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

Viewpoints Big Risks Of Buying Private Insurance With Medicaid Dollars One Month

first_imgViewpoints: ‘Big Risks’ Of Buying Private Insurance With Medicaid Dollars; One Month Of Sequestration The New York Times: Using Medicaid Dollars For Private Insurance The Obama administration and Republican officials in several states are exploring ways to redirect federal money intended to expand Medicaid, the main public insurance program for the poor, and use it instead to buy private health insurance for Medicaid recipients. The approach could have important benefits for beneficiaries and for the future of health care reform. But the idea also carries big risks. Federal officials will need to enforce strict conditions before agreeing to any redirection of Medicaid dollars that were originally intended to enlarge the Medicaid rolls (3/31).Forbes: The Arkansas-Obamacare Medicaid Deal: Far Less Than It First Appeared When Arkansas Gov. Mike Beebe (D.) first announced that he had reached a deal with the Obama administration to use the Affordable Care Act’s private insurance exchanges to expand coverage to poor Arkansans, it seemed like an important, and potentially transformative, development. … A Good Friday memo from the U.S. Department of Health and Human Services, however, splashes cold water on that aspiration. It’s now clear that the Beebe-HHS deal applies a kind of private-sector window dressing on the dysfunctional Medicaid program, and it’s not obvious that the Arkansas legislature should go along (Avik Roy, 4/1).USA Today: ‘Sequester’ Still Looks Stupid, As Planned: Our View Congress and the White House exempted some programs when they finalized the original deal, and the spending bill they agreed to last month to keep the government open to Sept. 30 spared some vital functions — food inspections, for example. But not enough. Nor does the sequester seriously address the major spending driver: health care costs. The best outcome would be for the sort of anger that forced Congress and the White House to re-open the government in 1996 to push Congress and the White House back to the table on a realistic budget deal this year. The outlines of that deal have been obvious for too long: Trim entitlement programs such as Medicare and Social Security, overhaul the hopelessly inefficient and corrupt tax code to bring in more money, and cut defense and domestic programs with a scalpel instead of an ax (3/31). USA Today: ‘Sequester’ Needed To Rein In Spending: Another View Let’s get real on the “sequester.” One month in, not much has changed. Nor is it likely to. Rather than devastating the federal government, the sequester is necessary to rein in the unbridled growth of federal spending. The sequester is certainly flawed. It’s a blunt instrument leaving the biggest spending drivers, entitlements, virtually untouched (Alison Fraser, 3/31). The Wall Street Journal: The Liberal Medicare Advantage Revolt A big political story this year is likely to be Democrats turning on their White House minders as the harmful and unpopular parts of the Affordable Care Act ramp up. On the heels of the recent 79-20 Senate uprising against the 2.3% medical device tax, now comes the surge of Democrats pleading on behalf of Medicare Advantage. Liberals have claimed for years to hate this program, but by now Advantage provides private insurance coverage to more than one of four seniors. And those seniors like it (3/29).The Chicago Tribune: Scrubbing Medicaid In January, Illinois launched an effort to scrub ineligible people from the state’s Medicaid rolls. … The initial results of this audit are … astonishing: Of the first 20,500 recipients screened by an outside contractor, the auditors recommend that 13,709 be removed from the rolls. Yes, that’s two-thirds of the first group screened, flagged as ineligible to receive their current Medicaid benefits. How so? In some cases, the recipients make too much money to qualify. In other cases, they don’t live in Illinois (3/31).The New York Times: The Campaign to Outlaw AbortionAnti-abortion groups have been trying to re-impose restrictions on abortion rights for 40 years, but the Legislature and governor of North Dakota have taken this attack on women’s reproductive health and freedom to a shocking new low … The clear message is the need for a stepped-up effort to hold state officials electorally accountable for policies that harm women in states where right-wing Republicans control the machinery of government (3/29).The Seattle Times: State Senate Health Care Committee Should Vote On Abortion MeasureAfter the Senate Health Care Committee hearing on the Reproductive Parity Act Monday, members should vote for it before a key deadline Wednesday. State lawmakers do not need to complicate this issue. House Bill 1044 would maintain insurance coverage for women seeking abortions after federal health reforms take effect (3/31).Los Angeles Times: The Starbucks Syndrome In Healthcare Medicare statistics, for example, reveal that Los Angeles leads the nation in the amount of medical services provided during the last six months of a person’s life. Healthy seniors here are also big consumers of healthcare, getting about 65% more MRI studies and utilizing ambulances three times as often as seniors elsewhere. Commercial insurance data point to similar patterns in the healthcare of the younger population in Southern California. What explains such avid use of medical services. … Part of the problem is that Angelenos approach healthcare as they do other kinds of consumption. They expect their CT scans, when they want them, in much the same way they expect their decaf caramel extra hot low-fat macchiatos. (Daniel J. Stone, 3/31). Los Angeles Times: Bump In The Road For Healthcare Law One figure in a new report neatly summarizes the potential pitfalls for Obamacare: 30.1%. That’s how much premiums could rise next year, on average, for the roughly 1.3 million moderate- and upper-income Californians who buy individual health insurance policies. Most of that increase is attributable to the insurance reforms in the 2010 law, also known as the Affordable Care Act. The bill’s title is not ironic — its provisions will slow the growth of healthcare costs and lead over time to a more rational and efficient system. But the transition will have some rough patches, and we’re about to hit one (3/29). Houston Chronicle: The Affordable Care Act Is A Poor SolutionSenator Orrin Hatch has speculated that the Affordable Care Act was designed to fail. A close look at the Act’s contents and history suggests he may be right. The Affordable Care Act is nothing more than a political stopgap, a waypoint on the road to something that might work. Republicans could stand around complaining or we could seize this opportunity to determine what comes next (Chris Ladd, 4/1).Richmond Times-Dispatch: Moving Forward On Medicaid: More Important Than EverAs a community physician for more than eight years, I’ve seen how medical care helps keep families strong and secure. When parents and their kids can access health care — and have a way to pay for it — they are much less likely to face unpaid bills or have to put off doctor visits. Instead of worrying about how their family is going to survive, they can focus on how their family is going to thrive. Unfortunately, too many Virginians — more than a million, in fact — find that getting health care is a real challenge because they don’t have insurance (Dr. Christopher Lillis, 4/1).The Wall Street Journal: The Skinny On Anti-Obesity Soda Laws New York Mayor Michael Bloomberg’s anti-obesity campaign to ban the sale of certain sugary drinks in large servings, especially sodas, was struck down last month in state court. A proposal for a penny-per-ounce excise tax on sweetened beverages also floundered in Vermont’s House of Representatives in February. … As an economist, I have two big gripes with such paternalistic public-health initiatives: The proposals aren’t grounded in data or compelling economic models, and soda taxes might catalyze a dismal chain reaction, with escalating government intrusions on personal freedom (Michael L. Marlow, 3/31).Oregonian: Don’t Take Portland’s Sick-Leave Mistake Statewide: Agenda 2013By voting to mandate paid sick leave last month, Amanda Fritz and her city council colleagues furthered Portland’s reputation as a place where businesses fear to tread. One way to protect city employers burdened by this mandate is to adopt a similar requirement statewide, erasing a competitive advantage a restaurant in, say, Beaverton might have over one in Portland. In other words, bail out Portland by making things tougher all over (3/31).USA Today: ER Key To Curb Painkiller Abuse Most opioids are prescribed in the doctor’s office, which has prompted some states to restrict primary care physicians like myself from prescribing them and to encourage referrals to pain specialists. New York City Mayor Michael Bloomberg has taken these curbs a step further by focusing on emergency departments. In January, he announced a voluntary initiative to limit prescription of opioid painkillers in the emergency rooms of the city’s 11 public hospitals. This approach should be expanded across the nation. From 2004 to 2009, the number of emergency visits in New York City hospitals related to opioid abuse or misuse more than doubled (Dr. Kevin Pho, 3/31).  This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.last_img read more