Current through September 18, 2024
1.4.1
Licensure Requirements
A. No
person, unless a licensed pharmacist shall retail, compound or dispense drugs,
medicine or poisons, except as provided pursuant to statutory provisions of
R.I. Gen. Laws §
5-19.1-8.
B. The Director has determined that, in the
interest of public health, a waiver of the requirements of §1.4.1 of this
Part is necessary under limited circumstances. Specifically, the waiver shall
only be applicable when such medication will be dispensed by a licensed
healthcare professional at the Block Island Health Center or, in the event that
the Block Island Health Center ceases to exist, to another pharmacy licensed in
the Town of New Shoreham, Rhode Island, and it is necessary to dispense
medication before the medication can be delivered to the island. The waiver
shall be subject to the following provisions:
1. Medication to be dispensed shall be
limited to legend drugs included in a written policy established by the Block
Island Health Center. A full instruction on the use of the product in plain
language shall be provided to the patient.
2. The Block Island Health Center shall keep
a written log of all medications dispensed pursuant to the waiver authorized by
this Part. The dispensing log shall contain, as a minimum, the following
information:
a. The name of the
prescriber;
b. The full name of the
patient;
c. The name of the drug
dispensed in accordance with R.I. Gen. Laws Chapter 21-31;
d. Quantity and strength of the drug
dispensed; and
e. The date of
dispensing.
3. Copies of
the dispensing logs shall be maintained for twenty-four (24) months from the
date the legend drug was dispensed and shall be made available to the
Department upon request.
4. Each
medication dispensed pursuant to the waiver authorized by this Part shall have
a label attached which meets the requirements of §1.5.17(A) of this
Part.
5. When required, the
healthcare provider who dispenses medication pursuant to the waiver authorized
by §1.4.1 of this Part shall be responsible for ensuring that all
necessary data is entered into the Department's Prescription Monitoring Program
(PMP) database in accordance with the Rules and Regulations for the
Prescription Drug Monitoring Program (Part 20-20-3 of this Title).
6. Any waiver utilized pursuant to this Part
shall not relieve the licensed healthcare provider of record-keeping or other
requirements of this Part.
1.4.2
Authorized Practices
A. In accordance with R.I. Gen. Laws §
5-19.1-22, nothing in the Act or
this Part shall apply to any practitioner with authority to prescribe who does
not maintain an open shop for the retailing, dispensing of medicines and
poisons, nor prevent him or her from administering or supplying to his patients
such articles as he/she may deem fit and proper.
B. Nothing in the Act or this Part shall
apply to, nor in any manner interfere with the business of, a general merchant
in selling and distributing non-narcotic, nonprescription medicines or drugs
which are prepackaged, fully prepared by the manufacturer for use by the
consumer, and labeled in accordance with the requirements of the State (R.I.
Gen. Laws Chapter 21-31) and Federal Food and Drug Acts.
1.4.3
Qualifications for Licensure:
Pharmacists
A. In addition to the
provisions of R.I. Gen. Laws §
5-19.1-14, every person in order to
be a licensed pharmacist shall:
1. If the
applicant is a foreign pharmacy graduate, have obtained full certification from
the FPGEC.
2. Have satisfactorily
completed the internship in accordance with §1.4.14 of this Part;
and
3. Have successfully passed
such examination as the Board and the Director may require in accordance with
§1.4.5(A) of this Part.
4. Not
have been convicted of any felony for violations involving controlled
substances subject to waiver by the Board upon presentation of satisfactory
evidence that such conviction does not impair the ability of the person to
conduct with safety to the public the practice of pharmacy.
5. Obtain and report an eProfile number from
NABP.
6. Meet such additional
requirements as may be established in this Part.
1.4.4
Application for Licensure and
Fee
A. Application for licensure shall
be made on forms provided by the Department, and which may be obtained at:
The Rhode Island Department of Health
Three Capitol Hill, Room 103
Providence, Rhode Island 02908
1. Said forms shall be completed and signed
by the applicant, and submitted to the Department no sooner than thirty (30)
days prior to the scheduled date of graduation. Such application shall be
accompanied by the following documents and fee (non-returnable):
a. A true copy of certificate of
birth;
b. One (1) unmounted recent
photograph, head and shoulders, front view, approximately two inches by three
inches (2" x 3") in size, of the applicant. Such photograph must be certified
by a member of the faculty of the college of pharmacy at which the applicant
matriculated;
c. Proof of
graduation from an accredited College of Pharmacy;
d. The application fee as set forth in the
Fee Structure for Licensing, Laboratory and Administrative Services Provided by
the Department of Health (Part 10-05-2 of this Title).
B. Application and supporting
documents shall be verified and reviewed by the Department. Eligibility for
examinations shall not be granted until after the applicant's date of
graduation.
C. No applicant shall
be approved or accepted for examination until he/she has met all requirements
of internship as set forth in §1.4.14 of this Part. Affidavit of
internship hours shall be submitted to the Department prior to application for
licensure.
D. Applications shall be
completed (including the submission of all supporting documents) within six (6)
months of the date of initial submission. Any application that is not completed
within this six (6) month time frame shall be deemed to be invalid, shall be
denied, and the applicant shall be required to submit a new application. No
fees shall be refunded.
1.4.5
Examination for Licensure
A. By Examination: Applicants shall be
required to pass a written examination, conducted in English, as the Board
deems most practical and expeditious to test the applicant's knowledge and
skills to engage in the practice of pharmacy in the State of Rhode Island,
pursuant to R.I. Gen. Laws §
5-19.1-14.
1. For written examination the Board requires
applicants to successfully pass the following examinations:
a. The North American Pharmacists Licensure
Examination (NAPLEX) or its successor examination of the National Association
of Boards of Pharmacy (NABP) which may be:
(1)
Administered in the State of Rhode Island with the passing grade as determined
by NABP and approved by the Board; or
(2) Administered in another State by the
licensing authority of the respective State, and provided the requirements of
§1.4.5(B) of this Part on transfer of grades are met; and
b. The Multistate Pharmacy
Jurisprudence Examination (MPJE) with a passing grade as determined by
NABP.
B.
Transfer of Grades
1. Applicants wishing to
participate in the National Association of Boards of Pharmacy Transfer of
Scores Program must comply with all the requirements of the National
Association of Boards of Pharmacy regarding the transfer of scores including
but not limited to the submission to the National Association of Boards of
Pharmacy the completed and signed NAPLEX SCORE TRANSFER FORM with accompanying
fee (non-refundable).
2. For
individuals seeking licensure in Rhode Island, the Board of Pharmacy will only
accept scores submitted directly by the National Association of Boards of
Pharmacy. Furthermore, each individual seeking licensure in the State of Rhode
Island must submit an application for licensure to the Department in accordance
with §1.4.12 of this Part and must meet all other statutory and regulatory
requirements in this Part.
3.
Applicants participating in the Transfer of Scores Program shall complete the
Multistate Jurisprudence Examination, as described in §1.4.5(A) of this
Part, within six (6) months of application to the Rhode Island Board of
Pharmacy.
1.4.6
Re-Examination
A. In case of
failure of any applicant to satisfactorily pass the NAPLEX Examination, and/or
the Multistate Pharmacy Jurisprudence Examination (MPJE), such applicant shall
be entitled to re-examination(s) in accordance with NABP guidelines.
B. Application for re-examination shall be
submitted to the Department and accompanied by the required fees in accordance
with §1.4.4 of this Part.
1.4.7
Without Examination by
Reciprocity
A. The Department shall,
without examination other than those required in §1.4.5 of this Part
relating to the practice of pharmacy, license as a pharmacist any individual
who has been duly licensed by examination as a pharmacist under the laws of
another State, Territory or Possession of the United States, if, in the opinion
of the Board, the applicant meets the qualifications required of professional
pharmacists in the State of Rhode Island.
1.
The Board of Pharmacy in each State in which the applicant holds or has held a
registration or license submits to the Board in the State of Rhode Island a
statement confirming the applicant to be or have been in good
standing.
2. The applicant shall
have passed the Multistate Pharmacy Jurisprudence Examination and the
examination of the National Association of Boards of Pharmacy in accordance
with the provisions of §1.4.5 of this Part.
3. The applicant shall submit to the
Department the Official Transfer of Pharmaceutic Licensure Application of the
NABP, a copy of his/her birth certificate, and the application fee as set forth
in the Fee Structure for Licensing, Laboratory and Administrative Services
Provided by the Department of Health (Part 10-05-2 of this Title).
1.4.8
Temporary
Ninety (90) Day License
A. In
accordance with R.I. Gen. Laws §
5-19.1-8 persons who provide
acceptable evidence of being currently licensed by examination or endorsement
under the laws of other States of the United States and the District of
Columbia, shall not be prevented from practicing in the State of Rhode Island
for a period of ninety (90) days from the date on the application receipt,
provided that they become duly licensed in the State of Rhode Island within
ninety (90) days. This original privilege to work ninety (90) days shall not be
extended or renewed and shall only be granted to an applicant on a one (1) time
basis.
B. The licensing agency in
each State in which the applicant holds or has held a registration or license
shall submit to the Board a statement confirming the applicant to be or have
been in good standing in that state.
1.4.9
Internship: Pharmacy
Interns
A. General Requirements
1. Any person who is a graduate of an
accredited program of pharmacy or who is a student enrolled in an accredited
program of pharmacy, or any graduate of a foreign College of Pharmacy who has
obtained FPGEC certification, may file with the Department an application for
licensure as a pharmacy intern. He/she shall be required to furnish such
information as the Department may prescribe and, simultaneously with the filing
of said application, shall pay to the Department a fee as set forth in the Fee
Structure for Licensing, Laboratory and Administrative Services Provided by the
Department of Health (Part 10-05-2 of this Title).
2. All licenses issued to pharmacy interns
shall be valid for a period of one (1) year, but in no instance shall the
license be valid if the individual is no longer making timely progress toward
graduation.
3. No pharmacy student
may serve an internship with a preceptor without holding a valid limited
license from the Board.
4. To
assure adequate practical instruction, pharmacy internship experience as
required under the Act and this Part shall be obtained after licensure as a
pharmacy intern by practice in any licensed pharmacy or other program meeting
the requirements promulgated in this Part, and shall include such instruction
in the practice of pharmacy as the Board shall prescribe.
5. Licensed pharmacy interns shall practice
only under the immediate supervision of a licensed pharmacist.
1.4.10
Limited
License
A. No pharmacy student enrolled
in a professional program of an accredited college of pharmacy may serve an
internship in the State of Rhode Island with a preceptor without holding a
valid limited license by the Board of Pharmacy pursuant to the provisions of
R.I. Gen. Laws §
5-19.1-15.
B. Prior to commencing internship, the
applicant must obtain a limited license from the Department. A limited license
shall be granted to an applicant who:
1. Is
eighteen (18) years of age or older;
2. Has satisfied the board that he/she is of
good moral and professional character;
3. Is enrolled in a professional program of
an accredited College of Pharmacy.
1.4.11
Foreign Graduates
Foreign graduates shall have obtained full FPGEC
certification prior to commencing internship.
1.4.12
Application and Fee
A. Application for limited licensure shall be
made on forms provided by the Department and which may be obtained at:
The Rhode Island Department of Health
Three Capitol Hill, Room 103
Providence, Rhode Island 02908
1. Said forms shall be completed and signed
by the applicant and submitted to the Department prior to accruing any hours.
Such application shall be accompanied by the following documents and fee
(non-returnable and non-refundable):
a. A copy
of certificate of birth to verify that the applicant is eighteen (18) years of
age or older;
b. Documented
evidence that the student is enrolled in a professional program of an
accredited college of pharmacy, and signed by the Dean of the College of
Pharmacy or his appointed designee;
c. The application fee as set forth in the
Fee Structure for Licensing, Laboratory and Administrative Services Provided by
the Department of Health (Part 10-05-2 of this Title).
2. Foreign Interns: The license application
requirement of a documented Social Security Number (SSN) may only be waived for
the initial license year. Subsequent license renewal shall require a documented
SSN. A foreign pharmacy intern may practice under a limited license without a
registered SSN at the discretion of the preceptor.
1.4.13
Issuance of Limited
License
A. The application and
credentials of the applicant shall be reviewed and verified by the Department.
Applicants found to meet the requirements herein shall be issued a limited
license. Said license unless sooner suspended or discontinued for due cause in
accordance with §1.4.2 of this Part, shall expire annually on the first
(1st) day of July. Said license may be renewed
annually, subject to the applicant meeting the requirements herein, and upon
submission of the annual license fee as set forth in the Fee Structure for
Licensing, Laboratory and Administrative Services Provided by the Department of
Health (Part 10-05-2 of this Title).
B. A limited license is not
transferable.
C. Every graduate of
an approved School of Pharmacy functioning as a pharmacy intern who has filed
with the Board a completed application, with supporting documents of
credentials, for licensure as a pharmacist, may upon receiving a receipt from
the Board for said application and documents, function as a pharmacy intern,
until such time as a license is received from the Department, and for no more
than one (1) year from the date of graduation from an ACPE-accredited College
of Pharmacy, and in each case he/she shall be supervised by a registered
pharmacist licensed in the State of Rhode Island.
1.4.14
Internship
A. The internship required of applicants for
licensure as pharmacists shall consist of one thousand five hundred (1,500)
hours, and shall be carried out under the supervision of a U.S. registered or
licensed pharmacist who shall act as a preceptor.
B. Applicants seeking licensure as a
pharmacist by reciprocity (§1.4.6 of this Part) shall have satisfied the
requirements of internship in the State of initial licensure.
C. Prior to application for examination, the
pharmacy intern shall submit, on forms provided by the Department, verification
of his/her practical experience under the supervision of a licensed pharmacist.
Any hours accrued prior to the issuance of the limited license shall not be
accepted as part of the internship requirement.
1.4.15
Duties and Responsibilities of
Pharmacy Interns
A. Pharmacy interns
may perform only those tasks in which they have proficiency, in the
professional judgment of the pharmacist-in-charge, but in no case shall ever
exceed what is permitted by Regulation or law.
B. A pharmacy intern may not perform a final
review or exercise final decision-making with respect to any of the following
without the prior review and approval of the licensed pharmacist: drug
utilization review; clinical conflict resolution, or dispensing process
validation.
C. A pharmacy intern
shall wear a name tag that indicates the intern's name and the intern's
licensure designation.
1.4.16
Issuance and Renewal of the
Pharmacist License
A. Upon completion
of the aforementioned requirements, a license shall be issued by the Department
to an applicant found to have satisfactorily met all the requirements herein.
Said license shall expire on the thirtieth (30th) of
June each year unless sooner suspended or discontinued.
B. Every person licensed as a pharmacist in
the State of Rhode Island who desires to renew his/her license shall file such
renewal application with the Department by the thirtieth
(30th) day of June each year. Said renewal shall be
duly executed together with the renewal fee as set forth in the Fee Structure
for Licensing, Laboratory and Administrative Services Provided by the
Department of Health (Part 10-05-2 of this Title).
1. Upon receipt of such application and
payment of such fee, the accuracy of the application shall be verified and a
license renewal shall be granted effective for up to two (2) years unless
sooner suspended or discontinued.
C. Every person licensed as a pharmacist in
this State who desires to renew his/her license must obtain an eProfile number
from the national association of boards of pharmacy.
D. Any person who allows his/her license to
lapse by failing to renew it on or before the thirtieth
(30th) day of June of each year may be reinstated
upon filing an application with payment of the renewal fee as set forth in the
Fee Structure for Licensing, Laboratory and Administrative Services Provided by
the Department of Health (Part 10-05-2 of this Title).
1. Any pharmacist license that has lapsed,
been revoked or suspended and the pharmacist has not practiced pharmacy, as
defined by the Board, for three (3) years requires that he/she take and pass
the same examinations required for initial licensure.
1.4.17
Continuing
Education
A. Pursuant to the provisions
of R.I. Gen. Laws §
5-19.1-14, any pharmacist, licensed
to practice pharmacy in Rhode Island, who seeks licensure renewal, shall be
required to have satisfactorily completed at least fifteen (15) hours (one and
a half (1.5) continuing education units) of continuing education courses
sponsored by a recognized provider between January
1st and December 31st of
each calendar year. One (1) hour or one tenth (0.1) continuing education units
of the required fifteen (15) hours of continuing education between January
1st and December 31st of
each calendar year shall be in the area of the law as classified by ACPE.
Furthermore, five (5) hours or one half (0.5) continuing education units
between January 1st and December
31st of each calendar year must be live hours. In
addition:
1. Immunizing pharmacists shall
complete one (1) hour or one tenth (0.1) continuing education units of the
required fifteen (15) hours of continuing education.
2. Any pharmacist participating in a
collaborative pharmacy practice agreement shall earn at least five (5)
additional contact hours or one half (0.5) continuing education units of
board-approved continuing education that addresses areas of practice generally
related to collaborative practice agreements each year and shall maintain
documentation of these hours at the practice site to be made available for
inspection by the Boards of Medical Licensure and Discipline and
Pharmacy.
3. Any pharmacist who has
not participated in a collaborative pharmacy practice arrangement for a period
of two (2) years and seeks to enter into such an arrangement, must have
obtained and/or maintained the certification set forth in this Part, as
applicable, or have earned fifteen (15) hours of relevant continuing education
within the prior year in the area of practice covered by the
agreement.
4. A pharmacist shall
not be subject to the continuing education requirements of this Part in the
year that he/she graduated, with the exception of the continuing education
requirement contained in §1.11.1(B)(7) of this Part; and
5. In emergency or hardship cases, a licensed
pharmacist may apply to the Board on forms provided by the Department for an
exemption from the continuing education requirements of this Part.
6. The annual application for license renewal
shall include affidavits signed by the applicant attesting to the fact that
he/she has satisfactorily completed an approved course(s) of continuing
education provided by a recognized provider, as defined in this Part.
Furthermore:
a. Certificates of continuing
education courses must be retained and safeguarded by each pharmacist for
review by the Department, if required and requested. Such certificate need not
be submitted with the application for licensure renewal; however, documentation
must be retained for two (2) years following the date of completion of the
course.
b. Any pharmacist whose
license has not been renewed for one (1) or more years must demonstrate
compliance with continuing education Regulations for the licensure period
immediately prior to application.
c. Pharmacists failing to comply with the
requirements of §1.4.17(A)(6) of this Part.
1.4.18
Recognized
Provider
A "recognized provider" is any person, group or
organization approved by the Board as responsible and competent to provide
continuing education courses and includes providers accredited by an
appropriate national, regional or state accreditation agency. Any provider
approved the Accreditation Council for Pharmaceutical Education (ACPE), the
Board of Pharmacy in another State or jurisdiction, or the provider of American
Medical Association (AMA) Category I programs shall be considered recognized
providers.
1.4.19
Continuing Education Credit for Postgraduate Pharmacy
Curriculum/Program
A. A licensed
pharmacist who is enrolled in a postgraduate Doctor of Pharmacy program shall
be awarded CEUs for satisfactory completion of courses within said curriculum
or program, provided that the sponsor of the postgraduate curriculum or program
is an accredited College of Pharmacy. A licensed pharmacist enrolled in other
postgraduate pharmacy programs may seek continuing education credit provided
that the application satisfies all requirements under this section and provided
further that the course provides instruction in one (1) or more of the
following areas: pharmacy, pharmaceutical sciences, pharmacy practice or
pharmacy law.
B. Students seeking
continuing education credit for postgraduate pharmacy education must maintain
official course transcripts for two (2) years after completion of the course
work.
1.4.20
Return
or Exchange of Drugs
A. Drugs,
medicines, sick room supplies, and items for personal hygiene, shall not be
accepted for return or exchange by any pharmacist, after such drugs, medicines,
sick room supplies, or items for personal hygiene have been taken from the
premises where sold, distributed, or dispensed, except under the following
conditions:
1. Recalls or Errors.
Prescription drugs may be returned in the event the drug is subject to a
manufacturer's recall or FDA recall, or if the drug is associated with a
medication error.
2. Prescription
Drugs. Unused prescription drugs may be accepted by wholesalers or pharmacies,
from which they were purchased, for return from nursing facilities, assisted
living residences, residential care facilities, community health organizations
and State correctional facilities that centrally store prescription drugs and
are licensed at the M1 licensure level by the Department, within forty-five
(45) days of dispensing.
a. The wholesaler or
pharmacy to which the following categories of prescription drugs are returned
may repackage, restock, and redistribute such medication:
(1) Unopened sections of blister pack
prescription medication, with seal intact;
(2) Unopened unit-dose containers of liquids
with the safety seal intact;
(3)
Unopened unit-dose containers of powders for oral solution with safety seal
intact; and
(4) Unused injectables,
with safety seal intact.
b. Exceptions. Notwithstanding the provisions
of §1.4.20(B)(1) of this Part, the unused prescription drug shall not be
accepted, repackaged or redispensed if:
(1)
The prescription drug is expired or beyond use date;
(2) The pharmacist accepting or redispensing
the drug, in his/her judgment has reason to believe that the prescription drug
is adulterated, mislabeled, or has been improperly stored;
(3) The prescription drug is defined as
controlled substances in R.I. Gen. Laws §
21-28-1.02; or
(4) It is a drug that can only be dispensed
to a patient registered with the drug's manufacturer in accordance with Federal
Food and Drug Administration requirements.
3. Recording: The wholesaler or pharmacy
shall maintain a record of the receipt of each drug, medicine, or device
showing the prescription number for which the material was acquired, and
quantity. Such records shall be kept on file in the pharmacy for a period of
two (2) years and shall be made available to the Department upon
request.
4. The wholesaler or
pharmacy shall be required to reimburse or credit the purchaser for any such
returned prescription drugs at original invoice price plus a restocking fee not
to exceed five dollars ($5.00).
5.
Sick Room Supplies/Equipment: A pharmacist may accept for return sick room
supplies/equipment provided such can be sanitized. If the surfaces of the sick
room supplies or equipment cannot be cleansed or sterilized, the articles are
not returnable. However, sick room supplies are not to be construed to mean nor
include hospital beds, wheel chairs, crutches and such other major equipment
used in the care and treatment of the sick and injured.
1.4.21
Multi-Drug
Single-Dosing Systems
A. General
Requirements
1. Requirements related to the
utilization of multi-drug single-dosing containers include the following:
a. The number of drugs placed in one package
cannot exceed the capacity of the container in order to prevent damage to the
individual dosage forms;
b. The
multi-drug single-dosing container may include controlled medications from
Schedule IV and V if such medications are prescribed for the patient on a
routine, customary basis;
c. The
labels must be of sufficient size to properly and clearly label each container
with all information required by State and Federal law and Rules
d. The integrity of each individual
multi-drug single-dosing container shall be maintained until the last drug dose
is administered to or taken by the patient.
2. A multi-drug single-dosing container shall
be designed to prevent the container from being re-closed, designed to show
evidence of having been opened, and designed in such a manner that the label
cannot be altered.
3. Once a
multi-drug single-dosing container has been properly labeled and dispensed to a
patient, and said container is returned to the pharmacy for any reason, the
drugs packaged in such container shall be considered adulterated and shall not
be returned to the pharmacy stock. Provided, however, drugs in multi-drug
single-dosing containers may be redispensed to the same patient to whom the
drugs were originally dispensed.
4.
Whenever a drug(s) in a multi-drug single-dosing container has/have been
discontinued, the remaining container(s) may be returned to the dispensing
pharmacy for the removal of the discontinued drug(s) for destruction. Under no
circumstances shall any of the remaining or discontinued drug(s) be returned to
the drug stock of the pharmacy or dispensed to any patient other than the
patient to whom the drugs were originally dispensed.
5. Nothing contained in this Part is meant to
prevent a nurse or a patient-specified caregiver from removing a discontinued
drug(s) from a container at the time of administration in order to be wasted as
directed by a pharmacist or from retaining up to a seventy-two (72) hour supply
of the continued drug(s) in the original container in order to maintain a
patient on his/her continuing drug administration schedule.
B. Labeling Requirements
1. Each individual, customized, multi-drug
single-dosing container shall bear a label, which, at a minimum, contains the
following:
a. The name of the
patient;
b. The name of the
prescribing practitioner of each drug;
c. The identifying serial number assigned to
the prescription drug order for each drug contained therein;
d. The name, strength, exact physical
description, and total quantity of each drug contained therein;
e. The directions for use, and/or time of
administration or time to be taken for each individual multi-drug single-dosing
container;
f. Either the dispensing
or preparation date, as well as a beyond-use (expiration) date for each drug
contained in the multi-drug singledosing container. The expiration date of each
drug included therein shall not be longer than one (1) year from the date of
preparation of the multi-drug single-dosing container. All drugs shall be
packaged in accordance with USP standards.
2. The name, address, and telephone number of
the pharmacy issuing the multi-drug single dosing container and any cautionary
statements necessary for the proper administration or storage of the medication
shall appear on the individualized patient container.
C. Exclusions. Multi-drug single-dosing
containers shall not include drug(s) that have the following characteristics:
1. USP-DI monograph or official labeling
requires dispensing in the original container;
2. Are incompatible with packaging components
or with each other;
3. Require
special packaging;
4. Are
controlled medications from Schedules II and III.
D. Requirements for Nursing Facilities and
Assisted Living Residences
1. Requirements
related to the utilization of multi-drug single-dosing containers in a nursing
facility or assisted living residence include the following:
a. The name, address, and telephone number of
the pharmacy issuing the multi-drug single dosing container and any cautionary
statements necessary for the proper administration or storage of the medication
shall appear on the medication administration record (MAR).
2. In a nursing facility or
assisted living residence licensed at the M-1 level, only a nurse, other
licensed person acting within his/her scope of practice, or selected
non-licensed personnel who have satisfactorily completed a State-Approved
Course in Drug Administration and have demonstrated competency in accordance
with the State-approved protocol in drug administration shall remove a
discontinued drug(s) from a container in order to be wasted in accordance with
policies and procedures of the facility.
E. Prescriptions. A prescription shall
contain the following information, at a minimum:
1. Full name and street address of the
patient;
2. Name, address, and if
required by law or Rules of the Board, DEA registration number of the
prescribing practitioner;
3. Date
of issuance;
4. Name, strength,
dosage form and quantity of drug prescribed;
5. Directions for use;
6. Refills authorized, if any;
7. If a written prescription, prescribing
practitioner's signature;
8. If an
electronically transmitted prescription, prescribing practitioner's electronic
or digital signature;
9. If a hard
copy prescription is generated from a facsimile or a prescribing practitioner's
electronic or manual signature, such prescription shall be applied to paper
that utilizes features that will ensure the prescription is not subject to any
form of copying and/or alteration;
10. Oral prescriptions shall be reduced
promptly to writing and stored either electronically or in hard copy
format.
1.4.22
Prescription Refill Information
A. No pharmacist shall fill or refill any
prescription after one (1) year from the date of issuance by the practitioner
without authorization from the practitioner.
B. Authorization for prescription refills is
presumed to be within the prescribed dosage or normal therapeutic use. Refiling
prescriptions more frequently than the prescribed dosage would require, or
refiling prescriptions in significant excess of normal therapeutic use, may
constitute unprofessional conduct based on drug utilization requirements in
§
1.16 of
this Part.
C. If deemed appropriate
in the pharmacist's professional judgement, a patient may receive, upon
request, drug quantities in excess of the face amount written on the
prescription for a non-controlled substance only, up to the total amount
authorized by refills. The pharmacist shall not dispense in excess of the face
amount of a prescription for controlled substance without authorization from
the prescriber for each prescription.
D. A pharmacist may refill a prescription for
a patient written by a practitioner who has expired or has had his/her license
to practice or controlled substance registration revoked, suspended, or
discontinued, for a period not to exceed ninety (90) days, if the prescription
was written by the practitioner prior to his/her death or action against
license and the prescription contains authorizations for refills.
E. Pharmacists shall only compound
prescriptions for a drug product(s) not included in the official compendium
(The U.S. Pharmacopoeia, N.F.) if the prescription clearly delineates in
writing all the ingredients to be included in the drug product. All such
prescriptions, drugs and ingredients must conform to the requirements of R.I.
Gen. Laws Chapters 21-31, 21-28, 5-19.1 and such other applicable statutory
requirements.
1.4.23
Electronic Transmission
A.
Technological devices for the transmission or communication of prescriptions
between licensed prescribers and pharmacists may be used in accordance with the
following requirements:
1. The transmission
of prescriptions for controlled substances shall comply with the provisions of
R.I. Gen. Laws Chapters 21-28 ("Controlled Substances Act"),
21 C.F.R. §
1306.08, R.I. Gen. Laws Chapter 5-37.3
("Confidentiality of Healthcare Information Act"), and all other Federal or
State laws.
2. Unless otherwise
prohibited by law, prescriptions may be transmitted by electronic means or
facsimile from the prescriber as defined in R.I. Gen. Laws Chapter 21-28 and
21 C.F.R. §
1306.08, for transmission of prescriptions to
the dispensing pharmacy. The facsimile copy of the prescription may serve as
the hard copy of the prescription except for prescription orders for Schedule
II drugs in accordance with the provisions of R.I. Gen. Laws Chapter
21-28.
3. In addition to all other
information required to be included on a prescription, an electronically
transmitted prescription and facsimile prescriptions shall include the date of
transmission.
4. A pharmacy
receiving an electronic transmission prescription shall either receive the
prescription in hard copy form or have the capacity to retrieve an electronic
copy of the prescription from the pharmacy's computer memory.
5. The patient shall have the right to choose
the manner in which his/her prescription is transmitted to the
pharmacy.
6. The patient shall have
the right to choose the pharmacy to which his/her prescription is
transferred.
7. The pharmacist
shall exercise professional judgment regarding the accuracy or authenticity of
the transmitted prescription consistent with existing laws and
Regulations.
8. Technological
devices shall not be used to circumvent documentation, verification, or any
provisions of the Act. Neither shall they be used to commit any other action
that may be deemed unprofessional conduct.
9. Technological devices shall be located
within the pharmacy.
1.4.24
Emergency Prescription
Refill
A. In the event a pharmacist
receives a request for a prescription refill and the pharmacist is unable to
readily obtain refill authorization from the prescriber, the pharmacist may
dispense a one (1) time emergency refill of up to a ninety (90) day supply of
the prescribed medication, providing that:
1.
The prescription is not for a drug in Schedule II, III, IV, and V appearing in
R.I. Gen. Laws Chapter 21-28;
2.
The medication is essential to the maintenance of life or to the continuation
of therapy of a chronic condition
3. In the pharmacist's professional judgment,
the interruption of therapy might reasonably produce undesirable health
consequences or may cause physical or mental discomfort; and
4. The dispensing pharmacist notifies the
prescriber of the emergency dispensing within a reasonable time after such
dispensing.
5. For an emergency
prescription refill, there shall be appropriate documentation in the patient
profile or on the hard copy of the prescription that an emergency refill has
been dispensed.