Complete Your CE Test Online - Click Here federal law. Practitioners should be certain they understand both their state and DEA controlled substance regulations. [For a state-by-state listing of state medical boards and medical examiners with information on state-specific regulations, see http://www.fsmb.org/state-medical- boards/contacts] To obtain a DEA registration, a practitioner must apply using a DEA Form 224. The DEA Certificate of Registration (DEA Form 223) is issued upon approval and must be maintained at the registered location in a readily retrievable manner and kept available for official inspection [7]. The CSA requires that a separate registration be obtained for each principal place of business or professional practice where controlled substances are manufactured, distributed, or dispensed [8]. A separate DEA registration for practitioners that want to participate in a Narcotic Treatment Program (NTP) that involves administering, dispensing, and prescribing specific Schedule II–V controlled substances. Physicians with this registration may treat only a limited number of patients at any one time, depending on their type of registration [9,10]. Recordkeeping and reporting The CSA requires that complete and accurate records be kept of all quantities of controlled substances manufactured, purchased, and sold. Each substance must be inventoried every 2 years. From these records it is possible, theoretically, to trace the flow of any drug from the time it is first imported or manufactured, through the distribution level, to the pharmacy or hospital that dispensed it, and then to the actual patient who received the drug [11]. All records related to controlled substances must be maintained and be available for inspection for a minimum of 2 years. Each inventory must contain the following information [12]: 1. Whether the inventory was taken at the beginning or close of business. 2. Names of controlled substances. 3. The finished form of the substances (e.g., 100 mg tablet). 4. The number of dosage units of each finished form in the commercial container (e.g., 100-tablet bottle). 5. The number of commercial containers of each finished form (e.g., four 100-tablet bottles). 6. Disposition of the controlled substances. It is important to note that inventory requirements extend to controlled substance samples provided to practitioners by pharmaceutical companies [13]. Records for Schedule I and II drugs must be kept separate from all other records maintained by the registrant [14]. Records for Schedule III, IV, and V substances must be kept in a readily retrievable form, or maintained separately from all other records [15]. Records of all dispensing of controlled substances and of certain administrations must be maintained by the practitioner. The CSA does not require the practitioner to maintain copies of prescriptions, unless such substances are prescribed in the course of maintenance or detoxification treatment of an individual [16]. Certain states require the use of multiple- copy prescriptions for Schedule II and/or other specified controlled substances. The DEA does not conduct routine inspections of practitioners; however, all DEA registrants are subject to unscheduled or complaint investigations if they are suspected to be in violation of the CSA [17]. Nursing consideration: Nurses must be aware of, and adhere to, legal and organizational mandates regarding record keeping, recording, and administration of scheduled substances. Prescribing requirements Prescriptions for controlled substances must include the patient’s full name and address, and the practitioner’s full name, address, and DEA registration number. The prescription must also include [18]: 1. Drug name. 2. Strength. 3. Dosage form. 4. Quantity prescribed. 5. Directions for use. 6. Number of refills (if any) authorized. A prescription for a controlled substance must be written in ink or indelible pencil or typewritten and must be manually signed by the practitioner on the date when issued. An individual (secretary or nurse) may be designated by the practitioner to prepare prescriptions for the practitioner’s signature [19]. The practitioner is responsible for ensuring that the prescription conforms to all requirements of the law and regulations, both federal and state. A prescription may not have to be issued for an individual practitioner to obtain controlled substances for their own inventory. Note that controlled substances that are dispensed with a legitimate prescription may not be delivered or shipped to individuals in another country. Any such delivery or shipment is a prohibited export under the CSA [20]. Since Schedule I drugs have been deemed to have no currently accepted medical use in the United States, they may only be used in research situations. Generally, they are supplied by only a limited number of firms to properly registered and qualified researchers. Schedule II prescribing requirements Schedule II controlled substances require a written prescription that must be signed by the practitioner. There is no federal time limit within which a Schedule II prescription must be filled after being signed by the practitioner [21]. Prescriptions for Schedule II drugs may not be refilled. While some states and many insurance carriers limit the quantity of controlled substance dispensed to a 30-day supply, there are no specific federal limits to quantities of controlled substances dispensed via a prescription [22]. However, health care providers may issue multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of a Schedule II controlled substances provided these conditions are met: 1. Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. 2. The individual practitioner provides written 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 each prescription. 3. The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse. 4. The issuance of multiple prescriptions is permissible under applicable state laws. 5. The individual practitioner complies fully with all other applicable requirements under the CSA and Code of Federal Regulations, as well as any additional requirements under state law. For Schedule II controlled substances, an oral order is permitted in an emergency situation [23]. The term emergency situation means those situations in which the prescribing practitioner determines [24]: 1. Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user. 2. No appropriate alternative treatment is available, including administration of a drug that is not a controlled substance under Schedule II of the CSA. 3. It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to the dispensing. In an emergency, a practitioner may call-in a prescription to the pharmacy for a Schedule II controlled substance and the pharmacist may dispense the prescription, provided the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. The prescribing practitioner must provide a nursing.elitecme.com Page 3