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classifications Describe drug regulation process Discuss Board of Pharmacy inspection process Discuss the importance of outdated drug disposal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 Profession Restriction Physician (MD) None Physician (DO)None Dentist (DMD/DDS) Dental practice only ARNPLegend & Schedule V; Schedule II-IV if joint practice agreements with MD/DO

Prescribing Authority Profession Restriction CRNALegend & Schedule II-V for anesthesia per order and per facility protocols Physician AssistantAs approved by the Medical Commission Physician AssistantAs above Certified (PA-C)

Prescribing Authority Profession Restriction 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 Profession Restriction Pharmacist (RPh)Initiate or modify Rx therapy under protocol with authorized prescriber Podiatric PhysicianFoot 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 RNPrescribed drugs LPNPrescribed drugs Respiratory CarePrescribed respiratory drugs Physical TherapistPrescribed topical drugs Dental HygienistLocal anesthetics/topical fluoride EMTPrescribed drugs/Epinephrine School employeePer Rx order, school policy

Prescribing Limitations Members of the following professions may not prescribe, administer, or dispense drugs: AcupuncturistCounselor ChiropractorDietitian/Nutritionist Dispensing OpticianLay Midwife OcularistOccupational Therapist Massage PractitionerPsychologist Pharmacy Technician

How many people have prescribing authority? MD18,879 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