Transcript State Regulation of Pharmacy Practice

State Regulation of Pharmacy Practice
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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.
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.
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.
Pharmacy Regulations
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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
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.
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
Board of Pharmacy
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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
Powers of the Board (ORS 689.135)
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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...
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:
(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...
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.
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.
Grounds for Discipline
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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
Range of Discipline
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“Letter of Concern”
Order of Reprimand
Fine (civil penalty)
Suspension of license
Revocation of license
“Creative” discipline
– pass MPJE, CE, supervision, no preceptor...
Impaired Pharmacists
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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!)
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.
Differences in Philosophy
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How much regulation??
Pharmacist in Charge (PIC) rule
Counseling
Technicians
Response to pharmacist shortage
“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!
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
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
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
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".
DIVISION 041
OPERATION 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.
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.
Personnel (Both Retail and Institutional
Drug Outlets) 855-041-0020
• Pharmacist-in-Charge:
– No pharmacist shall be designated pharmacistin-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.
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.
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.
Reporting Drug Loss
855-041-0037
• 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.
New Containers
855-041-0055
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.
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:
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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.
Customized Patient Medication Packages
855-041-0057
• “Salad Packs”
• two or more prescribed solid oral
dosage forms.
• 60-day expiration from package date
• labeling - see OAR
Prescription Files
855-041-0060
• storage of the information on the
prescription
• safeguarded and readily retrievable.
• Keep for at least three years
Sterile Parenteral Products
855-041-0063
• 48-hours or less expiration vs. > 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.
Sterile Parenteral Products
855-041-0063
• 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
Requirements for Prescriptions Prescription Refills 855-041-0065
• See OAR for specifics
• Generic substitution prohibited when MD
writes:
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No substitution;
N.S.;
Brand medically necessary;
Brand necessary;
Medically necessary;
D.A.W. (Dispense As Written); and
Words with similar meaning.
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;
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.
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.
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!
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 pharmacy’s 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.
Institutional Drug Outlets
• Definitions 855-041-0105
• Absence of Pharmacist 855-041-0120
• Drug Distribution and Control 855-0410130
– 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.
Institutional Drug Outlets
• Hospitals With Drug Rooms
• Supervision of Consulting Pharmacist 855-0410135
• the drug room must be supervised by a licensed
pharmacist...to act in the capacity of a parttime 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.
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.
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!
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.
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.
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 855-0410132; 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.
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.
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;
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).
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.
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.
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;
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.
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