 I'm really very sorry to impose on you like this, Dr. Jones, but I simply had no choice. You see, my physician is away on vacation and my therapist is out of town. Yes, Mrs. Smith. Well, what seems to be the problem? Well, I've been going through a lot of problems lately in my relationship and things came to a head the other night. And I haven't slept since quite frankly my nerves are shattered. So I was hoping to get just a few sleeping pills, maybe about ten or so to tide me over until my physician returns and then I can speak to him more properly about the situation. Well, you know, Mrs. Smith, I don't normally prescribe that type of medication for another doctor's patient. Well, I didn't normally take anything. I just need a little bit of rest right now and if I were to be honest, I'd say that the whole idea of medication frightens the heck out of me. Well, since your regular physician is out of town, I'll write you a prescription for a few Dalmene just to get you through the crisis. I really appreciate you helping me like this, Dr. Jones. And I think you should know that people speak very highly of you and now I see why. You can get this filled at any pharmacy. Oh, I forgot to mention that I'm allergic to Dalmene and drugs like that. I'm sorry. I see. Well, is there anything you've taken in the past for sleep that hasn't caused a reaction? Well, now that you mention it, yes. A few years ago, my father passed away and I was given something which worked just fine. It had a strange name with a Q. Quay something, I think. Was it Quailude? Yes, that's the name. Quailude. I remember it made me feel kind of strange, but at least I could get some sleep. Hmm, Quailude. I'll write you a prescription for Quailude. But you must be very careful not to drink any alcohol while taking these tablets. There you go. Thank you. Will this take very long? I'm leaving town for a few days and I'm catching a plane soon. No, this will only take a few minutes. Be sure not to drink alcohol while taking these tablets. That's a real nasty break you have here. After the shot I gave you for the pain wears off and could smart a bit. Usually I can handle pain, but it was really hurting before you gave me that shot. Let me write you a prescription for some aspirin and codeine for pain. Hey, thanks for fixing it up, Doc. Hi, can you fill this prescription for me? Yeah, let's see. What is it for? I'm gonna have to check this out with our head pharmacist. It'll just take a couple seconds. I'm sorry, we don't carry this particular medication in this pharmacy. But my arm is really starting to ache. Well, is there someplace close by I can get it filled? Young man, I'm sorry. I don't know the medication each pharmacy carries. You're gonna have to find that out for yourself. All right, give me all your money and your drugs. Yeah, your Quailudes, your Morphine, and your Demoral. I'll open the cash register for you, but I don't keep any scheduled drugs in the store. Don't lie to me! Unfortunately, any one or all of the previous scenarios are becoming familiar to us in our daily practice of pharmacy. For most of us, drug abuse has been something only remotely related to the profession of pharmacy. We tend to associate it with ghettos, illicit street drugs, and the dope-themed caricatures portrayed by the media. Rarely do we envision the abuse of drugs as occurring in a medical setting with health professionals as both active and passive participants. The diversion of prescription drugs is a serious problem, which emphasizes the need for all of us to keep abreast of the laws which govern the dispensing of abusable psychoactive drugs. It is estimated that over 200 million doses of psychoactive prescription drugs are diverted from legal channels annually. Approximately half of these result from thefts or forgeries, and the other half are diverted through corrupt professionals who make up only one to two percent of the medical community. Other studies estimate that 80 to 90 percent of diverted prescription drugs come from individual prescribers and dispensers. It's estimated that an illegal prescription is dispensed every four minutes in the United States. The Controlled Substances Act was designed to provide tools for health professionals to use to prevent abusable drugs from being easily diverted. Not so easily recognized is the harm to good health care caused by an overreaction to the problem of prescription drug abuse. Pharmacists who refuse to stock scheduled drugs or choose to deny these medications to patients with legitimate medical needs must remember that these drugs do indeed have valid medical indications. Irresponsible denial of any appropriately prescribed medication is poor medical care and damaging to our entire profession. The best way to strike a balance between being easily manipulated by drug abusers and being responsive to our patient needs is to keep up-to-date with the laws which regulate the dispensing of controlled substances. Indeed, most problems which result in the diversion of controlled substances to illegitimate use result from dated medical practices. Pharmacists who have not kept in touch with the various changes in drug abuse trends or the laws which regulate the distribution of controlled substances is a dated pharmacist. Two other improper pharmacy practices resulting in diversion of controlled substances are the so-called backdoor pharmacies and the impaired or addicted pharmacist. We emphasize the fact that a very small percentage of our fellow practitioners resort to dispensing drugs purely for profit or secondary gain. Pharmacists motivated purely by monetary, sexual favors or other non-medical gains who illegally and unethically provide drugs without valid authority or for an illegitimate purpose have no place in our profession. Though estimated to be a much lower percentage among pharmacists than in other professions, we must acknowledge that drug abuse and addiction does occur within our ranks. The impaired pharmacist is one in need of treatment and rehabilitation. Merely discharging such professionals and filing an unexplained controlled drug shortage report does no good for patient care, our profession and especially for the impaired pharmacist involved. Properly identified and guided into therapy, we can help to both salvage a career and promote a healthier profession. Finally, all health professionals must begin to recognize the steep social costs of the problem of substance abuse in our country. We have a definite responsibility to address this problem. By combining efforts with other health professionals, community and government agencies and with our own professional organizations, we can effectively begin to have an impact on the problem of prescription drug diversion. Mr. Gene Haslip Esquire is the Deputy Assistant Administrator in the Office of Diversion Control for the Drug Enforcement Administration. He describes the role and the responsibilities of the agency in regards to pharmacy practice. And in dealing with this problem of diversion, the federal government has mounted an aggressive effort. DEA since 1973 have sought to deal with the problem both at home and abroad through its various enforcement and regulatory actions. But neither the Drug Enforcement Administration or the government, federal or state governments, can deal with this problem effectively without the help of citizens. And this is particularly true of the pharmacy profession. Because the pharmacist oftentimes occupies the very point where much of the diversion of these drugs occurs. Whether through forged prescriptions or altered prescriptions or prescriptions which were unlawfully issued in the first place. The pharmacist because of his or her expertise is in a unique position to detect this diversion as it is occurring, to alert authorities and to work with the federal, state and local enforcement authorities to deal with the problem. In addition to that, the pharmacist because of his or her expertise is also a primary consultant and advisor to the patient as to the dangers of the abuse of these prescription drugs, the dangers to the patient or to the patient's family. And finally, the pharmacist can serve as a leader within the community to help generate the community response at the local level that can effectively deal with the problem. Therefore I'm certainly pleased to participate in this videotape sponsored by the N-A-B-P and I think you'll find it instructional in how you can fulfill your responsibilities and provide the leadership that the community needs. The misuse of psychoactive substances to affect mood, alter perceptions and manipulate states of consciousness has been documented in almost every culture since the beginning of written history. As societies evolved their own definitions of what constituted proper and improper use, they began to regulate the distribution of these agents. The evolution of these regulations has a long history of international cooperation which has influenced many of our laws governing controlled substances. The International Opium Commission of Shanghai in 1909 and the International Opium Commission of the Hague in 1912 committed our country to the regulation of narcotic drugs and resulted in the enactment of the Harrison Narcotic Act of 1914. This act embodied our first major laws regulating all aspects of commonly abused controlled drugs. Though often amended, it remained as the basis for our drug abuse laws until 1970, responding to the modern-day drug problems and especially to the expanding trends in the abuse of psychedelic and non-narcotic prescription drugs such as stimulants and sedative hypnotics. Congress passed the Controlled Substances Act of 1970 which took effect in May of 1971. Diversion of prescription drugs warrants special attention today. Benzodiazepines, barbiturates, other sedatives, prescription stimulants and licit narcotics continue to surface as major substance abuse problems in this country. It's becoming more and more evident that any substance capable of inducing a psychoactive effect whether it be over-the-counter, controlled or non-controlled may be misused and abused for non-medical purposes. Even though this videotape concentrates on controlled substances and the laws which regulate their handling it's important that pharmacists recognize their professional and ethical responsibility to use good judgment and intervene in situations where any drug is being abused for non-valid or no medical indications. The Drug Enforcement Administration, or DEA, is the federal agency responsible for enforcement of the Federal Controlled Substances Act. This act is the legal foundation of our profession's responsibility in handling and dispensing controlled substances. Here to discuss these broader applications of the CSA and the individual pharmacists' responsibilities to them is Mr. Gene Hayslip Esquire, the Deputy Assistant Administrator in the DEA Office of Diversion Control. Meeting with Ms. Ruth Vandevere, a member of the Oregon Board of Pharmacy and Hospital Pharmacist, Mr. Warren Amell, the Executive Director of the Montana Board of Pharmacy, Mr. George Heil with Smith, Klein and French Laboratories, and Brian Potter, a board member from the Oklahoma Board of Pharmacy and Community Pharmacist. The Federal Controlled Substances Act of 1970 is the comprehensive federal law which governs the manufacture, distribution, and prescribing of all legitimate drugs which also have a potential for abuse. This includes the narcotics, the stimulants, depressants, and the hallucinogenic drugs. Under this law, all businesses and professionals involved in this activity must register with the federal government and abide by the various regulations which are imposed to safeguard against their diversion into the illicit traffic. In addition to the federal law, each of the several states have enacted their own version of the Controlled Substances Act and these laws must also be observed. Mr. Hayslip, DEA controls the quantities of scheduled drugs manufactured by use of a quota system. Could you elaborate on a system for us and just how effective is it? Yes, this is an important tool in combating the diversion of legitimate drugs. The federal law requires us to set an annual production quota for all Schedule 1 and Schedule 2 drugs. Now the Schedule 1 drugs are those that are only involved in research, so the more practical and important exercise is the setting of quotas for the Schedule 2 drugs. In this, what we attempt to do is to provide a quota which will recognize the legitimate medical needs of the country and restrict production to that quantity. Experience has shown that if production exceeds legitimate needs, then the excess is apt to be diverted into the illicit traffic. This is the manner in which we use this tool. It's a very difficult tool to use. We have to exercise a great deal of circumspection in using the tool, but it can be very effective and I'll give you an example of that. Within recent years, we've seen a great deal of increase in the abuse of methaculone, the drug that is normally called qualudes or ludes in the illicit traffic, and so we have reduced the quota for the production of that particular Schedule 2 substances. In fact, we reduced it by 70% over the last two years, and the result has been that virtually all of that illicit diversion of methaculone has dried up. And I think in large measure, the quota tool has helped us deal with this national problem successfully. By law, the pharmacist has a responsibility along with the physician to determine whether a prescription is issued for a legitimate medical purpose. What does DEA suggest to help fulfill this responsibility? Well, I think it's important to emphasize that the law does place this responsibility on the pharmacist. The pharmacist does have a responsibility to examine the prescriptions presented to him or her to determine their bona fide nature. The pharmacist is not entitled to fulfill the prescription simply because it has been presented. And this, of course, is also an opportunity for the pharmacist to use the expert knowledge of the profession to ensure that the public is protected from the diversion of drugs by examining the prescription itself, ensuring that it has all of the elements required, by examining the patient and the manner in which the prescription has been presented, and of course bringing to bear that special knowledge of community practices and personalities so that in addition to being a responsibility, it's also an opportunity for the pharmacist to help fulfill the purposes of the federal law and to protect the community against the diversion of legitimate drugs. May a prescription written by an intern or a resident using the hospital's registration number be legally filled outside the hospital setting? Yes, it's certainly possible if the hospital has authorized the intern to use its registration number in this fashion. Now I think the important thing to emphasize here is that where the pharmacist has doubt as to whether the individual has been so authorized, it's important to go directly and check with the hospital authorities to ensure that this is permissible. What about controlled substances in a hospital setting? Are there any special security or other requirements? Well, the legal security requirements for the hospital are essentially the same as those for the community pharmacy. However, there are certainly special needs and circumstances that govern hospital practice because of the large number of employees who have access to controlled drugs and because of the large number of drugs which must be maintained on the setting itself. So I think it's an area that needs to be given special attention by the hospital authorities. The record keeping requirements are elaborate, must be elaborate to ensure that employees do not pilfer controlled substances. This is a constant problem in the hospital setting and this requires the maintenance of records not only at the dispensing station but of course at the central pharmacy location as well. Now, in addition to that, because of the large number of controlled substances that are frequently maintained, we find, unfortunately, that hospitals just as is true of the community pharmacy are increasingly becoming victimized by armed robberies and burglaries. So I think we can say that the security requirements here are special and need to focus most particularly on employee security. The following situations are commonly encountered in the pharmacy. Each helps to identify professional and legal applications of the CSA in our daily practice. Keep in mind that each state has its own laws regulating the handling of controlled substances. Your state board representative can assist you on how those laws interface with the CSA and how to apply them in each situation. There you go. Thank you. Never. Hello. Here we are. Will this take very long? I'm leaving town for a few days and I'm catching a plane soon. No, this will only take a few minutes. Be sure not to drink alcohol while taking these tablets. Did the pharmacist exercise good professional judgment in dispensing this CSA prescription? What other common prescription manipulations result in diversion of these substances to non-medical uses? Can a pharmacist be liable for improper prescribing habits of a properly registered physician? Can you identify a fictitious DEA number without having to check directly with the DEA? Despite the obvious manipulation of this prescription order, several thousand similar ones are dispensed by pharmacists each year. Substance abusers have learned that dress, flattery, and time pressure are important elements to the making or manipulation of both doctors and pharmacists for controlled drugs. They've devised extremely sophisticated schemes of getting controlled substances through legal channels, but unfortunately simple techniques are all they need most of the time. Pharmacists are charged with the responsibility to exercise professional discretion or good faith each time a prescription order is presented. When deciding on whether to furnish a controlled substance, pharmacists should address several questions in regards to the prescription order. The DEA and AMA, as well as several pharmacy organizations, have compiled lists of these questions, but most include the following. Is the prescribed drug a commonly abused substance? Can the prescribed drug be used in conjunction with another drug to produce an effect similar to that produced by a commonly abused drug? Is the patient receiving an unusual combination of drugs or antagonistic drugs? Is the quantity or dosage of the prescribed medication unusually large and or inconsistent with proper use of the medication? Is the prescription for a drug that is obviously not appropriate for the practitioner's scope of practice? Is the patient one of a significant number of patients who appear simultaneously or within a short time, bearing similar prescription orders for commonly abused substances from the same prescriber? Are the prescription orders identical or similar to the prescription orders consistently written by the same prescriber for the same commonly abused drug? Does the prescription order involve a geographical relationship of the pharmacy, the patient and physician which is unusual and for which no plausible explanation can be obtained? What is the consistency of the physician-patient relationship? Do people appear at the pharmacy bearing numerous prescription orders in the names of other patients for commonly abused substances? Has the prescription order been obviously altered, written with errors or irregularities? Is it a photocopy? Note, any criteria list such as this is incomplete in that it cannot cover every given situation. In the final analysis, a pharmacist must make a responsible judgment call consistent with sound professional standards. The most common prescription manipulation pitfall is the alteration of the written strength and or quantity prescribed and renewal designation on a controlled substance prescription order. These must be carefully noted in the evaluation of a prescription order for its validity. Drug abusers also copy a single valid prescription generating hundreds of seemingly valid prescriptions from the original. Doctor shopping and pharmacy shopping techniques are often employed. Doctor shopping involves the seeing of several different physicians with the same often valid medical complaint to generate several abusable drug prescriptions. Pharmacy shopping involves the patronizing of several different pharmacies to avoid the development of a tell-tale drug profile. Quick refills via lost, spoiled or stolen medication is another common manipulation for these drugs. Abusers often complain of drug wastage resulting from difficulty in handling child-proof containers. Stolen prescription pads account for many forged prescriptions each year. The phone forgery has evolved into a magnificent work of misguided resourcefulness. Often picking an authentic prescriber's day off, the forger will call the physician's exchange to give an accomplices' telephone number as the number where the physician can be reached. He then passes or calls in a forged prescription asking the pharmacist to verify the prescription by calling through his regular exchange. Pharmacists also report an increase in counterfeit prescriptions. All of us have probably encountered and even been victimized by other drug manipulations or drug diversion schemes. By referring back to the checklist established previously, we can hope to minimize the success of these methods. DEA regulations clearly state that a prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. Prescription orders which do not meet this criteria are deemed invalid or purported prescriptions. Examples of invalid prescriptions are a forged or false prescription a prescription issued by a person not licensed to prescribe drugs. A narcotic controlled drug prescription issued for the sole purpose of gratifying the craving of a narcotic addict or for continuing his drug dependence. A prescription issued for a fictitious person or for a person other than the one named as the patient on the prescription. A prescription issued for controlled substances for the prescriber's office use. A prescription issued not in the usual course of the prescriber's medical practice. It is therefore illegal and professionally irresponsible for a pharmacist to dispense prescription orders that are valid on their face even when a contacted prescriber affirms the order if the prescription obviously has been issued for an illegitimate purpose or is otherwise unlawful. All authorized controlled substances prescribers are issued individual DEA registration numbers consisting of two letters and seven digits. The first letter identifies the classification of the registrant. The second letter is the first letter of the prescriber's last name. The simple validity of the number is then checked by adding the first, third and fifth digits to arrive at a sum for step one. The second, fourth and sixth digits are then added together and multiplied by two to result in a product for step two. The numbers obtained in step one and step two are then added together. The last number of this sum is identical to the last digit of a valid DEA registry number. Note well, however, that this process does not always guarantee the validity of a DEA registration. Counterfeiting, regulation-wise drug abusers, borrowed registration numbers and other factors can result in valid looking DEA numbers on forged prescriptions while forgetfulness and transcription errors may result in invalid numbers for duly registered prescribers. Though the registry number verification formula may be helpful in identifying the most flagrant and unsophisticated forger, it's best to apply the elements listed in question one to help determine the validity of a controlled substance prescription order. Hey, this bottle of denerol's expired. I'll put it in the wand book. Wait a minute. Don't throw that away. Controlled substances require special disposal forms, order forms and record keeping. Special security and storage procedures are also required. What are the ordering requirements of controlled substances? Are there special requirements for storage and inventory for these drugs? What steps are necessary to legally dispose of outdated or damaged controlled substances? Under the controlled substances act, it's required that certain practitioners and all persons, firms and businesses that come in contact with controlled drugs must register with a DEA. Now, both pharmacies and hospitals register as dispensers of controlled substances. Come here. This permit certificate is evidence that my pharmacy is registered to handle controlled substances. Does that mean I'll have to register when I pass the board? No, employees of pharmacies don't have to register as long as the pharmacy itself is registered. Now, certain government practitioners, military personnel, law enforcement and several defense officials are also exempt. Now, separate pharmacies that are run or owned by the same company are required to have separate registrations at each site. While the satellite pharmacy services of hospitals may need only the hospital registration. What if you forget to re-register or move the store to a new location, go out of business? Well, in each case, the local branch, the DEA, and the Board of Pharmacy need to be notified in writing. Specific information about DEA registration forms and fees can be obtained from your State Board of Pharmacy or the registration unit, the Drug Enforcement Administration, Post Office Box 28083, Central Station, Washington, DC, 2005. The phone number is area code 202-254-8255. As you know, demoral is a Schedule II drug. Now, Schedule II drugs require the use of a special triplicate order form in order to obtain a drug for dispensing by the pharmacist. These order forms can be obtained by completing DEA Form 222-D, which is given to each new pharmacy or dispenser registrant. Now, federal laws don't require the use of special order forms for Schedule III through V drugs. They do, however, require adequate record keeping of such transactions. And some states require the execution of their own ordering forms for these drugs. To properly order C2 drugs, we must fill out this form for only Schedule II drugs. If any other drugs are ordered on this form, the supplier is required to void the order. Also, the triplicate order form must be filled out without separating any copies. What happens if orders get lost in the mail? Well, used or unused forms that get lost or stolen are immediately reported to the DEA in writing stating the facts surrounding the situation. And we should also generate a new order form and attach a copy of the written statement. Now, this statement should note that we did not receive the original order form and give the serial number and the date of the lost form. Now, this will also ensure that we get the medication for our patient's needs. Are orders ever rejected? Well, yes. If unacceptable or improperly executed, the order will be returned by the supplier with an explanation. What about shorts? Well, a partial filling of the order by the supplier is permitted, provided that the balance is shipped within 60 days. Boy, ordering these Schedule II drugs sure gets involved. Well, that's not all. The use of these orders forms is required when returning an unused container of Schedule II drugs to a supplier. Say we ordered some dexed drink and then decided we don't need any. We can contact the supplier and have him generate a form on his end, and we would proceed like a supplier to return the dexed drink back to him. Don't doctors use these forms, too? Well, doctors are prohibited by law from writing Schedule II prescription orders to obtain these drugs for their office use. Now, these order forms are the only way a pharmacist can supply Schedule II drugs to a physician for office practice. These are important forms. If I retire or sell my business, I could sell my entire inventory of Schedule II drugs to another registrant through the use of these order forms. Also, I would be required to return any unused forms, and my permit certificate would have to be returned to the DEA registration branch. The pharmacy dispenser must register with the DEA as a distributor if more than 5% of all his yearly controlled substance dosage forms are distributed as a supplier and not as a dispenser. He may also be required to register as a manufacturer if he manufactures for distribution a dosage form containing more than 20% of a narcotic controlled substance. C2 to C5 drugs could be stored in a securely locked, solidly constructed cabinet. Alternatively, they can be distributed throughout the non-controlled drug section in a manner that may obstruct theft. I chose the latter method, which I believe is more confusing to potential burglars. You mentioned something about a CS inventory next week. Are they required often? Well, fortunately, the controlled substances act requires an inventory of all scheduled drugs stocked, only upon the opening of a new pharmacy, and every two years thereafter. Though several options are provided for the date of subsequent biannual inventories, it generally cannot vary more than six months from the date of the original. The inventory of Schedule 2 drugs requires an actual count or measure of each unit. C3, C4, and C5 controlled drugs in opened containers can be estimated as to their quantity. However, open containers which originally held over 1,000 of these drug units must be counted exactly. Regulations also require the inventory of any newly added drug to the CSA schedule, or when a CSA drug is moved from one schedule to another, as was the case with Darvon and Coyleud during the mid-1970s. Copies of the inventory record do not have to be submitted to DEA, but should be retained and available for at least two years. The DEA requires that a pharmacy's controlled substances inventory log contain the following information, the name, address, and DEA registration number of the pharmacy, the date and time inventory was taken, in other words, the opening or closing of the business day, the signature of the person or persons responsible for inventory. DEA regulations require that the inventory of controlled drugs record the following information, the name of the drug, the dosage form, milligrams or milliliters, and the strength, the number of units or volume of each finished dosage form in each container, and the total number of commercial containers. Controlled drugs awaiting disposal must also be inventoried. Regulations were changed in 1980 to permit certain records to be kept at a central location rather than at the registered location. Executed order forms, prescriptions, and inventories, however, must still be kept at the registered site. Centralized record keeping requires DEA notification. Computerized record keeping at the registration site does not require DEA notification. These records must, however, be readily retrievable. The use of computers for records and refill information is subject to some specialized regulations. Check with your state board representative for more information. You can't throw away any controlled substance, and we might even have to inventory that outdated demoral if I don't get the proper forms in time. What we have to do is request DEA form 41 from a regional DEA director or the Board of Pharmacy. When they receive the completed form, they'll issue disposal instructions. In many states, the board also has the authority to dispose of controlled substances. They, in turn, will notify the DEA by submitting form 41. Jim's Rexall drugs. This is John. May I help you? This is Dr. Gregory Marcus at the Civic Medical Building. I'd like to order a prescription for Carl Taylor of 529 Clayton Street. Give him 20 acetaminophen with coding 30 milligrams. SIG I, Q4, PRN pain. My DEA number is AM7114135. Mr. Taylor, we'll pick that up today. Thank you, Dr. Marcus. We'll get that prescription ready today. Bye. In this historic and a commitment to professionalism, most pharmacists have been able to accomplish the task of learning and applying the multitude of controlled substance drug laws in their daily dispensing practices. In this situation, the pharmacist exercised his federal legal right to accept a Schedule III prescription over the phone. State laws vary with respect to controlled substances and should be discussed with your board representative. When state laws vary from federal ones, the general rule is to apply the more stringent set of health care regulations. Of equal importance to the legal considerations is the fact that this pharmacist exercised his professional responsibility to verify the physician's DEA number. Should he be unfamiliar with the physician's practice, he would also be professionally and legally obligated to verify that the prescription order was for an appropriate medical indication. To review, federal controlled substances laws divide drugs into five schedules. Schedule I drugs have a high abuse potential with no established medical use and are therefore rarely encountered in pharmacy practice. Schedule II drugs have a very high abuse potential and an established medical use. Schedules III to V drugs have decreasing abuse potential in relationship to their medical usefulness. Federal controlled substance laws for Schedule II through V include the full name and address of the patient, the full name and address, and DEA registration number of the prescribing doctor, the signature of the prescribing practitioner as of date of issuance, the date as of date of issuance. The prescribing practitioner is responsible for assuring that the written prescription contains all the required information, but the federal regulations place a corresponding responsibility for such prescription contents on the pharmacist actually filling the prescription. Upon obtaining the necessary information, the pharmacist may insert any omitted required items, except, of course, the prescribing practitioner's signature. In addition to the previous CSA prescription requirements, Schedule II prescription orders must be signed by the prescriber. It cannot be an initial or a stamped signature. Unlike Schedule III, IV and V drugs, oral or telephone prescription orders for CII drugs are permissible only under very specific regulations, and all CII prescriptions are non-refillable. Had the phone order been for a CII drug rather than a CIII drug, it would have been acceptable only in an emergency situation. Federal law requires that emergency oral Schedule II drug prescriptions be limited to only an amount of the drug to cover the emergency period. An appropriately written prescription order for only that amount must be received from the prescriber within 72 hours. If this is not received, the pharmacist must notify the nearest DEA office, or the DEA will consider the oral prescription void. If more of the drug is needed in excess of the 72-hour emergency period, the prescriber must generate another written prescription order. There is no difference in prescription requirements between Schedule III and IV drugs. Their separation into two classes is primarily for manufacturing and other requirements outside of the usual scope of pharmacy practice. Unlike Schedule II drugs, Schedule III and IV drugs are permitted to be ordered orally and by phone. Federal laws also allow the prescribing practitioner to authorize up to five refills within a six-month period. All oral prescription orders must be promptly reduced to writing by the pharmacist. Federal laws also provide that a bona fide agent of the physician, his office employee or nurse, may communicate a controlled substance's prescription from the physician to the pharmacist. Some state laws, however, do not permit this, and it's probably wiser to receive oral prescription orders or refill orders directly from the prescriber. All other prescription requirements are identical to those for C2 drugs. Federal laws also require the same prescription requirements for Schedule V drugs. These can be orally ordered and refilled like Schedule III and IV drugs. They differ from other controlled drugs in that they can be refilled without any specific limitation when authorized by the prescriber and do not require the special transfer warning label when dispensed. Certain states, however, do limit the number of refills and require special transfer warning labels. This prescription has been properly labeled in accordance with federal regulations. The DEA requires that all prescription labels of controlled substances for C2, III and IV drugs contain the name and address of the pharmacy, the prescription number, the date of dispensing, the name of the patient, the physician's name, the transfer warning statement, directions for use, and appropriate cautionary statements. The federal warning statement is not required on Schedule V prescription labels. All other label requirements are identical to those for C2, III and IV. Each state has its own additional label requirements, which often include the pharmacy phone number, the address of the patient, the physician's address, the quantity of the drug dispensed, the initials of the dispensing pharmacist, and others. In issuing a controlled substance prescription, a pharmacist must ensure that all necessary prescription requirements are documented on the prescription order. It's permitted to insert omitted information or correct items with two exceptions. He cannot insert the prescriber's signature for Schedule II substances and cannot postdate a prescription order. Controlled substance drug prescription orders must be dated on the actual date of issue, which can be ascertained and inserted by the pharmacist. It is not legal for a physician to issue blank signed prescription orders for his agent to complete to avoid this prohibition against postdating prescription orders. Upon completing the prescription and documenting all the appropriate information, pharmacists who choose not to maintain three separate files are required to stamp a red letter C on the lower right-hand corner of C3, IV and V prescriptions. Controlled drug prescription orders can only be dispensed by a pharmacist employed in a DEA-registered pharmacy or hospital. The prescription must also document the date it was dispensed. 80, 90, 5, and 5 makes 10. Thank you very much. Thank you. Hi, I'm Carl Taylor. Dr. Marcus Cullen, prescription for me? Yes, he did. Do you have some identification? Yeah, will my driver's license do? Sure. Okay, Mr. Taylor, I'll get your medicine. Okay. Mr. Taylor, this is your prescription for pain. Okay. Yeah, I was playing softball this morning, got a hip pointer, and Dr. Marcus told me to get plenty of rest and take these pain pills. You need to take one tablet every four hours as needed for pain. Now, please, don't drive or drink alcohol while taking them. They may cause drowsiness. Okay. Operally dispensed, controlled substances call for the pharmacist to ensure that the prescription is delivered directly to the patient or to the patient's representative. He must also make a judgment on the proper use of the medication even though the prescription order comes from an authorized prescriber and be ready to exercise his right to refuse dispensing it should it be ordered for an inappropriate use. As with all prescription orders, he must ensure that all usage and warning information is communicated to the patient. Once dispensed, the prescription for a controlled substance requires specific filing procedures. Under federal laws, three options are available to maintain these records. He may maintain three separate files, one for C2 prescription orders, one for C3, 4, and 5 prescription orders, and a third for non-controlled drug prescription orders. Alternately, two files may be maintained, one for C2 prescriptions, and the other for a combination of uncontrolled drugs, and C3, 4, and 5 drug prescriptions. This requires that a red C, not smaller than one inch high, be stamped on C3 through 5 drug prescription orders. Or, one file can contain all controlled drug prescriptions with the red C still stamped only on C3, 4, and 5 prescriptions. The other file would contain all uncontrolled prescription orders. First, C5 drugs have no such restrictions, and of course, C2 drugs cannot be refilled. Thank you. Dr. Marcus, OK, two refills. I'll just mark down the prescription and get that for you in a minute. You know I was supposed to rest this hip. Do you think I could get both of these refills now? I think that'll be all right. It'll be just a few minutes. OK. There are two problems in this situation. Technically, a prescription with no designated refill information is a no refill prescription. The pharmacist is required to generate a new phone order prescription in this situation, rather than handle it as a refill. The pharmacist also has a professional responsibility to consider the possibility of drug diversion when a request is made to dispense more than the face amount of a prescription. Some states even limit the maximum amount of dosage units that can be dispensed upon such requests. However, there are very valid reasons for such requests, and pharmacists are advised to contact the prescriber in these situations to request a new prescription for a larger amount if permitted by state laws. Had original refills been authorized, proper documentation of dispensed refill requests must be kept on the back of the prescription. Computerized information for C3 and C4 drugs is permitted only if the systems provide online cathode ray tube or hard copy printout retrieval providing all appropriate refill information. Retrieval of the previous six month refill history backed up with valid documentation which is kept on file for at least two years from the dispensing date. Printouts must be provided within 72 hours of the dispensing date if not available immediately. A refill by refill audit trail for any specific dosage form by brand name, generic name, or both. This must be retrievable to the DEA within 48 hours of a request. A fail-safe backup in case of computer breakdown. Hi, Dr. Daniels. How's everything at the nursing home? Good morning, David. We just admitted a new patient and he's going to need some percadan. I'd like to write you a prescription for 100 for him. I just filled out a prescription for a percadan. I've got about 20 tabs left. I'll get that to him today. Go ahead and fill out the prescription. I'll get the rest of them to him day after tomorrow. Partial dispensing of any C2 prescription order is permitted under federal laws as long as the balance of the prescription order is provided within 72 hours. If more than 72 hours elapses, the pharmacist must notify the prescriber and a new prescription order must be generated if the drug is still needed. In this case, however, new federal regulations extend this expiration date to 60 days for long-term care facilities like nursing homes. This regulation also allows pharmacists to define individual doses as partial dispensing of C2 prescription orders for patients in nursing homes. It mandates that each partial dispensing be recorded on the back of the prescription order or in some other uniformly kept and readily retrievable record. Here you are, Dr. Daniels. Thanks, David. Oh, I almost forgot. I had to use a couple of morphine serrets from the emergency kit last night. I'll have to write your prescription for that. All right. I'll get those for you right now. Long-term care facilities not registered with the DEA are allowed to maintain such drugs in their emergency kits provided that they comply with CSA regulations and are approved to do so by the state. These drugs must come from a DEA-registered dispenser. Separate records, inventories, and security must be maintained by the facility and a valid prescription must be written to cover the use of the dosage units dispensed. All right. Give me all your money and your drugs. Yeah, your quailudes, your morphine, and your demoral. I'll open the cash register for you, but I don't keep any scheduled drugs in the store. Don't lie to me. To whom should theft or robbery of CSA drugs be reported? Do robberies or a theft of CSA drugs result in a diversion control investigation? How are diversion control investigations conducted? For all of us, the most feared byproduct of increased prescription drug abuse is the concurrent increase in armed pharmacy robberies. Reversing this trend will require the efforts of all of us. However, we'll be helping not only ourselves, but all victims of drug misuse. After being robbed or when one discovers a theft or loss of CSA drugs, he should notify his local police department and file a report. A pharmacist must, by law, also obtain form DEA 106 from the nearest DEA office or Board of Pharmacy. The pharmacist must complete the form in triplicate. Once completed, the third copy is kept on file at the pharmacy, and the original and duplicate copies are sent to the appropriate DEA field office. Many states have additional reporting requirements, and your state board should also be contacted. Mr. Luck, please. Yes, and the pharmacy family. Thank you very much. Hello, my name is Mr. Garans. I'm with the Board of Pharmacy. Are you Mr. Luck? That's correct. What can I do for you? We noted that you've been burglarized twice and robbed once in the last six months. I'm here to look into the situation. Normally, a single theft, robbery, or loss would not result in an inspection. However, if the loss is of an unusually great magnitude or if several losses occur within a short period of time, a diversion control investigation may be initiated. There are several types of inspections by various agencies, but the three most important are the state board, FDA, and DEA inspections.