70 research outputs found
Shortage of plasma-derived medicinal products: what is next? narrative literature review on its causes and counteracting policies in Italy
No full text: Introduction: This paper describes the peculiarities of the plasma-derived medicinal product (PDMP) market and illustrates the results of a review of the literature on policies aimed at counteracting the shortage of PDMPs. Characteristics of PDMPs: Plasma is primarily used for the industrial production of blood products (80%). The demand for PDMPs, particularly immunoglobulins (IGs), is increasing. However, the production of PDMPs is complex, long (7-12 months), and expensive, accounting, according to US estimates, for 57% of the total costs of PDMPs compared to 14% for small molecules. PDMP market: Unexpected increases in clinical need cannot be addressed in the short term. Once the demand for some diseases is satisfied, the collection and fractionation of plasma will only be used to supply some specific patients. Hence, the full weight of the marginal costs, which remain constant, are borne by a few products. According to last liter economics, the industry stops producing when the marginal revenue equals the marginal cost, thereby reducing the convenience of producing the most commonly used PDMPs (albumin and IG). The imbalance between the demand and supply of PDMPs was exacerbated by the COVID-19 pandemic, which further increased the cost of plasma collection. Shortage issue and possible solutions: Policies to counteract this imbalance have also been discussed. If the demand is inappropriate, it should be reduced. If the demand is appropriate and supply cannot be increased, the demand should be prioritized for patients for whom PDMPs are the only available treatment. If the shortage depends on insufficient supply and technical and allocative efficiency, both production and supply should be improved, together with incentives for all stakeholders involved in the PDMP market to increase the sustainability of production/supply. The paper is focused on this second issue, that is supply-driven unbalance
AN EMBLEMATICAL CASE OF FIRST ACCESS IN EPILEPSY WHILE DRIVING ACCORDING TO THE ITALIAN LAW N. 41 OF 23 MARCH 2016 AND A REVIEW OF LITERATURE
No full textIntroduction: People with epilepsy, all over the world, have many problems in everyday life because of unpredictable seizures
that could hinder every human activity. In particular, they are restricted from driving because of the fear over seizure-related car accidents.
The purpose of this work is to raise some questions about risk of traffic accident, driving restriction and personal liability in
people with and without diagnosis of epilepsy.
Case presentation: We present a case of a 49-year-old woman who accidentally hit a pedestrian with her car, causing him severe
personal injury. After many clinical and instrumental examinations, the physicians diagnosed to her generalized epilepsy and she
started a daily anti-epileptic therapy.
Results: Studies have tried to estimate the real risk of road traffic accident in order to evaluate when a person with epilepsy
reaches an acceptable risk of driving, balancing public traffic safety and personal freedom, without a real success. Therefore, we present
an overview of laws regarding epilepsy-driving restriction and a recent court case related to a car accident during a first seizure,
according to the Italian law n. 41 of 23 march 2016 about personal injuries and murder caused by vehicular accident and a review of
Literature about the first seizure while driving.
Conclusion: We believe that the driver cannot be held liable for any personal injuries or murder caused by vehicular accident,
according to the Italian law n. 41 of 23 march 2016, likewise it happened in the case presented. Indeed, the crisis represent a temporary
reduction of liability (incapacity to understand and want), making the person not imputable for own actions during the time of
the seizure.
Keywords: first seizure, people with epilepsy (PWE), car accident, personal injuries
La responsabilità professionale medica nei minori. Uno sguardo medico-legale tra le ragioni della dottrina e quelle del cuore
No full textIntroduction. Over the past few decades there has been a steady increase in the number
of requests for medical professional liability.
Objective. A medico-legal observatory on professional liability cases has been
set up in an Italian university hospital, with the aim of monitoring and documenting
the characteristics of negligence disputes from a medico-legal point of view.
Methods. The general analysis includes over 1450 cases, archived between 2004 and 2019.
The subpopulation of cases concerning subjects < 18 years and equal to 184 cases
(13% of the total) is then examined.
Results. In 60% of cases, the claims related to the medical disciplinary area, 20% of the cases
to the surgical area and 12% to the emergency area, 8% related to the service area.
In the sample of the general population, the percentage of recognition of responsibility by doctors
of the facility is 33%, while in the case of minors it is observed equal to 45%.
Discussion. Multiple reasons can be highlighted to explain the phenomenon observed such
as the frequent absence of comorbidity in young patients, a particular empathy of the evaluator
in ascertaining cases relating to minors and probably regarding the presence of elements
of organizational deficiencies that may induce to recognize more responsibility. With regard
to the latter hypothesis, further studies will need to be carried out in the future.
Conclusion. The data collected can be useful from an educational and didactic point of view
for professionals dealing with minors and can benefit from useful references to the correct
and compilation of the medical record
Mycobacterium Chimaera: Clinical and medico-legal considerations starting from a case of sudden acoustic damage
No full textMycobacterium Chimaera is a microorganism that can cause nosocomial infections particularly in patients undergoing cardiac surgery. The specific case presented herein shows an original clinical presentation of the infection: sudden unilateral deafness as a result of septic embolization. Medico-legal experts appointed by the court in a civil liability dispute analyzed the case and submitted their expert opinion. This article analyzes the peculiar and innovative aspect of professional liability that can be attributed to the healthcare facility and the manufacturer of the equipment used in the operating room from a medical-legal point of view
The new Italian law 219/2017: an extraordinary clinical tool in internal medicine
No full textAbstract
On December 2017, Law 219 named
Provisions for informed consent and advance treatment
directives
was approved in Italy, and on one side this law helped the daily medical activity on the
other side it enhanced the patient's self-determination. This contribution analyzes the new
legislative disposition and the possible medical-legal and practical implications for patients
entrusted
in hospitals. In particular, it focuses on the usefulness of
an early planning of medical care
decision in complex pathological situations in order to enhance the patient's self-determination and
his eventual impassable refusal. It also safeguards the medical work from disputes and claims,
preserving medical autonomy and competence
La nuova legge sulla responsabilità professionale: cosa cambia in punto di linee guida?
No full textIl tema della sicurezza delle cure e quello della necessità di affrontare il nodo della
responsabilità professionale sono per la prima volta affrontati in Parlamento nel 2012,
anno in cui è promulgato un primo provvedimento, il cosiddetto “Decreto Balduzzi”,
che introduce la doverosità di attenersi a linee guida quale riferimento
per la valutazione dell’eventuale colpa del medico. Le principali innovazioni che
la legge 24/2017 ha introdotto su questi aspetti sono la regolamentazione dell’esercizio
professionale, basata su linee guida accreditate e buone pratiche, e le ricadute che questo
comporta sul versante della responsabilità per colpa. Nel presente articolo offriamo
una chiave di lettura della nuova legge, con particolare riguardo alle linee guida,
proponendo anche un confronto con i dettami del precedente assetto normativo
sul tema
IL RUOLO MEDICO-LEGALE NELL'ACCERTAMENTO DEL DANNO CATASTROFALE
No full textIl contributo analizza i presupposti fondamentali per il riconoscimento del c.d. danno catastrofale nell’ordinamento italiano, isolando i criteri indicati nelle sentenze di Cassazione proponendo un insieme di indirizzi metodologici in grado di delineare il ruolo e contributo medico-legale nella valutazione di tale danno.
The contribution analyzes the fundamental prerequisites for the recognition of the so-called catastrophic damage in the Italian legal system, isolating the criteria indicated in the judgments of the Court of Cassation and proposes a set of methodological guidelines capable of outlining the role and medical-legal contribution in assessing this damage
Seventeen-Year Medical Professional Liability Experience in a Level III University Hospital
No full textIntroduction: In recent decades, the number of medical professional liability disputes has grown exponentially, becoming a well-studied aspect of public healthcare. Legal medicine is an essential tool in managing this phenomenon. Methods: This article reports the results of the analysis of disputes for medical professional liability in a Level III University Hospital in Italy. The study covers the time period from 01.01.2003 to 31.12.2019. Results: About 33% of claims have been compensated. Those claims fall within the following categories: 37% in the surgical field, 17% in the field of internal medicine, and 35% in the emergency care field. As for the types of a medical mistake, compensation was awarded in 30% of diagnostic error cases, 26% of therapeutic error cases, 47% of execution error cases, and 55% of organizational deficiency cases. Discussion: The difference in the rate of compensation between the various medical fields or types of error depends on specific medico-legal characteristics. The aim of advanced healthcare systems is to prevent medical liability disputes by analyzing this phenomenon and improving clinical risk management programs. In particular, according to our study, events related to organizational deficiencies are the most preventable. In addition, through the use of a dedicated reporting procedure, medico-legal analysis of malpractice cases may be the key to risk reduction. Conclusion: Every major hospital should set up a medico-legal watchdog responsible for collecting and analyzing information on professional medical liability disputes in order to prevent and manage such events
Organizational liability: new frontier of medical malpractice? Seventeen-year experience as a medico-legal observer
No full textBACKGROUND: The study of claims for medical malpractice can be a useful tool to understand Clinical Risk. Indeed, the identification of the events that cause or foresee damage to the patient allows the proposal of new strategies to prevent the recurrence of the same event. This ensures better medical case security and health maintenance of individuals and overall society. In particular, this study focuses on the cases regarding secondary errors due to organizational deficit in order to understand the origins of such organizational deficit and to start specific prevention measures.METHODS: The claims for medical damage were analyzed in the period between 1st January 2003 and 31st December 2019 and divided in specific sub-categories.RESULTS: The claims due to deficiencies in organizational responsibility covers 10% of the total cases. The distribution according to the macro-areas shows that the surgical field is the most represented area (68%). The classification of these deficiencies shows the preponderance of "sentinel events" (30%) compared to "diagnostic/therapeutic delay" (27%) and "infections" (23%).CONCLUSIONS: From the present research, it was possible to identify the main cause of errors and propose specific risk mitigating measures to prevent such errors due to system deficiencies
Disabling outcomes after peripheral vascular catheter insertion in newborn patient: a case of medical liability?
No full textThe positioning of peripheral venous catheters (PVC) is an invasive procedure commonly performed in pediatrics hospital wards to obtain vascular access for the administration of fluids, medications and other intravenous (IV) therapies. Many studies exist about management of peripheral venous access in adults. On the contrary, scientific evidence on the management of this procedure in children and newborns, especially regarding the optimal duration of infusion and the possible related side effects, is still poor.
To minimize the risk of phlebitis, the guidelines of the US Centers for Disease Control and Prevention suggest the replacement of the catheter every 72–96 hours in adult patients, while in pediatric patients the catheter can remain in place for the entire duration of the IV therapy, unless complications arise
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