How to Survive a DEA Inspection Series: Controlled Substances and Hospital Pharmacy

Why Should You Attend:

It is important to understanding DEA regulations required of a hospital pharmacy. This training will give attendees better insight into steps to take to prevent the illicit use or diversion of any controlled substance by hospital staff.

This presentation will provide effective record-keeping and security procedures and will outline the due diligence required of a hospital in order to prevent diversion of drugs by their employees. The presentation is tailored for hospital senior and their mid-management, pharmacy managers and pharmacists who are responsible for administering, dispensing and prescribing Schedules II through V controlled substances that are purchased for hospital use.

Areas Covered in the Webinar:

• Role of DEA – Familiarize participants with the authority given to DEA when enforcing the laws and regulations pertaining to controlled substances and regulated chemicals.
• Controlled Substances Act – Briefly describes the civil actions that may be imposed on a hospital’s DEA registration for failures to comply with stringent DEA regulations pertaining to administering, dispensing and prescribing narcotic drugs.
• Due Diligence – This section provides numerous steps to take to prevent, detect, and investigate the theft, loss or diversion of controlled substances in a hospital setting and recommendations to be compliant with DEA regulations.
• Use of Automated Dispensing Systems – It is important for pharmacy management to closely monitor activities within the use of such automated dispensing systems (ADS) such as a Pyxis dispensing machine.
• Storage and Dispensing – This section covers the storage and dispensing of narcotic drugs from the hospital pharmacy to various ADS within in-patient wards, emergency rooms, treatment areas and hospital surgical areas.
• DEA Recordkeeping Requirements – This section covers the required records to be maintained in order to comply with DEA regulations. Records include receiving/shipping order forms and invoices, inventories, drug destructions, and theft/loss reports.
• DEA Security Requirements – This section covers the steps that a hospital can take in order to be in full compliance with DEA security requirements.
• DEA Drug Disposal Policy – Recently DEA developed a new regulation pertaining to the disposal of controlled substance in a hospital setting. Hospital pharmacies will need to maintain a method to destroy patient specific medications.

Who Will Benefit:

• Senior and mid-level managers
• Pharmacy managers and pharmacists

Carlos M Aquino
Consultant, PharmaDiversion, LLC

In January 2009, Carlos M. Aquino retired from the DEA Diversion and founded PharmaDiversion, LLC as a pharmaceutical consultant specializing in DEA controlled substance issues. His other work experience in the field includes 12 years with the Philadelphia Office of DEA and assigned to their diversion group (eight years as a diversion investigator and four years as a group supervisor).

Mr. Aquino has also served 24 years with the Philadelphia Police Department, after which he retired with the rank of police sergeant. During his tenure with them, he served the last ten years assigned to the Philadelphia DEA task force as a street supervisor and an undercover agent conducting illicit and pharmaceutical drug investigations.

Mr. Aquino graduated from Temple University with a BA in Criminal Justice and has also done an instructor’s development course at the DEA Training Center, Quantico, VA.

Topic Background:

Every day the public media report the theft of drugs from a hospital by an employee who was arrested for trafficking in stolen drugs. It could be a medical staff member of the hospital which may have taken the drugs from the pharmacy, their surgical center or never given to the patient. In many cases, the hospital learned that the employee had been stealing the drugs for a long period of time before it is detected by hospital management.

DEA requires stringent record-keeping, security and an effective hospital due diligence policy. The responsibilities are placed on hospital administrators and their management staff for accounting for controlled substances used in a hospital setting. Steps are required to be taken in order to detect and prevent diversion by hospital employees.

Since the passage of the Controlled Substances Act, more emphasis has been placed on hospitals, registered with DEA, to design and operate a system that prevents theft and diversion of narcotic drugs and will immediately detect thefts by their employees.

The responsibilities of a hospital is to assure DEA that all controlled substances purchased for administration is accounted for by the pharmacy and that effective steps are taken to prevent the diversion by hospital staff. The responsibility is not only placed on employees but management, from the immediate supervisor to the senior corporate management.

Violation of DEA regulations may lead to civil actions through the U.S. Attorney’s Office which may result in fines ranging from $10,000 to $25,000 for each violation. It can lead to DEA administrative actions including the modification of drug schedules or revocation of a DEA registration. Civil fine and legal resources may amount to thousands of dollar for failure to maintain an effective record-keeping, security and due diligence when handling and securing narcotic drugs.

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