ABSTRACT
Background : Ceftazidime is a third generation cephalosporin that has been commercially available through several manufacturers and distributors in Thailand because of its widely clinical use. However, there is no bioequivalent study of this drug in Thais.\ The present study was conducted to compare the in vivo bioequivalent of ceftazidime obtained from an original (reference), and a local (tested) manufacturer in healthy Thai volunteers.Objective: To determine if two ceftazidime preparations (Fortum and Forzid) of different manufacturers are bioequivalent when administered intramuscularly.Design: Double-blind single-dose, two-period, randomized crossover study.Subjects: Fourteen Healthy Thai Volunteers.Methods and Interventions: Ceftazidime 1 g was administered intramuscularly to subjects. Blood samples were collected at predetermined intervals and assayed for ceftazidime concentration with HPLC. Pharmacokinetic parameters were calculated from the observed plasma-concentration time profiles. Maximum plasma concentration (Cmax), time to peak concentration (Tmax), areas under the concentration-time curve from 0 to 12 h (AUC0-12) and 0 to infinity (AUC0-) were the primary parameters considered in the determination of bioequivalence.Results: The two ceftazidime preparations were generally well tolerated by all volunteers. Administration of both preparations resulted in similar mean values for every pharmacokinetic parameters. Statistical analysis revealed no significant difference between the two preparations in any parameter, indicating that the two preparations are statistically bioequivalent (p\<0.05). The 90% confident interval (CI) for the ratio of the means for the Cmax (0.9281-1.1272) and AUC0- (0.9311-1.0184), are within the Food and Drug Administration Guideline range of bioequivalence (0.80 to 1.25).Conclusions: These results demonstrated that the tested ceftazidime preparation (Forzid) is bioequivalent to the reference ceftazidime preparation (Fortum) when administered intramuscularly.
ABSTRACT
Background: Easy Asthma Clinic (EAC) at Srinagarind Hospital, Khon Kaen University, Thailand was established in February 2004. EAC is an ambulatory asthma clinic which implemented the Global Initiative for Asthma (GINA) guidelines and it has been incorporated into the practice. The goal of EAC is to improve the quality of care for asthmatic patients utilizing multidisciplinary approach involving physicians, nurses and pharmacists; however drug related problems (DRPs) have been still occurred because asthma is a chronic disease which requires long term medication therapy and special technique, these lead to the decrease in effectiveness of therapy. Therefore, pharmacist has an important role in managing these DRPs in order to improve the drug therapy in asthmatic patients. Objective: To study DRPs and pharmacist’s intervention on managing DRPs in EAC. Method: The descriptive and retrospective study design was conducted for patients in EAC, Srinagarind Hospital during 1st July 2005 to 30th June 2007. The selection criteria were patients who have been followed up at least two times. The outcomes of pharmacist’s intervention were evaluated in the following appointment. Result: There were 303 patients recruited, of which 111 (36.6 %) were males and 192 (63.4%) were females with their mean age of 54 years old. Numbers of visits were 906 (3 times per person). There were 225 patients (74.3%) with DRPs, 591 problems in total. The most DRPs were non-compliance (62.9%) and adverse drug reactions (ADRs) (36.2%). In terms of non-compliance, most highly occurred problems were incorrect technique of administrations (62.9%) and under dosage of medication (32.0%). A pharmacist resolved or prevented DRPs by counseling patients (98.7%) and consulting physicians (1.3%). Pharmacist’s interventions improved patient compliance (36.3%) by describing disease and the importance of using medications, teaching appropriate technique of administration (22.8%), counseling on management and prevention of ADRs (20.4%) and educating lifestyle modification (20.6%). Pharmacist’s intervention could resolve the problems (48.1%). Non-compliance was resolved 49.2%, ADRs were resolved 44.9% and other DRPs, which were discussed with the physician, were totally resolved. Conclusion: Pharmacist’s intervention on managing DRPs could resolve DRPs, and help patients to use their medications appropriately.