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Drug Distribution in Washington. Richard D. Morrison, Pharmacist Chief Investigator Washington State Board of Pharmacy. Objectives. Describe who may prescribe drugs in WA Describe drug classifications Describe drug regulation process Discuss Board of Pharmacy inspection process
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Drug Distribution in Washington Richard D. Morrison, Pharmacist Chief Investigator Washington State Board of Pharmacy
Objectives • Describe who may prescribe drugs in WA • Describe drug classifications • Describe drug regulation process • Discuss Board of Pharmacy inspection process • Discuss the importance of outdated drug disposal
Prescribing Authority • Must be authorized under State Law • Governed by: • Legend Drug Act • Food Drug and Cosmetic Act • Uniform Controlled Substances Act • Profession’s Practice Act • Rules adopted under above laws
Drug Classifications • Over the Counter (OTC) • Prescription Drugs (Legend drugs) • Caution Federal law prohibits dispensing except on the prescription of a physician • Prescription only • Controlled Substances • Classified in five Schedules according to potential for abuse • Schedules I, II, III, IV, IV, V
Controlled Substances Schedules I Heroin, marihuana, LSD, illegal substances II Morphine, oxycodone (Percodan, Percocet, OxyContin), codeine, cocaine, meperidine (Demerol), Ritalin, amphetamines, secobarbital, pentobarbital III Codeine combinations (Tylenol w/ codeine), hydrocodone combinations (Vicodin, Lortabs), Marinol IV Phenobarbital, benzodiazepines (Librium, Valium), propoxyphene (Darvon), Talwin V Codeine cough syrups, antidiarrheals
Who Regulates Drugs • FDA • Initial approval • Manufacture/distribution • DEA • Controlled Substances • Mfr/dist/storage/disposal • States • Board of Pharmacy • Boards - Professionals
Prescribing Authority ProfessionRestriction Physician (MD) None Physician (DO) None Dentist (DMD/DDS) Dental practice only ARNP Legend & Schedule V; Schedule II-IV if joint practice agreements with MD/DO
Prescribing Authority ProfessionRestriction CRNA Legend & Schedule II-V for anesthesia per order and per facility protocols Physician Assistant As approved by the Medical Commission Physician Assistant As above Certified (PA-C)
Prescribing Authority ProfessionRestriction Optometrist (OD) Topical eye Rx only for diagnosis or treatment (DX or TX on Rx). NO controlled substances Naturopath (ND) Limited list of drugs NO controlled substances Veterinarian (DVM) Animal treatment only
Prescribing Authority ProfessionRestriction Pharmacist (RPh) Initiate or modify Rx therapy under protocol with authorized prescriber Podiatric Physician Foot treatment only (DPM)
General Limitations on Prescribing • No self-prescribing of controlled substances • Okay, but not advisable to prescribe for family members • Medications must be for therapeutic purpose • There must be valid doctor-patient relationship • Medications must be within scope of practice
Drug Administration Authority Profession Licensed Midwife Restriction Administer medications prescribed by a physician and may use certain other drugs on own (e.g., postpartum oxytocin, vitamin K, Rho immune globulin, local anesthetics, lactated ringers solution, heparin locks, Magnesium Sulfate per protocol, and epinephrine for allergic reactions)
Drug Administration Authority ProfessionRestriction RN Prescribed drugs LPN Prescribed drugs Respiratory Care Prescribed respiratory drugs Physical Therapist Prescribed topical drugs Dental Hygienist Local anesthetics/topical fluoride EMT Prescribed drugs/Epinephrine School employee Per Rx order, school policy
Prescribing Limitations Members of the following professions may not prescribe, administer, or dispense drugs: Acupuncturist Counselor Chiropractor Dietitian/Nutritionist Dispensing Optician Lay Midwife Ocularist Occupational Therapist Massage Practitioner Psychologist Pharmacy Technician
How many people have prescribing authority? • MD 18,879 • DO 688 • DDS 5,237 • DPM 263 • DVM 2,113 • ARNP 2,000 • ND 466 • PA 1,422 • OD 1,134
Where are drugs used/stored? • Pharmacies (1200) • Drug Wholesalers (80) • Hospitals (110) • Outpatient Surgery Centers (50) • Practitioner Offices/Clinics (10,000) • Nursing Homes (400) • Adult Family Homes/Boarding Homes (500)
What is the scope of the drug disposal issue? • Thousands of sites • Thousands of people • Lack of knowledge about proper disposal • Lack of information
Board of Pharmacy - Inspections Inspection of pharmacies, drug wholesalers, drug manufacturers, outpatient surgery centers, researchers, humane societies, etc. • About every 18 months • Appropriate professional practices • Proper records • Proper storage • Proper control of Controlled Substances • Outdated Drugs
Board of Pharmacy - Investigations Investigation Process • Investigate drug law violations by any licensee • Pharmacy – dispensing without prescription • Theft of controlled substances • Diversion for personal use • Other health professionals • Diversion of drugs for sale or personal use • Forgeries, theft, substitution, records fraud, etc.
Importance of proper & prompt disposal of outdated drugs • Outdates are set aside to deal with later • No one pays much attention to them • They are subject to theft and abuse • The registrant is still responsible • It takes longer to investigate losses
Summary • Described who may prescribe drugs in WA • Described drug classifications • Described drug regulation process • Discussed Board of Pharmacy inspection and investigation process • Discussed the importance of disposal of outdated drugs