Comparative study of anti-inflammatory activity of some branded generic and generic non-steroidal anti-inflammatory drugs

Generic drugs play a very important role in health care. A study was undertaken to ascertain the equality or inequality between generics and branded generics. NSAIDs are the most commonly used drugs. So these drugs were chosen for the study. Selected branded generic and generic products of ibuprofen, nimesulide, and diclofenac sodium were tested by oral administration of their suspensions to different groups of rats. Freshly prepared drug suspensions equivalent to doses of 40, 10, and 5?mg/kg of ibuprofen, nimesulide, and diclofenac sodium, respectively, were administered orally to the rats and anti-inflammatory activity was measured by the carrageenan-induced rat paw edema model employing Zeitlin’s apparatus to measure the paw thickness. Statistical analysis by t-test, of the activity at the point of maximum difference indicated that with respect to anti-inflammatory activity generic ibuprofen and generic diclofenac sodium are better than branded generic ibuprofen and branded generic diclofenac sodium, respectively, and generic nimesulide is similar to branded generic nimesulide. All the products studied meet the Pharmacopoeial requirements. Hence it may be concluded that branded generic and generic NSAIDs, tested in this study, are of the same efficacy and inter-changeability among branded generics, and switching between branded generics and generics would not result in any difference in efficacy.     

Rates of abuse of tramadol remain unchanged with the introduction of new branded and generic products: results of an abuse monitoring system, 1994-2004

PURPOSE: The analgesic Tramadol HCl (Ultram) was approved in 1994 as a non-scheduled drug under the CSA provided that a novel risk-management program would be developed by an Independent Steering Committee (ISC). The risk-management program began in 1995 with the launch of Ultram, and has been modified over the past decade to accommodate Ultracet (Ultram and acetaminophen) in 2001 and generic tramadol in 2002. This provided a unique opportunity to study the potential changes in abuse as the generic and combination products became available. METHODS: To proactively detect cases of abuse and diversion, the ISC developed a comprehensive questionnaire which was completed quarterly by an extensive network of drug abuse experts (n = 309) and police agencies (n = 100) who were asked to indicate how many diversion cases involving Ultram, Ultracet, and generic tramadol were identified during the preceding 3 months and what were the ten most commonly diverted drugs in their catchment area during that period. RESULTS AND CONCLUSIONS: The data generated demonstrate that the abuse of tramadol remained very low despite new branded and generic formulations. Contrary to the hypothesis that cheaper generic drugs would lead to higher rates of abuse, we found no increase in abuse with the introduction of generic tramadol. Ultracet abuse rates, unlike those found with other widely used hydrocodone and oxycodone combination products, have been even lower than that observed for tramadol. Since the FDA has now mandated that proactive risk-management plans be implemented for new drugs, the tramadol risk-management plan may be useful as a prototypic model which can be modified to accommodate other drugs with abuse potential.     

Psychiatrists' decision making between branded and generic drugs

To study psychiatrists' decision making between generic and branded antipsychotics or antidepressants a hypothetical decision scenario involving decisions between branded and generic drugs was presented to a sample of German psychiatrists. Factors influencing this decision were identified using a regression analysis. n=410 Psychiatrists participated in the survey. Psychiatrists were more likely to choose branded drugs when imagining choosing the drug for themselves (vs. recommending a drug to a patient). In addition, psychiatrists were more likely to choose generic antidepressants than generic antipsychotics. Additional predictors for choosing a generic drug were a higher share of outpatients, less negative attitudes toward generics and higher uncertainty tolerance. In conclusion, psychiatrists' decision making in choosing between branded or generic antidepressants or antipsychotics is to a large extent influenced by vague attitudes towards properties of generics and branded drugs as well as by “non-evidence based” factors such as uncertainty tolerance.     

Difficulties in the production of identical drug products from a pharmaceutical technology viewpoint

Generic products reduce healthcare expenditure and create market competition, and it is broadly assumed that these drugs are identical to the original branded reference drug product. In practice, despite legislation demanding demonstration of pharmaceutical equivalence and bioequivalence, thereby ensuring the safety and efficacy of the product, generic products can differ significantly from the reference drug and amongst themselves, particularly in terms of pharmacokinetic properties. These differences most often relate to pharmaceutical technical differences in production of the active principle ingredient (e.g. different crystalline forms or particle size), to use of excipients (such as sugars) or to the manufacturing process itself (such as tablet manufacture). Furthermore, from the patient's perspective, changing from branded to generic drugs can give rise to concerns about switching. Although sufficient safeguards exist to ensure patient safety and generic drug efficacy, it should not be assumed that all generics are entirely identical.     

Availability of drug information on bioequivalence of generic products--findings of graduate interns at a university pharmacy

Access to drug information (DI) needed to evaluate generic product bioequivalence was studied to identify problems with the current status of DI availability and encourage proper use of DI. Ten items were chosen from among the stock of branded products at the University Pharmacy, and five corresponding generics were selected for each item. Conditions of access to information on pharmacokinetic tests and dissolution tests were rated and the assigned ratings compared. In the case of pharmacokinetic parameters obtainable from makers of generic drugs, we also performed Welch's t-test to compare the difference between values reported for branded and generic products. From the standpoint of individual tests, the pharmacokinetic tests yielded higher scores on the whole than did the dissolution tests, and low scores were obtained for the half-life of blood drug concentration (T1/2). We observed a tendency for the adequacy of information to depend more upon the drug item itself than upon the nature of the test. The percentage of tests allowing for comparison with branded products varied from 0%-75% (average 49%). Parameter by parameter, the range of variation was from 35% of Tmax to 63% of Cmax. Factors precluding comparison included insufficient data on branded products, mismatch in assayed chemical species between branded and generic, mismatch between final sampling time in AUC(t) measurement, dosage inconsistency, and insufficient data on generic products. DI should be provided in a manner that facilitates comparison of information supplied by generic drug makers with data released by makers of branded products.     

氨酚羟考酮依赖性及滥用风险分析

盐酸羟考酮是盐酸吗啡的衍生物,药理作用与吗啡相似,已有动物实验表明羟考酮与吗啡的强化效应相似,具有相同的精神依赖性潜力。在美国和澳大利亚等国,羟考酮类产品是最常被遭到转移和滥用的药品之一。虽然盐酸羟考酮的单方和复方制剂都有可能引发滥用,但在我国盐酸羟考酮的复方制剂即氨酚羟考酮是按照处方药管理,相对于按照麻醉药品管理的单方制剂流失和滥用的可能性更大。医疗机构和药品监管部门应当加强对氨酚羟考酮的管理和监测,积极避免流失和滥用的发生。     

Pharmacists’ perceptions of generic drugs in China

Perceptions of Chinese pharmacists towards generic drugs were evaluated by a cross-sectional study from Aug. 2018 to Dec. 2018. Online survey tool Sojump was adopted to release the questionnaires using convenience sampling. A total of 577 questionnaires by pharmacists were analyzed. A meaningful proportion of pharmacists expressed negative perceptions of generic drugs, such as perceiving generics as less effective, less safe and more likely to cause side effects compared to their branded equivalents. Educational campaigns that focus on misperceptions of generic drugs may be necessary.     

Efficacy, safety and pharmacokinetic study of a novel fentanyl-containing matrix transdermal patch system in Japanese patients with cancer pain

BACKGROUND AND OBJECTIVES: A novel transdermal matrix patch delivery system for fentanyl has been developed to deliver improved management of cancer pain compared with that obtained using current fentanyl reservoir patches. This study was carried out to assess the efficacy, safety and pharmacokinetic profiles of a 12.5 microg/h transdermal matrix fentanyl patch administered with the objective of replacing morphine, oral oxycodone or fentanyl injection formulations. The study also evaluated how the pharmacokinetic profiles of higher dose fentanyl patches (25, 37.5 and 50 microg/h) changed following dose adjustments to optimize management of cancer pain. METHODS: This open-label, multicentre study involved 87 patients of both sexes (> or =20 years) with a confirmed diagnosis of cancer. Patients were receiving any one of the following at the time of enrollment for the management of their cancer pain: (a) morphine <45 mg/day orally, <30 mg/day as suppositories, or <15 mg/day by injection; (b) oral oxycodone <30 mg/day; or (c) fentanyl injectable preparations <0.3 mg/day. The patients were administered a 3-day course of fentanyl transdermal matrix patch application three times. The initial dose was 12.5 microg/h, which could be increased when a new patch was applied if the physician deemed this to be appropriate based on pain intensity ratings and use of rescue medications. Efficacy outcomes included patients' global assessment scores (primary efficacy endpoint) measured on a five-step scale and dichotomous scores for physicians' global assessment. The occurrence of adverse events and changes in laboratory tests were evaluated as safety variables. Serum fentanyl levels were measured immediately after removal of the old patch on days 4, 7 and 10 to obtain data on trough serum concentrations. RESULTS: The percentage of patients in category 3 or higher (very satisfied, satisfied, or neither satisfied nor dissatisfied) for the patient's global assessment score was 89.4% (76/85), indicating high patient satisfaction and attainment of sufficient pain control after patients switched from their previously used opioid analgesics. Similar findings were obtained on physicians' global assessment scores. A total of 316 adverse events occurred in 78 (90.7%) of 86 patients who were administered at least one patch. These included nausea (31 [36.0%]), somnolence (26 [30.2%]), vomiting (22 [25.6%]), diarrhoea (17 [19.8%]), constipation (14 [16.3%]), pyrexia (11 [12.8%]) and insomnia (9 [10.5%]). The mean (+/- SD) serum fentanyl concentration determined on day 4 was 169.9 +/- 103.4 pg/mL (n = 83). Serum fentanyl measurement results indicated that the same fentanyl patch dose resulted in similar serum fentanyl levels, while increased doses produced higher serum fentanyl concentrations. CONCLUSION: The fentanyl matrix transdermal patch formulation employed in this study demonstrated sufficient cancer pain control for patients switching from morphine or oral oxycodone preparations. The patch tested was well tolerated and its use did not result in any increased incidence of adverse drug reactions over those commonly found with opioid analgesics.     

肿瘤专科医院门诊麻醉性镇痛药品使用分析

目的了解肿瘤专科医院门诊麻醉性镇痛药品使用情况。方法采用回顾性分析方法对2012年门诊4836张麻醉性镇痛药品处方进行分析和评估。结果处方使用频率最高的药品为盐酸羟考酮缓释片,其次为芬太尼透皮贴剂和硫酸吗啡缓释片。除磷酸可待因DUI值略大于1外,其余品种DUI值均小于1。结论该院麻醉性镇痛药使用合理,阿片类缓释剂型为癌痛患者的首选药物。