Nebraska MPJE

What legistation was created for the provisions for the fast track review of some NDA submissions to expedite approval of new drugs used to treat life-threatening conditions?

Food and Drug Administration (FDA) Modernization Act 1997

What legistation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses?

FDA modernization act 1997 enc

What act reduced the cose of orphan drugs?

Orphan drug act 1983

What act prohibited the adulteration or misbranding of food and drugs?

Pure Food and Drug Act 1906

What act required tha active ingredients be placed on the label of a drug's packaging and that drugs couldn't fall below purity levels established by the USP or National Formulary?

Pure food and drug act 1906

What amendment defined two categories - legend and OTC

Durham-humphrey 1951

What amendment mandated there must be "adequate directions for use" on the manufacturer's label for OTC's

Durham-Humphrey 1951

What amendment declared that all new drugs marketed in the U.S. had to be shown to be safe and effective

Kefauver-Harris 1962

What act was passed to correct the problem of diversion from the normal distribution channels. Prohibits drug from being re-imported into the U.S. Except by the manufacturer of said drugs.

Prescription Drug Marketing Act 1987

What act requires proper storage of drugs and maintenance of appropriate distribution records?

Prescription Drug Marketing Act 1987

What act prohibits sale, purchase, or trade of any drug which was purchased by a public or private hospital or other health care entity?

Prescription Drug Marketing Act 1987

What act prohibits the sale, purchase, or trade of any drug sample or drug coupon redeemable for a drug product?

Prescription Drug Marketing Act 1987

To be PIC what are the hourly requirements they must physically work in a pharmacy?

majority of the hours per week that the pharmacy is open averaged over a 12 - month period or 30 hours per week

Who must submit the Pharmacy Quality Assurance Report and when?

PIC and Annually

Who submits the Parkinson's Disease Registry Act to the Department semiannually?

PIC

Who needs to be notified if there's a change in pharmacy ownersip, address, PIC, or pharmacy closes?

Department of Health and Human Services

Within how many days should the department be notified that a pharmacy is closing?

30 days prior

Within how many days should the department be notified of the disposition/sale of inventory, prescription records, etc due to pharmacy closing?

15 days

When shold the department be notified of a change in PIC?

Immediately

What information is reported under the Parkinson's disease registry

Report shall include the name, address, and socical security number of the person for whom the drugs were prescribed and the name and address of the prescribing physician

How long must a pharmacy maintain inventory records

5 years

Within how many days should a copy of the initial CS inventory, annual inventory, and/or CS inventory take pursuant to change in PIC be forwarded to the Department?

Within 30 days after completion

In the event of a pharmacy closing what documents must be returned to the Department

Pharmacy license, pharmacy's DEA registration, all unused DEA 222 Forms

If CS inventory is transferred to another pharmacy, how long must those transfer records be maintained?

2 years

How often does a consult pharmacist have to physically be in the public health clinic?

30 days

May a pharmacy intern transfer CS?

Yes

May a pharmacy intern conduct DUR?

Yes

May a pharmacy intern oversee technicians?

No

May a technician receive an oral medication order?

No

May a technician Drug Product Select?

No

May a technician counsel or provide any professional consultations?

No

May a technician clarify a medical order?

No

Can supervision and/or verification be fulfilled via real-time audiovisual cmmunication?

Yes, for verification only if patient is resident of a facility

Requirements to be a pharmacy technician

Must be at least 18 years old, have met the educational requirements of a high school diploma, never been convicted of any nonalcohol, drug-related misdemeanor/felony, fulfill training requirements within the first 30 days of employment, apply for registration w/in 30 days of being hired

Supervision Ratio

2 technicians : 1 RPh

3 interns : 1 RPh

2 technicians and 1 intern : 1 RPh

Are interns receiving their experiential training applied to the supervision ratios

No

May retail pharmacies receive starter packs?

Yes, they are not considered samples and are intended for initiation of drug therpy for a patient. Also not labeled as a sample

Possession of prescription drug samples by retail pharmacies would be considered ________ ___________ by the FDA.

Drug diversion

When may institutional pharmacies receive prescription drug samples?

Licensed prescriber requested (disposition precisely recorded and stored separately from normal drug stock)

If a licensed practitioner provides written requiests for prescription drug samples, for how long must the manufacturer keep the request and who is responsible for the annual inventory of the samples?

3 years; sales representatives are responsible for prescription drug samples, including the annual inventory

What is proper refrigeration temperatures

36 to 46'F or 2 to 8'C

What is the proper freezer temperatures

-4 to 14'F or -20 to -10'C

What is the proper room temperature?

46 to 59'F or 8 to 15'C

A pharmacy must register as a wholesale drug distributor if it distributes more than:

5% gross dollar value of the total prescription drug sales revenue in a 12month period

Define long-term detox treatment

30 to 180 days

Define maintenance treatment

> 21 days

Define short term detox treatment

< 30 days

What act enables qualifying physicians to receive a waiver from the special registration requirements in the Controlled Substance Act for the provision of medication-assisted opioid therapy

Drug Addiction Treatment Act 2000 (DATA 2000)

May an optometrist prescribe C2's?

Yes but only topical ophthalmics

May a prescriber prescribe controlled substances to themselves?

No

Can an APRN dispense samples?

Yes, but not a APRN-CNS (clinical nurse specialist) they have no prescribing authority

May a midwife (APRN-CNM) prescribe C2's?

Only for up to 72 hours for pain only

When is the name of the prescriber (supervisor of PA) required to be on the label of a prescription written by a Physician's Assistant?

When required for reimbursement purposes

How can a pharmacist verify a prescriber is allowed to prescribe suboxone?

Confirm prescriber has been granted a waiver via SAMHSA website/phone, Check DEA# for leading letter "X"

What part of an RX may a pharmacist never change?

Patient name, drug name, Dr. Name/signature

Who should be contacted in the event that the pharmacist does not receive a cover script for an emerency verbal within 7 days of the oral C2 order?

The dea

What schedule is glutathione?

C2

What schedule is oxandrolone (Oxandrin)?

C3

What schedule is phendimetrazine?

C3

What schedule is be petaling (didrex)?

C3

What schedule is Ephedrine?

C4

According to federal law how much C5 containing opium can a Pharmacist sell within 48 hrs?

Not more than 240mL/8oz. Or 48 dosage units

According to federal law how much C5, other than opium containing, can be sold by a Pharmacist in 48 hrs?

Not more than 120mL/4oz or 24 dosage units

What are legal letters for the first letter in a prescriber's DEA number?

A, B, F, G, M

Prescription quantity for residents of LTCF must be ____ days, unless otherwise limited by the prescriber

60 days

If a RPh enters a practice agreement with a licensed medical practitioner to provide pharmaceutical care according to written protocols, how often must the agreement be reviewed, signed, and dated?

Every 12 months

A chart order in a hospital must contain?

Patient Name, Date of order, Drug name, strength, and sig, and prescriber's name

How long must a poison registry be maintained?

2 years from the last entry

When refilling a prescription that was initially dispensed in a threaded child-resistant container, the RPh must always replace:

The plastic closure

The labeling requirements do not apply when no more than how many days supply of a C2 is dispensed at one time for an institutionalized patient?

7 day supply

The labeling requirements do not apply when no more than how many days supply of a C3 through 5 may be dispensed at one time for an institutionalized patient?

34 day supply or 100 dosage units

Filing systems for prescription hard-copies?

2 file system - C2 in one drawer and C3 through non-controlled in another (C3-5 must be marked with a red C)

3 file system

How long should prescription hard-copies be maintained?

5 years

What is the purposes of drug product select?

To provide for the drug product selection of equivalent drug products and promote the greatest possible use of such products

What does Bioequivalent mean?

Same dosage form of identical active ingredients in identical amounts

What does Chemically equivalent mean?

Contain amounts of the identical therapeutically active ingredients in the identical strength, quantity, and dosage form and meet present compendial standards

When can a RPh not product select?

Patient or caregiver instructs not to, Prescriber specifies on phone or writes NDPS, DAW, or BMN

How many times may a prescription be transferred?

Once, unless they share a real-time online database

Who can conduct controlled and non-controlled transfers?

RPh or Intern

When a prescriber writes "do not label" on the original written prescription, what isn't placed on the dispensing label?

Drug name

When a prescription is written for an animal which of the following should be on the label: (A) name of animal, (B) species of animal, (C) name of owner

Species of animal and name of owner

List the requirements of Unit-Dose packaging system

(1) contains individually sealed doses, (2) May or may not attach the sealed doses to each other by placement in a card, (3) May not contain doses for greater than 14 days, (4) non-reusable

How long must a cancer drug repository logbook be maintained?

5 years

In accordance with Nebraska Pharmacy Law a RPh may accept return of the dispensed drug or device when?

Device is defective/malfunctioning, collected for the purpose of disposal, in response to a recall

How long should record of Form 41 be maintained?

5 years

Theft occurs at your pharmacy, what should you do?

Complete a DEA Form 106 (send org. To DEA, keep copy for pharmacy, and send copy to NE Department) and contact local law enforcement

What should be on the exterior of an e-kit box?

"Emergencies only"; listings of drugs: name, strength, quantity, route, and expiration; name, address, and telephone of pharmacy

What are the restrictions on the contents of an e-kit?

Can not contain multi dose vials, no more than 10 CS drugs, and no more than 50 total drugs

What information shall be on repackaged containers

Manufacturer, lot #, drug name, strength, dosage form, NDC, route, and expiration on a typewritten label

How often shall a e-kit be inspected by a RPh?

Once every 30 days and after reported use (must be inspected by a pharmacist)

How long shall record of inspection and delivery of e-kit be maintained?

5 years

Who determines the contents of an E-kit?

Supplying pharmacy and LTCF

How soon after the e-kit is opened, should the pharmacy be notified?

Within 24 hours

The licensee must notify the Department in writing by e-mail, fax, or postal within how much time of any change in environment which will adversely affect the potency, efficacy, safety, or security of the drugs, devices, or biological a in the pharmacy (accident, natural disaster, interruption in utility services)?

24 hours

The pharmacy must establish and implement disaster preparedness plans and procedures that address:

(1) How the pharmacy will provide storage of drugs at proper temp

(2) how the pharmacy will provide disposal of drugs in quality affected

(3) how the pharmacy will secure the drugs from the public

(4) how the pharmacy will maintain patient and inventory records

What drugs are allowed on a public health clinic's formulary?

Contraception, STD, and vaginal infections

Delegated dispensing permit, worker qualifications?

At least 18 y/o, earned high school diploma or equivalent, completed training, demonstrated proficiency

Requirements of a RPh, due to OBRA 90?

DUR (prospective and retrospective [medicaid]), Offer to Counsel, Maintain patient profile

Minimum required to maintain patient profile?

Name, address, telephone#, don, gender, significant medical history (allergies), RPh comments relevant to drug therapy

When is counseling not required?

Patient is in facility, refused by patient/caregiver, counseling may hurt patient-practitioner relationship, prescriber specifies to be "contacted prior to counseling"