In addition to any other requirements set forth in these
rules pertaining to the issuance of prescriptions of controlled substances, the
following additional requirements apply to all prescriptions, whether or not
said prescriptions are for controlled substances, legend drugs or any other
medication:
A. Prescriptions may not
be written outside of a valid licensee-patient relationship. While not all of
the elements in subsection A are necessary each time a prescription is
authorized (e.g., via appropriate telemedicine as defined in Rule 5.5 of Part
2635, calling in refills, taking call for a practice partner for short term
care, etc.), all initial encounters, and at reasonable intervals thereafter,
should conform to this rule and be done pursuant to a valid licensee-patient
relationship. The elements of this valid relationship are:
1. verify that the person requesting the
medical treatment is in fact who they claim to be;
2. conducting an appropriate history and
physical examination of the patient that meets the applicable standard of care,
which as previously stated may also be accomplished through appropriate
telemedicine as defined in Part 2635 Rule 5.5;
3. establishing a diagnosis through the use
of accepted medical practices, i.e., a patient history, mental status exam,
physical exam and appropriate diagnostic and laboratory testing;
4. discussing with the patient the diagnosis,
risks and benefits of various treatment options to obtain informed consent;
5. insuring the availability of
appropriate follow-up care; and
6.
maintaining a complete medical record available to patient and other treating
health care providers.
B. Electronic prescription transmission is
permitted provided the transmission meets applicable state and federal
standards for transmission. E-prescribing is the electronic entry of a
prescription by a licensee, the secure electronic transmission of the
prescription to a pharmacy, the receipt of an electronic message by the
pharmacy and E-prescription renewal requests sent electronically by the
pharmacy to the practitioner.
C.
Every written prescription delivered to a patient, or delivered to any other
person on behalf of a patient, must be manually signed on the date of issuance
by the licensee. This does not prohibit the transmission of electronic
prescriptions and telefaxed prescriptions (but not e-mail) for non-controlled
drugs to the pharmacy of the patient's choice. Such telefaxed or electronic
prescriptions must be authorized by a written or electronic signature and must
be issued in accordance with all other provisions of this rule. No
prescriptions for any form or compound containing nalbuphine HCl, carisoprodol,
butalbital compounds, or tramadol HCl shall be telefaxed.
D. Electronic prescriptions for controlled
substances are permitted if a practitioner has complied with the DEA
requirements and is using a certified electronic prescribing system for the
transmission of control substances prescriptions.
E. All written prescriptions must be on forms
containing two lines for the licensee's signature. There must be a signature
line in the lower right-hand corner of the prescription form beneath which must
be clearly imprinted the words "substitution permissible." There must be a
signature line in the lower left corner of the prescription form beneath which
must be clearly imprinted with the words "dispense as written." The licensee's
signature on either signature line must validate the prescription and designate
approval or disapproval of product selection. Each prescription form must bear
the preprinted name of the licensee or the licensee must clearly print his or
her name on the prescription form, in addition to the licensee's original
signature. In the event that the prescription form bears the pre-printed name
of more than one licensee, the licensee must clearly indicate the name of the
licensee writing the prescription. In the case of a prescription that is
electronically generated and transmitted, the licensee must make an overt act
when transmitting the prescription to indicate either "dispense as written" or
"substitution permissible". When done in conjunction with the electronic
transmission of the prescription, the prescriber's overt act indicates to the
pharmacist that the brand name drug prescribed is medically necessary.
F. If a prescription form which
does not contain two signature lines required in Part 2640, Chapter 1, Rule
1.11.D is utilized by the licensee, he or she must write in his or her own
handwriting the words "dispense as written" thereupon to prevent product
selection.
Every written prescription issued by a licensee for a legend
drug should clearly state whether or not the prescription should be refilled,
and if so, the number of authorized refills and/or the duration of therapy.
Licensees should avoid issuing prescriptions refillable on "prn" basis. If a
licensee chooses to issue a prescription refillable "prn", the life of the
prescription or time limitation must clearly be set forth on the prescription.
In no case shall a prescription which is refillable on a "prn" basis be
refilled after the expiration of one (1) year. Regardless of whether a
prescription is refillable on a "prn" basis or the prescription expressly
states the number of authorized refills, the use of said medication should be
re-evaluated on at least an annual basis. Upon the expiration of one (1) year,
a prescription becomes invalid, regardless of the number of refills indicated
or "prn" designation.
G.
Every written prescription issued by a licensee, bearing more than one
non-controlled medication, must clearly indicate the intended refill
instructions for each medication. Lack of clearly indicated refill instructions
prohibit the refilling of the medications. All unused lines on a multi-line
prescription blank must be clearly voided by the issuing licensee.
H. A prescription will no longer be valid
after the occurrence of any one of the following events:
1. Thirty (30) days after the death of the
issuing licensee.
2. Thirty (30)
days after the issuing licensee has moved or otherwise changed practice
location resulting in termination of the licensee patient relationship.
Termination of the licensee patient relationship results when a patient is no
longer able to seek personal consultation or treatment from the issuing
licensee.
3. Immediately after
loss of DEA Controlled Substances Privilege by the issuing licensee if the
prescription is for controlled substances.
4. Immediately upon revocation, suspension or
surrender of the licensee's license.
