Iowa Pharmacy Law Exam Flashcards Flashcards

Terms Definitions
How many members on board?
How many are pharmacists?
How many public members?
How long are they appointed for? For how many terms can they serve?
Max of 3, 3 year terms each
Appointed by whom?
Governor (Branstad-R)-Also a fun fact: Board appts political in nature (R-J)
How many compliance officers are there?
5 pharmacists
Who is the ED of IBPE?
Lloyd Jessen, JD, RPh
What is the mission of the IBPE to the public of Iowa?
Protect the health and safety of the public
Who can the board license and regulate?
Can license and regulate pharmacies, pharmacists, techs, interns, drug wholesalers, and controlled substance registrants
Examples of regulations the IBPE can inflict? 7 things
Set standards for the practice of pharmacy, makes policies and guidelines, makes regulatory changes, enforces pharmacy laws and rules, conducts routine inspections, investigate complaints, and perform disciplinary action
Pharmacists, techs, interns, and support personnel must report what to the IBPE? 3 things
Change in name, address, and place of employment. It must be in WRITING!
How long do they have to report this?
10 days
A pharmacy must notify the board of what changes?
Ownership change, location, PIC, legal name, permanent closing
How long do they have to notify BOP before pharmacy closing?
2 weeks
What section of Iowa law allows board authority to regulate pharmacy practice?
Sec 1.3
Are board meetings open to public?
Define quorum of BOP?
Majority of members (4 of 7)
What national group administers pharmacist lecensure?
What 2 tests are needed by Iowa to be licensed?
What scaled score is needed to pass each?
After passing an initial component, how long do you have to pass the other component?
1 year
Regarding pharmacy closure or change of ownership, records must be submitted to the board of what?
Record of sale/transfer of prescription drugs (controlled and non-controlled)
I am the PIC and notice that my counts on HCTZ are off by 560 pills. My counts on Lortab are off by 5 tablets. Do I need to report anything to the board? If so, what?
No report needed. Only THEFT or SIGNIFICANT loss of CONTROLLED SUBSTANCES ONLY must be reported to the board. Subjective definition...I would report any theft where I was held up, and loss > 50 tabs of controlled Rx.
When the flood happened in IC, if all controlled substances were accounted for, did WLG need to notify the board?
Yes! Notify of any accident, disaster, or emergency, that CAN POTENTIALLY affect the purity of drugs or devices.
What are the requirements for original (non-transfer reciprocity) pharmacy licensure in Iowa?
Graduate from ACPE accredited COP in the U.S., meet intern requirements, pass NAPLEX and MPJE.
How often does a pharmacist need to renew her license?
every 2 years
Foreign pharmacists must do what?
Take the FPGEC, TOEFL, intern hours
Regarding CE, what national provider's CE courses are always approved by the IBPE?
ACPE approved courses
Can I just use a cheap non-ACPE accredited source?
Only up to 50% of my hours can come from non-ACPE approved courses
How long do I have to keep my certificates of CE evidence?
4 years
How many CEU(s) (continuing education units) are required per renewal period (Q2Years)
3 CEU = 30 contact hours
Specific to the CE hours I get, are there specific SUBJECT requirements I must maintain?
Drug therapy = 50% of hours (so 15 hrs)
How do I know they are Drug therapy topics?
ACPE subject designation "01." I.E. 0000901 (000 = no co-sponsor; 09 = year of program; 01 = topic)
In my first renewal in 2013, do I have any special CE related topics other than above?
I am exempt from CE during my first renewal period.
What do I do with my license when I get it?
Display it in public location at pharmacy
What do I do with my original license card I get?
Must display it with license
When my renewal card arrives after my first renewal period, can I take down my original license card?
No, current license renewal must be displayed with the original (may be photocopy)
My pharmacy badge, at the minimum, must contain:
"Farah, Pharmacist" So your first name minimum and clearly identifies you as a pharmacist.
How can I get in trouble with the IBPE and have grounds for discipline?
False info provided, violation of pharmacy law, incompetence, immoral/unprofessional acts, felony conviction, moral turpitude.
WTF is moral turpitude?
"conduct that is considered contrary to community standards of justice, honesty or good morals."
What can they do to me?
suspend license, revoke it, fine me, public reprimands.
Intern badges must have:
designation of "pharmacy-inter" or "pharmacy student"
When can interns register?
After 1 semester of pharmacy school
Total hours requirements and breakdown?
1500 hours, 250 non-college hours
Who can be a preceptor to pharmacy student?
Any pharmacist in good standing
How many students can a preceptor supervise at one time?
Max of 2
What are my responsibilities to the student as a preceptor?
Sign/date/certify affidavit of hours, initial and date competencies in blue book
Can interns make judgmental functions that Techs are not allowed to?
Yes, interns can have judgmental functions delegated to them.
At the end of the day, who gets in trouble if the intern makes a mistake?
Pharmacist preceptor, as they have to technically be on duty when intern is getting experience
What can the intern do? 3 key things
1) Counsel 2) Review and assess patient record 3)Verify accuracy, validity, appropriateness of filled Rx
What is a pharmacy tech?
Person employed by licensed pharmacy in iowa to assist in the TECHNICAL FUNCTIONS of the practice of pharmacy
At the end of the day, who is responsible for the tech's actions?
Iowa licensed pharmacist working with tech
Tech badges must have what, at a minimum?
"Farah, Technician" At least their first name, and the designation of technician
If sandy is working for Sand pharmacy at 2 hours a week, does she need to register with the board?
Yes, any employed tech in Iowa needs to register and maintain registration during employment. Even a certified tech, tech trainee, or uncertified tech.
What is the purpose of pharmacy TECH REGISTRATION
Identification, tracking, and disciplinary action.
Does tech registration measure a tech's competency or ability to practice pharmacy?
NO!!!!!!! Certification measures competency
Is certification mandatory in Iowa?
Yes (as of July 2010)
As PIC, I hired Kelsey, a high school student, to work part-time as a tech. What do I need to advise her to register as with the board?
While she is working on getting her national certification as a tech, she needs to register with the board as a "tech trainee"
How long does Kelsey have to get her PTCB certification?
Within 12 months of being hired by me.
Of course there's an exception, right? What's "minimum prior employment?"
At least 2000 hours of work in the previous 18 months AND continued employment (2000 hours during any 18 months b/w Jan 1 2010 and Dec 31, 2013)
How long can the extension for minimum prior employment shield certified techs?
Till 12/31/2013
Can I ask my tech to talk to Mrs. Smith about what OTC APAP versus Tylenol product she can use?
No. only technical dispensing functions can be given to a tech
Who gets in trouble if tech messes up?
Supervising pharmacist
Can techs in Iowa accept new Rx orders from Dr or agent of?
Can they contact an office to get refill authorization?
What do I need to make sure to tell Kelsey before she does accept a new or refill Rx order?
I must have trained her as documented in my written policy and procedure manual how to contact an office to get this information.
Can a tech in iowa accept transfer Rx?
No, but intern can
In the policy and procedure manual for the pharmacy, the section on pharmacy techs must have what?
I have to make sure I have such a book in the pharmacy and I have to review it every once in a while to update/make changes regarding training and utilization of pharmacy techs.
What do I need to DOCUMENT in that book? and how long do I have to keep this documentation.
That I have trained a tech (and they need to sign off on this) and I need to maintain this for the duration Kelsey works for me.
Can a compliance officer for the board ask to see a physical copy of my training log and policy and procedure manual?
I'm thinking of hiring a pharmacy support person, Dave. What can he do as a PSP?
Can perform nontechnical duties assigned by me like deliver meds, billing, cashier or other clerical such tasks.
Do I have to register Dave with the board if he's just ringing up the scripts?
Who needs to get a PHARMACY license?(physical sites)
General (community), hospital, non-resident pharmacy, limited use license like in nuclear, correctional facility, vet practice setting
If I'm selling my pharmacy in favor of buying a failing pharmacy at a different location, can I just transfer the pharmacy license over to that location/name?
No. A NEW license application is required for changes in pharmacy NAME, LOCATION, OWNERSHIP, and PIC
How often do I need to renew the license for my pharmacy?
Every year (annually)
Now ready to open the pharmacy at its new location (I've remodeled a bit) Even though I notified the board of this change and they're okay with it, can I open my pharmacy after I get their affirmation that they received my new application?
No, you must wait for a PHYSICAL visit by a compliance officer to the new location before I can open up shop
Econofoods should have notified the board of its plan to close the pharmacy how long BEFORE they actually closed the pharmacy?
2 WEEKS minimum. Idiots.
Other than the board, were there any other people that needed to be notified?
Yes! The freaking DEA and PATIENTS!!
Can I give the board a call to let them know of my plans to close down my pharmacy?
NO, it must be WRITTEN (like ALL communication with the board, including change of name, etc.)
What "titled" pharmacist is required in order for the pharmacy to open?
Pharmacist in charge (PIC)
What reference library books do I have to have in my pharmacy before I open up doors?
1) Iowa pharmacy law and info manual
2) A patient info reference
3) Drug interaction
4. General info
5. Equivalency; satisfied by online orange book
6. Natural/herbal meds
7. PCC # (18002221222)
8. Whatever else you need for your region
What special certification does an Iowa pharmacist need to get to be able to practice pharmaceutical care?
All Iowa licensed pharmacists are eligible to practice pharm care.
Which 2 entities are responsible for the day-to-day operation of the pharmacy?
PIC and the pharmacy
What is the PIC specifically responsible for?
All functions delegated to interns, techs, and PSPs
When I'm doing the final check on an Rx, what do I have to make sure I maintain?
A record of the final verification for the accuracy, validity, completeness, and appropriateness of an Rx before it reaches the pt.
There's a lot of initials used in the Rx dispensing long do I have to maintain the record of pharmacist, intern, tech initials or ID codes?
2 years
In addition to the initials, what else do I have to have a record of regarding personnel who work at the pharmacy? (even part time)
All dates and shifts they worked must be maintained for 2 years
Describe items that must be included in the pharmacy (environmental requirements) 5 general items
Quality lighting, temp controlled, sink w/ hot and cold water, fridge WITH thermometer, Bulk counting machines
What additional documentation relating to bulk counting machines must I have?
Calibration and accuracy check must occur QUARTERLY and be DOCUMENTED
Mrs. Smith brings back the metoprolol I dispensed to her earlier. she received the 50mg IR tabs, not the 50mg XR. I take back the med. Before the tech can RTS the item, what must happen?
I need to check the drug physically to make sure it's correct before RTS.
When I'm done with a long day at the pharmacy, I must make sure that:
The pharmacy is locked and secured because I'm going to be absent.
I'm working at the pharmacy when I get a call from my brother saying he broke his arm and needs me to drive him to the hospital. Can I leave the pharmacy if I'm the only pharmacist there?
For two hours max, I can designate someone to be in charge while I'm gone to do technical and non-technical functions. I have to post a public notice that says RPh is gone and no Rx can exit the pharmacy department.
Can I get my stock from a Wisconsin-licensed wholesaler if it's closer to my location?
No, must be iowa licensed wholesaler (if the wholesaler in WI is also licensed in IA though, then it's okay, of course)
I work in a Critical Access hospital. I ran out of Valtrex...can I call the local pharmacy and purchase some of their meds until I can get the drug myself?
Yes, but this MUST be on a very limited basis and the pharmacy must be licensed in the U.S. (so I can drive over to a WI pharmacy if it's closer to me in IA)
Because it's so freaking expensive to maintain inventory of meds, can I just make orders daily and tell patients the meds will be here tomorrow of meds like Valtrex or azithromycin?
NO! You MUST maintain a sufficient inventory to fulfill the FORESEEABLE needs of patients.
When the darvocet removal from market notice was posted and sent to pharmacies, is there anything specific I needed to do?
I must have a system in place to handle such notifications and actions. Like "tech III shall review all notices of product recalls and remove drug from inventory and unit dose packs [hospital]"
Expired meds must be removed from inventory and not dispensed.
Can I tell patients how much medicine costs (without insurance or the cost to me)
Yes, as long as it's not false or misleading.
In advertising services, do I have to state the cost or charges for services?
Yes, as well as the effective date for the prices
Is this legal? "Come to Rx4U to pick up your generic Ambien faster, so you can get your snooze on faster!"
NO! No reference to ANY controlled substance may ever be made when advertising!!!!!!
What is CQI?
Continuous quality improvement. It's an ongoing process to detect, evaluate, and prevent med errors.
Is CQI "highly recommended, but optional" or is it required in Iowa?
What counts as a reportable event in reference to CQI?
Preventable event where the pt got the wrong med or it was administered to them (vaccine). Wrong dose, dose form, wrong patient got med, wrong packaging (like safety cap vs non), label, or directions. Any harm done to patient.
Who is in charge of making sure the pharmacy has a good CQI system in place?
Can the PIC delegate the administration and monitoring of the program?
Yes, but at the end of the day, the PIC gets burned if it doesn't meet the board standard.
Regarding CQI procedures, what is needed in the pharmacy policy and procedure manual??
a policy and procedure manual component for the operation and management of the CQI program.
What information is needed to prove proper adherence to CQI in iowa? 4 things
Documentation of staff training, identification and documentation of reportable events, analysis of the data to discover contributing factors, recommendations for changes.
I'm thinking of becoming an immunizing pharmacy. What do I need to do?
Get a written protocol with a physician "that can supervise you" and pass approved course of study.
Can any iowa licensed pharmacists perform Collaborative drug therapy management?
Only if they have a protocol set up with a physician. Ultimate responsibility for pt care by physican. But pharmacist is responsible for all DTM they perform.
What is the criteria for performing collaborative drug therapy management?
1) PharmD, 2) Residency that is ASHP accredited 3) BPS, NISPC or CCGP certified 4) IBPE approval
To be valid, the protocol for a community pharmacist to deliver MTM/CDTM requires what?
A written protocol authorized by physician and pharmacist that can be submitted to board of pharmacy OR board of medicine UPON REQUEST
A hospital protocol requires what?
Approval by hospital P&T committee (pharmacy and therapeutics committee)
For a prescription to be valid, the pharmacist is responsible to verify one very important factor regarding the prescribing physician. That is:
The the prescriber has a valid patient/prescriber relationship.
Dr. Grin has been prescribing meds for Mrs. Smith for 11 years, when he moves his practice to Wisconsin to be closer to his family. Mrs. Smith comes in for her metoprolol refill, what do I do?
His prescriptions are no longer valid and I must cancel the prescriptions and any refills. Since metoprolol cannot be sharply d/c, I can dispense it this one time till she can get a new PCP to write her an Rx. This is also true if PCP dies/quits medicine.
Who in iowa has unlimited prescribing authority, even for CONTROLLED substances?
DO, MD, and Nurse practitioner (within the NP's area of specialty)
PAs, when submitting an Rx must have what on the prescription?
The name of their supervising physician
I receive a script from Emily, the local P.A. for Secobarbital for little Joey Smith. Can I fill this?
NO. PAs are NOT allowed to write a prescription for a CII depressants (secobarbital, amobarbital, glutethimide, and pentobarbital, phenocyclidine)!!
Within their scope of practice, what other entities can write valid prescriptions in Iowa?
Dentists, optometrists, podiatrists and veterinarians.
Mrs. Smith vacations in Texas. Immediately before leaving Texas, she sees Dr. Angler regarding some bed bugs from the hotel (lawsuit in progress). Dr. Angler, PA, prescribes a prednisone taper for her, and she brings it into my pharmacy. Do I fill it?
Yes. As long as Dr. Angler would have been authorized to prescribe if he was practicing in Iowa, I can still fill the Rx.
Can perscribers write scripts for controlled substances for themselves, even one time?
Absolutely not.
What about for members of their family? Can they write a prescription for a controlled substance for a family member?
As long as it's NOT for an extended period of time. (So no zolpidem with 5 refills)
Written or electronic new Rx that are provided to the pharmacy must contain: (5 things)
1) date issued, 2) name + address of patient 3) drug name, strength, quantity and SIG 4) name + address + written/electronic signature of prescriber 5) DEA number (if controlled)
Faxed Rx must have:
All above + ID of the fax machine used to transmit 2) date and time of transmission. 3) name + address + phone # + fax # of pharmacy receiving Rx
Verbal Rx requires:
Everything above with the exception of written/electronic signature of prescriber (obviously don't forge it...). All above must be recorded in writing on the prescription.
Original prescriptions, whether transmitted orally, electronically, or in writing need to be maintained in the physical dispensing pharmacy and contain what?
Unique ID number for Rx and date filled.
Refill prescriptions must be documented with what?
Date of refill, pharmacist checker initials, name, strength, manufacturer, OR NDC of actual product dispensed
Non controlled substance Rxs are valid for how long in Iowa?
18 months after issue date
What? my pharmacy only does 1 year?
Yeah. WTF.
What is the max number of refills for an rx?
12 refills MAX.
Using my professional judgement, I can refill an expired Rx if 3 conditions are met:
1) I tried contacting the Dr with some effort and no response 2) failure to refill may induce patient suffering 3) I let the patient/agent of that the prescriber really needs to authorize the refill ASAP.
An Rx label is required to have: 8 things.
1. Rx number 2. name, address, phone of pharmacy 3. Patient name (animals = species and owner) 4. prescriber name 5. date of dispensing 6. Clear directions for use, and precautions 7. drug name, strength, and quantity, 8. pharmacist initials.
MPJE generally tricks by saying the following is required, but they're really NOT.
Beyond use or expiration date.
The metoprolol script for Mrs. Smith originally said "Toprol XL." What must I make sure her label says?
The label has to identify the generic name of the drug dispensed and may identify the brand name. "Metoprolol succinate generic for Toprol XL."
What if the script had been for atorvastatin?
The label must identify the brand name of the drug dispensed and may identify the generic name. "Lipitor for atorvastatin calcium"
Before I can transfer Mrs. Smith's prescription to Texas at her vacation spot, what must I have?
I need to have a request of Mrs. Smith or her caregiver.
Who can transfer an Rx in Iowa?
Pharmacists or pharmacy-interns under pharmacist supervision
If Mrs. Smith's metoprolol prescription was > 18 months from its original issue date, can I transfer it to texas?
NO! Rx must be valid, still have refills, and have been transferred less than the number of refills originally authorized.
How many times can I transfer Mrs. Smith's Ambien prescription?
ONCE! CIII, CIV, and CV prescriptions can be transferred ONLY 1 TIME!
Regarding computer requirements, what must my system have built in?
A warning system that does not allow the transfer or refill of controlled substances that have been previously transferred.
If i'm transferring an Rx between one hartig location to another, am I still limited by the number of transfers of controlled substances and non-controlled Rx?
You can transfer prescriptions up to their maximum number of refills or within 18 months of original issue date if the pharmacies share the same prescription record via a real-time, on-line database. (but more record keeping is required)
For transferring out a prescription, what record must I maintain? 4 things
1. Invalidate the Rx 2. REcord name, address and (if controlled) DEA # 3. Name of RPh transferring and RPH Receiving 4. Record date of transfer
For transferring in an Rx, what records must I maintain IN ADDITION TO THE ABOVE??? (4 new things in addition to above)
1. Indicate the prescription is transferred 2. Original date of issue and date of dispensing 3. original Rx number 4. Number of refills left and date of last refill 5. As above
Mrs. Smith asks me why I am dispensing metoprolol succinate instead of Toprol XL, the brand name. She has private insurance. What do I tell her?
I can use my professional judgement to dispense AB rated drug in Mrs. Smith's economic interest. I also should have informed her of the savings which will result from the substitution and pass on no less than 50% of the difference in AAC.
Ms. Kind comes into my pharmacy and asks to transfer her Ambien from another pharmacy. I do so and get her insurance information as well, Title XIX. I fill the Rx for zolpidem, but she says she's been getting Ambien at her other pharmacy. What can I do?
Explain to Ms. Kind that to bill her insurance for any cost of the Rx, I must dispense the generic product only. Would she like to pay cash for her brand name Ambien?
Mrs. Smith asks me to dispense brand name Toprol XL, can I do that?
Yes, because she requested this and she doesn't have publicly funded insurance (DAW = 2)
What if Mrs. Smith's prescriber had asked me to dispense brand name only, can I do that?
Yes, at his request (DAW = 1)
Patient profiles requires what to be considered complete?
1. Private 2. full name of patient 3. patient address + phone # 4. Age/DOB 5. Gender 6. Allergies 7. List of all Rx dispensed by my pharmacy, including numbers, name, strength, quantity, dispense date, and prescriber name.
If I'm doing a system cleanup to remove some old meds from patient profiles to make them easier to go through, how long do I have to make sure to maintain patient profile information?
2 years from latest entry in patient profile.
Patient record needs to include pharmacist comments relevant to drug therapy, such as:
1) Allergies, 2) Idiosyncrasies 3) Chronic conditions/disease states 4) Other OTC, herbal, Rx drugs or anything, really, that can impact a DUR
How can a pharmacist perform a DUR?
Review patient record, information from patient and each Rx drug or med order and take action to avoid potential problems.
Patient counseling is required for all new and refill prescriptions: True or false?
False. Required for NEW prescriptions only
Can I just say "Mrs. Smith, I'd like to counsel you on your new prednisone prescription if you would like."
No, an offer to counsel isn't enough. I SHALL counsel her on the new Rx
What must be posted in the pharmacy regarding counseling?
A statement saying "Iowa law requires the pharmacist or intern to discuss new prescriptions with patient"
What are the requirements for such a counseling area?
Area must be confidential, have access to patient and RPh, not allow patient access to Rx drugs, and maintain privacy.
What must a patient counseling experience contain?
1) drug name, description, intended use (if known), dosage form, dose ROA, expected action of the drug, duration of therapy. 3) Special directions and precautions, including storage 4) common severe SE, ADRs, interactions and CIs and ways to avoid them.
What if I'm deliver the new medication or I can't verbally counsel the patient?
There have to be ways to tell the patient that they can call the pharmacy for free, give written information, pictogram labels, and videos
What if the medication is going to a nursing home, where nurses admit the drugs.
I don't have to provide counseling in that situation
Can a patient refuse counseling?
Yes, but this must be documented, and absence of documentation of refusal will be presumed to signify that the offer was accepted and counseling was provided [legal situations can get fishy]
In what situations can I take back a medication, including Unit Dose meds?
Only if integrity has not in any way been compromised (i.e. don't take lantus back if it's been out in a hot day all day or you can't verify where it's been]
Where can a hospital pharmacy be located?
Area that allows for services for patients and is integrated with the facility's communication and transportation systems (I.E. you can't have a pharmacy in a whole other building where patients are cared for unless you have easy connection to transport)
Policies and procedures must identify what regarding pharmacists?
The minimum amount of time that a pharmacist is available
What can happen before meds can be sent to patients?
Pharmacist verification
If I'm discharging a patient on meds from the hospital, what are requirements for the packaging of those meds?
Same as outpatient med requirements
In hospitals without 24h pharmacy service, when drugs are dispensed to patients as a result of an ER visit, what must you have evidence of?
Policies and specific procedures on what can occur in these situations, including use of InstyMeds dispensing systems (omnicell, etc)
Are there specific requirements regarding the inventory of a hospital pharmacy?
A CURRENT specific formulary must be maintained
What is a stop order?
Orders to stop certain high potency meds that are "special" or bring them to a PCP's attention for renewal if needed. Otherwise, they are stopped. Example:
I don't regularly carry Accolate. Can the patient use his/her own?
Yes, but I have to have policies on what I need to mark on that Rx, etc.
I received samples of Valtrex from the manufacturer at the hospital pharmacy. Can I use them in inpatient care?
Can a patient use investigational meds inpatient?
Yes, if the pharmacist is a member of the IRB and the pharmacy is responsible for distributing and controlling these meds
Who is responsible for the security of the pharmacy?
Pharmacist on duty
On the ICU floor, we have certain emergency meds we need regular access to, what are requirements for their storage?
If they're in patient care areas, they must either be locked, or always visible to staff
Pharmacy computer security must ensure what?
That Rx record access is appropriately secured from unauthorized access
If the pharmacy is closed, can people gain access into the hospital pharmacy?
A Policy and procedure manual must designate who can have access to the pharmacy when it is closed in orer to obtain meds.
A PIC can designate a tech to be in the pharmacy when it is closed. What can the tech do?
Help a licensed professional locate a drug for EMERGENCY use. Tech can't dispense or deliver drug. Licensed professional must comply with closed pharmacy policies and procedures still. The tech CANNOT be asked to verify if the right drug was chosen.
The tech, in addition, needs to keep a log of what when he or she is in the pharmacy when the pharmacist is not there?
A log tracking everything he or she did while R.Ph was absent and how long the tech was alone.
Regarding the pharmacist verification of orders, how can this take place if the pharmacy is closed?
Contract with remote pharmacist preview and verification IF THE PHARMACIST IS LICENSED IN IOWA. They must also have all access to patient information and records inpatient hospital pharmacist would have on the scene. They must also be able to talk to Drs
What are automated medication distribution systems? AMDS
device that prepares and packages a drug for Unit Dose (UD dispensing, outpatient prescription vials, or dispenses prepackaged drugs.
Managing Pharmacy:
Licensed community pharmacy providing telepharmacy services at one or more licensed remote dispensing sites (PIC of managing pharmacy also serves as PIC of remote sites--You couldn't pay me to take that kind of responsibility)
Remote dispensing site:
Licensed pharmacy staffed by one or more qualified certified pharmacy techs.
Drugs in Emergency medical services programs have what requirements?
Policy and procedures on who has access, and safeguards against diversion. Also storage requirements, control and exhange of drugs, prescribing, disposal and destruction requirements.
Sterile compounding practices are:
standards for procedures for prep, label, distribution of sterile preps
What special considerations must be maintained for sterile compounding practices (USP 797):
Use of single dose/multi dose containers. Labeling requirements (patient specific/batch), equipment and apparel, QA and training of compounders.
Sterile compounded drugs must include what on patient label?
Patient name, name and quantity of all contents, preparer's and reviewing pharmacist's initials, BUD, prescribed flow rate. Auxillary labels as needed. ((((Unique serial # or prescription number for HOME CARE PATIENTS only))))
What is a nuclear pharmacy?
One that provides radiopharmaceutical services
Who is a qualified nuclear pharmacist?
Licensed pharmacist who has met established requirements for training in med use of radioactive materials (clinical nuclear pharmacy training, completion of a nuclear pharmacy residency, or certification program as BCNP)
What is a central fill pharmacy?
Pharmacy contracting with an origination pharmacy that provides prescription drug order filling on its behalf
What is an originating pharmacy?
Pharmacy that receives a prescription for a patient or prescriber, outsources the filling or processing functions to another pharmacy and dispenses the Rx to the patient
Mrs. Smith wants me to compound APAP tablets for her, can I do that?
No. I cannot compound a commercially available product UNLESS the compounded product is changed to produce for the patient a a significant difference.
Can I compound darvocet for a patient?
No! you can't compound something removed from the market because it was unsafe or ineffective!
THe utilization of electronic data in the pharmacy requires that:
There is a way to verify the authenticity of electronically transmitted data. Have safeguards in place. Be able to store and retrieve Rx info online. Verify controlled substance refills, daily printout or logbook required!!! SO MUST BE PHYSICAL COPY!!!!!
Consultant pharmacist:
Licensed pharmacist responsible for developing, coordinating and supervising pharm care services in LTC setting
Freedom of choice:
outlines Resident's right to choose provider of pharmacy services
The consulting pharmacist must:
set standards for med orders, stop orders, emergency drugs, and return and reuse of drugs and devices and assures safety of controlled meds.
Impairment is:
Inability to practice pharmacy or perform related technical functions with reasonable safety and skill because of alcohol, drugs, dependency, or addiction
Where can one go for help?
What is IPRN?
monitoring and advocacy peer review program created for the purpose of assisting impaired pharmacists, techs, and students
Toll free number?
1 877 890 IPRN
[email protected] (administered by IPA)
Who administers the controlled substances Act?
Jointly by the FDA and US DOJ (DEA)
What year was the controlled substances act administered?
What Iowa Act relates to the rules and regulations of controlled substances?
Iowa Uniform controlled substance act
What Iowa Board of Pharmacy chapters related to controlled substances?
Ch 10: Controlled substances. Ch 21: Electronic data in pharmacy practice. Ch. 37: Iowa Prescription Monitoring Program (IPMP)
Who is required to register with the DEA (federal overseer):
Prescribers, hospitals, pharmacies.
How often is registration renewal required?
Every 3 YEARS
Do pharmacists have to register with the DEA individually?
Who is required to register with Iowa BOP?
Prescribers, hospitals, and pharmacies
How often is registration renewal required?
Every 2 YEARS
Do pharmacists have to register with the board?
What is the structure of a DEA number?
2 letters, followed by 7 numbers. Last number known as "check digit"
First: A, B or M (midlevel practitioner)
Second: First letter of prescribers LAST NAME
followed by 7 digits
So, if i were to check the validity of a number, what do I do?
1. Verify letters as above. 2. Add digits 1,3,5 and then 3)Add digits 2,4,6 and multiply this sum x 2 and finally 4) Add the results and the last digit should correspond to the "check digit"
What is the abuse potential of C I meds?
High abuse potential
What is their current status of approved medical use in the U.S?
They are not approved for medical use because they lack accepted info for safety of use, even with medical supervision.
Examples of C - I?
Heroin, LSD, methaqualone
What is the abuse potential of C II meds?
High abuse potential
What is their current status of approved medical use in teh U.S.?
There is accepted medical use.
What can abuse of C II lead to?
Severe physical and psychological dependence
Examples of C II?
Cocaine, codeine, fentanyl, meperidine, methylphenidate, pentobarbital
What is the current abuse potential of C III meds in the U.S?
Less than C I or II
What is their current status for medical use in the u.S?
Accepted for medical use
What can their abuse lead to?
Moderate to low physical dependence, but HIGH psychological dependence.
So Tylenol #3 (apap/codeine) is a C II or C III?
C III...they can contain C II drugs at lower doses or in combo.
Other examples?
Anabolic steroids, dronabinol, lortab, etc.
What is the current abuse potential of C IV meds in the U.S?
Less than C III
Abuse can lead to?
Limited physical and psychological dependence compared to C III meds.
Can they contain C II or III meds at lower doses or in combo?
Yes (can't think of examples rightnow)
Examples of C IV meds?
Alprazolam, diazepam, phenobarbital, ambien
What is the current abuse potential of C V meds in the US?
Less than C IV
What can abuse lead to?
Limited physical and psychological abuse compared to C IV
Can they contain combo of C IV drugs at lower doses?
Yes (like robutussin AC)
Prometh with codeine (phenergan), Lamotil, pseudoephedrine
A container for a controlled substances must contain:
1. Symbol prominently located on the label "clear and large enough to be easily read" without removal from the shelf or easily seen on ispection of the labeling
To issue a prescription for a controlled substance, the pharmacist must verify that: (2 things)
1) prescriber is authorized to prescribe controlled substances in Iowa 2) Registered or EXEMPT from registration under CSA
What is the definition of prescription in the CSA?
Order for med dispensed to or for an ultimate user, but does NOT include an order for a medication which is dispensed for IMMEDIATE administration to the ultimate user
A controlled substance prescription must be dated when?
Date it is issued
Can I fill an Rx for a controlled substance using a pre-printed electronic signature as the Rx is brought by the patient directly to the pharmacy?
No. The REAL prescriber must sign, even though an agent of prescriber can prepare the Rx. At the end of the day, any error = physician gets burned.
Controlled substance Rx must include what information?
1) Name + address of patient 2) Drug name, strength, dosage form, quantity prescribed, and SIG 3)Prescriber name, address, and DEA number
What additional pharmacist verification must take place before dispensing a controlled substance Rx?
Verify that the script was issued for a legitimate medical purpose acting in their usual course of professional practice.
Dr. Tank, little Joey Smith's dentist, writes a prescription for Adderrall for Joey. It looks like the prescription follows all requirements and is appropriately signed. Can I fill it?
NO! Why would a dentist write a prescription for Adderrall? No.
If I had filled it (everything looked legit), what kind of disciplinary action can the IBPE take against me?
CORRESPONDING RESPONSIBILITY rests with me since I dispensed the prescription.
Can controlled substance prescriptions be faxed to the pharmacy?
C II, only for hospice (otherwise written only-special rules apply later discussed). C III, IV, and V can be written, verbal or faxed
Can controlled substances be e-prescribed?
Yes, if prescriber is appropriately credentialed
To to become credentialed?
2 factor authentication by government service provider or digital certificate
What are the 3 possible ways to authenticate prescriber signature?
1. something he IS (biometrics, etc) 2. Something he KNOWS (challenge Q)
3. Something he HAS (USB, hard token). But you need TWO!
If I get a prescription from a patient or prescriber I do not know, am I liable to verify the identity and validity of the prescriber e-script signature?
Yes. And I have to record how I verified its authenticity and my name since I verified it.
When are faxed C II prescriptions accepted?
Only if original, signed one is provided BEFORE dispensing of C II med.
Exceptions to this rule?
1) If marked as HOSPICE patient, 2) resident of LTC facility 3) Narcotic C II to be compounded for DIRECT parenteral (IV, IM, SC, epidural) admin to patient.
How long are controlled prescriptions valid?
6 months post original issue date.
Max Refills for C II substances:
None are allowed
C III, IV, V substances?
Max of 5 refills within 6 months from issue date.
Up to how many ambien tabs can I dispense to Mrs. Smith at one time?
No limit within 5 refills within 6 months.
Can multiple C II prescriptions be dispensed? What conditions must apply?
Yes, but must be for same med for same patient
Max quantity allowed?
90 day supply
What must practitioner do (and RPh must verify)
1) Legit medical purpose 2) Must write earliest date it can be dispensed (except on first Rx) 3) No undue risk of diversion or abuse
What changes can be made to a C II prescription WITHOUT consulting the prescriber?
Add patient address
After consulting a prescriber, what changes may be made to a c II rx?
1) Change drug strength and dosage form 2) Quantity 3) SIG 4) Date issued
What CAN'T the RPh change no matter what?
Patient name, prescriber signature/name, drug name (except to sub generic of course)
What can qualify as a CII emergency dispensing situation?
1) Immediate admin of CII is needed 2) No alternate Tx exists 3)It is unreasonable for the prescriber to provide the script to the pharmacist before dispensing.
In the emergency dispensing event, what must the pharmacist do?
1) Limit quantity dispensed to minimum 2) Reduce Rx to writing immediately 3) write "authorization for emergency dispensing" and DATE it 4) Good faith verification of prescriber (if he's unknown)
When do you have to have to receive the written Rx order by?
within 7 days of dispensing
What do I do if I don't get the Rx?
Contact board and DEA
Can I partial fill a C II?
What must I document to partial fill?
On the face of the orignal Rx, I must document that this was partial filled.
How long do I have to get the Rx filled by?
Within 72 hours.
What if I'm over the 72 hour limit? What do I do?
I need a new Rx now, so I have to contact the prescriber.
Exception to above?
LTC or terminally ill patients
What label must be applied to all controlled substance prescriptions?
"Warning: federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed"
Can C-V be dispensed without a prescription in Iowa?
Who can dispense?
pharmacist or intern under Rph supervision
What is the number of hours in which dispensing of a CV substance is limited under?
48 hours
Within that 48 hour period, dispensing to the SAME PURCHASER is limited to no more than 1 of what specific contents for Opium?
8 oz of any controlled substance containing opium OR 48 dosage units
What about Codeine containing cough syrup?
4oz of codeine containing syrup (max of 200mg/100mL)
What about for any other CV controlled substance? What's the max dosage units that can be dispensed?
24 dosage units
To dispense a CV OTC script, what documentation must I keep?:
Sewn or pages are glued bound book of records must be kept. 1) It has to contain patient name + address 2) Name and quantity of controlled substance purchased 3) Date of purchase 4) Name or Unique ID of pharmacist or intern
How old must the purchaser be? How can I verify this?
18 years old. Must ask for government issued PHOTO ID, if patient not known to RPh
Sudafed OTC dispensing is limited to how many mg to the same purchaser within a day? 30 days?
3600mg within the same day; 7500mg within a 30 day period
Am I still limited in what I can dispense if there is a valid prescription?
Nope, can dispense more than that with a valid prescription.
What must my record of OTC sudafed dispensing contain?
1) Name, address, and signature (can be electronic) of patient 2)date and time of purchase 3) name and quanitty of product 4) ID of pharmacist/intern
In addition to that, I must verify the age of the patient, how?
I MUST ask for a government issued photo ID that includes proof of age (as above, but I have to ask for the ID even if I know the patient).
Does Iowa have a real-time Pseudoephedrine tracking system (PTS)?
Yes (effective 2010), called National Precursor Log exchange (NPLEx--ha ha, funny NABP)
Even though an electronic real-time PTS exists, would the pharmacy ever be asked to produce a printed copy to the board?
Yes, the board or anyone authorized by law to get such information, can request a print-out of the PTS records.
When is a DEA form 222 required for use? For what scheduled substances?
For C II substances
Who can order DEA form 222? What does it come pre-printed with?
Only registrants with the DEA can order them b/c they come pre-printed and serially numbered with 1) name, address, and DEA number of registrants.
How does the triplet form work? Who gets what copy?
Copy 1(brown) = supplier. Copy 2 (green) = DEA, copy 3 (blue) = Purchaser (pharmacy must keep this). All kept x 2 Years
What is the controlled substance ordering system?
CSOS is an electronic alternative to the DEA form 222
What do I have to have to use this form?
A digital certificate for identity verification of ordering ANY SCHEDULED PRODUCT (C II = CV)
How long must inventory records of controlled substances be kept?
2 years
When is inventory required for controlled substances? What situations require inventory of controlled substances and how frequent in nature?
1. Initial for new registrants 2. annual inventory 3. change of ownership 4. change of PIC 5. change of location 6. D/c registered activity 7. Newly designated controlled substances (like if lipitor suddenly became a controlled substance)
What are examples of the types of records that must be kept x 2 years for controlled substances?
Records of receipt (222 forms, invoices), records of disbursement (prescriptions, record books, DEA 222 forms, invoices, institutional records, disposal records, and theft records)
Where can you keep C II records versus C III-V to non-controlled records?
C II records MUST be separate from all other records. C III to V must be kept so they're easy to retrieve if they're not kept separate from non-controlled records.
Where can controlled substances be stored within the pharmacy?
Either locked separately, or distributed throughout non-controlled substances
What must be reported to Iowa Board related to controlled substance loss?
Any theft or significant loss of controlled substance
When do I have to make a report by?
2 weeks of discovery, on forms provided by IBPE
What do I have to make sure to do?
I need to maintain a copy of the report form for my records
Is there anyone else I have to inform?
Inform DEA as well, including for loss of DEA form 222 by calling, writing, or faxing nearest DEA office
How do I get rid of several broken tabs of a controlled drug?
1) contact DEA registered and Iowa licensed revere distributor to take the meds 2) Per authorization from IBPE, I can A)deliver to BoP office or agent, or B) destroy in the presence of board authorized individual, or C) by special instruction of board.
A previously dispensed ambien tablet can be brought back to the pharmacy for destruction? or not? What conditions apply for its destruction?
1) RPh must destroy product in witness of other responsible adult 2) Must keep record of destruction to include A) Source of controlled substance B) Name, strength and dosage form C) Quantity returned and destroyed D) Date and signature of RPH + witness
What is the purpose of the Iowa prescription monitoring program (IPMP)?
To determine appropriate prescribing and treatment of patients without fear of contributing to a patient's abuse or dependence or diversion.
Is it mandatory to participate in the IPMP for pharmacies?
We must submit records of C II, C III, and C IV substances dispensed in Iowa at least twice monthly, but we don't HAVE to look at this information.
FAQs from BOP website
What information must I include in sending my change of address, employment, or name forms?
Old and new place of employnment, old and new name, license number, and must be e-mailed/faxed/mailed to BOP. Not phoned.
how many packs of sudafed is a pharmacist limited to dispense at one time?
No limit on packs, but quantity limited to 3600 in 24H federally and Iowa law limits quantity to 7500mg in a 30 day period.
Where can I go for more info on controlled sudafed dispensing laws?
Ch. 10
How can a pharmacist apply to the board of pharmacy for approval to participate in CDTP? (drug therapy management) if they don't have a pharmD or the other ways they automatically qualify?
Submit written request addressing: 1) training or education (CE) 2) Past collaborative experiences with prescribers. 3) RPh is residency director/preceptor 4) history of practice related to DTM; 4) any other helpful info. Request due 3W before board MTGs.
Do collaborative practice agreements need to be submitted to the board?
Community pharmacy ones do, but not hospital pharmacy ones.
Who must register with the board as a controlled substance registrant?
Any who admin, prescribe, distribute, manufacture, or dispense controlled substances under the iowa controlled substances act
How does one become licensed through IBP to drug wholesaler, nonresident pharmacy and pharmacy?
Online applications available. Otherwise, can contact board and submit completed applications with all fees.
How does a pharmacy tech register with board and when do they ahve to register by?
Within 30 days of being hired. Must complete application and pay $55
What about tech trainees or uncertified techs?
must complete application and pay $22
What if tech doesn't register within 30 days?
Must pay penalty in addition to completing application and original fee.
What are currently accredited certification boards for techs?
Do PSPs have to register? by when?
Yes, within 30 days of employment (as above) and pay $30 fee.
Does a LTC facility need controlled substance registration?
Yes, with the Iowa Board of Pharmacy if it administers ANY controlled drugs for patients, but NOT federal DEA registration
Is a Drug Wholesaler or pharmacy license required to dispense oxygen?
A Drug Wholesaler license is required if you are trans-filling oxygen containers or if you distribute medical oxygen at wholesale to entities other than patients.
Do I have to report a colleague who may be violating board rules?
Yes, reports must include name + address of colleague, and date + time + incident in question.
Can I be disciplined by the board if I don't report this?
Do I get immunity?
Yes, I get civil immunity, if I did not act in malice.
Can a pharmacy repack meds from another location into unit dose or med dose packs?
How does one report theft of product?
Break and enter report if controlled involved and submitted to board.
Can I verify a person's license number or current status with board?
E-mail, fax, or call for verbal confirmation (max of 5 phone at one time)
How do I get a list of all the pharmacies or pharmacists currently licensed in Iowa?
They provide list in pharmacy directory in whatever order they want.
How can I transfer my pharmacist license from another state to Iowa?
NABP app. Then submit app with fees to IBPE then take MPJE.
What is the difference between an inactive and a delinquent pharmacist license?
license is delinquent if not renewed. A license is inactive if the licensee failed to complete continuing education required for license renewal.
This is my first renewal after obtaining my pharmacist license by examination (or score transfer). Do I have to submit CE? How should I fill out the CE section on the renewal form? What dates do I need CE on my next renewal?
New pharmacists obtaining license by examination or score transfer in Iowa shall be exempt from continuing education requirements for their first license renewal. On the renewal application in the CE section on the 2nd page write "Exempt--1st Renewal."
You will need to obtain CE for your next renewal. Programs must be completed between when?
April (prior to the effective date of your license renewal) and June 30 of the year your license expires.
What happens if the Board files formal charges against a licensee or registrant?
tate law encourages the Board to enter into informal settlement negotiations prior to the initiation of "contested case proceedings." If no settlement-->AAG takes over
Is a licensee or registrant required to disclose disciplinary actions filed against his or her license?
Yes, Iowa law requires disclosing disciplinary actions filed against you. Report also adverse judgment in a professional malpractice action you are party, and every settlement of a claim against you.
When do reports have to be submitted by?
All reports are to be submitted to the Board within 30 days of a final decision in a disciplinary action and within 30 days after final action in a malpractice claim..
True or False: Pharmacies may store Rx records more than 12 months old in a secure area outside of the prescription department.
True. As long as the place is within the physical structure that houses the pharmacy.
Are animals allowed in the pharmacy?
No, not unless they're seeing dogs or pharmacy provides services for the TREATMENT of animals.
PSPs may perform the following tasks:
Clerk, receipt, process, inventory meds, filing PROCESSED Rx records, changing patient DEMOGRAPHIC info on computer, receipt of patient refill requests, deliver meds
What new substance become an imitation controlled substance in 2010?
K2 spice, (also red dragon smoke, pandora potpourri, smoke, skunk)
Can a pharmacist dispense a sudafed containing product to a patient who regularly comes into their practice without asking to see the patient's ID?
No. needs a government issued photo ID
If a hospital pharmacy participates in a hospital-wide DQI program, does the pharmacy need to implement a new CQI program?
No, as long as the hospital or corporate wide CQI program meets the objectives of 657 8.26.
Can pharmacies enter into collaborative practice agreements with NPs or PAs?
No. Must be DO or MD
If a patient is in a nursing home or is an ambulatory patient with a diagnosed terminal illness, can a schedule II Rx be partial filled or in partial quantities not to exceed how many days?
Yes, for periods not to exceed 60 days,
Can more than one C II drug be included on one prescription brought to the pharmacy?
Yes. Nothing in federal or state law excludes this.
Can a generic drug not listed int eh FDA (orange book) be substituted for a brand name product when the prescriber has not prohibited substitutions?
Yes, pharmacist can use professional judgement if not in orange book, particularly for drugs marketed before 1962
Can an Iowa pharmacy re-pack or re-label a supply of meds for a physician to dispense them from his/her office?
No, unless the pharmacy registers with the FDA as a drug repackager and qualifies to adhere to FDA cGMP.
What packaging and label must a physician in Iowa follow when he or she dispenses meds to a patient?
1. Name + address of dispenser 2. Date of the prescription or its filling 3. Patient name 4. SIG and cautions 5 (per IBME)Name and strength of dispensed drug 6. Must also adhere to Federal Poison prevention act and light resistant vial requirements.
When does pharmacy tech registration expire?
2nd last day of birth month following initial registration
Who is responsible to verify that all tech registration is valid and current?
Related to EMT pharmacy practice, what additional tech functions may be performed?
Inspecting pharmacy drug supplies in ambulance, emergency service, nursing home, etc.
Chapter 6 defines general pharmacy practice. To whom does this apply?
Whenever a pharmacist is involved except in a hospital setting
What are the responsibilities of the PIC (up to 10 listed here, 6 continued on next slide)?
1. CQI 2. Enough employees 3. Maintains Equipment/references needed 4. DUR 5. Counseling 6. Dispensing drugs to pts and overseeing process/personennel 7. Deliver drugs to patient/agent 8. Patient Med records maintained 9. Training staff 10. Inventory
What are the 6 final responsibilities of the PIC?
11. Distribute/dispose of meds 12. Maintain transaction records/inventory records 13. Theft/diversion controls 14. Pharmacy policy and procedures 15. Maintaining a legal pharmacy 16. Keep Rx department safe
Who is responsible for security and access to records?
Pharmacist on duty
What conditions apply for the return of controlled substances?
They must go to the same patient only.
If a hospital is not 24H, what must be the case?
There MUST to be a pharmacist "on call" to handle situations.
Duties of PIC in a hospital setting? all caps = different than outpatient
1. CQI 2. Enough staff 3. Equipment + references 4. DRUG INFO PROVIDED 5. DRUG MONITORING AND REVIEW 6. dispensing 7. Records maintained 8. Train stff 9. Dispose of drugs 10. Control records 11. no theft/diversion 12. Operations manual 13. Keep it legal
So which ones are unique to hospital PIC?
1. Drug information provided to patients/staff 2. Drug monitoring + drug use evals instead of 1) keeping Rx department separate from patients, 2) prospective DUR, 3) patient counseling.
What references are required in a hospital setting?
1. Iowa pharm law manual 2. General pharmacy 3. Drug equivalency 4. Patient info 5. PCC number 6. Drug Interactions 7. Injectable drug 8. Drug ID 9. Anything else needed for setting
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