RESUMO
PURPOSE: To determine the frequency and characteristics of safety advisories issued by medicines regulatory agencies in Australia, Canada, United Kingdom (UK) and the United States (US). METHODS: This retrospective analysis examines medicines safety warnings issued by the US Food and Drug Administration (FDA), Health Canada (HC), the Australian Therapeutic Goods Administration (TGA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) from January 1, 2007 until December 31, 2016. A database of warnings obtained from regulators' websites was developed and warnings were classified by communication type, drug, or therapeutic class focus, and the risk discussed. Advisories identifying the same drug or therapeutic class and risk were combined into groups termed "drug-risk issues" for comparisons between regulators. RESULTS: Over this 10-year period, 1441 advisories were identified, with the MHRA issuing the most advisories (MHRA = 469, FDA = 382, HC = 370 TGA = 220). Seventy two percent focussed on single drugs (1034/1441) and 58.7% were alerts (846/1441) posted on the regulators' websites. Diabetes drugs, smoking cessation drugs and immunomodulatory agents were the individual drug types most often subject to safety advisories, while antidepressants, antipsychotics, and proton-pump inhibitors were the top three therapeutic classes. Of 680 identified drug-risk issues, 3.8% (26/680) described a risk of death. By body system, cardiac effects were the most frequent: 10.4% (71/680). CONCLUSION: We found considerable differences in the use of advisories including frequency, communication type, and focus. Disparities in communication about emergent evidence on risks may mean that clinicians and patients in some countries are less well informed about medicine safety concerns than others.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Órgãos Governamentais/estatística & dados numéricos , Medicamentos sob Prescrição/efeitos adversos , Avaliação de Risco e Mitigação/organização & administração , Antidepressivos/efeitos adversos , Antipsicóticos/efeitos adversos , Austrália , Canadá , Rotulagem de Medicamentos/estatística & dados numéricos , Humanos , Hipoglicemiantes/efeitos adversos , Fatores Imunológicos/efeitos adversos , Disseminação de Informação , Farmacovigilância , Inibidores da Bomba de Prótons/efeitos adversos , Estudos Retrospectivos , Agentes de Cessação do Hábito de Fumar/efeitos adversos , Reino Unido , Estados UnidosRESUMO
BACKGROUND: The last two decades have seen the reintroduction of tourniquets into guidelines for the management of acute limb trauma requiring hemorrhage control. Evidence supporting tourniquet application has demonstrated low complication rates in modern military settings involving rapid evacuation timeframes. It is unclear how these findings translate to patients who have prolonged transport times from injury in rural settings. This scoping review investigates the relationship between time and distance on metabolic complications, limb salvage and mortality following tourniquet use in civilian and military settings. METHODS: A systematic search strategy was conducted using PubMed, Embase, and SafetyLit databases. Study characteristics, setting, mechanism of injury, prehospital time, tourniquet time, distance, limb salvage, metabolic response, mortality, and tourniquet removal details were extracted from eligible studies. Descriptive statistics were recorded, and studies were grouped by ischemia time (< 2 h, 2-4 h, or > 4 h). RESULTS: The search identified 3103 studies, from which 86 studies were included in this scoping review. Of the 86 studies, 55 studies were primarily in civilian environments and 32 were based in military settings. One study included both settings. Blast injury was the most common mechanism of injury sustained by patients in military settings (72.8% [5968/8200]) followed by penetrating injury (23.5% [1926/8200]). In contrast, in civilian settings penetrating injury was the most common mechanism (47.7% [1633/3426]) followed by blunt injury (36.4% [1246/3426]). Tourniquet time was reported in 66/86 studies. Tourniquet time over four hours was associated with reduced limb salvage rates (57.1%) and higher mortality rates (7.1%) compared with a tourniquet time of less than two hours. The overall limb salvage and mortality rates were 69.6% and 6.7% respectively. Metabolic outcomes were reported in 28/86 studies with smaller sample sizes and inconsistencies in which parameters were reported. CONCLUSION: This scoping review presents literature describing comparatively safe tourniquet application when used for less than two hours duration. However, there is limited research describing prolonged tourniquet application or when used for protracted distances, such that the impact of tourniquet release time on metabolic outcomes and complications remains unclear. Prospective studies utilizing the development of an international database to provide this dataset is required.
Assuntos
Serviços Médicos de Emergência , Militares , Humanos , Torniquetes/efeitos adversos , Estudos Prospectivos , Estudos Retrospectivos , HemorragiaRESUMO
INTRODUCTION: For poisoned patients, ambulance services may be the first point of contact for medical attention. With limited training in toxicology, ambulance services are encouraged to contact the Poisons Information Centre (PIC) for advice. This study aims to characterise referrals to a PIC from a state ambulance service with the purpose of improving information delivery and efficient use of these services. METHODS: This was a retrospective observational series of referrals to an Australian state PIC from ambulance staff from 1 January 2020 to 31 December 2020. Referrals were identified through the PIC Pharmhos database where the call originated from either a paramedic or emergency dispatch officer. Call reports were reviewed to extract data on patient demographics, exposure details and advice provided by the PIC. RESULTS: There were 1537 calls regarding 1420 poisoning exposures over the 12-month period, with 117 (7.6%) follow-up calls, representing 4.1% (1537/37835) of total calls to the PIC. Initial calls originated from paramedics in 999/1420 (70.4%) referrals, with dispatch officers referring 421/1420 (29.6%). Paediatric patients aged <15 years were involved in 492/1420 (34.6%) exposures with the commonest age range being 1-4 years. Most referrals involved pharmaceuticals exposures (756/1420 [53.2%]) followed by chemicals (557/1420 [39.2%]) and drugs of abuse (69/1420 [4.9%]). The commonest agents involved were paracetamol followed by quetiapine and sertraline. The PIC advised no treatment following benign exposures in 617/1420 (43.5%) calls, first aid measures in 333/1420 (23.5%) calls, supportive measures in 339/1420 (23.9%) calls and specific treatment in 32/1420 (2.3%) calls. Referral to the hospital was advised in 761/1420 (53.6%) calls, the majority of these were following deliberate self-poisonings (428/1420 [30.1%]). CONCLUSIONS: Ambulance staff commonly contact the PIC following benign exposures where no treatment is required. Ambulance referral to a PIC following suspected poisonings may have a role in preventing unnecessary transfer to hospital in poisoned patients.