Kansas MPJE

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Federal Register

Updated daily, this publication is made up of notifications from federal agencies, many of which pertain to new regulations

used by FDA for identification purposes, does not indicate approval status

NDC

Number of days a physician may administer a single day supply of methadone to a patient waiting for admission into narcotic treatment program

Number of days allowed to complete a partial fill for a C2 prescription for a patient residing in a LTCF

Number of days maximum supply that may be prescribed and dispensed on multiple C2 prescriptions with the same day of issuance

Number of days pharmacist has to obtain the original prescription from a physician for an emergency C2 script

Number of days prior to a proposed transfer a registrant must notify the DEA prior to transferring to another registrant

Number of days to complete a partial fill on a C2 prescription for a patient diagnosed as terminally ill

Number of days within which a Kansas-licensed pharmacist must notify the Board of Pharmacy of any change of address

Number of days within which a PIC must notify the board of ceasing to serve as PIC

Number of different OTC drugs maximum that may be offered for sale through a vending machine

Number of doses of codeine containing cough syrup that can be sold in 48 hours

No Limit

Number of doses, maximum, of C2 drug that may be prescribed and dispensed off of a single written C2 script

Number of doses, maximum, of C2 drug that may be prescribed and dispensed off of an emergency C2 script

approval to market a generic

Abbreviated New Drug Application (ANDA)

Requires child-resistant packaging and NO patient-package insert

Child Resistant &/or Patient Package Insert? potassium chloride liquid 10%, 16 oz

e. adequate directions for safe and effective use; cautions and warnings needed for the protection of the user; net contents of the package; name and address of the manufacturer, packer, or distributor

6. The label on the container of an OTC drug intended for sale directly to a patient must include: a. adequate directions for safe and effective use. b. cautions and warnings needed for the protection of the user. c. net contents of the package d. name and address of the manufacturer, packer, or distributor e. all of the above f. only a, b and c

a. The "brick and mortar" pharmacy

A "brick and mortar" pharmacy operates an Internet site that provides advertising for pharmacy services, provides some patient educational material, and accepts non-controlled prescription and OTC orders. Orders received from the Internet site are dispensed from inventory located in the physical pharmacy. Which of the entities must be registered with the DEA? a. The "brick and mortar" pharmacy b. The Internet site c. a and b d. Neither a nor b

d. one year from the date of issuance

A patient requests a refill of his prescription for diphenoxylate 2.5mg/Atropine sulfate 0.025mg. What are the limitations for refilling this prescription (with appropriate authorization) in Kansas? a. no refills permitted b. maximum of 5 refills c. maximum of 5 refills or 6 months, whichever comes first d. one year from the date of issuance

c. analgesic purposes.

A pharmacist can fill a prescription for methadone for what medical reason? a. maintenance of a patient's addiction. b. detoxification of an addicted patient. c. analgesic purposes. d. a and c

85% ; 30 days

A pharmacist in charge in Kansas must successfully pass the PIC exam with a score of at least ____% within ___ days of the change in the pharmacy registration at the location.

e. I. Power of Attorney II. Most recent controlled substance inventory III. State pharmacy registration

A pharmacist must send a copy of each of the following documents to the regional DEA office EXCEPT: I. Power of Attorney II. Most recent controlled substance inventory III. State pharmacy registration a. I only b. III only c. I and II only d. II and III only e. I, II and III

d. view this a marketing a new drug without an approved NDA; view you as a manufacturer.

A physician develops a product to relieve oral discomfort in cancer patients. He has a number of colleagues who are interested in using the product and asks you to compound it so that he may ship it to his colleagues in other states. He will supply you with a prescription marked "For Office Use" for a very large quantity of the preparation. The FDA would likely: a. view this a marketing a new drug without an approved NDA. b. view you as a manufacturer. c. consider your activities as being within the normal course of pharmacy practice. d. Both a and b

e. I. May directly administer a prescription drug. II. May prescribe a C-II drug by oral or telephonic communication in an emergency. III. May prescribe a C-III, C-IV, or C-V drug in writing.

A physician's assistant may legally perform which of the following activities under written protocol with a responsible physician? I. May directly administer a prescription drug. II. May prescribe a C-II drug by oral or telephonic communication in an emergency. III. May prescribe a C-III, C-IV, or C-V drug in writing. a. I only b. III only c. I & II only d. II & III only e. I, II, & III

90 day

A prescriber may issue multiple prescriptions authorizing a patient to receive a total of up to a ___-day supply of C-II medication providing the prescriber writes specific directions on each prescription indicating the earliest date it may be filled and no pharmacist fills it before that date.

e. none of the above.

A properly executed power of attorney: a. automatically expires in three years with the registration. b. authorizes an individual to sign any legal document on behalf of the person granting power of attorney. c. must be notarized. d. must be photocopied and the photocopy sent to the regional DEA office. e. none of the above.

14 days

A registrant transferring a pharmacy to another registrant must notify the nearest DEA office at least ____ days before the date of the proposed transfer

30 day supply

A treating physician shall not prescribe dispense or prescribe more than a ___ - day supply of controlled substances to treat obesity for a patient at one time.

c. intended use of the drug

According to DEA regulations, all of the following information is required for recording an OTC C-V sale, EXCEPT: a. name and address of purchaser b. name and quantity of drug c. intended use of the drug d. date of sale of the drug e. name or initials of dispensing pharmacist

Drug paraphernalia

According to Kansas law, syringes may be sold OTC but are considered to be ____ [(see definition 21-36a01(f)(11) and 21-36a10(b)]

a. Extemporaneously compounding medication on receipt of a valid prescription from a licensed practitioner for an individual patient.

According to the FDA Compliance Policy Guide, which of the following pharmacy activities does the FDA consider to be traditional pharmacy activity that is NOT subject to FDA enforcement? a. Extemporaneously compounding medication on receipt of a valid prescription from a licensed practitioner for an individual patient. b. Compounding a medication from components that have not been determined to meet official compendial requirements. c. Compounding drugs for third parties who resell the drugs to individual patients. d. Compounding drugs that have been withdrawn from the market due to safety concerns

d. a glass container on a prescription refill, provided a new child-resistant closure is used, plastic non-child-resistant containers and lids on prescriptions for which the patient has requested waiver.

According to the Poison Prevention Packaging Act of 1970, a pharmacist may reuse: a. a glass container on a prescription refill, provided a new child-resistant closure is used. b. plastic non-child-resistant containers and lids on prescriptions for which the patient has requested waiver. c. plastic child-resistant containers and lids on prescription refills. d. a and b e. a, b and c

a. prescription drug samples.

According to the Prescription Drug marketing Act of 1987, no person may sell, purchase, or trade: a. prescription drug samples. b. OTC drug samples. c. starter packages of prescription drugs. d. a and b e. a, b, and c

the quality or purity of the product is compromised; does not have the strength, quality or purity represented or expected; potentially contaminated or prepared under conditions not comforming to GMP

Adulteration

c. Copy 3

After a pharmacy purchaser completes a DEA Form-222, which copy does the pharmacy retain? a. Copy 1 b. Copy 2 c. Copy 3 d. Copies 1 and 2

>Community Pharmacy - buy with tax 190 proof alcohol from wholesalers for compounding >Hospital Pharmacy - buy tax free, compounding for inpatients only, not sold or distributed off premises

Alcohol Federal Regulations

c. Prepackaging medications in unit-dose containers.

All of the following practice activities must be performed by a licensed pharmacist EXCEPT: a. Performing drug regimen reviews. b. Interpreting and verifying patient medication records. c. Prepackaging medications in unit-dose containers. d. Ensuring the proper selection of prescription drugs, devices or suppliers.

Allowable number of refills of phentermine prescribed for treatment of obesity in KS

5 refills or 6 months

Allowable number of times and/or length of time a pharmacist may refill a C-III or C-IV Rx, if authorized

1 year from issuance

Allowable time limitation to refill C-V Rx if authorized

60 days

Allowable time to complete a partial fill for C-II for a pt in a LTCF

72 hrs

Allowable time to complete a partial fill for C-II for an ambulatory pt

b. 5000

Annually, a pharmacy dispenses by prescription 100,000 dosage units of controlled substances. Without obtaining registration as a distributor, the pharmacy can distribute to other registrants a maximum of how many dosage units? a. 2500 b. 5000 c. 7500 d. 10,000

>Form 225 >Pharmacy may stay a dispenser if they keep sales to other registrants under 5% of their sales

Application as a Manufacturer

Form 2632

Application form for approval of use of narcotic drugs in a treatment program.

C2 in one file, C3-5 in one file, non-controlleds in 3rd file C2 scripts in one file, C3-5 and non-controlleds together

Approved DEA filing methods for prescriptions

a. 5 days

As the pharmacist-in-charge of a retail pharmacy that is owned by a non-pharmacist, you are responsible for notifying the Board in writing within what period of time if you decide to quit as the pharmacist-in-charge? a. 5 days b. 10 days c. 14 days d. None of the above

>Yes : records, reports, required forms, equipment, CS, may take samples with a receipt >No : financial, sales, pricing data

DEA Inspections : What can and can't they inspect

Form-82

DEA Notice of Inspection form

Form 2633

DEA for for physicians authorized to administer and dispense narcotic drugs for treament of detoxification

Form-106 (Online)

DEA form used by pharmacists to report theft or significant loss

>Copy 1 - Suppliers (brown) >Copy 2 - DEA (green) >Copy 3 - Purchaser (blue)

DEA-222 Form - 3 Copies go to whom?

>Can be endorsed to another supplier, but must send all drugs to that new supplier

DEA-222 Form - What if Supplier can't supply Drug?

class of drugs sold only by a pharmacist or available only in a pharmacy

Behind the Counter Drugs (BTC)

one that supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury

Class 3 Medical Device

>Non-aqueous - 25% of Manufacturer's Expire date or 6 months. >USP or NF ingredients - 6 months or manufacturer's expire date >Aqueous - 14 days if stored between 2-8 Celsius >Anything else - duration of treatment or 30 days.

Beyond Use Dating : Compounded Non Sterile

Pharmacists can only participate with licensed locations

Branches or Pickup Stations

6 months

C-II Rx is valid for how many days from it date of issuance in KS

e. no dispensing occurs after 6 months from the date the prescription was issue; the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; each partial filling is recorded in the same manner as a refilling.

C-III and C-IV controlled substance prescriptions may be partially filled, provided: a. no dispensing occurs after 6 months from the date the prescription was issued. b. the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. c. each partial filling is recorded in the same manner as a refilling. d. a and b e. a, b, and c

>Class 1 : Serious adverse health/death >Class 2 : temporary or reversible >Class 3 : adverse health not likely

Classes of Drug Recalls

>Exact count of C-II, hydrocodone, and any CS in a container over 1000 doses >Estimated count of C-III thru C-V in containers less than 1000

CS Inventory Exact vs Estimated Counts

>Kept for 5 years (KS Law) >Maintained Separate from Others >Executed 222, Prescriptions, Inventory records, Power of attorney

CS Records : What is kept and time frame

>Unit dosed >Cancer drugs, or drugs used to treat side effects >Must have 6 months expiration left prior to donation >Can't be re-posited twice >No Controlled substances >Can charge a handling fee no more than $15

Cancer Drug Repository

>All the normal stuff, plus date it was delivered to the retail pharmacy and method of how it was delivered

Central Fill - Filling Site : C-II Rx

No, they can't send to patients or individual practitioners.

Central Fill Pharmacies : Send direct to patients?

>Write on Rx "Central Fill", with name, address, and DEA of Central Fill location, name of transferring pharmacist and date of transmission >Keep original on file for 2 years from fill date

Central Fill Retail Site : C-II Rx

Financial and Shipping records. C-II's must be kept at each site

Centralized CS Record Keeping

>Outgoing PIC needs to do a Controlled Substance inventory before leaving >Incoming PIC needs to do a CS inventory within 72hrs of taking over >Both records need to be kept for 5 years

Changing PIC

Requires NEITHER child-resistant packaging nor a patient-package insert

Child Resistant &/or Patient Package Insert? Anhydrous cholestyramine powder

Requires child-resistant packaging and NO patient-package insert

Child Resistant &/or Patient Package Insert? Haloperidol liquid concentrate, 15ml, dispensed in dropped bottle

Requires patient-package insert and NO child-resistant packaging

Child Resistant &/or Patient Package Insert? Ovral-28, 1 month

Requires patient-package insert and NO child-resistant packaging

Child Resistant &/or Patient Package Insert? Prempro™ dial pack

Requires child-resistant packaging and NO patient-package insert

Child Resistant &/or Patient Package Insert? isosorbide dinitrate 40mg sustained release tablets, #100

Requires NEITHER child-resistant packaging nor a patient-package insert

Child Resistant &/or Patient Package Insert? isosorbide dinitrate 5mg sublingual tablets, #100

Requires NEITHER child-resistant packaging nor a patient-package insert

Child Resistant &/or Patient Package Insert? methylprednisolone dosepak

Requires NEITHER child-resistant packaging nor a patient-package insert

Child Resistant &/or Patient Package Insert? nitroglycerin 0.4mg, S.L. tablets

Not more than : - 1.8 grams of codeine per 100 milliliters - 90 milligrams per dosage unit -with one or more active, nonnarcotic ingredients in recognized therapeutic amounts

Codeine C-III

Not more than 200 milligrams of codeine or any of its salts per 100 milliliters or per 100 grams.

Codeine C-V

>C-III : Not > 1.8g per 100ml or 90mg per dosage unit with at least 1 other non narcotic drug >C-V : Not > 200mg or any salts per 100ml or 100g

Codeine Scheduling

Ephedrine, pseudoephedrine, and phenylpropanolamine (EPPs)

Combat Meth...Act of 2005 - Listed Chemicals

>Signed, dated, product info, date, time >Kept for 2 years

Combat Meth...Act of 2005 - Logbook

>3.6g of base per purchaser per day >9g per purchaser per 30 days >7.5g per purchaser per 30 days if over mail order

Combat Meth...Act of 2005 - Sales Limits

>Yearly >Done of all on hand, including Rx's not picked up >"Opening of Business" or "Closing of Business"

Controlled Substance Inventory Records

c. II. Controlled substance prescriptions. III. Controlled substance inventory records IV. Executed DEA Form-222s

Controlled substance records that must be kept at the registration site include: I. Invoices for controlled substance purchases. II. Controlled substance prescriptions. III. Controlled substance inventory records IV. Executed DEA Form-222s a. I and II b. I, II, and III c. II, III, and IV d. I, II, III and IV

C-III

Controlled substance schedule of a preparation containing not more than 50 mg of morphine/100 mL or per 100g combined with non-narcotic active ingredients

C-III

Controlled substance schedule of buprenorphine SL

C-V

Controlled substance schedule of oral diphenoxylate with atropine

C-V

Controlled substance schedule of oral diphenoxylate/atropine

None

Controlled substance schedules for which office samples are allowed

None

Controlled substance schedules for which pre-printed scripts are permitted

>No employee convicted of CS felony or who had license revoked for cause without prior written permission from DEA

DEA : Employment Requirements

>At least 14 days prior >Return unused 222 Forms

DEA : Transferring Pharmacy Time Frame

> Defined dietary supplements and permit manufacturers to make certain claims that otherwise would have been illegal under the FDCA > Forced the FDA to regulate dietary supplements more as foods than as drugs

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Defined dietary supplements as foods rather than drugs and limited FDA's role in regulatioin Burden is on FDA to probe lack of safety prior to removal from market Defined specific claims manufacturers can make

Dietary Supplement Health and Education Act of 1994 (DSHEA)

a preparation intended to supplement the diet and provide nutrients (such as vitamins, minerals, fiber, fatty acids, or amino acids) that may be missing or may not be consumed in sufficient quantities in a person's diet Must contain disclaimer that FDA has not evaluated and is not intended to "diagnose, treat, cure, or prevent any disease"

Dietary supplement (also know as food or nutritional supplement)

C-V : Not > 2.5mg diphenoxylate and not < 25mcg atorpine per dosage unit

Diphenoxylate / Atorpine Scheduling

a. 120 ml within 48 hours

Dispensing a C-V, OTC cough syrup containing codeine is limited to which of the following? a. 120 ml within 48 hours b. 180 ml within 48 hours c. 240 ml within 48 hours d. No limitation if Barb Woods needs it!

1) Complete Form 41 and request permission from DEA 2) Use a reverse distributor's 222 and they submit the Form 41

Disposal / Destruction of C-II (2 ways)

codeine sulfate tabs Dilaudid inj. methadone tabs Tylox

Dolittle Pharmacy needs to order the following medications from their drug wholesaler. diazepam 10mg tablets 2 bottles of 100 codeine sulfate 30mg tabs 4 bottles of 100 Fioricet tabs 1 bottle of 100 Fiorinal tabs 2 bottles of 100 Dilaudid 2mg/ml inj. 5 boxes of 25 amps methadone 5mg tabs 2 bottles of 100 Tylox caps. 1 bottle of 100 Lomotil liquid 2.5mg/5ml 1 bottle of 60ml Which of the above drugs must be ordered from the wholesaler using a DEA-222 form?

c. He must give you two prescriptions: one covering #15 doses for the emergency time and one for the additional doses.

Dr. Johns would also like to continue Susan on this medication for two more weeks. Which of the following is true? a. He may write on the prescription he sends to you for the emergency period for a total of 45 doses. b. He may authorize and you may fill 2 refills on the emergency prescription you wrote. c. He must give you two prescriptions: one covering #15 doses for the emergency time and one for the additional doses. d. You may alter the emergency prescription to reflect the additional doses and have him sign his name on it.

d. 7 days

Dr. Johns, a DEA-registered internist, calls on Friday evening requesting that you dispense #15 Levo-Dromoran tablets to Susan Folkes. You are satisfied that the situation is an emergency. Dr. Johns must supply you with a signed prescription within how much time? a. 72 hours b. 96 hours c. 5 days d. 7 days

established ANDA process (abbreviated new drug application for generics) Deals with the efficacy of drugs marketed between 1938-1962

Drug Efficacy Study Implementation (DESI)

> Aka Waxman-Hatch Amendment > ANDA process initiated > Patent extensions, in certain cases to innovator drugs > Intent: make generic drugs more readily available to the public and, at the same time, provide incentives for manufacturers to develop new drugs

Drug Price Competition and Patent Term Restoration Act of 1984

AKA Waxman-Hatch Act Granted pharmaceutical manufacturers incentives by granting some market exclusivity Increased availability of generics Required FDA to publish an up-to-date list of all Rx and OTC drugs approved for safety and efficacy (The Orange Book)

Drug Price Competition and Patent Term Restoration Act of 1984

not likely to cause advers health effects

Drug Recall: Class 3

>Must be requested in writing and have written receipt >Only licensed prescribers, hospitals, and health care entities can request >Must follow normal inventory, etc

Drug Sample Restrictions

Must notify State Board at least 5 days prior

Drug Store : Changing PIC / Ownership

Drug recall class presenting reasonable probability of serious adverse health consequences or death

temporary or medically reversible adverse effects or remote possibility of serious adverse effects

Drug recall class presenting risk of !!!!!!

Subutex (buprenorphine) (C-III) Suboxone (buprenorphine/naloxone) (C-III)

Drugs Approved for Opioid Dependence Treatment

> Aka the Prescription Drug Amendment > Established 2 classes of drugs, prescription and OTC > Labels of prescription drugs need not contain "adequate directions for use" so long as they contained the legend, "Caution: Federal law prohibits dispensing without a prescription." > Authorizes oral prescriptions and refills of prescription drugs

Durham-Humphrey Amendment of 1951

Established 2 classes of drugs: Rx and OTC Established provisions for dispensing prescription drugs Established labeling requirements for OTC and prescription drugs Established use of NDC numbers

Durham-Humphrey Amendment of 1951

Hydrocodone

During CS inventory, an exact count must be taken of all C-II products and products containing _____

b. controlled substances destruction records.

During a routine DEA inspection, the pharmacist is required to allow the inspector to examine: a. personnel files of current employees. b. controlled substances destruction records. c. controlled substances pricing data. d. controlled substances sales revenue data. e. a and b

5 days

Each registrant shall notify the executive secretary of the Board in writing of any change in majority ownership of the operation for which the registration was issued within ___ days after the date the change in ownership becomes effective.

>Maintained by PIC of a medical care facility >May have controlled substances, as long as a Drug Committee limits what goes in >PIC in charge of inventory/maintenance

Emergency Medication Kit

30 mg Sudafed HCl : 146 tabs 60 mg Sudafed HCl : 73 tabs 120 mg Sudafed HCl : 36 tabs

Equiv table for Sudafed Tabs totaling 3.6g

>Sale among hospitals under common control or nonprofit entities >Emergency Medical Reasons > Alleviate a temporary shortage

Exceptions to Hospital Resales

>People working under a registrant (ie hospital) >Pharmacists >Law Enforcement, Armed Services, etc who dispense but not procure

Exemption to DEA Registration

Small number of patients (20-80) Evaluates safety Determines safe dosage range Identifies side effects

FDA Clinical Trials Phase 1

Small number of patients with condition (100-300) Establishes testing protocol Establishes if drug is effective Further evaluates safety

FDA Clinical Trials Phase 2

1000-3000 patients in a clinical setting Usually double-blinded Confirms effectiveness Monitors side effects Compares to commonly used treatments

FDA Clinical Trials Phase 3

Post-marketing surveillance

FDA Clinical Trials Phase 4

Federal Compliance Guide regarding Pharmacy Compounding Changed the wording of required legend to "Rx Only"

FDA Modernization Act of 1997

>Called MedWatch (drugs) & VAERS (vaccines) >Mandatory for Industry >Voluntary for Practitioners, Lay Public

FDA Post Marketing Surveillance

Dept. of Health and Human Services (DHHS)

FDA is under what regulatory agency?

>C-II : only for narcotic parentral pain, pt in LTCF, pt in a Medicare certified hospice care

Faxed orders for Controlled Substances

Federal offense to tamper with consumer products Requires tamper resistant packaging for OTC

Federal Anti-Tampering Act of 1982

>Federal Register - daily updates to laws >CFR - Final year end copy of Federal Register

Federal Register vs. Code of Federal Regulations (CFR)

72 hours

For central fill pharmacies, the length of time a Pharmacist has to verify accuracy of the computer record for filling/refilling of C-III-C-V Rx's

>Allows the FDA broader use of the fees generated from PDUFA, while substantially increasing the fees >Provides the FDA with significantly enhanced responsibilities and authority to regulate drug safety, including to: - Mandate labeling changes related to safety - Require clinical trial data reporting and registries - Require post-market (phase 4) clinical studies to assess risks - Require companies to implement risk evaluation and mitigation strategies (REMS) when necessary

Food and Drug Administration Amendments Act of 2007 (FDAAA)

Post marketing safety initiatives: Medguides, PPI, DTC advertising PPI must be dispensed each time Rx dispensed; in institutional setting given prior to first dose and every 30 days Provided FDA with the authority to impose risk evaluation and mitigation strategies (REMS) including Medguides and other restricted distribution programs

Food and Drug Administration Amendments Act of 2007 (FDAAA)

> Expedited availability of safe and effective drugs and devices > Changed "legend" to "Rx only" > Fast-track approval process for serious or life-threatening diseases > Expands the rights of manufacturers to disseminate unlabeled use information > Expands the FDA's authority of OTC drugs and establishes ingredient-labeling requirements for inactive ingredients

Food and Drug Administration Modernization Act of 1997 (FDAMA)

Focused on Safety New drug cannot be marketed until proven safe (drugs prior to 1938 were exempt) Power given to Congress via authority over interstate commerce

Food, Drug, and Cosmetic Act of 1938

> No new drug, cosmetic, or device could be marketed until proven safe > Labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs.

Food, Drug, and Cosmetic Act of 1938 (FDCA)

Form 2636

Form entitled Hospital Request for Methadone Detoxification Treatment

ATF-1447

Form for hospital pharmacies needing to purchase large quantities of tax-free grain alcohol

Form 106

Form to report substantial theft or loss of controlled stubstances

Form 41

Form to request permission to destroy damaged, outdated, or unwanted controlled substances

Form 510

Form used to apply for a new DEA chemical distributor registration

Form 224

Form used to apply for a new DEA dispenser registration

Form 363

Form used to apply for a new DEA narcotic treatment program registration

Form 222

Form used to order C-II controlled substances

Form 222a

Form used to order the forms used to order C-II controlled substances

Form 224a

Form used to renew a DEA dispenser registration

Form 224b

Form used to renew a DEA dispenser registration for a retail chain

Form 363a

Form used to renew a DEA narcotic treatment program registration

Form 222

Form used to send C-II controlled substances to a reverse distributor for disposal

>Only non-controlled >Must have a PIC >Normal drug record keeping

Health Department and Not for Profit Private Company Drug Restrictions

Notice of privacy practices must be provided to patients When PHI used for a purpose not associated with treatment, payment, or operations (TPO) consent must be obtained Established training requirements and requirements for Privacy Officer

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

investigational new drug

IND

b. C-III, C-IV, and C-Vs

If a pharmacist uses the 2-drawer manual filing system (not the computer) for storing controlled substance prescriptions as the primary method, which of the following schedules of medication should be marked with a red "C"? a. All C-IIs b. C-III, C-IV, and C-Vs c. C-III and C-IV only d. All non-controlled prescriptions

III. Affix the prescription label to the drug container

Identify which of the following functions can be performed by a Kansas pharmacy technician. I. Read and interpret the prescription II. Personally offer to counsel each patient with each new prescription III. Affix the prescription label to the drug container a. I only b. III only c. I & II only d. II & III only e. I, II, & III

b. Patient's age

In Kansas, a patient's medication profile record in a community pharmacy is required to contain all of the following information EXCEPT: a. Name and address of the patient b. Patient's age c. Initial date of dispensing and prescription number d. Name of the dispensing pharmacist e. Drug allergies and sensitivities

Hydrocodone

In Kansas, combination products containing this drug must be counted exactly during annual CS inventory, regardless of CS schedule

1 year

In Kansas, revocation of one's pharmacist license is for all time, except that any time after ___(amount of time) the licensee may reapply to the Executive Secretary of the Board of Pharmacy for reinstatement.

e. no dispensing occurs after 72 hours from the date it was partially filled; the pharmacist is unable to supply the full quantity; the quantity dispensed in the partial fill is recorded on the face of the prescription or in the computer record

In general, C-II controlled substance prescriptions may be partially filled provided: a. no dispensing occurs after 72 hours from the date it was partially filled. b. the pharmacist is unable to supply the full quantity. c. the quantity dispensed in the partial fill is recorded on the face of the prescription or in the computer record d. a and b e. a, b, and c

d. be a resident of Kansas; have been actively engaged in the practice of pharmacy in Kansas for 5 years prior to appointment.

In order to serve on the Kansas State Board of Pharmacy, you must: a. be a resident of Kansas. b. have been actively engaged in the practice of pharmacy in Kansas for 5 years prior to appointment. c. have had your name submitted to the governor by the Kansas Pharmacist Association. d. a and b only e. a, b, and c

>Duty of PIC to setup and maintain >Any reportable incident >Kept for 5 years >PIC must meet quarterly with Continuous Quality Improvement Program to go over incidents and steps to correct and prevent

Incident Reports

5 years

Incident reports must be kept on file for __ years in Kansas.

>Serves Drug needs of Jail, Juvy Hall, College, Places of business, hospice >Not a Dr. office or registered pharmacy >Must be supervised by pharmacist or practitioner for inventory and record keeping

Institutional Drug Room Definition

>Importers must be DEA registered >Must have a legitimate doctor/patient relationship >VIPPS - Verified Pharmacy Practice Sites

Internet Dispensing of CS

>Not Ipecac Fluid Extract >larger than 30ml is Rx and needs child resistant lid

Ipecac Syrup OTC / Child Resistant Caps

b. OTC.

Ipecac syrup, dispensed in 15-30ml unit-dose containers and labeled according to FDA requirements, may be considered: a. prescription only. b. OTC.

a. prescription drug and dispensed only upon prescriptive authorization.

Ipecac syrup, dispensed in a 4 ounce bottle to patient, is considered to be a(n): a. prescription drug and dispensed only upon prescriptive authorization. b. OTC drug and labeled accordingly. c. OTC drug and labeled with specific FDA labeling requirements.

b. I. patient requests standard packaging. II. prescriber requests standard packaging on the prescription for a specific patient.

It is not necessary to dispense an oral prescription drug for human use in a child-resistant container if the: I. patient requests standard packaging. II. prescriber requests standard packaging on the prescription for a specific patient. III. prescriber requests a blanket waiver for child-resistant packaging for all of the prescriptions of one patient. IV. pharmacist, in his/her professional judgment, deems it is not necessary. a. I b. I and II c. II and III d. II, III and IV

e. I. Acetazolamide (Diamox) II. Sodium Sulfacetamide solution 10% III. Oxycodone 2.5mg/APAP 325mg

It is within an opthalmologist's scope of practice to prescribe: I. Acetazolamide (Diamox) II. Sodium Sulfacetamide solution 10% III. Oxycodone 2.5mg/APAP 325mg a. I only b. III only c. I and II only d. II and III only e. I, II and III

Amphetamines will not be dispensed or prescribed to treat obesity

KS: Treatment of Obesity with Amphetamines

Kept for 5 years

Kansas CS Inventory

State board sends recommendations to Speaker of the House and President of Senate

Kansas Law on how Drugs get Scheduling

June 30 biennial

Kansas License renewal date

Can administer to age 6 and older

Kansas: Age restriction for flu vaccine

Can administer to age 18 and older

Kansas: Age restriction of vaccines (not flu)

Appointed by the Governor

Kansas: Board of Pharmacy Appointment

May inspect in a lawful manner drugs kept or for sale in Kansas pharmacy

Kansas: Board of Pharmacy Inspection Authority

Term is 4 years Serve a maximum of 2 terms

Kansas: Board of Pharmacy Term

Dispensing of a different drug product of the same dosage form, strength, and generic name than the brand name drug product prescribed Pharmacist may exercise brand exchange with a view toward achieving a lower cost for the patient unless marked DAW or FDA had determined not to be bioequivalent

Kansas: Brand Exchange

Dispensing of a different drug product of the same dosage form, strenth, and generic name than the brand name drug prescribed Pharmacist may exercise brand exchange with a view toward achieving a lower cost for patient unless marked DAW or FDA has determined not to be bioequivalent

Kansas: Brand Exchange

A C2 script is valid for 6 months from its date of issuance (no limit in federal law)

Kansas: C2 Script Length of Validity

C2 substances and products containing Hydrocodone must be counted exactly

Kansas: CS Inventory Exact Count

Resigning PIC must inventory prior to leaving position, new PIC must inventory all CS within 72 hours or beginning to function as PIC

Kansas: CS Inventory with PIC change

All written or emergency scripts for a C2 medication must be cancelled with the name of the pharmacy intern and the preceptor authorizing filling the prescription

Kansas: Cancelling C2 Scripts by intern

All written or emergency scripts for a C2 medication must be cancelled on the face of the prescription with the name of the pharmacist filling it

Kansas: Cancelling C2 scripts by pharmacist

Must notify the board in writing within 5 days of decision to quit as PIC

Kansas: Change in PIC notification to board

must notify the board in writing within 30 days

Kansas: Change of Residential Address

Every place occupied or used for the preparation for sale, manufacture, packing, storage, sale or distribution of any food or drug shall be properly lightd, drained, plumbed, ventilated and screened Conducted with strict regart to the influence of such condition upon the puruty and wholesomeness of foods or drugs therein produced Enforced by the Secretary of Health and Environment

Kansas: Condition of places the sell drugs

must be colored in such a way to make them readily distinguishable from food products

Kansas: Conditions for sale of poison

Poisons should be colored in such a way to make them readily distinguishable from food products

Kansas: Conditions for the sale of a poison

3 CEU (30 hours)

Kansas: Continuing Education Requirements

CS C2-C5 may not be issued on a prescription blank which is preprinted with the name of a proprietary preparation or strength or quantity or directions

Kansas: Controlled Substance Preprinted Blanks

Must be maintained on file for no less than 5 years from the date of last entry in the record.

Kansas: Controlled Substance Records

Cannot distribute C2-C5 samples (differs from Federal Law)

Kansas: Controlled Substance Samples

A prescription may not be issued in order for a practitioner to obtain CS for supplying himself or any other practitioner for the purpose of general dispensing to patients

Kansas: Controlled Substance for provider use

process bu which the responsible pharmacist shall

Kansas: Direct Supervision

process by which the responsible pharmacist shall observe and direct the activities of a pharmacy student or technician to a sufficient degree to assure that all activities are performed accurately, safely, and without risk or harm to patients ***And to complete the final check before dispensing***

Kansas: Direct Supervision

License must be displayed in an area usually occupied or visible to the public License may not be displayed if not a business were pharmacist is actively involved in profession

Kansas: Display of license

The Kansas Board of Pharmacy shall submit to the Speaker of the House of Representatives and the President of the Senate a report on substances proposed by the Board for scheduling, rescheduling , or deletion by the legislature.

Kansas: Drug Scheduling

Must be issued within the course of professional practice for legitimate medical purpose Must identify the transmitter's phone for verbal confirmation; date and time of transmission; identity of pharmacy to receive Must be transmitted by prescriber or designated agent May be saved as a hard copy or as an electronic document

Kansas: Electronic Prescription Transmission

Escript counts as hard copy for C2 order to be compounded for direct administration to patient by injection C2 order for resident of nursing facility, nursing facility for mental health, or assisted living facility C2 order for patient released by registered institution to a home hospice setting that continues to provide care

Kansas: Electronic Prescription Transmission C2 (3 cases where acceptable)

May be transmitted electronically

Kansas: Electronic Prescription Transmission C3-5

Quantity prescribed and dispensed limited to amount adequate to treat patient during emergency Must be reduced immediately to hard copy Prescriber must issue a written prescription within 7 days and write on the face "authorization for emergency dispensing" and date of the transmitted Rx order Upon receipt of written order, attach to hard copy, notify DEA if no written Rx received

Kansas: Emergency Script for C2

prescriber must issue within 7 days

Kansas: Emergency Script for C2: time to receive written order

C2 and narcotic drugs listed in any schedule are exceptions to the 7-day emergency refilling allowance

Kansas: Emergency refill of narcs

Pharmacist, pharmacy student, or intern Age 6 and up

Kansas: Flu shot requirements

Revocation is for all time but can apply in one year for reinstatement

Kansas: Hearings/appeals for License Revocation

Defined as "drug paraphenalia"

Kansas: Hypodermic needle designation

May temporarily suspend or limit the license in accordance with emergency adjudicative proceedings; may revoke, suspend, or place in probationary status or deny renewal

Kansas: Jurisdiction of the Board for License Revocation

must be labeled by the manufacturer and seller Label muse contain description of all the contents of the solution, statement of purity, percent concentration of DMSO in solution, manufacturer name and address Seller must give additional printed material to the purchaser that provides adequate warning against use that may be dangerous to the health of the user

Kansas: Labeling and Information requirements for selling non-prescription DMSO (dimethyl sulfoxide)

Label shall contain a description of all contents of the solution, staement of purity, the percent of DMSO in the solution, the manufactures name and address Seller or supplier muse provide addtional prointent material to the person receiving that provides adequate warning against use that may be dangerous to the health of the user

Kansas: Labeling requirements for selling non-prescription DMSO (dimethyl sulfoxide)

$150 $200 if late

Kansas: License Renewal Fee

May be licensed after taking law exam if already licensed in another state Shall file proof of training and educatuion to board Requirements based on requirements at the time of original licensure

Kansas: Licensure by reciprocity

A physician shall not dispense or prescribe additional CS to treat obesity for a patient who has not achieved a weight loss of at least 5% during the initial 90 days

Kansas: Long-term Obesity Treatment

Pharmacist, student, intern, and pharmacy technician must wear name tags designated with function

Kansas: Nametag Requirement

Physician may not prescribe nor dispense more than a 30 day supply

Kansas: Obesity Treatment Supply

Judgmental functions that constitute filling or refillin can only be performed by a pharmacist or pharmacy student under the direct supervision of a pharmacist. Only non-judgmental duties associated with preparation can be designated to a tech; in process and final checks must be done by a pharmacist

Kansas: Pharmacist Function in filling Rx: Judgmental Functions

rescription for the drug was issued with a valid pre-existing patient-prescriber relationship rather than an internet or telephone consultation

Kansas: Pharmacist Function in filling Rx: Legitimate Medical Purpose

Person responsible to the board for a registered establishment's compliance with the laws and regulations of the state Must pass the law exam by 85% or higher

Kansas: Pharmacist in charge

18 years old Graduate of an approved school Minimum of one year pharmaceutical experience under an approved preceptor Pass examination

Kansas: Pharmacist qualifications for licensure

an individual who is a prospective candidate foe examination as a licensed pharmacist and who is qualified to receive and is obtaining pharmaceutical experience set forth in the pharmacy practice act Can be an intern without being a student

Kansas: Pharmacy Intern

1500 hours

Kansas: Pharmacy Intern hour requirements

Must register with the board and pay fee All submissions are the responsibility of the intern not the preceptor Requires 1500 hours (hours do not count before admission to pharmacy school or registration as an intern)

Kansas: Pharmacy Intern requirements

Must notfy the board within 30 days of new employment

Kansas: Pharmacy Tech Job Change

1 RPh: 2 techs (if not certified) 1 RPh: 3 techs (if certified)

Kansas: Pharmacy Tech Ratio

Must complete training course within 180 days of employment Pharmacy keeps records of name and address of tech, date training course started, name and address of pharmacy

Kansas: Pharmacy Tech Training Course

$25 fee Expires 10-31

Kansas: Pharmacy Tech renewal

an individual, who under the direct supervision and control of a pharmacist may perform packaging, manipulative, repetitive, or other non-discretionary tasks related to the processing of a prescription; may not perform duties restricted to a pharmacist

Kansas: Pharmacy Technician

Must register with the board Must pass exam approved by the board within 30 days of becoming registered Pharmacy must maintain list of techs employed by the pharmacy Registration must be displayed

Kansas: Pharmacy Technician Registration

an individual registered with the board and enrolled in an accredited school of pharmacy

Kansas: Pharmacy student

Licensed pharmacist with at least 2 years of experience as a pharmacist who supervises students obtaining pharmaceutical experience required by law

Kansas: Preceptor

Cannot fill a prescription copy A copy issued for reference must bear "This prescription copy is issued for reference only"

Kansas: Prescription Copies

may be written, telephonic, or electronic Blank written orders must have two signature lines Prescription ordes shall be recorded in writing by the pharmacist and the record so made constitutes an original prescription A prescription is an order received for OUTpatients A medication order is for INpatients

Kansas: Prescription Format

Limited to one year from date of origin Controlled Substances limited to 6 months or 5 refills Refill at will: no limitation to the number of times it may be refilled except may not be refilled after the expiration of the time specified or one year (whichever is first)

Kansas: Refill limitations

May refill without authorization (not controlled substance) when all reasonable efforts to contact the prescriber have failed and in the pharmacist's professional judgment continuation is necessary for patient health and welfare. May only refill amount sufficient to maintain patient until provider can be contacted; no more than 7 days or one package. May not fill if prescriber states on Rx "no emergency filling"

Kansas: Refill without authorization

7 days or one package May not fill if prescriber states on Rx "no emergency filling"

Kansas: Refill without authorization limits

Medical dictionary Recognized reference in drug interactions Copy of the Kansas Controlled Substance Act and regulations

Kansas: Required references for community pharmacy (3)

Name and address of patient Initial date of dispensing and prescription number Name of the dispensing pharmacist Drug allergies and sensitivities

Kansas: Requirements for community pharmacy medication profile record

shall provide proog of ability to communicate verbally and in written form in English must pass English as a foreign language exam (TOEFL)

Kansas: Requirements of foreign grads

A person selling at retail non-prescription drugs that are fully pre-packaged by the manufacturer or distributor and are labeled for consumer use in accordance with state and federal regulations

Kansas: Retail Dealer

Controlled substance prescriptions C3-C5 may be transmitted by telephone by a prescriber or designated agent to the pharmacy. The transmission may be oral or by fax. If telephoned or faxed by other than the prescriber, the prescription shall bear the name of the person so transmitting the prescription.

Kansas: Telephone/Fax C3-C5 scripts

Physician shall personally take complete history and document it Physician shall prescribe nutritional counseling, including behavior modification and exercise for weight loss, and record those on the patient record The physician shall not dispense more that a 30 day supply of CS at one time The physician must monitor the patient and record the findings in the patient chart with each visit The physician shall not dispense or prescribe additional CS to treat obesity for a patient who was not achieved a weight loss of at least 5% during initial 90 days Law does not cover methylphenidate or pemoline

Kansas: Treatment of Obesity

unlawful for any person not a state licensed phamracist or any business that does not have a state licensed pharmacist in continuous employ to use or exhibit the words "pharmacy", "drugstore", or "apothecary"

Kansas: Use of the title "pharmacy" or "drugstore"

unlawful for any person not a state licensed pharmacist or any business that does not have a state licensed pharmacist in continuous employ to use or exhibit the words "pharmacy", "drugstore", or "apothecary"

Kansas: Use of title "pharmacy" or "drugstore"

A pharmacist or pharmacy student or intern working under the direct supervision and control of a pharmacist may administer influenza vaccine to a person 6 or older and may administer other vaccines to a person 18 or older pursuant to a vaccine protocol if the individual has successfully completed an accredited course of study and training and has current CPR certification

Kansas: Vaccine Administration Requirements

A pharmacist or a pharmacy student or intern working under the direct supervision and control of a pharmacist may administer pursuant to a vaccination protocol if they have successfully completed an accredited course of study and training and have current CPR certificate (must be able to furnish proof of completion to the board upon request)

Kansas: Vaccine Admisitration Guidelines

a written protocol, agreed to by a pharmacist and a person licensed to practive medicine and surgery by the state board of healing arts, which establishes procedures and recordkeeping and reporting requirements for administering a vaccine by the pharmacist for a period of time specified within, not to exceed two years

Kansas: Vaccine Protocol

may not exceed two years

Kansas: Vaccine Protocol time limit

All vaccinees will be given a written immunization record for their personal files Administration shall be promptly reported to PCP by mail, fax, or other electronic means. If patient does not have PCP it shall be eported to physician whom has entered the protocol. Immunization will also be reported to appropriate county or state immunization registries.

Kansas: Vaccine Record

All vaccinees will be given a written immunization recod for their personal files Administration shall be promptly reported to the PCP by fax, mail, or other electronic means. If patient does not have a PCP, report to the physician who has entered the protocol Report to appropriate county or state immunization registries

Kansas: Vaccine documentation

Pharmacist, pharmacy student, or intern Age 18 and up

Kansas: Vaccine requirements (not flu)

Poisons Prescription meds Drugs containing ephedrine Drugs intended for human use by hypodermic injection

Kansas: Vending machine items that cannot be sold

Identification of the owner Toll free telephone number of the owner Statement advising purchaser to check expiration date prior to using Telephone number for the state board

Kansas: Vending machine labeling requirements

Direct application of a drug, whether by injection, inhalation, ingection or other means by a practioner pursant to the lawful direction of a practioner. Nothing contained in the pharmacy act shall prohibit a duly licensed practioner from purchasing and keeping drugs, from compounding precriptions, or from adminsitering, supplying or dispensing to such practioner's patients such drugs as may be fit, proper, and necessary

Kansas: administer

> Required that drugs be proved not only safe, but also effective > Established Good Manufacturing Practices (GMP) requirements > Required informed consent of research subjects and reporting of adverse drug reactions > Retroactive to all drugs marketed b/w 1938 and 1962

Kefauver-Harris Amendment of 1962

Focused on safety AND efficacy Impacts all drugs after 1962 and new drugs with an NDA approved since 1938 Established effectiveness as a standard Established Good Manufacturing Practices (GMP) Transfered jurisdiction of Rx advertising from FTC to FDA

Kefauver-Harris Amendments of 1962

"Adequate directions for use"

Labeling requirements for OTC Drugs

"Adequate information for use"

Labeling requirements for Rx Drugs

30 days

Length of time Technician has to notify State Board of switching employers

5 years

Length of time a pharmacy must keep controlled substance records

30 days each RX ; 90 days max between them all

Max # of days supply that may be prescribed and dispensed on multiple C-II Rx's that have the same date of issuance

9g or 7.5g over mail order

Max amount of pseudoephedrine that can be sold to a purchaser in 30 days

Unlimited

Maximum number of doses (quantity) that may be prescribed and dispensed on a single C-II Rx

>Must have a PIC assigned >Registered nurse or PA can distribute drugs when PIC isn't around >May have an Emergency Med Kit

Medical Care Facility Requirements

Classification of all devices into 3 classes based on the degree of control necessary to assue safety and effectiveness; most regulated are class 3

Medical Device Amendment of 1976

> Provided for more extensive regulation and administrative authority regarding the safety and efficacy of medical devices by requiring: - Classification of devices according to their function - Premarket approval - Establishment of performance standards - Conformance with GMP regulations - Adherence to record and reporting requirements

Medical Device Amendments of 1976 (MDA)

Must be done within 7 days of the order being written

Medical Facility Drug Order Review

Added Part D (prescription drug benefit) to Medicare Provision for MTM Required development and implementation of standard for e-prescribing Permits importation of Rx drugs from Canada if HHS Secretary certifies safety

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

Plans must have MTM program that may be provided by a pharmacist; pharmacists to be reimbursed for time spent counseling targeted patients

Medication Therapy Management Services

List I - any precursor to Meth List II - substances key to making meth but aren't precursors

Meth. Anti-Prolif. Act 2000 : List I and II Chemicals

>Pharmacy may dispense only for analgesic purposes >Physician may administer in office 3 days total - 1 day at a time >Hospital Inpatients can receive if being treated at hospital for something other than detox

Methadone Detox Limitations

>Current copy of Kansas Pharmacy Practice Act, Kansas Uniform Controlled substances Act, and regulations for both acts >Drug Information Reference >Reference in Toxicology, Pharmacology, and Drug Interactions >Reference on drug equivalencies >Medical Dictionary

Minimum Requirements for a Pharmacy Library

the act of labeling the product falsely or in a misleading way Refilling a prescription without authorization is misbranding

Misbranding

CSOS - Controlled Substance Ordering System

Name of Electronic C-II ordering system

Form 363

Narcotic Treatment DEA Form

used for FDA identification purposes, does not indicate approval status required on all drugs (RX and OTC) 1st 5 numbers: manufacturer/distributor 2nd 4 numbers: drug name and dosage form 3rd 2 numbers: package size

National Drug Code (NDC)

Used if new drug is a newly discovered chemical or for an established drug offered in a new dosage form, with ne therapeutic claims, in new dosage levels, or for a different patient population

New Drug Application (NDA)

Number of business days within which a pharmacy must notify the local DEA Diversion Field Office after discovery of theft or significant loss of a CS

Number of consumer members on the Kansas Board of Pharmacy

Number of days a drug wholesaler, acting as a supplier, has to complete a DEA Form 222 before it becomes void

Number of doses, maximum, of medication a hospital emergency room may provide to an outpatient when local retail pharmacies are closed and there is no pharmacist on the premises

Number of grams maximum of pseudoephedrine base that may be sold to a single patient in 30 days

3.6

Number of grams maximum of pseudoephedrine base that may be sold to a single patient in a day

Number of hours a pharmacist has to verify accuracy of the computer record for filling/refilling C3-C4 prescriptions

Number of hours allowable to complete a partial fill for C2 for an ambulatory patient

120

Number of mL maximum of codeine-containing cough syrup that can be sold to a single patient in 48 hours

200

Number of mg maximum codeine per 100 ml or 100 g combined with non-narcotic active ingredients to be scheduled as a C5

Number of mg maximum codeine per dosage unit combined with non-narcotic active ingredients to be scheduled as C3

Number of months a C2 prescription is valid from issuance

Number of months a pharmacist may refill a C3-C4 if authorized

Number of months allowed to refill authorized C5 refills from the date of issuance

Number of months maximum between controlled substance inventories

Number of months minimum between controlled substance inventories

Number of pharmacists on the Kansas Board of Pharmacy

Number of pharmacy students or interns a Kansas pharmacist preceptor may supervise

Number of refills allowed for phentermine prescribed for obesity in Kansas

Number of times a C2 script can be transferred

Number of times a C3-C5 (with refills) can be transferred in Kansas if pharmacies do not share a real time computer system

Number of times a pharmacist may refill a C3-C4 prescription if authorized

Number of years HIPPA documentation, including signed acknowledgements of Notice of Privacy Practices, must be retained

Number of years a DEA dispenser registration is valid

Number of years a pharmacist must practice in Kansas to serve on the Board of Pharmacy

Number of years a pharmacy must keep controlled substance records after last entry (i.e., last refill)

Number of years a vaccination protocol that establishes what vaccines a pharmacist may administer, procedures for record keeping, and emergency response is considered valid

Number of years minimum age of individuals allowed to purchase C5s OTC

Number of years which incident reports must be kept in Kansas

> Mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as they are made in compliance with FDA regulations>

Nutrition Labeling and Education Act of 1990

Regulated by FTC

OTC Advertising

>Properly labeled with strength, etc >Printed material giving adequate warning of its dangers

OTC DMSO

OK to refill except: >Higher dose than OTC >Stated refill directions >C-V must have authorized refills

OTC Refills

>No amphetamines >30 day supply max >Pt must lose 5% of weight in first 90 days to continue with drug

Obesity Treatment

>For Medicaid Patients >Prospective DUR >Maintaining adequate medical records >Counseling >Lower cost back to state

Omnibus Budget Reconciliation Act (1990)

First fedeal law to directly address pharmacy practice standards Establised a federal policy requiring DUR (prospective instead of retrospective) Established standards of practice for pharmacists as a condition of participating in Medicaid program Rebates from "best price" go back to state Medicaid program

Omnibus Reconciliation Act of 1990 (OBRA 90)

a. C-IIs

On a controlled substance inventory, opened containers with which of the following drugs must be counted exactly? a. C-IIs b. C-II, C-III, and C-IVs in any size of container c. All controlled substances d. Only C-II, C-III, and C-IVs in opened containers

approved drug products with therapeutic equivalence evaluations

Orange Book

>NOT Official Compendium >Has approved RX, OTC that have conditional approval, blood products, products that were never marketed or pulled from market for reasons other than safety or efficacy >Does NOT include Pre-1938 drugs or DESI drugs (1938-1962) >Therapeutic equivalents

Orange Book Basics

No Code = no generic on market A = Equivalent B = Not Equivalent

Orange Book Therapeutic Equivalent Codes

therapeutically equivalent to the reference drug product

Orange Book: Code A

drugs in conventional dosage forms, NO bioequivalence problem

Orange Book: Code AA

established scientific bioequivalence, any potential problems have been identified and resolved

Orange Book: Code AB

not considered therapeutically equivalent

Orange Book: Code B

same active ingredient, identical strength, dosage form

Orange Book: Pharmaceutical Equivalents

bioequivalence, same clinical effect of safety profile when administered

Orange Book: Therapeutic Equivalents

Provide tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of "rare diseases or conditions"

Orphan Drug Act of 1983

Can't be PIC or more that one location that has on-premises Rx services of 30 hours or more weekly

PIC of more than one location

>Name, etc, allergies >Dr., Pharmacist dispensing >Initial date of filling, drug name, etc >Record Must be kept for 5 years from last entry

Patient Med Profile Requirements

>Same active ingredient(s) >Same dosage form/route >Same strength / concentration

Pharmaceutical Equivalent

a. yes

Pharmacist Erickson is the pharmacist in charge of a community pharmacy that offers on-premises pharmacist services for 55 hours per week. The local county hospital has requested that Jones also become the PIC for the county hospital pharmacy that has on-premises pharmacist services for 20 hours per week. May pharmacist Erickson legally be PIC at both registered sites? a. yes b. no

d. September 2, 2011

Pharmacist Van received a methylphenidate prescription that was dated March 1, 2011. On what date is this prescription no longer valid in Kansas? a. March 8, 2011 b. April 15, 2011 c. June 2, 2011 d. September 2, 2011

1)Must pass with 85% 2)Pharmacy may not go 30 days without having a Pharmacist in Charge

Pharmacist in Charge Exam

1:2

Pharmacist to Intern Ratio

>Unlicensed Techs = 1:2 >At least 2 licensed techs = 1:3

Pharmacist to Technician Ratio

Form 224

Pharmacy DEA Application as a Dispenser

>Form 224a >Renewal every 3 years

Pharmacy DEA Renewal Form

>Enforced by the Consumer Product Safety Commission >Defines tamper resistant vs Child resistant >Failure to abide by child resistant packaging is misbranding

Poison Prevention Packaging Act (1970)

All new and refilled scripts must be dispensed in child-proof container unless: Prescriber specifies for single prescription Patient indicates they do not want Container is being used in institution and maintained by health professionals SL Nitroglycerin or Isosorbide Potassium in UD form Aerosol containers for inhalation Oral Contraceptives or estrogens in dispenser pak Enforced by Consumer Product Safety Commission Failure to comply is MISBRANDING

Poison Prevention Packaging Act of 1970

Must be labeled as such and be specially colored

Poisons

> Blocks re-importation of exported US drugs > Bans the sale, purchase, or trade of drug samples > Prohibits hospitals and other health care entities from reselling their drug purchases to other businesses (exceptions) > Requires the state licensing of drug wholesalers

Prescription Drug Marketing Act of 1987

Prohibits sale, purchase, or trade or RX samples Restricts distribution to prescribers or hospital pharmacy (no retail pharmacy) Prescriber must write a written request for samples Guidelines for advertising Requires licensing of prescription drug wholesalers

Prescription Drug Marketing Act of 1987

Carry 12 or less OTC, and nothing injectable

Requirements to not have to carry a Retail Permit

> Requires manufacturers to pay fees for applications and supplements when the FDA must review clinical studies > The fees provide the FDA with the resources to hire more reviewers to assess these clinical studies and hopefully speed up the NDA reviews

Prescription Drug User Fee Act of 1992 (PDUFA)

5 years

Prescriptions in Kansas must be kept on file for __ years.

Must use a 222 form. Can NOT use a written Rx

Procedure for Dr. to get C-II from Pharmacy for office use

actice resolution of drug therapy problems through a comprehensive review of a patient's prescription at the point of dispensing; includes screening prescriptions, counseling patients, and documentation

Prospective Drug Use Review

Focused on Purity and Quality Prohibited the interstate transfer of adulterated or misbranded drugs Recognized USP/NF Standards

Pure Food and Drug Act of 1906

Prohibited the adulteration and misbranding of foods and drugs in interstate commerce

Pure Food and Drug Act of 1906

Enough to handle the emergency

Quantity of drug a Pharmacist may dispense to a Pt off an emergency C-II Rx

USP/NF and Homeopathic Pharmacopeia

References Officially Recognized by FDCA

Everyone except: 1) employees working under a registrant 2)Pharmacies already registered as a dispenser 3)Any person licensed by State Board of Healing Arts or Veterinary Examiners

Registration with State Board for dispensing CS

performed by DUR board of physicians and pharmacist to review medication use trends and data over a specified period of time and attempt to evaluate and improve medication use

Retrospective Drug Use review

Regulated by FDA

Rx Advertising

>Prevent illicit CS internet sales >Pharmacies must obtain a modified DEA registration >Exemptions : Indian Health and Federal entities

Ryan Haight Online Pharmacy Consumer Protection Act - 2009

Gave the FDA additional authority esp. related to postmarketing requirements and premarket notification and approval, while expediting the premarket device approval process

Safe Medical Devices Act of 1990

heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine ("ecstasy")

Schedule 1 Drug examples

Same as Federal "Central Fill"

Shared Order Filling Definition

>Share an electronic record >Same owner or written contract >Joint P&P manual

Shared Order Processing Requirements

application to allow a company to make changes to a product that already has an approved NDA. CDER must approve all changes to ensure that conditions originally set for the product are still met

Supplemental New Drug Application (sNDA)

Required for Medicaid outpatient scripts as of 2008 Enacted as a fraud reducing measure Must contain features to prevent copying, erasure or modifcation, and the use of counterfeit forms

Tamper Resistant Prescription Pads

a. Class I

The FDA has notified Slipshod Pharmaceutical Manufacturer that several lots of their OTC analgesics have been found to be contaminated with digitoxin and present serious threat to patients' safety. The FDA is likely to request that Slipshod announce which class of drug recall? a. Class I b. Class II c. Class III d. Class IV

e. route of administration, indication for use, combination of ingredients.

The FDCA defines a "new drug" as a previously approved drug entity with a new: a. route of administration. b. indication for use. c. combination of ingredients. d. a and b e. a, b and c.

> Authorized the FDA to ban individuals or firms from participating in the drug approval process if convicted of related felonies > Also imposes severe civil penalties for any false statements, bribes, failures to disclose material facts, and other related offenses

The Generic Drug Enforcement Act of 1992

7; 2 terms; 4 years each

The Kansas Board of Pharmacy consists of ___ members who are eligible to serve for a maximum of ___ terms of ___ years each (see 74-1603 & 74-1604).

c. Treatment activities

The minimum necessary requirement for disclosing PHI does NOT apply to: a. Payment for services b. Marketing activities c. Treatment activities d. a and c

c. FTC

The advertising of OTC products is regulated primarily by: a. FDA b. HHS c. FTC d. DEA

b. the state government

The authority to grant practitioners a license to prescribe drugs resides with: a. the federal government b. the state government c. the local district court d. none of the above

c. July 31, 2011

The expiration date on the manufacturer's label of a prescription drug is July 2011. The pharmacist should consider the expiration of this drug to be: a. July 1, 2011 b. July 15, 2011 c. July 31, 2011 d August 1, 2011

a. between 1938 and 1962.

The purpose of DESI was to prove efficacy of prescription and OTC drugs that were marketed: a. between 1938 and 1962. b. before 1938. c. after 1962. d. none of the above.

2:1; 3:1

The ratio of pharmacy technicians to pharmacists must not exceed ___ unless two of the technicians hold certification approved by the board, in which case the ratio of technicians to pharmacists may be ___.

c. Recognized reference on compounding and manufacturing

The reference library of a community pharmacy is required to include all of the following items EXCEPT: a. Medical dictionary b. Recognized reference in drug interactions c. Recognized reference on compounding and manufacturing d. Copy of the Kansas Controlled Substance Act and regulations

b. C-V

The statement: "Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed." Must appear on prescription medication containers which contain controlled substances in the following schedules EXCEPT: a. C-III b. C-V c. C-II d. C-IV e. It must be on containers of all of the above schedules.

2 years

The term "preceptor" in Kansas is defined as a licensed pharmacist who possesses at least ___ years of experience as a registered pharmacist and who supervises students obtaining their required pharmaceutical experience.

The total number of dosage units of all controlled substances distributed to DEA registrants by a practitioner during the twelve-month calendar year in which the practitioner is registered to dispense cannot exceed ___ percent of the total number of dosage units of all controlled substances distributed and dispensed during this time period.

>Pharmaceutically Equivalent >Bioequivalent

Therapeutic Equivalent

7 days

Time a pharmacist has to obtain the original RX from a Dr for an emergency C-II

One time

To comply with minimum CQI requirements in Kansas, a community pharmacy must meet at least ____ (how many times) each quarter of each calendar year to review all incident reports generated for each reportable event that occurred in that pharmacy since the last meeting.

>Immediate use : intended for immediate use >Low : Single transfer of sterile dosage forms. Manually measuring and mixing no more than 3 manufactured products into IV >Medium : TPN's or more than 3 injections >High : Non-sterile bulk drug that will be terminally sterilized

USP <797> Sterile Preparation Levels

>Private, independent organization >Combo of the United States Pharmacopeia (USP) and the National Formulary (NF). >Standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. >Enforceable by the FDA

USP-NF

combination of two official compendi: the United States Pharmacopeia (USP) and the National Formulary USP: Mongraphs for drug substances, dosage forms, compounded preparations; dietary supplements appear in separate section NF: Excipient monographs Drug product in US must conform to USP/NF standards to avoid possible charges of adulteration or misbranding

USP/NF

Code of Federal Regulations

Updated annually, this publication is made up of permanent rules and regulations promulgated by federal agencies

d. The pharmacy was robbed and C-IIs and 222 forms were taken; The pharmacy is planning to move to a new location; The owner (sole proprietor) of a community pharmacy dies.

Under which of the following circumstances does the pharmacist need to notify the DEA? a. The pharmacy was robbed and C-IIs and 222 forms were taken. b. The pharmacy is planning to move to a new location. c. The owner (sole proprietor) of a community pharmacy dies. d. All of the above.

>Only from adult care homes, mail order pharmacies, medical care facilities >No controls, unit dosed, and normal precautions >Not to be resold

Utilization of Unused Medications

Vaccine Adverse Event Reporting System

VAERS

>Verified Pharmacy Practice Sites >Site to verify a valid internet dispenser

VIPPS

AKA Drug Price Competition and Patent Term Restoration Act Granted pharmaceutical manufacturers incentives by granting some market exclusivity Increased availability of generics Required FDA to publish an up-to-date list of all Rx and OTC drugs approved for safety and efficacy (The Orange Book)

Waxman-Hatch Act of 1984

c. 73

What is the maximum number of pseudoephedrine HCl 60mg tablets a pharmacist may legally sell to one purchaser in one day if he/she presents the required identification? a. 36 b. 60 c. 73 d. 146

1)Name of the patient 2)Name of the Drug 3)Name of the prescribing Dr. 4)Date of the prescription

What on a C-II Script may not be changed?

a. 0%

When a DEA inspector conducts an audit of your controlled substances, what percent error are you allowed? a. 0% b. 3% c. 5% d. 10%

Attorney General in conjunction with the Secretary of Health and Human Services

Who determines Controlled Substance Schedules?

d. Seizure of the product (New Law - FDA can order a recall??)

When a manufacturer refuses to recall its violative drug product at the request of the FDA, which of the following legal remedies is available to the FDA? a. Publicity b. Injunction c. FDA-initiated recall d. Seizure of the product

e. do none of the above

When a pharmacist leaves the premises of a community pharmacy, a pharmacy intern may: a. continue to fill prescriptions as long as none are dispensed. b. take prescription transfers from other pharmacies. c. hand prescriptions to patients as long as they are refills and were filled by the pharmacist. d. a and c e. do none of the above.

e. pharmacy's identification number if different from the manufacturer's lot number, product's manufacturer or supplier, expiration date of the original container.

When a pharmacy repackages a drug product in unit-dose packages, a record should be maintained which includes among other things the: a. pharmacy's identification number if different from the manufacturer's lot number. b. product's manufacturer or supplier. c. expiration date of the original container. d. a and b e. a, b, and c

>New additive or proportion of additive changes >New combo of already approved drugs >For a new indication >New duration, dose, or method

When does a Approved Drug become a New Drug?

If registrant is using electronic record keeping

When is the Red "C" waived on Controlled substance record keeping?

At place of business readily retrievable

Where do you store DEA Registration Certificate?

a. Durham Humphrey

Which FDCA amendment exempted certain drugs from the "adequate directions for use" labeling requirement if they bear "Rx only" on their labels? a. Durham Humphrey b. Kefauver-Harris c. Prescription Drug Marketing d. Waxman-Hatch

e. Fraud when applying for registration or a permit; Intentionally falsifying or altering prescriptions; Unlawful diversion of drugs to others; Intentionally adulterating any drug.

Which items is(are) included in the definition of "unprofessional conduct" stated in the Kansas Pharmacy Practice Act? a. Fraud when applying for registration or a permit. b. Intentionally falsifying or altering prescriptions. c. Unlawful diversion of drugs to others. d. Intentionally adulterating any drug. e. All of the above.

e. USP/NF, Homeopathic Pharmacopeia

Which of the below is(are) officially recognized by the FDCA? a. USP/DI b. USP/NF c. Homeopathic Pharmacopeia d. a and b e. b and c

e. Dentists; Surgeons; Optometrists

Which of the below practitioners may apply for and receive a DEA registration number in Kansas? a. Dentists b. Surgeons c. Optometrists d. a and b only e. a, b and c

e. I. Develop or approve written policies and procedures for the pharmacy. II. Maintain records in the pharmacy describing the training and education regarding work functions performed by all pharmacy personnel. III. Inventory all controlled substances in the pharmacy within 72 hours after beginning to function as the PIC.

Which of the following activities is (are) the responsibility of a pharmacist-in-charge of a community pharmacy? I. Develop or approve written policies and procedures for the pharmacy. II. Maintain records in the pharmacy describing the training and education regarding work functions performed by all pharmacy personnel. III. Inventory all controlled substances in the pharmacy within 72 hours after beginning to function as the PIC. a. I only b. III only c. I & II only d. II & III only e. I, II, & III

d. II. C-II prescriptions in one file; C-III, C-IV, and C-V prescriptions in another file; Non-controlled prescriptions in a third file. III. C-II prescriptions in one file; C-III, CI-V and C-V and non-controlled prescriptions together.

Which of the following are DEA-authorized methods that a pharmacist may use to file hardcopy controlled and noncontrolled substance prescriptions? I. All prescriptions are filed together with C-II prescriptions stamped with a red "C". II. C-II prescriptions in one file; C-III, C-IV, and C-V prescriptions in another file; Non-controlled prescriptions in a third file. III. C-II prescriptions in one file; C-III, C-IV and C-V and non-controlled prescriptions together. a. I only b. III only c. I & II d. II and III e. I, II, & III

d. II. Thirty contact hours are required biennially for re-licensure. III. Failure to supply the Board of Pharmacy evidence of adequate CE will cause one's license to become inactive.

Which of the following are true concerning pharmacists' continuing education requirements in Kansas? I. One CEU is equal to one contact hour. II. Thirty contact hours are required biennially for re-licensure. III. Failure to supply the Board of Pharmacy evidence of adequate CE will cause one's license to become inactive. a. I only b. III only c. I & II only d. II & III only e. I, II, & III

d. A drug is prepared and packaged under unsanitary conditions, The drug's manufacturing procedures do not conform to GMP standards.

Which of the following circumstances would be considered "adulteration" under the FDCA? a. A drug is prepared and packaged under unsanitary conditions. b. The drug's manufacturing procedures do not conform to GMP standards. c. The drug is subject to the Poison Prevention Packaging Act and is not packaged accordingly. d. a and b e. a, b and c

e. A drug's label or labeling is false or misleading, A prescription for a legend drug is refilled without the prescriber's authorization, A drug is subject to the Poison Prevention Packaging Act is not packaged accordingly.

Which of the following circumstances would be considered "misbranding" under the FDCA? a. A drug's label or labeling is false or misleading. b. A prescription for a legend drug is refilled without the prescriber's authorization. c. A drug is subject to the Poison Prevention Packaging Act is not packaged accordingly. d. a and b e. a, b and c

d. a pharmacist or non-pharmacist, as designated in a current and properly executed power of attorney; the pharmacist or non-pharmacist, who signed the most recent DEA application for a controlled substance registration.

Which of the following has/have the authority to sign a triplicate DEA Form-222 in order to obtain C-II drugs from another registrant? a. a pharmacist or non-pharmacist, as designated in a current and properly executed power of attorney. b. the pharmacist or non-pharmacist, who signed the most recent DEA application for a controlled substance registration. c. a pharmacist who has received verbal authorization from the owner or manager of a pharmacy registrant. d. a and b e. a, b and c

d. Pharmacist; Pharmacy Technician; Pharmacy student and intern

Which of the following individuals are required to be identified by nametags if performing pharmacy-related duties? a. Pharmacist b. Pharmacy Technician c. Pharmacy student and intern d. All of the above

c. I. Allowing a pharmaceutical sales representative to peruse your prescription files to ascertain of a certain doctor is prescribing a new antidepressant. II. Providing a husband with a list of drug products and their therapeutic uses that his wife received last year.

Which of the following might represent a breach of privacy based on federal HIPAA? I. Allowing a pharmaceutical sales representative to peruse your prescription files to ascertain of a certain doctor is prescribing a new antidepressant. II. Providing a husband with a list of drug products and their therapeutic uses that his wife received last year. III. Allowing a pharmacy clerk to call out the names of waiting patients to pick up their prescriptions. a. I only b. III only c. I & II only d. II & III only e. I, II, & III

d. meperidine 50 mg tablets; diazepam 10 mg injections; methylphenidate 5mg tablets

Which of the following prescription medications can be mailed by a community pharmacy through the US Postal Service to a patient? a. meperidine 50 mg tablets b. diazepam 10 mg injections c. methylphenidate 5mg tablets d. all of the above

a. Community pharmacist compounds large bulk quantities of inhaler solution and ships the product to numerous out-of-state pharmacies for dispensing.

Which of the following situations may require a pharmacy to register with the FDA, be subject to FDA inspections, and comply with CGMP? a. Community pharmacist compounds large bulk quantities of inhaler solution and ships the product to numerous out-of-state pharmacies for dispensing. b. Hospital pharmacy repackages and relabels a drug product in unit-dose packaging for routine use for inpatients. c. Community pharmacist compounds drugs in anticipation of prescription drug orders based on routine prescribing patterns. d. a and b e. a, b, and c

I. Non-controlled prescriptions may be transferred as many times as there are authorized refills on the prescription.

Which of the following statements is (are) accurate concerning the transferring of prescriptions? I. Non-controlled prescriptions may be transferred as many times as there are authorized refills on the prescription. II. C-II prescriptions may be transferred only one time. III. Pharmacy technicians may process the prescription transfer in Kansas. a. I only b. III only c. I & II only d. II & III only e. I, II, & III

d. The FDA requires all commercial products to carry NDC numbers; NDC number identifies the drug, strength, and size of package and is frequently used for third-party claims submission

Which of the following statements is accurate concerning NDC numbers? a. The FDA requires all commercial products to carry NDC numbers. b. NDC number identifies the drug, strength, and size of package and is frequently used for third-party claims submission. c. An NDC indicates that the drug has received NDA approval. d. a and b e. a, b, and c

d. The customer must be at least 18 years old ; The purchaser must present suitable identification to the pharmacist if he or she is unknown to the pharmacist.

Which of the following statements is(are) accurate concerning the dispensing of OTC C-V cough preparations? a. The customer must be at least 18 years old. b. The pharmacy technician may complete the entire transaction, including the dispensing, under the supervision of a pharmacist. c. The purchaser must present suitable identification to the pharmacist if he or she is unknown to the pharmacist. d. a and c

d. It is legal to dispense a medication for an unapproved use.

Which statement is correct about dispensing a drug for a use that is unapproved by the FDA? a. It is illegal for a pharmacist to dispense a prescription for an unapproved use. b. It is illegal only if the pharmacist is aware that it is for an unapproved use. c. It is illegal if the use varies significantly from the regular usage (in terms of dose, etc.) d. It is legal to dispense a medication for an unapproved use.

c. January 1, 2012

While employed as a hospital pharmacy intern, you routinely repackage commercially available prescription drugs into USP-quality unit-dose containers. On January 1, 2011, you repackage Killacillin 200mg that carries an expiration date on the container of January 2, 2013. According to FDA recommendations, which expiration date should you place on the unit-dose packages? a. February 1, 2011 b. April 1, 2011 c. January 1, 2012 d. July 1, 2011 e. January 2, 2013

d. Attorney General in conjunction with the Secretary of Health and Human Services

Who has primary authority on the federal level for the scheduling, rescheduling, or de-scheduling of controlled substances? a. DEA b. FDA c. Attorney General d. Attorney General in conjunction with the Secretary of Health and Human Services

OTC - FTC RX - FDA

Who regulates drug advertising : OTC and RX?

A pharmacist or non-pharmacist as designated in a current and properly executed power of attorney A pharmacist or non-pharmacist who signed the most recent DEA application for a controlled substance registration

Kansas MPJE

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