By Peter Cohron, BSPharm, JD
Recently, the Drug Enforcement Administration (DEA) has been flexing its muscle. A few months ago, this government agency shut down pharmacies in Florida belonging to two of the three Big Chains, as well as a distribution center, for filling questionable prescriptions. A few weeks prior to this writing, the same entity sent down new regulations for the faxing of controlled substance refill requests.
The admirable aim of these actions is to attack drug abuse in this country. A problem for decades, drug misuse and abuse is now so rampant that it has been labeled an epidemic by the CDC.
Some lawyers—armchair and real–would argue the DEA lacks the jurisdiction to take such actions like the faxing regulation, and even other steps. This argument, not without merit, states that such actions belong to the states under the Tenth Amendment, which reserves to the States those issues not specifically mentioned in the text of the Constitution (nothing in that text mentions health care, controlled substances or prescriptions). Thus, all issues with medical care, abuse and otherwise, belong under state control solely. Others argue the opposite. Where there is a legitimate public need that will bear strict scrutiny, the federal government may “occupy the field” for the benefit of the people.
This is a good argument. Differing statutes and regulations in different states have led to varying, arbitrary, and disproportionate enforcement of laws seeking to curb drug abuse. These differentiations led to the proliferation of pain pill mils in those states with weak laws or poor enforcement.
Prior to seeking to have a bigger say in drug abuse issues, the DEA was not idle. Yet, its part was subservient to state law and its enforcement only seemed to worsen as many situations as it helped. For example, the DEA ordered limits to the amounts of some (mainly hydrocodone-containing products) controlled substances once pharmacies dispensed a certain amount. While seeking to cut off pharmacies filling questionable prescriptions, the result was that legitimate patients also were being left without medication or being forced to change pharmacies. Congress responded with a letter to the DEA identifying a disturbing trend that was “threatening the ability of legitimate patients from getting needed, life-saving drugs.” The DEA responded by backing off this policy to a degree; problems still exist in this area, though.
So, currently the DEA is looking into “occupying the field” by addressing prescription drug abuse and rein in pain pill mills nationally, rather than see it done state by state, and avoid the problems such as limiting controlled substances where innocent patients would suffer.
Just where the DEA will go with all this is still unknown. However, health care professionals across the entire field should take note. The closings in Florida and the new controlled substance fax refill regulation should only be considered the first salvo. A recent article in FDLI’s Food and Drug Policy Forum indicates the DEA is seeking a bigger role in determining just what constitutes a suspicious drug order. Again, the basis for national intervention is the plethora of differing definitions from the fifty states.
The worrisome part of this muscle flexing is that health care professionals, already long under the microscope for controlled substance prescribing and dispensing, will only see more scrutiny upon them as prescribing and dispensing becomes more complicated as new regulations are enacted.
So, the question comes down to how best to stay informed on these issues, as state regulatory boards as well as the federal government are showing less patience and leniency with those who even err in honest attempts to enforce existing law.
Before I list suggested means for staying up to date, let’s make a strong point here. Knowing the law and following it are two different things. Do NOT make the mistake of “putting the patient first” and not follow these laws in practice. These laws seek to continue to put the patient first as well as protect the entire populace. Getting caught not following the law for favored patients will not be met by leniency, nor is a certain patient worth seeing your license lost or suspended.
How to keep abreast as new laws come into play regarding drug abuse and misuse?
- Set aside part of your required continuing education and attend a CE on recent updates in the law. I suggest attending over an on-line or paper CE as the Q & A time will allow you to ask specific questions. Health care professionals in other professions should note the best of these are usually pharmacy law updates. Attending would be worth the money even if you did not get CE credit.
- At least every three months, check the website of your professional board. Most of these across the country have a place on their page for new info and updates. Again, non-pharmacists would be well advised to look at the state’s pharmacy board site also.
- Follow the topic in your professional journals. These often run behind implementation of the law by a few months but the articles are usually more detailed.
- Find a reference source. A lawyer, law professor, a professor who teaches health law, another member of your profession who keeps fully up to date. Especially if you have a fair amount of controlled substances being prescribed, dispensed or administered in your practice, or if you have ever had a professional or personal issue with controlled substances. Pay a retainer if need be.
In conclusion, drug abuse is a rampant problem in this country. The means to address and attack this issue, however, will only make more difficult the already complicated practices of health care professionals. Plus, these same professionals should be concerned that they may well be the target of enhanced enforcement. In the long run, while it has an admirable goal, DEA intervention into drug abuse issues such as determining what is a “suspicious order” is going to make life harder for health care providers.