Coincidences happen. Even when you get a flu shot.

The New York Times has an article about the CDC’s concern that people who get flu shots this year will blame anything that goes wrong with their health on shots. (i.e. Someone gets a flu shot, two days later he has a heart attack, so obviously flu shots cause heart attacks. RIGHT?)

So, those of us who remember our stats or are science-trained sometimes utter the phrase “correlation does not prove causation” in our sleep. But much of the rest of the country world isn’t so quick to remember this fact. The CDC is especially worried that the news media will seize on individuals’ claims that the vaccine made them sick, and publicize them, which will spread that misinformation to the general public who believe anything they hear on TV or read in USA Today.

Why do we care? If people want to make themselves crazy freaking out, why would nurse and lawyer want to get in the middle of that?

One big reason: we don’t want people who really need the protection to be afraid of getting it. Pregnant women are one such class — need the protection, but wanting to be extra careful. Senior citizens are another group who need the protection and may be more susceptible to scare tactics. It could really interfere with our public health goals of preventing this from becoming a pandemic if people are afraid to get the shot. Right, nurse?

So what can we do? We obviously can’t forbid “news” organizations from reporting these kinds of stories. (Hello, First Amendment.) What about some kind of voluntary agreement, where news organizations are made aware of the problem and its potential consequences, and agree not to report these kinds of stories without appropriate context describing the nature of the correlation? What if we set a threshold for how many incidents of the same sort must be observed before it becomes a “trend” that they could report? Admittedly this is more a question of journalistic ethics than of law, but… I want to be able to do something about it!

Other ideas? Anyone?

Swine flu again. . .

So there’s been more talk in the news about the impact of swine flu on the upcoming flu season– i’ve heard wild estimates that the incidence of flu could be double what we see in a normal flu season, with mostly mild to moderate disease. I’ve also heard estimates that ICU’s may be at 100% capacity entirely with flu patients. (heard mostly via NPR).

1. Not so much with the surge capacity?  We should get on that. Lawyer knows about this kind of thing from her days as a disaster preparedness VISTA.

2. Paying ICU nurses overtime = great for Nurse, expensive for hospital/medicare/whatever is paying. . .

3. Flu vaccines are coming to a hospital employee health deartment near you, but is there enough? And, speaking of, we generally vaccinate the most vulnerable– very young, very old, or compromised– in a situation like this, healthcare providers should perhaps be among the ones chosen. Those ventilators can’t work themselves. . .

And stay in!

Lawyer: This is my fourth and final post about legal issues surrounding public health emergencies. When can we isolate or quarantine people? How can we do it? What about can vs. must? This one is a real doozy — if we could count on people to do the socially responsible thing, we wouldn’t have to worry about this. But all kinds of reasons — from employers who won’t give paid leave or even guarantee you can keep your job, to lack of education about disease, to a general lack of community spirit, many people won’t voluntarily stay home or in a hospital if they are sick or have been exposed. Here are a few thoughts about the who/when/where/why of quarantine and isolation.

1. It really can prevent the spread of disease. In a real pandemic situation, if you keep the sick people away from everyone else (isolation) and those who have been exposed separate until an incubation period has passed (quarantine), the germs can’t get to the rest of the population anywhere near as fast.

2. We as a nation place strong value on individual liberty and have a real reluctance to confine people if we can help it at all. (Unlike, say, China.) And this is one of the great things about our country. But does this great value of ours override the government’s responsibility to keep its citizens safe? I’d say it does, until the danger is really imminent. (see China: overzealous.)

3. It’s not just in what you do — it’s in how you do it. New rules that are being hashed out and introduced require a mandated isolation to meet two tests: the isolation itself must be fair and warranted, and the means of conducting it must also be. There is a built-in due process mechanism that entitles an individual to an automatic medical review after a short period of isolation, and if the individual disagrees with the decision, he/she is entitled to make an appeal on medical grounds, and is entitled to a medical representative (sort of like a lawyer for them, except it’s a doctor.) If they go through this and still disagree and exhaust all the administrative channels, then they are entitled to a habeus hearing. Where they get an actual lawyer.

4. All these hearings and such introduce interesting questions — can an infected person appear in court? Can court personnel be excused if they aren’t comfortable? This has come up in the past in the case of TB, but it’s simpler there — often much more isolated, etc. Alternatives include telephonic hearings, which have been allowed in some contexts in the past. I’m starting to envision hearings via Skype or iChat. The times, they are a-changing.

Lots of sticky issues here. It’s the old safety vs. security debate that we are so fond of, in contexts ranging from forced searches at the airport to, well, pandemic preparedness. Tough stuff!

xposted Ready or Not

Don’t shoot yourself in the foot!

Lawyer:  Here is part three of my series on public health emergency law.

There are a number of measures written into various laws that allow government agencies more flexibility during public health emergencies. We have a lot of regulations surrounding health care, including privacy rules, procedures for various state-fudned health care programs, and regulations about the use of drugs and medical equipment, and when we need to act fast, these rules, which are important protections most of the time, can really get in the way of a quick and coordinated response. Here are a few interesting possibilities:

Emergency Use Authorizations: The Health and Human Services Secretary can ask the FDA commissioner to issue an authorization to use a drug or device that has not yet been approved if there is reason to believe that its risks are minimal and it will help with the health emergency. Likewise, they can authorize the use of an approved drug in a new population or for a new use. These have been used in the past, and there is one in place now allowing the use of flu drugs in children.

Certain laws relating to Medicare/Medicaid — specifally, some of the requirements of health care professionals (i.e. specific timetables for certain kinds of paperwork, requirement that the license be in the specific state where they are providiing services, etc.)

These kinds of built-in flexibilities are important to a functioning system! We wouldn’t want to operate this way all the time, but we also wouldn’t want to be bound by regulations that don’t make sense in a context that requires rapid action. The potential concern — that flexibility opens up the possibility for abuse — is mild in this context, and the alternative is far worse. (As I write this, Arizona has moved up in the list of states with the most cases, but the flu also continues to look mild, and the hot weather may slow its spread — here’s hoping!

(xposted on Ready or Not.)

Helping at the health department

So, nurse, after hearing lawyer discuss some of her duties as a volunteer coordinator, signed up to work in the Pima County public health department’s call center handling calls about the swine flu.kirk-telephone-lgjpg

Ever wonder who you’re talking to when you call a number like that for information? Well, it’s me! And other nurses and doctors who are either volunteers or employees.  What did we do? Logged calls, sorted them into either informational, medical triage, or epidemiology. People who wanted to know if there were cases reported in the area, or what the symptoms were, or when they should close the school. . . etc., were informational calls. We just answered their factual questions– and told them to wash their hands a lot and call back if they were concerned. (no confirmed cases in the county, regular flu symptoms, we will reevaluate if there are local cases confirmed and issue recommendations at that time). Triage questions were people saying, “my kid has a fever, I have a cough, I just threw up. .. ” and they want to know what to do (mild symptoms: stay home until you’ve had no symptoms for two-three days, severe symptoms: to go your MD, urgent care, or ER, respiratory distress: call 911). This category of calls is really why they have nurses on the line– we can make recommendations based on these reports. Finally, questions from medical offices, hospitals, and other health departments mostly went to the epidemiologists. Pretty neat, huh? We got a lot of all kinds of calls, and I think it’s a great way to spread factual information and quell panic.

Liability Issues

Part 2 of my series on legal issues surrounding public health emergencies: Liability.

Federal laws protect federal workers responding in an emergency, even temporary hires, and that’s great — but there are all kinds of other liability issues to take into account.

One that’s important to us: what about volunteers? Volunteers usually work with a local organization or a local government, not directly with the federal government, so it’s their rules that cover you. Pima County will cover registered volunteers of the county, even if they are temporarily registered in an emergency situation — but only if you are acting in a role assigned to you by the county after you register with them. States and counties have their own rules and plans, and it’s really a patchwork system.

It’s important for the government to provide good liability coverage for volunteers, because their services are likely to be needed — especially medical volunteers — but who wants to volunteer if they think they’re going to get sued? Take-home message: if you want to volunteer, make sure you find out what kind of liability coverage will be provided to you by the organization or government for which you are volunteering, because there is no federal law that automatically covers you.

Another interesting issue: use of experimental treatments. Since the PREP act was passed in 2005, the HHS secretary (btw: congrats, Ms. Sebelius!) can authorize emergency use (more about that in a later post in this series) of a not-yet-approved drug or use of approved drug for treating a potential health emergency. If this happens, broad protections are extended to everyone from the drug’s manufacturer to the nurse who gives the injection and everyone in between. They are basically immune from tort liability! (This applies to FDA-approved drugs, too, but the emergency use struck me as the most interesting application.) There’s plenty more to say, but for non-law geeks, this is probably enough for one sitting. Stay tuned for future posts on flexibility, availability of resources, and civil liberties!

xposted http://vcdc.wordpress.com

School Nurse = Public Health Hero!

In case you missed it, it was a school nurse in New York state who began the investigation that confirmed cases of swine flu. She recognized an unusual pattern of symptoms in a large group of students and called the health department. (see the NYT article).

Maybe this makes up for the other school nurse we’ve mentioned recently? I know most people think of school nurses as keepers of bandaids, but let’s just take a moment here! School nurses matter.

Public Health Emergency Law

Lawyer: This morning I participated in a conference call with several lawers from FEMA and HHS. They gave a broad overview of federal law as it applies to public health emergencies. It was interesting to me, but then, I’m a nerd, so I’ve tried to distill a few broad ideas from it to share.

First, there are two ways an emergency can be declared. Either the president can declare an emergency or a major disaster, or the HHS Secretary can declare a public health emergency (which he has just done.) The main reason for these declarations is to gain access to additional funds, supplies, or powers that may help control the emergency or, in this case, the potential emergency. The legal issues surrounding pandemic response can be grouped into several categories.

1. Liability. A lot of the laws surrounding disasters and emergencies deal with protecting emergency workers from being sued, altering licenscing regulations so that workers can more easily respond without sacrificing quality of care, and protecting volunteers. Federal laws generally apply only to federal employees. State laws vary widely.

2. Many of the laws are designed to give government agencies and hospitals more flexibility in emergency situations. Some temporarily relax requiremetns surrunding medicare and medicaid, and there is a program that allows for the emergency use of drugs or other treatments that have shown themselves to be helpful but have not yet been approved by the FDA.

3. Some laws make provision for the availability of resources - -not money as much as medical personnel (HHS commissioned corps, for example) and the Strategic National Stockpile, a large collection of medications, medical devices, supplies, and equipment that would help the US to respond to a public health emergency. The public health emergency declaration isused early this week gives the federal government the authority to deploy these resourcesnot just domestically, but overseas, if there is evidence that such an action would protect our own national security.

4. Perhaps the most fascinating legal questions concern safety vs. civil liberties. In particular, this applies to quarantine laws, which are actually in the process of being rewritten for a world in which people don’t generally travel by ship. The new laws, which are due to be passed mid-June (we’ll see) include a procedure for appeals to take care of the 5th ammendment concerns that often acompany quarantine and isolation ideas.

Lots of issues to explore here. Unless breaking news demands my blogging attention, I might take the next few entries to look at each of these areas in more detail. Stay tuned!

xposted http://vcdc.wordpress.com

Perspectives on Swine Flu

This article form the BBC has some really interesting perspectives from a variety of folks living in the affected area.

It’s alarming — but it’s also interesting and gives this public health emergency a much more human face.

I (lawyer) will be listening to a CDC-sponsored conference call tomorrow on Federal Public Health Emergency Law — watch for an update tomorrow with more info!

Swine Flu: Nurse’s take.

Ok, I wrote this post before I saw Lawyer’s post, so sorry if there’s repitition!

So there’s an outbreak of swine flu in Mexico, which has killed some 68 so far– it’s in the news, and as a health care worker in Arizona, we’ve gotten some information about it at work, too, as there have been cases in the American southwest. Now there are 8 reported cases in NYC, too. This disease, unlike other strains, appears to spread human to human. The Mexican government has cancelled public events and closed schools to try to contain it, but President Calderon is seeking additional powers to inspect peoples’ homes and quarantine people. (see http://www.nytimes.com/2009/04/26/world/americas/26mexico.html?_r=1&hp) .

swine-cp-3491542

There is special concern over this virus because it’s killing otherwise healthy young adults, unlike other types of flu which usually strike the very  young and very old. The CDC and the WHO are worried, obviouly– but how to strike a balance between being prepared and inciting panic? Within the U.S., containment isn’t a viable strategy because there are cases spread out with no link found. So, is Mexico on the right track? Does quarantine  work? Is it warranted? When are a person’s individual rights superceded by public health needs?  Remember the guy who flew on an airplane while knowingly actively infected with TB? We all pretty much decided that wasn’t ok, right? Let’s find that boundary.

I think we’d better straighten out our plans BEFORE there’s a pandemic. At least from first-hand experience, hospitals are getting ready! Staff are being educated and supplies and drugs inventoried.

One of the best things we can do at this stage is educate people: flu is a respiratory virus, it’s transmitted by droplets. Cover your mouth and nose when you sneeze, WASH YOUR HANDS, and stay home if you’re sick.

Check out the CDC’s swine flu podcast for more information: http://www2a.cdc.gov/podcasts/player.asp?f=11226