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Pharm 441: LAW > Federal Pharm Law > Flashcards

Federal Pharm Law Flashcards

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1
Q

What is the highest form of law

A

The constitution

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2
Q

What are the two kinds of laws in the U.S

A

Federal and State

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3
Q

What are laws made by legislatures?

A

statutes

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4
Q

What is the responsibility of the legislature

A

To enact laws (statutes)

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5
Q

What is the hierarchical order of statues

A
  1. federal statutes
  2. State constitutions
  3. State Legislation
  4. Ordinances
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6
Q

What is used to interpret and define statues?

A

Administrative regulations.
EX: A state legislature mandates that pharmacists must complete a certain number of CEs over a period of time. These regulations will be promulgated (promoted / enforced) by the state pharmacy board to provide the details

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7
Q

What is an Administrative agency?

A

Created by a legislature to implement a desired change to policies or to administer a body of substantive law when the legislature itself cannot proform these functions (i.e. State Board of Pharmacy)

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8
Q

Some examples of Administrative agencies?

A

Department of health and Human services (DDHS)
FTC
U.S. Justice department

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9
Q

What kind of agency is the state board of pharmacy

A

A state administrative agency

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10
Q

What are the types of law

A

Civil Law
Administrative law
Criminal Law
Common Law

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11
Q

What does Civil Law focus on

A

Determines private rights and liabilities
It is a private action that is prosecuted by the injured party
Think: relationship between individuals

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12
Q

What does Administrative Law focus on

A

This is the law that is created and enforced by government agencies

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13
Q

What does Criminal Law focus on

A

Specifies what conduct is a crime
Establishes appropriate punishments
Its an act against society that is prosecuted by the government
THINK: individuals roles in society

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14
Q

What does common Law focus on?

A

Law made by courts
Duty of the court is to apply the proper law to the facts before it and resolve the matter thro judicial decisions in which there is no statute that applies

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15
Q

What defines Negligence?

A
  1. failing to do something that a reasonable person would do (omission)
  2. Doing something that a resonable person would not do (commission)
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16
Q

What are the elements of negligence?

A
  1. Duty owed
  2. Breach of duty
  3. Causation
  4. Damage
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17
Q

How many elements of negligence must be proven to be legally liable

A

ALL 4!!!

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18
Q

How is duty owed defined as an element of negligence?

A

An obligation imposed on an individual requiring that they exercise a reasonable standard of care while preforming any acts that could harm others

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19
Q

How is breach of duty defined as an element of negligence?

A

Violation of the legal obligation to an individual.

EX: Dispensing errors; RPh filling an RX in another way than how the prescriber ordered it

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20
Q

How is causation an element of negligence?

A

Law requires proof that the RPhs misconduct caused the alleged dmg

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21
Q

How is damage defined as an element of negligence?

A

A loss or injury to a person or property

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22
Q

Key facts about Federal vs State Laws

A

A state has the authority to regulate in any area that congress has regulated
If there is a conflict Fed Law>State law (unless state is more stringent)
Is state law is less strict than fed law, the RPh who fills rx under state law would violate fed law

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23
Q

What are the 4 things that consitute a DRUG under law?

A
  1. A substance recognized in the US Pharmacopeia (USP); Homeopathic Pharmacopeia, or National Formulary(NF)
  2. Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
  3. Substance (other than food) intended to affect the structure or function of the body
  4. Substance intended for use as a component of any substances specified in clause (1), (2), (3),; but doesnt include devices or their components
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24
Q

How is a new drug defined

A
  1. Not recognize, among experts, to be safe and effective for use under the conditions presented in the labeling of the drug
  2. A drug, after investigation to determine its safe, but has not been used to material extent or enough time under conditions
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25
Q

How is a device defined?

A

An insturument, apparatus, or similar artical

  1. recognized in the NF, or USP
  2. Intended for use in diagnosis of disease or in cures for man or animal
  3. intended to affect the structure or any function of the body of man or other animal; which does not do so thro chemical action within the body (is not metabolized to get its purpose)
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26
Q

How is a cosmetic defined by law

A
  1. substance applies to human body for cleaning, beautifying, promoting attractiveness
  2. Substances does not include soap
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27
Q

What are the elements of a Prescription drug

A

Drug intended for use by man which:

  1. Is a habit-forming drug; or
  2. has toxicity or other potential for causing a harmful effect, not safe unless under supervision
  3. is limited by an approved application - to use under the professional supervision of a practitioner licensed by the law to administer such a drug
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28
Q

Elements of OTC drugs

A

drugs recognized among experts to be safe and effective for use (i.e. non rx)

  • must comply with currect good manufacturing practices (CGMP)
  • must contain “adequate directions for use” must be written so clearly a layperson can safely use
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29
Q

What is a new drug application?

A

Procedure for obtaining FDA pre-marketing approval of a drug; must be proven safe and effective
may require 18 to 24 months

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30
Q

What is the new drug application generally reserved for approval of

A

new chemical entities or new indications/dosage/route of administration for previously-approved drugs

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31
Q

Abbreviated New Drug Application (ANDA)

A
  • approving a generic of a previously approved drug
  • Can only apply for once a patent on an approved drug expires
  • No need for safety or efficacy date, but do need bioequivalence studies
  • Takes 6 to 8 months
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32
Q

Supplemental New Drug Application (SNDA)

A

Application process for previously FDA approved drug products, that want to request a change to the production of the drug, manufacturing process of the drug, or the labeling of a drug

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33
Q

What is an OTC Monograph

A

Regulation specifying the conditions (dosage, indications) where specific active ingredients and combos may be formulated in OTC products with prior FDA approval
- These are published for therapeutic classes, e.g. cough/cold products, analgesics, acne products

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34
Q

What is the National Drug Code (NDC)

A

11 digit, 3 segment number identifying all drug products

*required for all OTC and prescription drugs

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35
Q

First section of NDC

A

represents the manufacturer or distributor (AKA labeler)

5 dig

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36
Q

Second Section of NDC

A

Represents the product

4 dig

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37
Q

Third Section of NDC

A

represents the packaging

2 dig

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38
Q

What is the primary concern for adulteration

A

The PHYSICAL CONDITIONS of drugs or devices and the environment of their manufacture

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39
Q

What is the primary concern with Misbranding?

A

With the REPRESENTATIONS made by the manufacture concerning the drug or device

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40
Q

Adulteration prohibits in INTERSTATE commerce drugs that:

A
  1. Prepared, pack in unsanitary conditions
  2. Manufactured with GMP standards
  3. In a container with poisonous or deleterious mats that may leach
  4. Contains or is an unsafe color additive
  5. Varies from official compendia
  6. Either a new unsafe animal drug or animal feed containing a drug
  7. Class 3 medical device without premarket approval
  8. AN OTC drug not packaged in tamper-resistant package
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41
Q

A drug is misbranded if:

A
  1. labeling is false of misleading
  2. Label fails to state name and place of business of manufacturer
  3. label info in not prominently placed
  4. Does not bear adequate directions
  5. Is habit forming but does not have caution warning
  6. Does not bear generic name
  7. Listed in compendia, but not labeled and packed by standards
  8. package or drug is misleading in the way it is filled or formed
  9. subject to deterioration
  10. health endangering if used in the manner suggested by the label
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42
Q

What is a LABEL

A
  • Display of written, printed, or graphic matter upon the immediate container of any article
  • if info is required it must be on the outside of the container and clearly visible
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43
Q

What is LABELING

A

-All label and other wirtten matters: upon any container of any of its wrapper of accompanying such article
-Law requires certain info to accomany the drug but not necessarily be places on the label
EX: package insert

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44
Q

What are the parts of the Patient Info Program?

A
  • Medication Guides “MedGuides”

- Consumer Medication Info (CMI)

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45
Q

What are the Medguides of the patient info program?

A
  • Manufacturese are required to provide for drugs that pose “serious and significant” concern to public
  • FDA approval - labeled
  • Manufacturer procides to dispenser, dispenser gives to pt
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46
Q

What is the consumer Medication info (CMI) of the patient info program?

A
  • mandated that written info in provided to the pt for every drug every time a new rx is dispensed (annoying papers for new rx)
  • Provides consumers with key info about their RX i.e. how to take, storage info, etc.
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47
Q

What does REMS stand for

A

Risk Evaluation and Mitigation Strategies

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48
Q

When and what started REMS and whats its goal?

A

Came into effect March 2008 as part of Title 9 of FDAAA

goal= ensure a drug’s benefit outweighs its risk

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49
Q

What are REMS Challenges (I)

A

New REMS can be required for new or existing drugs
Need to change existing REMS
There is no standardized design or implementation for REMS

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50
Q

REMS Challenges (II)

A

Number of REMS continues to grow
- approximatley 100 new REMS since July 2009
REMS not limited to outpatient pharmacies

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51
Q

What are the Elements of REMS

A
  • product / contact info
  • goals of REMS
  • Medication guides
  • Communication plans
  • Elements to assure safe use (ETASU)
  • implementation system
  • Assessment (18 months, 3 years, and 7 years post)
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52
Q

What are medication guides and when are they needed?

A

Paper hand-outs desinged to be given along with medications
Required if:
-labeling could prevent serious adverse effects
-info regrading serious risks could affect pts decision to use med
-Med is important to health, and adherence to directions is crucial to drugs effectiveness

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53
Q

What are Communication plans?

A

Designed to support the implementation of REMS by targeting communication at healthcare providers

  • assists with healthcare provider implementation of REMS
  • explains safety protocols
  • May be disseminated thro professional societies
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54
Q

What are the Elements to Assure Safe use (ETASU)

A

Required medical interventions or other actions healthcare professionals need to execute prior to prescribing or dispensing the drug to the patient
-May have multiple requirements

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55
Q

What are the REMS that may be required for the Elements to assure safe use (ETASU)

A
  • HCP who prescribe the med might need specific training
  • Pharmices, practitioners, or healthcare setting that dispense the med are certified
  • Meds dispensed to pt only in a certain setting
  • Drug is dispensed only to pt with evidence of safe-use conditions
  • pts are subject to certain monitoring
  • pts enrolled in a registry
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56
Q

What is a class I recall

A

Reasonable probability use will cause serious adverse health consequences or death

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57
Q

Class II recall

A

Use may cause temporary or medically reversible adverse health consequences
Probability of serious adverse health consequences is remote

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58
Q

Class III recall

A

Use is not likely to cause adverse health consequences

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59
Q

Whats is the withdrawal process for product recalls

A

Manufacturer is responsible for contacting seller

  • seller contact consumer
  • Rph knows what drugs get recalled
  • Manufacture can initiate recall without FDA
  • FDA may initiate a product recall
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60
Q

What are the Current Good Manufacturing Practice (CGMP)

A

Regulations that establish minimum requirements for all things drugs

  • Purpose: Ensure that the drug is safe and meets quality / purity requirements
  • If it doesnt meet GMP its adulterated
  • Must be registered with the FDA and inspected every 2 years
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61
Q

What is the orange book

A
  • Approved drug products with therapeutic equivalence evaluations
  • book that ensures that all generic products substituted for trade-name products are bioequivalent
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62
Q

What is the coding system used by the orange book

A

Two-letter coding system
The first letter is eaither an A or B
A= therapeutically equivalent
B=not considered to be equivalent

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63
Q

What is the purple book

A

lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).

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64
Q

What is a Biological product defined as

A

The term “biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

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65
Q

What are voluntary reporting prgrams

A 
MedWatch
-voluntary reporting system
-allows healthcare professionals to report
serious events
potential and actual product use error
quality errors
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66
Q

What happened on July 1, 2009 for what a pharmacist must provide patients with as a statment

A

Call dr for medical advice about side effects. May report side effect to FDA

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67
Q

Plane B one-step emergency contraceptive

A

June 20, 2013 FDA approved Plan B one-step for use without rx or age requirement

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68
Q

Avalable planB on the market

A 
Plan B one-step (OTC, unrestricted age)
Plan B (OTC, women over 18 or older)
Ella (rx only)
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69
Q

What are the steps in new drug development process?

A
  1. Pre-clinical testing (animal testing)
  2. File IND (investigational new drug)
  3. Clinical trials (3 phases)
  4. File NDA (new drug application)
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70
Q

What is an Investigational New Drug (IND) application?

A

Its goal is the safety of individuals participating in the trials

  • if not rejected withing 30 days can move to phase 1
  • FDA can term at any time if drug is to toxic
  • only 1 in 10 drugs make ti this far
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71
Q

What is Phase I in clinical trials

A

Safety testing; small sample of healthy patients; the purpose of phase I is to detect adverse effects, not to determine efficacy.

72
Q

What is Phase II in clinical trials

A

Limited number of patients who actually have the disease for which the drug is indicated for; the purpose of phase II is to determine the efficacy of the drug and the dosages at which the efficacy occurs.

73
Q

Phase III of clinical trials

A

Larger studies – hundreds or even thousands of patients; often multi-center, safety and efficacy in patients meeting strict criteria; risk-to-benefit analysis

74
Q

Post-marketing surveillance (phase IV)

A

On-going evaluation of safety and efficacy

FDA can rescind its prior NDA approval at this point if necessary

75
Q

whats the reason for drug laws in the US

A

to protect the US public

76
Q

What was the U.S. Pharmacopeia - 1820

A

A group of physicians met to establish the first compendia standard of drug products
-set up a system of standards, quality control, and a national formulary

77
Q

What is the United States Pharmacopeia (USP)

A

Official compendia which contains monographs of active ingredients which include the approved titles, definitions, descriptions, and standards for identity, quality, strength, purity, packaging, stability, and labeling for a drug

78
Q

What is the national Formulary (NF)

A

Monogroahs of inactive ingredients

79
Q

What happened on 1980 with the USP/NF

A

combined into one compendium, which now serves as the official compendium for drug standards in the United States

80
Q

Must a drug meet all compendia standards?

A

Yes, it must be recognized in the USP/NF or HPUS or it is considered misbranded or adulterated

81
Q

Pure food and Drug Act of 1906

A

Prohibited the adulteration and misbranding of foods and drugs in interstate commerce

82
Q

What were some of the loop holes of the Pure Food and Drug Act of 1906?

A
  • Labels not required to list ingredients
  • Misbranding provisions of the law did not prevent false or misleading efficacy claims, it only prevented false statements as to the drug’s identity (i.e., strength, quality and purity)
  • Did not provide authority to ban unsafe drugs
  • Did not regulate cosmetics or medical devices
83
Q

What is the Harrison Narcotic Act of 1914

A

Requires Rx for products exceeding the allowable limit of narcotics; and mandates increased record-keeping for physicians and pharmacists who dispense them

84
Q

What is the Food, Drug and Cosmetic act of 1938

A

Requires that new drugs cannot be marketed until proved safe for use under the conditions described on the label and approved by the FDA.

85
Q

What is the Durham-Humphrey Amendment of 1951

A

FDCA required all drug products to be labeled with adequate directions for use, however, many drug products are not safe for administration without medical supervision

  • Established two drug classes; RX and OTC
  • authorized oral RX and refills
86
Q

Kefauver-Harris Amendment of 1962

A

Required drugs be proven not only safe, but also effective
Made retroactive to all drugs marketed between 1938 and 1962
-OTC and RX drugs subject to special packaging requirements EX: child-resistant container

87
Q

Medical devices Act of 1976

A

Congress amended the FDCA to provide authority regarding safety and efficacy of medical devices according to their function

88
Q

Class I medical devices

A

Low risk of harm, no pre-market testing

EX: tongue depressors, bandages, bedpans

89
Q

Class II medical devices

A

Safety and efficacy must be evaluated

EX: hearing aids, forceps

90
Q

Class III medical devices

A

Usually life-supporting devices, pre-market approval is required
EX: soft conact lenses, pacemakers, replacement heart valves

91
Q

Orphan Drug Act of 1983

A

Provided tax and licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of “rare disease or conditions” that affect relatively few people

92
Q

What is a rare disease defined as

A

Affects less than 200,000 people in the US

93
Q

Drug Price Competition and Patent term restoration act of 1984

A

Streamlined the generic drug approval process

-extended patent extensions to innovator drugs

94
Q

Where do you go to find REMS

A

REMS@FDA

95
Q

What does the Medicare/Medicaid fraud and abuse statute prohibit

A
  1. Knowing making a false statement of material fact in any application for a benefit or payment
  2. prohibits kickbacks
96
Q

What are some of the criminal punishments for medicare/Medicaid fraud

A

Felony conviction
$25,000 fine
5-years imprisonment
Could also be subject to state licensing actions

97
Q

What is the Medicaid Fraud Control Unit (MFCU)

A

Works with attorney general (AG)
Have state authority to investigate health care fraud/abuse
Works with Federal Prosecutors to enforce laws

98
Q

What should a prescription be written on?

A

Tamper-resistant prescription pads

99
Q

What are the features of tamper-resistant prescription pads

A

Unauthorized copying of a completed or blank pad
Erasure or modifications of info written on the prescription pad by the prescriber
Use of counterfeit prescription pads in order to be considered tamper resistant by a state
Must have at least two of these

100
Q

What part of the government has control over the Federal controlled substance act (CSA)?

A

Drug Enforcement Agency (DEA)

Administers all parts of the CSA

101
Q

What is the CSA designed as?

A

A closed system
It’s goal is to be able to trace controlled substances (CS) from the time its manufactured to the time it’s dispensed
Intent is to PREVENT DIVERSION of CS into illegal channels

102
Q

What are a “controlled substance” or “scheduled drugs”

A

Drugs that have the potential for addiction and abuse

103
Q

What power does the attorney general have when it comes to a drugs schedules?

A

Has the authority to place a drug in a schedule, place an unscheduled drug into a schedule, or remove a drug from scheduling

104
Q

What is a schedule-1 drug (C1)

A

Drug or other substance has a high potential for abuse
The drug or other substance has no currently accepted medical use in treatment in US
Lack of accepted safety for use of the drug or other substance under medical supervision
EX: heroin, MDA, LSD, marijuana

105
Q

What is a schedule- II drug (C2)

A

Has high potential for abuse
Has a currently accepted medical use in treatment in the US
Abuse of the drug or other substance may lead to severe physical or psychological dependence
EX: cocaine, amphetamine, morphine, methadone

106
Q

What is a schedule- III (C3) drug?

A

Drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II
The drug or other substance has currently accepted medical use in treatment in US
Abuse of the drug or other substance may lead to moderate or low physical dependence or HIGH psychological dependence
EX: ketamine, amobarbital, steroids

107
Q

What is a schedule IV- (C4)

A

Drugs or substance has a low potential for abuse relative to the drugs or other substances in schedule III
Has currently accepted medical use in treatment in US
May lead to limited physical dependence or psychological dependence relative to C3s
EX: benzodiazepines, weight loss stimulates, sleep aids

108
Q

What is a schedule V - (C5) drug?

A

Drug or other substance has a low potential for abuse relative to C4s
Currently accepted medical use in treatment in US
May lead to limited physical dependence relative to C4s
EX: cough syrups with codeine, antidiarrheal products

109
Q

What are the groups required to register with the DEA?

A
  1. Manufacturers of CS
  2. Distributors of CS (Mckession)
  3. Reverse distributing CS (who comes to collect it)
  4. Dispensing CS (a pharmacy)
  5. Research with C1
  6. Research with C2-C5
  7. Narcotic treatment program using C2-5
  8. Conduct chemical analysis with C1-5
  9. Importing/exporting C1-5
110
Q

How often do manufacturers and distributors need to register with the DEA?

A

They must do so annually

111
Q

How often do dispensers need to register with the DEA?

A

Dispenser= prescribers/pharmacies

It’s determined by AD but is usually between 1-3 years or 36 months from initial expiration date

112
Q

What does it mean to dispense a CS

A

To deliver a CS to an ultimate user or research subject by a lawful order of a practitioner

113
Q

What does manufacturing mean in terms of a CS

A

Production, preparation, propagation, compounding, or processing of a drug, either directly or indirectly, by extraction from natural origin or chemical synthesis
Also includes packing, labeling or re-labeling

114
Q

What does distributing mean in terms of a CS

A 
To deliver (other than by administering or dispensing) a CS. 
A store can give to another store as long as they don’t give more than 5% 
This is like McKesson delivering to us or interstore transfer
115
Q

Does every player need to register with the DEA in handling CS?

A

YES! Each place of business (manufacturers, distributors, or dispensers) are requires a separate registration
Each store in a chain pharmacy

116
Q

What are the individual practitioner registration requirements?

A

Only need to maintain one registration when prescribing from more than one office, provided that the practitioner only prescribes CS and doesn’t administer, dispense or store CS in more than one office

117
Q

Who are defined as practitioners

A

A physician, vet, scientific investigators, pharmacy, hospital, or other person licensed by appropriate authority may conduct research, distribute or dispense CS in course of professional practice or research

118
Q

What is a Midlevel practitioner

A

NP, nurse midwife, nurse anesthetist, clinical nurse specialist, PA

119
Q

Can an individual practitioner who is an agent or employee of a hospital administer, dispense, and prescribe a CS under the registration of the hospital or institution?

A

Yes, as long as dispensing, administrating, or prescribing is done in usual course of professional practice and the IP is authorized or permitted by jurisdiction.

120
Q

Can an intern, resident, or foreign-trained physician dispense under the hospital registration?

A

Yes, they use the insinuations DEA followed by an internal code which connects to the person
These can be requested to verify an RX

121
Q

Who is exempt from registration?

A 
Agent (employee) of registered manufacturer, dispenser, distributor, if acting in normal business (pharmacist) 
Common or contact carrier of warehouse ( delivery driver)
Ultimate user (patient) 
Some fed jobs where practicers are in short supply, will be give a placebo DEA or if military they use the service ID
122
Q

What form is used to get a new registration from the DEA?

A

DEA form 224

123
Q

What DEA form is used to get a renewal application?

A

DEA form 224a

124
Q

What DEA form is needed for the renewal of retail/chain pharmacy

A

DEA form 224b

125
Q

Does a change of address need a new registration?

A

Yes, physical address change or postal address change requires new DEA registration

126
Q

What must be done if you terminate registration with the DEA

A

If you discontinue their business or transfer to another person you must notify the nearest DEA office

127
Q

What must be done if you transfer a business with the DEA

A

Must notify DEA 14 days prior to transfer
Name, address, DEA# of old business and new business
Date on which CS inventory will be transferred
Take inventory on transfer day

128
Q

How is a DEA number set up

A

First two characters: the first one denotes what level the practitioner is and the second letter is the registers initial for last name

129
Q

How do you verify a DEA number?

A

Add the first, third, and fifth digit
Add the second, fourth, and sixth digit and multiply by 2
Add those numbers together
The right most digit of those together should match the 9th digit of the DEA number

130
Q

Who should C2 records be kept

A

All CS records need to be kept for 2 years at place of registration
Records and inventories of C2s must be kept separately from other records
Must be readily retrievable

131
Q

What are the three types of records involved in CS?

A 
Inventory 
Drugs received (records of receipt)
Ex: invoices for C3-5, DEA 222
Drugs dispersed (records of dispersal)
Ex: prescriptions, record books, DEA 222, invoices
132
Q

What are some of the records that need to be kept

A
  1. Office order forms, executed and I executed (DEA 222)
  2. Power of attorney (POA)
  3. Receipts and invoices for C3-5
  4. All inventory records
  5. Records of CS distributed
  6. Record of CS dispensed
  7. Report of theft or losses (DEA 106)
  8. Drugs surrendered for disposal (DEA 41)
  9. Records of transfers between pharmacies
  10. DEA registration certificate
133
Q

What are the two options for storing control files

A

Option 1: 3 separate files (C2, C3-5, nonconfrols)
Option 2: 2 separate files (C2, and C3-5 along with non-controls, or C2-5, and non-controls)
All records need to be readily retrievable

134
Q

What are some of the inventory requirements for CS

A

Initial inventory needs a complete and accurate count of CS on hand, record the inventory date and time taken (open and close of business)
Must have biennial (every 2 years) of inventory there after

135
Q

What is required for the schedule II drug inventory

A

Actual physical count

136
Q

What is required for schedule III-V inventory?

A

Estimated counts can be made

Exception: need an actual physical count required if the container holds more than 1000 units and has been opened

137
Q

What are the records needed to transfer CS between dispensers

A
  1. Receiving registrant must issue DEA form to supplying registrant
  2. Don’t need to register as distributor
  3. Total number of CS distributed cannot exceed 5% of all CS dispensed
    If you’re over 5% you are required to register as a distributor
138
Q

What DEA form is needed for disposal of CS

A

DEA form 41

139
Q

What are some of the ways a registered practitioner may dispose of CS inventory

A
  1. Delivery to a reverse distributor
  2. Return or recall, return to whom it was obtained or manufacture
  3. Request assistance from the special agent in charge of the local DEA
140
Q

What are some of the ways patients can dispose of CS

A
  1. Federal, state, tribal, or local law enforcement may collect CS from ultimate users and personal lawfully entitled to dispose
  2. Take-back events
  3. Mail-back events
  4. Collection receptacles
141
Q

What form is used to order C2s

A 
DEA form 222
Triplicate form
Serially numbered 
Issued with registrants name, address and registration number 
Authorized activity
142
Q

How are C3-5 ordered?

A

Invoiced or a packing slip can be used

Must retain record for 2 years

143
Q

What is the process for a DEA 222 form

A

Rph fills it out and sends copy 1 and 2 to supplier
The purchaser (pharmacy) retains copy 3 with C2 records
Once issued by pharmacy, valid for 60 days

144
Q

What happens when the supplier gets the DEA 222 form

A

The supplier keeps copy 1, then forwards copy 2 to DEA

145
Q

What does the purchaser (pharmacy) do upon receipt of C2 order from supplier?

A

Records number of containers on each line
Date on which containers are received
All done on 3rd copy and must keep the record for 2 years

146
Q

What is the power of attorney (POA) when it comes to ordering CS

A

The individual who signed the most recent registration or re-registration can with one or more individuals to obtain and execute the form 222
*cant be done for long-term used if say someone goes on maternity leave

147
Q

What are some errors by the purchaser that can be fixed on a 222 form

A
  1. Misspelling as long as there is no question of what the drug is
  2. Date is missing as long as it is not more than 60 days after receipt
  3. Package size is missing *only if one package size, otherwise have to void it
  4. Strength of drug missing * only if 1 strength is available
    Supplier may NOT complete number of line items complete is missing
148
Q

A CS prescription may be issued by?

A
  1. Practitioner authorized to prescribe CS in the state in which they are practicing
  2. Registered with the DEA or exempt for registration
149
Q

What is the purpose of CS prescription?

A
  1. Issued for legit medical purpose
  2. Prescription may not be issued to obtain medications for “office use” for general dispensing to patients
  3. Rx may not be issued for “detox treatment” or “maintenance treatment”
  4. Both RPh and practitioner are responsible for the proper prescribing and dispensing of CS
150
Q

How much a C2 proscription be written?

A

Must be hand written with ink or indelible pencil or typewritten
Exceptions:
1. Oral emergency
2. E-script

151
Q

How can a C3-5 be written/given

A

May be written (including fax) or verbal

152
Q

What are some rules when it comes to a paper rx

A

Must be written with ink or indelible pencil, typewriter, or printed on a computer printer must be manually signed by the practitioner (wet signature)

153
Q

What must be done for an Rx that is computer generated that is printed out or faxed?

A

The practitioner must manually sign the rx (wet signature)

154
Q

What must a CS contain per federal guide lines

A
  1. Full name and address of pt
  2. Date rx was issued
  3. Physician signature
  4. Drug name, dosage form and strength
  5. Quantity of drug prescribed
  6. Directions of us
  7. Name, address and DEA # of practitioner
155
Q

What’s needed for oral emergency schedule 2 rx

A
  1. Must include all content of written rx
  2. Quantity limited to emergency period
  3. RPh immediately reduces rx to writing *may be faxed to pharmacy - written will still be needed
  4. Written rx must be received in 7 days *can be mailed or delivered in person, must have “authorization for emergency dispensing” written on it, RPh must attach written rx to oral on, if rx not received RPh must report to DEA
156
Q

How is an emergency situation defined for a C2 prescription

A
  1. Immediate administration is necessary and proper
  2. No appropriate alternate treatment is available
  3. Not possible for dr to provide written rx to RPh prior to dispensing
157
Q

Can you fax a C3-5 rx?

A

Yes, it must include all content of written rx

May serve as an original rx

158
Q

Can you fax and C2 rx? Per federal requirements

A

Yes, as long as RPh receives the original written rx
May serve as an “original” rx if
*C2 narcotic compound for direct admin. To pt by parenteral, IV, IM SQ or intraspinal
C2 for resident of long term care facility (LTCF)
C2 for pt enrolled in hospice certified by Medicare or license by the state *Rx must date the pt is a hospice pt

159
Q

What are the labeling requirements for a C2-5 rx?

A
  1. Date of initial filling and if refilled, date of filling
  2. Pharmacy name address
  3. Serial number of rx (rx number)
  4. Name of pt
  5. Name of prescribing physician
  6. Directions of use
  7. Cautionary statements
160
Q

When don’t the labeling requirements apply to a prescribed drug

A

If it’s for the administration to an institutionalized patient via a medication order, provided that

  1. No more than 7-days supply for C2
  2. No more than 34 days supply for C3-5
  3. Drug is not in the possession of the pt before administration
161
Q

Can you partial fill a C2 prescription per federal laws?

A

Yes, as long as some rules are followed

  1. RPh must note qty supplied on rx
  2. Balance of rx must be filled within 72 hours, if unable to fill in 72 hours the RPh must call prescriber and tell them no further quantity can be given without new rx
162
Q

How many C2s can a dr write for a patient at one time

A

They total qty prescribed can not exceed 90 days supply
Must have legit medical purpose
Does. It pose undue risk of abuse
Rx must contain date of issue/date of earliest filling

163
Q

How must C1 drugs be stored

A

Must be stored in a securely locked, substantially constructed cabinet

164
Q

How should C2-5 drugs be stored

A
  1. Must be stored in a securely locked cabinet or distributed throughout the inventory of non controlled meds to deter theft
  2. Individual practitioners must store them in a securely locked cabinet at all times
165
Q

What is required for C3-5 drugs to be transferred?

A

Can only be done on a one-time basis, unless pharmacies are electronically linked and share real-time, online database to transfer back and fourth.

166
Q

Can you mail a CS ?

A

Yes, you can use USPS as long as you follow some rules

  1. Inner container is marked and sealed and placed in plain outer container or securely wrapped
  2. The inner container is also lived to show the name and address of the pharmacy, practitioner or other person dispensing rx
  3. Outside wrapper or container is free of markings that would indicate nature of contents
167
Q

Can you send CS out of the country?

A

No, it requires a special permit and you must be registered with the DEA as an exporter

168
Q

Can a pharmacy accept CS that has already been dispensed?

A

Yes, as long as the collectors are registered with the DEA and follows their rules for taking back meds

169
Q

Which DEA form is used for theft or significant loss of CS

A

DEA form 106
Send original to DEA field office
Maintain a copy for 2 years

170
Q

What are the limits for selling methanphetaimes over the counter?

A

3.6 gram/day per person
9 grams within 30 day period
7.5 grans within 30 day period by mail order
* 3+6= 9

171
Q

What must be kept in the log book for the combat methamphetamine epidemic act of 2005?

A

Kept for 2 years and contains:

  1. Products by name
  2. Qty sold
  3. Name and address of purchaser
  4. Date and time of sales
172
Q

What qualifies a physician for an opioid treatment program?

A
  1. Must be board certified in addiction
  2. May not treat more than 30 opioid-dependent patients at a time in first year
  3. After one year, they can apply to treat up to 100 opioid-dependent pt
  4. Must obtain special DEA that contains an X
  5. Must have both regular DEA number and X DEA number
173
Q

What is the “three day rule” in opioid treatment programs

A

Allows prescribers who have not obtained the special “X” ADMINISTER but not prescribe narcotics to patients for relieving acute withdrawal systems for up to 3 days
*rph is not allow e to dispense rx for acute withdrawal symptoms, exemption is only for administration of the drug by the prescriber

174
Q

What is a central fill pharmacy?

A

A pharmacy that fills rx for a retail pharmacy
First pharmacy receives the rx and then sends it to a second pharmacy to prepare and deliver back to the first pharmacy for dispensing to the pt
*developed to assist in handling increased volumes of rxs

175
Q

What are the advantages of a central fill pharmacy?

A

Increased efficiency of resources
Free RPh time for patient care activities
Reduces dispensing errors and reduces patient wait times

176
Q

What are some of the things that are needed for a rx filled at central fill pharmacy?

A

Label: must contain a unique identifier (central pharmacy DEA number) indicates where it was filled
A central fill pharmacy cannot accept a rx directly from a patient or individual practitioner or deliver a rx to a patient or individual

Pharm 441: LAW (5 decks)

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