Global landscape analysis of no-fault compensation programmes for vaccine injuries: A review and survey of implementing countries.

To update the landscape analysis of vaccine injuries no-fault compensation programmes, we conducted a scoping review and a survey of World Health Organization Member States. We describe the characteristics of existing no-fault compensation systems during 2018 based on six common programme elements. No-fault compensation systems for vaccine injuries have been developed in a few high-income countries for more than 50 years. Twenty-five jurisdictions were identified with no-fault compensation programmes, of which two were recently implemented in a low- and a lower-middle-income country. The no-fault compensation programmes in most jurisdictions are implemented at the central or federal government level and are government funded. Eligibility criteria for vaccine injury compensation vary considerably across the evaluated programmes. Notably, most programmes cover injuries arising from vaccines that are registered in the country and are recommended by authorities for routine use in children, pregnant women, adults (e.g. influenza vaccines) and for special indications. A claim process is initiated once the injured party or their legal representative files for compensation with a special administrative body in most programmes. All no-fault compensation programmes reviewed require standard of proof showing a causal association between vaccination and injury. Once a final decision has been reached, claimants are compensated with either: lump-sums; amounts calculated based on medical care costs and expenses, loss of earnings or earning capacity; or monetary compensation calculated based on pain and suffering, emotional distress, permanent impairment or loss of function; or combination of those. In most jurisdictions, vaccine injury claimants have the right to seek damages either through civil litigation or from a compensation scheme but not both simultaneously. Data from this report provide an empirical basis on which global guidance for implementing such schemes could be developed.

Ocular Anesthesia-Related Closed Claims from Ophthalmic Mutual Insurance Company 2008-2018.

PURPOSE: To evaluate the types of anesthesia-related closed claims and their contributing factors, using data from the Ophthalmic Mutual Insurance Company (OMIC). DESIGN: Retrospective analysis of preexisting data. PARTICIPANTS: Plaintiffs who filed a professional liability claim or suit (written demand for money) against OMIC-insured ophthalmologists, ophthalmic practices, or surgicenters in which the surgical case occurred. METHODS: Plaintiff claims were collected from the OMIC database from 2008 to 2018 using search queries for terms associated with known complications of ophthalmic anesthesia. MAIN OUTCOME MEASURES: Number and types of anesthesia-related injuries and claims, who administered the anesthesia, the outcomes of the claim or suit, cost to defend, and payments made to plaintiffs. RESULTS: Sixty-three anesthesia-related claims or suits were filed by 50 plaintiffs. Anesthesia-related injuries included globe perforation (n = 17), death (n = 13), retrobulbar hemorrhage (n = 7), optic nerve damage (n = 4), vascular occlusions (n = 2), pain (n = 2), eye or head movement resulting in injury (n = 2), and 1 case each for numbness, diplopia, and tooth loss during intubation. All but 1 patient who died had preexisting, significant comorbidities. Two deaths were related to brainstem anesthesia. Regarding the type of anesthesia in the closed claims, retrobulbar and peribulbar anesthesia were the most common types (n = 16 each), followed by local infiltration around the lids and facial nerve (n = 6), topical anesthesia (n = 5), and general anesthesia (n = 5). In 2 cases, the exact type of anesthesia was unknown but not general. The 5 topical with sedation anesthesia-related claims were due to inadequate pain control (n = 2), ocular movement resulting in capsular rupture (n = 2), or death (n = 1) allegedly related to excessive or inadequate monitoring of sedation. There were 5 claims related to general anesthesia including 4 deaths and 1 tooth loss during intubation. Sedation was alleged to be a factor in 5 cases resulting in death. Anticoagulants were a factor in 3 retrobulbar hemorrhage cases. CONCLUSIONS: Although claims and suits were infrequent given the large number of insured ophthalmologists and the large number of surgical cases requiring various types of anesthesia performed over the 10.5-year study period, severe injuries can occur.

What is the present situation of vascular surgery? Considerations and reflections based on real practice.

"For the best vascular care to every patient, every day" is the goal of our practice, but is it a possible goal? Where are we now? The general idea is that we are pursuing the right way. The evolution of our discipline in the last two decades has been extraordinary and we reaffirm that we are the leaders in diagnose and treatment of the arterial pathology. Unfortunately, we can find some cases in which reality has to be faced as hardly as it can be, remembering us that we still have to go further with our job. The delay in the diagnose and treatment could lead to a permanent deficit and a money loss for the national health system due to prolonged hospitalization, multiple re-hospitalizations, loss of working capacity. This must be avoided. We strongly suggest that a vascular surgeon should be present in all the Emergency Room and should be routinely involved in the management of patients. The routine use of dedicated interdisciplinary protocols should be strongly advocated. Vascular surgery, as medical specialty, should be recognized as single specialty in all countries and as "peculiar" by the National Authority as well as Neurosurgery and Cardiac Surgery.

[Psychiatric polypharmacy: hazard through drug-drug-interaction and possibilities for prevention]. / Psychiatrische Polypharmazie: Risiken durch Arzneimittel-wechselwirkungen und mögliche Vermeidungsstrategien.

Psychiatric diseases and comorbidity have increased over the past years. Commonly used psychotropic drugs contain a high risk of drug interactions and adverse drug events (ADE). With a frequency of 10-12% psychotropic drugs are, among all pharmaceuticals, the most common cause of hospitalisation due to ADE. During a hospital stay the application of psychotropic drugs can also lead to adverse drug events--sometimes due to drug interactions. Currently, ADEs and drug interactions are the most frequent cause of death for in-patients (18% of all causes of death) with an overall mortality of 0.95%. As studies have shown, hospitals as well as insurers could save a considerable amount of resources by implementing a system with on-ward pharmacists, hereby reducing ADE and re-hospitalisation rates. In recent studies a large amount of current ADEs were rated as preventable. Patient impairment due to ADE is leading to an increase in liability cases with an expected 5% increase of compensation payments in 2011. To evaluate these ADE-related cases, a pharmaceutical assessment should be included in the expert trials, especially since a lack of awareness of medication errors is prevalent. When aiming towards a successful drug therapy, physicians must also consider that cheaper substances may often have an unfavourable drug interaction profile.

Toward safer practice in otology: a report on 15 years of clinical negligence claims.

OBJECTIVES/HYPOTHESIS: To determine the characteristics of medical negligence claims arising from otological practice. STUDY DESIGN: Retrospective analysis of medical negligence claims contained in the National Health Service Litigation Authority (NHSLA) database. METHODS: Claims relating to otology and neurotology between 1995 and 2010 were obtained from the NHSLA database and analyzed for cause of injury, type of injury, outcome of claim and costs. RESULTS: Over 15 years there were 137 claims in otology, representing 26% of all the claims in otolaryngology. Of these, 116 have been closed, and 84% of closed claims resulted in payment. Of the 97 successful claims, 63 were related to operative complications. This included six cases of wrong side/site surgery, and 15 cases of inadequate informed consent. The most common injuries claimed were hearing loss, facial paralysis, and additional/unnecessary surgery. Middle ear ventilation and mastoid surgery were the procedures most commonly associated with a successful claim. There were 15 successful claims of misdiagnosis/delayed diagnosis, with chronic suppurative otitis media the condition most frequently missed. There were nine successful claims related to outpatient procedures, of which seven were for aural toilet and six claims of medical mismanagement, including three cases of ototoxicity from topical medications. There were also four successful claims for morbidity due to delayed surgery. CONCLUSIONS: This is the first study to report outcomes of negligence claims in otology. Claims in otology are associated with a high success rate. A significant proportion of claims are not related to surgery and represent areas where safety should also be addressed.

Potential risk factors for prolonged recovery following whiplash injury.

A retrospective analysis of insurance data was made of 600 individuals claiming compensation for whiplash following motor vehicle accidents. Three hundred randomly selected claimants who had settled their injury claims within 9 months of the accident were compared with 300 who had settled more than 24 months after the accident. We compared the two groups to identify possible risk factors for prolonged recovery, for which settlement time greater than 24 months was a marker. Variables considered included demographic factors, type of collision, degree of vehicle damage, workers compensation, prior claim or neck disability, treatment and time to settlement. Consulting a solicitor was associated with a highly significant, four-fold increase of late settlement of the claim. A concurrent workers' compensation claim, prior neck disability and undergoing physiotherapy or chiropractic treatment were weakly associated with late settlement. The degree of damage to the vehicle (as indicated by cost of repairs) was not a significant predictor of late settlement. Late settlement may be the direct effect of legal intervention, independent of the severity of the injury. Whilst the financial benefit to the claimant of consulting a solicitor is apparent, the benefit of prolonged disability is not. It may be to the advantage of both insurers and claimants if those likely to proceed to late settlement could be recognised early and their claims settled expeditiously.

How intermediate tax sanctions may be applied to IDSs.

Recently issued proposed regulations describing how the IRS intends to enforce the intermediate tax sanctions statute of the Internal Revenue Code have important ramifications for integrated delivery systems (IDSs). The regulations' interpretation of who within an IDS may be subject to excise taxes under the statute is broad, basing an individual's risk of being taxed on his or her degree of influence over a given entity within the organization, rather than over the organization as a whole. To protect individuals within an IDS from exposure to intermediate tax sanctions, the organization should understand who is likely to be at risk and take steps to ensure that all transactions with such persons are in compliance with the conditions set forth in the proposed regulations.