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Flashcards in Controlled Substance Logs Deck (71):
1

What are controlled substances?

-Substances of high abuse potential.

2

Controlled substances are outlined in?

The Controlled Substance Act of 1970 (the law) which reduced drug abuse by defining certain legal and illegal acts pertaining to the use of these substances.

3

What agency did the Controlled Substance Act of 1970 establish and why?

The Drug Enforcement Agency. It was established to enforce the law.

4

The Controlled Substances Act of 1970 is a law that was designed to?

Provide an approved means for proper manufacture, distribution, dispensing, and use of controlled substances through licensing of legitimate handlers of these drugs.

5

What type of system is the Controlled Substances Act of 1970, is it effective?

A "closed" system. It has been very effective in reducing the diversion of these drugs into the illicit market.

6

How many classes (schedules) of controlled substances are there?

There are 5 classes (schedules) of controlled substances.

7

What are the Classes (Schedules) based on?

Their use or abuse potential.

8

Schedule I Info

Schedule I Info

  • High abuse potential.
  • Research use ONLY.
  • LSD, Heroin
  • DEA Form C-222 required.
  • No acceptable medical use (this includes veterinary medicine)!

9

Schedule II Info

Schedule II Info

  • High abuse potential.
  • Requires a written prescription.
  • No refills on script.
  • DEA form C-222 required.
  • Oxymorphone, Morphine, etc.
  • Abuse may lead to severed addiction.
  • Maximum supply is 30 days.

10

Schedule III Info

Schedule III Info

  • Less abuse potential than I and II.
  • Oral or written script, up to 5 refills in 6 months.
  • DEA registration number.
  • Hycodan, anabolic steroids, etc.
  • Abuse may lead to moderate dependence.

11

Schedule IV Info

Schedule IV Info

  • Low abuse potential.
  • Oral or written scripts with 5 refills in 6 months.
  • DEA registration number.
  • Diazapam, Phenobarbital
  • Abuse may lead to limited dependence.

12

Schedule V Info

Schedule V Info

  • Low abuse potential.
  • No DEA limits on dispensing.
  • DEA registration number.
  • Lomotil, Robitussin AC
  • Lowest potential for abuse.

13

What do the veterinarians who use these drugs need to have?

The veterinarian (NOT the practice/facility) MUST have a DEA license number.

14

Records must be maintained?

On the acquisition and distribution of controlled substances.

15

All controlled substance records must be?

"Readily retrievalbe" if an inspector appears at the hospital.

16

A recording system must be set up to account for?

A recording system must be set up to account for:

  1. Recepit of CS.
  2. Inventory of CS.
  3. Legal distribution of CS.
  4. Signature sheet for anyone (staff) who can handle CS.
  5. Scripts to local pharmacies.
  6. Use of CS in hospital

17

What is on the signature sheet for CS, who has to sign it?

A signature sheet has the persons signature, printed name, and intitials. Everyone who can handle CS has to be listed on the signature sheet, this includes the receptionist if they are allowed to take the meds from a vet or a tech and give them to the owner.

18

What do you need to do when you give a client a script for a local pharmacy?

Make two photocopies. Put one in the patient files and another in a binder to track any outgoing scripts.

19

In New York State, a pharmacy in a veterinary hospital is?

Under the same regulations as a human pharmacy.

20

Any supplier who you will buy CS from must?

Have a photocopy of the doctors current BNDD registration number on file.

  • BNDD = Bureau of Narcotics and Dangerous Drugs

21

The DEA receives copies of all your CS order forms and invoices. Order for excessive amounts or unusual items may trigger what?

An audit.

22

What can trigger an audit?

Since the DEA receives copies of all your CS order forms and invoices, orders for excessive amounts or unusual items can trigger an audit.

23

Ordering Schedule II Drugs

Ordering Schedule II Drugs

  • Form C-222, a triplicate form must be filled out and mailed to the supplier.
  • The supplier keeps a copy.
  • A copy is sent to the DEA.
  • The 3rd copy is returned to you with the order.

24

Receiving Schedule II Drugs

Receiving Schedule II Drugs

  • When a schedule II drug is received, the appropriate boxes on your copy of the form C-222 need to be filled out with the number received and the date of receipt.
  • Attach this form to your CS log copy of the invoice.

25

The audit trail of all CS must be?

Clear, concise, and readily retrievable.

26

You must keep good records of?

Receipt, inventory, and eventual legal distribution of all CS.

27

When received, all controlled substances must be?

Recorded and numbered in the unopened container log.

28

A seperate log must be mainted for?

Each drug and form of that drug.

Examples:

  • Phenobaritol Injectable
  • Phenobarbitol 60 mg tablets
  • Phenobarbitol 30 mg tablets

29

Copies of all _____ must be __________?

Copies of all invoices for CS must be kept, and readily available.

30

Schedule _________ must be labeled __________?

Schedule III, IV, and V must be labeled with a 1 inch high red C in the lower right hand corner.

31

Schedule II must be?

Readily identifiable from III, IV, and V.

32

All of the schedules can be kept?

In separate folder or mixed in the same one.

33

All controlled substances MUST be kept?

In a double locked box.

34

It is advisable to keep stock items in?

A safe and only open, in use, containers in the double lock box.

35

If any controlled substance need refrigeration, they must be?

In a special double lock box that affixes in the refrigerator or the refrigerator needs to be padlocked.

36

When taken out of stock, CS has to be?

Logged in an open container log while at the same time, being logged out of the unopened stock log.

37

A signature and initial sheet for anyone who has access to and use of the drug logs needs to?

Be kept in the front of one of your logs (usually the unopened stock log).

38

Any scripts given to clients to take to local pharmacies needs to be?

Copied and kpet in a file so that they can be tracked.

  • Make two copies, one for the patient record, and 1 for the DEA file.

39

In New York State, we have to use?

Specific State prescription pads that void themselves if tampered with or photocopied.

40

In the open use CS log, all use has to be documented with?

In the open use CS log, all use has to be documented with?

  • Date
  • Patient / Client Name
  • Patient / Client ID Number
  • Amount Used
  • New balance left in the container.
  • Initials of the staff member who drew up or counted out the drug.

41

Frequent audits of your CS should be done (frequency)?

Depending on the size of the facility.

  • Daily
  • Every shift
  • Etc

42

A _____ drug inventory is mandatory _____?

A biennial drug inventory is mandatory by DEA regulations.

43

Keep all CS records for?

5+ years since the statute of limitations is 5 years.

44

A seperate inventory of _____ must be recorded and? 

A seperate inventory of Ketamine on hand must be recorded and stored with the biennial drug inventory records. This is due to severe Ketamine drug abuse issues.

45

Which substance is now a controlled substance in NYS? When and why?

Tramadol (a pain medication) is a controlled substance as of March 1st, 2013 because of the increasing abuse of the drug.

46

Any and all employees that have access to CS must be?

Screened. This includes Drs, techs, assistants, receptionists, kennel staff, and possibly groomers.

47

Anyone who has been ______ can not have access to or handle CS.

Convicted of a felony.

48

It is illegal to use outdated CS since?

It is considered adulterated.

49

In addition to not be able to use an outdated cs, they cannot?

Be thrown away.

50

Outdated CS should, with the appropriate documentation be?

Outdated CS should, with the appropriate documentation be?

  • Returned to the supplier.
  • Given to a reverse distributor.
  • Given to a disposal agency.
  • Obtain DEA on site destruction permission
    • (Not all states, can be done in NY)

51

What is the best thing to do with outdated controlled substances?

It is best to return to the supplier if possible. The supplier fills out all the necessary DEA paperwork and gets the authorization. You then send it back with the paperwork keeping your copy of the paperwork.

  • This is no cost to the veterinarian.

52

Reverse Distributor (what, cost, availiablity)

You can contract with a reverse distributor who also fills out all the paperwork with the DEA and then picks up the CS from you to destroy.

  • No cost to the veterinarian.
  • Hard to find reverse distributors.

53

Disposal Agency (what, cost)

Disposal agency also fills out all the DEA paperwork and picks up from you.

  • There is a fee for the service.

54

DEA On Site Destruction Permission

If returning to the supplier, reverse distributor, and disposal agencies are not an option, then you can fill out the appropriate paperwork and DEA forms.

  • DOH-2340
  • DOH-166
  • C-222 (if a schedule II)
  • Submit the above to your regional DEA office for auth to do an on site disposal.

55

If an outdated CS is returned or destroyed, it must?

Be logged out of stock.

56

Justification for the use of all CS must be?

Clearly demonstrated in the patient's medical record.

  • There has to be a valid Client / Patient / Doc relationship.

57

Any loss or theft of CS?

Must be reported to the DEA.

58

If a DEA inspector show up at the practice, shows proper ID, and has a warrant or subpoena, you must?

Immediately show them all the CS records, except for financial records.

59

Penalties, up to and including?

Revocation of the veterinarian's BNDD number can be assessed.

60

In order to control CS abuse, NYS requires all pharmacies, human and veterinary, to?

Upload by the 15th of the following month a record of all the CS that has been dispensed from the practie in the past month.

  • CS dispensed to the client, not for in house use.

61

The NYS Heal Dept's supercomputer checks?

To see if people are getting multiple scripts for CS from different doctors, or if doctors are writing abnormally large amounts of CS scripts. These trigger an investigation.

62

Article 33 of the Public Health Law and Part 80 of Title 10 regulations require pharmacies to?

Electronically submit information to the New York State Department of Health (NYSDOH) from all prescriptions dispensed for controlled substances. Such information must be submitted not later than the 15th of the month following the month in which the controlled substance was dispensed.

63

NDC Number tells?

What medication and strength.

64

You cannot fill prescriptions for any medications for other?

Practioners unless you are a licensed pharmacist employed in a registered pharmacy.

65

Compounding of substances without?

A special license as a compoundng pharmacy is illegal.

66

You cannot order compounded substances from a compounding pharmacy and?

Re-dispense them to your patients. This is distributing. You can only order them for in hospital use.

67

When filling out the NYS Form for CS online, what do you check for submitter type?

Dispensing Practitioner

68

When filling out the NYS Form for CS online, what do you enter for the "Pharmacy RX No."?

9999

69

When filling out the NYS Form for CS online, what do you enter for the official NYS Serial No?

ZZZZ

70

When filling out the NYS Form for CS online, what do you enter for the date written?

The same date as the date filled.

71

When filling out the NYS Form for CS online, what is the payment type?

Cash (or self) Pay