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Federal Law > Pharmacy Practice > Flashcards

Pharmacy Practice Flashcards

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1
Q

This amendment authorizes oral prescriptions and the number of refills as indicated in the initial prescription

A

Durham-Humphrey Amendment

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2
Q

What kinds of drugs can the FDA authorize to categorize as prescription?

A

Drugs that are:

  • unsafe except for use under supervision of a practitioner because of: the toxicity, the method of use, or the collateral measures necessary to use the drug
  • subject to the NDA approval process
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3
Q

Who can authorize e-prescribing?

A

The states

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4
Q

Can you e-prescribe Medicare prescriptions?

A

Yes, and these laws preempt state restrictions

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5
Q

(T/F) A prescriber’s employee (office staff, nurse) can legally authorize a refill

A

Depends, have they been granted prescriptive authority by the state law? If yes, they can.

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6
Q

(T/F) An employee/agent may (state law permitting) transmit or communicate the refill authorization or new prescription from the prescriber

A

True

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7
Q

What is prescriptive authority?

A

prescription drugs may be prescribed by a practitioner licensed by law to administer such a drug

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8
Q

Who licenses healthcare providers?

A

States, not the federal government

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9
Q

Can state place limits on the schedule of drugs a prescriber may prescribe?

A

Yes

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10
Q

Are pharmacists required to label their prescription drugs for dispensing the same way that manufacturers have to do so?

A

No, under Durham Humphrey they do not have to but federally, the label should not be false or misleading, the drug should not be an imitation drug, the drug must not be sold under the name of a different drug, the packaging and label must conform to official compendia standards, and it the drug is liable to deteriorate, it must be packaged and labeled appropriately (states can add on additional requirements)

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11
Q

AZ requires additional information on outpatient labels

A 
Pharmacy name and address
RX number (serial number)
Date of dispensing
Prescriber name 
For animals, the name of the owner and species
Directions for use
Any cautionary statements
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12
Q

The BUD of a drug shall not be later than

A

1) the expiration date on the manufacturer’s container or

2) 1 year from the date the drug is dispensed, whichever is earlier

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13
Q

FDA can switch a prescription drug to OTC status if they can prove that that product can be labeled that the consumer can do what three things?

A
  1. Self-diagnose
  2. Self-treat
  3. the supervision of a practitioner is not required
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14
Q

What applications are used to switch from Rx to OTC?

A

NDA or SNDA

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15
Q

What are three ways to switch from Rx to OTC status?

A
  1. Manufacturer may request the switch by submitting an NDA or SNDA (only applies to the manufacturer’s product not to generics or other similars)
  2. Manufacturer or other parties may request an OTC switch through a citizen petition to the FDA
  3. The FDA may add or amend an OTC monograph (this would apply to all drug products)
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16
Q

What is considered the third class of drugs?

A

Behind the counter (BTC) drugs

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17
Q

What is required to be given to every patient for oral contraceptives and estrogen containing drugs?

A

Patient Package Insert - if this is not included, this is considered misbranding

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18
Q

Institutions such as hospitals and LTCFs have the option of providing a PPI each time the drug is administered OR before the first dose and every how many days after?

A

30 days

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19
Q

Useful patient information that would accompany every new prescription?

A

Consumer Medication Information (CMI)

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20
Q

A medication guide program for drugs that pose a serious and significant concern. These should be issued with certain prescribed drugs and biological products when the agency determines that certain information is necessary to prevent serious adverse effects; patient decision-making should be informed by information about a known serious side effect with a product, or patient adherence to directions for the use of a product are essential to is effectiveness

A

MedGuides

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21
Q

When are MedGuides required?

A

A. patient or patient’s agent requests one
B. The drug is dispensed in a outpatient setting and the patient will use the drug without the direct supervision of a healthcare professional (community or hospital amb care setting)
C. First time a drug is dispensed to a healthcare professional for administration to a patient in an outpatient setting such as a clinic or infusion center
D. First time a drug is dispensed in an outpatient setting of any kind after a MedGuide is materially changed
E. When a drug is subject to a REMS that includes specific requirements for reviewing or providing a MedGuide

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22
Q

When are MedGuides NOT required?

A

When drug is administered to a patient in an inpatient setting or when administered to an established patient in an outpatient setting - clinic, dialysis, or infusion

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23
Q

Can a drug be legally prescribed and dispensed for off-label indications or dosages?

A

Yes

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24
Q

(T/F) Pharmacies are exempt from registering with the FDA as a manufacturer if they do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs

A

True

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25
Q

What do pharmacies need to do if they are deemed manufacturers?

A
  • Register for FDA license
  • Might have to apply for IND
  • Conform to the regulations regarding current GMP
26
Q

Are pharmacies that repackage OTC drugs or in any way change the container, wrapper, or labeling of these products for resale considered manufacturers?

A

Yes, they must register

27
Q

Are pharmacies that repackage prescription drug products for sale to other healthcare providers considered manufacturers?

A

Yes, they must register (but no guidance on dispensing to LTCF.. states have different practices)

28
Q

When are pharmacies exempt from adequate directions for use, cGMP, and new drug requirements for their compounded products?

A
  1. it is for an individual patient based on the receipt of a valid prescription and compounded by a licensed pharmacists or physician (meaning pharmacy cannot compound for another reseller like a pharmacy or hospital)
  2. It is for a “limited quantity” if prepared in anticipation of receiving a prescription. The amount anticipated must be legitimately based on the established practice history between the prescriber, pharmacy, and patients
  3. The product is not essentially a copy of a commercially available product, unless compounded only occasionally, and not in inordinate amounts
  4. It is compounded in compliance with the USP chapters on compounding using bulk substances that comply with monograph standards, if one exists
  5. Compounding only with FDA approved drugs that have not been withdrawn or removed from the market because of safety or efficacy issues
29
Q

What are outsourcing facilities?

A

A facility registered with the FDA that has one geographical location engaged in the compounding of sterile drugs and ships them interstate with out an individual prescription and without quantity limitations

30
Q

Are pharmacists allowed to substitute a generally equivalent drug for the prescribed drug?

A

Yes, there are mandatory substitution states and permissive substitution states

31
Q

(T/F) It is considered misbranding if a generic drug is labeled as a brand name

A

True

32
Q

Does therapeutic equivalence equal therapeutic substitution?

A

No

33
Q

Narrow therapeutic index (NTI) drugs/Narrow Therapeutic Ratio (NTR) drugs have less than how many fold difference between the median lethal dose and the median effective dose?

A

Two-fold

34
Q

This amendment:
Requires states to license wholesale distributors of prescription drugs
Ban the reimportation of prescription drugs, except by the manufacturer or for emergency use
Ban the sale, trade, or purchase of drug samples
Mandate storage handling and recordkeeping requirements for samples
Ban the trafficking in or counterfeiting of drug coupons
Prohibit the resale of prescription drugs purchased by hospitals or health care facilities with certain exceptions

A

Prescription Drug Marketing Act of 1987 (PDMA)

35
Q

(T/F) Drug samples may only be distributed to practitioners licensed to prescribe or to pharmacies of hospitals or health care entities at the written request of the prescriber on a form that includes the information specified by law

A

True

36
Q

If a sample is shipped or mailed, what must be executed for the sample on deliver and returned to the manufacturer or distributor

A

A written receipt that contains the name/address of the requesting prescriber, name/address of the hospital or health care entity receiving sample, name/address/title/signature of the person acknowledging delivery of the sample, proprietary or established name and strength of the drug sample, quantity and lot or control number, date of delivery

37
Q

Are starter packs distributed by manufacturers free to pharmacies considered samples?

A

No, because they are not labeled as samples and can be sold

38
Q

What are the exceptions under PDMA where hospitals, health care entities, or charitable organizations can sell, purchase, or trade prescription drugs?

A
  • Drugs were purchased from a group purchasing organization or from other member hospitals for its own use
  • sales or purchases to nonprofit affiliates
  • sales or purchases among hospitals or healthcare entities under common control
  • sales or purchases for emergency medical reasons (ex. temporary shortage)
  • selling or dispensing pursuant to prescription
39
Q

Are hospitals and healthcare entities allowed to return mistakenly ordered and outdated prescription drug products to wholesalers and manufacturers?

A

Yes, as long as drugs are properly stored and handled and proper records are kept

40
Q

What must a person who is engaged in wholesale distribution of a prescription drug in interstate commerce (who is not the manufacturer or an authorized distributor of record for that drug) provide to whoever receives the drug?

A

A pedigree, or statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them

41
Q

Who is an authorized distributor of record?

A

A distributor that has an “ongoing relationship” (written agreement between manufacturer and distributor) with a manufacturer to distribute that manufacturer’s drug products

42
Q

When does the PMDA allow the reimportation of prescription drugs?

A

If it is by the original manufacturer or for emergency use

43
Q

The Medicare Prescription Drug Improvement and Modernization Act allows who to promulgate regulations that facilitate the wholesale importation of prescription medications from Canada

A

The secretary of HHS (to date, secretary has refused to recognize any certification)

44
Q

Has the FDA permitted personal importation of small amounts of drugs?

A

Yes, only if
1) intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means
2) there is no known commercialization or promotion to persons residing in the US by those involved in the distribution of the product at issue
3) product is considered not to represent an unreasonable risk
4) individual seeking to import the product affirms in writing that it is for the patient’s own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed inn the US responsible for treatment with product
OR
1) there is evidence that the product is for continuation of a treatment begun in a foreign country and
2) they are not approved in the US and are used for the treatment of a serious condition for which no satisfactory treatment is available in the US

45
Q

The Department of Homeland Security Appropriations Act of 2007 states that

A

an individual patient may import an FDA approved prescription drug from Canada as long as individuals are transporting the drug on their person, the quantity does not exceed a 90ds and the total combined quantity does not exceed 50 dosage units, it is not a controlled substance or biologic product, and the drug is dispensed in original container and declared at customs

46
Q

Under the FDCA, is the FDA permitted to inspect all pharmacies where drugs are held at reasonable times, within reasonable limits, and in a reasonable manner?

A

No, pharmacies that don’t manufacture, prepare, or compound drugs or devices for sale other than in the regular course of business are exempt
(However, the FDA can inspect to determine whether it is engaging in manufacturing)

47
Q

What does the FDA need to conduct an inspection?

A

No warrant needed, just their credentials and a notice of inspection. FDA does not need to state the reason for inspection

48
Q

Can pharmacies use tax free alcohol?

A

No, community pharmacies that use alcohol to compound prescriptions commonly use tax-paid ethyl alcohol, purchased from an authorized retail or wholesale outlet

49
Q

Which entities use tax free ethyl alcohol?

A

1) State or political subdivisions
2) Educational institutions
3) Laboratories
4) Hospitals, blood banks
5) Pathology laboratories in connection with hospitals
6) Nonprofit clinics
[all for scientific, mechanical, and medicinal purposes and in the treatment of patients]

50
Q

Can medicines made with tax free alcohol be sold to outpatients?

A

No, may not be sold

51
Q

How must tax free alcohol be stored?

A

In a securely locked storeroom with the labels and markings on the containers intact.

52
Q

When tax free alcohol containers are empty, what must you do before discarding?

A

Labels and the markings must be obliterated before discarding & records of use must be kept

53
Q

(T/F) Omnibus Budget Reconciliation Act of 1990 (OBRA 90) is the first federal law that directly addresses pharmacist practice standards

A

True

54
Q

OBRA 90 recognizes a public expectation of pharmacists to detect and resolve problems with what?

A

Drug therapy

55
Q

OBRA 90 establishes a federal policy requiring what to ensure that drug therapy is as safe and effective as possible?

A

DUR - drug use review

56
Q

(T/F) OBRA 90 is only for Medicaid patients

A

False, it extends to all patients

57
Q

What are the three main areas of OBRA 90?

A

Rebates, Demonstration projects, and DUR (drug utilization reviews)

58
Q

Which area of OBRA is this: requires manufacturers to provide pharmaceuticals to Medicaid at their “best price”, the lowest price at which they sell the product to any consumer

A

Rebates

59
Q

Which area of OBRA is this: address pharmacist provided DUR services and patient care outcomes and effectiveness, efficiency, and cost-effectiveness of online computerized DURs and face-to-face consultation

A

Demonstration projects

60
Q

The DUR part of OBRA 90 has three sections of continuous quality improvement

A

1) Retrospective review: physicians and pharmacists oversee review on data concerning the use of medications over a particular period of time and compare those data with criteria for medication use previously developed by DUR board (ideal therapy and determines whether actual medication use conforms to the ideal, finds DDI, duplications, or continuing therapy for too long, or not long enough)
2) Educational program: targeting physicians and pharmacists using face to face, symposia, and written materials to improve the way medications are used
3) Prospective review: pharmacists consider prescribed drug therapy and apply professional expertise, DUR board can review new data developed as a result of prospective DUR

61
Q

Components of a prospective DUR

A
  1. Screen prescriptions before dispensing
  2. Patient counseling by pharmacist
  3. Pharmacist documentation of relevant information: requires pharmacists to maintain a written record that contains information about patients and the pharmacist’s impressions of the patient’s drug therapy
62
Q

Can patients refuse counseling under a prospective DUR?

A

Yes, patients have the right to refuse but it is only effective if the patient truly understood the offer and really did not want the counseling

Federal Law (7 decks)

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