Ohio News: DEA Issues

Published in the August 2006 Ohio State Board of Pharmacy Newsletter

Drug Enforcement Administration (DEA) has recently published several items that should be of interest to health care practitioners around the country. These items may all be found on the DEA Diversion Web site www.deadiversion.usdoj.gov.

In the Federal Register of September 6, 2006 (Volume 71, Number 172, Page 52724-52726), DEA published a proposed rule dealing with the issuance of multiple prescriptions for Schedule II controlled substances. The notice may be found at www.deadiversion.usdoj.gov/fed_regs/rules/2006/fr0906.htm. By issuing this proposed rule, DEA is once again proposing to allow prescribers to issue, where appropriate, multiple Schedule II prescriptions to a patient on one visit. Please note that this is a proposed rule. The comment period will be open until November 6, 2006. After reviewing the comments received, DEA will make a decision about making the rule permanent. The wording of the proposed rule changes is as follows.

Sec. 1306.12 Refilling prescriptions; issuance of multiple prescriptions.
(a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.
(b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met:
(i) The individual practitioner properly determines there is a legitimate medical purpose for the patient to be prescribed that controlled substance and the individual practitioner is acting in the usual course of professional practice;
(ii) The individual practitioner writes instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill the prescription;
(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and
(v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.
Sec. 1306.14 Labeling of substances and filling of prescriptions.
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(e) Where a prescription that has been prepared in accordance with Sec. 1306.12(b) contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date.

Once again, please note that this is a proposed change to DEA rules. It will not be permanent until DEA makes that decision some time in the future. Meanwhile, the Board encourages prescribers and pharmacists to continue to care for their patients in an appropriate manner. Many of you know that the Board disagreed with DEA’s comments in November 2004 that multiple Schedule II prescriptions were “tantamount to a refill” and have encouraged and expected you to continue to treat patients effectively, including the issuance of multiple Schedule II prescriptions when appropriate. This proposed rule shows that the policy makers at DEA have changed their opinions to be more in line with our thinking. Please continue to treat patients effectively and appropriately during this interim period until the proposed regulations become final.

In the same issue of the Federal Register, DEA also published a policy statement on the use of controlled substances in the treatment of pain. That policy statement is also available on the DEA Web site at www.deadiversion.usdoj.gov/fed_regs/notices/2006/fr09062.htm. This policy statement outlines the approach and reasoning of DEA in its enforcement of the controlled substance laws and regulations. Prescribers and pharmacists who routinely treat patients with controlled substances should read this carefully. Hopefully, a careful reading will eliminate some of the fears that health care practitioners have when treating legitimate patients.

One of the most important concepts to keep in mind in both of these cases, multiple Schedule II prescriptions and pain treatment, is the mandate that the medication be prescribed and dispensed “for a legitimate medical purpose” (quoting from federal and Ohio requirements). If a health care practitioner is prescribing, dispensing, or administering controlled substances for a legitimate medical purpose, there will be no problems with law enforcement agencies. Legitimate medical purpose is defined by your fellow practitioners and the licensing boards, not by the law enforcement agencies. Always act in the best interests of the patient and there should be no problems.

One other new publication from DEA that may be of interest to prescribers and pharmacists alike is the revised version of DEA’s Practitioner’s Manual. This was issued in August of this year, so it contains current information about the laws, regulations, and DEA policy for prescribers. This Manual as well as DEA’s other practice oriented manuals may be found at www.deadiversion.usdoj.gov/pubs/manuals/index.html.