Given law enforcement’s current focus on combating the opioid epidemic, controlled substance-dispensing physicians are under increased scrutiny from local, state, and federal governments. Below is a brief overview of the law and regulations covering physicians’ office-based dispensing of controlled substances, specifically those pertaining to prescription drug monitoring, practice management, security, and diversion prevention.

• Routinely monitor compliance with your state’s dispensing and PDMP laws.

Any physician dispensing controlled substances from their office must ensure their practice complies with the applicable federal laws and regulations, namely the federal Controlled Substances Act. They also must know and be in compliance with their respective state dispensing laws.  Some states prohibit physician dispensing, others restrict which controlled substances can be dispensed (or their quantity and frequency), while some states require dispensing physicians obtain an additional license, as well as follow their Board of Pharmacy regulations. Many states regulate who must hand the medicine to the patient, often mandating that only the physician can do so. 

More importantly, physicians dispensing controlled substances must know and comply with their respective state’s Prescription Drug Monitoring Program (“PDMP”) requirements. PDMPs are electronic databases that collect designated information on dispensed controlled substances. After conducting any PDMP mandated prescriber queries, approved physician dispensers must promptly report certain dispensed controlled substance information to their respective state’s PDMP.  In most states, dispensing physicians can delegate the PDMP query and data input to a few specifically identified practice employees.

State legislatures have also amended their state PDMP laws to make them more rigorous in light of the opioid crisis, and law enforcement and professional licensing boards are increasingly scrutinizing PDMP records to track controlled substance prescribing and dispensing rates.

• Protect your practice from theft.

Dispensing controlled substances requires the implementation of a strong system of inventory control and medication security. Having these substances in stock places your practice at greater risk of a break-in and increases the possibility of employee theft.

All controlled substance dispensers are required to provide effective controls to guard against theft and diversion of them and must be bolted or cemented to the floor. Additional controls might include: a wall safe or locked steel cabinet; a storage unit alarm system; video surveillance of medicine storage locations; and employing security personnel. How substantial your security measures need to be is based on your practice location, the type of physical buildings it’s in, the type and quantity of controlled substances stored on the premises, the control of public access to the facility, the adequacy of practice’s alarms and detection systems, and the availability of local police protection.

If you do become a victim of theft, the theft must be reported to the DEA immediately, and may, depending on the state, have to be reported to additional regulatory and law enforcement entities, like the state medical board, state pharmacy board, or local law enforcement.   

• Always prescribe medication for a legitimate medical purpose.

It goes without saying: both prescribers and dispensers are responsible for ensuring that controlled substances are issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. A person who knowingly fills a prescription not issued for a legitimate medical purpose and not in the usual course of professional practice can be found civilly or criminally liable under the Controlled Substances Act. Enforcement actions can cost you your medical license, hospital privileges, DEA authorization to prescribe substances, and revocation of panel participation.

Some state courts have permitted individual controlled substance users who admittedly broke laws to obtain controlled substances to bring civil actions against their doctors and pharmacists for negligent prescribing and dispensing that allegedly caused the users’ drug addiction. Of course, a criminal conviction lead to a prison sentence and a hefty fine and possibly a restitution award.

In addition, malpractice insurance might not provide coverage or even a legal defense for a dispensing physician in a dispensing lawsuit because the court may find that the controlled substances were dispensed not for a legitimate medical purpose and not in the usual course of professional practice.  Such illegal conduct is usually not covered by insurance.  Physicians should contact their malpractice insurance carrier before dispensing controlled substances.

• Check the background of your employees, train yourself and your staff on drug-seeking behavior, and restrict the number of employees with access to controlled substances.

In most cases, physician controlled substance dispensing removes the pharmacist from the prescription review process. Pharmacists often alert physicians to prescribing errors or a patient’s controlled substance prescription history, leading some to conclude that physician dispensing eliminates a crucial second check of the prescribed drug therapy, potentially increasing the chances of diversion. In light of this, physician controlled substance dispensers must be well trained in identifying drug-seeking behavior among their patients and must thoroughly train their employees in how to recognize it. They must screen prospective employees to ensure they do not have past controlled substance and/or theft felony convictions and can be trusted to work in a security stringent office. 

They should also restrict the number of employees who have access to controlled substances and the prescription and dispensing records.  Many instances of diversion start where a physician or the physician’s employee dispenses a controlled substance to a family member, a mistress, or fellow employee “off the books.” Never prescribe a controlled substance to anyone without logging its dispensation. Dispensers must ensure they and their staff are proactive in monitoring the practice’s patients, its drug supply, its PDMP reporting, and its internal records.

And if at all possible, avoid treating and prescribing a scheduled narcotic to anyone near and dear to you.

• Don’t be afraid to dispense controlled substances, but be cautious.

Though the potential liability may dissuade practitioners from dispensing controlled substances, it’s possible to do so in a compliant and safe manner that greatly reduces the chances of diversion and law enforcement scrutiny. Consult with experienced counsel or compliance professionals for assistance. There are no ‘do-overs’ when it comes to the DEA so be sure to get it right the first time.