52 Prescription Writing And The Law.docx

L. Kaur

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WRITING & SUBMITTING PRESCRIPTIONS What Is a “Prescription”? = Definition from ORC 4729.01 (H)  "Prescription" means a written, electronic, or oral order for drugs or combos or mixtures of drugs to be used by an individual or for treating a particular animal, issued by licensed health professional authorized to prescribe drugs.  Note: an order to dispense a drug to an inpatient for immediate admin in a hospital is not a prescription (DEA)! PRESCRIPTIONS = Rules developed by the Ohio Board of Pharmacy  OAC 4729-5-30 “Manner of issuance of a prescription”. OAC 4729-5-13 “Prescription format” What is a “Valid” Prescription? OAC 4729-5-30 A  A prescription, to be valid, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of his/her professional practice. Prescription Writing: OUTPATIENT Prescription Format (OAC 4729-5-30) 1) Prescriber’s full name 2) Prescriber’s address 3) Prescriber’s office phone number = Allows pharmacist to contact prescriber if there are any questions 4) Date prescription was written - If unreasonable amount of time has passed since the prescription was written, the pharmacist should refuse to fill it without verification by phone  Cannot be filled for 1st time > 6 months after issuance! 5) Patient’s full name 6) Patient’s full address 7) Name of medication = Generic or brand name can be used. Use of BOTH helps to reduce errors!! 8) Strength of meds in metric units, e.g. mg of drug per tablet, even if only 1 strength available (helps avoid errors) - Note: 20% solution = 20 g drug in 100 mL solution 9) Quantity of medication prescribed - Number of tablets, capsules, etc. & Volume, if a liquid - How much should be prescribed? Depends on: o Anticipated duration of therapy o Cost, cost of drug versus cost of refill o Frequency of contact with physician o Potential for abuse o Potential for toxicity or overdose o Standard packaging o First prescription might be smaller to establish tolerability 10) Directions for use (Sig:) - Simpler the better…Compliance is better with once a day dosing - The following should be explained to the patient by both the prescriber and the pharmacist o How to take the drug o When to take the drug o How much drug to take o Length of treatment period o Purpose of the medication - Drug name, purpose (helps avoid errors), and length of treatment should also be on the label 11) Number of refills and/or period of time over which it may be refilled - Write “zero” or “none”, not “0” if no refills (bc PT can change this) - “Refill PRN” is not a valid refill authorization! - Refills must be limited to one year maximum (3 refills for 3 months, 1 yr is still max amount of time of script) - Schedule II controlled drugs may not be refilled!! 12) Waiver for requirement for childproof container - Pharmacist must use childproof container unless specifically requested not to by prescriber or PT (arthritis) 13) Warnings, etc, to be added to label, e.g. “may cause drowsiness”, “do not drink alcoholic beverages” 14) Prescriber’s signature = Prescription = signed on day written, in ink & as it would be on legal document 15) State license number – prescriber # from license 16) DEA registration # if prescription = controlled substance. DEA discourages use if prescription is not for a controlled drug.

L. Kaur

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PRESCRIPTIONS for CONTROLLED SUBSTANCES DEA Registration & the “DEA license” (...Sounds like another expense!) 

1970, Controlled Substances Act - Administered & enforced by the o Bureau of Narcotics and Dangerous Drugs, a part of the US Dept. of Treasury until 1973, when o The Drug Enforcement Administration (DEA), D.o.J., was formed by merging the BNDD with the Bureau of Drug Abuse Control assumed responsibility in 1973 - Introduced o Controlled-drug schedules o Registration system to register manufacturers, distributors, dispensers, medical professionals and researchers to access “controlled substances” (pretty much anyone except the PT)

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Controlled Substance Schedules http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSe arch.cfm?CFRPart=1308 - Schedule I = High abuse potential & NO currently accepted medical use in USA, o Ex: THC, cannabis, marihuana, heroin, LSD -

Schedule II = High abuse potential, but have accepted medical uses, o Ex: morphine, hydrocodone + APAP, cocaine, amphetamine, methylphenidate, pentobarbital,

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Schedule III = Lower abuse potential & accepted medical use in USA, o Ex: dronabinol, “anabolic” steroids, some combo opioids. Note: hydrocodone + acetaminophen = sched II

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Schedule IV = Low abuse potential & accepted medical use in USA, o Ex: diazepam etc., phenobarbital, pentazocine

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Schedule V Even lower abuse potential, no script required, distrusted by pharmacist in limited # o Even lower abuse potential, prescription not required, but must be distributed by a pharmacist in limited amounts to persons over 18 and records kept, o Ex: codeine-containing cough medicines and diphenoxylate- containing anti-diarrheals

Drug Enforcement Administration: Registration System/“DEA LICENSE”  OFFICE of DIVERSION CONTROL - “Goal to ensure controlled substances are readily available for medical use, while preventing their distribution/diversion for illicit sale and abuse”  DEA registration “number” is necessary to - Manufacture and Distribute - businesses - *Dispense, administer or prescribe – health professionals* - Pharmacy to fill prescriptions - Purchase controlled substances “DEA Registration”  Registrants must comply with a series of regulatory requirements relating to drug security, records accountability, and adherence to standards.  Fees as of April 16, 2012  *Practitioners, Mid-level Practitioners, Pharmacies, Hospitals/ Clinics, and Teaching Institutions pay a fee for a 3 yr period, which approximates to $244 per annual registration period. Drug Enforcement Administration (DEA) LICENSE (OAC 4729-17-13)  Hospital employees and those in approved training programs are not required to have their own number, but can use hospital’s DEA #  Person is assigned a specific internal code number by the hospital - used as a suffix to the hospital D.E.A. registration number.  (C) The administering, dispensing, or prescribing must be done in the usual course of his/her professional practice and only within the scope of his/her employment.

L. Kaur

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Prescription Writing: OUTPATIENT PRESCRIPTION FORMAT (OAC 4729-5-13)  For non-controlled drugs - 1) Must be in compliance with rule 4729-5-30 - 2) If handwritten or typed, must have no more than 3 prescriptions on each prescription order form - 3) If preprinted form is used, with multiple drug names and strength combinations o ONLY ONE combo can be selected (so pt can’t check more boxes) & none can be a controlled substance - Order exempt from rule if an electronic transmission system is used to fax prescription to pharmacy 

For all controlled drugs - 1) Must be in compliance with rule 4729-5-30 - 2) If handwritten, typed or preprinted, must have only one prescription on each order form o If preprinted can only list one drug/dose comb. - 3) Quantity must be written both numerically (e.g. “30”) and alphabetically (e.g. “thirty”) - Order exempt from rule if an electronic transmission system is used to fax prescription to pharmacy -

RESTRICTIONS (ORC 3719-05) o 1) A schedule II drug shall be dispensed only upon a written prescription (Except in an emergency) o 2) Schedule II drugs: No refills are allowed; however… (practitioner’s DEA Manual, pg 19)  Since Dec 19, 2007, DEA has allowed multiple PS to be written covering up to 90 days supply,e.g. 3 PS to cover 3 months. Fill dates must be specified, and all 3 PSs must still be signed on day written. o 3) Schedule III/IV drugs: May be refilled up to 5x in the 6 months from date written o 4) Pharmacist must keep PS for 3 years, record PT & Prescriber names & address, DEA #, drug, amount & date

Who can prescribe controlled drugs? Prescription Writing: OUTPATIENT Controlled Substances (ORC 3719-06)  (A) (1) A licensed health professional authorized to prescribe drugs, …rules adopted by the state board of pharmacy, may, except as provided in division (A)(2) or (3) of this section, do the following: - a) Prescribe schedule II, III, IV, and V controlled substances; - b) Administer or personally furnish to patients schedule II, III, IV, and V controlled substances; - c) Cause schedule II, III, IV, and V controlled substances to be administered under the prescriber's direction and supervision.  (A)(3) A licensed health professional authorized to prescribe drugs who is a PA is subject to all of the following: - a) A controlled substance may be prescribed or personally furnished only if it is included in the physiciandelegated prescriptive authority… - b) A schedule II CS may be prescribed only in accordance with ORC 4730.41 and 4730.411 of Revised Code. - c) No schedule II controlled substance shall be personally furnished to any patient.  (B) In exercising physician-delegated prescriptive authority, a physician assistant is subject to all of the following: …(ORC 4730.41) - 3) If the physician assistant possesses physician- delegated prescriptive authority for controlled substances, the physician assistant shall register with the federal drug enforcement administration. - 4) If the physician assistant possesses physician- delegated prescriptive authority for schedule II controlled substances, the physician assistant shall comply with section 4730.411 of the Revised Code.  (A) Except as provided in division (B) or (C) of this section, a physician assistant may prescribe to a patient a schedule II controlled substance only if all of the following are the case: (ORC 4730.411) - 1) The patient is in a terminal condition, … - 2) The physician assistant's supervising physician initially prescribed the substance for the patient. - 3) The prescription is for an amount that does not exceed the amount necessary for the patient’s use in a single, twenty-four-hour period.  (A) Except as provided in division (B) or (C)… may prescribe… a schedule II controlled substance …:  (B) The restrictions on prescriptive authority in division (A) of this section do not apply if a physician assistant issues the prescription to the patient from any of the following (1-13) locations: - (1)-(12) Practice locations regulated by the state; (7 days supply) - (13) Private practice, but only if it is owned by the physician(s);  (C) A physician assistant shall not issue to a patient a prescription for a schedule II controlled substance from a convenience care clinic….

L. Kaur

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OTHER MEANS OF SUBMITTING a PRESCRIPTION  Telephone  Fax  E-transmission Prescription Writing: Outpatient Prescription Format: TELEPHONE  Prescriptions & refills may be transmitted orally by phone by prescriber/authorized agent (must provide full name) to - Pharmacist - Licensed pharmacy intern, if authorized by supervising pharmacist on duty - Recording device within the pharmacy, if pharmacist is unavailable o Pharmacist must convert recording to a written prescription and is responsible for its validity Prescription Writing: Outpatient Prescription Format: FAX Transmission  FAX Transmission of original written prescriptions - Must be authorized and signed by prescriber - Must include full name of prescriber and if applicable full name of prescriber’s agent sending FAX o Fax must include header information identifying origin - Prescription for schedule II controlled substances may not be faxed, except under special conditions, e.g. o the patient is a hospice patient  Original must be retained by the prescriber in the patient’s records for 3 years - (fax or transcribed prescription must be retained by pharmacist?? Not written anywhere) Prescription Writing: Outpatient Prescription Format: E-Transmission  Ohio Board of Pharmacy approved electronic prescription transmission system may be used - System must require: “Positive identification” of the prescriber as defined in rule 4729-5-01, e.g. o Magnetic card reader, etc. plus a password - And full name of any authorized agent of the prescriber who transmits the prescription.  Computer data must be retained for a period of three years at the prescriber’s office Substitution of Generic Drugs (ORC 4729.38)  Pharmacist may substitute a generic drug for the brand name drug (RLD), unless: - Patient requests brand name drug - Prescriber handwrites “dispense as written” or “D.A.W.” on written prescription - Price of brand name drug to patient is lower  Pharmacist must inform patient if a generic drug is available and of their right to refuse it, unless - State is paying for drug - Patient is in a hospital, nursing home, etc. Prescription Writing: INPATIENT “Drug Orders” (OAC 4729-17-09)  Procedures will depend on the written policies and procedures developed by the facility  At a minimum “orders for drugs” must include - Name of patient - Name, strength and dosage form of drug - Directions for use, including route of administration if other than oral - Date prescribed, and - Prescriber’s positive identification

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Ex used in class…Dr. Beavis wife for hand written Vicodin script Vicodin (hydrocodone + APAP) was the most frequently prescribed drug in the USA How often should the PT take the drug? Can’t read it on the script (4x/day, prn) = pt can’t figure it out. Would a pharmacist fill this prescription? NO bc coffee spilled, can’t read it, etc Are refills allowed? NO Ex: script for Dr. Beavis = Lipitor 90 tablets 3x/month. Not filled bc cheaper generic. Ex: Beavis Daughter = for Zyrtec 30 tablets, 11 refills (11 refills for 1 year). (not filled bc monthly script)

L. Kaur

Eliminating Errors in ORDERING and PRESCRIBING DRUGS Sources of Information on PRESCRIBING ERRORS  FDA http://www.fda.gov/Drugs/DrugSafety/MedicationErr ors/default.htm - FDA collects data via MedWatch and monitors reports from ISMP, and USP  Institute for Safe Medication Practices (ISMP) http://www.ismp.org/  United States Pharmacopeia (USP) http://www.usp.org/  In 2006, the FDA and ISMP began a campaign to eliminate use of error-prone abbreviations REPORTING ERRORS  Errors should be reported to - Medwatch at FDA or - USP-ISMP Medication Error Reporting Program o Operated by the USP in cooperation with ISMP. Confidential national voluntary program o Info is forwarded to FDA, manufacturers, excludes reporters name & contact info unless permission is granted o https://www.ismp.org/orderForms/reporterrortoISMP.asp  If errors are not reported, changes in labeling, procedures, etc. cannot be developed THE PROBLEM  Ambiguous medical notations, which lead to miscommunication of drug orders are one of the most common causes of medication errors  Can be caused by poor handwriting  Information needs to written clearly - Inappropriate error-prone abbreviations and - Misuse of zeroes and decimal points - Confusion of metric and other dosing units - Confusion between drugs with similar names  Many abbreviations are commonly used on prescriptions… Abbreviations often used on PRESCRIPTIONS  a before; p after  bid 2x per day  c with; s without  tid 3x per day  pc after meals  qid 4x per day  PO by mouth  q every  PR per rectum  qd every day  SC, SQ  qod every other day  IM intramuscular  qh every hour  IV intravenous  q2h every 2 hours, etc  IA intra-arterial  qam every morning  Sig label  qhs every night at bedtime  OS left eye  hs at bedtime  OD right eye  qs sufficient quantity  sos if needed  prn when needed Consequences of Using Error-Prone Abbreviations  Reader guesses correctly: - Result: No problem for patient  Reader makes enquiries to determine or clarify what was intended: - Result: Start of patients therapy delayed, health professional’s time is used unnecessarily  Reader misinterprets prescription or order: - Result: Patients gets wrong drug or dose, which may lead to patient harm and possible death  Need to take guesswork out of instructions Campaign to Eliminate Errors = 2006, FDA & ISMP began a campaign to eliminate use of error-prone abbreviations  Institute for Safe Medication Practices publishes list of error prone abbreviations  National Coordinating Council for Medication Error Reporting and Prevention - publishes list of dangerous abbreviations and recommendations

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L. Kaur

ERROR-PRONE NOTATIONS  Joint Commission’s “do not use” list - Must be adopted by a hospital for JC (JCAHO) accreditation and should NEVER be used

Examples  Intended dose of 4 units in patient history interpreted as 44 units  “U” should be written out as “unit”      

“Potassium chloride QD” in medication order interpreted as QID Should be written as “daily” Intended dose of “.4 mg” interpreted as 4 mg from medication order Should be written as “0.4 mg” Intended recommendation of “less than 10” was interpreted as 40 “<” should be written out as “less than”

Other Error-Prone Notations on ISMP List = These are also on the UTMC “do not use list”

Other Error-Prone Notations on ISMP List  Drug name, dose and units run together can be confusing  Problem – “name+dose”, if drug name ends in “l”, - Inderal40 mg; Tegretol300 mg have been mistaken for Inderal 140 mg and Tegretol 1300 mg  Problem – “dose+units” - 10mL or 10mg have been mistaken for 1000L or 1000g handwritten “m” can look like 0 or 00  Solution = To avoid such errors, leave plenty of space between drug name, dose and unit of measure

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L. Kaur

Error-Prone DRUG ABBREVIATIONS included on ISMP List Abbreviation Meaning AZT zidovudine (Retrovir) CPZ Compazine (prochlorperazine) HCT hydrocortisone HCTZ hydrochlorothiazide MTX methotrexate PCA procainamide PTU propylthiouracil T3 Tylenol with codeine No. 3 TNK TNKase ZnSO4 zinc sulfate

Interpretation azathioprine chlorpromazine hydrochlorothiazide hydrocortisone (seen as HCT250 mg) mitoxantrone patient controlled analgesia mercaptopurine liothyronine “TPA” morphine sulfate

Error-Prone Drug Abbreviations  CONCLUSIONS = Drug name abbreviations can easily be confused  TO AVOID MISTAKES = Always write out complete drug name THE PROBLEM (CON’T)  confusion of metric & other dosing units (info needs to be written clearly)  Apothecary units are archaic, but are sometimes still used… Examples of APOTHECARY UNITS  What are apothecary units? Obsolete units used by an apothecary (Br. Ob.) - 1 grain (gr) = 0.065 g or 65 mg (15 gr = 1g) - 1 ounce (oz) = 30 mL - 1 teaspoonful = 5 mL - 1 tablespoon = 15 mL - 1 quart (qt) = 1000 mL - 2.2 pounds (lb.) = 1 kilogram (kg) - 1 minim = 1 drop - 20 drops = 1 mL Error-Prone UNITS of MEASURE  CONCLUSIONS - Apothecary units are unfamiliar to many practitioners - Upon dispensing, conversion to metric units can lead to miscalculations of dose  TO AVOID MISTAKES - It may be helpful to know what they are, but… - Always use metric units when writing a prescription TO AVOID ERRORS RELATED to ABBREVIATIONS  RECOMMENDATIONS from FDA & ISMP - Implement the Institute for Safe Medication Practices “Do Not Use” List - Complete list is located at: www.ismp.org/Tools/errorproneabbreviations.pdf - The ISMP and the FDA recommend that ISMP’s list of error- prone abbreviations be considered whenever medical information is communicated... Consider Use in All Forms of Communication  Written orders  Internal communications  Telephone/verbal prescriptions  Computer-generated labels  Labels for drug storage bins  Medication administration records  Preprinted protocols  Pharmacy and prescriber computer order entry screens

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L. Kaur

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Do Not Use Error-Prone Abbreviations Even in Print  May still be confused  Perpetuates the impression that they are acceptable  May be copied into written orders  Out of sight out of mind! Perpetuation of the use of error-prone abbreviations, example  “U” in a prominent professional journal article should be written out as “unit”  “QD” in advertisement should be written out as “daily” FDA-ISMP Recommendations for Healthcare Professionals  Avoid ambiguous abbreviations in written orders, computer- generated labels, medication administration records, storage bins/shelf labels, and preprinted protocols.  Work with computer software vendors to make changes in electronic order entry programs.  Provide examples when educating staff on how using error-prone abbreviations have led to serious patient harm.  Provide staff with ISMP’s list of error-prone abbreviations.  Introduce healthcare students to the list of error-prone abbreviations THE PROBLEM  Confusion between drugs with similar names  Even drug names written in full, both printed and handwritten can be confused… CONFUSED DRUG NAMES  Many drugs have names that sound or look like other drug names, especially when hand written  ISMP publishes a list on their web-site of pairs of drug names that have led to errors

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Could this be a problem?

Ex of Confused Names CNS Drugs

Drugs for Diabetes

Drugs for Treating Pain

GI System Drugs CONFUSED DRUG NAMES  To minimize errors when writing a prescription  Write clearly!!!  Also - Use both trade name & generic name - Include dose,(ex: 10 mg even if only one exists) - Include indication for which drug was prescribed  Any of these could alert pharmacist to an error in writing or interpretation Other Resources = For more information and tools to help promote safe practices, visit:  www.ismp.org/tools/abbreviations or http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/default.htm

L. Kaur

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RECORD KEEPING RESPONSIBILITIES for DRUG PRESCRIBERS  OAC 4729-9-22 & OAC 4729-9-14 Record Keeping: DANGEROUS DRUGS (OAC 4729-9-22)  Prescriber needs to keep a record of all dangerous drugs received, administered, dispensed, sold or used  All records must include - Drug Info: The kind, strength and quantity of the drug, and the dates received and dispensed, etc. - People Info: The name & address of person from whom received and for whom dispensed, administered, etc.  How must records be kept? - Permanent patient medical records are appropriate records for drugs dispensed or administered, the date dispensed, etc. and the name and address of person for whom dispensed - Records must be kept in same location as the dangerous drugs - Records must be kept in that location for 3 years Record Keeping: CONTROLLED SUBSTANCES (OAC 4729-9-14)  How must records be kept? - Records same as for other drugs except permanent patient medical records are appropriate records only for the name and address of person for whom dispensed or administered  In addition = Prescriber must maintain an inventory of all controlled substances & must take a new inventory every 2 yrs SECURITY REQUIREMENTS  Prescriber shall provide supervision & control of dangerous drugs and adequate safeguards to assure that dangerous drugs are being distributed in accordance with all state & federal laws (OAC 4729-9 sections 5, 6, 9, 11, 15)  Security of prescription blanks and D.E.A. controlled substance order forms (OAC 4729-9-09) - Availability must be limited to authorized persons  Security of dangerous drugs (OAC 4729-9-11) - Drugs should be stored in a secure area to deter and allow detection of unauthorized access - Should monitor for suspicious orders, unusual usage or questionable disposition Security Requirements: DISPOSAL of CONTROLLED SUBSTANCES (OAC 4729-9-06)  Prescriber must send list showing the name and quantity of the drugs to the Ohio Board of Pharmacy  Executive director then authorizes and instructs prescriber to dispose of the drugs, by - Transfer to an authorized person - By destruction in presence of a Board of Pharmacy officer, agent or inspector, etc. - Other means specified by the Board of Pharmacy Security Requirements: THEFT or LOSS of DRUGS (OAC 4729-9-15)  Upon discovery, the drug theft or significant loss must be reported to - Board of Pharmacy – immediately by telephone - Law enforcement authorities - D.E.A. – if it is a controlled drug o Federal D.E.A. form (DEA-106) must be used and a copy must be filed with State Board of Pharmacy within 30 days of discovered theft or loss Security Requirements: THEFT or LOSS of FORMS (OAC 4729-9-15)  Prescription blanks or written prescriptions, whether or not already dispensed, upon discovery the theft must be immediately reported to - Board of Pharmacy - Law enforcement authorities  Official DEA order forms, upon discovery, the theft must be immediately reported to - Board of Pharmacy - Law enforcement authorities - The Drug Enforcement Administration (D.E.A.)