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Exam 3 Flashcards

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1
Q

Criminal Law

A

Defines the limitations of the relationship between an individual and society.
An act so unacceptable that society is offended by it
Intent to harm or knowledge that the law is being violated.
Example- filling controlled substance without a prescription

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2
Q

Who brings upon law suits in criminal laws?

A

Lawsuits are brought by society through a district attorney or US attorney.
Can be charged with a crime if there is a statute prohibiting the conduct.
Possible sanctions- fine and/or prison sentence
Purpose- to deter an undesirable activity, punish and/or rehabilitate the wrong-doer

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3
Q

Civil Law

A

Pertains to the relationship among individuals in society

Government is NOT a party in a civil suit

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4
Q

2 major subdivisions of civil law

A

Contract law- duties that individuals have because they entered into an agreement
Tort law- duties created by law, NOT the parties themselves
Lawsuit is brought by one private party who sues the other party alleging an injury.
Purpose- to compensate the injured party for damages caused by the wrongdoer and deter undesirable activity

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5
Q

Administrative Law

A

Pertains to the relationship between government and a regulated profession, trade, or industry
Board of pharmacy may discipline licensees and registrants for violations of both federal and state laws governing the legal distribution of drugs.
Possible sanctions- warnings, fines, license suspension/revocation, probation
Purpose- to deter an undesirable activity, punish and/or rehabilitate the wrong-doer.

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6
Q

A wrongful act may subject someone to:

A

Criminal action
Civil action
Administrative action
Any combo of the 3

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7
Q

Tort

A

A civil wrong or wrongful act, whether intentional or accidental, from which injury occurs to another. Torts include all negligence cases as well as intentional wrongs which result in harm

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8
Q

Malpractice

A

Negligence performed by a professional

Tort law

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9
Q

Purposes of malpractice law

A

Deterrence

Compensate them to make them “whole”

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10
Q

4 elements of a malpractice suit

A
  1. ) Duty owed
  2. ) Breach of duty
  3. ) Causation
  4. ) Damages
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11
Q

In a malpractice suit, the plaintiff must prove

A

All 4 have been breached

Duty owed, breach of duty, causation, damages

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12
Q

In a malpractice action, the defendant must prove

A

Just one was not breached.
Comparative negligence- pt noticed wrong med and took anyway
Statute of limitations- about 1 year

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13
Q

Duty

A

To act as a reasonably prudent pharmacist would in a particular situation or to meet a general standard of care (plaintiff’s lawyer would introduce “expert witnesses”)

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14
Q

Breach (of duty)

A

failure to meet the standard of care (or act as a reasonably prudent pharmacist) or fulfill duties owed to patients

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15
Q

Cause

A

Both actual cause and proximate (legal) cause

Generally to be proximate cause it must be foreseeable and without certain types of intervening causes or factors

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16
Q

Proximate cause

A

If a defendant is to be liable for the harm, each of the links must be foreseeable to the defendant

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17
Q

Patient continuously receives early refills of amitriptyline. Patient is stockpiling and not taking daily as prescribed. Patient decides to take ~60 tablets to commit suicide and succeeds. Is the dispensing pharmacist liable?

A

No, this would not be foreseeable by a prudent pharmacist

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18
Q

Damages

A

Normally harm or damage cannot be undone but courts will try to make the aggrieved party “whole” or in other words put them in a comparable situation to if they had not been harmed.
Pay for loss of work/earning potential, pain and suffering, medical expenses
Very rarely do courts consider awarding punitive damages
Factors to consider- repeated behavior, likely to cause serious harm, careless indifference, personal gain, and cover-up

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19
Q

Vicarious liability

A

Pharmacists are generally liable for mistakes made by supervised technicians. Employers are generally liable for mistakes made by employees, including pharmacists

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20
Q

Malpractice insurance

A

Often not covered if you willfully violate a statute
Fairly inexpensive to get independent individual coverage
If only covered by employer, conflicts of interest can be a problem; also not covered if an issue arises outside of the workplace

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21
Q

Pharmacist Mary managed Compoundit Pharmacy and employed an intern, Jim, who impressed her with his intelligence and maturity. Mary never needed to show Jim how to do anything more than once. One day Mary showed Jim how to compound a prescription for a topical product for a facial skin disorder. A few weeks later the patient requested a refill, and Mary told Jim to prepare it while she
tended to other business. After Jim compounded the drug, he asked Mary if she would check it. Mary looked at the label and told Jim it was fine. A couple of days later the patient called saying that his skin was burning up. Mary told him to go to the emergency room immediately. The hospital determined that the compound contained 46% active ingredient as opposed to the required 0.46% and that the error caused the patient to suffer 3rd degree burns and permanent facial scarring. The patient sued Jim, Mary and Compoundit.
Explain why compoundit might be liable

A

Vicarious liability

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22
Q

Pharmacist Sue worked as a relief pharmacist at Philmore Pharmacy and
dispensed two prescriptions for a patient, Ralph. One prescription was a refill for digoxin and the other was a new prescription for erythromycin. Sue was very busy and inadvertently switched the labels on the vials. Ralph is legally blind and normally his daughter serves as his caregiver and picks up his prescriptions. That day, however, she was out of town and would be for the whole week, and Ralph’s son assumed the role of caregiver. The son picked up the prescriptions and administered them to Ralph as directed on the labels:
Digoxin four times daily
Erythromycin once daily
After a few days, Ralph suffered digitalis toxicity and his bacterial infection worsened. He was hospitalized and later sued Sue and Philmore Pharmacy.
Would punitive damages be warranted?
Explain how the defense of comparative negligence could be used in this case.
Would it be a good defense in this situation?

A

Punitive damages- no, cant prove intention
Comparative negligence would not be a good defense in this case. You have to accept people as they are and this patient was at a higher risk of harm.

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23
Q

How does Ohio define “compounding”?

A

The preparation, mixing, assembling, packaging, and labeling of one or more drugs, including the combining, mixing, diluting, pooling, reconstitution, repackaging, or otherwise altering of a drug or bulk drug substance

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24
Q

What is not included in compounding?

A

Adding flavoring to a conventionally manufactured drug product
Preparing conventionally manufactured drug products according to directions (Abx). Pharmacist must perform final check.

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25
Q

You dispense 10 compounded progesterone cream prescriptions per month (4 ounces each). May you prepare 5 lbs of cream in advance?

A

No, you will not use all of that

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26
Q

If you compound in advance, how must the compound be labeled?

A

Name, strength, and quantity of each drug used in the compound
Identification of the repacker by name (or last 7 digits of TDDD#)
Pharmacy control #
Pharmacy BUD

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27
Q

For all compounded products, the pharmacy must comply with:

A

USP 795
USP 797
503A of FDCA
USP 800- enforcement delayed until 2/1/22
Inspect and approve the compounding process
Perform the final check of the finished product
Ensure label includes “compounded drug product”

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28
Q

503A of the FDCA

A

Compounded prescriptions must be for individual, identified patients
Differentiates between compounding and manufacturing
Do not compound list
States that compounded drugs are exempt from cGMP, labeling of drugs with adequate directions for use, NDA

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29
Q

In compounding, the pharmacist is responsible for:

A

All compounding records

Proper maintenance, cleanliness, and use of all compounding equipment

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30
Q

Examples of when FDA may initiate enforcement action against a pharmacy (activities not considered compounding)

A

Compounding drugs removed from marked for safety reasons
Compounding from bulk ingredients not approved by the FDA
Using commercial-scale compounding equipment
Compounding for third parties for resale
Compounding drugs that are commercially available or that are essentially copies of commercially available products

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31
Q

May pharmacists compound medications for physicians to use in their offices?

A

No, not pt specific

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32
Q

May pharmacists compound medications for veterinarian offices?

A

Yes
Only if not commercially available and used to treat an emergency, unanticipated procedure, or for diagnostic purposes
Must be limited quantitiy

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33
Q

May pharmacists compound products for OTC sale?

A

No

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34
Q

May pharmacies compound illegal drugs and sell them to another pharmacy?

A

No

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35
Q

May pharmacies compound medications unavailable due to supply/backorder issues?

A

Yes if on FDA Drug Shortages List

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36
Q

− If a pharmacy not physically located in Ohio wants to ship/deliver compounded drugs to patients in Ohio then the “non-resident” pharmacy’s responsible person must be an
________________-

A

Ohio licensed pharmacist

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37
Q

A pharmacy must report to the BOP within _______of discovery of any product quality issue attributed to compounding.

A

72 hours

Issues may include mistaken for another product, contamination, any chemical, physical, or deterioration

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38
Q

What is an outsourcing facility?

A

Compound and provide non-patient specific products (sterile and nonsterile)
Must be registered with the FDA as an outsourcing facility
Must be registered with the Ohio BOP as a wholesaler distributor of dangerous drugs with an outsourcing facility classification. Responsible person must be a pharmacist.

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39
Q

What are outsourcing facilities permitted under?

A

DQSA (Drug quality and security act)

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40
Q

An outsourcing facility would like to also compound patient-specific prescriptions. May it do this?

A

Only if they also have a pt specific TDDD license

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41
Q

Outsourcing facilites are subject to increased FDA oversight

A

Must submit list of all drugs compounded to the FDA
Subject to FDA inspection
Must comply with cGMP
Must report AE to the FDA

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42
Q

Are drugs compounded by outsourcing facilities FDA approved?

A

No- but facilities must still be registered with FDA

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43
Q

Do pharmacies that occasionally compound products for prescribers to use in their offices need to register as outsourcing facilities?

A

Yes unless they are vet offices

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44
Q

T/F Any prescriber office which accepts compounded products or compounds their own products, must be registered as a TDDD in Ohio

A

True

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45
Q

A local physician specializes in hormone replacement therapy for women and would like patients to receive their compounded prescriptions at her office. You work at a community pharmacy. May the physician fax the prescriptions to you, you compound them, and then have them delivered to the physician’s office for pick-up by the patient?

A

Yes

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46
Q

Prescription pick up station

A

No pharmacist shall dispense dangerous drugs to a place that offers a “pick up station” for the purpose of having prescriptions filled or delivered unless all of the following apply:

  • Site is licensed as a TDDD
  • Receipt, storage, control, and distribution are in the full and actual charge of a health care professional
  • An appropriate recordkeeping system is in place
  • Counseling is offered
  • There is clear and convincing evidence that delivery of prescription directly to pt would lead to danger to patient or public
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47
Q

USP 800 hazardous drugs

A

Intent: protect health care workers, the environment, and the patient
Applies to every site that handles or stores or uses hazardous drugs

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48
Q

Which drugs are hazardous?

A

A drug that has any of the 6 characteristics:

  • Carcinogenicity
  • Teratogenicity
  • Reproductive toxicity in humans
  • Organ toxicity in low doses
  • Genotoxicity
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49
Q

Key aspects of USP 800

A

HD must be separate from non-HD
HF must be in negative pressure environment
Details PPE that should be used when handling HD
Monitor for employee health
Full history/ physical documented at hiring and then f/u performed throughout employment

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50
Q

How may a medication order be transmitted to the pharmacy in an institutional facility?

A

Written
Orally- by personnel authorized by the written policies and procedures of the facility (acting as an agent of the prescriber), pharmacist must document full name of agent, must be verified by the prescriber within a “reasonable time”. No oral CIIs
Via fax- must keep
Via electronic system approved by the BOP, access to this system must be limited to licensed health care professionals using positive identification. If entered by someone other than the prescriber, there must be a positive identification of prescriber within a reasonable period of time

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51
Q

What is required on an institutional medication order?

A 
Patient name
Name, strength, and dosage form of drug
Directions for use
Route of administration (even if oral)
Date prescribed
Prescribers positive identification

Must include everything the same as community and add route

52
Q

What are the labeling requirements for medications dispensed for patients of an institutional facility? Unit dose

A

Manufacturer requirements
If the pharmacy packages their own unit dose medications, they must include lot#, BUD, and last 7 digits of TDDD or pharmacy name

53
Q

What are the labeling requirements for medications dispensed for patients of an institutional facility? Parenteral (inpatient use)

A

Patients full name
Name and amount of parenteral solution (0.9% NaCl)
Name and amount of drugs added
Expiration Date
Name and address of institutional facility
Cautionary statements (if required by manufacturer/FDA)

54
Q

What are the labeling requirements for medications dispensed for patients of an institutional facility? parenteral (outpatient)

A

Patients full name
Name and amount of parenteral solution (0.9% NaCl)
Name and amount of drugs added
Expiration Date
Name and address of institutional facility
Cautionary statements (if required by manufacturer/FDA)
PLUS
name, address, telephone # of pharmacy
Prescribers full name
Directions for use (including route of admin)
Date of dispensing
Storage conditions

55
Q

Mr. Burns reports to the ED of a small, rural community hospital with the chief complaint of confusion and left-sided numbness with facial drooping. It is determined that he is having a CVA and he needs IV alteplase ASAP. It is after hours and the hospital pharmacy is
closed. The ED staff looks in the contingency drug supply inventory list and it does not contain alteplase. May someone from the ED staff enter the hospital pharmacy to obtain the alteplase?

A

In Ohio yes
Must be for an emergency and not in the contingency drug supply
Must have 2 employees- 1 must be licensed to administer dangerous drugs

56
Q

If the ED staff enters a pharmacy after hours without a pharmacy do they have to document this?

A

Yes- document your name, what you took, when they took it, how much they took
Pt name
Can only take what they need

57
Q
  1. Mr. Burns responds well to the alteplase therapy, however he is admitted for observational care. The hospital pharmacy is still closed and Mr. Burns needs several medications. May the nursing staff again enter the pharmacy to obtain these?
A

Yes if they are crucial to withstand life and not in the contingency drug stock

58
Q

At 0600 the hospital pharmacy opens and the patient’s needed medications are sent to the floor shortly thereafter. His medications include Percocet 5/325 mg PRN pain and an albuterol inhaler, among others. The hospital is not on the “cutting edge of technology” and still uses medication carts with locking drawers to store medications on the floors. At 0830 Mr. Burns requests a dose of Percocet. What must the nurse document when removing a dose from the medication cart?

A

Nurses own identification, pt name

Whats left in cabinet and how much they gave

59
Q

The patient would like to keep an albuterol inhaler at his bedside in case he has an asthma attack. How must this be labeled?

A

Must look like an outpatient pharmacy label

60
Q

At 1600 there is a shift change from the nursing staff. During the controlled substance reconciliation of the medication cart, it is noticed that 4 tramadol 50 mg tablets are missing. The proof of use sheet is matched with the inventory and the nurses are unable to determine why
there is a discrepancy. Who must be notified?

A

The pharmacy director

61
Q

It is determined that Mr. Burns potassium is low so the attending physician asks the floor nurse to order 20 mEq KCl in D5W. How may this order be transmitted to the pharmacy? What is required on the label?

A

Written, called on by prescriber or agent of prescriber, faxed, or EPIC
Must include pt name, pharmacy name and addition, everything else required

62
Q

Mr. Burns continues to improve and he is transferred to a LTCF for follow up care. The LTCF contracts with a local independent pharmacy for medications and pharmacy services. The facility’s attending physician reviews Mr. Burns hospital discharge medication list and orders the appropriate medications from the pharmacy. Later in the week Mr. Burns
experiences severe pain and the attending physician would like to order Percocet. May he call this in to the pharmacy?

A

Yes if it is a true emergency. Need to get prescription within 7 days

63
Q

The physician orders #60 Percocet tablets, however the LTCF would only like to keep 10 on supply at a time. May you partially fill this?

A

Yes, can partial fill for 60 days in LTCF (30 days anywhere else) for controls

64
Q

Mr. Burns’ pain improves over the next few weeks and the physician would like to transition him to tramadol instead. May the floor nurse call the pharmacy with this order on behalf of the physician?

A

Yes, but the nurse must be an agent of the prescriber

65
Q

Mr. Burns has Medicare so the LTCF must ensure a monthly drug regimen review is performed by a consultant pharmacist. During the first monthly review, the pharmacist identifies that several of his medications are not dosed correctly based upon his renal function. The
pharmacist communicates this to the attending physician. Must the physician abide by the pharmacist’s recommendation?

A

No, but they are legally required to acknowledge it

66
Q

Mr. Burns develops may friendships during his stay. Unfortunately, one of his friends (also a resident of the LTCF) passes away suddenly. How may the facility dispose of his medications?

A

Take back box in LTCF
Dispose w/ two people- pharmacy and supervisor nurse)
Send back to pharmacy if pt never touched

67
Q

Who owns the drugs in a drug kit?

A

The pharmacy that services them

68
Q

According to Ohio law, what is considered an institutional facility?

A

Hospital, freestanding emergency department, inpatient rehab facility, ambulatory surgical facility, nursing home, inpatient psychiatric service provider, facility that provides medically supervised detox services, juvenile correctional facility

69
Q

Is an assisted living facility considered an institutional facility?

A

No, assisted living facilities offer help with activities of daily living (personal or custodial care) but no or very little medical care

70
Q

Who is “in charge” of a institutional pharmacy? What are their roles?

A

The institutional pharmacy director
-Must sign TDDD
-Is responsible for the practice of pharmacy performed within the institution
-Must develop, implement, supervise, and coordinate all services provided by the pharmacy
In conjunction with appropriate committees, is responsible for developing policies and procedures

71
Q

When must the BOP be notified of a change in pharmacy director?

A

Within 10 days

72
Q

Access to dangerous drugs when a pharmacist is not present

A

Use contingency drug supplies

A pharmacist MUST be available for emergencies when the institutional pharmacy is closed (On call)

73
Q

Contingency drug supplies

A

Drugs which may be required to meet the therapeutic needs of inpatients when a pharmacist is not available
Must only be used in the absence of a pharmacist
Must be stored in a locked cabinet constructed and located outside of the pharmacy

74
Q

What must the pharmacy director do with a contingency drug supply

A

Designate those who may obtain access (must be licensed healthcare professionals)
Determine the drugs to be included
Ensure the drugs are properly labeled and packaged in sufficient quantities
Institute recordkeeping procedures to account for drugs used. must include positive identification of person who obtained drugs

75
Q

What if a drug is really needed, the pharmacy is closed, and it is not in the contingency drug supply?

A

Can get in pharmacy

  • Identify personnel authorized to access pharmacy AND conditions
  • Ensure a minimum of 2 employees of the institution accompany each other (>1 must be licensed by board of nursing or medicine)
  • Provide written record of emergency access to the pharmacy
76
Q

What must written records of access into a closed pharmacy include?

A

The names, titles, and positive identification of all institutional personnel accessing the pharmacy
Date and time of access
Name and quantity of drug obtained
Name of patient
Name of ordering prescriber
These records must be filed with the pharmacy director within 24 hours and maintained in the pharmacy for 3 years

77
Q

May dangerous drugs be stored on the patient floors of an institution?

A

Yes
Policies and procedures must:
-Provide for a limited quantity of drugs to be maintained at any one location
-Provide for proper storage and labeling of such drugs
-Provide for the storage in a secure area
-Provide for notification of the responsible person when the drug supply has been accessed and/or drugs used
-Provide for inspection of the drug supply on a regular basis to detect unauthorized use of drugs and expired drugs

78
Q

Are there any special requirements for dispensing and stocking controlled substances in an institution?

A

Stored in a secure location with access limited to authorized individuals
Packaged in a tamper evident, unit of use containers
A “proof of use sheet”

79
Q

What is required on a proof of use sheet?

A

Pt name
Date and time of access
Drug name, strength, and quantity obtained
Positive identifier of person doing the admin
Positive identifier of both the person and witness who waisted a partial dose

80
Q

At every shift change a reconciliation must be conducted by BOTH the leaving and arriving licensed healthcare professional responsible for the security of these drugs in the area in which they are stored.
What is required in this reconciliation?

A

Physical count of the controlled substances and proof of use sheets
Inspection of the packaging to ensure its integrity
Positive identification of the persons conducting the reconciliation

Unresolved discrepancies must be reported to pharmacy director.

81
Q

If controlled substances are maintained in areas outside of the pharmacy and are stored in a secure, automated storage system that meets at least the following requirements, then the proof of use sheet and reconciliation at every shift change ________-

A

Is not required

Example would be a pyxis machine

82
Q

Minimum requirements for a secure, automated storage system

A

Positive identification of every person accessing the system
Date and time of access
Pt name
Drug name, strength, quantity removed
Positive identification of both the person and the witness who waste a partial dose of a control
-Access to a controlled substance must be limited to one drug and strength at a time
-All controlled substances must be packaged in tamper evident containers unless the system only allows access to one individual dose at a time
Periodically, the pharmacy director shall cause a reconciliation of the automated storage system to be conducted (inventory at least yearly)

83
Q

What regulations govern LTCF medication use?

A

CMS regulations

84
Q

Skilled nursing facility

A

Must provide pharmacy services, must have consulting and dispensing pharmacy services

85
Q

CMS has established the following minimum performance and service criteria:

A

Comprehensive inventory
Pharmacy operations and prescription orders
Special packaging
IV meds
Compounding/alternative forms of drug composition
Pharmacist on-call service
Delivery service
Emergency boxes and emergency box log books
Misc reporting and prescription ordering supplies

86
Q

<14 day dispensing cycles “short cycles”

A

Required for Medicare Part D beneficiaries (to minimize waste)
Exceptions- generics, drugs for acute illnesses, liquids, eye/ear drops, nasal sprays, topicals, parenterals
Drugs must be dispensed in original container per FDA

87
Q

Drug regimen review

A

Each residents drugs must be reviewed at least once monthly by a consultant pharmacist

  • Or when resident is admitted or readmitted to the facility (can be done remotely)
  • Or has a change in status
  • Must report issues to attending physician, director of nursing, and director of medicine. Reports must be acknowledged.
88
Q

What are the minimum materials required to open and maintain an pharmacy?

A 
References
Equipment
Stock of drugs
Prescription containers
Space and fixtures
Pharmacy hours
Personnel
89
Q

References required to start a pharmacy

A

Access to all current federal and state laws affecting pharmacy- must have internet access
Other references necessary to conduct pharmacy in a manner in the best interest of the patients served
Phone # of poison control center

90
Q

Fridge/freezer temperature logs

A

Must keep daily with observations or with an alarm.

must have a procedure of what to do in the case that it is out of range

91
Q

Personnel in pharmacy

A

Must be appropriately staffed to operate in a safe and effective manner
All employees must be identified by a name tag that includes 1st name and role.

92
Q

You hire a new employee for your pharmacy, what is required?

A

CMS Fraud, Waste, and Abuse training- upon hire and annually
Office of inspector general list review
OSHA training
HIPAA training

93
Q

CMS fraud, waste, and abuse training

A

Must be completed upon hire and at least annually thereafter
Required for Medicare Part D billing
Pharmacies must have programs to prevent waste, fraud, and abuse
Prohibits knowingly making a false statement for payment
Anti-kickback provision= prohibits anyone from knowingly soliciting, receiving, offering, or paying remuneration in exchange for referrals or furnishing any goods or services paid for by Medicare or Medicaid

94
Q

Office of inspector General List Review

A

Search upon hire and at least annually thereafter
Lists those who are excluded from participation in Medicare, Medicaid, and all other Federal health care programs
No payment will be made for anything that an excluded person or anyone who employs or contracts with the excluded person provides

95
Q

OSHA training

A

Must complete upon hire and at least annually thereafter if job duties place him/her in contact with bloodborne pathogens
Employer must have an exposure control plan
-Training must be available at no charge and Hep B vaccine must be offered free of charge

96
Q

What to do if a pharmacy closes?

A

Must file WRITTEN notice to the BOP within 30 days
May be submitted in person, by verified fax, or by certified mail
This notice must include the following information- name, address, TDDD #, name address TDDD# or wholesaler where drugs will be transferred to, name and address of the secure location where all records will be kept, the proposed date of discontinuing business
Complete a controlled substances inventory on the date of the closing business
The pharmacies TDDD# must be returned to the BOP for cancellation
The pharmacies DEA registration certificate and any usued DEA form 222s must be returned to the DEA

97
Q

Inspections

A

Ohio BOP routinely conducts pharmacy inspections- works collaboratively with the DEA and FDA
Pink slip violations may be issued
Following inspection, a summary sheet of findings is provided to responsible person
If BOP asks to take anything, ask got a receipt or ask if a copy will suffice

98
Q

What are your options for offering low-cost or free medications to patients in Ohio?

A

Register as a stand alone charitable pharmacy (TDDD required)
Register as a “regular” pharmacy (TDDD) and participate in the drug repository system

99
Q

What is a charitable pharmacy

A

Stand alone entity, registered as a charitable pharmacy
Must follow ALL federal and state laws/regulations just like any other pharmacy
Minimum materials required, security requirements, recordkeeping, prospective DUR, pt counseling, responsible person, etc.
-TDDD
-Exempt from federal taxation
-Cannot be a hospital

100
Q

What is a drug repository system

A

System that allows unused drugs to be recycled for use by patients who could otherwise not afford them

101
Q

Who may participate in a drug repository system?

A

Any pharmacy
Any hospital
Any nonprofit clinic

102
Q

Why may donate drugs to these programs?

A

Drug repository= TDDD, wholesaler, person it was legally dispensed to pursuant to a prescription order (cannot have had custody of it, signed a form to say facilities can donate on their behalf)
Charitable pharmacies- all of the above + drug samples obtained from a manufacturer or manufacturer rep

103
Q

Both the drug repository system and charitable pharmacies, donors must complete a donor form, which must be kept on file for

A

3 years
States that the donor is the owner of the drug and intends to voluntarily donate the drug and signed
Invoice must be created and donor/recipient must each keep a copy- includes name/address of each, drug name, maunfacturer, strength, quantitty, date

104
Q

What type of drugs may be donated to drug repository systems

A

All drugs except for drug samples and controls if
- in original sealed container and tamper-evident unit dose packaging
If it was packaged by apharmacy, its name and any other pharmacy identifiers must be removed
Drug never in possession of ultimate user
>6 months exp
Orally administered cancer drugs even if not in their original, sealed tamper-evident packaging. But no controls or drugs that require storage at proper temps
Controlled substances in LA/ER form for treatment of OUD

105
Q

What types of drugs may be donated to a charitable pharmacy?

A

All the same as a drug repository except they can receive samples
-Must Not be controlled or expired. Must be labeld sample
No 6 month exp rule

106
Q

Who may receive meds from charitable pharmacies or drug repositorys

A

The recipient (patient) must have valid Rx and the dispensed drug must have a full, outpatient label
Drug repository system- residents of Ohio with no reasonable means to pay for the drug prescribed or is a patient of a nonprofit clinic
Must sign a recipient form and may be charged handling fee
Charitable pharmacy- determines eligibility. Must be free, no handling fee

107
Q

A patient utilizes the services of a mail order pharmacy and has the following “left over” drugs due to therapy changes. May she donate the following to a charitable pharmacy or the repository system?
o Lisinopril #90 in an amber prescription bottle
o Pulmicort Respules for nebulizer #180 sealed in their original packaging
o Alprazolam #100 in the original, sealed manufacturer bottle

A

No

108
Q

A manufacturer has left over sealed drug samples (Xarelto®). May the manufacturer donate them to a charitable pharmacy? What about the drug repository system?

A

Charitable- yes

drug respository- no

109
Q

A long term care facility patient passes away and all of his unit dose medications, that were kept in the medication cart, are left over. Some were unit dosed by the pharmacy. May his power of attorney donate them to a charitable pharmacy? What about the drug repository system?

A

Yes

for drug repository must have BUD >6 months

110
Q

You work at a community pharmacy that participates in the drug repository system. How do you document that a patient’s drug was dispensed from this program?

A

Sign pt form that lists drug

Have Rx

111
Q

A non-profit health care clinic would like to participate in the drug repository system.
Does the clinic need to hire a pharmacist to manage it?

A

No- just have to have a healthcare provider licensed to administer drugs

112
Q

Xecor makes several drugs including Anxless®, approved by the FDA for anxiety. Recent studies sponsored by Xecor indicate that Anxless® may be a promising treatment for hypertension. Dr. Mabel is a pharmacy professor whom Xecor approached to see if she would be willing to present hypertension CE programs. The company told Dr. Mabel it would pay her $2,000 per one-hour program, and the company would give her the slides to use. Dr. Mabel agreed, and Xecor sponsored a CE program at a local restaurant personally inviting the pharmacists. Most of the program was about the recent studies demonstrating how effective Anxless® is for hypertension. The company also distributed
articles to attendees discussing these studies. The FDA monitored the program and issued warning letters to Xecor and Dr. Mabel.
What legal violations did Xecor commit?

A

Discussed off label use
Drug company produced slide
Paid directly- drug company must go through third party to pay (CE office)

113
Q

If a company would like to disseminate off label use information, what is required?

A

Peer reviewed journal
Book chapter
Guidelines
Have to say not FDA approved

114
Q

FDA requires the following for drug advertisements:

A

True statement- established name of the drug, formula, showing quantity, brief summary
Fair balance- requires scope, depth, and detail of info for side effects and contraindications be the same as for effectiveness

115
Q

Do fair balance rules apply for reminder advertising?

A

No

116
Q

Do ads for OTC medications require “true statement” and “fair balance”

A

No- must be truthful and not misleading

FTC regulates OTC advertising

117
Q

Mrs. Smith pays cash for all of her prescriptions. A friend has recently informed her that she can buy her medicines online from a Canadian pharmacy and save a lot of money. As Mrs. Smith’s pharmacist, she asks for your advice on purchasing her drugs from Canada.
What would be the best information to provide?

A

Inform Mrs. Smith that she is only allowed to purchase her medications in the United States

118
Q

How can you import meds from Canada?

A

You have to carry it across yourself
Max 90 day supply
Can’t be a biologic or control

119
Q

What about controlled substances? Isn’t there a “personal use exemption” for importation of controlled substances, regardless of the country?

A

If vial is labeled and it has to be on person

Max 50 dosage units of all controls combined

120
Q

Is there ever a situation where non-FDA approved drugs may be imported into the United States?

A

Yes- compassionate use policy

Paperwork must be filled out by physician

121
Q

May anyone re-import FDA approved drugs?

A

Yes but only if the manufacturer does it

In emergency situation

122
Q

Only a pharmacy licensed as a TDDD or a licensed pharmacist may display a sign or advertise using these words:

A

Pharmacy, drugs, drug store, drug store supplies, pharmacist, druggist, pharmaceutical chemist, apothecary, drug sundries, medicine

123
Q

Retail pharmacies may advertise drugs they sell/dispense by name or therapeutic class as long as the advertisement includes the following information:

A

Brand name, generic name, dosage form
Price charged for specific quantity
Price advertising is considered reminder advertising by FDA

124
Q

Can you advertise selling hypodermics OTC?

A

No

125
Q

If asked, you are required to disclose pricing information to the following:

A

To all persons on the premises of the pharmacy requesting such information
To all persons on the phone who identifies themselves as having a valid prescription
Not required or CIIs if lives or property could be endagered

126
Q

Advertising of compounding services:

A

Allowed to
Solicit prescriptions from prescribers
Advertise that you offer the services
Advertise the compounding of particular drugs or classes, but cant say what they are for

127
Q

A person that sells dried herbs and extracts opens a flea market booth and calls it “Nature’s Pharmacy”. Is this allowed?

A

No, they dont have TDDD

Law (4 decks)

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