Ohio MPJE

When can a central fill dispense a rx directly to the pt?

- a DUR is conducted -pt counseling is provided -positive ID is provided -follows other rules and regulations

Can a fax be sent from a computer?

No they become illegal except: 1. the fax prescription operates within a closed system 2. can be accepted during a temporary outage

DEA form 222

Order form for CII substances

How often must control substance inventories be taken?

Must be conducted annually. You have 13 months after your last inventory

T/F the 12 week limit does not apply to Qsymia and Belviq

True

define in-state health care facility

any of the following licensed as a terminal distributor of dangerous drugs in the state of OH including hospital, ambulatory surgical facility, or an EMD organization

define in state pharmacy

any pharmacy located in OH that ships, mails, or delivers, in any manner, drugs at retail in or out of OH. an in-state pharmacy does not include a nuclear pharmacy

Who can participate in the drug repository program?

any pharmacy, hospital, or non profit clinic licensed as a terminal distributor of dangerous drugs

T/F commercially available products can be compounded

false

T/F controlled substance samples can be accepted at a charitable pharmacy

false

T/F prescribers can write controls for a family member

false

T/F rules of Sudafed apply to prescription drugs

false

T/F tech trainees do not have to wear a name tag saying pharmacy tech trainee

false

T/F the board requires submission to dispose of controlled substances

false

T/f the law applies to codeine and hydrocodone containing cough syrup

false

t/f buprenorphine used for opioid dependence and antidiarrheals are classified as opioid analgesics

false

t/f interns can administer injectable medications

false

t/f naloxone protocol rules apply to inpatient pharmacies

false

t/f sales of naloxone to local or state law enforcement count towards 5% rule

false

t/f the 14 day rule applies to refills on II-V prescriptions

false

t/f the law applies to compounded opioid rxs

false

t/f a proscriber can post date a prescription

false physicians must date the prescription on the day it is signed but can write do not fill until

T/F according to federal law all records must be kept for 3 years

false 2 years federal 3 years state

T/F if the prescription does not comply the pharmacist has 24 hours to receive verbal, faxed, or electronic confirmation of authenticity by prescriber or prescribers agent

false 72 hours

T/F only physicians can obtain an X DEA

false PAs can compete training and treat up to 30 patients

T/F only retail pharmacists are required to register with OARRS

false all pharmacist are required to register

t/f once the protocol is signed the pharmacist can only inject for that physicians pts

false can administer for anyone with a rx

even though for OH inventory has to be yearly the FDA only requires biannually so what must the pharmacist do?

every 2 years write DEA biennial inventory on top of inventory

1994 Dietary Supplement Health and Education Act

expanded the definition of dietary supplements and restricted the FDA's regulatory authority over them.

T/F the prescribing APN is not subject to the same restrictions as the collaborating physician

false if their collaborating physician is a podiatrist the APN can only treat that disease state

T/F PAs do not need a certificate to prescribe

false if they are licensed to prescribe they will have an RX after their license

t/f bulk compounding is legal and is not considered manufacturing

false it is considered manufacturing and is illegal

T/F OARRS cannot be part of the medical record

false it may

T/F the pharmacist does not have to verify a consent form was filled out for the minor

false must verify before dispensing can dispense without consent...use professional judgement

T/F 3 controls are aloud on one rx

false only one

T/F state law can be less restrictive than federal

false state can only be more restrictive

T/F the law prohibits the provider from writing more than a 90 day supply

false they can write it but you can't fill it

T/F protocols and treatment guidelines do not have to be approved by the board

false they must be approved

T/F APNs do not need a collaborating physician

false they must even if it isn't in the same office all the time

What patients can be managed under a consult agreement?

only pts of physicians listed in the consult agreement

Wholesalers are required to design and operate a system which identifies suspicious orders how?

orders for controlled substances, gabapentin, and naltrexone which are orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency

DEA form 224

original registration for DEA license

T/F optometrists do not have their own DEA

false they would if they want to prescribe controlled substances (will begin with M) if they wish not to prescribe controls than they do not need one

t/f a technician working at a federal facility needs be the registered

false unless wanting to work at another facility

t/f the board must notified you before showing up for an inspection

false, they can come whenever they want

T/F the quantity of a controlled medication only need to be written in numbers

false, words and numbers

T/F you can give a provider a copy of an OARRS report

false, you can discuss it with them but they must get their own copy

When does registered pharmacy techs registration expire?

march 31st on even numbered years

do vets have to follow the opioid acute pain rules?

no

Who must the pharmacist talk to to change a C-II?

the prescriber directly

Rules regarding DAW?

the provider must write in their handwriting DAW, dispense as written, medically necessary, brand only to prevent generic substitution or orally phone in the DAW type written or check marks are not approved DAWs -patient may request brand -label must read generic substitution made if changed to generic

DEA form 41

to destroy controlled substances

When can cocaine HCl be used?

topical anesthetic for mucous membranes in surgical situations or as a topical anesthetic where medically appropriate for injuries that do no involve mucous membranes

who can sterile compound?

trainee and certified

T of F methadone can be dispensed for pain

true

T/F ERs have to report to OARRS

true

T/F PAs can only see patients in an office or location where their supervising physician is actively seeing patients

true

T/F PAs can prescribe controlled substances but must have their own DEA

true

does the 14 days of written and 90 supply rule apply if the proscriber is from out of state?

yes

Medical marijuana can be used for the following conditions?

(a) Acquired immune deficiency syndrome (b) Alzheimer's disease (c) Amyotrophic lateral sclerosis (d) Cancer (e) Chronic traumatic encephalopathy (f) Crohn's disease (g) Epilepsy or another seizure disorder (h) Fibromyalgia (i) Glaucoma (j) Hepatitis C (k) Inflammatory bowel disease (l) Multiple sclerosis (m) Pain that is either chronic and severe or intractable (n) Parkinson's disease (o) Positive status for HIV (p) Post-traumatic stress disorder (q) Sickle cell anemia (r) Spinal cord disease or injury (s) Tourette's syndrome (t) Traumatic brain injury (u) Ulcerative colitis

Definition of a misbranded drug

*A drug that its labeling is false or misleading. *A drug that fails to have on it information required by law *Label not as prominently displayed as required by law *Name on label is not in an official compendium *CS habit forming not labeled *Inadequate instructions for use *Offered for sale as an imitation of or using name of another drug

What security features must a tamper resistant rx pad have?

*all 3 are required for all outpatient medicaid rxs, this is policed by medicaid -1+ industry recognized features designed to prevent unauthorized copying of computed or black prescription forms --high security watermarks on reverse side or therm-chromic ink -1+ industry recognized features designed to prevent the erasure or modification of information written no the rx by the prescriber --tamper resistant background ink that shows erasures or attempts to change written info -1+ industry recognized features designed to prevent the use of counterfeit prescription forms --sequentially numbered blanks, duplicate or triplicate blanks

The course must include what review of the medication?

--a review of conditions treated or prevented --MOA --appropriate route of administration --appropriate injection sites and ensuring patient privacy --appropriate dosage and administration schedules --appropriate monitoring and treatment for adverse effects and proper use of epinephrine and benadryl --appropriate pt populations --precautions and contraindications --proper storage

How long does a pharmacy have to notify the board of a change of responsible pharmacist?

-10 days

How long does a pharmacy intern have to return the internship license to the board?

-10 days

What are the foreign pharmacy graduate requirements to become pharmacists?

-1740 total required hours in OH -up to 500 hours can be obtained from a site other than a pharmacy licensed as a terminal distributor (but formal request must be made) -must report hours by March 1 for all hours obtained the previous year -pass test of spoken English

How long do you have to notify the board of a name change, address or employment?

-30 days

How long does a pharmacy or wholesaler have to notify the board of a change of ownership, business name, trade name, category, or address?

-30 days

How many days in advance does a pharmacy have to notify the board of closing?

-30 days

Requirements for continued education?

-40 hours every 2 years -2 hours of law and 2 hours of patient safety/medication errors -1 contact hour = 0.1 CEUs -must be reported by September 15th -no carryover -a pharmacist may satisfy the CE requirements by providing evidence at the time of renewal that he/she has met the requirements of and is currently certified by a board approved specialty --they are still required to do their 2 hours of law and patient safety/med errors -keep record of CE for one year after reporting

How much training is needed to become immunization certified?

-5 hour board of pharmacy approved course in the administration of immunizations --at least one hour of instruction and physical participation in administration techniques --must provide a method to evaluate the mastery of the material

How long does a pharmacy intern have to inform the board and employer if no longer enrolled in pharmacy school?

-72 hours

What is the structure of the board of pharmacy?

-9 members total, appointed by the governor -8 pharmacists and 1 consumer, at least 60 years old -4 year term and reappointed once for one additional 4 year term -terms begin July 1

What is a dangerous drug?

-A drug that is required to have "Rx only" or any similar language -Can only be dispensed with an Rx -Contains CV substance (except Robitussin AC) -Drug intended to be administered by injection into the human body other than thru a natural orifice

Schedule V Controlled Substances

-Atropine / Diphenoxylate (lomotil) -novahistine -Codeine/guaifensin (robitussin AC) -Tylenol/codeine elixir -pregabalin (Lyrica) -Cannabidiol (Epidiolex) -promethazine/codeine

Class III Medical Devices

-Class II regulations + premarketing approval -manufacturers must demonstrate safety and efficacy i.e. IUDs, pacemakers, heart valves, artificial hips

What requires positive ID of the pharmacist?

-Data entry -prospective DUR -Dispensing -Counseling -Administering immunizations -Rx info reduced to writing from order by phone, fax, or recording device

What is the minimum standard of a pharmacy?

-Drug library (laws and references) -Poison Control Center # -Equipment necessary to conduct pharmacy -Drugs and Rx containers -Well-lighted, well-ventilated, clean and sanitary -Adequate physical security -Posted pharmacy hours -appropriately staffed -Staff in contact with patients, must have name tag with job title

What must faxed prescription contain?

-Includes full name of prescriber or agent that transmitted Rx -the original prescription or the refill authorization must be manually signed by the prescriber -Include header info to identify origin of Rx -the original prescription should be placed in the pts file

What are the practitioners in Ohio?

-MD, DO, Podiatrist Vet, DDS -nurse practitioner -optometrist -interns and residents -out of state practitioners

How can a nursing home patient's med be destroyed?

-a licensed OH pharmacist and the director of nursing can destroy a controlled substance on site. -Both must personally witness and document the destruction. --date of destruction --patient name --drug name and strength --quantity --method of destruction --positive ID of the 2 individuals involved in the destruction

Who is the responsible pharmacist?

-RPh who signs the terminal distributor's license -must be present a sufficient amount of time to provide supervision -can only be responsible for one pharmacy -10 days to notify the board of a change -a complete inventory must be made of all controlled substances on the day the change is effective

Drug Supply Chain Security Act

-Requirements for tracing prescription drug products through pharmaceutical supply distribution chain. -deadline for pharmacies was march 2016 -pharmacies must receive transaction information and transaction history from the previous owner and maintain it for 6 years -wholesalers are providing this service to pharmacies who order from them -if the pharmacy selling the product to someone else they must provide this unless it is patient specific -this is a federal law but state board will likely pass their own laws

What needs to be on the small container at an outpatient pharmacy?

-Rx number -patient name

Who can terminate consent for a consult agreement? What must happen after that?

-The pharmacist, physician, or patient can terminate it -if pt terminates - pharmacist and physician must be notified in writing -if the pharmacist or physician terminates - provide written notification to all other parties involved and record in medical record

define a protocol

-a definitive set of written treatment guidelines that include definitive orders for drugs and their specific dosages which have been authorized by a prescriber to be used by licensed health care professionals when providing limited medical services to individuals in an emergency situation when a prescriber is not immediately available -a definitive set of written treatment guidelines that include definitive orders for drugs and their specific dosages which have been authorized by a prescriber to be used by licensed health care professionals when administering biologicals or vaccines to prevent disease

What is a primary disease?

-a disease that arises spontaneously and is not associated with or caused by a previous disease, but may lead to a co-morbid disease

When can commercially available products be compounded?

-a drug shortage -if a pt has an allergy and needs a medication made without a certain inert ingredient -if a pt needs a dosage form different from what is commercially available

When can drugs be removed from a terminal distributor?

-a licensed health professional authorized to prescribe may temporarily remove prescription drugs from the terminal distributors to treat current or prospective patients but these must be returned within 24 hours -a person authorized to furnish or dispense naloxone must return it within 24 hours to a terminal distributor -a licensed health professional may temporarily remove non-controlled substance prescription drugs or immunizations from the terminal distributor to treat current or prospective patients but these must be returned within 24 hours

Define a point of care location

-a location within an institutional facility that stores prescription drugs and all of the following apply --the point of care location is a licensed terminal distributor --dangerous drugs are not owned by a institutional facility where to point of care location is located --dangerous drugs stored are owned by another institutional facility licensed as a terminal distributor --the location may be used for administering, personally furnishing, or dispensing of all rx drugs --this does not apply to pharmacy supplied contingency drugs in an institutional facility licensed as a terminal distributor

Pharmacists can partially fill a prescription for 60 days when?

-a patient is terminally ill -a patient is in a LTC facility or nursing home **not assisted living

define a preprinted order

-a patient specific definitive set of drug treatment directive to be administer to an individual patient who has been examined by a prescriber -this prescriber has determined that the drug therapy in the preprinted order is appropriate and safe when used according to the condition in the preprint order

When is it acceptable for a certified tech to fill automated dispensing cabinets?

-a pharmacist is available to answer questions -a pharmacist is responsible for conducting routine verifications of the activities to prevent diversion of drug -a pharmacist is fully responsible for all activities conducted by the tech

What is a managing pharmacist?

-a pharmacist managing a patient's drug therapy pursuant to a consult agreement

What is included in the consent that must be received from the patient that will be involved in a consult agreement?

-a pharmacist may be utilized in the management of the patient's care -the patient has the right to participate or withdraw from the consult agreement this consent may be part of the patient's initial consent to treatment

Rules regarding compounding for physician use (in-office)

-a pharmacist may compound a drug if requested by a prescriber or agent of a proscriber to use for direct administration to pts (only in state pharmacies) -total amount supplied cannot exceed 5% of total dollar sales -only for non commercially available products -should only be provided if: to treat an emergency situation, unanticipated procedure for which a time delay would neg affect pt outcomes, for a diagnostic procedure -72 hour supply limit -topical products should not exceed 60 grams/60 mLs -cannot sell to other pharmacies or wholesalers -prescribers can only administer to their own pts -each must have a BUD

Rules regarding compounding for vets to use

-a pharmacist may compound a drug if requested by a prescriber or agent of a proscriber to use for direct administration to pts (only in state pharmacies) -total amount supplied cannot exceed 5% of total dollar sales -only for non commercially available products -should only be provided if: to treat an emergency situation, unanticipated procedure for which a time delay would neg affect pt outcomes, for a diagnostic procedure -a limited quantity of the drug may be supplied to the vet, meaning: --sufficient for the vet's office use consistent with the expiration date --reasonable considering the intended use of the compounded medication and nature of the vet's practice --RPh use their own professional judgment to determine what amount is appropriate -vet may furnish up to a 7 day supply of a compounded drug to a pt -cannot sell to other pharmacies or wholesalers -vets can only administer to their own pts

Can pharmacists administer rabies vaccines?

-a pharmacist or intern cannot provide the initial post exposure vaccine -they can administer follow up post exposure vaccines -a pharmacist or intern can provide pre-exposure rabies vaccines

What is a complimentary supply?

-a prescription drug that is provided without charge to a pharmacy to assist patients in the initiation of drug therapy -these are not considered to be samples

What is an occasional sale?

-a wholesale sale of a commercially available prescription drug to another terminal distributor or person exempted from being a terminal distributor such as vets, dentists, docs

What are the library requirements of a pharmacy?

-access to and utilize the references necessary to conduct a pharmacy in a manner that is in the best interest of the patient served and comply with all state and federal laws -phone number to nearest poison control center -able to access all current federal and state laws, regulations, and rules governing the legal distribution of drugs in OH

How to check a DEA number?

-add digit 1 + 3 + 5 -add digits 2 + 4 + 6 then multiple by 2 -then add the 2 numbers together and the last number must much the last number of the DEA

When should OARRS be checked?

-adds a new drug -OARRS has not be reviewed in 12 months -prescriber or patient is located outside of the usual geographical area -receiving OARRS drugs from more than one provider -showing signs of potential abuse -monitor for other states if live close to a boarder

At a minimum written quality assurance programs should address

-adequate training and continuing competency monitoring of all personnel every 6 months for low-med risk and every 4 months for those who make high risk compounds in --personal cleaning --proper attire --aseptic technique --proper clean room conduct --clean room disinfecting procedures -continued verification of end products -continued verification of automated compounding devices -continued verification of BUDs -end product testing -end product testing for bulk compounding for particulate matter and pyrogens

Who must submit to the board of pharmacy for the drug database?

-all pharmacies and physicians in the state of Ohio that dispense and med reported to OARRS to outpatients in Ohio

What is a federal legend?

-all prescription drugs must have "Rx only" or a variation of this on the stock bottle

Rules regarding record keeping for drug repository programs?

-all records and forms must be kept for 3 years -all invoice must be created by the donor location and include --name and address of the donor location --brand name of drug or generic name and manufacturer or NDC number --strength --quantity --date drug was sent to the pharmacy, hospital, or clinic --name and address of the recipient pharmacy, hospital, or clinic -both the donor and recipient locations must receive a copy of this invoice and keep it for 3 years

schedule IV controlled substances

-alprazolam -armodafinil (Nuvigil) -suvorexant (Belsomra) -butorphanol -chloral hydrate -chlordiazepoxide -clonazepam -clorazepate -diazepam -diethylproprion -ethchlorvynol -flurazepam -flunitrazepam (Rohypnol) -halazepam -lorazepam -mephobarbital -meprobamate -methohexital -midazolam -oxazepam -paraaldehyde -pemoline -pentazocine (Talacen, Talwin) -phenobarbital -phentermine -prazepam -propxyphene -temazepam -tramadol (Ultram, Ultracet) -triazolam -zolpidem (Ambien) -quazepam (Doral) -estazolam (Prosom) -fenfluramine (Pondimin) -mazindol (sanorex) -modafinil (Provigil) -Zaleplon (Sonata) -eszopiclone (Lunesta) -carisoprodol (Soma) -lorcasrein (Belviq) -phentermine (adipex) -Phentermine/topiramate (Qysmia)

Schedule II Controlled Substances

-amphetamine (dexedrine, dextrostat) -amobarbital -codeine -dexmethylphenidate (Focain) -dextroamphetamine (Adderall) -dihydrocodeine -diphenoxylate -morphine + naltrexone (embeda) -ethylmorphine -fentanyl (duragesic, Actiq, Fentora, subsys, onsolis, ionsys, sublimaze, lazanda) -hydrocodone/APAP (Vicodin, lortab, maxidone, Norco, xodol, zydone) -hydrocodone/ibuprofen (vicoprofen) -hydromorphone (dilaudid, exalgo) -glutetimide -levorphanol -lisdexamfetamine (Vyvanse) -meperidine -methamphetamine -methylphendiate (Concerta, ritalin, daytrana, metadate, Methylin) -morphine (kadian, avinza, MS Contin, duramorph, astramorph, depodur, arymo ER) -opium -oxycodone (oxycontin, oxyir, oxyfast, roxybond) -oxycodone/ibuprofen (combunox) -oxymorphone (Opana, numorphan) -pentobarbital -phencyclidine and phenmetrazine -secobarbital -oxycodone/APAP (Percocet, tylox, roxicet) -oxycodone/aspirin (Perodan) -oxycodone/naloxone (Tarqiniq ER) -tapentadol (Nucynta) -hydrocodone bitartrate ER (zohydro ER) -oxycodone SR (remoxy) -hydrocodone SR (Hysingla SR) -oxycodone/naltrexone (Troxyca ER) -oxycodone (Xtampza) -hydrocodone (Vantrela ER) -benzhydrocodone/APAP (Apadaz) -sufentanil (Dsuvia)

to obtain info from the drug database state, federal, or local law enforcement must have?

-an active case # assigned by the investigating agency or department and approval by a supervisor -complete a request in the OARRS system

What is a comorbid disease?

-an additional disease that co-occurs with a primary disease

What conditions must be met for drugs that are returned to stock in a pharmacy?

-an expiration date must be placed on the container -the drugs returned to stock must be kept in the prescription bottle it was dispensed in with the original patient label on it -when dispensing the product to a new patient, a new container must be used -if there is a drug recall, all medication on the shelf must be removed if the exact lot number is not known -if the medication wished to be returned was with a delivery agent, the medication either needs to have been in the stock bottle still or there is a way to show that it had not be tampered with -none of these apply to medications that are dispensed inpatient

Rules of using a central fill pharmacy

-an originating pharmacy may outsource prescription filling or refilling to a central fill pharmacy provided the pharmacies have the same owner or the pharmacies have entered into a written contract or agreement -both pharmacies must have access to common electronic files, online database, or have appropriate tech to allow secure access to sufficient info necessary or required to dispense or process prescriptions -originating pharmacy is responsible for maintaining records of rxs filled or refilled -the label shall display the name and address, rx # of the originating pharmacy -a staff member at the originating pharmacy should keep record of of the delivery from the central fill and keep records for 3 years

What is considered to be a business day?

-any day other than Saturday, Sunday or holiday recognized by the state of Ohio

What is considered to be "readily retrievable"?

-records must be able to be produced for review within 3 business days

What is a virtual wholesale distributor?

-any person engaged in wholesale distribution of dangerous drugs in or into OHIO -the wholesaler has title to the drugs but does not take physical possession of the drugs

to receive an intern license what must the student do?

-apply to the board for a license -provide a head to shoulders photograph -pay a fee -must have completed 60 semester hours or 90 quarter hours of college already -has begun taking professional pharmacy courses to become a pharmacist and is enrolled in a school of pharmacy -provided a criminal background check

What is needed for fluid therapy prescriptions?

-aseptic conditions -laminar flow with 6 month certification -antineoplastic prepared in equipment that minimizes employee exposure (vertical flow hood)

What is needed on the consent for opioids for a minor?

-assess minors metal health -the risks associated with an opioid -signature of the parent or guardian on the consent form -no more than 72 hours if the person signing the consent is not the parent or guardian -it is recommended to attach the consent with the prescription to the pharmacy

Regulations of a nuclear pharmacist/pharmacy?

-be certified as a nuclear pharmacist through BPS and have 200 hours instruction in nuclear pharmacy -labels must read radiation symbol and caution radioactive material on both inner and outside container

The policy and procedure manual for sterile product prescriptions must...

-be site specific -address a quality assurance program for the purpose of monitoring personnel qualifications, training and performance, product integrity equipment, facilities, and guidelines regarding patient education, and finished compounded drug product -justification for the chosen BUD -handling of cytotoxic waste -must be current and available

Where is pseudoephedrine kept?

-behind the counter or locked case accessible only by the retail assistant -sales are not limited to only pharmacies

What must be included if a pharmacy advertises a price of a medication?

-brand name -generic name -strength -dosage form -price for specific quantity

what are the requirements of a treatment guideline?

-can only be initiated by a prescriber and orders must be made by the prescriber -the prescriber must create an order in the pts record to adjust orders -applies only to adjusting dose or frequency of administration of a specific drug previously ordered -applies only to drugs that may require calculations for specific dosing and frequency adjustments -applies only to drugs that have therapeutic doses much lower than could cause harm to the patient, does not apply to drugs with therapeutic doses that can cause harm to the patient -can be performed without requiring the exercise of medical judgement -must have predictable and safe outcomes -would not cause serious or immediate harm to the pt if an error occurred

When can you dispense simultaneous refills?

-cannot be a controlled substance -must be to maintain drug taken on a reg basis to treat a chronic disease, prevent disease, or a contraceptive -the total cannot exceed a 90 day supply

Rules regarding schedule V OTCs?

-cannot sell OTC if previously written as a RX for 2 weeks? -boiled schedule V become C-IIIs -only one preparation every 48 hours --30mg morphine and ethylmorphine --125mg opium and dihydrocodeine --250mg codeine -must fill out a booklet with name, date, address, drug, strength, quantity, and dispenser -18+ years old to buy -ephedrine and CBD oil is also a schedule V

What is a terminal distributor's license?

-category I - single dose injections of IV fluids -category II - any dangerous drug -category III - controlled substances -a terminal distributor's license is cumulative...if you have a category III license you can dispense drugs in categories I, II, and III -you must post your terminal distributor's license in a visible area -if there is a change to the license a new app and fee must be filed within 30 days to the Board

What can a pharmacist do under a consult agreement?

-changing the duration of treatment of current therapy -adjusting the strength, dose, dosage form, frequency, administration, or route of administration -discontinue the use of a drug -administer a drug, if the drug is included in the consult agreement -add a drug to the patient's drug therapy -order blood and urine tests and if specified within the practice protocols that are part of the consult agreement, evaluate the results related to drug therapy being managed --HOWEVER, these tests do NOT authorize the pharmacist to make a diagnosis

Describe the classes of drug recalls

-class I - will cause either serious ADRs or death -class II - may cause temp or medically reversible ADRs on health or where the probability of serious ADRs is remote -Class III - exposure is not likely to cause ADRs

Class II Medical Devices

-class I regulations + performance standards i.e. tampons, contact lens solution, heating pads, syringes, and condoms

Requirements of APNs to become certified to prescribe

-complete a course of study in advanced pharmacology -1500 hours of externship (500 hours direct supervision) -licensed by the board of nursing

How can individuals obtain their information from a drug database?

-complete a notarized request form giving them such information to the board -submit a complete form in person or by mail -the information must be picked up from the board and must show proof of identification -pay the cost of printing

to inject medication the pharmacist must meet the following?

-completed the course in administration of these drugs -receive and maintain BLS certification -practice according with a protocol

What is a third party logistics provider?

-contracts with a manufacturer or wholesaler to provide or coordinate warehousing, distribution, or other services on their behalf but does not take title of prescription drugs or have responsibility for their sale or disposition -must have a license as a wholesale distributor, registered as a business

1984 Drug Price Competition and Patent Restoration Act

-created the ANDA for generic drugs and restored some of patent life for the time a drug sat at the FDA waiting approval

What log must be kept for sudafed?

-date -time -drug -quantity -purchaser signature -printed name -address Records kept for 3 years

What must be logged if changing a prescription?

-date and time of the change -changes made -pharmacist making the change -the FULL name of the agent of a prescriber who gives the pharmacist authorization -the employee of a pharmacy with contact must have a name tag with their name and job title

What must be present in the physician established protocol to administer immunizations?

-describe length of time the pharmacist must observe the individuals for ADRs (pt must be in the general area of the pharmacist) this could also be an intern -have a method to address emergency situations --can have epi or Benadryl available -have a method to notify the physician or board of health within 30 days -the protocol must be annually reviewed with the physician -must be accessible if the board asks for the protocol -must state the location immunizations can be given -must contain information on the vaccines that can be given -information on what needs to be recorded

what must the protocol for naloxone include?

-description of clinical pharmacology of naloxone -indication for use -precautions and contraindications -assessment and followup actions -authorization to be dispensed --name, dose, route of administration, required delivery device, and directions for use -any additional pt instructions --must tell pt to seek medical help before or after administering naloxone

Positive ID is required in an inpatient facility?

-dispensing -compounding -repackaging -removal and possession of a controlled substance to administer to a patient -waste a controlled substance

What can be changed on a prescription without calling the provider?

-dosage form -strength -quantity -directions

What records need to be kept for compounded or repackaged drugs?

-drug, strength, and dosage form -manufacturer lot number -generic manufacturer -pharmacy control number -manufacturers expiration date -positive ID of RPh -pharmacy expiration date --one year or the expiration date on the original container whichever is less

Define a contingency drug

-drugs required to meet the therapeutic needs of patients when a RPh is unavailable --drugs stored in a locked cabinet/enclosure located outside the institutional pharmacy --designate who has access --determine what drugs are stored in this manner --drugs must be properly labeled and packaged in sufficient quantities --positive ID of who is removing drug --reconciliation/audit procedures

What is the donor form for the drug repository program?

-each donor must sign a form stating that the donor is the owner of the drug and voluntarily donates it to the program

When can a pharmacist enter into a consult agreement with one or more physicians?

-each physician has an ongoing physician-patient relationship with each patient whose drug therapy is being managed -the diagnosis for which each patient has been prescribed drug therapy is within the scope of practice of each physicians practice -each pharmacist has training and experience related to the particular diagnosis for which drug therapy is prescribed

What is a recipient form?

-each recipient of a donated drug must sign a form stating they understand the immunity provisions of the program and must include: --signature and date of the recipient --brand name of the drug donated or generic name and manufacturer or NDC --strength --quantity donated --date drug was donated

what is an appropriate way to notify a provider?

-electronic mail -interoperable electronic medical record system -fax -electronic prescribing system -electronic pharmacy record system -documented verbal communication

What can be considered a written notice?

-electronic mail -interoperable electronic medical records system -fax -electronic prescribing system -electronic pharmacy record system -any other method in writing that provides notice in a timely manner

What forms of communication can occur in a consult agreement between the pharmacist and physician?

-electronic mail that confirms delivery -interoperable electronic medical records system -fax that confirms delivery -electronic prescribing system -electronic pharmacy record system -documented verbal communication -any other method of documented notification as outlined in a consult agreement

The kiosk must meet all the following?

-electronically protected against unauthorized access -bolted to the floor or in wall -constructed to prevent break-ins or tampering -sound an alarm or transmit a notification to on site security if a break in is attempted

What is needed for a filed prescription never dispensed?

-enter into computer and saved on pts profile -must have positive ID of the pharmacist who entered the information -file the hard copy as usual

How often should laminar flow hoods have environment monitoring?

-every 6 months to certify operation efficiency -plan to immediately fix the problem, must be in place if there is a problem -records kept for 3 years

What is the statement of preceptor form?

-form that must be submitted to the board for each intern within 30 days of beginning work as an intern

what is required to be kept for recordkeeping of injections?

-full name and address of pt -DOB -gender -allergies -date of administration -name, strength, and dose of drug administered -lot number and expiration date of drug -route -location of injection site -positive ID of the pharmacist -ID of ordering physician

What must an immunization protocol contain about keeping record?

-full name and address of the patient -patient's DOB or age -gender -allergy information -date of administration by the pharmacist -name, strength, and dose of the adult immunization administered -lot number and expiration date of the immunization -route of administration -location of the injection site -positive ID of the administering pharmacist -documentation of pts informed consent this info must be immediately retrievable for the previous 12 months and readily retrievable for the last 36 months (3 working days)

What information must be available in a patient's profile?

-full name of patient -residential address and telephone number -date of birth -gender -drug related allergies -previous drug reactions -history or active chronic conditions or disease states -drug therapy records -OTC drugs and devices -pharmacist's comments relative to drug therapy -any other information given to pharmacist by patient or caregiver * profiles should be maintained for at least 1 years after last rx

Each time a pharmacist injects a medication they must?

-get permission from the patient or guardian is <18 -pt must be offered a private room -the pharmacist must observe the pt -notify the physician within 7 days of administration -methods to address emergency situations -must have a physician established protocol before administering and should be resigned every 2 years -records of administration should be kept for 3 years

Class I Medical Device

-good manufacturing practices -premarketing review; safety -proper labeling truthful advertising -i.e. ice bags, crutches, blood pressure kits

Who can obtain data from a drug database?

-government rep -prescriber -pharmacist -individual (their own info only)

What 2 conditions cause a medication to be considered a prescription drug?

-habit forming -unsafe for use except under the supervision of a practitioner

What needs to be done if a pharmacist wants to be authorized to prescribe controlled substances as per a consult agreement?

-have a valid controlled substance prescriber registration issued by the Ohio State Board of Pharmacy -must submit an application and valid consult agreement -must obtain and keep current a valid DEA registration from the federal government -the DEA registration must be submitted to the board within 30 days -if the consult agreement is not valid the license is void

USP 800

-hazardous drugs which includes --carcinogenicity --teratogenicity or developmental tox --reproductive tox --organ tox in low doses --genotoxicity --new drugs that mimic existing hazardous drugs in structure or tox -requirements go into effect 12/19

Schedule I Controlled Substances

-heroin -ecstasy -LSD -marijuana -mescaline -peyote -psilocybin -methaqualone -bath salts -spice -K2 -GHB -etizolam

Prescription Drug Marketing Act

-hospitals can sell to: patients in the ER, patients being discharged by the hospital (first fill only), and its own staff -prescription drugs cannot be re-imported into the US once they have left the country -regulates samples --RPh cannot possess RX samples --MD's must request samples in writing --sales reps must store samples under proper conditions --sales reps must keep samples locked up --sales reps must keep records for 3 years --annual inventory

Define generic drug

-identical active ingredient -meets identical FDA approval

What is the 5% rule?

-if a pharmacy has >5% of sales due to selling medications to people other than patients, they must receive a wholesaler's license

How do wholesalers report to OARRS?

-if you sell controlled substances to another pharmacy, physician, or terminal distributor you must register as a wholesale distributor with OARRS and report this transaction through OARRS -the transaction is reported by number of packages not doses. you can report fractional quantities as a decimal -if transferring controlled substances between stores owned by the same corporation or owner, you must report as well

In order to compound prescriptions, a pharmacy shall meet the following minimum standards...

-inspect and approve the compounding process -perform the final check on the finished product -be responsible for all records of the compounded products -be responsible for proper maintenance, cleanliness, and use of all equipment -personnel will wear appropriate clean and protective clothing to protect themselves from chemical exposure and drugs products from contamination -the pharmacist must assure the environmental control of products shipped -the responsible pharmacist must make sure a system is in place for appropriate disposal of cytotoxic or hazardous waste

When does the 5% rule not apply?

-inter-company sales between pharmacies that are under common ownership -among hospitals or health care entities under common control

How long should records and invoices for controls be kept?

3 years

when can a pharmacist, intern, or certified tech administer lab tests?

-intern or tech are supervised by a pharmacist -the pharmacy is a terminal distributor and certified CLIA -the test does not need a provider order -pharmacist or intern can interpret the results if it relates to a patients drug therapy

What must the controlled substance inventory include?

-inventory date -time the inventory was taken (opening or closing) -drug name -drug strength -dosage form -number of units or volume -total quantity DEA recommends name, address, and DEA registration # of the registrant and signature of the person or persons responsible for taking the inventory

What must be on a faxed prescription to ensure that it is valid?

-it must be manually signed by the prescriber -if an "agent" of the physician is transmitting the faxed prescription, his/her full name must be included -it must have a header with location transmitted and date it was faxed -the original prescription at the physician's office will be placed in the patient's chart

Can a C-II be partially filled for a non terminally ill, non LTC facility patient?

-it must be requested by the patient or prescriber --the total quantity cannot exceed the original quantity -can be partial filled for 30 days from the date the rx was WRITTEN -information must be recorded on the back of the rx: --date dispensed --quantity dispensed --remaining quantity --the new prescription number if needed bc computer system will not let you refill a C-II --initials of the dispensing pharmacist

Rules regarding poisons

-keep records for 5 years -external use (labeled) preparations are not poisons -16 years old to buy a poison (written permission if less the 16) -poison record book: name of purchaser, address (purchaser), poison, quantity, dispenser RPh, and purpose

What insulin products are prescription only?

-lantus -novalog -humalog/admelog -levemir -apidra -afrezza -toujeo

Requirements of lapsed licenses?

-less than 3 years - pay 162.50 and prove CE is up to date -greater than 3 years - must retake the NAPLEX and MPJE exams and repeat criminal background check -EXCEPTION: if a pharmacist has continually prated pharmacy in another state under a license issued by that state, must pay fee and show proof of CE

What is a practitioner?

-licensed health care professional authorized to prescribe drugs

Who can donate drugs?

-licensed terminal distributor, wholesale distributor, or a person who was legally dispensed a dangerous drug pursuant to a patient specific order -a person donating may not have taken custody of the drug prior to the donation (even if they are unit doses) -a person can donate the rest of the meds in an institutional pharmacy but must sign a waiver -must remove pharmacy and patient info before dispensing

what medications can a pharmacist inject?

-long acting/extended release opioid antagonists initial and subsequent doses -long acting/extended release antipsychotic -hydroxyprogesterone caproate for pregnant women -medroxyprogesterone for nonpregnant women -cobalamin, cyancobalamin, tydroxycobalamin, or other fda approved B12 injections

What is the BUD of low, medium, and high risk compounds?

-low: 48 hours at room, 14 days in fridge, and 45 days frozen -med: 30 hours at room, 9 days in the fridge, and 45 days frozen -high: 24 hours at room, 3 days in fridge, and 45 days days frozen

What is the poison prevention act?

-making it difficult for child < 5 years old to open -required for all rx drugs except nitroglycerin and externally applied drugs -patient can request non child proof caps -legally you must ask each time -MD may request non child proof caps for their patient -reduce request into writing but still check periodically

Methods of positive ID for the pharmacist?

-manual signature on a hard copy record -a magnetic card reader -a bar code reader -a biometric method -a proximity badge reader -a board approved system of randomly generated personal questions -a printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who prescribed administered or dispensed the dangerous drugs

What is a wholesale sale?

-means any sale in while the purpose of the purchaser is to resell the article purchased or received

When can optometrists prescribe methylprednisolone?

-must be 18+ -is being used to treat allergies -is being prescribed on the basis of an individuals particular episode of illness -in an amount that does not exceed the amount packaged for a single course of therapy

Who is eligible for the drug repository program?

-must be a resident of Ohio AND -has no active third party prescription drug reimbursement coverage for the drug prescribed OR -is a patient of a non profit clinic

Rules required by a internet pharmacy site?

-must be licensed -must maintain accreditation as a VIPPS (verified internet pharmacy practice site) from NABP -Must provide the following information on their website: --full name and address under which they are licensed --name of the responsible pharmacist from terminal distributors license --phone # where they may be contacted during normal business hours --list of states where they can legally sell drugs --name, address, and how a drug law enforcement agency in each state may be contacted -any Ohio licensed pharmacy requesting personal information from the public by the internet must provide security and confidentiality

Course requirements to administer injections?

-must be offered by an ACPE provider. -must contain at least 1.5 hours of live or home study coursework for each 5 types of injections -30 minutes of live or home study must inches a review of sterile technique in injecting dosages preparations -one hour must be live and supervised physical participation in administration tech -if the course covers opioid antagonists, one hour of coursework reviewing the tests to be conducted and how to evaluate -must have a way to evaluate comprehension

Rules on counseling

-must be offered unless it could cause harm to the patient -if cannot offer pt or caregiver the offer has to be given in writing or by phone -leaflets and videos are not substitution for counseling -Technicians cannot counsel

rules prior to discontinuing business of a pharmacy

-must file a written notice with the board at least 30 days in advance of closing -must include: --name, address, and terminal distributor's number --name, address, and terminal distributors number or wholesaler number of who the drugs will be sold or transferred to --name and address of a secure location when all records will be kept and confidentially must be assured -on date of discontinuing business a complete control substance inventory must be done -pharmacy must return the terminal distributor's license for cancellation

What are the requirements to sell prescription drugs?

-must have a license and wholesaler must have a license -operating hours of the pharmacy department must be posted -no prescription pick up station

What are the requirement for optometrists to prescribe?

-must have a therapeutic pharm agent certificate to prescribe and must be related to the visual system of the body -can only prescribe --anti-infectives --anti-allergy drugs --antiglaucoma agents --analgesics that are not controlled --epi for emergency situations to counteract anaphylaxis --anti-inflammatory drugs except steroids

Rules regarding access to the pharmacy when it is closed

-must have written policies and procedures -policy of who has access and under what circumstances -must have a written record of names, times, what was taken, patient name, and MD name -must be filed within 24 hours and records kept for 3 years -two employees are needed to remove drug and one must be a health care professional authorized to administer drugs

Rules regarding controlled substance record keeping for floor stock

-must record quantities greater than a 72 hour supply -packaged in a tampon evidence unit dose package -secure location with limited access -proof of use sheet which includes: pts name, date and time of access, drug strength, quantity obtained, positive ID of the person doing the dispensing -at EVERY shift change a reconciliation must be conducted by both the arriving and leaving health care professional responsible for the security of the drugs in this area --physical count and reconciliation with proof of use sheet --inspection of packaging to ensure its integrity --persons doing the reconciliation --report any theft to director of pharmacy immediately

Rules regarding APNs prescribing controlled substances

-must register with the DEA and get their own DEA number -cannot use their collaborating physicians DEA -Their DEA number will start with M -the only place APNs cannot write C-IIs is APN owned/run clinics and convince care clinics

Rules of theft or loss of prescription drugs?

-must report immediately to DEA if their is theft or loss --DEA form 106 -must also report the theft to the board within 30 days -must report any theft or loss of prescription blanks and prescription documents immediately

What must be on a prescription label in an outpatient pharmacy?

-name and address of dispenser -directions -full name of patient -full name of prescriber -date of dispensing -cautions -Rx number -drug name and strength -quantity -if compounded, say so

What needs to be on an IV bag outpatient?

-name and address of the pharmacy and telephone number -full patient name -full name of the prescriber -directions and route of administration -date of dispensing -any cautions -name and volume of parental solution -name and amount of the drugs added -quantity of the drug dispensed if appropriate -expiration date -storage conditions

Required components of patient counseling?

-name and description of drug -dosage form, dose, strength, frequency, route of administration, and duration of use -use and expected action -directions for use -common side effects/adrs, interactions, and contraindications -techniques for self monitoring of drug therapy -storage and disposal requirements -refill information -what to do if a dose in missed

What must be submitted to the board to be a mail order pharmacy?

-name and license number of the responsible pharmacist and all other staff pharmacist -phone # for the responsible pharmacist to be reached -normal delivery time -any special packaging or procedures -procedure if the package is delayed or not available -process of a prescription for an acute illness -process to ensure therapy is not interrupted

What must an immunization protocol contain about each vaccine?

-name and strength -precautions and contraindications -intended audience or patient populations -appropriate dosage -appropriate administration schedules -appropriate routes of administration -appropriate injection sites

What needs to be on a label on an inpatient unit dose?

-name of drug -route of administration -strength -lot number and expiration date -manufacturer or repacker -special storage conditions

record keeping when compounding must include?

-name of the drugs, strength, and dosage form used -quantity of drugs added to each container -disposal of any unused drugs and amount during the process -lot numbers of the ingredients -generic manufacturer's name if a generic is used -date of compounding -expiration date -positive ID of the pharmacist

What must all inpatient orders contain?

-name of the patient -name, strength, and dosage form of the drug -directions for use -route of administration -date -prescriber's positive ID

What must the donor form include for the drug repository program?

-name of the person originally dispensing the drug -signature of the responsible person and date signed -brand name or generic name of the drug -manufacturer or NDC -strength -quantity donated -date drug was donated

what must be on the label by the prescriber for a sample?

-name of the prescriber -patient name -directions for use

What is required on an OTC label?

-name of the product -name and address of manufacturer or repacked -net contents of the package -est. name and amount of all active ingredients -name of any habit forming drug contained in preparation -cautions and warning needed for protection of the user -adequate directions for safe and effective use -number to call if side effects occur * if the above is not there it is considered misbranded and becomes a rx drug

what must anticipatory compounding contain?

-name, strength, and quantity of each drug used in the compounded prescription -identification of the repackager by name or by the final seven digits of its terminal distributor's license -pharmacy control number -pharmacy's expiration date or BUD -compounded drug product or similar statement

Rules regarding a prescription drop-off area

-new or refill prescriptions may be deposited into a secured area within the building where the pharmacy is located when a pharmacist is not on duty -only a pharmacist may have access to the area -operating hours of the prescription department must be posted

Rules regarding syringes

-no longer have to keep record for sale -no displays that are accessible (must be behind the counter) -can be advertised -can sell if you know they are for a legal purpose

Requirement of the pharmacist regarding weight loss controlled substances

-not responsible for documentation of total weight loss or pf maintenance of weight loss -if the person is clearly not 27 + risk factor or 30 BMI do not fill prescription -do not dispense any controlled substance for weight loss past 12 weeks except Qysmia and Belviq -in general no refills are allowed -no more than 7 days can lapse in therapy -Vyvanse may be used for binge eating disorder

What are the rules for having multiple drugs in the same container?

-number of drugs cannot exceed capacity of container -maximum of 31 day supply -regular outpatient label -expiration date of not more than 60 days -when one drug is discontinued, everything in the package is adulterated and may not be used

When can charitable pharmacies dispense samples?

-obtained from a manufacturer -samples provided by a prescriber must keep record of the transfer: name and address of the provider, name, strength, and quantity of the sample, date transferred, and name and address of the charitable pharmacy -records must be kept for 3 years -samples must be in the original packaging from the manufacturer and marked as a sample -stored in proper conditions -have a lot and expiration date

Who can participate in a consult agreement?

-only Ohio licensed pharmacists and physicians -NO PA's or nurse practitioners

Rules regarding prescription copies?

-only pharmacists can transfer controlled substances -can fax copies but must be able to ID pharmacists -unlimited amount of transfers for non controls but only one transfer for controls (III-V) --unless transferred between a shared database

What can be in a hospital self service kiosks?

-only rxs filled at the hospital pharmacy -no refrigerated or hazardous drugs in kiosks

When can a pharmacist dispense a sample?

-only those working at charitable pharmacies

Regulations for ordering C-IIs?

-order using a DEA 222 form -Top (Brown) - goes to supplier -Middle (Green) - goes to supplier (mails to DEA) -Last (blue) kept for files (Must keep for 2 years) -if the wholesaler does not have the product in stock they have 60 days to fill the order before a new form is needed -if you make a mistake you must void the whole form -if a physician wants a c-ii for office use the pharmacy must become the wholesaler and draw up an invoice for them -the supplier may void parts or all of the order by notifying the purchaser in writing. The supplier must indicate the voiding in copies 1 and 2 of the DEA form by drawing a line through the cancelled items and printing void in the space provided for the number of items shipped

Options for drug orders

-orders through an electronic record - must be sent from provider with positive ID -oral orders to the pharmacist -faxed orders

What information must be given for a transfer?

-original rx # -name and address of the pharmacy transferring the rx, and DEA if it is a controlled substance -date the rx was written -original # of refills -date of last refill -# of valid refills remaining -full name of the transferring pharmacist (and intern if applicable) pharmacist receiving must record the date of transfer pharmacist transferring must include in their database the date of transfer, name of the pharmacist (and intern if applicable) making the transfer, name and address of the pharmacy, DEA if controlled substance

What policy and procedure manual is required for central fill pharmacy?

-outline the responsibilities of each of the pharmacies -include list of name, addresses, telephone numbers, and all license/registration numbers of the pharmacies participating -includes all policies and procedures

what training is required by a technician?

-packaging and labeling -pharmacy terminology -basic drug information -basic calculations -quality control procedures -state and federal statues, rules, and regulations regarding pharmacy technician duties, intern duties, prescription drug order process procedures, drug record keeping requirements, patient confidentiality, security requirements, and storage requirements

schedule III controlled substances

-paregoric -APAP/codeine #2, #3, #4 -benzphetamine -buprenorphine -butabarbital -butalbital w/ aspirin (Fiorinal) -dihydrocodeine/APAP/caffeine -methaprylon -phendimetrazine -aspirin/codeine #2, #3, #4 -dronabinol (Marinol) -buprenorphine/naloxone (zubsolv, Suboxone) -ketamine -GHB sodium oxybate -perampanel (Fycompa -Sodium oxybate (Xyrem)

Requirement of partially filling a C-II for a terminally ill or nursing home pt?

-partial fill can only occur at the same pharmacy as the original rx was filled -the total quantity cannot exceed the original quantity -can be partial filled for 60 days from the date the rx was WRITTEN -information must be recorded on the back of the rx: --date dispensed --quantity dispensed --remaining quantity --the new prescription number if needed bc computer system will not let you refill a C-II --initials of the dispensing pharmacist

When can a C-II be faxed?

-patient is in a nursing home or LTC facility -patient in hospice -compounded sterile product for a narcotic substance *in this case the faxed copy is the original copy

What needs to be on an IV bag inpatient?

-patient name -name and amount of parental solution -name and amount of the drugs added -expiration date or beyond use date -name and address of the institution of pharmacy -cautionary statements, if required

rules regarding patient package inserts

-patient package inserts must be given with estrogen and oral contraceptives -given with new and refilled prescriptions -hospitals have to send up a patient package insert to the patient for these drugs the first time it is dispensed and every 30 days thereafter

What 3 things can never be changed on a C-II rx?

-patients name -prescribers signature -drug prescribed

When should a pharmacist recommend MTM services?

-performing or obtaining a patients health status assessment -developing a medication treatment plan for monitoring or evaluating a pts response to therapy -monitoring the safety and effectiveness of medication therapy -performing a medication review to identify, prevent, or resolve medication related problems -providing education and training to a patient or patient's agent on the use or administration of a medication -documenting the delivery of care, communications with health care providers, and other appropriate documentation -services to enhance adherence with drug regimens -integrating MTM with the overall health management plan for a pt -providing safe custody and security of all records and compliance with state and federal laws

What info is required to be reported to OARRS?

-pharm DEA -pharm's name address, and phone # -full pt name -pts residential address -pts phone # -pts DOB -gender -prescribers name and DEA -date the prescription was written -date of dispensing -indication of new or refill -number of refills dispensed -NDC -quantity dispensed -day supply -rx # -source of payment -pharms NPI -prescribers NPI -ICD-10 code -CDT code for dentists

definition of a preceptor

-pharmacist whose license is in good standing, of good moral character, and is qualified to direct the practical experience of an intern -a pharmacist can be a preceptor for an unlimited number of pharmacy interns but no more than 2 interns can be working with each pharmacist on duty -unless employed by a school of pharmacy a preceptor must have at least one year of practice experience as a licensed pharmacist

Rules regarding immunizations?

-pharmacists and interns can give immunizations recommended by the ACIP to individuals 13+ without a prescriptions -pharmacists and interns can give immunizations recommended by the ACIP to individuals 7-13 with a prescriptions -pharmacists and interns can give flu shots to individuals 7+ -cannot give allergy shots -each immunization must be added to the protocol -the supervising pharmacist must be immunization certified for an intern to give immunizations -must be able to document that he/she has the training criteria for immunizations -shingles vaccine can be given to 50+ -can administer recommended travel vaccines -for patients 18+ the pharmacy will notify their physician of the immunization within 30 days or the board of health if they do not have a provider (does not apply to flu)

What price information must be available for those that ask?

-pharmacists must disclose price information for all drugs EXCEPT those schedule II drugs

How much medication can be given to the pt?

-the amount of drug cannot exceed a 72 hour supply -if the pt is on a consistent drug therapy the amount of drug cannot exceed a 30 day supply or the smallest standard unit. Only on non controlled rxs and only once in a 12 month period

What conditions must be met for a pharmacist to be able to dispense a dangerous drug other than a CII without a written or oral prescription from a licensed health care professional authorized to prescribe drugs?

-pharmacy has a record of a prescription for the drug in the name of the patient who is requesting it and the prescription has no refills or the refills have expired (they have to have record of the rx but this does not mean that pharmacy has specifically filled the rx before, could use a database or PMR) -R. Ph is unable to contact the prescriber for refill authorization -in the pharmacist's judgment, the drug is essential to sustain life, continues therapy for a chronic condition, or failure to dispense the drug could result in harm to the health of the patient

What are the requirements for a pharmacy to operate?

-pharmacy must have pharmacist in charge -only pharmacists may have the keys to the pharmacy -no false advertising or misleading signs -counseling can be done by the intern or pharmacist

What is a terminal distributor?

-pharmacy that dispenses drugs at a retail price -this includes laboratories

define originating pharmacy

-pharmacy that uses a central fill pharmacy to fill or refill a prescription

Rules regarding prescribing a controlled substance for weight loss

-physicians can prescribe a 30 day supply of a controlled substance for weight reduction -C-IIs cannot be prescribed for weight reduction -can prescribe for 12 weeks -a pt may restart a weight reduction program with a controlled substance 6 months after the last day a short term controlled substance was taken for weight reduction

Rules of a prescription for a hospice patient?

-preprinted prescription forms can containing as many rxs as they want -additional rxs can be added -preprinted rxs can be controls but not C-IIs -C-IIs can be added if prescriber signs -prescriber should indicate the amount of rxs on the form by manually writing the number or initialing each drug -all written rxs must be signed -can be faxed -agent can send verbal orders except C-IIs

Rules regarding e-prescriptions

-prescriber or agent must write full name on rx -if controls are sent the software should be approved through the DEA -DAW doesn't have to be handwritten -does not need to be signed -cannot be sent from computer to fax -if the transmission fails the pharmacy must make sure the rx has not been filled when receiving the hard copy

What is a serial number?

-prescription number

How is not required to be licensed as a pharmacy tech?

-pricing -cashiering -drug purchasing -delivering and scheduling delivers -answering non-professional phone inquires -transporting medications within a hospital -documenting and processing third party billing information -drug inventories -transporting drugs from loading dock or warehouse to other areas -stocking or retrieving from inventory non-controlled substances that are not dispensed by the pharmacy -support personnel may retrieve patient records to perform clerical duties related to the practice of pharmacy but cannot enter prescriptions

labeling of a compounded product for a vet

-proper storage requirements -BUD -name of active and inactive ingredient -amount or percentage of active drug ingredient -quantity -route of administration -pharmacy name, address, phone #, and control # -statement compounded drug product (this can be done by an auxiliary label)

Checklist for pharmacists for thalidomide

-register your pharmacy with the manufacturer Celgene -collect and file patient consent forms -register the patient via phone or fax during the first dispensing -28 day supply max with no refills -do not dispense any further medication if the pt has a 7 day supply or greater remaining from the old rx -verify pt registration before filling each prescription

What is required in a prospective DUR?

-review for over or under utilization -therapeutic duplications -drug disease state contraindications -drug drug interactions -incorrect drug dose -drug allergy interaction -abuse/misuse -inappropriate duration of treatment -food/nutritional supplements-drug interactions

what must be counseled to pt to receive naloxone?

-risk factors for overdose -strategies to prevent overdose -signs of overdose -steps in responding to overdose -information on naloxone -procedures for administering naloxone -proper storage and expiration -information on where to obtain a referral for substance abuse treatment

Professional duties of an intern?

-sale of schedule V control substances -the receipt of oral prescriptions -the transfer of a prescription copy -pt counseling -give immunizations to 13+ without a prescription, 7 with a prescription, or 7+ for flu

What drugs should be reported to OARRS?

-schedule II-V (V written on a prescription or sold to a prescriber at wholesale) -gabapentin -medical marijuana from an Ohio dispensary within 5 minutes of a sale (this does not impact their NARX score) -naltrexone products (except Contrave)

rules for plan B oral contraceptive

-sold as an OTC or with an rx -does not need to be behind the counter can be anywhere in the store

who can you dispense naloxone to?

-someone at risk of opioid overdose -a family member or friend of someone at risk of opioid overdose

Labeling requirements for in office compounds

-statement "for direct patient administration only" -statement "not for resale" -storage requirements -BUD -name of active and inactive ingredient -amount or percentage of active drug ingredient -quantity -route of administration -pharmacy name, address, phone #, and control #

if a pharmacy wants to store records off site what must be on the request form to the board?

-terminal distributor number of the pharmacy -license number of the alternative location -name and address of the alternative location -the time frame of the records to be moved off site

What should be done if a pharmacist is no longer authorized to prescribe controlled substances per the consult agreement?

-the Board must be notified within 5 business days

What must be included on the written consult agreement?

-the diagnoses and disease being managed under the consult agreement including whether each disease is primary or comorbid -a description of the drugs or drug categories the agreement involves -a description of the procedures, decision criteria, and plan the pharmacist is to follow in acting under the consult agreement -a description of the how the pharmacist is to comply with the records of each action taken and at what regular intervals this will take place

When may a physician administer, prescribe, or dispense a controlled substance III-V for maintenance and detox if?

-the drug must be FDA approved for this use -cannot be methadone (this can only be given if the prescriber is a DEA registered treatment provider) -must have a special registration # from the DEA

treatment guidelines must meet the following requirements in order to be approved by the board?

-the drug shall only be administer by an individual legally authorized to administer drugs listed on the treatment guideline -the prescriber must make a compete assessment and diagnosis of the pt prior to ordering a set of treatment guidelines

When can a sterile compound be made for non-patient specific patient?

-the entity is registered with FDA 503B -the entity is licensed by the Ohio board as wholesaler with an outsourcing classification --must have a responsible pharmacist listed -submit your FDA registration as an outsourcing facility -the outsourcing facility must comply with the labeling and record keeping requirements under section 503B -if dispensing patient specific drugs it must have a terminal distributors license

An entity may provide, without a patient specific prescription, a non-patient specific sterile compound drug preparation if the following...

-the entity is registered with the FDA as an outsourcing facility under section 503B and comply with labeling and record keeping -the entity is licensed as a wholesaler by the board and have a responsible pharmacist -if dispensing patient specific must have a terminal distributors license

What must be on a compounded product made in advance?

-the name, strength, and quantity of each drug used in the compounded prescription -the identification of the repackager by name or by the final six digits of its terminal distributor of dangerous drugs license number -pharmacy control number -the pharmacy's expiration date or beyond use date -"compounded drug product"

How does the pharmacist fill an emergency fill?

-the pharmacist must create a new rx and document it as an emergency fill -for 1 years after the sale the pharmacist must keep record of: --the name and address of the pt --name and address of the individual receiving the drug (if different than pt) --amount dispensed --original rx number

Rules regarding seeing pts on Qsymia and Belviq

-the physician must meet face to face for the initial visit and least every 30 days for 3 months of treatment -after 12 weeks the physician may authorize refills for the controlled substance 5 times within a six month period

When can an rx be left on the voicemail?

-the prescriber or agent must provide his/her complete name -the pharmacist must reduce to writing right away -the pharmacist must assure validity

Rules regarding oral emergency opioid rxs?

-the quantity prescribed and dispensed should be enough for only the emergency period -the pharmacist should write down the oral rx and verify with prescriber -the pharmacist must receive the written prescription from the prescriber within 7 days can be written or e-scripted -attach the two rxs and write authorization for emergency dispensing on it -the pharmacist should notify the DEA if not received in 7 days

An electronic order for controlled substances may not be filled if any of the following occur...

-the required data field have not been completed -the order is not signed using a digital certificate issued by DEA -the digital certificate used has expired or been revoked prior to signature -the purchasers public key will not validate the digital certificate -the validation of the order shows that the order is invalid for any reason if it is not accepted the supplier must let the purchaser know and provide a reason

Responsibility of the pharmacist regarding accutane

-the responsible site pharmacist must register and activate the pharmacy in the iPLEDGE system -the dispensing pharmacist must get authorization and risk management authorization (RMA) number before filling and dispensing prescription -upon receiving authorization, the dispensing pharmacist can fill a prescription for a max of 30 day supply

What needs to be done if a pharmacist wants to be authorized to prescribe a non controlled substances as per a consult agreement?

-the rx should include the required info of the consulted physician -Phone # where the pharmacists can be reached -positive id (including manual signature) on the prescription of the pharmacist

Rules regarding DEA suffixes used by a hospital

-the suffix should be a combination of numbers preceded by a hyphen after the hospitals DEA number -all hospitals are required to submit internal codes electronically to the board. Changes must be communicated within 5 business days

What does it mean to refuse to grant or renew a license?

-to deny original or continued licensure for a period of at least 24 months

When should the pharmacist review OARRS if prescribing a controlled substance?

-when adding a controlled substance -adjusting a controlled substance (i.e. changing strength, dose, dosage form, route, or frequency)

How many patients can a prescriber with a special registration # see?

-while waiting for their DEA clearence they can see 1 pt -once they receive their clearance they can see up to 30 pt for the first year -then they can see 100 pts -if the prescriber wants after 2 years (or 1 years with the 100 pt) they can ask for a waiver to see up to 275 pts

pharmacies and wholesalers must also report, what data is needed?

-wholesaler # of pharmacy DEA number -purchasers DEA number -NDC number of drug sold -quantity -date -invoice # of transaction number

What must the pharmacist do to a controlled prescription if it is transferred out?

-write the word void on the original rx -write the date of the transfer -his or her signature -name, address, and DEA of the pharmacy where the prescription was transferred

Can technicians compound?

-yes but the rph must inspect and approve the final check -must wear clean clothes and protective apparel -no counseling -pharmacist is totally responsible for the process -only certified techs can compound sterile compounds

Can APNs provide samples?

-yes for non controlled drugs -must be on the master formulary -limited to a 72 hour supply or less

can a pharmacy compound if there is a drug shortage?

-yes the pharmacy must request an exemption from the board -the request must be made by the medical director and the responsible pharmacist -should only be for direct administration of its own patients -the board may place restrictions: a limit to the quantity and limit of the time the exemption is in effect

How long does the pharmacy have to get rid of outdated drugs and how long does the wholesaler?

1 year at the pharmacy level - should be kept in a separate area of the pharmacy which prohibits access by unauthorized people 2 years for wholesalers

Can drugs be removed from a terminal distributor?

1) a licensed health professional authorized to prescribe may temp remove drug from the terminal distributor to treat current or prospective patients - must be returned within 24 hours 2) a person authorized to furnish or dispense naloxone must return in it within 24 hours 3) a licensed health professional may temp remove non-controlled drug or immunizations from the terminal distributor to treat current or prospective patients - must be returned within 24 hours

how many interns engaged in MTM with a pharmacist is?

2

How soon must you compete an inventory for a new controlled substance?

10 days this is if the medication becomes a control or if it moves to a higher class

What CE is required for registered techs?

10 hours every 2 years, 2 hours of pharmacy law and 2 of med safety

Any USP chapter under ____ is considered federally enforceable

1000

Parts of a prescription?

1. date issued 2. name, professional title, and address of the prescriber 3. telephone number where proscriber can be reached 4. full name and residential address of patient 5. drug name and strength 6. quantity 7. appropriate and explicit directions 8. number of times or period of time for refills 9. trade name or generic name 10. DEA number if a controlled substance 11. ICD-10 code for all controlled substances and gabapentin 12. day supply for controlled substances and gabapentin

ACPE program number codes?

1. disease state management/drug therapy 2. AIDS therapy 3. Law 4. General pharmacy 5. patient safety 6. immunizations 7. compounding, sterile and non sterile

Define pharmacy practice

1. managing drug therapy 2.dispensing and compounding drugs 3. dispensing devices 4. counseling pts 5. review of drug regiments 6. review of drug utilization 7. drug therapy advice

What 2/3 factor ID is required by physicians to send controlled substances?

1. something they know (password) 2. something they have (token) 3. something they are (biometric: thumb-print scan)

The law requires an opioid analgesic prescription be filled _____ of the date written on the prescription

14 days

How long is a consult agreement good for?

2 years

What is the correct temp of a refrigerated product?

2-8 degrees C

How long must invoices for controlled substances be kept?

3 years -Keep III-V in one file and IIs in another

How long should inventory records be kept?

3 years do not send to DEA but have record

Max MED for acute pain?

30/day

How many pharmacy tech trainees can a pharmacist supervise?

3 at one time

How to store rxs and invoices?

3 separate rx files: non controls, III-Vs, and IIs invoices of III-V should be together and Its together

How long must MTM records be kept?

3 years

How long must pharmacists maintain record of each action taken for each patient under a consult agreement with positive identification?

3 years

How many non controls can be on 1 rx?

3 no controlled with a non control and no more than 1 controlled medication per rx

How long must record of destruction be kept?

3 years

How many attempts do you have to pass the NAPLEX and MPJE?

5

How far in advanced can drugs be compounded based on routine, regularly observed dispensing patterns?

30 days

how many days do techs have to report name, address, or employment change?

30 days

how many days do you have to let the board know of the changes you have made since their visit?

30 days

how many days do you have to fill a partially filled C-II?

30 days from the date written

how soon to you have to let the board know you are dispensing naloxone and how long once you are no longer dispensing?

30 days, 30 days

How much pseudoephedrine can a person purchase in 30 days?

3.6 grams per day 9 grams per month

How long does the pharmacy have to notify the provider if a change of biological product is made?

5 business days

how long does a wholesaler have to report a suspicious order?

5 days if there were no suspicious orders that month on the 15th they must report a zero report on the 15th

How long do you have to fill C-IIs other than opioids?

6 months

Max day supplies of opioid for acute pain?

7 days for adults and 5 days for minors

What is the MED threshold in OH?

80 MEDs

The law prohibits the dispensing of more than a ____ supply of an opioid analgesic

90 day

how long must kiosks video cameras keep their records?

90 days

what drugs are prohibited to be sold directly to the patient, patient's representative, or patient's private residence?

ALL criteria must be met -indicated for the treatment of cancer or cancer related illnesses -must be administered IV or by subq -cannot seasonally be self administer by the patient or an individual assisting the patient with self administration -does not apply if the pt is in a nursing home or long term care facility or hospice

define sterile

Absence of all living microorganisms including spores

What is the purple book?

Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

What is the Orange Book?

FDA publication of approved drug products with therapeutic evaluations.

Definition of obesity

BMI > 30 or BMI > 27 with an existing comorbid factor such as diabetes, heart disease, etc.

What must be on the label if the drug is compounded?

Compounded drug product or similar statement -not necessary for non sterile compounds that require reconstitution -doesnt apply to inpatient rxs -auxiliary labels do not meet the legal requirement

Definition of adulterated

Contains any poisonous or deleterious substance which may render it injurious to users when used as directed -includes out of date drugs and anything that effects the actual medication

How do you order C-II?

DEA 222

define registry number

DEA number

DEA form 224a

DEA re-registration form

What must prescribers add to a controlled prescription?

ICD-10 code or CDT for dentists

Define IND

Investigational New Drug

DEA form 225

License to manufacture controlled substances

Define NDC

National Drug Code. if a drug has an NDC that does not mean it has been approved

Define NDA

New Drug Application

1911 Shirley Amendments

Prohibited false and misleading claims for drug products

1906 Pure Food and Drug Act

Prohibits the sale and transport of adulterated or mislabeled food, drinks and drugs. Prohibits the mislabeling and misbranding of products.

1983 Orphan Drug Act

Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases. diseases with < 200,000 pts in the US or diseases with >200,000 pts but the cost of development will never be repaid

Prescription Drug Marketing Act of 1984

Regulated samples, cannot re-import drugs from other countries, regulates who hospitals can sell to

When is the intern or pharmacist renewal day?

September 15th

Define ANDA

The abbreviated new drug application -contains data that allow the review and ultimate approval of a generic drug product

1951 Durham-Humphrey Amendment

This act distinguishes legend drugs(prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs "Caution:Federal law prohibits dispensing without a prescrition", requires physician supervision for the purchase of legend drugs. Also, over the counter drugs without medical supervision are required to have on the label: Product Name, Name and Address of manufacturer, Active ingredients, quantities of all other ingredients whether active or not

What is USP 795?

USP has developed uniform standards for Nonsterile Compounding to enhance patient safety and to protect pharmacists. This chapter includes categories of compounding (simple, moderate, and complex), definitions of terms (beyond use dates, hazardous drugs, stability, etc.), and criteria for compounding each drug preparation

equation for MED

[(strength of drug) * (conversion factor) * (quantity)] / day supply then add together with other drugs with day supply left

define non-retrievable

a condition or state to which a controlled substance is permanently altered the physician or chemical condition irreversibly

Define Opioid Analgesics

a controlled substance that has analgesic pharmacologic activity at the opioid receptor of the CNS and includes drugs and their salt forms and chemical congeners

define MTM

a distinct group of services intended to optimize therapeutic outcomes of a pt. MTM can be an independent service provided by a pharmacist or can be in conjunction with dispensing with the objectives of any of the following: --enhancing appropriate medication use --improving medication adherence --increasing detection of ADRs --improving collaboration between prescriber and pharmacist --improving outcomes

define outsourcing facility

a facility located at one geographic location that is engaged in anticipatory compounding of sterile drugs and complies with FDA section 503B of the FDC act

what classification is needed to provide MTM?

a limited category II license with an MTM classification

Define prescriber

a person authorized by the ORC to prescribe dangerous drugs as part of their professional practice or a pharmacist authorized to manage drug therapy pursuant to a consult agreement but only if authorized in the agreement and only to the extent specified in the consult agreement

What is corresponding responsibility?

a pharmacist has a responsibility (as well as the physician) for the prescriptions they fill that this rx was for a legitimate medical purpose

Define pharmacist responsibility

a pharmacist is ultimately responsible for every prescription dispensed by a pharmacy. It is up to the pharmacist to conduct the final check for accuracy and DUR on every prescription dispensed

rules regarding diabetic shoe fittings?

a pharmacist or intern can fit someone for diabetic shoes and inserts it is recommended to receive intrusion before doing

Define nonresident pharmacy

a pharmacy outside of OH is prohibited from shipping compounded drugs into OH unless it is in the pursuant to a patient specific prescription. it must obtain licensure as a non resident terminal distributor. if a nonresident pharmacy wants to ship patient specific compounds into OH, it must have some type of inspection report that is less than 2 years old

What is a charitable pharmacy?

a pharmacy that has a terminal distributors license, is exempt from federal taxation, is not a hospital

define fluid therapy pharmacy

a pharmacy where the primary purpose is to compound and dispense parenteral compounded sterile product prescriptions

What security must the pharmacy have?

a physical barrier or alarm system approved by the board

define institutional facility

a place where medical care is provided on site and a medical record documenting episodes of care, including medication orders and administered is maintained i.e. hospital, convalescent homes, developmental facilities, long-term care facilities, nursing homes, psychiatric facilities, rehab facilities, developmental disability, facilities, level III sub acute detox facility, state or local correctional facility

define sample

a prescription drug that has been placed in a container marked as a sample by a manufacturer. samples may only be provide to and furnished by a prescriber

define verified pharmacy program

a program operated by the NABP that conducts inspections of pharmacies

who can accept new written, faxed, or e-scripts?

all

who can count and pour drugs into containers?

all

who can enter information in a patients profile?

all

who can non sterile compound?

all

who can package and sell drugs to a pt?

all

who can place drugs into containers prior to dispensing?

all

who can prepare and affix labels?

all

who can send or receive e-scripts between pharmacies accessing the same prescription record in a centralized database or linked computer system?

all

who can stock and retrieve drugs from inventory?

all

What medications must have exact counts?

all C-II and any C-III-V with more than 1000 package size

What drugs are eligible to be donated?

all dangerous drugs except controls and samples may be donated but must: -be in their original seal -been in possession of a licensed healthcare provider -must have an expiration date of 6 months or greater -must have a lot and expiration date

Define abandoned application

an application for any license with the Board of Pharmacy is considered abandoned if the application fails to complete all application components within 30 days after being notified by the board of an incomplete application *a terminal distributor or wholesaler has 90 days to demonstrate compliance of all laws once a complete application is submitted

What is a drug?

an article USP recognized for use in diagnosis, cure, treatment, or prevention of disease in man or animals, Also, any article, other than food, intended to affect the structure or any function of the body of humans or animals

Define pharmacy

any area or room where prescriptions are filled or where drugs dangerous drugs, or poisons are compounded, sold, offered, or dispensed

What is a drug of abuse?

any dangerous drug

Define guidance

best practice not a law, although the FDA can take action based on its guidance

What and who are limited practitioners?

can only write rxs within their scope of practice vets, optometrists, dentists, and podiatrists

What is section 503A of the federal food drug and cosmetic act?

conditions that must be satisfied for drug products compounded by a pharmacist or physician to be exempt from cGMP

define poison

deleterious to adult life in quantities of 4 grams or less

define cytotoxic

drug shown to be carcinogenic or mutagenic to humans through active or passive exposure

When do drugs expire?

drugs expire at the end of the month i.e. if that label says 1/19 it expired 1/31/19 at that time it has lost 10% of potency

What can anabolic steroids, growth hormones, HCG, or other hormones not be used for?

enhance athletic ability anabolic steroids are schedule III drugs

What is USP 797?

first set of enforceable sterile compounding standards issued by USP. Describes the conditions and practices to prevent harm from microbial contamination, excessive bacterial endotoxins, variability in intended strength of the preparation, unintended chemical and physical contaminants, and ingredients of inappropriate quantity

How many refills for schedule III-IV?

five refills or 6 months

define law enforcement agency

gov entity that employs peace officers to perform law enforcement duties

Doctors can write for who and vets can write for who?

humans, animals

when can a drug be transferred from pharmacy to pharmacy without a wholesalers license?

if it a pharmacy owned by the same company or same individual (that counts for hospitals)

How long is can someone give consent for to see their patient record?

if written consent until the consent is rescinded

Define poppy straw

includes all parts of the poppy plant except seeds

Who must provide positive identification on a phoned in rx or transferred rx?

intern and pharmacist

what CE is required for certified techs?

maintain license, the requirements are specific for CPT

can C-II prescriptions be refilled?

no - no refills on C-II prescriptions

Are there any restriction to mailing rxs?

no anything can be mailed included controlled substances -it should be packaged in something that does not indicate the package is a rx

Does the patient have to pick the rx up within 14 days of date written?

no but it must be filled

if the pharmacist is immunization certified are they exempt from training?

no but they may have different requirements

Can an intern transfer controlled medications?

no only non controlled

who can contact prescribers or agents to obtain clarification for a prescription as long as the clarification does not require professional judgement?

only certified

who can send/receive prescription transfers for non controlled substances?

only certified

who can stock automated dispensing cabinets, crash carts, or floor stock?

only certified

who can accept new verbal rxs for non controls?

only certified

Where can hospital self service kiosks be and who can use them?

on hospital campus and must be located in the immediate proximity of the pharmacy where only hospital employees can access. there must be a barrier to detect unauthorized entry for hospital employees and their families only

If a physician dies, retires, becomes disabled, or stops practicing, how long are the prescriptions this doctor has written valid for?

one more refill

how long is registration as a pharmacy trainee last?

one year

How many refills for schedule V?

one years

define ultimate user

person who has lawfully obtained and who possess a pharmaceutical drug for their own use or for the use of a member of their household or their animal

define personal supervision

pharmacist must be in the prescription department in full and actual charge

Who can stock the kiosk?

pharmacist, intern, tech

define a central fill pharmacy

pharmacy or central filling operation licensed as a terminal distributor of dangerous drugs acting as an agent or or under contract with an originating pharmacy to fill or refill a prescription. A central fill pharmacy may also be the originating pharmacy

What must be presented to buy Sudafed?

photo ID to verify identity and age 18+

define parenteral

piercing mucous membranes or the skin barrier through more than one layer of skin. must be a sterile compound

What is required if electronically prescribing in an inpatient facility?

positive identification of a licensed health care professional

What is compounding?

preparing, mixing, assembly, packaging, and labeling of one or more drugs -for a prescription issued by a provider -for modification of a rx made in accordance with a consult agreement -for research, teaching activities, or chemical analysis -for anticipatory compounding -for request made by a prescriber for a drug that is to be used for direct administration

1938 Federal Food, Drug, and Cosmetic Act

prevented new drugs from being marketed before being properly tested for safety

define mail back program

program operated by an authorized collector or law enforcement agency to accept prescriptions to collect expired and unused medications -can collect OTC, prescription, and controlled medications

Which DUR is required?

prospective is required at the time of prescription dispense retrospective is optional

How often should this data be uploaded and for how long?

reported daily and is in the database for 2 years

define authorized collectors

registered manufacturers, distributors, reverse distributors, narcotic treatment program, hospital/clinic with an onsite pharmacy, or retail pharmacy that is authorized to destroy controlled substances

who can accept verbal refill authorizations for non controls substances as long as there is no change from the original rx?

registered or certified

DEA Form 106

report of theft or loss of controlled substances

what rxs must be immediately retrievable?

rxs from the past 12 months

what must be on an inpatient at bedside prescription?

same as the outpatient label if patient is self medicating at their bedside

explain a drugs schedule

schedule I: has no medicinal use and cannot be prescribed schedule II: high potential for abuse and severe psychological or physical dependence schedule III: moderate potential for abuse and high psychological dependence. or moderate to low physical dependence schedule IV: lower potential for abuse and limited psychological or physical dependence

1962 Harris-Kefauver Amendment

scientific proof of efficacy DESI drugs - drugs marketed between 1938-1962 were studied to determine their effectiveness, classified as either effective, probably effective, possibly effective, ineffective

define drug collection receptacle

secured, lined receptacle into which rxs can be deposited to collect expired and unused medications -can collect OTC, prescription, and controlled medications

define dispense

sell, leave with, dispose of, change, barter, give away, or deliver

when does a certified pharmacy tech's registration expire?

sept 30th on even number years

What does shall and should mean in terms of laws?

shall - it is required should - strongly recommended

define beyond use date

the date or time after which a compound drug product shall not be administered, stored, or transported. the date is determined from the date and time the preparation is compounded

Define dispense

the final association of a drug with a particular patient pursuant to a prescription, drug order, or other lawful order of a prescriber. It also means the professional judgement and responsibility for interpreting, labeling, preparing, compounding, and packaging a specific drug

How can a pharmacy send outdated C-II to a reverse distributor?

the reverse distributor must issue a DEA 222 form or electronic equivalent Then the pharmacy becomes the wholesaler but the reverse distributor is in charge of destruction an d filling out the DEA 41 form

If copayments or deductibles are waived who is at fault?

the terminal distributor not the individual pharmacist

define access to drug stock

this includes not only physical access but also influence over the handling of prescription drugs including purchases, inventories, issuance of medical orders, etc. it does not include maintenance, janitorial, IT, or other staff that may need limited, supervised access

Define emergency drug

those drugs required to meet immediate needs to save or sustain live in an emergency (crash cart)

T/F a licensed wholesaler or terminal distributor of dangerous drugs cannot sell compounded drugs or drugs used for the purpose of compounding to a business unless that business is a licensed terminal distributor

true

T/F a practitioner can request the drug name be omitted from the label

true

T/F an APN must have a certificate to prescribe to prescribe medication

true

T/F anything accompanied with a therapeutic claim is a drug

true

T/F attorney general decides the schedule of drugs

true

T/F board of nursing requires APNs to write Rx after their license number if they can write rxs

true

T/F compounding should only be done for patient specific orders

true

T/F if a C-II is faxed to "get a rx ready" the pharmacist may not dispense the prescription until they receive the original copy

true

T/F if prescription is not on tamper resistant paper medicaid has right not to reimburse medication

true

T/F physicians dispensed meds have to report to OARRS

true

T/F records of controls received, administered, dispensed, sold, or used must be backed up daily if on computer

true

T/F standing order and protocol are equivalent

true

T/F state law regulates single ingredient pseudoephedrine but federally regulates any product with pseudoephedrine

true

T/F the faxed prescription must contain header information identifying the origin of the fax

true

T/F the full name of the agent calling in the control is required

true

T/F under the controlled substance act each action: dispensing, wholesaling, repackaging, manufacturing requires separate DEA registration

true

t/f MTM can be provided by a pharmacist or intern

true

t/f a criminal background check is required in the past 24 months for licensure

true

t/f a pharmacist can run naloxone under insurance and make a prescription for record keeping

true

t/f a toll free number must be on the kiosk for patient counseling

true

t/f all technicians must be registered with the state board of pharmacy

true

t/f pharmacist shipping out of Ohio are exempt from the opioid laws

true

t/f prescriber is required to write a day supply

true

t/f the pharmacy where the drug is dispensed does not have to be the pharmacy where is it administered

true

T/F PAs have a formulary

true 1. drugs they can prescribe 2. drugs they cannot prescribe 3. the physician must start therapy but PAs can continue

T/F all rx drugs must be dispensed with the FDA toll free number to report side effects

true can be preprinted on the rx vial cap on a separate piece of paper in consumer medication info or leaflets in an FDA approved MedGuide a stick on the vial or container

t/f both registered and certified technicians must be 18 years old and have a high school or GED diploma

true (registered are grandfathered in prior to 2009)

T/F optometrists can only prescribe controlled substances with codeine or hydrocodone for a max of 4 days

true and must contain a non-narcotic active ingredient -60mg of codeine max -7.5mg of hydrocodone max

t/f you do not need a rx to administer if this is under a consult agreement

true but can only use the physicians under the consult agreement

T/F records of inventory can be kept at another location

true but have to notify the board...if don't hear for 60 days than it is approved

t/f the pharmacist can maintain a multi dose vial for the pt

true but the medication is the pts so they may ask for the medication back

T/F interns can register as delegates of the pharmacist

true but this must be a paid internship not an IPPE/APPE

T/F preprinted controls with only one drug listed are legal

true cannot have more than one option

T/F for Ohio medicaid claims APNs do not have their own provider number

true use a generic number for now

Who is required to report suspicious ordering to the board?

wholesalers, virtual wholesalers, manufacturers, and outsourcing facilities

What is needed to prescribe an opioid to a minor?

written consent unless: --it is a medical emergency --during a surgery --filing out consent would be harmful to the patient --is occurring in a hospital or healthcare setting --is a compound

What is a prescription?

written, oral, fax, or electronic (if board approved) --pharmacies are no longer required to print out electronic prescriptions but still must be maintained for 3 years

acceptable forms of a schedule III-Vs?

written, oral, faxed, electronic

Are nurses at LTC facilities agents for docs for controls III-V?

yes

Can the prescriber write do not fill until on the rx?

yes and the 14 days will start from then, he can do this for up to 90 days after date written

t/f techs can compound

yes but need site specific training and training of USP 795 and 797

Is is allowed for a pharmacist to be temporarily gone from the pharmacy and it still remain open?

yes but no dispensing may occur during that time period -the techs can continue working but everything that needs a pharmacist final check cannot leave the pharmacy until the pharmacist has returned -policies and procedures regarding what may occur when a pharmacist is temporarily gone must exist

Can C-IIs be ordered online?

yes through CSOS, these records must be maintained for 2 years this is optional

pharmacy out of stock of a C-II?

you have 72 hours to fill it