Search This Blog

Follow by Email

Tuesday, October 25, 2011

Should you get a flu shot? (plus comments on intranasal and intradermal vaccination)

Influenza is a nasty viral illness characterized by fever, headache, sore throat, runny nose and a cough. These words don't come close to conveying the actual misery of a real whomping case of the flu. Most of my patients with the flu feel too miserable to come in to the office, which is good, because influenza is very contagious. Not only is it contagious when it first occurs, it remains contagious for 1-2 weeks. But I stray from my description. The patients who do come in to see me with the flu are usually too miserable to adequately describe their symptoms, preferring to moan and answer my questions with short answers. I have had the flu several times, and what I most vividly remember is being nearly unable to move. Usually when I get the flu, I start the day out thinking that I might be getting a little cold, but that I can certainly work. Then the viruses start doubling and infecting my vulnerable cells and I realize that I need to get home. I have traditionally been able to time this pretty well, arriving at my house just before I am completely unable to take another step. I will then sit down on the couch and wait until somebody asks me if I want something at which time I will ask for water which I will be too miserable to drink. Highlights of the symptoms I remember include feeling like my eyes and the linings of my nose had been burned, so I would be unable to either close or keep open my eyelids without pain, hurting in every muscle, whether I moved it or not, mouth dry, bad taste, can't drink because throat hurts too much, racking dry cough. One time years ago my husband and I both came home from work with the flu at the same time, sat down and spent the next 2 hours trying to decide if either of us had energy to reach for the TV control. The flu rarely involves gastrointestinal symptoms, so really does not cause nausea or diarrhea, though the recent H1N1 swine flu was associated with these things, but not to a major extent. The flu is mostly seasonal (though now we have a circulating  year round H1N1 from last years over-advertised pandemic) and occurs anytime starting November on up through March. Each year there are 2 major varieties of the flu, an A and a B type, each usually a different serotype than the previous year.

Not only is influenza really unpleasant acutely, it can last for over a week, and then cause a sinus infection that can take weeks to clear or a cough that can persist for months. It can even kill people, either through weakening their systems or from direct effects, such as infecting the brain, causing severe life threatening viral pneumonia or even heart problems. Each year 30-40 thousand people die of direct effects of the flu, which is a huge loss of life and mostly underappreciated. Most of those who die of the flu are very young or very old or weakened by disease, but not all. Some healthy people get the flu and die.  In the influenza epidemic of 1917, 50-100 million people died over 3 years it lasted, and they were primarily young and not otherwise ill. Some years, however, flu outbreaks are pretty minimal.

The influenza vaccine has existed since the 1940s, and has been tested extensively since then. Each year now the vaccine is created anew, based on the predicted viruses identities for the next year.  Vaccine side effects are usually quite mild, though causing the body to create disease fighting antibodies is sometimes associated with a vaguely ill feeling. People do not get the flu, per se, from the flu shot, though they might become ill in the doctors office while waiting to be vaccinated by being around other coughing and sneezing patients.  In 1976 a vaccination aimed at preventing swine flu ended up causing a severe nerve disorder called Guillain Barre syndrome in 1 of 100,000 people who received the shot. Guillain Barre can also happen in a person due to any actual infection, including influenza itself.

Being vaccinated results in a rise in the antibodies that protect against the particular variety of the flu that the vaccine was designed to prevent. In many studies of flu shot effectiveness it has been shown that people who get vaccinated are less likely to go to the hospital, get pneumonia or die. During an influenza outbreak, usually about 1 in 10 people under the age of 19 become infected and it is possible to judge the presence of flu in a community by large numbers of students being absent from school.  Vaccinated healthy people are less likely to miss work during flu season and vaccinated elderly people have a 68% reduction in death during flu season. Some of this effect may be due to the fact that healthier and more affluent elderly people are more likely to be vaccinated than the poor and homebound, but this does not entirely explain the effect. Healthy vaccine recipients are significantly more likely to have good immune response to the vaccine than elderly or very young or otherwise medically vulnerable people, so their protection from the virus is probably correspondingly higher. Some years vaccine designers guess wrong about which influenza virus will be the most prevalent and so there have been years when the vaccine was all but useless. Production of enough antibody after vaccination to protect against flu varies significantly for different subgroups of people, from as low as 20-30% in older adults and as high as over 60% in healthy volunteers.  The fact that the only a small proportion of the elderly respond to flu vaccines in any measurable way, and yet their death rate during the flu season is profoundly reduced does bring into question whether getting the flu shot is merely a marker of good health rather than protecting against disease.

Each year about 100million people receive the flu shot in the US. Some much smaller number of people are vaccinated by the nasal route, receiving, instead of an inactivated vaccine, a live virus that infects the body without causing harm, thus raising the flu related antibodies more naturally. Evidence suggests that this route of vaccination may be more effective in children, but recent studies have overall shown more influenza type disease in recipients of the live vaccine. The more common, inactivated flu vaccine is given as a shot in the upper arm, into the muscle. It can cause aching that may last a few days, and occasionally causes significant swelling. Two years ago when there was a vaccine shortage information was released showing that injection just under the skin into the subcutaneous tissue of 1/5th of the volume of a standard flu shot was at least as effective as the intramuscular injection. It was suggested that physicians might be able to give more shots to more people with less vaccine if they did the vaccination this way. This year, as an experiment, I vaccinated myself and my family with a smaller than standard dose of flu vaccine subcutaneously. We all felt that it stung a little bit more, but didn't ache as deeply as the intramuscular route but was otherwise a little bit superior due to the shorter and tinier needle that is usually used for that type of injection. I have been curious, for the last two years, about why a subcutaneous injection of the flu vaccine had not become standard of care if it works better and utilizes fewer resources. Vaccines are very big business, though I'm not sure exactly what the numbers are. The biggest manufacturers of influenza vaccine are Sanofi Pasteur and Glaxo Smith Kline. If they make even 2 dollars per shot, which is probably a low estimate, the profits would be $200 million dollars in the US alone. If influenza shots were given subcutaneously, the world could get by with 1/5th the amount of vaccine, significantly reducing profits. But I just read in the Medical Letter today that Sanofi Pasteur has figured out how to avoid that pitfall of cost savings by producing a single dose subcutaneous injection of flu vaccine for...only $4 more per dose than their standard flu vaccine which costs the pharmacist or physician $12! Clever Sanofi Pasteur. If we physicians are not mindless sheep, however, we will figure out that we can start giving 1/5th size subcutaneous flu shots with tiny little needles in the not to distant future.

So--bottom line--should you get a flu shot? Probably yes. If you are healthy, your antibody response will be robust and you will be less likely to get the flu this year, miss work, feel terrible and possibly (but not likely) die.  If you are very old or infirm, your immune response will be less but your downside should you get sick is significantly higher, and might more reasonably include dying. It also seems clear that more research is needed to define exactly who will benefit from flu shots, and that the ethics of withholding flu shots from a random group of people in order to do good science is complex. If it turns out that flu shots really don't protect well from death and disease, we are wasting a colossal amount of resources in vaccinating everybody as we are now.

What is the very best way to prevent the flu? Probably by avoiding exposure to sick people by having more comprehensive policies to discourage sick people from going to work and school.  This will never be perfectly effective due to the fact that people can be significantly contagious before they get sick enough to realize that they need to be home. That said, I do wonder if even this approach is optimal. It may be that frequent exposure to germs in levels insufficient to cause actual disease might serve to immunize those exposed and make them less likely to catch or spread the disease in the future.

Flu shots are available to anyone at a cost of about $25 a pop at grocery stores and pharmacies and are covered by virtually all insurance companies. They are usually offered to patients starting in late September commercially, but since immunity only lasts for 3-4 months and outbreaks frequently occur after January, waiting to get the vaccine until the end of October is recommended.  In the US flu vaccine is recommended for all people over the age of 6 months, including pregnant mothers. It is particularly recommended for healthcare workers who are more often exposed and who have a higher likelihood of spreading the disease to vulnerable populations.

Saturday, October 22, 2011

The perfect electronic medical record

I have had a love hate relationship with our computerized medical record since we first started using it in 2007. Much like computers in all of American society, the idea that our computerized medical record is just a small facet of what we do, involved in the storage of information, is a gross simplification. In the US (also elsewhere, but I can't speak for Europe or Asia from much personal experience) the ubiquitous presence of computers has affected how we work, play, think, communicate. These interfaces with brains that we use so frequently have made us fatter, more connected to each others' thoughts, less connected to each others' bodies, has reduced our ability to use non-visual senses, has partially convinced us that 3 dimensions are optional, and I could go on for hours (at which time all hope of going out for a walk would be gone.) In my medical office, my near-umbilical connection to my laptop has touched all parts of what I do. The production of a document, which integrates information from as many sources as I am aware of that refer to my patient, is one of the most important goals of a visit. I also try to solve the patient's problem and answer their questions and listen to them, but I do it within the context of my computerized medical record. This sounds overstated, but in my particular case I think it is pretty accurate. So the fact that our particular software package sucks is profoundly irritating.

Now "sucks" is a pretty strong word, and I only use it because we just had an update which has been as infested with bugs as a cheap motel and I am frustrated. Oh so slow. I feel like some sort of a bivalve sea creature as I wait for the screen to allow me access to my patient's vital information. I feel trapped and claustrophobic as I attempt to stay within one layer of the record while needing simple information such as what happened last time or how old they are, that exists but is clicks away. The love part of "love hate" comes in when I see how many great features there are, including the ability to communicate to other doctors in my practice and support staff and pharmacies in a way that is accurate and nearly instant, and the fact that I can organize and transmit information that is coordinated and readable to the patient or to unconnected physicians in a printed format. That doesn't sound like much, though, in return for essentially marrying a computer.

I can, however, imagine a computerized medical record that I would really love, and have been doing that exercise for the last few days. I will now state what I want, and maybe at some time in the future, the universe will provide.

I would like my documentation system (EMR, for electronic medical record) to allow me to record information quickly and efficiently. I would like it to remind me to do things that I don't want to be thinking about while I am trying to concentrate on listening to my patient and formulating a reply or solution or whatever is called for. I want my EMR to keep me from doing obviously stupid things. I would also like it to tell me how late I am getting for my next patient. This is not much to ask, and I know computers can do this stuff. In fact, it may be that somebody's EMR somewhere in the world does do this.

When I first sit down with a patient, my nurse has been in the room, has gotten vital signs (blood pressure, weight, pulse, temperature) and, time allowing, has asked what issues the patient has and even typed them up in the medical record (yay Joy, you are an awesome nurse.) I would like my EMR to have already given my patient a chance to answer some of the more routine questions, such as "is this really your medication list?" and "in addition to your issues today, do you have any alarming symptoms such as passing blood or fainting or chest pain?" When I first looked at the screen it would show me a summary of the most recent medical visit and labs, so I would be reminded of salient information. I would then like to have a discussion with my patient about what they want help with and the stories, questions and answers surrounding that (the history of present illness.) I then want my computer to prompt me to ask questions about the corresponding systems. (Patient says "trouble swallowing", computer brings up review of nose throat and intestinal system "do you have post nasal drip, cough with eating, vomiting, heartburn or blood in the stool".) I then want it to remind me to review the background information: still in the same job? marriage? family history, clues to stress related issues? medical history? Then I will do my physical exam. I want it to highlight any abnormalities of the vital signs (sometimes I don't notice until later that the patient's blood pressure was elevated) and come up with a form to document my exam that is consistent with what I normally do. After I finish that, I would like it to highlight any area that the complaint suggests would need more careful examination. Then I want it to ask me what medical orders I wish to add and which medications I wish to prescribe or change. If I order a medication that interacts with another or that the patient is allergic to, I would like it to tell me (it does this now, but in such a ridiculously lame way that it is unusable). If I order a test or procedure that has been done or ordered in the last year, it should tell me that, too. Then I want it to suggest patient education handouts which I would press a button to print out. I would then tell the patient what I am thinking, ask if they had any other questions and the EMR would notify the nurse to come back in and it would lead her through a brief review of preventive medicine recommendations to tell the patient (due for a mammogram, stuff like that), but only once or twice yearly for any given patient. The nurse would also then make sure the patient had prescriptions and followup information which would already be clearly documented in the record. As far as reminding me how late I am, I would like there to be an appointment bar at the edge with present time and color coding and actual numbers to indicate how long my upcoming patients have been waiting.

Could I go through all of this in a 15 minute appointment? Depending on the complexity of the problem, most likely yes. Would the patient feel heard and supported? I think yes. I know for sure that if I spent less time in combat with stupid evil software  I would have more mind and heart to spend on being a human helping another human in need.

Computerized medical records are here to stay because their potential for improvement in communication is so awesome. The most important trick is for us to make them facilitate real care of patients rather than let them suck us into their information vortex only to have us lose sight of what we as caregivers are for.

Wednesday, October 19, 2011

Telemedicine: where could it lead?

I have only 6 more days in my present job as a primary care internist in my home town. The process of wrapping things up has been new and time consuming, but ultimately very rewarding. I get to see patients I've known for over a decade, in some instances, and review what has happened with their lives and their health and we work on future plans for maintaining what they have gained and getting a handle on problems still bothering them. We say goodbyes and good lucks and talk about the important, big stuff, like hopes and dreams and medication refills. Interspersed among these appointments and phone calls are multiple communications about my next job, whatever that will turn out to be.

I am signed up with 2 locums companies, and in contact with 4 recruiters who are my agents, as well as the recruiters that are associated with my possible new jobs. The phone calls are mostly really interesting, since I get to hear about new places and how they are doing what they do in health care. Many of the jobs that sound perfect have been non-starters because they need me at times when I can't be there, or for lengths of time that would take me away from my family for too long. Primary care positions would like me to be around Monday through Friday, with the occasional call weekend in some cases, for 3 months. This could work if they are within a reasonable traveling distance of my home and family, which does cut down on my options. Hospitalist positions, where I would take care of just patients in hospital, usually for 12 hours each day, are considered full time if I work 1 week on and one week off. If they are willing to fly me in and out, and the location is within a reasonable distance of an airport, that could work anywhere in the country. I would not have to be away for so long that my dog forgets who I am.  Of all the jobs I could get, I would prefer "traditional internal medicine" which involves both outpatient and inpatient work because I think it will teach me more about a whole community and how it is coordinated to do health care. It is good  locum tenens etiquette to apply for only one position at a time, which can lead to serial disappointments and presently I remain on the edge of my seat as I wait for confirmation of my first assignment. I'm sure it will be just fine and dandy, whatever it is, but it would be so reassuring to know where I will be in 2 months.

My resources for this adventure (my 2 years off from my regular primary practice) include quite a few friends and colleagues who have done or are still doing locum tenens (latin for "place holder") work. They tell me what places they have liked, where the ethics or the support might be thin, which companies take care of their clients. Sometimes they even know of specific needs, where I might work without using a recruiter at all. One such opportunity is doing telemedicine.  Telemedicine is the practice of taking care of patients remotely, using telephone or computer. It is often practiced in places where the right doctor cannot be present physically, such as when a rare specialist is needed in a tiny hospital. It is used to share expertise over great distances, and is used internationally by some medical aid organizations. At the recommendation of a friend, I contacted an organization called MDLivecare, which provides telehealth services domestically, with private clients (people who arrange e-visits on their own) and corporate subscribers. A large company may wish to provide their employees with a way to contact a physician quickly, easily and inexpensively as a way to reduce time lost from work and in order to provide services more inexpensively. The telehealth visits include many of the trimmings of a real doctor visit, including documentation of what was discussed, communication with the primary care physician if there is one, and even prescription of medications (though controlled substances are strictly out.)

At some point in the future I will probably know more about telemedicine because I will probably try  doing it. I have always enjoyed the challenge of treating patients over the phone, and having a video chat interface will be even easier than that. Much can be communicated verbally, and though loss of the touch aspect of medicine is a considerable hindrance to some diagnoses, I think it will be really interesting to see how much can be done in this type of an encounter.

Yesterday I visited with a patient who had a very odd neurological problem, a "funny walk" that was new and didn't really fit into patterns I had seen before. More than anything, I wanted her to be able to see a world class neurologist, who could probably ask a couple of questions, watch her walk down the hall and know what she had. But we were in a small town in a small state, and getting to a world class neurologist is probably nearly beyond her. It would be so simple, if telemedicine were more widely accepted, to call my favorite world class neurologist, web cam her funny walk, tell him my concerns and ask any questions he might have and get our answer. What presently hinders this are the fact that even practicing telemedicine requires a state license, and that there are no easy ways to bill for this service. Clearly that needs to change. We have technology at our fingertips that would reduce human suffering and we are hamstrung in our ability to use it. I look forward to the inevitable adjustments in payment schemes and regulations that will allow us to use what we have to its best advantage.

Wednesday, October 5, 2011

Meaningful use: the top heavy nit picky route to possibly better health care

As part of the 2009 American Recovery and Reinvestment act (the massive stimulus package enacted at the beginning of our economic slump) doctors were offered money to start using computerized medical records for their patients insured by Medicare and Medicaid.  It was felt to be evident at that time that use of a computers to document patients' medical encounters would make communication between providers better, reduce errors, reduce redundancy of testing and procedures and overall streamline documentation. Many physicians had already started on the road to making their records digital, but government support made others take the big step.  Our office bought a very expensive computer software package from GE along with all of the hardware to support it in 2007, and by the time the stimulus package passed, we had almost adjusted to the change. We figured we would probably be well set up to be rewarded for having made this momentous change before the majority of offices.

Adjusting to an electronic health record (EHR) is not easy.  The programs for keeping such records are extremely complex, owing to the demands of privacy, legal issues, communication with other entities, drug prescribing, and the fact that most of these programs have been written over many years by programmers who no longer work for the same company and are no longer around to explain the rationale of the code they wrote, much less to fix it. The resulting products do really weird things and don't do some of the normal things that one would expect them to do.  They don't automatically check spelling, for instance. They do lag, significantly. Perfectly simple tasks make them crash, and though these bugs are fixed, they reappear whenever there is an update. Of course, my experience is with GE's product, in our office, and doesn't necessarily apply to all EHRs, but from what I hear, many of them are plagued with the same problems.

In our office in the weeks following changing from dictating or writing our notes and communicating our plans orally or in handwritten notes to doing about all of this with a computer interface, our productivity dropped precipitously. If we could see half the number of patients we had seen prior to EHR it was a good day. People, including physicians, cried, yelled, quit their jobs. It was kind of awful. We had sick people to treat, and we couldn't access their histories, write their prescriptions, and we would sit with them, powerless in front of a computer screen that would not navigate to what we needed. After a couple of years we had almost become as fast as we were before computers, but truly we have never entirely recovered. Some things are definitely better. Our notes are readable. We know what we have prescribed and when. We are reminded of schedules for vaccinations and that sort of thing. We can produce a nice looking typed note for work in a couple of minutes. But we still spend lots of time staring at a screen rather than focusing on a patient and I, personally, am still slower, even though I am quite comfortable with computers.

It was a disappointment when we learned, about a year ago, that our computer system did not qualify us for any sort of reward through the Recovery and Reinvestment Act. What was required was "meaningful use" of an electronic health record. How, we wondered, were we to make it meaningful? It sure felt meaningful to us. The cost of it was pretty meaningful: over $100,000 for the initial investment, plus more than that much in updates and lost productivity. For a bunch more money, we found out, we could have "meaningful use" and be eligible for some payments. We have embarked on that road, and a rocky one it is.

Meaningful use requires 15 "core measures" be met along with 5 out of 10 menu items. We don't have do do every one with every patient, at least not yet, but we need to make a good start. The 15 core measures are:
1. We need to enter our orders (for things like tests and consults) on the computer.
2. We need to have the drug ordering part of the program be set up to tell us about drug interactions.
3. We need to keep an updated computerized problem list for each patient.
4. We have to transmit our prescriptions electronically, those that legally can be sent that way.
5 and 6. We have to keep active medication and allergy lists.
7. We have to keep demographic information of everybody, stuff like age, sex, language and ethnicity.
8. We have to keep record of all vital signs, including the body mass index and be able to graph growth in children.
9. We need to document whether the patient smokes (age 13 and older.)
10. We need to be able to transmit clinical quality data to Medicare.
11. We need to have our EHR help us make clinical decisions about at least one condition.
12. We need to supply patients with a summary of their health record on demand, including diagnoses, allergies, medications.
13. Within 3 days of a visit, the patient needs to receive a summary of their visit, including their problems
medication changes, what referrals were made and to whom, with contact information and what followup was recommended
14. We need to be able to transmit medical records to other providers electronically.
15. Our records must be secure.
The 10 menu items, from which we can choose 5, require that we:
1. Check insurance formularies so that patients know if the prescribed drug is covered and what other options are available.
2. Have lab tests be entered in such a way that the EHR can search them and use that data in various ways (i.e. not a scanned image.)
3. Generate lists of patients with specific condition.
4. Send patients reminders for followup for certain conditions and for prevention.
5. Provide patients with electronic access to their health information within 4 days of results being available.
6. Provide patient specific education resources (I think this means things like handouts on specific diseases.)
7. Do "medication reconciliation" -- making sure that medication lists from each provider are the same.
8. Provide summaries of care when a patient is transferred from one doctor to another.
9. Electronically submit vaccination data to agencies that collect that data.
10. Submit data on diseases or syndromes observed to appropriate agencies (like Dept of Health for infectious disease outbreaks.)

Most of these requirements are both reasonable and a good idea. Some of them are a really great idea, but figuring out how to do them is going to be a bear. The main one that has me worried is the summary of the patient visit. I used to write summary letters to patients after their yearly physicals. It took forever. Not only did I need to document the visit for my chart, I had to rewrite it in a way that a patient would understand. It just about doubled the amount of time it took to document a visit. It was also a great gesture, and I'm sure the patients usually benefited from it and appreciated it. I won't deny it is a good idea, but with the slowness of computer documentation as it is now, I wonder where we will find the time. I'm pretty sure that even a good computer can't take the data from a doctor's visit and turn it into prose that will be comprehensible to a real person, so to the extent that these documents are really useful, they will have to be generated by the doctor. We are expecting a bunch of new patients to be needing primary care doctors in the next several years, associated with a shortage of these providers, which will make it nearly impossible to spend more time in documentation.

Another thing that worries me is the requirement to submit data on quality to Medicare. Some measures health care quality are deeply meaningful, for instance, is the patient happier and healthier due to a medical encounter? Unfortunately, those outcomes are difficult to measure. Instead we measure whether diabetic patients have their blood sugars below a certain, somewhat arbitrary number, or whether women over a certain age have gotten mammograms. Many of the things that we decide are good and important in health care turn out to be not good when the next study comes out. For instance, we found that vitamin E wasn't good for anything, then found that it effectively treats fatty liver in obese patients. We still disagree about how often to get mammograms on patients, and screening for prostate cancer is a hotly disputed topic.

The updates to make our computer systems jump through these hoops will make us tear out our hair, once again, and stare helplessly at poorly functioning screens while sick patient wait for our help. I still hope that one day the intelligent and computer savvy generation behind me will be hired by Medicare to produce an EHR that is as lithe, supple and fast as a cheetah and we will all use that wonderful product which will be affordable due to economies of scale. I'm waiting eagerly. If that cheetah-like EHR comes to exist, it may well improve efficiency, reduce error and lead to better communication.

So how much money is offered to physicians who choose to attempt meaningful use? If we achieve this in 2011, we get $18,000 each. In 2012 we would get 12K, in 2013, 8K, 2015 4K and then in 2015, if we haven't achieved it, we will be penalized 1% of our medicare payment, then 2% the following year.  If it takes until 2012, we only get 3 years of bonus, and so on. At most we can make $44,000 from meaningful use. That is a lot of money. It is also a drop in the bucket compared to what we will have spent in computer software, hardware and lost productivity. But that cat is out of the bag, and $44,000 is still a lot of money. The present meaningful use criteria will be replaced by stricter criteria, and it is not at all clear what those will be.

I'm not entirely sure what to think of this whole process. It seems that we are scurrying in vaguely the right direction, with better patient care as a goal, and an electronic health record as a tool to reach that goal. The way we are going about it, however, seems haphazard and destabilizing. Our aversion to truly standardizing our concepts of quality and our medical records is making these transitions much more difficult that they need to be.