Iowa MPJE Review Flashcards
1
Q
Display of license - what is required?
A
display original license and evidence of current renewal publicly
2
Q
What info is available for public inspection for each person licensed by the board?
A
- Name 2. Address of record 3. License number 4. Date of issuance of the license
3
Q
Family planning clinic - is it regulated by Iowa code (155a)?
A
Family planning clinic may dispense birth control drugs and devices upon the order of a physician (physical presence of a pharmacist etc as in 147.107.2and3 not required)
4
Q
Control substance -definition
A
drug substance, immediate precursor ,or other substance listed in division II of chapter 124
5
Q
Pharmacist in charge - definition (PIC)
A
Pharmacist designated on a pharmacy license as the pharmacist who has the authority and responsibility for the pharmacy’s compliance with the laws and rules pertaining to the practice of pharmacy
6
Q
Internship program
A
1.apply to the board-subject to approval 2.register during training 3.must meet standards - registrations may be revoked, suspended or denied if in violation of the laws in any state relating to prescription drugs, controlled substances or non rx drugs.
7
Q
Pharmacist-intern - definition
A
person enrolled in a college of pharmacy, actively pursuing pharmacy degree,or registered with the board for the purpose of obtaining instructions in the practice of pharmacy from a preceptor (includes foreign graduate)
8
Q
Pharmacist - preceptor
A
any pharmacist licensed to practice pharmacy whose license is current and in good standing.
9
Q
can a pharmacist serve as preceptor while the pharmacist’s license is the subject of disciplinary sanction?
A
no
10
Q
Preceptor requirements (board of pharmacy rules, 657-4.9(155A)
A
1.licensed pharmacist 2. responsible for initialing and dating competencies obtained by intern and for completing affidavits for number of hours and dates for intern’s training 3. responsible for all functions performed by intern
11
Q
how many interns may preceptor supervise concurrently?
A
no more than two
12
Q
Pharmacy technician- purpose of registration
A
establish competency and identification,tracking and disciplinary action for violations
13
Q
who is ultimately responsible for the actions of a pharmacy tech?
A
Iowa licensed pharmacist who is on duty in Iowa -licensed pharmacy and who is responsible for supervising the tech’s actions
14
Q
how to register to be a pharmacy technician?
A
complete application for registration within 30 days of accepting employment in an Iowa pharmacy (board shall receive an application before 30 days expire)
15
Q
technician training
A
still needs an application for registration as a trainee withing 30 days prior to training on-site (including college based or ashp program or tech training through work experience)
16
Q
required certification after july1/2010
A
12 month to complete ICPT or PTCB Pharmacy Technician Certification Board (PTCB ) and the Institute for the Certification of Pharmacy Technicians (ICPT).
17
Q
pharmacist license - components
A
fee and ceu 30 hrs 2 law 03, 2 patient safety 05,15 drug therapy 01 or 02 second 30th of june
18
Q
segments of NDC
A
The NDC is a unique 10-digit identifier assigned to each medication. It has 3 segments: The Labeler code identifies the company that manufactures or distributes the drug. The Product segment identifies the strength, dosage form, and formulation. The Packa
19
Q
What is the term for a pharmaceutical agent that has been developed specifically to treat a rare medical condition?
A
Orphan drugs are for rare diseases, which means the disease effects less than 200,000 people in the US. The Orphan Drug Act of 1983 is meant to encourage companies to development drugs for these diseases.
20
Q
purpose of Phase 3 clinical studies
A
Phase 3 studies involve large groups of patients, and are usually conducted as double-blind procedures. The main purpose is to evaluate the drug’s effectiveness against a control group of patients that are given a placebo.
21
Q
A drug is found to be under-strength, although it is not used to treat a life-threatening disease. What type of recall will be required?
A
Class I recalls are for dangerous or defective products that may cause serious harm. Class II recalls are for products that may cause a temporary health problem. Class III recalls are for products that are unlikely to cause any health problems.
22
Q
After a prescription has been filled and dispensed, who is the legal owner of the prescription?
A
It is legally owned by the pharmacy and should not be given to the patient. A copy of the prescription should be offered if the patient requests it.
23
Q
For a drug to be considered Pharmaceutically Equivalent, all of the following must be true EXCEPT
A
The excipient is the inactive substance that carries the active ingredients, and they do not need to be identical for a drug to be a pharmaceutical equivalent.
24
Q
Which of the following would not be a privacy violation under HIPPA? I. Leaving message re:rx with the patient’s spouse. II. Allowing a pharm sales rep to review patient’s rx files III. Mailing a prescription reminder to a patient in a sealed envelope.
A
HIPPA allows only allows you to leave a message that contains the minimally necessary information. A pharmaceutical sales rep would never be allowed to review a patients file. Mailings are okay if they are in a sealed envelope.
25
there is evidence that a new drug could create a risk to the human fetus based on investigational studies. However,benefits of the drug may justify use of the drug in pregnant women despite risks. What pregnancy category would this drug be classified in?
Category A drugs are the safest for pregnancy and Category X are the most dangerous.
26
Heroin would be classified as which type of controlled substance?
Schedule I controlled substances are those with a high potential for abuse, no accepted medical use, and a lack of accepted safety information.
27
Which of these would be classified as Schedule III controlled substances? I. Anabolic Steroids II. Marinol III. Morphine
anabolic steroids and marinol(Morphine is a Schedule II controlled substance)
28
tech check tech program
program established by PIC who has determined that one or more certified pharmacy techs are qualified to safely check work of other certified tech and provide final verification for rx dispensed for subsequent admin to patient in institutional setting
29
required hours for internships
Required hours of internship 1500 hours total: 1250 hours - college based clinical program 250 hours - under the supervision of a preceptor in a licensed pharmacy
30
notifications to the Board : pharmacy
Permanent closing Change of ownership,location,pic Sale/transfer of drugs on closing/change ownership Change of legal name Theft or significant loss of controlled Disasters etc affecting strength, purity, or labeling of drugs, medications, devices,
31
notification to the board: pharmacist
A pharmacist shall report in writing to the board within 10 days a change of name, address, or place of employment
32
notification to the board : wholesaler
closing wholesale distrib in state Change of ownership,location,wholesaler's responsible individual legal name Theft/significant loss of any controlled substance on discovery Disasters etc that affect strength,purity,labeling of medications, devices
33
validity of rx based on:
To be valid, each prescription drug order issued or dispensed in this state must be based on a valid patient-practitioner relationship
34
written rx should contain:
The date of issue Name and address of patient Name, strength, and quantity of drug, medicine, or device Directions for use Name, address, and written signature of practitioner DEA # if controlled substance
35
What additional items are required on a faxed prescription?
ID # of fax machine used to fax Time and date of transmission Name, address, phone #, and fax # of pharmacy Rx is being sent to
36
What 2 items are not required on an oral prescription called in?
Written signature of practitioner Address of the practitioner
37
What is the limit of refills on non-controlled substances
12 refills during 18 month (in practice- only 12 month)
38
when can rx be refilled whithout authorization:
rxt is unable to contact MD with reasonable effort may create patient suffering RXT informs the patient or the patient's agent at the time of dispensing, and the practitioner re: reauthorization is required rx may be refilled once till authorization
39
CS : SCHEDULES FIORINAL
CS III BUTALBITAL WITH ASPIRIN
40
PARTIAL FILL FOR CS II - I.E.MORPHINE FOR TERMINALLY ILL PATIENT
UP TO 60 DAYS IF PATIENT IS IN LTCF OR TERMINALLY ILL . DOCUMENT DATE, QTY DISPENSED , QTY REMAINING, ID OF DISPENSING PHARMACIST ON THE BACK OF RX
41
PARTFILL FOR CS-
UP TO 72HRS - IF LATER- OBTAIN NEW RX
42
USE OF AFTER HOURS LOCKED CABINETS
ONLY IF PHARMACY CLOSED ONLY AUTHORIZED PERSON WRITTEN DR ORDER PLACED INSIDE LOG MAINTAINED
43
• Does state have controlled substance(s) drugs of concern schedule differently than the Feds CSA? If so which drugs?
Yes (ephedrine, PSE, and PPA are schedule V)
44
Time limit on prescription refills?
18 months non-CS , 6 months limit on rx in controlled substance C-III to C-V C-II- NA
45
Does state allow sale of C-V preps OTC?
Yes (must be sold by pharmacist or intern only in the pharmacy
46
Does state have a CS Rx PMP
Yes- C-II to C-IV
47
Marijuana schedule
Marijuana schedule C-II (state)
48
Dronabinol
Dronabinol (Tetrahydrocannabinol (THC) ) C-III (state)
49
Ephedrine, phenylpropanolamine, pseudoephedrine CS SCHEDULE? ELECTRONIC REAL TIME RECORDS?
C-V Records must be kept for 2 years. Effective in 2010, purchase records shall be recorded in the real‐time electronic pseudoephedrine tracking system (PTS) called the National Precursor Log Exchange (NPLEx).
50
Ephedrine, phenylpropanolamine, pseudoephedrine LIMIT?
3600 MG IN 24HRS 1 PACKAGE IN 24 HRS 7500 MG IN 30DS
51
Ephedrine, phenylpropanolamine, pseudoephedrine WHO can purchase?
Purchaser must be at least 18 years of age and present a government‐issued photo ID, including proof of age Pharmacist is responsible for verifying name and that photo on the ID matches the purchaser
52
RESTRICTIONS ON SALE Ephedrine, phenylpropanolamine, pseudoephedrine -CAN MORE THAN 7500 MG BE SOLD IN 30DS?
Pseudoephedrine exceeding the maximum 7500mg / 30 days may be dispensed for a legitimate medical purpose with a prescription
53
Ephedrine, phenylpropanolamine, pseudoephedrine
Dispensing record must contain • Name, address and (electronic) signature of the purchaser • Date and time of purchase • Name and quantity of product • Name or unique identification of the pharmacist or pharmacist‐ intern who approved dispensing
54
Ephedrine, phenylpropanolamine, pseudoephedrine PTS PRINT OUT AVAILABLE?
The pharmacy shall be able to produce a hard‐copy printout of transactions recorded in the PTS (pseudoephedrine tracking system) upon request by the board or its representatives or those authorized by law to receive such information
55
CS registration
Must renew every 2 years (state) Must renew every 3 years (federal)
56
Pentazocine, ZOLPIDEM(AMBIEN) ZOLEPON(SONATA) Phentermine Soma (Carisoprodol) BUTORPHNOL (STADOL)
C-IV
57
Lomotil (diphenoxylate w/ atropine) Promethazine/codeine elixir(PHENERGAN)
C-V 2.5MG/25MCG diphenoxylate w/ atropine Promethazine/codeine elixir C-V
58
CAN C-II RXS BE FAXED TO PHARMACY?
permitted ONLY if the pharmacist receives the original written, signed prescription before actual dispensing
59
Exceptions (fax = original)
1. Narcotic CII to be compounded for direct parenteral (IV, IM, SC, epidural) administration to a patient 2. For resident of a long‐term care facility 3. For a hospice patient
60
adding 1000 mg of codeine to tylenol with codeine compound 120/12mg/5ml makes final mix schedule ...
C-III (FINAL MIX CONTAIN 1.24 G IN 100ML - IF UNDER 1.8G/100ML - C-III
61
PATIENT OR CAREGIVER REFUSED COUNSELING - CORRECT ACTION FOR RXT?
OBRA-90 -DOCUMENT SUCH REFUSAL , NO OBLIGATION TO COUNSEL IF DOCUMENTED REFUSAL
62
MID LEVEL PRACTITIONERS ARE..
NURSE PRACTITIONER, ANESTHETIC SPECIALIST,MIDWIFE,PHYSICIAN ASSISTANT. LICENSED OR REGISTERED OR PERMITTED TO PRESCRIBE CONTROLLED SUBSTANCES
63
OPIUM 100MG/100ML (KAOLIN PECTATE PG, KAOPECTALIN PG, PAREPECTOLIN)
Schedule
C-V
64
LYRICA (PREGABALIN) VIMPAT (LACOSAMIDE)
| schedule
C-V
65
CODEINE MIX 200MG/100ML(ROBITUSSIN AC, PHENREGAN WITH CODEIN)
schedule
C-V
66
DIFENOXIN -0.5MG /25MCG ATROPINE(MOTOFEN) DIHYDROCODEINE 10MG/100ML ETHYLMORPHINE 100MG/100ML
schedule
C-V
67
OTC SALE OF C-V: QTY,WHO?
PURCHASER SHOULD BE AT LEAST 18 YEARS OLD OPIUM 240 ML/48 DOSAGE UNITS OTHER C-V 120ML/24DOSAGE UNITS
68
MAX AMOUNT OF CODEINE ALLOWED FOR SALE OTC IN 48HRS
CODEINE CONTAINING (ROBITUSSIN AC ) MAX 4OZ=120ML IN 48HRS
69
morphin-CS?
C-II IF 0.5MG/ML-CS-III
70
DESTRUCTION OF CS-II FORMS ,WHERE ETC
PHARMACY MAY SEND AT ANY TIME TO REVERSE DISTRIBUTOR, REVERSE DISTRIBUTOR MUST ISSUE DEA-222 FORM TO PHARMACY
71
DEA-41 FORM
SUBMITTED TO DEA WHEN DRUGS ARE DESTROYED BY REVERSE DISTRIBUTOR
72
DESTRUCTION OF CS-III TO V
NAME,DOSAGE FORM,STRENGTH, QUANTITY, DATE WHEN SENT to reverse distributor
73
CISPLATIN COMPOUNDED UNDER:
ONCOLOGY AND HAZARDOUS -COMPOUNDED UNDER VERTICAL LAMINAR FLOW IN CLASS II BIOLOGY SAFETY CABINET
74
DEA 363
TREATMENT OF ADDICTION/PRESCRIBING CS C-II (IE METHADONE) APPLICANT FILLS DEA FORM 363
75
TO PROVIDE MAINTENANCE AND ADDICTION TREATMENT PRESCRIBER MUST:
OBTAIN SEPARATE DEA REGISTRATION (FORM DEA363) REGISTER WITH CSAT(CENTRE FOR SUBSTANCE ABUSE TREATMENT) WITHIN SAMHSA (SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION) FEDERALLY (DHHA) AS WELL AS REGISTER WITH STATE METHADONE AUTHORITIES
76
PRESCRIBE CS CIII-V FOR ADDICTION TREATMENT DR.MUST:
TO ADMINISTER,PRESCRIBE OR DISPENSE CS III-V FOR ADDICTION (BUPRENORPHINE ETC) DR MUST REQUEST WAIVER SMA-167 AND FULFILL REQIREMENTS OF CSAT CSAT SENDS TO DEA, DEA REVIES AND APPROVES DR GETS UNIQUE ID NUMBER
77
BUPRENEX USE :
APPROVED FOR PAIN, BUT CANNOT BE PRESCRIBED FOR ADDICTION TREATMENT -EVEN 3 DAY RULE EXCEPTION DOES NOT APPLY
78
3-DAY RULE (OR 72 HOUR RULE)
DR NOT REGISTERED FOR ADDICTION TREATMENT - MAY ADMINISTER (NOT PRESCRIBE) CII TO TREAT ACUTE WITHDRAWAL SYMPTOMS PROVIDING: 1. ONLY 1 DAY SUPPLY OF MEDS AT A TIME 2. TREATMENT CAN ONLY LAST 72 HRS 3.CAN NOT BE EXTENDED
79
AFTER 72 HOUR RULE -
PATIENT MUST BE REGISTERED IN ADDICTION TREATMENT PROGRAM
80
REFILLS
CS III-V - NO MORE THAN 5 REFILLS WITHIN 6 MONTH FOLLOWING DATE OF ISSUE NO REFILLS ON C-II REGULAR RX 12 REFILLS WITHING 18 MONTH OF DATE ISSUED
81
WHAT IS CQI
CONTINUOUS QUALITY IMPROVEMENT PROGRAM
82
WHAT IS REPORTABLE UNDER CQI
INCORRECT DRUG INCORRECT DRUG STRENGTH INCORRECT DOSAGE FORM DRUG RECEIVED BY WRONG PATIENT INADEQUATE OR INCORRECT PACKAGING, LABELING OR DIRECTIONS ANY INCIDENT RELATED TO RX DISPENSED THAT HAS POTENTIAL TO RESULT IN SERIOUS HARM TO THE PATIENT
83
WHO IS RESPONSIBLE FOR ENSURING CQI
EACH PHARMACY AND PIC - POLICIES AND PROCEDURES ,TRAINING ,ANALYZING DATA COLLECTED - AN MIN ANNUAL MEETING WITH RELATED PERSONNEL
84
IF EVENT DISCOVERED- APPROPRIATE ACTIONS?
PERSONNEL TRAINED TO INFORM PHARMACIST ON DUTY NOTIFYING PATIENT OR CAREGIVER NOTIFYING PRESCRIBER COMMUNICATING DIRECTIONS TO CORRECT THE ERROR COMMUNICATING INSTRUCTIONS FOR MINIMIZING ANY NGATIVE IMPACT
85
CQI RECORDS
FILED CHRONOLOGICALLY BY DATE OF DISCOVERY EVENTS SHALL BE DOCUMENTED AS SOON AS PRACTICABLE AND INCLUDE DESCRIPTION OF THE EVENT, DATE AND TIME OF DISCOVERY ,NAME OF STAFF PERSON THAT DISCOVERED EVENT NAME OF ALL INDIVIDUALS RECORDING AND REVIEWING
86
VACCINE ADMINISTRATION BY PHARMACISTS
AUTHORIZED PHARMACIST MEANS IOWA LICENSED PHARMACIST WHO HAS MET THE REQUIREMENTS
87
WHAT ARE THE REQUIREMENTS FOR VACCINE ADMINISTRATION
COMPLETED AN ORGANIZED COURSE OF STUDY IN COLLEGE OR PHARMACY SCHOOL OR ACPE CEU PROGRAM ON VACCINE ADMINISTRATION THAT REQUIRES CERTIFICATE IN THE AMERICAN HEART ASSOCIATION OR RED CROSS BASIC CARDIAC LIFE SUPPORT PROTOCOL FOR HEALTH CARE PROVIDERS
88
OTHER REQUIREMENTS FOR VACCINE ADMINISTRATION
PROTOCOL SIGNED BY LICENSED IOWA PRESCRIBER SHALL EXPIRE NO LATER THAN 1 YEAR FROM EFFECTIVE DATE BE EFFECTIVE FOR PATIENTS WHO HAVE NO CONTRAINDICATIONS AND MEET CDC (CENTRE FOR DISEASE CONTROL AND PREVENTION) CRITERIA
89
IN CASE OF SERIOUS COMPLICATION RE VACCINE ADMINISTRATION
NOTIFY PRESCRIBER WHO SIGNED PROTOCOL WITHIN 24 HOURS OF EVENT AND SUBMIT REPORT TO VAERS
90
if closing pharmacy -notify who -time frame
Pharmacy SHALL NOT execute sale or closing unless there is adequate time to notify : PIC OF CLOSING PHARMACY(40DAYS) ,BOARD AND DEA (30DAYS),PATIENTS (30DS),PIC OF RECEIVING PHARMACY(30DS)
91
CLOSING PHARMACY- INVENTORY
RX DRUGS TRANSFERED-COMPLETE INVENTORY AS OF CLOSE OF BUSINESS.=ENDING INVENTORY =ADDITIONAL OR STARTING INVENTORY FOR RECEIVING PHARMACY
92
CLOSING PHARMACY - INVENTORY (CONT.)
1. DEA222 FOR CII TRANSFERRED 2.INVENTORY OF CS 3.ESTIMATED INVENTORY OF NON CS RX DRUGS 4.INCLUDE NAME,STRENGTH,DOSE/FORM, QTY 5.CS FOR DISTRUCTION OR DISPOSAL - TRANSFERRED SAME WAY - NEW PHARMACY RESPONSIBLE
93
CLOSING PHARMACY-RECORDS
RECORDS PERTAINING TO TRANSFER OF CS -SELLER TO BUYER- ON THE DATE OF SALE
94
CLOSING PHARMACY - RETURN WHAT AND WHEN
WITHING 10 DAYS -RETURN PHARMACY LICENSE CERTIFICATE, STATE CSA REGISTRATION CERTIFICATE- TO BOARD WITHIN 10 DAYS- RETURN DEA CERTIFICATE, UNUSED DEA CII ORDER FORMS(DEA222) - TO DEA OFFICE
95
CLOSING PHARMACY
COVEROR REMOVE ALL SIGNS VISIBLE TO PUBLIC IF LOCATION NO LONGER LICENSED PHARMACY NOTE RE: PHARMACY CLOSED CAN BE DISPLAYED FOR UP TO 6 MONTH
96
UNIVERSAL PRACTICE STANDARTS
PHARMACEUTICAL CARE- PROMOTE HEALTH,PREVENT DISEASE,OPTIMIZE DRUG THERAPY, DRUG THERAPY PROBLEMS-IDENTFY,PREVENT,RESOLVE DRUG THERAPY PLAN-ASSESS ,EVALUATE,MONITOR,SUGGEST
97
PHARMACY OPERATIONS - RESPONSIBILITY
THE PHARMACY AND PIC RESPONSIBLE FOR COMPLIANCE WITH FEDERAL AND STATE LAWS,RULES,REGULATIONS RELATING TO PHARMACY PRACTICE ND OPERATIONS
98
PRACTICE FUNCTIONS, VERIFICATIONS
PHARMACIST IS RESPONSIBLE FOR ANY AND ALL DELEGATED FUNCTIONS, INCLUDING INTERNS, TECH,PSP PROVIDE,DOCUMENT FINAL VERIFICATION FOR ACCURACY,VALIDITY,COMPLETENESS AND APPROPRIATENESS OF PTS RX PRIOR TO DELIVERY OF MEDS
99
PSP
PHARMACY SUPPORT PERSON
100
PHARMACIST ID
DISPLAY VIVBLE TO PUBLIC ORIGINAL LICENSE AND CERTIFICATES OF RENEWAL (COPY) ,BADGE=FIRST NAME,PHARMACIST
101
ID CODES - REGULAR AND TEMPORARY STAFF
PERMANENT LOG OF INITIALS OR ID CODES KEPT FOR MIN 2 YEARS, AVAIL FOR BOARD INSPECTIONS, FOR TEMPORARY STAFF-DATES AND SHIFTS WORKED ALSO. APPLIES TO RXT,INTERNS,TECHS,PSP
102
ENVIROMENT AND EQUIPMENT
REFRIGIRATION-WITH THERMOMETER SINK WITH HOT/COLD WATER LOCATED WITHING PHARMACY DEPARTMENT SECURE BARRIER IN ABSENCE OF RXT LIGHT,VENTILATION,TEMPERATURE, HUMIDITY- MAINTAINED TO PROPER STORE DRUGS ORDERLY AND CLEAN
103
BULK COUNTING MACHINES
RXT TO ID AND VERIFY PRIOR TO FILLING CELL OR BIN, RECORD OF PERSON WHO FILLED AND ID MAINTENED (DATED AND SIGNED) CALIBRATE AND VERIFY ACCURACY AT LEAST QUARTERLY (DATE AND SIGN BY PERSON CHECKED)
104
REMODEL OR RELOCATION - INSPECTION
NOTIFY BOARD AT LEAST 30 DAYS PRIOR TO COMMENCEMENT (APPLIES TO PREMISES CURRENTLY OCCUPIED OR INSTALLATION OF STERILE COMPOUNDING FACILITY) PRIOR OR DURING OR AT TEMPORARY LOCATION- ON SITE INSPECTION BY BOARD MAY BE REUIRED
105
AMDS -AUTOMATED MEDICATION DISTRIBUTION SYSTEMS
DEVICE THAT PREPARES, PACKAGES OR DISPENSES SPECIFIED UNITS OF DRUG- INCLUDES PACKAGING INTO OUTPATIENT VIALS, OR PREPACKAGED DRUGS
106
AUTOMATED PHARMACY SYSTEM
USES AMDS TO MONITOR AND CONTROL DISPENSING, AND PROVIDES FOR DUR AND COUNSELING VIA ELECTRONIC METHOD BETWEEN PHARMACY AND REMOTE DISPENSING SITE
107
CENTRALIZED AMDS
LOCATED IN THE PHARMACY
108
DECENTRALIZED AMDS
LOCATED WITHING INSTITUTION WHERE DRUGS ARE DISPENSED BUT OUTSIDE OF PHARMACY DEPARTMENT
109
OUTPATIENT AMDS
DISPENSING RX FOR AMBULATORY PATIENTS AT REMOTE DISPENSING SITE
110
REMOTE DISPENSING SITE
LICENSED PHARMACY STAFFED BY ONE OR MORE QUALIFIED CERTIFIED PHARMACY TECHNICIANS AT WHICH TELEPHARMACY SERVICES ARE PROVIDED THROUGH A LICENSED MANAGING PHARMACY
111
WHO IS IN CHARGE OF THE REMOTE SITE
PIC OF MANAGING PHARMACY =PIC OF THE REMOTE SITE
112
RESPONSIBILITIES OF PIC - AMDS
ASSIGNING,DISCONTINUING,CHANGING DRUG & INFO ACCESS TO AMDS +COMPLIANT WITH STATE AND FED REGULATIONS FILLED,STOCKED, IN GOOD WORKING ORDER ENSURING ADEQUATE SAFE GUARDS RE INFO AND DRUG ACCESS ,CONFIDENTIALITY
113
WHO IS RESPONSIBLE FOR PERSONNEL TRAINING ?
PIC
114
NOTIFICATION TO THE BOARD- RE: AMDS
WRITTEN NOTICE AT LEAST 30 DAYS PRIOR TO AN INSTALLATION, REMOVAL ,OR SIGNIFICANT UPGRADE TO AMDS
115
NOTICE TO THE BOARD RE AMDS SHOULD INCLUDE:
NAME,ADDRESS,LICENSE OF THE PHARMACY LOCATION OF AMDS ID OF PIC NAME,MANUFACTURER,MODEL OF SYSTEM DESCRIPTION OF CHANGE OR UPGRADE AND INTENDED USE OF THE AMDS COPY OF THE QUALITY ASSURANCE PLAN
116
LICENSE REQUIREMENTS FOR TELEPHARMACY
MANAGING PHARMACY - GENERAL PHARMACY LICENSE REMOTE DISPENSING SITE- LIMITED PHARMACY LICENSE (IT IS CONSIDERED AN EXTENSION OF MANAGING PHARMACY)
117
DEMONSTRATE NEED FOR THE REMOTE SITE TO THE BOARD
NOT APPROVED IF WITHING SAME COMMUNITY OR 15 MILES OF MANAGING PHARMACY CONSIDER NEED FOR THIS SERVICE AND AVAILABILITY OF PHARMACISTS
118
INSPECTIONS OF AMDS
MONTHLY INSPECTIONS, REPORTS TO BE AVAILABLE TO THE BOARD FOR A MIN OF 12 MONTH FROM DATE OF INSPECTION
119
HOW OFTEN TO TEST AMDS
MIN EVERY 6 MONTH -DOCUMENT TESTING OF EACH SYSTEM, INCLUDING ELECTRONIC AUDIO VIDEO COMMINICATIONS COMPONENTS
120
RANDOM VERIFICATION BY A PHARMACIST (DECENTRALIZED AMDS)
ONE DAY EACH MONTH , ALL DRUG DOSES OR BINS IN 5% OF COMPONENTS UTILIZED SHALL BE VERIFIED BY PHARMACIST OR ONE DAY EACH MONTH 5% OF THE DRUG DOSES OR BINS CONTAINED IN EACH COMPONENT SHALL BE VERIFIED BY A PHARMACIST (IF LESS THAN FIVE -VERIFY ALL)
121
CATEGORIES OF ERRORS IDENTIFIED IN DECENTRALIZED AMDS
INCORRECT DRUG, DOSE, DOSAGE FORM ,OTHER ERRORS(INCLUDE DESCRIPTIONS)
122
CATEGORIES OR ERRORS IDENTIIED IN CENTRALIZED AMDS
COMPUTER ORDER ENTRY ERROR, INCORRECT DRUG,DOSE,DOSAGE FORM,INCORRECT QTY-EXTRA DOSES,INCORRECT QTY-SHORT DOSES,OTHER (DESCRIBE)
123
DO THESE AMDS ERRORS HAVE TO BE SUBMITTED TO THE BOARD?
YES, FIRST QUARTERLY REPORT:CATGORIES,TOTAL NUMBER, REASONS FOR ERRORS, CORRECTIVE ACTIONS TAKEN, AND, AVERAGE ACCURACY
124
WHEN TO START RANDOM VERIFICATION?
IF THE AVERAGE ACCURACY DURING INITIAL 60 DAYS IS 99.7% FOR ALL DRUG DOSES DISPENSED
125
RANDOM VERIFICATION BY PHARMACIST (CENTRALIZED AMDS)
5% OF ALL DRUG DOSES DISPENSED DAILY BY AMDS VERIFIED BY PHARMACIST OR 100% OF ALL DRUG DOSES DISPENSED ON A SPECIFIC DAY EACH MONTH TO BE VERIFIED BY PHARMACIST
126
IF AVERAGE ACCURACY OF AMDS IS NOT 99.7% FOR THE INITIAL 60 DAY PERIOD?
100% OF DRUG DOSES SHALL BE VERIFIED UNTIL 99.7% ACHIEVED FOR 60 CONSECUTIVE DAYS
127
REPORTING OF ERRORS TO THE BOARD
1ST YEAR - QUARTERLY,AFTER 1 YEAR WHEN ACCURACY LESS THAN 99.7% WRITTEN REPORT INCLUDING CORRECTIVE ACTIONS
128
OUTPATIENT AMDS- VERIFICATION AND REPORTING
ALL OUTPATIENT RXS -VERIFIED BY PHARMACIST PRIOR TO BE DISPENSED. REPORTS SUBMITTED QUARTERLY
129
REPORT ERRORS ID IN OUTPATIENT AMDS:
INCORRECT DRUG,QUANTITY,DOSE,DOSAGE FORM, DIRECTIONS FOR USE,PATIENT NAME,OTHER LABEL INFO,COMPUTER ORDER ENTRY ERROR,OTHER (DESCRIBE)
130
CAN A PHARMACY TECH AT REMOTE LOCATION RECIEVE ORAL RX ORDERS FROM PHYSICIANS?
NO, ALL ORAL RX ORDERS SHOULD BE COMMUNICATED TO THE PHARMACIST
131
RX LABEL INFO FROM REMOTE SITE
RX NUMBER WHICH CAN ID REMOTE SITE, NAME&ADDRESS OF REMOTE SITE,NAME&DDESS OF MANAGING PHARMACY,NAME OF PATIENT,NAME OF DR,DATE OF DISPENSING,SIG &PRECAUTIONS,ID OF SUPERVISINF PHARMACIST AND TECH WHO DISPENSED AT REMOTE SITE,NAME,STRENGTH &QTY OF DRUG
132
IF GENERIC SELECTED FOR BRAND-
LABEL AS SUCH: ATORVSTATIN, GENERIC FOR LIPITOR (BRAND)
133
BRAND SELECTED FOR GENERIC PRESCRIBED
LABEL AS SUCH: LIPITOR FOR ATORVASTATIN
134
RECORDS AT REMOTE SITE -
KEEP SEPARATELY FROM MANAGING PHARMACY
135
DOCTOR WITH SEPARATE PRACTICE OFFICES - HOW MANY CS REGISTRATIONS?
SEPARATE CS REGISTRATION REQUIRED FOR EACH LOCATION OF PRACTICE
136
DOCTOR WITH PRIVATE OFFICE WORKING AT A HOSPITAL- HOW MANY CS REGISTRATIONS?
ONE FOR OFFICE LOCATION- PRESCRIBER IS NOT REQUIRED TO MAINTAIN SEPARATE CS REGISTRATION FOR HOSPITAL
137
SECURITY REQUIREMENTS FOR CS
CS C-I SHALL BE STORED IN SECURELY LOCKED SUBSTANTIALLY CONSTRUCTED CABINET CS C-II TO V MAY BE STORED IN SECURELY LOCKED SUBSTANTIALLY CONSTRUCTED CABINET OR MAY BE MIXED THROUGHOUT THE STOCK OF NONCONTROLLED SUBSTANCES TO OBSTRUCT THEFT OR DIVERSION
138
WHEN AND WHERE TO REPORT THEFT OR LOSS
TO DEA - IMMEDIATELY UPON DISCOVERY OF THEFT OR SIGNIFICANT LOSS OF CS TO THE BOARD- WITHIN 2 WEEKS (IN WRITING,ON FORMS PROVIDED BY BOARD)
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WHAT CAN BE ADDED BY A PHARMACIST TO CS RX?
PATIENT'S ADDRESS (WITH VERIFICATION) AFTER CONSULTING WITH DR- PHARMACIST MAY CHANGE: DRUG STRENGTH DOSAGE FORM DRUG QTY DIRECTIONS FOR USE DATE THE RX WAS ISSUED DR'S ADDRESS OR DEA REGISTRATION NUMBER
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WHAT CAN NEVER BE CHANGE BY PHARMACIST ON CS RX?
PATIENT'S NAME CS PRESCRIBED (EXCEPT FOR GENERIC SUBSTITUTION NAME OR SIGNATURE OF PRESCRIBER
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PARTIAL FILL FOR CS C-II
DUE TO SHORT SUPPLY - WITHING 72 HOURS, AFTER 72 HRS- ONLY NEW RX FOR LTCF-OR TERMINALLY ILL- 60 DAYS
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CS C-II -TOTAL DURATION FOR RX
IN MULTIPLE RX WITH START DATES FOR UP TO 90 DAYS
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IF EMERGENCY RX NEEDED?
PRESCRIBER CAN CALL OR FAX C-II RX PHARMACIST PREPARES WRITTEN OR PRINTED RECORD PHARMACIST RESPONSIBLE FOR VERIFYING PRESCRIBER IF NOT KNOWN DOCTOR RESPONSIBLE FOR PROVIDING WRITTEN SIGNED RX FOR EMERGENCY QTY TO BE DELIVERED TO PHARMACIST
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EMERGENCY DEFINED AS:
IMMEDIATE ADMIN REQUIRED NO APPROPRIATE ALTERNATIVE AVAILABLE PRESCRIBER UNABLE TO PROVIDE ELECTRONIC OR MANUALLY SIGNED WRITTEN RX
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WHAT ADDITIONAL INFO WRITTEN ON THE FACE OF WRITTEN RX FOR EMERGENCY QTY?
"AUTHORIZATION FOR EMERGENCY DISPENSING"
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IF WRITTEN RX FOR EMERGENCY SUPPLY IS NOT DELIVERED WITHING 7 DAYS?
PHARMACIST SHALL NOTIFY THE BOARD AND THE DEA
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CAN YOU REFILL C-II RX ?
NO - ONLY MULTIPLE RXS WITH AUTHORIZED START DATES FOR MAX 90DAYS TOTAL
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CAN YOU ALTER AUTHORIZED FILL DATES?
NO -THE PHARMACIST SHALL NOT CONTACT THE PRESCRIBER FOR VERBAL AUTHORIZATION PRIOR TO DATE WRITTEN
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HOW MANY MULTIPLE RXS FOR CONSECUTIVE FILLING ARE ALLOWED?
AS MANY AS PRESCRIBER FEELS NECESSARY TO PROVIDE ADEQUATE PATIENT CARE ,BUT NOT MORE THAN FOR 90 DAYS
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CAN I FILL RX FAXED TO PHARMACY FOR C-III -V?
YES. WITHING 6 MONTH OF ISSUE AND NOT MORE THAN 5 TIMES
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MAY PRESCRIBER AUTHORIZE ADDITIONAL REFILLS ON C-III-V BY CALLING IT IN?
YES, BUT TOTAL QTY INCLUDING ORIGINAL RX SHOULD NOT EXCEED 6 MONTH SUPPLY AND NOT BE REFILLED MORE THAN 5 TIMES
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WHO MAY DISPENSE OTC C-V ?
PHARMACIST OR INTERN UNDER SUPERVISION
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CAN A CASHIER COMPLETE SALE OF C-V?
YES, BUT ONLY AFTER PHARMACIST FULFILLED PROFESSIONAL AND LEGAL RESPONSIBILITIES
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WHEN SELLING C-V OTC ,RECORD WHAT?
IN THE BOUND RECORD BOOK WITH PAGES SEWN OR GLUED TO THE SPINE, RECORD NAME/ADDRESS -PURCHASER NAME AND ID OF SELLING PHARMACIST/INTERN NAME/QTY OF C-V PURCHASED/ DATE OF PURCHASE
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SELLING PSE,EPHEDRINE, PHENYLPROPANOLAMIE OTC - WHO CAN SELL AND HOW TO RECORD?
RPH, INTERN - THEN CASHIER CAN COMPLETE SALE. RECORDED IN REAL TIME PTS=PSEUDOEPHEDRINE TRACKING SYSTEM.PHARMACY SHALL BE ABLE TO PRINT HARD COPY OF SUCH TRANSACTION
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WHAT PTS RECORD SHALL CONTAIN?
NAME,ADDRESS,SIGNATURE OF PURCHASER PRODUCT:NAME/QTY-TOTAL MGS OF E,PSE,PPA DATE/TIME RPH/INTERN-ID
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WHAT ELSE IS REQUIRED IN THE PHARMACY CONCERNING SALE OF PSE,PPA,EPHE?
NOTICE POSTED:WHOEVER KNOWINGLY FALSIFIES (OR OTHER )LOG BOOK OR RECORDS -SHALLBE FINED 250K /INDIV OR 500K IF ORGANIZATION AND/OR PRISON 5YEARS
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INVENTORY OF C-II- HOW OFTEN AND HOW LONG TO KEEP RECORD OF?
NOT LESS THAN ANNUALLY AND KEEP RECORDS FOR 2 YEARS FROM THE DATE OF INVENTORY
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HOW TO KEEP C-II INVENTORY
PERPETUAL INVENTORY RECORD- MATCH ALL DRUGS RECIEVED WITH ALL RX FILLED - IF DISCREPANCY -NOTIFY PIC. PHYSICAL INVENTORY COUNT - ONCE A YEAR. RECORDS SHOULD MATCH/RECONCILED WITH PERPETUAL INVENTORY. MUST INCLUDE ID OF INDIVIDUAL PERFORMING INVENTORY
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COLORS OF DEA 222
BROWN+GREEN (SUPPLIER +DEA) -& BLUE(PURCHASER)
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INVENTORY OF C-I AND C-II AND HYDROCODONE (SOLID ORAL,INJECTABLE )
EXACT COUNT OR MEASURE
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INVENTORY C-III,IV,V
QTY COULD BE ESTIMATED , EXCEPT FOR HYDROCODONE SOLID ORAL AND INJECTABLE-EXACT COUNT IF BOTTLE OPENED : >100 - EXACT COUNT LIQUID ORAL HYDROCODONE CONTAINING PRODUCTS-MEASURED TO NEAREST INCREMENT OR ESTIMATE TO NEAREST QUARTER
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STERILE COMPOUNDING
1.PREPARED ACCORDING TO LABELED INSTRUCT.EXPOSE TO POTENTIAL CONTAMIN. 2.CONTAINS NONSTERILE ING THAT MUST BE STERILIZED BEFORE ADMIN 3. BIOLOGIC,DIAGNOSTIC OR OTHER THAT REQ.TO BE STERILE WHEN ADMINISTERED
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ANTE AREA
ISO CLASS 8 OR SUPERIOR AREA WHERE PREPARATIONS ARE MADE (INCLUD.LABEL GENERATING ,PERSONNEL HYGIENE ,ORDER ENTRY
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ASEPTIC PROCEDURE
METHOD THAT INVOLVES SEPARATE STERILIZATION OF PRODUCT AND PACKAGE,TRANSFER INTO AND CLOSURE OF CONTAINER UNDER AT LEAST ISO 5 CONDITIONS USING PROCEDURES TO PRECLUDE CONTAMININATION BY MICROORG DURING PROCESSING
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BIOLOGICAL SAFETY CABINET
BSC=VENTILATED CABINET WITH OPEN FRONT, INWARD FLOW FOR PERSONNEL PROTECTION, DOWNWARD HEPA FILTERED LAMINAR AIR FLOW FOR PRODUCT PROTECTION AND HEPA-FILTERED EXHAUSTED AIR FOR ENVIRONMENTAL PROTECTION
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BEYOND USE DAY ESTABLISHED
BASED ON RELIABLE LITERATURE SOURCES, MAINTAIN WRITTEN JUSTIFICATION OF STANDARDS OR, IF NOT AVAIL.-24 HOUR EXPIRY DATE
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ADDITIONAL REFERENCE REQUIREMENT FOR COMPOUNDING STERILE PRODUCTS
1.CURRENT REFERENCE RELATED TO STERILE PRODUCTS AND PREPARATIONS 2. GENERAL INFO REFERENCE 3. INJECTABLE DRUG COMPATABILITY REF 4. REFERENCE RELATED TO HAZARDOUS DRUGS
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EXTRA PROCEDURE REQUIRED IN STERILE COMPOUNDING
AIR SAMPLING FOR BACTERIAL CONTAMINATION, PRESSURE DIFFERENTIAL MOITORING - OR AIRFLOW BETWEEN BUFFER AND ANTE ROOMS AND ANTE AND GENERAL PHARMACY ROOM
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POLICIES AND PROCEDURES MANUAL
WRITTEN POLICY AND PROCEDURES MANUAL SHALL BE PREPARED, IMPLEMENTED, MAINTAINED AND ADHERED TO FOR COMPOUNDNG, DISPENSING, DELIVERY,ADMINISTRATION,STORAGE, AND USE OF STERILE PREPARATIONS.
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WHAT IS INCLUDED IN POLIC AND PROC MANUAL?
QUALITY ASSURANCE PROGRAM, SAMPLING, PREPARATION RECALL,HAZARDOUS PRODUCTS AND INFECTIOUS WASTE. HAS TO BE AVAILABLE FOR PERIODIC REVIEWS AND INSPECTION BY THE BOARD
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LABEL REQUIREMENTS FOR STERILE PREPARTION
PATIENT SPECIFIC: NAME,QUANTITY OF ALL CONTENTS, PATIENT'S NAME, RX NUMBER,INTIALS OF PREPARER AND REVIEWERS,STABILITY (BUD),PRESCRIBED FLOW RATE IN ML/HR IF APPLICABLE,AUX LABELS
173
IF STERILE PRODUCT PREPARED AS BATCH -WHAT IS REQUIRED
NAME AND QUANTITY OF ALL CONTENTS, INTERNAL CODE IDENTIFYING DATE AND TIME OF PREPARATION, AND UNIQUE ID OF PREPARER'S AND PHARMACIST'S, STABILITY,AUX LABELS
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LOW RISK PREPARATIONS=preparations compounded under following conditions-
ISO-5,3 OR LESS PRODUCTS,2 OR LESS ENTITIES(BAGS,VIALS) PREPARED BY OPENING AMPULE, PENETRATING STOPPER WITH STERILE NEEDLE AND TRANSFERRING TO ANOTHER FOR ADMIN.
175
STORAGE CONDITIONS FOR LOW RISK
ROOM 48HRS, COLD FOR 14DAYS,FROZEN SOLID -20 c FOR 45 DAYS
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EXAMPLES OF LOW RISK PREPARATIONS
MANUAL MEASURING AND MIXING 3 OR LESS MANUFACTURED PRODUCTS INCLUDING INF USION OR DILUTENT TO COMPOUND NUTRITIONAL SOLUTIONS
177
LOW RISK PREPARATIONS WITH 12 HOUR OR LESS BEYOND USE DATE
ADMINISTRATION SHALL COMMENCE WITHING 12 HOURS OF THE START OF COMPOUNDING
178
MEDIUM RISK PREPARATIONS
COMPOUNDED ASEPTICALLY UNDER LOW RISK CONDITIONS -MULTIPLE OR SMALL DOSES OF STERILE PRODUCTS ,MULTIPLE ADMINISTRATIONS OR MULTIPLE PATIENTS. COMPLEX ASEPTIC MANIPULATIONS, LONG PROCESS
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STORAGE CONDITIONS FOR MEDIUM RISK
ROOM 30HOURS, COLD FOR 9 DAYS, SOLID FROZEN -25C FOR 45 DAYS
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EXAMPLES OF MEDIUM RISK
TPN FLUIDS, 3 OR MORE AMPULES OR VIALS INTO ONE FINAL STERILE CONTAINER, INFUSION DEVICES
181
HIGH RISK PREPARATIONS
PREPARATIONS THAT EITHER ARE CONTAMINATED OR AT RISK TO BE WHEN COMPOUNDED AND REQUIRES TERMINAL STERILIZATION
182
STORAGE CONDITIONS FOR HIGH RISK
ROOM 24HRS,COLD 3 DAYS, SOLID FROZEN -25C 45 DAYS
183
IMMEDIATE USE STERILE PREPARATIONS
PREPARED AND ADMINISTERED WITHING 1 HOUR AFTER COMPOUNDING IS COMPLETED.
184
WHERE IMMEDIATE USE PREPARATIONS ARE UTILIZED?
EMERGENCY ROOM TREATMENT OR CARDIO RESUSCITATION WHERE DELAY SUBJECT PATIENT AT RISK
185
HOW HAZARDOUS DRUGS SHOULD BE COMPOUNDED?
VERTICAL FLOW CLASS II OR CLASS III BIOLOGICAL SAFETY CABINET (BSC) OR COMPOINDING SAFETY ISOLATOR (CAI)
186
POLICIES AND PROCEDURES FOR HAZ DRUGS PREP INCLUDE..
STORAGE AND HANDLING, CAUTION LABELING,PREP AREA, PROTECTIVE APPAREL, TECHNIQUES,TRAINING, WASTE,SPILLS
187
PHARMACISTS VERIFICATION OF STERILE COMPOUNDS MUST INCLUDE..
VISUAL INSPECTION OF LABELING,PHYSICAL INTEGRITY, EXPECTED APPEARANCE,FINAL FILL AMOUNT
188
MEDIA-FILL TESTING BY PERSONNEL PERFORMED
ANNUALLY FOR LOW AND MEDIUM RISK, SEMI-ANNUALLY FOR HIGH RISK
189
HOW OFTEN CLEAN ROOMS, LAMINAR AIRFLOW HOODS AND BARRIER ISOLATORS NEED TO BE CERTIFIED
EVERY 6 MONTH AND WHEN DEVICE IS RELOCATED
190
REQUIRED PROCEDURES FOR ENVIROMENTAL MONITORING
AIR SAMPLING AND PRESSURE DIFFERENTIAL MONITORING
191
NUCLEAR PHARMACY - REQUIREMENTS FOR PHARMACIST
LICENSED IN IOWA, MEET MIN STANDARDS OF TRAINING FOR MED USES OF RADIOACTIVE MATERIALS - SUBMIT AFFIDAVIT OF IT TO BOARD. COMPLETE 90 HRS COLLEGE TRAINING+160 hrs practical CLINICAL training .COMPLETE RESIDENCY.COMPLETE CERTIFICATE PROGRAM (ACPE)
192
NUCLEAR PHARMACIST - ALTERNATIVE REQUIREMENTS
LICENSED IN IOWA, CERTIFIED BY BOARD OF PHARMACEUTICAL SPECIALTIES AS A BOARD CERTIFIED NUCLEAR PHARMACIST (BCNP) -SUBMIT AFFIDAVIT TO BOARD
193
WHAT ADDITIONAL AREA REQUIRED FOR NUCLEAR PHARMACY
AT LEAST 25 FT SQUARE SEPARATE FROM NON RADIOACTIVE DRUGS FOR STORAGE AND PRODUCT DECAY
194
ADDITIONAL LABELS FOR INNER IMMEDIATE CONTAINER OF A RADIOACTIVE DRUG
STANDARD RADIATION SYMBOL,WORDS "CAUTION-RADIOACTIVE MATERIAL",NAME OF PHARMACY ,RX NUMBER
195
ADDITIONAL LABELS FOR OUTER CONTAINER
NAME OF RADIONICLIDE,CHEMICAL FORM,AMOUNT OF RADIOACTIVE MATERIAL CONTAINED IN MLLI OR MICROCURIES,IF LIQUID - VOLUME IN CUBIC CM,REQUESTED CALIBRATION TIME FOR THE AMOUNT CONTAINED
196
EQUIPMENT REQUIREMENTS FOR NUCLEAR PHARMACY
LAMINAR FLOW HOOD, DOSE CALIBRATOR, REFRIGERATOR, SINGLE CHANNEL SCINTILLATION COUNTER, MICROSCOPE, AUTOCLAVE,INCUBATOR ,RADIATION SURVEY METER.
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IF A PHARMACISTS LICENSE IS SUSPENDED, SURRENDERED OR REVOKED ,WHEN CAN APPLICATION BE MADE TO REINSTATE
INITIAL APPLICATION FOR REINSTATEMENT MAY NOT BE MADE UNTIL 1 YEAR HAS ELAPSED FROM THE DATE OF TE BOARD ORDER OR THE DATE OF VOLUNTARY SURRENDER
198
WHAT IS REQUIRED TO REINSTATE LICENSE?
NABP EXAMS - NAPLEX AND IOWA MPJE
