Drug Distribution in Washington

Richard D. Morrison, PharmacistChief InvestigatorWashington State Board of Pharmacy

Objectives

Describe who may prescribe drugs in WADescribe drug classificationsDescribe drug regulation processDiscuss Board of Pharmacy inspection processDiscuss the importance of outdated drug disposal

Prescribing Authority

Must be authorized under State LawGoverned 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 substancesII 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) NonePhysician (DO) NoneDentist (DMD/DDS) Dental practice onlyARNP Legend & Schedule V;

Schedule II-IV if joint practice

agreements with MD/DO

Prescribing Authority

Profession Restriction CRNA Legend & Schedule II-V

for anesthesia per order and per facility protocols

Physician Assistant As approved by the Medical Commission

Physician Assistant As aboveCertified (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 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 MidwifeRestriction

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

Profession Restriction RN Prescribed drugsLPN Prescribed drugsRespiratory Care Prescribed respiratory drugsPhysical Therapist Prescribed topical drugsDental Hygienist Local anesthetics/topical fluorideEMT Prescribed drugs/EpinephrineSchool employee Per Rx order, school policy

Prescribing Limitations

Members of the following professions may not prescribe, administer, or dispense drugs:Acupuncturist CounselorChiropractor Dietitian/Nutritionist Dispensing Optician Lay MidwifeOcularist Occupational Therapist Massage PractitionerPsychologistPharmacy 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 sitesThousands of people Lack of knowledge about proper disposalLack 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 useForgeries, theft, substitution, records fraud, etc.

Importance of proper & prompt disposal of outdated drugs

Outdates are set aside to deal with laterNo one pays much attention to themThey are subject to theft and abuseThe registrant is still responsibleIt 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