Establishing a Practice Site

1
Establishing a Practice Site
2
Opening a business in WA

• Business are licensed by state and local entities
• Resources for new businesses are available on
  www.access.wa.gov
• Form of businesses has tax and liability
  consequences
• Proprietorship Partnerships
• Owners personal assets at risk
• Partners responsible for other partners
  liabilities
• Corporations have more limited risk
• S-Corporations taxed like a partnership
• Full corporations have double taxation

3
Licensing Registration

• Corporations limited partnerships must register
  with Secretary of State
• Master License System
• Tax registration
• LI registration
• Corporation registration
• Trade name
• Business registration separate from licenses
  needed for hospitals, pharmacies, nursing homes,
  etc.

4
Pharmacy Applications

• Board of Pharmacy
• One application form for all pharmacies
• Differential hours supplemental application
• Ancillary personnel supplemental application
• Must be submitted 30 days prior to a Board
  meeting
• DEA use form 224, online application process

5
Community Pharmacies Differential Hours

• Pharmacy security
• Drop off box or mail slot for Rxs
• Distinct telephone number
• Recording of phone calls if answered in main
  store when RPh not present
• Oral Rxs may be recorded if hours are announced
  by answering machine
• Operating hours displayed at entrance if in
  larger store, at entrance to larger store and
  near the pharmacy
• Advertising must list operating hours

6
Physical standards adequate stock

• Must have appropriate supplies to meet needs of
  patients
• No outdated drugs in stock
• Free from adulteration, contamination, or
  deterioration
• Properly labeled
• Stored in accordance with USP standards

7
Physical standards adequate facilities

• New or remodeled buildings must comply with local
  codes
• 30 to 50 foot-candles of illumination
• Adequate ventilation
• 3 linear ft (18 deep) of counter for each
  pharmacist or intern
• Sink with hot cold running water
• Refrigerator with thermometer
• 2-8C (36-46F)
• No food where drugs are stored

8
Physical standards sanitary conditions

• Walls, ceilings in good repair. No peeling or
  cracked paint.
• Adequate trash receptacles
• Hot cold water in restroom, soap towels,
  clean and sanitary
• Equipment in good repair and clean
• Professional personnel and their apparel must be
  neat and clean

9
Adequate equipment

• Washington is less prescriptive than most states
• Must have equipment needed for the types of
  prescriptions filled
• Must have a WA law book in a binder
• Must have other references needed for pharmacists
  to furnish information to patients and
  practitioners concerning drugs

10
Poison control

• Must have one bottle of Syrup of Ipecac in stock
  at all times
• Telephone number of nearest poison control center
  
• National Poison Center Number
• 1-800-222-1222
• Connects to Washington Poison Center in Seattle
  when dialed from anywhere in WA

11
Inspections Grades

• Class A 90-100
• Conditional 80-89
• 60 days to improve to Class A
• Unsatisfactory
• 14 days to improve to Class A
• 5 pts taken off for violation of ancillary
  personnel rules ? automatic Unsatisfactory grade
• Self-inspection procedures

12
Most Common Problems Identified on Inspections

• Retail Pharmacies
• Patient records
• CRC records
• Completed labels
• Drugs properly labeled
• Pharmacy assistant use

• Inpatient Pharmacies
• Policy and procedure
• Patient records
• Ancillary staff use
• Completed labels

13
Non-Resident Pharmacies

• Sell or ship drugs to patients in WA
• Must register with WA Board of Pharmacy
• Registered regulated by home state
• Must put 800-number on label for patients to
  receive consultation
• Must maintain patient profiles
• Must provide patient information
• May be disciplined or fined by WA if home state
  doesnt investigate a complaint within 45 days.

14
Regulation of non-ambulatory pharmacies

• Board of Pharmacy
• Board of Health
• JCAHO
• Medicaid (DSHS)
• Medicare

15
Different regulatory scheme

• Policy driven
• Relies on institutional checks and balances
• Medical staff model
• Chief of staff (Hospital)
• Medical director (ECF)
• Pharmacy and Therapeutics Committee includes
  pharmacist
• Key differences in labeling, distribution
  systems, and CSA accountability

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Hospitals WAC 246-873

• 040 Must have director of pharmacy
• Appropriately qualified by education, training,
  and experience
• 050 Must have 24 hour pharmacy services
• 060 Plan for emergency outpatient meds
• 080 Distribution of drugs
• 090 Administration of drugs
• 100 Investigational drugs
• 110 Additional responsibilities

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Drug distribution and control

• MUSTS
• Control of all drugs throughout hospital
• Monthly inspections of all areas where drugs are
  stored or used
• Monitoring of drug therapy
• Provision of drug information
• SHOULDS
• Obtaining and recording drug use histories
• Preparation of all sterile products
• Distribution and control of all
  radiopharmaceuticals
• Administration of drugs
• Prescribing

18
Drug distribution and control (2)

• Director maintains policies, with annual updates
• Labeling (see assignment)
• Pharmacist must see copy of order before drugs
  dispensed, except according to policies developed
  to handle emergencies
• Controlled substance accountability
• Handling of recalls, ADRs, and error reporting

19
Long-term Care Types of senior housing

• Independent living
• Assisted living
• Nursing care
• Alzheimers care
• Continuous Care Retirement Communities

20
Considerations in selecting senior care
facilities (SNFs)
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Levels of care

• Basic care provided by aide or family caregiver
• Personal care
• Supervision
• Safety
• Skilled care RNs, RPT, RT
• Supervised drug therapy
• Treatments
• Sub-Acute Care
• Comprehensive inpatient care for patient
  recovering from illness
• Daily review and assessment

22
General descriptors

• ECFs extended care facilities
• LTCFs long-term care facilities

23
Independent living

• Descriptors
• Congregate care
• Retirement communities
• Senior apartments
• Provide meals and activities
• Pharmacies may provide special services, such as
  bingo cards, but follow ambulatory care rules

24
Assisted living

• Descriptors
• Adult family homes
• Board and care facilities
• Adult habitation centers
• Adult foster care
• Nurses may provide medication assistance
• Pharmacies may provide customized containers

25
Med-packs(WAC 246-869-255)

• Bingo cards and dosage cassettes
• Original bulk Rx container stays in pharmacy
• Up to 31 day supply
• Patient or agent must request non-CRC
• Labeled with same information for each drug as
  for outpatient Rx

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ECFs WAC 246-865(Skilled Nursing Facilities)

• 060 Pharmaceutical services
• Must have consultant pharmacist
• Pharmaceutical services committee
• Labeling
• D/Cd drugs, returns, CSA accounting
• Labeling unit dose, MUD, traditional
  prescription systems
• 030 Emergency kits
• 040 Supplemental dose kits
• 070 Pass meds

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OBRA-87 Requirements for LTC facilities

• Pharmacists must be involved in care of patient
• Development of a comprehensive care plan for each
  resident
• Residents therapy must be free of unnecessary
  drugs
• Duplicative therapy
• Excessive duration
• Inadequate monitoring
• Inadequate indications for use
• Use of drugs in presence of ADRs
• Comprehensive reviews of psychotropic drugs and
  plan to reduce use in each patient
• Drug Regimen Review by pharmacist q 30 days

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Parenteral Products, Non-Hospitalized Patients
WAC 246-871

• Policy and procedure
• Class 100 environment
• Pharmacist in charge
• Must have training in aseptic technique QA
• Clinical services
• Monitoring
• Training
• Administration
• Quality assurance
• QA program reviewed annually
• Errors, ADRs, Pt. Satisfaction, Sterility

29
Nuclear PharmaciesWAC 246-903

• Permit issued only to nuclear pharmacist
• Nuclear pharmacist must
• Meet radiation control agency (RCA) standards
• Meet training or experience requirements of WAC
  246-903-030
• Must submit equipment list to Board and RCA prior
  to licensure of pharmacy