Chapter 480-18 OPIOID TREATMENT PROGRAM CLINIC PHARMACIES
For purposes of this chapter, the following definitions
apply:
| (a) |
Administer. The term
administer means to give one, single dose of a pharmacy prepared narcotic
controlled substance. |
| (b) |
Board.
Board means the Georgia State Board of Pharmacy. |
| (c) |
Compound. The term compound means to mix,
prepare, package or change the dosage form of a narcotic controlled substance
for use in or by an opioid treatment program. |
| (d) |
CSAT. CSAT means the Center for Substance
Abuse Treatment. |
| (e) |
DEA. DEA means
the United States Drug Enforcement Administration. |
| (f) |
DHR. DHR means the Georgia Department of
Human Resources. |
| (g) |
Dispense. The
term dispense refers to the actions of a pharmacist when he/she fills a
prescription drug order and prepares either a single dose or multiple doses in
patient-specific take-home containers with narcotic controlled substances for
an opioid treatment program. |
| (h) |
Director of Pharmacy Services. Director of Pharmacy Services shall be a
pharmacist, licensed with the Board, who shall direct, oversee, establish
protocols and be responsible for all pharmacy related transactions at an opioid
treatment program clinic pharmacy. |
| (i) |
Emergency kit. An emergency kit is a kit
containing drugs which may be required to meet the immediate therapeutic needs
of patients and which are not available from any other authorized source within
the clinic in sufficient time to prevent risk of harm to patients; |
| (j) |
GDNA. GDNA means the Georgia Drugs &
Narcotics Agency. |
| (k) |
Licensed
medical personnel. The term licensed medical personnel is used to describe
employees of an opioid treatment program clinic licensed by the State of
Georgia as health care professionals, i.e. physicians, pharmacists,
nurses. |
| (l) |
Medication dosing
station. The term medication dosing station is used to describe the location
where doses of medication are administered. |
| (m) |
Medication order. The term medication
order is used to describe the manner in which a physician orders, via written,
verbal or electronically transmitted means, the administration of a narcotic
controlled substance to the ultimate user. |
| (n) |
Methadone clinic. Methadone clinic is
defined the same as a narcotic treatment program clinic or an opioid treatment
program clinic. |
| (o) |
Methadone
treatment program. Methadone treatment program is defined the same as a
narcotic treatment program or an opioid treatment program. |
| (p) |
Narcotic maintenance. The term narcotic
maintenance means a treatment procedure in which individuals use an approved
narcotic controlled substance over a period of time to relieve withdrawal
symptoms and reduce narcotic craving in combination with rehabilitation
services. |
| (q) |
Narcotic treatment
program. Narcotic treatment program or NTP, also known as an opioid treatment
program, is defined as a program licensed or otherwise authorized, by the State
of Georgia Department of Human Resources (DHR), the Substance Abuse and Mental
Health Services Administration (SAMHSA) and the U.S. Drug Enforcement
Administration (DEA) to operate a narcotic substance abuse program using
narcotic replacement procedures for individuals dependant on opium, morphine,
heroin or any derivative or synthetic drug in that group. |
| (r) |
Narcotic treatment program clinic
pharmacy. Narcotic treatment program clinic pharmacy, is defined as a pharmacy
licensed by the Board which is designated as an on-site pharmacy department of
a narcotic treatment program. |
| (s) |
On-site pharmacy. On-site pharmacy (OSP) is a licensed opoid treatment program
clinic pharmacy. |
| (t) |
Opioid
replacement center. Opioid replacement center (ORC) is an opioid treatment
program. |
| (u) |
Opioid treatment
program. Opioid treatment program (OTP), is an opioid replacement program or a
narcotic treatment program licensed, or otherwise authorized by the State of
Georgia Department of Human Resources, the Substance Abuse and Mental Health
Services Administration, and the U.S. Drug Enforcement Administration. This
program operates as a narcotic substance abuse program using narcotic
replacement procedures for individuals dependant on opium, morphine, heroin or
any derivative or synthetic drug in that group. |
| (v) |
Opioid treatment program clinic pharmacy.
Opioid treatment program clinic pharmacy is a licensed pharmacy which is
designated as an on-site pharmacy department located in and operated by any
opioid treatment program or opiate replacement treatment program. |
| (w) |
Opioid treatment program clinic pharmacy
license. An opioid treatment program clinic pharmacy license is issued by the
Georgia State Board of Pharmacy to an opioid treatment program clinic
pharmacy. |
| (x) |
Outpatient.
Outpatient shall mean an opioid treatment program patient who is treated on an
outpatient basis. |
| (y) |
SAMHSA.
SAMHSA means the Substance Abuse and Mental Health Services
Administration. |
| (z) |
Take-home dose.
The term take-home dose means a quantity of a physician ordered narcotic
controlled substance dispensed by an opioid treatment program clinic pharmacy
which an individual can take away from the OTP clinic, as set forth in the
Georgia Department of Human Resources rules. |
| (1) |
All opioid treatment program (OTP)
clinics must have an on-site pharmacy. All such pharmacies shall obtain a
license by registering with the Georgia State Board of Pharmacy (Board). Such
license shall be renewed biennially with the Board. Before a Board license can
be issued, an opioid treatment program clinic must meet all the requirements
for licensure and registration as provided by both state and federal law and
all Board rules. |
| (2) |
Licensure and
Applications. Certificates of registration or
licensure shall be issued only to those opioid treatment program clinic
pharmacies who meet the following requirements:
| (a) |
Submission of an application with the
following information:
| 1. |
The name, full
business address, and telephone number of the licensee; |
| 2. |
All trade or business names used by the
licensee; |
| 3. |
Address, telephone
number, and the name of the Director of Pharmacy |
| 4. |
The type of ownership or operation (i.e.,
partnership, corporation, or sole proprietorship); and |
| 5. |
The name(s) of the owner and/or operator
of the licensee, including:
| (i) |
If a person,
the name of the person; |
| (ii) |
If a
partnership, the name of the partnership and the name of each
partner; |
| (iii) |
If a sole
proprietorship, the full name of the sole proprietorship and the name of the
business entity; or |
| (iv) |
If a
corporation, the corporate name, the name and title of each corporate officer
and director, the state of incorporation; and the name of the parent company,
if any. |
| (v) |
If operations are
conducted at more than one location by a single opioid treatment program clinic
pharmacy, each such location shall be licensed by the Board. |
|
|
|
| (3) |
Payment
of an application fee. Application fees shall not be refundable. |
| (4) |
Applicant must file a report from the
Director of the Georgia Drugs and Narcotics Agency (GDNA) certifying the
applicant possesses the necessary qualifications for a license. |
| (5) |
Licenses become null and void upon the
sale, transfer or change of mode of operation or location of the
pharmacy. |
| (6) |
Licenses are required
to be renewed June 30th of each odd numbered year and may be renewed upon the
payment of the required fee for each pharmacy and the filing of an application
for renewal. Said renewal is for a two year period. If the application for
renewal is not filed with the Board and the fee paid before September 1st, of
the odd numbered year, the license shall lapse and shall not be renewed. An
application for reinstatement shall be required. Reinstatement shall be at the
sole discretion of the Board. |
| (7) |
Changes in any licensee information pertaining to this rule shall be submitted
in writing to the Board prior to such change. |
| (8) |
The Board will consider the following
factors in determining eligibility for licensure of applicants in charge of the
facility who are applying for an opioid treatment program clinic pharmacy
license:
| (a) |
Convictions of the applicant
under any Federal, State, or local laws relating to wholesale or illegal
distribution of dangerous drugs or controlled substances; |
| (b) |
Any felony convictions of the applicant
under Federal, State, or local laws; |
| (c) |
The furnishing by the applicant of false
or fraudulent material in any application made in connection with drug
manufacturing or distribution; |
| (d) |
Suspension or revocation by Federal, State, or local government of any
pharmacist, pharmacy or other health care license currently or previously held
by the applicant; |
| (e) |
Compliance
with licensing requirements under previously granted licenses, if
any; |
| (f) |
Compliance with
requirements to maintain and/or make available to the State Licensing Authority
or to Federal, State, or local law enforcement officials, those records
required to be maintained by the opioid treatment program clinic pharmacies;
and |
| (g) |
Other factors or
qualifications the Board considers relevant to and consistent with the public
health, safety and welfare. |
|
| (9) |
The Board reserves the right to deny a
license to an applicant if it determines that the granting of such a license
would not be in the best interest of the public. |
| (10) |
The pharmacist's wall certificate issued
by the Georgia State Board of Pharmacy (Board), along with the current renewal
license of each full-time pharmacist, employed at the pharmacy, shall be
displayed in a conspicuous place, near the prescription department where such
pharmacist is actively engaged in the practice of pharmacy.
| (a) |
While employed in a pharmacy on a
full-time basis, if a pharmacist has not yet received his/her Board issued
pharmacist wall certificate, in its place such pharmacist shall post a copy of
his/her current Board issued pocket license card; |
| (b) |
Any pharmacist employed on a part-time
basis at a pharmacy shall post a copy of his/her current Board issued pocket
license instead of posting his/her pharmacist wall certificate; and |
| (c) |
Any pharmacist employed as a relief or
"prn" pharmacist need not post any type of Board issued license, but such
pharmacist must maintain and present upon request his/her current Board issued
pocket license. |
|
| (11) |
Any
letter(s) from the Board which have granted a licensee any exception(s) and/or
exemption(s) from this, or any other rule, must be posted and/or displayed next
to the current Board of Pharmacy permit; and |
| (12) |
No pharmacist or intern/extern shall
display his/ her license in any pharmacy where he or she is not employed or
engaged in the practice of pharmacy, and shall not knowingly permit any other
person to use his or her license for the purpose of misleading anyone to
believe that such person is the holder or recipient of said license or intern
certificate. |
The personnel shall be as follows:
| (a) |
Director of Pharmacy Services. Each OTP
clinic pharmacy shall be under the direction of a Director of Pharmacy
Services, hereafter referred to as the Director. The Director shall:
| 1. |
Direct, oversee and be responsible for all
activities related to pharmacy transactions at an opioid treatment program
clinic pharmacy; |
| 2. |
Be a pharmacist
licensed by the Board to practice; |
| 3. |
Be charged with meeting all of the
requirements of applicable state and federal laws and rules; |
| 4. |
Be employed on a full-time or part-time
basis consistent with the need and objectives of the OTP clinic. |
| 5. |
Shall have such other duties and
responsibilities as set forth in this chapter. |
|
| (b) |
Supportive Personnel. The Director of an
OTP clinic pharmacy shall be assisted by a sufficient number of licensed
pharmacists and other personnel as may be required to operate such pharmacy
competently, safely, and to meet the needs of the outpatients of the OTP clinic
pharmacy. |
| (c) |
Secretary and
clerical personnel shall be provided to assist with record keeping, report
submission, and other administrative duties, provided such personnel do not
perform any dispensing duties. |
| (d) |
Supervision. All of the activities and operations of each OTP clinic pharmacy
shall be personally and directly supervised by the Director or his/her
pharmacist designee.
| 1. |
All functions and
activities of supportive personnel shall be supervised by an adequate number of
registered pharmacists to insure that all such functions and activities are
performed competently, safely, and without risk of harm to patients; |
| 2. |
Personal supervision can only be
accomplished by the physical presence of a licensed pharmacist in the OTP
clinic pharmacy. |
| 3. |
The Director of
Pharmacy shall insure that all supportive personnel will be trained in the
matters of an opioid treatment program clinic pharmacy. |
| 4. |
The Director of Pharmacy shall develop and
implement written policies and procedures to specify the duties to be performed
by such supportive personnel. These policies and procedures shall, at a
minimum, specify that supportive personnel are personally and directly
supervised by a licensed pharmacist while on duty in the pharmacy, and that
supportive personnel are not assigned duties which may be performed only by
licensed pharmacists. |
|
The following regulations shall be followed in the absence of a
pharmacist:
| (1) |
General. Access to
drugs in the absence of a licensed pharmacist shall be limited to specifically
authorized licensed medical personnel consistent with policies and procedures
of the Director. Such areas shall be sufficiently secure to deny access by
unauthorized persons. The Director shall, in conjunction with the appropriate
committee of the narcotic treatment program clinic, develop a list of the drugs
to be accessible and shall ensure that:
| (a) |
Such drugs available therein, are properly labeled, with drug name, strength,
lot number and expiration date; |
| (b) |
Only prepackaged drugs are available therein, in amounts sufficient for
immediate therapeutic requirements; |
| (c) |
Whenever access to such area shall have
been gained, written physician's orders and proof of use for controlled
substances are provided; |
| (d) |
All
drugs therein are inventoried no less than once per week. A system of
accountability must exist for all drugs contained therein; and |
|
| (2) |
Written policies and
procedures are established to implement the requirements of this
subsection. |
| (3) |
Emergency Kits.
Drugs may be provided for use by authorized licensed health care personnel by
emergency kits, provided such kits meet the following requirements:
| (a) |
Drugs included. The Director and the
medical staff of the clinic shall jointly determine the drugs, by identity and
quantity, to be included in the emergency kits. Such drugs shall also be
approved by the Board or its authorized agent; |
| (b) |
Storage. Emergency kits shall be stored
in limited access areas and sealed to prevent unauthorized access, and to
insure a proper environment for preservation of the drugs within
them; |
| (c) |
Labeling-exterior. The
exterior of emergency kits shall be labeled so as to clearly and unmistakably
indicate that it is an emergency drug kit and is for use in emergencies only.
In addition, a listing of the drugs contained therein, including name,
strength, quantity, and expiration date of each drug shall be attached. Nothing
in this section shall prohibit another method of accomplishing the intent of
this section, provided such method is approved by the Board upon a
recommendation of the GDNA. |
| (d) |
Labeling-interior. All drugs contained in emergency kits shall be labeled in
accordance with such state and federal laws and regulations which pertain
thereto; and shall also be labeled with such other and further information as
may be required by the medical staff of the clinic to prevent misunderstanding
or risk of harm to the patients; |
| (e) |
Removal of drugs. Drugs shall be removed
from emergency kits only pursuant to a valid physician's order, by authorized
licensed clinic personnel, or by a pharmacist for the clinic
pharmacy; |
| (f) |
Notification.
Whenever an emergency kit is opened, the pharmacy shall be notified; and the
pharmacy shall replace or re-stock and reseal the kit within a reasonable time
so as to prevent risk of harm to patients. In the event the kit is opened in an
unauthorized manner, the pharmacy and other appropriate personnel of the
facility shall be notified; |
| (g) |
Inspections. Each emergency kit shall be opened and its contents inspected by
the pharmacy at least once every ninety (90) days. Upon completion of
inspection, the emergency kit shall be re-sealed. |
|
| (4) |
Access to pharmacy. Whenever any drugs
are not available from an after hours safe or emergency kit(s), and such drugs
are required to treat the immediate needs of a patient whose health would
otherwise be jeopardized, such drugs may be obtained from the pharmacy pursuant
to the physician's order and the requirements of this subsection.
| (a) |
At any given time, there may be only one
licensed health care professional who is designated in the policies and
procedures, to have access to the pharmacy and to remove drugs
therefrom. |
| (b) |
Such licensed health
care professional shall be designated in writing by the Director of the OTP
clinic pharmacy and shall, prior to being permitted to obtain access to the
pharmacy, receive thorough education and training by the Director or his or her
designee in the proper methods of access, removal of drugs, and records and
procedures required. |
| (c) |
Such
licensed healthcare professional shall at a minimum record on a suitable form
the name of any drug, the strength, amount, date and time removed from the
pharmacy and his or her signature and title. |
| (d) |
Such licensed healthcare professional
shall place the container from which the drug is removed in a conspicuous place
in the pharmacy to be promptly reviewed and inspected by a
pharmacist. |
| (e) |
Procedures. The
Director, in conjunction with the medical staff of the clinic, shall develop
and implement written policies and procedures to insure compliance with the
provisions of this subsection. |
|
| (1) |
Physical Area. An OTP clinic pharmacy
shall have within the clinic which it serves, sufficient floor space allocated
to it to insure that drugs are prepared in sanitary, well-lighted and enclosed
space, and which meet the other requirements of this section, the Georgia
Pharmacy laws, and other applicable state and federal laws and rules. Such
space shall be at a minimum 150 square feet. Such space shall include all areas
which are assigned and under the direct control of the Director. |
| (2) |
Minimum equipment. No OTP clinic pharmacy
licensed in accordance with O.C.G.A. Title 26, Ch. 4 shall engage in the
practice of filling, compounding or dispensing prescription drugs for an OTP
Clinic unless it shall possess the following items:
| (a) |
Copies of and/or electronic access to
current reference materials appropriate to the practice of pharmacy related to
OTP. These reference materials shall be authoritative on at least the topics of
drug interactions; patient counseling; compounding and pharmaceutical
calculations; and generic substitution. |
| (b) |
Authoritative, current antidote
information as well as the telephone number of the regional poison control
information center shall be posted or readily available in areas both inside
and outside of the pharmacy where drugs are stored or patients are being cared
for. |
| (c) |
Current copies or
electronic or computer access to the following:
| 1. |
The Georgia Pharmacy Practice Act/Drug and
Cosmetic Act, O.C.G.A. §§26-4 and 26-3; |
| 2. |
The Georgia Controlled Substances
Act/Dangerous Drug Act, O.C.G.A. §16-13; |
| 3. |
The official rules of the Georgia State
Board of Pharmacy. |
|
| (d) |
Equipment:
| 1. |
Sink in working condition with
both hot and cold running water; |
| 3. |
One oral solid
counting tray; |
| 4. |
Typewriter, word
processor or computer with label printer; |
| 5. |
A refrigerator in working order with a
thermometer. |
| 6. |
Any other equipment
the Board may deem necessary for a specialized practice setting where such a
specialized practice takes place. |
|
| (e) |
Weighing and labeling:
| 1. |
Appropriate prescription labels consistent
with the requirements of O.C.G.A. §§16-13, 26-3 and 26-4; and
|
| 2. |
Appropriate auxiliary labels
that should be used in the pharmacist's professional judgement. |
| 3. |
A class A balance with metric and
apothecary weights or an electronic class I or II balance. |
|
| (f) |
An adequate supply of drugs used in an
OTP Clinic setting. |
| (g) |
Assorted
sizes and types of appropriate dispensing containers. |
|
| (3) |
The Director in an OTP clinic pharmacy
may submit to the Board a typed request for a variance to the provisions
relating to the minimum equipment requirements.
| (a) |
The reason for requesting each variance
must be included in the typed request; |
| (b) |
A variance shall be granted by the Board
only when, in the judgement of the Board, there are sound reasons for doing so
which relate to the necessary or efficient delivery of health care. |
| (c) |
Any variance granted by the Board shall
be in writing, and the variance must be posted in the pharmacy next to the
current Board issued license certificate. |
|
| (1) |
General. A drug distribution system is
the entirety of that mechanism by which a physician's drug order is executed,
from the time the practitioner transmits the order either orally, in writing,
or electronically to a licensed health care professional to the time the
ordered drug is administered to the patient or delivered to the patient for
self-administration. No drugs can be dispensed or administered without a
physician's medication drug order. |
| (2) |
Responsibility. The Director shall be
responsible for the safe and efficient distribution, control, and
accountability for drugs. The other professional staff, including the
physicians, at the OTP clinic shall cooperate with the Director in meeting this
responsibility and in ordering, administering, and accounting for the drugs and
devices so as to achieve this purpose.
| (a) |
The
Director shall establish written policies and procedures for the distribution
of medications including emergency kits, etc. to achieve this goal.
| 1. |
The drugs must be identified up to the
point of administration; |
| 2. |
The
pharmacy must receive a direct, electronic (only for drugs to be administered
on site) or mechanical copy of a physician's order before the first dose of
medication is dispensed as defined by the clinic stat order policy. |
| 3. |
At a minimum, the pharmacy must maintain a
patient profile for each OTP clinic patient for use in prospective and
retrospective drug reviews, for comparing with the central registry as required
by the DHR and to report violators to the GDNA and DHR, for discharge from
another OTP, and for urine or blood tests to check for drug positive test
results. |
| 4. |
Records of all
transactions of the OTP clinic pharmacy, such as daily drug dosing summaries,
daily drug inventory sheets, patient medication profiles, and bulk drug
inventory records must be maintained by the clinic pharmacy as may be required
by law, and as may be necessary to maintain accurate control over and
accountability for all drugs and devices within the scope of the clinic
practice. |
| 5. |
All drug invoices must
be attached to their accompanying DEA form 222 order form and must be filed
separately from all other drug records. A biennial inventory of all controlled
substances on hand must be taken every two years from the date of the pharmacy
opening for business. This inventory must be an accurate count of all such
drugs, signed in indelible ink by the pharmacist taking the inventory and dated
on the date it is taken. |
| 6. |
Any
drug compounded by the pharmacy must be accounted for by use of a compounding
log form. This form, at a minimum must display the date the drug was
compounded, the name of the drug, the strength, quantity made, manufacturer's
lot number, manufacturer's expiration date, and the signature of the pharmacist
compounding the drug. |
| 7. |
Nothing in
this section shall prohibit the use of computerized records, where such records
meet all other requirements of the law. An OTP clinic pharmacy may not dispense
or administer prescription medications other than OTP program medications;
and |
| 8. |
The pharmacy must participate
in those aspects of the OTP clinic patient care evaluation program which relate
to drug and device utilization and effectiveness. |
|
| (b) |
All records must be maintained by the
pharmacy for a minimum of two years and be readily retrievable upon request by
an agent of the Board. |
|
| (3) |
Labeling:
| (a) |
For use inside the clinic, all drugs
dispensed by an OTP clinic pharmacy, including those for use in an after hours
safe or emergency kit shall be dispensed in appropriate containers and
adequately labeled so as to identify at a minimum:
| 1. |
Brand name or generic name of the
drug; |
| 3. |
Lot number assigned by either the drug
manufacturer or the clinic pharmacy; and |
| 4. |
Expiration date assigned either by the
drug manufacturer or the clinic pharmacy. |
|
| (b) |
Any drug container dispensed by the
pharmacy for take-home use by an OTP clinic patient must display a label which
contains at least the following:
| 2. |
Name of the prescribing
physician; |
| 3. |
Name, address and
telephone number of the OTP clinic pharmacy; |
| 4. |
Drug name (either brand or generic
name); |
| 7. |
Expiration date of the drug as determined
by the pharmacy; |
| 8. |
"Federal
Caution" for controlled substances; |
| 9. |
Clinic Pharmacy serial number for that
specific prescription drug order; |
| 10. |
Any other labeling or information as
required by the DEA; |
|
| (c) |
All take-home medication dispensed by the pharmacy, including one-time use
containers, must be in child-proof containers which meet the requirements of
the U.S. Consumer Product Safety Commission. |
|
| (4) |
Discontinued drugs. The Director shall
develop and implement policies and procedures to insure that discontinued and
outdated drugs and containers with worn, illegible, or missing labels are
returned to the pharmacy for proper disposition. |
| (5) |
Accountability of controlled substances.
| (a) |
Nothing shall prohibit the use of
controlled substance drugs issued via proof of use forms for general or
emergency use for specific patients. Proof of use controlled substances forms
shall be provided by the pharmacy. |
| (b) |
Each proof of use form shall display the
name of the patient to or for which it has been issued and an indication that
the drugs are for general or emergency use and a serial number. The form shall
also show the date the form was issued and the signature of the pharmacist
issuing the form and the signature of the licensed medical practitioner
receiving the form for storage in the after-hour safe. A detachable receipt
reflecting all the previous information must be returned and filed by the
pharmacy as a safeguard to prevent drug diversion. |
| (c) |
Each proof of use sheet shall provide
space to record the administration information necessary to account for each
dose of medication. This information shall specify at a minimum:
| 1. |
Drug name, strength, and dosage
form; |
| 3. |
Name of
prescriber. This shall include, at a minimum, the first initial and complete
last name of the prescriber; |
| 4. |
First and last name of the patient; |
| 5. |
Date and time of administration to
patient; |
| 6. |
Signature of individual
administering the dose, which shall include at a minimum, the first and last
name and title; |
| 7. |
Documentation of
destruction of all unused portions by two signature verifications of licensed
healthcare professionals; |
| 8. |
Proof
of receipt of medication bearing identifying serial numbers; |
| 9. |
Date the medication was issued and date
the proof of use form was returned. |
|
|
| (6) |
Any OTP clinic pharmacy licensed by the
Board may make on-premises destruction of small quantities of controlled
substances prepared for oral administration provided:
| (a) |
The controlled substance is the remainder
of a single-dose unit; and, |
| (b) |
The
single-dosage unit from which the ordered dose was prepared is the nearest
possible size to the dose ordered. |
|
| (7) |
Perpetual inventory of Schedule II
controlled substances shall be required and accountability of said drugs shall
be by an appropriate form indicating at a minimum the date used, name of
shipper or drug recipient, corresponding serial number of a drug order, invoice
or proof of use form, and quantity received or issued. |
| (8) |
Recall. The Director shall develop and
implement a recall policy and procedure to assure that all drugs within the
clinic included on the recall are returned to the pharmacy for proper
disposition. |
| (9) |
Suspected adverse
drug reactions. All suspected adverse drug reactions shall be reported
immediately to the ordering physician, the pharmacy, and to the appropriate
committee of the clinic. An appropriate entry on the patient's pharmacy profile
shall also be made. |
| (10) |
Security.
All areas occupied by an OTP clinic pharmacy shall be capable of being locked
by key or combination, so as to prevent unauthorized personnel access except by
force. Such areas shall meet the security requirements of all applicable
Federal and State laws and rules. Only those persons so authorized shall be
permitted to enter these areas.
| (a) |
All drugs
shall be stored in designated areas within the clinic pharmacy or all
dispensing medications shall be stored in designated areas within the clinic
which are sufficient to insure proper sanitation, temperature, light,
ventilation, moisture control, segregation, and security. Drug storage areas
shall be locked or otherwise secured when licensed health care professionals
are not present. |
| (b) |
Storage for
Schedule II controlled substances shall be in an enclosed room or space with
controlled limited access capable of showing forced entry is preferable.
However, a safe or a lockable metal cabinet that is permanently affixed to the
structure is acceptable. |
| (c) |
Whenever any area of an OTP clinic pharmacy is not under the personal and
direct supervision of authorized licensed personnel, such areas shall be locked
and secured. |
|
| (11) |
Reports and records. The Director shall maintain access to and submit, as
appropriate, such records and reports as are required to insure patient health,
safety and welfare. Such records shall be readily available and subject to
inspections by the Board, the GDNA or its designated agents. All such records
shall be maintained for a minimum of two years. These shall include, at a
minimum, the following:
| (a) |
Patient profile,
chart or other appropriate record; |
| (b) |
Proof of use forms for controlled
substances; |
| (c) |
Reports of
suspected adverse drug reactions; |
| (d) |
Inventories of after hours safe(s) and
emergency drug kits, |
| (e) |
All
perpetual inventories maintained by the pharmacy, and all other records
pertaining to controlled substances, including a biennial controlled substances
inventory; |
| (f) |
Such other records
and reports as may be required by Federal or State laws and/or rules; |
|
| (12) |
The compounding, labeling and
quality control of large volumes of opioid treatment medication is the
responsibility of a pharmacist and shall be prepared within the on-site
pharmacy. |
| (1) |
No drug shall be dispensed or
administered except upon receipt of a medication drug order written by a
licensed medical practitioner granted rights to prescribe in an OTP.
| (a) |
A licensed medical practitioner must
write an initial dosing medication order for each patient prior to any
medication being dispensed or prepared by the OTP clinic pharmacy. |
| (b) |
In emergency situations, a verbal order
may be given by the physician and it must be signed by the physician within 72
hours, or such order would be considered a violation of these rules. |
| (c) |
Any adjustment to a patient's dosage
regimen is considered to be a new medication order. Such orders shall be
written per protocol developed by the clinic's medical director and signed by
the ordering physician within 72 hours. |
|
| (2) |
Drugs shall be administered by authorized
licensed personnel in accordance with policies and procedures specified by the
Director of Pharmacy Services under applicable laws and rules and regulations,
and by usual and customary standards of good medical practice which protect the
public health, safety and welfare. Only licensed personnel shall administer
medications. |
| (1) |
The Director shall establish policies and
procedures relating to drugs brought into the OTP clinic by outside sources.
Such drugs shall not be administered unless they can be precisely identified.
Administration shall be pursuant only to an authorized practitioner's
prescription drug order. These medications shall be kept in the pharmacy. If
such drugs are not to be administered, the medication shall be returned to an
adult member of the patient's family or stored by the pharmacy and returned to
the patient upon discharge. Nothing in this section shall prohibit another
method of accomplishing the intent of this section provided such method is
approved by the Board. |
| (1) |
Board
Inspection. The Board, through either the GDNA or by its qualified designee,
shall, at a minimum, inspect each OTP clinic pharmacy once every two (2) years
to verify compliance with the laws and these rules and regulations.
| (a) |
The Director shall maintain a copy of the
inspection report in the OTP clinic pharmacy and shall submit a copy of the
report to the DHR Methadone Authority. |
| (b) |
Any discrepancies or deficiencies noted
shall be corrected within thirty (30) days of the inspection. |
| (c) |
Written notice of such corrections or a
plan of action to correct deficiencies shall be filed with the GDNA within
thirty (30) days after receipt of the inspection report. |
|
| (2) |
Director inspections. The Director shall
no less than once each month, either personally or by qualified designee,
inspect all matters within the jurisdiction and responsibility of the pharmacy
and make appropriate written records of such inspections. Such inspections
shall, at a minimum, verify that:
| (a) |
Drugs
are dispensed only by licensed pharmacists or licensed pharmacy interns/externs
acting under the direct supervision of a licensed pharmacist; |
| (b) |
Non-licensed pharmacy personnel are
properly directed and supervised; |
| (c) |
Drugs for external use are stored
separately and apart from drugs for internal use or injection; |
| (d) |
Drugs requiring special storage
conditions to insure their stability are properly stored; |
| (e) |
No outdated drugs are stocked in the OTP
clinic pharmacy or the facility it serves; |
| (f) |
Distribution and administration of
controlled substances are properly and adequately documented and reported by
both pharmacy and other licensed medical personnel; |
|
Whenever the DHR central registry determines that a patient is
improperly utilizing more than one OTP at the same time, and notifies the
Director, the Director shall notify the Board and the GDNA.
