REVIEW OF FEDERAL LAW FOR PHARMACY TECHNICIANS DR. SULLIVAN S MONOGRAPH

REVIEW OF FEDERAL LAW FOR PHARMACY TECHNICIANS DR. SULLIVAN S MONOGRAPH

REVIEW OF FEDERAL LAW FOR PHARMACY TECHNICIANS ACTIVITY DESCRIPTION This program will assist pharmacy technicians to understand the federal laws applicable to pharmacy. Topics covered include package inserts, dispensing controlled substances and schedule II controlled substances. The information in the monograph is based on the Federal Law and the Federal Controlled Substance Act. Some of the information may be different in different states. States can make their own laws more restrictive than federal law, but not less restrictive. All questions regarding the practice of pharmacy should be directed to a pharmacist or the Board of the Pharmacy in the state where the technician works. TARGET AUDIENCE The target audience for this activity is pharmacy technicians in hospital, community, and retail pharmacy settings. LEARNING OBJECTIVES After completing this activity, the pharmacy technicians will be able to: Identify when it is appropriate to provide Patient Package Inserts Describe common legal issues when dispensing controlled substances Identify the legal requirements specific to schedule II controlled substances ACCREDITATION PHARMACY PharmCon, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. NURSING PharmCon, Inc. is approved by the California Board of Registered Nursing (Provider Number CEP 13649) and the Florida Board of Nursing (Provider Number 50-3515). Activities approved by the CA BRN and the FL BN are accepted by most State Boards of Nursing. CE hours provided by PharmCon, Inc. meet the ANCC criteria for formally approved continuing education hours. The ACPE is listed by the AANP as an acceptable, accredited continuing education organization for applicants seeking renewal through continuing education credit. For additional information, please visit http://www.nursecredentialing.org/renewalrequirements.aspx Universal Activity No.: 0798-0000-13-124-H03-T Credits: 1 contact hour (0.1 CEU) Release Date: February 14, 2013 Expiration Date: February 14, 2016 ACTIVITY TYPE Knowledge-Based Home Study Monograph FINANCIAL SUPPORT BY Pharmaceutical Education Consultants, Inc. 1

ABOUT THE AUTHOR Donnie Sullivan is a Professor of Clinical Pharmacy and Director of Experimental Education at The Ohio State University. He received his B.S. in pharmacy from Ohio State University in 1990, his MS from Ohio State University in 1991, and his Ph.D. is Pharmacy Administration from Ohio State University in 1996. He has published several peer-reviewed articles and five consumer drug reference books. He has taught courses in pharmacy law, medication error prevention, and OTC products for 15 years. He has done more than 90 professional presentations on pharmacy law, medication error prevention techniques, and OTC products all across the U.S. He has been voted professor of the year by his students in 13 of his 14 years at Ohio Northern University. Donald Sullivan, Ph.D. Professor of Clinical Pharmacy and Director of Experimental Education, Ohio State University FACULTY DISCLOSURE It is the policy of PharmCon, Inc. to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer of any commercial product(s) and/or service(s) discussed in an educational activity. Donald Sullivan reports no actual or potential conflict of interest in relation to this activity. Peer review of the material in this CE activity was conducted to assess and resolve potential conflict of interest. Reviewers unanimously found that the activity is fair balanced and lacks commercial bias. Please Note: PharmCon, Inc. does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced and objective. Occasionally, authors may express opinions that represent their own viewpoint. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient or pharmacy management. Conclusions drawn by participants should be derived from objective analysis of scientific data presented from this monograph and other unrelated sources. 2

The information provided below is based on the Federal Law and the Federal Controlled Substance Act. Some of the information may be different in different states. States can make their own laws more restrictive than federal law, but not less restrictive. For example: As of the beginning of 2013, tramadol is not a controlled substance under federal law. However, some states have made it a schedule IV controlled substance (Kentucky is one example). Technicians should always check with their pharmacist regarding your own state s individual rules and laws regarding controlled substances when issues or questions arise regarding the practice of pharmacy. This program is for educational purposes. All questions regarding the practice of pharmacy should be directed to a pharmacist or the Board of the Pharmacy in the state where the technician works. Patient Package Inserts 1,2 The requirement of pharmacies to provide patient package inserts (PPIs) has been around for several years. The requirements for providing PPIs are for estrogen drug products including estrogen containing oral contraceptives. PPIs are also required for progesterone containing oral contraceptives as well. Pharmacies are required to provide a PPI for each package dispensed. The means that a PPI must be provided with each new and refill prescription dispensed for products in the above mentioned classes. Manufacturers are required to provide PPIs for pharmacies to dispense to patients with these prescriptions. If a pharmacy does not provide a PPI with an oral contraceptive, the product is considered to be misbranded and the pharmacy is in violation of federal law. Many pharmacies think that PPIs are not required for inpatients (hospital patients) and nursing home patients. This is not true. Federal law states that PPIs must be provided to the patient with the first dose of one of these medications and every 30 days thereafter. As a technician, if you are not sure if a PPI should be given to a patient or not, consult your pharmacist for direction. Common Legal Issues When Dispensing Controlled Substances 3,4 Let s discuss a couple of common situations that can occur when pharmacists are dispensing prescriptions for schedule II drugs. What should a pharmacist do if they do not have 3

enough medication in stock to fill a prescription for a schedule II drug? For example: The patient presents a prescription for Percocet 2.5/325 tablets #90 and the pharmacy only has 45 tablets in stock. In this situation, the pharmacy has 72 hours to dispense the remaining quantity (in this example 45 tablets). The pharmacy must order and obtain the remaining 45 tablets and dispense them within 72 hours. The pharmacist should also document on the front of the prescription the quantity (45 tablets) dispensed. If the pharmacy cannot dispense the remaining 45 tablets within 72 hours, the pharmacist must notify the prescribing practitioner. After 72 hours, no further medication can be dispensed from this original prescription. The patient may have to obtain a new prescription from the prescriber. In another related situation, what if the patient presents a prescription for Percocet 2.5/325 tablets #60 and can only afford 30 tablets at this specific time? In this situation, the patient can only receive what they can afford at the time of dispensing. The pharmacist cannot dispense the remaining quantity (30 tablets) at any time in the future. The 72 hour rule only applies to situations when the pharmacy does not have enough medication in stock. It does not apply to the situation when the patient cannot afford the entire quantity at the time of dispensing. What about for schedule III and IV controlled substances? Consider this example: A patient brings you a prescription for Vicodin, one tablet QID, prn #100 with 4 refills. The patient does not have health insurance and must pay cash for their prescriptions. The patient only wants to get 50 tablets at a time. How many times can the pharmacist fill this prescription with a quantity of 50? This is a point of confusion for many pharmacists. Vicodin is a schedule III controlled substance. Every pharmacist knows the maximum number of refills on a schedule III controlled substance is 5 refills or 6 months. However, does that mean this patient can only receive 5 refills of 50? Under federal law, the answer to that question is no. In this situation, this is a considered a partial refill. The total quantity on the prescription, including refills, is 500 tablets. The patient is entitled to the entire quantity prescribed, even if this means the number of partial fillings exceeds five. However, the total quantity dispensed in all partial fillings cannot exceed the total quantity prescribed and all partial fills must be dispensed within 6 months of the date the prescription was written. Theoretically, the patient could receive 9 partial refills (the original 50 tablets plus nine partial refills of 50 tablets) within a 6 month 4

period. Pharmacists should also realize that each partial filling is recorded in the same manner as a refill. Finally, the six month time period for all the partial fills begins from the date the prescription was written and not the date of first dispensing. Requirements for Faxing a Schedule II Prescription 3,5 In general, pharmacists can receive prescriptions via a facsimile (fax) machine for all prescription drugs except schedule II controlled substances. However, there are three exceptions when pharmacies can receive a faxed prescription for a schedule II controlled substance. 1) A pharmacy can receive a faxed schedule II prescription for a narcotic substance for any patient in hospice care. The prescriber must note on the prescription that it is for a hospice patient. 2) A pharmacy can receive a faxed schedule II prescription for patients in long-term care facilities or nursing homes. This does not include assisted living facilities. 3) A pharmacy can receive a faxed schedule II prescription for a narcotic substance for any patient undergoing home infusion/intravenous (IV) pain therapy. In all three of the above circumstances, the faxed prescription is considered to be the original prescription and should be processed and filed accordingly. The prescriber does not have to send the original prescription to the pharmacy. In other instances (other than the three discussed above), a physician may want to fax a schedule II controlled substance prescription to the pharmacy so the pharmacist can have it ready when the patient arrives. It is important to know that the pharmacist cannot dispense the medication until the patient brings the original, hard copy prescription from the physician, and the pharmacist should verify it against the faxed copy. The hard copy, written prescription is considered the original prescription and should be filed accordingly. Requirements for Oral Schedule II Prescriptions 3,7 In some rare circumstance, a prescriber may need to call in an oral prescription for schedule II drug for a patient. Even though this is a very infrequent situation, pharmacists should know the legal requirements. First, many pharmacists think that they can only dispense 5

no more than a 72 hour supply of a schedule II drug on an oral prescription. This is not true. The amount a pharmacist can dispense is defined as enough for the emergency period. In these situations, the pharmacist and prescriber must discuss the patient s situation and use their collective professional judgment. In certain cases only a 24 hour supply may be necessary, but in other cases more than a 72 hour supply may be necessary. The pharmacist should document this conversation with the prescriber. Requirements of a pharmacist regarding an oral schedule II prescription are as follows: 1) The quantity prescribed and dispensed should be enough for only the emergency period. 2) The pharmacist should immediately reduce the oral prescription to writing and it must contain all of the information required for a written prescription for a controlled substance. 3) The pharmacist must receive the written prescription from the prescriber within 7 days. This written prescription must be attached to the oral prescription taken by the pharmacist. On this written prescription must be the statement Authorization for Emergency Dispensing. The written prescription may be delivered in person or by mail with the postmark on the envelope within the seven day period. Once software systems are approved by the DEA, an electronic prescription may be sent by the physician to the pharmacy in lieu of a written prescription. 4) If the physician does not provide the written prescription within seven days, the pharmacist should notify the local DEA office. Requirements for Partially Dispensing Schedule II Controlled Substances 3,8 A caregiver for a terminally ill patient comes into your pharmacy. The patient received a prescription from his doctor for Percocet 5/325, #120, one tablet 6 hours. The caregiver tells the pharmacist that the patient has taken a turn for the worse and may only live 72 hours. The caregiver wants to know, Do I have to get the entire 120 tablets filled? The answer in this specific case is No. There are two situations in which pharmacists can partially dispense a schedule II controlled substance: 1) for terminally ill patients and 2) for patients in a long-term care facility. This does not include assisted living facilities. In the above situation, the pharmacist could dispense twelve Percocet 5/325 tablets and the patient would have 108 tablets remaining to be dispensed. However, if a pharmacist is going to partially dispense a schedule II prescription to either a terminally ill or hospice patient, there are some regulations he/she must follow. 6

Before partially dispensing a schedule II controlled substance, the pharmacist must confirm that the patient is either terminally ill or resides in a long-term care facility. This must be written on the prescription. The partial dispensing can only occur at the pharmacy where the original prescription is on file. In pharmacies that utilize a shared database, partial dispensing can only occur at the specific location where the original prescription was first filled. Also, the total quantity dispensed through all partial fills cannot exceed the total quantity on the written prescription. Partial dispensing of the prescription can occur for 60 days from the date the prescription was written, not the date of the first partial dispensing. The 60-day timeclock starts with the date on the prescription. Any quantity left-over after 60 days cannot be partially dispensed. At the time of each partial dispensing, the following information must be recorded on the back of the original prescription: a) date dispensed b) quantity dispensed c) remaining quantity d) The new prescription number of each partial dispensing if it is different from the original prescription number. e) Written initials of the dispensing pharmacist If the computer system does not permit refilling of a schedule II controlled substance, a new prescription number for the partial dispensing must be assigned. In the computer database, a notation must be included that identifies this new prescription number as a partial dispensing. A prescription bearing the new prescription number must be placed in the schedule II file. The prescription for each partial filling must also show the prescription number for the original. Multiple Prescriptions for Schedule II Drugs 9,10 Let s consider this example. A parent takes their child to visit their physician for a follow-up visit regarding their ADHD on September 1 st, 2012. The child has been taking Adderall XR 10mg, #60, once daily in the morning for 18 months. The parent has seen a 7

dramatic improvement in the child s behavior at home and school. The last visit to the physician was on July 15 th, 2012 when the parent received a prescription for the same 60 daysupply of drug. The physician knows the patient has enough medication until September 14 th, 2012. He does not want the parent to have the prescription filled until that date. What should the physician do? The physician may be tempted to post-date the prescription with the date September 14 th, 2012. This is illegal. Prescriptions must be dated on the day that the physician signs and issues the prescription. Therefore the date on the prescription must be September 1 st, 2012. Post-dated prescriptions are illegal. The best option for the physician is to write in the directions of the prescription, Do not fill until September 14 th, 2012. A change in federal law allowing physicians to do this and issue multiple prescriptions for schedule II drugs became effective on December 19, 2007. This law allows physicians to issue multiple prescriptions for a schedule II drug with do not fill until on them for up to a 90 day supply of medication. Let s consider another example. A physician decides that he/she only needs to see a child every 90 days for his ADHD. The date of the physician visit is October 1, 2012. The physician could write three prescriptions on October 1, 2012 for Adderall XR 5mg, #30, one daily. The first prescription would have nothing additional in the directions. The second prescription would have Do not fill until October 31, 2012 in the directions, and the third would have Do not fill until December 1, 2012. All three of these prescriptions would have the date issued as October 1, 2012. With these dates on the prescriptions, pharmacists are prohibited from filling them before these dates. Also, the physician is not required to write these prescriptions in 30 day increments. Another physician may want to issue six prescriptions for a 14 day supply on each with the appropriate do not fill until dates on each one. In summary, the total days supply when multiple prescriptions are issued for a schedule II drug with do not fill until on it is 90 days. Example: What if the physician does not want to issue three separate prescriptions with do not fill dates on them and wants to write just one prescription for Adderall XR 5mg, #90, one daily? Is this legal? The answer is Yes as long as it is for a legitimate medical purpose. However, some states may have laws that limit the quantity and/or days supply on a prescription for a schedule II drug, so be careful. Finally, this law does not require physicians to see their patients every 90 days. The length of time between appointments and care that 8

needs to be given is left up to the discretion of the physician. In some cases, patients who are very stable on their therapy may need to be seen only two or three times a year. References 1. 21 CFR 310.515 2. 21 CFR 310.501 3. Leonhard, Michele, Rannazzisi, Joseph, and Caverly, Mark. Pharmacists Manual. Drug Enforcement Administration, 2010. Washington. DC. 4. 21 CFR 1306.23 5. 21 CFR 1306.13 6. 21 CFR 1306.11 7. 21CFR 1306.11(d) 8. 21 CFR 1306.13 9. 21 CFR 1306.04 10. 21 CFR 1306.05 9

ACTIVITY TEST 1. Patient package inserts must be given with both new and refill prescriptions for oral contraceptives. A. True B. False 2. A prescription is brought to the pharmacy for Dilaudid 1mg tablets (schedule II), #50. The pharmacy only has 25 tablets in stock. How long does the pharmacy have to dispense the remaining 25 tablets? A. 24 hours B. 48 hours C. 72 hours D. 30 days E. 45 days 3. A patient comes to the pharmacy with a prescription for oxycodone 5mg tablets (schedule II) #50. The patient wants to get 25 tablets filled today and 25 tablets filled in two weeks. Can the pharmacist fill the remaining 25 tablets in two weeks? A. Yes B. No 4. A patient brings a prescription for Vicodin (schedule III) #100 tablets. The patient only wants to get 10 tablets filled at a time. How long does the patient have to get the remaining 90 tablets filled? A. 24 hours B. 48 hours C. 7 days D. 6 months E. None. The entire 100 must be filled at the same time. 5. A physician wants to call in an oral prescription for Dilaudid 2mg (schedule II) for a patient who is homebound with terminal cancer. What is the maximum amount the physician can prescribe on an oral prescription for a schedule II drug? A. 1 day supply B. 2 day supply C. 3 day supply D. enough for the emergency period 10

6. If a physician calls in an emergency oral prescription for a schedule II narcotic (Percocet 5/325 ), he/she has to get the written original prescription to the pharmacy. A. 24 hours B. 48 hours C. 7 days D. 10 days E. 30 days 7. Physicians may fax a schedule II prescription to the pharmacy under which of the following circumstances: A. A narcotic pain killer for a hospice patient B. For a patient in a nursing home or long-term care facility C. For a patient undergoing narcotic home infusion (IV) pain therapy D. a and c only E. a, b, and c 8. Pharmacists can partially dispense schedule II controlled substances for which of the following patients? A. nursing home patients B. patients who are terminally ill C. A patient who wants to try just 2 tablets to make sure they work before buying the rest D. a and b only E. all of the above 9. Partial dispensing of a schedule II controlled substance can occur for from the date the prescription was written. A. 10 days B. 30 days C. 60 days D. 6 months 10. A physician can write Do Not Fill Until on one or more schedule II prescriptions for up to A. 30 days B. 60 days C. 90 days D. 6 months E. This cannot be done under any circumstances. Please submit your final responses on freece.com. Thank you. 11