Exam 2- Prescription writing & controlled drugs

Question 1

What are the legal requirements to be on every written prescription?

Answer 1

i. Applies to all meds
1. Date of issuance
2. Name of patient add client’s last name
3. Drug name, strength, dosage form, quantity, directions (including ROA), number of refills authorized
4. Name & address of prescriber
5. DAW vs. Substitution permitted
6. If written, practitioner’s signature
7. If controlled substance, address of patient & DEA #

Question 2

True or false- If you designate an agent to call for you to fill a verbal prescription, they must provide their identity to the pharmacist

Answer 2

True, the date of issuance will be different from the written, cannot call in a CII medication

Question 3

What are the characteristics for prescribing a CII drug?

Answer 3

Must include the patient’s physical address; must be written w/ physical signature; expires after 6mos; NO REFILLS
Can write up to 3 one-month prescriptions to equal 90d supply
a. Enter date you write prescription then “Do not fill before mm/dd/yyyy
Can be phoned in for an emergency for up to a 48hr supply
Written prescription of the emergency must be given to pharmacy w/n 7d from the receipt of the oral prescription

Question 4

What are the characteristics for prescribing CIII-V drugs?

Answer 4

Can be written or called in; expires after 6mos; up to 5 refills

Question 5

What are the requirements to include on the prescription LABEL?

Answer 5

i. Date of filling/refilling
ii. Name & address of pharmacy/clinic
iii. Prescription number- unique number to identify in system
iv. Prescriber name
v. Patient name
vi. Drug name- if generic, also include drug manufacturer
vii. Directions for taking medication
viii. Initials of pharmacist or veterinarian if clinic
ix. Caution: federal law restricts this drug to use by or on the order of a licensed vet
x. If controlled- Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed
xi. Must be dispensed in child-resistant container, unless client asks specifically for non-child resistant container

Question 6

What is the framework of the Controlled Substance Act?

Answer 6

i. The CSA classified all regulated controlled substances under federal law into 1 of 5 scheduled
ii. Became legal framework for DEA to enforce the manufacture, distribution, & possession of CS
iii. Requires persons who handle CS to register w/ DEA
iv. “Controlled substance”- substances controlled by federal or state laws
v. Placed in schedules based on-
1. Legitimate medical use
2. Potential for abuse & addiction
3. Safety or dependence liability

Question 7

What is the classification of Schedule I drugs?

Answer 7

1. No currently accepted medical use
2. Lack of accepted safety for use under medical supervision
3. Examples:
   a. Heroin
   b. Ecstasy
   c. Peyote
   d. Marijuana
   e. LSD

Question 8

What is the classification of schedule II drugs?

Answer 8

1. High potential for abuse w/ severe psychological or physical dependence
2. Has accepted medical use in treatment
3. Examples
   a. Hydromorphone
   b. Hydrocodone
   c. Morphine
   d. Cocaine
   e. Methadone
   f. Fentanyl
   g. Pentobarbital
   h. Codeine

Question 9

What is the classification of schedule III drugs?

Answer 9

1. Potential for abuse < schedule I & II
2. Abuse may lead to moderate or low physical/psychological dependence
3. Examples:
   a. Ketamine
   b. Buprenorphine
   c. Codeine products containing <90mg per dosage unit (Tylenol w/ codeine)
   d. Telazol
   e. Anabolic steroids
   f. Pentobarbital w/ Phenytoin (Beuthanasia)
   g. MS→ Pseudoephedrine

Question 10

What is the classification of schedule IV drugs?

Answer 10

1. Lower abuse potential compared to schedule 3
2. Abuse may lead to limited physical/psychological dependence
3. Examples
   a. Alprazolam
   b. Diazepam
   c. Midazolam
   d. Alfaxalone
   e. Butorphanol
   f. Tramadol
   g. Phenobarbital
   h. Clorazepate

Question 11

What is the classification of schedule V drugs?

Answer 11

1. Lower potential for abuse relative to schedule 4
2. Primarily preparations containing limited quantities of narcotic & stimulant drugs
3. Examples
   a. Diphenoxylate (Lomotil)
   b. Pregabalin

Question 12

What is the Prescription Monitoring Program?

Answer 12

All controlled substance dispensing information shall be transmitted to the PMP for prescriptions w/ >48hr supply on out-patient basis
Information collected:
1. Recipient name & DOB
2. Date dispensed
3. Quantity
4. Number of days’ supply
5. Prescriber’s DEA number
6. NDC of controlled substance
7. Method of payment
Dispensing of controlled substances by a veterinarian are EXEMPT from reporting to PMP
Prescriptions written by a vet & filled by a pharmacy are REQUIRED to be reported by the pharmacy
1. If you call in a prescription to the pharmacy, you info will be on the PMP Handling
1. Under the CSA, a vet who performs research, distributes, dispense a controlled substance MUST be registered w/ DEA or be exempt from registration
2. Apply using a DEA Form 224
3. Renewed every 3yrs via DEA Form 224a

Question 13

What is the process for DEA registration?

Answer 13

1. Apply using a DEA Form 223- “Certificate of Registration”
2. Must be maintained at registered location in readily retrievable manner
3. Separate registrations required for separate locations
4. Obtaining CS for clinic
   a. CII must be ordered using a DEA 222 Form
   i. Online version is CSOS
   b. CIII-V via invoice from distributor
5. DEA strongly opposes use of DEA number for any purpose other than which it was intended
   a. Do NOT give out your DEA number unless it is for a controlled substance

Question 14

What are the requirements for storing controlled drugs in the clinic?

Answer 14

i. Storage of CII-V must be in a securely locked, substantially constructed cabinet
ii. Inventory
1. Federal requirement- every 2yrs
2. Inventory must contain following:
a. Whether taken at beginning or close of business
b. Controlled substance drug names
c. Finished form of drug (100mg tablet)
d. Number of dosage units of each finished form (100 count bottle)
3. Inventory records maintained for 2yrs

Question 15

What are the requirements for dispensing controlled drugs?

Answer 15

i. Recordkeeping
1. Must maintain complete & accurate records for each CS received, sold, delivered, or disposed of.
2. All records of CS must be maintained for minimum of 2yrs
3. CII & CIII-V must be separate
a. Certain states require records to be kept longer
4. Records—
a. All DEA form 222 for CII
b. Receipts &/or invoices for CIII-V
c. Inventory- including initial & biennial
d. Records of distribution (sales to other registrants, returns to vendors)
e. Record of what dispensed (prescription or logbook)
f. Reports of Theft or Significant Loss (DEA form 106)
g. Records of controlled substances destroyed (DEA form 41)
h. DEA registration certificate (DEA Form 223)

Question 16

What is the process for disposal of controlled substances?

Answer 16

i. All expired or unused controlled substances must be given to a reverse distributer licensed by DEA
ii. CI-II transferred via DEA Form 222, CIII-V via invoice
iii. CS that cannot be returned have to be logged & disposed per state & federal requirements
iv. All copies of records must be maintained for 2yrs
v. Thefts or Significant Losses of Controlled Substances
1. Call local police then contact local DEA
a. Complete DEA Form 106 w/n 1 business day of discovery
2. If breakage or spillage occurs
a. Complete DEA Form 41
3. Significant loss
a. Use your best judgement
b. Some state stricter than DEA (MS BOP)
vi. CSA authorizes DEA to enter & inspect any place where controlled substances are kept or persons registered