Brand name concerta

This forum made possible through the generous support of SDN members, donors, and sponsors. Thank you.

ancienbon

Full Member
10+ Year Member
Joined
Jul 27, 2010
Messages
769
Reaction score
246
When md writes for brand name concerta and the cvs computer wont let you change it to the generic you have in stock, do you call the md to write for generic?

Members don't see this ad.
 
They would have to write a brand new rx. Some of the generics have recently been ruled as not being AB equivalent.
 
Dispense Actavis authorized generic because it is the same, even the same alza imprint (acquisition cost might be the almost the same as well). Mallinckrodt and Kremers ANDA generics are BX-rated so those should not dispensed instead of brand anyway. Authorized generics are not AB-rated because they literally are the brand product but different packaging and might have a slightly modified imprint.

Ex: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=038ae416-4bd5-411b-bd28-d4f0af5c2ab7 (shows Actavis methylphenidate ER is authorized generic)

Technically, calling to get approval of non-OROS methylphenidate ER would be considered a dosage form change and might be permitted depending on the state.
 
Last edited:
Members don't see this ad :)
Make sure you also look to see if brand is cheaper. Some insurances prefer it right now.
 
Either dispense brand or get the MD to write it for methylphenidate ER. (and if you're a staffer tell your PIC to order the good stuff)
 
They would have to write a new script, and the only generic AB rated for Concerta is Actavis. If they write for Methylphenidate ER you can use any generic.

On another note... how is the system not letting you change it to brand if you put DAW1?
 
State specific. I am in California and we are able to do this. From The Scripts July 2011...

Q. If a physician prescribes MS Contin 30mg qty 60 1 bid, can the pharmacist call the physician and request to change the prescription to Kadian 30mg qty 60 1 bid without requesting a new prescription? And if the physician authorizes this change over the phone and the pharmacist documents the conversation with the physician for this change on the original prescription, is all pharmacy law fulfilled?

A. The answer to both questions is yes. After you have discussed changing the prescription with the prescriber and received permission to do so, the change can be made on the prescription, and no new prescription is required. The Board recommends documenting the discussion with the prescriber, including the receipt of consent, on the prescription. (CCR 1716 and B&PC 4073)
 
  • Like
Reactions: 1 users
State specific. I am in California and we are able to do this. From The Scripts July 2011...

Q. If a physician prescribes MS Contin 30mg qty 60 1 bid, can the pharmacist call the physician and request to change the prescription to Kadian 30mg qty 60 1 bid without requesting a new prescription? And if the physician authorizes this change over the phone and the pharmacist documents the conversation with the physician for this change on the original prescription, is all pharmacy law fulfilled?

A. The answer to both questions is yes. After you have discussed changing the prescription with the prescriber and received permission to do so, the change can be made on the prescription, and no new prescription is required. The Board recommends documenting the discussion with the prescriber, including the receipt of consent, on the prescription. (CCR 1716 and B&PC 4073)

If you can change a drug you might as well be able to call it in completely.
 
The drug (active ingredient) is not being changed per se, but an "error" in the implied dosage form (Kadian implies capsules with ER beads).

CA regulations are frustratingly vague with respect to errors or omissions, and any guidance is also vague and inconsistent. Back in January 2001 there was guidance on what required elements on the old triplicate forms cannot be omitted (issue date, prescriber name, prescriber signature, patient name, and name of drug), but in the "The Scripts" newsletter from July 2011 cited above, the board notes that "Title 16, CCR 1716 and 1761, relating to deviating from the requirements of a prescription and errors/omissions on a prescription, do not address whether to send the prescription back to the physician for a new prescription in such instances. They do, however, require the pharmacist to obtain prior consent of the physician before making any change to the prescription. The Board recommends that the pharmacist note the conversation with the physician on the back of the prescription, and enter the changes on the front as one possible method of documentation."

The regulations are clear that a controlled substance prescription shall be signed and dated by the prescriber in ink on the controlled substance prescription form if a hard copy is issued.

The easy thing to do is to send it back and make the prescriber's office fix it. Otherwise the office will print the same error month after month after month

Jan 2001 The Script: http://www.pharmacy.ca.gov/publications/01_jan_script.pdf
July 2011 The Script: http://www.pharmacy.ca.gov/publications/11_jul_script.pdf
 
  • Like
Reactions: 1 user
Partially true regarding the signature and date in ink. It is clear that both date and signature is required to be handwritten in ink for CII rx, but the handwritten DATE in ink is NOT CLEAR for CIII-CV.

If you can find reference that clearly states CIII-CV requires DATE in ink, let me know.

The drug (active ingredient) is not being changed per se, but an "error" in the implied dosage form (Kadian implies capsules with ER beads).

CA regulations are frustratingly vague with respect to errors or omissions, and any guidance is also vague and inconsistent. Back in January 2001 there was guidance on what required elements on the old triplicate forms cannot be omitted (issue date, prescriber name, prescriber signature, patient name, and name of drug), but in the "The Scripts" newsletter from July 2011 cited above, the board notes that "Title 16, CCR 1716 and 1761, relating to deviating from the requirements of a prescription and errors/omissions on a prescription, do not address whether to send the prescription back to the physician for a new prescription in such instances. They do, however, require the pharmacist to obtain prior consent of the physician before making any change to the prescription. The Board recommends that the pharmacist note the conversation with the physician on the back of the prescription, and enter the changes on the front as one possible method of documentation."

The regulations are clear that a controlled substance prescription shall be signed and dated by the prescriber in ink on the controlled substance prescription form if a hard copy is issued.

The easy thing to do is to send it back and make the prescriber's office fix it. Otherwise the office will print the same error month after month after month

Jan 2001 The Script: http://www.pharmacy.ca.gov/publications/01_jan_script.pdf
July 2011 The Script: http://www.pharmacy.ca.gov/publications/11_jul_script.pdf
 
11164. Except as provided in Section 11167, no person shall
prescribe a controlled substance, nor shall any person fill,
compound, or dispense a prescription for a controlled substance,
unless it complies with the requirements of this section.
(a) Each prescription for a controlled substance classified in
Schedule II, III, IV, or V, except as authorized by subdivision (b),
shall be made on a controlled substance prescription form as
specified in Section 11162.1 and shall meet the following
requirements:
(1) The prescription shall be signed and dated by the prescriber
in ink
and shall contain the prescriber's address and telephone
number;

...

http://www.leginfo.ca.gov/cgi-bin/displaycode?section=hsc&group=11001-12000&file=11150-11180

Edit: Also this FAQ on controlled substance prescriptions addresses the "minimum requirement" for controlled substances. Of course, it is pure negligence to omit the freakin' patient's name (adding the patient name would absolutely not be permissible in Arizona), so I personally would deny the script outright. The key word is that the pharmacist can make changes. "Can" is not "must." (Aside, I love that the law is clear that you can't fill out-of-state CII scripts for patients in California. **** entitled snowbirds, **** transient dip****s from Florida, etc.)

http://www.pharmacy.ca.gov/licensing/prescribe_dispense.shtml

Can a pharmacist fill a prescription for a controlled substance if an error is found on the prescription?

The prescriber’s signature and the date written are required to be written by the prescriber. Everything else can be written by the prescriber or his or her agent. Therefore, the pharmacist can make changes to any other information on the prescription as long as the pharmacist verifies the change with the prescriber first.
 
Last edited:
  • Like
Reactions: 1 user
Thanks. I've been enforcing it. But other pharmacists disagrees with me and letting it go
 
Members don't see this ad :)
State specific. I am in California and we are able to do this. From The Scripts July 2011...

Q. If a physician prescribes MS Contin 30mg qty 60 1 bid, can the pharmacist call the physician and request to change the prescription to Kadian 30mg qty 60 1 bid without requesting a new prescription? And if the physician authorizes this change over the phone and the pharmacist documents the conversation with the physician for this change on the original prescription, is all pharmacy law fulfilled?

A. The answer to both questions is yes. After you have discussed changing the prescription with the prescriber and received permission to do so, the change can be made on the prescription, and no new prescription is required. The Board recommends documenting the discussion with the prescriber, including the receipt of consent, on the prescription. (CCR 1716 and B&PC 4073)

Still violates DEA regulations. You MAY NOT change the drug being dispensed on a C-II Rx.
 
  • Like
Reactions: 1 user
There is no "future" rule yet (AFAIK) regarding changes to CIIs. Current DEA policy is to defer to the states. See below

http://www.deadiversion.usdoj.gov/faq/prescriptions.htm
Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedule II?
Answer: On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that "the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)…may not be modified orally."

The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber [emphasis mine]. (Policy Letter)

Therefore, when information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies [emphasis mine] to decide whether it is appropriate to make changes to that prescription.
 
  • Like
Reactions: 1 users
Here is another twist to California regulations (that I wasn't familiar with b/c I don't work in California):

http://www.pharmacy.ca.gov/publications/12_mar_script.pdf
I received an electronically printed Schedule II prescription from a hospital, and the date was not handwritten, it was printed electronically. If the issue date is not handwritten, does the patient have to obtain a new prescription, or are we allowed to call the doctor to verify the date?

A. The date does not have to be handwritten when the prescription forms are generated by a computerized prescription generation system from a hospital or other licensed health care facility (H&SC section 11162.1 [c][4] ). Forms for licensed health care facilities, “…that are printed by a computerized prescription generation system may contain the prescriber’s name, category of professional licensure, license number, federal controlled registration number, and the date of the prescription.” Additionally, institutional style forms do not require the quantity check-off boxes. If boxes are present on a prescription form, the boxes may be checked off or not, as long as the quantity is entered elsewhere on the form (H&SC section 11162.1[c][4]).
 
  • Like
Reactions: 1 user
Partially true regarding the signature and date in ink. It is clear that both date and signature is required to be handwritten in ink for CII rx, but the handwritten DATE in ink is NOT CLEAR for CIII-CV.

If you can find reference that clearly states CIII-CV requires DATE in ink, let me know.

From the Scripts March 2013.

Q. If the date of issue of a Schedule II prescription is omitted, can it be obtained by verbal consult with the prescriber and documented on the hard copy?

A. The prescriber’s failure to sign or enter the issue date is considered to be a “fatal flaw” on a Schedule II prescription and must be returned to the prescriber for a corrected or new prescription. For Schedules III, IV, and V controlled substance prescriptions that contain omissions or errors, 16, CCR section 1761(a) states that the pharmacist may make corrections to the prescription after contacting and receiving permission from the prescriber.
 
  • Like
Reactions: 1 user
All this said, how likely is it that you are going to talk to the prescriber personally for corrections? (For example, MA allows consultation with a prescriber's agent for schedules 3, 4, 5, and 6, but only the prescriber him/herself for schedule II, whereas AZ and CA are clear that the prescriber must be consulted for corrections on all scripts, not an agent)
 
Do you guys call when the script doesn't specify caps or tabs? Another pharmacist did and it was busy as hell today and I just wanted to slap her for wasting time and not just putting it through for caps. One of the stores I float at calls every time to switch amoxicillin tabs to caps... So annoying
 
Do you guys call when the script doesn't specify caps or tabs? Another pharmacist did and it was busy as hell today and I just wanted to slap her for wasting time and not just putting it through for caps. One of the stores I float at calls every time to switch amoxicillin tabs to caps... So annoying

I never understood this mentality. Is it that they love making more work for themselves? Do they just enjoy telling patients that they have to call the dr office before they can fill it? Rather have the techs (or themselves) on the phone than filling scripts or running register?

Personally I consider my time too valuable to call about tabs or caps. If they didn't specify, they don't care.
 
Do you guys call when the script doesn't specify caps or tabs? Another pharmacist did and it was busy as hell today and I just wanted to slap her for wasting time and not just putting it through for caps. One of the stores I float at calls every time to switch amoxicillin tabs to caps... So annoying
Wait pause, other pharmacist???
 
There is no "future" rule yet (AFAIK) regarding changes to CIIs. Current DEA policy is to defer to the states. See below

http://www.deadiversion.usdoj.gov/faq/prescriptions.htm
Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedule II?
Answer: On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that "the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)…may not be modified orally."

The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber [emphasis mine]. (Policy Letter)

Therefore, when information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies [emphasis mine] to decide whether it is appropriate to make changes to that prescription.

NO, NO NO.... You may change or add the dosage form, drug strength, quantity, directions for use or issue date. Under no circumstances is there a rule, law or policy that allows you to change the drug......
 
  • Like
Reactions: 1 user
We already went over this. Most pharmacists would not change the active ingredient due to professional judgment but the DEA language is clear. Some states specify issue date can't be changed, some allow it. Post-dating is strictly illegal, so someone exercising professional judgment wouldn't even touch the issue date (where allowed), refuse the script, and contact the prescriber office letting them know post-dating is illegal, where the arrogant employees will then state they don't give a ****. Some states are stricter than others. Some pharmacists will wonder why the federal standards for CIII-CV are stricter than for CII and not unreasonably apply the federal standards for CIII-CV to CII prescriptions regardless of what the state they are in allows.
 
In Texas it's easier to memorize the list of things you can't change.

Name of doctor
Name of patient
Name of drug
Date

Everything else is fair game with prescriber approval
 
We already went over this. Most pharmacists would not change the active ingredient due to professional judgment but the DEA language is clear. Some states specify issue date can't be changed, some allow it. Post-dating is strictly illegal, so someone exercising professional judgment wouldn't even touch the issue date (where allowed), refuse the script, and contact the prescriber office letting them know post-dating is illegal, where the arrogant employees will then state they don't give a ****. Some states are stricter than others. Some pharmacists will wonder why the federal standards for CIII-CV are stricter than for CII and not unreasonably apply the federal standards for CIII-CV to CII prescriptions regardless of what the state they are in allows.

It's clear you can't. Read everything they publish. You can only change what I listed.
 
Apparently you don't know what an inline url is (to the DEA FAQ that I referenced). There is even a dea policy letter referenced on the FAQ page: http://www.deadiversion.usdoj.gov/faq/multiple_rx_clarification_ltr_102010.pdf

What the DEA does or does not allow for modifications is not ensconced in the controlled substance act but stated by policy. Many states, following the policy I quoted, have enforced stricter requirements either as guidance/policy or regulations already stated explicitly what is allowed
 
Last edited:
Do you guys call when the script doesn't specify caps or tabs? Another pharmacist did and it was busy as hell today and I just wanted to slap her for wasting time and not just putting it through for caps. One of the stores I float at calls every time to switch amoxicillin tabs to caps... So annoying

Since you work at Walmart does it count as a qualifying event to switch tabs to caps (things with irrelevant PK/PD differences like omeprazole caps vs tabs, amoxicillin caps vs tabs, ranitidine caps vs tabs, hctz 12.5 caps vs tabs are the most common) deliberately without actual consultation (99.9999% the prescriber doesn't care). Or is something that a market director or manager will try to pin on you if they want to get rid of you?

Compared to CVS, WM seems a lot more strict due to 4-point check, and they are more strict on overtime as well
 
Last edited:
Apparently you don't know what an inline url is (to the DEA FAQ that I referenced). There is even a dea policy letter referenced on the FAQ page: http://www.deadiversion.usdoj.gov/faq/multiple_rx_clarification_ltr_102010.pdf

What the DEA does or does not allow for modifications is not ensconced in the controlled substance act but stated by policy. Many states, following the policy I quoted, have enforced stricter requirements either as guidance/policy or regulations already stated explicitly what is allowed

I suggest you read ALL of the information on the DEA web site. If you do, you will see that changing certain things are permitted and certain things are not permitted, Changing MS-Contin to Kadian is not permitted now or ever.
 
I already have, which is why I posted various links to show what the DEA's policy officially is as of this moment (defer to state regulations, other federal laws/regulations and professional judgment). Some state boards issued policies based on this:

New Mexico: no changes to patient name, drug name, prescribing physician, and tells pharmacists to follow the policy on schedule III-V (which allows issue date change): http://www.rld.state.nm.us/uploads/FileLinks/a5bdc4c0017d4bf294dd2cbfea6f294e/C-II changes 4-10.pdf

Massachusetts: no changes to patient name, drug name, prescriber name, prescriber signature, issue date/"earliest date to be filled" (as DEA does not permit oral modifications on earliest date to be filled): http://www.mass.gov/eohhs/docs/dph/...acy-joint-policy-2012-01-prescrip-changes.doc
 
Last edited:
Now let's use logic and reading comprehension. Let's quote the DEA website first:

Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V?
Answer: The pharmacist may add or change the patient's address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions.

The pharmacist is never permitted to make changes to the patient's name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber's signature.
http://www.deadiversion.usdoj.gov/faq/prescriptions.htm#rx-7

So now we have determined you cannot change the controlled substance prescribed on a C-III-V prescription. Now let's look at the rules for C-II.

Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedule II?
Answer: On November 19, 2007, the DEA published in the Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule II Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that "the essential elements of the [schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)…may not be modified orally."

The instructions contained in the Rule's preamble are in opposition to DEA's previous policy which permitted the same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral consultation with the prescriber. DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber. (Policy Letter)

Therefore, when information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.
http://www.deadiversion.usdoj.gov/faq/prescriptions.htm#rx-7

Now using all of our skills you can see that you CANNOT change the drug prescribed on C-III-V prescription so therefore since you are following that rule for C-II prescriptions you also cannot chnage the the drug prescribed on a C-II prescription. Now there are inconsistencies about changing the dosage form, drug strength, drug quantity, directions for use but there is NO discrepancy about changing the drug prescribed it is prohibited in all cases for any controlled substance. Your out for non C-II prescriptions is you can always call and get a new verbal order for the item you want to change which is not an option for C-II prescriptions.
 
When you apply DEA rules for CIII-CV (because clearly that clause applies to CIII-CV and this clause comes AFTER the FAQ about CII) to CII, that is using your professional judgment (the DEA says it is permissible to use your professional judgment).

I already said it is "not unreasonable" to use your professional judgment (within the bounds of federal and state policy and/or regulation), but that is different than the DEA saying you must do so (that is, recognize that you can't change the drug name for CIII-CV so why should you even consider it for CII despite the policy letter deferring to state regulations or policy).

There is a discrepancy with respect to federal policy about oral modifications to schedule II controlled substances, including name of drug by implication, because the DEA freakin' acknowledged it. Rules for oral modifications on all controlled substances are not addressed in the CSA but a matter of DEA policy. DEA policy is clear on CIII-V, and for CII the current policy is to defer to state regulations/laws, federal law (oral modifications are NOT addressed in the CSA) and professional judgment. Again go ahead and use your professional judgment, who cares.
 
Last edited:
When you apply DEA rules for CIII-CV (because clearly that clause applies to CIII-CV and this clause comes AFTER the FAQ about CII) to CII, that is using your professional judgment (the DEA says it is permissible to use your professional judgment).

I already said it is "not unreasonable" to use your professional judgment (within the bounds of federal and state policy and/or regulation), but that is different than the DEA saying you must do so (that is, recognize that you can't change the drug name for CIII-CV so why should you even consider it for CII despite the policy letter deferring to state regulations or policy).

There is a discrepancy with respect to federal policy about oral modifications to schedule II controlled substances, including name of drug by implication, because the DEA freakin' acknowledged it. Rules for oral modifications on all controlled substances are not addressed in the CSA but a matter of DEA policy. DEA policy is clear on CIII-V, and for CII the current policy is to defer to state regulations/laws, federal law (oral modifications are NOT addressed in the CSA) and professional judgment. Again go ahead and use your professional judgment, who cares.

No it says there are things you can change and things you can't change. There is a discrepancy in that the new rules prohibits changing things permitted in another section however since the original section also prohibits changing the drug dispensed there is no discrepancy about changing the the drug dispensed. It is prohibited in both sections.

Original Rule: Can't change A. Can Change B, C, D.

New Rule: Can't change anything.

Clarification: Oops, we goofed. There is a problem with changing B, C, D. Since there is a discrepancy. use your professional judgement. Except there is no discrepancy about changing A, and since there is no discrepancy there is nothing to use your professional judgement about. It only applies to the discrepancy, not everything about the entire rule.
 
The original rule is actually "In a Q&A section [on the DEA Diversion website], the website instructed regarding CIIs that a 'pharmacist may change or add the dosage form, drug strength, drug quantity, direction for use, or issue date only after consultation with and agreement of the prescribing practitioner.'" http://deadiversion.usdoj.gov/mtgs/drug_chemical/2011/gallagher.pdf (This the DEA's presentations on the policy update in question in this thread).

The new rule (based on the policy on multiply issued prescriptions) is "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." http://www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm

The DEA did not say "there is a conflict regarding policy on changing only dosage form, drug strength, and drug quantity." (These are the only 3 things that are explicitly cited that are common to both "rules.")

The DEA said: "DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber." By "conflict" DEA really means conflict between the rules in general, not conflict between rules on changing only dosage form, strength, or drug quantity.

That is why the DEA says until they come up with a future rule, "pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber," basically ignoring the federal "rules" in favor of what state regulations or policies permit.

In other words "neither rule applies so do what the states permit within federal regulations" is the official policy. And you can't say "can't change name is federal law" because to be truly adherent, federal regulation says CIIs must be written, so oral modification of ANYTHING contravenes the law because the practitioner didn't write it, yet the DEA allows pharmacists to adhere to state regulations until the future rule is created.

"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..." => prescription must be written. Nothing permitting modification.. http://www.deadiversion.usdoj.gov/21cfr/21usc/829.htm

"All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner... Where an oral order is not permitted, paper prescriptions shall be written with ink or indelible pencil, typewriter, or printed on a computer printer and shall be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed" => invalid prescription if missing any element. Nothing in the CSA permitting modification of CIIs. http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_05.htm
 
Last edited:
The original rule is actually "In a Q&A section [on the DEA Diversion website], the website instructed regarding CIIs that a 'pharmacist may change or add the dosage form, drug strength, drug quantity, direction for use, or issue date only after consultation with and agreement of the prescribing practitioner.'" http://deadiversion.usdoj.gov/mtgs/drug_chemical/2011/gallagher.pdf (This the DEA's presentations on the policy update in question in this thread).

The new rule (based on the policy on multiply issued prescriptions) is "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." http://www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm
http://www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm

This is where your understanding of law and reading comprehension fail you miserably. It is a not a NEW RULE that replaces the old rule. This is a NEW rule about the ability to issue multiple prescriptions to one patient at a single time. In that rule they foolishly said you could not do something you could do before. However, there is no rule any time, anywhere that says you can change the drug to be dispensed. They don't say the whole rule is null and void. They say the items in question are what is at stake. This does not suddenly give the pharmacist the right to change the item ordered. It is strictly forbidden and I have enough friends who are lawyers and enough real world experience to know your interpretation is way off. You are free to do what you want. I would never swap kadian for MS Contin. Feel free to do it of you wish.

The DEA did not say "there is a conflict regarding policy on changing only dosage form, drug strength, and drug quantity." (These are the only 3 things that are explicitly cited that are common to both "rules.")

The DEA said: "DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber." By "conflict" DEA really means conflict between the rules in general, not conflict between rules on changing only dosage form, strength, or drug quantity.

No, you read incorrectly. It says since there is conflict about what you can change as one rule says one thing and one rule says another thing, you follow state law. But since neither rule mentions changing the drug prescribed then you can't chnage the drug prescribed. You don't suddenly gain new rights. If one of the rules in question said you could change the drug prescribed and one didn't you would be correct. But since neither rule permits it, it is not permitted.

That is why the DEA says until they come up with a future rule, "pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber," basically ignoring the federal "rules" in favor of what state regulations or policies permit.

In other words "neither rule applies so do what the states permit within federal regulations" is the official policy. And you can't say "can't change name is federal law" because to be truly adherent, federal regulation says CIIs must be written, so oral modification of ANYTHING contravenes the law because the practitioner didn't write it, yet the DEA allows pharmacists to adhere to state regulations until the future rule is created.

"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..." => prescription must be written. Nothing permitting modification..

Your interpretation is wrong. There are things you are permitted to change it does not require a new order. It does not become a verbal order. Your reasoning is silly. That means any change you make would have to be followed up with a written order and only for a 72 hour emergency supply. You just pulling turds out of your rectal opening.
 
If it's written for 10 mg oxycodone daily can you just change it to 2 oxycodone 5 mg daily. I've seen pharmacists do that a lot. I guess technically your not changing the drug...???
 
If it's written for 10 mg oxycodone daily can you just change it to 2 oxycodone 5 mg daily. I've seen pharmacists do that a lot. I guess technically your not changing the drug...???

I'm in California. From the Scripts March 2012,

Q. If a physician writes a prescription for Dilaudid 8mg qty 20 : 1 tab po q6h prn severe pain, can we change it to Dilaudid or Hydromorphone 4mg qty 40 : 2 tablets (8mg) po q6h prn severe pain without requesting a revised prescription? We currently have 4mg, not 8mg, in stock. Can we legally change the strength to what we have in stock as well as the quantity so that the dose and total number of doses match with those in the original prescription?

A. The use of Dilaudid/hydromorphone 4mg in place of Dilaudid 8mg is allowed under B&PC 4052.5. If the change does take place, the patient must be advised. Also, if the generic hydromorphone is used, the patient must be advised of this as well (B&PC 4073[e]).
 
Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V?
Answer: The pharmacist may add or change the patient's address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions.
The pharmacist is never permitted to make changes to the patient's name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescriber's signature.

This doesn't make any sense. It is perfectly legal for a doctor or his agent to telephone in a prescription for a CIII - CV drug. So OK, I won't change the Tylenol/Codeine prescription that needs changing, I will just cancel it and write a new prescription for tramadol via the phone order.
 
This is where your understanding of law and reading comprehension fail you miserably. It is a not a NEW RULE that replaces the old rule. This is a NEW rule about the ability to issue multiple prescriptions to one patient at a single time. In that rule they foolishly said you could not do something you could do before. However, there is no rule any time, anywhere that says you can change the drug to be dispensed. They don't say the whole rule is null and void. They say the items in question are what is at stake. This does not suddenly give the pharmacist the right to change the item ordered. It is strictly forbidden and I have enough friends who are lawyers and enough real world experience to know your interpretation is way off. You are free to do what you want. I would never swap kadian for MS Contin. Feel free to do it of you wish..

Do not change the subject. I talking about the whole clause on "essential elements" in the multiple script policy, not the multiple script policy itself. (Just because this was mentioned in the multiple script policy doesn't mean it applied only to multiple scripts.) By "new rule" you were referring to the DEA's own interpretation of the Controlled Substance Act itself ("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... may not be modified orally.") This is the DEA's writing, not mine.

Since you have worked a long time, of course for a long time the old DEA oral modification guidance applied (from the Q&A website that no longer exists) until they screwed up and forgot about it when they came up with the new policy on multiply issued prescriptions. This is why they acknowledged this in their own clarification letter, right here (previously cited): http://www.deadiversion.usdoj.gov/faq/multiple_rx_clarification_ltr_102010.pdf.

Again, the "old rule" (I am referring to you terminology in scare quotes so you can't put more words in my mouth or claiming I'm arguing something that I'm not) said you can orally change dosage form, drug strength, drug quantity, direction for use, or issue date only. The "new rule," which is actually the DEA's own interpretation of the CSA, says you can't change "essential elements," which is basically "change nothing." Both the "old rule" and the "new rule" (a.k.a. the Controlled Substance Act as interpreted by the DEA) do not permit changing drug name, but the "new rule" (the Controlled Substance Act as interpreted by the DEA) is stricter. You can say, "well, the old rule has an implicit 'notwithstanding anything to the contrary'," and I would agree (otherwise the DEA's own guidance is invalid, which doesn't make sense), but the DEA clearly saw it as enough of a problem (not reconciling the old and the new statements) to issue that clarification letter rather than just say the "old rule" still stands.

You say, "you don't suddenly gain new rights." Actually, that is what happened (in certain states like California where the oral modification policy is liberal) because the current DEA instruction is "to adhere to state regulations or policy," right here: http://www.deadiversion.usdoj.gov/faq/multiple_rx_clarification_ltr_102010.pdf and on the FAQ cited earlier, not "to adhere to state regulations or policy + the 'old rule'." I already showed that states do differ in what is permissible to change and some of them are going off the DEA's "old rule," and some are, even smarter, still stricter.

If you think this letter does not instruct people to ignore the "old rule" despite phrases like "DEA recognizes the resultant confusion regarding this conflict" (which is a conflict between the "old rule" and the DEA's interpretation of the CSA) ... well that's precisely why the DEA recognizes the need for a future rulemaking on the matter of oral modifications of CIIs.

As far as Kadian vs MS Contin, I wouldn't change it in AZ for the same reason I wouldn't change it in CA... not an omission and depending on the context not an error. No state or federal law states that you "must" change anything anyway.

Edit: I do not care to beat a dead horse anymore when all the information is available for everyone to see, so please refrain from churlish references to human anatomy and appeals to your lawyer friends and claiming the things the DEA said are things that I said.
 
Last edited:
When md writes for brand name concerta and the cvs computer wont let you change it to the generic you have in stock, do you call the md to write for generic?

Law aside...question is should you even do so? ...not sure if someone mentioned it but this particular manufacturers generic version isn't as bioequivalent as previously thought...

http://www.fda.gov/Drugs/DrugSafety/ucm422568.htm
 
In CA can we dispense Concerta for Rx written for methylphenidate ER upon pt request?
 
Last edited:
Top