Federal Pharm Law Flashcards
(176 cards)
1
Q
What is the highest form of law
A
The constitution
2
Q
What are the two kinds of laws in the U.S
A
Federal and State
3
Q
What are laws made by legislatures?
A
statutes
4
Q
What is the responsibility of the legislature
A
To enact laws (statutes)
5
Q
What is the hierarchical order of statues
A
- federal statutes
- State constitutions
- State Legislation
- Ordinances
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
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)
8
Q
Some examples of Administrative agencies?
A
Department of health and Human services (DDHS)
FTC
U.S. Justice department
9
Q
What kind of agency is the state board of pharmacy
A
A state administrative agency
10
Q
What are the types of law
A
Civil Law
Administrative law
Criminal Law
Common Law
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
12
Q
What does Administrative Law focus on
A
This is the law that is created and enforced by government agencies
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
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
15
Q
What defines Negligence?
A
- failing to do something that a reasonable person would do (omission)
- Doing something that a resonable person would not do (commission)
16
Q
What are the elements of negligence?
A
- Duty owed
- Breach of duty
- Causation
- Damage
17
Q
How many elements of negligence must be proven to be legally liable
A
ALL 4!!!
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
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
20
Q
How is causation an element of negligence?
A
Law requires proof that the RPhs misconduct caused the alleged dmg
21
Q
How is damage defined as an element of negligence?
A
A loss or injury to a person or property
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
23
Q
What are the 4 things that consitute a DRUG under law?
A
- A substance recognized in the US Pharmacopeia (USP); Homeopathic Pharmacopeia, or National Formulary(NF)
- Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
- Substance (other than food) intended to affect the structure or function of the body
- Substance intended for use as a component of any substances specified in clause (1), (2), (3),; but doesnt include devices or their components
24
Q
How is a new drug defined
A
- Not recognize, among experts, to be safe and effective for use under the conditions presented in the labeling of the drug
- A drug, after investigation to determine its safe, but has not been used to material extent or enough time under conditions
25
How is a device defined?
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)
26
How is a cosmetic defined by law
1. substance applies to human body for cleaning, beautifying, promoting attractiveness
2. Substances does not include soap
27
What are the elements of a Prescription drug
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
28
Elements of OTC drugs
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
29
What is a new drug application?
Procedure for obtaining FDA pre-marketing approval of a drug; must be proven safe and effective
may require 18 to 24 months
30
What is the new drug application generally reserved for approval of
new chemical entities or new indications/dosage/route of administration for previously-approved drugs
31
Abbreviated New Drug Application (ANDA)
- 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
32
Supplemental New Drug Application (SNDA)
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
33
What is an OTC Monograph
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
34
What is the National Drug Code (NDC)
11 digit, 3 segment number identifying all drug products
| *required for all OTC and prescription drugs
35
First section of NDC
represents the manufacturer or distributor (AKA labeler)
| 5 dig
36
Second Section of NDC
Represents the product
| 4 dig
37
Third Section of NDC
represents the packaging
| 2 dig
38
What is the primary concern for adulteration
The PHYSICAL CONDITIONS of drugs or devices and the environment of their manufacture
39
What is the primary concern with Misbranding?
With the REPRESENTATIONS made by the manufacture concerning the drug or device
40
Adulteration prohibits in INTERSTATE commerce drugs that:
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
41
A drug is misbranded if:
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
42
What is a LABEL
- 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
43
What is LABELING
-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
44
What are the parts of the Patient Info Program?
- Medication Guides "MedGuides"
| - Consumer Medication Info (CMI)
45
What are the Medguides of the patient info program?
- 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
46
What is the consumer Medication info (CMI) of the patient info program?
- 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.
47
What does REMS stand for
Risk Evaluation and Mitigation Strategies
48
When and what started REMS and whats its goal?
Came into effect March 2008 as part of Title 9 of FDAAA
| goal= ensure a drug's benefit outweighs its risk
49
What are REMS Challenges (I)
New REMS can be required for new or existing drugs
Need to change existing REMS
There is no standardized design or implementation for REMS
50
REMS Challenges (II)
Number of REMS continues to grow
- approximatley 100 new REMS since July 2009
REMS not limited to outpatient pharmacies
51
What are the Elements of REMS
- 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)
52
What are medication guides and when are they needed?
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
53
What are Communication plans?
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
54
What are the Elements to Assure Safe use (ETASU)
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
55
What are the REMS that may be required for the Elements to assure safe use (ETASU)
- 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
56
What is a class I recall
Reasonable probability use will cause serious adverse health consequences or death
57
Class II recall
Use may cause temporary or medically reversible adverse health consequences
Probability of serious adverse health consequences is remote
58
Class III recall
Use is not likely to cause adverse health consequences
59
Whats is the withdrawal process for product recalls
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
60
What are the Current Good Manufacturing Practice (CGMP)
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
61
What is the orange book
- Approved drug products with therapeutic equivalence evaluations
- book that ensures that all generic products substituted for trade-name products are bioequivalent
62
What is the coding system used by the orange book
Two-letter coding system
The first letter is eaither an A or B
A= therapeutically equivalent
B=not considered to be equivalent
63
What is the purple book
lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).
64
What is a Biological product defined as
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.
65
What are voluntary reporting prgrams
```
MedWatch
-voluntary reporting system
-allows healthcare professionals to report
serious events
potential and actual product use error
quality errors
```
66
What happened on July 1, 2009 for what a pharmacist must provide patients with as a statment
Call dr for medical advice about side effects. May report side effect to FDA
67
Plane B one-step emergency contraceptive
June 20, 2013 FDA approved Plan B one-step for use without rx or age requirement
68
Avalable planB on the market
```
Plan B one-step (OTC, unrestricted age)
Plan B (OTC, women over 18 or older)
Ella (rx only)
```
69
What are the steps in new drug development process?
1. Pre-clinical testing (animal testing)
2. File IND (investigational new drug)
3. Clinical trials (3 phases)
4. File NDA (new drug application)
70
What is an Investigational New Drug (IND) application?
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
71
What is Phase I in clinical trials
Safety testing; small sample of healthy patients; the purpose of phase I is to detect adverse effects, not to determine efficacy.
72
What is Phase II in clinical trials
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
Phase III of clinical trials
Larger studies – hundreds or even thousands of patients; often multi-center, safety and efficacy in patients meeting strict criteria; risk-to-benefit analysis
74
Post-marketing surveillance (phase IV)
On-going evaluation of safety and efficacy
| FDA can rescind its prior NDA approval at this point if necessary
75
whats the reason for drug laws in the US
to protect the US public
76
What was the U.S. Pharmacopeia - 1820
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
What is the United States Pharmacopeia (USP)
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
What is the national Formulary (NF)
Monogroahs of inactive ingredients
79
What happened on 1980 with the USP/NF
combined into one compendium, which now serves as the official compendium for drug standards in the United States
80
Must a drug meet all compendia standards?
Yes, it must be recognized in the USP/NF or HPUS or it is considered misbranded or adulterated
81
Pure food and Drug Act of 1906
Prohibited the adulteration and misbranding of foods and drugs in interstate commerce
82
What were some of the loop holes of the Pure Food and Drug Act of 1906?
- 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
What is the Harrison Narcotic Act of 1914
Requires Rx for products exceeding the allowable limit of narcotics; and mandates increased record-keeping for physicians and pharmacists who dispense them
84
What is the Food, Drug and Cosmetic act of 1938
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
What is the Durham-Humphrey Amendment of 1951
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
Kefauver-Harris Amendment of 1962
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
Medical devices Act of 1976
Congress amended the FDCA to provide authority regarding safety and efficacy of medical devices according to their function
88
Class I medical devices
Low risk of harm, no pre-market testing
| EX: tongue depressors, bandages, bedpans
89
Class II medical devices
Safety and efficacy must be evaluated
| EX: hearing aids, forceps
90
Class III medical devices
Usually life-supporting devices, pre-market approval is required
EX: soft conact lenses, pacemakers, replacement heart valves
91
Orphan Drug Act of 1983
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
What is a rare disease defined as
Affects less than 200,000 people in the US
93
Drug Price Competition and Patent term restoration act of 1984
Streamlined the generic drug approval process
| -extended patent extensions to innovator drugs
94
Where do you go to find REMS
REMS@FDA
95
What does the Medicare/Medicaid fraud and abuse statute prohibit
1. Knowing making a false statement of material fact in any application for a benefit or payment
2. prohibits kickbacks
96
What are some of the criminal punishments for medicare/Medicaid fraud
Felony conviction
$25,000 fine
5-years imprisonment
Could also be subject to state licensing actions
97
What is the Medicaid Fraud Control Unit (MFCU)
Works with attorney general (AG)
Have state authority to investigate health care fraud/abuse
Works with Federal Prosecutors to enforce laws
98
What should a prescription be written on?
Tamper-resistant prescription pads
99
What are the features of tamper-resistant prescription pads
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
What part of the government has control over the Federal controlled substance act (CSA)?
Drug Enforcement Agency (DEA)
| Administers all parts of the CSA
101
What is the CSA designed as?
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
What are a “controlled substance” or “scheduled drugs”
Drugs that have the potential for addiction and abuse
103
What power does the attorney general have when it comes to a drugs schedules?
Has the authority to place a drug in a schedule, place an unscheduled drug into a schedule, or remove a drug from scheduling
104
What is a schedule-1 drug (C1)
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
What is a schedule- II drug (C2)
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
What is a schedule- III (C3) drug?
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
What is a schedule IV- (C4)
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
What is a schedule V - (C5) drug?
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
What are the groups required to register with the DEA?
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
8. Importing/exporting C1-5
110
How often do manufacturers and distributors need to register with the DEA?
They must do so annually
111
How often do dispensers need to register with the DEA?
Dispenser= prescribers/pharmacies
| It’s determined by AD but is usually between 1-3 years or 36 months from initial expiration date
112
What does it mean to dispense a CS
To deliver a CS to an ultimate user or research subject by a lawful order of a practitioner
113
What does manufacturing mean in terms of a CS
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
What does distributing mean in terms of a CS
```
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
Does every player need to register with the DEA in handling CS?
YES! Each place of business (manufacturers, distributors, or dispensers) are requires a separate registration
Each store in a chain pharmacy
116
What are the individual practitioner registration requirements?
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
Who are defined as practitioners
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
What is a Midlevel practitioner
NP, nurse midwife, nurse anesthetist, clinical nurse specialist, PA
119
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?
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
Can an intern, resident, or foreign-trained physician dispense under the hospital registration?
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
Who is exempt from registration?
```
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
What form is used to get a new registration from the DEA?
DEA form 224
123
What DEA form is used to get a renewal application?
DEA form 224a
124
What DEA form is needed for the renewal of retail/chain pharmacy
DEA form 224b
125
Does a change of address need a new registration?
Yes, physical address change or postal address change requires new DEA registration
126
What must be done if you terminate registration with the DEA
If you discontinue their business or transfer to another person you must notify the nearest DEA office
127
What must be done if you transfer a business with the DEA
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
How is a DEA number set up
First two characters: the first one denotes what level the practitioner is and the second letter is the registers initial for last name
129
How do you verify a DEA number?
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
Who should C2 records be kept
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
What are the three types of records involved in CS?
```
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
What are some of the records that need to be kept
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
What are the two options for storing control files
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
What are some of the inventory requirements for CS
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
What is required for the schedule II drug inventory
Actual physical count
136
What is required for schedule III-V inventory?
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
What are the records needed to transfer CS between dispensers
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
What DEA form is needed for disposal of CS
DEA form 41
139
What are some of the ways a registered practitioner may dispose of CS inventory
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
What are some of the ways patients can dispose of CS
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
What form is used to order C2s
```
DEA form 222
Triplicate form
Serially numbered
Issued with registrants name, address and registration number
Authorized activity
```
142
How are C3-5 ordered?
Invoiced or a packing slip can be used
| Must retain record for 2 years
143
What is the process for a DEA 222 form
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
What happens when the supplier gets the DEA 222 form
The supplier keeps copy 1, then forwards copy 2 to DEA
145
What does the purchaser (pharmacy) do upon receipt of C2 order from supplier?
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
What is the power of attorney (POA) when it comes to ordering CS
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
What are some errors by the purchaser that can be fixed on a 222 form
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
A CS prescription may be issued by?
1. Practitioner authorized to prescribe CS in the state in which they are practicing
2. Registered with the DEA or exempt for registration
149
What is the purpose of CS prescription?
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
How much a C2 proscription be written?
Must be hand written with ink or indelible pencil or typewritten
Exceptions:
1. Oral emergency
2. E-script
151
How can a C3-5 be written/given
May be written (including fax) or verbal
152
What are some rules when it comes to a paper rx
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
What must be done for an Rx that is computer generated that is printed out or faxed?
The practitioner must manually sign the rx (wet signature)
154
What must a CS contain per federal guide lines
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
What’s needed for oral emergency schedule 2 rx
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
How is an emergency situation defined for a C2 prescription
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
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Can you fax a C3-5 rx?
Yes, it must include all content of written rx
| May serve as an original rx
158
Can you fax and C2 rx? Per federal requirements
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
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What are the labeling requirements for a C2-5 rx?
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
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When don’t the labeling requirements apply to a prescribed drug
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
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Can you partial fill a C2 prescription per federal laws?
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
How many C2s can a dr write for a patient at one time
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
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How must C1 drugs be stored
Must be stored in a securely locked, substantially constructed cabinet
164
How should C2-5 drugs be stored
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
What is required for C3-5 drugs to be transferred?
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
Can you mail a CS ?
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
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Can you send CS out of the country?
No, it requires a special permit and you must be registered with the DEA as an exporter
168
Can a pharmacy accept CS that has already been dispensed?
Yes, as long as the collectors are registered with the DEA and follows their rules for taking back meds
169
Which DEA form is used for theft or significant loss of CS
DEA form 106
Send original to DEA field office
Maintain a copy for 2 years
170
What are the limits for selling methanphetaimes over the counter?
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
What must be kept in the log book for the combat methamphetamine epidemic act of 2005?
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
What qualifies a physician for an opioid treatment program?
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
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What is the “three day rule” in opioid treatment programs
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
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What is a central fill pharmacy?
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
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What are the advantages of a central fill pharmacy?
Increased efficiency of resources
Free RPh time for patient care activities
Reduces dispensing errors and reduces patient wait times
176
What are some of the things that are needed for a rx filled at central fill pharmacy?
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
