What are they?
Per the DEA's definition in the interim ruling document* (page 6). "Controlled substances are drugs and other substances that have a potential for abuse and psychological and physical dependence; these include opioids, stimulants, depressants, hallucinogens, anabolic steroids, and drugs that are immediate precursors of these classes of substances."
Why is this such a hot topic?
"The consequences of prescription drug abuse are seen in the data collected by the Substance Abuse and Mental Health Services Administration on emergency room visits. In the latest data, Drug Abuse Warning Network (DAWN), 2006: National Estimates of Drug-Related Emergency Department Visits8, SAMHSA estimates that, during that one year, approximately 741,000 emergency department visits involved nonmedical use of prescription or over-the-counter drugs or dietary supplements, a 38 percent increase over 2004. Of the 741,000 visits, 195,000 involved benzodiazepines (Schedule IV) and 248,000 involved opioids (Schedule II and III). Overall, controlled substances represented 65 percent of the estimated emergency department visits involving prescription drugs or over-the-counter drugs or dietary supplements. Between 2004 and 2006, the number of visits involving opioids increased 43 percent and the number involving benzodiazepines increased 36 percent. Of all visits involving nonmedical use of pharmaceuticals, about 224,000 resulted in admission to the hospital; about 65,000 of those individuals were admitted to critical care units; 1,574 of the visits ended with the death of the patient. More than half of the visits involved patients 35 and older." This is a direct quote from page 21-22 of the interim rule document (they list their sources on page 21)
Worse, these drugs are almost to a fault highly addictive and life altering or shattering if not properly issued and used (sometimes even if things are all done properly the results have bad results). This has always created the further problem that addiction and misuse can lead to prescription theft, black marketeering of these drugs, and identity theft of individuals and doctors, etc.
Why is this ruling necessary?
Well, one of the big hang ups and reasons for doctors not embracing e-prescribing fully, has been the hang up of not being able to do e-prescribing for controlled substances. With the passing of the ARRA (stimulus) program and the HITECH fight for EHRs, questions of "meaningful use" have been and will continue to be bounced around for some time. The electronic submission, signing, and acceptance of controlled substance prescription is part of this.
How will this rule affect me if I don't do e-prescribing, or I still need to write out or call in prescriptions?
It won't. The interim rule mentions several times (including on page 34), that this interim ruling is not a replacement for any of the existing rules regarding written or oral prescriptions.
"Ok, I'll bite. How will this allow me to send my controlled substance prescriptions electronically, I would love for them to be as easy as the rest of my e-prescribing?"
The biggest problem with being able to do this so far has been the way to digitally sign and authenticate the person submitting the e-prescription. The interim rule is laying out options and how it sees things proceeding. The interim rule also allows for future tweaks for when EHRs are more up to speed and submitting prescriptions directly, rather than going through on online ASP (active service provider).
- The prescribers will need to sign up and and receive credentialing to be an authorized e-prescriber. I imagine that this may not be much different than signing up for an NPI number or getting a "digital" certificate like stores use to let you know they are secure for shopping. My gut tells me they may not be free either, but that was never mentioned, nor how often you may need to reapply or re-up your certification. It looks like it may be necessary and possible to also credential someone(s) else in your office to be a signee also (more about why in a minute). How this will be handled potential by someone like RxNT, or potentially your future EHR or practice management software was also not specifically laid out. (I think they are trying to allow some space here for future options as well.) Suggestions included a "digital certificate" or possibly a piece of hardware, a "hard token", like a usb thumbdrive or "dongle" perhaps that has authentication coding and your key and access built into it. There was also mention of this being a part of using the credential, the other part would be logging in with a password or pin code. The example they give is like using a bank ATM card.
- They are also going to require a two-factor authentication protocol (i.e. to credentialed people to "sign" off on controlled substance e-prescription will be necessary). For a single doctor practice, this may be where your office manager or biller will need to be "credentialed" to allow you to complete the 2-factor sign off process. You might also ask, "well what if I have both my office manager and biller credentialed, can they sign off on prescriptions without me?" The answer would be no. Part of the credentialing will include what the "level" of the credential is, i.e. doctor, nurse, general staff, etc. (See pages 24-30 for more info on these.)
I think, like the interim rules for "meaningful use" and EHR certification, this rule will be modified and changed (tweaked) over the next couple of years. It is inevitable. What this rule will logically help, in the future, will be how EHR patient records are signed, authenticated, and logged also.
MORE?
Here is the link to the actual document for the interim ruling: http://www.federalregister.gov/OFRUpload/OFRData/2010-06687_PI.pdf (all 334 pages of it). Don't forget as mentioned at the beginning, there will be a window for comments if you choose to do so.
Written by Penny H, Genius Solutions' News Editor
Please feel free to add comments and thoughts here as well. The comments will come to me, so I can moderate the posting, and then they will appear with the article.
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