State Regulation of Pharmacy Practice

1
State Regulation of Pharmacy Practice

• Abood - Chapter 7 (pgs. 280-300)
• Pharmacy is self-regulated profession
• Board of Pharmacy regulates
• Legislature grants power to Board
• Board members appointed by Governor and approved
  by Senate
• See ORS 689.115 Membership qualifications
  appointment vacancy.

2
Basis for Regulation

• ORS 689.025 Policy purpose. (1) The practice of
  pharmacy in the State of Oregon is declared a
  professional practice affecting the public
  health, safety and welfare and is subject to
  regulation and control in the public interest. It
  is further declared to be a matter of public
  interest and concern that the practice of
  pharmacy, as defined in this chapter, merit and
  receive the confidence of the public and that
  only qualified persons be permitted to engage in
  the practice of pharmacy in the State of Oregon.
  This chapter shall be liberally construed to
  carry out these objects and purposes.

3
Basis for Regulation

• (2) It is the purpose of this chapter to promote,
  preserve and protect the public health, safety
  and welfare by and through the effective control
  and regulation of the practice of pharmacy and of
  the registration of drug outlets engaged in the
  manufacture, production, sale and distribution of
  drugs, medications, devices and such other
  materials as may be used in the diagnosis and
  treatment of injury, illness and disease.

4
Pharmacy Regulations

• Not a How to Practice Pharmacy manual
• Establish minimum requirements
• Practicing to the minimum standard is unsafe!
• Board relies on voluntary compliance
• Board receives calls daily from pharmacists
  asking how to get as close to minimum standard as
  possible
• Pharmacists must hold managers and employers
  accountable for safe working environments
• Professional associations in Oregon have not been
  effective advocates for high standards of practice

5
Oregon Board of Pharmacy

• Mission
• ...to promote, preserve, and protect the public
  health, safety and welfare by regulating the
  practice of pharmacy and the quality and
  distribution of drugs and medical devices.

6
Oregon Board of Pharmacy

• What the mission is NOT
• promote, preserve, and protect the profession of
  pharmacy
• promote, preserve, and protect the profits of
  pharmacies
• promote, preserve, and protect the status quo

7
Board of Pharmacy

• Members appointed by Governor
• Approved by the Senate
• Two four-year terms possible
• Accountable to the Governor and citizens of
  Oregon
• Legislature controls budget
• OSPA-assembled Task Force may recommend
  appointees to Governor

8
Powers of the Board (ORS 689.135)

• Set and collect fees
• Adopt rules (rulemaking)
• Investigate violations of statutes and rules
• Discipline licensees
• pharmacists, interns, drug outlets,
  manufacturers, technicians (?)
• Elect officers, hire Executive Director, have
  meetings, meet pharmacy students...

9
ORS 689.155 Authority of Board over medications,
drugs, devices and other materials rules.

• The State Board of Pharmacy shall also have the
  following responsibilities in regard to
  medications, drugs, devices and other materials
  used in this state in the diagnosis, mitigation
  and treatment or prevention of injury, illness
  and disease

10
(1) The regulation of the sale at retail, the
administering by pharmacists to the extent
provided in ORS 689.645 and 689.655 and the
dispensing of medications, drugs, devices and
other materials including the right to seize any
such drugs, devices and other materials found to
be detrimental to the public health and welfare
by the board after appropriate hearing as
required under ORS 183.310 to 183.550. (2) The
specifications of minimum professional and
technical equipment, environment, supplies and
procedures for the compounding, administering and
dispensing of such medications, drugs, devices
and other materials within the practice of
pharmacy and any drug outlet. (3) The control of
the purity and quality of such medications,
drugs, devices and other materials within the
practice of pharmacy and any drug outlet. (4) The
issuance and renewal of certificates of
registration of drug outlets for purposes of
ascertaining those persons engaged in the
manufacture and distribution of drugs, receiving
and collecting annual fees therefrom and
suspending, revoking or refusing to renew such
registration in the manner provided in this
chapter
And the list goes on and on...
11
Rulemaking

• ORS 689.205 Rulemaking. The State Board of
  Pharmacy shall make, adopt, amend and repeal such
  rules as may be deemed necessary by the board,
  from time to time, for the proper administration
  and enforcement of this chapter. Such rules shall
  be adopted in accordance with the procedures
  specified in ORS 183.310 to 183.550.

12
Enforcement

• ORS 689.145 Enforcement powers of board. The
  responsibility for enforcement of the provisions
  of this chapter is vested in the State Board of
  Pharmacy. The board shall have all of the duties,
  powers and authority specifically granted by and
  necessary and proper to the enforcement of this
  chapter, as well as such other duties, powers and
  authority as it may be granted from time to time
  by law.

13
Grounds for Discipline

• false statements when applying for license
• violation of statutes or rules
• conviction of a felony
• conviction of an act involving moral turpitude
• unprofessional conduct
• immoral conduct or character
• gross immorality
• habitual impertinence
• incompetence

14
Range of Discipline

• Letter of Concern
• Order of Reprimand
• Fine (civil penalty)
• Suspension of license
• Revocation of license
• Creative discipline
• pass MPJE, CE, supervision, no preceptor...

15
Impaired Pharmacists

• Chemical dependency
• Pharmacists encouraged to self-refer
• Board does not know of self-referrals
• Encourages pharmacists to seek assistance
• Applies to interns, technicians
• Pharmacist Recovery Network (PRN)
• See ORS 689.342 (and come on Thursday!)

16
Diversion Program

• ORS 689.342 Pharmacists Diversion Program
  Supervisory Council appointment term
  compensation and expenses. (1) There is
  established a Pharmacists Diversion Program
  Supervisory Council consisting of five members
  appointed by the State Board of Pharmacy for the
  purpose of developing and implementing a
  diversion program for chemically dependent
  licensees regulated under this chapter. No
  current board member or staff shall serve on the
  council.

17
Differences in Philosophy

• How much regulation??
• Pharmacist in Charge (PIC) rule
• Counseling
• Technicians
• Response to pharmacist shortage

18
Regulating for Outcomes

• Board micro-manages pharmacy
• Rules should reflect desired outcomes, not
  process
• Pharmacists are professionals and will do the
  right thing
• Pharmacists have (or should have) control over
  their work environment
• Pharmacists will naturally practice safely - it
  is bad for business to harm your customers!

19
Standards of Practice

• Higher standard than statutes and rules
• Promoted by professional associations
• ASHP, ASCP, APhA, etc.
• Board does not establish S of P
• they set minimum standards
• Standards of Practice can be difficult to
  determine
• Peer review panels can help

20
Standards of Practice

• The Board exists because market forces do not
  protect the public
• The profession can not self regulate and rely
  on the Board to intervene only after bad outcomes
  happen!
• In Oregon, who determines S of P??
• prevailing practice ? S of P

21
Medication Errors

• A major topic in the press recently
• Processes to make medication use safer
• Pharmacists must improve accuracy of dispensing
• Standardize processes, minimize distractions
• Accountability for appropriateness of medication,
  dose, drug interactions

22
DIVISION 035 OPERATION OF NONPRESCRIPTION AND
MEDICAL DEVICE AND GAS OUTLETS

• Minimum Standards for Nonprescription Drug
  Outlets
• Drug outlets shall have floor space and shelving
  to insure that drugs are stocked and stored in
  sanitary, well-lighted areas. Where applicable,
  temperature, ventilation and moisture controls
  shall be employed.
• Expiration dates on drug outlet drugs shall be
  the responsibility of each drug outlet to insure
  products are in date.
• There shall be no advertisements of any kind by a
  drug outlet using the following or similar terms
  "drug store", "pharmacy", "apothecary".

23
DIVISION 041OPERATION OF PHARMACIES (RETAIL AND
INSTITUTIONAL DRUG OUTLETS)CONSULTING
PHARMACISTS AND OPERATION OF DRUG ROOMS

• Pharmacies shall be registered as either retail
  drug outlets or institutional drug outlets or
  both.
• Pharmacy registration expires March 31 annually.
• A change of ownership requires the approval of
  the Board and a new certificate of registration.
• No pharmacy shall be operated until a certificate
  of registration has been issued to the pharmacy
  by the Board.

24
Personnel (Both Retail and Institutional Drug
Outlets) 855-041-0020

• Pharmacist-in-Charge
• responsible for the daily operation of the
  pharmacy.
• along with other licensed pharmacy personnel
  involved with management of the pharmacy, must
  ensure that the pharmacy is in compliance with
  all state and federal laws and rules governing
  the practice of pharmacy and that all controlled
  substance records and inventories are maintained
  in conformance with the keeping and inventory
  requirements of federal law and board rules.

25
Personnel (Both Retail and Institutional Drug
Outlets) 855-041-0020

• Pharmacist-in-Charge
• No pharmacist shall be designated
  pharmacist-in-charge of more than two pharmacies
  without prior written approval by the Board.
• conduct an annual inspection of the pharmacy by
  February 1st.
• shall verify, on employment and annually, the
  licensure of pharmacists and the registration of
  technicians under their supervision.

26
Personnel (Both Retail and Institutional Drug
Outlets) 855-041-0020

• Pharmacists
• All pharmacists while on duty, shall be
  responsible for complying with all state and
  federal laws and rules governing the practice of
  pharmacy.
• All pharmacists and pharmacist-interns shall
  notify the Board of Pharmacy in writing of any
  change in employment location or change of
  residence address within 15 days.

27
Operation of Pharmacy(Both Retail and
Institutional Drug Outlets)855-041-0025

• Supervision
• A pharmacy may only be operated when a pharmacist
  licensed to practice in this state is present.
  This means that the pharmacist must be physically
  present in the pharmacy or institutional
  facility.
• Sanitation
• Pharmacies shall be kept clean.
• Persons working in a pharmacy shall practice
  appropriate infection control.

28
Reporting Drug Loss855-041-0037

• Disasters, accidents and emergencies which may
  affect the strength, purity, or labeling of drugs
  or devices shall immediately be reported to the
  Board.
• When there are reasonable grounds to believe that
  drugs have been stolen, the pharmacist shall
  immediately notify the Board.
• At the time a Report of Theft or Loss of
  Controlled Substances (D.E.A. Form 106) is sent
  to the Drug Enforcement Administration, a copy
  shall be sent to the Board. When loss of
  controlled substances is due to burglary or
  robbery, a copy of the police report shall be
  sent to the Board.

29
New Containers855-041-0055

• In filling the original prescriptions, nothing
  but new containers may be used. A patient's
  original container may be refilled if clean and
  the label is legible and up to date. The
  container shall comply with the current
  provisions of the Federal Consumer Packaging Act
  (Public Law 91-601, 91st Congress, S. 2162) and
  rules or regulations adopted thereunder. It must
  also conform with the current United States
  Pharmacopeia/National Formulary monographs for
  preservation, packaging, storage and labeling.

30
Defines Labeling and Container Requirements for
Repackaged Drugs - 855-041-0056

• Drugs prepackaged by a pharmacy for later on own
  use dispensing on prescription shall be in a
  container meeting USP standards and labeled to
  identify at a minimum
• Brand name, or generic name and manufacturer
• Strength
• Lot number
• Manufacturer's expiration date, or any earlier
  date which, in the pharmacist's professional
  judgment, is preferable.
• An internal control number which references
  manufacturer and lot number may be utilized.

31
Customized Patient Medication Packages855-041-005
7

• Salad Packs
• two or more prescribed solid oral dosage forms.
• 60-day expiration from package date
• labeling - see OAR

32
Prescription Files855-041-0060

• storage of the information on the prescription
• safeguarded and readily retrievable.
• Keep for at least three years

33
Sterile Parenteral Products855-041-0063

• 48-hours or less expiration vs. gt 48 hr
• documentation of training and QA
• procedure for verification by the pharmacist of
  the preparation of each completed parenteral
  product
• The drug and dose ordered are appropriate for the
  patient
• The correct drug and solution were selected
• The label is correct and complete and
• The calculation of the amount transferred is
  correct.

34
Sterile Parenteral Products855-041-0063

• Labeling In addition to regular labeling
  requirements
• Rate of infusion, as appropriate
• Expiration date
• Storage requirements or special conditions, if
  applicable
• Name and concentration of all ingredients
  contained in the parenteral products, including
  primary solution and
• Handwritten initial of the pharmacist certifying
  for accuracy.
• Written policies and procedures

35
Requirements for Prescriptions - Prescription
Refills 855-041-0065

• See OAR for specifics
• Generic substitution prohibited when MD writes
• No substitution
• N.S.
• Brand medically necessary
• Brand necessary
• Medically necessary
• D.A.W. (Dispense As Written) and
• Words with similar meaning.

36
Labeling 855-041-0065

• Name, address and telephone number of the
  pharmacy
• Date
• Identifying number
• Name of patient
• Name of drug, strength, and quantity dispensed
  when a generic name is used, the label shall also
  contain the name of the manufacturer or
  distributor
• Directions for use by the patient
• Name of practitioner

37
Labeling 855-041-0065

• Required precautionary information regarding
  controlled substances
• Such other and further accessory cautionary
  information as required for patient safety
• An expiration date after which the patient should
  not use the drug or medicine. Expiration dates
  must be the same as that on the original
  container unless, in the pharmacist's
  professional judgement, a shorter date is
  warranted and
• any dispensed prescription medication, other than
  those in unit dose packaging, shall be labeled
  with its physical description, including any
  identification code that may appear on tablets
  and capsules.

38
Transfer of Prescription Information Between
Pharmacies 855-041-0075

• Prescriptions may be transferred between
  pharmacies for the purpose of refill dispensing
  provided that
• the prescription is invalidated at the sending
  pharmacy and
• the receiving pharmacy obtains all the
  information constituting the prescription and its
  relevant refill history in a manner that ensures
  accuracy and accountability.
• Prescriptions for controlled substances (III-V)
  can only be transferred one time.
• Pharmacies using the same electronic prescription
  database are not required to transfer
  prescriptions for dispensing purposes.

39
Duties of the Pharmacist Receiving an Oral
Prescription 855-041-0085

• (1) The date when the oral prescription was
  received.
• (2) The name of the patient for whom, or the
  owner of the animal for which, the drug is
  dispensed.
• (3) The full name and, in the case of controlled
  substances, the address and the DEA registration
  number of the practitioner or other number as
  authorized under rules adopted by reference under
  OAR 855-080-0085.
• See OAR 855-041-0085 for the rest!

40
Drug Outlet Procedures

• Each pharmacy registrant is accountable for
  establishing, maintaining, and enforcing their
  written procedures for
• Securing their legend drugs and the area in which
  they are prepared, compounded, stored or
  repackaged
• Performing mandatory prospective drug utilization
  reviews
• Verifying the accuracy of all completed
  prescriptions and medical orders before they
  leave the pharmacys secured legend area
• Documenting the identification of the
  pharmacist(s) responsible for the verification of
  each dispensed medication
• Ensuring the delivery of each completed
  prescription to the correct party
• Providing appropriate confidential professional
  advice concerning medications to patients or
  their agents and
• Ensuring that all who work in the pharmacy are
  appropriately registered and adequately trained
  to perform their duties.

41
Institutional Drug Outlets

• Definitions 855-041-0105
• Absence of Pharmacist 855-041-0120
• Drug Distribution and Control 855-041-0130
• director of pharmacy shall establish written
  procedures for the safe and efficient
  distribution of pharmaceutical products.
• pharmacy shall be operated at least part time,
  five days a week.
• span of supervision shall extend to all areas of
  the hospital where drugs are stored.

42
Institutional Drug Outlets

• Hospitals With Drug Rooms
• Supervision of Consulting Pharmacist 855-041-0135
• the drug room must be supervised by a licensed
  pharmacist...to act in the capacity of a part-
  time director
• The pharmacist shall provide on-call service at
  all times
• Adequate storage facilities for drugs will be
  provided and
• All drugs supplied shall be labeled so as to
  insure that recalls can be effected and that
  proper control and supervision of such drugs may
  be exercised.

43
Institutional Drug Outlets

• Emergency Kits
• Emergency kit drugs are those drugs which may be
  required to meet the immediate therapeutic needs
  of inpatients, and which are not available from
  any other authorized source in sufficient time to
  prevent risk of harm to patients by delay
  resulting from obtaining such drugs from such
  other source.
• Supplying Pharmacist. All emergency kit drugs
  shall be prepared by a licensed pharmacist.

44
Pharmacists Serving Long Term Care Facilities and
Community Based Care Facilities

• Long term care facility means a facility with
  permanent facilities that include inpatient beds,
  providing medical services, including nursing
  services but excluding surgical procedures except
  as may be permitted by the rules of the director,
  to provide treatment for two or more unrelated
  patients. Long Term Care facility includes
  skilled nursing facilities and intermediate care
  facilities but may not be construed to include
  facilities licensed and operated pursuant to ORS
  443.400 to 443.455.
• NURSING HOME! ? ADULT CARE HOMES!

45
Pharmacists Serving Long Term Care Facilities and
Community Based Care Facilities

• Community Based Care Facility means a home,
  facility or supervised living environment
  licensed or certified or otherwise recognized by
  an agency of the state of Oregon which provides
  24-hour care, supervision, and assistance with
  medication administration. These include but are
  not limited to Adult Foster Homes, Residential
  Care Facilities (RCF), Assisted Living Facilities
  (ALF), Group Homes for the Developmentally
  Disabled and Mentally Retarded and Inpatient
  Hospice.

46
Pharmacists Serving Long Term Care Facilities and
Community Based Care Facilities

• Drug Distribution and Control 855-041-0160
• Pharmacies or pharmacists that supply emergency
  drug kits to and/or accept returned medications
  from long term care facilities or community based
  care facilities must
• Assist in the establishment and supervision of
• The policies and procedures for the safe storage,
  distribution, administration, and disposition of
  drugs
• The maintenance of controlled drug accountability
  records and
• The policies and procedures for professional
  advice/ medication counseling of patients and/or
  their care givers.

47
Pharmacists Serving Long Term Care Facilities and
Community Based Care Facilities

• Continued
• Have some pharmacists visit and provide
  consultant services on a regular basis
• Have some pharmacists perform the quality
  assurance activities defined in OAR 855-041-0132
  and
• Supervise the implementation of the policies and
  procedures involving the security, storage,
  stocking, labeling, and notification of use of
  emergency drugs kits and supplemental drug
  supplies.

48
Correctional Facilities

• Drug dispensing in a correctional facility shall
  be from a pharmacy or from a drug room. The
  facility shall have a pharmacist who acts as a
  consultant to the institution, develops policies
  and procedures on drug distribution, procurement
  and management, monitors for compliance, performs
  drug utilization reviews, and may delegate
  registered nurses to withdraw drugs for
  administration to patient/inmates.

49
Collaborative Drug Therapy Management 855-041-0400

• A pharmacist shall engage in collaborative drug
  therapy management only under a written protocol
  that includes
• The identification, either by name or by
  description, of the participating pharmacist(s)
• The identification, by name, of the participating
  practitioner(s)
• The name of the principal pharmacist and
  practitioner who are responsible for development,
  training, administration, and quality assurance
  of the arrangement

50
Collaborative Drug Therapy Management 855-041-0400

• A detailed description of the collaborative role
  the pharmacist(s) shall play, including but not
  limited to
• Written protocol for specific drugs pursuant to
  which the pharmacist will base drug therapy
  management decisions for an individual patient.
• Circumstances which will cause the pharmacist to
  initiate communication with the practitioner,
  including but not limited to the need for new
  prescription orders and reports of patients
  therapeutic responses or adverse effects.
• Training requirement for pharmacist participation
  and ongoing assessment of competency, if
  necessary.
• Quality assurance and periodic review by a panel
  of the participating pharmacist(s) and
  practitioner(s).

51
Collaborative Drug Therapy Management 855-041-0400

• Authorization by the practitioner(s) for the
  pharmacist(s) to participate in collaborative
  drug therapy.
• A provision for the collaborative drug therapy
  arrangement to be reviewed and updated, or
  discontinued at least every two years and
• A description of the mechanism for the
  pharmacist(s) to communicate to the
  practitioner(s) and for documentation of the
  implementation of the collaborative drug therapy.

52
Collaborative Drug Therapy Management 855-041-0400

• Collaborative drug therapy management is valid
  only when initiated upon the prescription order
  of a participating practitioner for each
  individual patient.
• Nothing in this rule shall be construed to allow
  therapeutic substitution.
• The collaborative drug therapy protocol must be
  kept on file in the pharmacy and made available
  to the Board of Pharmacy and to the Board of
  Medical Examiners upon request.

53
Administration of Vaccines By Pharmacists

• A pharmacist may administer vaccines to persons
  who are over the age of eighteen as provided by
  these rules.
• A pharmacist may administer vaccines to a person
  who is over the age of eighteen only if
• The pharmacist has completed a course of training
  accredited by the Centers for Disease Control and
  Prevention, the American Council on
  Pharmaceutical Education or a similar health
  authority or professional body approved by the
  Board and the Oregon Health Division
• The pharmacist holds a current basic
  Cardiopulmonary Resuscitation (CPR) certification
  issued by the American Heart Association or the
  American Red Cross

54
Administration of Vaccines By Pharmacists

• The vaccines are administered in accordance with
  an administration protocol approved by the Oregon
  Health Division and
• the pharmacist has a current copy of the CDC
  reference, "Epidemiology and Prevention of
  Vaccine-Preventable Diseases".
• No pharmacist may delegate the administration of
  vaccines to another person.

55
Administration of Vaccines By Pharmacists

• Protocols, Policies and Procedures 855-041-0510
• pharmacists must follow written protocols
  approved by the Oregon Health Division for
  administration of vaccines and treatment of
  adverse events following administration of a
  vaccine(s).
• The pharmacy must maintain written policies and
  procedures for handling and disposal of used or
  contaminated equipment and supplies.
• The pharmacy must give the appropriate Vaccine
  Information Statement (VIS) to the patient or
  legal representative with each dose of vaccine
  covered by these forms. The pharmacist must
  ensure that the patient or legal representative
  is available and has read, or has had read to
  them, the information provided and has had their
  questions answered prior to administering the
  vaccine.
• The pharmacy must report adverse events to VAERS,
  and PCP
• Record Keeping and Reporting 855-041-0520