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State Regulation of Pharmacy Practice

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Title: 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
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