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)

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.

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.

Trouble Sleeping? – Is Intermezzo the Solution?

You may be feeling soporific after ingesting large quantities of tryptophan containing turkey, but the day before Thanksgiving, the Federal Drug Administration (FDA) announced the approval for zolpidem tartrate sublingual tablets, known as Intermezzo, by Transcept Pharmaceuticals Inc.

This is not a new molecule. It’s actually the same medication as Ambien, but it’s formulated to dissolve under the tongue, and the dose is lower. Ambien is dosed at 5 or 10 mg, but Intermezzo comes in 1.75 mg for women, and 3.5 mg for men. When Ambien is prescribed, it’s generally recommended that it only be taken if one can sleep for 8 hours afterwards, as otherwise one may still be sedated when driving, etc. Because the dose of  Intermezzo is lower, one only needs 4 hours. So if you wake up at 2 am and can’t get back to sleep, it might be a good option.

I have several concerns, however.

Because the name is completely different, there is some risk that patients might inadvertently take Intermezzo and Ambien thereby taking too much, though admittedly it would be at most only a 35% increase over the maximum dose.

My biggest problem with this is cost. Ambien was manufactured by Sanofi-Aventis, but went generic in April 2007 with multiple manufacturers, and is now pretty cheap. Around that time Sanofi-Aventis came out with Ambien CR, packaging zolpidem in a time release pill to make it last longer. It is probably a little better for some people, but I think it basically was a way to extend the patent. In addition, Sonata (zaleplon) works similar to Ambien, but it has a shorter half life. That means it gets out of your system faster. That’s bad if you take it at bed time and tend to awake in the middle of the night, but great if you only want to take it if you wake up in the middle of the night and get can’t back to sleep. That’s just like Intermezzo, only generic.

With Intermezzo you can pay more for less! This is not the first time pharmaceutical companies have done this. Recently Somaxon Pharmaceuticals came out with the sleep medication Silenor. This is doxepin in a 3 or 6 mg pill, and supposedly works better than the higher dose generic pills. At Drugstore.com, 10 mg doxepin costs $28.99 for 90 capsules (note you can’t just split them), or about $10 per month. Silenor is more than ten times the price for about half as much medication.

Transcept Pharmaceuticals, Inc. is also attempting to do the same thing with TO-2061, a low dose form of ondansetron (Zofran) for obsessive-compulsive disorder. Wouldn’t you know it, but ondansetron is generic now.

Penny Wise, Pound Foolish

A patient of mine has been on cyclobenzaprine, a muscle relaxer, intermittently for over a year. Now her insurance, a Humana, Medicare plan, said they will no longer cover it. I pointed out to them that the medication is generic and at Costco one could purchase 100 pills for $9.93 without insurance. That would be enough to last her over 3 months. The Costco price for tizanidine they suggested I switch her to costs even more. They told me to check their website for what they cover, which I did. It said cyclobenzaprine is covered, though on some of their plans it requires prior authorization, which is what I tried to obtain. Besides the risk of switching a medication to something new, Humana wasted the time of my nurse and I for what would be a minuscule, if any savings. They would not budge other than saying she had to first try and fail tizanidine.

I understand the need to control costs, but forcing doctors to change from one cheap medication to another cheap one is not the way to do it. It doesn’t save significant amount of money, and it frustrates their customers (the patients) and their physicians.

Insurance companies such as Humana place no value on physicians time. I hope other physicians join me contesting such things from time to time. Don’t just accept the first no. Make them deal with extra phone calls and faxes when they are unreasonable. If enough of us protested, I think we could force them to change their ways. Occupy Medical Insurance Companies Movement, anyone?

Free Speech and Off-Label Drug Use

When pharmaceutical representatives talk to physicians and others about their products, they are only allowed to talk about indications (reasons) to use the product as approved by the Food and Drug Administration. Doctors are free to prescribe for other reasons, and often do so for good reasons.  Drug companies may pay dearly if they break the rules. Pfizer paid 2.3 billion due to promoting Bextra for off-label use, for example.

This rule was put into effect decades ago to protect consumers. Since then there have been a number of examples of products promoted for things that in retrospect didn’t work as advertized. If you’re old enough, you’ve probably heard the term snake oil.

According to the Wall Street Journal there are now several court cases that may change these rules. In June the U.S. Supreme Court struck down a Vermont law and cited the First Amendment in a case involving pharmacies sharing data with pharmaceutical companies to help them market their drugs to doctors. That has opened the door for the companies to now claim the same free speech rights to market drugs off-label.

If the companies gain this ability, it would be bad for patients. Basically they could say whatever they want. Besides talking about off label use where there is legitimate reasons to use their product, they could claim anything they wanted to say. “Our drug is more effective than our competitor,” even if it’s not. “Our drug is perfectly safe,” even if it’s not. “Our drug will make you lose weight, increase your IQ, improve your looks, and make you live 10 years longer, “even if it won’t, but if you believe it, let me tell you about a bridge for sale.

I learn about a lot of new drugs because the sales reps come to my office to tell me about their product. As it is, I listen to them skeptically and off challenge what they say. Although they are restricted on what they can say, they can choose what information to emphasize and how to make their product look good without actually lying. If they can promote off label, I won’t know what to believe. Then my strategy might be to stop seeing reps.

Prior Authorization – License to Kill (our time)

A patient of mine informed me that her insurance didn’t want to cover a medication, and preferred a similar generic medication, which she previously tried but did not tolerate. She asked me to Call Humana’s  pharmacy review board. I usually leave such things to my nurse, but called them myself. A voice recognition system asked me for the patient’s account number and date of birth. After providing these, I was connected to a human, who asked for the same information. When I pointed out that I had just supplied the information, she said it didn’t come through, but made no offer to investigate why not.

If their menu system is not capable of transmitting such information to the computer screen of the people working for them, then they should not ask for the information using the automated system in the first place. This was not a onetime glitch, but something the nurses in my office encounter regularly. Our time is valuable. It’s bad enough that we have to justify our prescriptions, but it’s disrespectful of our time when we have to repeat ourselves with patient identification information. We have better things to do with our time.

Before deciding to post this, I decided to call again and give them a chance to say they would try and improve things. First I went to their website and clicked the For Providers link. I didn’t want to have to register, so I clicked the Customer Support button. Next I clicked the Contact Humana button. At the top it said they welcomed email, but one had to register to send messages securely. So I called their phone number for providers. Someone answered and wanted my patients ID number and date of birth. I informed I just had a question about the pre-authorization process, and not about a particular patient. She said that was another department and she transferred me, but not before asking for my name and call back number (I gave her my name, but told her I didn’t want a call back).

The next person again asked for my name and call back number. I explained my concern about being asked for the same patient information more than once. “That’s the process we’re required to follow,” she replied. I asked if they were interested in improving how they do things and she repeated what she had said. I asked if I could talk to someone who could improve the process. She told me they don’t have such a person!

I hope Humana and other pharmacy benefit managers take note. It may be your job to save your customers money, but you don’t have to waste physician’s and their office staff’s time. I hope the cynical view, that you do on it purpose to discourage prior authorizations, is not true.

Medication Errors

Not infrequently Express Scripts, Medco, or other similar companies send a fax to alert me that my patient is taking two similar medications. Occasionally it’s intentional, but most of the time it means something went wrong.

Sometimes I change a patients’ medication to something similar to achieve better efficacy, to minimize side effects, or due to cost. Although I always put the changes in writing for the patient, telling them what to start and what to stop, this doesn’t always work. Patients may get an automatic refill of the original medication from the pharmacy or call it in when they notice a pill bottle is almost empty. Sometimes they go by a medication list they’ve generated, but not updated, rather than the printout I give them.

Sometimes patients end up on two similar medications after getting one from a specialist who doesn’t realize a patient is taking something, because the patient didn’t bring the list I gave them, and they don’t remember everything they take. For example I might have the patient on lisinopril for hypertension, and their cardiologist prescribes the similar benazepril.

A similar medication error happens when we tell patients to stop a medication and they don’t for similar reasons as above.

So the faxes are helpful when these things are caught, but it would be better if it occurred at the the time the prescription is sent to the pharmacy.  Ideally the pharmacy computer would automatically connect to the physician’s electronic medical record (EMR), particularly the primary care doctor, and compare medication lists. If they had medications to refill that didn’t match the EMR record, they would call to double check if the patient could not give them a good reason for the discrepancy. In addition, the pharmacy computer could keep track of all the chronic medications a patient has filled. If the patient doesn’t get the prescription refilled in a timely manner, their computer would query the physician computer to make sure it was still an active medication. If so they would call the patient (and maybe in the future talk to the patient’s medication list carried on their computer/mobile device) and remind them to refill their medication, assuming someone hadn’t stopped it, the patient was taking samples, or some other good reason.

If you use a program such as Quicken, you can download credit card and other transactions and reconcile them with entries you’ve entered. Comparing medications would be a similar process.

There are certainly barriers to such a solution. Electronic health records would need to have medication fields standardized, and there would need to be protocols to exchange the information. I’m not sure, but I think some of this already exists. Of course there are legal issues such as HIPAA.

As John Lennon said, “You may say I’m a dreamer, but I’m not the only one. I hope someday you’ll join us, and the world will be as one.”

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