Assessment of Prescribing Practices and Factors Related to Antibiotic Prescribing in Community Pharmacies.

Background and Objectives: Overprescribing of antibiotics is one of the important contributors of antimicrobial resistance globally. A high proportion of antibiotics prescribed in community settings are unnecessary or inappropriate. This study assesses the prescribing practices and factors related to antibiotic prescribing in community pharmacies in United Arab Emirates (UAE). Materials and Methods: A cross-sectional study utilizing a quantitative approach was carried out in the community pharmacies of Ras Al Khaimah (RAK), UAE. Six hundred and thirty prescription encounters from 21 randomly selected community pharmacies were investigated using World Health Organization (WHO) core prescribing indicators. Factors related to antibiotic prescribing were identified using logistic regression analyses. Results: In 630 prescription encounters, a total of 1814 drugs were prescribed. Out of these, the most commonly prescribed drug class was antibiotics (43.8% prescriptions) and the antibiotic was amoxicillin/clavulanic-acid (22.4%). The average number of drugs per prescription was 2.88, which was higher than the WHO recommended value of 1.6-1.8. In addition, more than half of the prescriptions (58.6%) had drugs by generic names and the majority of the drugs prescribed (83.8%) were from the essential drug list, which were lower than the optimal values of 100%. The majority of the antibiotics prescribed in the study were from the WHO's Access group antibiotics. Multivariable logistic regression analysis identified patient age (children-OR: 7.40, 95% CI: 2.32-23.62, p = 0.001 and adolescent-OR: 5.86, 95% CI: 1.57-21.86, p = 0.008), prescriber qualification as general practitioner (OR: 1.84, 95% CI:1.30-2.60, p = 0.001), and number of drugs per prescription (OR: 3.51, 95% CI: 1.98-6.21, p < 0.001) as independent factors associated with antibiotic prescribing. Conclusions: This study reveals considerable variations from the WHO recommendations for the different prescribing indicators in the community pharmacies of RAK, UAE. In addition, the study reports overprescribing of antibiotics in the community setting, indicating the need for interventions to promote rational use of antibiotics in a community setting.

Zingerone [4-(3-Methoxy-4-hydroxyphenyl)-butan-2] Attenuates Lipopolysaccharide-Induced Inflammation and Protects Rats from Sepsis Associated Multi Organ Damage.

The present investigation aimed to evaluate the protective effect of Zingerone (ZIN) against lipopolysaccharide-induced oxidative stress, DNA damage, and cytokine storm in rats. For survival study the rats were divided into four groups (n = 10). The control group was treated with normal saline; Group II received an intraperitoneal (i.p) injection (10 mg/kg) of LPS as disease control. Rats in Group III were treated with ZIN 150 mg/kg (p.o) 2 h before LPS challenge and rats in Group IV were given ZIN only. Survival of the rats was monitored up to 96 h post LPS treatment. In another set, the animals were divided into four groups of six rats. Animals in Group I served as normal control and were treated with normal saline. Animals in Group II were treated with lipopolysaccharide (LPS) and served as disease control. Group III animals were treated with ZIN 2 h before LPS challenge. Group IV served as positive control and were treated with ZIN (150 mg/kg orally). The blood samples were collected and used for the analysis of biochemical parameters like alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST), blood urea nitrogen (BUN), Cr, Urea, lactate dehydrogenase (LDH), albumin, bilirubin (BIL), and total protein. Oxidative stress markers malondialdehyde (MDA), glutathione peroxidase (GSH), myeloperoxidase (MPO), and (DNA damage marker) 8-OHdG levels were measured in different organs. Level of nitric oxide (NO) and inflammatory markers like TNF-α, IL-1ß, IL-1α, IL-2, IL-6, and IL-10 were also quantified in plasma. Procalcitonin (PCT), a sepsis biomarker, was also measured. ZIN treatment had shown significant (p < 0.5) restoration of plasma enzymes, antioxidant markers and attenuated plasma proinflammatory cytokines and sepsis biomarker (PCT), thereby preventing the multi-organ and tissue damage in LPS-induced rats also confirmed by histopathological studies of different organs. The protective effect of ZIN may be due to its potent antioxidant potential. Thus ZIN can prevent LPS-induced oxidative stress as well as inflammatory and multi-organ damage in rats when administered to the LPS treated animals.

Population pharmacokinetics of lamotrigine in Indian epileptic patients.

PURPOSE: The aim of this analysis was to describe the pharmacokinetics of oral lamotrigine (LTG) in Indian epileptic patients using a population pharmacokinetic (PPK) modeling approach to confirm that the PK is similar to that of the Caucasian population, and to evaluate and confirm the impact of covariates predictive of inter-individual variability using a simulation platform. METHODS: Blood samples were obtained from 95 patients, and LTG plasma concentrations were determined. Population PK modeling was performed using NONMEM. A one-compartment PK model with first-order absorption and elimination was used to describe the LTG PK. Log-likelihood profiling and normalized prediction distribution errors (NPDE) were used for model evaluation. A simulation study was performed to investigate dose regimens. RESULTS: Clearance (CL) was estimated to be 2.27 L/h with inter-individual variability (IIV) of 29 CV%. Volume of distribution (V) was estimated to be 53.6 L (31 CV% IIV). Body weight and concurrent use of carbamazepine and valproate were identified as significant covariates on clearance. Log-likelihood profiling indicated that parameters could be estimated with adequate precision, and NPDE indicated that the model adequately described the data observed. The simulation study illustrated the impact of carbamazepine and valproate on LTG PK, and negligible differences in PK between Indian and Caucasian patients. CONCLUSIONS: This is the first PK analysis of LTG in Indian patients. The population PK model developed adequately described the data observed. Comparison of identified PK parameters with previous PK analyses in Caucasian patients indicates that CL of LTG is similar, while V is somewhat lower compared with Caucasian patients, but this is not expected to lead to relevant differences in PK profiles during steady state.

Prescription Pattern of Antihypertensive Drugs: An Experience from a Secondary Care Hospital in the United Arab Emirates.

OBJECTIVE: The aim of the study was to examine the prescription pattern of antihypertensive drugs used in a secondary care hospital in the United Arab Emirates (UAE). METHODS: It was a prospective, observational study carried out in 588 adult hypertensive patients presenting to medicine outpatient and inpatient departments of Dibba Hospital, Fujairah, UAE. The study was conducted for a period of 6 months from December 2017 to May 2018. Demographic and clinical data were collected from electronic patient case records and documented. Prescriptions were studied overall for drug use details and for specific types of antihypertensive drugs. The World Health Organization Anatomical Therapeutic Chemical/Defined Daily Dose methodology was further used to calculate utilization. Statistical analysis of data was performed using Statistical Package for the Social Sciences 24.0. FINDINGS: Of the 588 study participants, majority of the patients were on two-drug combination antihypertensive therapy (n = 210, 35.5%) followed by monotherapy (n = 188, 32.1%) and three-drug combination (n = 136, 23.1%). Calcium channel blockers were the most frequently (51%) prescribed class both in monotherapy and in combination therapy while angiotensin receptor blockers and angiotensin-converting enzyme inhibitors (55.9%) were the most preferred agents for monotherapy. Among individual antihypertensive drugs, amlodipine was prescribed the most (266 prescriptions), irrespective of monotherapy or combination therapy. CONCLUSION: Our study represents the current prescribing trends of antihypertensive drugs in a secondary care hospital in the UAE. The use of antihypertensive drugs largely conforms to international guidelines, but still, there is room for improvement in terms of rational drug utilization.

Use of Phosphate Binders in End-Stage Renal Disease: An Experience From a Secondary Care Hospital in United Arab Emirates.

OBJECTIVE: Hyperphosphatemia in end-stage renal disease (ESRD) is associated with many serious patient-level consequences including cardiovascular events and mortality. The purpose of this study was to investigate the use of phosphate binders in ESRD patients on maintenance hemodialysis. MATERIALS AND METHODS: The study was a prospective observational cohort study including adult ESRD patients undergoing hemodialysis at a secondary hospital in United Arab Emirates. Patient characteristics were compared as per type of phosphate binder used. Bivariate and multivariate multinomial logistic regression analyses were carried out to determine variables that were independently associated with use of different phosphate binders. RESULTS: Phosphate binders used at our study site were sevelamer, calcium carbonate, and a combination of sevelamer and calcium carbonate. Bivariate multinomial logistic regression analysis revealed that serum phosphorous (odds ratio [OR]: 0.14, 95% confidence interval [CI]: 0.04-1.09, P = 0.047; OR: 0.10, 95% CI: 0.03-0.89, P = 0.042), calcium (OR: 0.11, 95% CI: 0.02-0.86, P = 0.041; OR: 0.22, 95% CI: 0.01-0.96, P = 0.012), and calcium-phosphorous product (OR: 0.20, 95% CI: 0.06-0.64, P = 0.008; OR: 0.16, 95% CI: 0.05-0.54, P = 0.003) levels were significantly lower in patients on sevelamer per se as well as in patients on combination therapy, respectively when compared to calcium carbonate per se. Multivariate multinomial logistic regression analysis revealed that in sevelamer and combination groups, cardiovascular diseases (OR: 0.12, 95% CI: 0.02-0.65, P = 0.022; OR: 0.10, 95% CI: 0.01-0.88, P = 0.038) were significantly lesser compared to calcium carbonate group after being adjusted for other variables in the model. CONCLUSION: We observed that hyperphosphatemia and related events in our study population were better controlled by sevelamer per se and combination therapy than calcium carbonate per se. Further large scale, multicenter studies are required to confirm and establish these findings.

Short communication: pattern of adverse drug reaction related queries received by the drug information centre of a tertiary care teaching hospital.

Accurate information about safety of drugs is very essential for health care professionals in identifying, preventing and managing Adverse Drug Reactions (ADRs), thereby ensuring safe use of medications. The objective of the present study was to assess the pattern of drug information (DI) queries related to ADRs received by the Drug Information Center (DIC) of a tertiary care teaching hospital. Retrospective evaluation of the DI queries received in the DIC over a period of three and a half years (January 2002-July 2005) was done for various parameters such as purpose and type of query, characteristics of the drugs and reactions involved, and references used. Out of 2312 DI queries received, 600 (25.9%) were related to ADRs. Majority of the queries were from the department of medicine (80.5%) and was received during ward rounds (76%). In most of the queries, the information was sought for better patient care (66.3%) and the enquirer wanted the information immediately (59.5%). The category of ADR queries most commonly asked was regarding identification of an ADR (54.3%). Considering the reaction characteristics, the organ system most commonly involved in the queries was nervous system (14.7%) and the reaction was fever and skin rash (14%). Most of the queries were on uncommon reactions. Drug class most commonly involved in the queries were antibacterials for systemic use (18.6%) and the most frequently involved drug was phenytoin (35%). MICROMEDEX system was used as the reference in answering most (57.1%) of the queries. Information on ADRs is among the most sought information on drugs by the health care professionals. Evaluation of pattern of these queries could reveal opportunities for educational and other interventions in promoting safer drug use in a health care setting. DICs could play a major role in promoting drug safety and it needs to be well equipped to respond to these needs.

Current challenges in adherence to clinical guidelines for antibiotic prophylaxis in surgery.

UNLABELLED: To study the impact of guidelines on surgical antibiotic prophylaxis in clinical practice, barriers involved in adherence to guidelines and how to overcome the same. METHODS: Literature pertaining to prophylactic antibiotic usage was searched. Medscape, Medline, Cochrane, Surgical Infection Prevention (SIP) project databases were reviewed. Recent articles from relevant journals, texts, and standard guidelines were also studied. RESULTS: Local guidelines seem more likely to be accepted and followed than those developed nationally. Major barriers involved in adherence to guidelines include lack of awareness about the guidelines, general perception of guideline as a bureaucratic rather than educational tool. Some practitioners perceive guidelines as "cookbook medicine" that does not permit them to make their own medical decisions. Other barriers are complex, multi-step systems that create confusion, decrease accountability. Methods for guideline adherence include surveillance and data analysis, new systems to facilitate documentation and improving workflow, education regarding current evidence-based guidelines and promoting the development of local guidelines or protocol, development and implementation of reminders to facilitate adherence to the local guidelines. CONCLUSION: A multidisciplinary steering team of surgeons, infectious disease specialists, pharmacists, anesthesiologists, microbiologists and nurses should develop local guidelines suitable to their institution and methods for adherence to prevent the surgical site infections. The gap between evidence-based guidelines and practice must be addressed in order to achieve optimal practice in this domain.

Drug utilization review of cephalosporins in a secondary care hospital in United Arab Emirates.

Background Cephalosporins are one of the most commonly used antibiotics in United Arab Emirates (UAE). Few studies have been carried out to evaluate the antibiotic utilization pattern in UAE in spite of the obvious increase in cephalosporins resistance during the past decade. Objective To assess the prescriptions pattern of cephalosporins among physicians at a secondary care hospital in Ras Al Khaimah, UAE. Method This observational prospective study was carried out during October 2013 to April 2014. The data of in patients were documented in the predesigned patient profile form and was analyzed for patient's, drug's and drug's therapy related parameters. Results The 3rd generation cephalosporins constituted 83.6 % of the prescriptions, with ceftriaxone being the most commonly used one (81.1 %). They were mainly prescribed for the treatment of the lower respiratory tract infections (60.2 %). Seven (3.5 %) different ADRs linked to cephalosporin use were observed ranging from oral thrush to clostridium difficile infection. A total of 1039 antimicrobial and nonantimicrobial medications were prescribed concomitantly with cephalosporins. Conclusion The 3rd generation cephalosporins were commonly prescribed by parenteral route. Thus, there is a strong need for rationalizing their use to preserve their efficacy and prevent the development of resistance in the region.

Cost of adverse drug reactions in a South Indian tertiary care teaching hospital.

In India, very few reports on the cost of adverse drug reactions (ADRs) are available. There is a need to study this aspect of health care in order to understand the economic burden imposed by ADRs. The aim of the current work was to study the costs associated with documented ADRs in a tertiary care teaching hospital. This study was conducted in medical wards of a south Indian tertiary care teaching hospital over a 6-month period. The study protocol was assessed and approved by the institutional ethics committee. A total of 317 ADRs from 246 patients were identified during the study period. The present study used an intensive monitoring method to detect ADRs and assessed an incidence of 32.7% adverse reactions in the monitored group. The causality, severity, predictability, and preventability of the documented ADRs were assessed. The total cost to the hospital due to ADRs was found to be Rs. 1,567,397 (US$36 451). The average cost per patient hospitalized with an ADR was Rs. 4,945 (US$115). The cost per reaction was found to be higher in the Indian context, as the per capita annual expenditure on health in this country is around US$109.

Drug safety reports on complementary and alternative medicines (ayurvedic and homeopathic medicines) by a spontaneous reporting program in a tertiary care hospital.

OBJECTIVES: The objectives of this study were to initiate a pharmacist-coordinated program to improve the adverse drug reaction (ADR) reporting on complementary and alternative medicines (CAM) in a tertiary care hospital and to evaluate the pattern of the reported ADRs. DESIGN: A targeted approach was taken in increasing the ADR reporting to CAM in a tertiary care hospital in South India. Suspected ADRs to CAM spontaneously reported over a period of 24 months were selected for evaluation. Reported ADRs were evaluated for patient demographics, reaction and drug characteristics, causality, severity, and outcome. RESULTS: A total of 12 ADRs to CAM were reported, which included 9 to Ayurvedic and 3 to homeopathic medicines, which accounted for 1.5% of the ADRs reported to the ADR reporting unit. ADR resulted in hospitalization in 5 patients. The system organ class most commonly involved included skin and appendage disorders (58.3%). Only four of the reactions were previously reported in the literature. The mean time for onset of the ADR after the administration of the drug was 27.8 +/- 36.1 days. The suspected drug was withdrawn in all the reports that resulted in recovery, with mean time for recovery 5.9 +/- 3.6 days. The majority (66.6%) were moderate in severity and 2 were severe in nature. On causality assessment, 6 were probable in nature and the remaining were possible. CONCLUSIONS: Even though there were fewer ADRs reported by this spontaneous reporting system, it gave valuable information regarding the potential for adverse effects with these agents. The study has reinstated the potential role of spontaneous reporting in identifying lesser reported ADRs, including those to CAM. Such hospital-based programs can contribute much in increasing the safety-related data of these agents.

Poisoning severity score, APACHE II and GCS: effective clinical indices for estimating severity and predicting outcome of acute organophosphorus and carbamate poisoning.

Self-poisoning with organophosphorus (OP) compounds is a major cause of morbidity and mortality across South Asian countries. To develop uniform and effective management guidelines, the severity of acute OP poisoning should be assessed through scientific methods and a clinical database should be maintained. A prospective descriptive survey was carried out to assess the utility of severity scales in predicting the outcome of 71 organophosphate (OP) and carbamate poisoning patients admitted during a one year period at the Kasturba Hospital, Manipal, India. The Glasgow coma scale (GCS) scores, acute physiology and chronic health evaluation II (APACHE II) scores, predicted mortality rate (PMR) and Poisoning severity score (PSS) were estimated within 24h of admission. Significant correlation (P<0.05) between PSS and GCS and APACHE II and PMR scores were observed with the PSS scores predicting mortality significantly (P< or =0.001). A total of 84.5% patients improved after treatment while 8.5% of the patients were discharged with severe morbidity. The mortality rate was 7.0%. Suicidal poisoning was observed to be the major cause (80.2%), while other reasons attributed were occupational (9.1%), accidental (6.6%), homicidal (1.6%) and unknown (2.5%) reasons. This study highlights the application of clinical indices like GCS, APACHE, PMR and severity scores in predicting mortality and may be considered for planning standard treatment guidelines.

Effectiveness of an educational program to promote pesticide safety among pesticide handlers of South India.

OBJECTIVES: Occupational poisoning with pesticides is common in developing countries because farmers are often under trained, illiterate and consider it impractical and expensive to use safety equipment, especially in tropical climates. Greater benefit of education programs on prevention can be obtained if initiated in areas having higher occurrence of poisoning. Hence, the present study evaluated occurrence of poisoning and effectiveness of educational interventions among pesticide handlers in areas having high occurrence of occupational poisoning. METHODS: Two villages of Udupi district of South India were identified by spot mapping and targeted for a public education program on safe handling of pesticides, the impact of which was assessed using a knowledge attitude and practice (KAP) questionnaire. Education was provided using a structured individualized training program to 74 pesticide handlers. Three point KAP assessments were carried out at baseline, immediately after training and after 1 month of training. Nonparametric Kruskal-Wallis tests and Friedmann tests were used to compare scores at different time points and between groups. RESULTS: Occurrence of occupation related poisoning was 33% and common in three villages of the district. The average baseline KAP score of 30.88 +/- 10.33 improved after education significantly (P < 0.001) at first follow-up 45.03 +/- 9.16 and at second follow-up 42.9 +/- 9.54. A decline of score between the first and second follow-up may be attributed to decline in knowledge retention. Demographics like gender, literacy and presence of children affected KAP score and there was no influence of geography, age or frequency of pesticide use. CONCLUSIONS: Educational intervention among pesticide handlers improved the KAP score for safe pesticide handling. We recommend that continuous education and training programs for agricultural workers will promote awareness and minimize the hazards of occupational pesticide exposure.

Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital.

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs aims to identify and quantify the risks associated with the use of drugs. The present study was undertaken to characterize the pattern of ADRs reported in a tertiary care teaching hospital (Kasturba Hospital, Manipal) in South India. The study was conducted based on the ADRs reported between March 2004 and February 2005 (12 months) to the ADR reporting unit of the hospital. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics, and outcome of the reactions. Assessment was also done for causality, severity, preventability, and predisposing factors. A total of 408 ADRs which were reported during the 12 months period were evaluated. The overall incidence of ADR calculated from the patient population was 0.15%. At least one ADR was reported in 1.14% of the hospitalised patients and in 0.012% of the outpatients. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly adults and older adults (0.23%) were significantly higher than other age groups. Type A reactions (72.5%) accounted for majority of the reports and a greater share of the ADRs were described to be very common (43.4%) in the literature. Dermatological system (23.5%) was the most commonly affected organ system with skin rash (10.5%) as the most frequently reported reaction. Antineoplastic agents (21.8%) was the drug class most commonly involved, while phenytoin (7.8%) was the individual drug most frequently reported. The suspected drug was withdrawn for the management of the ADR in majority (56.6%) of the reports. In 74.8% of the reports the patient recovered from the reaction at the time of evaluation. Upon causality assessment, majority of the reports were rated as probable (53.7%). Mild and moderate reactions accounted for 50.5 and 43.9%, respectively. In 28.7% of the reports, the reaction was considered to be preventable. At least one predisposing factor was present in 79.9% of the reports and the most common predisposing factors associated were polypharmacy and multiple disease state. Evaluating the relationship between patient characteristics and reaction characteristics, type A reactions were more common among elderly adults (85.92%) and type B reactions more common in adults (35.01%) compared to other age groups. In conclusion, the pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use.