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Physician's Guide to Medicine - Controlled Substances
What is a "controlled substance" under
Missouri law?
What are the characteristics of controlled
substances?
Who may prescribe controlled substances?
Can a nurse administer and dispense controlled substances?
Can a physician assistant administer and dispense
controlled substances?
What are the guidelines for granting
registration?
Can registration be suspended or revoked?
What are the guidelines for restriction,
suspension or revocation of a registration?
What are the recognized purposes of prescribing
controlled substances?
Is there a limitation on the quantity of controlled
substances that may be prescribed to a patient?
Can the quantity prescribed at one time be
increased?
What are the record keeping requirements for
controlled substances?
What are the storage requirements for controlled substances?
What are labeling requirements for controlled substances?
Can the holder of a temporary license in a training
program prescribe controlled substances?
May a physician prescribe controlled substances to
himself or herself?
Is it permissible to prescribe controlled substances
to family members?
What is the penalty for violating controlled substances laws?
What is a "controlled substance" under Missouri law?
"Controlled substance" means a drug,
substance or immediate precursor in Schedules I through V listed in the Missouri
Controlled Substances Act.
What are the characteristics of controlled substances?
Schedule I: Drugs in this schedule have no
accepted medical use in treatment in the United States and have a high abuse
potential. Examples include such street drugs as heroin, LSD, and marijuana.
Schedule II: Drugs have accepted medical uses and high abuse potential with
severe psychological or physical dependence. Some examples include cocaine,
codeine, dilaudid, and demerol. Some stimulants and depressants are also
included.
Schedule III: Drugs have accepted medical uses and an abuse potential less than
those in Schedules I and II and abuse of the substance may lead to moderate or
low physical dependence or high psychological dependence. Some examples include
Tylenol with codeine, codeine, and nalorphine.
Schedule IV: Drugs have accepted medical uses and abuse potential less than
those in Schedule III and abuse of the substance may lead to limited physical
dependence or psychological dependence or psychological dependence relative to
the substances in Schedule III. Some examples include cough syrups containing
codeine, Valium, Darvon, and Robitussin AC.
Schedule V: Drugs have accepted medical use and abuse potential less than those
in Schedule IV and the substance has limited physical dependence or
psychological dependence liability relative to the controlled substances listed
in Schedule IV. This schedule consists primarily of preparations containing
limited quantities of certain narcotic drugs for antidiarrheal purposes.
Who may prescribe controlled substances?
A physician in good faith and in the course of
his or her professional practice only, may prescribe, administer, and dispense
controlled substances or may cause the same to be administered by a nurse or
intern under his or her direction and supervision. However, the physician must
first be registered with the Federal Drug Enforcement Administration and the
State Bureau of Narcotics and Dangerous Drugs before he or she can prescribe and
distribute controlled substances in the State of Missouri. A separate
registration is required at each principal place of business where controlled
substances are stored or distributed, and the Missouri Department of Health is
authorized to inspect a registrantīs premises to assure compliance with the
Controlled Substances Act. The physician has the burden of proving registration,
record keeping, and order form compliance.
Can a nurse administer and dispense controlled substances?
A physician may allow a nurse under his or her direct
supervision to administer controlled substances.
The administering or dispensing of a controlled substance by a nurse pursuant to
a collaborative practice arrangement shall be accomplished only under the
direction and supervision of the collaborating physician, or other physician
designated in the collaborative practice arrangement, and shall only occur on a
case-by-case determination of the patientīs needs following verbal consultation
between the collaborating physician and collaborating nurse. The required
consultation and the physicianīs directions for the administering or dispensing
of controlled substances shall be recorded in the patientīs chart and in the
appropriate dispensing log. These recordings shall be made by the collaborating
nurse and shall be co-signed by the collaborating physician following a review
of the records.
A nurse shall not, under any circumstances, prescribe controlled substances.
Can a physician assistant administer and dispense controlled substances?
A physician assistant may administer or
dispense a controlled substance to a patient, but only pursuant to a physician
assistant supervision agreement which is specific to the clinical conditions
treated by the supervising physician. A physician assistant shall not, under any
circumstances, prescribe controlled substances.
What are the guidelines for granting registration?
No registration will be granted to anyone
who has been convicted of a controlled substance misdemeanor within the last two
years, or anyone who has been convicted of a controlled substance felony within
the last seven years. Moreover, registration will not be issued if the Missouri
Department of Health determines that issuance would be against the public
interest. In determining the public interest, the following factors shall be
considered:
(1) Maintenance of effective controls against diversion of controlled substances
into other than legitimate medical, scientific, or industrial channels;
(2) Compliance with applicable state and local law;
(3) Any convictions of an applicant under any federal or state laws relating to
any controlled substance;
(4) Past experience in the manufacture or distribution of controlled substances
and the existence in the applicant's establishment of effective controls against
diversion;
(5) Furnishing by the applicant of false or fraudulent material information on
any application field under the Missouri Con- trolled Substances Act;
(6) Suspension or revocation of the applicant's federal registration to
manufacture, distribute or dispense narcotics or controlled dangerous drugs as
authorized by federal law; and
(7) Any other factors relevant to and consistent with the public health and
safety.
Can registration be suspended or revoked?
A registration to distribute or dispense
controlled substances may be suspended or revoked by the Missouri Department of
Health for various reasons, such as:
(1) Furnishing false or fraudulent material information on any application filed
under the Missouri Controlled Substances Act;
(2) Being convicted of a felony under any state or federal law relating to any
controlled substance;
(3) Having one's federal registration to manufacture, distribute or dispense
suspended or revoked;
(4) Violating any federal controlled substance statute or regulation, or any of
the state laws pertaining to controlled substance; or
(5) Having one's professional license to practice suspended or revoked.
What are the guidelines for restriction, suspension or revocation of a
registration?
Before a Missouri controlled substances
registration can be restricted, suspended, revoked, or an application denied,
the Missouri Department of Health must serve upon the registrant or applicant a
notice of violations committed by the registrant or applicant upon which the
Department would base a proposed action. The Missouri Department of Health must
also first provide the registrant an opportunity for an informal conference to
discuss these issues.
Once these steps have been taken, the Missouri Department of Health may propose
to restrict, suspend or revoke a registration or deny an application. The
registrant or applicant then has the opportunity to oppose such an action by
filing their case with the Administrative Hearing Commission.
Note: Any registration placed under a restriction or limitation by the Missouri
Department of Health is termed to be "under probation."
Emergency suspension of registration
If the Department finds that there is imminent danger to the public health or
safety, it may suspend any registration simultaneously with the institution of
proceedings under Section 195.040.7 of the Controlled Substances Act. The
suspension will continue in effect until the conclusion of the proceedings,
unless sooner withdrawn by the Missouri Department of Health, absolved by a
court or stayed by the Administrative Hearing Commission.
What are the recognized purposes of prescribing controlled substances?
Federal law
Federal regulations clearly specify legitimate purposes for prescribing
controlled substances:
(1) A prescription for a controlled substance is effective only if it is issued
for a legitimate medical purpose by a physician acting in the usual course of
professional practice;
(2) Physicians may not issue a prescription to obtain controlled substances for
dispensing to patients; instead, physicians must use DEA Form 222 to obtain
controlled substances for their office use through regular supply sources. A
physician who orders controlled substances for use by all physicians in an
office or clinic must register with DEA as a distributor; or
(3) Physicians may not issue prescriptions to dispense narcotic drugs for
detoxification or maintenance treatment of a person who is dependent on narcotic
drugs unless separately registered with DEA, FDA, and Missouri Department of
Health as a narcotic treatment program.
However, a physician can administer (but not prescribe) narcotic drugs to a
patient daily for up to three days while arrangements are being made for
referral to an existing narcotic treatment program.
Missouri law
Missouri has additional laws and regulations that further delineate what is a
legitimate prescription order. Prescription orders for controlled substances
must be dated and signed on the day issued. A prescription also must include the
following information:
(1) Name and address of the patient (street and city);
(2) Name, address, and DEA registration number of the physician;
(3) Signature of the physician;
(4) Name and quantity of drug prescribed; and
(5) Directions for use.
Is there a limitation on the quantity of controlled substances that may be
prescribed to a patient?
The quantity of Schedule II controlled substances
prescribed or dispensed at any one time is limited to a thirty-day supply. The
quantity of Schedule III, IV or V controlled substances prescribed or dispensed
at any one time is limited to a ninety-day supply.
Can the quantity prescribed at one time be increased?
Yes. These supply limitations may be increased
up to three months if the physician describes on the prescription form the
medical reason for requiring the larger supply.
What are the record keeping requirements for controlled substances?
Physicians must maintain records of all controlled
substances received in their offices including samples.
Federal law
Federal regulations require dispensing physicians to keep records of all
narcotic drugs administered or dispensed and of other controlled substances
administered or dispensed if the patient is charged for the dispensing service.
Missouri law
According to a regulation of the Missouri State Board of Registration for
Healing Arts, all controlled substances dispensed from an office by a physician
must be recorded in a log book. Each instance of dispensing must be recorded
chronologically in the log book and each entry must include the following
information:
(1) Name of drug;
(2) Dosage form and strength of the substance;
(3) Quantity dispensed;
(4) Name and address of the patient (street and city);
(5) Date of dispensing; and
(6) Name or initials of the physician.
Physicians registered to dispense controlled substances must keep records and
inventories as required by federal law and any additional regulations of the
Missouri Department of Health. The form of records is prescribed by the Missouri
Department of Health.
What are the storage requirements for controlled substances?
Under federal law, physicians must store controlled
substances in their offices or clinics in a securely locked, substantially
constructed cabinet or safe. Access to the storage area should be kept to a
minimum.
Reporting loss or theft
Any loss or theft of controlled substances or DEA order forms must be reported
to the DEA field office in Chicago using DEA Form 106.
Thefts also must be reported to local police and BNDD, P.O. Box 570, Jefferson
City, MO 65102.
For more information concerning controlled substances, please contact the State
of Missouri Department of Health, Bureau of Narcotics and Dangerous Drugs at
(573) 751-6321, or the Drug Enforcement Administration, Compliance Division at
(314)425-3264 in St. Louis, or (913) 236-3176 in Kansas City.
What are labeling requirements for controlled substances?
It is unlawful to distribute any controlled substance in
a commercial container that does not bear a label identifying such substance in
accordance with federal laws.
Whenever a pharmacist or other practitioner sells or dispenses any controlled
substance on a prescription issued by a physician, dentist, podiatrist or
veterinarian, he or she must affix to the container in which the drug is sold or
dispensed, a label showing his or her name and address; the name of the patient;
the name of the physician, dentist, podiatrist or veterinarian by whom the
prescription was written; and such directions as may be stated on the
prescription.
Can the holder of a temporary license in a training program prescribe
controlled substances?
Yes. A temporary licensee may prescribe legend drugs,
including controlled substances, within the framework of the training program in
which he or she is enrolled. In these instances, the licensee uses the
institutionīs DEA number, with a special distinguishing suffix.
May a physician prescribe controlled substances to himself or herself?
No. Controlled substances may be
self-administered only if prescribed or dispensed by another practitioner.
Is it permissible to prescribe controlled substances to family members?
While there is no legal prohibition of prescribing
controlled substances to family members, it is not uncommon for physicians who
do this to fail to keep adequate written medical records justifying the course
of treatment. Physicians who do prescribe or dispense any drugs to family
members must maintain the same medical records and charts as for any other
patient.
What is the penalty for violating controlled substances laws?
It is a felony to violate any of the laws regulating the
sale, use, prescription, and administration of controlled substances.
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