Chapter 2 csa Flashcards
(147 cards)
1
Q
Which drug classification?
High potential for abuse and severe potential for dependence (addiction)
Includes: opiates and derivatives (heroin, dihydromorphine), hallucinogens (LSD), peyote, mescaline, depressants (methaqualone)
A
Schedule I drugs
note, treat marijuana as if it’s schedule I even though it is legal in FL, it is still schedule I under federal law, and whichever law is stricter always applies in the law
also - BOP doesn’t license medical marijuana
2
Q
Which drug classification?
High potential for abuse. Have currently accepted use in treatment in the US. Abuse of the drug or other substances may lead to severe physical or psychological dependence (addiction)
includes:
opium (morphine, codeine, dihydrocodeine, oxycodone, apap+hydrocodone/vicodin, methadone, meperidine, hydromorphone, fentanyl, cocaine),
stimulants (amphetamine, methamphetamine, phenmetrazine, methylphenidate)
depressants (pentobarbital, secobarbital, amobarbital, glutethimide, phencyclidine)
A
Schedule II drugs
3
Q
Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence
A
Schedule III drugs
Tylenol #3 (aspirin/apap + codeine)
suppository forms of amounts pentobarbital, secobarbital, amobarbital
stimulants - chlorphentermine, phendimetrazine, benzphetamine
anabolic steroids - testosterone, ketamine, paregoric
NOTE: some states schedule Fioricet (butalbital+apap+caffeine) FLORIDA DOES NOT
4
Q
What schedule is Fioricet?
A
It is not scheduled under Florida law.
5
Q
Under federal law, the suppository forms of amobarbital, secobarbital, and pentobarbital are schedule ______, but other dosage forms are schedule ______.
Under Florida law, it includes all dosage forms of these products under schedule _____.
A
schedule III - suppository
Schedule II - other dosage forms
Florida law –> ALL schedule II
6
Q
Low potential for abuse, abuse may lead to limited physical or psychological dependence (relative to schedule III)
A
Schedule IV
Narcotics (dextropropoxyphene, difenoxin <1mg, atropine sulfate <25mcgs)
depressants (alprazolam, chloral hydrate, diazepam, lorazepam, phenobarbital)
stimulants (diethylpropion, phentermine)
carisoprodol, tramadol, pentazocine, butorphanol
7
Q
Drug schedule of
phenmetrazine
A
CII
8
Q
Drug schedule of
phendimetrazine
A
CIII
9
Q
Drug schedule of
phentermine
A
CIV
10
Q
What drug class is pregabalin (Lyrica), antitussive products containing codeine, and antidiarrheal products containing opium
A
CV
11
Q
Is Epidiolex a controlled substance (CV)?
A
No, DEA removed these products from CV.
12
Q
Manufacturers may apply to DEA to exempt a product or chemical from certain provisions of the CSA if the product or chemical is not likely to be abused. List 4 drugs on this list.
A
- Phenomarbital
- Butalbital
- Chlordiazepoxide
- Meprobamate
13
Q
____________ _____________ are chemicals that, in addition to legitimate uses, are used in manufacturing a controlled substance.
A
Listed Chemicals
14
Q
In addition to specifically chemicals, OTC products containing (3 drugs) are considered Listed Chemicals
A
1) Phenylpropanolamine
2) pseudoephedrine
3) ephedrine
These are NOT controlled substances under federal law but are subject to certain sales limitations and other restrictions.
15
Q
Federally, who schedules controlled substances?
A
US Attorney General, as head of the Department of Justice (which DEA is under), may add, delete, or reschedule substances but must obtain a scientific and medical recommendation from the FDA.
16
Q
Per State law, who may add, delete, or reschedule substances under the FLCSA?
A
The Florida Attorney General
17
Q
A pharmacy may compound narcotic controlled substances pursuant to a rx as long as the concentration is not greater than ___%
*applies to aqueous or oleaginous solutions or solid oral dosage forms.
A
20%
DEA may consider compounding a narcotic rx greater than 20% to be manufacturing, which would require the pharmacy to be registered with the DEA as a manufacturer
18
Q
A narcotic substance must be compounded with one or more _____________
A
non-narcotic therapeutic ingredients
19
Q
Any prescription for a narcotic that is not mixed with another drug, regardless of concentration, will always be a schedule ___
A
Schedule II.
For example, I f codeine or opium is only being mixed with water or simple syrup, it is still a CII regardless of the concentration.
20
Q
Narcotic compounding
Codeine CV limit
A
200mg/100ml
21
Q
Narcotic compounding
Codeine CIII limit
A
1.8g/100ml and 90mg/dosage unit
Anything above this limit would be a schedule II
22
Q
Narcotic compounding
Dihydrocodeine CV limit
A
100mg/100ml
23
Q
Narcotic compounding
Dihydrocodeine CIII limit
A
1.8mg/100ml and 90 mg/dosage unit
anything above this would be schedule II
24
Q
Narcotic compounding
Opium CV limit
A
100 mg/ml
25
Narcotic compounding
Opium CIII (federal law)
500mg/100ml and 25mg/dosage unit
CIII limit per Florida law, none is listed
Florida law does contain a limit for opium for schedule V of 100mg/100ml, this means that under Florida law, any compounded opium product greater than 100mg/100ml goes from schedule V straight to schedule II ****
26
Narcotic compounding
Morphine CV limit
non line - no morphine products are CV, they are either CII or CIII
27
Narcotic compounding
Morphine CIII limit
50mg/100ml
28
A compounded narcotic prescription will NEVER be a schedule ___
IV
29
T or F
While everyone who distributes, manufactures, or dispenses any controlled substances must register with the DEA, there is no state controlled substance registration in Florida.
True
30
Dispensers (pharmacies and practitioners) register every __ years with the DEA
3 years
31
Registration form for dispensers, including pharmacies, is DEA form ___
Form 224
Renewal form for dispenser is DEA Form 224a
32
An applicant can authorize another individual to sign the application and renewals by filling out a ____________ granting that individual the authority and filing that ___________ with the DEA Registration Unit
Power of Attorney
33
Who does not have to register with the DEA?
An agent or employee of any registered manufacturer, distributor, or dispenser if acting in the usual course of business or employment
a common or contract carrier or warehouseman or an employee thereof whose possession is in the usual course of business or employment
an ultimate user (pt) who possesses such substance for a lawful purpose
officials of the US armed services, Public Health Service, or Bureau of prisons acting in the course of their official duties
Military and federal practitioners
34
Temporary Use of Registration Upon Sale of a PHarmacy; the previous owner agrees that the controlled substance activities of the pharmacy may be carried out under his or her DEA registration and shall remain in effect for no more than how many days after the purchase date?
45 days
35
When ordering Schedule II Controlled Substances what form is required for each sale or transfer of CII drugs?
DEA Form 222
36
On a DEA Form 222, which CS must contain only orders for these substances?
etorphine hydrochloride and diprenorphine (animal tranquilizers)
37
What must be noted on a DEA Form 222?
- number of lines completed
- Name and address of supplier from whom the CS are being ordered
- signed (or electronically signed) by the registrant (individual, partner, or officer) or by the person authorized to execute DEA form 222
38
For a DEA Form 222, a registrant may authorize other individuals to execute forms by creating a Power of Attorney (POA). This POA does or does NOT need to be sent to the DEA?
Does NOT
A POA must be signed by the person granting the power, the person receiving the power (attorney-in-fact), and two witnesses
Only the actual registrant may grant a POA for signing DEA Form 222
39
Ordering CII
A supplier may provide a partial quantity for the requested amount, but the remaining quantity must be sent within __ days or the order becomes void
60 days
40
No DEA Form is valid more than __ days after its execution by the purchaser
60 days
with the exception of certain DoD orders
41
Ordering CII
If a completed order form is lost or stolen, purchaser must prepare another DEA Form 222 along with...
a statement containing the serial number and date of the lost form, and stating that the goods covered by the first order were not received because the form was lost
42
A pharmacy may fax a completed DEA Form 222 to a supplier; however the supplier..
may not ship the product until the original DEA Form 222 is received and verified.
43
Who provides the original DEA Form 222 and keeps a copy for their own records?
the purchaser/person obtaining the product
44
T or F
DEA allows electronic ordering of Schedule II controlled substances through Controlled Substances Ordering System (CSOS)
True
45
Who may correct a defective electronic order of CII?
NO ONE; the purchaser must issue a new order for the order to be filled
and the original statement must be linked to the statement of nonacceptance to the new order. The original statement must be retained for TWO YEARS
46
How are Schedule III-V controlled substances ordered?
through normal ordering processes from a wholesaler or manufacturer, but must be documented by a pharmacy with an invoice provided by the wholesaler or manufacturer
47
Ordering Schedule III-V CS
The invoice must contain
name of controlled substance
dosage form and strength
number of units per container (ex 100 tablet bottle)
quantity received (containers)
date of receipt
name, address, and DEA # of the registrant from where the CS was received
48
A pharmacy does not have to register with the DEA as a distributor as long as total quantities of CS distributed during a 12-month period does not exceed __% of total quantity of all CS dispensed and distributed during that same 12-month period
5%
of ALL controlled substances!!!! (not just CII)
49
What is required for a transfer of CII?
DEA Form 222
NOTE: this is filled out by the requester!
50
What is required for a transfer of CIII-V?
an invoice provided by the supplier (ie the pharmacy)
NOTE: this is filled out by the supplier (pharmacy)!
51
Where may pharmacies store CS?
-in a secure cabinet that is locked
-dispersal throughout the non-controlled stock to deter theft
may NOT store all CS on one unsecured shelf
52
Theft or significant loss of controlled substances must be reported in writing to DEA within _____ of discovery.
within one business day
DEA also recommends notifying local police
53
Florida law requires notification of a theft or significant loss of CS to the county sheriff within ___ upon discovery
24 hours
failure to do so is a first degree misdemeanour
54
Florida law requires the prescription department manager (PDM) of a pharmacy to notify the FL BOP of any theft or significant loss of any CS within ___ after discovery of theft or loss
one business day
55
Complete ________ for theft or loss of controlled substances
DEA Form 106
*not immediately necessary but an initial notification must be provided in writing to the DEA within one business day
must be submitted within 15 days
56
DEA requires any unusual or excessive loss or disappearance of a listed chemical to be reported to DEA ______
earliest practicable opportunity
a written report must be provided within 15 days and must include a description of the circumstances of the loss
57
What warning is required to be on the label of Schedule II-IV for Federal Transfer Warning?
Florida law requires this on ALL CS!!!! CII-CV
"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
58
On-site destruction of CS in a pharmacy must be done using
DEA Form 41
59
What does DEA Form 41 require?
-name of drug
-NDC # of drug
-Strength
-dosage form
-package size
-quantity of the CS destroyed
-method of destruction
-two witness signatures*
60
The two witness signatures for a DEA Form 41 must be done by
1) PDM or consultant rph AND DEA agent or Department of health inspector
2) PDM or consultant rph AND medical director or his or her physician designee; or director of nursing or his or her licensed nurse designee; or sworn law enforcement officer
61
Florida rule on destruction using DEA Form 41 also states that the completed and witnessed DEA Form 41 must be sent to the closest DEA office within __ business day of destruction
one business day
62
When using a Reverse Distributor for destruction of CS inventory, what form is required?
The transfer must be documented with:
- an invoice for CIII-V CS
- DEA Form 222 for CII
{the reverse distributor fills out the DEA Form 222 and sends to the pharmacy}
NOT DEA Form 41 as this is a transfer!
63
Disposal of Dispensed CS at nursing homes/institutional class I pharmacy
may be destroyed with documentation showing
-name, quantity, strength, dosage form of drug
-patient's name
-rx #
-name of institution
*does not required DEA Form 41
64
Destruction of CS CS at nursing homes/institutional class I pharmacy must be witnessed by
-consultant pharmacist
-director of nursing
-facility administrator
-licensed physician, mid-level practitioner, nurse, or another pharmacist employed by or under contract with the facility
-law enforcement office
65
Who must review all CS destruction to ensure compliance?
consultant pharmacist; every MONTH
66
LTCF staff may dispose pt's CS into an authorized collection receptacle. Disposal into a collection receptacle must occur within __ business days after the d/c of use by the pt
three business days
67
An initial inventory of a pharmacy is required by when
the first day the pharmacy is open for business
68
Both federal and Florida law require a CS inventory how often?
every 2 years
the inventory may be done on the pharmacy's regular physical inventory date, which is nearest to, and does not vary more than SIX MONTHS from the biennial date that would apply.
69
Newly schedule drugs or drugs moved from one schedule to another must be inventoried when
on the day scheduled or moved to a new schedule
70
An exact count of inventory is required for all
CIIs
71
T or F
An estimated count is allowed for CIII-V
True
72
An estimated count is allowed for CIII-V products UNLESS...
the container fold more than 1,000 tablets or capsules
73
Records of CS must be maintained for __ years under both the federal and Florida CSA.
two years
Note - Florida rules require that the original rx records be kept for 4 years from the date of last dispensing, and that would include CS rx.
74
T or F
DEA does not require records and inventories of CII be kept separately from all other records
False
CII separate from all
CIII-V must be readily retrievable, separate or intermixed with non-controlled drugs
75
Unless a pharmacy is notified by DEA that permission to keep central records is denied, the pharmacy may begin maintaining central records __ days after notifying DEA
14 days
76
Central records shall not include .....
-executed/completed DEA order forms (DEA Form 222)
-prescriptions
-inventories
*must be kept at the pharmacy
77
Minimum standards before refusing to fill a CS prescription include
1) initiate communication w/ patient
2) initiate communication w/ prescriber
3) PDMP (mandatory)
78
If a pharmacist has reason to believe that a prescriber is involved in the diversion of CS, the pharmacist shall report such prescriber to...
Florida Department of Health
79
Mandatory CE required a mandatory __-hr CE on. validation and counseling of rx for CE and opioids
2 hour
80
Every pharmacy must maintain a computerized record of CS dispensed ("summary record")
A hard-copy print out summary of such record covering the previous ___ day period shall be made available within __ hours of request by any authorized law enforcement personnel
60-day period
72 hours of
81
Law enforcement agencies do not have direct access to PDMP, but may request...
summary record from pharmacy
may request information from the PDMP for an active investigation from the **Department of health** if they have entered into a user agreement with the department
82
Pharmacies are required to produce records of dispensing from the computer system of all prescription dispensed (not just CS) upon request from an authorized agent of the department of health within __ hrs
48 hrs
83
A pharmacist must report fradulent prescriptions within __ hrs after learning of the fraud or attempt fraud or at the close of the next business day, whichever is later
24 hrs
84
Who can prescribe controlled substances under Florida Law?
DEA Registration # required;
-MD (medical doctors)
-DO (osteopathic physicians)
-DDS/DMD (dentists)
-DPM (podiatrist)
-DVM (vets)
-OD (certified optometrists)
85
What are optometrists permitted to prescribe (CS)?
tramadol
acetaminophen with codeine/tylenol#3
86
Physician assistants have authority to prescribed CS must be delegated by a supervising physician
CII CS are limited to a __ day supply
7-day supply
87
Where may PAs/APRN not prescribe CS?
pain management clinic
88
PAs may not prescribe psychiatric mental health CS for children younger than
18
only psychiatric nurses can.
89
APRNs have authority to prescribe CS but must be delegated by a supervising physician
CII CS are limited to a __ day supply; who does this limitation not apply to?
7-day supply
does not apply to psychiatric medication prescribed by psychiatric nurses
90
Regarding out of state prescribers/prescriptions, pharmacists can dispense an order if the pharmacist determines the order is valid AND necessary for treatment of a ____ or _____ condition ONLY
chronic or recurrent
NOT acute
91
T or F
Any rx for a CS issued in another country is NOT permitted
TRUE
a practitioner in another country cannot have a DEA registration!
Unclear for non-controlled rxs... but go with not valid as well
92
Prescriptions from Telehealth providers are valid assuming they are based on...
a valid practitioner-patient relationship
93
Telehealth providers may not prescribe controlled substances under Florida law, unless the CS is prescribed for
1) tx of a psychiatric disorder
2) inpatient tx at a hospital
3) tx of pt receiving hospice service
4) tx of a resident of nursing home facility
94
T or F
Designated Agents can communicate a rx for a CIII-CV but cannot authorize or prescribe
TRUE
may NOT verbally communicate emergency CII rx to a pharmacist; this task cannot be delegated.
95
When are electronic prescription not required?
1) the practitioner and dispenser are the same entity
2) rx cannot be transmitted electronically under the most recently implemented version of the National Council for Rx Drug Programs SCRIPT Standard
3) Waiver
4) impracticality determined by prescriber and would adversely impact pt's medical condition
5) drug under research protocol
6) rx contains elements that may not be included in e-prescribing
7) pt is in hospice care or nursing home facility
8) to compare rx drug prices (prescriber must document in medical record)
96
What are the requirements for a written Controlled Substance Rx?
1) must be manually signed by practitioner and dated on the date issued
2) must be written on a counterfeit-proof rx pad obtained from a vendor approved by the Florida Department of Health (DOES NOT APPLY TO VETERINARIANS)
97
Counterfeit-proof rx pads must meed specific requirements, including:
1) background color must be blue or green and resist reproduction
2) that pad or blank must be printed on artificial water marked paper
3) the pad or blank must resist erasures and alterations
4) the word "void" or "illegal" must appear on any photocopy or other reproduction of the pad or blank
5) the prescription must contain specific information, including a unique tracking identification # for each order on the front of the pad/blank
98
T or F
A prescription for a CS may not be issued on the same rx blank with a rx for a non-controlled drug OR with a rx for a controlled drug in a different schedule
True
if both drugs are in the same schedule, they can appear on the same rx blank
99
Requirements on a CS Prescription
Full name and address of the patient
Drug name, strength, and dosage form
Quantity prescribed (FL law requires quantity prescribed be written numerically AND as a word; #20 (twenty))
Directions for use
of refills authorized, if any (not for CII)
Name, address, and DEA# of practitioner
If CII later date – earliest date on which a pharmacy may fill rx
FL law requires ALL written CS: rx #, initials of rph filling, and date filled
100
Verbal rx are not valid for _______ unless it is an emergency
CII
101
Verbal rx ARE valid for _____
CIII-V
102
Florida does not allow a pharmacist to dispense more than a 30 day supply for a schedule ___ from a verbal prescription.
CIII
103
Fax prescriptions are valid for CIII-V but must have
prescriber's original signature
*electronic signature is not valid on faxed CS
Faxes for CII are only allowed in limited circumstances
104
CII prescriptions must either be _____ or ______ submitted
written or electronically submitted (verbal not permitted unless an emergency)
105
Under Florida law, all prescriptions (including CII) must be filled within ___ after the date or the first date authorized to fill
one year (CII, non-controlled rx); for CII, use clinical judgement
CIII-V are only valid for 6 months
106
All prescribers in FL are subject to ______________ when prescribing CII opioid products for acute pain.
quantity limits
107
There is a ___ day supply limit when a practitioner issues multiple C-II prescriptions the same day
90 day supply
108
What can pharmacists change on a written CII prescriptions?
FL BOP does has not provided guidance, but generally:
drug stregnth
dosage form
quantity
directions for use
*MUST contact prescriber/verbal permission, documents rx change, initials of dr, pharmacists initials
109
What items can a pharmacist not change on a written CII?
name of patient
name of drug
name or signature of prescriber
110
When can a CII be sent via facsimile/fax per DEA and serve as the original written rx?
1) pt undergoing home infusion/IV pain therapy
2) pts in LTCFs
3) pt in hospice care
111
Emergency Dispensing of a CII pursuant to a verbal rx must be from the prescriber and is limited to a ____ hour supply (FL law)
72-hr supply
*this is different from Federal law, which is quantity needed*
112
Emergency Dispensing of a CII pursuant to a verbal rx -
the prescription order must be reduced to writing by the pharmacist and contain all information except
the practitioner's signature
113
Emergency Dispensing of a CII pursuant to a verbal rx -
Within __ days after authorizing an emergency telephone prescription, the prescribing practitioner must furnish the pharmacist a signed or a valid electronic rx for the CS prescribed
7 days
114
Emergency Dispensing of a CII pursuant to a verbal rx -
the rx should be marked "______________________"
"Authorization for Emergency Dispensing"
115
Emergency Dispensing of a CII pursuant to a verbal rx -
If the prescriber fails to deliver a written or electronic rx, the pharmacist must notify the nearest _________ office
DEA
116
Partial dispensing of a CII -
If a pharmacist is unable to fill the entire quantity on a CII rx, a partial quantity may be provided so long as the remaining quantity is provided within _____.
72 hours, or it goes void &rph must notify the dr
117
Under the CARA of 2016, federal law allows partial fills of CII for up to ___ days if requested by the patient or the prescriber
30 days
The total quantity dispensed may not exceed the original quantity prescribed
Applies to written and electronic rx, but not to emergency verbal CII
118
For terminally ill and LTCF patients, both federal and Florida law allow partial fills of CII prescriptions as many times as needed as long as the partial fillings are record on the rx or maintained in the computer system.
All partial fills for terminally ill and LTCF patients must be completed within __ days.
60 days
119
FL Restrictions on the Treatment of Acute pain-
For the treatment of acute pain, an rx for an opioid drug listed in CII may not exceed a __ day supply
3 day supply
ONLY APPLIES TO SCHEDULE II OPIOIDS FOR TX OF ACUTE PAIN.
120
FL Restrictions on the Treatment of Acute pain-
For the treatment of acute pain, an rx for an opioid drug listed in CII may not exceed a 3 day supply, EXCEPT a prescriber can prescribe a 7 day supply IF:
1) professional judgement
2) indicates "Acute Pain Exception" on rx
3) adequately documents in the pt's medical records of the condition and lack of alternative tx options that justify deviation
121
FL Restrictions on the Treatment of Acute pain-
For the treatment of pain other than acute pain, a prescriber must write "_________" on an rx for an opioid listed in CII
Non-acute pain; the 3-day and 7-day rule would not apply here
122
When must a prescriber prescribed an emergency opioid antagonist with a CII opioid?
for the treatment of pain related to a traumatic injury with an injury severity score of 9 or greater
123
Only __________ pharmacies can dispense CII or CIII rxs.
community pharmacies (including limited community pharmacy permits)
* a few exceptions
124
Dispensing (all) CS, what are the identification requirements?
- valid photographic ID (if person not known to rph)
- if ID not available, prescriber can verify validity
- verification of health plan eligibility through a real-time inquiry or adjudication system (cash-paying pts)
125
How many CIII-V prescription be filled?
Written, verbal, and facsimile
May be filled from electronic rx as long as all DEA security requirements are met
126
Florida law restricts verbal prescription for CIII to no more than ___ day supply
30
127
CIII-V may be refilled as indicated on the original rx up to __ times in the __ month period from the dated the prescription was issued
5 refills in 6 months
*no limit on partial fills, so long as the total amount dispensed doe snot exceed the total number of dosage units authorized and it is within 6 month period
128
Refills of CIII-V may be transferred to another pharmacy on a _________ basis.
one-time
if pharmacies share an electronic, real-time, online database of rx, they may transfer up to the max number of refills permitted by law and the prescriber's authorizatino
129
T or F
For CIII-V, only refills may be transferred. DEA rules do not permit a pharmacy to transfer an original CS rx that has been received at a pharmacy, but not yelled filled, to another pharmacy.
TRUE
unless both pharmacies have the capability to forward and receive the electronic prescription for a controlled substance using an electronic sharing program.
FL LAW allows transfer of original prescription, not just refills!!!!!!!
(confusing?)
130
FL Law allows certain schedule V products to be purchased from a pharmacy without an rx.
The total quantity that may be sold to any one purchaser within a 48-hr time period may not exceed:
___ of codeine
__ of dihydrocodeine
___ of ethyl morphine
___ opium
120 mg of codeine 120 cc/4oz
60mg of dihydrocodeine
30mg of ethyl morphine
240mg opium 240cc/8oz
131
Who may dispense OTC sales of Schedule V products?
ONLY a pharmacist
purchaser must be 18yo, ID if not known to rph, bound record book (name and address of purchaser, name and quantity of CS, date of purchase, name of pharmacist initials)
132
Methadone for the use of detoxification and maintenance of narcotic users can not be dispensed in a pharmacy (only pain tx)
short term detox: __ days
long term detox: __ days
30 days
180 days
133
What are the only drugs that may be dispensed under risk management program (MAT for opiate dependence)
Subutex (buprenorphine)
Suboxone (buprenorphine/naloxone)
C-III
Prescriber must have an X code = DATA wavered practitioner; this can be filled at a pharmacy
(DATA 2000 waiver)
Must be administered to pt within 14 days of delivery
134
The State Surgeon General issued a statewide naloxone standing order for al pharmacies in FL that authorizes the dispensing of nalaxone to ______________
emergency responders
*pharmacies would need to have a separate standing order from a physician in order to dispense naloxone to pts, caregivers, or others
135
Retail sales limits of pseudoephedrine
___g/day
___g/30 days
mail service limitation
Mobile Retail Vendors/flea markets
3.6g/day
9g/30 days
7.5g/ 30 days
7.5g/30 days
#146 - 30 mg tablets
#73 - 60 mg tablets
#26 - 120 mg tablets
(daily limit of 3.6g)
MUST either be in blister or unit-dose packaging
Must be 18 (FL law)
136
Who runs the Electronic Online Reporting of Controlled Substances Evaluation program (E-FORCSE)
FL's PDMP
ran by Florida Department of Health
137
E-FORCSE
Who is mandated to access and consult the PDMP to review a patient's CS dispensing history each time a CS is prescribed or dispensed?
pharmacists (for ALL new and refill rxs), prescribers, dispensers, designees
138
When is accessing and consulting the PDMP not required?
1) patient is under 16yo
2) prescribing/dispensing for hospice pt
3) non-narcotics in CV --> Lyrica (pregabalin), Brivact (brivaracetam), Limpet (lacosamide), Potiga (ezogabine-not on market)
4) when system is nonoperational as determined by the FDOH; or due to temporary technological or electrical failure
139
A prescriber or dispenser, or their designee, who does not consult the PDMP for any reason in the exceptions, shall document the reason and shall not prescribe or dispense greater than a _____ day supply of CS to the patient.
3 day
140
Each time a CS is dispensed to an individual in the state, the CS must be reported through the PDMP system ______________
as soon as thereafter as possible, but no later than the close of the next business day after the day the CS is dispensed
*if technical or electrical issues, no more than 30 days
141
What are the exemptions from reporting to the PDMP?
1) All acts of administration
2) the dispensing of a CS in the healthcare system of the Department of Corrections
3) dispensing of a CS to a person under the age of 16
4) pharmacies and registered dispensing practitioners that do not dispense CS in or into the state but submit a "Notification of Exemption From Reporting" and must renew exemption every two years when renewing their pharmacy permit.
142
Exemptions from PDMP reporting -
pharmacies and registered dispensing practitioners that do not dispense CS in or into the state but submit a "Notification of Exemption From Reporting" and must renew exemption every ____ years when renewing their pharmacy permit.
2 years
143
E-FORCSE -
A dispense that has no dispensing transactions to report for the preceding business day must submit a ________ ________ report as described in the Data Submission Dispenser Guide
zero activity report
144
E-FORCSE
Dispensing information with errors or omissions shall be corrected and resubmitted by the reporting dispenser within ____ day of receiving electronic or written notice from the program manager or support staff of the error of omission
one business day
145
E-FORCSE
The following information must be reported by a pharmacy in the E FORCSE system
Name of prescribing practitioner, practitioner DEA # and NPI #
Date prescription was issued and filled
Method of payment (cash, insurance)
Name, address, telephone #, and DOB of person for whom the rx was written
Name, NDC #, quantity, and strength of the CS dispensed
Name, DEA #, pharmacy permit, and address of pharmacy
Whether rx was an initial or refill and # of refills ordered
Name of indivial picking up CS rx and type of identification provided
146
Who may directly access info in the PDMP?
pharmacists, prescribers, dispensers (may appoint a designee to access the PDMP to request and receive information)
remember, law enforcement do not have access to PDMP info, but can requesting directly from the PDMP program at the DOH and only for an active investigation; they can request a pharmacy to produce a summary record of CS in the last 60 days from a specific prescriber or to a specific patient from a pharmacy
147
T or F
PDMP data is confidential and considered PHI
TRUE
remember, law enforcement do not have access to PDMP info, but can requesting directly from the PDMP program at the DOH and only for an active investigation; they can request a pharmacy to produce a summary record of CS in the last 60 days from a specific prescriber or to a specific patient from a pharmacy
