Wednesday, July 8, 2009

State drug laws that impede the lives of the most needy

I'm only going into Schedule II drugs here even though I think everything in the DEA schedules should be reviewed. The reason for the focus is that a great number of people for what the government has classified as, "legitimate medical reasons," regularly take Schedule II drugs. Like multiple times a day, for years and even lifetimes and generally so that they can function within society. Ergo, excessive restrictions on the ability of individuals to get these drugs that they need run counter to their purpose and much more likely to put an impossible strain on these people than on others who need drugs that are less interesting to the feds.

As a bit of background: the DEA has broken what it considers to be "dangerous" drugs into 5 categories. Schedule I drugs are the worst and Schedule 5 drugs are the least bad of of the bunch. Like Robitussin falls in 5 and Ecstasy falls in 1. My use of "dangerous" in quotes and "bad" were intentionally demeaning as the standards used by the DEA are at best, random. The issue isn't whether you're going to die from ingesting the substance (in which case, rat poison, for example, should be on here) but rather whether it's addictive and then as a mitigating factor, whether it has any "accepted" (also a defined term) medical use. Such that things that are extremely similar end up in different categories. That's a huge 30K miles above view, but it will do for now.

To give you a sense of what we're working with on the federal level, you should know that Congress actually took the time to set out requirements for anti-drug ads to be placed on NASA websites. I kid you not:
"Anti-drug Message on Internet Sites
Pub. L. 106-391, title III, Sec. 320, Oct. 30, 2000, 114 Stat. 1597, provided that: "Not later than 90 days after the date of the enactment of this Act [Oct. 30, 2000], the Administrator [of the National Aeronautics and Space Administration], in consultation with the Director of the Office of National Drug Control Policy, shall place anti-drug messages on Internet sites controlled by the National Aeronautics and Space Administration.'' Your tax dollars at work.

So back to Schedule II drugs. These are the real bug-a-boo for both regulators and patients. Schedule II is basically made up of what would be Schedule I drugs but for the lack of a direct path to the Schedule I drugs (a bunch of the items in Schedule II are necessary precursors to creating Schedule I drugs but will not, in and of themselves, produce Schedule I effects) and that they have, at this point in time, an accepted medical use, however limited. For example, Cocaine and Coca leaves are on Schedule II because, despite what the media would have you believe, both have consistently throughout history had very important medical uses. Coca leaves, for example, are used the way Americans use coffee in many parts of the world and without any particularly interesting effect. Cocaine was regularly used until it, like most of the other drugs on this schedule, became the subject of some xenophobic crackdown and it became politically popular to put people in jail for using it. (see "Prohibition" in the link for the cocaine-specific story, although Marijuana ended up on Schedule I because of racism against non-Europeans as did Opium)

But other Schedule II drugs include amphetamines, drugs like Ritalin and Dexedrine and Adderall, which are used by adults and children with ADD/ADHD, fatigue disorders, and other illnesses whose symptoms can be improved through the addition of a stimulating medication. The latter category is vast, often including diseases whose definitions are constantly changing and that 10 years ago didn't even have a name, but also include certain degenerative diseases and even depression. Many people who take these medications are not taking them for a month, like as a dose of antibiotics, but often for an extremely long period of time. Moreover, the type of people who need these drugs are often less mobile, less able to communicate their needs and problems, less able to go through the hoops of doctor approval, followed by insurance approval, followed by the horror of trying to actually get your medications from a pharmacy, followed by figuring out why it's all costing you so much. They are some of our more vulnerable citizens.

As a corollary, Schedule II also contains some of the stronger painkillers available by prescription. These include OxyContin, Demerol and Percocet. Obviously, these are potentially dangerous and not to pop the DEA's bubble or anything, but I've had to bring several people through what would have been a lethal Robitussin overdose, so I'm not entirely clear on why there is a distinction here. In any case, people on these drugs are typically in very severe pain. The type of pain that makes life unbearable and even impossible. Other prescription painkillers are further down on the list (Vicodin, for example, is a Schedule III drug) and you can safely assume that if Vicodin addresses your issues, you have no idea what kind of pain the people who OxyContin is prescribed to are going through. Thus, they experience the same, if not to an even greater degree, problems that those on amphetamines face. Mainly that it is very difficult for them to jump through the hoops the federal government, insurance companies and doctors have created. And again, imagine your elderly grandmother with a broken hip and a bad back. You really don't want her having to jump through hoops.

So why am I so whiny about this? 21 USC 829 (regarding distribution of "controlled substances") provides with regards to Schedule II drugs that "Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act (21 U.S.C. 353(b)). Prescriptions shall be retained in conformity with the requirements of section 827 of this title. No prescription for a controlled substance in schedule II may be refilled."

Okay. So 1) you need a physical written prescription. It cannot be called in or faxed to the pharmacy or any of those permutations. So as someone in severe pain or suffering from any number of debilitating maladies actually has to go and pick it up and physically transport it to a pharmacy. And 2) no refills. So that's the real stinger. When you combine the two, it means that effectively, you have to go to your doctor's office every month and get a new prescription even if you're in a stable condition with regards to your malady and there's no need for you to see your doctor.

Luckily, I am not the only person who thought this was offensive and outrageous. To be honest, it's rather lucky that medications that people considered by society to be worthy of concern are actually being hurt by arcane, racist and illogical drug laws. There is at least a chance that the drug laws will be reformed.

The DEA first publicly responded to this issue in August 2004 by posting on its website under a frequently asked questions section stating that with regards to Schedule II pain medication, that doctors should issue multiple post-dated prescriptions during one visit to make the process less arduous. This was removed from the website in November 2004 and specifically interdicted as a practice. But, obviously, that didn't solve the problem.

So the DEA began, in a most un-DEA move, liberally interpreting the law. Basically, the DEA concluded that the reference to "refills" not being allowed didn't really mean "refills" in the traditional sense, like when it says you have X refills left on your prescription bottle. In fact, it never really explained what "refill" would mean that would distinguish it from what they've allowed as of the end of 2007. But I'm ahead of myself.

The DEA issued final rule-making in late 2007 providing that doctors could write sequential prescriptions during the course of a single visit with a patient and give these to the patient, and that in sum, the prescriptions would account for a 90-day supply of the medication. To be clear, you still can't fill them all at once. It's not a 90-day prescription. It's pretty much exactly what the FAQs section of the DEA website said you could do in August 2006 and then very forcefully said you couldn't a few months later.

What's really interesting about this particular story and why I wonder very much why it hasn't gotten much (if any) media play, is that it indicates that the radical insane period of the war on drugs may be coming to an end. I can absolutely positively understand the issues governmental leaders have with having Columbian or Mexican cartels creating horrible violence across the country. But to put those people in the same category as citizens who are going to their doctors to get prescriptions for medical conditions and then going to a pharmacy to fill them is absolutely cuckoo. What's a bit sad is that the lawmakers couldn't come to this rational conclusion on their own. They had to wait until a critical mass of citizenry came forward to express their distaste. Our lawmakers should do more than that. They should critically analyze laws and their laws should be cleanly targeted. And as a final point, it shouldn't be that you can only get these things fixed when people with diminished abilities due to illness are affected. This should apply to anyone and everyone who is a citizen. We all deserve to have not just a responsive government, but a proactive one.

More on the issue with divergent state laws later.

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