in Handling Controlled Substances

Transcription

1 Chapter 7: The Pharmacy Technician s Responsibility in Handling Controlled Substances 4 Contact Hours By Bradley Gillespie, PharmD who has over 20 years experience spanning the regulatory, pharmaceutical biotech and human nutritional supplement industries. Author Disclosure: Bradley Gillespie and Elite Professional Education, LLC do not have any actual or potential conflicts of interest in relation to this lesson. Universal Activity Number (UAN): H04-T Activity Type: Knowledge-based Initial Release Date: June 1, 2015 Expiration Date: June 1, 2017 Target Audience: Pharmacy Technicians in a community-based setting. To Obtain Credit: A minimum test score of 70 percent is needed to obtain a credit. Please submit your answers either by mail, fax, or online at PharmacyTech.EliteCME.com. Learning objectives Understand the depth and breadth of the problems presented by the abuse of controlled substances. Appreciate the challenges faced by the Drug Enforcement Administration in its efforts to safely manage the use of controlled substances. Realize the critical value of a controlled system of distribution to achieve best practices in the transactional management of controlled substances. Recognize the basic foundations of controlled substance scheduling. Introduction This pharmacy technician continuing education course was developed with three key goals in mind: It will describe the abuse potential of controlled substances and the need to apply more rigorous controls than those required for other prescription medications. It will describe the unique challenges for pharmacy technicians in the management of controlled substances, from helping with the proper registration of the pharmacy to allow for the management of controlled substances, from ordering, managing, and dispensing of product to generating and maintaining adequate records. It will provide a high level summary of the federally mandated procedures that have been put in place to safeguard the drug distribution of controlled substances, including the prevention of diversion and abuse. As practicing pharmacist technicians, it is critical that we fully realize the potential hazards associated with the abuse of controlled substances. All actively practicing pharmacy technicians who come into contact with controlled substances must be totally aware and compliant with all of the laws governing their practice (which includes the entire cycle of registration with the Drug Enforcement Administration, from dispensing controlled substances to keeping proper records of all transactions). In addition, because of rapidly changing technologies, pharmacy technicians must be aware of laws Questions regarding statements of credit and other customer service issues should be directed to This lesson is $ Educational Review Systems is accredited by the Accreditation Council of Pharmacy Education (ACPE) as a provider of continuing pharmaceutical education. This program is approved for 4 hours (0.4 CEUs) of continuing pharmacy education credit. Proof of participation will be posted to your NABP CPE profile within 4 to 6 weeks to participants who have successfully completed the post-test. Participants must participate in the entire presentation and complete the course evaluation to receive continuing pharmacy education credit. Understand all of the processes needed to manage controlled substances throughout the drug-use process, as well as know which DEA form should be used to document each of the steps. Fully understand the requirements of both paper-based and electronic controlled substance record-keeping systems. Understand the requirements for inventorying controlled substances. Appreciate the extent of abuse allowed by the purveyance of controlled substances over the Internet, and recognize that there are unique requirements for such specialized commerce, separate and apart from that required for traditional brick and mortar pharmacies. governing the role of the Internet in the distribution of controlled substances. The controlled substances of choice for abuse are constantly evolving, just are methods of diversion. Although the U.S. government is doing all that it can to keep up with these changes, pharmacy technicians, on the front line of drug distribution, are key players in keeping our society safe and healthy while still providing the medications needed to treat legitimate medical issues. To do this to perfection, it is critical that pharmacy technicians are up-to-date on all aspects of the Controlled Substances Act and their responsibilities to make sure that these potentially hazardous medications are properly managed throughout the prescribing and distribution cycle. Although this course is designed to be comprehensive and thorough in its characterization of pharmacy practice as it is applied to controlled substances, it will not cover every eventuality that could be encountered. It also is critical to note that this course was developed based on applicable federal laws only. Every knowledgeable and competent pharmacy technician will also be well-versed in applicable state-specific controlled substance laws and how they apply to their respective practice settings. For sake of example, some state-specific regulations are discussed in the course where applicable to illustrate potential differences that may exist between the laws. PharmacyTech.EliteCME.com Page 60

2 Why do we need a Controlled Substances Act (CSA)? As early as the 1800s, when morphine and cocaine were discovered, Americans have been battling the problems caused by drug addiction and abuse. By the early 1900s, the United States, in the midst of its first serious drug epidemic, began the process of effecting restrictions designed to limit the availability of opium and coca. These restrictions were a success, severely curtailing the unsafe use of many dangerous drugs. By the time the United States entered World War II, drug abuse was not even considered a serious problem. 1 This vacation from drug abuse, though, was short-lived. By the time the 1960s were under way, new drugs presenting new challenges, such as marijuana, various psychedelics and amphetamines, were all the rage. The government realized that a new drug-based culture was developing, and rapidly acted to better understand and subsequently curb the new problem drugs. In 1973, the U.S. Drug Enforcement Administration (DEA) was formed with the express purpose of enforcing federal drug laws, with a specific focus on those with a high potential for abuse. 1 Although the use of illicit drugs remains a problem and the mission of DEA is currently the same, new challenges are now present in controlling the inappropriate use of prescription medications. Pharmacy technicians are in an ideal position to make a positive impact on this particular problem. Although any drug can be dangerous if not used properly, the DEA recognizes that certain drugs have a higher potential for dependency or abuse. Further, the agency fully appreciates that while some dangerous drugs have a legitimate medical use, many do not, and may be potentially more dangerous than others. 2 The Controlled Substances Act (CSA) of 1970 was designed as a comprehensive law that brings together a number of existing regulations and statutes regulating the manufacture and distribution of narcotics, anabolic steroids, depressants, and stimulants, and chemicals used in the illicit production of controlled substances. All substances falling under this law are then categorized based on their medicinal value, potential to cause harm and their prospect for abuse and addiction. 3 What is the DEA and what are its responsibilities? The primary role of the DEA is to strictly enforce all federal drug laws. In addition to enforcing drug laws, DEA also has the mandate to bring to justice any people or organizations involved in the growing, manufacture or distribution of controlled substances. Additionally, DEA is charged with supporting nonenforcement programs that are designed to reduce the presence of illicit controlled substances, both domestically and internationally. The CSA and its associated regulations formed its backbone-implementing federal requirements governing the disposition of both legal and illicit drugs. 4 While the mission of DEA is complex, its primary responsibilities include the following: 4 Investigating and preparing for prosecution major violators of controlled substance laws. Investigating and preparing for prosecution criminals and drug gangs responsible for violence and terrorizing of citizens. Managing a national drug intelligence program in cooperation with federal, state, local and foreign officials. Seizing for forfeiture assets derived from or intended to be used for illicit drug trafficking. Controlled Substance Act guidelines Based on the guidelines laid out in the CSA, all transactions involving controlled substances must take place within a closed system of distribution established by the U.S. Congress. By definition, this closed system requires that any parties that come into contact with a controlled substance, i.e., the manufacturers, distributors, prescribers, pharmacies and all others, need to be fully registered and compliant with DEA regulations. Included in that is a requirement that all involved parties are required to carry out strict accounting for all controlled substance transactions (manufacturer s batch records, pharmacy orders, physician prescriptions, dispensing records, and so on). All such records must be stored separate from other documents and be maintained in a format that is readily retrievable. 5 In cases where a state board of pharmacy is required to revoke the license of a pharmacy, DEA will typically request that the pharmacy also surrender its DEA registration. If the pharmacy should refuse, then DEA would seek administrative action to revoke the registration. Less serious infractions of full compliance may be dealt with through a Enforcing the provisions of the CSA on the manufacture, distribution and dispensing of legally produced controlled substances. Working with federal, state and local agencies (as well as foreign governments) to reduce the availability of illicit drugs of abuse in the U.S. market through nonenforcement measures, such as crop eradication, crop substitution and training. Coordinating with the U.S. secretary of state and U.S. ambassadors on all programs associated with drug law enforcement in foreign countries. Liaise with the United Nations, Interpol and other organizations on matters related to international drug control programs. In the context of pharmacy, the DEA has two major jobs: prevention of the diversion and abuse of controlled substances, while at the same time ensuring that the supply of legal controlled substances remains available to meet legitimate needs for these drugs. To carry out this important mission, DEA works hand-inhand with state, local and other federal authorities. 5 letter of admonition or an administrative hearing. In cases where there is inadequate evidence to justify a full prosecution, DEA may apply criminal or civil sanctions to protect public health and safety. 5 Although not part of the CSA, DEA is also interested in managing the sale of over-the-counter products containing ephedrine, phenylpropanolamine and pseudoephedrine, because these substances can serve as the starting material in the manufacture of dangerous amphetamine-like drugs. According to the Combat Methamphetamine Epidemic Act of 2005, these products are categorized as schedule listed chemicals (SLCS). The sale of SLCS is limited to 3.6 grams at a time, requires that they be locked behind the pharmacy counter, and that a log be maintained of all purchases. Monthly sales are limited to 9 grams per month per purchaser, and each seller is required to certify that he or she is in compliance with these requirements. 6 A more detailed description of the Combat Methamphetamine Epidemic Act of 2005 is offered below. Page 61 PharmacyTech.EliteCME.com

3 What is scheduling? The CSA lists substances that fell under its control when the act was put into place in Additionally, since then, about 160 new substances have been added, removed or moved from one schedule to another. To view the current official list, it is likely best to consult the most current issue of Title 21 Code of Federal Regulations Part Schedule I: Schedule I controlled substances either have no currently medically acceptable use in the United States, a lack of accepted safety for use even if properly medically supervised, or have a high potential for abuse. Schedule 1 substances include MPPP, heroin, marijuana, lysergic acid diethylamide (LSD), peyote, ecstasy and methaqualone. Additionally, some materials can be temporarily included in schedule Schedule II: Controlled substances categorized as schedule II all have a high potential for abuse and can lead to severe psychological or physical dependence. Schedule II narcotics include codeine, morphine, hydromorphone (Dilaudid), oxycontin (OxyContin, Percocet), Methadone (Dolphine), meperidine (Demerol), fentanyl (Sublimaze, Duragesic), morphine, codeine and opium. Schedule III: Controlled substances in this schedule generally are considered to have a potential for abuse less than substances listed in schedules I or II, and all have a medically acceptable use in the United States. The abuse of these drugs may lead to moderate or low physical dependence or high psychological dependence. Schedule III drugs include chlorphentermine, secobarbital, products containing less than Schedule IV: Compared to controlled substances categorized in schedule II and III, substances in schedule IV have a low potential for abuse or dependence and all have a medically acceptable use in the United States. Schedule IV items include preparations containing not more than 1 milligram of difenoxin and not less than 25 micrograms of Schedule V: Compared to controlled substances categorized into schedules I, II, III and IV, substances in this schedule have a low potential for abuse and consist primarily of preparations containing limited quantities of certain narcotics. All controlled substances categorized as schedule V have a medically acceptable use in the United States. In many cases, Combat Methamphetamine Epidemic Act of 2005 Methamphetamine ( meth ) is a highly addictive, dangerous and illegal drug. Although there are a number of chemical processes that can be used to manufacture methamphetamine, ephedrine, pseudoephedrine and phenylpropanoloamine, safe, effective and widely used over-the-counter medications can be used as starting materials in the manufacture of methamphetamine. 15 The Combat Methamphetamine Epidemic Act of 2005 became law in March 2006 and was effective immediately. This act was designed primarily to affect persons or establishments selling products containing ephedrine, pseudoephedrine and phenylpropanolamine. As defined in the law, a regulated seller means a retail distributor (including pharmacies). Further, the law defines a retail sale as the purchase of one of the described products at a retail distributor, further Controlled substances that fit under the CSA are currently divided into five schedules, based on whether the drug has an acceptable medical use in the United States, its relative potential for abuse, and likelihood of causing dependence when abused. Some examples from each schedule are listed below: I, subject to emergency scheduling. 8 Schedule I controlled substances can be distinguished from other controlled substances by the fact that prescriptions for these drugs may not be written, and these drugs are not easily available for clinical use. 9 Nonetheless, some of these compounds are tested in well-controlled clinical trials under appropriate levels of supervision. Schedule II stimulants include cocaine, amphetamine (Dexedrine, Adderal), ethamphetamine (Desoxyn) and methylphenidate (Ritalin). Miscellaneous schedule II controlled substances include amobarbital, glutethimide and pentobarbital. 10 Although these drugs do have a high potential for abuse, because they do have currently accepted medical uses in the United States, they can be prescribed with severe restrictions milligrams of hydrocodone per dosage unit (Vicodin), and products containing no more than 90 milligrams of codeine per dosage unit (Tylenol with codeine) and buprenorphine (Suboxone). Additional schedule III drugs include benzphetamine (Didrex), phendimetrazine, ketamine and anabolic steroids such as Depo- Testosterone. 12 atropine sulfate per dosage unit, alprazolam (Xanax), clonazepam (Klonopin), chlorazepate (Tranxene), diazepam (valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril) and triazolam (Halcion), fenfluramine, pentazocine and sibutramine. 13 preparations appearing in schedule V are used for their antitussive, anti-diarrheal and analgesic properties. Examples of schedule V products include preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC, Phenergan with Codeine and ezogabine). 14 defined as a grocery store, general merchandise store, drug store or other entity. The law sets daily sales limits of ephedrine, phenylpropanolamine and pseudoephedrine at 3.6 grams per purchaser, without regard to how many individual sales are transacted, and requires that all non-liquid forms of these medications be packaged in 2-unit blister packages whenever technically possible. Monthly purchases may not exceed 9 grams per purchaser. The law also affects sellers who distribute using mail order. Such distributors are required to identify the purchaser prior to shipment of the product and submit mail order reports. Mail orders are limited to 7.5 grams of medication per 30-day period. PharmacyTech.EliteCME.com Page 62

4 Product placement Distributors of affected products must place merchandise in such a way that customers do not have direct access before completion Logbook provisions Distributors of affected products are required to keep a written or electronic logbook of sales that includes, at a minimum: Name of product. Quantity sold. Names and addresses of buyers. Date and time of sales. These logbook requirements apply only to larger purchases and are not relevant to single sales of packages containing up to 60 mg of pseudoephedrine. The distributor may not complete the sale of the product without first checking the buyer s government-issued photo identification card. The purchaser is required to sign the logbook and enter the information prescribed above. It is the seller s responsibility to ensure that the information entered into the logbook is accurate, based on the identification presented. Further, it is the responsibility of the seller to enter into the logbook information describing the name of product and the quantity dispensed. Self-certification and training Each distributor of affected products must self-certify that everyone responsible for delivering such products to consumers has undergone adequate training to ensure that each understands the requirements that apply to the sale of these products. Such self-certification must be submitted to the U.S. attorney general, and each distributor must retain a Pharmacy registration Before a pharmacy can legally dispense any controlled substances, it must go through the formal process of becoming registered with the DEA. Registration is accomplished using a standardized DEA Form 224, which can be completed on paper or in an online format. When completing DEA Form 224, the applicant must be sure to identify all of the drug schedules that will be dispensed because the registration is specific to the prospectively identified category of controlled substances. Moreover, the applicant must be fully aware of any applicable state requirements; federal registration with DEA does not override state restrictions or laws. As such, usually applicants should contact any applicable state licensing authorities before completing DEA Form 224. In some states, a state-sanctioned, separate controlled substances registration number is required. In that case, this information should be included in the federal application. 17 However, this sequence may not be appropriate in all states. For example, the Idaho Board of Pharmacy suggests first applying for DEA registration and then submitting a completed application for permission to manage controlled substances to the state. 18 Clearly, best How are controlled substances ordered? Participation in the process of ordering medications is a key role of practicing pharmacy technicians. The procedure for ordering many medications, including certain schedules III-V controlled substances, follows procedures similar to that of ordinary medications. Nonetheless, the process of ordering schedule II controlled substances requires specialized processes that follow a specific protocol. DEA Form 222 must be completed to document all orders for schedule II controlled substances. Specific questions that may be encountered by a pharmacy technician when completing DEA Form 222 are discussed below. 21 of the sale (must be kept behind the counter, or in a locked cabinet inaccessible to customers). Lastly, the logbook is required to contain a notice to purchasers noting that: Entering false statements or misrepresentations in the logbook may subject the purchaser to criminal penalties under 18 U.S.C and such notice must specify the maximum fine ($250,000.00) and term of imprisonment (5 years). The distributor is required to maintain the logbook with all entries for a period of no less than two years after the final entry was made. The only purpose of the logbook is to comply with the provisions of the CSA and to protect public health and safety (for example, in the case of a product recall). Any distributor that, in good faith, releases the contents of their logbook to federal, state of local law enforcement officials is immune from liability for such release unless it can be proven that such release is shown to be grossly negligent or a part of willful misconduct. copy. Separate self-certifications are required for each place of business in the event that one entity operates more than one establishment. Copies of the self-certification must be made available to appropriate federal, state or local officials, as requested. 16 practices suggest that the applicable laws and regulations from each state must be researched and closely followed to ensure appropriate compliance. After the pharmacy receives DEA registration allowing it to order and dispense controlled substances, it will be issued a certificate of DEA registration that needs to be displayed in a prominent location in the vicinity of where the controlled substances are stored. This certificate and all related documents need to be kept separate from the other pharmacy papers and readily available for inspection by DEA or any authorized state or federal official. 19 DEA registration is valid for a period of three years. Within 60 days before the registration expires, renewal applications are automatically mailed to the pharmacy. As such, it is critical that any changes in address are immediately reported in writing to DEA to ensure proper delivery. The U.S. Postal Service will not forward renewal applications. The registration is renewed using DEA Form 224a. Should the pharmacy move to a new state, the renewal application should include a copy of the new state license and state controlled substance registration. 20 Question: If a wholesaler receives a DEA Form 222 with only minor misspellings in the name or address of the registrant, can it be accepted? Answer: Yes. A DEA Form 222 with only minor typographical errors can be accepted. The DEA Form 222 is acceptable in cases where there is no question as to what product is described in the document, even with misspellings in the name of the controlled substance. Page 63 PharmacyTech.EliteCME.com

5 Question: If certain sections of DEA Form 222 are not filled in by the pharmacy placing the controlled substance order, can the wholesaler fill in the missing sections? Answer: The wholesaler is permitted to fill in some missing sections. Acceptable sections include: Date of the form. The wholesaler may enter the date on DEA Form 222. If possible, the date entered should be determined based on the issue date of the document. The DEA Form 222 would be considered valid if the date of issuance is no more than 60 days from the date of receipt of DEA Form 222 at the wholesaler. Size of the package. The intended size of the package cannot be completed by the wholesaler if omitted by the orderer unless the specific product is available in only one size. In cases where multiple sizes are available, the wholesaler cannot enter the package size, and the line item with the missing package size must be voided. Strength of the controlled substance. Analogous to the missing package size situation, if the controlled substance is available in only one strength, there is no requirement to indicate the strength of the product in the name of drug section of DEA Form 222. Nonetheless, if the controlled substance is available in multiple strengths, then the wholesaler may not provide this missing information, and the line item with the missing strength must be voided. Last line completed. The Last line completed area of DEA Form 222 must always be completed by the orderer. If the orderer should enter an incorrect number in this section, for example, an incorrect tally of the total number of packages ordered, the entire DEA Form 222 is considered invalid and must be voided. Storage of controlled substances Because of the potential for diversion and abuse of controlled substances, the law is clear in its description of their storage requirements. The key elements listed here were abstracted from the UC-San Diego controlled substances program, which adheres to the provisions spelled out in the CSA. They can be kept in mind when developing a sound and secure storage strategy: Controlled substances must be stored according to their schedule number. Schedule II-V controlled substances must be kept in a locked cabinet or drawer that is inaccessible from either above or below. The following ancillary equipment must be installed, according to the following standards: Padlock and hinges: The mounting bolts or screws attaching the hinges and hasp must be inaccessible when the door is closed and the lock is fastened. Question: Are there any circumstances where a wholesaler can accept a DEA Form 222 when the size of the container or strength is incorrectly described on the form? Answer: In cases where there is no question about the strength and size of the controlled substance ordered, it is appropriate for the wholesaler to accept a DEA Form 222 with such errors. Nonetheless, if the controlled substance is available in containers of different sizes or strengths, then this missing information may not be provided by the wholesaler, and the line item with the missing container size or strength must be voided. For ordering schedules III-V controlled substances, documentation similar to that required for ordering conventional prescription medications is required. Typically, when ordering schedules III-V controlled substances, the pharmacy technician should be sure to maintain either an invoice or packing slip that documents, at a minimum, when the products were received, and confirms the accuracy of the order received to that placed with the wholesaler. Further, some additional information must be captured on the invoice or packing slip, including the actual name of the controlled substance product, the formulation type, the total number of containers, and the number of dosage units per container. All documents generated describing the order and receipt of all controlled substances, schedule II-V, must be maintained using some system that keeps the documents separate from other pharmacy papers and in a state that is readily retrievable for inspection by either DEA or other relevant federal or state authorities. 5 Safes and steel cabinet equivalents: Such containers must either weigh in excess of 750 pounds or be cemented or bolted to the floor or wall. Storage units: Storage must be adequately secure to indicate forced entry. Drawers: Drawers used to store controlled substances need to be either the upper or lower drawers in the stack. The use of the top drawer is preferred. It is important to remember that storage facilities identified for controlled substances must be used only for controlled substances, and all contents must be properly recorded in the applicable inventory control logbooks. One last thing to keep in mind is to never transfer controlled substances from their original container to an alternative container. Controlled substance storage facility access restrictions When developing standard operating procedures for managing controlled substances in your pharmacy, there are several key precautions to keep in mind. All access to controlled substances must be restricted to a prospectively prepared list of authorized personnel, who must always follow the following precautions: Maintain any keys to storage areas in the physical custody of authorized personnel at all times. It is acceptable to produce multiple copies of keys for assignment to authorized personnel. Should an authorized person leave his or her position at the pharmacy, it is critical to: Change the combinations on any applicable combination locks. Retrieve the authorized individual s keys prior to departure. Document the change in personnel in the applicable inventory log book. Ensure that the list of authorized personnel is modified to omit the departing person s name. PharmacyTech.EliteCME.com Page 64

6 How to legally transfer controlled substances Although schedule II controlled substances typically are ordered using DEA Form 222 for sale by the ordering pharmacy, there may be situations when these controlled substances need to be transferred to another, properly registered facility, such as another pharmacy, the manufacturer or a wholesaler. In such cases, a DEA Form 222 must also be completed to document this change in disposition. In cases where there is a need to transfer schedules III-V controlled substances between properly registered facilities, all attributes of the transfer must be properly documented, either electronically or in writing. Necessary details include the following attributes: the date of the transfer, and the quantity, dosage form, strength and name of the schedules III-V controlled substance involved. In addition to these product-specific details, the documents must also include the DEA registration numbers of all involved parties and their names and addresses. 22 Although certain themes remain constant between different sorts of transfers, some key requirements are specific to the type of transfer. Transfer of controlled substances between pharmacies Should a pharmacy cease operations or change ownership, it is legal to transfer custody of its controlled substance inventory to another properly licensed and registered pharmacy as long as the following guidelines are followed: A complete and comprehensive inventory must be taken on the day of transfer. Documentation of this inventory must include the drug name, dosage form, strength, quantity and date transferred. A DEA Form 222 or its electronic equivalent must be generated to document the transfer of all schedule II controlled substances. Transfer of controlled substances to the original supplier or manufacturer Any pharmacy that has custody of a controlled substance may return it to the original manufacturer or supplier as long as it is properly registered with DEA. The pharmacy initiating the transfer must properly document the transfer. Proper documentation must include the following written information: The date the transfer occurred. The quantity, strength and dosage form of the involved controlled substance. This inventory will form the basis of the final inventory for the pharmacy that is ceasing operation and transferring custody of controlled substances. At the same time, this inventory can serve as the initial inventory of the acquiring pharmacy. Accurate and complete copies of the inventory must be included in the records of both pharmacies. No submission to DEA is required for this inventory, but it is critical to note that the inventory documents must be maintained by both businesses for a period of not less than two years. The DEA registration number, name and address of the supplier or manufacturer who received the controlled substance. In the case where schedule II controlled substances change custody, the official record will be DEA Form 222 or its electronic equivalent. While no submission to DEA is required for this inventory, it is critical to note that the inventory documents must be maintained by both businesses for a period of not less than two years. 5 What if controlled substances are lost or stolen? DEA is very serious about the management of controlled substances and considers the theft or loss of controlled substances a very serious situation. If a significant loss (based on the discretion of the pharmacy is there a likely explanation for the loss?) or theft of a controlled substance occurs at a pharmacy, this needs to be reported to DEA within one business day. Theft or significant loss The actual circumstances of the significant loss or theft should be documented using DEA Form 106. A completed DEA Form 106 should be sent to the local DEA division field office. Examples of the information needed to complete DEA Form 106 include the following items: name and address of the pharmacy; DEA registration number; date of the theft or loss; contact information for any involved law enforcement officials; type of theft, any identifying marks on the labels of the containers involved; and a listing of all controlled substances missing. In-transit loss If all or part of an in-transit shipment of a controlled substance does not arrive at its intended destination, the responsibility for reporting this loss falls on the wholesaler. After the pharmacy has taken custody Breakage and spillage From time to time, breakage or spillage of a controlled substance is expected in the practice of a pharmacy technician. Such losses do not constitute a reportable loss. If there is breakage or spillage, any controlled substance that can be recovered must be disposed of according to applicable DEA regulations. Such disposal must be Theft of a controlled substance constitutes a criminal event that should also be reported to the local police and state regulatory authorities, in addition to notifying DEA. If there is any question of whether a crime has been committed, the pharmacy technician should take a conservative approach, and work with the pharmacist to properly report the event. If, after DEA notification, it is determined that no theft or loss occurred, completion of DEA Form 106 is not required. Nonetheless, the pharmacy must notify DEA of this fact in writing to resolve the initial report. A copy of submitted DEA Form 106 must be maintained by the issuing pharmacy for a period of no less than two years. Although the management of significant losses is similar, regardless of circumstances, some differences do exist, and are explained in greater detail below: of the controlled substance, it is the responsibility of the pharmacy to report the loss. In either case, the loss is reported to DEA using DEA Form 106. reported to DEA using DEA Form 41 (Registrants, Inventory of Drugs Surrendered). A copy of submitted DEA Form 41 must be maintained by the pharmacy for a period of no less than two years. Page 65 PharmacyTech.EliteCME.com

7 Controlled Substance Registrant Protection Act of 1984 (CSRPA) The CSRPA was enacted to provide some protection to pharmacies registered to distribute controlled substances. According to the CSRPA, thefts and robberies of controlled substances can be federally investigated in some cases if any of the following conditions are met: The value of the affected controlled substances exceeds $500. Execution of the crime involved interstate or foreign commerce. A person was killed or seriously injured as a result of the crime. The CSRPA also describes the penalties that may be applied to perpetrators convicted of violating its provisions: 5 Burglary or robbery A maximum fine of $25,000 and/or 20 years imprisonment. If a dangerous weapon was involved, the maximum penalty increases to a fine of $35,000 and/or 25 years imprisonment. If the crime resulted in death, the penalty can be as high as a $50,000 fine and/or life imprisonment. Unfortunately, theft, including armed robberies, is occurring at alarming frequency by people seeking to procure controlled substances for illicit use. The following case, though, illustrates the critical role that an alert pharmacy technician can play in countering such acts. What records need to be kept on controlled substances? As an underlying philosophy, if a pharmacy technician should determine that conflict exists within the requirements laid out in federal versus state requirements for record keeping, the pharmacy must develop a record keeping system that is compliant with all applicable laws and requirements. Pharmacies need to maintain comprehensive, complete and current records for each controlled substance in their inventory. These documents need to provide full accountability for all controlled substances from the time that the controlled substance is ordered until it is dispensed to the ultimate end user. All such required records need to be maintained in such a way that they can be readily retrieved for at least two years for inspection by DEA or other authorized federal or state regulators. All schedule II-related documents must be kept separate from all other pharmacy papers. Schedules III-V-related documents may be either stored separately or in such a way that they can be readily separated from other business records. DEA is clear on the definition of readily retrievable. Key elements include the following: Police in Wisconsin recently gave credit to two alert pharmacy technicians for helping to apprehend a man responsible for a series of oxycodone thefts and robberies from pharmacies in Madison, Wisconsin, and surrounding areas. In this case, the individual entered the pharmacy, and asked whether a prescription was ready for another person. A pharmacy technician answered no, and the man left the store. Before he was able to leave, though, the two pharmacy technicians on duty recognized the man as a suspect in previous thefts from other area pharmacies. The police were notified, and the suspect was arrested outside of the store. The arresting officers found knives in his pocket, and the suspect admitted that he had planned to rob the pharmacy. Because of the number of crimes under investigation, the FBI is participating in the investigation of the thefts. Local police estimate that in excess of $87,000 worth of prescription medications has been stolen in the string of thefts under investigation, occurring over a period of approximately four months. 23 Records that are stored electronically or mechanically must be able to be separated from other records in a reasonable amount of time. They must be able to be readily identified by an asterisk, redline or in some other visually identifiable manner. Controlled substance documents that must be maintained by a pharmacy include: DEA Form 222 (paper or electronic equivalent) for all schedule II controlled substances. Power of attorney authorization describing who can sign forms. Any receipts or invoices involved in the procurement of schedules III-V controlled substances. All inventory records of controlled substances. Any record of controlled substance transfers between registered facilities. Records of any dispensing of controlled substances. Reports of any theft or significant loss of controlled substances (DEA Form 106, when applicable). Inventory of drugs surrendered (DEA Form 41, when applicable). DEA registration certificate. Self-certification certificate or logbook documenting adherence to the Combat Methamphetamine Epidemic Act of Prescription records DEA does not stipulate whether pharmacies should maintain their prescription records using either an electronic or paper-based system. The correct system for each pharmacy will be determined by the specifics of its operation and the preference of the operator. Nonetheless, there are few central themes to keep in mind when selecting a record-keeping system: All systems must accommodate both federal and state requirements. All prescription records must be kept in a format that makes them readily retrievable by DEA and state authorities. Pharmacies have three different options to satisfy DEA record-keeping requirements: Paper option 1 (three separate files) A separate file describing all schedule II controlled substances dispensed. A separate file describing all schedules III-V controlled substances dispensed. A separate file for all non-controlled substances dispensed. Paper option 2 (two separate files) A separate file for all schedule II controlled substances dispensed. A separate file for all other drugs (schedules III-V controlled substances and uncontrolled substances). If this approach is adopted, then all controlled substance prescriptions must be marked with a red C stamp at least one inch high. Electronic prescription records (Option 3) Key elements of electronic record keeping systems include: In cases where a prescription is created, signed, transmitted and received electronically, all records related to that prescription need to be maintained by the pharmacy electronically. All electronic records for a prescription need to be kept for at least two years from either the date they were created or received by the pharmacy. It is important to remember that this record retention time may be superseded either at present or in the future by applicable federal or state law. PharmacyTech.EliteCME.com Page 66

8 Controlled substance records need to be readily retrievable from all other records. Electronic controlled substance records must be either easily readable or rendered into a format that any person can read. All electronic record keeping systems need to be maintained in a manner meeting the requirements spelled out in 21 C.F.R Although the records can be maintained on computers or servers that are remotely located, the records must be readily retrievable at the registered location upon request of DEA or other law enforcement officials. Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed and date filled. 5 Pharmacy technicians, especially after completing this course, certainly are aware of the importance of complying with all aspects of the CSA, including record keeping. Nonetheless, to reinforce the seriousness of DEA and its treatment of the law, it is useful to consider the recent (April 2013) settlement reached between CVS Pharmacy and DEA. CVS agreed to pay an $11 million penalty to settle claims made against it for record-keeping violations under the CSA. According to a DEA press release, CVS violated the CSA and record-keeping regulations by: 1. The creation, entry and maintenance of dummy DEA registration numbers for prescribers on dispensing records, some of which were subsequently provided to state prescription monitoring programs. 2. Dispensing prescriptions for prescribers with invalid DEA registration numbers. 3. Entering and maintaining store records, including prescription bottle labels containing DEA registration numbers of nonprescribing practitioners, instead of the DEA registration numbers of the actual prescriber. Although CVS was not required to admit liability, and the government did nothing to concede the legitimacy of its claims, CVS did acknowledge publicly that each of its DEA-registered stores is required to comply with CSA-mandated record-keeping requirements as well as any regulations that may be implemented in the future. 24 All of the CSA violations that CVS was accused of are well within the practice scope of pharmacy technicians. As such, an astute pharmacy technician serves in an ideal role to help ensure that his or her practice remains compliant with all applicable laws. What are the inventory requirements for controlled substances? One task in which pharmacy technicians play an integral role is inventorying controlled substances. By definition, an inventory is a comprehensive, complete and accurate listing of all forms of controlled substances in the possession of the DEA-registered pharmacy. The method of inventorying varies by type and bottle size of controlled substance. An actual, physical count is required of all medications categorized as schedule II controlled substances. Actual counts also are required for schedules III-V controlled substances contained in bottles holding more than 1,000 dosage units. For smaller containers of schedules III-V controlled substances, an estimated count will suffice. The CSA mandates that all documents of inventory activities be maintained within a registered location in a readily retrievable manner for a period of no less than two years. Further, all documents on the inventory of schedule II controlled substances must be kept separate from documents from the inventory of all other controlled substances. The CSA describes multiple types of inventories. Different inventories include the following: Initial inventory When an initial DEA registration is granted, the pharmacy is required to conduct what is called an initial inventory. The initial inventory is a count of every controlled substance (regardless of schedule) in its possession (either actual, or estimated, as described above). Even in cases where there are not yet any controlled substances in its possession, the pharmacy must still complete the required documentation, showing a zero inventory. While there is no stipulation that the inventory be submitted to DEA, the Code of Federal Regulations does provide an outline of the information that needs to be included in the initial inventory documentation. Key elements include: The date that the inventory was conducted. A statement of what time of day the inventory was conducted, at the start or close of business. The descriptive name of each controlled substance inventoried. The formulation of each controlled substance inventoried, for example, 20 mg tablet. The size of each container, i.e., the number of dosage units per container, for example, a 1,000-tablet bottle. The number of containers of each finished form, for example, number: 6; 50-tablet bottles. A count of each controlled substance in possession of the pharmacy (count to be conducted as described above). Although not required, DEA suggests that inventory record documents include the DEA registration number name, address of the pharmacy, and the signature of the person ultimately responsible for the conduct of the inventory. Biennial inventory Following the initial inventory, each pharmacy registered to dispense controlled substances is required to take a biennial (every two years) inventory. All of the information required for the initial inventory is required for the biennial inventory. While the exact date of the biennial inventory is not described in the CSA, it must occur within two years Newly scheduled controlled substance inventory On some occasions, a drug that was not previously scheduled is scheduled. In other cases, a controlled substance can be re-scheduled. Should either of these occur, an inventory (with the count completed, as described above) needs to be conducted as of the effective date of re-scheduling or initial scheduling. As with initial and biennial of the previous inventory. As with the initial inventory, there is no requirement to submit inventory documents to DEA, although they must be maintained in a readily retrievable state for a period of no less than two years. inventories, all related documents must be maintained in a readily retrievable state for a period of no less than two years. 5 Page 67 PharmacyTech.EliteCME.com

9 What are the prescription requirements for controlled substances? Although there are similarities between prescription format and requirements for controlled substances and ordinary prescriptions, the astute pharmacy technician will be aware of several attributes unique to orders for controlled substances. Key ideas to keep in mind are described below. Schedule II controlled substances Except in cases where directly dispensed by the practitioner (nonpharmacist) to the ultimate patient, schedule II controlled substances may not be dispensed without the written prescription of an authorized practitioner except in certain emergency situations. In such circumstances, schedule II controlled substances can be dispensed as Schedule III and IV controlled substances Except in cases where directly dispensed by the practitioner (nonpharmacist) to the ultimate patient, schedule III and IV controlled substances may be dispensed with a written or oral prescription (if the prescription is given by an oral order, it shall be promptly reduced to a written format by the pharmacist 25 ). Such prescriptions may a result of an oral prescription, provided that the oral prescription is followed up with a complete written prescription within seven calendar days. Refills are never permitted for prescriptions written for schedule II controlled substances. 5 not be filled or refilled more than six months after the date that the prescription was originally written. Moreover, the prescription may not be refilled more than five times after the original filling unless properly renewed by the prescriber. 5 Schedule V controlled substances No schedule V controlled substances may ever be dispensed for any reason other than for a medically valid use. 5 Non-prescription drugs with the potential for abuse If it ever appears to the U.S. attorney general that a drug not considered a prescription drug should be considered as such because of its potential for abuse, he or she shall advise the secretary of Health and Human Services Controlled substances and the Internet No controlled substance that is a prescription drug shall be delivered, distributed or dispensed by means of the Internet without a valid prescription (same prescription requirements as for a brick and mortar pharmacy). A prescription is considered valid if the following requirements are met: 5 The prescription is issued for a legitimate medical purpose in the usual course of professional practice. The prescriber has conducted at least one in-person medical evaluation of the patient or is a covering practitioner for another practitioner who has conducted such an evaluation. Faxed prescriptions for controlled substances Prescriptions received by fax are never valid for schedule II controlled substances. However, prescriptions for schedules III-V controlled substances may be transmitted by fax from the prescriber or a prescriber s agent and received by the dispensing pharmacy. In this Telephone prescription of controlled substances The only time that a schedule II controlled substance can be prescribed by telephone is in certain emergency situations, as described previously. With schedules III-V controlled substances, a pharmacy can dispense based on an oral prescription, provided that it is promptly Transfer of schedules III-V prescription information If a pharmacy is properly registered with the DEA, it may transfer original prescription information for schedules III-V controlled substances to another properly DEA registered pharmacy for the purpose of refill dispensing on a once-only basis. However, if pharmacies are electronically linked with a real-time, online database, the transfers may occur up to the maximum number of refills permitted by the prescriber s authorization. to furnish his or her office with all available, relevant data to make this determination. 5 An in-person medical evaluation is defined as a medical evaluation that is conducted with the patient in the physical presence of the practitioner. The dispensing of a controlled substance is pursuant to regulations consistent with effective controls against diversion. 26 If a pharmacy technician has any concern about the validity of a prescription for a controlled substance, he or she has an obligation to bring these concerns to the attention of the pharmacist on duty at that time. Pharmacy technicians should be aware that to fill a questionable prescription for a controlled substance might be interpreted as a felony offense. 27 case, the faxed prescription is considered equivalent to the original prescription, as long as the prescriber has manually signed the prescription (prior to faxing). 5 reduced to a written form before dispensing. All of the information required for a written prescription must be collected for an oral prescription, of course, without the signature of the prescriber. 5 Transfers of controlled substance prescriptions are tightly controlled and subject to a number of requirements, including: The transfer communication must not involve a pharmacy technician; the conversation must be between two registered pharmacists. The pharmacy technician should, though, be aware of the transfer requirements. PharmacyTech.EliteCME.com Page 68