Iowa MPJE Review Flashcards
Display of license - what is required?
display original license and evidence of current renewal publicly
What info is available for public inspection for each person licensed by the board?
- Name 2. Address of record 3. License number 4. Date of issuance of the license
Family planning clinic - is it regulated by Iowa code (155a)?
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)
Control substance -definition
drug substance, immediate precursor ,or other substance listed in division II of chapter 124
Pharmacist in charge - definition (PIC)
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
Internship program
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.
Pharmacist-intern - definition
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)
Pharmacist - preceptor
any pharmacist licensed to practice pharmacy whose license is current and in good standing.
can a pharmacist serve as preceptor while the pharmacist’s license is the subject of disciplinary sanction?
no
Preceptor requirements (board of pharmacy rules, 657-4.9(155A)
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
how many interns may preceptor supervise concurrently?
no more than two
Pharmacy technician- purpose of registration
establish competency and identification,tracking and disciplinary action for violations
who is ultimately responsible for the actions of a pharmacy tech?
Iowa licensed pharmacist who is on duty in Iowa -licensed pharmacy and who is responsible for supervising the tech’s actions
how to register to be a pharmacy technician?
complete application for registration within 30 days of accepting employment in an Iowa pharmacy (board shall receive an application before 30 days expire)
technician training
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)
required certification after july1/2010
12 month to complete ICPT or PTCB Pharmacy Technician Certification Board (PTCB ) and the Institute for the Certification of Pharmacy Technicians (ICPT).
pharmacist license - components
fee and ceu 30 hrs 2 law 03, 2 patient safety 05,15 drug therapy 01 or 02 second 30th of june
segments of NDC
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
What is the term for a pharmaceutical agent that has been developed specifically to treat a rare medical condition?
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.
purpose of Phase 3 clinical studies
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.
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?
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.
After a prescription has been filled and dispensed, who is the legal owner of the prescription?
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.
For a drug to be considered Pharmaceutically Equivalent, all of the following must be true EXCEPT
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.
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.
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.
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.
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.
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)
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
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
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,
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
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
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
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
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
What 2 items are not required on an oral prescription called in?
Written signature of practitioner Address of the practitioner
What is the limit of refills on non-controlled substances
12 refills during 18 month (in practice- only 12 month)
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
CS : SCHEDULES FIORINAL
CS III BUTALBITAL WITH ASPIRIN
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
PARTFILL FOR CS-
UP TO 72HRS - IF LATER- OBTAIN NEW RX
USE OF AFTER HOURS LOCKED CABINETS
ONLY IF PHARMACY CLOSED ONLY AUTHORIZED PERSON WRITTEN DR ORDER PLACED INSIDE LOG MAINTAINED
• 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)
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
Does state allow sale of C-V preps OTC?
Yes (must be sold by pharmacist or intern only in the pharmacy
Does state have a CS Rx PMP
Yes- C-II to C-IV
Marijuana schedule
Marijuana schedule C-II (state)
Dronabinol
Dronabinol (Tetrahydrocannabinol (THC) ) C-III (state)
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).
Ephedrine, phenylpropanolamine, pseudoephedrine LIMIT?
3600 MG IN 24HRS 1 PACKAGE IN 24 HRS 7500 MG IN 30DS
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
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
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
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
CS registration
Must renew every 2 years (state) Must renew every 3 years (federal)
Pentazocine, ZOLPIDEM(AMBIEN) ZOLEPON(SONATA) Phentermine Soma (Carisoprodol) BUTORPHNOL (STADOL)
C-IV
Lomotil (diphenoxylate w/ atropine) Promethazine/codeine elixir(PHENERGAN)
C-V 2.5MG/25MCG diphenoxylate w/ atropine Promethazine/codeine elixir C-V
CAN C-II RXS BE FAXED TO PHARMACY?
permitted ONLY if the pharmacist receives the original written, signed prescription before actual dispensing
Exceptions (fax = original)
- 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
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
PATIENT OR CAREGIVER REFUSED COUNSELING - CORRECT ACTION FOR RXT?
OBRA-90 -DOCUMENT SUCH REFUSAL , NO OBLIGATION TO COUNSEL IF DOCUMENTED REFUSAL
MID LEVEL PRACTITIONERS ARE..
NURSE PRACTITIONER, ANESTHETIC SPECIALIST,MIDWIFE,PHYSICIAN ASSISTANT. LICENSED OR REGISTERED OR PERMITTED TO PRESCRIBE CONTROLLED SUBSTANCES
OPIUM 100MG/100ML (KAOLIN PECTATE PG, KAOPECTALIN PG, PAREPECTOLIN)
Schedule
C-V
LYRICA (PREGABALIN) VIMPAT (LACOSAMIDE)
schedule
C-V
CODEINE MIX 200MG/100ML(ROBITUSSIN AC, PHENREGAN WITH CODEIN)
schedule
C-V
DIFENOXIN -0.5MG /25MCG ATROPINE(MOTOFEN) DIHYDROCODEINE 10MG/100ML ETHYLMORPHINE 100MG/100ML
schedule
C-V
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
MAX AMOUNT OF CODEINE ALLOWED FOR SALE OTC IN 48HRS
CODEINE CONTAINING (ROBITUSSIN AC ) MAX 4OZ=120ML IN 48HRS
morphin-CS?
C-II IF 0.5MG/ML-CS-III
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
DEA-41 FORM
SUBMITTED TO DEA WHEN DRUGS ARE DESTROYED BY REVERSE DISTRIBUTOR
DESTRUCTION OF CS-III TO V
NAME,DOSAGE FORM,STRENGTH, QUANTITY, DATE WHEN SENT to reverse distributor
CISPLATIN COMPOUNDED UNDER:
ONCOLOGY AND HAZARDOUS -COMPOUNDED UNDER VERTICAL LAMINAR FLOW IN CLASS II BIOLOGY SAFETY CABINET
DEA 363
TREATMENT OF ADDICTION/PRESCRIBING CS C-II (IE METHADONE) APPLICANT FILLS DEA FORM 363
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
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
BUPRENEX USE :
APPROVED FOR PAIN, BUT CANNOT BE PRESCRIBED FOR ADDICTION TREATMENT -EVEN 3 DAY RULE EXCEPTION DOES NOT APPLY
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
AFTER 72 HOUR RULE -
PATIENT MUST BE REGISTERED IN ADDICTION TREATMENT PROGRAM