Acid Revelations – Acid Reducers and Asthma in Children

The Journal of the Medical Association recently published an article about the use of lansoprazole (Prevacid) for children with poorly controlled asthma. It had been thought that gastoesophageal reflux disease (GERD) contributed to asthma exacerbations because acid would come up from the stomach and get into the lungs.

By putting tubes down the nose and into the stomach and esophagus it was known that children often have reflux when they have breathing problems, even without having heartburn symptoms. Proton pump inhibitors (PPI’s) such as lansoprazole, omeprazole (Prilosec), pantoprazole (Protonix) and others, markedly decrease the amount of acid produced in the stomach. Even if the contents reflux into the esophagus (think of an old fashioned coffee percolator), there would be less irritation if it was less acidic.

In adults with asthma and reflux symptoms, studies have shown the PPI’s help their lung function. Despite lack of conclusive studies showing benefits in children, its use in them markedly increased between 2000 and 2005. It made intuitive sense and the medications seemed pretty safe.

In this study children with poorly controlled asthma without gastroesophageal reflux (GER) symptoms not only did not do better with lansoprazole, they had more adverse events with increased respiratory infections. There were also six times as many activity related fractures in those on the medication. Although it didn’t quite reach statistical significance because of the relatively small numbers, the PPI’s are known to be associated with osteoporosis in adults.

This illustrates the important difference in statistics between association and causation. Just because two things occur together, doesn’t meant that one causes the other, and even so, it doesn’t mean treating one will treat the other. There is an old joke of a man walking around carrying an umbrella on a sunny day. “Why are you carrying an umbrella when it’s not raining,” asked his friend. “To keep the tigers away,” he replied. “But there are no tigers around here,” his friend objected. “See, it works,” he answered.

The accompanying JAMA editorial called the use of proton pump inhibitors for asthma a case of, “therapeutic creep.” That’s using medications beyond what the scientific evidence shows. This is not necessarily wrong. For example I commonly recommend vitamin D for my patients even though we still don’t have definitive evidence. In such cases, though, it’s good to remember the limits of what we know and beware of potential risks. As Hippocrates reportedly first said, Primum non nocere – First do no harm.

Even my dog’s veterinarian suggested using using over-the-counter Zantac or Pepcid for reflux because my dog sometimes threw up on the rug. Now I don’t feel so bad that I ignored her advice.

Prior Prior Authorization

I prescribed Chantix for one of my patients recently. CVS Caremark faxed us a, “CLINICAL PRIOR AUTHORIZATION CRITERIA REQUEST FORM”. It said to complete the form then fax it to them. Once received they would fax a, “DRUG SPECIFIC CRITERIA FORM”.

Why couldn’t they just have sent the specific criteria form in the first place? It didn’t take long to fill out the first form, but why should I have to sign my name twice for one medication for one patient? In addition someone had to take the time to sort through the office faxes and then get it to me, and my nurse had to fax it back, then had to send the fax confirmation to shredding, not to mention that we are paying for the paper, ink and electricity for these faxes.

Chantix only has one use, to help people stop smoking. Why should there be any criteria for coverage? Either cover it or don’t. Maybe they want to know if the patient tried generic bupropion first (actually they subsequently asked if they were taking it at the same time). Well they could have checked their records and seen that the patient was prescribed it in the past and conclude that it didn’t work. They asked if the patient would be monitored for depression. Sure, that is a reported side effect of the medication. But it’s not like CVS Caremark is asking if I know the side effect of all the medications I prescribe.

Pharmacy Benefit Managers like CVS Caremark should stop over burdening physicians with needless paperwork.

Audacious Align Avarice

Align is a probiotic manufactured by Proctor & Gamble. It’s a little pricy, but I often recommend it to patients with diarrhea or abdominal cramps. They’ve supplied me with $5.00 coupons to give to my patients.

Imagine my surprise to find the 2012 coupons are $4.50. Give me a break!

According to their web site, boxes of Align now have over $50 worth of coupons for their other products, as shown below. I guess that’s why they had to knock 50 cents off the price.

$10.00 off ONE
42 ct. Prilosec OTC®

$4.00 off ONE
Metamucil® Product

$5.00 off ONE
Olay® Professional Pro-X Product

$1.00 off ONE
Head & Shoulders Product

$7.00 off ONE
Crest® 3D Whitestrips Professional Effects

$10.00 off ONE
Braun Electric Shaver or Epilator (excluding MobileShave)

$1.00 off ONE
Bounty® 6-roll ct. Towels or Larger OR Two — Towels or Napkins ANY SIZE

$5.00 off ONE
PUR® Pitcher or Faucet Mount System

$1.00 off ONE
Charmin® Freshmates® Product

$1.00 off ONE
Oral-B® Pulsar, CrossAction, Advantage, or TWO Indicator or Cavity Defense

$1.00 off ONE
Charmin® Product

Buy ONE
Gillette® Deodorant, Get ONE Gillette Body Wash (Up to $4.29)

Surprising HIPAA Violation

The Health Information Portability Act (HIPAA) has criteria about not violating patient privacy, and potential harsh penalties for doing so. One needs to not only avoid saying a patient’s name to the public (meaning people not involved in the patient’s care), but not even to provide enough identifying information to allow someone to identify a patient. If you say you saw a 45-year-old male architect for diabetes, and there aren’t that many architects in town, you’ve probably supplied enough information for someone to figure out who you’re talking about.

I’m usually pretty conscious of it, and some of my colleagues are used to me ‘coughing’ “HIPAA” when they say a patient’s name aloud. One day, however, while eating lunch with my colleagues, I told the story of an 80+ man who came in complaining of a large bruise on his leg that he sustained after a fall when he tripped while running backwards. One of my colleagues said, “Was that Bob Smith*?”

“How did you know?” I asked.

“We go on the ski bus together and after he gets off he always runs backwards around the bus!”

*Not his real name, and yes, I got his permission to post this story.

Practicing Medicine Without a License

Not infrequently, patients question me about a medication because they’ve heard it’s unsafe. Often it’s from lawyers advertising the dangers of a particular medication or medical product. Although on occasion this may be a good service, most of the time it’s not.

All medications have both benefits and risks, and just because there is a potential problem, doesn’t mean it’s not worth the risk, and it doesn’t mean that alternatives are any safer.

Lately I’ve had patient’s refuse to take Actos for fear of bladder cancer. I don’t see lawyers advertizing about sulfonylureas, probably because they are generic, but they are more likely to cause hypoglycemia, which is much more common than bladder cancer, and may be more serious.

Maybe we need lawyers to go after the lawyers. “Did you suffer any problems after stopping a medicine because you read that it’s dangerous?” Sure, they’ll claim first amendment rights, but maybe they could charge them with practicing medicine without a license.

Epic Customizations

Epic is the electronic medical record (EMR) I use at work (actually my company calls it MultiCare Connect). There are a number of customizations one can do to increase efficiency, and I’ve done a lot. Keep reading to learn just how much.

There are SmartPhrases. These are shortcuts to write out text. Instead of writing “past medical history” one can write “.pmh” and it will automatically enter the three words. A SmartPhrase can contain other SmartPhrases enabling one to generate the shell of a note with a few key strokes, then just fill in the portions that cannot be automatically added.

There are SmartLists. This allows one to basically use a drop down box to select one or more options. Although I have 55 of them, each one consists of multiple entries. For example, if I want to enter the specialists a patient sees, I may select the cardiology and gastroenterology SmartLists, then select the physician the patient sees from each list.

There are a number of different Preference Lists. This is typically used to order various things and save them in the way you want, to save time later. In my Medication Preference List, for example, for an antibiotic it may say to take the medication twice a day until finished and include the proper amount of pills. In the description I write that it’s an antibiotic so my patients know what the medicine is for, and to lessen the chances the pharmacist may misread it. I also include an end date so the medication won’t show up on the patient’s medication list after they have finished taking them. It’s a bit of work, but once saved, it’s very quick to use in the future.

SmartText is kind of a SmartPhrase tied to certain situations. I’ve probably written more than one, but there is no easy way for me to look up which ones I’ve created.

SmartSets allows one to set up templates to do such things as place multiple orders and associate them with diagnoses and notes, and basically speed up various paperwork we have to do. Unfortunately a few years ago Epic made it much more difficult to write or edit SmartSets, so I’ve pretty much stopped working on them.

Letter Templates are just like they sound. I have one to tell women their PAP smear was normal, one to ask their employer to excuse them from work, one asking for a patient to be excused from jury duty due to their medical condition, etc. Unfortunately, as with the SmartSets, it’s no longer easy to write new ones or modify my existing ones.

For the medication dictionary, not only can I add words, but I can set it to auto correct words. If I type “referal”, for example, it will automatically change it to “referral”.

I use Dragon NaturallySpeaking to dictate parts of my notes, but I go beyond with custom scripts. For example, if I say, “order anemia panel” it will enter the proper codes for a CBC, iron/TIBC, ferritin and vitamin B12.

I’m constantly updating, but as of last week, these are the customizations I’ve done in each category.

Tool Number
SmartPhrase 1203
SmartText 1
SmartSet 28
Letter Template 16
Dictionary 5861
Preference Lists
Charges 4
EKG 3
Office Visits 1
Education 3
Immunizations/Injections 13
Labs 335
Imaging 170
Medications 3594
Orders 3
Procedures 41
Referrals 278
Supplies 2
Dragon Scripts 302
Total 11914

Each of the 11,914 items is a customization. It may be as simple as a word added to the dictionary, or represents paragraphs of text, a list of hundreds of items, or dozens of lines of computer code. Having been on Epic since 1998, that means I’ve averaged about a 1000 customizations a year.

All these customizations makes Epic very powerful, but unfortunately it was not designed well to share. Many of the items, such as Preference Lists, can be shared, but only by individuals importing someone’s list. If someone imports my Medication Preference List, it goes out of date as soon as I make a change. My list is so long it may take 5 minutes or so to import the list, and even if faster, most people are not going to remember to import the list regularly. It’s like backing up one’s computer. If not set to do so automatically, most people won’t do it. In addition when one imports someone’s list, it doesn’t show where it came from. I think it would be far better if people could subscribe to preference lists similarly to how one follows people on Facebook or Twitter. My medication preference list was designed for internists seeing adult patients. A family practitioner should be able to subscribe my list, to use on their adult patients, and another list to cover their pediatric patients. It is difficult to share customizations within my own company, and far harder still to share with people in other medical groups. Consequently thousands of people have to reinvent the Epic wheel.

Viewing Doctor’s Notes

Should patients be allowed to see doctor’s notes? Legally they can, but that doesn’t necessarily mean it’s a good idea. Patients would like to, but physicians are not so sure. People make strong arguments, but I think it’s really nuanced.

Physicians often write down the differential diagnoses. Say you’ve lost a little weight without trying. It could be a lot of things such as stress, cancer, an overactive thyroid, an ulcer, HIV AIDS, tuberculosis or a thousand other things. After asking a number of questions and doing an exam, I may decide that it’s unlikely that there’s any serious medical problem going on and prescribe a medication for depression. When I see you back in a month I’ll order additional tests if you have not responded as expected, and particularly if you’re still losing weight. But in my first note, I would have likely at least mentioned some of the diagnostic possibilities, and probably using medical terminology such as malignancy. I write these for a number of reasons. Mostly it makes for good care. Just in case it turns out to not be depression, when I look back at my prior note it will remind me of some of the concerns I had. It also provides a road map of what I was thinking if the patient has to see another physician, whether it’s because I’m on vacation, they have to go to the emergency room or see another physician. The note is also necessary due to malpractice concerns. Doctors are usually not expected to know the future, but the legal assumption is that if you didn’t write it down, it didn’t happen. If you don’t show that you considered the possibility of a serious condition, the presumption is it didn’t cross your mind.

Psychiatrists are allowed to protect their notes. Is that because their patients are too unstable to see their notes? Is it because the psychiatrist needs to record things that a patient may misinterpret? During the course of treatment they might have some insight about a patient’s problems, but not know whether their guess is right. By recording their thoughts they can later go back and review them, improve their diagnosis and treatment, and better help the patient. Well the majority of psychiatric care in the United States is actually provided by primary care physicians. There are not enough psychiatrists to treat all the cases of depression and anxiety. But primary care physicians notes are not similarly protected.

One measure of the benefit of a treatment is the number needed to treat. For example, one may need to treat 20 patients with a cholesterol medication for a year for every heart attack prevented. Conversely is the number needed to harm. Depending on age, it’s estimated that for about every 1500 abdominal CT scans, one person will get cancer as a result of the radiation. A good clinician will be correct the majority of time. How many patients will be harmed by reading chart notes (needless worry, additional tests that have their own risks and costs ordered because of that fear, physicians not recording important information for fear of it being read by a patient) for every patient that benefits?

I’m not embarrassed by what I write in a patient’s chart, but patients might be if they read it. Imagine a man asks a family member to review his medical records to see if they think he has been getting good care, given his recent heart attack. He probably forgot that a few years ago he spoke with me about sexual problems he was having.

The system I suggest would be a juried one. Patients could request their records, and in most cases the physicians would grant access to most or all of the record. If there was parts they did not want to show, they could explain why to the patient. If the patient did not accept the answer, they could appeal to a third party health advocate who would then decide whether it should be released or not. This would only apply to patients who are not bringing legal action. I think this approach would make physicians a little more comfortable, and lead to better patient care.

Obamacare and the Supreme Court

This week the Supreme Court agreed to hear a legal challenge to the healthcare reform law, colloquially known as ‘Obamacare”. They have scheduled 5 1/2 hours for oral arguments, dividing the law into four parts, that they will hold over two days. According to a number of articles, this is pretty much unprecedented in modern history. Since 1970 the typical case is allotted one hour for oral arguments, with 30 minutes for each side.

I’m not a lawyer, but I was astounded by these numbers. I realize that the Supreme Court justices spend a lot of time reading written briefs, and probably have internal discussions, but only spending an hour listening to arguments for an issue that has hit the highest court of the nation does not sound like much time to me. If I have a complicated patient in my office, it’s not so unusual that I end up spending an hour on them, and unless they are going on Hospice, they always get a follow-up visit. The Supreme Court gets about 10,000 petitions a year, and only rules on a small fraction of them. Before it gets to that level, many lawyers and judges have already debated the issues, and if the answer was obvious, it would probably have been settled. It seems stingy to me to only giving one hour for oral arguments for cases at that level.

Even 5 1/2 hours doesn’t sound like much. The 12 members of the debt reduction super committee couldn’t come to an agreement on debt reduction after working on the issue for more than 3 months. That’s far more time than the Supreme Court will spend working on the health care law, and I’m not sure that it’s that much less complex than dealing with debt reduction. Of course the justices have the great advantage of not having to worry about getting re-elected.

Medicaid Documentation Nightmare

Washington State Medicaid has new requirements for ordering imaging tests. I ordered a dobutamine Cardiolite stress test for one of my patients. The coder in my office brought me the Cardiac Imaging Questionnaire – CarePlanner/iEX form. It had 41 questions which she gave to me because she can’t tell from the chart how to fill it out! As it turned out I didn’t have to answer all the questions, but it still took a while to figure out what questions I needed to answer and look up the information in the chart.

Physicians usually lose money when seeing patients on Medicaid since the reimbursement is less than the cost. Add in ridiculous paperwork burdens, and they may find that primary care doctors start referring their patients to specialists rather than do the test themselves. Then the Washington State Department of Social and Health Services (DSHS) can pay for the cardiology consult instead, to be followed by the test I wanted to do in the first place, or a more costly cardiac catheterization. If I think a patient needs a test, it’s pretty rare when the specialist does not agree that the patient needs that, or a more expensive test, done. Making it more cumbersome for primary care physicians will likely ultimately raise costs, not decrease them.

Let the Sunshine In, Let the Sunshine In

A GlaxoSmithKline representative came by to drop off samples in my office and asked if there was anything else they could do for us. GSK makes some inhalers so I asked if they could supply spacers to give to patients, something they used to do. Spacers come in different designs, but basically it’s a plastic tube that fits between an inhaler, such as albuterol, and the mouth. The extra distance causes the medication particles to get smaller, so they deposit deeper in the lungs. The spacers are relatively inexpensive, probably less than the cost of the inhaler for a week, and can last years, but because insurance companies usually don’t cover them, patient’s usually don’t get them. Handing one out in the physician office is a good way to get patients to use one, plus the proper use can be demonstrated in the office.

The representative said that his company was not giving the spacers, and in light of the Physician Payment Sunshine Act, doubted they would. This proposed regulation of the Centers for Medicare and Medicaid Services (CMS), part of Section 6002 of the Affordable Care Act, stipulates that, effective 3/1/12, that pharmaceutical companies report payments to physicians over $10. It makes no difference whether the spacers are for the physician, or their patients.

The purpose of the Physician Payment Sunshine Act is to discourage physicians from making prescription decisions based on financial inducements. Just to be clear, pharmaceutical companies don’t just give physicians cash to prescribe their medications, which would clearly be immoral, if not illegal, but can give other incentives in the form of meals, books, speaking fees, etc. In this case, however, the reporting requirements are not consistent and don’t make sense. They don’t have to report leaving samples of their inhaler, which costs far more than a spacer, but they would have to report the spacer, even though it could be used with inhalers made by other manufacturers. Although in balance I like having samples, they tend to encourage one to prescribe them since we don’t have generic samples. I think insurance companies would save money providing free generic samples, but that’s another story.

The bill was introduced by senators Charles Grassley, R-Iowa, and Herb Kohl, D-Wisconsin. As recently reported by 60 Minutes, congressmen can legally trade on insider information, so this law was hypocritical (in fact I see that only 25% of the Sunshine Act sponsors senators are sponsoring the Stop Trading on Congressional Knowledge Act  S.1871 or S.1903 bills) . But as physicians we are ‘Hippocratical‘ and hold ourselves to a higher standard. That said, I think there are many instances where it’s legitimate for physicians to accept items of value from pharmaceutical companies.

The science of medicine advances at a fast rate, and it’s difficult, if not impossible, to keep up to date. This is true for specialists, and even more so for primary care physicians. The majority of medications I prescribe every day were not available when I was a resident in training. One way I help stay up to date is to listen to pharmaceutical representatives, or physicians they bring in, while I eat a meal they provide. There is no quid pro quo agreement to prescribe their medications, and many a rep can attest that I frequently challenge what they say. But what they do get is some of my time and a chance to present information that ultimately may benefit my patients. True, there are other ways to get the information, but time is the problem. I have to eat, so that’s a good time to talk. Listening to top physicians they’ve flown in, and having the opportunity to ask questions, is very valuable. I also participate in research trials (needed to create new medications), and those fees will show up in the database. The act would not make such payments illegal, but the concern is that the public will not be able to put the numbers in context and it may incorrectly imply impropriety.

Physicians and other providers do need to be careful they are not unduly biased by pharmaceutical companies, and I have a lot of concerns about pricing manipulations of medical drugs, but when it comes to the Physician Payment Sunshine Act, I think it’s pointing a light at the wrong place, or at least with too broad a beam.