Download LICENSING OF PHARMACISTS (855-19)

Rules Hearing - 2006
• Pseudoephedrine
– Makes it a C-III
• Technician education and training
– National certification, minimum age and
education requirement
• Vaccinations/immunizations
– Influenza vaccine down to 15 years
• Returned drugs
– Clarifies what pharmacies can accept
LICENSING OF PHARMACISTS
OAR 855-019
• Hold an earned degree from an ACPE
accredited college of pharmacy
• North American Pharmacist Licensure
Examination (NAPLEX).
• Score of not less than 75 shall be a passing
score
• 91 days minimum between re-takes
• Multistate Pharmacy Jurisprudence
Examination (MPJE).
General Reciprocity Requirements
855-019-0015
• qualified under ORS 689.265 and these rules
• pass the computer-based MPJE examination
• be registered by written examination in the state
on which the applicant bases the reciprocity
application and must be in good standing in that
state
– minimum of 2000 hours of work as a licensed
pharmacist
– Met the internship requirements of this state within
the one-year period immediately previous to the date
of such application
– application for transfer of pharmaceutic licensure, fee,
and
– photocopy of state-issued birth certificate must be
submitted to and approved by the Board
Reinstatement of Licenses
855-019-0040
• A pharmacist license that is not renewed by the
deadline may be reinstated as follows:
– Payment of the annual license fees for all years during which
the license has been lapsed and for the current year and the
delinquent fees for those years; and
– Certification of the continuing education requirement for all
years in which the license has lapsed.
• Pharmacists in good standing who have retired from
the practice of pharmacy after having been licensed
20 years must pay only the annual license fees for the
year in which they seek a license but shall be subject
to the requirement of certification of continuing
education.
Petition for Reinstatement of RPh License
855-019-0050
• A pharmacist license which has been revoked,
suspended or restricted will be reinstated only if the
Board finds, upon a presentation made by the
petitioner, that there is a reasonable assurance that
the public interest will be protected if relicensure
occurs.
Continuing Pharmacy Education Required for
Pharmacist License Renewal 855-021-0005
(1) During the period from June 1 through May 31 of
each license renewal cycle, each pharmacist must have
satisfactorily completed one and one half (1.5)
continuing pharmacy education units (CEU's) in an
approved continuing pharmacy education program Ten
contact hours equals 1 CEU. Fifty minutes equals 1
contact hour.
(2) Section (1) does not apply to pharmacists applying for
the first annual renewal of their license if they have
not been licensed by the Board for at least one year
prior to July 1 of the renewal period.
Continuing Pharmacy Education Required for
Pharmacist License Renewal 855-021-0005
• (a) A program shall consist of therapeutics, or
pharmacy and drug law or other aspects of health
care. At least eleven of the required fifteen hours
of continuing education credit must be earned in
the areas of therapeutics. At least one hour of
continuing education credit must be earned in the
area of pharmacy and drug law.
• (b) Programs shall provide for examinations or
other methods of evaluation to assure
satisfactory completion by participants.
INTERNSHIP REGULATIONS
OAR 855-031
• (1) A "pharmacy intern" means any person who
has:
– Completed the first professional year and is in good
academic standing at an ACPE accredited school or
college of pharmacy, or
– Is a graduate of an ACPE accredited school or college
of pharmacy, or
– Holds a certificate from the Foreign Pharmacy
Graduate Equivalency Committee, and has passed the
Test of Spoken English (TSE) with a score of not less
than 50,
– And is licensed with the Oregon Board as an intern.
INTERNSHIP REGULATIONS
OAR 855-031
• Read all of OAR 855-031, please!!
• The entire contents of 855-031 will be
fair game for the final exam even if we
do not discuss specifics in class.
• You will need to know this division in
preparation for licensure as Pharmacy
Intern this Summer.
INTERNSHIP REGULATIONS
OAR 855-031
• A "preceptor" means a pharmacist
licensed and in good standing,
registered as a preceptor by the Board
to supervise the internship training of
an intern.
• "Internship" means a professional and
practical experience program approved
by the Board.
Internship Reports
855-031-0040
• The Intern Experience Affidavit/Hours Log must list
the actual number of hours worked and the dates
covered by those hours.
• Each Experience Affidavit/Hours Logs must be
notarized.
• The internship experience Affidavit/Hours Log(s)
must be signed by the pharmacy intern and the
preceptor(s).
The intern may report to the Board voluntarily the
preceptor's aptitude and willingness to perform the
duties of a preceptor, or must do so upon request
by the Board.
Rule Change - 2004
• Allows a non-pharmacist to supervise an intern
with prior approval of the Board:
• Approved Internship Experience Areas
855-031-0015
• (d) The preceptor must obtain prior approval
from the Board if the preceptor wishes to
designate a non-pharmacist to be responsible
for the direct supervision of the intern during
the clerkship experience.
Oregon Death With Dignity Act
• Ballot measure #16 in 1994
– Passed 51% to 49%
– Did not go into effect due to injunction by Federal
Judge Michael Hogan (Eugene)
• 1997 Legislature
– Placed repeal measure before voters (Measure #51)
– Repeal defeated 60% to 40%
• Appeal to Supreme Court to repeal Act
– Supreme Court denied to hear the appeal, law goes
into effect in December, 1997
Oregon Death With Dignity Act
• Very controversial morally and ethically
• In 2001, Attorney General Ashcroft rules that Assisted
Suicide was not a “legitimate medical purpose” for the
use of controlled substances and threatened to suspend
or revoke DEA registrations doctors who participated.
• Oregon sues John Ashcroft and USDOJ
• Federal Judge Robert Jones (Portland) places injunction
on Ashcroft ruling
• Appealed to Ninth Circuit Court – injunction upheld.
• Appeal to US Supreme Court – upheld, January 2006
Who May Initiate a Written
Request for Medication?
An adult who is capable, is a resident of
Oregon, and has been determined by the
attending physician and consulting physician
to be suffering from a terminal disease, and
who has voluntarily expressed his or her wish
to die, may make a written request for
medication for the purpose of ending his or
her life in a humane and dignified manner in
accordance with ORS 127.800 to 127.897
Patient Eligibility
• be an adult ( 18 years)
• be “capable” (able to make and communicate
health care decisions)
• be an Oregon resident (> 6 months)
• have a terminal illness with less than six
months to live
• voluntarily request a prescription for lethal
drugs
Requirements
• Two verbal requests to physician, separated by at
least 15 days
• Written request to physician
• Prescribing and a consulting physician confirm the
diagnosis and prognosis
• Prescribing and a consulting physician must
determine whether patient is capable. If either
physician believes judgment impaired by a psychiatric
or psychological disorder, such as depression, patient
must be referred for counseling
• Prescribing physician must inform the patient of
feasible alternatives to assisted suicide including
comfort care, hospice care, and pain control
Requirements (Cont’d)
• Prescribing physician must request, but may not
require, the patient to notify their next-of-kin of the
prescription request
• Refer the patient for counseling if, in the opinion of
either the attending physician or the consulting
physician, the patient may be suffering from any
mental disorder, including depression, causing
impaired judgment;
• Request that the patient notify next of kin (the
patient does not have to comply); and
• Offer the patient the opportunity to rescind the
request at any time.
The Prescription
Oregon Board of Medical Examiners Rule:
(1) Dispense medications directly, including ancillary
medications intended to facilitate the desired
effect to minimize the patient's discomfort,
provided the attending physician is registered as a
dispensing physician with the Board of Medical
Examiners, has a Drug Enforcement Administration
(D.E.A.) certificate, and complies with the
provisions of ORS 677.089, OAR 847-015-0015 and
OAR 847-015-0025; or
The Prescription (Cont’d)
(2) With the patient's written consent:
(a) Contact a pharmacist, and inform the pharmacist
of the purpose of the prescription, and
(b) Deliver the written prescription personally or by
mail to the pharmacist who will dispense the
medications to either the patient, the attending
physician, or an expressly identified patient's agent.
Pharmacist Issues
• 10.1 Pharmacists, just as other health care
professionals, may choose to not participate,
and are under no obligation to participate. If
declining to participate when asked by a
physician, the pharmacist must inform the
physician that they are unwilling. The
pharmacist must provide the pharmacy
records upon request by the physician and
may assist the physician in finding a willing
pharmacist, but is under no obligation to do
so.
The Oregon Death with Dignity Act: A
Guidebook for Health Care Professionals
Pharmacist Issues
• 10.2 Pharmacists must be aware of and
respect their employer’s institutional
policies regarding the Act before
making any decision whether or not to
participate. 10.3 Pharmacists need to
assess their personal feelings and
convictions about physician-assisted
suicide in order to appropriately
respond to inquiries from physicians,
patients, and others.
The Oregon Death with Dignity Act: A
Guidebook for Health Care Professionals
Pharmacist Issues
• 10.5 If the pharmacist has any question
about the purpose or details of any
prescription, it is his/her duty to confer with
the prescriber and have those questions
answered.
• 10.6 The attending physician may obtain the
prescribed medication from the pharmacist
and present it to the patient personally. The
pharmacist can facilitate this by delivering
the medication directly to the physician’s
office.
The Oregon Death with Dignity Act: A
Guidebook for Health Care Professionals
Pharmacist Issues
• 10.7 The participating pharmacist should be
prepared to discuss important pharmaceutical
information and patient instructions with the
physician. The attending physician assumes
responsibility for advising on appropriate drug use
when providing the medication directly to the
patient.
• 10.8 Pharmacies should develop policies and
procedures to ensure confidentiality for patients,
physicians, and pharmacists in handling
prescriptions for the purpose of ending life as set
forth in the Act.
The Oregon Death with Dignity Act: A
Guidebook for Health Care Professionals
Pharmacist Issues
• 10.9 The dispensing health care professional
(pharmacist, physician, or health care facility)
must report to the Oregon Department of
Human Services upon dispensing a lethal
prescription pursuant to the Act. A
photocopy, submitted by mail or facsimile, of
the prescription label including the name of
the dispensing health care professional and
the phone number of the prescribing
physician would meet this requirement.
The Oregon Death with Dignity Act: A
Guidebook for Health Care Professionals
Prescriptions and Deaths 1998-2004
Collaborative Drug Therapy Management
• Refers to pharmacists writing
prescriptions or inpatient orders under
a protocol
– Written protocol reviewed and agreed to
by a prescriber
– Prescriber orders protocol to be applied to
an individual patient
– Common in hospitals and increasing in
community and LTC pharmacy practice
Collaborative Drug Therapy Management
• Widespread practice without specific rule prior
to 1996
• Currently described in OAR 855-041-0400
• Rule took about three years to draft and adopt
• Opposition from Oregon Medical Association
(MDs) and Pharmaceutical Research and
Manufacturers of America (PhRMA)
• PhRMA concern about “therapeutic
substitution”
• OMA concern about “turf”
Collaborative Drug Therapy Management
• Examples:
– Therapeutic interchange within specific drug
classes (H2 antagonists –
famotidine/ranitidine/ cimetidine/nizatidine)
– Drug dosing and monitoring (aminoglycosides,
anticoagulants, theophylline, TPN)
– Weight-based dosing (acetaminophen,
antibiotics, pediatrics)
– Community pharmacy (diabetes, cholesterol,
asthma management)
Collaborative Drug Therapy Management
OAR 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
OAR 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
OAR 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
OAR 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.
All rules start out as
somebody’s “bright idea”!
This rule actually took a
committee of 12 people,
including members of the
board of Pharmacy, OMA,
PhRMA, Board of Medical
Examiners, and pharmacists,
to draft.
FAMILY PHARMACY
4156 Main Street
Corvallis, OR 97332
(541) 737-9384
1
2
Patient Name___________________ Date____________
Address_______________________
Drug:
Quantity:
Directions:
Refill X_____
3
Signed:_____________, MD
DEA #:_________________
Elements of a Prescription
• 1 = Patient information
• 2 = Drug therapy instructions/protocol
• 3 = Prescriber’s authorization
(signature)
• 1 + 2 + 3 = complete prescription
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;
Authority to administer vaccines
and immunizations: ORS 689.645
• (1) In accordance with rules adopted by the State Board of
Pharmacy under ORS 689.205, a pharmacist may administer vaccines
and immunizations only to persons who are more than 18 years of age.
• (2) The board is authorized to issue, to licensed pharmacists who
have completed training accredited by the Centers for Disease
Control and Prevention, the American Council on Pharmaceutical
Education or a similar health authority or professional body,
certificates of special competency in the administration of vaccines
and immunizations to persons more than 18 years of age.
• (3) The board shall adopt rules relating to the reporting of the
administration of vaccines and immunizations to a patient’s primary
health care provider and to the Department of Human Services.
Authority to administer vaccines
and immunizations: ORS 689.645
• (4) The board shall adopt rules requiring pharmacists to establish
protocols for the administration of vaccines and immunizations to
persons more than 18 years of age.
• (5) The board shall convene a volunteer Immunization Advisory
Committee consisting of no more than nine members for the purpose
of advising the board in promulgating rules under this section. The
committee shall consist of one representative from the Department
of Human Services, two representatives from the Board of Medical
Examiners, two representatives from the Oregon State Board of
Nursing and two representatives from the State Board of Pharmacy
and no more than two pharmacists other than the representatives
from the State Board of Pharmacy.
Authority to flush intravenous lines and to
administer drugs and medical devices
ORS 689.655
• (1) Only as provided in this section and in accordance with rules
adopted by the State Board of Pharmacy under ORS 689.205, a
pharmacist may:
• (a) In collaboration with and under an order from a physician, nurse
practitioner or physician assistant practicing within the scope of
practice allowed by law, flush heparin or saline through existing
intravenous lines that are connected to a person;
• (b) In collaboration with and under an order from a physician, nurse
practitioner or physician assistant practicing within the scope of
practice allowed by law, attach an infusion pump or enteric feeding
pump to existing intravenous lines or enteric feeding lines that are
connected to a person, and activate the pump;
Authority to flush intravenous lines and to
administer drugs and medical devices
ORS 689.655
• (c) Administer drugs and devices in a medical emergency within
a health care facility in the presence of and under the direction
of a physician or nurse practitioner; and
• (d) Administer a drug or device to a person in the course of
teaching the person to self-administer the drug or device that the
person will be required routinely to self-administer as part of a
course of therapy ordered by a physician, nurse practitioner or
physician assistant practicing within the scope of practice allowed
by law.
• (2) Nothing in this section shall be construed to allow a
pharmacist to establish an intravenous or enteric line or to
attach or activate a pump for any intrathecal medication.
Administration of Vaccines By Pharmacists
OAR 855-041-0500
• (1) A pharmacist may administer
vaccines to persons who are over the
age of eighteen as provided by these
rules. For the purposes of this rule, a
person is over the age of eighteen the
day following their eighteenth birthday.
Administration of Vaccines By Pharmacists
(2) A pharmacist may administer vaccines to a person who is over the
age of eighteen only if:
(a) 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;
(b) The pharmacist holds a current basic Cardiopulmonary
Resuscitation (CPR) certification issued by the American Heart
Association or the American Red Cross;
(c) The vaccines are administered in accordance with an
administration protocol approved by the Oregon Health Division; and
(d) the pharmacist has a current copy of the CDC reference,
"Epidemiology and Prevention of Vaccine-Preventable Diseases".
Administration of Vaccines By Pharmacists
• Protocols, Policies and Procedures OAR 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
Administration of Vaccines By Pharmacists
• Record Keeping and Reporting OAR 855-041-0520
• (1) A pharmacist who administers any vaccine shall maintain the
following information in the pharmacy records regarding each
administration for a minimum of three years:
– (a) the name, address, and date of birth of the patient;
– (b) the date of the administration and site of injection of the vaccine;
– (c) the name, dose, manufacturer, lot number, and expiration date of the
vaccine or immunization;
– (d) the name and address of the patient’s primary health care provider, as
identified by the patient;
– (e) the name or identifiable initials of the administering pharmacist;
– (f) the date the pharmacist reported the vaccination information to the
patient's primary health care provider, as identified by the patient, and,
when required, to the Health Division if different from the date of
administration;
– (g) documentation of provision of informed consent for administration of
vaccines and for transmission of records to a primary care provider, the
Oregon Health Division and the Board of Pharmacy;
– (h) which Vaccine Information Statement (VIS) was provided;
– (i) the date of publication of the VIS; and
– (j) the date the VIS was provided.
Administration of Vaccines By Pharmacists
• (2) A pharmacist who administers any vaccine must
report in writing to the patient's primary health
care provider, as identified by the patient, the
information required to be maintained by OAR
855-041-0520(1). The report shall be made within
fourteen days of the date of administration. The
pharmacist must also report to the Oregon Health
Division as required for vaccines specifically
identified by the Division.
• (3) A pharmacist who administers vaccines must
report to the Board of Pharmacy, on a form
provided by the Board:
– (a) the vaccine administered,
– (b) the age of the patient, and
– (c) the zip code of residence of the patient.
REMOTE DISPENSING
OAR 855-041-0600
• Definitions
• (1) “Automated Pharmacy System” (APS) means a
mechanical system that performs operations or
activities, including but not limited to, those related
to the storage, packaging, dispensing, or distribution
of medications, but not including compounding or
administration, and that collects, controls, and
maintains all transaction information.
• (2) “Remote Dispensing Machine” (RDM) means a
component of an Automated Pharmacy System that
contains prepackaged drugs for dispensing.
• (3) “Responsible Pharmacy” means the licensed
pharmacy that is responsible for the APS and RDM.
REMOTE DISPENSING
855-041-0610
• Duties and Responsibilities of the
Pharmacist-in-Charge.
• Each RDM must be under the
supervision of the Pharmacist-in-Charge
of the Responsible Pharmacy. The
Pharmacist-in-Charge must:
– (a) Ensure safety, accuracy, security, and
patient confidentiality;
– (b) Define access to the RDM and to
medications contained within …