The Board has been receiving questions from many pharmacies and pharmacists concerning a couple of issues related to controlled substances.  Here are the questions and the Board’s answers:

1. The Board of Medical Practice recently disciplined a physician, Sheftel Japhe Cohen (aka “Shep” Cohen).  Dr. Cohen agreed to voluntarily surrender his license.   The “Facts” section of the order issued by BMP indicates that a review of Dr. Cohen’s practice found issue with the manner in which he prescribed controlled substances.  The question that the Board has been receiving is – are prescriptions that were written by Dr. Cohen while he was still licensed legally valid to dispense?  Unfortunately, state law is less than crystal clear on this matter.  One possible interpretation of Minnesota Statutes Section 152.11 would suggest that the prescriber must have a current DEA registration at the time of dispensing. But it might also be interpreted as meaning that the DEA registration needs to be current at the time of prescribing.  However, the Federal Controlled Substance Act and related regulations do clearly state that a pharmacist has a “corresponding responsibility” to make sure that controlled substance prescriptions are dispensed for legitimate medical purposes in the usual course of practice.  When presented with a controlled substance prescription written by Dr. Cohen, pharmacists should consider the BMP disciplinary order when they are using their professional judgment to determine if the prescription was written for a legitimate medical purpose and in the course of usual practice. If you would like an electronic copy of the BMP order, which is a public document, please send an e-mail to pharmacy.board@state.mn.us.
2. The Board regularly receives questions about what information can be changed on controlled substance prescriptions.  The Board has also been made aware that certain pharmacy benefit management companies have, while conducting audits, taken money back from pharmacies if the pharmacist added a prescriber’s DEA number to a prescription (in case where the DEA number was not printed on hand-written on the prescription).  The PBMs may have shown pharmacists a letter that they received from the DEA last year indicating that pharmacies are not allowed to add DEA numbers to prescriptions. I attended the annual meeting of the National Association of Boards of Pharmacy towards the end of May and attended a presentation given by Gary Boggs, Executive Assistant to the Deputy Assistant Administrator for the DEA Office of Diversion Control.  I asked Mr. Boggs about this issue and he very clearly stated that the following statement, which is found on the DEA’s Web site still applies (emphasis added):

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)

In essence, for Schedule II prescriptions, the DEA is deferring to the states concerning what can be changed on the prescriptions. The Board has the following FAQ questions and answers on its Web site:

WHAT INFORMATION CAN BE CHANGED (OR ADDED) TO A SCHEDULE II PRESCRIPTION BY A PHARMACIST? 

The DEA is currently deferring to the states on this issue. The Minnesota Board of Pharmacy has adopted this position:

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 with the agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. The pharmacist may add the DEA number of the prescriber upon determining that the prescription is legally valid. 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.

Note that you must contact the prescriber in order to make changes on a schedule II prescription.

The Board will be adding the following FAQ question and answer to its Website:

WHAT INFORMATION CAN BE CHANGED (OR ADDED) TO A SCHEDULE III – V PRESCRIPTION BY A PHARMACIST?

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.  The pharmacist may add the DEA number of the prescriber upon determining that the prescription is legally valid. 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.

Mr. Boggs also indicated that a pharmacist may add a DEA number to a controlled substance prescription. A pharmacist who questions the validity of a prescription must, of course, contact the prescriber to verify the information contained on the prescription.

Discussion