Controlled Substances in Georgia: A Primer
Controlled substances are defined as "drugs, substances, or immediate precursors included in Schedules I through V of Article II of the federal Comprehensive Drug Abuse Prevention and Control Act (referred to as the ‘Federal Act’)." Within Georgia’s Controlled Substances Act ("CSA"), O.C.G.A. § 16-13-20 through -93, drug classes are generally organized by their addictiveness and potential for abuse. As particular drugs are introduced into the general population, they are evaluated and re-scheduled, as necessary, in a federal CSA and a Georgia CSA.
The primary state body with authority over controlled substances from a regulatory standpoint is the Georgia Composite Medical Board ("GCMB"). The GCMB is empowered to promulgate rules and regulations governing the treatment of patients by licensed physicians. The prescribing and dispensing of controlled substances, regardless of whether prescriptions for them are issued legitimately, are unregulated medical matters subject to review by the GCMB . And when acting in accordance with its rule-making authority, the GCMB has wide discretion.
O.C.G.A. § 16-13-21 provides that In determining whether a drug or another substance referred to in Code Section 16-13-22 through 16-13-25 is to be classified as a controlled substance, the Department of Human Resources [through drugs and substance abuse experts] shall consider the following factors: producing, or having a sociopolitical impact on, these various classifications. Essentially, a drug can only be placed at the highest CS Schedule I level if it passes a rigorous scientific test that shows that it has absolutely no legitimate medical use. The higher levels give these drugs some legitimate medical uses. This hierarchy is important to understand because it is not unusual for a prosecutor to try to charge a controlled substance that is less addictive or less dangerous than the ones that the person is actually accused of distributing.
Prescribing Legal Controls
Legal requirements for prescribing controlled substances in Georgia
Physicians, psychologists, physician assistants, nurse practitioners, and optometrists are considered authorized providers for purposes of issuing an official prescription of a controlled substance. Under O.C.G.A. §16-13-71(e), the following individuals can issue an official prescription: physicians, dentists, podiatrists, advanced practice registered nurses certified by the Board of Nursing pursuant to Chapter 26 of Title 43, physician assistants registered with the Composite State Board of Medical Examiners under Code Section 43-34-102, and optometrists licensed under Chapter 30 of Title 43 who are certified to use therapeutic pharmaceutical agents pursuant to Code Section 43-30-35.13" The statute exempts medical interns to the extent that they are authorized to write prescriptions in the course of their internship under the supervising doctor’s supervision. The physician may be the medical intern’s supervising doctor.
Official prescription forms are defined by O.C.G.A. §16-13-71(a)(11) as follows: "’Official prescription’ means a drug or device prescription order or medication order, written or transmitted to a pharmacy to be filled or dispensed, prepared by an authorized practitioner on an official prescription form which has been validated by the Georgia Drugs and Narcotics Agency as of January 1, 2014. Practice aides are illegal and do not conform to Georgia law. They expose the provider to both professional misconduct and criminal prosecution."
As of January 1, 2014, all prescriptions for a Schedule II controlled substance must be issued on an official prescription form. Pursuant to O.C.G.A. §16-13-71(a)(12)"’Official prescription form’ means a counterfeit-resistant prescription form, which meets the specifications established by the Georgia Drugs and Narcotics Agency, which may be issued for the prescribing of controlled substances; provided, however, that such term shall not include prescription drug orders transmitted orally or electronically." O.C.G.A. § 16-13-71.1(b) further states that drug orders transmitted electronically must be issued immediately prior to transmitting the order and cannot be pre-signed or have any other signature affixed thereto.
The official prescription form must include: the practitioner’s license number; the quantity of drug in both written and numerical form; directions for use of the drug in written form; the date of issuance; the signature of the practitioner; and the patient’s name, address, and age. If the drug is for a medical patient, the practitioner must mark "medical patient" on the prescription form.
The Prescription Drug Monitoring Program (PDMP) in Georgia
In 2011, Georgia implemented the Prescription Drug Monitoring Program (PDMP). This is an electronic controlled substance database that all practitioners, pharmacies, pharmacists, and healthcare entities may utilize to assist with tracking and monitoring patients’ controlled substance prescriptions. In utilizing the PDMP, we can help deter prescription drug abuse, catch early signs of abuse, and catch diversion of these medications. Prescription representatives may now view each patient’s controlled substance history from all prescribers and all dispensers. The PDMP collects, stores, and transmits all Schedule II, III, IV, and V controlled substances that are dispensed to Georgia residents. It includes information on both controlled substance medications dispensed against prescriptions and medical providers who are licensed to write Georgia prescriptions. All collected PDMP data is protected and secure. It does not include any drug testing or urine drug screen results.
Practitioners should initiate utilization of the PDMP beginning October 2015. Some practitioners do not have usernames and passwords to access the PDMP site and they must request these now. If practitioners have been utilizing the PDMP, they must ensure that their usernames and passwords have not expired and that they can still access the site. Practitioners can access patients’ PDMP prescription fill histories on the PDMP website. Practitioners are also able to delegate access to the PDMP. Only the practitioner listed as the prescriber can delegate to other individuals, such as nurses and administrative staff. A practitioner must be physically present in the office when the delegate accesses the PDMP for their account. Delegated individuals cannot access another practitioner’s PDMP data and are not allowed to give or sell the practitioner’s data. Practitioners cannot delegate their PDMP access to other practitioners. To register for an account, practitioners should go to the Georgia PDMP website. Please note that there was an uptick in prescribing prior to the PDMP’s initiation, which could adversely affect the pain management practice because many patients believe they will not be enabled to obtain medications as easily once the PDMP is initiated. We will not see the full impact of the PDMP until it has been active for some time.
Rights and Responsibilities of Patients
No matter how you slice it, the simple fact is that medicine, and especially pain management, are complex endeavors. It is commonly accepted that no doctor or clinic can be expected to be perfect. However, some things are well within a practitioner’s control. This is especially true where, to be blunt, "pill mills" have created a situation in which they frequently may not be held accountable for their actions. This is especially true if you’re not one of the shrinking number of "responsible" providers who are still willing to prescribe appropriately under the current circumstances.
For this reason, it’s incumbent on every responsible provider to inform patients of their rights and responsibilities when it comes to drug prescriptions. In Georgia, that basically comes down to a few simple principles.
First, consent is always required. A patient has the right to enter into a written agreement with his or her prescriber for drugs that fall under either Georgia or Federal level II, III, and IV controlled substances. Non-compliance with an agreement can lead to criminal penalties for the doctor involved in the form of civil fines. Because of such consequences, physicians find themselves under constant scrutiny when they agree to treat patients with such medications. Legal counsel for a physician should be consulted whenever a patient is treated with these drugs.
Second, there are standards in Georgia and Federal minimum standards that need to be adhered to when it comes to the consent process. All patients must be completely and fully advised of the benefits and risks associated with treatment. This is no small matter, especially in chronic pain situations . In addition, patients need to be informed of alternatives to the proposed treatment, if any are available (sometimes there are none). Consent is a voluntary process; accordingly, no one can be forced to consent to a procedure. In short, the patient should feel free to walk away from the treatment at any time, even after providing consent.
Another important piece of information for patients is that Virginia has adopted the Health Insurance Portability and Accountability Act (HIPAA). This is basically a privacy law that provides safeguards against the disclosure of protected health information. If your records end up disclosed accidentally, you have the right to file a complaint with the provider and/or the Department of Human Health and Services (DHHS). By filing a complaint, you can potentially improve the care of others using that provider in the future.
Patients should also be advised of their right to receive treatment in a manner that does not interfere with family, employment, or other such activities. Responsible pain providers understand that addiction is a risk that should be weighed against the potential benefits of the medication prescribed. There are significant privacy issues that need to be considered during this process, and providers have been known to seek informed consent from patients who have been through the process before. This is to determine whether or not the patient has ever been addicted to prescription drugs previously and if so, whether they have managed through withdrawal in the past. Patients should be counseled about the potential ramifications of treatment with controlled substances; doctor’s and clinics should have the primary responsibility for ensuring that suffering patients are treated properly.
Criminal Penalties for Non-Compliance
The penalties for violating Georgia’s controlled substance prescription requirements are significant for both practitioners and patients. While the medical community is sanctioned primarily through actions by the Georgia Composite Medical Board, the consequences to patients for violating the law can come in the form of criminal prosecution or even civil litigation.
Healthcare Providers:
For practitioners, violations generally fall into one of two categories: violations pertaining to the actual prescribing of controlled substances and violations pertaining to record keeping. For both types of violations, the standard for "harm" to patients is minimal. For record keeping violations, the Board may sanction a practitioner even where harm to patients cannot be shown. In the context of prescribing violations, such as writing prescriptions for purposes other than the treatment of a patient’s injury, illness or disease, the law states, a practitioner may subject himself to disciplinary actions by exhibiting the following "unprofessional conduct": "(A) Prescribing or dispensing drugs or recommending any drug for other than legal medical purposes; or (B) Prescribing, dispensing, or recommending any controlled substance without the existence of a valid physician-patient relationship; or (C) Prescribing, dispensing, or recommending any drug for other than medically accepted uses and in manners and amounts inconsistent with accepted standards of medical practice." As set forth above, the above standards must be met only to "subject the practitioner to any and all disciplinary actions" by the Board, which would include a fine, probation, suspension, or revocation of licensure.
Patients:
For patients, the penalties range from criminal prosecution to civil litigation for personal injuries based upon allegations of medical malpractice. O.C.G.A. § 16-13-30(b) makes it illegal for a person to knowingly obtain or attempt to obtain any controlled substance by fraud, deceit, misrepresentation, or other such means. Under this Code section, a person convicted of such an offense is guilty of a felony and can be punished by 2-15 years of imprisonment. Furthermore, where a patient obtains a prescription not only by practicing fraud or deception but also obtaining a prescription from more than one provider "without fully disclosing to each physician from whom such person seeks a prescription the previous or existing prescription sought from another physician or the other physicians," such person can not only be criminally prosecuted under O.C.G.A. § 16-13-30(b), but also be found civilly liable under O.C.G.A. § 16-13-30(c) for any injuries proximately caused by the patient’s obtaining the unlawful prescription.
Unfortunately for patients, and practitioners alike, there may also be significant financial incentives to violate Georgia’s controlled substances laws. Where a patient obtains prescription drugs through fraudulent means and sells those drugs for a profit, he or she may be in violation of O.C.G.A. § 16-13-30.1, which states that "[n]o person shall, except as authorized by Article 2 of this chapter, manufacture, deliver, possess with intent to manufacture or deliver, or possess with intent to manufacture or deliver more than two hundred (200) doses or dosage units of any controlled substance during any single transaction or at any time within any 30-day period." Code section 16-13-30.1 then establishes mandatory minimum sentencing requirements. For example, where the amount of controlled substances possessed is more than 200 doses, the offender faces 2-8 years of imprisonment, and is subject to a fine of $2,000-$10,000. A conviction under this Code section is considered a felony and any sentence must be served without parole, probation, or furlough.
Recent Developments and Changes in the Law
In the wake of the ongoing opioid crisis and a crackdown on the illegal diversion of medications, Georgia has seen a few notable recent changes when it comes to the controlled substance prescription laws. In 2017, House Bill 249 was signed into law, making it mandatory for all prescribing physicians to apply for and receive a Drug Enforcement Agency (DEA) permit number in order to prescribe controlled substances under the Georgia Controlled Substance Act [O.C.G.A. § 16-13-190 et sequi (2010)]. This applies to all prescribers, including nurse practitioners and physician assistants (PAs), midwives and doctors of osteopathy, amongst many others. Before this law, these medical professionals would basically do the "paperwork" work of getting prescriptions issued by their physician supervisors at the time that they were writing a prescription. In 2017, one of the most substantial changes in the Georgia controlled substance prescription law was initiated with the passing of House Bill 249. HB 249 also initiated a mandated two-day, four-hour continuing medical education (CME) credit hour requirement, which must be completed by all doctors who prescribe controlled substances. Another House Bill 249 requirement is that all controlled substance prescriptions must be transmitted (in written or electronic form) to the pharmacy by the physician who actually writes the prescription and cannot be provided to the patient first . The only exception to this is when a situation of an emergency occurs, where the doctor may authorize a prescription for a 72-hour/three-day supply of the medication.
In mid-2018, the Georgia Controlled Substance Monitoring Database requiring all prescribers to log prescriptions online within 24-hours of issuance of the prescription was officially implemented. This database is accessible by all prescribers, dispensers, and authorized law enforcement officials to search patients’ prescription history in order to identify individuals who could benefit from referral and treatment. All Georgia prescribers register with the Drug Database to access this tool. In addition, pharmacies are now required to provide documentation when dispensing any controlled substances that are exempt from the usual prescription requirement, like over-the-counter medications containing pseudoephedrine. Also, beginning in late April, Georgia legislators started studying the possible elimination of the current 90-day supply limit oriented towards chronic pain patients. Proponents of this change argue that it would eliminate the stigma against long-term chronic pain management patients. So far, this law has only been studied, but not yet enacted.
