scholarly journals Timeline of Authorization and Reimbursement for Oncology Drugs in Italy in the Last 3 Years

2017 ◽  
Vol 1 ◽  
pp. maapoc.0000007 ◽  
Author(s):  
Mariangela Prada ◽  
Matteo Ruggeri ◽  
Carmen Sansone ◽  
Dalila De Fazio ◽  
Alessia Tettamanti ◽  
...  
Keyword(s):  
European Medicines Agency ◽  
Approval Time ◽  
Evaluation Time ◽  
Italian Market ◽  
Health Care Structure ◽  
Care Structure ◽  
The Mean ◽  
Human Use ◽  
The Impact ◽  
Mean Time

Introduction The main purpose of this analysis was to quantify the time elapsed between the validation date of European Medicines Agency (EMA) centralized procedure and the first purchase of a product by at least 1 Italian health care structure, evaluating different variables that affect the process, the number of products approved by the Committee for Medicinal Products for Human Use (CHMP) that are available on the Italian market (July 2016), and the impact of the Cnn class for oncology drugs in Italy. Methods A panel of oncology products has been defined, which considered drugs approved by the EMA between January 2013 and December 2015, and authorized for the treatment of oncology diseases, excluding generics. Data were obtained via the EMA website by the Agenzia Italiana del Farmaco (AIFA; the Italian Medicine Agency) meeting reports, by official administrative acts of marketing authorization, and the date of the first purchase (first day of the first handling month). Results The mean time of EMA evaluation for the considered panel of medicines was about 441 days (standard deviation (SD) 108; range 266-770); the average approval time for AIFA was about 248 days (SD 131; range 85-688). Interestingly, the mean AIFA evaluation time decreased significantly from 264 days for products submitted to AIFA assessment in 2013-2014 to 219 days for products evaluated in 2015-2016. Focusing on the regional access, both the timing and the number of drugs available for patients were widely different from region to region. Discussion A reduction in the approval time in the last 2 years has been observed in Italy. However, several variables influence the efficiency of the process and need to be addressed to make the access to drugs timely and efficient.

scholarly journals The impact of COVID-19 infection on hip fracture 30-day mortality

Trauma ◽  
2021 ◽  
pp. 146040862094972
Author(s):  
Ahmed Fadulelmola ◽  
Rob Gregory ◽  
Gavin Gordon ◽  
Fiona Smith ◽  
Andrew Jennings
Keyword(s):  
Hip Fracture ◽  
Hip Fractures ◽  
Hospital Admissions ◽  
The Elderly ◽  
Primary Outcome Measure ◽  
Time To Death ◽  
Significant Difference ◽  
The Mean ◽  
The Impact ◽  
Mean Time

Introduction: A novel virus, SARS-CoV-2, has caused a fatal global pandemic which particularly affects the elderly and those with comorbidities. Hip fractures affect elderly populations, necessitate hospital admissions and place this group at particular risk from COVID-19 infection. This study investigates the effect of COVID-19 infection on 30-day hip fracture mortality. Method: Data related to 75 adult hip fractures admitted to two units during March and April 2020 were reviewed. The mean age was 83.5 years (range 65–98 years), and most (53, 70.7%) were women. The primary outcome measure was 30-day mortality associated with COVID-19 infection. Results: The COVID-19 infection rate was 26.7% (20 patients), with a significant difference in the 30-day mortality rate in the COVID-19-positive group (10/20, 50%) compared to the COVID-19-negative group (4/55, 7.3%), with mean time to death of 19.8 days (95% confidence interval: 17.0–22.5). The mean time from admission to surgery was 43.1 h and 38.3 h, in COVID-19-positive and COVID-19-negative groups, respectively. All COVID-19-positive patients had shown symptoms of fever and cough, and all 10 cases who died were hypoxic. Seven (35%) cases had radiological lung findings consistent of viral pneumonitis which resulted in mortality (70% of mortality). 30% ( n = 6) contracted the COVID-19 infection in the community, and 70% ( n = 14) developed symptoms after hospital admission. Conclusion: Hip fractures associated with COVID-19 infection have a high 30-day mortality. COVID-19 testing and chest X-ray for patients presenting with hip fractures help in early planning of high-risk surgeries and allow counselling of the patients and family using realistic prognosis.

scholarly journals Translating the fabrication of protein-loaded poly(lactic-co-glycolic acid) nanoparticles from bench to scale-independent production using microfluidics

2020 ◽  
Vol 10 (3) ◽  
pp. 582-593 ◽  
Author(s):  
Carla B. Roces ◽  
Dennis Christensen ◽  
Yvonne Perrie
Keyword(s):  
Particle Size ◽  
Glycolic Acid ◽  
Polymeric Nanoparticles ◽  
Physicochemical Characteristics ◽  
European Medicines Agency ◽  
Protein Encapsulation ◽  
Human Use ◽  
Rate Ratios ◽  
The Impact ◽  
Process Controls

AbstractIn the formulation of nanoparticles, poly(lactic-co-glycolic acid) (PLGA) is commonly employed due to its Food and Drug Administration and European Medicines Agency approval for human use, its ability to encapsulate a variety of moieties, its biocompatibility and biodegradability and its ability to offer a range of controlled release profiles. Common methods for the production of PLGA particles often adopt harsh solvents, surfactants/stabilisers and in general are multi-step and time-consuming processes. This limits the translation of these drug delivery systems from bench to bedside. To address this, we have applied microfluidic processes to develop a scale-independent platform for the manufacture, purification and monitoring of nanoparticles. Thereby, the influence of various microfluidic parameters on the physicochemical characteristics of the empty and the protein-loaded PLGA particles was evaluated in combination with the copolymer employed (PLGA 85:15, 75:25 or 50:50) and the type of protein loaded. Using this rapid production process, emulsifying/stabilising agents (such as polyvinyl alcohol) are not required. We also incorporate in-line purification systems and at-line particle size monitoring. Our results demonstrate the microfluidic control parameters that can be adopted to control particle size and the impact of PLGA copolymer type on the characteristics of the produced particles. With these nanoparticles, protein encapsulation efficiency varies from 8 to 50% and is controlled by the copolymer of choice and the production parameters employed; higher flow rates, combined with medium flow rate ratios (3:1), should be adopted to promote higher protein loading (% wt/wt). In conclusion, herein, we outline the process controls for the fabrication of PLGA polymeric nanoparticles incorporating proteins in a rapid and scalable manufacturing process.

Patient Access to Hepatitis C Treatment After Incorporation of Pharmacists in a Hepatology Clinic

2021 ◽  
pp. 001857872110375
Author(s):  
Frank A. Fanizza ◽  
Jennifer Loucks ◽  
Angelica Berni ◽  
Meera Shah ◽  
Dennis Grauer ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Medication Adherence ◽  
Hcv Treatment ◽  
Clinical Pharmacists ◽  
The Mean ◽  
Group 2 ◽  
Cure Rates ◽  
The Impact ◽  
Mean Time ◽  
Group 1

Background: Modern hepatitis C virus (HCV) treatment regimens yield cure rates greater than 90%. However, obtaining approval for treatment through the prior authorization (PA) process can be time consuming and require extensive documentation. Lack of experience with this complex process can delay HCV medication approval, ultimately increasing the amount of time before patients start treatment and in some cases, prevent treatment altogether. Objectives: Assess the impact of incorporating clinical pharmacists into specialty pharmacy and hepatology clinic services on medication access, patient adherence, and outcomes in patients being treated for HCV. Methods: We performed a retrospective cohort exploratory study of patients seen in an academic medical center hepatology clinic who had HCV prescriptions filled between 8/1/15 and 7/31/17. Patients were categorized by whether they filled prescriptions prior to (Pre-Group) or after (Post-Group) the implementation of a pharmacist in clinic. The Post-Group was further divided according to whether the patient was seen by a pharmacist in clinic (Post-Group 2) or if the patient was not seen by the pharmacist, but had their HCV therapy evaluated by the pharmacist before seeking insurance approval (Post-Group 1). Results: The mean time from the prescription being ordered to being dispensed was longer in the Pre-Group (50.8 ± 66.5 days) compared to both Post-Groups (22.2 ± 27.8 days in Post-Group 1 vs 18.9 ± 17.7 days in Post-Group 2; P < .05). The mean time from when the prescription was ordered to when the PA was submitted was longer in the Pre-Group (41.6 ± 71.9 days) compared to both Post-Groups (6.3 ± 16 in Post-Group 1 vs 4.1 ± 9.7 in Post-Group 2; P < .05). Rates of medication adherence and sustained virologic response were similar between all groups. Conclusion: Incorporation of clinical pharmacists into a hepatology clinic significantly reduced the time patients waited to start HCV treatment. In addition to improving access to medications, implementation of the model helped to maintain excellent medication adherence and cure rates.

Telephone Calls to an Infectious Diseases Fellow

PEDIATRICS ◽  
1995 ◽  
Vol 95 (5) ◽  
pp. 753-754
Author(s):  
Mark F. Cotton
Keyword(s):  
Infectious Disease ◽  
Infectious Diseases ◽  
Time Allocation ◽  
Primary Care Physicians ◽  
First Year ◽  
Educational Value ◽  
The Mean ◽  
Telephone Calls ◽  
The Impact ◽  
Mean Time

Objective. There is no information on the impact and nature of telephone calls directed to subspecialists. The main objective was to document prospectively all calls directed to a first-year infectious diseases fellow, to determine their content, origin, educational value, and time allocation. Results. Three hundred fifty-nine calls were received over a 71-day period from March 24 through May 20, 1992. The mean number of daily calls was 5.1 ± 3.3. Mean time per call was 7 ± 5.4 minutes. Cumulatively, 41.7 hours were spent responding to telephone calls. The subgroup with the most calls (44.3%) was from pediatricians in practice. Seventy percent of calls were for advice about case management. Forty percent of calls were considered educational to the fellow. Conclusions. This study confirms the importance of the infectious disease subspecialist as a resource for primary care physicians.

Quality of febrile neutropenia management in a regional cancer center emergency department.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 104-104
Author(s):  
Priyanka Kapil ◽  
Katherine Enright
Keyword(s):  
Emergency Department ◽  
Febrile Neutropenia ◽  
Antibiotic Therapy ◽  
Cancer Site ◽  
Cancer Center ◽  
Time To Initiation ◽  
The Mean ◽  
The Impact ◽  
Mean Time

104 Background: ASCO's current guidelines for febrile neutropenia (FN) management support antibiotic administration within one hour of presentation to the emergency department (ED). Prompt initiation of antibiotic therapy is vital to decrease the likelihood of adverse outcomes. Many studies, however, have reported significant delays in antibiotic initiation with mean wait times far exceeding ASCO's guidelines. We aimed to assess the quality of FN management at a regional cancer centre ED. Methods: Patients undergoing chemotherapy who visited the ED at the Peel Regional Cancer Center in Ontario, Canada between 04/12 - 03/13 were identified using electronic medical records. Patients were excluded if there was no record of chemotherapy delivery within 30 days prior to ED visit. ICD-10 codes and chart data were used to identify patients who had presented for either fever or infection. The primary outcome measures were three major quality of health indicators; time to assessment by a physician, Canadian Triage and Acuity Scale (CTAS) score, and time to initiation of intravenous antibiotics. Results: In total 239 records were included in the analysis. CTAS score was concordant with recommendation for FN (level 1-2) in 85% of patients and did not vary based on primary cancer site (p = 0.17). The mean time to physician assessment was 97.2 min and the mean time to initiation of IV antibiotics was 194.7 min. Overall, 14.6% of patients received their first dose of antibiotic therapy within the recommended 1 hour window. Conclusions: Our audit identified a large margin for improvement in the time to initiation of antibiotic therapy for chemotherapy patients with suspected FN. Prompt recognition and initiation of standardized treatment pathways for FN in the ED may improve the time to initiation of antibiotic therapy. In an attempt to address this gap in quality we have developed and distributed a standardized wallet-sized fever card to all patients receiving cytotoxic chemotherapy within our regional cancer program. This card contains information pertaining to the current chemotherapy treatment and recommended ED treatment protocols for FN. An evaluation of the impact of these cards is ongoing.

scholarly journals The impact of angling experience on the efficiency of float fishing using different hook types

2019 ◽  
Vol 27 (1) ◽  
pp. 41-46
Author(s):  
Tomasz K. Czarkowski ◽  
Andrzej Kapusta
Keyword(s):  
The Mean ◽  
Catch Rates ◽  
Time Required ◽  
The Impact ◽  
Mean Time

Abstract The aim of the study was to compare the catch efficiency of novice and experienced anglers float fishing with different hook types. The mortality of fish that were caught and released was determined based on the experience of the angler and the type of hook used. The mean catch rates of the experienced angler was 46.7 fish per hour, while that of the novice angler was 33.7 fish per hour. The landing efficiency of fish using hooks with micro-barbs was higher than that with barbless hooks. Angling experience had a significant impact on the mean time required to unhook caught fish and also on the mortality of the fish released. The lowest mortality was noted in fish caught by experienced anglers fishing with barbless hooks. The results of the study suggest that angling experience does not have a great impact on parameters characterizing the quality of angling catches. The efficiency of float fishing performed by novice and experienced anglers was similar. Differences were noted in the time required to unhook the fish and in the mortality of the fish released.

scholarly journals Improved Arrangement and Capacity for Medication Transactions: A Pilot Study to Determine the Impact of New Technology on Medication Storage and Accessibility

2018 ◽  
Vol 53 (5) ◽  
pp. 338-343
Author(s):  
Matthew Kelm ◽  
Udobi Campbell
Keyword(s):  
New Technology ◽  
Medication Administration ◽  
Product Performance ◽  
Satisfaction Survey ◽  
Pharmacy Technician ◽  
The Mean ◽  
Medication Storage ◽  
New Generation ◽  
The Impact ◽  
Mean Time

Purpose: A new-generation automated dispensing cabinet (ADC) deployment is described. Methods: A single-center retrospective-prospective pilot product performance study was conducted, and prospective nurse satisfaction survey and pharmacy technician product performance feedback survey were performed to determine the impact of new technology on medication storage and accessibility. The study measured efficiency of the 9:00 am medication pull for nursing users, assessment of nursing perceptions of medication administration pre- and postinstallation of the cabinetry, pharmacy technician perceptions of working with the cabinetry, and assessment of the efficiency of the pharmacy technician restock process. Results: In total, 2981 total nursing medication retrieval processes for the 9 am standard medication administration time (SMAT) time were analyzed: 1321 in the preoptimization phase and 1660 in the postoptimization phase. Analysis of the mean time per transaction confirmed a significant improvement from 10.5 to 10.3 seconds per transaction ( P = .026) in the postoptimization configuration. The modified assessment of nursing satisfaction survey demonstrated increased satisfaction with many aspects of the new-generation cabinetry. Pharmacy technician survey data highlighted beneficial aspects of the device, while restock data showed an increase in the time spent restocking the cabinet from 11.5 seconds in the preoptimization phase compared with 21.3 seconds in the postoptimization phase ( P < .0001). Conclusion: ADC installation and inventory optimization had a statistically significant improvement in the mean time per nursing transaction. Nursing and pharmacy technician surveys demonstrated a trend of enhanced satisfaction with the platform.

scholarly journals On the time evolution at a fluctuating exceptional point

Nanophotonics ◽  
2019 ◽  
Vol 8 (8) ◽  
pp. 1319-1326 ◽  
Author(s):  
Christian Wolff ◽  
Christos Tserkezis ◽  
N. Asger Mortensen
Keyword(s):  
Time Evolution ◽  
Evolution Operator ◽  
Exceptional Point ◽  
Initial State ◽  
Time Evolution Operator ◽  
External Perturbations ◽  
Sensing Applications ◽  
The Mean ◽  
The Impact ◽  
Mean Time

AbstractWe theoretically evaluate the impact of drift-free noise on the dynamics of ${\cal P}{\cal T}$-symmetric non-Hermitian systems with an exceptional point, which have recently been proposed for sensors. Such systems are currently considered as promising templates for sensing applications, because of their intrinsically extremely sensitive response to external perturbations. However, this applies equally to the impact of fabrication imperfections and fluctuations in the system parameters. Here we focus on the influence of such fluctuations caused by inevitable (thermal) noise and show that the exceptional-point eigenstate is not stable in its presence. To this end, we derive an effective differential equation for the mean time evolution operator averaged over all realizations of the noise field, and via numerical analysis we find that the presence of noise leads to exponential divergence of any initial state after some characteristic period of time. We therefore show that it is rather demanding to design sensor systems based on continuous operation at an exceptional point.

Relationship Between Time from Ambulance Call to Arrival at Emergency Center and Level of Consciousness at Admission in Severe Stroke Patients

2012 ◽  
Vol 28 (1) ◽  
pp. 39-42 ◽  
Author(s):  
Kazuhiro Ohwaki ◽  
Takehiro Watanabe ◽  
Takayuki Shinohara ◽  
Tadayoshi Nakagomi ◽  
Eiji Yano
Keyword(s):  
Clinical Information ◽  
Stroke Patients ◽  
Publication Type ◽  
Emergency Center ◽  
Severe Stroke ◽  
Level Of Consciousness ◽  
The Mean ◽  
Prehospital Delays ◽  
The Impact ◽  
Mean Time

AbstractIntroductionTimely access to acute medical treatment can be critical for patients suffering from severe stroke. Little information is available about the impact of prehospital delays on the clinical conditions of stroke patients, but it is possible that prehospital delays lead to neurological deterioration. The aim of this study was to examine the impact of prehospital delays related to emergency medical services on the level of consciousness at admission in patients with severe stroke.MethodsThis retrospective study assessed 712 consecutive patients diagnosed with cerebrovascular diseases who were admitted to an intensive care unit in Tokyo, Japan, from April 1998 through March 2008. Data, including the time from the call to the ambulance service to the arrival of the ambulance at the patient location (on-scene), and the time from the arrival of the ambulance on-scene to its arrival at the emergency center were obtained. The following demographic and clinical information also were obtained from medical records: sex, age, and Glasgow Coma Scale (GCS) score at admission.ResultsThe mean time from ambulance call to arrival on-scene was 7 (SD=3) minutes, and the mean time from ambulance call to arrival at the center was 37 (SD=8) minutes. A logistic regression model for predicting GCS scores of 3 and 4 at admission was produced. After adjusting for sex, age, and time from arrival on-scene to arrival at the center, a longer call-to-on-scene time was significantly associated with poor GCS scores (OR = 1.056/min; 95% confidence interval, [CI] = 1.008-1.107). After adjusting for sex and age, a longer call-to-arrival at the center time also was significantly associated with poor GCS scores (OR = 1.020; 95% CI = 1.002-1.038).ConclusionsPrehospital delays were significantly associated with decreased levels of consciousness at admission in patients suffering from a stroke. As level of consciousness is the strongest predictor of outcome, reducing prehospital delays may be necessary to improve the outcomes in patients with severe stroke.OhwakiK, WatanabeT, ShinoharaT, NakagomiT, YanoE. Relationship between time from ambulance call to arrival at emergency center and level of consciousness at admission in severe stroke patients. Prehosp Disaster Med. 2012;28(1):1-4.

scholarly journals The Impact of Preemptive Perianal Anaesthetic Block in Open Haemorrhoidectomy – a randomised controlled trial

2021 ◽  
Vol 15 (9) ◽  
pp. 2165-2167
Author(s):  
Wajeeha I. Andrabi ◽  
M Asadullah Khawaja ◽  
K. Fatima ◽  
S I. Hussain Andrabi ◽  
A. Shafique ◽  
...  
Keyword(s):  
Placebo Group ◽  
Hospital Stay ◽  
Pain Intensity ◽  
P Value ◽  
Open Hemorrhoidectomy ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
The Impact ◽  
Mean Time

Background: the study was conducted to analyze the efficacy of 0.75% ropicaine at perianal block for open haemrrhoidectomy with regards to pain intensity, first demand of analgesia and hospital stay. Method: 50 patients were selected for open haemrrhoidectomy under GA which were divided into two groups.it was a randomized control trial in which sealed envelope method was used for the group delegation in which Group A was designated to the patients having the perianal block with 0.75% ropivacaine while the group B was the placebo group having normal saline injected in the perianal region. The variables compared were the first demand of analgesia, pain intensity and the duration of the hospital stay. In order to make the site of injection more authentic the injections were sited under ultrasound guidance. Results: The pain intensity which was analyzed with the visual analogue score (VAS) had a median of 3.8 (high=6, low=3) in group A while 5.5 (high=8, low=4) in the Group B with the p value of < 0.05. The mean time recorded for the first demand of analgesia was 6.20 ± 1.20 hours in the Group A which had improved from 1.20 ± 1.0 hours in the Placebo Group while the p value was < 0.001, while the mean time of hospital stay got reduced from 22.5±3.30 hours to 12.4 ± 3.10 hours with the significant p value of < 0.002. Conclusion: It was observed that with preemptive analgesia with 0.75% ropivacaine administered led to a substantial reduction in pain perception, request for an analgesic and hospital stay. Therefore it is appropriate to administer it before open hemorrhoidectomy. Keywords: preemptive anaesthesia, local anesthesia, postoperative pain, ropivacaine, open hemorrhoidectomy

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