The Next Wave of Civil, Criminal, and Administrative Liability: The Georgia Prescription Drug Monitoring Program

The Georgia Prescription Drug Monitoring Program (PDMP) is an electronic database used to monitor the prescribing and dispensing of controlled substances in the state of Georgia. The law is already in effect and regulates physicians and pharmacists in the state of Georgia beginning January 1, 2018. As of July 1, 2018, physicians and pharmacists must comply with the requirements set forth in the PDMP. If you are not already signed up and in compliance with the PDMP, your medical or pharmaceutical license is at risk, and you are potentially at risk of lawsuits, penalties, and even criminal charges under the new PDMP.

Recent Trends in Georgia

The PDMP was put into place in Georgia to respond to the ongoing opioid crisis. The PDMP is a one-two punch that requires Dispensers to upload prescriptions information into the PDMP and requires Prescribers to reference that information when prescribing controlled substances to patients. The opioid crisis is on the cusp of being the next big wave of lawsuits (think cigarette manufactures of the 1990s), and already we have seen the Georgia Legislature and the corresponding professional boards respond to the public outcry regarding opioids.

We have already begun to see increased litigation regarding opioid prescribing practices, and we have begun to see a coinciding response by the Georgia Composite Medical Board. The Georgia Board of Pharmacy and Georgia Board of Nursing will likely soon follow if they have not already begun to take action.

Additionally, we have already seen random chart audits by the Georgia Composite Medical Board for prescribers with DEA licenses. In short, this is an issue that healthcare professionals cannot afford to ignore.

Who Does the PDMP Cover?

The Georgia Prescription Drug Monitoring Program is set forth at O.C.G.A. § 16-13-57 et seq. as part of the Georgia Controlled Substances Act. The PDMP applies to two broad categories of healthcare professionals: Dispensers and Prescribers.

A Dispenser is defined as any healthcare professional who is licensed to dispense or deliver a Schedule II, III, IV, or V drug as well as benzodiazepines ("Controlled Substances"). Please note that "dispense" is defined so broadly by the Georgia Legislature that it might actually include healthcare providers who prescribe controlled substances.

A Prescriber is any physician or other person who is licensed by the State of Georgia to prescribe Controlled Substances.

Those practitioners who maintain both a medical license and a pharmacy license should be aware that they may fall under both classifications under the PDMP.

Requirements of the PDMP

To register for the PDMP, please go to https://georgia.pmpaware.net. Requirements set forth by the PDMP can be broken into three subparts: Prescribers, Dispensers, and delegates.

Prescribers

Prescribers must look up and review the PDMP database each time the patient is prescribed a Controlled Substance and again at least once every 90 days thereafter. There are several exceptions to this look-up requirement, including the following:

● Prescription is for no more than a three-day supply and no more than 26 pills;

● The patient is in a hospital or health care facility and the pills will be administered and used on that premises;

● The patient has had outpatient surgery at a hospital or ambulatory surgical center and the prescription is for no more than a 10-day supply and no more than 40 pills;

● The patient is terminally ill or under the supervised care of an outpatient hospice program; or

● The patient is receiving treatment for cancer.

Please periodically check O.C.G.A. § 16-13-63(a)(2)(A)(i)-(v) for updates on these exclusions.

In addition to checking the PDMP each time the Controlled Substance is prescribed and every 90 days thereafter, the Prescriber must also do the following:

● Make, or cause to be made, a notation in the patient's chart stating the date and time upon which the inquiry was made to the PDMP and the name of the individual who made the search and review.

This information will likely be recorded by the PDMP search engine to cross-check and verify the accuracy of the medical professional's chart notations.

Dispensers

Dispensers must enter certain information into the PDMP each time a prescription is dispensed. The information that must be reported includes, but is not limited to, the following:

● DEA permit number or approved dispenser facility controlled substance identification number;

● Date the prescription was dispensed;

● Prescription serial number;

● If the prescription is new or a refill;

● National Drug Code (NDC) for drug dispensed;

● Quantity and strength dispensed;

● Number of days supply of the drug;

● Patient's name;

● Patient's address;

● Patient's date of birth;

● Patient gender;

● Method of payment;

● Approved prescriber identification number or prescriber's DEA permit number;

● Date the prescription was issued by the prescriber; and

● Other data elements consistent with standards established by the American Society for Automation in Pharmacy, if designated by regulations of the department.

This information must be submitted within 24 hours of the issuance of the prescription. If a Dispenser does not dispense any Controlled Substance within a 24-hour period, the Dispenser shall still make a report to the PDMP indicating that fact.

Delegates

The PDMP does allow for Prescribers and Dispensers to delegate the certain duties of complying with the PDMP to a very limited number of persons (two delegates per shift or rotation). Prescribers and Dispensers should note that they may only delegate to individuals to retrieve and review documentation from the PDMP in very limited circumstance and, of course, the Prescriber and Dispenser are civilly and criminally liable for the actions or inactions of their delegates.

Delegates must meet specific requirements. They must be members of the Prescribers or Dispenser's staff. They must hold a current license as a dentist, dental hygienist, optometrist, physician, physician assistant, podiatrist, pharmacist, pharmacist intern, or pharmacist technician (it does not appear that nurses or non-clinicians can be a delegate as stated in the Georgia Department of Public Health Regulations). However, the Georgia Attorney General's Office has issued an official opinion allowing physicians and pharmacists to delegate their PDMP responsibilities to registered nurses and licensed practical nurses. (Georgia Attorney General Official Opinion 2016-7). Additionally, a delegate must be free from felony conviction or any conviction regarding drug use, possession, or sale. Prescribers and Dispensers who wish to make use of a delegate should closely read the requirements of the Georgia Administrative Code § 511-7-2-.04.

Prescribers and Dispensers should note that the PDMP does not explicitly allow Prescribers and Dispensers to delegate the responsibility of verifying information from the PDMP and entering information into the PDMP. Instead, while delegates are allowed to review information in the PDMP and report it to a Prescriber, the statutes do not actually explicitly state that this absolves Prescribers and Dispensers of their obligations to perform their respective required actions under the PDMP.

Common sense would suggest that if a delegate is authorized to access the PDMP, and that person is called a "delegate," the delegate should be allowed to operate in place of the Prescribers and Dispensers. However, until this aspect of the law becomes clear, a better practice would be for Prescribers and Dispensers to satisfy their respective obligations in lieu of using delegates.

As stated above, the regulations issued by the Georgia Department of Public Health Regulations suggest that delegates cannot be nurses or non-clinicians. However, in a telephone call placed to the Georgia Department of Public Health PDMP hotline, staff members have confirmed that nurses and non-clinicians can both serve as delegates and perform all of the duties and obligations required of Dispensers and Prescribers. In a similar vein, the Georgia Attorney General's Office has decreed that RNs and LPNs can serve as delegates, but this opinion does not explicitly reach a ruling on non-clinicians as delegates other than authorizing "staff" to serve as delegates. This may be a case in which what the law says and how the law is enforced are different, and until this issue is clarified by the Georgia Legislature and the Department of Public Health, practitioners should proceed carefully when using delegates.

One final word of caution on delegates. Delegates must independently register and pass a test to become a credentialed delegate. Delegates should not be accessing the PDMP under a Prescriber or Dispenser's account or log-in information and risk severe criminal penalties for Prescribers, Dispensers, and delegates alike for doing so.

Penalties for Violation of the PDMP

The penalties of violations of the PDMP can be harsh and differ between Prescribers and Dispensers. Both Prescribers and Dispensers can be subject to Board audits and adverse licensure procedures (to include suspension and forfeiture of licensure) for violations of the PDMP, among other remedies. In addition to Board investigations and other administrative penalties, the PDMP imposes other penalties.

Prescribers

Prescribers' liability is unclear under the PDMP as it is currently drafted. In O.C.G.A. § 16-13-63(a)(2)(C), the statute provides that a Prescriber cannot be held civilly or criminally liable to any person for injury, death, or loss to person or property for either looking up a patient in the PDMP database and still prescribing the Controlled Substance or for failure to look up the patient in the PDMP database altogether. However, in O.C.G.A. § 16-13-63(b), the statute states that except as limited in O.C.G.A. § 16-13-63(a)(2), a person who is injured as result of any violation of the PDMP shall have a cause of action for actual damages and punitive damages and can even recover attorney's fees and litigation expenses.

Whether Prescribers will ultimately be liable to patients or their families for violations of the PDMP will remain to be seen, but this potential liability, and certainly the likelihood of administrative penalties and adverse licensure decision, are enough reasons to strictly comply with the PDMP.

Dispensers

Dispensers cannot be held civilly, criminally, or administratively liable for failing to look up the patient in the PDMP. However, in addition to administrative penalties and adverse licensure actions, Dispensers can potentially be held civilly liable for failure to input information into the PDMP.

Additionally, Dispensers can be held criminally liable for knowingly and intentionally failing to input the requisite information, or knowingly and intentionally inputting incorrect information, into the PDMP. Such an offense will result in felony charges with 1-5 years of jail time, up to a $50,000.00 fine, or both.

Additional Liabilities

Any individual (Prescribers, Dispensers, and delegates) who negligently uses, releases, or discloses information from the PDMP or violates the PDMP shall be guilty of a misdemeanor. Any subsequent violation is a felony punishable by 1-3 years of jail time or a fine up to $5,000, or both.

Any individual (Prescribers, Dispensers, and delegates) who knowingly and intentionally uses, releases, or discloses information from the PDMP or violates the PDMP shall be guilty of a felony and can face 1-5 years of jail time or a $50,000.00 fine, or both.

Obtaining information under false pretenses (which could include delegates accessing the information under Prescribers and Dispensers' accounts) can subject that person to a felony conviction with 1-5 years of jail time or a $100,00.00 fine, or both.

Finally, any person who violates the PDMP with an intent to sell the information, obtain a personal or commercial benefit, or maliciously harm the patient shall be guilty of a felony with 2-10 years of jail time, a $250,000.00 fine, or both.

In Summary

As this article highlights, the duties and requirements of the PDMP are detailed and burdensome. The penalties of failing to comply, however, are harsh. Any physician, pharmacist, or healthcare provider in Georgia who prescribes or dispenses with Controlled Substances must immediately comply with the requirements of the PDMP. Additional information can be found at https://dph.georgia.gov/pdmp or by contacting the Author.

William Drought is an Associate at Oliver Maner LLP in Savannah, Georgia. Mr. Drought's practice areas include medical malpractice defense and representing physicians, nurses, and other professionals in front of their respective licensing Boards. Mr. Drought's email address is [email protected], and his telephone number is (912) 236-3311.