Comparison of Efficacy of Granisetron and Promethazine in Control of Hyperemesis Gravidarum.

PURPOSE: Hyperemesis gravidarum is the third leading cause of hospitalization during pregnancy. 5-HT3-receptor antagonists are the most effective against chemotherapy-induced nausea and vomiting and radiation. This randomized study aimed to compare and evaluate the efficacies of granisetron and promethazine for controlling nausea and vomiting of pregnancy. METHODS: The included patients were administered (oral and intravenous) granisetron and promethazine randomly. The patients were evaluated for nausea and vomiting by a senior gynecology resident blinded to designated drugs. RESULTS: This study revealed that granisetron significantly decreased nausea and vomiting in pregnant women (p < 0.05). Greater patient satisfaction and lesser adverse drug reactions in women receiving granisetron observed in this study suggest that it can be introduced as a more effective and safer drug in comparison with promethazine. CONCLUSIONS: Considering the prevalence of nausea and vomiting of pregnancy and hyperemesis gravidarum, we can state that it is a health-related problem with economic, social and psychological dimensions. All efforts especially simple outpatient strategies to reduce its severity will help the pregnant woman continue her pregnancy with more satisfaction.

Role of pharmacist counseling in pharmacotherapy quality improvement.

OBJECTIVE: Hospitalization and subsequent discharge home often involve discontinuity of care, multiple changes in medication regimens, and inadequate patient education regarding the instruction of drug use, respiratory devices, and disease information and also lack of information about the drug's side effects that can lead to medication nonadherence and low level of treatment satisfaction. Hence, we decided to design a study to determine the effect of patient counseling at discharge and also their follow-up by pharmacist on their treatment satisfaction and medication adherence. METHODS: A total number of 154 patients within the age of 18-65 years old participated in the study from August 2013 to March 2014. Patients in the intervention group received pharmacist counseling and necessary education about their prescribed medications at discharge. We set up two follow-up schedules for this group and one for control group, and then we compared the medication adherence and satisfaction in two groups. The primary outcome of this study was a significant increase in adherence to medication regimen and treatment satisfaction of the case group compare to control group after the intervention of pharmacist at the time of discharge. FINDINGS: There were significant differences in medication adherence and satisfaction between the groups at the time of second follow-up. Medication adherence in the study group is 42.9% more than the control group, also the treatment satisfaction determined to be 33.5% more than patients in control group. Furthermore, we found that, in intervention group, no one is readmitted while among the patients in control group eight people readmitted. CONCLUSION: Counseling patients at the time of discharge and regular follow-up improves patient's medication adherence and treatment satisfaction and consequently improves clinical outcomes.

Comparing the Efficacy of 8 Weeks Treatment of Cipram® and its Generic Citalopram in Patients With Mixed Anxiety-Depressive Disorder.

BACKGROUND: Patients with mixed anxiety-depressive disorder (MADD) suffer both anxiety and depression. Antidepressants, especially, selective serotonin reuptake inhibitors are among agents of choice for treating this condition. OBJECTIVES: This study compared the efficacy of Cipram® with its generic, citalopram. PATIENTS AND METHODS: Forty adult outpatients (between 18 to 55 years of age) with a diagnosis of MADD who met the trial criteria, entered this double-blind, randomized study. Subjects were assigned to receive either generic citalopram or Cipram® for 8 weeks. Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) were utilized to assess depression and anxiety at baseline, weeks 4 and 8 of the study. Statistical analysis was performed using SPSS 14.0. RESULTS: Twenty patients received citalopram (mean dosages of 22 mg/day during the first 4 weeks and 33 mg/day during weeks 4 to 8) and 20 received Cipram® (mean dosages of 22 mg/day during the first 4 weeks and 29 mg/day during weeks 4 to 8). Both treatments were noted to be effective in improving the symptoms of MADD at weeks 4 and 8. The mean differences of HAM-D and HAM-A between Citalopram and Cipram® groups were significantly different at the end of week 4 (HAM-D: P = 0.038, HAM-A: P = 0.025), but not at the end of week 8 (HAM-D: P = 0.239, HAM-A: P = 0.204). Both medications were tolerated well by the patients. CONCLUSIONS: This study suggests that the efficacy of citalopram is similar to that of Cipram® in the treatment of MADD after 8 weeks. Meanwhile, Cipram® may reduce depression and anxiety quicker than its generic, citalopram.

Effectiveness of regular versus glargine insulin in stable critical care patients receiving parenteral nutrition: a randomized controlled trial.

STUDY OBJECTIVE: To compare the effectiveness and safety of two glycemic control regimens in stable critical care patients receiving parenteral nutrition (PN). DESIGN: Prospective, randomized open-label clinical trial. METHODS: Eligible postoperative critical care patients in the ICU began PN on the first to the seventh day of ICU admission. The PN admixture included regular insulin, in doses sufficient to maintain 3 or more goal blood glucose (BG) levels between 110 and 180 mg/dl. After 3 to 5 days of PN containing regular insulin, patients were randomized to 3 more days of regular insulin at the same dose or 80% of their total daily regular insulin dose provided in PN solution as glargine insulin. Capillary BG monitoring was performed every 6 hours. RESULTS: Twenty one patients were randomized to each treatment group. Median APACHE II scores were not significantly different between the two groups within the first 24-hour of ICU admission. There were no significant differences between the two groups at day 3 for mean daily dextrose (306.9 ± 46.2 vs. 305.2 ± 52.2 g; p=0.913) or insulin (18.3 ± 8.8 vs. 19.5 ± 10.0 units; p=0.696) doses. The percentage of BG values in the goal (110-180 mg/dl), hyperglycemic (> 180 mg/dl), and hypoglycemic (< 70 mg/dl) BG levels were similar between the two groups (69.0% vs. 66.7%, p=0.567; 11.9% vs. 11.1%, p=0.780; 0% vs. 1.6%, p=0.124, respectively). Mean daily BG levels were not significantly different between the two groups on each of the 3 study days (day 1: 140 ± 20 vs. 131 ± 25 mg/dl, p=0.194; day 2: 136 ± 20 vs. 140 ± 18 mg/dl, p=0.498; day 3: 142 ± 15 vs. 140 ± 19 mg/dl; p=0.741). CONCLUSION: These data suggest that, compared with regular insulin added to PN, glargine insulin results in similar glycemic control and rates of hyperglycemia and hypoglycemia in stable critical care patients.

Didactic Lecture Versus Interactive Workshop for Continuing Pharmacy Education on Reproductive Health: A Randomized Controlled Trial.

Pharmacists are routinely providing reproductive health counseling in community pharmacies, but studies have revealed significant deficits in their competencies. Therefore, continuing pharmacy education (CPE) could be utilized as a valuable modality to upgrade pharmacists' capabilities. A randomized controlled trial was designed to compare the efficacy of CPE meetings (lecture based vs. workshop based) on contraception and male sexual dysfunctions. Sixty pharmacists were recruited for each CPE meeting. Small group training using simulated patients was employed in the workshop-based CPE. Study outcomes were declarative/procedural knowledge, attitudes, and satisfaction of the participants. Data were collected pre-CPE, post-CPE, and 2 months afterward and were analyzed using repeated measure analysis of variance and Mann-Whitney U test. Results showed that lecture-based CPE was more successful in improving pharmacists' knowledge post-CPE (p < .001). In contrast, a significant decrease was observed in the lecture-based group at follow-up (p = .002), whereas the workshop-based group maintained their knowledge over time (p = 1.00). Knowledge scores of both groups were significantly higher at follow-up in comparison with pre-CPE (p < .01). No significant differences were observed regarding satisfaction and attitudes scores between groups. In conclusion, an interactive workshop might not be superior to lecture-based training for improving pharmacists' knowledge and attitudes in a 1-day CPE meeting.

Knowledge and attitude assessment of Iranian multiple sclerosis patients receiving interferon beta.

BACKGROUND: Multiple sclerosis (MS) patients permanently confronted with serious challenges from treatment regimen. Developing a new questionnaire in MS management, through evaluation of patients' perspectives and knowledge regarding treatment will help to identify the sources of tension, and to build a therapeutic alliance. We purposed to describe MS patients' understanding of their treatments. METHODS: About 425 completed and returned questionnaire were assessed of a total of 500 recruited MS patients. The knowledge of correct using interferon-beta (IFN-ß) and attitude toward medical care were assessed using self-reported questionnaires consisted of 25 items with validity of multidisciplinary panel and pre-testing on 20 patients. RESULTS: Knowledge about IFN-ß therapy was very low; however, attitude was at a high level. Female patients, self-injection ability, higher educational level, normal functional status, delay from the start of diagnostic workup to definite diagnosis, and being younger were related to a higher level of knowledge. Attitude was associated with functional status, family history of disease and the summary of knowledge variable. CONCLUSION: Developing educational interventions are needed for MS patients regarding to their low levels of knowledge.

No Superiority of Granisetron Over Metoclopramide in Prevention of Post-operative Nausea and Vomiting: A Randomized Clinical Trial.

PURPOSE: Post-operative nausea and vomiting (PONV) is considered as one of the most disturbing sequels of surgeries under general anesthesia, which if not controlled appropriately increases post-operative morbidity, nursing burden, and general healthcare costs. In this study, we compared granisetron with its brand Kytril(®) and also with metoclopramide regarding PONV management. METHODS: A total of 180 obstetrics and gynecology patients who underwent surgeries under general anesthesia participated in this prospective study at the Dr. Shariati Teaching Hospital, Tehran, Iran. The patients were randomly assigned to single-dose generic granisetron (40 mcg/kg), Kytril(®) (40 mcg/kg), or metoclopramide (0.2 mg/kg) at the end of the surgery. Two episodes of emetic symptoms (nausea and vomiting) were recorded by a gynecologist who had no knowledge of which treatment each patient had received. This gynecologist observed the patients at three different intervals: 0-6, 6-12, and 12-18 h post-surgery. RESULTS: One hundred and thirty-seven patients (76.1 %) underwent hysterectomy and 40 patients (22.2 %) underwent myomectomy. Each group consisted of 60 patients (33 %). The incidence of vomiting in the first 6, 12, and 18 h post-surgery was 22, 15.2, and 13.3 % for granisetron; 18.6, 10, and 8.3 % for Kytril; and 22, 11.9, and 5 % for generic metoclopramide, respectively. There was no significant difference in the incidence of PONV with any of these agents. CONCLUSIONS: All three anti-nausea and vomiting agents, granisetron, its brand (Kytril), and generic metoclopramide, have a similar effect to manage PONV in obstetrics and gynecological surgeries. Trial registration This trial is registered with www.irct.ir, number IRCT201010134927N1.

Evaluation of febrile neutropenia in patients undergoing hematopoietic stem cell transplantation.

The aim of this study was to determine the incidence and causes of fever as a major problem contributing to transplantation related mortality among patients undergoing hematopoietic stem cell transplantation (HSCT) and evaluation of antibiotic use, according to reliable guidelines.We retrospectively reviewed hospital records of 195 adult patients who underwent HSCT between 2009-2011 at hematology-oncology and bone marrow transplantation research center. Baseline information and also data related to fever and neutropenia, patient's outcomes, duration of hospitalization and antibiotic use pattern were documented.A total of 195 patients were analyzed and a total of 268 febrile episodes in 180 patients were recorded (mean 1.5 episodes per patient). About 222 episodes (82%) were associated with neutropenia which one-fourth of them were without any documented infection sources. Microbiologic documents showed that the relative frequencies of gram positive and gram negative bacteria were 62.5% and 37.5%, respectively. The hospital stay duration was directly related to the numbers of fever episodes (P<0.0001).The rate of febrile episodes in autologous stem cell transplantation was significantly higher compared to allogeneic type (P<0.05).It is necessary to determine not only the local profile of microbiologic pattern, but also antibiotic sensitivities in febrile neutropenic patients following hematopoietic stem cell transplantation, and reassess response to antibiotic treatment to establish any necessity for modifications to treatment guidelines in order to prevent any fatal complications from infection.

An educational intervention to improve nurses' knowledge, attitude, and practice toward reporting of adverse drug reactions.

BACKGROUND: The reporting of adverse drug reactions (ADRs) by nurses in hospitals is very important. AIMS: This study was aimed at investigating the impact of an educational intervention to improve ADR reporting and whether trained nurses had better knowledge, attitude, and practice toward ADR reporting. MATERIALS AND METHODS: A total of 300 nurses in a tertiary care teaching hospital in Tehran, Iran were evaluated with a knowledge, attitude, and practice (KAP) questionnaire regarding ADR reporting in March 2010. After this, an educational program about ADR was provided to nurses. Then the nurses were re-evaluated by the same questionnaire. Comparisons were made of the attitude and knowledge within nurses, before and after education. Data were analyzed using SPSS software. P < 0.05 was considered as significant level. Independent-sample t-test was used to measure the intervention effect. RESULTS: The response rate was 61.3% (N = 184). Knowledge of nurses before the intervention was significantly less than the knowledge after the intervention (P = 0.001). Also, there was a significant effect on attitude (P = 0.002). During the follow-up period of 4 months after the intervention, 26 spontaneous reports were received. CONCLUSION: Continuous ADR educational program, training, and integration of ADRs' reporting into the activities of the nurses would likely improve ADR reporting.

Impact of clinical pharmacist-based parenteral nutrition service for bone marrow transplantation patients: a randomized clinical trial.

PURPOSE: Parenteral nutrition (PN) is a well-documented supportive care which maintains the nutritional status of patients. Clinical pharmacists are often involved in providing PN services; however, few studies have investigated the effect of a clinical pharmacy-based PN service in resource-limited settings. METHODS: We designed a randomized clinical trial to compare the clinical pharmacist-based PN service (intervention group) with the conventional method (control group) for adult patients undergoing hematopoietic stem cell transplantation in Shariati Hospital, Tehran, Iran (2011-2012). In the intervention group, the clinical pharmacists implemented standard guidelines of nutrition support. The conventional method was a routine nutrition support protocol which was pursued for all patients in the bone marrow transplantation wards. Main study outcomes included nutritional status (weight, albumin, total protein, pre-albumin, and nitrogen balance), length of hospital stay, time to engraftment, rate of graft versus host disease, and mortality rate. Patients were followed for 3 months. RESULTS: Fifty-nine patients were randomly allocated to a study group. The overall intake (oral and parenteral) in the control group was significantly lower than standard daily needed calories (P < 0.01). Patients in the intervention group received fewer days of PN (10.7 ± 4.2 vs. 18.4 ± 5.5 days, P < 0.01). All nutritional outcomes were either preserved or improved in the intervention group while the nutritional status in the control group was deteriorated (P values < 0.01). Length of hospital stay was significantly shorter in the intervention group (P < 0.01). Regarding PN complications, hyperglycemia was observed more frequently in the intervention group (34.5 %, P = 0.01). Two patients in the control group expired due to graft versus host disease at the 3-month follow-up. CONCLUSION: A clinical pharmacist-based nutrition support service significantly improved nutritional status and clinical outcomes in comparison with the suboptimal conventional method. Future studies should assess the cost effectiveness of clinical pharmacists' PN services.

Medication errors in an emergency department in a large teaching hospital in tehran.

Medication errors have important effects on increased length of hospitalization, increased mortality and costs. We assessed the incidence of medication errors and characterize the error types in an emergency department in a large teaching hospital in Tehran. We also investigated the effect of Emergency Department pharmacists on patient safety with regard to recovery of potentially harmful medication errors. The study was conducted in the 24 bed emergency department from February to March, 2010 at a 600-bed teaching hospital. Two hospital pharmacists and two clinical pharmacy residents observed care provision and collected data on medication errors. Demographic data, type of medication error, the recorded stage of error, date and time of occurrence and report, who made the error, probability of error were recorded from medical records. We used chi-squared and independent sample t- tests for analyzing the data. We recorded 203 medication errors during 180 hours. The incidence of medication errors was 50.5% at various levels in the emergency department. Significant difference in age means was seen between the patients with and without medication errors. Seventy four point nine percent of errors were recorded as definitely an error. Most recorded errors were made by nurses (44.5%) and occurred in administrating stage (63.6%). Given that the rate of the errors was relatively high, it seems that the presence of clinical pharmacist can be beneficial.

Efficacy of continuing education in improving pharmacists' competencies for providing weight management service: three-arm randomized controlled trial.

INTRODUCTION: Weight management is a new public health role for community pharmacists in many countries. Lack of expertise is one of the key barriers to counseling obese patients. We evaluated the comparative efficacy of three alternative continuing education (CE) meetings on weight management. METHODS: We designed a randomized controlled trial comparing didactic lecture, lecture plus case discussion, and lecture plus small-group training. It was conducted in 2011 in Tehran. Pharmacists' knowledge, attitudes, and competence were evaluated immediately before, immediately after and one month after each meeting via standardized questionnaires and case vignettes. Participants' satisfaction was evaluated after each meeting. Data were analyzed using repeated measure analysis of variance and chi-squared tests. RESULTS: Sixty pharmacists were randomly allocated to each study arm. There were no demographic differences between the arms at the baseline. The knowledge scores significantly improved for all interventions over time. At the follow-up, the small-group training arm obtained significantly higher knowledge scores (p < 0.001, effect size = 0.54). The competence scores in lecture plus case discussion and lecture plus small-group training meetings improved over time (effect size 0.14 and 0.34; difference nonsignificant). Small-group training resulted in significantly higher satisfaction scores (p = 0.005). The interventions' effects on attitudes were similar. DISCUSSION: This is the first study on the implementation and efficacy of various types of CE meetings for community pharmacists to provide weight management services. Lecture plus small group training resulted in better learning retention over time and higher satisfaction. Future studies should evaluate the effects of various types of CE meetings on pharmacists' behavior and their cost-effectiveness.

Evaluation of treatment with Oseltamivir during the 2009 H1N1 (swine flu) pandemic: the problem of incomplete clinical information.

During the H1N1 (swine flu) pandemic of 2009, the World Health Organization (WHO) confirmed more than 14,000 deaths globally; this included a death toll of 147 in Iran. In order to evaluate (a) the appropriateness of the Oseltamivir dose through calculation of a patient's creatinine clearance (CrCl) and (b) the quality of data in the medical charts, we conducted a retrospective study at the Shariati Hospital in Tehran. All admissions to the hospital between the dates 1 October 2009 and 31 January 2010 were evaluated, amounting to a total of 51 patients' charts, including 8 outpatient charts. Of these 51 charts, 26 (51%) contained all the information necessary to evaluate the CrCl. However, there was at least one piece of information missing (e.g. the patient's weight; serum creatinine) from each of the remaining 25 charts (49% of the sample), which made it impossible for us to evaluate the dose. These results demonstrate how crucially important it is to ensure that all the necessary patient information is correctly registered at the time of admission in order to minimise medication errors.

Knowledge, attitudes and practice of nurse regarding adverse drug reaction reporting.

BACKGROUND: Adverse drug reactions (ADR) are ranked as some of the major causes of patient morbidity and mortality. Spontaneous reporting of ADRs has remained the cornerstone of pharmacovigilance and is important in maintaining patient safety. This study was conducted to assess the nurses' knowledge and attitude towards pharmacovigilance, reasons for not reporting ADRs, and their pharmacovigilance practice. MATERIALS AND METHODS: A questionnaire was prepared to investigate knowledge, attitude and practice (KAP) of nurses regarding ADR reporting. In November 2009, the questionnaires were given to 500 nurses of a teaching hospital in Tehran. FINDINGS: Knowledge and practice of participants were not satisfying; however, their attitude towards pharmacovigilance was at a high level. About 91% of the nurses had never reported an ADR. Most nurses liked to report the ADRs to the physicians (87.1%) and pharmacists in hospital's ADR center (1.8%) rather than the ADR National Center. The main cause of under-reporting of the suspected ADRs was unawareness about the existence of such a national center. Among nurses who had reported ADR for at least once, the majority preferred using phone (10 out of 50) or Yellow Cards (7 out of 50). Only 1 person out of 50 preferred using internet for submitting the reports. CONCLUSIONS: Since the nurses in this study had little knowledge and poor practice regarding the pharmacovigilance and spontaneous reporting system, interventions such as holding pharmacovigilance workshops in the hospitals focusing on the aims of pharmacovigilance, completing the Yellow Card and clarifying the reporting criteria are strongly recommended.

Iranian pharmacists' knowledge, attitude and practice regarding counterfeit drugs.

Background Awareness of pharmacists about counterfeit drugs is necessary for health improvement in community. The purpose of the present study is to assess the knowledge and measure the professional attitude and practice of Iranian pharmacist about counterfeit drugs. In August 2008, a knowledge, attitude and practice (KAP) study was performed in a national sample of 794 pharmacists who participated in an Iranian Pharmacist Association congress. A questionnaire was prepared to collect Demographic and professional characteristics, Knowledge, attitude and practice of pharmacists regarding counterfeit drugs. The mean percent of participants who answer each practice questions correctly is 13.62% and none of questions have more than 14.7% of correct answer, while the participants' attitude towards the subject is at high level. None of demographic factors represented a significant relationship with knowledge and the only related parameters with attitude, were age and gender. Increasing age of pharmacists resulted in attitude improvement (p = 0.013) and women>s attitudes were better than men (p = 0.05).The only related parameters with practice, were the number of working hours per a week and attitude. Increasing the number of working hours per a week, resulted in decreasing the desirable practice (p = 0.041) and attitude also had a direct relationship with practice (p = 0.011). Conclusion The most important finding in the present study was the pharmacists> low knowledge and practice level about counterfeit drugs, while their attitude towards this subject was at a high level. The results point out the need for designing and implementing educational programs.

Efficacy of Generic Granisetron vs Kytril® for PONV in Major Gynecological Operations: A Randomized, Double-blind Clinical Trial.

Background Granisetron is a first-generation 5-HT3-receptor antagonist that has shown efficacy in preventing postoperative nausea and vomiting (PONV). In this randomized double-blind parallel-group clinical trial, we assessed the efficacy of generic granisetron versus Kytril®, in the prevention of PONV in patients undergoing general anesthesia for gynaecological surgeries. Method One hundred and twenty patients who were supposed to undergo major gynaecological surgeries (myomectomy and hysterectomy) in Dr. Shariati Teaching Hospital, Tehran, Iran were randomly assigned to either single dose generic granisetron (40 mcg/kg), or Kytril® (40 mcg/kg) at the end of the surgery. Two episodes of emetic symptoms (nausea and vomiting) were recorded by a gynaecologist who had no knowledge of which treatment each patient had received. This gynaecologist observed the patients at three different intervals: 6, 12 and 18 h post surgery. At the end of the observation period each patient evaluated the satisfaction with the study drug, and the gynaecologist evaluated sedation of the patients. Results In the generic granisetron group 47 and 13 patients, and in the Kytril® group 45 and 15 patients underwent hysterectomy and myomectomy respectively. No difference was observed between two treatment groups regarding postoperative nausea and vomiting control during 18 hours after the drugs administration. Also there were no differences in the satisfaction with the study drug between the generic granisetron and Kytril®. No difference in sedation scores was observed between two groups. Conclusion Generic granisetron exerts efficacy against PONV after gynaecological surgeries which is non-inferior to that of Kytril®.

The evaluation of albumin utilization in a teaching university hospital in iran.

The goal of this study was to evaluate the pattern and the suitability of the human Albumin usage according to the available and reliable guidelines. A concurrent, cross-sectional study was performed in Shariati Hospital (associated with Tehran University of Medical Sciences, Tehran, Iran). All inpatient adults that were prescribed albumin during the study period were evaluated to register the indications for albumin usage and specific patient information. The total 1281 vials of Albumin were prescribed for 135 patients during the study period. The most common reasons to prescribe albumin were volume expansion after the heart surgery (53.3%), nutrition source in malnourished patients (19.3%), paracentesis (12.9%), plasmapheresis (9.6%), hypoalbuminemia (3%) and the others (2.1%). Only 411 vials (32.1%) prescribed with 34 prescriptions (25.2%) were utilized appropriately based on the guidelines. The results showed that based on the guidelines, the most prescriptions of albumin in this hospital have not been written appropriately. Therefore, educational programs on using guidelines may help reduce albumin usage and treatment costs.