Page 1 Federal Requirements Study Guide for the PTCB® Exam
This study guide for the PTCB® exam covers all of the material that is on the test as of the January 2020 revision. The previous test material was divided into nine sections, while this new test groups material into only four. The new test assesses mostly the same content, with a few added items which are covered in our new materials.
Of the four areas of study covered in the PTCB® exam, questions about federal requirements occupy only about 12.5% of the entire test, but you’ll need to know this material well. In the old test, these concepts were located in questions about Laws and Regulations and “Sterile and Non-Sterile Compounding*. There do not seem to be any additional concepts assessed on the new test that were not present on the old test.
Handling and Disposal of Pharmacy Substances and Waste
Extreme caution should always be used when handling or disposing of 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 Safety Data Sheet (SDS) for that specific product.
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 Safety Data Sheets (SDS), that outline appropriate handling, storage requirements, and cleanup procedures for the hazardous product. Hazardous materials and chemicals should be stored separately from other materials. Many times, they can be stored in a negative pressure room where they will later be handled. This type of material also needs to be stored in a leakproof container that is labeled as “hazardous drug waste” until it is disposed of safely.
In case of accidental exposure, 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 SDS for the specific product you are working with. Follow all instructions for cleanup of the hazardous materials, including the use of specific spill kits that allow you to safely clean up the product. It is also important to report any incidents to your supervisor.
Non-hazardous materials should also be handled and disposed of in the correct manner, even though they may not pose potential harm to the individual. Although PPE is not required, these materials should also be handled with care. Non-hazardous waste may not pose a risk of potential harm to the individual but may pose a risk to the environment if not disposed of correctly.
These materials have the potential to cause harm if dumped down the drain, which inevitably may end up in our waterways. Depending on the material, they will either end up in solid landfill or destroyed by incineration. Non-hazardous waste can range from materials used to prepare a compounded product to products that have passed their intended expiration date.
A pharmaceutical substance is any substance used for therapeutic treatment. To simplify it, pharmaceutical substances are medications or the ingredients used to make them. Medicine like warfarin, tretinoin, finasteride, and methotrexate fall under the hazardous pharmaceutical substance list. Non-hazardous pharmaceutical substances include drugs like amoxicillin, diphenhydramine, ranitidine, or atorvastatin. Expired pharmaceutical substances can be sent back to the manufacturer for reverse distribution. Vaccines, syringes, and needles must be disposed of in a sharps container to prevent an accidental needle stick.
Controlled substances are medications that carry a high risk for abuse and misuse. These types of medications are highly regulated by the DEA and are categorized into schedules based on their level of potential abuse and misuse. Each pharmacy contains a designated area, such as a vault or locked cabinet, where certain controlled medications are segregated to maintain accurate inventory and reduce the potential for diversion.
The movement of controlled substances from the manufacturer to pharmacy and then from pharmacy to patient is highly regulated by the DEA. Each step in the life cycle of a controlled substance must be traceable to ensure proper handling and minimize any potential for diversion or unethical practices.
Schedule II prescriptions must be sent electronically from the practitioner to the pharmacy or handwritten on a secure prescription blank if the practitioner has a waiver on file (dependent on the jurisdiction). Faxes are only acceptable for hospice or long-term care patients. Telephonic emergency Schedule II prescriptions are limited to a 72-hour supply or enough to cover the emergency period, depending on the jurisdiction. Verbal emergency Schedule II prescriptions must be followed up with an electronic or hard copy per DEA regulations.
To combat the current opioid crisis, some states limit the day’s supply and amount of opioid(s) that can be prescribed to 100 morphine milliequivalents (MME) per day. Anything above this amount would require a certain exemption and ICD-10 code. Nothing on a Schedule II prescription can be altered, even with confirmation from the practitioner. A new prescription would need to be sent if the initial prescription was found to be erroneous or not written correctly by law. The expiration date is based on your state’s regulations, typically within 90 days of the written date, as federal regulations do not suggest a specific time limit.
Remember, with regard to pharmacy regulations, pharmacies must follow both federal and state laws. However, when each is different (for example, the expiration of a Schedule II prescription), the stricter of the two must be followed. Schedule IIs are typically limited to a 30-day supply maximum per state regulations.
Schedule III-V prescriptions can be handwritten, electronically sent, faxed, and even taken over the phone. These have a lesser risk for abuse compared to the Schedule II classification. These prescriptions are valid for six months from the date written and are limited to a 90-day supply maximum per fill.
Schedule II prescriptions are not permitted to be written with any refills. If a patient’s insurance has specific quantity limits or the patient does not want to fill the entire quantity of a Schedule II, the remainder is forfeited and can not be refilled. Hospice patients are eligible to partially fill a Schedule II in increments, and such prescription expires 60 days from the written date. Schedule III-V prescriptions are limited to a maximum of five refills or six months.
Controlled substances cannot be filled early. Typically, a one to two-day leeway period is acceptable; however, some insurances will reject the pharmacy claim until the actual day the refill is due.
Transfer of Prescription
Schedule II medications cannot be transferred from one pharmacy to another. Even if the pharmacies share a common database (for example, a Walmart® to another Walmart), a transfer is not allowed by law.
Schedule III-Vs can be transferred between pharmacies one time only, 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 remaining.
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.
Schedule III-V transfers are indicated by law for refill purposes only. This means that if the prescription was never initially filled, it is non-transferable. The following needs 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
DEA Controlled Substance Schedules
As briefly mentioned above, controlled substances are categorized in certain schedules based on their potential for abuse and misuse. Schedule I drugs have the highest abuse potential but are not on the market as they are not acceptable medical treatments and lack therapeutic benefit. Schedule II drugs have the highest abuse potential for medications currently on the market. The risk for abuse and misuse lessens as the schedule number increases, so Schedule V drugs have the lowest risk.
Since controlled prescriptions have quantity and day supply limitations, it is important to know how to calculate a prescription’s days supply. As mentioned above, some states also require that opioid prescriptions do not exceed 100 MME (combined if multiple prescriptions), unless a special exemption is listed. Although the pharmacist is ultimately responsible for making sure each prescription coincides with federal and state regulations, the pharmacy technician should also be knowledgeable to catch inconsistencies before reaching the pharmacist for the final check.
Here are a few of the most common opioids seen in pharmacy practice and their MME conversion factors:
For a more thorough list and printable resource, be sure to visit the CDC website for the topic entitled Calculating Total Daily Dose of Opioids for Safer Dosage.
Here is an example of a calculation involving a controlled medication:
Oxycodone 5 MG Tablet
1 tablet by mouth 3 times daily as needed for chronic pain # 84 (eighty four) tablets
Is this prescription valid for dispensing? Find out with these calculations:
84 tablets total / 3 tablets daily = 28 days supply
5 MG x 3 tablets daily = 15 MG of oxycodone daily
15 MG x 1.5 MME Factor = 22.5 MME
This prescription is valid as it does not exceed 100 MME/day and is written for a 28-day supply, which is less than the 30-day max limit for chronic pain.