Treatment comes first in HHS antiviral guidance

first_img Risk of resistanceHHS also says that several comments focused on risks and uncertainties related to antiviral use, including the possibility of resistant viruses and adverse events. In addition, in response to a suggestion that families should be able to stockpile antivirals, HHS says that any recommendations on home stockpiling will depend on the results of pending studies. In the revised guidance, school dormitories may be considered a “closed setting for post-exposure prophylaxis during an outbreak,” if the students have not been dismissed HHS is buying antiviral drugs for the Strategic National Stockpile, and states are stockpiling the drugs with a 25% federal subsidy. The overall goal for public stockpiles is 81 million treatment courses, including 75 million courses for treatment and 6 million for containment and for delaying the spread of pandemic flu into the United States. Prophylaxis of high-risk healthcare and emergency services personnel for the duration of community pandemic outbreaks Roche and GlaxoSmithKline, the makers of oseltamivir and zanamivir, respectively, are developing home kits designed for stockpiling, HHS says. “Approval of these ‘medkits’ by the Food and Drug Administration will depend on studies showing that the kits can be appropriately maintained, the instructions understood, and the drug used appropriately at the correct time,” the agency says. “Any HHS guidance on home stockpiling will depend on the results of these studies and FDA approval of these products.” Containing or suppressing initial pandemic outbreaks overseas and in the United States with treatment and postexposure prophylaxis (PEP) among individuals identified as exposed to pandemic flu and for geographically targeted prophylaxis in areas where exposure may occur Reducing introduction of infection into the United States early in an influenza pandemic as part of a risk-based policy at US borders Like the draft version, the revised guidance says that antivirals for preventive treatment of healthcare workers and others will have to come mostly from supplies bought by private organizations and businesses for their employees. About 73 million courses are currently in federal and state stockpiles, according to HHS’s response to comments on the guidance. It also says “many federal agencies” are “acquiring additional stockpiles to support prophylaxis as recommended in the guidance,” but it does not list the amounts of these supplies. Dec 16, 2008 (CIDRAP News) – A revised federal guidance document on the use of antiviral drugs in an influenza pandemic reaffirms that public supplies of the drugs should be reserved mainly for treating the sick and that preventive treatment for high-risk workers should rely on private supplies. HHS also released a separate document summarizing the 28 comments it received on the draft version and presenting responses to them. At the same time, HHS released a revision of its guidance on employer stockpiling of antivirals, with no major changes. Despite the risks related to antiviral stockpiling, the working group that wrote the recommendations considers them appropriate and the pandemic threat great enough to justify the investment in the context of other preparedness measures, the document says. Providing antiviral prophylaxis to the families of healthcare and emergency workers is not recommended, because they have no greater risk of pandemic flu than the general population The problems of cost and limited shelf-life may be reduced through programs recently announced by the antiviral manufacturers, whereby organizations can reserve an up-to-date supply of the drugs by paying a small annual per-regimen fee, the revised guidance says. At the time of a pandemic, organizations could pay for the drugs and receive them within 48 hours. The agency added two significant pieces to the guidance in response to comments. One addresses implementation difficulties, mainly concerning barriers to the stockpiling of antivirals for health and emergency workers; the other deals with risks and uncertainties, such as antiviral resistance and treatment effectiveness. Its recommendations are just that—not standards of care or requirements HHS says the 28 comments it received on the draft guidance came from public health workers, healthcare providers, healthcare organizations, the pharmaceutical industry, business associations, public health organizations, and labor groups, among others. See also: “Antiviral resistance does represent a threat to the potential effectiveness of treatment and prophylaxis,” HHS acknowledges in its responses to the comments. The emergence of oseltamivir resistance in some influenza A/H1N1 viruses last winter illustrated this. But there is no evidence that use of oseltamivir induced this resistance, and H1N1 and other seasonal flu viruses remain susceptible to zanamivir, the agency adds. Editor’s note: This story was revised Dec 17 to include an item that was mistakenly left out of the list of five main recommendations on antiviral use in a pandemic. In addition, the guidance says that a recent declaration by HHS Secretary Mike Leavitt provides that state and local governments will be immune to liability related to the use of oseltamivir and zanamivir only to the extent the drugs are obtained by voluntary means, not confiscation. The Public Readiness and Emergency Preparedness (PREP) Act gives the HHS secretary the authority to do that, the document states. Some other comments addressed several of the same difficulties mentioned by those who commented on the general guidance: the cost of antivirals, limited shelf-life of the drugs, and the possibility of government confiscation. In its response, HHS makes generally the same points as in its response to comments on the general guidance. The PREP Act provides immunity from tort liability for both public and private groups that make, distribute, and administer antivirals in accordance with the HHS secretary’s declaration, the guidance says. In addition, the guidance document says that mathematical modeling studies suggest that “antiviral treatment and prophylaxis would remain beneficial overall unless some of the pandemic viruses introduced into the U.S. at the beginning of a pandemic are both resistant and fully transmissible.” Lowering barriers to implementationSeveral commentators said private organizations are unlikely to buy antivirals for their employees because of the cost, and several suggested that the federal government should buy the additional supplies needed to implement the guidance, according to HHS. Others said more information and materials were needed to support implementation. Treating people with pandemic flu who present for care early during their illness and would benefit from such treatment As for the possibility of government seizure of private antiviral supplies, the revised guidance says this would be very unlikely. Health officials who participated in a working group convened by the Association of State and Territorial Health Officials (ASTHO) “recognized the benefits of enhanced preparedness and coordination between public and private sectors and emphasized that this authority would be very unlikely to be used,” HHS says. The thrust of the general guidance is that, in a pandemic, antivirals should primarily be used to treat the sick, but they should also be used to prevent illness in high-risk healthcare and emergency workers and to both prevent and treat illness in the context of initial outbreaks both in the Untied States and overseas. The guidance pertains mainly to the two licensed neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Leavitt made the declaration on Oct 10 on grounds that governmental seizure of antivirals “would undermine national preparedness efforts and should be discouraged,” it adds. The Department of Health and Human Services (HHS) issued its draft guidance on the topic in June. A revision released yesterday includes no major changes but does have some new material added in response to comments, particularly on implementation problems and risks and uncertainties. No members of the interagency working group that wrote the guidance had ties to the antiviral drug manufacturers, and the latter were not included or consulted in developing the guidance The guidance also states that the antivirals may be less effective if “the usual dose and duration of therapy are not optimal for a pandemic virus.” In the responses to comments, HHS says that side effects of oseltamivir and zanamivir are uncommon. However, the guidance says that widespread use of the drugs may lead to the identification of new side effects. It notes that neurobehavioral problems have been seen in a few people treated with oseltamivir The revised guidance says that barriers to antiviral stockpiling for healthcare workers include not only the cost, but also drug shelf-life, the potential for seizure of private stockpiles by state health departments, and liability concerns. These problems were identified in the stakeholder meetings conducted in developing the guidance. Prophylaxis of healthcare and emergency services workers who are not at high exposure risk, people with compromised immune systems who are less likely to be protected by pandemic vaccination, and people living in group settings such as nursing homes and prisons if outbreaks occur in their facilities The five main recommendations are unchanged in the revised guidance. It calls for using antivirals for the following purposes: Revised guidance for employersThe revised guidance on employer stockpiling of antivirals, like the draft released in June, recommends that businesses providing frontline healthcare and emergency services plan to provide preventive antivirals for employees who will be exposed to sick people in a pandemic. It also says that critical infrastructure employers should “strongly consider” providing antiviral prophylaxis for essential workers. In its responses to the comments, HHS also states that: In a separate document, HHS says it received comments on the draft employer guidance from 31 stakeholders, ranging from academics and labor unions to critical infrastructure companies and public health groups. Several of the comments focused on whether antiviral stockpiling would be considered a “standard of care.” In its response, HHS says its recommendations are only guidance and do not establish a requirement, but rather represent a prudent approach. The revised version also reiterates that employers will have to acquire their own antiviral stockpiles for preventive use, since there are no plans for major expansion of public stockpiles. Despite the various measures designed to facilitate implementation of the guidance, some organizations will probably not have “the capacity or willingness to comply,” the document states. “In such settings, it is important to emphasize that antiviral drugs are only one component of a comprehensive program to protect workers and maintain essential services.” HHS report “Considerations for Antiviral Drug Stockpiling by Employers in Preparation for an Influenza Pandemic” Jun 3 CIDRAP News story “HHS offers pandemic guidance on masks, antivirals”last_img read more

Investigation under way after Air Force training aircraft skids off runway in East Java

first_img‘We’ll find the cause of [the incident] through the investigation,” he added.The accident happened at around 1 p.m. on Monday when the South Korean-made jet fighter trainer, belonging to the Indonesian Air Force, was used for a routine training exercise.The aircraft skidded off the runway during take-off. At that time, the cadet was sitting in front while the instructor was sitting behind, and both managed to get out of the aircraft afterward, Fajar said.”They are currently receiving treatment at hospital,” he added.Less than two months earlier, an Indonesian Air Force Hawk 209 jet fighter crashed on June 15 in a residential area of Kampar regency in Riau. At least two houses were damaged and no fatalities were reported. (afr)Topics : The Indonesian Air Force has launched a probe into an accident of a T-50 Golden Eagle jet fighter that skidded off the runway during a training course at Iswahjudi Air Force Base in Madiun, East Java, on Monday.No casualties were reported. An Air Force instructor and a cadet pilot who was piloting the aircraft suffered minor injuries in the accident, Air Force spokesperson Air Commodore Fajar Adriyanto said.”[The aircraft] sustained significant damage,” Fajar said on Monday without elaborating further on the matter.last_img read more

Inter Milan make enormous bid for Liverpool and Man Utd target Nicolas Pepe

first_imgAdvertisement Advertisement Nicolas Pepe is attracting a lot of attention this summer (Picture: Getty Images)Liverpool and Manchester United could be set to miss out on one of their transfer targets this summer after Inter Milan made a huge bid for Lille’s Nicolas Pepe.The winger has attracted attention from a number of Europe’s biggest clubs after an impressive couple of seasons in Ligue 1, scoring 37 goals in 79 appearances for Lille.Bayern Munich, Arsenal, Atletico Madrid, Liverpool and Manchester United have all reportedly shown an interest, but Inter have made their move first.The Serie A side have made a bid of €75m (£67m) for the 24-year-old, reports TF1 in France, while L’Equipe report the bid is as high as €90m (£80m) although it has not been accepted by the player or the club as yet.AdvertisementAdvertisementADVERTISEMENTLiverpool are the club most likely to challenge Inter for his signature, with L’Equipe reporting that Jurgen Klopp has a ‘special liking’ for the Ivory Coast international.However, while the Reds are thought to have held talks over a potential move, they are yet to make a bid for Pepe.More: FootballRio Ferdinand urges Ole Gunnar Solskjaer to drop Manchester United starChelsea defender Fikayo Tomori reveals why he made U-turn over transfer deadline day moveMikel Arteta rates Thomas Partey’s chances of making his Arsenal debut vs Man CityOpinions on Pepe have been split with Bild reporting that Bayern Munich have decided he is not of the required standard to be made a top target, and is on their ‘B-list’ of summer options.Liverpool legend also questioned Pepe’s skills, telling ESPN: ‘I really don’t get this one. Yes he’s had a good season but he just doesn’t look like a Liverpool player to me.‘He’s a little unorthodox, he looks gangly. He has got it done, the stats bear that out.‘Unfortunately it is Ligue 1 and I’m not a huge fan of Ligue 1, I don’t think the standard is particularly great. Before the season kicks off we know PSG have won the league. I’m not sure of this.‘I’m not sure where it’s coming from to be honest but I don’t think this guy fits in with Liverpool.’MORE: Liverpool interested in re-signing Philippe Coutinho in summer transferMORE: Jurgen Klopp considers €50m move for Junior Firpo as cover for Liverpool star Andrew Roberston Commentcenter_img Inter Milan make enormous bid for Liverpool and Man Utd target Nicolas Pepe Metro Sport ReporterSunday 23 Jun 2019 6:40 pmShare this article via facebookShare this article via twitterShare this article via messengerShare this with Share this article via emailShare this article via flipboardCopy link87Shareslast_img read more

Buyer beware: Don’t be pressured into buying a home: REBAA

first_imgThe REBAA is warning house hunters not to be pressured into buying a home.DON’T BE PRESSURED BY THESE PHRASES: “There’s a second private viewing happening tonight/tomorrow etc.” “Think how much it would mean to your wife/husband/kids.” “This is one of a kind/once in a generation/unique.” “Last chance to buy and settle before Christmas” (particularly relevant nowgiven standard 42-day settlement period). “There’s lots of interest and the vendor is thinking about moving the auctionforward so best to put in your best offer prior.” “Word on the grapevine is that this area is being considered for rezoning.” “There’s strong interest in this property so you better get a hurry along.” “We’ve issued 15 contracts so we expect the price to go well above reserve.” “The owner has already rejected $X so you need to be at $Y” — but theunsuspecting buyer doesn’t know if it is a true offer. “The property is likely to sell over the weekend so you need to make an offernow if you want a chance to own it.”(Source: REBAA) iStock photo of agent handing over keys in front of a for sale / sold sign. For On the Pulse column in Cairns Post weekend real estate liftout.AS the steam starts to come out of Australia’s housing market, house hunters are being warned not to succumb to pressure to buy.The Real Estate Buyers Agents of Australia (REBAA) claims it is seeing signs of increasing pressure from selling agents to close deals amid evidence of a softening house price market in several capital cities.REBAA president Rich Harvey said the property pendulum was beginning to swing infavour of buyers and some selling agents were feeling pressure to make a sale and using shrewd tactics to seal the deal.“Many buyers are unaware of the tactics that selling agents use to influence theirbuying decisions and may inadvertently fall victim to subtle pressure by eitheroverpaying or making an unsuitable purchase,” he said.“Often it’s just the odd throw away comment that the selling agent drops inconversation to the buyer that ratchets up the buyer’s fear of missing out.“Buyers need to enter negotiations armed with extensive research and with theireyes wide open and if they are unsure, inexperienced, or lack time, get professionaland independent advice to ensure they are paying the right price.”But the Real Estate Institute of Queensland has accused the REBAA of unfairly attacking real estate agents.“The REIQ has worked very hard to improve the perceptions of all real estate practitioners — including sales agents and buyers agents — in the eyes of the public,” REIQ chief executive Antonia Mercorella said.“These sorts of comments, from an industry group no less, serves to drag us all down in the eyes of the public.”Ms Mercorella said if Mr Harvey had any knowledge of dummy bidding going on in Queensland he should hand that information directly to the Office of Fair Trading.Mr Harvey responded with an apology and acknowledged most selling agents were “ethical professionals who act in the best interests of their vendors”.“As a consumer advocacy group our primary aim is to educate buyers on the buying process which, on the rare occasion, includes pushy sales tactics that many buyers may not distinguish.” GET THE LATEST REAL ESTATE NEWS DIRECT TO YOUR INBOX HERE FIVE PRESSURE TACTICS TO WATCH OUT FOR:1. Reference to new unapproved infrastructure improvements2. Dummy bidders at auction (an illegal practice)3. A biased comparable sales list 4. Embellished comparable sales5. ‘Shopping’ offers around (Source: REBAA) CENTURY-OLD BRISBANE B&B SELLS CONSTRUCTION WORK GOING STRONG More from newsParks and wildlife the new lust-haves post coronavirus23 hours agoNoosa’s best beachfront penthouse is about to hit the market23 hours ago QUEENSLANDERS WARNED OVER STORMS last_img read more

Tax Free budget

first_imgLocalNews Tax Free budget by: – June 29, 2011 Share Share 14 Views   no discussions Tweetcenter_img Sharing is caring! Share Prime Minister Skerrit. Photo credit: GIS NewsNo new taxes have been announced in the %432. 5 million dollar budget which was presented to parliament this morning.Prime Minister Roosevelt Skerrit says government cannot impose any taxes on the people of Dominica.Click here to listen to the Prime Minister: Vibes will bring you more from the Prime Ministers budget presentation.Dominica Vibes Newslast_img

No bail bond for murder suspect

first_imgThe 20-year-old resident Bryan LoEstremos was caught on the strength of an arrest warrant around 11:15 a.m. onWednesday, a police report showed. BACOLOD City – The court recommendedno bail bond for the temporary liberty of a murder suspect arrested in BarangaySalvacion, Murcia, Negros Occidental. Estremos was detained in the lockupcell of the Murcia police station./PNcenter_img Officers of the municipal policestation served the warrant issued by Judge Phoebe Gargantiel-Balbin of theRegional Trial Court Branch 45 here dated Jan. 27.  last_img

Antiviral drug Avigan to be tested on 100 COVID1-19 patients

first_imgJapan will provide enough anti-flu drug for clinical trials on its efficacy against the COVID -19, she added.DOH is already formulating guidelines on which hospitals will conduct the trial as she stressed that the consent of the patients are necessary for the trial, she further said.Japan has been conducting clinical studies into Avigan, also known as favipiravir, after scientists suggested it had been effective in treating COVID-19 patients.“Patuloy po ang pakikipag-ugnayan sa Japan para sa supply of this drug which is Avigan na ipapadala po nila. Nakapagbigay na sila ng go-signal dahil po dito,” Vergeire said.Based on the latest data from the DOH, the Philippines has a cumulative 9,684 confirmed COVID-19 cases including 637 deaths, and 1,408 recoveries./PN MANILA – Clinical trials to test the effectiveness of Avigan, made by Fujifilm of Japan, against the new coronavirus disease 2019, will soon begin in the country, according the Department of Health. At total of 100 COVID -19 patients will be among those who will be part of the clinical trials, said DOH Undersecretary Maria Rosario Vergeire said in a virtual press conference.last_img read more

Djokovic breaks down in tears after hosting Belgrade tennis exhibition

first_imgAn emotional Novak Djokovic could not hold back the tears while hosting a charity event at his tennis complex by the Danube River on Sunday.Although he missed out on Sunday’s Adria Tour final, in which Dominic Thiem beat Serbian Filip Krajinovic 4-3 2-4 4-2, the event revived a lot of fond memories for him. The 17-time Grand Slam champion staged the exhibition while international tennis remains suspended due to the COVID-19 pandemic.“I was very emotional on the court today (Sunday). Childhood memories started flooding back, including those of growing up on these courts and playing here as a young boy,” the 33-year-old told reporters after being cheered on by a 4,000-strong capacity crowd.“I was overwhelmed and those were tears of joy after the match.“I try to give back to where I come from and be conscious of my childhood and my upbringing.“This tennis was an epicentre of people from my childhood days getting together for this tournament, including my former coaches. They were all here.” World number one Djokovic beat Germany’s Alexander Zverev on Sunday in his last round robin match, but failed to secure his place in the final.This was after both players and Krajinovic ended up with 2-1 win-loss records and an identical 5-3 set difference in their section.Krajinovic, who stunned Djokovic on Saturday, squeezed through on the basis of having the best games differential among the three.However, he was powerless to stop Thiem in the final.“This tournament was for a good cause and we all gave our best,” Thiem said after finishing off the weekend with a 100 percent winning record. “Many high quality matches in a great atmosphere, in front of a full crowd. So, it was a perfect weekend.“A very big `thank you’ to everyone, including Novak and his team. You all made my first trip to Serbia a very special one.”The eight-man tournament featured a more streamlined format than what is seen on the main tour, with sets slashed to best-of-seven games.The second leg of the tour will be held in Croatia’s coastal resort Zadar next weekend.RelatedPosts COVID-19: NCAA to revoke erring airlines licence over non-compliance FRSC to Schools: We’ll arrest, prosecute drivers who flout COVID-19 rules Djokovic clinches fifth Italian Open title The third leg due in Montenegro on June 27 and June 28 was scrapped on Saturday over coronavirus concerns and the final leg is set for Bosnia’s Banja Luka on July 3 and 4.Reuters/NAN.Tags: COVID-19Dominic ThiemFilip KrajinovicNovak Djokoviclast_img

Obertan never lost hope

first_imgForgotten man Gabriel Obertan has insisted he never doubted himself after easing the pressure on beleaguered Newcastle boss Alan Pardew with a priceless winner. Obertan told NUFC TV: “I have always been confident in myself and my ability, so it might be a surprise for some people, but not for me. I have been grinding quite a while for this and it’s just a great feeling at the moment. “I just kept on working hard. I know the most important thing is working when people don’t see you. “It’s easy to train when you have got the coaches patting you on the back, but these moments when you are by yourself are the moments when you really have to work hard and dig deep.” Obertan appeared to be surplus to requirements at St James’ as Pardew re-shaped his squad during the summer, and he was not even on the plane when the Magpies headed for New Zealand as part of their pre-season preparations. However, he was the toast of the Toon on Saturday evening after finally ending the club’s wait for a first Barclays Premier League win of the campaign at the eighth attempt, in the process sparing them from a worst ever start. On an eventful day on Tyneside – there are rarely any other kind – Obertan and his team-mates had to wait an hour to set about their task after the dressing panels surrounding a newly-erected giant TV screen were loosened by the wind, requiring a speedy repair job by hastily-summoned engineers. Thereafter, it proved far from straightforward as stubborn Leicester defence and sub-standard finishing kept the scoreline unchanged until 19 minutes from time. Leicester full-back Richie de Laet strode forward and unleashed a long-range shot which cannoned back off midfielder Jack Colback and the ball dropped kindly for Papiss Cisse, who fed Obertan on the left. The 25-year-old winger secured a 1-0 victory over the Foxes with a decisive 71st-minute strike which underlined both the talent he has and the fact that it has remained largely unfulfilled during his time on Tyneside. But former the Manchester United midfielder revealed he never lost faith in himself as he redoubled his efforts to to persuade Pardew he still had a role to play at St James’ Park after it appeared that his days in the north-east were over. The winger, as he had done repeatedly during the game, exploited the space ahead of him at pace and cut inside before setting himself and blasting an unstoppable shot past keeper Kasper Schmeichel and into the bottom corner, his first goal for almost two years and just his third for the club. Obertan’s strike prompted a huge sigh of relief, but it took a determined rearguard action to hang on to the points as Tim Krul denied Danny Drinkwater and Steven Taylor blocked substitute Anthony Knockaert’s last-ditch effort. Obertan said: “It’s great. I have been waiting for a while to score at St James’. It was a tough season for me last year. I’m glad I get to be back in the team and be useful. “It was tough, but we persevered and we had the patience and it paid off. We worked really hard in training and it was a tough situation. It was great to get the three points and we get a breather for the next game.” Leicester boss Nigel Pearson was frustrated by defeat, but confident his promoted team will improve as the season goes on. He said: “I am very pleased with the group of players I have got. I know that they are very disappointed with aspects of certain performances, but we have given, for the most part this season so far, a very good account of ourselves and I think we are very capable. “We will get better, so that’s just part and parcel of dealing with the demands of a league which requires quality on lots of different levels.” Press Associationlast_img read more