DISPENSING REQUIREMENTS FOR CONTROLLED SUBSTANCES Alan R. Spies, RPh, JD, MBA, PhD * ABSTRACT The dispensing f cntrlled substances in cmpliance with federal regulatins is a functin that is critical t the day-t-day activities f pharmacists, and as such, this article reviews the majr Drug Enfrcement Administratin requirements in regard t prcessing and dispensing Schedule II thrugh V prescriptins. Regulatins n Schedule II prescriptins are relatively stringent, with refills being prhibited and verbal rders permitted nly in emergency situatins and with a prvisin that a written prescriptin is sent t the pharmacy within 7 days f the verbal rder. Regulatins fr Schedule III, IV, and V prescriptins are mre lenient, because prescriptins may be cmmunicated rally r by facsimile t the pharmacist in nnemergency situatins, and up t 5 refills within 6 mnths f the date written n the script are allwed. Als discussed are regulatins pertaining t electrnic cntrlled substance prescriptins, changes t the face f a cntrlled substance prescriptin, and central fill pharmacies. Requirements fr prcessing f scheduled prescriptins (eg, drug name, strength, dsage frm, quantity prescribed, directins fr use, and number f refills) and labels affixed t dispensed medicatins (eg, pharmacy name and address, prescriptin number, date f initial dispensing, and US Fd and Drug Administratin warning label prhibiting transfer f the script) are very specific. Assessing legitimate medical purpse f a scheduled prescriptin is a majr respnsibility fr pharmacists, and in this regard, several techniques that drug-seeking individuals may use in btaining cntrlled substances are described. (Adv Stud Pharm. 2008;5(8):245-249) *Assistant Prfessr f Pharmacy Administratin, Suthwestern Oklahma State University, Cllege f Pharmacy, Weatherfrd, Oklahma. Address crrespndence t: Alan R. Spies, RPh, JD, MBA, PhD, Assistant Prfessr f Pharmacy Administratin, Suthwestern Oklahma State University, Cllege f Pharmacy, 100 Campus Drive, Weatherfrd, OK 73096. E-mail: alan.spies@swsu.edu. Many federal and state regulatins gvern the distributin f cntrlled substances. Althugh mst pharmacists abide by these laws, a review f the majr aspects f these regulatins may minimize uncertainties that arise in the day-t-day dispensing f cntrlled substances and may, ultimately, imprve cmpliance with the Cntrlled Substances Act (CSA). This article includes a summatin, frm the US Drug Enfrcement Administratin (DEA), f the federal requirements fr pharmacist dispensing f cntrlled substances. Drugs and drug prducts under the jurisdictin f the CSA are divided int 5 schedules, with agents in Schedules II thrugh V categries having an accepted medical use in the United States. Fr all cntrlled substance prescriptins, the pharmacist must make certain that the prescriptin is dated and signed n the date when issued. Furthermre, the prescriptin must include the patient s full name and address, as well as the practitiner s name, address, and registratin number. 1 Federal law requires the prescriptin t include the drug name, strength, dsage frm, quantity prescribed, directins fr use, and number f refills. 1 In situatins in which an ral prescriptin is nt permitted, the prescriptin must be written in ink r indelible pencil, r it must be typewritten and signed by the practitiner. 1 GENERAL REQUIREMENTS FOR SCHEDULE II SUBSTANCES Schedule II substances require a written prescriptin that must be signed by the practitiner. Althugh many states have enacted time frames under which Schedule II substance prescriptins may be filled, federal law des nt place a time limit under which these prescriptins must be filled after being signed by the practitiner, nr des it place quantity limits n any prescriptins. Hwever, it is imperative fr the pharmacist t use prfessinal judgment in determining whether the prescriptin is still needed by the patient (eg, a narctic prescriptin filled several weeks after being written). University f Tennessee Advanced Studies in Pharmacy 245
EMERGENCY DISPENSING OF A SCHEDULE II SUBSTANCE Fr Schedule II substances, an ral rder is nly permitted in emergencies, which include situatins in which immediate administratin f the drug is necessary fr prper treatment f the intended ultimate user, when n alternative treatment is available (including a nn-schedule II substance), and when it is nt pssible fr the prescriber t prvide a written prescriptin at that time. 1 If, in the pharmacist s prfessinal judgment, a true emergency situatin arises, a practitiner may telephne a Schedule II prescriptin t the pharmacy, and the pharmacist may dispense the prescriptin, prvided that: 1. The drug prescribed and dispensed must be limited t the amunt needed t treat the patient during the emergency perid. Prescribing r dispensing beynd the emergency perid must be pursuant t a written prescriptin rder. 2. The prescriptin rder must be immediately reduced t writing by the pharmacist and must cntain all infrmatin, except fr the prescribing practitiner s signature. 3. If the prescriber is nt knwn t the pharmacist, the pharmacist must make a reasnable effrt t verify that the phne authrizatin came frm a valid practitiner by verifying the practitiner s telephne number with that listed in the directry and by making ther gd faith effrts t insure prper identity. 1 In these limited situatins, a pharmacist must receive, within 7 days, a written and signed prescriptin frm the practitiner fr the cntrlled substance with Authrizatin fr Emergency Dispensing written n its face. 1 Upn receipt, the dispensing pharmacist must attach this written prescriptin t the riginal ral prescriptin. The pharmacist must ntify the nearest DEA Diversin Field Office if the written prescriptin has nt been received within 7 days; hwever, the pharmacist shuld remind the practitiner abut the prescriptin befre calling the DEA. FAXING PRESCRIPTIONS FOR SCHEDULE II SUBSTANCES A pharmacist may fill a faxed Schedule II prescriptin, prvided that the riginal prescriptin is presented t the pharmacist and verified against the facsimile at the time f actual dispensing. The DEA regulatins prvide 3 situatins in which a facsimile prescriptin fr a Schedule II cntrlled substance can serve as the riginal prescriptin fr dispensing. These 3 situatins are prvided in the accmpanying Pharmacist Checklist. PRE- AND POST-DATING OF SCHEDULE II PRESCRIPTIONS The DEA released a final rule amending current regulatins t allw practitiners t prvide individual patients with multiple prescriptins fr the same Schedule II cntrlled substance (Table 1). 2 The prescriptins must be filled sequentially s that the cmbined effect allws a patient t receive, ver time, a 90-day supply f that cntrlled substance. A pharmacist may nt fill a prescriptin fr a Schedule II cntrlled substance befre the date nted n the prescriptin. Als, all prescriptins issued as multiple prescriptins must be dated and signed n the date f issuance (ie, the same date f issuance must be n each prescriptin). The final rule became effective n December 19, 2007. GENERAL REQUIREMENTS FOR SCHEDULE III V SUBSTANCES A prescriptin issued by a practitiner fr Schedule III, IV, and V substances may be cmmunicated either rally, in writing, r by facsimile t the pharmacist, and it may be refilled if authrized n the prescriptin and if the pharmacist determines the refills t be apprpriate. REFILLS Whereas Schedule II prescriptins may nt be refilled, Schedule III and IV prescriptins may be refilled if authrized n the prescriptin. Hwever, the prescriptin may nly be refilled up t 5 times within 6 mnths after the date written n the prescriptin. After 5 refills r after 6 mnths (whichever ccurs first), a new prescriptin is required. Schedule V prescriptins may be refilled as authrized n the prescriptin and, under federal law, Schedule V refills have less stringent requirements. When a prescriptin fr any cntrlled substance in Schedule III, IV, r V is refilled, infrmatin that must be entered n the back f the prescriptin includes the dispensing pharmacist s initials, the date n which the prescriptin was refilled, and the amunt f drug dispensed n that refill. If the pharmacist nly initials and dates the back f the prescriptin, it will be assumed that the pharmacist dispensed a refill fr the full face amunt f the prescriptin. 1 The DEA regulatins prvide that as an alternative t recrding refill infrmatin n the back f a prescriptin, an autmated data prcessing system may be used fr the strage and retrieval f refill infrmatin fr prescriptin rders 246 Vl. 5, N. 8 Nvember 2008
Table 1. Key Prvisins f the DEA Final Rule Regarding the Issuance f Multiple Prescriptins Cnfirms that a refill f a prescriptin fr a Schedule II cntrlled substance is prhibited. Allws an individual practitiner t issue multiple prescriptins authrizing the patient t receive a ttal f up t a 90- day supply f a Schedule II cntrlled substance, prvided the fllwing cnditins are met: Each separate prescriptin is issued fr a legitimate medical purpse by an individual practitiner acting in the usual curse f prfessinal practice; The individual practitiner prvides written instructins n each prescriptin (ther than the first prescriptin, if the prescribing practitiner intends fr that prescriptin t be filled immediately) indicating the earliest date n which a pharmacy may fill each prescriptin; The individual practitiner cncludes that prviding the patient with multiple prescriptins in this manner des nt create an undue risk f diversin r abuse; The issuance f multiple prescriptins as described in this sectin is permissible under the applicable state laws; and The individual practitiner cmplies fully with all ther applicable requirements under the Act and these regulatins, as well as any additinal requirements under state law. Clarifies that the final rule shuld nt be cnstrued as mandating r encuraging individual practitiners t issue multiple prescriptins r t see their patients nly nce every 90 days when prescribing Schedule II cntrlled substances. Rather, individual practitiners must determine n their wn, based n sund medical judgment, and in accrdance with established medical standards, whether it is apprpriate t issue multiple prescriptins and hw ften t see their patients when ding s. A pharmacist may nt fill a prescriptin befre the date specified n a prescriptin that has been written in accrdance with the new rule and cntains instructins frm the prescribing practitiner indicating that the prescriptin shall nt be filled until a certain date. All prescriptins issued as multiple prescriptins must be dated and signed n the date f issuance (ie, the same date f issuance must be n each prescriptin). DEA = US Drug Enfrcement Administratin. Reprinted with permissin frm American Pharmacists Assciatin (APhA). APhA Summary f DEA Final Rule: Issuance f Multiple Prescriptins fr Schedule II Cntrlled Substances. Nvember 19, 2007. Available at: http://www.pharmacist.cm/am/template.cfm?sectin= Issues&TEMPLATE=/CM/CntentDisplay.cfm&CONTENTID=14622. Accessed September 17, 2008. 2 if certain cnditins are fulfilled. These cnditins are prvided in the Pharmacist Checklist. TRANSFER OF PRESCRIPTION INFORMATION The DEA permits the transfer between pharmacies f riginal prescriptin infrmatin fr Schedules III, IV, and V cntrlled substances fr the purpse f refills n a 1-time basis, if permissible under state law. Pharmacies that share an nline database cntaining infrmatin required fr a valid prescriptin (such as in chain pharmacies) may transfer up t the maximum refills permitted by law and the prescriber s authrizatin. 1 ELECTRONIC CONTROLLED SUBSTANCE PRESCRIPTIONS Under the CSA, Electrnic Prescriptins fr Cntrlled Substances (EPCS) II thrugh V are nt cnsidered valid prescriptins and, therefre, it is illegal t fill them. As such, a pharmacist wh receives an EPCS shuld call the practitiner t btain a verbal rder fr the medicatin (r written rder if a Schedule II medicatin). But in light f the enactment f the Medicare Prescriptin Drug Imprvement and Mdernizatin Act, the DEA is addressing this issue with a prpsed rule summarized in the Sidebar. 3 CHANGES TO THE FACE OF A CONTROLLED SUBSTANCE PRESCRIPTION Upn verificatin f a cntrlled substance prescriptin, the pharmacist is permitted t make infrmatin-related changes (eg, adding r changing the patient s address) prvided by the patient r script bearer. Hwever, the majrity f ther changes (ie, dsage frm, drug strength, drug quantity, directins fr use, and issue date) can be made nly after cnsultatin with, and agreement f, the prescribing practitiner. Such cnsultatins and crrespnding changes shuld be nted n the prescriptin, as well as n the patient s medical recrd. The pharmacist is never permitted t make changes t the patient s name, cntrlled substance prescribed (except fr generic substitutin permitted by state law), r the prescriber s signature. 4 DISPENSING REQUIREMENTS FOR SCHEDULE II V SUBSTANCES Pharmacists dispensing a prescriptin fr a cntrlled substance must affix t the cntainer a label shwing the pharmacy name and address, the serial (prescriptin) number, date f initial dispensing, name f the patient, name f the prescribing practitiner, University f Tennessee Advanced Studies in Pharmacy 247
directins fr use, and any cautinary statements cntained n the prescriptin (as required by law). 1 Federal US Fd and Drug Administratin regulatins require that the label f any drug listed as a cntrlled substance in Schedules II, III, r IV cntain the fllwing warning: CAUTION: Federal law prhibits the transfer f this drug t any persn ther than the patient fr whm it was prescribed. 1 This label is nt required fr a Schedule V prescriptin. PARTIAL DISPENSING The pharmacist may partially dispense a prescriptin fr a Schedule II cntrlled substance if he r she is unable t supply the full quantity f a written r emergency ral (telephne) prescriptin, prvided that the pharmacist ntes the quantity supplied n the frnt f the written prescriptin (r n a written recrd f the emergency ral prescriptin). 1 The remaining prtin shuld be dispensed within 72 hurs f the first partial dispensing; hwever, if the remaining prtin cannt be dispensed within that time frame, the pharmacist must ntify the prescribing practitiner. The pharmacist may nt dispense any additinal quantity after 72 hurs have passed, unless a new prescriptin is presented. A prescriptin fr a Schedule II cntrlled substance fr a terminally ill patient r lng-term care facility patient may be partially filled fr up t 60 days frm the date f prescriptin issuance. The pharmacist may partially dispense a prescriptin fr a Schedule III thrugh V cntrlled substance if the pharmacist ntes the quantity dispensed and initials the back f the prescriptin rder. 1 The partial dispensing may nt exceed the ttal amunt authrized in the prescriptin rder and must ccur within the 6-mnth time frame. It is permissible t dispense a prescriptin fr a quantity that is less than the face amunt prescribed, resulting in the actual number f dispensings being greater than the number f refills indicated n the prescriptin. 1 DISPENSING REQUIREMENTS FOR CENTRAL FILL PHARMACIES Central fill pharmacies are required t cmply with the same security requirements that are applicable t retail pharmacies, including the general requirement t have in place effective prcedures t guard against theft and diversin f cntrlled substances. 1 Central fill pharmacies are permitted t prepare bth initial and refill prescriptins; hwever, they are nt permitted t fill r mail prescriptins directly t the patient r individual practitiner. Retail pharmacies may SIDEBAR. DEA-PROPOSED RULE ON ELECTRONIC CONTROLLED SUBSTANCE PRESCRIPTIONS DEA is prpsing t revise its regulatins t prvide practitiners with the ptin f writing prescriptins fr cntrlled substances electrnically. These regulatins wuld als permit pharmacies t receive, dispense, and archive these electrnic prescriptins. These prpsed regulatins wuld be an additin t, nt a replacement f, the existing rules. These regulatins prvide pharmacies, hspitals, and practitiners with the ability t use mdern technlgy fr cntrlled substance prescriptins while maintaining the clsed system f cntrls n cntrlled substances dispensing; additinally, the prpsed regulatins wuld reduce paperwrk fr DEA registrants wh dispense r prescribe cntrlled substances and have the ptential t reduce prescriptin frgery. The prpsed regulatins wuld als have the ptential t reduce the number f prescriptin errrs caused by illegible handwriting and misunderstd ral prescriptins. Mrever, they wuld help bth pharmacies and hspitals t integrate prescriptin recrds int ther medical recrds mre directly, which wuld increase efficiency, and wuld reduce the amunt f time patients spend waiting t have their prescriptins filled. DEA = US Drug Enfrcement Administratin. Reprinted with permissin frm 21 CFR Parts 1300, 1304, et al. Electrnic prescriptins fr cntrlled substances; prpsed rule. Fed Regist. 2008;73(125):36721-36782. Available at: http://edcket.access. gp.gv/2008/pdf/e8-14405.pdf. Accessed September 17, 2008. 3 transmit Schedule II thrugh V prescriptin infrmatin t a central fill pharmacy by fax, prvided that the retail pharmacy maintains the riginal hard cpy f the prescriptin and the central fill pharmacy maintains the facsimile. DEA als allws prescriptin infrmatin t be transmitted electrnically by the retail pharmacy t the central fill pharmacy, as lng the prescriptin infrmatin is maintained by bth parties in a readily retrievable manner and is in cmpliance with state and federal recrdkeeping requirements. 1 ASSESSING LEGITIMATE MEDICAL PURPOSE OF A SCHEDULED PRESCRIPTION Abuse f cntrlled substances is a serius scial and health prblem in the United States, and as healthcare prfessinals, pharmacists share respnsibility fr minimizing the prescriptin drug abuse and diversin prblem. The law hlds the pharmacist respnsible fr knwingly dispensing a prescriptin that was nt issued in the usual curse f prfessinal treatment and, as such, the dispensing pharmacist must maintain cnstant vigilance against frged r altered prescriptins. 1 Drug-seeking individuals use a 248 Vl. 5, N. 8 Nvember 2008
variety f techniques t btain cntrlled substances. In ne scenari, patients lking fr additinal amunts f legitimately prescribed drugs may alter the practitiner s prescriptin, r they may have printed prescriptin pads using a legitimate dctr s name, but with a different call-back number that is answered by an accmplice t verify the prescriptin. Sme individuals may call in their wn prescriptins and give their wn telephne number fr call-back cnfirmatin. Legitimate prescriptin pads may be stlen frm practitiners ffices and used t write prescriptins using fictitius patient names and addresses. Individuals may g t emergency departments in hpes f receiving a cntrlled substance prescriptin Table 2. Characteristics f Prescriptins Nt Issued fr Legitimate Medical Issues and Frged Prescriptins The fllwing criteria may indicate that a prescriptin was nt issued fr a legitimate medical purpse: The prescriber writes significantly mre prescriptins (r in larger quantities) cmpared t ther practitiners in yur area. The patient appears t be returning t frequently. A prescriptin that shuld last fr a mnth in legitimate use is being refilled n a biweekly, weekly, r even a daily basis. The prescriber writes prescriptins fr antagnistic drugs, such as depressants and stimulants, at the same time. Drug abusers ften request prescriptins fr uppers and dwners at the same time. Patient appears presenting prescriptins written in the names f ther peple. A number f peple appear simultaneusly, r within a shrt time, all bearing similar prescriptins frm the same practitiner. Numerus strangers, peple wh are nt regular patrns r residents f yur cmmunity, suddenly shw up with prescriptins frm the same practitiner. Characteristics f Frged Prescriptins Prescriptin lks t gd ; the prescriber s handwriting is t legible. Quantities, directins, r dsages differ frm usual medical usage. Prescriptin des nt cmply with the acceptable standard abbreviatins r appear t be textbk presentatins. Prescriptin appears t be phtcpied. Directins written in full with n abbreviatins. Reprinted with permissin frm Appendix O. In: Pharmacist s Manual: An Infrmative Outline f the Cntrlled Substances Act f 1970. 8th ed. Washingtn, DC: Drug Enfrcement Administratin; 2004. Available at: http://www.deadiversin.usdj.gv/pubs/manuals/pharm2/appendix/appdx_.htm. Accessed September 17, 2008. 5 fr pain and then altering r cpying it. The quantity f drugs prescribed and frequency f prescriptins filled are nt necessarily indicatins f fraud r imprper prescribing, especially if the patient is being treated with piids fr pain management and experiences tlerance r physical dependence. Table 2 includes characteristics f frged prescriptins and prescriptins nt issued fr legitimate medical issues. 2,5 In preventing abuse f cntrlled substances, it is imprtant t get t knw the prescriber and his r her signature, the prescriber s DEA registratin number, and the patient. If there is a questin abut any aspect f the prescriptin, the prescriber shuld be called fr verificatin r clarificatin. If a discrepancy is identified, the patient must have a plausible reasn befre the medicatin is dispensed. Pharmacists wh suspect a frged r altered prescriptin shuld nt dispense it and, instead, call their lcal plice. In cases in which a pattern f prescriptin abuse is suspected, the State Bard f Pharmacy r the lcal DEA ffice shuld be cntacted. 2 CONCLUSIONS Because virtually all practicing pharmacists dispense cntrlled substances n a regular basis, it is critical t maintain a current knwledge base f bth federal and state regulatins. After all, ne must knw the law in rder t cmply with it. REFERENCES 1. Pharmacist s Manual: An Infrmative Outline f the Cntrlled Substances Act f 1970. 8th ed. Washingtn, DC: Drug Enfrcement Administratin; 2004. Available at: http://www.deadiversin.usdj.gv/pubs/manuals/pharm 2/index.htm. Accessed September 17, 2008. 2. American Pharmacists Assciatin (APhA). APhA Summary f DEA Final Rule: Issuance f Multiple Prescriptins fr Schedule II Cntrlled Substances. Nvember 19, 2007. Available at: http://www.pharmacist.cm/am/template. cfm?sectin=issues&template=/cm/cntentdisplay.cfm&c ONTENTID=14622. Accessed September 17, 2008. 3. 21 CFR Parts 1300, 1304, et al. Electrnic prescriptins fr cntrlled substances; prpsed rule. Fed Regist. 2008;73(125):36721-36782. Available at: http://edcket.access.gp.gv/2008/pdf/e8-14405.pdf. Accessed September 17, 2008. 4. Office f Diversin Cntrl. General questins and answers. US Department f Justice Drug Enfrcement Administratin Web site. Available at: http://www.deadiversin.usdj.gv/ faq/general.htm. Accessed September 10, 2008. 5. Appendix O. In: Pharmacist s Manual: An Infrmative Outline f the Cntrlled Substances Act f 1970. 8th ed. Washingtn, DC: Drug Enfrcement Administratin; 2004. Available at: http://www.deadiversin.usdj.gv/pubs/ manuals/pharm2/appendix/appdx_.htm. Accessed September 17, 2008. University f Tennessee Advanced Studies in Pharmacy 249