Rules Hearing - 2006

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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

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LICENSING OF PHARMACISTSOAR 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).

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General Reciprocity Requirements855-019-0015

• 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

4
Reinstatement of Licenses855-019-0040

• 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.

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Petition for Reinstatement of RPh
License855-019-0050

• A pharmacist license which has been revoked,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.

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Continuing Pharmacy Education Required
forPharmacist 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.

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Continuing Pharmacy Education Required
forPharmacist 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.

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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.

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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.

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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.

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Internship Reports855-031-0040

• 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.

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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.

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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

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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

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Who May Initiate a WrittenRequest 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

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Patient Eligibility

• be an adult (? 18 years)
• be capable (able to make and communicate health
  care decisions)
• be an Oregon resident (gt 6 months)
• have a terminal illness with less than six months
  to live
• voluntarily request a prescription for lethal
  drugs

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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

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Requirements (Contd)

• 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.

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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

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The Prescription (Contd)

• (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.

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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
22
Pharmacist Issues

• 10.2 Pharmacists must be aware of and respect
  their employers 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
23
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 physicians office.

The Oregon Death with Dignity Act A Guidebook
for Health Care Professionals
24
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
25
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
26
Prescriptions and Deaths 1998-2004
27
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

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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

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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)

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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

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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).

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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.

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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.

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All rules start out as somebodys 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.
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FAMILY PHARMACY 4156 Main Street Corvallis, OR
97332 [phone] Patient Name________________
___ Date____________ Address______________________
_ Drug Quantity Directions Refill
X_____ Signed_____________, MD DEA
_________________
1
2
3
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Elements of a Prescription

• 1 Patient information
• 2 Drug therapy instructions/protocol
• 3 Prescribers authorization (signature)
• 1 2 3 complete prescription

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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

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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 patients primary health care
  provider and to the Department of Human Services.

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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.

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Authority to flush intravenous lines and to
administer drugs and medical devicesORS 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

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Authority to flush intravenous lines and to
administer drugs and medical devicesORS 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.

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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.

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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".

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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

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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 patients 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.

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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.

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REMOTE DISPENSINGOAR 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.

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REMOTE DISPENSING855-041-0610

• 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