DISPENSING REQUIREMENTS FOR CONTROLLED SUBSTANCES - Pharmacy

University of Tennessee Advanced Studies in Pharmacy 245 ABSTRACT The dispensing of controlled substances in compliance with federal regulations is a ...
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DISPENSING REQUIREMENTS FOR CONTROLLED SUBSTANCES —

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Alan R. Spies, RPh, JD, MBA, PhD*

ABSTRACT The dispensing of controlled substances in compliance with federal regulations is a function that is critical to the day-to-day activities of pharmacists, and as such, this article reviews the major Drug Enforcement Administration requirements in regard to processing and dispensing Schedule II through V prescriptions. Regulations on Schedule II prescriptions are relatively stringent, with refills being prohibited and verbal orders permitted only in emergency situations and with a provision that a written prescription is sent to the pharmacy within 7 days of the verbal order. Regulations for Schedule III, IV, and V prescriptions are more lenient, because prescriptions may be communicated orally or by facsimile to the pharmacist in nonemergency situations, and up to 5 refills within 6 months of the date written on the script are allowed. Also discussed are regulations pertaining to electronic controlled substance prescriptions, changes to the face of a controlled substance prescription, and central fill pharmacies. Requirements for processing of scheduled prescriptions (eg, drug name, strength, dosage form, quantity prescribed, directions for use, and number of refills) and labels affixed to dispensed medications (eg, pharmacy name and address, prescription number, date of initial dispensing, and US Food and Drug Administration warning label prohibiting transfer of the script) are very specific. Assessing legitimate medical purpose of a scheduled prescription is a major responsibility for pharmacists, and in this regard, several techniques that drug-seeking individuals may use in obtaining controlled substances are described. (Adv Stud Pharm. 2008;5(8):245-249) *Assistant Professor of Pharmacy Administration, Southwestern Oklahoma State University, College of Pharmacy, Weatherford, Oklahoma. Address correspondence to: Alan R. Spies, RPh, JD, MBA, PhD, Assistant Professor of Pharmacy Administration, Southwestern Oklahoma State University, College of Pharmacy, 100 Campus Drive, Weatherford, OK 73096. E-mail: [email protected].

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any federal and state regulations govern the distribution of controlled substances. Although most pharmacists abide by these laws, a review of the major aspects of these regulations may minimize uncertainties that arise in the day-to-day dispensing of controlled substances and may, ultimately, improve compliance with the Controlled Substances Act (CSA). This article includes a summation, from the US Drug Enforcement Administration (DEA), of the federal requirements for pharmacist dispensing of controlled substances. Drugs and drug products under the jurisdiction of the CSA are divided into 5 schedules, with agents in Schedules II through V categories having an accepted medical use in the United States. For all controlled substance prescriptions, the pharmacist must make certain that the prescription is dated and signed on the date when issued. Furthermore, the prescription must include the patient’s full name and address, as well as the practitioner’s name, address, and registration number.1 Federal law requires the prescription to include the drug name, strength, dosage form, quantity prescribed, directions for use, and number of refills.1 In situations in which an oral prescription is not permitted, the prescription must be written in ink or indelible pencil, or it must be typewritten and signed by the practitioner.1 GENERAL REQUIREMENTS FOR SCHEDULE II SUBSTANCES Schedule II substances require a written prescription that must be signed by the practitioner. Although many states have enacted time frames under which Schedule II substance prescriptions may be filled, federal law does not place a time limit under which these prescriptions must be filled after being signed by the practitioner, nor does it place quantity limits on any prescriptions. However, it is imperative for the pharmacist to use professional judgment in determining whether the prescription is still needed by the patient (eg, a narcotic prescription filled several weeks after being written).

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EMERGENCY D ISPENSING OF A SCHEDULE II SUBSTANCE For Schedule II substances, an oral order is only permitted in emergencies, which include situations in which immediate administration of the drug is necessary for proper treatment of the intended ultimate user, when no alternative treatment is available (including a non-Schedule II substance), and when it is not possible for the prescriber to provide a written prescription at that time.1 If, in the pharmacist’s professional judgment, a true emergency situation arises, a practitioner may telephone a Schedule II prescription to the pharmacy, and the pharmacist may dispense the prescription, provided that: 1. The drug prescribed and dispensed must be limited to the amount needed to treat the patient during the emergency period. Prescribing or dispensing beyond the emergency period must be pursuant to a written prescription order. 2. The prescription order must be immediately reduced to writing by the pharmacist and must contain all information, except for the prescribing practitioner’s signature. 3. If the prescriber is not known to the pharmacist, the pharmacist must make a reasonable effort to verify that the phone authorization came from a valid practitioner by verifying the practitioner’s telephone number with that listed in the directory and by making other good faith efforts to insure proper identity.1 In these limited situations, a pharmacist must receive, within 7 days, a written and signed prescription from the practitioner for the controlled substance with “Authorization for Emergency Dispensing” written on its face.1 Upon receipt, the dispensing pharmacist must attach this written prescription to the original oral prescription. The pharmacist must notify the nearest DEA Diversion Field Office if the written prescription has not been received within 7 days; however, the pharmacist should remind the practitioner about the prescription before calling the DEA. FAXING PRESCRIPTIONS FOR SCHEDULE II SUBSTANCES A pharmacist may fill a faxed Schedule II prescription, provided that the original prescription is presented to the pharmacist and verified against the facsimile at the time of actual dispensing. The DEA regulations provide 3 situations in which a facsimile prescription for a Schedule II controlled substance can serve as the origi-

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nal prescription for dispensing. These 3 situations are provided in the accompanying Pharmacist Checklist. PRE- AND POST-DATING OF SCHEDULE II PRESCRIPTIONS The DEA released a final rule amending current regulations to allow practitioners to provide individual patients with multiple prescriptions for the same Schedule II controlled substance (Table 1).2 The prescriptions must be filled sequentially so that the combined effect allows a patient to receive, over time, a 90-day supply of that controlled substance. A pharmacist may not fill a prescription for a Schedule II controlled substance before the date noted on the prescription. Also, all prescriptions issued as multiple prescriptions must be dated and signed on the date of issuance (ie, the same date of issuance must be on each prescription). The final rule became effective on December 19, 2007. GENERAL REQUIREMENTS FOR SCHEDULE III–V SUBSTANCES A prescription issued by a practitioner for Schedule III, IV, and V substances may be communicated either orally, in writing, or by facsimile to the pharmacist, and it may be refilled if authorized on the prescription and if the pharmacist determines the refills to be appropriate. R EFILLS Whereas Schedule II prescriptions may not be refilled, Schedule III and IV prescriptions may be refilled if authorized on the prescription. However, the prescription may only be refilled up to 5 times within 6 months after the date written on the prescription. After 5 refills or after 6 months (whichever occurs first), a new prescription is required. Schedule V prescriptions may be refilled as authorized on the prescription and, under federal law, Schedule V refills have less stringent requirements. When a prescription for any controlled substance in Schedule III, IV, or V is refilled, information that must be entered on the back of the prescription includes the dispensing pharmacist’s initials, the date on which the prescription was refilled, and the amount of drug dispensed on that refill. If the pharmacist only initials and dates the back of the prescription, it will be assumed that the pharmacist dispensed a refill for the full face amount of the prescription.1 The DEA regulations provide that as an alternative to recording refill information on the back of a prescription, an automated data processing system may be used for the storage and retrieval of refill information for prescription orders

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Table 1. Key Provisions of the DEA Final Rule Regarding the Issuance of Multiple Prescriptions •

Confirms that a refill of a prescription for a Schedule II controlled substance is prohibited.

•

Allows an individual practitioner to issue multiple prescriptions authorizing the patient to receive a total of up to a 90day supply of a Schedule II controlled substance, provided the following conditions are met: o

Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;

o

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;

o

The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;

o

The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and

o

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.

•

Clarifies that the final rule should not 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.

•

A pharmacist may not fill a prescription before the date specified on a prescription that has been written in accordance with the new rule and contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date.

•

All prescriptions issued as multiple prescriptions must be dated and signed on the date of issuance (ie, the same date of issuance must be on each prescription).

DEA = US Drug Enforcement Administration. Reprinted with permission from American Pharmacists Association (APhA). APhA Summary of DEA Final Rule: Issuance of Multiple Prescriptions for Schedule II Controlled Substances. November 19, 2007. Available at: http://www.pharmacist.com/AM/Template.cfm?Section= Issues&TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=14622. Accessed September 17, 2008.2

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if certain conditions are fulfilled. These conditions are provided in the Pharmacist Checklist. TRANSFER OF PRESCRIPTION INFORMATION The DEA permits the transfer between pharmacies of original prescription information for Schedules III, IV, and V controlled substances for the purpose of refills on a 1-time basis, if permissible under state law. Pharmacies that share an online database containing information required for a valid prescription (such as in chain pharmacies) may transfer up to the maximum refills permitted by law and the prescriber’s authorization.1 ELECTRONIC CONTROLLED SUBSTANCE PRESCRIPTIONS Under the CSA, Electronic Prescriptions for Controlled Substances (EPCS) II through V are not considered valid prescriptions and, therefore, it is illegal to fill them. As such, a pharmacist who receives an EPCS should call the practitioner to obtain a verbal order for the medication (or written order if a Schedule II medication). But in light of the enactment of the Medicare Prescription Drug Improvement and Modernization Act, the DEA is addressing this issue with a proposed rule summarized in the Sidebar.3 CHANGES TO THE FACE OF A CONTROLLED SUBSTANCE PRESCRIPTION Upon verification of a controlled substance prescription, the pharmacist is permitted to make information-related changes (eg, adding or changing the patient’s address) provided by the patient or script bearer. However, the majority of other changes (ie, dosage form, drug strength, drug quantity, directions for use, and issue date) can be made only after consultation with, and agreement of, the prescribing practitioner. Such consultations and corresponding changes should be noted on the prescription, as well as on the patient’s medical record. 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.4 DISPENSING REQUIREMENTS FOR SCHEDULE II–V SUBSTANCES Pharmacists dispensing a prescription for a controlled substance must affix to the container a label showing the pharmacy name and address, the serial (prescription) number, date of initial dispensing, name of the patient, name of the prescribing practitioner,

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directions for use, and any cautionary statements contained on the prescription (as required by law).1 Federal US Food and Drug Administration regulations require that the label of any drug listed as a controlled substance in Schedules II, III, or IV contain the following warning: “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”1 This label is not required for a Schedule V prescription. PARTIAL D ISPENSING The pharmacist may partially dispense a prescription for a Schedule II controlled substance if he or she is unable to supply the full quantity of a written or emergency oral (telephone) prescription, provided that the pharmacist notes the quantity supplied on the front of the written prescription (or on a written record of the emergency oral prescription).1 The remaining portion should be dispensed within 72 hours of the first partial dispensing; however, if the remaining portion cannot be dispensed within that time frame, the pharmacist must notify the prescribing practitioner. The pharmacist may not dispense any additional quantity after 72 hours have passed, unless a new prescription is presented. A prescription for a Schedule II controlled substance for a terminally ill patient or long-term care facility patient may be partially filled for up to 60 days from the date of prescription issuance. The pharmacist may partially dispense a prescription for a Schedule III through V controlled substance if the pharmacist notes the quantity dispensed and initials the back of the prescription order.1 The partial dispensing may not exceed the total amount authorized in the prescription order and must occur within the 6-month time frame. It is permissible to dispense a prescription for a quantity that is less than the face amount prescribed, resulting in the actual number of dispensings being greater than the number of refills indicated on the prescription.1 DISPENSING REQUIREMENTS FOR CENTRAL FILL PHARMACIES Central fill pharmacies are required to comply with the same security requirements that are applicable to retail pharmacies, including the general requirement to have in place effective procedures to guard against theft and diversion of controlled substances.1 Central fill pharmacies are permitted to prepare both initial and refill prescriptions; however, they are not permitted to fill or mail prescriptions directly to the patient or individual practitioner. Retail pharmacies may

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SIDEBAR. DEA-PROPOSED RULE ON ELECTRONIC CONTROLLED SUBSTANCE PRESCRIPTIONS DEA is proposing to revise its regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. These regulations would also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These proposed regulations would be an addition to, not a replacement of, the existing rules. These regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing; additionally, the proposed regulations would reduce paperwork for DEA registrants who dispense or prescribe controlled substances and have the potential to reduce prescription forgery. The proposed regulations would also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Moreover, they would help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which would increase efficiency, and would reduce the amount of time patients spend waiting to have their prescriptions filled. DEA = US Drug Enforcement Administration. Reprinted with permission from 21 CFR Parts 1300, 1304, et al. Electronic prescriptions for controlled substances; proposed rule. Fed Regist. 2008;73(125):36721-36782. Available at: http://edocket.access. gpo.gov/2008/pdf/E8-14405.pdf. Accessed September 17, 2008.3

transmit Schedule II through V prescription information to a central fill pharmacy by fax, provided that the retail pharmacy maintains the original hard copy of the prescription and the central fill pharmacy maintains the facsimile. DEA also allows prescription information to be transmitted electronically by the retail pharmacy to the central fill pharmacy, as long the prescription information is maintained by both parties in a readily retrievable manner and is in compliance with state and federal recordkeeping requirements.1 ASSESSING LEGITIMATE MEDICAL PURPOSE SCHEDULED PRESCRIPTION Abuse of controlled substances is a serious social and health problem in the United States, and as healthcare professionals, pharmacists share responsibility for minimizing the prescription drug abuse and diversion problem. The law holds the pharmacist responsible for knowingly dispensing a prescription that was not issued in the usual course of professional treatment and, as such, the dispensing pharmacist must maintain constant vigilance against forged or altered prescriptions.1 Drug-seeking individuals use a

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variety of techniques to obtain controlled substances. In one scenario, patients looking for additional amounts of legitimately prescribed drugs may alter the practitioner’s prescription, or they may have printed prescription pads using a legitimate doctor’s name, but with a different call-back number that is answered by an accomplice to verify the prescription. Some individuals may call in their own prescriptions and give their own telephone number for call-back confirmation. Legitimate prescription pads may be stolen from practitioners’ offices and used to write prescriptions using fictitious patient names and addresses. Individuals may go to emergency departments in hopes of receiving a controlled substance prescription

Table 2. Characteristics of Prescriptions Not Issued for Legitimate Medical Issues and Forged Prescriptions The following criteria may indicate that a prescription was not issued for a legitimate medical purpose: • The prescriber writes significantly more prescriptions (or in larger quantities) compared to other practitioners in your area. • The patient appears to be returning too frequently. A prescription that should last for a month in legitimate use is being refilled on a biweekly, weekly, or even a daily basis. • The prescriber writes prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time. Drug abusers often request prescriptions for “uppers and downers” at the same time. • Patient appears presenting prescriptions written in the names of other people. • A number of people appear simultaneously, or within a short time, all bearing similar prescriptions from the same practitioner. • Numerous “strangers,” people who are not regular patrons or residents of your community, suddenly show up with prescriptions from the same practitioner. Characteristics of Forged Prescriptions • Prescription looks “too good”; the prescriber’s handwriting is too legible. • Quantities, directions, or dosages differ from usual medical usage. • Prescription does not comply with the acceptable standard abbreviations or appear to be textbook presentations. • Prescription appears to be photocopied. • Directions written in full with no abbreviations. Reprinted with permission from Appendix O. In: Pharmacist’s Manual: An Informative Outline of the Controlled Substances Act of 1970. 8th ed. Washington, DC: Drug Enforcement Administration; 2004. Available at: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/appendix/appdx_ o.htm. Accessed September 17, 2008.5

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for pain and then altering or copying it. The quantity of drugs prescribed and frequency of prescriptions filled are not necessarily indications of fraud or improper prescribing, especially if the patient is being treated with opioids for pain management and experiences tolerance or physical dependence. Table 2 includes characteristics of forged prescriptions and prescriptions not issued for legitimate medical issues.2,5 In preventing abuse of controlled substances, it is important to get to know the prescriber and his or her signature, the prescriber’s DEA registration number, and the patient. If there is a question about any aspect of the prescription, the prescriber should be called for verification or clarification. If a discrepancy is identified, the patient must have a plausible reason before the medication is dispensed. Pharmacists who suspect a forged or altered prescription should not dispense it and, instead, call their local police. In cases in which a pattern of prescription abuse is suspected, the State Board of Pharmacy or the local DEA office should be contacted.2 CONCLUSIONS Because virtually all practicing pharmacists dispense controlled substances on a regular basis, it is critical to maintain a current knowledge base of both federal and state regulations. After all, one must know the law in order to comply with it.

REFERENCES 1. Pharmacist’s Manual: An Informative Outline of the Controlled Substances Act of 1970. 8th ed. Washington, DC: Drug Enforcement Administration; 2004. Available at: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm 2/index.htm. Accessed September 17, 2008. 2. American Pharmacists Association (APhA). APhA Summary of DEA Final Rule: Issuance of Multiple Prescriptions for Schedule II Controlled Substances. November 19, 2007. Available at: http://www.pharmacist.com/AM/Template. cfm?Section=Issues&TEMPLATE=/CM/ContentDisplay.cfm&C ONTENTID=14622. Accessed September 17, 2008. 3. 21 CFR Parts 1300, 1304, et al. Electronic prescriptions for controlled substances; proposed rule. Fed Regist. 2008;73(125):36721-36782. Available at: http://edocket.access.gpo.gov/2008/pdf/E8-14405.pdf. Accessed September 17, 2008. 4. Office of Diversion Control. General questions and answers. US Department of Justice Drug Enforcement Administration Web site. Available at: http://www.deadiversion.usdoj.gov/ faq/general.htm. Accessed September 10, 2008. 5. Appendix O. In: Pharmacist’s Manual: An Informative Outline of the Controlled Substances Act of 1970. 8th ed. Washington, DC: Drug Enforcement Administration; 2004. Available at: http://www.deadiversion.usdoj.gov/pubs/ manuals/pharm2/appendix/appdx_o.htm. Accessed September 17, 2008.

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