Wednesday, October 9, 2013

The humbug of Induction phase in Suboxone (Buprenorphine) Therapy

A shameful chapter of American medicine is the way the doctors authorized to prescribe Suboxone (buprenorphine)  have abused this privilege to financially exploit narcotic addicts. The latter are no match for the doctors. Not only because the balance is so much in favor of the doctor with the prescription pad in his hands, which the addict knows has the power to immediately end  withdrawal symptoms, but years of drug seeking life style leaves them emotionally and cognitively scarred, and they often feel like a thief, unworthy of asking anything of anybody. Finally when you are feeling physically sick from withdrawal you are incapable of negotiating with the doctor on his fees. 
Addicts are one group of patients whom the doctors should not charge more than what they charge their other patients for equivalent amounts of time.
It therefore comes as a surprise that while for their regular patients - who actually may require more medical skill, time, attention, and coordination with other medical personnel - doctors charge anywhere from 35 to 120 dollars, with Suboxone patients they want to charge 400 dollars for the first visit, and anywhere from 100 to 200 dollars for subsequent visits.
At least these were the rates when Suboxone first came to the market. The rates have gone down some since DEA now allows 100 instead of 30 Suboxone patients in one's practice, but, still,  most Suboxone-doctors nevertheless want at least 200 dollars for the first visit, and anywhere from 65 to 150 for return visits.
Also it is not uncommon for Suboxone-doctors to ask for additional monies besides what the insurance pays, which really is illegal.
Why they do it? And what has enabled them to indulge in this kind of highway robbery?
To prescribe Suboxone,  DEA requires special training - it can hardly be called special for it requires all of 8 hours of listening to lectures on a single day - and submission of the proof of having done so. DEA then issues a special unique identification number and voila the Suboxone doctor is born. Does that much of effort deserves charging 400 dollars to the patient and then hundreds more on subsequent visits?
Anyway, without this identification number, which is really the doctor's DEA number with letter X in front of it, the pharmacy does not honor the doctor's order for Suboxone.
It is this number which since only few doctors go through the special training empowers them to charge exorbitantly.
How difficult is that special training?
The training requires eight hours of passive listening to lectures in a one-day conference, delivered usually by two Suboxone specialists, majority of whom I have found to be just the kind who will gouge 400 dollars from some down-and-out kid who does not have a dime to his name, having blown all his money on drugs, and whose medical fees in all likelihood is being paid by a struggling spouse or a beleaguered parent.
Why more doctors don't take this training?
Because doctors like the rest of us are neophobic. If their practice is going good they don't want to get out of their comfort zone and acquire a new skill. But more so because of the prejudice we harbor towards drug addicts as trouble makers. And this contempt and fear of narcotic addicts has some merit. Addicts can be very difficult population to deal with when they are not as much interested in giving up their addiction but in procuring Suboxone to actually support their habit through selling it on the street and using the money to buy their drug of choice.
Yet charging these sick people - yes, some of whom who do indulge in crime, including prostitution, to support their habit, are often liars par excellence and on rare occasions can be hostile and outright assaultive to the doctor when he refuses to give them as much medications as they would like - such high medical fees is unethical.
Why did the DEA place this special training hurdle?
The need for special training to prescribe Suboxone arose because the way Methadone Clinics had degenerated into turning narcotic dependency - from the mildest to the severest - into a life long affair of going to those Clinics.  Anybody who came to them instead of being put on appropriate dose of Methadone which would have been equivalent to what they were abusing were actually put on way higher doses of Methadone than were necessary to prevent withdrawal and then instead of tapering down, believe it or not, the dosages were  ratcheted upwards to make their habit worse. This was the standard modus operandi of these Methadone Clinics and its logic was to make whoever came to the Clinic its permanent client. It may not be too out of the way to add here that many of the Pain Management Clinics also are nothing more than fronts to hook people on narcotics, spinal steroid shots, and other medical shenanigans for life.
So it was to prevent Suboxone treatment turning into another Methadone Clinic fiasco that the DEA, with good intentions, made it compulsory for doctors to get that 8-hour special training before they could prescribe Suboxone, and to restrict the doctor from not having more than 30 Suboxone patient at a time in his practice. The latter of course was placed there for the doctor to not give up his medical practice and become a Suboxone pill mill.
Alas DEA did not succeed! It may not be wrong to mention here that quite a few of these specially trained doctors are doing with Suboxone what the Methadone Clinic entrepreneurs did and still do. They often start patients on three Suboxone a day, 90 tablets at a time, and tell them that they should be at such a high dose for a whole year, before they will be ready for tapering, and thus hook them on Suboxone, which by the way is as addicting as any other opiate.
And finally, after this long introduction we come to the issue of the need for special induction phase in initiating Suboxone treatment.
Much of the mystique of prescribing Suboxone lies in its complex induction phase. Many doctors even after getting that special training and identification number will not take the first step of seeing opiate addicts because they find the induction phase of treatment too complex, confusing and impractical. They are too scared that they will mess up the treatment of the patient by not following the induction phase protocol and thus get in to trouble. And this reasoning is not entirely baseless. Not the fear that they will somehow harm the patient but that they will not be able to adhere to the protocol.
If one reads the drug company's information package insert, one is not supposed to just prescribe Suboxone and tell the patient to not take the first dose of it till the withdrawal symptoms become unbearable, but to have the patient come and sit in your office till you decide that  his withdrawal symptoms have become unbearable and then personally give him the first dose.
And there are further hurdles. The first dose is supposed to be not that of Suboxone - which is a combination of Buprenorphine and Naloxone - but of Subutex - which is Buprenorphine without Naloxone. The rationale is that Naloxone which is an opiate antagonist will worsen the opiate withdrawal. This is a bunch of nonsense. If you instruct the patient to not take the first dose of Suboxone till the withdrawal symptoms become unbearable the Naloxone in the Suboxone hardly has a worsening effect upon the withdrawal.
The guidelines also want the doctor to write the first prescription for just two or three Sabutex tablets and ask the patient to go and get them from the pharmacist. Then the doctor is supposed to assess him hourly or bihourly with a special rating scale called COWS - Clinical Opiate Withdrawal Scale - and only when the rating scale tells the doctor that the patient is in sufficient withdrawal the doctor is supposed to give him the first dose of Subutex. And then the patient is supposed to wait further for the doctor to keep doing the rating scale periodically and decide if he requires more than one Subutex tablet or not. And this assessment shenanigans is supposed to be carried on for the next few days.The guidelines require the patient to come multiple times in the first week for doctor to assess him daily with the rating scale to further fine tune what is the most appropriate dose of Subutex/Suboxone for him - one, two or three. And since it is illegal for the doctor to hold medication in the office that is prescribed for a specific patient, the latter is supposed to go every day to the pharmacist to get his daily supply of two or three Subutex.
 If one wants to avoid sending the patient to the drug store repeatedly, the guideline also gives the doctor the wonderful option to keep a supply of Subutex in the office. An option that given the penchant for American Justice to trap and turn one and all into the category of criminals to expand their business, can land the doctor, if he is not dotting every i and crossing every t in his bookkeeping, in serious trouble.
Does any doctor really follows these guidelines or more importantly is it really possible to follow all these commands in private practice? Are drug addicts capable of complying with this kind of quackery? Do they have the money, resources, gas in their car, if they have a car to begin with, to go daily to the pharmacy and get a fresh round of Subutex? Does their insurance - most of them have Medicaid or are uninsured - covers these Subutex prescriptions? Is it really practical for withdrawing opiate addicts to sit in your waiting room with your regular patients for hours at a stretch without scaring them? Does the mumbo-jumbo of COWS, for that matter any rating scale, really superior to clinical assessment of the patient through observation and common sense questioning by the doctor? Is any drug addict really capable of  coming to your office, get the prescription of Sabutex, take it to the pharmacy, wait there for it to be filled, return to your office, sit there for hours for assessments and then go home, only to repeat the routine the next day? And finally after giving the first dose of Sabutex and making the patient sit in your waiting room and periodically assessing him really tells you much whether the patient requires one, two, or three Suboxone a day?
The answer to all the above questions is a resounding no.
No doctor really follows these guidelines? They do some half-ass going through the motions of them, enough to convince themselves that their charging 400 dollars for the first visit is justified.
Yet these top-down guidelines exist, and turn away many doctors from treating narcotic addiction which has become such a large problem across the nation.
I have been prescribing Suboxone for eight years and must have treated hundreds of narcotic addicts with good results and without practicing any of these complicated rules of Induction Phase of therapy.
All I do is to make a careful clinical assessment of how much opiate the patient was abusing, how severe is his withdrawal, how honest and sincere he is in giving up his habit, and if he is not there to get some Suboxone as a temporary fix because he has run out of money and wants to stave off the withdrawal till he can go back to his drug of choice.
The first visit lasts for 45 minutes if he pays me 110 dollars, or for 30 minutes if he can afford no more than 70 dollars. And through this assessment, which is not corrupted with stupid rating scales - which are made for subnormal doctors who cannot think of medicine in qualitative terms but must turn everything into numbers - I can almost always make out whether the patient requires one, one and one-and-a-half, or two 8-mg. Suboxone tablets a day. Almost 90 percent of the patients fall in to these three categories. Very rare ones require three tablets a day. Patients who are switching from Methadone to Suboxone almost always require three tablets - incidentally of Subutex instead of Suboxone - because they have a very bumpy withdrawal.
I give the patients 7 or 11 or 14, and for very few 21 tablets, for the first week and ask them to come back when that period elapses. I emphasize to them to not take their first dose of Suboxone till their withdrawal becomes unbearable. Most of the patients are not Suboxone naïve, having already taken  Suboxone here and there, obtained from friends or bought on the street, and they know very well how not to take it till the withdrawal symptoms are intense. Their knowledge of their withdrawal symptoms is first hand and much superior to any assessment done by the doctor directly or through his rating scale.
In a week when they return, I reassess their Suboxone need and titrate the dosage up or down. It is rarely that I have to titrate upwards. In my practice there is always a constant pressure to keep ratcheting down the Suboxone, for it is as addicting as any other opiate.
I have never had any failure with this simple approach. It is also not a huge deal if some patient was given 14 tablets for first week when 11 or 7 would have sufficed. Also it is a rare patient who has gotten 7 tablets when 11 or 14 would have been more appropriate. And such a patient always has the option to come a couple of days earlier if he runs out of his Suboxone before the 7 days.
Why if initiation of treatment with Suboxone is so simple have the DEA, the doctors, and other interested parties have made it into such a rocket science?
Because there is always a tendency in humans to make their profession look more complicated - which justifies them charging more money and makes them feel more important than they are - than it is. Also it increases the scope of employment. There is a huge industry to treat narcotic addiction. The government regulators if they can make medical business more complicated and time consuming then their power increases and their department size increases.
Finally this kind of bullshit masquerading as evidence-based science is a significant component of  medicine. The art or science or quackery of medicine is heavily laced with many such useless protocols and  unnecessary regulations. The reason for this is because the payment for much of medical activity is made by third parties. So there is a built in mechanism to make medical treatment as dilatory and nonsensical as one can get away with. When one analyzes these protocols carefully most of the steps present there are useless, if not outright counterproductive, often harming than helping patients.
I remember in 1976, when I started my residency in psychiatry to admit a mental patient through ER would take all of 30 minutes. There was no money in keeping them in the ER. Now on average it takes 17 hours. For everybody and his mother, aunt, and brother are having a go at the patient in the ER in the name of triage and multi-disciplinary approach.  Are these multiple assessments by the clerk, nurse, social worker, ER doctor in the ER have any real meaning in improving patient's psychiatric condition. All they achieve is to exhaust the patient, and his relatives who have to sit through this period of ordeal in the waiting area, without doing any good to him.  But all this has become necessary to generate a stackful of medical notes so they can bill thousands of dollars to the government and private insurances and have documentation to prove it.

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