Assessment Committee Research Articles

Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.

This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks. The main objectives of the system are to promote and protect public health by supporting the availability of medicines including those that fulfil previously unmet medical needs, and reducing the burden of adverse drug reactions. These are achieved through a proactive, risk proportionate and patient-centred approach, with high levels of transparency and engagement of civil society. In the European Union, pharmacovigilance is now fully integrated into the life cycle of medicinal products, with the planning of pharmacovigilance activities commencing before a medicine is placed on the market, and companies encouraged to start planning very early in development for high-innovation products. After authorisation, information on the safety of medicines continues to be obtained through a variety of sources, including spontaneous reports of adverse drug reactions or monitoring real-world data. Finally, the measurement of the impact of pharmacovigilance activities, auditing and inspections, as well as capacity building ensure that the system undergoes continuous improvement and can always rely on the best methodologies to safeguard public health.

SAGES Technology and Value Assessment Committee safety and effectiveness analysis on immunofluorescence in the operating room for biliary visualization and perfusion assessment.

SAGES Technology and Value Assessment Committee safety and effectiveness analysis on immunofluorescence in the operating room for biliary visualization and perfusion assessment.

Europe may call TiO2 a carcinogen

The risk assessment committee of the European Chemicals Agency (ECHA) has proposed that the white pigment titanium dioxide be classified as a potential carcinogen. The move was requested by Anses, the French environmental and occupational health agency. TiO2 is the world’s most widely used white pigment. It provides white color, opacity, and UV blocking to consumer goods including paints, plastics, paper, foods, cosmetics, and medicines. It is also used in tattoos and toothpaste. In 2015, Anses asked ECHA to classify TiO2 as a presumed carcinogen by inhalation, citing studies in rats that resulted in the formation of malignant tumors. The request noted that the World Health Organization’s International Agency for Research on Cancer (IARC) has listed TiO2 as possibly carcinogenic to humans since 2006. The ECHA committee concluded that TiO2 is a potential carcinogen, which is a less restrictive legal status than a presumed carcinogen. It says studies suggest the

Critical Questions Regarding Gadolinium Deposition in the Brain and Body After Injections of the Gadolinium-Based Contrast Agents, Safety, and Clinical Recommendations in Consideration of the EMA's Pharmacovigilance and Risk Assessment Committee Recommendation for Suspension of the Marketing Authorizations for 4 Linear Agents.

For magnetic resonance, the established class of intravenous contrast media is the gadolinium-based contrast agents. In the 3 decades since initial approval, these have proven in general to be very safe for human administration. However, in 2006, a devastating late adverse reaction to administration of the less stable gadolinium-based contrast agents was identified, nephrogenic systemic fibrosis. The result of actions taken by the European Medicines Agency and the US Food and Drug Administration, stratifying the agents by risk and contraindicating specific agents in severe renal dysfunction, has led to no new cases being identified in North America or Europe. Subsequently, in 2014, long-term deposition in the brain of gadolinium was first shown, after administration of 2 nonionic linear chelates, gadodiamide, and gadopentetate dimeglumine. This has led to an intense focus on the question of in vivo distribution, possible dechelation, and subsequent deposition of gadolinium, together with substantial clarification of the phenomenon as well as stratification of the agents on this basis. This review focuses on 8 critical questions regarding gadolinium deposition in the brain and body, with the answers and discussion therein important for future regulatory decisions and clinical practice. It is now clear that dechelation of gadolinium occurs in vivo with the linear agents and is responsible for this phenomenon, with key experts in the field recommending, except where there is no suitable alternative, a shift in clinical practice from the linear to macrocyclic agents. In addition, on March 10, 2017, the Pharmacovigilance and Risk Assessment Committee of the European Medicines Agency recommended suspension of the marketing authorization for 4 linear gadolinium contrast agents-specifically Omniscan, Optimark, Magnevist, and MultiHance (gadodiamide, gadoversetamide, gadopentetate dimeglumine, and gadobenate dimeglumine)-for intravenous injection. Cited in the report was convincing evidence of gadolinium deposition in the brain months after injection of these linear agents. Primovist/Eovist (gadoxetic acid disodium) will remain available, being used at a lower dose for liver imaging, because it meets an important diagnostic need. In addition, a formulation of Magnevist for intra-articular injection will remain available because of its very low gadolinium concentration.

Campania Preventability Assessment Committee (Italy): A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions.

Purpose: This study aims to investigate preventability criteria of adverse drug reactions (ADRs) involving non-steroidal anti-inflammatory drugs (NSAIDs) by analyzing individual case safety reports (ICSRs) sent through Campania region (Italy) spontaneous reporting system from July 2012 to October 2016.Methods: For all the ICSRs that reported NSAIDs as suspected drug, a trained multidisciplinary team of Campania Pharmacovigilance Regional Centre composed of clinical pharmacologists and pharmacists with pluriannual experience in Pharmacovigilance assessed preventability by using the P-method.Results: In all 19,039 ICSRs were sent to Campania Pharmacovigilance Regional Centre, of which 550 reported NSAIDs as suspected drug. In total, 94 cases (17.1%) out of 550 ICSRs were preventable. In the 94 preventable cases, 201 critical criteria were detected of which 182/201 (90.5%) related to healthcare professionals' practices, 0/201 (0.0%) to drug quality, and 19/201 (9.5%) to patient behavior. The most detected critical criteria were the necessary medication not given (52/182; 28.6%), labeled drug–drug interaction (36/182; 19.7%), incorrect drug administration duration (31/182; 16.9%), wrong indication (26/182; 14.2%), therapeutic duplication (18/182; 10.0%), and documented hypersensitivity to administered drug or drug class (10/182; 5.6%). In seventeen (18.1%) preventable cases, there were 19 critical criteria involving non-compliance (15/19 critical criteria; 78.9%) and self-medication with the non-over-the-counter drugs (4/19 critical criteria; 21.1%). In all, 17 out 94 (18.1%) preventable cases involved over-the-counter drugs.Conclusion: A call for action for Campania Pharmacovigilance Regional Centre is necessary in order to promote initiatives to increase the awareness of healthcare professionals and citizens on the risk associated with inappropriate use of NSAIDs.

Osteochondral Allograft Transplantation and Opening Wedge Tibial Osteotomy: Clinical Results of a Combined Single Procedure.

Objective To evaluate the outcome of patients who have undergone simultaneous osteotomy and osteochondral allograft (OCA) transplantation. Our hypothesis is that use of high tibial osteotomy and fresh OCA in a combined procedure is safe and effective without increasing morbidity in comparison to OCA alone. Design A case series of 17 patients underwent tibial osteotomy and simultaneous OCA during a single surgery. Osteotomy was indicated when axial alignment was within the affected compartment. Patients had a minimum of 2 years of follow-up after surgery. The mean graft size was 8.7 cm2, with 82% located on the medial femoral condyle alone and 18% involving the medial femoral condyle and one or more other sites. Data collection included demographics, osteotomy correction, graft site(s) and area, and clinical evaluation. Failure was defined as conversion to arthroplasty. Results Two of 17 patients (12%) failed at a mean of 9.3 years. The remaining 15 patients (88%) had intact allografts with mean survival of 8.1 years (SD 3.3). Five patients (29%) had an additional procedure, all undergoing osteotomy hardware removal. Of those with surviving allografts, mean pain and function scores improved significantly from the preoperative to postoperative assessment and International Knee Documentation Committee total scores improved significantly from 40.9 ± 15.4 preoperative to 75.5 ± 24.0 at latest follow-up ( P = 0.003); 92% of patients were satisfied with the results of the surgery. No postoperative complications occurred. Conclusion Combining high tibial osteotomy and OCA in properly selected patients is safe and effective.

Rethinking the Appraisal and Approval of Drugs for Fracture Prevention.

Background: In January 2014, the EMA's Pharmacovigilance Risk Assessment Committee recommended that strontium ranelate no longer be used for osteoporosis. However, EMA's Committee for Medicinal Products for Human Use decided to restrict its use rather than ban it. Starting from this fact, evidence of drugs for fracture prevention over the last 30 years was reviewed and lessons to be learnt from this story are highlighted.Findings: The general belief that drug therapy may become a “solution” for fragility fractures is challenged. The key points of the article are as follows:Lessons 1–5: Bone density and morphometric vertebral compression are not reliable surrogate endpoints. In fact, clinically relevant endpoints are essential to assess harms and benefits in clinical trials. There is a need for assessing overall harm-benefit with well-designed trials, taking into account that drug therapy may not be more effective in high-risk patients. Lessons 6–10: While bisphosphonates and strontium ranelate show a questionable harm-benefit ratio on hip fracture prevention, denosumab results are inconclusive and no benefit has been proved coming from calcitonines or teriparatide. After decades of widespread use, effectiveness of drugs for osteoporosis remains uncertain, yet adverse effects are more apparent.Conclusions: Well-designed and large trials over prolonged follow-up periods, measuring clinically relevant outcomes as hip and other disabling fractures, are urgently needed in order to properly understand the harm-benefit ratio of commonly prescribed drugs. Regulatory agencies should be more transparent and make individual-patient data from all clinical trials publicly available, allowing for independent assessment and pooled analysis.

Risk of pneumonia with budesonide-containing treatments in COPD: an individual patient-level pooled analysis of interventional studies

BackgroundConcerns have been raised that treatment of COPD with inhaled corticosteroids may increase pneumonia risk. Responding to a request from the European Medicines Agency Pharmacovigilance Risk Assessment Committee, a pooled analysis of interventional studies compared pneumonia risk with inhaled budesonide-containing versus non-budesonide-containing treatments and the impact of other clinically relevant factors.MethodsAstraZeneca-sponsored, parallel-group, double-blind, randomized controlled trials meeting the following criteria were included: >8 weeks’ duration; ≥60 patients with COPD; inhaled budesonide treatment arm (budesonide/formoterol or budesonide); and non-budesonide-containing comparator arm (formoterol or placebo). Primary and secondary outcomes were time to first pneumonia treatment-emergent serious adverse event (TESAE) and treatment-emergent adverse event (TEAEs), respectively, analyzed using Cox regression models stratified by study.ResultsEleven studies were identified; 10,570 out of 10,574 randomized patients receiving ≥1 dose of study treatment were included for safety analysis (budesonide-containing, n=5,750; non-budesonide-containing, n=4,820). Maximum exposure to treatment was 48 months. The overall pooled hazard ratio (HR), comparing budesonide versus non-budesonide-containing treatments, was 1.15 for pneumonia TESAEs (95% confidence interval [CI]: 0.83, 1.57) and 1.13 for pneumonia TEAEs (95% CI: 0.94, 1.36). The annual incidence of pneumonia TESAEs was 1.9% and 1.5% for budesonide-containing and non-budesonide-containing treatments, respectively. Comparing budesonide/formoterol with non-budesonide-containing treatment, the HRs for pneumonia TESAEs and TEAEs were 1.00 (95% CI: 0.69, 1.44) and 1.21 (95% CI: 0.93, 1.57), respectively. For budesonide versus placebo, HRs were 1.57 for pneumonia TESAEs (95% CI: 0.90, 2.74) and 1.07 for pneumonia TEAEs (95% CI: 0.83, 1.38).ConclusionThis pooled analysis found no statistically significant increase in overall risk for pneumonia TESAEs or TEAEs with budesonide-containing versus non-budesonide-containing treatments. However, a small increase in risk with budesonide-containing treatment cannot be ruled out; there is considerable heterogeneity in study designs and patient characteristics, particularly in the early budesonide studies, and each study contributes <40 pneumonia TESAEs.

Erratum to: Diacerein: Benefits, Risks and Place in the Management of Osteoarthritis. An Opinion-Based Report from the ESCEO.

Diacerein is a symptomatic slow-acting drug in osteoarthritis (SYSADOA) with anti-inflammatory, anti-catabolic and pro-anabolic properties on cartilage and synovial membrane. It has also recently been shown to have protective effects against subchondral bone remodelling. Following the end of the revision procedure by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) constituted a panel of 11 experts to better define the real place of diacerein in the armamentarium for treating OA. Based on a literature review of clinical trials and meta-analyses, the ESCEO confirms that the efficacy of diacerein is similar to that of non-steroidal anti-inflammatory drugs (NSAIDs) after the first month of treatment, and superior to that of paracetamol. Additionally, diacerein has shown a prolonged effect on symptoms of several months once treatment was stopped. The use of diacerein is associated with common gastrointestinal disorders such as soft stools and diarrhoea, common mild skin reactions, and, uncommonly, hepatobiliary disorders. However, NSAIDs and paracetamol are known to cause potentially severe hepatic, gastrointestinal, renal, cutaneous and cardiovascular reactions. Therefore, the ESCEO concludes that the benefit-risk balance of diacerein remains positive in the symptomatic treatment of hip and knee osteoarthritis. Furthermore, similarly to other SYSADOAs, the ESCEO positions diacerein as a first-line pharmacological background treatment of osteoarthritis, particularly for patients in whom NSAIDs or paracetamol are contraindicated.

Study design of GENERAL (general practitioners and embolism prevention in NVAF patients treated with rivaroxaban: Real-life evidence): A multicenter prospective cohort study in primary care physicians to investigate the effectiveness and safety of rivaroxaban in Japanese patients with NVAF

BackgroundRivaroxaban, a direct oral anticoagulant (DOAC), has become available for stroke prevention in patients with non-valular atrial fibrillation (NVAF). However, little is known about its effectiveness and safety when prescribed by general practitioners in real-life settings. MethodsGENERAL is a multicenter, prospective, non-interventional observational study of patients receiving rivaroxaban for NVAF in daily clinical practice prescribed specifically by general practitioners. The target number of participating medical institutions is 500–700 clinics with fewer than 20 beds and the target number of participants is 5000. The baseline clinical data, including antidementia medication and frailty, and follow-up data including concomitant treatment and outcomes until September 2018 (maximum three years) will be collected. The primary efficacy endpoints will be stroke and/or systemic embolism and the secondary endpoints will be major bleeding meeting the ISTH guidelines, non-major and clinically relevant bleeding, onset of symptomatic stroke (ischemic/hemorrhagic), systemic embolism, deep vein thrombosis/pulmonary thromboembolism, myocardial infarction and/or cardiovascular death, and systemic embolism. Based on the provided information, the event assessment committee will investigate the endpoint-related events. The annual incidence and predictive factors for primary/secondary endpoint will be investigated based on underlying disease, age, renal function, and CHADS2, CHA2DS2-VASC, and HAS-BLED scores using Cox regression. We will also compare the incidence of the primary/secondary endpoint between the present study, EXPAND study, and FUSHIMI AF registry study. ResultsThe results of this study are currently under investigation. ConclusionThis study will provide important information regarding the effectiveness and safety of rivaroxaban treatment in Japanese patients with NVAF among general practitioners.

Mid-Term Outcomes of Anterior Cruciate Ligament Reconstruction with Far Anteromedial Portal Technique.

PurposeThe purpose of this study was to evaluate the mid-term outcomes of anatomic anterior cruciate ligament (ACL) reconstruction using two anteromedial (AM) portals by comparing with short-term follow-up results.Materials and MethodsFifty patients who were treated by ACL reconstruction using a two AM portal technique were evaluated retrospectively. The follow-up period was at least 5 years. The mean follow-up period was 68.5±13.9 months. The mid-term clinical outcomes were compared with short-term (≥12 months) results. For the assessment of knee stability, anterior tibial translation was evaluated using the Lachman test and the KT-2000. Rotational stability was evaluated using pivot shift test. For clinical assessment, the Lysholm and International Knee Documentation Committee scores were used.ResultsThe average anterior translation was 2.1±1.4 mm at the short-term follow-up and 2.8±1.8 mm at the mid-term follow-up. Stability and midterm clinical outcomes were not significantly improved compared to the short-term follow-up results. At the mid-term follow-up, anteroposterior (AP) instability assessed by the KT-2000 was slightly increased, but still acceptable. On the other clinical physical evaluation, there was no statistically significant difference.ConclusionsThe short-term and mid-term outcomes of ACL reconstruction using the two AM portal technique were not significantly different except for AP stability although the value was less than 3 mm at both follow-ups. Therefore, this operative technique could be considered a satisfactory alternative for ACL reconstruction.

Socio-Ethical Implications of Implantable Technologies in the Military Sector [Guest Editorial

The military sector has been investing in nanotechnology solutions since their inception. Internal assessment committees in defense programmatically determine to what degree complex technologies will be diffused into the Armed Forces. The broad term nanotechnology is used in this Special Issue of IEEE Technology and Society Magazine to encompass a variety of innovations, from special paint markers that can determine unique identity, to RFID implants in humans. With the purported demand for these new materials, we have seen the development of a fabrication process that has catapulted a suite of advanced technologies in the military marketplace. These technologies were once the stuff of science fiction. Now we have everything from exoskeletons, to wearable headsets with accelerated night vision, to armaments that have increased in durability in rugged conditions along with the ability for central command without human intervention. Is this the emergence of the so-called supersoldier, a type of Iron Man?

Child involvement in treatment planning and assessment in Israel

AbstractWhat can facilitate at‐risk children's involvement in treatment planning and assessment? We examine this question by investigating the perceptions, attitudes, and characteristics of Israeli social workers. We examine whether their seniority, views on the importance of children's participation, and their attitudes toward parents are related to their report of at‐risk children's involvement in treatment planning and placement decisions. At‐risk children's involvement includes preparing them to appear before the committees that handle placement decisions for youth and the social workers' willingness to consider children's opinions. Eighty coordinators of these committees in social services departments in Israel participated. Our findings indicate that, based on the coordinators' answers, at‐risk children are more likely to be involved in treatment planning and assessment committees when the child protection officers prepare parents prior to participating in the committee meetings, and when the coordinators assigned the case are more senior. The influence of children's opinions on the decisions of the committees was predicted by the weight their parents' opinions carried and whether their parents received any relevant materials prior to the committee meetings. Our findings highlight the importance of involving parents in treatment planning and assessment committees' decision making.

Signal detection activity on EudraVigilance data: analysis of the procedure and findings from an Italian Regional Centre for Pharmacovigilance

ABSTRACTBackground: In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV). Our aim is to describe the procedure of signal detection on EV data and to present results obtained by the our pharmacovigilance centre.Method: Data are extracted from EV database, which collects suspected Adverse Drug Reactions (ADRs) of medicinal products in Europe. We are appointed to supervise digoxin, nicardipine, delapril, manidipine and hydrochlorothiazide/ramipril. ADRs are coded through MedDRA Preferred Terms and collected in the electronic Reaction Monitoring Report (eRMR). Statistical analysis is based on the Proportional Reporting Ratio (PRR) as a measure of disproportionality.Results: Up to April 2016 we have analyzed 45 eRMR for each drug. Two signals for nicardipine were submitted to the Pharmacovigilance Risk Assessment Committee of European Medicines Agency (EMA): acute pulmonary oedema (off-label use as tocolytic) and thrombocytopenia.Conclusions: Our experience shows the scientific and regulatory value of signal detection activity on EV data in order to continuously evaluate the benefit/risk profile of recent and older drugs.

火STPA系鋼の長時間クリープ強度に関する再評価

In 2015, re-evaluation of the long-term creep strength of the CSEF steels was once again conducted by “the Assessment Committee on Creep Data of High Chromium Steels” since additional creep test data had been accumulated as well as the knowledge and experience of CSEF steels since the previous review conducted in 2010. The new long-term data exhibited lower creep strength than that obtained from the master creep life equation for KA-STPA type steel determined in 2010, then the master creep life equation was again reviewed on the basis of the new data using the same regression method as that used in 2010. In the present paper, we review the results for base metal and welded joints of the steel.

Open-Label Single-Sequence Crossover Study Evaluating Pharmacokinetics, Efficacy, and Safety of Once-Daily Dosing of Nitisinone in Patients with Hereditary Tyrosinemia Type 1.

Background: Although nitisinone is successfully used to treat hereditary tyrosinemia type 1 (HT-1) with the recommended twice-daily dosing, data describing a long half-life motivate less frequent dosing. Therefore, in agreement with the Pharmacovigilance Risk Assessment Committee at the European Medicines Agency, this study was performed to investigate the switch to once-daily dosing. Methods: This open-label, non-randomized, single-sequence crossover study evaluated the pharmacokinetics, efficacy, and safety of once-daily compared to twice-daily dosing of nitisinone in patients with HT-1 (NCT02323529). Well-controlled patients of <2, 2 to <12, 12 to <18, and ≥18 years of age who were on twice-daily dosing were eligible for participation. Nitisinone and succinylacetone levels were determined from dry blood spots by tandem mass spectrometry. The primary endpoint was Cmin of nitisinone after ≥4 weeks of treatment on each dosing regimen. Secondary objectives were evaluation of efficacy and safety during each dosing regimen. Results: In total, 19 patients were enrolled and 17 included in the per-protocol analysis set. The mean (SD) nitisinone Cmin decreased by 23%, from 26.4 (10.2) to 21.2 (9.9) μmol/L in dry blood spot samples (not equivalent to plasma concentrations), when patients switched from twice- to once-daily dosing. There was no apparent age- or bodyweight-related trend in the degree of Cmin decrease. No patient had quantifiable succinylacetone levels during the once-daily treatment period, indicating efficacious treatment. All adverse events were mild or moderate and judged unrelated to nitisinone. Conclusion: The switch to once-daily treatment with nitisinone appeared efficacious and safe in the treatment of patients with HT-1.

Analysis of health economics assessment reports for pharmaceuticals in France – understanding the underlying philosophy of CEESP assessment

ABSTRACTBackground: Despite the guidelines for Economic and Public Health Assessment Committee (CEESP) submission having been available for nearly six years, the dossiers submitted continue to deviate from them, potentially impacting product prices.Objective: to review the reports published by CEESP, analyse deviations from the guidelines, and discuss their implications for the pricing and reimbursement process.Study design: CEESP reports published until January 2017 were reviewed, and deviations from the guidelines were extracted. The frequency of deviations was described by type of methodological concern (minor, important or major).Results: In 19 reports, we identified 243 methodological concerns, most often concerning modelling, measurement and valuation of health states and results presentation and sensitivity analyses; nearly 63% were minor, 33% were important and 4.5% were major. All reports included minor methodological concerns, and 17 (89%) included at least one important and/or major methodological concern. Global major methodological concerns completely invalidated the analysis in seven dossiers (37%).Conclusion: The CEESP submission dossiers fail to adhere to the guidelines, potentially invalidating the health economics analysis and resulting in pricing negotiations. As these negotiations tend to be unfavourable for the manufacturer, the industry should strive to improve the quality of the analyses submitted to CEESP.

Evaluation of the activity of a Functional and Interdisciplinary (Social and Healthcare) Geriatric Unit (FISHGU) for hospitalized patients at an acute hospital

Introduction : The Functional and Interdisciplinary (Social and Healthcare) Geriatric Unit (FISHGU) or “UFISS de Gariatria in Spanish” (Unidad Funcional Interdisciplinar Sociosanitaria) is a multidisciplinary team provides management and multidimensional geriatric assessment for hospitalized patients at acute care hospital. They also play a role in the coordination of resources between the different levels of care. The FISHGU (UFISS de Geriatria) of Hospital Sociosanitario Francoli (HSSF) was created and set up in 2002. The team is composed of 2 physicians experienced in geriatric medicine, 1 clinical nurse specialist and 1 social worker. It is located on the 2nd Floor of HSSF, and the standard hours of workdays are 35 hours a week and 7 hours a day from 08:00 to 15:00 hours. Its scope of activity is hospital wards of acute care hospital, basic areas of primary care and coordination with other hospitals. Aims : - Our team completed multidimensional geriatric assessments. - Inpatient care of elderly with multiple co-morbidities (Chronic Complex Patients and Terminal Chronic Diseases Patients) that requires global and close attention (physical, psychological and social) to the special needs (occupational and physical therapy, etc) and geriatric syndromes that arise in this vulnerable population. Functions : - Acute hospital-wide consultation team with direct control over implementation of recommendations. - An ORTHOGERIATRIC collaborative intervention program for fragility fractures. - Comprehensive discharge planning with acute hospital wards. - Coordination with Nurse Case Manager of acute hospital. - Coordination of resources between the different levels of care (primary care teams, intermediate care facilities and acute hospital care). - Collaboration with the Interdisciplinary Assessment Committee of The Healthcare Region of Tarragona (CIMSS). Results : - During 2014, 838 assessments have been conducted. Eighty one patients more than 2013. - 35.2% of assessments were collected from Traumatology and ORTHOPEDIC Surgery, 22% Internal Medicine, 10.1% Neurology, 4.7% Rehabilitation unit, 4.4% Vascular Surgery, 4% Cardiology, 3.8% Gastroenterology, 2.8% Pneumology, 2.5% General Surgery, 2.5% Case Management, 2% Neurosurgery, and 2.3 others. - 99.6% has been evaluated on the same day. The remaining 0.4% % was assessed on the next day. - The time until admission to HSSF since the assessment of the FISHGU was within 48 hours in 33.2% of patients, 28% less than 4th day, and the remaining cases between 6-10 days. - 24% of the total were proactive evaluations. Conclusions : Based on the above mentioned data: - It has been demonstrated 11% increasing activity over the previous year, due to the ORTHOGERIATRIC programme. - Our FISHGU is a multidimensional unit, and growing proactivity (24%) due to the periodic and regular sessions with Traumatology, Neurology, Rehabilitation and Internal Medicine. - We believe that depending on the screening and targeting criteria used to identify eligible patients, the potential for impact could be quite large and raises the question of the physical and manpower capacity of the FISHGU to meet the apparent demand.

En alternativ ph.d.-afhandlings udfordring af den praktiske teologi

Tenna Mose Rhiger has written a PhD dissertation in which she has developed a new approach to the celebration of service in the Evangelical Lutheran Church in Denmark with the aim of furthering the intimate presence of pastors during service. The purpose of this extended review of Rhiger’s dissertation is first to share the enthusiasm of the assessment committee for the project as well as its perspectives for Practical Theology and the celebration of service in the Evangelical Lutheran Church in Denmark. Secondly, the authors behind the review wish to advance some critical reflections on the formal requirements forsimilar experimental research projects in the future since this dissertation– as the pioneer work that it is – is likely to set the standards for “product dissertations” in the future.

The “Fluad Case” in Italy: Could it have been dealt differently?

ABSTRACTDuring the influenza vaccination campaign 2014–2015, the reporting of 3 deaths within 48 hours of vaccination with Fluad brought the Italian Medicines Agency (AIFA) to pronounce the withdrawal of 2 batches of vaccine, based on the precautionary principle. Investigations by the Italian National Institute of Health, and by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee at the European Medicines Agency (EMA) responsible for monitoring and assessing the safety profiles of human drugs, concluded that there was a lack of causality between the reported deaths and the vaccines administered. However, the media impact of the decision taken by AIFA, resulted in a lower influenza vaccination coverage compared with the previous years. The aim of our study was to identify possible critical points that may have led to a non-perfect management of the event. A review of the regulatory framework in place was performed, with a particular focus on the Guidelines on Good Pharmacovigilance Practices developed by the EMA to facilitate the signal management process. The management of reports involves the following steps: signal detection, its validation and confirmation, analysis and prioritization, assessment, recommendations for action and the exchange of information. In our opinion, both the signal detection phase and the phase of validation have been critical: the withdrawal of vaccine batches is possible even in case of a single suspected serious adverse reaction. However, aspects such as the biological plausibility, the presence of potential alternative causes and previous awareness should also be considered. Furthermore, the number of reported deaths was consistent with the expected background mortality rate in the vaccinated cohort. The disproportionate media coverage given to the AIFA decision resulted in a reduced vaccine confidence in the general population and in a decreased immunization coverage. Improving the communication on vaccine safety issues is crucial at this stage to restore a climate of trust in this powerful tool for primary prevention.