Controlled Substances Part 2

Question 1

Federal law requires a controlled substances inventory how often? When is the inventory taken? What is counted and by whom?

Answer 1

O Every 2 years following the initial inventory
O Must be taken on the anniversary of the initial inventory
O Inventory requirements
O CI or CII: exact measure must be counted by the pharmacist
o CIII-V: estimated count is sufficient unless the container holds greater than 1000 dosage units in which case and exact count is necessary
O Inventories must be kept at the registered location for two years

Question 2

Texas law requires a controlled substances inventory how often? When is the inventory taken? What is counted and by whom? What extra measure is required for the Texas inventory that is not required for the Federal inventory?

Answer 2

O Every two years
O Initial inventory is required to be signed by the PIC and notarized within 72 hours or 3 working days
O Annual inventory is required for all controlled substances plus all dosage forms of nalbuphine (Nubain)
O Required to be signed by the PIC and notarized within 72 hours or 3 working days

Question 3

Texas law requires a controlled substances inventory at the time of a change in pharmacist in charge (PIC). Describe this process.

Answer 3

O On the day of change an inventory of the following shall be taken
O Must include: All controlled substances, all dosage forms containing nalbuphine and Soma (carisoprodol) and all dosage forms containing tramadol

Then the incoming PIC does some stuff

Question 4

What must the incoming PIC do?

Answer 4

O Delete name of the departing PIC on the pharmacy license
O Enter name of the incoming PIC on the pharmacy license
O Notify the board in writing within 10 days that a change of PIC has occurred
O If the inventory was not taken by both pharmacists, the statement must give an explanation

Question 5

Inventory records must be filed and kept in the pharmacy for how long?

Answer 5

2 years

Question 6

The TSBP require notification within 10 days of a change in?

Answer 6

PIC
Address of pharmacy
Address of pharmacists
Employment change of pharmacy

Question 7

What about the change of employment by a technician?

Answer 7

Report electronically or in writing to the board within 10 days of change of employment giving the name and license number of the old and new pharmacy and registration number

Question 8

What determines who may prescribe scheduled substances in individual states?

Answer 8

The medical practice act in each individual state defines who may prescribe drugs including schedule II substances in that state. Federal Law honors these states acts

Question 9

ANP/PA Prescribing limitations on controlled substances

Answer 9

O A physician may delegate to an APN or PA the authority to prescribe or order a drug or device only it the prescription:
O Is for a schedule III, IV, or V substance (no CII’s except for above)
O Is for a period not to exceed 30 days (or maybe 90 days with recent revision?)
O May be refilled only after consultation with the delegating physician and the consulting is noted in the patient’s chart
O Is for a child under 2, the prescription and the consultation is noted in the patient’s chart

Question 10

A prescription for a substance in Schedule III, IV and V must include:

Answer 10

O Name, address, birthdate of patient
O Address of patient
O Quantity of drug written in both numbers and text
O Signature of prescriber (unless verbal order or electronic prescription)
O Tamper-resistant paper

Question 11

Prescriptions for a Schedule III, IV and V substance:

Answer 11

O The prescriber may allow up to 5 refills
O The prescription is only valid for 6 months from date of issuance
O The prescription may be transferred only once to another pharmacy (unless the Walgreen’s rule. Explain transfer policy between pharmacies that share a real-time computer system)

Question 12

At the time a prescription for a scheduled substance is filled in Texas, the prescription information is transmitted directly to what agency?

Answer 12

Texas Department of Public Safety (DPS)

Question 13

When a prescription is partially filled, when is information sent to DPS?

Answer 13

Only send information to DPS once you have completely filled the script within 7 days. DO NOT send information every time you give out a partial fill to the DPS
Ex: Say you have a prescription for #100 MS Contin Tabs (CII) → Say the patient is only getting 10 at a time –> The patient has 60 days to exhaust that one script → Once you dispense tablet #100 within the 60 days –> Then you can send information to DPS in 7 days once the prescription is completely filled

Question 14

What information is provided electronically to DPS?

Answer 14

1. Prescribing practitioner’s valid DEA registration #
2. Official perscription control # (For CII’ only)
3. Patient or animals name, age, DOB, & address (city, state, & zip code)
4. Date the prescription was issued & filled
5. NDC # of controlled substance dispensed
6. Qty of controlled substance dispensed
7. Pharmacy prescription #
8. Dispensing pharmacy’s DEA registration #

Question 15

Pharmacists may dispense a ______ supply (how much) of a prescription drug including controlled substances _____ without authorization from the practitioner.

Answer 15

72 hour

Schedules 3-5

Question 16

Prescriptions for Schedule II Drugs (federal law)

Answer 16

Must be written or electronic

No refills on C-II substances

Question 17

How many days does the prescriber have to supply hard copy of prescription?

Answer 17

7 days

Question 18

What constitutes an emergency situation?

Answer 18

Emergency: (1) Immediate administration is necessary for patients care; (2) no proper alternative treatment is available;(3) not reasonably possible for the prescriber to present a written prescription prior to dispensing

** All 3 determinations must be met to qualify as an emergency so that a C2 substance may be dispensed upon an oral prescription

Question 19

In 1982, the Texas legislature passed a provision calling for the monitoring of prescriptions written for ______ controlled substances. This program was created to be ____.

Answer 19

schedule II;

an efficient, cost effective tool for investigation and prevention of drug diversion

Question 20

What are safety features of the Texas Official Prescription?

Answer 20

Control number
Pantograph
Thermochromatic ink

Question 21

Define Control Number

Answer 21

unique to that form; used for audit trail. Located in the uppermost portion of the form, in the bottom left position

Question 22

Define Pantograph

Answer 22

Scanning and copying produce a VOID on the face of the prescription

Question 23

Define Thermochromatic ink

Answer 23

Applying heat or vigorously rubbing the thumbprint will reveal the word SAFE (DPS seal)

Question 24

Practitioner (prescriber) responsibilities

Answer 24

Complete the prescription according to federal and state requirements:
• Patient’s complete NAME, ADDRESS (including city, state, and zip code), and AGE OR DATE OF BIRTH, (if patient if an animal, the owner and species of animal [e.g. “dog”])
• Controlled substance prescribed
• Quantity of controlled substance prescribed, written numerically and as a word
• Intended use or diagnosis, if not deemed detrimental to the patient’s well-being
• Dated as of the day the prescription is written (cannot be post-dated)
• Preference for brand, if necessary
• Instructions for use (stamped or pre-printed instructions are permitted, however, the instructions must be legible and appear on all copies)
• Signature (manually signed, not stamped)

Question 25

On the transmitted or mailed prescription, indicate:

Answer 25

• Name, Address (including zip code), age of patient
• DPS Registration number of prescriber
• Official RX Control Number
• Date filled
• Pharmacy prescription number
• NDC code of the controlled substance dispensed
• Quantity dispensed, if less than the quantity prescribed (reporting prescribed quantity not required if quantity is changed)
• Pharmacy’s DPS registration number

Question 26

What does the pharmacist do when filling a C-II prescription using the Texas Official Prescription form?

Answer 26

Name of dispensing pharmacist w/ a signature
RX #
Date

Question 27

A Texas Official Prescription can be filled up to _____ (how long) from the date of issuance.

Answer 27

21 days from date written so technically 22

Question 28

When a Texas Official Prescription is incomplete, what information is the pharmacist prohibited from supplying or changing?

Answer 28

Name of the patient
Name of the drug
Name of the prescribing physician
Date of the prescription

Question 29

Define E-Prescribing

Answer 29

Actual prescriptions that are transmitted electronically directly to the pharmacy
Schedule II substance is prescribed via e-script, a paper copy of the form is not needed.

Question 30

When Dispensing an Official Prescription, the pharmacist records on the form:

Answer 30

1. Dispensing pharmacist signs his/her name
2. Pharmacist dates the prescription
3. Fills in the prescription number

Question 31

Electronic submission of C-II prescription in Texas when does the information need to be submitted to DPS?

Answer 31

Within 7 days

Question 32

DPS Responsibilities

Answer 32

O Provide prescriptions at cost to practitioners
O Securely maintain prescription records
O Respond to requests for information

Question 33

When is the 90-day supply rule applicable?

Answer 33

When each form of the multiple set is written for the identical schedule II substance and the total quantity does not exceed a 90 day supply

Question 34

Administered C-II drugs

Answer 34

O If a doctor administers or dispenses in his office, he checks the appropriate boxes (administered or dispensed) pharmacists should not see the official prescription form in this case!
O Practitioner should always sign the “dispense as written” line when administered or dispensed in his office
Practitioner sends both copies 1 and 2 to DPS (Texas Department of Public Safety): Practitioner retains copy 3 for his/her records

Question 35

Procedure for when more than one drug is written on an Official Prescription

Answer 35

• No more than one prescription can be written on one form
• If the doctor has written for 2 C-II drugs on 1 form, the prescription is invalid & patient has to get 2 separate prescriptions
• If the physician writes for a C-II and another controlled substance (III, IV, V) or dangerous drug, a pharmacist can “X” out the non-scheduled drug and transfer it to a pharmacy prescription pad; The prescription can be filled , filed in C-II file with the appropriate copy mailed to DPS; prescription for dangerous or III, IV, V drug can be filed in appropriate file
• If a physician writes for a non-schedule II drug on an official prescription form: fill the prescription, on copies 1 and 2, indicate that the drug is NOT a C-II, if a scheduled drug, indicate the schedule, if not scheduled, indicate that drug is a dangerous drug

Question 36

Dispensing pharmacist shall record on the back of Copy 1 what for a partial fill?

Answer 36

Date of the partial fill
Quantity dispensed
Remaining quantity
Initials

Question 37

Define Emergency Dispensing

Answer 37

• Immediate administration of drug is necessary for proper treatment of the intended ultimate user (patient)
• No appropriate alternative treatment is available including administration of a drug which is not a controlled substance under Schedule II
• Not reasonably possible for the doctor to provide a written prescription to a pharmacist prior to dispensing

Question 38

Procedure for Emergency Dispensing

Answer 38

Rx is marked EMERGENCY DISPENSING plus have the DEA and DPS number of the doctor

Question 39

When is a written copy required?

Answer 39

Within 7-days provide the pharmacy with a written copy of the emergency prescription on an official prescription by delivering it or mailing it postmarked within 7 days

Question 40

Upon receiving the hard copy?

Answer 40

The pharmacist attaches Copy 2 to his hand written emergency prescription in his files & electronically sent to DPS

Question 41

If the physician fails to get it to the pharmacy in 7 days who do you notify?

Answer 41

DEA and DPS

Question 42

When is a Texas Official Prescription not used when Schedule II drugs are used?

Answer 42

LTCF if it is an emergency 
Admittance to the hospital
Life flight helicopter
TDCJ: correctional facility
Animal hospital

Question 43

When can a prescriber fill an out of state prescription?

Answer 43

If they are involved in dispensing/delivery or mailing of controlled substances
If its issued by a prescribing practitioner in the other state in ordinary course of practice
- If they submit and get approved by the director and the state board of pharmacy

Question 44

Can a Texas patient see a physician in another state?

Answer 44

YES
• 1st option-if the physician doesn’t hold a Texas license then the patient can have the prescription filled in the state that the physician resides.
• 2nd option- patient can have the pharmacist at the local pharmacy in Texas make a special request to the Director (DPS) to fill the prescriptions for that one patient at their pharmacy.