A pharmacy practice involves many laws and regulations. Over 12% of the questions on the PTCB exam deal with them, so follow the outline below as you study. If there are areas in which you think you need additional practice or help, please consult other resources before taking the test.
Hazardous materials can be defined as any chemical or drug that poses potential harm to the person preparing or coming in contact with it. The Occupational Safety and Health Administration (OSHA) has standards to protect employees who work with hazardous materials. This includes proper personal protective equipment (PPE) and procedures for dealing with different types of hazardous substances. Often, manufacturers of such products send written documentation, known as Material Safety Data Sheets (MSDS), that outline appropriate handling, storage requirements, and cleanup procedures for the hazardous product.
The storage requirements of hazardous materials are often dependent on the type of material. Regardless of the type, hazardous materials and chemicals should be stored separately from other materials. Often, they can be stored in a negative pressure room where they will later be handled.
Extreme caution should be used when handling a hazardous material. When near, or in contact with, any of these types of materials, you need to use personal protective wear as outlined in the MSDS for that specific product.
Disposal of hazardous waste must be separate from the disposal of other waste and the waste must be labeled as “hazardous drug waste.” It also needs to be stored in a leakproof container that is labeled as such until it is disposed of safely.
In case of accidental exposure to hazardous material, you should be aware of the equipment available in your workplace to emergently help minimize exposure and injury. This could include an eyewash station, shower, or other emergent cleaning mechanism. Follow the instructions on the MSDS for the specific product with which you are working. Follow all instructions for cleanup of the hazardous materials, including the use of specific spill kits that allow you to safely clean the product. It is also important to report any incidents to your supervisor.
Always use caution when manipulating or using any hazardous materials. Follow the instructions on the MSDS for the product and the safety regulations of your specific work area. If unsure of the appropriate procedure for storing or handling materials, ask your supervisor. Doing so can help prevent accidental exposures.
Depending on the type of chemical and level of exposure, the management may vary. Always inform your supervisor of an accidental exposure and follow the recommendations outlined in the MSDS for the product you are using. In the event of facial or eye contact with a hazardous substance, remove any contact lenses prior to washing out the eyes and do not reinsert the lenses. Use the appropriate eye wash station to irrigate your eyes. If unavailable, use hands to flush eyes with water for at least 15 minutes. In the event of skin contact, remove any contaminated clothing immediately and rinse the area for at least 15 minutes.
Schedule II drugs cannot be transferred.
Schedule III-V drugs can be transferred between pharmacies one time, unless the pharmacies share an online, real-time database. In that case, the prescription can be transferred between the two locations until it expires or there are no refills left. All transfers must occur between two pharmacists. The prescription should be voided by the original pharmacy after transfer and a notation that it is a transferred prescription should be written by the current pharmacy. The following need to be included when transferring a prescription:
original prescription date and dispensing date
number of refills remaining
the name of the transferring pharmacist
the DEA number, name, and address of the transferring pharmacy
According to the Comprehensive Drug Abuse Prevention and Control Act of 1970 (also commonly referred to the Controlled Substances Act of 1970), all controlled substances need to maintain accurate and up to date records and inventory. A complete and accurate inventory of all controlled substances helps maintain the pharmacy’s inventory and keeps the pharmacy aligned with federal regulations. It can also help prevent drug diversion and misuse of medications. The regulations for record-keeping can be broken up into three categories: schedule II, schedule III-V, and non-controlled substances. The following documentation guidelines focus only on the requirements of the first two groups.
Schedule II must be ordered using a DEA 222 form. This form is specific to Schedule II drugs, must be completed in triplicate, and can be handwritten or typed. The three copies are retained by different stops in the supply chain to ensure consistency. The top copy is for the supplier of the schedule II medications, the middle copy is sent to the DEA, and the bottom copy is sent back to the purchaser. Once filled out, the DEA 222 form is valid only for 60 days. A maximum of 10 different medications can be ordered on one form, and the form must be signed by the pharmacist who is registered with the DEA. The registrant pharmacist is typically the pharmacist in charge or the pharmacy manager.
Alternatively, a Controlled Substance Ordering System (CSOS) can be used in place of a DEA 222 form for ordering Schedule II drugs. The pharmacy must meet specific electronic requirements to ensure digital security when using the CSOS.
There are no special ordering requirements for Schedule III-V drugs. They can be ordered through the same mechanism as non-controlled medications.
After receiving an order, the pharmacist in charge must verify each item and document the date each was received on copy three of the original order form that accompanies the order. Copy 3 of each order form must be maintained in the pharmacy for at least 2 years.
There are no special receiving requirements for Schedule III-V drugs. Follow the rules for non-controlled drugs.
Controlled substances may be returned to the supplier. The pharmacy must fill out a DEA 222 form to return Schedule II drugs.
In the event of lost or stolen controlled substances II-V, the DEA and local law enforcement must be notified immediately. The pharmacist must then fill out a DEA 106 form that details the medications involved in the theft. The original form is sent to the DEA and a copy should be retained for the pharmacy’s records. Spilling a small amount of a liquid or breaking a few tablets does not need to be reported. Only a significant loss of controlled substances requires a DEA 106 form.
Outdated, damaged, or unwanted controlled substances may be destroyed under the authorization of the DEA. To destroy the medications, the pharmacy or distributor must fill out a DEA 41 form. The form must contain:
dates, location, and method of destruction
the NDC, name, strength, dosage form, and quantity of the medications being destroyed
signatures of two witnesses of the destruction (should be employees)
To prescribe controlled substances, a provider must have a valid DEA number. It is the responsibility of the pharmacist to verify the DEA number as being accurate. In general, the DEA number consists of two letters followed by seven numbers. The first letter identifies the type of DEA registrant and the second number is the first letter of the prescriber’s last name.
To verify the DEA number, follow these steps:
Add the first, third, and fifth numbers together.
Add the second, fourth, and sixth numbers together.
Multiply the sum in the second step by 2.
Add the total from steps 1 and 3 together.
Verify that the second digit of the sum in step 4 is the same as the last digit of the prescriber’s DEA number.