LUNCH AND LEARN Pharmacy Law: The Ins and Outs of Controlled Substances January 8, 2016 Featured Speaker: Joseph J. Bogdan, Pharm.D., R.Ph., J.D. Pharmacist Attorney Lisle, Illinois 1 CE Activity Information & Accreditation (Pharmacist and Tech CE) 1.0 contact hour Funding: This activity is self funded through PharMEDium. It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Bogdan has no relevant commercial and/or financial relationships to disclose. 2 www.proce.com 1
Online Evaluation, Self-Assessment and CE Credit Submission of an online self assessmentand and evaluation isthe only way to obtain CE credit for this webinar Go to www.proce.com/pharmediumrx Print your CE Statement online Live CE Deadline: February 5, 2016 CPE Monitor CE information automatically uploaded to NABP/CPE Monitor within 1 to 2 weeks of the completion of the self assessment and evaluation Event Code Code will be provided at the end of today s activity Event Code not needed for On Demand 3 Ask a Question Submit your questions to your site manager. Questions will be answered at the end of the presentation. Your question...? 4 www.proce.com 2
Resources Visit www.proce.com/pharmediumrx to access: Handouts Activity information Upcoming live webinar dates Links to receive CE credit 5 LUNCH AND LEARN Pharmacy Law: The Ins and Outs of Controlled Substances January 8, 2016 Featured Speaker: Joseph J. Bogdan, Pharm.D., R.Ph., J.D. Pharmacist Attorney Lisle, Illinois 6 www.proce.com 3
Outline the differences in state vs federal pharmacy law Identify the role of the Drug Enforcement Administration concerning controlled substances under the Federal Controlled Substance Act Compare and contrast the five schedules of controlled substances Describe the ordering and recordkeeping requirements for Shdl Schedule II-V IIVcontrolled substances Discuss the professional and legal ramifications of controlled substance diversion Drug Enforcement Administration (DEA) Controlled Substances Act (CSA) Controlled Substance Ordering System (CSOS) Food & Drug Administration (FDA) www.proce.com 4
Controlled substances are drugs with high to moderate potentials for abuse and so are strictly regulated by state and federal laws Abuse of these drugs may have detrimental effects on the physical, psychological, and social welfare of individuals. The law that regulates the manufacture, dispensing, distribution and possession of all controlled substances is referred to as the Controlled dsubstances Act (CSA). The goal of the CSA is to ensure that these drugs are not accessed readily by inappropriate means. Enforce the controlled substances laws and regulations of the United States Pursue criminal and civil justice of the US organizations involved in the growing, manufacture, or distribution of controlled substances appearing in or destined d for illicit it traffic in the US www.proce.com 5
The Controlled Substances Act gives the DEA the authority to enforce rules that dictate prescribing and ddispensing i of controlled substances to patients. Pharmacies that dispense scheduled medications must obtain a state license from the DEA and must be renewed every 3 years. The DEA is responsible for making sure registrants abide by security codes and storage requirements set forth by the controlled substance act. Controlled substances are classified into CI, CII, CIII, CIV, and CV The DEA and FDA are responsible for determining which drug is placed into which schedule The classifications are based on abuse potential, and accepted and approved medical use in the US www.proce.com 6
Classification. Schedule I: Heroin, (LSD), Marijuana Schedule II: Fentanyl, Sufentanil, Remifentanil, Meperidine, Methadone, Hydromorphone, Morphine Schedule III: Ketamine, Buprenorphine Schedule IV: Methohexital, Lorazepam, Phentermine Schedule V: Promethazine VC, Cheratussin AC Definition No accepted medical use, and high potential for abuse High potential for abuse that may lead to psychological or physical dependence Moderate potential for abuse, low physical or psychological dependence Low potential for abuse as compared to schedule III Low potential for abuse as compared to schedule IV Pharmacies that dispense scheduled meds must obtain a state license from the DEA o Form 224: used to register a new pharmacy Pharmacy registration must be renewed every 3 years o Form 224a: Registrant can renew online no more than 60 days prior to the current expiration date Corporations that own or operate a chain of pharmacies may submit a single DEA Form www.proce.com 7
Schedule II medications Receiving registrant must issue a DEA Form 222 or an electronic equivalent to the registrant transferring the drugs Schedules III-V Must be documented in writing to show the drug name, dosage form, strength, quantity, and date transferred Document must include names, addresses, and DEA registration numbers of parties involved in the transfer of controlled substances Records involving the transfer must be kept readily available by the pharmacy for 2 years Complete inventory Documents the drug name, dosage form, strength,,quantity, and date transferred DEA Form 222 or the electronic equivalent must be prepared to document the transfer of schedule II controlled substances A copy of the inventory must be included in the records of each pharmacy www.proce.com 8
Pharmacist must maintain a written record showing: Date of transaction Name, strength, dosage form, and quantity of controlled substance Supplier or manufacturer s name, address, and registration number Form 222 or the electronic equivalent Drugs should be sent to a DEA-registered reverse distributor who handles the disposal of controlled substances Schedule II Reverse distributor must issue Form 222 or the electronic equivalent to the pharmacy Schedules III-V Pharmacy must maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date transferred Registered reverse distributor Responsible for submitting DEA Form 41 (Registrants Inventory of Drugs Surrendered) www.proce.com 9
The mission of the office of diversion control is to prevent, detect and investigate the diversion of pharmaceutical controlled substances and chemicals from legitimate channels of distribution. While ensuring adequate and uninterrupted supply of controlled substances to meet legitimate medical, commercial and scientific needs. Diversion is the movement of legitimate controlled substances into other legitimate channels for other than legitimate medical, scientific and/or research purposes. Diversion can occur at ANY TIME, ANY PLACE, under ANY circumstance by ANYONE. The common denominator is the HUMAN FACTOR. www.proce.com 10
If theft occurs Report within 1 business day of the discovery of the theft or loss Notify in writing the local DEA Diversion Field Office Notify local law enforcement and state regulatory agencies Pharmacy must also complete a DEA Form 106 Records for purchased, received, stored, distributed, dispensed, or otherwise disposed of Must be readily retrievable Records kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time, and/or Records kept in such a manner that certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records Maintained for at least 2 years for inspection and copying by duly authorized DEA officials www.proce.com 11
Schedule II Maintained separately from all other records of the registrant Schedules III, IV, and V Must be maintained either separately from all other records OR in such a form that the information required is readily retrievable from the ordinary business records Must be made readily retrievable by use of a red "C" stamp not less than 1 inch high If a prescription is created, signed, transmitted, and received electronically, all records related to that prescription i must be retained electronically ll The electronic application must be capable of printing out or transferring the records in a format that is readily understandable to an administrative or other law enforcement agent at the registered location Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed, and date filled www.proce.com 12
Executed and unexecuted official C-II order forms Power of Attorney authorization to sign order forms Receipts and/or invoices for schedules III, IV, and V controlled substances Records of controlled substances dispensed (i.e., prescriptions, schedule V logbook) Reports of Theft or Significant Loss (DEA Form 106), if applicable Inventory of Drugs Surrendered for Disposal (DEA Form 41), if applicable All inventory records of controlled substances, including initial and biennial inventories, dated as of beginning or close of business Records of controlled substances distributed (i.e., sales to other registrants, returns to vendors, distributions to reverse distributors) Records of transfers of controlled substances between pharmacies DEA registration i certificate Self-certification certificate and logbook (or electronic equivalent) as required under the Combat Methamphetamine Epidemic Act of 2005 www.proce.com 13
Required to be performed with initial DEA registration and biennially No requirement to submit a copy of inventory to DEA Schedule II controlled substances must be kept separate from all other controlled substances Date of inventory Whether inventory was taken at the beginning or close of business Name of each controlled substance inventoried Finished form of each of the substances E.g., 10-milligram tablet Number of dosage units of each finished form in the commercial container E.g., 100-tablet bottle Number of commercial containers of each finished form E.g., four 100-tablet bottles A count of the substance www.proce.com 14
Schedule I and II controlled substances Official order form DEA Form 222 Electronic equivalent Controlled Substance Ordering System (CSOS) DEA form or electronic equivalent required for each Distribution Purchase Transfer Controlled Substance Ordering System (CSOS) Allows for secure electronic transmission of schedule II drugs Public Key Infrastructure (PKI) technology Users must obtain digital certificate for electronic ordering CSOS certificates are free of charge May be a charge for use of ordering software by the suppliers Must be signed using digital signature Issued by Certification Authority run by the DEA www.deaecom.gov or (877) 332-3266 www.proce.com 15
Schedules III, IV, and V controlled substances Registrant must keep a receipt (invoice or packing slip) documenting Date drugs were received Accuracy of order confirmation Name of each controlled substance Finished form Number of dosage units of finished form in each container Number of containers ordered Number of containers received Receipts must be maintained in a readily retrievable manner, in the event of a DEA inspection Pre-Employment Screening Background checks, drug screening Updated Background Checks Every Five Years Random Drug Screening Physical Security Controls SOP s for Handling Controlled Substances Limited Access to Controlled Substances Limited Access to Alarms, Keys, Pass Codes www.proce.com 16
Limited Access to Dispensing Areas At Least two employees at all times Cameras in all areas where CS are being dispensed Secure access to CS ordering systems (CSOS) Do not post the password for ordering CS electronically on the wall of the pharmacy Limited Power of Attorney status for signing gdea 222 order forms Tell Physicians to secure their prescription pads Limited Access to Dispensing Areas Must be dated and signed on the date issued Must be written in ink, indelible pencil, or typewritten Prescription must include: Patient s full name and address Practitioner's full name, address, and DEA registration number Drug name Strength Dosage form Quantity prescribed Directions for use Number of refills authorized www.proce.com 17
May not be changed: Patient name Drug name (except for generic substitute permitted by state law) Name of prescribing practitioner (including signature) May be changed: Strength of drug, quantity of drug, directions for use Pharmacist must contact prescribing practitioner and obtain verbal permission for change Pharmacist must document on the prescription: Change that was authorized Name or initials of individual granting authorization Initials of pharmacist Physician Dentist Podiatrist Veterinarian Mid-level practitioner (MLPs): nurse practitioners, physician assistants, optometrists, midwives Authority to prescribe varies greatly by state Pharmacist is responsible for verifying gprescribing gparameters per state Pharmacist may check DEA diversion website www.deadiversion.usdoj.gov Registration Registration Resources MLP Authorization by State www.proce.com 18
Ai Animal lshlt Shelter Nurse Practitioners Optometrists Physician Assistants Practitioner Ambulance Services, Doctors of Oriental Medicine, Euthanasia Technicians, Homeopathic Physician, Medical Psychologists, Naturopathic Physician, Nursing Homes, Registered Pharmacists Prescribing Rights 2N & 3N Line 1: Animal Shelter Line 2: Euthanasia Technician s Name 2N, 3, 3N, 4, 5 Prescribe, Dispense & Administer Only Prescribe 30 day supply for C-II Optometrists 3, 4, 5 Prescribe 2N, 3, 3N, 4, 5 Prescribe, Dispense & Administer Only Prescribe 30 day supply for C-II No Authority Verification of practitioner registration Pharmacist has a responsibility to ensure that a prescription has been issued by an appropriately registered practitioner Construction of a valid DEA registration number First letter A, B, or F for physicians, dentists, veterinarians M for mid-level practitioners Second letter B J 6 1 2 5 3 4 1 First letter of registrants last name Verifying the numbers 1. Add together the 1st, 3rd and 5th digits 2. Add together the 2nd, 4th and 6th digits; double it 3. Add the two totals together 4. The second digit in that total is the check digit Example: DEA Number www.proce.com 19
Valid purpose of issue Legitimate medical purpose Practitioner acting in the usual course of professional practice Corresponding responsibility and good faith dispensing A prescription issued not in the usual course of professional treatment is invalid The pharmacist is required to exercise sound professional judgment The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin A pharmacist who deliberately ignores this, may be prosecuted Such action is a felony offense, which may result in loss of license Rule became effective June 1, 2010 Provides practitioners with option of writing prescriptions for controlled substances electronically Permits pharmacies to receive, dispense, and archive prescriptions Ability to use technology while maintaining closed system Pharmacy application requirements Must be able to import, display, and store required contents Must be able to digitally sign Must allow the pharmacy to limit access for annotation, alteration, or deletion to specific individuals or roles Must have an internal audit trail that documents each processing step When a prescription is received electronically, it must be stored electronically www.proce.com 20
Written prescription must be manually signed Electronic prescription must meet all DEA requirements Oral order is only permitted in emergency situation See emergency dispensing Refills Prohibited for schedule II controlled substances New regulation became effective December 19, 2007 Practitioner may issue multiple prescriptions p authorizing the patient to receive up to a 90-day supply of a schedule II drug Each prescription must be issued on separate prescription blank Practitioner must indicate the earliest date on which it may be filled Should not create an undue risk of diversion of abuse Individual practitioner must comply with all requirements This includes state laws www.proce.com 21
May be sent through facsimile to expedite filling process Original prescription must be presented to the pharmacist and verified against the facsimile at time of dispense Pharmacy may consider the facsimile prescription as the original in 3 cases: 1. To be used in a compound for direct administration to a patient Parenteral, intravenous, intramuscular, subcutaneous, or intraspinal 2. Used for a resident of a long-term care facility 3. Patient enrolled in a hospice-care program Program needs to be certified and/or paid by Medicare, or Program licensed by the state Prescription should note that it is for a hospice patient Prescription may be transmitted by facsimile Facsimile is considered equivalent to an original prescription Practitioner must manually sign the prescription Telephone authorization Oral prescription made by the practitioner and promptly reduced to writing by the pharmacist is considered valid Refills May be refilled if authorized on the prescription Only up to 5 times within 6 months after the date of issue Pharmacist must initial, date, and state the quantity filled on the back of the prescription www.proce.com 22
Pharmacy may transfer original prescription information to another pharmacy for the purpose of refill dispensing Can be done on a one-time basis only Pharmacies electronically sharing an online database may transfer up to the maximum amount of refills allowed by law Transfer must be communicated between 2 licensed pharmacists Pharmacist must record the following information: Write the word VOID on the face of the invalidated prescription On the reverse of the prescription record: Name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving information Record date of transfer and name of the pharmacist transferring Pharmacist dispensing a prescription for a controlled substance must affix to the package a label showing: Pharmacy name and address Prescription number Patient name Name of prescribing practitioner Directions for use FDA requires that drugs in schedules II, III, or IV must contain: CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed Controlled substance must be dispensed to the patient or a member of the patient s household Otherwise would be distribution and not dispensing www.proce.com 23
Emergency prescription is defined as: Immediate administration of the drug is necessary for proper treatment No alternative treatment is available (a drug that is not schedule II) Not possible for the practitioner to provide written prescription In case of an emergency, a practitioner may telephone a schedule II prescription to the pharmacist who may dispense it A written and signed prescription p must be provided within 7 days Prescription must have written on the front: Authorization for Emergency Dispensing and the date of oral order Pharmacist must notify DEA if prescription not received within 7 days Partial quantity may be dispensed if full quantity cannot be filled Pharmacist should document quantity supplied on the front of the prescription Remaining portion may be dispensed within 72 hours of the first partial dispensing If not filled or cannot be filled, the pharmacist must notify practitioner No further quantity may be supplied beyond 72 hours www.proce.com 24
Pharmacy may distribute controlled substances, without being registered as a distributor, for the purpose of general dispensing Pharmacy or practitioner that will receive the controlled substances must be registered to dispense the controlled substances Distribution and receipt of the controlled substance must be recorded Transfer must be documented on an official DEA Form 222 or electronic equivalent Total number of dosage units of all controlled substances distributed may not exceed 5 percent of all controlled substances dispensed by the pharmacy within a calendar year www.proce.com 25