On February 5, 2009, U.S. District Judge Stephen Robinson in the Southern District of New York sentenced a pharmacist, Ivan Romero, to a term of imprisonment of 5 years and ordered him to pay restitution in the amount of $36,158.49. The sentence followed Romer’s entry of a guilty plea to illegally distributing and dispensing Oxycodone, a Schedule II controlled substance, without a valid written or oral prescription.
According to the documents filed in the case, Romero worked as a supervising pharmacist at the Broadway Pharmacy in White Plains, New York. Romero was responsible for running the pharmacy operation, filling prescriptions, and ordering and dispensing medication, including controlled substances, from the pharmacy’s suppliers. During that time Romero took Oxycodone and Hydrocodone, both of which are controlled substances, from the pharmacy’s stocks and distributed it for unlawful, non-medical, purposes. Pharmacy records show that Romero unlawfully diverted 348 grams of Oxycodone and 295.86 grams of Hydrocodone in this manner. There are approximately 453 grams in a pound so over 1/2 pound of each drug was dispensed illegally.
COMMENTARY. THIS CASE IS A REMINDER AS TO THE DEA REQUIREMENTS FOR PHARMACIES AND PRACTITIONERS WHO DISPENSE SCHEDULE II CONTROLLED SUBSTANCES.
Pharmacies, physicians and other practitioners who dispense and store Schedule II controlled substances must be vigilant in complying with DEA requirements. In this case, given that the pharmacist stole the controlled substances – the pharmacy should have been able to tell there was a theft or significant loss. In this case, the pharmacy would have been required to report the theft or loss of any controlled substances within one business day of discovery of such loss or theft. The practitioner would have also had to complete and submit DEA Form 106 which may be found at http://www.deadiversion.usdoj.gov/.
The DEA’s rules are strict and violation can result in significant fines and potential loss of DEA number. Each practitioner must maintain inventories and records of controlled substances listed in schedule II separately from all other records maintained by the registrant. Likewise, inventories and records of controlled substances in schedules III, IV, and V must be maintained separately or in such a form that they are readily retrievable from the ordinary business records of the practitioner. All records related to controlled substances must be maintained and be available for inspection for a minimum of two years.
A registered practitioner is required to keep records of controlled substances that are dispensed to the patient, other than by prescribing or administering, in the lawful course of professional practice. A registered practitioner is not required to keep records of controlled substances that are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment.
Pharmacies and practitioners should conduct regular audits of the records and have someone in charge of the records who is not involved in dispensing so the risk of diversion is minimized. As part of the audit, check the records of the suppliers to ensure that it all matches up. We have seen pain management clinics who have been subjected to over $1 million in fines for not having the proper record keeping required by the DEA. Even though the clinics were not diverting the Schedule II substances, unknown employees had done so. When the DEA got involved the lack of record keeping caused significant DEA issues even though there were no criminal charges against the clinics.
Be well-prepared for DEA audits in advance and make sure that you have proper legal advice and follow-up so that your staff is strictly following the rules. It is too easy to get lax or forget how important these issues are for the business health of your pharmacy or medical clinic.
Any questions or comments should be directed to: firstname.lastname@example.org. Tracy Green is a principal at Green and Associates in Los Angeles, California. They focus their practice on the representation of individuals, businesses, and licensed professionals, particularly health care professionals and businesses including pharmacies, pharmacists, pain management clinics, weight loss clinics, individual physicians, corporate providers and group practices, in civil, administrative and criminal cases.