I'm posing this as a question to all you wonderful pharmacy professionals out there:
What exactly is a pharmacist allowed to change on a CII prescription without having to obtain a new hard copy?
I used to know that pretty much the only things that had to be 100% correct were the patient's name, the name of the medication being prescribed, and the prescribers signature. Otherwise, a pharmacist, after obtaining clarification from the office, could change the date written, quantity prescribed, and directions.
A few months ago, one of our pharmacists told me that apparently the DEA made new, stricter guidelines regarding what could and could not be changed on a CII prescription. It was part of that notice about post-dating prescriptions. I read the notice several times, and I couldn't figure out where it said the requirements about what changes a pharmacist could make had changed. However, the pharmacist who told me was so adamantly sure that it's making me question myself.
I still adhere by the old rules, which made a lot of sense to me. A couple other pharmacists on staff now want to obtain a new hard copy for any change, which I think is stupid even if it is, infact, correct.
I've looked all over the net for some kind of confirmation about this but have been unable to find it. Could someone please enlighten me to the actual law and provide me a link to an official looking web page that states it? I would greatly appreciate it.
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8 comments:
What state are you in?
State law, if stricter than federal law, overrides federal law.
In my state, CA, I can request some changes by fax and attach them to my original hard copy if the ORIGINAL prescriber signs and dates the changes I specify. I'm very, very clear on what I want changed.
A covering prescriber cannot make the change, nor can an employee (receptionist, PA, RN,etc..)
Its made my life a lot easier!
My state goes entirely by federal law for CII scripts. Therefore, I just need to know what the ferderal law is.
I was at one of those ce conventions recently and the director of our state board spoke. Surprisingly, I was fairly impressed. While he didn't speak specifically about what you are discussing, he did discuss this type quandary in broader terms. Nerdy RPhs, which seems to be most of them, asked all these questions about the exact letter of the law about this and that. HIs reply was simple and points out one of our professions many problems. We are supposed to be professionals, and used our training, experience etc... to make wise judgements, to seek the intent in a Rx. Hardly a script would get filled if we held them all to every little rule in rx writing. No, if we recognize the intent of the rx and our professional judgement leads us to know what the doctor intended, then we fill it that way. I'm with you I think, fill the thing if you know what the doctor wants or can clarify with a phone call. I'm not going to waste my time or the dr.'s if I know what is intended. For all those anal by the book goobers, pharmacy can be reduced to a vending machine. If they aren't careful, that's what they will get. We are our own worst enemies.
Take a look at the Pharmacist Letter (February I think).
I don't have it in front of me now, but if I'm interpreting it right I believe it recommended a new hard copy for all changes until the new laws are clarified.
http://www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm
This is the DEA's statement in the Nov 07 Federal Register -- somewhere in there (apparently) is a statement that tightens up the regulations re: pharmacists making changes on C-2 scripts -- but to be honest I can't find it. Yes, see the Jan 08 Pharmacists Letter with a follow-up in the Feb 08 issue. Apparently the DEA is going to clarify this whole thing -- I expect we'll see it in Pharmacists Letter when it happens.
In my state, a pharmacist can change pt's address, drug strength, quantity and directions after consulting the prescriber.
I specifically asked our state board inspector what's up with the new rules, and he said go ahead and follow our state rules -- that the DEA ruling will be clarified because not allowing pharmacist changes will be too burdensome for everyone.
They address the topic Jan, Feb, and March. Some pharmacists may ask for a new Rx while others may continue making changes in accordance to past DEA Q&A guidelines. Fuzzy, but I guess best interest of the patient and due care come into play with documentation of prescriber approval.
There was just an article about this in Pharmacist's Letter. Apparently, the DEA inadvertently changed the laws when they rewrote they redid the dating and do not fill before rules. They're in the process of clarifying their position, but until they come out they seem to be saying do what's in the best interest of the patient and you won't get in trouble.
http://www.deadiversion.usdoj.gov/faq/general.htm
Here's the DEA FAQ on the subject.
OK, I looked again at the Federal Register DEA statement and I think this is the applicable part:
The Final Rule being issued today states expressly that, where a practitioner has issued multiple prescriptions in accordance with the rule, no pharmacist may fill any prescription before the date specified by the practitioner. The rule contains no exceptions to this requirement. In addition, because the CSA states that prescriptions for schedule II controlled substances must be written (21 U.S.C. 829(a)), the essential elements of the prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed, and--in the case of multiple prescriptions under this Final Rule--the earliest date on which the prescription may be filled) may not be modified orally."
So they are saying you can't modify
the "essential elements" of the
prescription ORALLY, which implies a new hard copy is needed... but
apparently a clarification is coming.
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