FDA and Generic OxyContin

As recently reported in the Wall Street Journal, the pain killer OxyContin is set to go generic next year, and Purdue Pharma is trying to postpone it.

A funny thing often happens before a drug goes generic. Close to that time the manufacturer comes up with a new indication, formulation or dose. They claim it’s an improvement in the product, but it often has the appearance of coincidentally coming out close to when they would lose exclusive rights to sell the product. And wonder of wonders, they often get the market to themselves for a longer period of time because of it.

As someone who treats a lot of patients with pain, from my perspective OxyContin is a fairly good drug. Because it’s timed release oxycodone, it often gives better pain control, has a lot of dosing flexibility, and probably has less potential of causing addiction than immediate release oxycodone. Less is not none, however, and it’s still a frequently abused drug, whether swallowing the pills, or more illicitly, snorting or injecting it.

OxyContin has a new formulation containing polyethylene oxide that makes it harder to crush or inject. Although it’s not yet clear how effective it will be, the street price has decreased, suggesting it is a less desirable drug for someone wanting to get high. So Purdue Pharma is arguing that no one should be allowed to sell timed release oxycodone that does not have the protection they have, which of course is itself patented until 2025. Purdue Pharma is being sued for allegedly previoulsy making false claims to doctors, minimizing the risk of addiction. That has bearing on their new claim that it’s the new and improved version that has the low risk.

Besides that the improved safety is still not certain, their logic is false. From the perspective of controlling drug abuse, supply will meet demand. People will find better ways to process the new OxyContin pills to make them easier to abuse, or they will use substitutes.

From the perspective of a clinician treating pain patients, the cost of the pills and insurance formularies often dictate what doctors can prescribe. I often don’t prescribe OxyContin now, even when I want to, because of this, and have to prescribe controlled release morphine (which used to be sold as the brand MS Contin), methadone, which is a tricky drug to prescribe with a higher risk of accidental overdose, or use other alternatives.

I hope the FDA does not accept Purdue Pharma’s argument. They should either allow generic OxyContin, with or without the polyethylene oxide contained in the new pills, or allow generic manufacturers to use other similar methods of deterrence.

Cruise Health

As I wrote about last time, I attended the ACP Internal Medicine 2012 meeting in New Orleans. Afterwards my wife and I took a cruise on the Carnival Conquest ship that left from New Orleans and stopped at the ports of Cozumel, Jamaica and Grand Caymen.

On the first day of the cruise there is a mandatory safety briefing on deck where they discuss such things as how to board the lifeboats in the event of an emergency. The announcer appropriately discussed the importance of washing hands, but incorrectly said, “the hotter the better.” When it comes to washing your hands, cold water works as well as hot water, except that if it’s cold, people won’t wash their hands as long because it’s uncomfortable. The same is true if the water is too hot. Thus warm water is recommended.

We took an excursion to see the Mayan ruins of Tulum near Cozumel, Mexico. Before leaving the ship we were warned not drink the local water. Near the ruins in a tourist shopping center I was tempted to eat at a Häagen-Dazs ice cream stand. I figured the ice cream was safe, but I worried about the water used to clean the scoops. It was probably safe, but I didn’t want to take a chance.

Obesity is a common problem in the United States and elsewhere, and is particularly a problem in the South. This was reflected in the passengers having embarked in New Orleans. Although people understandably eat excessively on a cruise, to which I’ll take the 5th Amendment, there are opportunities to do some healthy things on a cruise. I took advantage of their gym and exercised every day, though few did. Most of the time half the people exercising were crew members.

While looking for something else, I happened to walk by an ongoing talk on Secrets To A Flatter Stomach. I sat down and listened. The speaker was a personal trainer, certified by the Australian Institute of Fitness. He was buff, which automatically makes one feel he knows what he’s talking about. In fact his advice on exercise and nutrition was sound, and he did a great job explaining things. He then talked about detox and the need to get rid of toxic water trapped around fat. They invited people to sign up for a 1 hour personal analysis and consultation at a 2 for 1 special of $35. I spoke with the speaker’s colleague, a man from Scotland, and also buff. I asked if they would be repeating the lecture as I thought my wife would enjoy hearing it. He said he would cover the same material at the consultation, and more, and do an analysis with equipment not available in the United States (this model is available in the US and seems close to the 310e V8.0 they used). I was skeptical about the detox, but the cost was pretty low so I signed up.

At our meeting he first had us fill out questionnaires about our health, including what medications we were taking and why. I purposely didn’t answer the question about occupation, but admitted I was a physician when he later asked. He then went on to tell me he had a BSC degree in Sports Science from the University of West of Scotland, which he said was about equivalent to a physician in the United States. It’s not. He ran a bio-electrical impedance test attaching an electrode to the ankle and wrist. Running a very low voltage and current, that you cannot feel, through the body, it calculates body fat, lean body weight, body water and metabolic rate. The calculations require the body weight, which he asked about, but did not measure (towards the end of a cruise the actual weight is likely to be significantly higher than the stated weight!). Although the equipment he used may not be available in the US, it’s similar to the Tanita bathroom scale I have at home. My device calculates body fat, though you have to do your own calculations to derive the other numbers, and the results he obtained were very similar to my results at home.

He said I needed to lose 6.1 lbs of fat, and admitted I was among the healthiest he had tested on the cruise, but that I also had  12.5 lbs of toxic water to remove. According to his handout, that put me in the level of, “High levels of accumulative toxic waste circulating the cells of the body. Damage to Liver and Kidneys apparent. Weight gain is inevitable. Degeneration of joints and muscle tissue. High Blood Pressure / High cholesterol.” He recommended a 3 month detox program for $300. Most people, “needed” a 6 month program, which consisted of two 3 month cycles, and some needed a year’s worth. They would then do a 3 month cycle every few years or so depending, less often if following a healthy diet. My credit card would be charged that day, and the product shipped the next, so we could get started on it as soon as we returned home. The products are supposed to cleans the digestive tract, kidneys and liver. They contain various herbal products, algae, plantain seeds for fiber, and a low dose thyroid product of some sort, and one is also supposed to eat alkaline forming foods. I was naturally skeptical. He claimed that his analysis showed that I needed detoxification because I had problems with my cholesterol. He said that with his device he didn’t need to do blood tests. How did he know about my cholesterol problem? Because I told him! Actually it’s not that much of a problem, but I try to be proactive.

He said that evening there would be a nutrition class, but only for those who signed up. He encouraged me to sign up for the detox, but said he wasn’t worried because they get 60 people per week to sign up. While we were talking he was interrupted by someone asking if a person could be signed up for a consultation, even though his schedule was full.  He said he would let us think about it while he took care of something. The class was later held in the gym in a glass walled off section. I counted 19 attendees. To show the legitimacy of the program, he said his company contracts with Carnival and other cruise lines to offer the program, and has been in business for years. I asked for clinical study references to support detoxification. He said he could give it to me, but not until after I signed up. I declined.

If you take a cruise, try to get in some exercise, if nothing more than some extra walking. I advise you to save your money and not spend it on a detox program, and don’t forget your sunscreen.

Drug Shortages and the Joint Commission Stance

Periodically there have been drug shortages in the United States, which comes as a surprise to many. There are a number of reasons for this.

Recently one of my company’s pharmacists informed the physicians in my group of a nationwide shortage of bupivicaine and lidocaine, medications used for anesthesia, similar to what your dentist may give you before drilling your tooth.

I suggested that maybe we should be allowed to use such products past the expiration date until the shortage was resolved. They replied that they can’t do that because of Joint Commission standards.

So I wrote to the Joint Commission and eventually spoke with a nurse there. Their position was that it’s not safe to use a drug past its expiration date and they were just following guidelines by the Food and Drug Administration and others. I said that although I would generally agree that it is preferable not to use expired medications, in the case of shortages that may not be the case.

Imagine you have a life threatening infection with a bacterial organism resistant to all antibiotics but one, and there is a shortage of that antibiotic. In fact the hospital you are in has a box of antibiotics that expires at midnight tonight. They can give you only one dose then will have to throw away the rest, even though antibiotics would normally be given for 10 days and they don’t know when they will be able to get more.

Are you really safer as a result of throwing away the rest of the vials of the only antibiotic to treat your infection? In the interest of fair and balanced discussion I admit that I’ve eaten tuna fish after the date stamped on the can. But seriously, the risk of a complication from a slightly outdated medication is almost non-existent, and certainly less than the risk of going without.

Physicians going on medical missions to third world countries used to bring with them expired medications to administer to patients, the thought being that they were safe and better than nothing. Due to liability concerns, that pretty much doesn’t happen anymore, a fact said Joint Commission nurse brought up. In fact a 1997 article in the New England Journal of Medicine pointed out that at least half of the drugs donated to the Bosnian conflict were unusable because they had expired, and said pharmaceutical companies may have dumped the medications to get tax write offs and avoid disposal costs. That may have been the case, and could be addressed by not granting write offs for expired drugs, but that doesn’t mean they couldn’t have safely used the medications.

A 1979 law required pharmaceutical companies to give a date they guarantee the full potency and safety of a drug. They stand to gain financially when customers throw away good medicine because it has, “expired”. In fact the military conducted a study to see if they could extend how long they keep medications in order to cut back on the cost of destroying and replacing a billion dollars of inventory every 2-3 years. They found that 90% of the more than 100 drugs they tested were safe and effective up to 15 years after the expiration date. This program is now used by the Department of Defense, the Department of Veteran Affairs, the US Postal Service and the Bureau of Federal Prisons.

The nurse at the Joint Commission pointed out that I could decide whether the risk was warranted to use an expired drug. But in reality, I don’t get the chance to even discuss it with a patient to give them a choice. Hospitals risk a large financial penalty, and potentially even being shut down, for violating Joint Commission standards. Those drugs are going to go in the trash the day before they expire, shortage or no shortage.

I think the Joint Commission should modify their standards. At the least it should say that drugs should not be used after the expiration date unless their are shortages, or delivery problems due to disaster, in which case the medications should only be used if there are not suitable alternatives, and it’s felt that the benefits exceed the risks.

Waiting Times and the Misery Index

Last month the Wall Street Journal ran an article, called the Wait-Time-Misery Index, about how frustrated people get waiting for deliveries or service repairs at home. Like when you need the cable company to come out and they say they will be there between 9:00 am and 1:00 pm. You have errands to run but your stuck. Companies such as General Electric and Verizon have been working to get the time windows from 4 hours down to 2 hours.

I understand the frustration, but when it comes to timely delivery (no puns about obstetrics here), doctors are held to a much higher standard. Patients often get upset or walkout if I’m an hour late, and sometime even if it’s only 15 minutes. The companies have difficulty delivering in a short time window because there are so many variables that they can’t always predict. They may get tied up in traffic, be delayed by weather, or a 30 minute service call turns in to a 2 hour one. But just like the companies, doctors have similar issues. A patient scheduled for a 15 minute appointment may have an hour’s worth of problems, and rescheduling isn’t an option. Or we may get unscheduled calls when a patient of ours shows up in the emergency room, or maybe a lab test comes back that demands our immediate attention. Just maybe the doctor themselves are slower than usual because they have a cold or were awakened 3 times the night before while on call.

I sympathize with patients frustration when I run late, and get frustrated myself because it means longer hours for me too, but I assure you that if I’m running late, it’s not because I’ve been playing golf.

Limiting Medication, But Not Really

Once again, CVS Caremark wasted my time. On 1/27/12 they sent me a copy of a letter they sent my patient saying they only provided a limited supply of tramadol to my patient because it’s subject to plan quantity limits. The directions I wrote said that she could take up to 8 pills per day. I only wrote for 60 pills, though, so I didn’t understand why the letter.

It took me about 10 minutes, but a customer representative said I could have ordered 240 pills at a time and it should have gone through. He didn’t know why the letter went out. I pointed out that besides the fact that his company wasted paper and postage mailing out the letters, it probably caused my patient to be concerned, and it wasted my time. He apologized and said the coverage should not be a problem. I said that surely this wasn’t the only mistaken letter they’ve sent out and said he should pass this on to his supervisor.

Mistakes happen, but the answer should not be, as Gilda Radner said, “Never mind!” Instead organizations should apologize and try to figure out why it happened, and what can be done to prevent it from happening in the future. When a pharmacy benefit manager, such as CVS Caremark, does otherwise, the message is they don’t care if they waste doctor’s time.

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)

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?

How Primary Care Docs Became Assistant Shoe Salesmen

Nurse practitioners, physician assistants, pharmacists and naturopaths have gained the right to prescribe medications traditionally only done by a physician. But the Medicare Therapeutic Shoe Bill requires that the physician managing the diabetic condition certify the need for footwear and inserts.

So although the podiatrist truly has the expertise in this arena, it falls on the patient’s primary care physician or endocrinologist to do the paperwork. Congress might have been concerned that because podiatrists profit from selling inserts or shoes, that someone else should determine whether it’s really needed. In fact, though, us primary care docs are overworked and don’t have much time to deal with such paperwork. If we deny that the patient needs it, especially after their podiatrist already told them they do, the patients get mad at us.

I think the best way to minimize fraud would be to have patients pay a portion of the cost, say 25%. That way they are less likely to get a shoe or insert unless they feel they really need it. Actually Medicare pays 80% of the allowable amount so patients pay up to 20% if they don’t have secondary insurance. Since most patients are going to buy a pair of shoes in any case, I think they should pay what a similar non-medical shoe would cost, and Medicare would pick up the difference. That way there would be no financial incentive for patients to get shoes they don’t really need, and doctors could stop being the watchdog.

At the very least, Congress should allow nurse practitioners and physician assistants to do the paperwork.

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.

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