Complete Guide to Controlled Substances!

What are controlled substances?

The Controlled Substances Act was passed in 1970 and laid out the foundations for how controlled substances should be handled. This includes the storage of these drugs as well as the documentation that needed to be completed for records and safety purposes.

There are five classes – or schedules – of controlled substances. Schedule I drugs have the highest abuse potential whereas later schedules have lower abuse potential. The DEA – or Drug Enforcement Agency – oversees how controlled drugs are handled and managed within healthcare settings.

The DEA can if it chooses to, opt to add a drug from a schedule or to change drugs within different schedules. Furthermore, drug manufacturers can lobby for changes within these schedules.

Here are some example drugs that are included in each of the 5 schedules:

• Schedule 1 – LSD, heroin, crack cocaine, marijuana
• Schedule 2 – amphetamines, fentanyl, methadone
• Schedule 3 – combination narcotics
• Schedule 4 – hypnotic and benzodiazepine drugs
• Schedule 5 – Cough preparations with codeine; Lomotil, too

Bear in mind that some of these drugs – such as marijuana and cocaine – are now used in some states for therapeutic purposes, or for the purpose of cosmetic surgery.

How are Controlled Substances Handled?

Due to the nature of controlled substances and their abuse potential, it was vital that an organization – such as the DEA – was established to oversee how these drugs are managed and monitored in the pharmacy setting.

For the PTCB exam, candidates are expected to have a thorough understanding of the above schedules – as well as examples of drugs included in each – as well the conditions required of pharmacies and other healthcare settings in maintaining and monitoring how these drugs are stored, documented, and dispensed:

• When ordering schedule II drugs, DEA Form 222 must be completed and signed by the pharmacist. Forms are issued in triplicate form; with one of the forms retained by the drug supplier, the second by the pharmacy, and the third sent to the DEA. There are ten lines in each order form and the signature provided must be that of the registrant or the individual assigned as the power of attorney. However, many pharmacies now use digital means to order Schedule II drugs. This is known as the Controlled Substance Ordering System (CSOS), permitting more rapid processing of the receipt of these drugs. As paper is not used, it also reduces the risk of error.
• Upon receiving the order, the pharmacist must confirm that the correct medicinal order has been received.
• Containers for controlled substances can be identified as they always bear a large red C along with the schedule of the medicine.
• For schedule III through to V drugs, Form 222 does not need to be completed.
• Expired or damaged controlled substances must be reported to the DEA using Form 41. Expired drugs should never be returned to the manufacturer.
• If controlled substances have been stolen, Form 106 must be completed and sent to the DEA as soon as possible.
• These documents must be stored within the pharmacy for at least 2-years, depending on individual state requirements.
• Secure prescriptions for Schedule II drugs may be initially refilled up to 6-months after the prescription date.
• For Schedule III through to V drugs, they may be refilled 5-times within a 6-month period.
• Prescriptions for Schedule II substances may not be taken over the phone. Telephone prescriptions are permitted to be taken for all other drugs.

Final Thoughts

As a pharmacy technician, it is incumbent upon you to understand the role that controlled substances play in the pharmacy setting:

• Why these drugs are controlled?
• How are these drugs ordered?
• What documentation must be filled?
• How these documents are filed and for how long?

By committing these details to memory, it will serve you well on the day of your PTCB exam. MCQ questions on controlled substances can appear right throughout the exam – whether it’s the Medication section, the Federal Requirements section, or the Order Entry and Processing section. This is one of the core subjects that you need to have a robust grasp of.

If you have an account with PTCB Test Prep, you already have access to your learning portal where you can learn more about controlled substances. If not, take a few moments to register now.