found stable in DUS for 3 weeks at room temperature, and for 3 months at 4°C and −20°C. All the urine samples of benzodiazepine users were found positive by conventional method as well as the DUS method. Conclusion: DUS method proved to be efficient for BZD testing with advantages of ease of collection, transportation, minimal invasiveness and small sample volume. It offers a useful alternative for BZD testing especially in developing countries where logistics of sample collection and transportation could be an important concern.
  5 3,724 106
Iatrogenic metrorrhagia after the use of itraconazole for onychomycosis
Piotr Brzezinski, Sandra Jerkovic Gulin, Dario Gulin, Anca Chiriac
November-December 2017, 49(6):470-471
DOI:10.4103/ijp.IJP_838_16  PMID:29674803
We present first case report on itraconazole, a drug very commonly used for onychomycosis, used along with simvastatin that caused metrorrhagia. The suggested probable mechanism is the inhibition of steroidogenesis, especially estrogens that resulted in low-estrogen breakthrough bleeding. This article emphasizes the importance of drug interaction check prior the initiation of onychomycosis treatment.
  3 3,508 105
Three-dimensional drugs: A new era in the pharmaceutical development
Harish Kumar, Ajay Prakash, Phulen Sarma, Bikash Medhi
November-December 2017, 49(6):417-418
DOI:10.4103/ijp.IJP_119_18  PMID:29674795
  2 4,625 381
Prof. K. P. Gupta: An exemplary pharmacologist of India
Syed Ziaur Rahman
November-December 2017, 49(6):472-473
  - 2,891 131
Switching of antihypertensive drugs at tertiary care government hospital, Hyderabad, India: A cross-sectional retrospective investigation
Varsha Varakantham, Ashok Kumar Kurakula Sailoo, Venkaiah Kodali, Dinesh Kumar Bharatraj
November-December 2017, 49(6):438-444
DOI:10.4103/ijp.IJP_590_17  PMID:29674798
OBJECTIVE: Switching of antihypertensive drugs is attributed to uncontrolled blood pressure (BP) which imposes a great burden on health economics. But again, switching leads to accomplishment of the goal BP, thereby improving the health status. Such studies are well documented in developed nations but rarely reported in developing countries, especially in India. Therefore, the aim of this study was to evaluate various factors associated with switching of antihypertensive drugs. METHODS: A cross-sectional retrospective investigation was performed using a standardized schedule adapting the World Health Organization indicators for drug utilization in a tertiary care government hospital, Hyderabad, India. A total of 429 prescriptions were monitored for a switchover to a different antihypertensive drug in 180 days. RESULTS: The results revealed that the duration of hypertension (HTN) >5–10 years (adjusted odds ratio [aOR] = 3.73, P < 0.05), two or more symptoms of HTN (aOR = 3.42, P < 0.05), 2014 prescriptions (aOR = 4.54, P < 0.001), polytherapy (aOR = 2.85, P < 0.001), noncompliance to National List of Essential Medicine (NLEM) (aOR = 1.631, P < 0.05), and systolic BP (SBP) (aOR = 1.77, P < 0.05) were the predictors, which were highly likely to switch (38.5%) the antihypertensive drugs. Diuretics (0.7%) were poorly prescribed, the first line of therapy suggested by Seventh Joint National Committee (JNC VII). Stepwise logistic regression analysis revealed, the calendar year 2014 (odds ratio [OR] = 3.23, P < 0.001), polytherapy (OR = 2.5, P < 0.001), and the level of SBP ≥140 mmHg (OR = 1.82, P < 0.01) as the three major predictors which showed a likelihood of switching medication. CONCLUSIONS: Findings of the study reveals predictors of the switchover like uncontrolled SBP, duration of HTN, compliance with the list of NLEM drugs, polytherapy, enabling the clinicians to critically analyze the patients' profile, and hence, reach target BP soon, i.e., decreased cardiovascular risk.
  - 4,478 186
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