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Guide To Prescribing, Administering and Dispensing Controlled Substances
See also:
Schedule of Controlled Substances Common Examples
State and Federal Limitations on Prescriptions for Controlled Substances
This guide is published to assist and educate Missouri physicians in their
handling of controlled substance issues. This edition includes changes to
Missouri law that became effective in 1998
Task Force Suggestions and Cautions
Patient Care
Do not prescribe in the absence of medical need. Do a workup sufficient to
support a diagnosis, including all necessary tests.
Determine what other drugs the patient is using. Obtain the names and addresses
of any other practitioners the patient may be seeing. Verify the patient’s
current address.
Use non-abusable drugs first or determine their inappropriateness through trial
or documented history before beginning a regimen of controlled drugs.
Take the time to explain to the patient the relative risks and benefits of the
drug based on the information in FDA labeling requirements or professional drug
literature.
Maintain regular monitoring of the patient, including regular and frequent
physical evaluation.
Make sure you are in control of the supply of drugs.
Maintain a thorough medical record that includes history and physical diagnosis,
medical indication supporting the diagnosis, and a treatment plan with
appropriate referrals.
Keep detailed records of the patient’s progress or lack of progress. Review
frequently.
Do not prescribe, dispense or administer controlled drugs outside the scope of
your professional practice, or in the absence of a formal practitioner-patient
relationship.
Drug Seeking Patients
Be aware of the drug-seeking patient (see "What Are Common Characteristics of
Drug-Seeking Patients?"
Secure your prescription pads.
Prescribing
Do not presign prescription blanks or use signature stamps; an original
signature is required.
A prescription must be dated on the day it is issued; do not predate or postdate
prescriptions.
Record Keeping
Violations of state and federal controlled substance law occur most often in the
area of required record keeping. Become familiar with the requirements of the
law in this area. Maintain adequate records of all prescriptions, written
orders, telephone orders and authorized refills, as well as all controlled
substance dispensing and administration. Registration Information
Controlled substances registrations from the Bureau of Narcotics and Dangerous
Drugs (BNDD) and the federal Drug Enforcement Administration (DEA) are required
for an individual practitioner to conduct any activities with controlled
substances in Missouri. A DEA registration may not be required in certain
situations. Individual practitioners include physicians, dentists, optometrists,
podiatrists and veterinarians. Practice sites such as offices and clinics are
not registered separately from individual practitioners.
Registered professional nurses may obtain BNDD registrations, but may not obtain
DEA registrations, if they have collaborative practice arrangements with a
physician. The nurse acts as an agent of the physician when administering or
dispensing controlled substances, and the registration does not permit
additional activities.
BNDD registration is required annually. DEA registration must be renewed every
three years. The registration terminates if the practitioner discontinues
practice at the registered location, and the practitioner may no longer
prescribe, administer, dispense or possess controlled substances. BNDD must be
notified at least three weeks prior to change of practice location.
Administering/Dispensing
A BNDD registration is required for administering or dispensing controlled
substances. The registration may be maintained at any Missouri practice
location, and allows the practitioner to administer and dispense from controlled
substance supplies held under the registration of another practitioner. A DEA
registration is not required if the practitioner only administers or dispenses
(but does not prescribe) as an agent of another practitioner who is registered
with BNDD and DEA.
Prescribing
A BNDD registration is required for prescribing controlled substances, either by
writing, telephoning or faxing a prescription to be filled by a pharmacy. The
registration may be maintained at any Missouri practice location. A DEA
registration is required for prescribing except when the practitioner is an
agent or employee of a hospital acting within the scope of employment of the
hospital.
Maintaining Supplies
Both BNDD and DEA registrations are required for maintaining controlled
substances supplies. Separate registrations must be maintained at each separate
location where supplies are maintained. If supplies are received under more than
one practitioner’s DEA registration number at the same location, the supplies
and required records must be kept separate.
A Guide to Prescribing, Administering and Dispensing Controlled Substances in
Missouri
The abuse of prescription drugs – especially controlled substances – is a
serious social and health problem in Missouri and the United States. As a
practitioner, you share responsibility for solving the prescription drug abuse
and diversion problem.
You have a legal and ethical responsibility to uphold the law and to help
protect society from drug abuse.
You have a professional responsibility to prescribe controlled substances
appropriately, guarding against abuse while ensuring that your patients have
medication available when they need it.
You have a personal responsibility to protect your practice from becoming an
easy target for drug diversion, which could result in legal actions against you
and loss of your professional license. It is not the intent of these guidelines
to limit or deny the access of legitimate patients to controlled substance
medications of recognized and appropriate therapeutic value.
You have a legal responsibility to acquaint yourself with the state and federal
requirements for the prescribing and dispensing of controlled substances. Should
you fail to abide by the requirements, you are subject to the loss or
restriction of controlled substances privileges and discipline by the
appropriate professional state licensing board.
This guide will help you meet these responsibilities. It summarizes key aspects
of Missouri and federal controlled substances law and outlines common sense
procedures that practitioners can use to prevent diversion of these drugs from
their practice.
What Are Controlled Substances and Who "Controls" Them?
A controlled substance is a drug or drug product that comes under the
jurisdiction of the federal Controlled Substances Act of 1970. The narcotic,
depressant, stimulant, hallucinogenic and anabolic steroid drugs that are
covered by the Controlled Substances Act (CSA) are listed in one of five
schedules. Schedule I substances have no accepted medical use in the U.S. and
have high abuse potential. Schedule II drugs have high abuse potential with
severe psychic or physical dependence liability, and in general are substances
that have therapeutic utility. Schedules III-V include drugs with decreasing
levels of abuse potential. By clicking here you will find representative
examples listed by common name or generic name, and some are accompanied by a
common trade name in parentheses. There are some differences between federal and
state listings of controlled substances.
The Comprehensive Drug Control Act of 1989, administered by the Bureau of
Narcotics and Dangerous Drugs in the Missouri Department of Health, closely
parallels the federal law. In some instances, however, Missouri’s law is more
stringent and takes precedence over federal law. For example, in Missouri,
narcotic-containing cough syrups and certain ephedrine products are listed in
Schedule IV and cannot be purchased without a prescription.
Missouri has established a diversion control and prevention program, coordinated
among state and federal agencies, to identify and stop diversion. BNDD regularly
evaluates drug purchases and other information and then reports suspected or
potential diversion to the licensing agencies. These agencies further evaluate
violations of law or standards of professional conduct, and proceed accordingly.
What Constitutes a Legitimate Prescription for a Controlled Substance?
Federal and state regulations clearly specify legitimate purposes for
prescribing controlled substances:
A prescription for a controlled substance is effective only if it is used for a
legitimate medical purpose by a practitioner acting in the usual course of
professional practice.
Three criteria should be met:
1. The patient must desire treatment for a legitimate illness or condition.
2. A practitioner must establish a legitimate need through assessment, utilizing
pertinent technical diagnostic modalities.
3. There must be reasonable correlations between the drugs prescribed and the
patient’s legitimate needs.
The Intractable Pain Act, passed in 1995, provides guidelines for the treatment
of chronic, intractable pain. This law was intended to clarify the parameters
for treating chronic pain with controlled substances. The physician must
document the diagnosis and treatment of chronic pain in the patient record and
the use of controlled substances must be therapeutic in nature and the manner
utilized. Physicians may not prescribe or dispense controlled substances to a
patient for chemical dependency unrelated to intractable pain or to a patient
who the physician knows, or should know is using the medication in a
nontherapeutic manner. Physicians may be subject to disciplinary action for
nontherapeutic use of controlled substances, failing to keep accurate on-going
treatment records, failing to keep complete and accurate controlled substance
records, writing false or fictitious prescriptions, or prescribing controlled
substances in a manner inconsistent with state or federal drug laws.
Practitioners may not issue a prescription to obtain controlled substances for
dispensing to patients. Practitioners must use DEA form 222 to obtain Schedule
II controlled drugs.
Controlled drugs for a practitioner’s personal use must be prescribed by another
appropriate practitioner, on the basis of an established practitioner/patient
relationship. Practitioners are prohibited by law from prescribing or dispensing
controlled drugs for personal use except in a medical emergency.
It is recommended that practitioners do not prescribe, dispense or administer
controlled drugs to office staff or family members. These activities may be
investigated by both the appropriate professional state licensing board and BNDD.
For dentists, veterinarians, podiatrists and optometrists certified to use
therapeutic pharmaceutical agents licensed by their respective professional
boards, the prescribing, administering, dispensing or distribution of controlled
substances is limited to the scope of their respective professional practice
after establishment of a practitioner/patient relationship. If the practitioner
does prescribe, dispense or administer to office staff or family members, these
individuals must be treated in the same manner as regular patients. This
includes maintaining a chart, listing a diagnosis, plan of treatment and
prognosis, and using the same documentation and care as with regular patients.
Prescriptions may not be issued to dispense narcotic drugs for detoxification or
maintenance treatment of a person who is dependent on narcotic drugs. However, a
practitioner may 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.
How Do You Issue a Legal Prescription?
Prescriptions for controlled substances must be dated and signed on the day
issued. A prescription also must include the following information:
Name and address of the patient, including street and city,
Name, address and DEA registration number of the practitioner,
Signature of the practitioner,
Name and quantity of drug prescribed,
Directions for use.
It is the practitioner’s responsibility to provide this information. It is the
pharmacist’s responsibility to verify that it is properly provided.
Practitioners who prescribe Schedule II controlled substances must maintain a
record of all such prescriptions, either in the patient’s chart or in a separate
log. If the patient’s chart is used, all Schedule II prescription information
must be highlighted in some manner so as to be readily retrievable.
If a separate log is maintained for Schedule II prescriptions, which is highly
recommended, the record should include the date, full name and address of the
patient, the drug name, strength, dosage form, and quantity.
While Schedule III, IV and V controlled substance prescriptions are currently
not required to be entered in the patient chart, it is strongly recommended that
all prescription and refill information be entered in the chart to confirm that
controlled substance prescriptions were written or authorized.
What Procedures and Records Are Necessary for Dispensing and Administering?
The practitioner must provide direct supervision to employees who assist in
administering and dispensing. Administering and dispensing cannot occur unless
the practitioner is physically in the registered location, except when a
registered nurse is administering or dispensing under a collaborative practice
arrangement.
Under a collaborative practice arrangement with a physician, a registered nurse
may administer or dispense controlled substances after direct consultation with
the physician, within the nurse’s scope of practice and consistent with their
skill, training and competence. The nurse may not prescribe controlled
substances. The nurse may obtain a Missouri Controlled Substances Registration,
although it is not required and does not permit additional activities, but may
not obtain a DEA registration. The collaborative practice physician must
maintain BNDD and DEA registrations at the collaborative practice site and is
responsible for all controlled substance activities, including purchasing
controlled substances and authorizing receipt of controlled substance samples.
Drugs dispensed must be packaged in child-resistant containers and must be
labeled with the date, the name and address of the practitioner, the name of the
patient, the drug’s name and strength, and directions for use.
Records must be maintained for two years for all controlled substances received,
dispensed, administered or otherwise disposed of, including invoices, return
receipts, dispensing, administration and destruction records.
A dispensing log must be maintained separate from the patient’s medical record
and must include:
Complete patient name,
Complete patient address, including city,
Drug name, strength and dosage form,
Quantity dispensed,
Date dispensed,
Name or initials of person dispensing.
A recommended dispensing/administration form is available from BNDD.
Administration records must contain the same information as dispensing records.
Although they may be kept in the patient’s medical record, they must be readily
retrievable. It is recommended they be kept on the dispensing/administration
log.
A complete inventory must be recorded every two years. A continuous (perpetual)
inventory is also recommended and can be conveniently maintained as part of the
dispensing/administration log for each drug. Note that a perpetual inventory
does not fulfill the requirement for a complete inventory taken every two years.
Records must be kept of controlled substances transferred or distributed to
other practitioners or other office locations. A license from the Missouri State
Board of Pharmacy may be required in certain situations.
Expired or unwanted controlled substances may not be destroyed by the
practitioner except in special circumstances when permission is granted by DEA.
They may be returned to the original supplier using DEA Form 222 for Schedule II
or a proper record of transfer for Schedules III-V. They may also be transferred
to a DEA-registered "reverse distributor" company. A list of these companies is
available from BNDD or DEA. Partially used dosage units such as syringes and
single-use ampuls may be destroyed if the destruction is witnessed and
documented by two persons.
Controlled substance samples must be treated in the same manner as any other
controlled substance, including receiving, inventory, dispensing and destruction
records. Procedures for packaging and labeling when dispensing must be followed.
If more than one practitioner in the same office receives controlled substances
(including samples) under separate DEA registrations, all records and supplies
must be maintained separately. Contact BNDD for procedures to combine records
and supplies under a primary practitioner in group practice situations.
Where Should Controlled Substances Be Stored?
Under federal law, practitioners 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 restricted to persons specifically
authorized to handle controlled substances.
Any loss or theft of controlled substances or DEA order forms must be reported
to DEA and BNDD. Contact BNDD at 573/751-6321 for loss reporting forms. Thefts
of controlled substances should be reported to local police.
What Can Practitioners Do to Prevent Diversion and Prescription Drug Abuse?
Adherence to state and federal regulations goes a long way in protecting your
practice from becoming a source of drug diversion and prescription drug abuse.
Forged and altered prescriptions are a major source of drug diversion.
Suggestions for Practitioners:
Store all unused prescription pads in an appropriately secure/locked place.
Minimize the number of pads in use at one time.
Have prescription blanks numbered consecutively when printed so you can tell if
some sheets are missing.
Never sign prescription blanks in advance.
Write out the actual amount of medication prescribed in addition to using an
Arabic or Roman numeral.
Write prescriptions in ink or indelible pencil to prevent changes.
Do not use your prescription blanks for writing notes or memos.
Do not leave prescription pads in unattended examining rooms, office areas or in
your bag or car where they can be easily picked up.
Respond to a pharmacist’s request for prescription verification. It is the
responsibility of the pharmacist to deny the prescription without sufficient
verification.
What Are Common Characteristics of Drug-Seeking Patients?
The drug-seeking patient, also known as a "professional patient," is usually
unfamiliar to the practitioner, but may become a regular patient if he or she
finds the practitioner easy to manipulate in obtaining desired medications. The
person may claim to be from out-of-town and has lost or forgotten a prescription
of medication. Abusers may contend to be a patient of a practitioner who is
currently unavailable, and ask for a prescription renewal. Drug seekers
generally have no interest in diagnosis, fail to keep appointments for further
diagnostic tests or refuse to see another practitioner for consultation.
Drug-seeking patients may involve children or the elderly in their scams.
Manipulative Approaches Often Used by the Drug-Seeking Patient Include:
Feigning physical problems, such as back pain, kidney stone or headache in an
effort to obtain narcotic drugs.
Feigning psychological problems, such as anxiety, insomnia, fatigue or
depression in an effort to obtain stimulants or depressants.
Deceiving the practitioner, such as by requesting refills more often than
originally prescribed.
Pressuring the practitioner by eliciting sympathy or guilt, or by direct
threats.
Feigning narcolepsy in an effort to obtain amphetamines or methylphenidate.
What Should a Practitioner Do When Confronted by a Suspected Drug-Seeking
Patient?
1. Be alert for "scams." See Scam of the Month booklet.
2. Watch for these signs of a drug-seeking patient:
a new patient coming for pain, age 25-45,
residence is distant from your office,
patient claims to be referred by another practitioner,
unusual behavior in waiting room,
appearance – extremes of slovenliness or being over-dressed,
patient frequently appears when you are about to commence rounds, or frequently
appears on Friday afternoon,
inconsistent signs of acute pain – no signs displayed while waiting but the
patient commences to show symptoms when in examination room,
gives history with textbook symptoms,
physical exam shows evidence of treatment by other practitioners or of
addiction,
patient shows unusual knowledge of controlled substances,
patient requests a specific controlled drug,
patient is reluctant to try a different drug,
asks for a Schedule IV drug initially, but calls back or revisits asking for a
Schedule II.
3. Examination and documentation:
Always perform a thorough exam appropriate to condition.
Always document examination results and questions you asked the patient.
Questions the treating physician should ask:
What other practitioners are you currently seeing for this or any other
condition?
When did you last see other practitioner?
What drugs have been prescribed for this condition?
Are you currently taking any controlled drugs?
What controlled drugs, strength and frequency?
What over-the-counter drugs are you currently taking?
Have you ever been treated for alcohol or chemical dependency?
Written answers to these questions on a form are helpful.
Discuss standard procedure for evaluating new patients requiring controlled
drugs.
Request picture I.D., or other I.D. and Social Security number; copy and include
in chart.
Call previous practitioner, pharmacist or hospital to confirm.
Confirm telephone number if provided by patient.Write prescriptions for limited
quantities.
Confirm current address at each visit.
4. Sharing information on patients:
Contact local law enforcement and BNDD.
Attempting to obtain a controlled substance by fraud, deceit or
misrepresentation is a felony, and information communicated to a practitioner in
these circumstances is not privileged.
Use the phrase "A person using the name _________ attempted to . . ."
Keep any list of suspects confidential.
Persons who provide information to the BNDD in good faith are not subject to
civil damages as a result.
Know Yourself and Your Practice – Practitioners as Sources of Drug Diversion
The American Medical Association outlines four types of practitioners, the "Four
D’s," who are sources of drug diversion. If you or a colleague fit one of these
categories, it’s time to evaluate your practice or demonstrate peer concern.
Dishonest – or "script" – practitioners, who willfully and knowingly prescribe
controlled drugs for purposes of abuse and usually for profit.
Disabled – or impaired – practitioners, whose professional competence has been
impaired by drug abuse, alcoholism or other physical or mental disorders.
Deceived practitioners who unwittingly acquiesce to some patients’ insistent
demands for medication. Typically, these practitioners prescribe drugs in larger
amounts or for longer periods of time than are medically indicated.
Dated practitioners who have not kept pace with developments in pharmacology or
drug therapy. These practitioners are poor prescribers, not because they intend
to be, but because they lack information or understanding. They may be
prescribing excessive amounts of drugs for exceptionally long periods of time,
prescribing types of drugs that are not indicated for the condition or
prescribing drugs when another type of therapy is indicated.
Recognition and Appreciation
This Missouri Task Force publication was made possible by generous financial
support provided through the Missouri Pharmaceutical Manufacturers Association.
For Additional Information, Contact:
Bureau of Narcotics and Dangerous Drugs
P.O. Box 570
Jefferson City, MO 65102
573/751-6321
Caution
The purpose of this information is to educate and inform the prescriber of the
regulations and statutes pertaining to controlled substances. It is not the
intent to reduce or deny the use of controlled substances where medically
indicated. Nothing in this booklet shall be construed as authorizing or
permitting any person to do any act that is not authorized or permitted under
other federal or state laws. In addition, none of the policy and information in
this booklet may be construed as authorizing or permitting any person to do any
act that is not authorized, or refuse to meet any requirements imposed under the
regulations published in the most recent publication of the Code of State
Regulations or the Revised Statutes of Missouri.
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