MPJE Review - South Carolina Pharmacy Association
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May 12, 2014 SCPhA MPJE Review 3 SCPhA MPJE Review May 12, 2014 About the test… MPJE Review: South Carolina and Federal Laws & Regulations • 2 hour seating time – no breaks • 90 Multiple-Choice Questions ▫ 75 questions used to calculate test score ▫ 15 questions used as field questions • Passing score is 75 (not a %) Jennifer L. Baker, PharmD, RPh Clinical Assistant Professor South Carolina College of Pharmacy jbaker@sccp.sc.edu ▫ Determined by ability level • If at first you don’t succeed… ▫ Retake after minimum of 30 days per NABP ▫ 5 Chances to Pass per State 2 SCPhA MPJE Review 4 May 12, 2014 MPJE: What is it? • Multistate Pharmacy Jurisprudence Examination • NAPLEX/MPJE Bulleting: www.nabp.net • Tests on mastery of pharmacy law as outlined by MPJE Competency Statements • Computer-adaptive examination SCPhA MPJE Review May 12, 2014 Potential Question Format • • • • Multiple Choice Multiple Response Ordered Response Take advantage of the tutorial offered prior to starting your test ▫ Assesses answers for each question ▫ Estimate of ability level based on difficulty level of questions answered correctly J. Baker 1 May 12, 2014 SCPhA MPJE Review 5 SCPhA MPJE Review 7 May 12, 2014 SCPhA MPJE Review Important Reminders May 12, 2014 Study Tips • You cannot change your answers once your choice is confirmed! • You cannot go back and review questions! • You cannot skip questions! • No distinction made between federal and state regulations • • • • • Concentrate on major topics DO NOT memorize exact citations Know date of origin for major laws Spend time on Controlled Substances Act Pay attention to “shall” or “may” ▫ Answer each question in terms of prevailing laws in state you are seeking licensure 6 SCPhA MPJE Review Common Errors • Not reading the question carefully Which one of the following is NOT required to be placed by the pharmacist onto a prescription? Which one of the following is NOT required to be placed by the pharmacist onto a prescription label? • Basing answers on what you do in the pharmacy in which you are employed • Basing answers on recent changes in law ▫ Questions updated usually twice a year J. Baker 8 May 12, 2014 SCPhA MPJE Review May 12, 2014 Testing Tips • Read each question carefully ▫ Determine what concept, general principle, or specific law is being tested Stricter law applies • Classify drugs specifically mentioned ▫ Controlled substance, non-CS, or OTC • Assume each question is straightforward • Don’t overanalyze 2 May 12, 2014 SCPhA MPJE Review 9 SCPhA MPJE Review 11 May 12, 2014 SCPhA MPJE Review Study Materials May 12, 2014 Study Materials • South Carolina Board of Pharmacy Site ▫ www.llr.state.sc.us/POL/Pharmacy/ Pharmacy Policy & Procedures Drug Product Selection Act • Federal Law ▫ Guide to Federal Pharmacy Law www.apothecarypress.com www.amazon.com SC Code of Laws Title 39 Chapter 24 ▫ Code of Federal Regulations/CSA Adulterated, Misbrands or New Drugs and Devices www.deadiversion.usdoj.gov/21cfr/index.html SC Code of Laws Title 39 Chapter 23 ▫ Controlled Substances Act (Pharmacist’s Manual) Dept of LLR: State Board of Pharmacy SC Code of Regulations Chapter 99 www.deadiversion.usdoj.gov/pubs/manuals/index.ht ml 10 SCPhA MPJE Review 12 May 12, 2014 Study Materials • SC Pharmacy Practice Act (SC Code of Laws Title 40 Chapter 43) ▫ http://www.scstatehouse.gov/code/t40c043.php • SC Controlled Substances Regulations (SC Code of Regulations Chapter 61-4) - scroll down to 61-4 ▫ http://www.scstatehouse.gov/coderegs/c061a.php • Poisons, Drugs and Other Controlled Substances (SC Code of Laws Title 40 Chapter 53) ▫ http://www.scstatehouse.gov/code/t44c053.php • Prescription Monitoring Act (SC Code of Laws Title 44 Chapter 53) SCPhA MPJE Review May 12, 2014 MPJE Competency Statements • Area 1: Pharmacy Practice ▫ 84% of Test • Area 2: Licensure, Registration, Certification, & Operational Requirements ▫ 13% of Test • Area 3: Regulatory Structure and Terms ▫ 3% of Test ▫ http://www.scdhec.gov/administration/drugcontrol/pmp-legislativesummary.htm J. Baker 3 May 12, 2014 SCPhA MPJE Review 13 SCPhA MPJE Review May 12, 2014 15 SCPhA MPJE Review Area 1: Pharmacy Practice May 12, 2014 Area 1: Pharmacy Practice • 1.01: Identify the legal responsibilities of the pharmacist and other pharmacy personnel. • 1.06: Identify the requirements for the distribution and/or dispensing of nonprescription pharmaceutical products, including controlled substances. • 1.02: Identify the requirements for the acquisition and distribution of pharmaceutical products, including samples. • 1.07: Identify the proper procedures for keeping records of information related to pharmacy practice, pharmaceutical products and patients, including requirements for protecting patient confidentiality. • 1.03: Identify the requirements that must be observed in the issuance of a prescription/drug order 14 SCPhA MPJE Review May 12, 2014 Area 1: Pharmacy Practice • 1.04: Identify the procedures necessary to properly dispense a pharmaceutical product, including controlled substances, pursuant to a prescription/drug order. • 1.05: Identify the conditions for making an offer to counsel or counseling appropriate patients, including the requirements for documentation. J. Baker 16 SCPhA MPJE Review May 12, 2014 Area 2: Licensure, Registration, Certification, & Operational Requirements • 2.01: Identify the qualifications, application procedure, necessary examinations, and internship requirements for licensure, registration, or certification of individuals engaged in the manufacture, storage, distribution, and/or dispensing of pharmaceutical products (prescription and nonprescription). 4 May 12, 2014 SCPhA MPJE Review 17 SCPhA MPJE Review 19 May 12, 2014 SCPhA MPJE Review Area 2: Licensure, Registration, Certification, & Operational Requirements May 12, 2014 Know Relevant Laws/Regulations • 2.02: Identify the requirements and application procedure for the registration, licensure, certification, or permitting of a practice setting or business entity. • Obtaining/maintaining RPh license—including CE credits • Structure/duties of BOP and authorized inspection bodies • Standards of practice for filling/refilling Rx • Drug substitution • Purchasing, storing, and record keeping of drugs • 2.03: Identify the operational requirements for a registered, licensed, certified, or permitted practice setting. Including dispensing Controlled Substances 18 SCPhA MPJE Review Area 3: Regulatory Structure and Terms • 3.01: Identify the purpose of, and the terms and conditions found in, the laws and rules that regulate or affect the manufacture, storage, distribution, and dispensing of pharmaceutical products (prescription and nonprescription), including controlled substances. • 3.02: Identify the authority, responsibilities, and operation of the agencies or entities that enforce the laws and rules that regulate or affect the manufacture, storage, distribution, and dispensing of pharmaceutical products (prescription and nonprescription), including controlled substances. J. Baker 20 May 12, 2014 SCPhA MPJE Review May 12, 2014 Know Relevant Laws/Regulations • Counseling patients, confidentiality of Rxs and medical records • Registration/maintenance of pharmacy Community and Institutional • Pathways/requirements for bringing new drugs to market • Individual laws/regulations that impact the practice of pharmacy Federal or state 5 May 12, 2014 SCPhA MPJE Review 23 SCPhA MPJE Review May 12, 2014 Pharmacist-in-Charge PPA 40-43-30(40) A pharmacist currently licensed in this State who accepts responsibility for the operation of a pharmacy in conformance with all laws pertinent to the practice of pharmacy and the distribution of drugs and who is in full and actual charge of the pharmacy and personnel Area 1: Pharmacy Practice 1.01: Identify the legal responsibilities of the pharmacist and other pharmacy personnel. 22 SCPhA MPJE Review Duties of Pharmacy Personnel • Pharmacist-In-Charge (PIC) • Consultant Pharmacists • Registered Technicians • State Certified Technicians (CPhT) • Pharmacy Interns/Externs 24 May 12, 2014 SCPhA MPJE Review May 12, 2014 Pharmacist-In-Charge PPA 40-43-86(B) • PIC at only one location • Must spend sufficient time in pharmacy • Accepts full and actual charge of the pharmacy and personnel • Clerical Staff J. Baker 6 May 12, 2014 SCPhA MPJE Review 25 SCPhA MPJE Review SCPhA MPJE Review May 12, 2014 Pharmacist-In-Charge Duties Pharmacist-In-Charge Duties PPA 40-43-86(B) • Notify BOP of changes ▫ ▫ ▫ ▫ 27 May 12, 2014 • Establish/Implement Policies and Procedures Employment or PIC Responsibility Pharmacy Ownership Pharmacy Address Pharmacy Closing ▫ Duties of Pharmacy Technicians ▫ Management of drug recalls ▫ Automated systems • Policies and Procedures for Institutions • File required reports ▫ ▫ ▫ ▫ ▫ Reports required by state or federal laws and regulations • Respond to BOP Violations • Sign/Renew pharmacy permit Provision of drugs in pharmacist absence Specific authorized personnel have access Night Cabinet Drug Inventory list Stop-order policy 26 SCPhA MPJE Review 28 May 12, 2014 Pharmacist-In-Charge Duties • Ensures proper licensure, certification, or registration • Ensure technicians and interns wear proper identification • Maintain list of pharmacy technicians SCPhA MPJE Review May 12, 2014 Consultant Pharmacist PPA 40-43-30(36) • Permit Consultant Pharmacist ▫ A pharmacist licensed in this State who acts as a consultant for a permit holder other than a pharmacy or an institution ▫ BOP has specific form for this list J. Baker 7 May 12, 2014 SCPhA MPJE Review 29 SCPhA MPJE Review 31 May 12, 2014 SCPhA MPJE Review Consultant Pharmacist Duties Consultant Pharmacist Duties PPA 40-43-86(C) PPA 40-43-86(C) • Every permit holder issued by BOP requires consultant pharmacist May 12, 2014 • Drug Information Resource Exceptions: Pharmacy, Wholesalers, Permitted facility supplying only Oxygen Allowed to be Consultant at one or more locations ▫ Bring current drug information to attention of staff ▫ Be available by phone for questions • Agree in writing to assume responsibilities ▫ 10 days to notify BOP of changes • Signs new/renewal permit application 30 SCPhA MPJE Review SCPhA MPJE Review Consultant Pharmacist Duties Consultant Pharmacist Duties PPA 40-43-86(C) PPA 40-43-86(C) • Establish/Implement Policies and Procedures ▫ ▫ ▫ ▫ Recordkeeping system for drugs Drug recalls Removal of outdated/adulterated drugs Duties of employees Procurement Sale Storage J. Baker 32 May 12, 2014 Compounding Distribution May 12, 2014 • Monthly inspections for compliance with policies and procedures ▫ Reports are responsibility of consultant pharmacist • Monthly patient record review ▫ Document on patient record ▫ Review for potential adverse reactions, allergies, interactions, lab test modification ▫ Advise physician of any recommended changes 8 May 12, 2014 SCPhA MPJE Review 33 SCPhA MPJE Review 35 May 12, 2014 SCPhA MPJE Review Registered Technician Duties Registered Technician Duties BOP P/P 140 BOP P/P 140 • Provide effective, appropriate, and safe pharmacy services May 12, 2014 • Handle legend drugs Check for drug outdates Accept/Stock drug shipments • Prepare Prescriptions Process/Discard medications for returned credit • Handle legend drugs Stock automatic dispensers • Compound and mix medications • Compound and mix medications Mix drugs in dry form with water to activate Prepare IV solutions Repackage bulk medications 34 SCPhA MPJE Review 36 May 12, 2014 SCPhA MPJE Review May 12, 2014 Registered Technician Duties Certified Pharmacy Technician BOP P/P 140 PPA 40-43-30(54) • Prepare Prescriptions Receive written prescription or medication orders Receive verbal refill requests • An individual who is a registered pharmacy technician and who has completed the requirements set forth in 40-43-82(B). Initial interpretation of orders Enter Rx information into patient profile Select appropriate drugs/devices Fill/maintain unit dose carts Change unit dose medication cassettes J. Baker 9 May 12, 2014 SCPhA MPJE Review 37 SCPhA MPJE Review 39 May 12, 2014 SCPhA MPJE Review State Certified Technician Duties Intern/Extern Duties (PPA 40-43-82(B)) PPA 40-43-85 May 12, 2014 • Interpret/Evaluate Medical Orders • Receive/Initiate verbal phone orders for non- • Participate in drug/device selection controlled substances • Provide patient counseling • Conduct Rx transfers • Perform drug regimen reviews Institutional Setting: • Provide pharmacy care • Check a technician’s medication refill • Receive phone/verbal orders • Check a technician’s repackaging 38 SCPhA MPJE Review Pharmacy Interns/Externs PPA 40-43-30(21, 27) • Extern Individual currently enrolled in an approved college or school of pharmacy who is on required rotations for obtaining a degree in pharmacy • Intern Individual currently registered by certificate in this state to engage in the practice of pharmacy while under the personal supervision of a pharmacist and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist. J. Baker 40 May 12, 2014 SCPhA MPJE Review May 12, 2014 Clerical Duties • Enter patient information into profiles Name Address DOB • • • • Phone NumbersInsurance Order pharmaceuticals Perform billing functions Nonprofessional telephone inquiries Process Rx sales transaction ▫ Includes CV non-Rx sales after pharmacist signs book ▫ Includes sales of CMEA covered products 10 May 12, 2014 SCPhA MPJE Review 41 SCPhA MPJE Review 43 May 12, 2014 Employment Ratio PPA 40-43-86(B)(4)(b-c) • One Pharmacist : Three Technicians ▫ At least TWO of these three technicians must be statecertified • Institutional Pharmacy Employment ratio: 1:3 Daily operational ratio determined by PIC • Exclusions Clerical Support Pharmacy Interns/Externs One pharmacist : One Intern Technician Students on clinical rotation SCPhA MPJE Review May 12, 2014 Federal Laws: Acquisition/distribution • Food & Drug Act of 1906 ▫ Prohibited Interstate Commerce of adulterated food, drinks, drugs ▫ Did not regulate cosmetic products or medical devices • Fair Packaging & Labeling Act ▫ Requires consumer products in interstate to be properly labeled (including OTC) 44 SCPhA MPJE Review May 12, 2014 Federal Laws: Acquisition/distribution • Prescription Drug Marketing Act 1987 (Dingle Bill) Area 1: Pharmacy Practice 1.02: Identify the requirements for the acquisition and distribution of pharmaceutical products, including samples. J. Baker ▫ Enacted to correct problem of diversion from normal distribution channels Proper storage/maintenance of distribution records Restricts resale of drug products by hospitals Wholesalers must be state licensed Companies must be registered 11 May 12, 2014 SCPhA MPJE Review 45 SCPhA MPJE Review 47 May 12, 2014 SCPhA MPJE Review May 12, 2014 Labeling of Samples Dingle Bill: Restricts sales/purchase/trade of drug samples 39-23-55 • Sample: unit of a drug not intended to be sold and intended to promote sale of drug • Labeling not required for sample if non-controlled • Bars retail pharmacies from receiving samples ▫ Starter packs are allowed Distributed free to pharmacies Not considered samples; intended for initiation of drug therapy for a patient Vouchers or coupons ▫ Exemption does not apply if following dispensed: More than 120 dosage units or 30 day supply of drug in solid form More than 8 ounces drug in liquid form • If sample is not in manufacturer’s original packaging, physician must label it to meet requirements of nonsample Rxs • Institutional pharmacies may receive samples ▫ Licensed prescriber requested ▫ Disposition is precisely recorded ▫ Store separately from normal drug stock ▫ If adequate directions for use are not provided by manufacturer, physician shall give adequate written directions 46 SCPhA MPJE Review Dingle Bill: Restricts sales/purchase/trade of drug samples • Licensed practitioners provide written requests for samples ▫ Drug Manufacturers/Distributors keep requests for 3 yrs ▫ Sales representatives are responsible for samples/annual inventory J. Baker 48 May 12, 2014 SCPhA MPJE Review May 12, 2014 An inspector from the FDA enters your community pharmacy. She may issue citations if which of the following are found: I. II. III. Drug samples being sold/dispensed pursuant to a prescription Recalled prescription drugs among the drug stock Samples stored in the drug stock A. B. C. D. I only I & II only II & III only I, II, & III 12 May 12, 2014 SCPhA MPJE Review 49 SCPhA MPJE Review 51 May 12, 2014 SCPhA MPJE Review May 12, 2014 "Wholesale distributor" does not include (PPA 40-43-30(52)): Distribution PPA 40-43-30(15) • "Distribute" means the delivery of a drug or device other than by administering or dispensing. • • Intracompany sales Health care entity that is a member of a grouppurchasing organization Sale/purchase/ trade of a drug for emergency medical reasons • ▫ Pharmacies: gross dollar value of the transfers may not exceed five percent of the total legend drug sales revenue during a consecutive twelvemonth period 50 SCPhA MPJE Review May 12, 2014 Wholesale Distributor Person engaged in wholesale distribution of prescription drugs/devices Manufacturers Repackagers Own-label distributors Private-label distributors Retail pharmacies (that conduct wholesale distribution) J. Baker Warehouses: Manufacturers Distributors Chain Drug Wholesaler Area 1: Pharmacy Practice 1.03: Identify the requirements that must be observed in the issuance of a prescription/drug order 13 May 12, 2014 SCPhA MPJE Review 53 SCPhA MPJE Review 55 May 12, 2014 SCPhA MPJE Review Definition of practitioner May 12, 2014 Optometrists Prescriptive Authority (40-37-105) 40-43-30(45) • Anyone authorized by law to diagnose and prescribe drugs and devices. • Who may prescribe in S.C.? 1. Physician 2. Dentist 3. Osteopath 4. Podiatrist 5. Veterinarian 6. Licensed nurse practitioner (certified)*: C-III – CV only 7. Optometrists: CIII – CV only with limitations 8. Physician assistants*: CII (limited); CIV – CV 5. May prescribe controlled substance analgesics in Schedules III, IV, V in a 7 day or less supply 6. Rx’s for topical steroids limited to maximum of 21 days of therapy unless optometrist is in communication and collaboration with an ophthalmologist ▫ Acting in regular course of professional practice ▫ *Based on prescriptive authority within protocols 54 SCPhA MPJE Review Optometrists Prescriptive Authority PPA 40-43-86(S); 40-37-105 1. “Diagnostically certified” optometrists 2. May purchase, possess, administer, supply and prescribe pharmaceutical agents 3. Prescribing is limited to anesthetics, antihistamines, antimicrobials, antiglaucoma, OTC drugs J. Baker 56 May 12, 2014 SCPhA MPJE Review May 12, 2014 Nurse Prescriptive Authority 40-33-33 F(1) • • ▫ Must be Board of Nursing recognized Nurse Practitioner, Clinical Nurse Practitioner or a Certified Registered Nurse Anesthetist Shall perform delegated medical acts according to an approved protocol between the nurse and the physician Delegated Medical Acts include: a. Medical conditions for which therapies may be initiated, continued or modified; b. Treatments that may be initiated, modified or continued; c. Drug therapies that may be prescribed; d. Situations that require direct evaluation or referral to the physician 14 May 12, 2014 SCPhA MPJE Review 57 SCPhA MPJE Review 59 May 12, 2014 SCPhA MPJE Review May 12, 2014 Definition of a prescription Nurse Prescriptive Authority 40-33-33 F(1) PPA 40-43-30(47) • Standards for Rx by nurse practitioners with prescriptive authority: 1. Oral or written order for a legitimate medical purpose within the practitioner’s usual course of practice and including orders from collaborative pharmacy practice 2. Given individually for the specific person for whom prescribed 3. Directly from the prescriber or prescriber’s agent to a pharmacist or pharmacist’s agent 1. Shall comply with all state and federal laws 2. Limited to drugs and devices utilized to treat common well-defined medical problems within the specialty field of the nurse practitioner as authorized by the physician and listed in approved written protocols 3. Controlled substances in C-II cannot be prescribed. May prescribe C-III thru C-V if registered with DHEC • Telephone (oral) orders are permissible 58 SCPhA MPJE Review Physician’s Assistants 1. May prescribe if certified by the S.C. Medical Board 2. May prescribe Schedule II - V controlled substances if registered with DHEC/DEA • • • J. Baker 60 May 12, 2014 Must be expressly approved in scope of practice with supervising physician Oral dose: limited to 72 hour supply Parenteral dose: (only in hospital setting): limited to a 24 hour order SCPhA MPJE Review May 12, 2014 Prescription Drug Order Requirements (PPA 40-43-86(E)) • Patient information ▫ Full name ▫ Address • Prescriber information ▫ ▫ ▫ ▫ ▫ Name Address & Telephone Number Degree of prescriber License number DEA number (where required by law) 15 May 12, 2014 SCPhA MPJE Review 61 SCPhA MPJE Review 63 May 12, 2014 SCPhA MPJE Review Preprinted Prescriptions Refills (PPA 40-43-86(E); 44-53-360(d)) Prescription Drug Order Requirements (PPA 40-43-86(E)) • Non-Controlled Drugs • Date of issuance ▫ One drug/set of instructions per blank ▫ CS: Dated/Signed on date of issue • Drug information ▫ ▫ ▫ ▫ ▫ May 12, 2014 • Controlled Drugs ▫ Preprinted blanks are prohibited Name Strength Dosage form Quantity Directions for use • Number of authorized refills ▫ PRN refills good for 2 years for non-controls ▫ Controlled substances No refills unless specifically indicated PRN refills = 5 refills or 6 months, whichever occurs first 62 SCPhA MPJE Review Prescriber Signature PPA 40-43-86(H); BOP P/P #66 • Two signature lines required on Rx ▫ “Dispense as Written” ▫ “Substitution Permitted” • Board policy #66 ▫ Practitioner is responsible for the integrity of the Rx ▫ Pharmacist is responsible for checking with practitioner if there is any doubt of validity ▫ Use professional judgment in accepting or refusing to fill Rx J. Baker 64 May 12, 2014 SCPhA MPJE Review May 12, 2014 Electronic Prescribing • Code of Laws, Title 44, Chapter 117 ▫ Prescription Information Privacy Act ▫ www.scstatehouse.gov/code/t44c117.htm • • • • Patient-practitioner relationship Rx IDs transmitter & recipient Pharmacy of patient’s choice Secure prescriber signature 16 May 12, 2014 SCPhA MPJE Review 65 SCPhA MPJE Review 67 May 12, 2014 SCPhA MPJE Review Electronic Prescribing May 12, 2014 Immunization Practice in SC INDIVIDUAL PRESCRIPTION • Routing company registers with BOP • Rx Format ▫ Meets all requirements of 40-43-86(E) ▫ Generic substitution instructions must be clear • Pharmacy can not incentivize e-prescribers PRESCRIBER ISSUED PROTOCOL/STANDING ORDER/DIRECTIVE FOR PRESCRIBER’S PATIENTS ONLY PRESCRIBER ISSUED PROTOCOL/STANDING ORDER/DIRECTIVE FOR ANY AND ALL PATIENTS Age restriction None 18 + As may be identified within ? Vaccine restriction None Influenza only As may be identified within ? Administration by Pharmacy Intern Yes No As may be identified within ? Authorization derived from: SC Code of Laws 40-43-30 (1) 40-43-30 (39) 40-43-30 (44) 40-43-30 (47) Board of Pharmacy Policy and Procedure #138 Board of Medical Examiners Policy SC Code of Laws 40-43-190 Board of Medical Examiners Policy SC Code of Laws 40-43-30 (1) 40-43-30 (39) 40-43-30 (44) 40-43-30 (47) Board of Pharmacy Policy and Procedure #138 Board of Medical Examiners Policy SC Code of Laws??? Board of Pharmacy Policy and Procedure #138???? • Pharmacy Policies/Procedures ▫ Integrity/confidentiality Rx/Pt info BOARD OF MEDICAL EXAMINERS PROTOCOL SECTION 40-43-30(47) "Prescription drug order" means a lawful order from a practitioner for a drug or device for a specific patient, issued for a legitimate medical purpose within the prescriber's course of legitimate practice and including orders derived from collaborative pharmacy practice. 66 SCPhA MPJE Review May 12, 2014 Authority to Administer 40-43-30(1): “Administer” means the direct application of a drug or device pursuant to a lawful order of a practitioner to the body of a patient by injection, inhalation, ingestion, topical application, or any other means. Vaccine Administration Any vaccination • Patient specific prescription • Protocol signed by prescriber Influenza vaccine • Patient specific prescription • Protocol signed by prescriber • State protocol J. Baker Area 1: Pharmacy Practice 1.04: Identify the procedures necessary to properly dispense a pharmaceutical product, including controlled substances, pursuant to a prescription/drug order. 17 May 12, 2014 SCPhA MPJE Review 69 SCPhA MPJE Review 71 May 12, 2014 SCPhA MPJE Review Federal Laws: Dispensing May 12, 2014 Federal Law: PPPA • Durham-Humphrey Amendment 1951 • Refills must be in containers with new plastic parts ▫ Established two classes of drugs Prescription Safe and effective when used as intended under medical supervision Nonprescription ▫ Replace cap and bottle if plastic ▫ Glass can be reused, but plastic closure replaced • One package size of OTC must be safety locked Safe and effective when used as labeled without medical supervision ▫ “This package for household without young children” ▫ All Rx bottles must have legend: “Caution: Federal Law prohibits dispensing without a prescription” ▫ Verbal orders for prescriptions and refills 70 SCPhA MPJE Review 72 May 12, 2014 Federal Law: PPPA • Poison Prevention Packaging Act 1970 ▫ Administered by US Consumer Product Safety Commission ▫ All oral medications must be dispensed in childresistant containers ▫ Childhood ingestions reduced by child-resistant packaging ▫ Packaging difficult for children to open ▫ Requirements for iron products SCPhA MPJE Review May 12, 2014 Federal Law: PPPA • New/refill prescriptions must be in childresistant closure unless: ▫ Prescriber specifies none to be used (one Rx) ▫ Patient indicates they do not want such closure Differentiate single request vs blanket waiver ▫ Drugs are maintained/administered by health professionals Not including nursing homes http://www.cpsc.gov/Media/Documents/Regulations-Laws--Standards/VoluntaryStandards/Poison-Prevention-Packaging-A-Guide-for-Healthcare-Professionals/ J. Baker 18 May 12, 2014 SCPhA MPJE Review 73 SCPhA MPJE Review 75 May 12, 2014 SCPhA MPJE Review May 12, 2014 Permission to not use a poison prevention closure on a prescription may be granted by the Federal Law: PPPA • Customer must choose to receive non-child resistant packaging • Blanket waivers acceptable I. Patient II. Prescriber III. Pharmacist Best practice: Written waiver with follow up Document on the Rx (A) I only (B) I & II only (C) II & III only (D) I, II, & III • Dispensing pharmacist is responsible • The test is whether the prescription is likely to enter a home 74 SCPhA MPJE Review Exemptions from PPPA • Nitroglycerin-SL • Isosorbide dinitrate SL/Chew ≤10mg • ASA or APAP Effervescent or Granules 76 May 12, 2014 • Anhydrous cholestyramine or colestipol packets • Aerosol containers Inhalation therapy • OC’s in dialpacks SCPhA MPJE Review May 12, 2014 When refilling a prescription that requires a poison prevention container, the pharmacist must always replace a I. Glass container II. Plastic container III. Plastic closure • Potassium supplements Unit dose packaging J. Baker (A) I only (B) I & II only (C) II & III only (D) I, II, & III 19 May 12, 2014 SCPhA MPJE Review 77 SCPhA MPJE Review SCPhA MPJE Review May 12, 2014 Labeling of Prescriptions Restricted Distribution Programs • • • • • • • • • • • 79 May 12, 2014 40-43-86(I)(4); 39-23-50(b)(2) STEPS: thalidomide iPLEDGE: isoretinoin Prescribing Program for Lotronex (PPL) Tracleer Access Program (TAP) Clozaril National Registry Tikosyn in Pharmacy System (T.I.P.S) Exjade Patient Assistance & Support Services (EPASS) Fosamax Paget’s Patient Support Program IRESSA Access Program Xyrem Success Program Resources for Expert Assistance & Care Helpline (REACH) • Drug dispensed by filling/refilling: Name/address of dispenser (pharmacy) Prescription (serial) number Name of prescriber Name of patient Date of filling Drug dispensed and strength (if multiple strengths marketed) Include labeling requirements if dispensing generic Directions for use by patient Any special cautionary statement Initials of dispensing pharmacist 78 SCPhA MPJE Review Prescription Drug Order Requirements • NOTHING abridges the right of a pharmacist to refuse to fill or refill a prescription • (PPA Section 40-43-86(E)(6)) ▫ ▫ ▫ ▫ J. Baker 80 May 12, 2014 Rx is suspected forgery/fictitious RPh would violate law by filling Drug/product is not in stock RPh believes drug may be harmful to patient SCPhA MPJE Review May 12, 2014 Labeling Parenteral Solutions • • • • • • • • • Name of solution and volume of solution Patient’s name Infusion rate Bottle sequence number or other system control method Name and quantity of each additive Date of preparation Beyond-use date and time of parenteral admixture Ancillary precaution labels Identity of preparer and checking pharmacist 20 May 12, 2014 SCPhA MPJE Review 81 SCPhA MPJE Review 83 May 12, 2014 SCPhA MPJE Review Generic Substitution Generic Substitution PPA 40-43-30(20) PPA 40-43-86(H); 39-24-30,40 May 12, 2014 • Pharmacist may use professional judgment to substitute • "Equivalent drug product" means a drug product which has the same established name and active ingredients ▫ Same name, active ingredients ▫ Same dosage form and strength ▫ Therapeutically equivalent drug product Same efficacy and toxicity • Prescriber must authorize substitution to meet the same compendia or other applicable standards, but which ▫ Consent by proper signature ▫ Verbally give permission which must be documented • Patient or caregiver must consent to receive substituted drug may differ in shape, scoring, packaging, excipients and expiration. ▫ Blanket authorizations not acceptable 82 SCPhA MPJE Review Generic Substitution PPA 40-43-30(51) • "Therapeutically equivalent" means a drug product with the same efficacy and toxicity when administered to an individual as the originally prescribed drug as provided for in Section 39-24-40 • 39-24-40(4) includes administered to individual in same dosage form J. Baker 84 May 12, 2014 SCPhA MPJE Review May 12, 2014 Generic Substitution Rx Requirements PPA 40-43-86(H); Drug Product Selection Act • Brand name or generic drug manufacturer must be noted on file copy • Unless prescriber indicates name of drug may not appear on the prescription label, Rx label must indicate substitution ▫ List brand name ▫ Generic name/manufacturer ▫ “Generic for” 21 May 12, 2014 SCPhA MPJE Review 85 SCPhA MPJE Review 87 May 12, 2014 SCPhA MPJE Review One-Time Emergency Refill of NonControlled Rx May 12, 2014 Follow up question In this case of unauthorized refills, the dispensed quantity of the refilled drug should be limited to a: A. One-day supply B. Seven-day supply C. Three-day supply D. Thirty-day supply • May occur AFTER attempting to reach prescriber • Up to 72 hour supply may be dispensed • Medication must be “essential” ▫ Refill necessary to continuation of therapy or maintenance of life • Continuation will be safe • Prescriber must be contacted within 72 hours 86 SCPhA MPJE Review May 12, 2014 Which of the following is true regarding refilling a prescription drug/device when the pharmacist fails to obtain authorization from the prescriber? I. II. III. A. B. C. D. J. Baker Pharmacist can fill Rx drug/device if he thinks that it is required for the continuation of therapy for chronic conditions Pharmacist can fill the Rx drug/device if he thinks that the interruption of therapy may produce serious health consequences. Pharmacist can fill the Rx drug/device if the refill of the Rx is not for a controlled substance. I only I and II only II and III only All 88 SCPhA MPJE Review May 12, 2014 Transferring Prescriptions • Who Can Transfer Prescriptions? ▫ Pharmacist ▫ Pharmacy Intern/Extern: Non CS Under supervision of supervising pharmacist Regulations do not explicitly state interns/externs can or can not transfer prescriptions ▫ State Certified Technician: Non CS Upon approval of supervising pharmacist Not every registered technician 22 May 12, 2014 SCPhA MPJE Review 89 SCPhA MPJE Review 91 May 12, 2014 SCPhA MPJE Review When is transferring permissible? Receiving pharmacy PPA 40-43-86(G) PPA 40-43-86(G) • Transfer of original prescription information for purpose of dispensing refills • Occurs between licensed or permitted pharmacies • Occurs between two pharmacists May 12, 2014 • Document “transfer” on Rx • Record Rx info including: ▫ Date of issue and Rx number of original Rx ▫ Date/time of transfer ▫ Transferring pharmacy name/address Pharmacy DEA number if controlled substance Rx ▫ Not one pharmacist accessing an information file containing data for several locations ▫ Name of pharmacist giving transfer ▫ Manufacturer or brand name of drug dispensed ▫ Documentation that receiving pharmacist will dispense refills based on transferring pharmacist’s certification Unless all locations are under common ownership or accessed by contractual agreement of the pharmacies 90 SCPhA MPJE Review SCPhA MPJE Review Transferring Pharmacy Transferring Prescriptions PPA 40-43-86(G) PPA 40-43-86(G) • Record date of transfer • Record name/address of receiving pharmacy • Record name of pharmacist receiving transfer • Document receiving pharmacist is authorized to dispense all remaining refills based on original prescription • Any remaining refills must be voided J. Baker 92 May 12, 2014 May 12, 2014 • Transfer requirements may be facilitated by use of computer, data, or fax • Transfer records must be readily available • Original and transferred prescriptions drug order must be maintained two years from date of last refill • Transfer must be compliant with current state and federal laws on controlled substances 23 May 12, 2014 SCPhA MPJE Review 93 SCPhA MPJE Review 95 May 12, 2014 SCPhA MPJE Review Transferring Prescriptions May 12, 2014 Emergency Kits Summary 40-43-86 B(6)(d) • Institutional facilities without pharmacy • Include drugs required to meet immediate therapeutic needs of patients • All Prescriptions ▫ Transferred in and out of South Carolina ▫ All refills are transferred ▫ Not available from other sources in sufficient time to prevent risk of harm by delay from obtaining from other sources Any remaining refills are voided ▫ All records must be maintained for 2 years • Must be provided/sealed by a pharmacist • Supplying pharmacist and institution jointly determine drugs, identity/quantity • Non-Controlled Substances ▫ Rx can be transferred as long as there are authorized refills remaining Unshared and Shared Databases 94 SCPhA MPJE Review Transferring Prescriptions Summary • Controlled substances ▫ Between licensed pharmacists ▫ Common Database Origination: Rx can be transferred as long as there are authorized refills and can transfer out one-time If received from a pharmacy that does not have shared database: you can NOT transfer the Rx again within your shared database ▫ Unshared Database 96 May 12, 2014 SCPhA MPJE Review May 12, 2014 Emergency Kits 40-43-86 B(6)(d) • Must be stored in secured areas to: ▫ Prevent unauthorized access ▫ Ensure proper environment for preservation • Exterior must be labeled ▫ Clearly indicate for use in emergencies only ▫ List of drugs included Name, strength, quantity ▫ Supplying pharmacist Name, address, telephone number One-time transfer of all refills J. Baker 24 May 12, 2014 SCPhA MPJE Review 97 SCPhA MPJE Review 99 May 12, 2014 SCPhA MPJE Review May 12, 2014 State of Emergency Emergency Kits 40-43-86 B(6)(d) 40-43-170 • Drugs must be removed only by a valid medical order • Whenever opened • Pharmacist has enough Rx information • In pharmacist’s professional opinion: ▫ Medication is essential ▫ Pharmacist must be notified ▫ Pharmacist restocks/reseals kit within reasonable time • Pharmacist puts information to written Rx marked “Emergency Refill” • Expiration Date ▫ Prescriber notified within 15 days ▫ Earliest date of expiration of drug/device in kit ▫ Pharmacist must replace expired drug/device • Prescription: non-controlled substances 98 SCPhA MPJE Review 100 May 12, 2014 SCPhA MPJE Review State of Emergency State of Emergency 40-43-170 40-43-170 • Governor issues state of emergency in affected county • Pharmacist may dispense one-time emergency refill up to 15 day supply May 12, 2014 • Pharmacist not licensed in SC but currently licensed in another state may dispense medications in those affected counties if: ▫ Current licensure can be proven ▫ Engages in legitimate relief effort • Disaster preparedness ends with state of emergency J. Baker 25 May 12, 2014 SCPhA MPJE Review 101 SCPhA MPJE Review 103 May 12, 2014 SCPhA MPJE Review Compounding Compounding Area 40-43-30(7) • The preparation, propagation, conversion, or processing of a drug or device by extraction from substances of natural origin or independently by means of chemical or biological synthesis, • or the preparation, mixing, assembling, packaging, or labeling of a drug or device • As the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice, PPA 40-43-86-CC(6) • or for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. May 12, 2014 • Pharmacist ensures accurate weights/measurements at each stage of compounding procedure • Procedures put in place to monitor output of compounded prescriptions ▫ ▫ ▫ ▫ ▫ Capsule weight variation Adequacy of mixing Clarity pH of solutions Procedures to prevent microbial contamination when medications are purported to be sterile 102 SCPhA MPJE Review SCPhA MPJE Review Compounding Compounding 40-43-30(7) PPA 40-43-86-CC(6) • Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. • Does NOT include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling J. Baker 104 May 12, 2014 May 12, 2014 • Formulas/logs maintained manually or electronically • Formulas must include: ▫ ▫ ▫ ▫ ▫ Ingredients Amounts Methodology Equipment Any special information regarding sterile compounding 26 May 12, 2014 SCPhA MPJE Review 105 SCPhA MPJE Review 107 May 12, 2014 SCPhA MPJE Review Compounding Logs May 12, 2014 Pharmacist Compounding 40-43-86(CC) PPA 40-43-86 (CC) • Pharmacists shall maintain proficiency through current awareness and training. • Comprehensive and include ingredients, amounts, methodology, equipment • Date of compounding • Date of expiration • Assign Compound Batch/Lot number • List all ingredients ▫ Continuing education shall include training in the art and science of compounding and the rules and regulations of compounding. • Pharmacy technicians may assist the pharmacist in compounding. ▫ Pharmacist is responsible for training and monitoring the pharmacy technician. ▫ Duties must be consistent with the training received. ▫ Lot number ▫ Expiration 106 SCPhA MPJE Review May 12, 2014 Dispensing Compounds • Date of dispense • Prescription must have lot number • May sell to licensed practitioner ▫ Pharmacist must have contract with physician or licensed practitioner in order to sell them compounded products ▫ Contract must specify that the compounds are intended for office use only, and lot numbers/expiration dates must be maintained and readily retrievable on patient records/charts J. Baker 108 SCPhA MPJE Review May 12, 2014 Compounding vs Manufacturing When does small-scale prescription compounding become manufacturing? • Quantity is reasonable for filling existing or anticipated Rx • Compounded drug products are not commercially available FDA-approved products • Dosage forms are not sold to other pharmacies or third party such as physician offices 27 May 12, 2014 SCPhA MPJE Review 109 SCPhA MPJE Review 111 May 12, 2014 SCPhA MPJE Review May 12, 2014 Which of the following actions is (are) permissible under the FDA rules for prescription compounding by pharmacies? I. Advertising to eye doctors that the pharmacy can compound sterile, isotonic ophthalmic solutions II. Sending brochures to nurse practitioners that indicate the pharmacy compounds topical ointments for the treatment of skin rashes III. Informing an allergy specialist that the pharmacy can economically compound 50mg diphenhydramine capsules (A) I only (B) III only (C) I & II only (D) I, II, & III Compounding vs Manufacturing When does small-scale prescription compounding become manufacturing? • Ingredients must meet official standards Can not be withdrawn/removed from market • Pharmacy may advertise it specializes in prescription compounding Not actively solicit business for specific products • Interstate distribution is no more than 5% of total Rxs filled by that pharmacy 110 SCPhA MPJE Review Compounding vs Manufacturing (continued) • Compounding is different from manufacturing, which is guided by GMPs (see Good Manufacturing Practices for Bulk Pharmaceutical Excipients 1078 ). Some of the characteristics or criteria that differentiate compounding from manufacturing include the existence of specific practitioner–patient–compounder relationships; the quantity of medication prepared in anticipation of receiving a prescription or a prescription order; and the conditions of sale, which are limited to specific prescription orders. (USP 795 PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS) J. Baker 112 May 12, 2014 SCPhA MPJE Review May 12, 2014 A pharmacy begins to receive prescriptions for a capsule mixture that is not available commercially. The usual prescription is for 14 capsules to be taken once daily with two refills. What is the maximum number of capsules the pharmacist may compound under FDA guidelines? A. B. C. D. 14 only 42 only Not more than 100 A sufficient quantity to meet anticipated prescriptions and refills 28 May 12, 2014 SCPhA MPJE Review 115 SCPhA MPJE Review May 12, 2014 Pharmacist Duties Prospective Drug Review • • • • • • • Area 1: Pharmacy Practice 1.05: Identify the conditions for making an offer to counsel or appropriately counsel patients, including the requirements for documentation. Over-utilization or under-utilization Therapeutic duplication Incorrect drug dosage or Duration of Therapy Drug-disease contraindications Drug-drug interactions Drug-Allergy Interactions Clinical Abuse/Misuse 114 SCPhA MPJE Review Federal Laws • Omnibus Reconciliation Act 1990 (OBRA) ▫ Drug Utilization Review Prospective (pharmacy) Retrospective (state required for Medicaid) ▫ Counseling Requirements “offer to discuss” medications with patient/caregiver ▫ Obtain patient specific information J. Baker 116 May 12, 2014 SCPhA MPJE Review May 12, 2014 Pharmacist Counseling Duties PPA 40-43-86(L) • Pharmacist must personally offer counseling for a new Rx • Alternative forms of information may supplement counseling ▫ Information leaflets ▫ Pictogram labels ▫ Video Programs 29 May 12, 2014 SCPhA MPJE Review 117 SCPhA MPJE Review 119 May 12, 2014 SCPhA MPJE Review Pharmacist Counseling Duties May 12, 2014 Patient Package Inserts (PPIs) PPA 40-43-86(L) • Educate the patient about proper use and potential dangers of using certain products • Counseling is not required for inpatients or ER ▫ When other licensed health care professionals administer ▫ Primarily focused on oral contraceptives • Ambulatory: Initial fill and every refill • Institutions: Prior to first administration and every 30 days thereafter • Applies to anyone who dispenses drugs • Counseling is not required when refused by patient or caregiver ▫ Including hospital pharmacies and LTCF ▫ Doctors in their own practice 118 SCPhA MPJE Review Pharmacist Counseling Topics PPA 40-43-86(L) • • • • • • • • J. Baker 120 May 12, 2014 Name/description of drug/dose Dosage form Route of administration Techniques for self-monitoring Duration of therapy/Refill information Side effects/Contraindications Proper storage How to handle a missed dose SCPhA MPJE Review May 12, 2014 MedGuides • FDA requires when ▫ Patient labeling could prevent serious adverse effects ▫ Product has serious risks relative to benefits ▫ Patient adherence to directions is crucial • FDA must approve language before distribution • Dispenser required to give to patient 30 May 12, 2014 SCPhA MPJE Review 121 SCPhA MPJE Review MedGuides • Review complete list: ▫ http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm ▫ Common classes 123 May 12, 2014 SCPhA MPJE Review May 12, 2014 Federal Law: OTCs Federal Anti-Tampering Act 1982 • Tamper-Resistant Packaging ▫ Select OTC products and cosmetics ▫ Provides barrier-to-entry Antidepressants/SSRIs ADHD NSAIDs Fluoroquinolones Thiazolidinediones Protects against intentional contamination of OTCs ▫ Alerts consumer to tampering Examples: safety-seals 124 SCPhA MPJE Review May 12, 2014 OTC Labeling Requirements • Area 1: Pharmacy Practice 1.06: Identify the requirements for the distribution and/or dispensing of nonprescription pharmaceutical products, including controlled substances. J. Baker Seven-Point Label 1. Name of product 2. Name/address of manufacturer, packer, distributor 3. Net contents of package 4. Established name of all active ingredients and certain inactive ingredients 5. Name of any habit-forming drug present 6. Cautions/warnings to protect the consumer 7. Adequate directions for use 31 May 12, 2014 SCPhA MPJE Review 125 SCPhA MPJE Review 127 May 12, 2014 SCPhA MPJE Review May 12, 2014 SCPhA MPJE Review May 12, 2014 OTC Labeling Requirements • Other labeling may include ▫ ▫ ▫ ▫ ▫ Statement of intended use Dosage range for different ages How often it can be safely taken Route or method of administration Other factors that may affect efficacy ▫ ▫ Take with food, etc Pregnancy/Nursing Sodium and other Electrolytes 126 SCPhA MPJE Review Drug Facts Label (1999) • Created standard order ▫ ▫ ▫ ▫ Active ingredients Purpose Uses Warnings “Ask your doctor or pharmacist about food or drug interactions” ▫ Directions ▫ Other information ▫ Inactive ingredients J. Baker 128 May 12, 2014 Prescriptions for OTC • Pharmacist can refill without prescriber authorization unless ▫ Dose requested is greater than recommended amount on OTC label ▫ Prescriber limited refills on original prescription ▫ Drug is Schedule V where refills must be designated by prescriber ▫ Individual state has set time limit for refills 32 May 12, 2014 SCPhA MPJE Review 129 SCPhA MPJE Review 131 May 12, 2014 SCPhA MPJE Review Nonprescription drugs May 12, 2014 CV Prescriptions PPA 40-43-86(U) • Sold in original, unbroken prepackaged containers OR • Dispensed/profiled as Rx • Rx may be written or oral orders ▫ If ordered as prescription, CV follows regulations of CIII-CIV prescription orders • May be dispensed without prescription ▫ Must then be treated in all respects like prescription in regards to counseling and labeling 130 SCPhA MPJE Review 132 May 12, 2014 CV Prescriptions • Drugs having an accepted medical use • Low potential for abuse relative to CIVs • May lead to limited physical or psychological dependence SCPhA MPJE Review May 12, 2014 Dispensing CVs by Pharmacists CSA 61-4(518) • Distribution made only by a pharmacist ▫ Not even employee under supervision of pharmacist ▫ Sales transaction can be handled by non-pharmacist employee • Quantity Limits ▫ ▫ ▫ ▫ ≤ 240 ml (8oz) of substance containing opium ≤ 120 ml (4oz) of any other CV NMT 200mg codeine per 100ml or gm or 90 mg per dosage unit NMT 100mg dihydrocodeine per 100ml or mg Divisible by 5 J. Baker 33 May 12, 2014 SCPhA MPJE Review 133 SCPhA MPJE Review 135 May 12, 2014 SCPhA MPJE Review May 12, 2014 For how long should the CV record book be maintained? Dispensing CVs by Pharmacists CSA 61-4(518) Purchaser: • Must be 18 years of age or older • May not purchase substance again in any 48 hour period • Must provide suitable ID if unknown to pharmacist A. B. C. D. One year Two year Three years Five years 134 SCPhA MPJE Review 136 May 12, 2014 Dispensing CVs by Pharmacists CSA 61-4(518) Record Book for CV Distribution • Maintained by pharmacist • Name/address of Purchaser • Name/quantity of substance purchased • Date of purchase • Name or initials of pharmacist SCPhA MPJE Review May 12, 2014 CMEA: Combat Methamphetamine Epidemic Act of 2005 www.deadiversion.usdoj.gov/meth/index.html • Ephedrine, pseudoephedrine, phenylpropanolamine • Storage ▫ Behind counter or in locked cabinet • Sales Limits ▫ Applies to ALL products containing these ingredients: single ingredient, multiple ingredient, solid dosage form, liquid dosage form, etc. ▫ Daily: 3.6 gram daily sales limit ▫ 30 Days: 9.0 gram 30-day sales limit No more than 7.5 gram may be acquired through mail/shipment J. Baker 34 May 12, 2014 SCPhA MPJE Review 137 SCPhA MPJE Review SCPhA MPJE Review May 12, 2014 A 35 year old customer wishes to know how many 30mg Sudafed tablets he can purchase at one time. Which of the following is the correct answer: CMEA • Logbook ▫ Does not apply to single sales ≤ 60mg ▫ Written or electronic A. B. C. D. Maintain at least 2 years ▫ ▫ ▫ ▫ 139 May 12, 2014 Product and quantity purchased Purchaser: name, address, signature with date/time Date/time of sale SC now has required real-time online database 12 60 120 240 • Photo Identification of purchaser ▫ Does not apply to single sales ≤ 60mg ▫ Government issued 138 SCPhA MPJE Review May 12, 2014 CMEA • Employee training ▫ Anyone dealing with purchasers ▫ DEA established training requirements ▫ Submit proof of training online • Exclusion ▫ The sales limits, logbook, etc. do NOT apply to non-legend (OTC) products that are prescribed and subsequently dispensed according to a legitimate prescription. J. Baker Area 1: Pharmacy Practice 1.07: Identify the proper procedures for keeping records of information related to pharmaceutical products, including requirements for protecting patient confidentiality. 35 May 12, 2014 SCPhA MPJE Review 141 SCPhA MPJE Review 143 May 12, 2014 SCPhA MPJE Review Patient Records Confidential Information PPA 40-43-86(J) (PPA 40-43-30(8)) May 12, 2014 • Privileged information maintained in a patient’s records or which is communicated to a patient as part of patient counseling • May be released only to the patient, to those practitioners and pharmacists where, in the pharmacist’s professional judgment, release is necessary to protect the patient’s health and well being, and to other persons or governmental agencies authorized by law to receive such confidential information. • Contain at a minimum: ▫ ▫ ▫ ▫ ▫ Full name of patient Address/telephone number of patient Patient’s age/date of birth Gender All prescription drug orders within past 2 years at that pharmacy ▫ Comments relevant to patient/drug therapies 142 SCPhA MPJE Review Obtain Necessary Patient Information (PPA 40-43-86(J)(2)) • • • • • Allergies Drug reactions Idiosyncrasies Chronic Conditions/Disease States Other medications: including OTCs 144 May 12, 2014 SCPhA MPJE Review May 12, 2014 HIPAA: Health Information Portability & Accountability Act • Intent: ▫ Assure security and privacy of patients’ medical records ▫ While allowing the flow of public health information (PHI) to provide high quality health care • Every health care provider who transmits health information is a covered entity J. Baker 36 May 12, 2014 SCPhA MPJE Review 145 SCPhA MPJE Review 147 May 12, 2014 SCPhA MPJE Review HIPAA: Health Information Portability & Accountability Act May 12, 2014 Patients’ Records are Confidential from pharmacy perspective: • Includes prescriptions, patient record systems (Rx profiles), and recorded RPh comments relevant to patient therapy • Pharmacies (and all Medical Facilities) • May only be released to: ▫ ▫ ▫ ▫ ▫ Have HIPAA Privacy Officer • Patients report perceived violations to DHHS Office for Civil Rights • Private information being de-identified Patient Pharmacist/personnel authorized to handle Rx Prescriber/authorized personnel Legal Personnel BOP Inspectors DEA Inspectors • Use professional judgment ▫ NPI requirement implemented May 2007 Necessary to protect patient’s health/well-being 146 SCPhA MPJE Review HIPAA: Health Information Portability & Accountability Act • Patients should be notified of their rights and how their health care information may be used ▫ Consents to release of information ▫ How to access information ▫ How medical information may be disclosed to each other • Documenting privacy notice ▫ Document by signed statement or log book ▫ Person named in insurance policy can rep family ▫ Maintain records of these notices for 6 years from date of signature or last date of Rx dispense ▫ No requirement for future signatures J. Baker 148 May 12, 2014 SCPhA MPJE Review May 12, 2014 Confidential Communication • Refill reminders for patients ▫ Keep drug name/use private • Consultations ▫ Minimize likelihood of accidental disclosure to surrounding people ▫ Phone calls/answering machines: Minimal information • Picking up Rxs: pharmacist judgment ▫ Unnecessary for patient to give written permission 37 May 12, 2014 SCPhA MPJE Review 149 SCPhA MPJE Review 151 SCPhA MPJE Review May 12, 2014 Mr. Bill comes to your pharmacy and asks for the medication records of his 15 year old son because he is working on his taxes for the previous year. The pharmacist gives him the medication records of his son. The pharmacist was in accordance with state and federal law. True or False? May 12, 2014 Which of the following might represent a breach of privacy based upon the federal Health Insurance Portability and Accountability Act (HIPAA)? I. Allowing a pharmaceutical sales representative to review your prescription files to ascertain if a certain prescriber is prescribing his company’s new antidepressant II. Sending a postcard to remind a patient that his Prozac prescription needs to be refilled III. Providing a husband with a list of drug products and therapeutic uses that his wife received last year (A) I only (B) I & II only (C) II & III only (D) I, II, & III 150 SCPhA MPJE Review Explanation: HIPAA • Healthcare providers cannot disclose medication records or the history of patients without prior approval of patients or otherwise permitted by the law. The only exception under this law is when the patient is designated a minor by the court. J. Baker 152 May 12, 2014 SCPhA MPJE Review May 12, 2014 Records for Dispensing PPA 40-43-86(N) • Ready/Retrievable within 24 hours (non-CS) ▫ ▫ ▫ ▫ ▫ Quantity dispensed for original/refills Date of dispensing original/refills Serial number/equivalent if institution Identification of dispensing pharmacist Name/Manufacturer of dispensed drug • Prescriptions and patient records must be maintained for 2 years from original date or date of last activity 38 May 12, 2014 SCPhA MPJE Review 153 SCPhA MPJE Review 155 May 12, 2014 Readily Retrievable defined by Controlled Substances Regulations (CSA 61-4(101(t))) • Registrant is able to produce controlled substances records in a timely manner ▫ Within one hour • Records are segregated, sorted, or filed so that controlled substance information may be derived within a reasonable time by inspector ▫ Within a few hours SCPhA MPJE Review May 12, 2014 License/Registration/Certificates (PPA 40-43-82, 83, 84) • All must be displayed in public view ▫ ▫ ▫ ▫ Pharmacist Technician Intern Pharmacy permit • Legal documents: copies can NOT be displayed for public viewing • If floating: must have wallet card 156 SCPhA MPJE Review May 12, 2014 Pharmacist Registration PPA 40-43-110, 130 Area 2: Licensure, Registration, Certification, & Operational Requirements • License expires annually on April 30th • Application & fees postmarked by April 1st ▫ License is lapsed if not renewed by May 1 • Annual CE Requirements ▫ 15 Total Hours (ACPE and/or CME I) 6 Live Hours 7.5 Hours in Drug Therapy or Patient Management ▫ Excess carry over 1 year J. Baker 39 May 12, 2014 SCPhA MPJE Review 157 SCPhA MPJE Review 159 May 12, 2014 SCPhA MPJE Review Technician Registration Obtaining BOP Permits PPA 40-43-82, 130 PPA 40-43-83 • Registration expires annually on June 30th • Annual CE Requirements ▫ 10 Total Hours (ACPE and/or CME I) 4 Live Hours ▫ All hours completed in excess may be held over for 1 registration year • Disciplined pharmacist may not work as pharmacy technician May 12, 2014 • Written application for a new permit must be submitted to the BOP at least 45 days before the opening of the facility • Facility must pass inspection by BOP • Each location must be permitted • No registrations/permits are transferable • Permits expire annually on June 30 158 SCPhA MPJE Review 160 May 12, 2014 SCPhA MPJE Review Technician State Certification Facility Permit Classifications PPA 40-43-82 SC Code of Regs Chap 99-43 • • • • • Work 1000 hours as a technician Complete BOP approved technician course Have high school diploma/equivalent Pass the PTCB exam Fulfill CE Requirements May 12, 2014 • Pharmacy Permit ▫ Authorized to dispense legend drugs/devices ▫ Requires PIC • Non-Dispensing Drug Outlet Permit ▫ Authorized to administer & store legend drugs ▫ Includes clinics, wholesalers, manufacturers, distributors ▫ Requires consultant pharmacist Exceptions: Facility only manufactures, wholesales, and distributes J. Baker 40 May 12, 2014 SCPhA MPJE Review 161 SCPhA MPJE Review 163 May 12, 2014 SCPhA MPJE Review Facility Permit Classifications Mail Order Pharmacies SC Code of Regs Chap 99-43 PPA 40-43-89(N) • Medical Gases/Legend Devices Permit May 12, 2014 • Must comply with laws for operation in the state in which it is located and with this provision of SC Pharmacy Practice Act • Must annually provide copy of inspection report from its state with renewal in SC • Records must be maintained of controlled substances or dangerous drugs/devices dispensed to patients in SC ▫ Authorized to dispense medical gases and legend devices pursuant to order ▫ Requires consultant pharmacist • Non-Resident Pharmacy Permit ▫ Facilities located outside of South Carolina ▫ Primary business is mail order ▫ Authorized to sale, distribute, or dispense legend drug/devices in this state 162 SCPhA MPJE Review 164 May 12, 2014 SCPhA MPJE Review Wholesale Distributor Permits Mail Order Pharmacies PPA 40-43-89(2) PPA 40-43-89(N) • Changed in any information must be reported to BOP within 30 days • Must employ adequate personnel with education/experience to safely/lawfully engage in wholesale distribution May 12, 2014 • Pharmacists that do not practice in SC but are employed by mail order facilities do not have to be licensed in SC • One pharmacist : Two technicians ▫ If not defined by their state statutes/regs • Must be open not less than six days or forty hours week • Must provide toll-free service for patients ▫ Number must be on their label J. Baker 41 May 12, 2014 SCPhA MPJE Review 165 SCPhA MPJE Review 167 May 12, 2014 SCPhA MPJE Review Federally Qualified Health Centers PPA 40-43-70 • This section does not prevent a licensed practitioner, as defined in Section 40-43-30(45), from dispensing a drug or device for a patient of an FQHC if: 1. a drug dispensed by the FQHC is properly labeled in accordance with state and federal law; 2. the patient is given a choice of receiving the drug or device from the FQHC or from another provider; May 12, 2014 Federally Qualified Health Centers PPA 40-43-70 4. … an FQHC without a retail pharmacy • FQHC must certify to the board that it made a good faith effort with an existing retail pharmacy within five miles of the FQHC health center delivery site • the existing retail pharmacy would have provided prescription drugs to all FQHC patients at the same cost, convenience, and efficacy provided by the proposed new FQHC health center delivery site 166 SCPhA MPJE Review SCPhA MPJE Review May 12, 2014 Federally Qualified Health Centers Federally Qualified Health Centers PPA 40-43-70 PPA 40-43-70 3. as it pertains to an FQHC without a retail pharmacy, the FQHC must obtain and maintain an FQHC permit as designated by this section; and a) monthly shall conduct and submit to the Board of Pharmacy self inspections and maintain written checklists that are readily available to the Board of Pharmacy for on-site visits b) designate a pharmacist duly licensed by and in good standing with the Board of Pharmacy as a consultant pharmacist to be responsible for the duties stated in this section at the FQHC permit holder’s location. Consultant pharmacist : 5. … an FQHC with a permitted retail pharmacy: a) FQHC’s retail pharmacy must be permitted pursuant to Section 40-43-83 b) Obtain/maintain an FQHC permit for its affiliated health center delivery sites without an on-site pharmacy ▫ ▫ ▫ J. Baker 168 May 12, 2014 Signs new/renewal application along with the FQHC permit holder Agrees in writing to assume the responsibilities of a consultant pharmacist. Performs/maintains written quarterly inspections that are readily available. i. ii. c) those affiliated delivery sites will be subject to the inspection requirements outlined in item (3) of this subsection the FQHC pharmacist may serve as the consultant pharmacist for the FQHC’s affiliated delivery sites; with prior approval of the Board of Pharmacy, the FQHC pharmacist may serve as the pharmacist in charge for more than one pharmacy at a time and need not be physically present in the pharmacy to serve as its pharmacist in charge. 42 May 12, 2014 SCPhA MPJE Review 169 SCPhA MPJE Review 171 May 12, 2014 SCPhA MPJE Review Mr. Jones owns three pharmacies in South Carolina. How many pharmacy permits does he require? May 12, 2014 Pharmacy Requirements PPA 40-43-86(A-7,8,9) • Pharmacy References to keep on hand SC Pharmacy Practice Act A. One B. Three SC Controlled Substances Act & Regulations SC Drug Act SC Board of Pharmacy Newsletter Equivalent Drug Product Evaluations Facts and Comparisons 170 SCPhA MPJE Review SCPhA MPJE Review May 12, 2014 Pharmacy Requirements Area for Compounding/Dispensing PPA 40-43-86(A) PPA 40-43-86(A) • Sufficient size for safe/proper storage of prescription drugs & compounding Secure pharmacy barriers with physical barriers • • • • Designate PIC Maintain areas for patient counseling Maintain current drug reference materials Display sign when appropriate “Pharmacy Department Closed, Pharmacist Not on Duty” J. Baker 172 May 12, 2014 • Dry/well ventilated, free from obnoxious odors, adequate lighting • Drugs/pharmaceuticals/chemicals in neat, orderly manner Free from dust, insects, rodents, or contamination • Outdated, damaged, defaced, unlabeled products removed from active stock 43 May 12, 2014 SCPhA MPJE Review 173 SCPhA MPJE Review May 12, 2014 Area for Compounding/Dispensing PPA 40-43-86(A) • Refrigerated pharmaceuticals/ biologicals maintained at proper temperature • All compounding stocks/materials labeled Area 3. Regulatory Structure and Terms Conform in purity/strength as required by law • Rx compounding counter is only for compounding 174 SCPhA MPJE Review Area for Compounding/Dispensing PPA 40-43-86(A) • Rx department has only necessary equipment/products • Sink with hot water only for cleaning hands or equipment • Pharmacists and personnel clean hands/fingernails before compounding • Storing of pharmaceutical products in washroom is prohibited J. Baker 176 May 12, 2014 SCPhA MPJE Review May 12, 2014 Food and Drug Administration • Enforces FDCA ▫ Seize any adulterated or misbranded food, drug, or cosmetic—with court approval • Approve new drug entities • Approve drug package insert labeling 44 May 12, 2014 SCPhA MPJE Review 177 SCPhA MPJE Review 179 May 12, 2014 SCPhA MPJE Review Federal Laws: Manufacturing May 12, 2014 Federal Laws: Manufacturing • Food Drug & Cosmetic Act (FDCA) 1938 • Good Manufacturing Practices (GMP) Regulated by FDA No marketing until proven safe Drugs marketed prior 1938 were “grandfathered” ▫ Specify minimum requirements for manufacturing in US ▫ Assure pharmaceutical safety/quality ▫ Manufacturers are responsible for compliance Levothyroxine, digoxin, NTG, Phenobarbital • Kefauver-Harris Amendment 1962 Manufacturers must prove effectiveness and safety of drug before marketing FDA authority to regulate Rx drug advertisements Informed consent in clinical investigations Reporting adverse drug reactions Creation of GMP Register with FDA Describe manufacturing/production (NDA process) FDA inspection approx. every 2 years Unless history of deficiencies requires more 178 SCPhA MPJE Review Federal Laws: Manufacturing • Orphan Drug Act 1983 Provides incentives (tax and licensing) to promote research, approval, marketing of drugs for rare diseases Rare Disease = affects < 200,000 persons in US • FDA Modernization Act 1997 J. Baker 180 May 12, 2014 Added legend requirement, “Rx Only” Provisions to fast track some NDA Encouraged research for new uses of drugs Clarification on compounding by pharmacies SCPhA MPJE Review May 12, 2014 Federal Laws: Manufacturing • Dietary Supplement Health Education Act (DSHEA) ▫ Products may be marketed without proof of efficacy ▫ Products currently on market do not have to be proven safe ▫ Not required to manufacture under GMPs ▫ May make structure/function claims on labels if statements do not indicate product will diagnose, cure, treat, or prevent disease Label must state claims not reviewed by FDA 45 May 12, 2014 SCPhA MPJE Review 181 SCPhA MPJE Review 183 May 12, 2014 SCPhA MPJE Review May 12, 2014 Examples of Misbranded in a Pharmacy Adulterated vs Misbranded (39-23-40) • A drug is adulterated if: • Mixing different lot numbers • Labeling Rx with trade name but dispensing generic product instead • Refilling Rx without authorization of prescriber • Labeling Rx with one strength, but actually dispensing another strength ▫ Contains in whole/part any filthy, putrid, or decomposed substance Or ▫ Has been prepared, packaged, or held under unsanitary conditions Or ▫ Has been manufactured under conditions that do not meet GMP standards Or ▫ Contains unapproved color additive 182 SCPhA MPJE Review Adulterated vs Misbranded (39-23-40) • A drug is misbranded if: ▫ The labeling is false or misleading in ANY MANNER ▫ Manufacturers Missing name/location of manufacturer, packer, distributor Quantity of container contents is not present All required information is not prominent Adequate directions for use/warnings (OTC) J. Baker 184 May 12, 2014 SCPhA MPJE Review May 12, 2014 A drug product consisting of tablets may be declared misbranded under all of the following guidelines EXCEPT: A. B. C. D. Does not meet assay limits Does not indicate number of tablets present Official names of certain ingredients not used Name and location of manufacturer is missing 46 May 12, 2014 SCPhA MPJE Review 185 SCPhA MPJE Review 187 May 12, 2014 SCPhA MPJE Review FDA: New Drug Approval 17 year process May 12, 2014 Types of NDAs • Discovery timeframe: 2-10 years • Pre-clinical testing (INDA) • Phase I testing: 20-80 healthy volunteers • Innovator pharmaceutical companies: IND, NDA, SNDA • ANDA: abbreviated NDA Drug properties; safety Encourages generic development Require proof of similar properties to innovator’s drug • Phase II testing: 100-300 volunteers • SNDA: Supplement NDA Drug effectiveness and dosing • Phase III testing: 1,000-5,000 volunteers Drug effectiveness compared to control group • NDA & FDA Review • Phase IV: Post-marketing testing Change in labeling/packaging of already marketed drug Change in manufacturing location Change in synthesis of drug Change in production procedure of drug 186 SCPhA MPJE Review Investigational New Drug Application • • • • • INDA submitted before testing on humans FDA has 30 days to approve/disapprove Safety is determined by results of animal testing Step before entering 4 Test Phases Treatment IND Allows patients not enrolled in a clinical trial who have life threatening illness for which there is no cure to receive IND Treatment protocols must be submitted AIDS, some cancers, Alzheimer’s & Parkinson’s Diseases J. Baker 188 May 12, 2014 SCPhA MPJE Review May 12, 2014 FDA: Package Inserts Must be informational, not promotional Description of Drug Clinical pharmacology Adverse reactions Indications/Usage Abuse/Dependency Potential Contraindications Symptoms/Treatment Warnings/Precautions Overdose Dosage/Administration Date of most recent revision 47 May 12, 2014 SCPhA MPJE Review 189 SCPhA MPJE Review 191 May 12, 2014 SCPhA MPJE Review Drug Recall Classes May 12, 2014 Pregnancy Warnings • C: Safety during human pregnancy not determined; animal studies are either positive for fetal risk or not conducted; use if benefits outweighs potential risk • Class I Serious adverse health consequences including death. Recall includes pharmacy stock and notifying patients. Fioricet Zoloft & Prozac • Class II • D: Positive evidence of risk to human fetus through ADR data; use only if benefits are acceptable despite risks Temporary or reversible effects, remote probability of serious effects. Recall pharmacy stock. Paxil Phenytoin • Class III Drug product is unlikely to cause adverse health consequences. • X: Contraindicated in pregnant women and in women of childbearing age unless contraception is used Accutane Thalomid Lipitor 190 SCPhA MPJE Review 192 May 12, 2014 SC Legislature Pregnancy Warnings • A: Studies show no risk to fetus Folic Acid Levothyroxine • B: No studies in pregnant women, but animal studies failed to demonstrate risk to fetus Acetaminophen Diphenhydramine Glucophage J. Baker Dept Health/Environmental Control Dept Labor, Licensing, Regulation Bureau of Drug Control Board of Pharmacy 48 May 12, 2014 SCPhA MPJE Review 193 195 Board of Pharmacy SCPhA MPJE Review May 12, 2014 Pharmacy Practice Act (PPA 40-43-10) Inspectors Permit Facilities Pharmacy Non-Dispensing Drug Outlet Medical Gases/Legend Devices Non-Resident Pharmacy FQHC License Pharmacists Register Technicians Active Inactive Lapsed Registered Register Interns State Certified • The purpose of this chapter is to promote, preserve, and protect the public health, safety, and welfare by and through the effective control and regulation of the practice of pharmacy; the licensure of pharmacists; the licensure, permitting, control, and regulation of all sites or persons, in or out of this State, that distribute, manufacture, possess, or sell drugs or devices within this State, as may be used in the diagnosis, treatment, and prevention of injury, illness, and disease of a patient or other individual. 194 SCPhA MPJE Review 196 May 12, 2014 SCPhA MPJE Review Board of Pharmacy BOP Responsibilities (PPA 40-43-40) (PPA 40-43-60(D)) • Eight Members ▫ 6 RPh Members from Congressional districts Eventually there will the 7 to include newest district ▫ 2 Members appointed by Governor Lay Person at large Pharmacist at large Serve co-terminously with appointing Governor May 12, 2014 • Regulates the practice of pharmacy • Regulates sale/dispensing of drugs, poisons, devices • Establish minimum specifications for facilities • Confine to Rx order a drug found to be dangerous to public if dispensed w/o Rx • Terms ▫ 6 year terms ▫ Limit: Two consecutive terms J. Baker 49 May 12, 2014 SCPhA MPJE Review 197 SCPhA MPJE Review 199 May 12, 2014 SCPhA MPJE Review BOP Responsibilities May 12, 2014 Numbers to Remember (PPA 40-43-60(D)) • 10 Days Rule • Seize drugs/devices constituting imminent dangers to public health/welfare • Promulgate regulations necessary to carry out PPA • License pharmacists, permit facilities, etc • Adopt professional rules of conduct for pharmacists Anyone leaving or starting a job Change of PIC Change of Consultant Pharmacist Change of address (facility or person) Permanent closing • 30 days notification Theft or loss of drugs/devices Controlled substances ▫ Notify BOP and DHEC (DEA Form 106) Conviction of any employee 198 SCPhA MPJE Review May 12, 2014 BOP Inspections (PPA 40-43-60) • • • • Biennial inspections of all facilities Inspect for compliance Violations must be corrected Inspectors Controlled Substances ▫ Pharmacists licensed in South Carolina J. Baker 50 May 12, 2014 SCPhA MPJE Review 201 SCPhA MPJE Review 203 May 12, 2014 SCPhA MPJE Review Bureau of Drug Control DHEC Bureau of Drug Control May 12, 2014 (44-53-480) • Drug Inspectors ▫ Pharmacists ▫ Officer/employee of Bureau of Drug Control Inspectors • Inspect at least once every 3 years Manufacturing Distribution ▫ All practitioners/registrants who manufacture, dispense, distribute controlled substances Dispensing 202 SCPhA MPJE Review May 12, 2014 DHEC Drug Inspectors (44-53-480(c)) • The Department of Health and Environmental Control may contract with the Board of Pharmaceutical Examiners for the Chief Drug Inspector of the Board of Pharmacy and his assistants, to enforce the provisions of this article with respect to inspections and audits which apply to pharmacists or pharmacies whether located in drugstores, hospitals or other health care facilities. J. Baker 204 SCPhA MPJE Review May 12, 2014 DHEC Drug Inspectors (44-53-480) • While in the performance of their duties as prescribed herein, shall have: (1) Statewide police powers; (2) Authority to carry firearms; (3) Authority to execute and serve warrants, etc 51 May 12, 2014 SCPhA MPJE Review 205 SCPhA MPJE Review 207 May 12, 2014 SCPhA MPJE Review DHEC Drug Inspectors (44-53-480) May 12, 2014 DEA Registration (4) Authority to make investigations to determine whether there has been unlawful dispensing of controlled substances or the removal of such substances from regulated establishments or practitioners into illicit traffic; (5) Authority to seize property; and (6) Authority to make arrests without warrants for offenses committed in their presence. • Individuals (researchers), manufacturers, distributors, exporters, narcotic treatment programs, dispensing locations (pharmacies) must be registered by DEA in order possess controlled substances • Separate/special registration is required for detoxification/maintenance treatment 206 SCPhA MPJE Review 208 May 12, 2014 Federal Laws: Acquisition/distribution • Controlled Substances Act Administered by DEA Regulates buying, inventorying, prescribing, dispensing, storing, using, destroying • Harrison Narcotics Act 1914 Controlled distribution/usage of narcotics SCPhA MPJE Review May 12, 2014 DEA Registration • Pharmacies use DEA Form 224 • Each location must have registration EXCEPT Warehouses by registrants for storage Practitioner’s office that only prescribes Common carriers (e.g. freight delivery companies) Office where sales are only solicited, made, etc • DEA Registration is valid for 36 months • Renewal forms are sent 60 days out Notify DEA in writing if forms not received 45 days J. Baker 52 May 12, 2014 SCPhA MPJE Review 209 SCPhA MPJE Review SCPhA MPJE Review May 12, 2014 Distribution of Controlled Substances DHEC Registration • • • • 211 May 12, 2014 (61-4.1401) DHEC Registration is valid for 12 months Separate registration for each location PIC is considered the registrant Reregister within 60 days of expiration Practitioner who is registered to dispense a CS, may distribute to another practitioner (w/o registering to distribute) provided that: 1. Renewal forms are sent 60 days out Notify DHEC in writing if forms not received 45 days before renewal 2. 3. 4. Other practitioner is registered to dispense CS Proper records are kept (CS 316(c) and 316 (e)) DEA Form 222 is used for Schedule I or II Total number of CS dosage units distributed must not exceed 5% of all CS dispensed in 12 month period 210 SCPhA MPJE Review Security SCPhA MPJE Review May 12, 2014 When a pharmacist conducts a controlled substance inventory, which of the following must be included? (61-4.406) • A registrant may not employ anyone, who has access to CS, who has been convicted of a felony offense relating to controlled substances, without a waiver from DHEC and the DEA • Employees are responsible to report drug diversion J. Baker 212 May 12, 2014 I. II. III. A. B. C. D. Drugs stored in a warehouse for the registrant at a different location Drugs ordered for a customer but not yet paid for All controlled substance dispensed over the past 30 days I only I and II only II and III only I, II, and III 53 May 12, 2014 SCPhA MPJE Review 213 SCPhA MPJE Review May 12, 2014 215 SCPhA MPJE Review Controlled Substances Hospital Setting (61-4 Part 1900) May 12, 2014 Controlled Substances Hospital Setting (61-4 Part 1900) • Administrative head is ultimately responsible for proper safeguarding and handling ▫ Responsibilities may be delegated • Physicians’ orders shall appear on doctor's order sheets, no Rx is required • Verbal/Telephone orders are permissible only if absolute necessity ▫ Physician must verify order within 72 hours • Prescriptions are not required for controlled substances in floor stock ▫ Request for the drug appears on the prescriber's orders which must be signed by the physician ▫ Administration is recorded on a medication administration record (MAR) ▫ CS not kept as floor stock and not administered to patient must be returned to pharmacy within 72 hours after order is discontinued 214 SCPhA MPJE Review May 12, 2014 Controlled Substances Hospital Setting (61-4 Part 1900) • Practitioner must be authorized to handle controlled substances/prescribe in the state • Hospital verifies practitioner is permitted to dispense, administer, or prescribe ▫ And authorizes them to do so under the hospital DEA and assigns a specific internal code for each practitioner • Within scope of practice in the hospital or institution J. Baker 216 SCPhA MPJE Review May 12, 2014 Controlled Substances Hospital Setting (61-4.1912, 1913) • Physician cannot obtain CS for his/her own office from hospital inventory • Unlawful to Dispense hospital stock to employees Dispense CS to outpatients on a physician’s order • Patient must be physically examined by physician in ER or outpatient facility before administration of CS 54 May 12, 2014 SCPhA MPJE Review 217 SCPhA MPJE Review 219 May 12, 2014 SCPhA MPJE Review Definition of practitioner May 12, 2014 Checking DEA Number 40-43-30(45) Anyone authorized by law to diagnose and prescribe drugs and devices. Who may prescribe controlled substances in S.C.? 1. Physician 2. Dentist 3. Osteopath 4. Podiatrist 5. Veterinarian 6. Licensed nurse practitioner (certified)*: C-III – CV only 7. Optometrists: CIII – CV only with limitations 8. Physician assistants*: CII (limited); CIV – CV BB1234563 • Add 1st, 3rd, 5th Digits together 1+3+5=9 • Add 2nd, 4th, 6th Digits & Multiply by 2 (2 + 4 + 6) 2 = 24 • Add both sums together 9 + 24 = 33 • Last digit of sum same as DEA last digit ▫ Acting in regular course of professional practice ▫ *Based on prescriptive authority within protocols 218 SCPhA MPJE Review 220 May 12, 2014 Prescriptions for Controlled Substances (61-4.1003) • May be communicated by agent of practitioner directly to the pharmacist ▫ Act of prescribing may not be delegated • Must contain all required information ▫ Including full name/address of patient ▫ DEA Number (printed or written) SCPhA MPJE Review May 12, 2014 Which of the following digits would make this DEA number an authentic one: BC445987__ A. B. C. D. E. 6 7 8 9 0 • Same signature as a legal document Handwritten Written in ink or indelible pencil • Corresponding liability on RPh for accuracy J. Baker 55 May 12, 2014 SCPhA MPJE Review 221 SCPhA MPJE Review SCPhA MPJE Review Prescriptions for Controlled Substances • Out-of-State CS Prescriptions (61-4.114) ▫ ▫ ▫ ▫ 223 May 12, 2014 May 12, 2014 Patient-Practitioner Relationship (61-4.1103) • Relationship includes, but is not limited to: Pharmacist knows patient Requires proper ID and documents on Rx Good faith inquiry into legitimacy of Rx Rx meets all SC requirements ▫ Sufficient knowledge of the medical need ▫ Determination of the benefit to risk ratio of the use of such substance ▫ Good faith determination of the identity and address of the patient ▫ Determination of the physical condition of the patient ▫ Practitioner shall be in personal attendance of the patient at the time of issuance of the prescription. 222 SCPhA MPJE Review 224 May 12, 2014 Prescriptions for Controlled Substances • Out-of-State CS Prescriptions (61-4.114) ▫ Practitioner requirements Acts within scope of practice Would be allowed to prescribe in SC Holds valid DEA number in place of origin of Rx SCPhA MPJE Review May 12, 2014 Patient-Practitioner Relationship (61-4.1103) • Due to the likelihood of the loss of objectivity required in making the necessary medical decisions in order to properly prescribe or dispense controlled substances. • Usually can not acquire a valid patientpractitioner relationship with: ▫ Himself or herself ▫ Member of his or her immediate family, ▫ Non-family members (i.e., fiancé or fiancée, close personal friend, paramour, etc.) if presence of extreme compassion, ardor, extortion, etc. J. Baker 56 May 12, 2014 SCPhA MPJE Review 225 SCPhA MPJE Review 227 May 12, 2014 SCPhA MPJE Review Patient-Practitioner Relationship May 12, 2014 CII Prescriptions (61-4.1103) • In the event of a bona fide emergency situation, where great detriment to the health or safety of a patient may be involved, a practitioner may administer, dispense or prescribe limited amounts of controlled substances to any person, notwithstanding the provisions of this Section, until such time as another objective practitioner can be contacted. • High potential for abuse • May lead to severe psychological or physical dependence • Current accepted medical use • Opiates, opioids, most amphetamines & barbiturates • Dispense no more than 31 day supply (61.4-1102) ▫ No limit on transdermal patches (44-53-360(e)) • Rx Expires 90 days from date of issue (61.4-1102) 226 SCPhA MPJE Review Identification Requirement (44-53-360(i)) • Prescription for a controlled substance in schedules II-V may not be filled unless the dispenser know the recipient or requires proper identification and notes the identification source on the prescription. ▫ Rx Number ▫ Government Issued photo ID: Type, State/Entity, Number ▫ Verify picture with person ▫ Initials of employee collecting ID information ▫ Be conscious of HIPAA/Confidentiality J. Baker 228 May 12, 2014 SCPhA MPJE Review May 12, 2014 Purchasing CII Drugs • DEA Form 222 ▫ www.deadiversion.usdoj.gov ▫ 1-800-882-9539 • Power of Attorney Other individuals may be authorized to obtain and execute order forms POA signed by same person who signed most recent application for registration and by individual obtaining authorization 57 May 12, 2014 SCPhA MPJE Review 229 SCPhA MPJE Review Spring 2014 The address printed on DEA 222 for SCPhA Patient Care pharmacy is incorrect. In that case, the (select one): A. B. C. D. 231 May 12, 2014 Emergency CII Fill 61.4-102(n) Registrant must return the form to the DEA to correct the error Registrant should rewrite the correct address before ordering drugs Registrant should not worry about the address Registrant should place the correct address label on the wrong address before ordering the drug. • What constitutes an emergency? ▫ Immediate administration is necessary for proper treatment ▫ No appropriate alternative treatment in another schedule is available ▫ It is not reasonably possible for prescriber to provide a written Rx to give patient prior to dispensing 230 SCPhA MPJE Review May 12, 2014 CII Prescriptions • Must be written order signed by prescriber • Exceptions ▫ Emergency fill per verbal order with follow up of written Rx within 72 hours ▫ Fax is acceptable as original Rx for patients on/in home infusion, LTCF, hospice Written, signed, “Voided” Rx maintained in patient’s medical record • Multiple CIIs Rxs can be issued by a practitioner for up to total 90 day supply J. Baker 232 SCPhA MPJE Review May 12, 2014 Emergency CII Fill (61.4-1101(d)) • Oral authorization from prescriber • Quantity is limited to the amount adequate to treat the patient during the emergency period • Write “Authorization for Emergency Dispensing” on Rx • Good faith inquiry into legitimacy • Written Rx Received within 72 hours ▫ If Rx not received, DHEC Drug Control must be contacted 58 May 12, 2014 SCPhA MPJE Review 233 SCPhA MPJE Review 235 May 12, 2014 SCPhA MPJE Review May 12, 2014 Partial Fill of CIIs for LTC or Terminally Ill Patients (61.4-1105(b)) Partial Filling of CIIs • Patient may request less quantity than prescribed • Pharmacy may not have full quantity in stock • Patient may have terminal illness or be in LTCF • Document on Prescription “Terminally Ill” or “LTCF patient” Date of partial fill Quantity dispensed Authorized quantity remaining • CII Rx’s for these patients only valid for 30 days from date of issue ▫ Partial Fill for up to 30 days 234 SCPhA MPJE Review 236 May 12, 2014 Partial Fill of CII by Pharmacy 61.4-1105(a) • Document quantity dispensed on face of Rx • Remaining quantity must be dispensed within 72 hours • No further quantity may be supplied beyond 72 hours without a new Rx SCPhA MPJE Review A partial filling of a Schedule II prescription is permissible under which of the following circumstances? I. The patient is over 65 and only wants half the number of doses prescribed by the physician because he can not afford the full amount II. The prescriber indicates that she would like the patient to get half the prescription today and the rest in a week if the medication agrees with him III. The pharmacist is out of stock and will provide the balance of the prescription to the patient in 72 hours A. B. C. D. J. Baker May 12, 2014 I only I and III only II and III only I, II, and III 59 May 12, 2014 SCPhA MPJE Review 237 SCPhA MPJE Review 239 May 12, 2014 SCPhA MPJE Review CIII Prescriptions May 12, 2014 CV Prescriptions • Drugs have accepted medical use • Potential for abuse less than CI or CII • May lead to moderate or low physical dependence or high psychological dependence • Drugs having an accepted medical use • Low potential for abuse relative to CIVs • May lead to limited physical or psychological dependence • If dispensed as OTC: see OTC section • If dispensed as Rx: see CIII-CV section 238 SCPhA MPJE Review 240 May 12, 2014 CIV Prescriptions • Drugs have accepted medical use • Low potential for abuse relative to CIIIs • May lead to limited physical or psychological dependence Spring 2014 CIII - CV Prescriptions 61.4-1201 • Rx may be ▫ Written and signed by a practitioner ▫ Fax of a written prescription transmitted to the pharmacy ▫ Oral prescription made by individual practitioner Promptly reduced to writing by pharmacist • Practitioner may administer or dispense directly to patient in course of normal practice (same with CIIs) J. Baker 60 May 12, 2014 SCPhA MPJE Review 241 243 Spring 2014 SCPhA MPJE Review Faxed Prescription Refills for CIII – CV 61.4-1201 May 12, 2014 (61.4-1202,1203) • Maximum of 5 refills allowed before Rx expires 6 months after date of issue • PRN Refills may not exceed 5 refills • May be refilled no sooner than 48 hours • If exact daily dosage not specified: • Fax OF a written, signed Rx • Include in addition to Rx requirements: ▫ Name, address, phone of prescriber ▫ Time/date of transmission ▫ Name of intended pharmacy ▫ Calculate date of refill from usual daily dosage on package insert 242 Spring 2014 CIII - CV Prescriptions 61.4-1202, 1203, 1204 • Dispense no more than 90 day supply • Rx expires 6 months after issue date • If exact daily dosage not specified: ▫ Calculate date of refill from usual daily dosage on package insert 244 SCPhA MPJE Review Partial Filling of CIII – CV May 12, 2014 (61.4-1205) • Partial filling is recorded in same manner as a refilling but it is NOT a refill! • Total quantity dispensed does not exceed total quantity prescribed • 6 months expiration from date of issue • Practitioner-Patient relationship required J. Baker 61 May 12, 2014 SCPhA MPJE Review 245 SCPhA MPJE Review SCPhA MPJE Review Partial Filling of CIII-Vs May 12, 2014 CS Changes Allowed Patient Request • • • • 247 May 12, 2014 Example: Xanax 1mg #90 Sig: i tid Patient only wants 45 Patient is not required to wait 15 days for the balance or a portion of the Rx After consultation with a prescriber, the pharmacist is permitted to change: • Patient Address • Drug Strength • Drug Quantity • Dosage Form • Directions for Use 246 SCPhA MPJE Review Partial filling of a schedule IV controlled substance prescription is permissible, provided that I. II. III. A. B. C. D. J. Baker Each partial filling is recorded Total quantity dispensed in all partial filling does not exceed the total quantity prescribed Total price charged for the partial fillings does not exceed the total price the patient would have paid with a complete filling of the prescription I only III only I and II only I, II, and III 248 May 12, 2014 SCPhA MPJE Review May 12, 2014 CS Changes Not Permitted The following changes require a new Rx •Patient’s name •Controlled substance prescribed Except for generic substitution •Prescriber’s signature 62 May 12, 2014 SCPhA MPJE Review 249 SCPhA MPJE Review 251 May 12, 2014 SCPhA MPJE Review May 12, 2014 Prescriptions for Controlled Substances Controlled Rx with No Date of Issue (61.4-1202) • After filling, RPh must document • Contact practitioner prior to dispensing controlled substance ▫ Date of original fill ▫ Initials of pharmacist ▫ Quantity dispensed (if different) • Document the issue date and communication with prescriber 250 SCPhA MPJE Review Changing Date of Controlled Rx • NO DATE CHANGES are allowed for any controlled substance, even if prescriber is contacted • Can obtain new verbal Rx for non-CIIs J. Baker 252 May 12, 2014 SCPhA MPJE Review May 12, 2014 The partial fill of morphine for a terminally ill patient must be completed within 72 hours of the initial fill. True or False 63 May 12, 2014 SCPhA MPJE Review 253 SCPhA MPJE Review 255 May 12, 2014 SCPhA MPJE Review A patient presents a prescription for MS Contin 30mg tablets #60 to his local pharmacy & indicates that he would only like to get 30 of the tablets now and will return to get the other 30 in a week if the medication agrees with him. The pharmacist should: A. Call the prescriber to get permission to dispense 30 B. Dispense 30 tablets as requested by the patient C. Advise the patient that the full 60 tablets must should be supplied at one time or the remaining tablets will be void D. Fill the prescription as requested by the patient but advise the patient that the balance must be picked up within 72 hours May 12, 2014 Controlled Substance Inventory (61.4 Part 700) • Inventory taken annually on May 1st ▫ Maintain records for 2 years ▫ Separate inventory for each registered location ▫ Must get permission from DHEC to complete on a different date • Record: ▫ ▫ ▫ ▫ ▫ Exact count of CI-CIIs Estimated count of CIIIs-Vs (exact if > 1000 ct bottle) Whole numbers only Date/Time inventory taken (beginning or end of business day) Who completed inventory • Other times to take inventory ▫ Non-Controlled to Controlled change ▫ Change in PIC 254 SCPhA MPJE Review All of the following are Schedule I controlled drugs EXCEPT: A. B. C. D. J. Baker Heroin LSD Methylphenidate Marijuana 256 May 12, 2014 SCPhA MPJE Review May 12, 2014 Controlled Substance Inventory • Stocking (61-4.405) ▫ CIIs-CVs may be stored in a secure cabinet OR ▫ CIIs-CVs may be dispersed throughout stock of noncontrolled substances • Thefts (61-4.406-408) ▫ BOP, DEA, DHEC must be contacted directly upon discovery of loss ▫ DEA Form 106 ▫ Breakage, damage or spillage is not a “loss” 64 May 12, 2014 SCPhA MPJE Review 257 SCPhA MPJE Review 259 May 12, 2014 SCPhA MPJE Review Purchasing/Transferring Controlled Substances (61-4.603) May 12, 2014 Controlled Substances Records • Records must reflect transfer from one registrant to another • Must ▫ ▫ ▫ ▫ ▫ Readily retrievable ▫ Kept for two years • Invoice records must clearly indicate date/quantity CS are received Be readily retrievable Be complete and accurate Maintain purchase/transfer records Maintain disposition records (prescriptions) ▫ CII records must be kept separate ▫ CIII-Vs separate or with non-controls 258 SCPhA MPJE Review 260 May 12, 2014 SCPhA MPJE Review May 12, 2014 Dispensing Records for Controlled Substances (61-4.603) Which of the following require an exact count when taking inventory? • A. Reflects sale or disposition of CS ▫ Readily Retrievable/Complete and Accurate ▫ ▫ Daily printouts verified, signed, by each individual who filled Rx that day Maintained for 2 years Maintain 3 files (per State law) B. C. D. Dalmane Concerta Halcion Darvon Compound 1. CII 2. CIII – CV 3. Non-Controlled Substances J. Baker 65 May 12, 2014 SCPhA MPJE Review Spring 2014 SCRxIPTS Spring 2014 SCRxIPTS • State Prescription Monitoring Program • • • • 44-53-1650 ▫ http://www.scdhec.gov/administration/drugcontr ol/pmp.htm Doctor shoppers and unscrupulous prescribers Data provided by dispensers Schedules II – IV Frequency: ▫ Daily on days open for business ▫ Zero dispensing also reported • Persons authorized to receive data 1. 2. 3. 4. 5. 6. 7. 8. Practitioner/pharmacist who certifies request is for purpose of providing Tx for bona fide patient Individual requests their own information LLR representative involved in investigation of designated person Local, state, federal law enforcement directly involved in investigation of designated person SC DHHS regarding Medicaid program recipients Properly convened grand jury pursuant to subpoena issued for records Personnel of Drug Control for administration and enforcement of program Qualified personnel involved in research/education 264 44-53-1640 Spring 2014 SCRxIPTS • Dispenser electronically submits Rx info ▫ ▫ ▫ ▫ ▫ ▫ ▫ ▫ ▫ ▫ J. Baker Dispenser DEA registration number Date drug was dispensed Prescription number Whether Rx was new or refill NDC for drug dispensed Quantity dispensed Approximate number of days supplied Patient name, full address, date of birth Prescriber and their DEA registration number Date prescription issued by prescriber SCPhA MPJE Review May 12, 2014 Mailing Controlled Substances • USPS permits mailing CS • No mailing of poisons or alcohol-containing products that can be considered beverages • Packaging: ▫ Inner container is properly marked/sealed Including Rx label requirements ▫ Outer container is plain, secure Free of markings that indicate nature of contents 66 May 12, 2014 SCPhA MPJE Review 265 SCPhA MPJE Review 267 May 12, 2014 SCPhA MPJE Review • DEA Required Records • • • • • • • DEA Form 222 Power of Attorney to sign Order Forms Receipts/Invoices for CIII – CVs Inventory records of controlled substances Records of distribution or dispensing Report of Theft or Loss (DEA Form 106) Inventory of Drugs Surrendered for Disposal (DEA Form 41) • Transfer records between pharmacies • DEA Registration certificate In which of the following locations would you not find pharmaceutical manufacturer’s drug samples? a. b. c. d. e. • May 12, 2014 I. hospital pharmacy II. physician’s office III. chain or community pharmacy I only III only I & II only II & III only I, II, and III The primary responsibility for oversight of prescription drug advertising rests with the: a. b. c. d. e. FTC DEA FDA HCFA USP 268 SCPhA MPJE Review • Review Questions Just a few J. Baker May 12, 2014 Patient counseling shall include which of the following elements? a. b. c. d. e. Techniques for self-monitoring drug therapy Refill history Potentially serious side effects or interactions Both A & C Both B & C 67 May 12, 2014 SCPhA MPJE Review 269 SCPhA MPJE Review • 271 May 12, 2014 SCPhA MPJE Review On April 5, 2013, a patient calls about a refill of his Ritalin-SR prescription. The prescription was issued on January 15, 2013 and initially dispensed on February 20, 2013 for a 31 day supply. The prescription was marked for one refill. According to SC law, which of the following could the pharmacist legally do without prescriber intervention? May 12, 2014 The requirement that pharmacists must offer to counsel patients concerning their prescriptions was included in which of the following congressional actions? a. b. c. d. e. a. dispense the drug since one authorized refill remains b. dispense the drug by writing a new prescription, referencing the original, and marking no refill c. dispense a 72 hour supply and contact the prescriber d. either B or C is acceptable e. none of the above Durham-Humphrey Amendment of 1951 FD&C Act of 1938 Kefauver-Harris Amendment of 1962 Prescription Drug Marketing Act of 1987 Omnibus Reconciliation Act of 1990 270 SCPhA MPJE Review Nonprescription products containing which of the following must not be directly accessible to the consumer? I. Pseudoephedrine II. Phenylpropranolamine III. Dextromethorphan a. I only b. III only c. I & II only d. II & III only e. I, II, & III J. Baker 272 May 12, 2014 SCPhA MPJE Review May 12, 2014 The purchasing agent of your hospital suggests that the hospital purchase a two-year’s supply of a popular antibiotic at a special price. Which of the following are legal activities? I. Purchase of that quantity of the antibiotic for hospital use II. Sell a portion of the antibiotic to another area hospital III. Sell a portion of the antibiotic to a community pharmacy a. b. c. d. e. I only III only I & II only II & III only I, II, and III 68 May 12, 2014 SCPhA MPJE Review 273 SCPhA MPJE Review SCPhA MPJE Review Evidence indicates that a marketed drug product may have a new use for another condition. In order to claim this new indication, a drug manufacturer must: a. b. c. d. e. 275 May 12, 2014 Submit an abbreviated NDA Submit a supplemental NDA Submit an NDA Apply for patent protection Inform FDA in writing of the revised labeling May 12, 2014 Which of the following is NOT true regarding the ratio of technicians to pharmacists: a. In a community pharmacy when working at a 1:1 ratio, there are no requirements for technician state certification. b. In an institutional pharmacy, there is a 3:1 employment ratio and the operational ratio is determined by the pharmacist in charge c. In a community pharmacy when working at a 2:1 ratio, both pharmacy technicians must be state certified. d. In a community pharmacy when working at a 3:1 ratio, two of the technicians must be state certified. e. None - All of the above are true 274 SCPhA MPJE Review Which of the following is NOT a requirement that must be met in order for a pharmacy technician to become recognized as state certified: a. Pass the Pharmacy Technician Certification Board Examination b. Pass the Multi-State Jurisprudence Examination c. Complete a Board of Pharmacy approved technician education course d. Acquire 1000 hours of experience working as a registered technician e. Fulfill state CE requirements for pharmacy technicians J. Baker 276 May 12, 2014 SCPhA MPJE Review May 12, 2014 A pharmacist who fills an oral morphine sulfate prescription in an emergency does not receive the written prescription within 72 hours from the prescriber. The pharmacist must I. Notify DHEC Bureau of Drug Control II. Notify the SC Board of Medical Examiners III. Call the patient and request that he/she obtain a written prescription to cover the oral order a. b. c. d. e. I only III only I & II only II & III only I, II, & III 69 May 12, 2014 SCPhA MPJE Review 277 SCPhA MPJE Review May 12, 2014 Final Thoughts • Study the laws/regulations – not just the slides! • Get to know your BOP and DHEC inspectors! • If in doubt, ask questions Good luck! J. Baker 70 Note: This is been reprinted with permission from the DHEC Bureau of Drug Control for educational purposes. Pharmacies must request permission to provide emergency kits for LTC facilities. EMERGENCY DRUG KIT PERMISSION Exception Number: Date Issued: Pursuant to a request for exception to the Controlled Substances Regulation (S.C. Code Ann. of , SC, Controlled Substances Registration Number is granted Reg. 61-4) permission to maintain emergency drug kits containing controlled substances in Long Term Care Facilities licensed by the Department of Health and Environmental Control at premises other than the registered location under the following conditions: (a) The controlled substances emergency drug kit shall contain not more than ten (10) controlled substances entities (schedules II-V) as determined by the pharmacy supplier. (a) Controlled substances drugs for emergency use shall be obtained through the pharmacy which regularly provides drugs to the facility and these controlled substances shall remain the property of the pharmacy until legally administered. (a) Controlled substances for emergency use shall be provided in single unit-dose form. (a) A facility shall be permitted to possess not more than three (3) doses of each controlled substances drug entity in the kit. The ten drug entities may be of the same or different concentrations, strength, or dosage unit form. (a) The controlled substances emergency drug supply shall be used only for a bona fide medical emergency situation in which the attending physician makes the determination that the immediate administration of the controlled substance is necessary for the proper medical treatment of the intended ultimate user, and that it is not reasonably possible to obtain the controlled substance pursuant to a prescription, consistent with good medical practice. The controlled substances emergency kit shall not serve as a routine source of medication for facility patients. (a) The attending physician shall substantiate in the patient record either by written or verbal order the necessity for the use of any controlled substances contained in the emergency kit. Items used from the kit shall be promptly replaced by the pharmacist-supplier based on chart orders that are forwarded to the pharmacy. A written prescription shall be provided by the attending physician, within seventy-two (72) hours of the order for emergency administration, for schedule II controlled substances administered pursuant to this exception. (a) The controlled substances emergency kit shall be stored in a securely locked, substantially constructed cabinet, meeting the standards of federal and state regulations governing the storage of controlled substances. (a) Only those persons designated by the Administrator and Pharmacist of the facility shall have access to the controlled substances emergency kit. (i) The pharmacist-supplier of the controlled substances drugs stored in the institution for emergency use shall have the primary responsibility for the proper control and accountability of such drugs in the facility. (j) No person, individual, practitioner, or facility shall be permitted to perform, by virtue of this section of these regulations any act otherwise prohibited by law. (j) Nothing in these regulations shall compel any licensed pharmacist or any pharmacy registered under the State or Federal Controlled Substances Acts to provide controlled substances for emergency use to any facility. (j) The Division of Health Licensing and the Bureau of Drug Control of the South Carolina Department of Health and Environmental Control shall be notified in writing by both the facility and the pharmacist-supplier of the name and location of the facility in which the pharmacist intends to place an emergency kits containing controlled substances and the names, strengths, and quantities of the controlled substances to be contained therein. (j) Facilities maintaining a controlled substances emergency kit shall be subject to unannounced inspection by the Bureau of Drug Control at any reasonable time, in order that compliance with the controlled substances regulations may be ascertained. (j) The administration of controlled substances to the patients of the facility shall be performed only by persons authorized by an individual practitioner and in compliance with the laws of this State. South Carolina Department of Health and Environmental Control Wilbur L. Harling, Director Bureau of Drug Control dhec/bdc/07212003
