MPJE

What schedule drugs have to say “CAUTION: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed” on the container?

Schedule II-IV

Can prescribers write multiple prescriptions for a schedule II drug at one time? And if so, what are the rules?

Yes, they can (usually 2-3 at a time). The issue date must be the same for all of the prescriptions and must be filled sequentially. It also cannot exceed a 90-day supply.

Who can grant a blanket waiver for use of child-resistant containers?

The patient

Which of the following is federally classified as a schedule III drug?

1. Sonata

2. Soma

3. Qsymia

4. Fiorinal

5. Fioricet

Fiorinal

Which emergency contraceptive requires a prescription in order to be dispensed?

Ella

How far in advance of the expiration date does the DEA send out registration renewal notices?

60 days

What written information is available for all Rx drugs and is generally stapled or placed in the bag with the medication?

Consumer Medication Information (CMI)

What program implemented by the DEA includes over 3,000 collection sites nationwide that participate in a national program to collect unneeded prescription drugs?

Take-back

What information can be found on the Safety Data Sheet for valganciclovir? (SATA)

• Personal protective equipment recommendations

• First aid procedures

• Drug compatibility information

• Spill clean-up procedures

• Significant drug interactions

• Personal Protective Equipment Recommendations

• First aid procedures

• Spill clean-up procedures

What controlled substance schedule is topical cocaine in?

Schedule II (commercially available cocaine has acceptable medical uses — topical anesthesia for mucous membranes)

A pharmacy going out of business and the owner wants to sell his entire drug stock to the pharmacy down the street. What forms will be used to document the sale of drugs?

DEA Form 222 - for the sale of Schedule II drugs

Invoice - for the sale of Schedule III-V drugs and non-controlled drugs

Above what quantity of magnesium will the labeling of a nonpresription drug need the following warning statement:

Ask a doctor before us if you have:

• Kidney stones

• A magnesium-restricted diet

600 mg

A pharmacist is preparing a dose of IV vancomycin according to the following formulation record. Assuming no sterility testing is completed, what is the risk category for this compound?

It is considered category 2 since it was prepared in a standard cleanroom, but did not meet additional requirements to qualify as category 3 (ex: sterility testing)

What is the Prescription Drug Marketing Act of 1987 in regard to buying drugs from other countries and bringing them into the US?

Patients cannot buy drugs in other countries and bring them into the US, except under both of these conditions:

• The quantity is ≤ 90-day supply and is for the patient (cannot be resold).

• An effective treatment is not available in the US, the condition is serious and the drug being imported has no unreasonable risk.

According to federal law, which of the following is a scheduled drug that can be sold without a prescription?

1. Sudafed

2. Ephedrine

3. Cheratussin AC

4. Lyrica

5. Gabapentin

Cherratussin AC contains codeine and could be sold without a prescription unless a state specific law does not allow it. Sudafed and ephedrine are not federally scheduled drugs, but can be should without a Rx as well.

What was the first law that required new drugs to be proven safe (if used as directed) before being marketed?

Food, Drug and Cosmetic Act

What percent of the total controlled substances sold per year can a pharmacy sell to other pharmacies or prescribers, without registering as a distributor?

As long as the number of dosage units is < 5% of the total number of controlled substances sales per year.

A home health aide accompanies an elderly woman to the pharmacy and asks the woman for her credit card to pay for the prescriptions. The aide becomes impatient and grabs the card out of the woman's hand. The pharmacist notices some bruising on the woman's arm and suspects elder abuse. Who should the pharmacist reports these suspicions to?

• US Department of Justice

• Social services

• DEA

• Pharmacy store manager

• State board of pharmacy

Social services

What schedule is correct for codeine 15 mg tablets?

Schedule II since it is the single ingredient and not in a combination product.

What does the FDA regulations require for “adequate directions for use” on OTCs?

OTC drugs must contain adequate directions for use for a layperson to understand, including (when applicable) the dosing, preparation, frequency, duration, time and route of administration.

What two areas did The Drug Quality and Security Act of 2013 differentiate between?

Traditional compounding pharmacies vs. outsourcing facilities

Based on federal law, how long must a pharmacy keep the biennial controlled substances inventory record?

Initial and biennial inventory records for controlled substances must be kept for 2 years. Some states have longer record keeping requirements.

Based on the REMS program, what threshold must the ANC be at or above to initiate Versacloz treatment?

Agranulocytosis (loss of granulocytes, which are required to fight infection) limits the use of Clozapine (Clozaril, Versacloz), along with a risk of seizures. Do not initiate clozapine if the ANC is below 1,500/mm³. Therapy must be interrupted if the ANC drops to <1,000/mm³ during treatment.

Who can receive prescription drug samples, when requested by a prescriber?

Hospital pharmacies

Which type of prescriptions are permitted for schedule III-V drugs?

Faxed, oral, written, typewritten, electronic

When there is breakage, damage, or spillage or some other form of destruction, any recoverable substances must be disposed of according to DEA requirements. When this disposal occurs, it must be reported to the DEA on what form?

DEA Form 41

What is misbranding?

It is the lack of required information on the package and in the labeling or the information is illegible (cannot be read), false or misleading information, imitating another drug or promising false cures, missing special precautions needed to prevent decomposition (ex: protect from light), improper packaging (ex: lack of Poison Prevention Packaging) or incomplete labeling of additives. Additionally, if the ingredients differ from the standard of strength, quality or purity (as determined by USP) the product is considered misbranded.

A pharmacist receives a prescription for Vicodin, but the patient insists that the prescription was supposed to be for Zohydro ER. What should the pharmacist do?

Return the prescription to the patient and have the prescriber issue a new prescription.

What is considered a dietary supplement according to the FDA?

A product (other than tobacco) intended to supplement the diet by increasing dietary intake and is not used as the conventional food or as the sole item of a meal or diet. It contains one or more of the following ingredients: a vitamin, mineral, herb, or other botanical, or amino acid, and their concentrates and extracts.

What is DEA Form 224?

DEA Form 224 is a registration form for retail pharmacies, hospitals/clinics, teaching institutions, practitioners, or mid-level practitioners in order to prescribe controlled substances.

Which entities need to register using the DEA Form 224?

Pharmacies and individual prescribers who write for controlled substances

A 23-year-old female patient comes into the clinic asking for emergency contraception. It has been 92 hours since she had unprotected sex. Which of the following is the best emergency contraception for this patient?

Ella (ulipristal) can be taken up to 120 hours after intercourse. Plan B One-Step and similar products are FDA-approved for administration up to just 72 hours after unprotected sex.

What is a Class III recall?

It is associated with the lowest severity and is unlikely to cause any adverse health effects.

If a bottle of MS Contin is missing one tablet during a controlled substances inventory, does the pharmacist need to report this to the DEA?

No, only significant losses should be reported; a single tablet is not considered significant.

What is the max # of Sudafed 30 mg tablets that can be purchased OTC in one day from a pharmacy, per federal restrictions?

146 — the max amount of pseudoephedrine that can be purchased in one day (3600 mg) is based on the base amount of the drug. Pseudoephedrine hydrochloride (Sudafed) 30 mg contains 24.6 mg of base.

If a patient wants a partial fill of a Schedule III drug, what are the rules regarding filling the rest of the quantity written on the prescription?

Partial fills are permitted for schedules III-V by the DEA if it is recorded in the same manner as a refill. No dispensing can occur beyond 6 months past the date of the issue.

What do the middle numbers of the NDC represent xxxxx-xxx-xx?

The drug

When do pharmacies report significant losses and thefts of controlled substances to the local DEA office and which form do they use?

Must report in writing within one business day upon discovery and complete a DEA 106 when the circumstances of the theft or significant loss are known

What method can a patient use to discard tramadol tablets she no longer needs if she has no local drug take-back program in her area?

The patient should remove the tramadol from its original container and mix it with an undesirable substance like used coffee grounds and dispose of it in a sealed bag into the trash.

How should the pharmacist counsel a patient on the various options for disposing of a used fentanyl patch?

Flush the used patch down the toilet (removes risk immediately from the home). Or the used patch can be taken to a DEA-authorized collector and local and national medicine take-back programs.

Which DEA registration form is required for narcotic treatment centers?

Form 363 (Narcotic treatment programs are also called opioid treatment programs)

A cough syrup contains: dihydrocodeine bitartrate 3 mg, chlorpheniramine maleate 2 mg, and phenylephrine HCL 7.5 mg per 5 mL. What schedule is this drug?

Schedule V since the compound contains only 60 mg of dihydrocodeine in 100 mL which falls below the “not more than” limit for schedule V (100 mg/100mL)

Pharmacy A is out of Syndros and would like to purchase 30 mL from Pharmacy B. Which form should be used to document this transfer?

DEA Form 222 — this is always needed when a schedule I or II drug changes locations

A pharmaceutical company has conducted animal and human clinical trials for a new biological drug to treat Alzheimer’s Disease. Which type of application must the pharmaceutical company submit to the FDA?

BLA (Biologics License Application) since it is a biologic product

Which clinical trial phase is the first to be conducted on human subjects?

Phase I

A tablet contains diphenoxylate 2.5 mg and atropine sulfate 25 mcg. What schedule is this tablet in?

Schedule V — this compound contains 2.5 mg of diphenoxylate per tablet, which is equal to the “not more than” limit for schedule V

What is an Assessment of Risk (AoR)?

A pharmacy can conduct an AoR that permits modification of the USP 800 requirements for HDs with lower risk by developing a plan to limit staff exposure.

What activities do not require an AoR?

Activities that do not require manipulation, such as counting and packaging can be covered under an AoR. If manipulation is required, the full USP 800 requirements must be followed.

What is a Class I recall?

It is the most serious recall because there is reasonable probability that the drug will cause serious harm or death.

Which regulatory body is responsible for enforcing laws regarding controlled substances?

Drug Enforcement Agency (DEA)

A prescription for Androgel is written on February 1 and not filled until February 15. When is the last day that it can be refilled?

August 1 — Schedule III drug prescriptions expire 6 months after the issue date

How much controlled substance can a pharmacy compound into a cream formulation that is to be used in a clinic in the same medical building?

A pharmacy cannot compound a preparation that contains >20% controlled substances.

What is the preferred method for disposing Duragesic patches?

The best option is to take advantage of DEA-authorized collection receptacles (which include the take-back programs for controlled drugs) or other programs, such as household hazardous waste collection events. If a take-back program or a DEA-authorized collector is not readily available, fentanyl-containing products are on the FDA flush list and can be flushed for disposal.

According to the DEA, how long must prescription records for controlled substances be kept?

The DEA requires all records of controlled substances to be kept for 2 years.

Which drugs must be stored separately from the rest of the pharmacy drug stock?

Investigational new drugs, expired drugs, and recalled drugs

The drug approval process begins with pre-clinical testing with animals. If the pre-clinical testing on animals is promising, the next step would be to file an investigational new drug (IND) application. Who files the IND?

The manufacturer goes through the drug approval process and if approved, can market the drug.

What do the numbers at the end of the NDC mean xxxx-xxx-xx?

The packaging (pack size)

Which of the following drugs require child-resistant packaging?

• Nitrostat sublingual tablets

• Fiorinal tablets

• Pancrelipase capsules

• Yaz tablets

• Medroxyprogesterone tablets

Fiorinal - child-resistant packaging is required for most Rx medications to prevent ingestion by children. The other answer choices do not require child-resistant packaging.

When can a health care provider (HCP) prescribe controlled substances using a hospital’s DEA number?

The HCP is authorized by their state to prescribe controlled substances, and they are employed by that hospital.

Explanation: Prescribing scheduled drugs requires a state license to practice and a DEA registration to enable the prescribing be extended to scheduled drugs. If a resident is at a hospital with DEA registration, a separate individual registration is not required.

What are the options for pharmacies to file prescriptions?

1. One file for schedule II drugs, a second file for schedule III-V drugs, and a third file for non-controlled drugs. (3 files total)

2. One file for schedule II drugs, a second file for schedule III-V and non-controlled drugs. A red “C” must be stamped on schedule III-V prescriptions. (2 files total)

How long can the pharmacist partially fill a controlled drug prescription if the patient resides in a long-term care facility?

For terminally ill patients or those residing in long-term care facilities, the pharmacist can fill prescriptions in increments for up to 60 days from the date the prescription was written.

Above what quantity of sodium will the labeling of a nonprescription drug need the warning statement “Ask a doctor before use if you have a sodium-restricted diet”?

140 mg