Georgia Law Primer_Prescriptions and Labels.pptx
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Georgia Law Primer: Prescriptions and Patient Labels TRACEY MEADE, PHARM.D. BCGP Objectives Describe where to find laws, rules, and regulations for the practice of pharmacy in the state of Georgia Define responsible pharmacy personnel working in pharmacy settings Define prescription dru...
Georgia Law Primer: Prescriptions and Patient Labels TRACEY MEADE, PHARM.D. BCGP Objectives Describe where to find laws, rules, and regulations for the practice of pharmacy in the state of Georgia Define responsible pharmacy personnel working in pharmacy settings Define prescription drug orders in different practice settings Define dangerous drugs and controlled substances Present practitioners that may prescribe dangerous drugs and controlled substances in the state of Georgia Explain prescriber DEA numbers and how to validate them Outline federal and state requirements for community pharmacy prescriptions and community pharmacy patient labels Briefly discuss the utilization of auxiliary labels Introduce the concept of Errors & Omissions Where do I find pharmacy law or rules and regulations? https://gbp.georgia.gov/ Pharmacy Personnel Pharmacist individual health care provider licensed by this State to engage in the practice of pharmacy Pharmacy Intern individual who is 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 Pharmacy Personnel Certified Pharmacy Technician Nationally Certified: individual who has passed the National Pharmacy Technician Certification Board exam or a Board of Pharmacy approved exam and has maintained current certification Pharmacy Technician individual other than an intern or extern, who assists in preparing, compounding, and dispensing medicines under the personal supervision of a licensed pharmacist and who is required to register as a pharmacy technician Cashier/Clerk individual in the prescription area performing clerical functions- they are not registered or licensed Prescription [Drug Order] “An order for a medication which is dispensed to the ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user” (e.g. an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription) (21 CFR § 1300.01(b)) Prescription [Drug Order] Medication/Chart Order [in a hospital/institutional setting] Defined: “A lawful order entered on the chart or a medical record of an inpatient or resident of an Institutional Facility by a Practitioner or his or her designated agent for a Drug or Device.” (NABP Model Act) Chart orders are for persons who are patients in hospitals, nursing homes, or other institutional settings (i.e. inpatients). Medication/Chart Orders Dangerous Drugs and Controlled Substances Dangerous Drug "any drug, other than a controlled substance, which cannot be dispensed except upon the issuance of a prescription drug order by a practitioner authorized under this chapter.” (OCGA 1613-21-6.1) Controlled Substances/Scheduled Drugs (see OCGA 16-13-21-4) Have the potential for addiction and abuse Warrant more strict regulation and control Non-narcotic vs. narcotic Types of Prescribers/Practitioners MD—Doctor of medicine DO—Doctor of osteopathy DMD—Doctor of medical dentistry DDS—Doctor of dental surgery DPM—Doctor of podiatric medicine DVM—Doctor of veterinary medicine OD—Doctor of Optometry (optometrist) PA—Physician’s NP*—Nurse Assistant Practitioner Mid-level practitioners Prescribing Authority ALL Practitioners must write prescriptions for a legitimate medical purpose and within their scope of practice Optometrists prescribe medications pertaining only to eye health NPs and PAs have limitations that vary with their practice Veterinarians can prescribe only for animals Dentists are limited to medications for dental problems Prescribing Authority- Georgia Nurse Practitioner (NP) Doctor of Optometry (OD) Physician Assistant (PA) Non-controls Non-controls Non-controls CIII, CIV, CV CIII, CIV (oral analgesics) Limited to 72 hours use CIII, CIV, CV CII—Hydrocodone products only Limited to 48 hours use Scope of practice = eye only Prescribing Controlled Substances Individual practitioner who is Authorized in the state s/he is authorized to practice Registered under the Controlled Substance Act (CSA- 21 CFR § 1306.03) Drug Enforcement Agency (DEA) Registration Number Assigned DEA Numbers 9-character number consisting of 2 alphabet letters followed by 7 digits First Letter: A/B/F/G - practitioners M – mid-level practitioners P or R – distributors Second Letter: Usually, but NOT always the first letter of the registrant’s last name 6-digits: Unique computer generated number Last number is a computer calculated check digit and a key to verifying the number Verifying DEA Number Verify first and second characters Step 1: Add 1st, 3rd, and 5th digits Step 2: Add 2nd, 4th, and 6th digits and multiply this sum by 2 Step 3: Add the two results The very last digit of this final number should be the same as the ninth “check” digit of the DEA number Practice Prescriber is Edward Dawson, M.D. DEA number is AD5426817 Verifying First letter A, B, F or G- yes Second letter first letter of last name – yes Add 1st, 3rd, and 5th numbers (5 + 2 + 8 = 15) Add 2nd, 4th, 6th numbers x 2 (4+6+1=11 x 2 =22) Add 7 results together (15 + 22 = 37) is the last digit of number – valid number South University Medical Group 709 Mall Blvd. Savannah GA 31406 912-555-5555 Patient Name: Jessie James Address: 100 Cowboy Loop Sav, GA 31405 Rx Date 6/14/22 Lanoxin 0.25 mg #30 Sig: one tab po qd Tara Buford, MD _______________________ Dispense as Written Refills: 3 Written Prescription Substitution Permitted Brand Necessary South University Pharmacy 709 Mall Blvd. Sav, GA 31406 Back Tag Rx# 123456 RPh: LS 6/14/22 Rx # 123456 Jessie James 6/14/22 RPH: LS Take one tablet by mouth once daily Dr. Buford Discard 6/14/2023 Prescription [bottle] Labe Modes for Prescribing Medications Written/Hard Copy Wet Typed and then signed Verbal Telephone Prescriber’s office Another pharmacy Voicemail Electronic Fax E mail (escribe) Georgia Law: Requirements of a Written Prescription Drug Order (Dangerous Drug) Date of issuance Patient (date written) Full patient name Full patient address Prescription Drug Information Name of drug Strength of drug (if more than 1 exists) Dosage form (if more than 1 exists; may be inferred from directions and not stated specifically) Quantity (may be inferred from directions and not stated specifically) Prescriber Name Prescriber address Prescriber’s signature (if written Rx) SIG/directions Brand Necessary – if necessary* Refill information (no refill info = 0 refills; prn refills = up to 1 year) Prescription/serial # (assigned by the pharmacist upon filling the prescription) What non-legal info may be on non-controlled, Written Rx: Georgia Patient DOB Patient Allergies Patient phone # Prescriber phone or fax # Prescriber NPI # Prescriber DEA # Documentation on a written prescription A pharmacist must record the following on a [the back] of a prescription • Generic substitution made (OCGA 26-4-81) • Include the identity of subbed product • Include the manufacturer • Upon filling (OCGA 26-4-80 (g)) • the date of dispensing • Pharmacist’s identity • Upon refilling (OCGA 26-4-80 (e)(g)) • The date of dispensing • The quantity dispensed • Pharmacist’s identity *note: most pharmacies utilize computerized systems that record/maintain this information, therefore, it is not necessary for the pharmacist to make refill notes on the original prescription Back tags Labels (i.e. back tags) help record additional required documentation Legal documentation elements: Pharmacist identifier Prescription/Serial number Date dispensed Substitutions for Brand name products Include on the original prescription Identity of dispensed product Corresponding manufacturer RETAIL Prescription Drug LABEL: Requirements for Prescription Drug Order: NonControlled Medications (Federal & State Law) FEDERAL REQUIREMENTS Name and address of dispenser Pharmacy name and address GEORGIA REQIREMENTS (OCGA 26-4-80 (k) (1)(2) ALL FEDERAL REQUIREMENTS Name and address of pharmacy Name of the patient (if stated in the Rx) A prescription number Name of prescriber Prescription/serial number Name of the patient Directions for taking the medication Date of filling/refilling Date of filling/refilling Name of prescriber Directions for use Initials/identifying code of dispensing pharmacist Other information required or deemed necessary by pharmacist Substitution statement, if applicable (see OCGA 26-4-81) Cautionary statements- if contained in the prescription Patient label Patient Receipt Auxiliary labels Prescription Labels Rx Backtag label Patient LABEL GA Law Requirements for Prescription Drug Order: Generic Substitutions Drug Name • Written for brand or generic brand name dispensed brand name goes on label • Written for brand generic dispensed generic name + manufacturer + “substituted for: brand name” go on label • Written for generic filled for generic generic name on label RPh ID = name or initials of the dispensing pharmacist • In lab, you must handwrite your initials on the patient label RX: 0001768 RPH: TRM DATE: 7/21/20 QTY: #60 Mfg: TEVA Disp: Atenolol 5mg tablet Sub for: Tenormin 50 mg tablet Auxiliary Labels or Cautionary LABELS Considerations for Auxiliary Labels Make sure the aux labels are appropriate and applicable for your medication AND your patient For example: Do not take if pregnant or breastfeeding is not applicable for a male patient or female child not of child bearing age In general, a max of 3 auxiliary/cautionary labels should be used If you are not sure what recommended auxiliary labels to use, check patient counseling, side effects, precautions, administration, storage, and the education tabs in your drug references Errors and Omissions and Practice REFER TO RECORDING/LECTURE POSTED IN BRIGHTSPACE FOR MORE INFORMATION Errors and Omissions A pharmacist must review prescriptions to ensure accuracy Errors Omissions Examples include Correct information on prescription Prescriber info Drug info Correct information on the patient label Correct patient Necessary documentation by state law Pharmacists must review prescription, patient label, medication bottle, backtag Error or Omission on non-controlled Prescription What do you do? Problem Error in the prescription order as written • • • • Drug/diagnosis do not match Patient allergy Drug/drug interaction w/ other meds in profile Rx expired Omission-Insufficient information to fill the prescription • • • • Correction Patient name Date written Drug info Prescriber info or signature Contact the physician regarding the error • Clarify and MD change medication • Obtain new Rx Obtain missing info from prescriber • Call prescriber, clarify, record missing info on Rx and document on Rx Bruce Wayne, MD 1 Medical Park Drive #1 Savannah, GA 31406 912-666-6666 Patient: Abraham Lincoln Date: 7/18/22 Address: 19 Waters Ave Savannah GA 31406 DOB: 4/22/80 Penicillin allergy Methocarbamol 500 mg #90 Sig: i-ii tab po qid Rx 3 REFILLS _____ __Dr. Bruce Wayne________ South University Pharmacy Dispense as Written 709 Mall Blvd Savannah, GA 31406 DEA: AW 1234563 912-333-3333 RX # 6050622 Orig. 7/18/22 Date: 7/18/22 Abraham Lincoln Substitution Permitted Lic# 65432 NPI: 1234567890 Take one to two tablets by mouth daily Qty: 90 Methocarbamol 500mg tab MFG: Watson Refills: 3 Discard After: 7/18/23 RPh: LK Dr. Bruce Wayne Caution: Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. RX: 6050622 RPH: LK DATE: 7/18/22 QTY: #90 MFG:Watson Disp: Methocarba mol 500mg #2 Rick Ottoman, MD 2 Marshland Road RX: 6050612 RPH: HPC Savannah, GA 31405 DATE: 7/18/22 912-666-6666 QTY: #9 MFG: Mylan Patient: Justin Bieber Date: 7/18/22 Disp: Address: 1445 Tumbleweed Lane, Columbia, SC 29203Sumatriptan succinate DOB: 12/5/68 NKDA 100mg Imitrex 100 mg tablet Substituted Rx for: #9 100 Sig: i tab po at onset of migraine, may repeatImitrex x1 in 2h if mg migraine persists 1 refill __________________ Dr. Rick Ottoman Dispense as Written South University Pharmacy Substitution Permitted 709 Mall Blvd Savannah, GA 31406 DEA: BO 1234563 912-333-3333 RX # 6050612 Orig. 7/18/22 NPI: 2345678901 Date: 7/18/22 Justin Bieber Take one tablet by mouth at onset of migraine, may repeat once in 2 hours if migraine persists Qty: #9 Sumatriptan Succinate 100 mg tablet Substituted for Imitrex 100 mg tablet MFG: Mylan Refill: 1 Discard After: 7/18/23 RPh. HPC Dr. Rick Ottoman Caution: Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was Lic# 23456 Bruce Wayne, MD 1 Medical Park Drive #3 Savannah, GA 31406 RX: 6050617 RPH: HPC DATE: 7/18/22 QTY: 1 bottle (2.5ml) MFG: Bausch & Lomb Disp: Latanoprost 0.005% solution 912-666-6666 Patient: Bradley Stewart Date: 5/10/22 Address: 10 Waters Ave Savannah, GA 31406 DOB: 05/4/70 NKDA Rx Latanoprost 0.005% eye drops #1 bottle (2.5ml) Sig: i gtt os qd x 7 days 11 Refills ___________ Dispense as Written Substitution Permitted South University Pharmacy DEA: BW 1234563 709 Mall Blvd Savannah, GA 31406 Lic#912-333-3333 23456 NPI: 2345678901Orig. 5/10/22 RX # 6050617 Date: 07/18/22 Bradley Stewart Instill one drop into left eye once a day for 7 days Qty: 1 bottle (2.5ml) Latanoprost 0.005% solution MFG: Bausch & Lomb Refill: 11 Discard After: 7/18/23 RPh. HPC Dr. Bruce Wayne Caution: Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was
