• Shuffle
    Toggle On
    Toggle Off
  • Alphabetize
    Toggle On
    Toggle Off
  • Front First
    Toggle On
    Toggle Off
  • Both Sides
    Toggle On
    Toggle Off
  • Read
    Toggle On
    Toggle Off
Reading...
Front

Card Range To Study

through

image

Play button

image

Play button

image

Progress

1/84

Click to flip

Use LEFT and RIGHT arrow keys to navigate between flashcards;

Use UP and DOWN arrow keys to flip the card;

H to show hint;

A reads text to speech;

84 Cards in this Set

  • Front
  • Back

How often must registration to manufacture or distribute controlled substances be obtained?

Annually

If a business owns three different locations manufacturing or distributing controlled substances, how many registrations must be made?

Three

At what times may the department inspect to ensure registration and compliance?

At reasonable times.

What persons or business activity is allowed within the pharmacy?

Only those related directly to the practice of pharmacy.

How long must persons involved with controlled substance use and movements keep records?

Five years

What kind of reporting is required of controlled substance loss and when?

24 hours since knowledge of the loss. A written report is required within 3 days.

Which classes of controlled substance use or movement must be reported?

CI, CII, and others as designated by the department.

Who may veterinarians prescribe controlled substances for?

Not humans.

What are special dispensing rules for methadone use in treatment programs?

Administration, dispensing, and changes must be approved prior by the treating physician.

What size may controlled substance prescription forms be?

4x5 - 4.5x6.5 inches

Within how long must the duplicate CII prescription provided with each prescription be forwarded to the department?

Seven days. Physical forwarding may be waived if an approved electronic method is used.

How long must duplicate CII prescriptions be retained by the department?

Two years

How may CIIs be filled for LTC or patients with a terminal illness be filled?

They may be in partial quantities in individual dosage units.

How long after writing a CII prescription may it be filled?

Three days (or seven days?)

How many refills may a CII have?

None

How long after an non-CII controlled prescription is written may it be filled or refilled?

3 months

How many refills may a non-CII controlled prescription have?

2 refills

When may a pharmacist fill an oral precription for a CII?

During an emergency. It must be reduced to writing by the practitioner within 72 hours.

What controlled prescriptions may be received by telephone, and how are they handled?

non-CII. A pharmacist must receive the prescription. The practitioner's oral code must be recorded on the rx. They must be put in writing by the pharmacist immediately.

How often must pharmacies report controlled substance dispensing?

At least every seven days. All information associated with the dispensing is included.

How may controlled substance prescriptions be filed?

CIIs must be kept in a central file. Non-CIIs must be at stamped with a one inch red "c" in lower right corner. They may kept consecutive with the non-controlleds or in a database that prints all prescriptions daily.

Who may view prescription records?

Only officers.

How may expired etc controlled substances be disposed?

Sent to or destroyed by an authorized agent of the department.

How may usable controlled substance be disposed of?

They may be transferred to another registrant if unopened, or returned to the distributor. They may also be disposed of through an authorized agent.

How are complaints against a license managed?

They are delegated to the department

How long does a board have to inform an applicant for a license?

One year

What allowance do armed forces have on their license?

They can have their expired license reinstated within 120 days after they are discharged.

What are a licensee's responsibility regarding their address?

The board must be informed of any personal or business address change within 30 days

If judged at fault during professional practice, how and within how long must it be reported to the board?

Written notice within 30 days

What is the maximum duration of a license revocation?

5 years

What are the grounds and duration of immediate license suspension?

Either immediate threat to personal safety, or fraud upon consumers. Twenty days, within which a hearing is held.

When is a drug adulterated? (3)

It is at all filthy, or quality purity or strength differs from compendium, or if it is labeled for a different quality strength or ingredient

When is a drug misbranded? (9)


If the labeling is misleading or inaccurate, if contents and manufacturer are absent, if addictive properties aren't labeled, directions aren't adequate, packaging will keep from drug deterioration, the dosing is dangerous, it is an uncertified insulin or antibiotic batch, it is expired, or is a rx that does not include "rx only"

When is an appropriate "use by" date?

The date on the manufacturer package, or one year from dispensing, whichever is earlier.

When can "take as directed" be used ?

When referring to written instructions, not oral.

How long may a prescription with refills "as needed" or "prn" be refilled?

Up to 12 months from the date written, plus once more in the following 3 months for no more than 30 days that does not fall outside these 15 months.

What three additional items must a prescription transfer contain?

The date of the original prescription, the date of the last refill, the number of refills remaining.

In what instance may the symptom or condition be written on the drug label?

When the provider writes it in the directions for use.

What additional requirement must an out of state prescription follow?

The practitioners full name, address, and phone number must be recorded in the prescription record.

Under what condition must a pharmacist use the brand name of a prescription?

When the practitioner hand writes "brand medically necessary" or similar on the prescription.

Under what condition can an anti-epileptic medication be generic substituted?

Consent of the practitioner and patient or guardian.

What medications are classified CII in Hawaii? (16, some classes)

opium (various forms)


codeine


hydrocodone


hydromorphone


morphine


oxycodone


oxymorphone


coca and derivitives


fentanyls, various


methadone


tapentadol


phencyclidine


secobarbital


amphetamine (various)


methylphenidate


lisdexamfetamine

What are the limits per dose to make codeine only CIII?

Not more than 1.8gm per 100ml, or 90mg per dosage unit

What are the limits per dose to make hydrocodone only CIII?

Not more than 300mg per 100ml, or 15mg per dosage unit

What are the limits per dose to make opium only CIII?

Not more than 500mg per 100ml or 100gm, or 25mg per dosage unit

What are the limits per dose to make morphine only CIII?

Not more than 50mg per 100ml or 100gm, or 25mg per dosage unit

How long may a CII be held in a pharmacy between filling and dispensing?

Seven days

What is required of interns, residents, foreign-trained physicians, or VA physician prescribing?

They must include on their prescriptions the hospital registration number, and a special internal code identification number

What is required of official (ie government or armed forces) MDs writing prescriptions?

They must include on the prescription their service branch, and service ID number.

What is required of a physician assistant writing controlled substance prescriptions?

The DEA number of himself and the supervising physician, both their names address and phone numbers. The supervising physician must initial the medical record entry within seven working days.

What restrictions are there on the filling of controlled substances by central fill pharmacies?

They cannot fill CIIs, and must be owned or contracted with the main pharmacy.

What is allowable regarding partial fills of CIIs?

CIIs may be partial fill if the pharmacy lacks the full quantity and notes the amount supplied on the face of the prescription. The remainder must be filled within 72 hours, and if not the precriber must be notified.

What is allowable regarding partial fills of non-C2 controlled substances?

As noncontrolled, except no may occur three months after using the prescription.

What allowances are made for CII prescribing for patients in long-term care or hospice?

"LTCF patient" or "TI" must be recorded on partial fills. They may be partially filled three times. Record on the back of the prescription or other record the fill dates, the amounts dispensed and remaining, and the pharmacist. The prescription is valid for 30 days.

How may faxed CII prescriptions be filled?

The original signed must reach the pharmacist before dispensing. Parental narcotics compounded for direct administration may be faxed, and "Home Infusion IV" must be written in red ink. LTCF and hospice CIIs may be faxed and those designations written in red ink.

What is the maximum amount of methadone or LAAM dispensible in an outpatient addiction program?

14 days

How may a controlled substance be dispensed to someone not known to the pharmacist?

Name, signature, and ID details must be documented. If the patient lacks ID then the prescriber can be called to verify their identity.

What is the maximum number of packages of pseudoephedrine that may be carried without a pe permit?

Three

What are the storage and sale limits of pseudoephedrine?

Maximum 3.6gm daily, 9gm per 30 days. PE must be kept behind the counter and given directly to the patient. They must have ID, sign, and everything is recorded in a log. Transmit this info to the National Precursor Log Exchange before completing the sale.

How long is a written certification for medical marijuana valid?

One year

Who may receive controlled substance samples?

Not ARNPs or PAs

Who may prescribe controlled substances?

Physicians, dentists, podiatrists, veterinarians, ARNPs with prescriptive authority. PAs may prescribe nonCIIs. NDs and optometrists may not prescribe controls.

What is the prescriptive authority of NDs?

No controlled substances. They may prescribe anything on the state naturopathic formulary, which includes treatment for most common medical issues.

What is the mechanism for license renewal?

It must be renewed by Dec 31st of each odd numbered year. 30 hours of CE must be completed. Expired licenses can be renewed for a fee within three years.

What is required to administer vaccines to 14-17 year olds?

A training program every other biennium. A vaccination record must be provided to the patient, and forwarded to their medical home including administration details within 72 hours.

What are the requirements regarding a pharmacist in charge?

There must be a pharmacist present to work with, receive, or dispense prescriptions.

What are the rules regarding display of pharmacist license?

It must be conspicuously displayed in the place of business, and held in the owner's possession at all times. Relief pharmacist license do not need to be displayed.

What is the prerequisite to obtain a pharmacy intern license?

Complete one year of pharmacy school. Interns are termed assistants in HAR-95

When may a pharmacy permit be applied for?

At least 15 days before a board meeting.

What are the minimum reference and equipment requirements for a pharmacy? (6 of each)

USP formulary, DEA regulations, state controlled substance laws, state food and drug laws, state pharmacy law, prescription files. Class A prescription balance, mortar and pestle of glass or porcelain, refrigerator, various bottles and vials, liquid measuring devices, prescription labels.

What are allowances for night cabinets and after hours pharmacy access in institutions?

Night cabinet contents must have proper labels and be prepackaged in sufficient amounts with prescriptions left when drugs are withdrawn. Audited monthly, inventoried quarterly. Night access to pharmacies are allowable in clinical emergencies by pre-selected instructed individuals.

What are allowances for emergency kits for facilities with no on site pharmacy?

They must be clearly marked as for emergencies only, the medications labeled, and expired meds removed proactively.

Who may receive oral non-controlled prescriptions? How are faxed non- controls handled?

Pharmacists only, and they are reduced to writing immediately. Faxes must be from the prescriber, otherwise they function as written prescriptions.

Who may receive transfers, and what must be recorded?

Pharmacists only on both sides. The sender writes void and invalid on the face of the prescription, and the date and pharmacist names on the back. The receiver writes transfer on the front and the sender's name and address, and original rx number.

How may prescriptions for controlled substances be transferred?

CIIs may not be transferred. Other controls may be transfered only once unless there is a real time database. The DEA numbers of the pharmacies must be recorded on the old and new prescription paper.

What are some advertising requirements for pharmacies?

Advertising can occur in any media, but with intention to provide information, not create demands for drugs. Brand names must be included. Three common quantities must be used for price advertisements. Everything must be true and informative. Controlled substances cannot be advertised.

What is required for emergency contraception collaborative agreements?

The agreement between pharmacist and physician must be sent to the board within 7 days. The pharmacist must complete an ACPE approved training. Dispensing is allowed if <120 hours have passed and recent menstruation has occurred. Plan B is preferred, but others may be used in prudent circumstances. N/V meds are included in authority. The patient must be refered to the physician.

What is the DEA Form for significant controlled substance loss?

DEA Form 106

What are the DEA Forms for controlled substance destruction by a pharmacist?

Form 4, and then Form 41. Submit at least 2 weeks before destruction, can be done once yearly.

What is the DEA Form for registration and termination of registration?

Form 224 renewed every three years. To terminate, notify DEA in writing and include a voided Form 222.

When must controlled substance inventory be done for DEA?

On registration, and then biennially. CIIs exact, other controls can be estimated for containers of less than 1000 units.

What are the volume limits of total controlled substance transfers?

No more than 5% of what is dispensed annually, or else are considered a distributor.

What are pharmacy technician license requirements? What is the technician to pharmacist ratio?

None, technicians are "unregulated". Not stated, assumed no limit.

What are DEA requirements for business transfer of ownership?

Notify at least 14 days before transfer, with details of new registrant or if moving or closing. Inventory controls, both sides keep records for at least 2 years.