General Pharmacy Laws and Rules Pt 3

Question 1

What non-self-injectable drugs are pharmacist prohibited from dispensing?
Hint - 3 categories

Answer 1

Drugs that meet all of the following criteria:
1) Indicated for the treatment of cancer or cancer-related illness
2) Must be administered via IV or SubQ
3) Cannot reasonably be self-administered by the pt or person assisting pt with self-administrations

Question 2

What are the 3 exceptions to the non-self-injectable cancer drug rule?

Answer 2

1) Pt lives in a nursing home, residential care facility, rehab facility, or similar institution
2) Pt is an adult and a hospice pt or client of a home health agency and pharmacy has been informed about staff administration by the pt, prescriber, or prescriber’s agent
3) Pt is a minor and a hospice pt or client of a home health agency and pharmacy has been informed about staff administration by the prescriber, prescriber’s agent, or parent/guardian

Question 3

T/F: All prescribers are required to obtain explicit informed consent if prescribing an opioid to a minor.

Answer 3

True (exceptions for emergencies, surgery incidents, facilities, and pt harm)

Question 4

The informed consent for prescribing opioids to a minor must contain what 3 components?

Answer 4

1) Assessment of minor’s mental health and substance abuse history
2) Discussing risk of opioids with minor and minor’s parents/guardians
3) Signature of parent/guardian

Question 5

If an authorized adult (other than a parent/guardian) signs the consent form for a minor to receive an opioid, what is the max days supply that can be dispensed for that opioid?

Answer 5

72 hour supply

Question 6

To store records off-site, a request must be submitted to the board of pharmacy that contains what 4 items?

Answer 6

1) The terminal distributor number of the pharmacy
2) License number of the requestor
3) Name and address of the off-site location
4) Time frame of the records to be moved off-site

Question 7

T/F: A pharmacy cannot make sales of naloxone at wholesale.

Answer 7

False, can make occasional sales of naloxone at wholesale to state and local law enforcement agencies

Question 8

T/F: The 5% limit does not apply to naloxone wholesale.

Answer 8

True

Question 9

What counseling points are pharmacists/interns required to include in naloxone education materials?
Hint - 8 points

Answer 9

1) Risk factors for opioid overdose
2) Strategies to prevent opioid overdose
3) Signs of opioid overdose
4) Steps in responding to an overdose
5) Info on naloxone
6) Procedures for administering naloxone
7) Proper storage and expiration of product
8) Info on where to obtain a referral for substance abuse treatment

Question 10

T/F: A physician approved protocol for naloxone is required to dispense naloxone without a prescription.

Answer 10

True (I don’t think this has changed)

Question 11

T/F: A pharmacist/intern can fit and measure pts for therapeutic diabetic shoes.

Answer 11

True

Question 12

What 5 types of injectable medications can a pharmacist administer so long as they have an ongoing relationship with the prescriber?

Answer 12

1) LA or ER opioid antagonists
2) LA or ER antipsychotics
3) Hydroxyprogesterone caproate for pregnant women
4) Medroxyprogesterone acetate for non-pregnant women
5) B12 injections (cobalmin, cyanocobalmin, etc.)

Question 13

In order to administer an injectable medication, what 3 criteria must a pharmacist meet?

Answer 13

1) Must complete a course in administration of these drugs
2) Must have BLS certification
3) Must practice in accordance with a protocol

Question 14

If an injectable medication is given, when must the physician be notified by?

Answer 14

Within 7 days of the encounter

Question 15

T/F: A pharmacist must have a physician established protocol to administer injectable medications.

Answer 15

True, and it must be signed every 2 years

Question 16

How long must records of injections be kept for?

Answer 16

3 years

Question 17

T/F: A pharmacy intern can administer injections (not vaccines) under supervision of a pharmacist.

Answer 17

False, only pharmacists can administer injections

Question 18

What 6 forms of communication are considered acceptable ways to notify a provider?

Answer 18

1) Email
2) Interoperable electronic medical record system
3) Fax
4) Electronic prescribing system
5) Electronic pharmacy record system
6) Documented verbal communication

Question 19

Define medication therapy management (MTM)

Answer 19

A distinct group of services intended to optimize therapeutic outcomes of a pt - includes appropriate med use, med adherence, ADR detection, etc.

Question 20

In the state of Ohio, who can provide MTM?

Answer 20

An Ohio licensed pharmacist, supervised intern, or a pharmacist practicing in another state practicing within that state’s laws

Question 21

How many interns per pharmacist can be engaged in MTM?

Answer 21

Max of 2 interns per pharmacist (unless otherwise approved by the board)

Question 22

How long must MTM records be maintained for?

Answer 22

3 years

Question 23

T/F: A terminal distributor is subject to an onsite inspection/investigation without notice from the board.

Answer 23

True

Question 24

If a violation is found during an inspection, written notice of the actions the licensee has taken to correct the violations must be submitted to the board within what time frame?

Answer 24

30 days

Question 25

T/F: Hospital self-service kiosks are available for use by the public.

Answer 25

False, they are to be used by hospital employees and their family members only

Question 26

T/F: Refrigerated meds cannot be stored in hospital self--service kiosks.

Answer 26

True

Question 27

Hospital self-service kiosks must be continuously monitored by video camera. How long must the video footage be kept for?

Answer 27

90 days

Question 28

T/F: Drugs kept in a self-service kiosk that have not been picked up can be returned to stock.

Answer 28

True

Question 29

Suspicious orders (identified by wholesalers) must be reported to the board within how many days of the order being identified as suspicious?

Answer 29

5 days

Question 30

If no suspicious orders are identified by a wholesaler within a month, what must be submitted to the board?

Answer 30

A zero report must be filed by the 15th of the next month

Question 31

Pharmacists are required to self-report criminal convictions, felonies, medical errors as a result of recklessness/unprofessionalism etc. to the board within how many days of the event?

Answer 31

10 days

Question 32

T/F: A pharmacist can dispense naltrexone without a prescription.

Answer 32

True, under the following circumstances: 1) Can verify the pt has a record of injectable LA naltrexone with no refills (can be at another pharmacy as long as that pharmacy is contacted) 2) Pharmacist is unable to obtain refill auth at that time 3) The pharmacist judges that the drug is needed to continue therapy and failure to dispense the drug could result in pt harm

Question 33

If oral naltrexone is dispensed w/o a prescription, what is the max days supply that can be dispensed?

Answer 33

5 day supply

Question 34

If naltrexone is dispensed w/o a prescription, when must the pharmacist notify the prescriber by?

Answer 34

Within 5 days

Question 35

T/F: There is no limit to the number of times naltrexone can be dispensed w/o a prescription or additional refills.

Answer 35

True, but professional judgement should be used

Question 36

T/F: When dispensing naltrexone w/o a prescription, it must be reported to OARRS.

Answer 36

True

Question 37

T/F: A pharmacist can dispense an Epipen without a prescription.

Answer 37

True (with a physician-established protocol and pt counseling provided)

Question 38

When reporting elder abuse, what 4 items must be included in the report?

Answer 38

1) Elder adult's name, address, and approx. age 2) Caregiver's name and address (if known) 3) Nature and extent of alleged abuse, neglect, or exploitation 4) Basis of the pharmacist's belief that this has occurred

Question 39

What 2 methods can be used to ensure proper fridge/freezer temps?

Answer 39

1) Temp logs with at least daily observations 2) A temp monitoring system capable of alerting staff of a temp excursion

Question 40

T/F: Food can be stored in the same fridge/freezer as drug products.

Answer 40

False, don't do it

Question 41

How long must fridge/freezer temp records be maintained for?

Answer 41

3 years

Question 42

A pharmacist must verify the accuracy of all drugs dispensed by an automated pharmacy system for how long?

Answer 42

45 days (continuous)

Question 43

What accuracy must an automated pharmacy system have?

Answer 43

99.985% accuracy

Question 44

Quality assurance to review an automated pharmacy system must review how many prescriptions to ensure accuracy?

Answer 44

At least 5% of all dispensed prescriptions

Question 45

If an automated pharmacy system selects an incorrect drug, what must occur until the problem is fixed?

Answer 45

A pharmacist must verify 100% of the drugs dispensed by the system

Question 46

T/F: Remote prescription processing includes dispensing.

Answer 46

False, it only includes receiving, interpreting, evaluating, clarifying, prescription approval, and order processing (DUR, therapeutic interventions, etc.)

Question 47

T/F: Remote prescription processing must be done in the United States.

Answer 47

True

Question 48

T/F: Remote prescription processing must be done in Ohio if the outpatient pharmacy is located in Ohio.

Answer 48

False, it can be done in any state as long as they abide by that state's laws

Question 49

What tasks are included in technician remote prescription entry?

Answer 49

Prescription entry, prescription clarification, processing insurance coverage, and other data entry

Question 50

What types of tech(s) can perform remote prescription entry?

Answer 50

Trainees, registered, and certified techs (and interns)

Question 51

Which medications are not included in the dispensing nicotine replacement therapy (NRT) laws?

Answer 51

Chantix and Zyban

Question 52

T/F: A pharmacist can dispense prescription nicotine replacement therapy products without a prescription (per the NRT law).

Answer 52

True (with a physician-signed protocol)

Question 53

If a NRT is dispensed w/o a prescription, the pharmacist must notify the pt's provider within what time frame?

Answer 53

72 hours

Question 54

Define drug of abuse

Answer 54

Any prescription drug

Question 55

Define controlled substance

Answer 55

Any schedule I, II, III, IV, or V product

Question 56

When can schedule I drugs be used?

Answer 56

They can only be used for reasearch

Question 57

Define poppy straw

Answer 57

All parts of the poppy plant, except the seeds

Question 58

What forms of a prescription are considered to be original prescriptions?

Answer 58

Written, oral, fax, or electronic

Question 59

What is a registry number?

Answer 59

DEA number

Question 60

Define opioid analgesic

Answer 60

A controlled substance that has analgesic pharmacologic activity at the opioid receptors of the CNS and includes drugs, their salt forms, and chemical congeners

Question 61

What are characteristics of CI drugs?

Answer 61

No medicinal use and cannot be prescribed, only used for research

Question 62

What are characteristics of CII drugs?

Answer 62

High potential for abuse and severe psychological or physical dependence

Question 63

What are characteristics of CIII drugs?

Answer 63

Moderate potential for abuse, high risk for psychological dependence, or mod-low risk for physical dependence

Question 64

What are characteristics of CIV drugs?

Answer 64

Lower potential for abuse and limited psychological/physical dependence

Question 65

Opioid scripts must be filled within __________ of the date written or do not fill date.

Answer 65

14 days (except refills of CIII-CV meds)

Question 66

What is the max days supply that can be dispensed for an opioid analgesic?

Answer 66

90 day supply (nothing is stopping a prescriber from writing for more than 90 days; it is up to the pharmacist to enforce this)

Question 67

T/F: Buprenorphine used for addiction, dependence, or antidiarrheal is not classified as an opioid analgesic.

Answer 67

True

Question 68

If an opioid CII is partial filled and the initial fill was within the 14 day limit, how long can the remainder be dispensed?

Answer 68

The remaining amount can be dispensed within 30 days of the date issued/written

Question 69

T/F: A pharmacist can change the issue date of a controlled prescription.

Answer 69

True, after consultation with and agreement of the prescriber

Question 70

When prescribing opioids for acute pain for adults, what is the maximum days supply that can be dispensed?

Answer 70

7 days

Question 71

When prescribing opioids for acute pain for minors (with parental/guardian consent), what is the maximum days supply that can be dispensed?

Answer 71

5 days

Question 72

For acute pain management with opioids, the total morphine equivalent dose cannot exceed what?

Answer 72

An average of 30 MED per day

Question 73

Limitations to opioid dose and days supply for acute pain management do not apply to which patient populations?

Answer 73

Opioids prescribed for cancer, palliative care, hospice/end-of-life care, medication assisted treatment for addiction, and any scripts written by vets

Question 74

Prescribers must indicate days supply on prescriptions for which medications?

Answer 74

Controlled substances and gabapentin

Question 75

New law states all CII scripts must be issued electronically except in what cases? Hint - 7 cases

Answer 75

1) Temporary technical, electrical, or broadband failure 2) Nursing home residents or hospice care pts 3) Prescriber is employed by/under contract with the same entity that operates the pharmacy 4) Prescriber feels an e-script cannot be issued in a timely manner or pt's condition is at risk 5) When an Rx is issued from a health care facility or ED and the prescriber determines it would be impractical or delay care that could impact the pt's condition 6) The law doesn't apply to prescribers that issue <50 CII scripts per year 7) The law doesn't apply to vets

Question 76

T/F: Under federal law, all Medicare Part D and Medicare Advantage Plans require all controlled substance prescriptions to be issued electronically.

Answer 76

True (as of 1/1/23)

Question 77

If a partial CII is dispensed due to the pharmacy being out of stock of the medication, when must the remainder be filled by?

Answer 77

72 hours

Question 78

What form is used to order CII medications?

Answer 78

DEA 222 form

Question 79

What are the 3 things a pharmacist cannot change or clarify on a CII script?

Answer 79

1) Patient's name 2) Prescriber's signature 3) Drug prescribed

Question 80

For a non-opioid CII medication, when must the first fill occur by?

Answer 80

Must be filled within 6 months of the date written (14 days only applies to opioids)

Question 81

If an emergency oral prescription for a CII is given, the pharmacist must receive the written prescription from the provider within __________.

Answer 81

7 days

Question 82

If a pharmacist does not receive a written script to go with an emergency oral script within the expected time frame, who must be notified?

Answer 82

The local DEA office

Question 83

A written prescription that is sent in after an emergency oral prescription must be marked with what statement?

Answer 83

"Authorization for Emergency Dispensing"

Question 84

If a wholesaler does not have a CII product in stock, how much time do they have to fill the order before a new form is needed?

Answer 84

60 days

Question 85

T/F: If a mistake is made filling out a DEA 222 form, the whole form must be voided.

Answer 85

True, you cannot erase and rewrite it

Question 86

If CII drugs are ordered electronically via the DEA's Controlled Substance Ordering System (CSOS), how long must the order records be maintained for?

Answer 86

2 years

Question 87

T/F: CII medications can be stored dispersed throughout the rest of the non-controlled pharmacy stock.

Answer 87

False, CII medications must be stored in a securely locked, substantially constructed cabinet or safe

Question 88

T/F: CIII-CV drugs can be stored with CII drugs

Answer 88

True

Question 89

T/F: CIII-CV medications can be stored dispersed throughout the rest of the non-controlled pharmacy stock.

Answer 89

True

Question 90

How many refills can be written for a CV substance?

Answer 90

1 year's worth of refills

Question 91

How many refills can be written for a CIII-CIV substance?

Answer 91

5 refills or 6 months worth of refills If partial fills are being used, the patient can receive more than 5 refills (up to the total number of tablets prescribed) as long as it is all dispensed within 6 months

Question 92

T/F: Long-term care nurses can fax or call-in oral CIII-CV prescriptions.

Answer 92

True

Question 93

T/F: A CV med cannot be dispensed OTC if written previously as a prescription within 6 months.

Answer 93

True

Question 94

How much of a CV can be dispensed OTC in a given time?

Answer 94

Only one preparation can be dispensed every 48 hours

Question 95

How old do you have to be to purchase a CV med OTC?

Answer 95

18+ years old

Question 96

What DEA form is used to register for a DEA license?

Answer 96

DEA form 224 (form 224a to re-register)

Question 97

What DEA form is used to get a license to manufacture controlled substances?

Answer 97

DEA form 225

Question 98

What DEA form is used in the disposal of controlled substances?

Answer 98

DEA form 41

Question 99

What DEA form is used in the theft or loss of controlled substances?

Answer 99

DEA form 106

Question 100

Per Ohio law, how often must an inventory of controlled substances be completed?

Answer 100

Annually (must be completed within 13 months of the previous inventory)

Question 101

Per federal law, how often must an inventory of controlled substances be completed?

Answer 101

Every 2 years

Question 102

When taking an inventory count of all controlled substances, which drugs can you estimate the count for (not required to physically count)?

Answer 102

CIII-CV drugs in package sizes less than or equal to 1000 count

Question 103

When taking an inventory count of all controlled substances, which drugs must be physically counted?

Answer 103

All CII drugs CIII-CV drugs in package sizes greater than 1000 count

Question 104

T/F: Records of controlled substances received, administered, dispensed, sold, or used can be kept electronically.

Answer 104

True, as long as the method is approved by the board

Question 105

When must an inventory count be performed for a specific drug?

Answer 105

If a non-controlled substance becomes a controlled substance OR a controlled substance moves to a higher schedule, the drug must be counted on the date it was changed

Question 106

T/F: Only licensed clinics can dispense methadone.

Answer 106

False - only licensed clinics can dispense methadone for drug abuse; anyone can dispense methadone for pain

Question 107

A pharmacist can partial dispense a CII script for up to 60 days in what 2 situations?

Answer 107

1) Terminally ill pt 2) Pt in a long-term care facility or nursing home This information must be written on the prescription Any tablets remaining on the script after 60 days are lost

Question 108

For pts not terminally ill or in a nursing home/LTC, a pharmacist can partial dispense a CII drug for up to how many days?

Answer 108

30 days from the date written

Question 109

Scripts for CII meds cannot be faxed in EXCEPT for what 3 circumstances?

Answer 109

1) Pt is a resident of a nursing home or long term care facility 2) Pt is a hospice pt (indicated on the script) and the script is for a narcotic 3) The script is for a compounded sterile product for a narcotic substance