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Minimise Risk (minimise + risk)
Selected AbstractsBiosimilars: pharmacovigilance and risk management,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2010Leyre Zuņiga Ph.D. Abstract Biosimilars cannot be authorised based on the same requirements that apply to generic medicines. Despite the fact that the biosimilar and reference drug can show similar efficacy, the biosimilar may exhibit different safety profile in terms of nature, seriousness or incidence of adverse reactions. However, the data from pre-authorisation clinical studies normally are insufficient to identify all potential differences. Therefore, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase including continued risk,benefit assessment. The biosimilar applicant must provide the European Medicines Agency (EMEA) with a risk management plan (EU-RMP) and pharmacovigilance programme with its application, including a description of the potential safety issues associated with the similar biological medicinal product that may be a result of differences in the manufacturing process from the reference biologic. The most critical safety concern relating to biopharmaceuticals (including biosimilars) is immunogenicity. Risk management applies scientifically based methodologies to identify, assess, communicate and minimise risk throughout a drug's life cycle so as to establish and maintain a favourable benefit,risk profile in patients. The risk management plan for biosimilars should focus on heightens the pharmacovigilance measures, identify immunogenicity risk and implement special post-marketing surveillance. Although International Nonproprietary Names (INNs) served as a useful tool in worldwide pharmacovigilance, for biologicals they should not be relied upon as the only means of product identification. Biologicals should always be commercialised with a brand name or the INN plus the manufacturer's name. Copyright Š 2010 John Wiley & Sons, Ltd. [source] Air travel and the risk of deep vein thrombosisAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 1 2006Niels G. Becker Background:The magnitude of the risk of venous thromboembolism (VTE) following air travel has been difficult to resolve due to lack of adequate data. We determine the association more precisely by using a large dataset and an improved method of analysis. Method:Data on air-travel history for each of 5,196 patients hospitalised for VTE in Western Australia from 1981 to 1999 is analysed using a log-linear regression model for the probability that a flight triggers VTE and for the baseline hazard rate for VTE hospitalisation. Results:The risk of VTE being triggered on the day of an international flight relative to a flight-free day is 29.8 (95% CI 22.4-37.3). Evidence that this relative risk depends on age is weak (p=0.06), but the absolute risk clearly depends on age. The annual relative risk for an individual taking one international flight, compared with an individual of the same age taking no flight, is estimated to be 1.079. The estimated median time from flight to hospital admission is 4.7 days (95% CI 3.8-5.6) and the estimated 95th percentile is 13.3 (95% CI 10.3-16.8). Conclusions:Evidence for an association between international air travel and VTE hospitalisation is strong and passengers should be advised on ways to minimise risk during long flights. While 29.8 is a large relative risk, it must be remembered that the baseline risk is very small and the relative risk applies only to the unobserved triggering of a deep vein thrombosis episode on the day of travel; the consequent hospitalisation occurs on one of numerous ensuing days. [source] Can fishermen allocate their fishing effort in space and time on the basis of their catch rates?FISHERIES MANAGEMENT & ECOLOGY, Issue 1 2001An example from Spermonde Archipelago, Indonesia, SW Sulawesi Spatial and temporal patterns in catch rates and in allocation of fishing effort were analysed for the coastal fishery in Spermonde Archipelago, Indonesia, to assess whether fishermen can optimise their strategy from catch information, or whether they fish under great uncertainty and merely minimise risks. On average 517 fishing units operated in the 2800 km2 area, catching 21 t fish day,1. Major gear categories were hook and line (59% of total effort and 5% of total catch), and lift nets (16% of total effort and 70% of total catch). The size of individual resource spaces varied with gear type and was smaller in unfavourable weather conditions. Although spatial patterns in catch rates at the scale of the whole archipelago were evident, fishermen could not differentiate between locations, as catch variance within their individual resource spaces was high relative to the contrasts in spatial patterns. The aggregated distribution of fishing effort in Spermonde must be explained by factors such as the small scale of operations, rather than fish abundance. [source] Navigating ethical discharge planning: A case study in older adult rehabilitationAUSTRALIAN OCCUPATIONAL THERAPY JOURNAL, Issue 1 2010Evelyne Durocher Background:, Ethical issues are becoming more complex as individuals live longer with increased disability and medical needs. This article elucidates common ethical issues encountered in discharge planning with older adults. Methods:, We conducted normative ethical analysis of a clinical case using methods of philosophical inquiry, including thick description, reflexivity, conceptual clarification and examination of competing arguments for internal consistency. Results:, The analysis demonstrates how health-care teams struggle to balance protection from harm while honouring informed choices. We argue that ethical discharge planning requires judicious identification of client values, even if these conflict with team determinations of best interests. Conclusion:, Dialogue is needed to identify risks, help clients determine their personal level of acceptable risk and determine provisions to minimise risks. [source] | ||||||||||