Dispensing controlled substances

April 15, 2011

DEA's "Office of Diversion Control" prevents, detects, and investigates the diversion of controlled substances from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical needs. To accomplish this mission, the DEA sets forth regulations designed to prevent any such diversion.

Key Points

Due diligence

Healthcare practitioners (physicians and pharmacists alike) should undertake proactive measures to ensure that a narcotic regimen is being used for legitimate medical purposes.

As a result, a pharmacist must "carefully review all purported controlled substance prescriptions to ensure that the prescription meets all of the legal requirements for a valid prescription. The pharmacist has a duty to inquire further as to any question surrounding the satisfaction of any or all of the legal requirements for a valid prescription, depending on the particular circumstances, including the requirement that the prescription be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice."

By undertaking due diligence in this regard, a pharmacist will help ensure compliance with DEA requirements.

Verification

Additionally, DEA regulations dictate that the pharmacist must verify that a controlled substance prescription contains the patient name, address, drug name and strength, quantity prescribed, and directions for use, as well as the name, address, and DEA number of the issuing practitioner. The pharmacist must further verify that the prescription is dated as of, and signed on, the date that it is issued.

Factors that the DEA will review when determining the potential for drug diversion, include but are not limited to the following:

Written agreements

Written patient agreements with physicians and/or pharmacies help the pharmacy monitor the legitimacy of a patient presenting for a narcotic prescription. At least one such company offers physicians, pharmacies, and patients alike the opportunity to electronically document such a relationship. The website of the Patient Physician Trust Partnership ( http://www.pptp.net/) offers information in this regard and a product intended to ensure greater compliance in the treatment of patients with controlled substances.

This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws.

Ned Milenkovich is a member at McDonald Hopkins, LLC, and chairs its drug and pharmacy practice group. He is also a member of the Illinois State Board of Pharmacy. Contact Ned at 312-642-1480 or at nmilenkovich@mcdonaldhopkins.com
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