Dealing with controlled substances used for pain therapy (Proceedings)

The Controlled Substance Act was initiated to stop the diversion of narcotics, especially opioids for the purpose of abuse and misuse. Opioids are the number one cause of death in drug overdoses. The Act is aimed at giving us, the practitioner, some reasonable guidelines for ordering, storing, handling and prescribing these drugs.

The four most common pitfalls that Special Agents of the DEA run up against are: Bi-annual inventories not being done, poor record keeping, lack of screening of employees and theft. These, among other items will be discussed

Registration. Every person or entity that handles controlled substances must be registered with the DEA. This means every person in the practice that prescribes or directs to be administered a controlled substance, must be registered. You can register three ways. www.deadiversion.usdoj.gov Any DEA field office. By phone at 1800-882-9539. Always keep your registration certificate onsite at the location of the drugs.

Security. Every registrant is required to maintain adequate security against theft. Location of the premises, types of controlld substances and volumes maintained determines the type of security you need to maintain. Low crime areas with minimal amounts of drugs may only need a locked cabinet. High crime areas or clinics with large volumes of drugs should have an immoveable large locked metal cabinet or vault. All thefts should be reported immediately to the DEA field office

Employees. Every employee handling a controlled substance should have a background check. The DEA field office will perform a background check on an employee if they receive a signed letter by both the administrator and the employee on letterhead requesting the background check as provided for in Section 1301.93 in the Code of Federal Regulations. You should include this information in the letter.

Safeguards. Keep prescription pads in a safe place. Write numbers of quantity and refills as an integer. Never send home a "note" on a prescription pad. Never pre-sign prescription pads. Always assist the pharmacist if they call with a question on a written prescription. Contact the local DEA if you suspect that someone might be diverting. Use tamper resistant prescription pads for controlled substances.

Inventory. Schedule II paperwork must be kept separate from all other scheduled drugs, and they must all be kept separate from other business records. You must maintain these records a minimum of two years. You must also do a bi-annual inventory of drugs on hand. They won't fault you for doing them more often. The bi-annual inventory must contain the following information. 1. Whether the inventory was done at the beginning or end of the day. 2. The names of the drugs inventoried. 3. Each finished form of the drug, (e.g. 100 mg tabs). 4. The number of doses per container. 5. The number of containers. 6. The disposition of the drugs.

Disposal of Controlled Substances. Contact your DEA office, they all handle each situation differently. Some allow self-destruction of drugs, others use reverse distributors.

Prescriptions. Make sure each prescription has the patient's full name and address, the veterinarian's full name and address and DEA number, the drug name, the strength, the dosage form, the quantity, directions, refills and that it is written in ink or typewritten, then signed by the doctor.

References.

www.deadiversion.usdoj.gov/index/html