by Christine Woolstenhulme, CPC, CMRS, QCC, QMCS
January 29th, 2018
As an effort to cut down on opioid abuse and related crimes, in August of 2017 the Attorney General Sessions established a new Department of Justice (DOJ) section called “Opioid Fraud and Abuse Detection Unit”. Due to the serious public health issue and drug overdose deaths, this unit was established and is devoted strictly to investigate and prosecute opioid-related crimes.
State Prescription Drug Monitoring Programs (PDMPs)
The state-level implementation of a prescription monitoring program called Prescription Drug Monitoring Programs (PDMPs) will help identify inappropriate prescribing trends. Each state uses an electronic database to track controlled substance prescribing and dispensing. The PDMP’s will show providers their patients’ most recent prescriptions. This will aid the provider's decisions, protect high-risk patients, and identify inappropriate prescribing trends.
Rules when dispensing a drug
Ignorance is no excuse when a controlled substance is dispensed to a patient. All providers medical and dental need to understand how it is viewed in the lawful course of professional practice including, inventory and disposal of controlled substances and record-keeping requirements. For complete information, the US Department of Justice provides a Practitioner's Manual.
Department of Justice (DOJ) requires the following when writing a prescription for controlled substance,
“A prescription for a controlled substance must be dated and signed on the date when issued. The prescription must include the patient’s full name and address, and the practitioner’s full name, address, and DEA registration number.”
In addition, the prescription must also include:
- drug name
- quantity prescribed
- directions for use
- number of refills (if any) authorized (1)
Records must be maintained for at least two years and available at any time during those two years when a controlled substance has been prescribed.
The practitioners Manual from the Department of Justice (DOJ) covers prescription requirements such as who can issue a prescription for a controlled substance, the purpose of prescribing such as being issued for a legitimate medical purpose with the practitioner being responsible for proper prescribing and dispensing. The pharmacist has an additional responsibility when the prescription is filled to ensure it is a legitimate and valid prescription.
Controlled substances under the Controlled Substance Act (CSA) are divided into 5 schedules or classifications as assigned by the DEA.
Schedule I Controlled substances:
"Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.
Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine ("Ecstasy")."
Schedule II: (No prescription for a controlled substance in schedule II may be refilled.)
"Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.
Examples of Schedule II narcotics
Examples of Schedule
Other Schedule II substances
Schedule III and IV Substances:
"Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.
Examples of Schedule III narcotics
Examples of Schedule
Schedule IV Controlled Substances:
"Substances in this schedule have a low potential for abuse relative to substances in Schedule III.
Examples of Schedule IV substances include: alprazolam (Xanax®), carisoprodol (Soma®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®)."
Schedule V Substances: No controlled substance in schedule V may be distributed or dispensed for anything but a medical purpose.
"Substances in this schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.
Examples of Schedule V substances
- No prescription for a controlled substance in schedule II may be refilled.
- Schedule III and IV Substances may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.
State vs. Federal laws
Each state has different requirements for prescribing and documentation for controlled substances. The DEA states, "When federal law or regulations differ from state law or regulations, the practitioner is required to abide by the more stringent aspects of both the federal and state requirements. In many cases, state law is more stringent than federal law and must be complied with in addition to federal law. Practitioners should be certain they understand their state as well as DEA controlled substance regulations."
The DEA published a rule on the Federal Register effective June 1, 2010, on Electronic Prescriptions for Controlled Substances. This rule was revised to provide options to practitioners allowing prescriptions for controlled substances to be submitted and written electronically. In addition, pharmacies are now able to receive, dispense, and archive these electronic prescriptions.
Dental providers are no exception, according to Pittsburg state Dentistry Board, “failure to comply with applicable states dental Practice Act requirements will be considered unprofessional conduct and will subject the non-complying dentist to disciplinary action as authorized in section 4.1(a)(8) of the act (63 P. S. § 123.1(a)(8)).
One example of Dental fraud indictment states the government charged a Pittsburg dentist with the following in November 2017:
Distribution of Hydrocodone and Oxycodone, Schedule II and III controlled substances, outside the usual course of professional practice;
- Using or Maintaining a Drug-Involved Premises;
- Health Care Fraud; and
- Omitting Material Information from Required Reports, Records, and Other Documents.
Potential fines and sentencing
The U.S. Attorney’s Office press release stated “if the defendant is convicted of the charges, the law provides for:
- A maximum total sentence on all counts of incarceration of up to 3,974 years;
- A fine of $197,500,000; and
- A term of supervised release of 598 years, or all.”
Be sure you follow your own state's rules or Federal law see (State vs. Federal laws), here is Pennsylvania’s Rule:
§ 33.207. Prescribing, administering and dispensing controlled substances for Dentists.
(a) When prescribing, administering or dispensing controlled substances as defined in section 4 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § 780-104), a dentist shall comply with, or cause compliance with, the following minimum standards:
(i) In good faith in the course of the dentist’s professional practice.
(ii) Within the scope of the dentist-patient relationship.
(iii) In accordance with treatment principles accepted by a responsible segment of the profession.
Section 2 covers the Dental examination and medical history required by a Dentist practicing in Pittsburg, “A dental examination shall be conducted and a medical history shall be taken before a dentist initially prescribes, administers or dispenses a controlled substance to a patient. The examination and medical history shall be complete enough to justify the prescription, administration or dispensation of the controlled substance. The examination shall focus on the patient’s dental problems, and the resulting diagnosis shall relate to the patient’s specific complaint. The patient’s dental record shall contain written evidence of the examination and medical history.”
Section 33.207(a)(3), states any time a controlled substance is prescribed, administered or dispensed, the records patients dental record must contain the following information:
(A) The name, quantity, and strength of the controlled substance.
(B) The directions for use.
(C) The date of issuance.
(D) The condition for which the controlled substance was issued.
Under Section 33.207(a)(3)(ii), “ A patient’s dental record that contains entries pertaining to the issuance of controlled substances shall be retained by the dentist for a minimum of 5 years following the date of the last entry of any kind in the record.”
(4) Emergency prescriptions. If an emergency requires the issuance of a prescription, an appropriate short-term prescription may be telephoned to a pharmacist. An emergency prescription for a Schedule II controlled substance shall be covered by a written prescription delivered to the dispensing pharmacist within 72 hours. A dentist may not order a renewal or a refill of an emergency prescription unless the order is in writing and the dentist has given the patient a dental examination and has taken a medical history as required by paragraph (2).
(5) Exception. This subsection, except for paragraph (1), does not apply when a controlled substance is prescribed, administered or dispensed to a patient in a healthcare facility regulated by the Department of Health or by the Department of Public Welfare.
(b) A dentist’s failure to comply with this section will be considered unprofessional conduct and will subject the noncomplying dentist to disciplinary action as authorized in section 4.1(a)(8) of the act (63 P. S. § 123.1(a)(8)).
(c) This section does not restrict or limit the applicability of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § § 780-101—780-144) or of another statute or regulation and does not relieve a dentist from complying with more stringent standards that may be imposed by another regulation or statute.
The importance of a compliance plan goes without saying when the Department of Justice (DOJ) is actively pursuing and looking at dental and medical practices to ensure they comply with Federal and State rules. Find out where you are lacking in your performance before the DOJ tells you.