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Law Day 2 > Controlled Substances > Flashcards

Controlled Substances Flashcards

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1
Q

Schedule I

A
  • high potential for abuse an dependence
  • no currently accepted medical use in treatment in the United States
  • these substances may NOT be prescribed
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2
Q

Schedule I Examples

A 
LSD
PCP
Marijuana
Mescaline
Heroin
Peyote
Methaqualone
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3
Q

Schedule II

A
  • high potential for abuse and may lead to dependence
  • has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions
  • abuse of the drug or other substance may lead to severe psychologic or physical dependence
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4
Q

Schedule II Examples

A

Cocaine, morphine, codeine, dihydrocodeine, Dilaudid (hydromorphone), fentanyl, amphetamine, secobarbital, amobarbital, pentobarbital, methylphenidate, Ritalin®, Tylox® (Oxycodone/APAP), Demerol® (Meperidine), Mepergan Fortis® (Meperidine/Promethazine), (as of 2014) hydrocodone, hydrocodone/acetaminophen (Vicodin), methadone

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5
Q

Schedule III

A
  • drug or substance has a potential for abuse less than those in schedules I and II
  • has a currently accepted medical use in treatment in the United States
  • abuse may lead to moderate or low physical dependence or high psychologic dependence
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6
Q

Schedule III Examples

A

Tylenol® with codeine #3, anabolic steroids, growth hormone, amobarbital suppository, secobarbital suppository, pentobarbital suppository, stimulants, ketamine
Schedule II with something else (Tylenol 3, aspirin with codeine, etc)

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7
Q

Schedule IV

A
  • drug or substance has a low potential for abuse relative to the drugs and substances in schedule III
  • the drug or substance has a currently accepted medical use in treatment in the United States
  • abuse may lead to limited physical dependence or psychologic dependence relative to those substances in schedule III
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8
Q

Schedule IV Examples

A

Valium®, Ativan®, Ambien® **Now Tramadol (Ultram®)!

Phenobarbital, stimulants, carisoprodol, pentazocine and butorphanol

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9
Q

Schedule V

A
  • drug or substance has a low potential for abuse relative to those in schedule IV
  • drug or substance has a currently accepted medical use in treatment in the United States
  • abuse may lead to limited physical or psychologic dependence relative to those in schedule IV
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10
Q

Schedule V Examples

A

Novahistine DH, Robitussin AC (antitussive with codeine), Lomotil (antidiarrheal with opium)

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11
Q

Who may add, delete, or reschedule substances that must obtain a scientific and medical recommendation from FDA?

A

US Attorney General

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12
Q

Who may add delete or reschedule substances but cannot override acts made by the legislature?

A

The Commissioner of the Texas Department of State Health Services

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13
Q

What federal agency regulates controlled substances in the US?

A

Drug Enforcement Administration (Federal)

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14
Q

Who must obtain a registration to handle controlled substances?

A 
●	Manufacturing (Ex: Manufacturer) 
●	Distributing (Ex: Cardinal Health, McKesson) 
●	Dispensing (Ex: Pharmacies) 
●	Research (Ex: Laboratories) 
●	Instructional Activities (Ex: Drug Lab) 
●	Narcotic Treatment Program - CII-CV
●	Chemical Analysis 
●	Import of Controlled Substances 
●	Export of Controlled Substances
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15
Q

Which agency registration includes a waiver granting the agency the right to inspect records and the controlled premises?

A

DPS

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16
Q

Do pharmacists obtain individual controlled substances registrations? Why or why not?

A

Pharmacists do not register as individual practitioners unless they are allowed to prescribe controlled substances
Texas does not allow pharmacists to prescribe controlled substances

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17
Q

Who does not have to register with the DEA?

A
  • any agent or employee of any registered manufacture, distributor, or dispenser
  • A common or contract carrier or warehouse man or an employee there of whose possession is in the usual course of business
  • a patient
  • officials of the US armed services, public health services, or Bureau of prisons acting in the course of their official duties (not CIIs)
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18
Q

DEA 222***

A

Form used to order, sale, transfer schedule II substances
3 copies - purchaser submits copy 1 and copy 2 to the supplier and retains copy 3, supplier retains copy 1 and forward copy 2 to DEA, purchase your records on copy 3 the number of containers received and the date received with pharmacist initials
Signed by the person who last renewed the pharmacy DEA number or power of attorney
PURCHASER ALWAYS SUPPLIES THIS FORM

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19
Q

DEA 224

A

New application for retail pharmacy, hospital/clinic, practioner, teaching institution, or mid-level practitioner

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20
Q

DEA 225

A

New app for manufacturer, distributor, researcher, analytical laboratory, importer, exporter

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21
Q

DEA 363

A

New app for narcotic treatment programs (Ex: Methadone Clinic)

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22
Q

DEA 106

A

Form used to report theft or loss of controlled substances
Does not have to occur mediately if you need time to investigate the facts but must notify DEA in writingwithin one business day

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23
Q

DEA 41

A

Disposal and destruction of controlled substances form sent to the DEA Diversion Field Office listing the drugs to be destroyed, method of destruction, and at least two witnesses.
Must be done at least two weeks prior to proposed destruction date and the DEA will notify registrants in writing of the decision

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24
Q

When do you not have to fill out a DEA form 41?

A

When you transfer medications to an authorized and registered reversed distributor for destruction
Transfer must be documented with an invoice for schedule III-IV and a DEA form 222 for schedule II

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25
Q

What happens if a DEA 222 is lost?

A

Purchaser fills out a new DEA 222 form with the statement containing the serial number and the date of the last form and stating that the goods covered by the first order were not received because the form was lost

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26
Q

What is the “code” for determining is a DEA registration number is valid?

A
  • Consist of nine characters – 2 letters and 7 numbers
  • First letter will be either A, B, or F for a dispense, M for midlevel practitioner, P for a distributed
  • Second letter is the first letter of the registrant’s last name
  • Add 1st, 3rd, 5th digits
  • Add to the above sum the sum of the 2nd, 4th, and 6th digits multiplied by 2
  • The right most digit of the result should correspond with the ninth character
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27
Q

The DEA and DPS cannot inspect the pharmacy with regard to controlled substances; records not allowed to be inspected without the consent of the pharmacist include:

A

Financial data
Sales data
Pricing data

TSBP may inspect the pharmacies financial records in the course of an investigation of a specific complaint

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28
Q

DEA 222 form has three copies. These copies whether paper or electronic provide what three parties information regarding a transfer of Schedule substances?

A

O Copy One: sent by purchaser and retained by the supplier
O Copy Two: sent by purchaser to supplier then sent to DEA from supplier
O Copy Three: retained by the purchaser with date a pharmacist initials

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29
Q

When an order for schedule substance has been placed, the supplier has how long to complete the order?

A

60 days

Can partially fill as long as it is fully filled within 60 days

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30
Q

How many NDC numbers may be ordered on a DEA 222 form?

A

10

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31
Q

Who may sign a DEA 222 form?

A

Person authorized to sign the forms or a person with power of attorney to sign for that person

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32
Q

What is power of attorney and how is it used with respect to ordering Schedule II substances?

A

A copy of the power of attorney must be kept by the purchaser at the registered site with executed order forms

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33
Q

Describe the process by which Schedule substances are returned to the supplier.

A

Pharmacist contacts distributor and request that the distributor/wholesaler issue an order form, the pharmacist “fill” the order form with the meds he/she is returning. The pharmacy (acting as a distributor) would retain one copy and forward one to the DEA

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34
Q

Describe the process by which Schedule III, IV and V substances are ordered?

A

These substances are exempt from federal order form procedures (DEA 222) due to a lower potential for abuse and dependence

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35
Q

Describe the record of purchase of Schedule III, IV and V substances purchased?

A

Acquisition records of those substances consist of invoices or packing slips from the wholesaler/distributor/supplier

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36
Q

What are lawful methods of storage of Schedule II substances in a community pharmacy?

A

Must be stored in secure. Locked cabinet that is locked; CII’s may also be dispersed throughout the non-controlled stock in order to deter theft

37
Q

Describe the action taken in the event of a loss or theft of controlled substances. What form is used? What agencies must be notified?

A

O In the event of theft or significant loss of controlled substance
O Notify the appropriate divisional office of DEA, the DPS and TSBP upon discovery of theft/loss
O Complete DEA form 106 and provide copies to: DEA, DPS, TSBP, one for pharmacy’s record

38
Q

Commercials containers must be labeled to clearly indicate the schedule of the substance. Describe the symbol required and the placement of the symbol on that container.

A

The symbol must be located in the upper right corner of the label in the type size at least twice as large as the largest type otherwise printed on the label OR may be overprinted (similar to a watermark) in a contrasting color and in type size at least one-half the height of the label

39
Q

When a legend drug product that is already on the market becomes a scheduled substance, the manufacturer has how long to update the label?

A

180 days

40
Q

Which controlled substances records may not be kept at a central location?**

A

O Executed order forms 222
O Prescriptions
O Inventories
O These records must be maintained on the regular site at all times

41
Q

What are a pharmacy’s records of purchase for Schedule II substances? Where must the records be kept and for how long?

A

O DEA 222
O CII records MUST BE MAINTAINED SEPARATELY including prescription files, invoices, and receipts, inventories
O Inventories and records are to be kept for 2 YEARS from the date such inventory and records are made under federal & Texas regulations

42
Q

What are a pharmacy’s records of purchase for Schedule III, IV and V substances? Where must the records be kept and for how long?

A
  • Packaging lists or invoices
  • CIII, CIV, & CV records must be must be maintained separately including prescription files, invoices, and receipts, inventories
  • Inventories and records are to be kept for 2 years from the date such inventory and records are made under federal and Texas regulations
43
Q

What are a pharmacy’s records of controlled substance dispersal?

A

Prescriptions

44
Q

How must prescriptions be filed according to federal law?

A

O Three files: CII, CIII, CIV, CV
O Two files: CII – CV provided that CII, CIV, CV have the letter “C” no less than one inch high stamped in red ink on the lower right corner
O Two files: CII only, all others using the “Red C”

45
Q

What is the only lawful method of prescription filing in Texas?

A

3 file method

46
Q

Define the 3 File Method

A

Schedule II
Schedule III, IV, V
All records of dangerous drugs

47
Q

How often must dispensers register with the DEA for a controlled substance?**

A

Every 3 years

48
Q

Practitioner registration starts with?**

A

A, B, or F (or G for department of defense contractors)

49
Q

Use of hospital DEA number

A

Hospitals must assign a specific internal code for each practitioner authorized to use the hospital’s DEA number and this must be available at all times (aka a suffix after the DEA number)

50
Q

Who’s the registration begins with the letter M?

A

Mid level practitioners including advanced practice nurses, physician assistance if the state allows

51
Q

Temporary use of registration upon sale of a pharmacy

A

If the new owner has not yet obtained of the registration, they may continue operating under the previous owners registration if:
- New owner must expeditiously apply for an appropriate DEA and state licensure
- previous owner grants a power of attorney to the new owner with the following: previous owner agrees to allow controlled substance activity of the pharmacy to be carried out under their DEA registration, allows the new owner to carry-on the controlled substance is activity at the pharmacy including ordering, acknowledges that he or she will be held accountable for any of violations and
SHALL REMAIN IN EFFECT FOR no more than 45 DAYS AFTER PURCHASE!!

52
Q

Compounded Controlled Substances Scheduling**

A
  • If codeine or opium is only mixed with water simple syrup it is still scheduled two
  • pharmacy may compound narcotic controlled substance prescriptions as long as the concentration is not greater than 20%
  • must be compounded with one or more nonnarcotic therapeutic ingredients
53
Q

Codeine C4 limit?

A

200 mg per 100 mL

Require a prescription

54
Q

Codeine C3 limit?

A

1.8g per 100 mL and 90 mg per dose unit

Require a prescription

55
Q

Opium federal C4 limit?

A

100 mg per 100 ML

Require a prescription

56
Q

Opium Texas C4 limit?

A

50 mg per 100 ML

Require a prescription

57
Q

Opium C3 limit

A

500 mg per 100 ML’s and 25 mg producing unit

Require a prescription

58
Q

Can a DEA form 222 be faxed?

A

Yes but the supplier may only prepare the order not ship until the form is received and verified

59
Q

Controlled Substances Ordering System CSOS

A

Electronic ordering of schedule 2; allows electronic orders based on digital certificates which serve as an electronic equivalent to the DEA form 222

60
Q

How do you order schedule III-V Controlled Substances?

A

Through normal ordering process is from a wholesaler but must be documented by pharmacy with an invoice provided by the wholesaler or manufacturer containing: name, dosage form and strength, number of units per container, quantity of containers, date of receipt, name address and DEA number of pharmacist

61
Q

The 5% Rule

A

A pharmacy does not have to register with FDA as a distributor as long as total quantities of controlled substances distributed during a 12-month period does not exceed 5% of the total quantity of all controlled substances suspended and distributed during the same 12-month period

62
Q

Transferring Controlled Substances

A

If for a schedule II, you must have a DEA form 222 from the purchaser
If for a schedule III-V, you must send an invoice to the purchaser
Scheduled medications can only be sent to the address on the DEA 224 form

63
Q

Inventory Count Requirements

A
  • an exact count is required for all schedule IIs

- an estimated count is allowed for schedule III-IV unless the container holds more than 1000 tablets or capsules

64
Q

Perpetual Inventory Requirements in Texas

A
  • schedule to controlled substance is in a class C institutional pharmacy
  • all controlled substance is stored at a remote location under the remote pharmacy rules
  • all controlled substance is in a classy ambulatory surgical center
  • oh controlled substance is in a class of freestanding emergency medical facility pharmacy
65
Q

Inventory Timing Requirements

A
  • Initial inventory is required on the first day the pharmacy is open for business
  • newly scheduled drugs or drugs move from one schedule to another must be inventoried on the day scheduled or move to the new schedule
  • DEA requires a biennial inventory that must be maintained in the pharmacy for two years
  • TSBP requires an annual inventory
  • TSBP requires that inventories be signed by the pharmacist in charge and be notarized within three days of the day the inventory is completed excluding weekends
66
Q

Federal transfer warning

A

The following warning is required to be on the label of the schedule II-IV controlled substance when dispensed to the patient - “caution: federal law prohibits the transfer of this drug in person other than the patient for him it is prescribed.”

67
Q

Who does Texas law authorize to prescribe controlled substances?

A 
Physicians MD or DO
Dentist
Podiatrist
Veterinarians
Optometric glaucoma specialist
Schedule III-IVPolin advanced practice registered nurses and physician assistance with some restrictions
68
Q

Define designated agent’s

A

Can communicate a prescription for a C-3 C-4 C-5 but cannot authorize or prescribe
May not verbally communicate emergency C-2 prescriptions
Maybe non-employees of the physician with formal written appointment of agent by the prescriber specifically in nursing homes

69
Q

Written controlled substance prescriptions requirements

A

Manual signature

  • Full name and address a patient and date of birth
  • drug name, strength, and dosage form
  • quantity prescribed numerically and as a word
  • intended use of drug unless not in the best interest of the patient
  • name, address, and DEA number of the practitioner and telephone number
  • if for a schedule to prescription to be filled at a later date, the earliest date on which pharmacy may fill a prescription
70
Q

What on a C-2 prescription can a pharmacist not change?

A

Name a patient
Name of drug
Name of physician
Date written

71
Q

Process of changing something on a C2 prescription?

A

Call the prescribing practitioner and receive verbal permission for the change and document on the prescription that the change was authorized and the name or initials of the individual granting authorization and the pharmacist initials

72
Q

Changing things on a C-3, C4, C5 prescription

A

Technically the guidelines are the same as C2 but a new verbal prescription can be taken if something needs to be changed

73
Q

Verbal, fax, and electronic prescriptions

A

Verbal are not valid for C2
Verbal are valid for C-3, C4, C5
Fax prescriptions are valid for C3 C4, C5 with prescribers original signature and in special circumstances for C2
Electronic prescriptions for controlled substance is our volitive both the prescribers computer and pharmacies computer meet all DEA security requirements

74
Q

General Schedule 2 Requirements

A
  • require a written prescription on a Texas official prescription form signed by the practitioner
  • verbal prescriptions are not allowed except in an emergency
  • electronic prescriptions are allowed
  • C2 prescriptions cannot be refilled
  • under Texas law, a prescription for a C2 controlled substance must be filled within 21 days after the date issued on the first date authorized to fill (aka 22 days)
  • practitioners can issue multiple C2 prescriptions on the same day for a total of no more than 90 day supply with Earlysville dates
  • there is no quantity limit on a single controlled substance prescription
75
Q

Exceptions for faxing C2 prescriptions

A

1) prescribed narcotic for a patient undergoing home infusion or IV pain therapy
2) prescribing controlled substance is for patients in long-term care facilities
3) prescribing narcotics for a patient in hospice care
MUST BE A FAX OF THE TEXAS OFFICIAL PRESCRIPTION FORM

76
Q

Emergency Dispensing of C2

A
  • May be telephoned or faxed
  • Emergency means that the immediate administration of the drug is necessary for the proper treatment of the ultimate user and that no alternative treatment is available and it is not possible for the prescribing practitioner to provide a written prescription
  • Within seven days after authorizing an emergency telephone prescription, the prescribing practitioner must furnish the pharmacist a signed written official prescription or a valid electronic prescription
  • should be marked, “authorization for emergency dispensing.”
  • quantity is the amount needed to treat the patient during the emergency. Not a specific day supply
77
Q

Partial fills must be completed in what time?

A

30 days after the date the prescription is issued
For emergency verbal prescriptions, partial fills must be completed no later than 72 hours after the prescription was issued**
All partial fills for terminally ill and long-term care facility patient must be completed within 60 days
All partial fills for C2 must be filled within 72 hours per Texas law*

78
Q

Exemptions to the use of an official prescription form for C2

A

Hospital inpatient, person receiving treatment from a life flight helicopter or emergency medical ambulance or paramedics, inmates, animals, therapeutic optometrists, Out-of-state practitioners if preapproved, electronic prescriptions

79
Q

How many refills are allowed for C3, C4, C5 prescriptions?

A

Up to five times or six months

There is no limit to the number of partial fills so computer systems that invalidate after 5 partial fill are illegal

80
Q

How many times can you transfer a C3, C4, C5 prescription?

A

Refills may be transferred to another pharmacy on a one-time basis unless a pharmacy shares an electronic, real time, online database of prescriptions then they can be transferred up to the maximum number of refills permitted

81
Q

Prescription Monitoring Program PMP

A

Collects prescription dispensing data and all C2, C3, C4, C5 controlled substance is dispensed by pharmacy in Texas or to a Texas resident from an out-of-state pharmacy
- Designed to assist pharmacist and physicians and identifying patients who may be getting prescriptions for controlled substances from multiple physicians or having prescriptions filled by multiple pharmacies

82
Q

Information that is transmitted to TSBP for the PMP program?

A
  • official prescription control number
  • patients name, age, date of birth, address
  • date the prescription was issued and filled
  • NDC number of the controlled substance dispensed
  • quantity
  • pharmacy prescription number
  • pharmacy DEA registration number
83
Q

Methadone

A

Can only legally be dispensed as an analgesic unless it is provided through a registered narcotic treatment center for maintenance or detox of addicts

84
Q

Define short term detox

A

Dispensing of a narcotic drug in decreasing doses for a period not to exceed 30 days

85
Q

Define long term detoxification

A

Dispensing of a narcotic drug to a narcotic dependent person and decreasing doses in excess of 30 days but not in excess of 180 days

86
Q

Who can prescribe methadone for addiction?

A

I physician who is not part of a narcotic treatment program may administer no more than three days until the patient is enrolled
A hospital that is not part of a narcotic treatment program in minister narcotics if the patient is in the hospital for a condition other than addiction

87
Q

DATA-Waived Physician

A

Practitioner authorized to prescribe certain narcotics to treat opiate dependence through a risk management program shall have identification or “X” code which must be included with the prescribers DEA number
Drugs: Subutex/buprenorphine and Suboxone/buprenorphine + naloxone

88
Q

The combat methamphetamine epidemic act of 2005

A

Controls the cells of OTC products containing precursor chemicals used in the elicit manufacturing of methamphetamine
Must maintain an electronic or written log book with product name, quantity sold, name and address of purchaser, date and time of sales
Employees must be trained with DEA requirements for self certification and training
Mail service and mobile retail vendors have dose limitations too

89
Q

Pseudoephedrine retail sales limits

A

3.6 g per day and 9 g per 30 days

Must be at least 16 years old per Texas law

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