Controlled Substances!

Question 1

List of Common Schedule 1 Controlled Drugs

Answer 1

-3,4 methylenedioxymethamphetamine (MDMA)
-Gamma-hydroxybutyric acid (GHB)
-Heroin
-Lysergic Acid Diethylamide (LSD)
-Marijuana
-Mescaline
-Peyote

Question 2

List of Common Schedule 2 Controlled Medications

Answer 2

-Alfentanil
-Sufentanil
-Codeine (single ingredient)
-Fentanyl (Actiq, Fentora)
-Hydrocodone (Lortab, Vicodin)
-Hydromorphone (Dilaudid)
-Levorphanol
-Meperidine (Demerol)
-Methadone
-Morphine (MS Contin)
-Oxycodone (Oxycontin, Roxicodone, Xtampza ER)
-Oxymorphone
-Tapentadol (Nucynta)
-Cocaine
-Dronabinol (Solution Only!) (Syndros)
-Pentobarbital (Oral Formulation Only)
-Secobarbital (Oral Formulation Only)

Stimulants:
-Amphetamines
-Mixed Salts
-Methylphenidate

Question 3

List of Common Schedule 3 Controlled Medications

Answer 3

-Benzphetamine
-Buprenorphine (Butrans)
-Buprenorphine/Naloxone (Suboxone)
-Butabarbital
-Butalbital (Fiorinal)
-Codeine/Acetaminophen (Tylenol with Codeine #3, #4)
-Dronabinol (Capsules Only!) (Marinol)
-Ketamine
-Paregoric
-Perampanel (Fycompa)
-Phendimetrazine
-Sodium Oxybate and Oxybate salts (Xyrem)
-Testosterone and all Anabolic Steroids

Question 4

List of Common Schedule 4 Controlled Medications

Answer 4

-All Benzodiazepines
-Chlordiazepoxide (Librium)
-Clobazam (Onfi)
-Clorazepate (Tranxene)
-Eszopiclone (Lunesta)
-Suvorexant (Belsomra)
-Zaleplon (Sonata)
-Zolpidem (Ambien, Edluar, Zolpimist)
-Phentermine (Adipex-P)
-Phentermine/Topiramate (Qsymia)
-Carisoprodol (Soma)
-Modafinil (Provigil)
-Phenobarbital
-Tramadol

Question 5

List of Common Schedule 5 Controlled Medications

Answer 5

-Brivaracetam
-Codeine containing cough syrups (-tussins A/C)
-Diphenoxylate/Atropine (Lomotil)
-Lacosamide (Vimpat)
-Pregabalin (Lyrica)

Question 6

Barbiturate Schedules

Answer 6

Schedule 2: Single entity oral formulation of pentobarbital and secobarbital

Schedule 3:
-Suppository of secobarbital and pentobarbital
-Combination products of seco and pentobarbital and non-controls
-Butabarbital

Schedule 4: Phenobarbital

Question 7

Codeine Schedules

Answer 7

Schedule 2: single-entity products

Schedule 3: Combination tabs/caps containing codeine

Schedule 5: Combination cough syrups that contain codeine

Question 8

Dronabinol Schedules

Answer 8

Schedule 2: Oral solution

Schedule 3: Oral capsules

Question 9

Schedule 5 NMT Limit

Answer 9

A drug will be classified as Schedule 5 if the opioid quantity is NMT:
-200mg/100ml or mg Codeine
-100mg/100ml or mg Dihydrocodeine
-2.5mg Diphenoxylate and >= 25 mcg Atropine per dosage unit on

** if a drug exceeds the NMT quantity for schedule 5, look to the next (more restrictive) schedule criteria. Any drug exceeding the limits for a schedule 3, would be considered schedule 2.**

Question 10

Schedule 3 NMT Limits

Answer 10

A drug will be classified as Schedule 3 if the opioid quantity is NMT:

-1.8g/100mL Codeine or 90mg per dosage unit
-1.8g/100mL Dihydrocodeine or 90mg per dosage unit
-50mg/100mL or mg Morphine

If a drug exceeds the NMT quantity for schedule 5, look to the next (more restrictive) schedule criteria. Any drug exceeding the limits for a schedule 3, would be considered schedule 2.

Question 11

What are the FDA-approved Cannabis-derived products?

Answer 11

1-Cannabidiol (Epidiolex) - not controlled

2-Dronabinol (synthetic THC) approved for AIDS-associated anorexia and chemo-induced N/V
Oral Solution - Schedule 2
Oral Capsule - Schedule 3

3-Nabilone (synthetic cannabinoid similar to THC) Schedule 2

Question 12

Cannabis products: CBD and Hemp

Answer 12

In 2018, the Farm Bill was signed into federal law, which removed hemp from the definition of marijuana in the Controlled Substances Act. Since hemp products are legal, CBD can be extracted from hemp and used in TOPICAL products.
-As such, retail pharmacies can sell hemp-derived CBD-containing topical products.

Since pharmacies are registered by the DEA, they must operate within the confines of the federal law regarding marijuana. As such, pharmacies are not permitted to sell marijuana or drug paraphernalia.

Question 13

Controlled Substances Registrants

Answer 13

Hospital - Practitioners in a healthcare facility (e.g residents, physicians, mid-level practitioners) can prescribe controlled substances for patients within the institution using the facilities DEA number.

Question 14

Who can order Controlled Medications?

Answer 14

The DEA Registrant

-Each pharmacy location has one designated registrant. This is the only person authorized to order schedule 1 and 2 drugs, unless the registrant grants a power of attorney (POA) to another individual, allowing them to place orders in his/her absence.

POA:
-Can be granted to licensed or unlicensed pharmacy personnel
-The registrant may terminate a POA at any time by executing a Notice of Revocation.
-POA should be filed at the pharmacy with the executed DEA form 222 and must be readily retrievable. It is NOT submitted to the DEA. ice

Question 15

DEA Form 222

Answer 15

Available as a Single-Sheet Form! However, photocopies can be made.

Pharmacy orders drugs from a supplier:
Original - Supplier
Copies - Pharmacy, DEA
1-The pharmacy fills out the form and make a photocopy to keep for 2 years
2- The original goes to the manufacturer/supplier to be kept for 2 years.

The original stays at the origin of the drug!

Question 16

Controlled Substances Loss or Theft

Answer 16

A pharmacy must report a significant loss or theft of controlled substances to the local DEA office in writing within one business day of discovery.

After initially notifying the DEA, the pharmacy must conduct an investigation and submit Form 106 electronically to the DEA with the findings within 45 days of discovery.

If the investigation determines that theft or loss did not occur, then Form 106 does not need to be submitted. Instead, the registrar must notify the DEA in writing that there was no theft or loss.

Question 17

“Red Flags” of Diversion

Answer 17

1- Frequent requests for early refills
2- Prescriber and/or patient located an unusual distance from pharmacy
3- Patient profile reveals multiple prescribers for duplicate therapy
4- Similar or identical prescriptions for multiple patients from same prescriber
5- Prescription is not within prescribers scope of practice
6- Patient presenting to the pharmacy in groups
7- Unusual patient behavior, such as nervousness
8- Patient pays cash for an opioid prescription
9- Use of street slang to refer to a medication
10- Patient is prescribed a “ drug cocktail”
11- Pending federal or state action against prescriber

Question 18

Can a verbal prescription be received for Controlled Substances?

Answer 18

Yes - Only Schedule 3-5 (Faxed too!)

Schedule 2 cannot be faxed or given verbal.

Question 19

When can a faxed prescription for a Schedule 2 drug be valid?

Answer 19

1- Resident of a LTCF
2- Patient is enrolled in a hospice program
3- A drug compounded for administration to a patient by parenteral, IV, IM, subQ or intraspinal route.

Question 20

What are the Federal requirements for a Medicaid Prescription?

Answer 20

1- Preprinted serial numbers
2- The word ‘VOID’ appears when photocopied
3- Checkboxes to indicate the quantity dispensed

Question 21

Is medical marijuana limited to certain indications (if yes, what indications)?

Answer 21

Medical marijuana can be used in patients diagnosed with a qualifying condition:

1) Cancer associated with severe/chronic pain, nausea or severe vomiting, or cachexia or severe wasting
2) Glaucoma
3) HIV/AIDS
4) Amyotrophic lateral sclerosis (ALS)
5) Seizures
6) Severe and persistent muscle spasms, including those characteristic of multiple sclerosis
7) Inflammatory bowel disease, including Crohn’s disease
8) Post-traumatic stress disorder
9) Sickle cell disease
10) Chronic or intractable pain
11) Autism
12) Tourette syndrome, or chronic motor or vocal tic disorder
13) Obstructive sleep apnea
14) Terminal illness, with a probable life expectancy < 1 year

Question 22

Are pharmacists permitted to sell select schedule V cough syrups without a prescription?

Answer 22

No, codeine-containing cough syrups are schedule III controlled substances in Minnesota.