03-DDS 6215 RX Regs, Writing 2023 (1).pdf

 Prescribing Medications Pharmacology DDS 6215 Dr. Dan Skaar [email protected] Agenda and objectives Describe drug regulatory agencies Be able to write prescriptions with common conventions...

 Prescribing Medications Pharmacology DDS 6215 Dr. Dan Skaar [email protected] Agenda and objectives Describe drug regulatory agencies Be able to write prescriptions with common conventions List Controlled Substance categories and example drugs Understand risk management issues Describe drug overdose trends Describe national and state responses to opioid crisis  Prescription Drug Regulation Federal government – FDA – DEA State government – Departments of Public Health, Boards of Pharmacy and Dentistry Federal Drug Regulation FDA Federal Drug Regulation DEA State Drug Regulation State Drug Regulation  Legal Categories of Drugs OTC – Purchase without Rx – FDA reviews ingredients and labeling Monograph for each class – Nonconforming drugs have ”new” drug approval process – Rx to OTC change Prescription (Rx) – Requires Rx from licensed provider Controlled substances (Rx) – Schedules I through V Legal restrictions govern categories  Prescriptions Written, verbal, electronic orders – Prima facie evidence of patient relationship – Valid within specific time periods In MN up to one year for fulfillment of all Rxs – Schedule drug changes Legal document – Subject to local, state Prohibition era liquor Rx and federal laws  Prescription Prescribing Corresponding responsibility doctrine – Prescriber and pharmacist Prescriber responsibilities – Good faith patient examination – Rx issued for legitimate medical purpose Scope of practice – Not for office use or general dispensing  Prescription Prescribing Pharmacist responsibilities – Verification of Rx information – Held to “knowingly dispense” standard Medical purpose Patient safety Doses, quantities and frequency of Rxs  Prescription Components DEA # BC1276899 Rex Reiter, M.D. 136 Wright Way General information Boston, MA 02111 1-587-822-5536 (1-JUST CALL ME) Name Address Mr. Slim Foote 2001 Pathway Road, Lane, MA 20101 Date 2/02/02 Patient information ] (please print) Vicodin 5mg/325 # 15 (Fifteen) Drug information Sig. 1-2 tabs po q 4-6 h prn pain Prescriber information M.D. – DEA # 2 letters and 7 digits LABEL REFILL TIMES PRN NR INTERCHANGE MANDATED UNLESS THE PRACTICIONER WRITES THE WORDS ‘NO SUBSTITUTION’ IN THIS SPACE  Prescription Example Patient Name Patient Address Drug Name Drug Strength Drug Quantity # Sig. Dosing Directions X OR X Eg.2 Prescriber Name DEA # as needed  Common Abbreviations in Prescription Writing disp = dispense stat = immediately qd = every day po = by mouth (orally) qod = every other day bid = twice daily IV = intravenous tid = thrice daily IM = intramuscular qid = four times/day sq or sc = subcutaneous ac = before meals pc = after meals qs = sufficient quantity hs or qhs = at bedtime sig = directions for use prn = as needed mg = milligrams ml/cc = milliliters  Common Conversions in Prescription Writing Solids Liquids – 15.4 grain (gr) = 1 gram – 1 teaspoonful = – 1 gr = 60 mg – 1 tablespoonful = – ¼ gr – 1 fluid ounce= 30 ml – ½ gr – 1 l = 1.06 qt – 1 kg = 2.2 lb – 1 oz = 30 g – 1 lb = 454 g – 0.45 kg = 1 lb E.g. 180 lb adult ~ 82 kg  Avoid Prescription Writing Errors Write Legibly Rx directions Do not guess – 1x4 daily Use caution with – QID and q 6 hr decimal points – BID and TID – Avoid Complex directions can Decimal point naked, e.g..5 be confusing Trailing 0 after decimal – Analgesic regimens point, e.g. 5.0 – Accepted Write 1 mg Write 0.250 mg  Prescription Error Responsibility Licensed prescriber Pharmacist Staff administering medication Employing institution (e.g. hospital, clinic, practice) – “Vicarious Liability” Employer liable for employee actions  Controlled Substances Practitioner – Authorization – Registration DEA primary focus is preventing diversion to illicit market – Clinical prescribing decisions  Controlled Substances Schedule I High abuse potential. No approved medical use – Marijuana laws Lack accepted safety under medical supervision Eg. LSD, meth and heroin 1901 New York advertisement  Controlled Substances Schedule II Accepted medical use High abuse potential Severe dependence Highly regulated Drugs – Oxycodone (Percocet, Percodan, OxyContin) – Hydrocodone (Vicodin) – Morphine – Codeine (single entity) – Cocaine HCl  Controlled Substances Schedule II Prescription Writing Some states require multi-copy forms Rxs – Written – Electronic prescribing – Emergency authorization Refills – None – Exception of multiple RXs for 90 day supply for chronic pain DEA #  DEA Number Number provided to practitioners Allows writing Rxs for controlled substances Allows tracking of controlled substances Two letters, six numbers and one check digit – First letter identifies practice or institution type E.g. C for practitioner Second letter is first letter of last name of practitioner Formula to check validity – E.g. BJ6125341  Controlled Substances Schedule III Compared to Schedule II – Lower abuse potential – Less dependence Drugs – Codeine (Tylenol #3)  Controlled Substances Schedule IV Compared to Schedule III – Lower abuse potential – Less dependence Drugs – Benzodiazepines Alprazolam (Xanax) Triazolam (Halcion)  Controlled Substances Schedule III and IV Prescription Writing Written, faxed or oral prescriptions DEA # Dispensing regulations – Within 6 months of issue – 5 refill limit within 6 months of issue – New opiate and narcotic legislation May call in new Rx  Controlled Substances Schedule V Compared to Schedule IV – Lower abuse potential – Less dependence Cough medicines w codeine – Codeine as antitussive Antidiarrheal medicines Liquid codeine  Controlled Substances Schedule V Prescription Writing Dispense or refill within 1 year from date of issuance Mn statue – Contain codeine Time period and refills as with CIII-IV Prescribing Controlled Substances Risk Management Fraudulent RX Prescribing Controlled Substances Risk Management Be aware of drug seeking behavior – Late day or near weekend appointments – Claims allergy or lack of efficacy with specific drugs – Requests specific drug, higher doses or quantities Prescribing Controlled Substances Risk Management Ordering, prescribing, dispensing and administering medications – Scope of professional practice – Patient relationship – Caution prescribing for yourself, family or friends – Records Patients with known hx of dependence or addiction – Disciplinary actions Questions National Drug Overdose Trends NIH 1-2022 National Drug Overdose Trends Changing trends – Fentanyl Intense public and govt. interest – Monitoring programs – Drug Schedule changes – New rules and regulations CDC 2-2021  National Response to Opioid Crisis Professional organizations – State boards – ADA Dental education State legislatures Federal – FDA Insurance companies WSJ 2012 Prescription Management Programs  State and National Response Prescription Monitoring Programs (PMP) Detect diversion, abuse and misuse of controlled substances – Identify “Dr. shoppers” – Identifying inappropriate prescribing is not objective – Pharmacies electronically report Schedule II-V RXs – Patient and prescriber queries – State data exchange Goal to improve patient care Web sites – https://minnesota.pmpaware.net  National Prescription Monitoring Programs State status Minnesota Drug Overdose Trends Minnesota Drug Overdose Trends  Minnesota Response to Opioid Crisis Minnesota Prescription Monitoring Program Schedule II-V drugs Protected health information Queries Access to data Options if identify misuse – No obligation – May refuse to prescribe – May offer where to find support resources Opioid Misuse, Abuse and Overdose in Dentistry Opioid Misuse, Abuse and Overdose in Dentistry  Summary Recognize governing state and federal agencies Be able to write valid Rxs Know Controlled Substance Schedules and drug examples Recognize fraudulent Rxs Describe national and state narcotic abuse trends and initiatives addressing the opioid crisis 2004-2017