Safety profile of prasugrel and clopidogrel in patients with acute coronary syndromes in Switzerland.

OBJECTIVE: To assess safety up to 1 year of follow-up associated with prasugrel and clopidogrel use in a prospective cohort of patients with acute coronary syndromes (ACS). METHODS: Between 2009 and 2012, 2286 patients invasively managed for ACS were enrolled in the multicentre Swiss ACS Bleeding Cohort, among whom 2148 patients received either prasugrel or clopidogrel according to current guidelines. Patients with ST-elevation myocardial infarction (STEMI) preferentially received prasugrel, while those with non-STEMI, a history of stroke or transient ischaemic attack, age ≥75 years, or weight <60 kg received clopidogrel or reduced dose of prasugrel to comply with the prasugrel label. RESULTS: After adjustment using propensity scores, the primary end point of clinically relevant bleeding events (defined as the composite of Bleeding Academic Research Consortium, BARC, type 3, 4 or 5 bleeding) at 1 year, occurred at a similar rate in both patient groups (prasugrel/clopidogrel: 3.8%/5.5%). Stratified analyses in subgroups including patients with STEMI yielded a similar safety profile. After adjusting for baseline variables, no relevant differences in major adverse cardiovascular and cerebrovascular events were observed at 1 year (prasugrel/clopidogrel: cardiac death 2.6%/4.2%, myocardial infarction 2.7%/3.8%, revascularisation 5.9%/6.7%, stroke 1.0%/1.6%). Of note, this study was not designed to compare efficacy between prasugrel and clopidogrel. CONCLUSIONS: In this large prospective ACS cohort, patients treated with prasugrel according to current guidelines (ie, in patients without cerebrovascular disease, old age or underweight) had a similar safety profile compared with patients treated with clopidogrel. CLINICAL TRIAL REGISTRATION NUMBER: SPUM-ACS: NCT01000701; COMFORTABLE AMI: NCT00962416.

Quality and safety requirements for sustainable phage therapy products.

The worldwide antibiotic crisis has led to a renewed interest in phage therapy. Since time immemorial phages control bacterial populations on Earth. Potent lytic phages against bacterial pathogens can be isolated from the environment or selected from a collection in a matter of days. In addition, phages have the capacity to rapidly overcome bacterial resistances, which will inevitably emerge. To maximally exploit these advantage phages have over conventional drugs such as antibiotics, it is important that sustainable phage products are not submitted to the conventional long medicinal product development and licensing pathway. There is a need for an adapted framework, including realistic production and quality and safety requirements, that allowsa timely supplying of phage therapy products for 'personalized therapy' or for public health or medical emergencies. This paper enumerates all phage therapy product related quality and safety risks known to the authors, as well as the tests that can be performed to minimize these risks, only to the extent needed to protect the patients and to allow and advance responsible phage therapy and research.

Kuljettajien työn turvallisuus ja sen kehittäminen energia-alan kuljetustoiminnoissa

Työ kuuluu osana työn ja työliikenteen turvallisuuden kehittämishankkeeseen tavarankuljetusalalla. Hankkeen tavoitteena on selvittää kuorma-autonkuljettajan työpaikkatapaturmatilanteet ja tapaturmavaarat muun tutkimuksen pohjaksi. Diplomityössä kiinnitetään huomio tutkimushanketta tarkemmin energia-alan kuljetusten turvallisuustekijöihin. Diplomityön ja koko työn ja työliikenteen turvallisuuden kehittämishankkeen lähtökohtana on kuljettajan työnkuvan ongelmallisuus ja laajeneminen. Kuljettajien työ on tiukasti aikataulutettua ja työolot usein varsin vaihtelevia. Kuljettajien työ on yksintyöskentelyä vierailla paikoilla ja usein yötyötä. Työmääräykset kuljettajille tulevat lyhyellä varoitusajalla. Kuljettajien työturvallisuutta selvitettiin kirjallisuustutkimuksella, kenttätyöllä, kyselytutkimuksella kuljetusyrityksille sekä tilastoja tarkastelemalla.

Capturing diagnosis-timing in ICD-coded hospital data: recommendations from the WHO ICD-11 topic advisory group on quality and safety.

PURPOSE: To develop a consensus opinion regarding capturing diagnosis-timing in coded hospital data. METHODS: As part of the World Health Organization International Classification of Diseases-11th Revision initiative, the Quality and Safety Topic Advisory Group is charged with enhancing the capture of quality and patient safety information in morbidity data sets. One such feature is a diagnosis-timing flag. The Group has undertaken a narrative literature review, scanned national experiences focusing on countries currently using timing flags, and held a series of meetings to derive formal recommendations regarding diagnosis-timing reporting. RESULTS: The completeness of diagnosis-timing reporting continues to improve with experience and use; studies indicate that it enhances risk-adjustment and may have a substantial impact on hospital performance estimates, especially for conditions/procedures that involve acutely ill patients. However, studies suggest that its reliability varies, is better for surgical than medical patients (kappa in hip fracture patients of 0.7-1.0 versus kappa in pneumonia of 0.2-0.6) and is dependent on coder training and setting. It may allow simpler and more precise specification of quality indicators. CONCLUSIONS: As the evidence indicates that a diagnosis-timing flag improves the ability of routinely collected, coded hospital data to support outcomes research and the development of quality and safety indicators, the Group recommends that a classification of 'arising after admission' (yes/no), with permitted designations of 'unknown or clinically undetermined', will facilitate coding while providing flexibility when there is uncertainty. Clear coding standards and guidelines with ongoing coder education will be necessary to ensure reliability of the diagnosis-timing flag.

State of Logistics and Operations Management in Finnish and Swedish Companies – Survey Research Findings

In this research we are examining what is the status of logistics and operations management in Finnish and Swedish companies. Empirical data is based on the web based questionnaire, which was completed in the end of 2007 and early 2008. Our examination consists of roughly 30 answers from largest manufacturing (highest representation in our sample), trade and logistics/distribution companies. Generally it could be argued that these companies operate in complex environment, where number of products, raw materials/components and suppliers is high. However, usually companies rely on small amount of suppliers per raw material/component (highest frequency is 2), and this was especially the case among Swedish companies, and among those companies, which favoured overseas sourcing. Sample consisted of companies which mostly are operating in an international environment, and are quite often multinationals. Our survey findings reveal that companies in general have taken logistics and information technology as part of their strategy process; utilization of performance measures as well as system implementations have followed the strategy decisions. In the transportation mode side we identify that road transports dominate all transport flow classes (inbound, internal and outbound), followed by sea and air. Surprisingly small amount of companies use railways, but in general we could argue that Swedish companies prefer this mode over Finnish counterparts. With respect of operations outsourcing, we found that more traditional areas of logistics outsourcing are driving factors in company's performance measurement priority. In contrary to previous research, our results indicate that the scope of outsourcing is not that wide in logistics/operations management area, and companies are not planning to outsource more in the near future. Some support is found for more international operations and increased outsourcing activity. From the increased time pressure of companies, we find evidence that local as well as overseas customers expect deliveries within days or weeks, but suppliers usually supply within weeks or months. So, basically this leads into considerable inventory holding. Interestingly local and overseas sourcing strategy does not have that great influence on lead time performance of these particular sourcing areas - local strategy is anyway considerably better in responding on market changes due to shorter supply lead times. In the end of our research work we have completed correlation analysis concerning items asked with Likert scale. Our analysis shows that seeing logistics more like a process rather than function, applying time based management, favouring partnerships and measuring logistics within different performance dimensions results on preferred features and performance found in logistics literature.

The effects of safety climate and trust on job satisfaction

Job satisfaction has been a frequently studied concept in organizational behavior. Past research has shown that trust in top management is an important factor influencing job satisfaction. To date, little attention has been paid to safety climate perceptions as a possible predictor of job satisfaction. In our study we investigated the direct and interactive effects of trust in top management and individual-level perceptions of safety climate in predicting job satisfaction. The findings of this study point to the importance of positive perceptions of safety climate on employees' job satisfaction when trust in top management is low.

Les vaccins contre le zona : efficacité, sécurité, et rapport coût/bénéfices [Vaccines against Herpes zoster: Effectiveness, safety, and cost/benefit ratio].

CONTEXT: A vaccination against herpes zoster and its complication is available in France since June 2015. Its exact benefit for public health is still controversial and its level of protection is not optimal. All those reasons seem to suggest a low acceptation rate from general practitioners. OBJECTIVE: To evaluate the effectiveness, the safety, and the cost/benefit ratio of the vaccination against herpes zoster in people aged 50 year or over. DOCUMENTARY SOURCE: Systematic review in Medline and PubMed with research by key words: "herpes zoster vaccine", "zoster vaccine" and "post herpetic neuralgia vaccine". SELECTION OF STUDIES: Randomized and observational studies published in English and French language have been selected by two readers. RESULTS: On 1886 articles identified, 62 studies were included in this systematic review of which 21 randomized trials, 21 observational studies, and 17 medico-economic studies concerned the unadjuvanted vaccine. Considered studies showed an effectiveness of 50% against herpes zoster and 60% on post-herpetic neuralgia incidence of the unadjuvanted vaccine. Five randomized controlled studies were identified for the adjuvanted vaccine. The overall effectiveness of this vaccine was > 90% whatever the age of subjects including those over age 70 and 80. The medico-economic studies conducted in many countries have shown that vaccine policies were beneficial in individuals aged 60 years or over. LIMITATION OF THE WORK: Most of data of effectiveness, and tolerance result from 2 large controlled studies only (SPS and ZEST) for the unadjuvanted vaccine and only one for the adjuvanted vaccine. CONCLUSION: Despite controversy and few uncertainties, the vaccine significantly reduces herpes zoster and its complication incidence. In terms of public health objectives, it reduces the burden of the disease and has a positive medico-economic impact. Preliminary data concerning the adjuvanted vaccine, whilst very promising, are still too limited. Up to now, no group of people with particularly high risk of herpes zoster-related complication who will beneficiate the most of the vaccination has been identified yet and only an age criteria has been considered for the recommendation.

Safety and Immunogenicity of a Recombinant Adenovirus Serotype 35-Vectored HIV-1 Vaccine in Adenovirus Serotype 5 Seronegative and Seropositive Individuals.

BACKGROUND: Recombinant adenovirus serotype 5 (rAd5)-vectored HIV-1 vaccines have not prevented HIV-1 infection or disease and pre-existing Ad5 neutralizing antibodies may limit the clinical utility of Ad5 vectors globally. Using a rare Ad serotype vector, such as Ad35, may circumvent these issues, but there are few data on the safety and immunogenicity of rAd35 directly compared to rAd5 following human vaccination. METHODS: HVTN 077 randomized 192 healthy, HIV-uninfected participants into one of four HIV-1 vaccine/placebo groups: rAd35/rAd5, DNA/rAd5, and DNA/rAd35 in Ad5-seronegative persons; and DNA/rAd35 in Ad5-seropositive persons. All vaccines encoded the HIV-1 EnvA antigen. Antibody and T-cell responses were measured 4 weeks post boost immunization. RESULTS: All vaccines were generally well tolerated and similarly immunogenic. As compared to rAd5, rAd35 was equally potent in boosting HIV-1-specific humoral and cellular immunity and responses were not significantly attenuated in those with baseline Ad5 seropositivity. Like DNA, rAd35 efficiently primed rAd5 boosting. All vaccine regimens tested elicited cross-clade antibody responses, including Env V1/V2-specific IgG responses. CONCLUSIONS: Vaccine antigen delivery by rAd35 is well-tolerated and immunogenic as a prime to rAd5 immunization and as a boost to prior DNA immunization with the homologous insert. Further development of rAd35-vectored prime-boost vaccine regimens is warranted.

Safety of Prasugrel Loading Doses in Patients Pre-Loaded With Clopidogrel in the Setting of Primary Percutaneous Coronary Intervention: Results of a Nonrandomized Observational Study.

OBJECTIVES: The aim of this study was to assess the safety of the concurrent administration of a clopidogrel and prasugrel loading dose in patients undergoing primary percutaneous coronary intervention. BACKGROUND: Prasugrel is one of the preferred P2Y12 platelet receptor antagonists for ST-segment elevation myocardial infarction patients. The use of prasugrel was evaluated clinically in clopidogrel-naive patients. METHODS: Between September 2009 and October 2012, a total of 2,023 STEMI patients were enrolled in the COMFORTABLE (Comparison of Biomatrix Versus Gazelle in ST-Elevation Myocardial Infarction [STEMI]) and the SPUM-ACS (Inflammation and Acute Coronary Syndromes) studies. Patients receiving a prasugrel loading dose were divided into 2 groups: 1) clopidogrel and a subsequent prasugrel loading dose; and 2) a prasugrel loading dose. The primary safety endpoint was Bleeding Academic Research Consortium types 3 to 5 bleeding in hospital at 30 days. RESULTS: Of 2,023 patients undergoing primary percutaneous coronary intervention, 427 (21.1%) received clopidogrel and a subsequent prasugrel loading dose, 447 (22.1%) received a prasugrel loading dose alone, and the remaining received clopidogrel only. At 30 days, the primary safety endpoint was observed in 1.9% of those receiving clopidogrel and a subsequent prasugrel loading dose and 3.4% of those receiving a prasugrel loading dose alone (adjusted hazard ratio [HR]: 0.57; 95% confidence interval [CI]: 0.25 to 1.30, p = 0.18). The HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) bleeding score tended to be higher in prasugrel-treated patients (p = 0.076). The primary safety endpoint results, however, remained unchanged after adjustment for these differences (clopidogrel and a subsequent prasugrel loading dose vs. prasugrel only; HR: 0.54 [95% CI: 0.23 to 1.27], p = 0.16). No differences in the composite of cardiac death, myocardial infarction, or stroke were observed at 30 days (adjusted HR: 0.66, 95% CI: 0.27 to 1.62, p = 0.36). CONCLUSIONS: This observational, nonrandomized study of ST-segment elevation myocardial infarction patients suggests that the administration of a loading dose of prasugrel in patients pre-treated with a loading dose of clopidogrel is not associated with an excess of major bleeding events. (Comparison of Biomatrix Versus Gazelle in ST-Elevation Myocardial Infarction [STEMI] [COMFORTABLE]; NCT00962416; and Inflammation and Acute Coronary Syndromes [SPUM-ACS]; NCT01000701).

Safety and immunogenicity of a chimpanzee adenovirus-vectored Ebola vaccine in healthy adults: a randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a study.

BACKGROUND: The ongoing Ebola outbreak led to accelerated efforts to test vaccine candidates. On the basis of a request by WHO, we aimed to assess the safety and immunogenicity of the monovalent, recombinant, chimpanzee adenovirus type-3 vector-based Ebola Zaire vaccine (ChAd3-EBO-Z). METHODS: We did this randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a trial at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. Participants (aged 18-65 years) were randomly assigned (2:2:1), via two computer-generated randomisation lists for individuals potentially deployed in endemic areas and those not deployed, to receive a single intramuscular dose of high-dose vaccine (5 × 10(10) viral particles), low-dose vaccine (2·5 × 10(10) viral particles), or placebo. Deployed participants were allocated to only the vaccine groups. Group allocation was concealed from non-deployed participants, investigators, and outcome assessors. The safety evaluation was not masked for potentially deployed participants, who were therefore not included in the safety analysis for comparison between the vaccine doses and placebo, but were pooled with the non-deployed group to compare immunogenicity. The main objectives were safety and immunogenicity of ChAd3-EBO-Z. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02289027. FINDINGS: Between Oct 24, 2014, and June 22, 2015, we randomly assigned 120 participants, of whom 18 (15%) were potentially deployed and 102 (85%) were non-deployed, to receive high-dose vaccine (n=49), low-dose vaccine (n=51), or placebo (n=20). Participants were followed up for 6 months. No vaccine-related serious adverse events were reported. We recorded local adverse events in 30 (75%) of 40 participants in the high-dose group, 33 (79%) of 42 participants in the low-dose group, and five (25%) of 20 participants in the placebo group. Fatigue or malaise was the most common systemic adverse event, reported in 25 (62%) participants in the high-dose group, 25 (60%) participants in the low-dose group, and five (25%) participants in the placebo group, followed by headache, reported in 23 (57%), 25 (60%), and three (15%) participants, respectively. Fever occurred 24 h after injection in 12 (30%) participants in the high-dose group and 11 (26%) participants in the low-dose group versus one (5%) participant in the placebo group. Geometric mean concentrations of IgG antibodies against Ebola glycoprotein peaked on day 28 at 51 μg/mL (95% CI 41·1-63·3) in the high-dose group, 44·9 μg/mL (25·8-56·3) in the low-dose group, and 5·2 μg/mL (3·5-7·6) in the placebo group, with respective response rates of 96% (95% CI 85·7-99·5), 96% (86·5-99·5), and 5% (0·1-24·9). Geometric mean concentrations decreased by day 180 to 25·5 μg/mL (95% CI 20·6-31·5) in the high-dose group, 22·1 μg/mL (19·3-28·6) in the low-dose group, and 3·2 μg/mL (2·4-4·9) in the placebo group. 28 (57%) participants given high-dose vaccine and 31 (61%) participants given low-dose vaccine developed glycoprotein-specific CD4 cell responses, and 33 (67%) and 35 (69%), respectively, developed CD8 responses. INTERPRETATION: ChAd3-EBO-Z was safe and well tolerated, although mild to moderate systemic adverse events were common. A single dose was immunogenic in almost all vaccine recipients. Antibody responses were still significantly present at 6 months. There was no significant difference between doses for safety and immunogenicity outcomes. This acceptable safety profile provides a reliable basis to proceed with phase 2 and phase 3 efficacy trials in Africa. FUNDING: Swiss State Secretariat for Education, Research and Innovation (SERI), through the EU Horizon 2020 Research and Innovation Programme.

Transforming Maritime Safety Culture. Evaluation of the impacts of the ISM Code on maritime safety culture in Finland

The purpose of the METKU Project (Development of Maritime Safety Culture) is to study how the ISM Code has influenced the safety culture in the maritime industry. This literature review is written as a part of the Work Package 2 which is conducted by the University of Turku, Centre for Maritime Studies. The maritime traffic is rapidly growing in the Baltic Sea which leads to a growing risk of maritime accidents. Particularly in the Gulf of Finland, the high volume of traffic causes a high risk of maritime accidents. The growing risks give us good reasons for implementing the research project concerning maritime safety and the effectiveness of the safety measures, such as the safety management systems. In order to reduce maritime safety risks, the safety management systems should be further developed. The METKU Project has been launched to examine the improvements which can be done to the safety management systems. Human errors are considered as the most important reason for maritime accidents. The international safety management code (the ISM Code) has been established to cut down the occurrence of human errors by creating a safety-oriented organizational culture for the maritime industry. The ISM Code requires that a company should provide safe practices in ship operation and a safe working environment and establish safeguards against all identified risk. The fundamental idea of the ISM Code is that companies should continuously improve safety. The commitment of the top management is essential for implementing a safety-oriented culture in a company. The ISM Code has brought a significant contribution to the progress of maritime safety in recent years. Shipping companies and ships’ crews are more environmentally friendly and more safety-oriented than 12 years ago. This has been showed by several studies which have been analysed for this literature research. Nevertheless, the direct effect and influence of the ISM Code on maritime safety could not be isolated very well. No quantitative measurement (statistics/hard data) could be found in order to present the impacts of the ISM Code on maritime safety. In this study it has been discovered that safety culture has emerged and it is developing in the maritime industry. Even though the roots of the safety culture have been established there are still serious barriers to the breakthrough of the safety management. These barriers could be envisaged as cultural factors preventing the safety process. Even though the ISM Code has been effective over a decade, the old-established behaviour which is based on the old day’s maritime culture still occurs. In the next phase of this research project, these cultural factors shall be analysed in regard to the present safety culture of the maritime industry in Finland.

Thermal-Hydraulic Studies on the Safety Of VVER-440 Type Nuclear Power Plants

This thesis includes several thermal hydraulic analyses related to the Loviisa WER 440 nuclear power plant units. The work consists of experimental studies, analysis of the experiments, analysis of some plant transits and development of a calculational model for calculation of boric acid concentrations in the reactor. In the first part of the thesis, in the case of won of boric acid solution behaviour during long term cooling period of LOCAs, experiments were performed in scaled down test facilities. The experimental data together with the results of RELAPS/MOD3 simulations were used to develop a model for calculations of boric acid concentrations in the reactor during LOCAs. The results of calculations showed that margins to critical concentrations that would lead to boric acid crystallization were large, both in the reactor core and in the lower plenum. This was mainly caused by the fact that water in the primary cooling circuit includes borax (Na)BsO,.IOHZO), which enters the reactor when ECC water is taken from the sump and greatly increases boric acid solubility in water. In the second part, in the case of simulation of horizontal steam generators, experiments were performed with PACTEL integral test loop to simulate loss of feedwater transients. The PACTEL experiments, as well as earlier REWET III natural circulation tests, were analyzed with RELAPS/MOD3 Version Sm5 code. The analysis showed that the code was capable of simulating the main events during the experiments. However, in the case of loss of secondary side feedwater the code was not completely capable to simulate steam superheating in the secondary side of the steam generators. The third part of the work consists of simulations of Loviisa VVER reactor pump trip transients with RELAPSlMODI Eur, RELAPS/MOD3 and CATHARE codes. All three codes were capable to simulate the two selected pump trip transients and no significant differences were found between the results of different codes. Comparison of the calculated results with the data measured in the Loviisa plant also showed good agreement.

Maritime Safety in the Gulf of Finland. Review on Policy Instruments

Suomenlahden lisääntynyt meriliikenne on herättänyt huolta meriliikenteen turvallisuuden tasosta, ja erityisesti Venäjän öljyviennin kasvu on lisännyt öljyonnettomuuden todennäköisyyttä Suomenlahdella. Erilaiset kansainväliset, alueelliset ja kansalliset ohjauskeinot pyrkivät vähentämään merionnettomuuden riskiä ja meriliikenteen muita haittavaikutuksia. Tämä raportti käsittelee meriturvallisuuden yhteiskunnallisia ohjauskeinoja: ohjauskeinoja yleisellä tasolla, meriturvallisuuden keskeisimpiä säätelijöitä, meriturvallisuuden ohjauskeinoja ja meriturvallisuuspolitiikan tulevaisuuden näkymiä, ohjauskeinojen tehokkuutta ja nykyisen meriturvallisuuden ohjausjärjestelmän heikkouksia. Raportti on kirjallisuuskatsaus meriturvallisuuden yhteiskunnalliseen sääntelyn rakenteeseen ja tilaan erityisesti Suomenlahden meriliikenteen näkökulmasta. Raportti on osa tutkimusprojektia ”SAFGOF - Suomenlahden meriliikenteen kasvunäkymät 2007 - 2015 ja kasvun vaikutukset ympäristölle ja kuljetusketjujen toimintaan” ja sen työpakettia 6 ”Keskeisimmät riskit ja yhteiskunnalliset vaikutuskeinot”. Yhteiskunnalliset ohjauskeinot voidaan ryhmitellä hallinnollisiin, taloudellisiin ja tietoohjaukseen perustuviin ohjauskeinoihin. Meriturvallisuuden edistämisessä käytetään kaikkia näitä, mutta hallinnolliset ohjauskeinot ovat tärkeimmässä asemassa. Merenkulun kansainvälisen luonteen vuoksi meriturvallisuuden sääntely tapahtuu pääosin kansainvälisellä tasolla YK:n ja erityisesti Kansainvälisen merenkulkujärjestön (IMO) toimesta. Lisäksi myös Euroopan Unionilla on omaa meriturvallisuuteen liittyvää sääntelyä ja on myös olemassa muita alueellisia meriturvallisuuden edistämiseen liittyviä elimiä kuten HELCOM. Joitakin meriturvallisuuden osa-alueita säädellään myös kansallisella tasolla. Hallinnolliset meriturvallisuuden ohjauskeinot sisältävät aluksen rakenteisiin ja varustukseen, alusten kunnon valvontaan, merimiehiin ja merityön tekemiseen sekä navigointiin liittyviä ohjauskeinoja. Taloudellisiin ohjauskeinoihin kuuluvat esimerkiksi väylä- ja satamamaksut, merivakuutukset, P&I klubit, vastuullisuus- ja korvauskysymykset sekä taloudelliset kannustimet. Taloudellisten ohjauskeinojen käyttö meriturvallisuuden edistämiseen on melko vähäistä verrattuna hallinnollisten ohjauskeinojen käyttöön, mutta niitä voitaisiin varmasti käyttää enemmänkin. Ongelmana taloudellisten ohjauskeinojen käytössä on se, että ne kuuluvat pitkälti kansallisen sääntelyn piiriin, joten alueellisten tai kansainvälisten intressien edistäminen taloudellisilla ohjauskeinoilla voi olla hankalaa. Tieto-ohjaus perustuu toimijoiden vapaaehtoisuuteen ja yleisen tiedotuksen lisäksi tieto-ohjaukseen sisältyy esimerkiksi vapaaehtoinen koulutus, sertifiointi tai meriturvallisuuden edistämiseen tähtäävät palkinnot. Poliittisella tasolla meriliikenteen aiheuttamat turvallisuusriskit Suomenlahdella on otettu vakavasti ja paljon työtä tehdään eri tahoilla riskien minimoimiseksi. Uutta sääntelyä on odotettavissa etenkin liittyen meriliikenteen ympäristövaikutuksiin ja meriliikenteen ohjaukseen kuten meriliikenteen sähköisiin seurantajärjestelmiin. Myös inhimilliseen tekijän merkitykseen meriturvallisuuden kehittämisessä on kiinnitetty lisääntyvissä määrin huomiota, mutta inhimilliseen tekijän osalta tehokkaiden ohjauskeinojen kehittäminen näyttää olevan haasteellista. Yleisimmin lääkkeeksi esitetään koulutuksen kehittämistä. Kirjallisuudessa esitettyjen kriteereiden mukaan tehokkaiden ohjauskeinojen tulisi täyttää seuraavat vaatimukset: 1) tarkoituksenmukaisuus – ohjauskeinojen täytyy olla sopivia asetetun tavoitteen saavuttamiseen, 2) taloudellinen tehokkuus – ohjauskeinon hyödyt vs. kustannukset tulisi olla tasapainossa, 3) hyväksyttävyys – ohjauskeinon täytyy olla hyväksyttävä asianosaisten ja myös laajemman yhteiskunnan näkökulmasta katsottuna, 4) toimeenpano – ohjauskeinon toimeenpanon pitää olla mahdollista ja sen noudattamista täytyy pystyä valvomaan, 5) lateraaliset vaikutukset – hyvällä ohjauskeinolla on positiivisia seurannaisvaikutuksia muutoinkin kuin vain ohjauskeinon ensisijaisten tavoitteiden saavuttaminen, 6) kannustin ja uuden luominen – hyvä ohjauskeino kannustaa kokeilemaan uusia ratkaisuja ja kehittämään toimintaa. Meriturvallisuutta koskevaa sääntelyä on paljon ja yleisesti ottaen merionnettomuuksien lukumäärä on ollut laskeva viime vuosikymmenien aikana. Suuri osa sääntelystä on ollut tehokasta ja parantanut turvallisuuden tasoa maailman merillä. Silti merionnettomuuksia ja muita vaarallisia tapahtumia sattuu edelleen. Nykyistä sääntelyjärjestelmää voidaan kritisoida monen asian suhteen. Kansainvälisen sääntelyn aikaansaaminen ei ole helppoa: prosessi on yleensä hidas ja tuloksena voi olla kompromissien kompromissi. Kansainvälinen sääntely on yleensä reaktiivista eli ongelmakohtiin puututaan vasta kun jokin onnettomuus tapahtuu sen sijaan että se olisi proaktiivista ja pyrkisi puuttumaan ongelmakohtiin jo ennen kuin jotain tapahtuu. IMO:n työskentely perustuu kansallisvaltioiden osallistumiseen ja sääntelyn toimeenpano tapahtuu lippuvaltioiden toimesta. Kansallisvaltiot ajavat IMO:ssa pääasiallisesti omia intressejään ja sääntelyn toimeenpanossa on suuria eroja lippuvaltioiden välillä. IMO:n kyvyttömyys puuttua havaittuihin ongelmiin nopeasti ja ottaa sääntelyssä huomioon paikallisia olosuhteita on johtanut siihen, että esimerkiksi Euroopan Unioni on alkanut itse säädellä meriturvallisuutta ja että on olemassa sellaisia alueellisia erityisjärjestelyjä kuin PSSA (particularly sensitive sea area – erityisen herkkä merialue). Merenkulkualalla toimii monenlaisia yrityksiä: toisaalta yrityksiä, jotka pyrkivät toimimaan turvallisesti ja kehittämään turvallisuutta vielä korkeammalle tasolle, ja toisaalta yrityksiä, jotka toimivat niin halvalla kuin mahdollista, eivät välitä turvallisuusseikoista, ja joilla usein on monimutkaiset ja epämääräiset omistusolosuhteet ja joita vahingon sattuessa on vaikea saada vastuuseen. Ongelma on, että kansainvälisellä merenkulkualalla kaikkien yritysten on toimittava samoilla markkinoilla. Vastuuttomien yritysten toiminnan mahdollistavat laivaajat ja muut alan toimijat, jotka suostuvat tekemään yhteistyötä niiden kanssa. Välinpitämätön suhtautuminen turvallisuuteen johtuu osaksi myös merenkulun vanhoillisesta turvallisuuskulttuurista. Verrattaessa meriturvallisuuden sääntelyjärjestelmää kokonaisuutena tehokkaiden ohjauskeinoihin kriteereihin, voidaan todeta, että monien kriteerien osalta nykyistä järjestelmää voidaan pitää tehokkaana ja onnistuneena. Suurimmat ongelmat lienevät sääntelyn toimeenpanossa ja ohjauskeinojen kustannustehokkuudessa. Lippuvaltioiden toimeenpanoon perustuva järjestelmä ei toimi toivotulla tavalla, josta mukavuuslippujen olemassa olo on selvin merkki. Ohjauskeinojen, sekä yksittäisten ohjauskeinojen että vertailtaessa eri ohjauskeinoja keskenään, kustannustehokkuutta on usein vaikea arvioida, minkä seurauksena ohjauskeinojen kustannustehokkuudesta ei ole saatavissa luotettavaa tietoa ja tuloksena voi olla, että ohjauskeino on käytännössä pienen riskin eliminoimista korkealla kustannuksella. Kansainvälisen tason meriturvallisuus- (ja merenkulku-) politiikan menettelytavoiksi on ehdotettu myös muita vaihtoehtoja kuin nykyinen järjestelmä, esimerkiksi monitasoista tai polysentristä hallintojärjestelmää. Monitasoisella hallintojärjestelmällä tarkoitetaan järjestelmää, jossa keskushallinto on hajautettu sekä vertikaalisesti alueellisille tasoille että horisontaalisesti ei-valtiollisille toimijoille. Polysentrinen hallintojärjestelmä menee vielä askeleen pidemmälle. Polysentrinen hallintojärjestelmä on hallintotapa, jonka puitteissa kaikentyyppiset toimijat, sekä yksityiset että julkiset, voivat osallistua hallintoon, siis esimerkiksi hallitukset, edunvalvontajärjestöt, kaupalliset yritykset jne. Kansainvälinen lainsäädäntö määrittelee yleiset tasot, mutta konkreettiset toimenpiteet voidaan päättää paikallisella tasolla eri toimijoiden välisessä yhteistyössä. Tämän tyyppisissä hallintojärjestelmissä merenkulkualan todellinen, kansainvälinen mutta toisaalta paikallinen, toimintaympäristö tulisi otetuksi paremmin huomioon kuin järjestelmässä, joka perustuu kansallisvaltioiden keskenään yhteistyössä tekemään sääntelyyn. Tällainen muutos meriturvallisuuden hallinnassa vaatisi kuitenkin suurta periaatteellista suunnanmuutosta, jollaisen toteutumista ei voi pitää kovin todennäköisenä ainakaan lyhyellä tähtäimellä.

Finnair’s “New Silk Road” in the New Millennium: An Analysis of the Construction of Asia and of the Company

During the past century, an increasingly diverse world provided us with opportunities for intercultural communication; especially the growth of commerce at all levels from domestic to international has made the combination of the theories of intercultural communication and international business necessary. As one of the main beneficiaries in international business in recent years, companies in airline industries have developed their international market. For instance, Finnair has developed its Asian strategy which responds to the increasing market demand for flights from Europe to Asia in the new millennium. Therefore, the company manages marketing communication in a global environment and becomes a suitable case for studying the theories of intercultural communication in the context of international marketing. Finnair implemented a large number of international advertisements to promote its Asian routes, where Asia has been constructed as a number of exotic destinations. Meanwhile, the company itself as a provider of these destinations has also been constructed contrastively. Thus, this thesis aims at research how Finnair constructs Asia and the company itself in the new millennium, and how these constructions compare with the theories of intercultural communication. This research applied the theories of international marketing, intercultural communication and culture. In order to analyze the collected corpora as Finnair’s international advertisements and its annual reports in the new millennium, the methods of content analysis and discourse analysis have been used in this research. As a result, Finnair has purposefully applied the essentialist approach to intercultural communication and constructed Asia as an exotic “Other” due to the company’s market orientation. Meanwhile, Finnair has also constructed the company itself two identities based on the same approach: as an international airline provider between Europe and Asia, as well as a part of Finnish society. The combination of intercultural communication and international marketing theories, together with the combination of the methods of content analysis and discourse analysis ensure the originality of this paper.