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”http://www.flu.gov/planning-preparedness/business/antiviral_employer.pdf Jun 3 CIDRAP News story “HHS offers pandemic guidance on masks, antivirals”last_img read more

Zambian Fans Want FAZ to Petition FIFA over Nigeria’s Qualification

first_imgAccording to the Sports Editor of Times of Zambia, Elias Chipepo in a chat with THISDAY yesterday, most fans of the Chipolopolo who watched the match live are of the opinion that their team was ‘robbed’ of a legitimate goal mid way into the first half that could have put them in great advantage of qualification.“The fans no doubt are proud of the performance against ravaging the Super Eagles but felt shortchanged when the centre referee ruled invalid the goal scored midway in the first half. They now want FAZ to protest to FIFA on a possible replay in Uyo since Senegal has benefited from a similar scenario by ordering a replay with South Africa,” explained the Zambian Times editor.Aggrieved fans just like pundits were disappointed in referee Joshua Bondo’s decision to cancel Augustine Mulenga’s 24th minute goal.“Mulenga’s goal is a clear goal which could have stood but referee Bondo’s decision changed the course of the game for Zambia who secured home and away result against Algeria to raise the hope of their fans of making their first trip to the Mundial,” remarked Chipepo who was part of the traveling party to Uyo last weekend.The controversial call which is just one of many in the ongoing qualifying series no doubt will further justify FIFA’s decision to test-run the Assistant Video Referee (AVR) at the last FIFA Confederation Cup in Russia last summer.Already, Ghana has lodged a protest to FIFA over valid goal that was overruled by the South African referee in favour of Uganda.Last month, FIFA ordered a replay of the World Cup qualifying match between South Africa and Senegal after the referee awarded a penalty for a nonexistent handball.The referee Joseph Lamptey was banned for life due to his obvious match manipulation.The then Nigeria Football Association (NFA) was on the wrong side of referee’s misjudgment in the past with the final matches of Africa Cup of Nations against the Indomitable Lions of Cameroon at Maroc ’88 final match and Ghana/Nigeria 2000 as case studies.Henry Nwosu’s legitimate goal against Cameroon in the final match at Maroc ’88 was overruled by Mauritania Idrissa Sarr who later in the second half awarded a controversial penalty kick against Nigeria scored by legendary Roger Milla as a match decider.In the 2000 final at the National Stadium in Lagos, Tunisian referee Mourad Daami, overruled a penalty shootout goal from Victor Ikpeba to give Cameroon edge and the Indomitable Lions won the final match on penalties after 2-2 score line full time.On both occasions, the NFA wrote a protest letter to Confederation of African Football (CAF) knowing fully well that the result cannot be overturned but simply for administrative purpose.In the Europe qualification to South Africa 2010 World Cup finals, France legend, Thierry Henry scored a late minute dubious hand ball at Saint Dennis Stadium in Paris to earn the former world champions another ticket against Republic of Ireland whose FA protested to FIFA did not change the result.Although it was later revealed in the last days of former President Sepp Blatter that the Irish Federation was paid same amount of money meant for all federations that qualified for the tournament.Share this:FacebookRedditTwitterPrintPinterestEmailWhatsAppSkypeLinkedInTumblrPocketTelegram Femi SolajaPassionate football fans in Zambia are mounting pressure on the Football Association of Zambia (FAZ) to protest to FIFA for a possible rematch of last Saturday’s World Cup 2018 qualifying game against Nigeria that the Chipolopolo lost 1-0.This development is coming 48 hours after the world football body sent a congratulatory letter to the Nigeria Football Federation (NFF) and 12 other countries that have secured qualifications before the final games of the qualification series in November.Zambia needed either a draw or win to remain in contention for qualification for the first time in their football history but lost out via Alex Iwobi’s 74th minute goal to shoot Nigeria to her sixth appearance at the biggest football show piece.last_img read more

Emmanuel, Adegoke Win CBN Tennis

first_imgThe 40th edition of the event, which was held at the package ‘B’ of the Abuja National stadium also saw the women defending champion, Sarah Adegoke came from one game down to beat  Christy Agugbom 4-6, 7-6, 6-0 and retained her tittle.Both champions smiled home with N700,000 each and the giant singles’ trophy that goes with the cash prize.What Agugbom  lost in the singles final was gained in the doubles as she combined effectively wth her semi-final victim, Blessing Samuel to win the women’s doubles title by beating the duo of Rose Abu and Bukola Olowu 6-3, 6-1.The men’s doubles title went to the duo of Babalola and Shehu Lawal that defeated Philip Abayomi and Michael Osewa whom they outscored 6-2, 6-1.In his key note address during  the clossing ceremony of the grand finale, on saturday, the Governor of the Central Bank of Nigeria, Godwin Emefiele, who was represented by the CBN Deputy Governor Corporate Services, Edward Adamu, said the bank has since 1979, been supporting tennis in the country and has produced champions that have represented the nation in various international competitions and won laurels.Besides, he said the skill displayed by the players on court underscores the reason why the Apex bank has renained committed to the initiative that has always been staged in Lagos until this year that it was organised in Abuja to give the FCT tennis stakeholders a sense of belonging too.He said the Bank will continue to collaborate with the Nigeria Tennis Federation in the overall intrerest of the game in order to ensure steady development of tennis in the country and assured that the CBN Tennis Championship has come to stay..Speaking further, the Governor informed that the CBN is proud to be associated with  both the players and other stake holders for keeping fate with the annual championship that remains as the biggest tennis tournament in the country and pleaded with Nigerian youths yo take advantage of this and develop their skill.The event was also used to honour past champions like the winner of the inaugural edition Mr. Kehinde Ajayi.Share this:FacebookRedditTwitterPrintPinterestEmailWhatsAppSkypeLinkedInTumblrPocketTelegram Sylvester Emmanuel  on saturday emerged  as the new champion of the Central bank of Nigeria Senior Tennis championship by dethroning  the defending champion, Abdulmumuni Babalola with a score of 3-6,7-6 on 3, 6-4 in the final match.last_img read more